Equipo - 01 - ClinitekAdvantusLIS

Clinitek AdvantusTM and Clinitek® 500 Analyzers

Interface Specification 04826807 Rev. A, 2008-05 04826807 Rev. A

© 2008 Siemens Medical Solutions Diagnostics. All rights reserved. No part of this manual or the products it describes may be reproduced by any means or in any form without prior consent in writing from Siemens Medical Solutions Diagnostics. Clinitek Advantus, Clinitek, Multistix, Multistix PRO, N-Multistix, Uro-Hema-Combistix, Uristix, Hema-Combistix, Labstix, N-Neostix, Uro-Uristix, Combistix and Clinitek Microalbumin are trademarks of Siemens Medical Solutions Diagnostics. Lantronix and XPort are trademarks of Lantronix. Origin: Ireland (Clinitek 500), UK (Clinitek Advantus) The information in this manual was correct at the time of printing. However, Siemens Medical Solutions Diagnostics continues to improve products and reserves the right to change specifications, equipment, and maintenance procedures at any time without notice. If the system is used in a manner differently than specified by Siemens Medical Solutions Diagnostics, the protection provided by the equipment may be impaired. See warning and hazard statements. Clinitek Advantus and Clinitek 500 Interface Specification 1 04826807 Rev. A

Contents Using this Manual How this Manual is Organized . . . . . . . . . . . . . . . . . . . . . 0-1 Conventions Used in this Manual . . . . . . . . . . . . . . . . . . 0-2 1General Specifications Serial Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1 Clinitek 500 Serial Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1 Clinitek Advantus Serial Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2 Clinitek Advantus Ethernet Port . . . . . . . . . . . . . . . . . . . . . . . . .1-3

2Data Flow Transmission Specifications . . . . . . . . . . . . . . . . . . . . . . 2-1 Character Structure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1 Electrical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1 Interface Connections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2 Signal Levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2 Speed. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2 Data Link Layer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2 Data Characters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2 Data Transfer Phases. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3 Establishment Phase (Link Connection) . . . . . . . . . . . . . . . . . . . . . .2-4 Transfer Phase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4 Termination Phase (Link Release) . . . . . . . . . . . . . . . . . . . . . . . . . .2-7 Error Handling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7 Timeouts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8 Establishment Phase Timeouts. . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8 Transfer Phase Timeouts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8 Message Structure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8 Supported Record Types. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9 Communication Sessions. . . . . . . . . . . . . . . . . . . . . . . . 2-10 Request for Identification Communication Session . . . . . . . . .2-10 Standard ASTM Identification Request Session . . . . . . . . . . . . . . .2-10 Single Character Identification Request Session. . . . . . . . . . . . . . .2-12 Order Communication Session. . . . . . . . . . . . . . . . . . . . . . . . .2-14

Order Communication Session . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14 Order Data Exchange . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15 Results Reporting Communication Session. . . . . . . . . . . . . . .2-17 04826807 Rev. A 2 Clinitek Advantus Interface Specification Results Communication Session . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17 Results Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18 Results Data Exchange . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-20

3Formatting Test Records Record Structure and Content . . . . . . . . . . . . . . . . . . . . .3-1 Restricted Characters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1 Message Header Record Format. . . . . . . . . . . . . . . . . . . . . . . .3-4 Example of a Message Header Record . . . . . . . . . . . . . . . . . . . . . . 3-6 Language/Result Unit Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6 Message Terminator Record Format . . . . . . . . . . . . . . . . . . . . .3-7 Examples of a Message Terminator Record . . . . . . . . . . . . . . . . . . 3-8 Request Information Record Format . . . . . . . . . . . . . . . . . . . . .3-8 Example of a Request Information Record. . . . . . . . . . . . . . . . . . . . 3-8 Order Record Format. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-9 Examples of Order Record. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9 Patient Record Format. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10 Patient Record – Test Sequence Format. . . . . . . . . . . . . . . . . . . . 3-10 Example of the Patient Record – Test Sequence. . . . . . . . . . . . . . 3-10 Patient Record – Results Format . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11 Example of the Patient Record – Results Record . . . . . . . . . . . . . 3-11 Test Strip ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12 Error Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13 Result Record for Clinical Results Format . . . . . . . . . . . . . . . .3-14 Examples of Results Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16 Test Strip Assays and Abbreviations . . . . . . . . . . . . . . . . . . . . . . . 3-16

Appendix A: Safety Instructions Protecting Yourself from Biohazards. . . . . . . . . . . . . . . .A-1 References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-2

Appendix B: Service, Ordering, and Warranty Siemens Authorized Representative . . . . . . . . . . . . . . . .B-1 Limited Instrument Warranty and Service Delivery Policy. .B-1 Warranty Period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-1 Additional Service Period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-2 Service During Normal Hours. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-2 Extent of a Service Call . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-2 Service Outside Normal Hours. . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-2 Clinitek Advantus and Clinitek 500 Interface Specification 3 04826807 Rev. A

Replacement of Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2 Design Changes and Retrofitting of Instruments. . . . . . . . . . . . . . . B-3 Key Operator Designation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3 OSHA Requirements (US only). . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3 Warranty and Service Exclusions . . . . . . . . . . . . . . . . . . . . . . . . . . B-3 Information for Technical Assistance . . . . . . . . . . . . . . . B-5 Locating the System Serial Number and Versions. . . . . . . . . . .B-5 Addresses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-5

Appendix C: Result Unit Tables English and Chinese Conventional Units. . . . . . . . . . . . . . . . . . . . . C-1 English and Chinese S.I. Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-5 English Nordic Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-9 French Conventional Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-13 French S. I. Units. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-17

German Conventional Units. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-21 German S. I. Units. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-25 Italian Conventional Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-29 Italian S.I. Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-33 Japanese Conventional Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-37 Japanese JCCLS Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-41 Portuguese Conventional Units. . . . . . . . . . . . . . . . . . . . . . . . . . . C-45 Portuguese S.I. Units. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-49 Spanish Conventional Units. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-53 Spanish S.I. Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-57 Swedish Conventional Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-61 Swedish S.I. Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-65 Swedish Nordic Units. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-69

Appendix D: Clinitek 200/200+ Emulation Mode Data Transfer Characteristics. . . . . . . . . . . . . . . . . . . . . . . . . . .D-1 Output Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-1 Output Data Types. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-2 Global Formatting for all Data Sets Output to Serial Port . . . . . . . . D-3 Calculation of Checksum. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-3 Instrument ID Message (Serial Output Only) . . . . . . . . . . . . . . .D-5 Variable Field Definitions for Test Result Output . . . . . . . . . . . .D-7 CLINICAL Results Format Output . . . . . . . . . . . . . . . . . . . . . . .D-8 Global Formatting Requirements for all CLINICAL Mode Results. . D-8 Multistix“ Family of Test Strips. . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-9 Multistix PRO Family of Test Strips. . . . . . . . . . . . . . . . . . . . . . . . D-10 04826807 Rev. A 4 Clinitek Advantus Interface Specification

Result Value Conversions from Clinitek Advantus and Clinitek 500 to Clinitek 200 . . . . . . . . . . . . . . . . . . . .D-12 Result Value Conversions from Clinitek Advantus and Clinitek 500 to Clinitek 200+ . . . . . . . . . . . . . . . . . . .D-34 Appendix E: Glossary 04826807 Rev. A

Using this Manual The Clinitek AdvantusTM and Clinitek® 500 Interface Specification is written primarily for software developers who are familiar with implementing layered communications protocols. This manual provides the interface specifications for connecting the Clinitek Advantus and Clinitek 500 analyzers to your host computer or laboratory information system (LIS). The manual provides information on the data string and formatting of clinical results generated using the appropriate Clinitek reagent strips.

How this Manual is Organized The following table provides an overview of the manual and explains the contents of each section: If you want to . . . Refer to . . . review the specifications for the interface connections, Section 1, General Specifications understand how the data is transmitted between the analyzer and the computer or LIS, Section 2, Data Flow learn about the test result formats and how to set them up on your computer or LIS, Section 3, Formatting Test Records review biohazard guidelines, Appendix A, Safety Instructions contact

Siemens Medical Solutions Diagnostics Appendix B, Service, Ordering, and Warranty view result unit tables for all supported languages, Appendix C, Result Unit Tables learn about the Clinitek 200/200+ emulation mode and how to set it up on your computer or LIS, Appendix D, Clinitek 200/200+ Emulation Mode find a definition for an unfamiliar term, Appendix E, Glossary 2 Clinitek Advantus and Clinitek 500 Interface Specification: Using this Manual 04826807 Rev. A

Conventions Used in this Manual The Clinitek Advantus and Clinitek 500 Interface Specification uses the following text and symbol conventions: Convention Description Bold Bold type indicates the following: • text on the user interface. For example, if the word save appears as Save, it refers to the Save button on the user interface. • a key on the keyboard or a system key on the front of the system. For example, when the word enter appears as Enter, it refers to the Enter key on the keyboard. • the actual text of a message transmitted between the system and an LIS. the actual value stored in the database. Italic Italic type refers to the title of a document or a section title in this manual. For example, Overview of Layered Communications Protocols refers to Section 2 of this manual. CAUTION Caution statements alert you to conditions that may cause product damage or loss of data. On the system, this symbol indicates that you should refer to the manuals for more information. NOTE: Note statements alert you to important information that requires your attention. 04826807 Rev. A

1 General Specifications The Clinitek Advantus and Clinitek 500 Urine Chemistry Analyzers can transmit data to a computer or Laboratory Information System (LIS). The Clinitek Advantus analyzer can use either a serial interface or an ethernet port.

Serial Interface The following information details the serial interface for each analyzer: •Clinitek 500 serial port •Clinitek Advantus serial port •Clinitek Advantus ethernet port Clinitek® 500 Serial Port The serial port on the Clinitek Advantus analyzer is a 25 pin D-Connector. This port allows serial connectivity to an external computer or host. Settings for the Clinitek 500 serial port are described in the following tables: Table 1-1 Clinitek 500 Serial Interface Port Specifications Specification Description Voltage At receiver end (RD) ≥ +3 V is logic 0 (Space) ≥ −3 V is logic 1 (Mark)

At transmitter end (TD) ≥ +5 V is logic 0 (Space) ≥ −5 V is logic 1 (Mark) EIA-232-D 1986 Standard Cable length maximum 15.2 m (50 ft) Cable type null modem serial cable Pins 2 and 3 are crossed, pins 4 and 5 are crossed, pins 6 and 20 are crossed, and pins 1, and 7 are straight through. Data bit 8 bit with No Parity 7 bit with No Parity 7 bit with Even Parity 7 bit with Odd Parity The default is 8 bit characters. Handshake ON/OFF (for CT200/200+ emulation only) Checksum ON/OFF (for CT200/200+ emulation only) Baud rates 1200, 2400, 4800, 9600, 19200 The default is 9600 Parity NONE, EVEN, ODD The default is NONE. Stop Bit 1 (Binary 1) 1–2 Clinitek Advantus and Clinitek 500 Interface Specification: General Specifications 04826807 Rev. A Table 1-2 Clinitek 500 Serial Port Connector RS232 25 Pin (DB25) Clinitek AdvantusTM Serial Port The serial port on the Clinitek Advantus analyzer is a 9 pin male D-Connector. This port allows serial connectivity to an external computer or host. The settings for the serial port are independent of those for the ethernet port. Settings for the Clinitek Advantus serial port are described in the following tables: Table 1-3 Clinitek Advantus Serial Interface Port Specifications Pin Signal 1 Chassis ground 2 TXD 3 RXD 4 RTS 5 CTS 6 DSR 7 Signal ground 20 DTR Specification Description Voltage At receiver end (RD) ≥ +3 V is logic 0 (Space) ≥ −3 V is logic 1 (Mark) At transmitter end (TD) ≥ +5 V is logic 0 (Space) ≥ −5 V is logic 1 (Mark) EIA-232-D 1986 Standard Cable length maximum 15.2 m (50 ft) Cable type 9-pin null modem serial cable Pins 2 and 3 are crossed, pins 4 and 6 are crossed, pins 7 and 8 are crossed, and pins 1, 5, and 9 are straight through. Start bit 1 (Binary 0) Data bit 8 bit with No Parity 7 bit with No Parity 7 bit with Even Parity 7 bit with Odd Parity The default is 8 bit characters. Handshake ON/OFF (for CT200/200+ emulation only) Checksum ON/OFF (for CT200/200+ emulation only) Baud rates 1200, 2400, 4800, 9600, 19200 The default is 9600 Parity NONE, EVEN, ODD

The default is NONE. Stop Bit 1 (Binary 1) Clinitek Advantus and Clinitek 500 Interface Specification: General Specifications 1–3 04826807 Rev. A Table 1-4 Serial Port Connector RS232 9 Pin (DB9)

Clinitek Advantus Ethernet Port The Clinitek Advantus analyzer has the ability to connect to a hospital LIS through an ethernet port located at the rear of the instrument. This port offers a 10/100 base T connection using TCP/IP protocols. This connector is a Lantronix XPort 10/100mB Ethernet to RS232 port converter. Settings are independent of those for the RS232 serial port. The cabling required for the ethernet connector is as follows: Table 1-5 Cabling Requirements Table 1-6 Clinitek Advantus Ethernet Port Connector Twisted Pair, RJ45 Pin Signal 1 CD 2 RX 3 TX 4 DTR 5 Ground 6 DSR 7 RTS 8 CTS 9 RI (not used) Connection Requirement Instrument connecting to the network Standard straight through CAT5 Instrument connecting to the PC Standard crossover CAT5 Pin Signal 1 TD+ (or tpe 0) 2 TD- (or tpe 1) 3 RD+ (or tpe 2) 4 Common Mode Termination 5 Common Mode Termination 6 RD- (or tpe 3) 7 Common Mode Termination 8 Common Mode Termination 1–4 Clinitek Advantus and Clinitek 500 Interface Specification: General Specifications 04826807 Rev. A

Port number: 10001 MAC address, 00-20-4A-XX-XX-XX, the first, second and third bytes are fixed (00-20-4A) identifying the unit as a Lantronix product. The fourth, fifth and sixth bytes are unique numbers assigned to each unit. At the Setup menu, under network settings, you can enter either a static IP address or a DHCP name. The analyzer blocks the following IP addresses as Invalid: •0.0.0.0 •255.255.255.255 •127.X.X.X. The Internet Protocol and RFC-3300 assigned the following IP addresses as special use and you should avoid using them: •0.0.0.0/8 – This network broadcast address •169.254.0.0/16 – Used by the DHCP protocol •192.0.2.0/24 – Used for network testing •192.88.99.0/24 – Used by IPv4 to IPv6 relay hosts •192.18.0.0/15 – Used for host-to-host benchmarking •224.0.0.0/4 – Used for multicasting •240.0.0.0/4 – Reserved for use by IANA

In addition, avoid any address in which all bits outside the subnet mask are “1.” For example, if the subnet mask is 255.255.255.0, and address of the form X.X.X.255. The RFC 950 defines these as broadcast addresses that refer to every host on a local network so they should not be assigned to an individual host. Two bi-colored LEDs (light emitting diodes) are built into the port allowing the user to monitor the port status. Table 1-7 Port Status Link LED – Left side Activity LED – Right side This condition Means This condition Means Off No link Off No activity Amber 10Mbps Amber Half-duplex Green 100Mpbs Green Full-duplex 04826807 Rev. A

2 Data Flow The section contains the conventions used for the data exchanged between a host computer or LIS and the Clinitek Advantus and Clinitek 500 analyzers. NOTE:Some analyzer versions show Bayer in the record content. This a vestige of programming and does not imply any connection or relationship between Bayer and Siemens.

Transmission Specifications Transmission specifications include: •Character structure •Electrical characteristics •Interface connections •Signal levels •Speed

Character Structure The method of data transmission is serial-by-bit start/stop. The order of the bits in a character is: 1. One start bit, corresponding to a binary 0. 2. The data bits of the character, least significant bit being transmitted first. 3. Parity bit. 4. Stop bit(s), corresponding to a binary 1. The time between the stop bit of one character and the start bit of the next character may be of any duration. The data interchange circuit is in the marking condition between characters. The default character structure consists of one start bit, eight data bits, no parity bit, and one stop bit. Other character structures are supported, such as seven data bits and odd parity or seven data bits and even parity. The character bit sequencing, structure, and parity sense definitions conform to ANSI standards X3.15-1976 and X3.16-1976.

Electrical Characteristics The voltage and impedance levels for the generator and receiver circuits conform to the EIA-232-D-1986 standard. 2–2 Clinitek Advantus and Clinitek 500 Interface Specification: Data Flow 04826807 Rev. A

Interface Connections The Clinitek Advantus and Clinitek 500 support the connector requirements of ANSI standard E1381-91.

Signal Levels For the data interchange circuits, a marking condition corresponds to a voltage more negative than minus three volts with respect to signal ground at the interface point. A spacing condition corresponds to a voltage more positive than plus three volts with respect to signal ground at the interface point. Binary state ONE (1) corresponds to the marking condition; binary state ZERO (0) corresponds to the spacing condition. The signal levels conform to the EIA-232-D-1986 standard.

Speed The default data transmission rate is 9600 baud. The data transmission rates supported are 2400, 4800, 9600, and 19200.

Data Link Layer The data link layer contains the procedures for link connection and release, delimiting and synchronism, sequential control, error detection, and error recovery. The Clinitek Advantus and Clinitek 500 use a simple data link protocol. The data link protocol is designed for sending character based message text. Restrictions are placed on which characters may appear in the message text. The restrictions make it simpler for senders and receivers to recognize replies and frame delimiters. Additional characters are restricted to avoid interfering with software controls for devices such as multiplexers.

Data Characters The control characters that the computer sends to the analyzer to manage the data flow are shown in Table 2-1. NOTE:Depending on the analyzer configuration, the computer uses either the <ENQ> or the <BEL> character to initiate the request for identification. Clinitek Advantus and Clinitek 500 Interface Specification: Data Flow 2–3 04826807 Rev. A Table 2-1 Data Flow Control Characters The characters that the analyzer and computer use to communicate data sets are shown in Table 2-2. Table 2-2 Data Set Control Characters

Data Transfer Phases The data link mode of operation is a one-way transfer of information with alternative supervision. Information flows in one direction at a time. Replies occur after information is sent, never at the same time. It is a simplex stop-and-wait protocol. At times both systems are actively operating to transfer information - one side sending and the other side receiving. The remainder of the time the data link is in a neutral state waiting for one of the sides to request control. There are three distinct phases in transferring information between the Clinitek analyzer and a laboratory computer system: •Establishment Phase (Link Connection) •Data Transfer Phase •Termination Phase (Link Release) In each phase, one side directs the operation and is responsible for continuity of communication. The three distinct phases assure the actions of sender and receive are coordinated. Control Code Control Function <ENQ> ASTM request for identification message <BEL> single character request for identification message <ACK> Receiving system, either computer or analyzer acknowledges the receipt of the message. <NAK> Computer did not receive the data correctly, analyzer not to address the next data set. Control Code Control Function <STX> Start of text character <CR> Carriage return character <LF> Line feed character <EOT> End of text character 2–4 Clinitek Advantus and Clinitek 500 Interface Specification: Data Flow 04826807 Rev. A

Establishment Phase (Link Connection) The establishment phase determines the direction of information flow and prepares the receiver to accept information. The system with information available initiates the establishment phase. After the sender determines the data link is in a neutral state, it transmits the <ENQ> transmission control character to the intended receiver.

Upon receiving the <ENQ>, the receiver must respond to the sender before the sender can begin sending information. If the receiver is able to receive information, it responds with an <ACK> transmission control character signifying that it is ready. With this sequence of events, the establishment phase ends and the transfer phase begins. If the receiver cannot immediately receive information from the sender, the receiver replies with a <NAK> transmission control character. Upon receiving <NAK>, the sender must wait at least 10 seconds before again attempting to establish a communication link by transmitting another <ENQ>. If both systems simultaneously attempt to start a communication session by transmitting an <ENQ>, the data link is considered to be in contention. The Clinitek analyzer has priority to transmit information when contention occurs. The contention to start a communication session is resolved as follows: Upon receiving a reply of <ENQ> to its transmitted <ENQ>, the computer system must stop trying to transmit; it must prepare to receive. The computer sets a timer. If an <ENQ> is not received from the Clinitek analyzer within 20 seconds, a time-out occurs. After a time-out, the receiver regards the line to be in the neutral state and may again attempt to acquire the line by sending an <ENQ> to the Clinitek analyzer. If, however, the computer receives an <ENQ> from the Clinitek analyzer within the 20-second period, it must reply with an <ACK> or <NAK> depending on its readiness to receive information. Upon receiving a reply of <ENQ> to its transmitted <ENQ>, the Clinitek analyzer must wait at least 1 second before sending another <ENQ>. Transfer Phase During the transfer phase, the sender transmits messages to the receiver. The transfer phase continues until all the messages have been sent. Frames Each message is sent in a series of frames. A frame is a pre-defined subdivision of a message used to provide for periodic communication housekeeping such as error checks and acknowledgments. Each frame contains a maximum of 247 characters (including frame overhead). Messages longer than 240 characters are divided between two or more frames. Both the sender and receiver must be able to buffer one complete frame (247 characters). Clinitek Advantus and Clinitek 500 Interface Specification: Data Flow 2–5 04826807 Rev. A

Multiple messages are never combined in a single frame. Every message must begin in a new frame. Records are never split across frames. A frame is one of two types, an intermediate frame or an end frame. Intermediate frames terminate with the characters <ETB>, checksum, <CR> and <LF>. End frames terminate with the characters <ETX>, checksum, <CR> and <LF>. Messages less than 240 characters may be sent in one end frame. Longer messages are sent in intermediate frames with the last part of the message sent in an end frame. The frame structure is as follows: <STX> FN text <ETB> C1 C2 <CR> <LF> <-- intermediate frame . . <STX> FN text <ETX> C1 C2 <CR> <LF> <-- end frame where: Frame Number The frame number allows the receiver to distinguish between new and retransmitted frames. It is a single digit sent immediately after the <STX> character. The frame number is an ASCII digit ranging from 0 to 7. The frame number begins at 1 with the first frame of the Transfer phase. The frame number is incremented by one for every new frame transmitted. After 7, the frame number rolls over to 0, and continues in this fashion. <STX> Start of Text transmission control character FN single digit Frame Number 0 to 7 text Data Content of Message <ETB> End of Transmission Block transmission control character

<ETX> End of Text transmission control character C1 most significant character of checksum 0 to 9 and A to F C2 least significant character of checksum 0 to 9 and A to F <CR> Carriage Return ASCII character <LF> Line Feed ASCII character 2–6 Clinitek Advantus and Clinitek 500 Interface Specification: Data Flow 04826807 Rev. A Checksum The checksum permits the receiver to detect a defective frame. The checksum is encoded as two characters which are sent after the <ETB> or <ETX> character. The checksum is computed by adding the binary values of the characters, keeping the least significant eight bits of the sum. The checksum is initialized to zero with the <STX> character. The first character used in computing the checksum is the frame number. Each character in the message text is added to the checksum (modulo 256). The computation for the checksum does not include <STX>, the checksum characters, or the trailing <CR> and <LF>. The checksum is an integer represented by eight bits, it can be considered as two groups of four bits. The groups of four bits are converted to the ASCII characters of the hexadecimal representation. The two ASCII characters are transmitted as the checksum, with the most significant character first. For example, a checksum of 122 can be represented as 01111010 in binary or 7A in hexadecimal. The checksum is transmitted as the ASCII character 7 followed by the character A. Acknowledgments The sender sends one frame at a time. After a frame is sent, the sender stops transmitting until a reply is received. When the sender has transmitted the last character of a frame, it sets a timer. The receiver must reply to each frame sent within 15 seconds. If the sender has not received an <ACK>, a <NAK>, or an <EOT> in response to the frame sent within the 15-second time period, the sender enters the termination phase of the communication session by sending an <EOT>. A reply of <ACK> from the receiver signifies the frame was received successfully and the receiver is prepared to receive another frame. The sender then increments the frame number and sends the next frame or terminates the communication session. A reply of <NAK> from the receiver signifies the frame was not successfully received and the receiver is prepared to receive the frame again. Upon receiving a <NAK> in response to a frame, the sender increments a retransmit counter and retransmits the frame. If this counter shows a single frame was sent and not accepted six times, the sender stops attempting to send the frame and proceeds to the termination phase of the communication session by sending an <EOT>. A reply of <EOT> from the receiver tells the sender the frame was received successfully but does not want to continue the communication session. It is a request to the sender to stop transmitting. After receiving the receiver interrupt request, the sender sends the Message Terminator record and ends the communication session. Clinitek Advantus and Clinitek 500 Interface Specification: Data Flow 2–7 04826807 Rev. A

During the transfer phase, if the receiver responds to a frame with an <EOT> in place of the usual <ACK>, the sender interprets this reply as a receiver interrupt request. The <EOT> is a positive acknowledgment of the end frame and also a request to the sender to stop transmitting. The sender then enters the termination phase to return the data link to the neutral state. This gives the receiver an opportunity to enter the establishment phase and become the sender. The original sender must not enter the establishment phase for at least 15 seconds or until the receiver has sent a message and returned the data link to the neutral state. If the receiver requests the sender to stop transmitting results before all the result records have been sent and acknowledged for a patient, ALL the results for that patient must be retransmitted the next time results are sent. If the receiver requests the sender to stop transmitting results after the last result is sent for a patient, the next result transmission begins with the next patient record.

Termination Phase (Link Release) The termination phase returns the data link to the clear or neutral state. The sender notifies the receiver that all messages have been sent. The sender transmits the <EOT> transmission control character and then regards the data link to be in a neutral state. Upon receiving <EOT>, the receiver also regards the data link to be in the neutral state.

Error Handling A receiver checks every frame to guarantee it is valid. A reply of <NAK> is transmitted for invalid frames. Upon receiving the <NAK>, the sender must retransmit the last frame with the same frame number. Any characters occurring before the <STX> or after the end of the block character (the <ETB> or <ETX>) are ignored by the receiver when checking the frame. The receiver should reject a frame when: •A character error is detected (parity error, framing error, etc.) •The frame checksum sent does not match the checksum computed on the received frame •The frame number is not the same as the frame number for a previously rejected frame or the frame number is not one higher than the last accepted frame (modulo 8). Upon receiving a <NAK>, the sender increments a retransmit counter and retransmits the frame. If the retransmit counter shows a single frame was sent and not accepted six times, the sender must abort the message by proceeding to the termination phase. 2–8 Clinitek Advantus and Clinitek 500 Interface Specification: Data Flow 04826807 Rev. A

Timeouts Both sender and receiver use timers to detect loss of coordination between them. The timer provides a method for recovery if the communication line or the other device fails to respond. Establishment Phase Timeouts During the establishment phase, the sender sets a timer when transmitting the <ENQ>. If a reply of an<ACK>, <NAK>, or <ENQ> is not received within 15 seconds, a timeout occurs. After a timeout, the sender enters the termination phase. During the establishment phase, if the computer (as receiver) detects contention, it sets a timer. If an <ENQ> is not received within 20 seconds, a timeout occurs. After a timeout, the receiver regards the line to be in the neutral state. Transfer Phase Timeouts During the transfer phase, the sender sets a timer when transmitting the last character of a frame. If a reply is not received within 15 seconds, a timeout occurs. After a timeout, the sender aborts the message transfer by proceeding to the termination phase. As with excessive transmission of defective frames, the message must be retained so that it can be completely retransmitted. During the transfer phase, the receiver sets a timer when first entering the transfer phase or when replying to a frame. If a frame or <EOT> is not received within 30 seconds, a timeout occurs. After a timeout, the receiver discards the last incomplete message and regards the line to be in the neutral state. A receiver must reply to a frame within 15 seconds or the sender will abort the message and a time out occurs.

Message Structure This section describes the supported message types, the structure of those message types and their supporting records. Each message consists of a hierarchy of records of various types. The following rules apply when the analyzers are processing a message: •The laboratory computer system may ignore any field it does not require. •All fields in a record are always transferred. •The fields are always transferred in the positional order specified •All fields in records are variable length fields. Clinitek Advantus and Clinitek 500 Interface Specification: Data Flow 2–9 04826807 Rev. A

Supported Record Types

Both the Clinitek Advantus and Clinitek 500 analyzers support similar record types with the Clinitek Advantus supporting one additional record type. Table 2-3 describes the supported record types. Table 2-3 Supported Record Types Record Type Description Message Header Record marks the beginning of a message It is always the first record sent in a message. Request for Identification Record initiated by the laboratory computer Two different types of sessions are supported: a standard ASTM messaging session and a simple, single character message session. Patient Record contains information about a sample that applies to every Result record for that sample Result Record contains the result of a single test determination. Because Clinitek urine chemistry test strips contain multiple chemistry tests, the analyzer reports one result record for each result. Message Terminator Record signals the end of the record If transmission terminates prior to the Message Terminator record being received and acknowledged, the entire message must be retransmitted in a new session. That is, the patient records and all result records for that patient must be retransmitted. Order Record (Only the Clinitek Advantus analyzer supports this record.) sent by the computer system to the analyzer The order record provides the Clinitek Advantus analyzer with a list of sample IDs for which tests to perform. The functionality of the record only allows the remote computer to send a list of Sample IDs. It cannot send any additional information. 2–10 Clinitek Advantus and Clinitek 500 Interface Specification: Data Flow 04826807 Rev. A

Communication Sessions The Clinitek Advantus and Clinitek 500 analyzers support the following types of communication sessions: •Request for Identification session •Order Communication Session (Clinitek Advantus analyzer only) •Results Reporting session

Request for Identification Communication Session The computer or LIS initiates the Request for Identification communication session. Two different types of sessions are supported: •standard ASTM messaging session •single character message session Standard ASTM Identification Request Session The standard ASTM identification request session uses two types of messages: •request information message sent by the computer or LIS •identification message response sent by the analyzer ASTM Request Information Message The computer or LIS sends the request information message using the following logical structure: •message header record •request information record

The computer or LIS must send the request information record to the analyzer in a separate field from the message header record. NOTE:The computer or LIS does not send a message terminator record after the request information record. The analyzer sends the message terminator after replying to the request information query. ASTM Identification Message Response The analyzer sends the identification message response using the following logical structure: •message header record •message terminator record If transmission is terminated before the computer receives and acknowledges the message terminator record, you must resend the entire message in a new session. Clinitek Advantus and Clinitek 500 Interface Specification: Data Flow 2–11 04826807 Rev. A ASTM Communication Session The ASTM communication session follows the pattern displayed in this table: Table 2-4 Clinitek Advantus and Clinitek 500 ASTM Communication Analyzer Dir. Computer or LIS � Send <ENQ> to acquire the line <ACK> � � Send Header field <ACK> � � Send Request for Identification <ACK> � Send Identification (Header) � � <ACK> Send Message termination � � <ACK> � Send <EOT> to release the line 2–12 Clinitek Advantus and Clinitek 500 Interface Specification: Data Flow 04826807 Rev. A ASTM Data Exchange An example of actual data exchanged for the standard ASTM identification request session appears as shown in the following table: Table 2-5 ASTM Data Exchange NOTE:On the Clinitek Advantus, the manufacturer is Siemens Medical Solutions Diagnostics, the product ID is 1420, and the analyzer serial number is after the product ID in the analyzer transmission. Single Character Identification Request Session The single character identification request session uses two types of messages: •<BEL> character request message sent by the computer or LIS •identification message response sent by the analyzer. Single Character Request Message The computer or LIS sends the request information message using the <BEL> character. NOTE:The computer or LIS does not send a message terminator record after the request information record. The analyzer sends the message terminator after replying to the request information query. Row Analyzer Computer or LIS 1. 2. <ENQ> 3. <ACK> 4. <STX>1 H|\^&|||Laboratory Computer System Name|||||| |P|1|19970526101230<CR> <ETX>C1 C2<CR><LF> 5. <ACK> 6. <STX>2 Q|1<CR> <ETX>C1 C2<CR><LF> 7. <ACK>

8. <STX>1 H|\^&|||BAYER^6740^^01.00/ 01.00||||||010|P|1|1997052610130 0<ETX>C1 C2<CR><LF> 9. <ACK> 10. <STX>2 L|1|N<CR> <ETX>C1 C2<CR><LF> 11. <ACK> 12. <EOT> Clinitek Advantus and Clinitek 500 Interface Specification: Data Flow 2–13 04826807 Rev. A Single Character Identification Message Response The analyzer sends the identification message response using the following logical structure: •message header record •message terminator record If transmission is terminated before the computer receives and acknowledges the message terminator record, you must resend the entire message in a new session. Single Character Communication Session The single character communication session follows the pattern displayed in this table: Table 2-6 Single Character Communication Session Single Character Data Exchange An example of actual data exchanged for the single character identification request session appears as shown in the following table: Table 2-7 Single Character Data Exchange NOTE:On the Clinitek Advantus, the manufacturer is Siemens Medical Solutions Diagnostics, the product ID is 1420, and the analyzer serial number is after the product ID in the analyzer transmission. Analyzer Dir. Computer or LIS � Send <BEL> character Send identification (Header) � � <ACK> Send message termination � � <ACK> � Send EOT to release the line Row Analyzer Computer or LIS 1. 2. <BEL> 3. <ACK> 4. <STX>1 H|\^&|||BAYER^6740^^01.00/ 01.00||||||010|P|1|1997052610130 0<ETB>C1 C2<CR><LF> 5. <ACK> 6. <STX>2 L|1|N<CR> <ETX>C1 C2<CR><LF> 7. <ACK> 8. <EOT> 2–14 Clinitek Advantus and Clinitek 500 Interface Specification: Data Flow 04826807 Rev. A

Order Communication Session NOTE:Only the Clinitek Advantus analyzer supports the Test Order record. The Order communication session is initiated by the computer or LIS. The Order Communication session sends worklist information to the analyzer. The computer or LIS sends the order information message using the following logical structure: •Message Header • Order Record 1 • Order Record 2 • Order Record n

•Message Terminator If transmission is terminated before the computer receives and acknowledges the message terminator record, you must resend the entire message in a new session. Order Communication Session The order communication session follows the pattern displayed in this table: Table 2-8 Order Communication Session Clinitek Advantus Analyzer Flow Computer or LIS � Send <ENQ> to acquire the line <ACK> � � Send Header record <ACK> � � Send first Order record <ACK> � � Send second Order record <ACK> � � Send nth Order record <ACK> � � Send Message Termination record <ACK> � � Send <EOT> to release the line Clinitek Advantus and Clinitek 500 Interface Specification: Data Flow 2–15 04826807 Rev. A

Order Data Exchange An example of actual data exchanged for the order session appears as shown in the following table: Table 2-9 Order Data Exchange Row Analyzer Computer or LIS 1. <ENQ> 2. <ACK> 3. <STX>1 H|\^&|||Laboratory Computer System Name|||||| |P|1|20051007132700<CR> <ETX>C1 C2<CR><LF> 4. <ACK> 5. <STX>2 O|1|1234567890123<CR> O|2|1234567890123<CR> O|3|1234567890124<CR> O|4|1234567890125<CR> O|5|1234567890126<CR> O|6|1234567890127<CR> O|7|1234567890128<CR> O|8|1234567890129<CR> O|9|1234567890130<CR> O|10|1234567890131<CR> O|11|1234567890132<CR> O|12|1234567890133<CR> O|13|1234567890134<CR> <ETB>C1 C2<CR><LF> 6. <ACK> 7. <STX>3 O|14|1234567890135<CR> O|15|1234567890136<CR> O|16|1234567890137<CR> O|17|1234567890138<CR> O|18|1234567890139<CR> O|19|1234567890140<CR> O|20|1234567890141<CR> O|21|1234567890142<CR> O|22|1234567890143<CR> O|23|1234567890144<CR> O|24|1234567890145<CR> O|25|1234567890146<CR>

<ETB>C1 C2<CR><LF> 8. <ACK> Table continues on the next page. 2–16 Clinitek Advantus and Clinitek 500 Interface Specification: Data Flow 04826807 Rev. A

9. <STX>4 O|26|1234567890147<CR> O|27|1234567890148<CR> O|28|1234567890149<CR> O|29|1234567890150<CR> O|30|1234567890151<CR> O|31|1234567890152<CR> O|32|1234567890153<CR> O|33|1234567890154<CR> O|34|1234567890155<CR> O|35|1234567890156<CR> O|36|1234567890157<CR> O|37|1234567890158<CR> <ETB>C1 C2<CR><LF> 10. <ACK> 11. <STX>5 O|38|1234567890159<CR> O|39|1234567890160<CR> O|40|1234567890161<CR> O|41|1234567890162<CR> O|42|1234567890163<CR> O|43|1234567890164<CR> O|44|1234567890165<CR> O|45|1234567890166<CR> O|46|1234567890167<CR> O|47|1234567890168<CR> O|48|1234567890169<CR> O|49|1234567890170<CR> <ETB>C1 C2<CR><LF> 12. <ACK> 13. <STX>6 O|50|1234567890171<CR> <ETX>C1 C2<CR><LF> 14. <ACK> 15. <EOT> Row Analyzer Computer or LIS Clinitek Advantus and Clinitek 500 Interface Specification: Data Flow 2–17 04826807 Rev. A

Results Reporting Communication Session The Results Reporting communication session is initiated by the analyzer. When the analyzer has a test result to transmit, it notifies the computer or LIS. When the computer or LIS acknowledges the analyzer, the analyzer transmits the test results. The analyzer transmits the results message using the following logical structure: •Header • Patient 1 Result 1 Result 2 ... Result n •Message Terminator •Header • Patient 2 Result 1 Result 2 ... Result n

•Message Terminator If transmission is terminated before the computer receives and acknowledges the message terminator record, you must resend the patient records and all result records for that patient. Results Communication Session The results communication session follows the pattern displayed in this table: Table 2-10 Order Communication Session Analyzer Flow Computer or LIS Send <ENQ> to acquire the line � � <ACK> Send Header frame � � <ACK> Send first Patient frame � � <ACK> Send first Result frame � � <ACK> Send any additional Result frames � � <ACK> Table continues on the next page. 2–18 Clinitek Advantus and Clinitek 500 Interface Specification: Data Flow 04826807 Rev. A

The Order Communication session treats each patient record as an independent communication session. The analyzer transmits an <ENQ> to acquire the line to transmit the next patient record for each patient record that is available for transmission. Results Data To illustrate the transfer of data from the Clinitek Advantus and Clinitek 500 analyzers to a computer or LIS, the following illustration displays actual results data assuming these parameters: •urine chemistry test type is MULTISTIX 10 SG •color is reported •clarity is not reported •all chemistry tests on the strip are reported. •three tests are run Send Message Termination record � � <ACK> Send next <ENQ> to initiate next patient or Send <EOT> to release the line � Analyzer Flow Computer or LIS Clinitek Advantus and Clinitek 500 Interface Specification: Data Flow 2–19 04826807 Rev. A 00001 05-26-07 10:25 AM Tech ID: 323 ID: 312445446 COL YELLOW * GLU 250 mg/dL BIL NEGATIVE ! KET NEGATIVE SG <=1.005 * BLO SMALL pH 6.0 PRO NEGATIVE URO 1.0 E.U./dL NIT NEGATIVE * LEU TRACE 00002 05-26-07 10:25 AM Tech ID: 323 ID: 213543331

COL YELLOW GLU NEGATIVE BIL NEGATIVE KET NEGATIVE SG <=1.005 BLO NEGATIVE pH 5.5 PRO NEGATIVE URO 0.2 E.U./dL NIT NEGATIVE LEU NEGATIVE 00003 05-26-97 10:25 AM Tech ID: 323 ID: 398576435 * COL RED GLU NEGATIVE BIL NEGATIVE KET NEGATIVE SG <=1.005 * BLO MODERATE pH 6.0 PRO NEGATIVE URO 1.0 E.U./dL NIT NEGATIVE * LEU LARGE 2–20 Clinitek Advantus and Clinitek 500 Interface Specification: Data Flow 04826807 Rev. A

Results Data Exchange An example of actual data exchanged for the order session appears as shown in the following table: Table 2-11 Results Data Exchange Row Analyzer � Computer or LIS � 1. 2. <ENQ> 3. <ACK> 4. <STX>1 H|\^&|||BAYER^6740^^01.00/ 01.00||||||010|P|1|19970526102500<CR> <ETX>C1 C2<CR><LF> 5. <ACK> 6. <STX>2 P|1|00001|19970526102500|312445446|323<CR> P|2|C|P|MULTISTIX 10 SG|F|0000<CR> <ETX>C1 C2<CR><LF> 7. <ACK> 8. <STX>3 R|1|N|COL|12|YELLOW|1|0|A<CR> R|2|A|GLU|1|250^mg/dL|3|0|A<CR> R|3|N|BIL|2|NEGATIVE|1|0|A<CR> R|4|N|KET|3|NEGATIVE|1|0|E<CR> R|5|N|SG|4|<=1.005|1|0|A<CR> R|6|A|BLO|9|SMALL|4|0|A<CR> <ETB>C1 C2<CR><LF> 9. <ACK> 10. <STX>4 R|7|N|pH|5|6.0|3|0|A<CR> R|8|N|PRO|6|NEGATIVE|1|0|A<CR> R|9|N|URO|7|1.0^E.U./dL|2|0|A<CR> R|10|N|NIT|8|NEGATIVE|1|0|A<CR> R|11|A|LEU|10|TRACE|2|1|0<CR> <ETB>C1 C2<CR><LF>

11. <ACK> 12. <STX>5 L|1<CR> <ETX>C1 C2<CR><LF> 13. <ACK> 14. <EOT> <ENQ> 15. <ACK> 16. <STX>1 H|\^&|||BAYER^6740^^01.00/ 01.00||||||010|P|1|19970526102600<CR> <ETX>C1 C2<CR><LF> Table continues on the next page. Clinitek Advantus and Clinitek 500 Interface Specification: Data Flow 2–21 04826807 Rev. A

17. <ACK> 18. <STX>2 P|1|00002|19970526102500|213543331|323<CR> P|2|C|P|MULTISTIX 10 SG|F|0000<CR> <ETX>C1 C2<CR><LF> 19. <ACK> 20. <STX>3 R|1|N|COL|12|YELLOW|1|0|A<CR> R|2|N|GLU|1|NEGATIVE|1|0|A<CR> R|3|N|BIL|2|NEGATIVE|1|0|A<CR> R|4|N|KET|3|NEGATIVE|1|0|E<CR> R|5|N|SG|4|<=1.005|1|0|A<CR> R|6|N|BLO|9|NEGATIVE|1|0|A<CR> <ETB> C1 C2<CR><LF> 21. <ACK> 22. <STX>4 R|7|N|pH|5|5.5|2|0|A<CR> R|8|N|PRO|6|NEGATIVE|1|0|A<CR> R|9|N|URO|7|0.2^E.U./dL|1|0|A<CR> R|10|N|NIT|8|NEGATIVE|1|0|A<CR> R|11|N|LEU|10|NEGATIVE|1|0|A<CR> <ETB>C1 C2<CR><LF> 23. <ACK> 24. <STX>5 L|1<CR> <ETX>C1 C2<CR><LF> 25. <EOT> <ENQ> 26. <ACK> 27. <STX>1 H|\^&|||BAYER^6740^^1.00/ 01.00||||||010|P|1|19970526102500<CR> <ETX>C1 C2<CR><LF> 28. <ACK> 29. <STX>2 P|1|00003|19970526102500|398576435|323<CR> P|2|C|P|MULTISTIX 10 SG|F|0000<CR> <ETX>C1 C2<CR><LF> 30. <ACK> 31. <STX>3 R|1|A|COL|12|RED|3|1|A<CR> R|2|N|GLU|1|NEGATIVE|1|1|A<CR> R|3|N|BIL|2|NEGATIVE|1|1|A<CR> R|4|N|KET|3|NEGATIVE|1|1|A<CR> R|5|N|SG|4|<=1.005|1|1|A<CR> R|6|A|BLO|9|MODERATE|4|1|A<CR> <ETB> C1 C2<CR><LF> 32. <ACK> Row Analyzer � Computer or LIS � Table continues on the next page. 2–22 Clinitek Advantus and Clinitek 500 Interface Specification: Data Flow 04826807 Rev. A

NOTE:On the Clinitek Advantus, the manufacturer is SIEMENS, the product ID is 1420, and the analyzer serial number is included after the product ID in the analyzer transmission.

Resending the Results Frame If the laboratory computer calculates a different checksum value for a frame, the computer must refuse to accept that frame and the analyzer must resend the frame. The analyzer may send the frame a maximum of six times. If the frame is not accepted after the sixth transfer of the frame, the analyzer must terminate the communication session. The analyzer may then initiate a new session. Table 2-12 displays a retransmission of the third results frame from the previous example. In this instance, the laboratory computer does not calculate the same checksum value as that sent by the analyzer for the third frame (line 7). The laboratory computer refuses to accept the frame (<NAK>), and the Analyzer resends that frame. 33. <STX>4 R|7|N|pH|5|6.0|3|1|A<CR> R|8|N|PRO|6|NEGATIVE|1|1|A<CR> R|9|N|URO|7|1.0^E.U./dL|2|1|A<CR> R|10|N|NIT|8|NEGATIVE|1|1|A<CR> R|11|A|LEU|10|LARGE|5|1|A<CR> <ETB>C1 C2<CR><LF> 34. <ACK> 35. <STX>5 L|1|N<CR> <ETX>C1 C2<CR><LF> 36. <ACK> 37. <EOT> Row Analyzer � Computer or LIS � Clinitek Advantus and Clinitek 500 Interface Specification: Data Flow 2–23 04826807 Rev. A Table 2-12 Resending Results Data Exchange Row Analyzer � Computer or LIS � 1. <ENQ> 2. <ACK> 3. <STX>1 H|\^&|||BAYER^6740^^1.00/ 01.00||||||010|P|1|19970526102500<CR> <ETX>C1 C2<CR><LF> 4. <ACK> 5. <STX>2 P|1|00003|19970526102500|398576435|323<CR> P|2|C|P|MULTISTIX 10 SG|F|0000<CR> <ETX>C1 C2<CR><LF> 6. <ACK> 7. <STX>3 R|1|A|COL|12|RED|3|0|A<CR> R|2|N|GLU|1|NEGATIVE|1|0|A<CR> R|3|N|BIL|2|NEGATIVE|1|0|A<CR> R|4|N|KET|3|NEGATIVE|1|0|A<CR> R|5|N|SG|4|<=1.005|1|0|A<CR> R|6|A|BLO|9|MODERATE|5|0|A<CR> <ETB> C1 C2<CR><LF> 8. <NAK> 9. <STX>3 R|1|A|COL|12|RED|3|0|A<CR> R|2|N|GLU|1|NEGATIVE|1|0|A<CR> R|3|N|BIL|2|NEGATIVE|1|0|A<CR> R|4|N|KET|3|NEGATIVE|1|0|A<CR> R|5|N|SG|4|<=1.005|1|0|A<CR> R|6|A|BLO|9|MODERATE|5|0|A<CR> <ETB> C1 C2<CR><LF> 10. <ACK> 11. <STX>4 R|7|N|pH|5|6.0|3|0|A<CR>

R|8|N|PRO|6|NEGATIVE|1|0|A<CR> R|9|N|URO|7|1.0^E.U./dL|2|0|A<CR> R|10|N|NIT|8|NEGATIVE|1|0|A<CR> R|11|A|LEU|10|LARGE|5|0|A<CR> <ETB>C1 C2<CR><LF> 12. <ACK> 13. <STX>5 L|1|N<CR> <ETX>C1 C2<CR><LF> 14. <ACK> 15. <EOT> 2–24 Clinitek Advantus and Clinitek 500 Interface Specification: Data Flow 04826807 Rev. A

After six attempts, if the third frame is not successfully retransmitted, the data exchange ends as in Table 2-13. In Table 2-13, when the analyzer initiates a new session to send results, the patient records and all the result records for the third patient must be sent again. Table 2-13 Unsuccessful Resend Data Exchange Row Analyzer � Computer or LIS � 1. <ENQ> 2. <ACK> 3. <STX>1 H|\^&|||BAYER^6740^^1.00/ 01.00||||||010|P|1|19970526102500<CR> <ETX>C1 C2<CR><LF> 4. <ACK> 5. <STX>2 P|1|00003|19970526102500|398576435|323<CR> P|2|C|P|MULTISTIX 10 SG|F<CR> <ETX>C1 C2<CR><LF> 6. <ACK> 7. <STX>3 R|1|A|COL|12|RED|3|0|A<CR> R|2|N|GLU|1|NEGATIVE|1|0|A<CR> R|3|N|BIL|2|NEGATIVE|1|0|A<CR> R|4|N|KET|3|NEGATIVE|1|0|A<CR> R|5|N|SG|4|<=1.005|1|0|A<CR> R|6|A|BLO|9|MODERATE|5|0|A<CR> <ETB> C1 C2<CR><LF> 8. <NAK> 9. <STX>3 R|1|A|COL|12|RED|3|0|A<CR> R|2|N|GLU|1|NEGATIVE|1|0|A<CR> R|3|N|BIL|2|NEGATIVE|1|0|A<CR> R|4|N|KET|3|NEGATIVE|1|0|A<CR> R|5|N|SG|4|<=1.005|1|0|A<CR> R|6|A|BLO|9|MODERATE|5|0|A<CR> <ETB> C1 C2<CR><LF> 10. <NAK> 11. <STX>3 R|1|A|COL|12|RED|3|0|A<CR> R|2|N|GLU|1|NEGATIVE|1|0|A<CR> R|3|N|BIL|2|NEGATIVE|1|0|A<CR> R|4|N|KET|3|NEGATIVE|1|0|A<CR> R|5|N|SG|4|<=1.005|1|0|A<CR> R|6|A|BLO|9|MODERATE|5|0|A<CR> <ETB> C1 C2<CR><LF> 12. <NAK> Table continues on the next page. Clinitek Advantus and Clinitek 500 Interface Specification: Data Flow 2–25 04826807 Rev. A Communication when the Computer Refuses Transmission A problem can also occur on the laboratory computer side of the communication session making it impossible for the computer to continue to receive the test results from the Analyzer.

The laboratory computer transmits an <EOT> instead of an <ACK> to notify the analyzer that it cannot continue to receive results. If the laboratory computer asks to terminate the communication session before the analyzer transmits all the result records for a patient, the analyzer must resend all the information for that patient the next time it reports results. If the laboratory computer asks to end a results reporting session after receiving the termination for a particular message, the next time the computer report results, the analyzer does not have to resend that message and may begin with the next set of results. 13. <STX>3 R|1|A|COL|12|RED|3|0|A<CR> R|2|N|GLU|1|NEGATIVE|1|0|A<CR> R|3|N|BIL|2|NEGATIVE|1|0|A<CR> R|4|N|KET|3|NEGATIVE|1|0|A<CR> R|5|N|SG|4|<=1.005|1|0|A<CR> R|6|A|BLO|9|MODERATE|5|0|A<CR> <ETB> C1 C2<CR><LF> 14. <NAK> 15. <STX>3 R|1|A|COL|12|RED|3|0|A<CR> R|2|N|GLU|1|NEGATIVE|1|0|A<CR> R|3|N|BIL|2|NEGATIVE|1|0|A<CR> R|4|N|KET|3|NEGATIVE|1|0|A<CR> R|5|N|SG|4|<=1.005|1|0|A<CR> R|6|A|BLO|9|MODERATE|5|0|A<CR> <ETB> C1 C2<CR><LF> 16. <NAK> 17. <STX>3 R|1|A|COL|12|RED|3|0|A<CR> R|2|N|GLU|1|NEGATIVE|1|0|A<CR> R|3|N|BIL|2|NEGATIVE|1|0|A<CR> R|4|N|KET|3|NEGATIVE|1|0|A<CR> R|5|N|SG|4|<=1.005|1|0|A<CR> R|6|A|BLO|9|MODERATE|5|0|A<CR> <ETB> C1 C2<CR><LF> 18. <NAK> 19. <EOT> Row Analyzer � Computer or LIS � 2–26 Clinitek Advantus and Clinitek 500 Interface Specification: Data Flow 04826807 Rev. A

The analyzer must wait at least 15 seconds before attempting to take control of the line again and send additional results. When the analyzer does send an <ENQ> and receives a reply of <ACK> from the laboratory computer, the analyzer transmits the next set of results. Using the previously illustrated communication session, the information in Table 2-14 assumes that after the transmission of the first result, the laboratory computer is unable to continue to receive results. Table 2-14 Communication when the LIS NAKS Row Analyzer � Computer or LIS � 1. 2. <ENQ> 3. <ACK> 4. <STX>1 H|\^&|||BAYER^6740^^1.00/ 01.00||||||010|P|1|19970526102500<CR> <ETX>C1 C2<CR><LF>

5. <ACK> 6. <STX>2 P|1|00001|19970526102502|312445446|323<CR> P|2|C|P|MULTISTIX 8|F|0000<CR> <ETX>C1 C2<CR><LF> 7. <ACK> 8. <STX>3 R|1|N|COL|12|YELLOW|1|1|A<CR> R|2|A|GLU|1|250^mg/dL|3|1|A<CR> R|3|N|BIL|2|NEGATIVE|1|1|A<CR> R|4|N|KET|3|NEGATIVE|1|1|E<CR> R|5|N|SG|4|<=1.005|1|1|A<CR> R|6|A|BLO|9|SMALL|4|1|A<CR> <ETB>C1 C2<CR><LF> 9. <ACK> 10. <STX>4 R|7|N|pH|5|6.0|3|1|A<CR> R|8|N|PRO|6|NEGATIVE|1|1|A<CR> R|9|N|URO|7|1.0^E.U./dL|2|1|A<CR> R|10|N|NIT|8|NEGATIVE|1|1|A<CR> R|11|A|LEU|10|TRACE|2|1|A<CR> <ETB>C1 C2<CR><LF> 11. <ACK> 12. <EOT> 04826807 Rev. A

3 Formatting Test Records This section of the Clinitek Advantus and Clinitek 500 Interface Specification provides the information used to format the records that the analyzers support. NOTE:Some analyzer versions show Bayer in the record content. This a vestige of programming and does not imply any connection or relationship between Bayer and Siemens.

Record Structure and Content This part of the specification defines the conventions for structuring the content of the records and for representing the data elements contained within those structures. The Clinitek Advantus and Clinitek 500 support the following types of records: •Message Header Record •Message Terminator Record •Request Information Record •Order Record (Clinitek Advantus only) •Patient Record •Result Record All message data is represented as eight bit values within the range (0-126) as defined by the ASCII standard (ANSI X3.4-1986). Restricted Characters Table 3-1 identifies the characters that may not appear in message text. 3–2 Clinitek Advantus and Clinitek 500 Interface Specification: Formatting Test Records 04826807 Rev. A Table 3-1 Restricted Characters Within text data fields, only ASCII characters 32-126 are permitted as usable characters with the exception of those characters used as delimiter characters. The sender is responsible for screening all text data fields to ensure that the text does not contain delimiter characters. The contents of the data fields is case sensitive. Fields are identified by their position within a record. The position is obtained by counting field delimiters from the front of the record. This position-sensitive identification process requires that when the contents of the field are null, its corresponding field delimiter must be included in the record to ensure that the ith field can be found by counting (i-1) delimiters. Delimiters are not included for trailing null fields; that is, if the tenth field was the last field containing data, the record could terminate after the tenth field, and therefore would contain only nine delimiters. Table 3-2 describes the delimiter characters. Character ASCII Value HEX Value

<SOH> 001 01 <STX> 002 02 <ETX> 003 03 <EOT> 004 04 <ENQ> 005 05 <ACK> 006 06 <BEL> 007 07 <LF> 010 0A <CR> 013 0D <DLE> 016 10 <DC1> 017 11 <DC2> 018 12 <DC3> 019 13 <DC4> 020 14 <NAK> 021 15 <SYN> 022 16 <ETB> 023 17 Clinitek Advantus and Clinitek 500 Interface Specification: Formatting Test Records 3–3 04826807 Rev. A Table 3-2 Message Delimiter Characters Transmitted records may include more fields than are required by the receiving system. When processing a record, the receiving system may ignore any field it does not require. All fields in a record are always transferred, and the fields are always transferred in the positional order specified to facilitate accurate identification by the computer system. All fields in records are variable length fields. For all record types, dates are recorded in YYYYMMDD format and times are represented as HHMMSS. Date and time together are specified as a fourteen-character string: YYYYMMDDHHMMSS. Delimiter Character Representation Definition Record Delimiter Carriage Return <CR> (ASCII 13) The record delimiter marks the end of each record. Field Delimiter Vertical Bar (|) (ASCII 124) The field delimiter is used to separate adjacent fields. Repeat Delimiter Backslash (\) (ASCII 92) The repeat delimiter is used to separate variable numbers of descriptors for fields containing parts of equal members of the same set. Component Delimiter Caret (^) (ASCII 94) The component delimiter is used to separate data elements within a field. Escape Delimiter Ampersand (&) (ASCII 38) The escape delimiter is used within text fields to signify special case operations. Applications of the escape delimiter are optional and may be used or ignored at the discretion of either the transmitter or the receiver. All applications must accept the escape delimiter and use it to

correctly parse fields within the record. 3–4 Clinitek Advantus and Clinitek 500 Interface Specification: Formatting Test Records 04826807 Rev. A

Message Header Record Format The Message Header record consists of 15 fields of information with each field in a predefined position as described in Table 3-3. Table 3-3 Message Header Record Field Record Description 1. Record type H indicates a Message Header record type. 2. Delimiter definition 5 ASCII characters that define the delimiters used for all record types. • field delimiter (|) • repeat delimiter (\) • component delimiter (^) • escape delimiter (&) • carriage return to start a new line 3. Message control ID The Clinitek Communication Standard does not use this field and its position is represented by the field delimiter. When used, this field contains unique characters identifying the transmission for use in network systems having defined acknowledgement protocols outside the scope of ASTM Specification E1394. 4. Access password The Clinitek Communication Standard does not use this field and its position is represented by the field delimiter. When used, this field is a password as mutually agreed upon by the sender and receiver. 5. Sender name A component field containing the following elements: • manufacturer (required field) • analyzer product code (required field) For Clinitek Advantus, the code is 1420. For Clinitek 500, the code is 6470. • serial number The serial number is a maximum of 7 digits. When not used, the field displays component delimiters. For Clinitek Advantus, this is a required field. • software version The software version is a required component. 6. Sender street address The Clinitek Communication Standard does not use this field and its position is represented by the field delimiter. When used, this field contains the sender's street address. 7. Reserved field 8. Sender telephone number The Clinitek Communication Standard does not use this field and its position is represented by the field delimiter. When used, this field contains the sender's telephone number. Table continues on the next page. Clinitek Advantus and Clinitek 500 Interface Specification: Formatting Test Records 3–5 04826807 Rev. A

9. Characteristics of the server This field contains characteristics of the sender such as parity, checksums, and optional protocols.

Because you provide this information in the instrument's setup routine, this field does not always contain information and may be represented by the field delimiter. 10. Receiver ID The Clinitek Communication Standard does not use this field and its position is represented by the field delimiter. When used, this field contains the name or other ID of the receiver and is used to verify that the transmission is being received. 11. Comments This is a component field containing the language/result unit code Refer to Language/Result Unit Codes‚ page 3-6. 12. Processing ID This field indicates how to process the message: • P for Production: You may use the test results for patient tests. In normal clinical use, this is the only processing ID used. • T for Training: Test results obtained from this software are not for clinical use. • D for Debugging: Test results obtained from this software are not for clinical use. • Q for Quality Control: Used for obtaining quality assurance or regulatory data. Although the portions of the software that collect and process the data are validated, the test results obtained from this software are not for clinical use. 13. Version number This field is the version level of the Clinitek Communication Standard Specification This value is currently 1. 14. Date & Time of message This field contains the date and time this header record is sent. The format for this field is YYYYMMDDHHMMSS. NOTE: For Clinitek Advantus, the seconds field is always 00. For Clinitek 500, the seconds field records the seconds. 15. <CR> Carriage return Field Record Description 3–6 Clinitek Advantus and Clinitek 500 Interface Specification: Formatting Test Records 04826807 Rev. A

Example of a Message Header Record Clinitek Advantus software version V1.20/V1.00 and later: H | \^& | | | SIEMENS^1420 ^100123 ^01.20:001/V1.00 | | | | | | 010 | P | 1| 20070306102000 <CR> Clinitek Advantus software version V1.00:001/V1.00: H | \^& | | | BAYER^1420 ^100123 ^01.20:001/V1.00 | | | | | | 010 | P | 1| 20070306102000 <CR> Clinitek 500 software: H | \^& | | | BAYER^6470 ^^00.20/XP.11 | | | | | | 010 | P | 1| 19970526102000 <CR> Language/Result Unit Codes Field 11 of the Message Header record contains a code that indicates the language and the units of measurements used for the record. NOTE:To maintain compatibility with legacy instruments, the codes do not follow a logical order.

Table 3-4 Language Unit Codes Language Result Units Code English Conventional - Normal 010 English Conventional - PLUS System 011 English S.I. - Normal 020 English S.I. - PLUS System 021 English Nordic - Normal 030 English Nordic - PLUS System 031 French Conventional - Normal 040 French Conventional - PLUS System 041 French S.I. - Normal 050 French S.I. - PLUS System 051 German Conventional - Normal 060 German Conventional - PLUS System 061 German S.I. - Normal 070 German S.I. - PLUS System 071 Italian Conventional - Normal 080 Italian Conventional - PLUS System 081 Japanese Conventional - Normal 090 Japanese Conventional - PLUS System 091 Table continues on the next page. Clinitek Advantus and Clinitek 500 Interface Specification: Formatting Test Records 3–7 04826807 Rev. A * Only available on the Clinitek Advantus

Message Terminator Record Format The Message Terminator record consists of 4 fields of information with each field in a predefined position as described in Table 3-5. Spanish Conventional - Normal 100 Spanish Conventional - PLUS System 101 Chinese Conventional - Normal 110 Chinese Conventional - PLUS System 111 Chinese S.I. - Normal 120 Chinese S.I. - PLUS System 121 Portuguese Conventional - Normal 130 Portuguese Conventional - PLUS System 131 Japanese JCCLS - Normal 140 Japanese JCCLS - PLUS System 141 Italian* S.I. - Normal 150 Italian* S.I. - PLUS System 151 Spanish* S.I. – Normal 160 Spanish* S.I. - PLUS System 161 Portuguese* S.I. - Normal 170 Portuguese* S.I. - PLUS System 171 Swedish* Conventional - Normal 180 Swedish* Conventional - PLUS System 181 Swedish* S.I. - Normal 190 Swedish* S.I. - PLUS System 191 Swedish* Nordic - Normal 200 Swedish* Nordic - PLUS System 201 Language Result Units Code 3–8 Clinitek Advantus and Clinitek 500 Interface Specification: Formatting Test Records 04826807 Rev. A Table 3-5 Message Terminator Record Table Examples of a Message Terminator Record The following line of text is an example of a Message Terminator record: L | 1 | N <CR> or L | 1 <CR>

Request Information Record Format The computer or LIS sends the request information record to request that the analyzer send a Message Header record.

The request information record consists of 3 fields of information with each field in a predefined position as described in Table 3-6. Table 3-6 Request Information Record Table Example of a Request Information Record The following line of text is an example of a request information record: Q | 1 <CR> Pos Record Description 1. Record type L indicates a Message Terminator record type. 2. Record Sequence Number This is the nth occurrence of this record type within the message. Because this record uses only one Message Terminator record per message, this field always has a value of 1. 3. Message Control ID This field contains a code indicating the reason the message ended. The valid termination codes are as follows: • N or null field – normal termination • T – sender aborted • R – receiver requested abort • E – unknown system error • Q – error in last request for information • I – no information available from last query • F – last request for information processed 4. <CR> Carriage return Pos Record Description 1. Record type Q indicates a request information record. 2. Record Sequence Number This field records the nth occurrence of this record type within the message. 3. <CR> Carriage return Clinitek Advantus and Clinitek 500 Interface Specification: Formatting Test Records 3–9 04826807 Rev. A

Order Record Format NOTE:Only the Clinitek Advantus uses the Order Record. The computer or LIS sends the order record to provide the analyzer with a worklist of Sample IDs, listing the tests to be performed. The order record consists of 4 fields of information with each field in a predefined position as described in Table 3-7. Table 3-7 Order Record Table Examples of Order Record The following lines of text are examples of an order record in Clinitek Advantus: Analyzer Accepting only ID Information O | 1 | 078302465 <CR> Analyzer Accepting ID, Color, and Clarity O | 1 | 078302465^YELLOW^CLEAR <CR> Pos Record Description 1. Record type O indicates an order record. 2. Record Sequence Number This is the nth occurrence of this record type within the message. 3. Patient Identification This is a component field. NOTE: The Clinitek Advantus analyzer only accepts Sample ID information and rejects any further components. The sample ID must be the first component in the

Patient Identification field. The Sample ID field has no restriction on the number of characters, however, the Clinitek Advantus only accepts the first 13 values received. Any further characters are truncated from the Sample ID. 4. <CR> Carriage return 3–10 Clinitek Advantus and Clinitek 500 Interface Specification: Formatting Test Records 04826807 Rev. A

Patient Record Format The patient record contains information about a sample that applies to every result record for that sample. The two formats that apply to patients are as follows: •Test Sequence Format •Results Format Patient Record – Test Sequence Format The test sequence format consists of the fields described in Table 3-8. Table 3-8 Patient Record – Test Sequence Example of the Patient Record – Test Sequence The following line of text is an example of the patient record test sequence format: P | 1 | 00001 | 19970526102000 | 312432216 | 34010 <CR> Field Record Description 1. Record type P indicates a patient record. 2. Record Sequence Number This is the nth occurrence of this record type within the message. 3. Test Sequence Number This field contains the sequence number assigned to this test strip by the analyzer. • For patient results, the sequence number is 5 numeric characters. • For control results, the sequence number is 4 numeric characters with a leading C. 4. Date and Time The date and time the test strip is read at the first readhead. The format is YYYYMMDDHHMMSS. The seconds field is always 00. 5. Sample ID This field is optional. If the Sample ID option is set to Off or if no Sample ID is entered for this test, this field is empty. If the Tech ID option is set to On, the field contains a field delimiter. 6. Tech ID This field is optional. If the Sample ID option is set to Off or if no Sample ID is entered for this test, this field is empty. If the Tech ID option is set to On, the field contains a field delimiter. 7. Sample Location Not used. 8. <CR> Carriage return Clinitek Advantus and Clinitek 500 Interface Specification: Formatting Test Records 3–11 04826807 Rev. A

Patient Record – Results Format The results format consists of the fields described in Table 3-9. Table 3-9 Patient Record – Results Example of the Patient Record – Results Record The following line of text is an example of the results record: P | 2 | C | P | MULTISTIX 10 SG | F | 0000 <CR> Field Record Description

1. Record type P indicates a patient record. 2. Record Sequence Number This is the nth occurrence of this record type within the message. 3. Results Format This field holds the code for the output format of the results. The results format is C for Clinical results. 4. Test Mode The Test Mode field defines the type of test being run. For the Clinitek Advantus and Clinitek 500 analyzers, the test mode can be P for Patient or C for Control. 5. Test Strip ID The Test Strip ID field defines the type of reagent test strip used for the test. Refer to Test Strip ID‚ page 3-12. 6. Transfer Status The Transfer Status field has two options: • F for First Time Transfer • R for User Requested Resend. 7. Error Code This field indicates the error condition of the record and always contains a value. • If valid results are calculated for the test strip, the field contains 0000. • If a problem is detected that prevents clinical result values being reported, the field contains a code identifying the source of the problem. Refer to Error Codes‚ page 3-13. 8. Auxiliary Information Not transmitted in clinical mode. 9. <CR> Carriage return 3–12 Clinitek Advantus and Clinitek 500 Interface Specification: Formatting Test Records 04826807 Rev. A

Test Strip ID The following table displays the supported test strips by analyzer. Table 3-10 Test Strip IDs Clinitek Advantus Clinitek 500 Multistix 10 SG (N Multistix SG-L) Multistix 10 SG Multistix 9 Multistix 9 Multistix 9 SG Multistix 9 SG Multistix 8 SG Multistix 8 SG Multistix SG Multistix SG Multistix SG L Multistix SG L Multistix Multistix N-Multistix SG N-Multistix SG Nephrostix L Nephrostix L Uro-Hemacombistix Uro-Hemacombistix Uro-Hemacombistix SG L Uro-Hemacombistix SG L Uro-Labstix Uro-Labstix Uro-Labstix SG L Uro-Labstix SG Hemacombistix – Long Uro-Labstix SG L Lifestix Combistix SG – Long Multistix PRO® 7G Hemacombistix – Long Multistix PRO 10LB Uristix – Long Multistix PRO 10LS Lifestix Multistix PRO 11 Multistix PRO 6B Clinitek Microalbumin 9 Multistix PRO 6K Multistix PRO 7G Multistix PRO 7pH Multistix PRO 10 Multistix PRO 10LB Multistix PRO 10LS

Multistix PRO 10SB Multistix PRO 11 Clinitek Advantus and Clinitek 500 Interface Specification: Formatting Test Records 3–13 04826807 Rev. A

Error Codes The error code field may contain a value that represents multiple errors. For example, if a low dark value is detected under readhead 1 and a skewed strip is detected at readhead 2, the error code is 0109. Clinitek Advantus Error Codes The following table displays the error codes used by the Clinitek Advantus analyzer: Table 3-11 Clinitek Advantus Error Codes Clinitek 500 Error Codes The following table displays the error codes used by the Clinitek 500 analyzer: Table 3-12 Clinitek 500 Error Codes Error Codes Error Readhead 1 Readhead 2 Low dark value 0100 0001 High dark value 0200 0002 A-D converter over-range 0300 0003 Low lamp(s) level 0400 0004 Low channel output 0500 0005 Missing strip N/A 0006 Upside down or dry strip 0700 N/A Misaligned strip 0800 0008 Skewed strip 0900 0009 Reflectance > 100% 1000 0010 Auto strip type error 2000 N/A Detected strip does not match expected value N/A 0020 Divide by zero error 3000 0030 Error Codes Error Readhead 1 Readhead 2 Low dark value 0100 0001 High dark value 0200 0002 A-D converter over-range 0300 0003 Low lamp(s) level 0400 0004 Low channel output 0500 0005 Missing strip N/A 0006 Upside down or dry strip 0700 N/A Table continues on the next page. 3–14 Clinitek Advantus and Clinitek 500 Interface Specification: Formatting Test Records 04826807 Rev. A

Result Record for Clinical Results Format The result record contains the result of a single test determination. Because Clinitek urine chemistry test strips contain multiple chemistry tests, there is one result record for each result reported. •If you are reporting color or clarity, these physical results are contained in a separate record. •A result record may never appear without a preceding patient record. •On the Clinitek Advantus, microscopic data entered by the user is also reported using the results record. This data field follows the fields reporting clinical, color, and clarity records. •A maximum of six additional results are produced dependent upon the instrument configuration. The results format consists of the fields described in Table 3-13. Table 3-13 Result Records Misaligned strip 0800 0008 Skewed strip 0900 0009 Reflectance > 100% 1000 0010 Auto strip type error 2000 N/A Field Record Description

1. Record type P 2. Record sequence number The nth occurrence of this record type within the message 3. Test result status Indicates whether the result is normal or abnormal. • If the result is within the normal range for the test, this field contains an N. • If the test result is outside the normal range for the test, this field contains an A. • For microscopic data results on the Clinitek Advantus analyzer, this field reports N. 4. Test name abbreviation The abbreviation for the test or physical value. Abbreviations are language dependent. For microscopic data results on the Clinitek Advantus analyzer, this field contains the header name as configured by the user for the relevant microscopic data result. Refer to Test Strip Assays and Abbreviations‚ page 3-16. 5. Test number ID A numeric value for the test. Refer to Test Strip Assays and Abbreviations‚ page 3-16. Error Codes Error Readhead 1 Readhead 2 Table continues on the next page. Clinitek Advantus and Clinitek 500 Interface Specification: Formatting Test Records 3–15 04826807 Rev. A

6. Test result value and result unit of measure The clinical test result divided into a numerical component and a result unit of measure component. • For qualitative results such as positive, negative, normal, normal dilute, clear, or yellow, the record positions the result in the Test Result Value component of the field. The record does not use a component delimiter because the Result Unit of Measure portion of the field is empty. • For color and clarity results, the record does not use a component delimiter. • For ratio results that contain a quantitative value and a qualitative value (for example, P:C > 500 mg/g abnormal), the record divides the result into three subfields with the component delimiter inserted between subfields: >500 mg/g ABNORMAL. • For Clinitek Advantus microscopic data results, the record contains two components. The first component contains the user entered data, and the second the configured units for the entry, as in the following example: 45.4 /uL If no units for the selected microscopic data exist, the analyzer sends an empty component: 45.5 7. Clinical result level The level of the result with respect to the total number of reportable clinical result levels for the test. A level of 1 is assigned to the lowest test value. For example, a chemistry test may have five result levels as in

the following list: • NEGATIVE • TRACE • 30 mg/dL • 100 mg/dL • ≥300 mg/dL Because the value of 100 mg/dL is the 4th result level, the value assigned to the Clinical Result Level field is 4. For Clinitek Advantus microscopic data results, the value is always 1. Field Record Description Table continues on the next page. 3–16 Clinitek Advantus and Clinitek 500 Interface Specification: Formatting Test Records 04826807 Rev. A

Examples of Results Records Clinitek Advantus and Clinitek 500 analyzers: R | 1 | N | PRO | 6 | 100 ^ mg/dL | 4 | 0 | A <CR> Clinitek Advantus analyzer: R | 2 | N | RBC | 100 | 55000 ^ /uL | 1 | 0 | M <CR> Test Strip Assays and Abbreviations The following tables display the available tests for the supported test strips. •Table 3-14 displays the tests supported on the Clinitek Advantus and Clinitek 500 analyzers. It also displays the abbreviations and the numeric ID for each test. •Table 3-15 displays the microscopic data tests supported on the Clinitek Advantus analyzers. The numeric value for each test provides a non-language dependent identifier for later data analysis. 8. Altered decode status The state of decodes on the analyze: • If the analyzer does not use altered decodes, this field contains a 0. • If the analyzer does use altered decodes, this field contains a 1. • For Clinitek Advantus microscopic data results, this field always contains a 1. 9. Result origin The source of the test result: • If the analyzer calculates the result, the value is A. • If the result is entered manually, the value is M. • If the result is edited, the value is E. For Clinical Results, this is the last field in the record. • For Clinitek Advantus microscopic data results, the value is always M because the result is entered manually. 10. Auxiliary test information Not used for Clinical Result records. These are result records in a Patient Record with a value of ‘C’ in the Results Format field. 11. <CR> Carriage return Field Record Description Clinitek Advantus and Clinitek 500 Interface Specification: Formatting Test Records 3–17 04826807 Rev. A Table 3-14 Test Strip Assays and Abbreviations The following table contains microscopic data test and numeric IDs for results on the Clinitek Advantus analyzer: Table 3-15 Microscopic Data Results Test Abbreviation Numeric ID Glucose GLU 1 Bilirubin BIL 2

Ketone KET 3 Specific Gravity SG 4 pH pH 5 Protein PRO 6 Urobilinogen URO 7 Nitrite NIT 8 Occult Blood BLO 9 Leukocytes LEU 10 Color --- 11 Clarity --- 12 Creatinine CRE 13 Protein to Creatinine Ratio P:C 14 Albumin ALB 15 Albumin to Creatinine Ratio A:C 16 Microscopic Data Numeric ID Microscopic Data Numeric ID RBC /uL 100 PATH CASTS 115 RBC /HPF 101 PATH CASTS /HPF 116 RBC /LPF 102 PATH CASTS /LPF 117 WBC /uL 103 CYSTALS 118 WBC /HPF 104 CYSTALS /HPF 119 WBC /LPF 105 CYSTALS /LPF 120 EC /uL 106 YEAST 121 EC /HPF 107 YEAST /HPF 122 EC /LPF 108 YEAST /LPF 123 BACT /uL 109 SPERM 124 BACT /HPF 110 SRC 125 BACT /LPF 111 OTHER 126 CASTS /uL 112 TOTAL COUNT 127 CASTS /HPF 113 Custom data 128 CASTS /LPF 114 3-18 Clinitek Advantus and Clinitek 500 Interface Specification: Formatting Test Records 086D0001-01, Rev. A 04826807 Rev. A

Appendix A: Safety Instructions This information summarizes the established guidelines for handling laboratory biohazards. This summary is based on the guidelines developed by the Centers for Disease Control, the Clinical and Laboratory Standards Institute Document M29-A3, Protection of Laboratory Workers from Occupationally Acquired Infections, and the Occupational Safety and Health Administration’s Bloodborne Pathogens Standard.1–3

Protecting Yourself from Biohazards Use this summary for general information only. It is not intended to replace or supplement your laboratory or hospital biohazard control procedures. By definition, a biohazardous condition is a situation involving infectious agents biological in nature, such as the hepatitis B virus, the human immunodeficiency virus, and the tuberculosis bacterium. These infectious agents may be present in human blood and blood products and in other body fluids. The following are the major sources of contamination when handling potentially infectious agents: •needlesticks •hand-to-mouth contact •hand-to-eye contact •direct contact with superficial cuts, open wounds, and other skin conditions that may permit absorption into subcutaneous skin layers •splashes or aerosol contact with skin and eyes A–2 CLINITEK Advantus and CLINITEK 500 Interface Specification: Safety Instructions 04826807 Rev. A

To prevent accidental contamination in a clinical laboratory, strictly adhere to the following procedures: •Wear gloves while servicing parts of the instrument that have contact with body fluids such as serum, plasma, urine, or whole blood. •Wash your hands before going from a contaminated area to a noncontaminated area, or when you remove or change gloves. •Perform procedures carefully to minimize aerosol formation. •Wear facial protection when splatter or aerosol formation are possible. •Wear personal protective equipment such as safety glasses, gloves, lab coats or aprons when working with possible biohazard contaminants. •Keep your hands away from your face. •Cover all superficial cuts and wounds before starting any work. •Dispose of contaminated materials according to your laboratory’s biohazard control procedures. •Keep your work area disinfected. •Disinfect tools and other items that have been near any part of the instrument sample path or waste area with 10% v/v bleach. •Do not eat, drink, smoke, or apply cosmetics or contact lenses while in the laboratory. •Do not mouth pipet any liquid, including water. •Do not place tools or any other items in your mouth. •Do not use the biohazard sink for personal cleaning such as rinsing coffee cups or washing hands. To prevent needlestick injuries, needles should not be recapped, purposely bent, cut, broken, removed from disposable syringes, or otherwise manipulated by hand.

References 1. Centers for Disease Control. 1988. Update: Universal precautions for prevention of transmission of human immunodeficiency virus, hepatitis B virus and other bloodborne pathogens in healthcare settings. MMWR, 37:377–382, 387, 388. 2. Clinical and Laboratory Standards Institute (formerly NCCLS). Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline - Third Edition. CLSI Document M29-A3.[ISBN 1-56238-567-4]. Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2005). 3. Federal Occupational Safety and Health Administration. Bloodborne Pathogens Standard. 29 CFR 1910. 1030. 04826807 Rev. A

Appendix B: Service, Ordering, and Warranty This section provides the following information: •address of the Siemens Medical Solutions Diagnostics authorized representative, which is the Siemens contact within the European community •addresses for obtaining service and technical information and for ordering supplies •system warranty and service delivery policy information

Siemens Authorized Representative Siemens Medical Solutions Diagnostics Europe Limited Chapel Lane, Swords, Co. Dublin, Ireland

Limited Instrument Warranty and Service Delivery Policy Siemens and its authorized distributors may provide customers who acquire new Siemens instruments with a limited warranty either in a specific agreement or in standard language on their invoices. This limited warranty is designed to protect customers from the cost associated

with repairing instruments that exhibit malfunctions due to defects in materials and/or workmanship during the warranty period. Siemens, at its election, provides warranty service either by providing repair service of the instrument on site, or by exchanging the defective instrument or component, subject to the limitations and exclusions set forth in Replacement of Parts and Warranty and Service Exclusions below. Repairs, replacements or exchanges of instruments or components provided during the warranty or any additional service period, does not extend the warranty or service period beyond the initially agreed upon period. When the customer calls for service, the Siemens representative or authorized distributor informs the customer of the type of service available for the customer’s instrument, and instructs the customer as to how to obtain that service.

Warranty Period The limited warranty period generally commences upon installation of the original instrument at the customer’s location and extends for a period of 1 year thereafter, unless otherwise specifically agreed to by and between Siemens (or its authorized distributors) and customer in a writing signed by duly authorized representatives of both parties (sales representatives are generally not authorized representatives of Siemens for these purposes). B–2 Clinitek Advantus and Clinitek 500 Interface Specification: Service, Ordering, and Warranty 04826807 Rev. A

Additional Service Period The customers, with some exceptions, may purchase additional service coverage beyond any initial warranty period as part of the original instrument acquisition for second or subsequent years beyond the original installation date. The customer’s original Purchase Invoice or appropriate Agreement Addendum must indicate the term in months for additional service coverage. Service During Normal Hours The customer may obtain service for instruments during normal business hours by contacting the nearest Siemens location or authorized distributor. Refer to the list of Siemens locations in this section. Extent of a Service Call Warranty or service calls generally include onsite repair or exchange of instruments or components, travel to the location of the instrument, and onsite labor during normal business hours. A warranty or service call is initiated by the customer by following the instructions on how to obtain service for the customer’s instrument. The service call is considered complete when any defects in material or workmanship have been corrected by repair or replacement and the instrument conforms to the applicable specifications. When service is complete, the customer receives a copy of the documentation detailing all work performed by the Siemens representative or authorized distributor. Service Outside Normal Hours Customers, with some exceptions, may also request service to be delivered or an exchange to be initiated outside normal business hours, including evenings, weekend days, or nationally observed holidays, by contacting the nearest Siemens location or authorized distributor. Service performed outside normal hours is subject to a surcharge unless the customer has in place a service product option that provides service at the time requested. Replacement of Parts In performing service, Siemens or its authorized distributors provide appropriate parts to repair the instrument, or arranges for the exchange of the instrument or affected parts, at no charge with the exception of certain parts or subassemblies that are considered Customer Maintenance Items. Customer Maintenance Items include, but are not limited to, the following items: lamps, electrodes or sensors (which are covered by a separate warranty), reagents, calibrators, controls, paper, and pens. Consult the appropriate system operator’s manuals for a complete list of Customer Maintenance Items for any specific model of instrument. Clinitek Advantus and Clinitek 500 Interface Specification: Service, Ordering, and Warranty B–3 04826807 Rev. A

Design Changes and Retrofitting of Instruments

Siemens reserves the right to change the design or construction of specific models of instruments at any time without incurring any obligation to make such changes available to individual customers or instruments. If Siemens notifies customers of a change that improves the performance or reliability of their instrument, and requests to retrofit that instrument, the customer must agree to allow Siemens or an authorized distributor, at Siemens’ expense, to retrofit components or make design changes, which does not adversely affect the instrument’s performance characteristics. Key Operator Designation Each customer designates a key operator who is available to Siemens representatives to describe instrument malfunctions by telephone and/or to perform simple adjustments and corrections as requested. If a key operator is not designated or is unavailable when the customer requests service, the delivery of service may be delayed. OSHA Requirements (US only) When service is required at a customer location, the customer must provide the Siemens representative with adequate facilities that comply with the regulations of the Secretary of Labor under the Occupational Safety and Health Act (OSHA) of 1970, as amended. Warranty and Service Exclusions The following exclusions are in addition to any exclusions provided for in any written warranty or service agreement. IF ANY OF THE FOLLOWING EVENTS OCCUR, THE WARRANTY OR SERVICE PROVISIONS DO NOT APPLY: 1. Repairs or modifications have been made to the instrument by someone other than an authorized Siemens representative. 2. The instrument has been operated using accessories and supplies other than Siemens brand accessories, or consumable supplies and/or reagents not having the same grade, quality, and composition as defined in the system operator’s manuals. 3. Siemens has notified customers of a change that improves the performance or reliability of their instrument and customer has not agreed to retrofit or make design changes to the instrument. 4. Customer did not purchase the instrument from Siemens or one of its authorized distributors. 5. The instrument has not been installed within 90 days of shipment to the customer’s facility unless otherwise specified. B–4 Clinitek Advantus and Clinitek 500 Interface Specification: Service, Ordering, and Warranty 04826807 Rev. A

6. The customer has not performed appropriate customer maintenance procedures, as outlined in the system operator’s manuals. 7. The instrument has been misused or used for a purpose for which it was not intended. 8. The instrument has been damaged in transit to the customer or damaged by the customer while moving or relocating it without supervision by a Siemens representative. 9. Damage was caused by floods, earthquakes, tornados, hurricanes, or other natural or man-made disasters. 10. Damage was caused by Acts of War, vandalism, sabotage, arson, or civil commotion. 11. Damage was caused by electrical surges or voltages exceeding the tolerances outlined in the system operator’s manuals. 12. Damage was caused by water from any source external to the instrument. 13. The customer has purchased an alternative agreement whose terms of warranty or service supersede these provisions. Siemens or its authorized distributors can invoice customers, at current standard labor and parts rates, for instruments repaired to correct damage or malfunctions due to any of the reasons listed above.

OTHER THAN AS STATED ABOVE, THERE ARE NO OTHER WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE INSTRUMENT, ITS SALE TO THE CUSTOMER, ITS LEASE TO THE CUSTOMER, OR THE SALE OF THE INSTRUMENT TO THE CUSTOMER AT THE EXPIRATION OR TERMINATION OF THE LEASE AGREEMENT. SIEMENS SPECIFICALLY DISCLAIMS ANY AND ALL IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE. SIEMENSS LIABILITY FOR BREACH OF ANY WARRANTY OR SERVICE AGREEMENT SHALL BE LIMITED ONLY TO THE REPAIR OR REPLACEMENT OF DEFECTIVE EQUIPMENT AND SHALL NOT INCLUDE ANY DAMAGES OF ANY KIND, WHETHER DIRECT, INDIRECT, INCIDENTAL, CONTINGENT, OR CONSEQUENTIAL. SIEMENS SHALL NOT BE LIABLE FOR DELAY FROM ANY CAUSE IN PROVIDING REPAIR OR EXCHANGE SERVICE. ANY LIMITATIONS OR OTHER PROVISIONS NOT CONSISTENT WITH APPLICABLE LAW IN PARTICULAR JURISDICTIONS OR A SPECIFIC WRITTEN AGREEMENT DO NOT APPLY TO CUSTOMERS IN THOSE JURISDICTIONS OR SUBJECT TO THOSE AGREEMENTS. Clinitek Advantus and Clinitek 500 Interface Specification: Service, Ordering, and Warranty B–5 04826807 Rev. A

Information for Technical Assistance Refer to the procedures in this appendix to provide system information that you may need when you call for technical assistance.

Locating the System Serial Number Remove the test table. The serial number is located on the base plate assembly.

Addresses For technical assistance contact your local technical support provider. For customer service or additional information contact your local technical support distributor. Siemens Medical Solutions Diagnostics 511 Benedict Avenue Tarrytown, NY 10591 Siemens Medical Solutions Diagnostics Pty Ltd ABN 65 007 436 651 885 Mountain Highway Bayswater Victoria 3153 Australia Clinitek AdvantusClinitek 500 B–6 Clinitek Advantus and Clinitek 500 Interface Specification: Service, Ordering, and Warranty 04826807 Rev. A 04826807 Rev. A

Appendix C: Result Unit Tables English and Chinese Conventional Units Table C-1 English and Chinese – Conventional Test Abbreviation Normal Plus System SG <=1.005 1.010 1.015 1.020 1.025 >=1.030 No change pH 5.0 5.5 6.0 6.5 7.0 7.5 8.0

8.5 >=9.0 No change PRO NEGATIVE NEGATIVE Multistix Family of Test Strips TRACE 30�mg/dL 100�mg/dL >=300�mg/dL TRACE 1+ 2+ 3+ PRO NEGATIVE NEGATIVE Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G Clinitek Microalbumin 9 15�mg/dL 30�mg/dL 100�mg/dL 300�mg/dL LOW 1+ 2+ 3+ PRO NEGATIVE NEGATIVE Multistix PRO 6B Multistix PRO 6K 30�mg/dL 100�mg/dL 300�mg/dL 1+ 2+ 3+ NIT NEGATIVE No change POSITIVE GLU NEGATIVE NEGATIVE Multistix and Multistix PRO Families of Test Strips 100�mg/dL 250�mg/dL 500�mg/dL >=1000�mg/dL TRACE 1+ 2+ 3+ C–2 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A

GLU NEGATIVE NEGATIVE Clinitek Microalbumin 9 100�mg/dL 250�mg/dL 500�mg/dL 1000�mg/dL >=2000�mg/dL TRACE 1+

2+ 3+ 4+ KET NEGATIVE NEGATIVE TRACE 15�mg/dL 40�mg/dL >=80�mg/dL TRACE 1+ 2+ 3+ BIL NEGATIVE NEGATIVE SMALL MODERATE LARGE 1+ 2+ 3+ BLO NEGATIVE NEGATIVE TRACE-LYSED TRACE-INTACT SMALL MODERATE LARGE TRACE-LYSED TRACE-INTACT 1+ 2+ 3+ URO 0.2�E.U./dL 1.0�E.U./dL No change 2.0�E.U./dL 4.0�E.U./dL >=8.0�E.U./dL LEU NEGATIVE NEGATIVE TRACE SMALL MODERATE LARGE TRACE 1+ 2+ 3+ ALB 10�mg/L 30�mg/L 80�mg/L 150�mg/L No change CRE 10�mg/dL 50�mg/dL 100�mg/dL 200�mg/dL 300�mg/dL No change Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–3 04826807 Rev. A A:C Multistix and Multistix

PRO Families of Test Strips . <30�mg/g NORMAL No change 30–300�mg/g ABNORMAL >300�mg/g HIGH�ABNORMAL A:C Clinitek Microalbumin 9 NORMAL DILUTE <30�mg/g NORMAL No change 30–300�mg/g ABNORMAL >300�mg/g HIGH�ABNORMAL P:C Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G NORMAL�DILUTE No change NORMAL 150�mg/g ABNORMAL 300�mg/g ABNORMAL >500�mg/g ABNORMAL P:C Multistix PRO 6B Multistix PRO 6K NORMAL No change 300�mg/g ABNORMAL >500�mg/g ABNORMAL P:C Clinitek Microalbumin 9 NORMAL�DILUTE No change NORMAL 300�mg/g ABNORMAL 1500�mg/g ABNORMAL 3000�mg/g ABNORMAL >=5000�mg/g ABNORMAL Test Abbreviation Normal Plus System C–4 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A COL If color is “determined by the Tech”, an additional option of OTHER is available.

LT.�YELLOW YELLOW DK.�YELLOW LT.�ORANGE ORANGE DK.�ORANGE LT.�RED RED DK.�RED LT.�GREEN GREEN DK.�GREEN LT.�BLUE BLUE DK.�BLUE LT.�BROWN BROWN DK.�BROWN No change CLA CLEAR SL�CLOUDY CLOUDY TURBID OTHER No change Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–5 04826807 Rev. A

English and Chinese S.I. Units Table C-2 English and Chinese – S.I. Units Test Abbreviation Normal Plus System SG <=1.005 1.010 1.015 1.020 1.025 >=1.030 No change pH 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 >=9.0 No change PRO Multistix Family of Test Strips NEGATIVE TRACE 0.3�g/L 1.0�g/L >=3.0�g/L NEGATIVE TRACE 1+ 2+ 3+

PRO NEGATIVE NEGATIVE Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G Clinitek Microalbumin 9 0.15�g/L 0.3�g/L 1.0�g/L 3.0�g/L LOW 1+ 2+ 3+ PRO NEGATIVE NEGATIVE Multistix PRO 6B Multistix PRO 6K 0.3�g/L 1.0�g/L 3.0�g/L 1+ 2+ 3+ NIT NEGATIVE No change POSITIVE GLU NEGATIVE NEGATIVE Multistix and Multistix PRO Families of Test Strips 5.5�mmol/L 14�mmol/L 28�mmol/L >=55�mmol/L TRACE 1+ 2+ 3+ C–6 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A

GLU NEGATIVE NEGATIVE Clinitek Microalbumin 9 5.5�mmol/L 14�mmol/L 28�mmol/L 55�mmol/L >=110�mmol/L TRACE 1+ 2+ 3+ 4+ KET NEGATIVE NEGATIVE TRACE 1.5�mmol/L 3.9�mmol/L >=7.8�mmol/L TRACE 1+ 2+ 3+ BIL NEGATIVE NEGATIVE SMALL

MODERATE LARGE 1+ 2+ 3+ BLD NEGATIVE NEGATIVE TRACE-LYSED TRACE-INTACT Ca�25�Ery/uL Ca�80�Ery/uL Ca�200�Ery/uL TRACE-LYSED TRACE-INTACT 1+ 2+ 3+ UBG 3.2�umol/L 16�umol/L No change 33�umol/L 66�umol/L >=131�umol/L LEU NEGATIVE NEGATIVE Ca�15�Leu/uL Ca�70�Leu/uL Ca�125�Leu/uL Ca�500�Leu/uL TRACE 1+ 2+ 3+ ALB 10�mg/L 30�mg/L 80�mg/L 150�mg/L No change CRE 0.9�mmol/L 4.4�mmol/L 8.8�mmol/L 17.7�mmol/L 26.5�mmol/L No change Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–7 04826807 Rev. A A:C Multistix and Multistix PRO Families of Test Strips <3.4�mg/mmol NORMAL No change 3.4–33.9�mg/mmol ABNORMAL >33.9�mg/mmol HIGH�ABNORMAL A:C Clinitek Microalbumin 9 NORMAL�DILUTE <3.4�mg/mmol NORMAL

No change 3.4–33.9�mg/mmol ABNORMAL >33.9�mg/mmol HIGH�ABNORMAL P:C Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G NORMAL�DILUTE No change NORMAL 17.0�mg/mmol ABNORMAL 33.9�mg/mmol ABNORMAL >56.6�mg/mmol ABNORMAL P:C Multistix PRO 6B Multistix PRO 6K NORMAL No change 33.9�mg/mmol ABNORMAL >56.6�mg/mmol ABNORMAL P:C Clinitek Microalbumin 9 NORMAL�DILUTE No change NORMAL 33.9�mg/mmol ABNORMAL 170�mg/mmol ABNORMAL 339�mg/mmol ABNORMAL >=566�mg/mmol ABNORMAL Test Abbreviation Normal Plus System C–8 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A COL If color is “determined by the Tech”, an additional option of OTHER is available. LT.�YELLOW YELLOW DK.�YELLOW LT.�ORANGE ORANGE DK.�ORANGE LT.�RED RED DK.�RED LT.�GREEN GREEN DK.�GREEN LT.�BLUE BLUE DK.�BLUE

LT.�BROWN BROWN DK.�BROWN No change CLA CLEAR SL�CLOUDY CLOUDY TURBID OTHER No change Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–9 04826807 Rev. A

English Nordic Units Table C-3 English Nordic – Nordic Plus System Test Abbreviation Normal Plus System SG <=1.005 1.010 1.015 1.020 1.025 >=1.030 No change pH 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 >=9.0 No change PRO NEGATIVE NEGATIVE Multistix Family of Test Strips +/- 1+ 2+ 3+ TRACE 1+ 2+ 3+ PRO NEGATIVE No change Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G Clinitek Microalbumin 9 LOW 1+ 2+ 3+ PRO NEGATIVE No change Multistix PRO 6B Multistix PRO 6K 1+ 2+ 3+ NIT NEGATIVE No change POSITIVE GLU NEGATIVE NEGATIVE

Multistix and Multistix PRO Families of Test Strips 1+ 2+ 3+ 4+ TRACE 1+ 2+ 3+ C–10 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A

GLU NEGATIVE NEGATIVE Clinitek Microalbumin 9 1+ 2+ 3+ 4+ 5+ TRACE 1+ 2+ 3+ 4+ KET NEGATIVE NEGATIVE 1+ 2+ 3+ 4+ TRACE 1+ 2+ 3+ BIL NEGATIVE No change 1+ 2+ 3+ BLD NEGATIVE No change +/- +/-INTACT 1+ 2+ 3+ UBG 3.2�umol/L 16�umol/L No change 33�umol/L 66�umol/L >=131�umol/L LEU NEGATIVE NEGATIVE 1+ 2+ 3+ 4+ TRACE 1+ 2+ 3+ ALB 10�mg/L 30�mg/L 80�mg/L

150�mg/L No change CRE 0.9�mmol/L 4.4�mmol/L 8.8�mmol/L 17.7�mmol/L 26.5�mmol/L No change Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–11 04826807 Rev. A A:C Multistix and Multistix PRO Families of Test Strips <3.4�mg/mmol NORMAL No change 3.4-33.9�mg/mmol ABNORMAL >33.9�mg/mmol HIGH ABNORMAL A:C Clinitek Microalbumin 9 NORMAL DILUTE <3.4�mg/mmol NORMAL No change 3.4-33.9�mg/mmol ABNORMAL >33.9�mg/mmol HIGH ABNORMAL P:C Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G NORMAL�DILUTE No change NORMAL 17.0�mg/mmol ABNORMAL 33.9�mg/mmol ABNORMAL >56.6�mg/mmol ABNORMAL P:C Multistix PRO 6B Multistix PRO 6K NORMAL No change 33.9�mg/mmol ABNORMAL >56.6�mg/mmol ABNORMAL P:C Clinitek Microalbumin 9 NORMAL�DILUTE No change NORMAL 33.9�mg/mmol ABNORMAL 170�mg/mmol ABNORMAL 339�mg/mmol

ABNORMAL >=566�mg/mmol ABNORMAL Test Abbreviation Normal Plus System C–12 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A COL If color is “determined by the Tech”, an additional option of OTHER is available. LT.�YELLOW YELLOW DK.�YELLOW LT.�ORANGE ORANGE DK.�ORANGE LT.�RED RED DK.�RED LT.�GREEN GREEN DK.�GREEN LT.�BLUE BLUE DK.�BLUE LT.�BROWN BROWN DK.�BROWN No change CLA CLEAR SL�CLOUDY CLOUDY TURBID OTHER No change Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–13 04826807 Rev. A

French Conventional Units Table C-4 Français, unités conventionnelles Test Abbreviation Normal Plus System DEN <=1.005 1.010 1.015 1.020 1.025 >=1.030 No change pH 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 >=9.0 No change PRO NEGATIF NEGATIF Multistix Family of Test

Strips TRACES 0.3�g/L 1.0�g/L >=3.0�g/L TRACES 1+ 2+ 3+ PRO NEGATIF NEGATIF Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G Clinitek Microalbumin 9 0.15�g/L 0.3�g/L 1.0�g/L 3.0�g/L FAIBLE 1+ 2+ 3+ PRO NEGATIF NEGATIF Multistix PRO 6B Multistix PRO 6K 0.3�g/L 1.0�g/L 3.0�g/L 1+ 2+ 3+ NIT NEGATIF No change POSITIF GLU NEGATIF NEGATIF Multistix and Multistix PRO Families of Test Strips TRACES 2.5�g/L 5.0�g/L >=10.0�g/L TRACES 1+ 2+ 3+ C–14 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A

GLU NEGATIF NEGATIF Clinitek Microalbumin 9 TRACES 2.5�g/L 5.0�g/L 10�g/L >=20�g/L TRACES 1+ 2+ 3+ 4+ CET NEGATIF NEGATIF TRACES

0.15�g/L 0.4�g/L >=0.8�g/L TRACES 1+ 2+ 3+ BIL NEGATIF NEGATIF FAIBLE MOYEN FORT 1+ 2+ 3+ SNG NEGATIF NEGATIF TRACES-LYSE TRACES-INTACT env.�25�GR/uL env.�80�GR/uL env.�200�GR/uL TRACES-LYSE TRACES-INTACT 1+ 2+ 3+ URO 0.2�mg/dL 1.0�mg/dL No change 2.0�mg/dL 4.0�mg/dL >=8.0�mg/dL LEU NEGATIF NEGATIF env.�15�GB/uL env.�70�GB/uL env.�125�GB/uL env.�500�GB/uL TRACES 1+ 2+ 3+ ALB 10�mg/L 30�mg/L 80�mg/L 150�mg/L No change CRE 10�mg/dL 50�mg/dL 100�mg/dL 200�mg/dL 300�mg/dL No change Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–15 04826807 Rev. A A:C Clinitek Microalbumin and Multistix PRO Families of Test Strips <30�mg/g NORMAL No change

30-300�mg/g ANORMAL >300�mg/g ANORMAL�ELEVE A:C Clinitek Microalbumin 9 NORMAL,�DILUEE <30�mg/g NORMAL No change 30-300�mg/g ANORMAL >300�mg/g ANORMAL�ELEVE P:C Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G NORMAL,�DILUEE No change NORMAL 150�mg/g ANORMAL 300�mg/g ANORMAL >500�mg/g ANORMAL P:C Multistix PRO 6B Multistix PRO 6K NORMAL No change 300�mg/g ANORMAL >500�mg/g ANORMAL P:C Clinitek Microalbumin 9 NORMAL�DILUEE No change NORMAL 300�mg/g ANORMAL 1500�mg/g ANORMAL 3000�mg/g ANORMAL >=5000�mg/g ANORMAL Test Abbreviation Normal Plus System C–16 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A COL If color is “determined by the Tech”, an additional option of OTHER is available. CLR.�JAUNE JAUNE FONC.�JAUNE CLR.�ORANGE ORANGE FONC.�ORANGE

CLR.�ROUGE ROUGE FONC.�ROUGE CLR.�VERT VERT�

FONC.�VERT CLR.�BLEU BLEU FONC.�BLEU CLR.�MARRON MARRON FONC.�MARRON No change ASP LIMPIDE LEG.�TROUBLE TROUBLE OPAQUE AUTRE No change Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–17 04826807 Rev. A

French S. I. Units Table C-5 Français, unités internationales (SI) Test Abbreviation Normal Plus System DEN <=1.005 1.010 1.015 1.020 1.025 >=1.030 No change pH 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 >=9.0 No change PRO NEGATIF NEGATIF Multistix Family of Test Strips TRACES 0.3�g/L 1.0�g/L >=3.0�g/L TRACES 1+ 2+ 3+ PRO NEGATIF NEGATIF Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G Clinitek Microalbumin 9 0.15�g/L 0.3�g/L

1.0�g/L 3.0�g/L FAIBLE 1+ 2+ 3+ PRO NEGATIF NEGATIF Multistix PRO 6B Multistix PRO 6K 0.3�g/L 1.0�g/L 3.0�g/L 1+ 2+ 3+ NIT NEGATIF No change POSITIF GLU NEGATIF NEGATIF Multistix and Multistix PRO Families of Test Strips 5.5�mmol/L 14�mmol/L 28�mmol/L >=55�mmol/L TRACES 1+ 2+ 3+ C–18 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A

GLU NEGATIF NEGATIF Clinitek Microalbumin 9 5.5�mmol/L 14�mmol/L 28�mmol/L 55�mmol/L >=110�mmol/L TRACES 1+ 2+ 3+ 4+ CET NEGATIF NEGATIF TRACES 1.5�mmol/L 3.9�mmol/L >=7.8�mmol/L TRACES 1+ 2+ 3+ BIL NEGATIF NEGATIF FAIBLE MOYEN FORT 1+ 2+ 3+ SNG NEGATIF NEGATIF TRACES-LYSE TRACES-INTACT

FAIBLE MOYEN FORT TRACES-LYSE TRACES-INTACT 1+ 2+ 3+ URO 3.2�umol/L 16�umol/L No change 33�umol/L 66�umol/L >=131�umol/L LEU NEGATIF NEGATIF TRACES FAIBLE MOYEN FORT TRACES 1+ 2+ 3+ ALB 10�mg/L 30�mg/L 80�mg/L 150�mg/L No change CRE 0.9�mmol/L 4.4�mmol/L 8.8�mmol/L 17.7�mmol/L 26.5�mmol/L No change Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–19 04826807 Rev. A A:C Multistix and Multistix PRO Families of Test Strips <3.4�mg/mmol NORMAL No change 3.4-33.9�mg/mmol ANORMAL >33.9�mg/mmol ANORMAL�ELEVE A:C Clinitek Microalbumin 9 . NORMAL,�DILUEE <3.4�mg/mmol NORMAL No change 3.4-33.9�mg/mmol ANORMAL >33.9�mg/mmol ANORMAL�ELEVE P:C Multistix PRO 10LS

Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G NORMAL,�DILUEE No change NORMAL 17.0�mg/mmol ANORMAL 33.9�mg/mmol ANORMAL >56.6�mg/mmol ANORMAL P:C Multistix PRO 6B Multistix PRO 6K NORMAL No change 33.9�mg/mmol ANORMAL >56.6�mg/mmol ANORMAL P:C Clinitek Microalbumin 9 NORMAL�DILUEE No change NORMAL 33.9�mg/mmol ANORMAL 170�mg/mmol ANORMAL 339�mg/mmol ANORMAL >=566�mg/mmol ANORMAL Test Abbreviation Normal Plus System C–20 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A COL If color is “determined by the Tech”, an additional option of OTHER is available. CLR.JAUNE JAUNE FONC.JAUNE CLR.ORANGE ORANGE FONC.ORANGE CLR.ROUGE ROUGE FONC.ROUGE CLR.VERT VERT FONC.VERT CLR.BLEU BLEU FONC.BLEU CLR.MARRON MARRON FONC.MARRON No change ASP LIMPIDE LEG.�TROUBLE TROUBLE

OPAQUE AUTRE No change Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–21 04826807 Rev. A

German Conventional Units Table C-6 Deutsch, Einheiten: Konventionell Test Abbreviation Normal Plus System SG <=1.005 1.010 1.015 1.020 1.025 >=1.030 No change pH 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 >=9.0 No change PRO NEGATIV NEGATIV Multistix Family of Test Strips SPUR 30�mg/dL 100�mg/dL >=300�mg/dL SPUR 1+ 2+ 3+ PRO NEGATIV NEGATIV Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G Clinitek Microalbumin 9 15�mg/dL 30�mg/dL 100�mg/dL 300�mg/dL WENIG 1+ 2+ 3+ PRO NEGATIV NEGATIV Multistix PRO 6B Multistix PRO 6K 30�mg/dL 100�mg/dL 300�mg/dL 1+ 2+ 3+ NIT NEGATIV No change

POSITIV GLU NEGATIV NEGATIV Multistix and Multistix PRO Families of Test Strips 100�mg/dL 250�mg/dL 500�mg/dL >=1000�mg/dL SPUR 1+ 2+ 3+ C–22 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A

GLU NEGATIV NEGATIV Clinitek Microalbumin 9 100�mg/dL 250�mg/dL 500�mg/dL 1000�mg/dL >=2000�mg/dL SPUR 1+ 2+ 3+ 4+ KET NEGATIV NEGATIV SPUR 15�mg/dL 40�mg/dL >=80�mg/dL SPUR 1+ 2+ 3+ BIL NEGATIV NEGATIV SCHWACH MAESSIG STARK 1+ 2+ 3+ OBL 0�Ery/uL NEGATIV Ca�10�Ery/uL Ca�10�Ery/uL Ca�25�Ery/uL Ca�80�Ery/uL Ca�200�Ery/uL SPUR-LYSE SPUR-ZELLEN 1+ 2+ 3+ UBG 0.2�mg/dL 1.0�mg/dL No change 2.0�mg/dL 4.0�mg/dL >=8.0�mg/dL LEU 0�Leu/uL NEGATIV Ca�15�Leu/uL

Ca�70�Leu/uL Ca�125�Leu/uL Ca�500�Leu/uL SPUR 1+ 2+ 3+ ALB 10�mg/L 30�mg/L 80�mg/L 150�mg/L No change KRE 10�mg/dL 50�mg/dL 100�mg/dL 200�mg/dL 300�mg/dL No change Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–23 04826807 Rev. A A:K Multistix and Multistix PRO Families of Test Strips <30�mg/g NORMAL No change 30-300�mg/g ABNORMAL >300�mg/g STARK�ABNORMAL A:K Clinitek Microalbumin 9 A�OK�/�K�GERING <30�mg/g NORMAL No change 30-300�mg/g ABNORMAL >300�mg/g STARK�ABNORMAL P:K Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G P�OK�/�K�GERING No change NORMAL 150�mg/g ABNORMAL 300�mg/g ABNORMAL >500�mg/g ABNORMAL P:K Multistix PRO 6B Multistix PRO 6K NORMAL No change 300�mg/g ABNORMAL

>500�mg/g ABNORMAL P:K Clinitek Microalbumin 9 P�OK�/�K�GERING No change NORMAL 300�mg/g ABNORMAL 1500�mg/g ABNORMAL 3000�mg/g ABNORMAL >=5000�mg/g ABNORMAL Test Abbreviation Normal Plus System C–24 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A COL If color is “determined by the Tech”, an additional option of OTHER is available. HELL�GELB GELB DUNK.GELB HELL�ORANGE ORANGE DUNK.ORANGE HELL�ROT ROT DUNK.ROT HELL�GRUEN GRUEN DUNK.GRUEN HELL�BLAU BLAU DUNK.BLAU HELL�BRAUN BRAUN DUNK.BRAUN No change CLA KLAR FLOCKIG S.♦FLOCKIG TRUEB ANDERS No change Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–25 04826807 Rev. A

German S. I. Units Table C-7 Deutsch, Einheiten: Internationales Einheitensystem (SI) Test Abbreviation Normal Plus System SG <=1.005 1.010 1.015 1.020 1.025 >=1.030 No change pH 5.0

5.5 6.0 6.5 7.0 7.5 8.0 8.5 >=9.0 No change PRO NEGATIV NEGATIV Multistix Family of Tests SPUR 0.3�g/L 1.0�g/L >=3.0�g/L SPUR 1+ 2+ 3+ PRO NEGATIV NEGATIV Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G Clinitek Microalbumin 9 0.15�g/L 0.3�g/L 1.0�g/L 3.0�g/L WENIG 1+ 2+ 3+ PRO NEGATIV NEGATIV Multistix PRO 6B Multistix PRO 6K 0.3�g/L 1.0�g/L 3.0�g/L 1+ 2+ 3+ NIT NEGATIV No change POSITIV GLU NEGATIV NEGATIV Multistix and Multistix PRO Families of Test Strips 5.5�mmol/L 14�mmol/L 28�mmol/L >=55�mmol/L SPUR 1+ 2+ 3+ C–26 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A

GLU NEGATIV NEGATIV Clinitek Microalbumin 9 5.5�mmol/L 14�mmol/L 28�mmol/L

55�mmol/L >=110�mmol/L SPUR 1+ 2+ 3+ 4+ KET NEGATIV NEGATIV SPUR 1.5�mmol/L 3.9�mmol/L >=7.8�mmol/L SPUR 1+ 2+ 3+ BIL NEGATIV NEGATIV SCHWACH MAESSIG STARK 1+ 2+ 3+ OBL 0�Ery/uL NEGATIV Ca�10�Ery/uL Ca�10�Ery/uL Ca�25�Ery/uL Ca�80�Ery/uL Ca�200�Ery/uL SPUR-LYSE SPUR-ZELLEN 1+ 2+ 3+ UBG 3.2�umol/L 16�umol/L No change 33�umol/L 66�umol/L >=131�umol/L LEU 0�Leu/uL NEGATIV Ca�15�Leu/uL Ca�70�Leu/uL Ca�125�Leu/uL Ca�500�Leu/uL SPUR 1+ 2+ 3+ ALB 10�mg/L 30�mg/L 80�mg/L 150�mg/L No change KRE 0.9�mmol/L 4.4�mmol/L 8.8�mmol/L 17.7�mmol/L 26.5�mmol/L No change Test Abbreviation Normal Plus System

Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–27 04826807 Rev. A A:K Multistix and Multistix PRO Families of Test Strips <3.4�mg/mmol NORMAL No change 3.4-33.9�mg/mmol ABNORMAL >33.9�mg/mmol STARK�ABNORMAL A:K Clinitek Microalbumin 9 A�OK�/�K�GERING <3.4�mg/mmol NORMAL No change 3.4-33.9�mg/mmol ABNORMAL >33.9�mg/mmol STARK�ABNORMAL P:K Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G P�OK�/�K�GERING No change NORMAL 17.0�mg/mmol ABNORMAL 33.9�mg/mmol ABNORMAL >56.6�mg/mmol ABNORMAL P:K Multistix PRO 6B Multistix PRO 6K NORMAL No change 33.9�mg/mmol ABNORMAL >56.6�mg/mmol ABNORMAL P:K Clinitek Microalbumin 9 P�OK�/�K�GERING No change NORMAL 33.9�mg/mmol ABNORMAL 170�mg/mmol ABNORMAL 339�mg/mmol ABNORMAL >=566�mg/mmol ABNORMAL Test Abbreviation Normal Plus System C–28 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A COL If color is “determined by the Tech”, an additional

option of OTHER is available. HELL�GELB GELB DUNK.GELB HELL�ORANGE ORANGE DUNK.ORANGE HELL�ROT ROT DUNK.ROT HELL�GRUEN GRUEN DUNK.GRUEN HELL�BLAU BLAU DUNK.BLAU HELLBRAUN BRAUN DUNK.BRAUN No change CLA KLAR FLOCKIG S.�FLOCKIG TRUEB ANDERS No change Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–29 04826807 Rev. A

Italian Conventional Units Table C-8 Italiano, Unità - Convenzionali Test Abbreviation Normal Plus System PS <=1.005 1.010 1.015 1.020 1.025 >=1.030 No change pH 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 >=9.0 No change PRO NEGATIVO NEGATIVO Multistix Family of Tests TRACCE 30�mg/dL 100�mg/dL >=300�mg/dL TRACCE 1+ 2+ 3+ PRO NEGATIVO NEGATIVO Multistix PRO 10LS

Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G Clinitek Microalbumin 9 15�mg/dL 30�mg/dL 100�mg/dL 300�mg/dL BASSO 1+ 2+ 3+ PRO NEGATIVO NEGATIVO Multistix PRO 6B Multistix PRO 6K 30�mg/dL 100�mg/dL 300�mg/dL 1+ 2+ 3+ NIT NEGATIVO No change POSITIVO GLU NEGATIVO NEGATIVO Multistix and Multistix PRO Families of Test Strips 1.0�g/L 2.5�g/L 5.0�g/L >=10.0�g/L TRACCE 1+ 2+ 3+ C–30 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A

GLU NEGATIVO NEGATIVO Clinitek Microalbumin 9 1.0�g/L 2.5�g/L 5.0�g/L 10.0�g/L >=20.0�g/L TRACCE 1+ 2+ 3+ 4+ KET NEGATIVO NEGATIVO TRACCE 15�mg/dL 40�mg/dL >=80�mg/dL TRACCE 1+ 2+ 3+ BIL NEGATIVO NEGATIVO LEGGERO MEDIO FORTE

1+ 2+ 3+ SAN NEGATIVO NEGATIVO TRACCE(LIS.) TRACCE(INT.) LEGGERO MEDIO FORTE TRACCE(LIS.) TRACCE(INT.) 1+ 2+ 3+ URO 0.2�E.U./dL 1.0�E.U./dL No change 2.0�E.U./dL 4.0�E.U./dL >=8.0�E.U./dL LEU NEGATIVO NEGATIVO Ca�15�Cel/uL Ca�70�Cel/uL Ca�125�Cel/uL Ca500�Cel/uL TRACCE 1+ 2+ 3+ ALB 10�mg/L 30�mg/L 80�mg/L 150�mg/L No change CRE 10�mg/dL 50�mg/dL 100�mg/dL 200�mg/dL 300�mg/dL No change Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–31 04826807 Rev. A A:C Multistix and Multistix PRO Families of Test Strips <30�mg/g NORMALE No change 30-300�mg/g ANORMALE >300�mg/g MOLTO�ANORMALE�

A:C Clinitek Microalbumin 9 URINA�DILUITA <30�mg/g NORMALE No change 30-300�mg/g

ANORMALE >300�mg/g MOLTO�ANORMALE P:C Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G URINA�DILUITA No change NORMALE 150�mg/g ANORMALE 300�mg/g ANORMALE >500�mg/g ANORMALE P:C Multistix PRO 6B Multistix PRO 6K NORMALE No change 300�mg/g ANORMALE >500�mg/g ANORMALE P:C Clinitek Microalbumin 9 URINA�DILUITA No change NORMALE 300�mg/g ANORMALE 1500�mg/g ANORMALE 3000�mg/g ANORMALE >=5000�mg/ ANORMALE Test Abbreviation Normal Plus System C–32 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A COL If color is “determined by the Tech”, an additional option of OTHER is available. CHIA.GIALLO GIALLO SCUR.GIALLO CHIA.ARANCIONE ARANCIONE SCUR.ARANCIONE CHIA.ROSSO ROSSO SCUR.ROSSO CHIA.VERDE VERDE SCUR.VERDE CHIA.AZZURRO AZZURRO SCUR.AZZURRO CHIA.MARRONE MARRONE

SCUR.MARRONE No change ASP LIMPIDA LEG.�TORBIDA TORBIDA MOL.�TORBIDA ALTRO Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–33 04826807 Rev. A

Italian S.I. Units Table C-9 Italiano, Unità - Internazionali (SI) Test Abbreviation Normal Plus System PS <=1.005 1.010 1.015 1.020 1.025 >=1.030 No change pH 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 >=9.0 No change PRO NEGATIVO NEGATIVO Multistix Family of Tests TRACCE 0.3�g/L 1.0�g/L >=3.0�g/L TRACCE 1+ 2+ 3+ PRO NEGATIVO NEGATIVO Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G Clinitek Microalbumin 9 0.15�g/L 0.3�g/L 1.0�g/L 3.0�g/L BASSO 1+ 2+ 3+ PRO NEGATIVO NEGATIVO Multistix PRO 6B Multistix PRO 6K 0.3�g/L 1.0�g/L 3.0�g/L 1+ 2+

3+ NIT NEGATIVO No change POSITIVO GLU NEGATIVO NEGATIVO Multistix and Multistix PRO Families of Test Strips 5.5�mmol/L 14�mmol/L 28�mmol/L >=55�mmol/L TRACCE 1+ 2+ 3+ C–34 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A

GLU NEGATIVO NEGATIVO Clinitek Microalbumin 9 5.5�mmol/L 14�mmol/L 28�mmol/L 55�mmol/L >=110�mmol/L TRACCE 1+ 2+ 3+ 4+ KET NEGATIVO NEGATIVO TRACCE 1.5�mmol/L 3.9�mmol/L >=7.8�mmol/L TRACCE 1+ 2+ 3+ BIL NEGATIVO NEGATIVO LEGGERO MEDIO FORTE 1+ 2+ 3+ SAN 0�eri/uL NEGATIVO Ca�10�eri/uL Ca�10�eri/uL Ca�25�eri/uL Ca�80�eri/uL Ca�200�eri/uL TRACCE(LIS.) TRACCE(INT.) 1+ 2+ 3+ URO 3.2�umol/L 16�umol/L No change 33�umol/L 66�umol/L >=131�umol/L

LEU 0�Cel/uL NEGATIVO Ca�15�Cel/uL Ca�70�Cel/uL Ca�125�Cel/uL Ca�500�Cel/uL TRACCE 1+ 2+ 3+ ALB 10�mg/L 30�mg/L 80�mg/L 150�mg/L No change CRE 0.9�mmol/L 4.4�mmol/L 8.8�mmol/L 17.7�mmol/L 26.5�mmol/L No change Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–35 04826807 Rev. A A:C Multistix and Multistix PRO Families of Test Strips <3.4�mg/mmol NORMALE No change 3.4-33.9�mg/mmol ANORMALE >33.9�mg/mmol MOLTO�ANORMALE A:C Clinitek Microalbumin 9 URINA�DILUITA <3.4�mg/mmol NORMALE No change 3.4-33.9�mg/mmol ANORMALE >33.9�mg/mmol MOLTO�ANORMALE P:C Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G URINA�DILUITA No change NORMALE 17.0�mg/mmol ANORMALE 33.9�mg/mmol ANORMALE >56.6�mg/mmol ANORMALE P:C Multistix PRO 6B Multistix PRO 6K NORMALE No change

33.9�mg/mmol ANORMALE >56.6�mg/mmol ANORMALE P:C Clinitek Microalbumin 9 URINA�DILUITA No change NORMALE 33.9�mg/mmol ANORMALE 170�mg/mmol ANORMALE 339�mg/mmol ANORMALE >=566�mg/mmol ANORMALE Test Abbreviation Normal Plus System C–36 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A COL If color is “determined by the Tech”, an additional option of OTHER is available. CHIA.GIALLO GIALLO SCUR.GIALLO CHIA.ARANCIONE ARANCIONE SCUR.ARANCIONE CHIA.ROSSO ROSSO SCUR.ROSSO CHIA.VERDE VERDE SCUR.VERDE CHIA.AZZURRO AZZURRO SCUR.AZZURRO CHIA.MARRONE MARRONE SCUR.MARRONE No change ASP LIMPIDA LEG.�TORBIDA TORBIDA MOL.�TORBIDA ALTRO Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–37 04826807 Rev. A

Japanese Conventional Units Table C-17 日本語、単位 - 慣用単位(Japanese) Test Abbreviation Normal Plus System SG <=1.005 1.010 1.015 1.020 1.025 >=1.030 No change

pH 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 >=9.0 No change PRO - - Multistix Family of Test Strips +/- 30�mg/dL 100�mg/dL >=300�mg/dL +/- 1+ 2+ 3+ PRO - - Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G Clinitek Microalbumin 9 15�mg/dL 30�mg/dL 100�mg/dL 300�mg/dL LOW 1+ 2+ 3+ PRO - - Multistix PRO 6B Multistix PRO 6K 30�mg/dL 100�mg/dL 300�mg/dL 1+ 2+ 3+ NIT - No change + GLU - - Multistix and Multistix PRO Families of Test Strips 0.1�g/dL 0.25�g/dL 0.5�g/dL >=1.0�g/dL +/- 1+ 2+ 3+ C–38 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A

GLU - -

Clinitek Microalbumin 9 0.1�g/dL 0.25�g/dL 0.5�g/dL 1.0�g/dL >=2.0�g/dL +/- 1+ 2+ 3+ 4+ KET - No change +/- 1+ 2+ 3+ BIL - No change 1+ 2+ 3+ OB - No change +/-LYSED +/-INTACT 1+ 2+ 3+ URO 0.1�E.U./dL 1.0�E.U./dL No change 2.0�E.U./dL 4.0�E.U./dL >=8.0�E.U./dL WBC - No change +/- 1+ 2+ 3+ ALB 10�mg/L 30�mg/L 80�mg/L 150�mg/L No change CRE 10�mg/dL 50�mg/dL 100�mg/dL 200�mg/dL 300�mg/dL No change Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–39 04826807 Rev. A A:C Multistix and Multistix PRO Families of Test Strips . <30�mg/g NORMAL No change 30–300�mg/g ABNORMAL >300�mg/g

HIGH�ABNORMAL A:C Clinitek Microalbumin 9 NORMAL DILUTE <30�mg/g NORMAL No change 30–300�mg/g ABNORMAL >300�mg/g HIGH�ABNORMAL P:C Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G NORMAL�DILUTE No change NORMAL 150�mg/g ABNORMAL 300�mg/g ABNORMAL >500�mg/g ABNORMAL P:C Multistix PRO 6B Multistix PRO 6K NORMAL No change 300�mg/g ABNORMAL >500�mg/g ABNORMAL P:C Clinitek Microalbumin 9 NORMAL�DILUTE No change NORMAL 300�mg/g ABNORMAL 1500�mg/g ABNORMAL 3000�mg/g ABNORMAL >=5000�mg/g ABNORMAL Test Abbreviation Normal Plus System C–40 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A COL If color is “determined by the Tech”, an additional option of OTHER is available. LT.�YELLOW YELLOW DK.�YELLOW LT.�ORANGE ORANGE DK.�ORANGE LT.�RED RED DK.�RED

LT.�GREEN GREEN DK.�GREEN LT.�BLUE BLUE DK.�BLUE LT.�BROWN BROWN DK.�BROWN No change CLA - +/- 1+ 2+ OTHER No change Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–41 04826807 Rev. A

Japanese JCCLS Units Table C-18日本語、単位 - JCCLS (Japanese) Test Abbreviation Normal Plus System SG <=1.005 1.010 1.015 1.020 1.025 >=1.030 No change pH 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 >=9.0 No change PRO - - Multistix Family of Test Strips +/- 30�mg/dL 100�mg/dL >=300�mg/dL +/- 1+ 2+ 3+ PRO - - Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G Clinitek Microalbumin 9 15�mg/dL 30�mg/dL 100�mg/dL 300�mg/dL LOW

1+ 2+ 3+ PRO - - Multistix PRO 6B Multistix PRO 6K 30�mg/dL 100�mg/dL 300�mg/dL 1+ 2+ 3+ NIT - No change + GLU - - Multistix and Multistix PRO Families of Test Strips 100�mg/dL 250�mg/dL 500�mg/dL�

>=1000�mg/dL 1+ 2+ 3+ 4+ C–42 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A

GLU - - Clinitek Microalbumin 9 100�mg/dL 250�mg/dL 500�mg/dL 1000�mg/dL >=2000�mg/dL 1+ 2+ 3+ 4+ 5+ KET - No change +/- 1+ 2+ 3+ BIL - No change 1+ 2+ 3+ OB - No change +/-LYSED +/-INTACT 1+ 2+ 3+ URO 0.1�E.U./dL 1.0�E.U./dL No change 2.0�E.U./dL 4.0�E.U./dL >=8.0�E.U./dL WBC - No change

+/- 1+ 2+ 3+ ALB 10�mg/L 30�mg/L 80�mg/L 150�mg/L No change CRE 10�mg/dL 50�mg/dL 100�mg/dL 200�mg/dL 300�mg/dL No change Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–43 04826807 Rev. A A:C Multistix and Multistix PRO Families of Test Strips . <30�mg/g NORMAL No change 30–300�mg/g ABNORMAL >300�mg/g HIGH�ABNORMAL A:C Clinitek Microalbumin 9 NORMAL�DILUTE <30�mg/g NORMAL No change 30–300�mg/g ABNORMAL >300�mg/g HIGH�ABNORMAL P:C Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G NORMAL�DILUTE No change NORMAL 150�mg/g ABNORMAL 300�mg/g ABNORMAL >500�mg/g ABNORMAL P:C Multistix PRO 6B Multistix PRO 6K NORMAL No change 300�mg/g ABNORMAL >500�mg/g ABNORMAL

P:C Clinitek Microalbumin 9 NORMAL�DILUTE No change NORMAL 300�mg/g ABNORMAL 1500�mg/g ABNORMAL 3000�mg/g ABNORMAL >=5000�mg/g ABNORMAL Test Abbreviation Normal Plus System C–44 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A COL If color is “determined by the Tech”, an additional option of OTHER is available. LT.�YELLOW YELLOW DK.�YELLOW LT.�ORANGE ORANGE DK.�ORANGE LT.�RED RED DK.�RED LT.�GREEN GREEN DK.�GREEN LT.�BLUE BLUE DK.�BLUE LT.�BROWN BROWN DK.�BROWN No change Clarity - +/- 1+ 2+ OTHER No change Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–45 04826807 Rev. A

Portuguese Conventional Units Table C-10 Português, Unidades — Convencionais Test Abbreviation Normal Plus System DEN <=1.005 1.010 1.015 1.020 1.025 >=1.030 No change pH 5.0 5.5 6.0

6.5 7.0 7.5 8.0 8.5 >=9.0 No change PRO NEGATIVO NEGATIVO Multistix Family of Test Strips INDICIO 30�mg/dL 100�mg/dL >=300�mg/dL INDICIO 1+ 2+ 3+ PRO NEGATIVO NEGATIVO Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G Clinitek Microalbumin 9 15�mg/dL 30�mg/dL 100�mg/dL 300�mg/dL BIAXO 1+ 2+ 3+ PRO NEGATIVO NEGATIVO Multistix PRO 6B Multistix PRO 6K 30�mg/dL 100�mg/dL 300�mg/dL 1+ 2+ 3+ NIT NEGATIVO No change POSITIVO GLI NEGATIVO NEGATIVO Multistix and Multistix PRO Families of Test Strips 100�mg/dL 250�mg/dL 500�mg/dL >=1000�mg/dL INDICIO 1+ 2+ 3+ C–46 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A

GLI NEGATIVO NEGATIVO Clinitek Microalbumin 9 100�mg/dL 250�mg/dL 500�mg/dL

1000�mg/dL >=2000�mg/dL INDICIO 1+ 2+ 3+ 4+ CET NEGATIVO NEGATIVO INDICIO 15�mg/dL 40�mg/dL >=80�mg/dL INDICIO 1+ 2+ 3+ BIL NEGATIVO NEGATIVO PEQUENO MODERADO GRANDE 1+ 2+ 3+ SAN NEGATIVO NEGATIVO INDICIO-LISADO INDICIO-INTACTO PEQUENO MODERADO GRANDE INDICIO-LISADO INDICIO-INTACTO 1+ 2+ 3+ URO 0.2�mg/dL 1.0�mg/dL No change 2.0�mg/dL 4.0�mg/dL >=8.0�mg/dL LEU NEGATIVO NEGATIVO INDICIO PEQUENO MODERADO GRANDE INDICIO 1+ 2+ 3+ ALB 10�mg/L 30�mg/L 80�mg/L 150�mg/L No change CRE 10�mg/dL 50�mg/dL 100�mg/dL 200�mg/dL 300�mg/dL No change Test Abbreviation Normal Plus System

Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–47 04826807 Rev. A A:C Multistix and Multistix PRO Families of Test Strips <30�mg/g NORMAL No change 30-300�mg/g ANORMAL >300�mg/g ANORMAL�ALTO A:C Clinitek Microalbumin 9 DILUIDO�NORMAL <30�mg/g NORMAL No change 30-300�mg/g ANORMAL >300�mg/g ANORMAL�ALTO P:C Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G DILUIDO�NORMAL� No change NORMAL 150�mg/g ANORMAL 300�mg/g ANORMAL >500�mg/g ANORMAL P:C Multistix PRO 6B Multistix PRO 6K NORMAL No change 300�mg/g ANORMAL >500�mg/g ANORMAL P:C Clinitek Microalbumin 9 DILUIDO�NORMAL� No change NORMAL 300�mg/g ANORMAL 1500�mg/g ANORMAL 3000�mg/g ANORMAL >=5000�mg/g ANORMAL Test Abbreviation Normal Plus System C–48 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A COL If color is “determined by the Tech”, an additional

option of OTHER is available. CL.AMARELO AMARELO OSC.AMARELO CL.LARANJA LARANJA OSC.LARANJA CL.VERMELHO VERMELHO OSC.VERMELH CL.VERDE VERDE OSC.VERDE CL.AZUL AZUL OSC.AZUL CL.MARRON MARROM OSC.MARROM No change ASP CLARO POUCO�NEBULOSO NEBULOSO TURVO OUTROS No change Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–49 04826807 Rev. A

Portuguese S.I. Units Table C-11 Português, Unidades — Internacionais (SI) Test Abbreviation Normal Plus System DEN <=1.005 1.010 1.015 1.020 1.025 >=1.030 No change pH 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 >=9.0 No change PRO NEGATIVO NEGATIVO Multistix Family of Tests INDICIO 0.3�g/L 1.0�g/L >=3.0�g/L INDICIO 1+ 2+ 3+ PRO NEGATIVO NEGATIVO Multistix PRO 10LS

Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G Clinitek Microalbumin 9 0.15�g/L 0.3�g/L 1.0�g/L 3.0�g/L BIAXO 1+ 2+ 3+ PRO NEGATIVO NEGATIVO Multistix PRO 6B Multistix PRO 6K 0.3�g/L 1.0�g/L 3.0�g/L 1+ 2+ 3+ NIT NEGATIVO No change POSITIVO GLI NEGATIVO NEGATIVO Multistix and Multistix PRO Families of Test Strips 5.5�mmol/L 14�mmol/L 28�mmol/L >=55�mmol/L INDICIO 1+ 2+ 3+ C–50 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A

GLI NEGATIVO NEGATIVO Clinitek Microalbumin 9 5.5�mmol/L 14�mmol/L 28�mmol/L 55�mmol/L >=110�mmol/L INDICIO 1+ 2+ 3+ 4+ CET NEGATIVO NEGATIVO INDICIO 1.5�mmol/L 3.9�mmol/L >=7.8�mmol/L INDICIO 1+ 2+ 3+ BIL NEGATIVO NEGATIVO PEQUENO MODERADO GRANDE

1+ 2+ 3+ SAN NEGATIVO NEGATIVO INDICIO-LISADO INDICIO-INTACTO PEQUENO MODERADO GRANDE INDICIO-LISADO INDICIO-INTACTO 1+ 2+ 3+ URO 3.2�umol/L 16�umol/L No change 33�umol/L 66�umol/L >=131�umol/L LEU NEGATIVO NEGATIVO INDICIO PEQUENO MODERADO GRANDE INDICIO 1+ 2+ 3+ ALB 10�mg/L 30�mg/L 80�mg/L 150�mg/L No change CRE 0.9�mmol/L 4.4�mmol/L 8.8�mmol/L�����

17.7�mmol/L 26.5�mmol/L No change Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–51 04826807 Rev. A A:C Multistix and Multistix PRO Families of Test Strips <3.4�mg/mmol NORMAL No change 3.4-33.9�mg/mmol ANORMAL >33.9�mg/mmol ANORMAL�ALTO A:C Clinitek Microalbumin 9 DILUIDO�NORMAL <3.4�mg/mmol NORMAL No change 3.4-33.9�mg/mmol

ANORMAL >33.9�mg/mmol ANORMAL�ALTO P:C Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G DILUIDO�NORMAL No change NORMAL 17.0�mg/mmol ANORMAL 33.9�mg/mmol ANORMAL >56.6�mg/mmol ANORMAL P:C Multistix PRO 6B Multistix PRO 6K NORMAL No change 33.9�mg/mmol ANORMAL >56.6�mg/mmol ANORMAL P:C Clinitek Microalbumin 9 DILUIDO�NORMAL No change NORMAL 33.9�mg/mmol ANORMAL 170�mg/mmol ANORMAL 339�mg/mmol ANORMAL >=566�mg/mmol ANORMAL Test Abbreviation Normal Plus System C–52 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A COL If color is “determined by the Tech”, an additional option of OTHER is available. CL.AMARELO AMARELO OSC.AMARELO CL.LARANJA LARANJA OSC.LARANJA CL.VERMELHO VERMELHO OSC.VERMELH CL.VERDE VERDE OSC.VERDE CL.AZUL AZUL OSC.AZUL CL.MARRON MARROM

OSC.MARROM No change ASP CLARO POUCO�NEBULOSO NEBULOSO TURVO OUTROS No change Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–53 04826807 Rev. A

Spanish Conventional Units Table C-12 Español, Unidades: convencionales Test Abbreviation Normal Plus System DEN <=1.005 1.010 1.015 1.020 1.025 >=1.030 No change pH 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 >=9.0 No change PRO NEGATIVO NEGATIVO Multistix Family of Tests INDICIOS 30�mg/dL 100�mg/dL >=300�mg/dL INDICIOS 1+ 2+ 3+ PRO NEGATIVO NEGATIVO Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G Clinitek Microalbumin 9 15�mg/dL 30�mg/dL 100�mg/dL 300�mg/dL BAJO 1+ 2+ 3+ PRO NEGATIVO NEGATIVO Multistix PRO 6B Multistix PRO 6K 30�mg/dL 100�mg/dL 300�mg/dL 1+

2+ 3+ NIT NEGATIVO No change POSITIVO GLU NEGATIVO NEGATIVO Multistix and Multistix PRO Families of Test Strips 100�mg/dL 250�mg/dL 500�mg/dL >=1000�mg/dL INDICIOS 1+ 2+ 3+ C–54 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A

GLU NEGATIVO NEGATIVO Clinitek Microalbumin 9 100�mg/dL 250�mg/dL 500�mg/dL 1000�mg/dL >=2000�mg/dL INDICIOS 1+ 2+ 3+ 4+ CET NEGATIVO NEGATIVO INDICIOS 15�mg/dL 40�mg/dL >=80�mg/dL INDICIOS 1+ 2+ 3+ BIL NEGATIVO NEGATIVO BAJO MODERADO ALTO 1+ 2+ 3+ SAN NEGATIVO NEGATIVO IND.HEMOLIZ. IND.INTACTOS Apr�25�Hem/uL Apr�80�Hem/uL Apr�200�Hem/uL IND.HEMOLIZ. IND.INTACTOS 1+ 2+ 3+ URO 0.2�E.U./dL 1.0�E.U./dL No change 2.0�E.U./dL 4.0�E.U./dL

>=8.0�E.U./dL LEU NEGATIVO NEGATIVO Apr�15�Leu/uL Apr�70�Leu/uL Apr�125�Leu/uL Apr�500�Leu/uL INDICIOS 1+ 2+ 3+ ALB 10�mg/L 30�mg/L 80�mg/L 150�mg/L No change CRE 10�mg/dL 50�mg/dL 100�mg/dL 200�mg/dL 300�mg/dL No change Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–55 04826807 Rev. A A:C Multistix and Multistix PRO Families of Test Strips <30�mg/g NORMAL No change 30-300�mg/g ANORMAL >300�mg/g ALTAMENTE�ANORMAL A:C Clinitek Microalbumin 9 DILUIDO�NORMAL <30�mg/g NORMAL No change 30-300�mg/g ANORMAL >300�mg/g ALTAMENTE�ANORMAL P:C Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G DILUIDO�NORMAL No change NORMAL 150�mg/g ANORMAL 300�mg/g ANORMAL >500�mg/g ANORMAL P:C Multistix PRO 6B Multistix PRO 6K

NORMAL No change 300�mg/g ANORMAL >500�mg/g ANORMAL P:C Clinitek Microalbumin 9 DILUIDO�NORMAL No change NORMAL 300�mg/g ANORMAL 1500�mg/g ANORMAL 3000�mg/g ANORMAL >=5000�mg/g ANORMAL Test Abbreviation Normal Plus System C–56 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A COL If color is “determined by the Tech”, an additional option of OTHER is available. CL.AMARILLO AMARILLO OSC.AMARILLO CL.ANARANJAD ANARANJAD OSC.ANARANJAD CL.ROJO ROJO OSC.ROJO CL.VERDE VERDE OSC.VERDE CL.AZUL AZUL OSC.AZUL CL.MARRON MARRON OSC.MARRON No change ASP CLARO LIG.TURBIO TURBIO MUY�TURBIO OTROS Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–57 04826807 Rev. A

Spanish S.I. Units Table C-13 Español, Unidades: Internacional (SI) Test Abbreviation Normal Plus System DEN <=1.005 1.010 1.015 1.020 1.025 >=1.030

No change pH 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 >=9.0 No change PRO NEGATIVO NEGATIVO Multistix Family of Tests INDICIOS 0.3�g/L 1.0�g/L >=3.0�g/L INDICIOS 1+ 2+ 3+ PRO NEGATIVO NEGATIVO Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G Clinitek Microalbumin 9 0.15�g/L 0.3�g/L 1.0�g/L 3.0�g/L Bajo 1+ 2+ 3+ PRO NEGATIVO NEGATIVO Multistix PRO 6B Multistix PRO 6K 0.3�g/L 1.0�g/L 3.0�g/L 1+ 2+ 3+ NIT NEGATIVO No change POSITIVO GLU NEGATIVO NEGATIVO Multistix and Multistix PRO Families of Test Strips 5.5�mmol/L 14�mmol/L 28�mmol/L >=55�mmol/L INDICIOS 1+ 2+ 3+ C–58 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A

GLU NEGATIVO NEGATIVO Clinitek Microalbumin 9 5.5�mmol/L

14�mmol/L 28�mmol/L 55�mmol/L >=110�mmol/L INDICIOS 1+ 2+ 3+ 4+ CET NEGATIVO NEGATIVO INDICIOS 1.5�mmol/L 3.9�mmol/L >=7.8�mmol/L INDICIOS 1+ 2+ 3+ BIL NEGATIVO NEGATIVO BAJO MODERADO ALTO 1+ 2+ 3+ SAN 0�Eri/uL NEGATIVO Apr�10�Eri/uL Apr�10�Eri/uL Apr�25�Eri/uL Apr�80�Eri/uL Apr�200�Eri/uL IND.HEMOLIZ. IND.INTACTOS 1+ 2+ 3+ URO 3.2�umol/L 16�umol/L No change 33�umol/L 66�umol/L >=131�umol/L LEU 0�Leu/uL NEGATIVO Apr�15�Leu/uL Apr�70�Leu/uL Apr�125�Leu/uL Apr�500�Leu/uL INDICIOS 1+ 2+ 3+ ALB 10�mg/L 30�mg/L 80�mg/L 150�mg/L No change CRE 0.9�mmol/L 4.4�mmol/L 8.8�mmol/L 17.7�mmol/L 26.5�mmol/L

No change Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–59 04826807 Rev. A A:C Multistix and Multistix PRO Families of Test Strips <3.4�mg/mmol NORMAL No change 3.4-33.9�mg/mmol ANORMAL >33.9�mg/mmol ALTAMENTE�ANORMAL A:C Clinitek Microalbumin 9 DILUIDO�NORMAL <3.4�mg/mmol NORMAL No change 3.4-33.9�mg/mmol ANORMAL >33.9�mg/mmol ALTAMENTE�ANORMAL P:C Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G DILUIDO�NORMAL No change NORMAL 17.0�mg/mmol ANORMAL 33.9�mg/mmol ANORMAL >56.6�mg/mmol ANORMAL P:C Multistix PRO 6B Multistix PRO 6K NORMAL No change 33.9�mg/mmol ANORMAL >56.6�mg/mmol ANORMAL P:C Clinitek Microalbumin 9 DILUIDO�NORMAL No change NORMAL 33.9�mg/mmol ANORMAL 170�mg/mmol ANORMAL 339�mg/mmol ANORMAL >=566�mg/mmol ANORMAL Test Abbreviation Normal Plus System C–60 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A COL

If color is “determined by the Tech”, an additional option of OTHER is available. CL.AMARILLO AMARILLO OSC.AMARILLO CL.NARANJA NARANJA OSC.NARANJA CL.ROJO ROJO OSC.ROJO CL.VERDE VERDE OSC.VERDE CL.AZUL AZUL OSC.AZUL CL.MARRON MARRON OSC.MARRON No change ASP CLARO LIG.TURBIO TURBIO MUY�TURBIO OTROS No change Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–61 04826807 Rev. A

Swedish Conventional Units Table C-14 Engelsk og kinesisk, enheder - konventionelle Test Abbreviation Normal Plus System DEN <=1.005 1.010 1.015 1.020 1.025 >=1.030 No change pH 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 >=9.0 No change PRO NEGATIV NEGATIV Multistix Family of Test Strips SPAAR 30�mg/dL 100�mg/dL >=300�mg/dL SPAAR 1+

2+ 3+ PRO NEGATIV NEGATIV Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G Clinitek Microalbumin 9 15�mg/dL 30�mg/dL 100�mg/dL 300�mg/dL LAAG 1+ 2+ 3+ PRO NEGATIV NEGATIV Multistix PRO 6B Multistix PRO 6K 30�mg/dL 100�mg/dL 300�mg/dL 1+ 2+ 3+ NIT NEGATIV No change POSITIV GLU NEGATIV NEGATIV Multistix and Multistix PRO Families of Test Strips 100�mg/dL 250�mg/dL 500�mg/dL >=1000�mg/dL SPAAR 1+ 2+ 3+ C–62 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A

GLU NEGATIV NEGATIV Clinitek Microalbumin 9 100�mg/dL 250�mg/dL 500�mg/dL 1000�mg/dL >=2000�mg/dL SPAAR 1+ 2+ 3+ 4+ KET NEGATIV NEGATIV SPAAR 15�mg/dL 40�mg/dL >=80�mg/dL SPAAR 1+ 2+ 3+

BIL NEGATIV NEGATIV LITEN LAGOM STOR 1+ 2+ 3+ BLO NEGATIV NEGATIV SPAAR-LYSERAD SPAAR-INTAKT LITEN LAGOM STOR SPAAR-LYSERAD SPAAR-INTAKT 1+ 2+ 3+ URO 0.2�E.U./dL 1.0�E.U./dL No change 2.0�E.U./dL 4.0�E.U./dL >=8.0�E.U./dL LEU NEGATIV NEGATIV SPAAR LITEN LAGOM STOR SPAAR 1+ 2+ 3+ ALB 10�mg/L 30�mg/L 80�mg/L 150�mg/L No change KRE 10�mg/dL 50�mg/dL 100�mg/dL 200�mg/dL 300�mg/dL No change Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–63 04826807 Rev. A A:K Multistix and Multistix PRO Families of Test Strips . <30�mg/g NORMAL No change 30–300�mg/g ONORMAL >300�mg/g HOEG�ONORMAL A:K Clinitek Microalbumin 9

NORMAL�SPAEDNING <30�mg/g NORMAL No change 30–300�mg/g ONORMAL >300�mg/g HOEG�ONORMAL P:K Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G NORMAL�SPAEDNING No change NORMAL 150�mg/g ONORMAL 300�mg/g ONORMAL >500�mg/g ONORMAL P:K Multistix PRO 6B Multistix PRO 6K NORMAL No change 300�mg/g ONORMAL >500�mg/g ONORMAL P:K Clinitek Microalbumin 9 NORMAL�SPAEDNING No change NORMAL 300�mg/g ONORMAL 1500�mg/g ONORMAL 3000�mg/g ONORMAL >=5000�mg/g ONORMAL Test Abbreviation Normal Plus System C–64 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A COL If color is “determined by the Tech”, an additional option of OTHER is available. LT.GUL GUL DK.GUL LT.ORANGE ORANGE DK.ORANGE LT.ROED ROED DK.ROED LT.GROEN GROEN DK.GROEN

LT.BLAA BLAA DK.BLAA LT.BRUN BRUN DK.BRUN No change CLA KLAR ANINGEN�OKLAR OKLAR GRUMLIG ANNAT No change Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–65 04826807 Rev. A

Swedish S.I. Units Table C-15 Engelsk og kinesisk, Enheder - Internationale (SI) Test Abbreviation Normal Plus System DEN <=1.005 1.010 1.015 1.020 1.025 >=1.030 No change pH 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 >=9.0 No change PRO Multistix Family of Test Strips NEGATIV SPAAR 0.3�g/L 1.0�g/L >=3.0�g/L NEGATIV SPAAR 1+ 2+ 3+ PRO NEGATIV NEGATIV Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G Clinitek Microalbumin 9 0.15�g/L 0.3�g/L 1.0�g/L 3.0�g/L LAAG 1+ 2+

3+ PRO NEGATIV NEGATIV Multistix PRO 6B Multistix PRO 6K 0.3�g/L 1.0�g/L 3.0�g/L 1+ 2+ 3+ NIT NEGATIV No change POSITIV GLU NEGATIV NEGATIV Multistix and Multistix PRO Families of Test Strips 5.5�mmol/L 14�mmol/L 28�mmol/L >=55�mmol/L SPAAR 1+ 2+ 3+ C–66 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A

GLU NEGATIV NEGATIV Clinitek Microalbumin 9 5.5�mmol/L 14�mmol/L 28�mmol/L 55�mmol/L >=110�mmol/L SPAAR 1+ 2+ 3+ 4+ KET NEGATIV NEGATIV SPAAR 1.5�mmol/L 3.9�mmol/L >=7.8�mmol/L SPAAR 1+ 2+ 3+ BIL NEGATIV NEGATIV LITEN LAGOM STOR 1+ 2+ 3+ BLD NEGATIV NEGATIV SPAAR-LYSERAD SPAAR-INTAKT Ca�25�Ery/uL Ca�80�Ery/uL Ca�200�Ery/uL SPAAR-LYSERAD SPAAR-INTAKT

1+ 2+ 3+ URO 3.2�umol/L 16�umol/L No change 33�umol/L 66�umol/L >=131�umol/L LEU NEGATIV NEGATIV Ca�15�Leu/uL Ca�70�Leu/uL Ca�125�Leu/uL Ca�500�Leu/uL SPAAR 1+ 2+ 3+ ALB 10�mg/L 30�mg/L 80�mg/L 150�mg/L No change KRE 0.9�mmol/L 4.4�mmol/L 8.8�mmol/L 17.7�mmol/L 26.5�mmol/L No change Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–67 04826807 Rev. A A:K Multistix and Multistix PRO Families of Test Strips <3.4�mg/mmol NORMAL No change 3.4–33.9�mg/mmol ONORMAL >33.9�mg/mmol HOEG�ONORMAL A:K Clinitek Microalbumin 9 NORMAL�SPAEDNING <3.4�mg/mmol NORMAL No change 3.4–33.9�mg/mmol ONORMAL >33.9�mg/mmol HOEG�ONORMAL P:K Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G NORMAL�SPAEDNING No change NORMAL 17.0�mg/mmol

ONORMAL 33.9�mg/mmol ONORMAL >56.6�mg/mmol ONORMAL P:K Multistix PRO 6B Multistix PRO 6K NORMAL No change 33.9�mg/mmol ONORMAL >56.6�mg/mmol ONORMAL P:K Clinitek Microalbumin 9 NORMAL�SPAEDNING No change NORMAL 33.9�mg/mmol ONORMAL 170�mg/mmol ONORMAL 339�mg/mmol ONORMAL >=566�mg/mmol ONORMAL Test Abbreviation Normal Plus System C–68 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A COL If color is “determined by the Tech”, an additional option of OTHER is available. LT.GUL GUL DK.GUL LT.ORANGE ORANGE DK.ORANGE LT.ROED ROED DK.ROED LT.GROEN GROEN DK.GROEN LT.BLAA BLAA DK.BLAA LT.BRUN BRUN DK.BRUN No change CLA KLAR ANINGEN�OKLAR OKLAR GRUMLIG ANNAT No change Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–69 04826807 Rev. A

Swedish Nordic Units Table C-16 Engelsk nordisk, enheder - Nordisk Plus systemenheder Test Abbreviation Normal Plus System DEN <=1.005 1.010 1.015 1.020 1.025 >=1.030 No change pH 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 >=9.0 No change PRO NEGATIV NEGATIV Multistix Family of Test Strips +/- 1+ 2+ 3+ SPAAR 1+ 2+ 3+ PRO NEGATIV No change Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G Clinitek Microalbumin 9 LAAG 1+ 2+ 3+ PRO NEGATIV No change Multistix PRO 6B Multistix PRO 6K 1+ 2+ 3+ NIT NEGATIV No change POSITIV GLU NEGATIV NEGATIV Multistix and Multistix PRO Families of Test Strips 1+ 2+ 3+ 4+ SPAAR 1+ 2+ 3+ C–70 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A

GLU NEGATIV NEGATIV Clinitek Microalbumin 9 1+ 2+ 3+ 4+ 5+ SPAAR 1+ 2+ 3+ 4+ KET NEGATIV NEGATIV 1+ 2+ 3+ 4+ SPAAR 1+ 2+ 3+ BIL NEGATIV No change 1+ 2+ 3+ BLD NEGATIV No change +/- +/-INTAKT 1+ 2+ 3+ URO 3.2�umol/L 16�umol/L No change 33�umol/L 66�umol/L >=131�umol/L LEU NEGATIV NEGATIV 1+ 2+ 3+ 4+ SPAAR 1+ 2+ 3+ ALB 10�mg/L 30�mg/L 80�mg/L 150�mg/L No change KRE 0.9�mmol/L 4.4�mmol/L 8.8�mmol/L 17.7�mmol/L 26.5�mmol/L No change Test Abbreviation Normal Plus System Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables C–71 04826807 Rev. A A:K Multistix and Multistix

PRO Families of Test Strips <3.4�mg/mmol NORMAL No change 3.4–33.9�mg/mmol ONORMAL >33.9�mg/mmol HOEG�ONORMAL A:K Clinitek Microalbumin 9 NORMAL�SPAEDNING <3.4�mg/mmol NORMAL No change 3.4–33.9�mg/mmol ONORMAL >33.9�mg/mmol HOEG�ONORMAL P:K Multistix PRO 10LS Multistix PRO 10LB Multistix PRO 10SB Multistix PRO 7G NORMAL�SPAEDNING No change NORMAL 17.0�mg/mmol ONORMAL 33.9�mg/mmol ONORMAL >56.6�mg/mmol ONORMAL P:K Multistix PRO 6B Multistix PRO 6K NORMAL No change 33.9�mg/mmol ONORMAL >56.6�mg/mmol ONORMAL P:K Clinitek Microalbumin 9 NORMAL�SPAEDNING No change NORMAL 33.9�mg/mmol ONORMAL 170�mg/mmol ONORMAL 339�mg/mmol ONORMAL >=566�mg/mmol��

ONORMAL Test Abbreviation Normal Plus System C–72 Clinitek Advantus and Clinitek 500 Interface Specification: Result Unit Tables 04826807 Rev. A COL If color is “determined by the Tech”, an additional option of OTHER is available. LT.GUL

GUL DK.GUL LT.ORANGE ORANGE DK.ORANGE LT.ROED ROED DK.ROED LT.GROEN GROEN DK.GROEN LT.BLAA BLAA DK.BLAA LT.BRUN BRUN DK.BRUN No change CLA KLAR ANINGEN�OKLAR OKLAR GRUMLIG ANNAT No change Test Abbreviation Normal Plus System 04826807 Rev. A

Appendix D: Clinitek 200/200+ Emulation Mode This appendix provides the software communication protocol for the Clinitek® 200 and 200+ emulation mode for Clinitek Advantus and Clinitek 500 analyzers.

Data Transfer Characteristics The operator selectable data parameters for the Clinitek 200+ are shown in Table D-1. The Clinitek 200+ instrument uses two Stop Bits. Shaded values are the default option settings. Table D-1 Data Parameters

Output Data The transmission of test results data from the Clinitek 200+ instrument can be controlled by either the instrument or by the interfaced laboratory information system (LIS). If the Handshake option is set to ON, the communication protocol uses software handshaking and the LIS controls the transmission of data. If the Handshake option is set to OFF, the communication protocol does not use software handshaking and the instrument controls the transmission of data. Data transmission from the instrument can be suspended by a connected LIS in one of two ways: •The Handshake option can be set to ON and the hardware handshake line can be used to stop data flow. •An XOFF character (<DC3>) can be sent to the instrument to stop data flow. Data flow does not resume until an XON character (<DC1> or <DC2>) is sent. Parameter Setting Options (Shaded options are default options) Computer On Off Handshake On Off Checksum On Off Baud Rate 110 300 600 1200 2400 4800 9600 19200 Character Bits 7 8 Parity Even Odd None D–2 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A

The Clinitek 200+ always supports the receipt of the control characters shown in Table D-2 regardless of the setting for the Handshake option. Table D-2 Data Control Characters When the Handshake option is set to ON, the Clinitek 200+ supports the output control characters shown in Table D-3. Table D-3 Data Output Control Characters Output Data Types Data output from the Clinitek 200+ consists of two different data types: •Instrument ID message. •CLINICAL Results Format data sets. Control Character Control Function <CAN> Resets the RS-232 port to its default condition. <DC1>, <DC2> (XON) Enables data transmission. <DC3> (XOFF) Stops data output, instrument responds to no further input until an XON is received. <DC4 > Redirects all instrument internal printer (Clinitek 200+ printer) messages to the RS-232 port. Control Character Control Function <DC1>, <DC2> Prompt character. Send one set of test result data. If an <ENQ> control character was the last control character received, send the Instrument ID message instead of a test result data set. NOTE: If transmission was disabled during a previous data transmission, the <DC1> or <DC2> serves only as an XON control character and re-enables data transmission but sends no data. If transmission had been disabled but no data was being transmitted at the time, the <DC1> or <DC2> acts as both an XON and as the prompt character and data is sent. <ACK> The last test result data set was received and accepted by the LIS; address the next data set. <NAK> The last test result data set was not accepted by the LIS; when the next prompt character (<DC1> or <DC2>) is received, resend the same data set. <ENQ> Set a flag to send the Instrument ID Message when the next prompt character is received is received. NOTE: This control character is only active when the instrument is not in RUN mode. Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–3 04826807 Rev. A Table D-4 Control Characters Used in Data Sets Global Formatting for all Data Sets Output to Serial Port An <STX> is always output as the first character of a data set. A checksum of all bytes sent between the <STX> and <ETX> is obtained and truncated to 8 bits. The checksum is sent as the ASCII representation of two hexadecimal digits 0 through F, the most significant four bits first. These two ASCII characters are sent preceding the <ETX>. An <ETX> is always output as the last character of a data set. Calculation of Checksum Example Instrument ID Message with used to represent the SPACE character: Steps: 1. Determine the ASCII decimal value of each character (including the SPACE character) between but not including the <STX> and <ETX> control character. 2. Sum the ASCII values. (3725) Control Character Definition <STX> START OF TEXT character (02H, <^B>). <CR> Represents the carriage return character (0DH, <^M>). <LF> Represents the line feed character (0AH, <^J>).

Ck1 Upper 4 bits of an 8-bit checksum converted to an ASCII character "0-9 or A-F". Ck2 Lower 4 bits of an 8-bit checksum converted to an ASCII character "0-9 or A-F". <ETX> END OF TEXT character (03H, <^C>). Message ASCII Value of Characters ASCII Sum of Line <STX><CR><LF> 13+10 (<STX> is not included) 23 ID14:3709-11-0 0<CR><LF> 73+68+32+49+52+58+51+55+32+48+57+45+49+49+45 +48+48+13+10 882 CT200+3.00A<CR ><LF> 67+84+50+48+48+43+32+32+32+51+4 6+48+48+65+13+10 717 ENGLISH-CONV.< CR><LF> 69+78+71+76+73+83+72+32+45+32+3 2+67+79+78+86+46+13+10 1042 Multistix10SG< CR><LF> 77+85+76+84+73+83+84+73+88+32+4 9+48+32+83+71+13+10 1061 FF<ETX> (checksum and ETX are not included) 3725 D–4 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A

3. Divide the sum of the ASCII values by 256. Discard the quotient. (3725 / 256 = 14 with remainder of 141) 4. Convert the remainder to a hexadecimal value. (141 / 16 = 8 with a remainder of 13). Hexadecimal equivalent is 8D. 5. That value is the checksum. Insert it into the message packet prior to sending the <ETX>. ASCII Decimal Value Equivalent Hexadecimal Value 0 0 1 1 2 2 3 3 4 4 5 5 6 6 7 7 8 8 9 9 10 A 11 B 12 C 13 D 14 E 15 F Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–5 04826807 Rev. A

Instrument ID Message (Serial Output Only)

The instrument ID message is output to the serial port when an <ENQ> (05H) control character is received followed by a <DC1> or <DC2>. Even though the instrument ID message packet contains a checksum, the LIS does not have to acknowledge receipt of the packet. Table D-5 Variable Field Definition Table D-6 Instrument ID Packet Table D-7 Format for Language/Units Table D-8 Format for Test Strip Names for Multistix® Family Variable Variable Field Definition Represents the space character A Represents the time in 24-hour format. B Represents the date in the active date format. The formats are MM-DD-YY, DD-MM-YY, and YYMM-DD. C Represents the software version. D Represents the active language/unit option E Represents the active test strip option Line Line Content 1 <STX><CR><LF> 2 IDAA:AABB-BB-BB<CR><LF> 3 CT200+C.CCC<CR><LF> 4 DDDDDDDDDDDDDDDD<CR><LF> 5 EEEEEEEEEEEEEEEEEEEEEEE<CR><LF> 6 Ck1Ck2<ETX> ENGLISH-CONV. FRENCH-CONV. ITALIAN ENGLISH-+/- FRENCH-S.I. SPANISH ENGLISH-S.I. GERMAN Multistix10SG HEMACOMBISTIX MultistixPRO7G Multistix9 URO-HEMACOMBISGL MultistixPRO7PH Multistix8SG MultistixPRO10LB MultistixPRO6B Multistix5 MultistixPRO10LS MultistixPRO6K MultistixSGL MultistixPRO10SB N-MultistixSGL MultistixPRO10 D–6 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A Table D-9 Test Strips Supported by the Clinitek 200+ Table D-10 Test Strips Available for Selection on the Clinitek Advantus, but not supported by the Clinitek 200+ Clinitek Advantus Full Test Name Clinitek 200+ Name as Transmitted MULTISTIX 10 SG MULTISTIX♦10♦SG MULTISTIX 9 SG MULTISTIX♦9♦SG MULTISTIX 8 SG MULTISTIX♦8♦SG MULTISTIX 5 MULTISTIX♦5 URO-HEMA COMBISTIX SG L URO-HEMACOMBI♦SG♦L HEMA-COMBISTIX – LONG HEMA-COMBISTIX-LONG MULTISTIX PRO 10LB MULTISTIX♦PRO♦10LB MULTISTIX PRO 10LS MULTISTIX♦PRO♦10LS MULTISTIX PRO 10SB MULTISTIX♦PRO♦10SB MULTISTIX PRO 10 MULTISTIX♦PRO♦10 MULTISTIX PRO 7G MULTISTIX♦PRO♦7G MULTISTIX PRO 7PH MULTISTIX♦PRO♦7PH MULTISTIX PRO 6B MULTISTIX♦PRO♦6B MULTISTIX PRO 6K MULTISTIX♦PRO♦6K Clinitek Advantus Full Test Name Clinitek 200+ Name as Transmitted MULTISTIX SG MULTISTIX♦SG MULTISTIX SG L MULTISTIX♦SG L MULTISTIX MULTISTIX N-MULTISTIX SG N-MULTISTIX♦SG NEPHROSTIX L NEPHROSTIX♦L URO-LABSTIX SG URO-LABSTIX♦SG URO-LABSTIX SG L URO-LABSTIX♦SG♦L

MULTISTIX 9 MULTISTIX♦9 URO-HEMACOMBISTIX URO-HEMACOMBISTIX URO-LABSTIX URO-LABSTIX COMBISTIX SG - LONG COMBISTIX♦SG URISTIX - LONG URISTIX♦-♦LONG LIFESTIX LIFESTIX MULTISTIX PRO 11 MULTISTIX♦PRO♦11 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–7 04826807 Rev. A

Variable Field Definitions for Test Result Output The following table lists each variable and its respective definition as used in the format descriptions for all test result output. For consistency, the same variables are used in the definitions for both Result Formats, CLINICAL and TEST. The same variables are also used for serial, internal printer, and all supported external printer outputs. Table D-11 Variable Field Definitions Variable Definition Represents the space character * Represents the position used for marking a test result as abnormal for serial output, 80-column printer output, and form printer output. If Identify Abnormals is set to ON and the test result can be marked abnormal, an asterisk (*) is placed in this field. If this position is not used for the abnormal flag, it is filled with the space character. Represents the position used for marking a test result as abnormal for internal printer output. If Identify Abnormals is set to ON and the test result can be marked abnormal, a block character () is placed in this field. If this position is not used for the abnormal flag, it is filled with the space character. Ck1Ck2 Represents the checksum digits of the test results packet. <CR> Carriage Return control character <LF> Line Feed control character <ETX> End of Text control character <STX> Start of Text control character A Represents the Sequence Number assigned to the test result. B Represents the date in the user-selected format. Valid formats are MM-DD-YY, DD-MM-YY, and YY-MM-DD. C Represents the Specimen ID. The Specimen ID field can contain a maximum of 13 characters. Character positions not used are filled with the space character. The field is left justified. D Represents the color of the specimen. The translation for the word Color plus a colon and a space character plus the actual color value always equals 20 characters. Character positions not used are filled with the space character. The field is left justified. E Represents the clarity of the specimen. The translation for the word Clarity plus a colon and a space character plus the actual clarity value always equals 20 characters. Character positions not used are filled with the space character. The field is left justified. F Represents the clinical result for the test pad. The test result contains 12 characters. Character positions not used are filled with the space character. The field is left justified. D–8 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A

CLINICAL Results Format Output Global Formatting Requirements for all CLINICAL Mode Results While the order of presentation of test pad results is user-selectable, general sample information is always presented before the actual test results. That is, the Sequence Number assigned to the test result, the date of the test, the Specimen ID, and the Color and Clarity of the sample are always reported before the individual test results are reported. The number of lines of general information reported is dependent upon whether the Specimen ID option is set to ON or OFF.

For those tests that can be marked as abnormal (positive), an asterisk (*) is used to designate the clinical result as being outside of the normal range for serial output, 80-column printer output, and form printer output. For output to the internal printer, the block character () designates the clinical result as being outside of the normal range of results. For serial output data, the asterisk is always placed directly to the right of the reagent tag of the abnormal test result. For printed output data, the asterisk or block character is always placed directly to the left of the reagent tag of the abnormal test result. Table D-12 Serial Data Results Formats for General Information Variable Definition G Represents the quantitative result for the A:C Ratio. This field is variable in length and contains only the test result. H Represents the qualitative result for the A:C Ratio. This field is variable in length and contains only the test result. I If the P:C ratio is Normal Dilute or Normal this field displays that value. If the P:C ratio is Abnormal, this field contains the quantitative result for the P:C Ratio. This field is variable in length and contains only the test result. J If the P:C ratio is Abnormal contains the translation for Abnormal; otherwise this line is not printed (sent). Line # Line Content Specimen ID Set to NO Line Content Specimen ID Set to YES 1 <STX><CR><LF> <STX><CR><LF> 2 #A-AAABB-BB-BB<CR><LF> #A-AAABB-BB-BB<CR><LF> 3 ID=CCCCCCCCCCCCC<CR><LF> 4 Color:DDDDDDDDDD<CR><LF> 5 Clarity:EEEEEEEEEE<CR><LF> Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–9 04826807 Rev. A

Multistix Family of Test Strips Test result lines are present only for the test pads on the test strip. If a particular test pad is not present on the test strip, that test result line is eliminated. The default order of data output is the order of the reagent test pads on the test strip beginning with Channel 1. The output order can be rearranged by the operator. The format example uses a Multistix 10 SG test strip because that test strip supports all the reagent test pads in the Multistix family of test strips. The reagent tags used in the data are the tags supported by the language/unit selection. Serial Output Format Each line contains 20 characters plus the <CR><LF> control characters. Table D-13 Multistix Family of Test Strips NOTE:Lines 3, 4, and 5 are eliminated if the Specimen ID option is set to NO. When the Specimen ID option is set to YES, but the Color and/or Clarity options are set to NO, the Color value field and/or the Clarity value field are filled with the space character. Line # Line Content 1 <STX><CR><LF> 2 #A-AAABB-BB-BB<CR><LF> 3 ID=CCCCCCCCCCCCC<CR><LF> 4 Color:DDDDDDDDDD<CR><LF> 5 Clarity:EEEEEEEEEE<CR><LF> 6 GLU*FFFFFFFFFFFFFF<CR><LF> 7 BIL*FFFFFFFFFFFFFF<CR><LF> 8 KET*FFFFFFFFFFFFFF<CR><LF> 9 SGFFFFFFFFFFFFFF<CR><LF> 10 BLO*FFFFFFFFFFFFFF<CR><LF> 11 pHFFFFFFFFFFFFFF<CR><LF> PRO*FFFFFFFFFFFFFF<CR><LF> 12 URO*FFFFFFFFFFFFFF<CR><LF>

13 NIT*FFFFFFFFFFFFFF<CR><LF> 15 LEU*FFFFFFFFFFFFFF<CR><LF> 16 Ck1Ck2<ETX> D–10 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A

Multistix PRO® Family of Test Strips Test result lines are present only for the test pads on the test strip. If a particular test pad is not present on the test strip, that test result line is eliminated. The default order of data output is the order of the reagent test pads on the test strip beginning with Channel 1, with the exception of PRO, ALB, CRE and the ratios. PRO, ALB, CRE, A:C, and P:C are reported in that order after all other test pad results have been reported. The output order for any of the test pad results can be rearranged by the operator, but the ratio results are always output last and their order cannot be altered. The format examples do not represent valid test strips because there is no test strip in this family that supports all the test pads. The examples use all the possible test pads to illustrate the default order in which the results are reported. Test results for the ALB test pad are only reported for Multistix PRO 6B and Multistix PRO 6K test strips. For the other test strips in the Multistix PRO family, the ALB test pad is used in determining the clinical result reported for PRO. Likewise, the A:C ratio is only reported for the Multistix PRO 6B and Multistix PRO 6K test strips. Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–11 04826807 Rev. A Serial Output Format With the exception of the lines used for reporting ratio results, each line contains 20 characters plus the <CR><LF> control characters. The lines used for reporting ratio results are variable in length. Table D-14 Multistix PRO 10LB, 10LS, 10SB, 10, 7G, 7PH NOTE:Lines 3, 4, and 5 are eliminated if the Specimen ID option is set to NO. When the Specimen ID option is set to YES, but the Color and/or Clarity options are set to NO, the Color value field and/or the Clarity value field are filled with the space character. NOTE:If the P:C result is Normal or Normal Dilute, there is no quantitative (I) result reported. The qualitative result (J) is reported in its place. Line # Line Content 1 <STX><CR><LF> 2 #A-AAABB-BB-BB<CR><LF> 3 ID=CCCCCCCCCCCCC<CR><LF> 4 Color:DDDDDDDDDD<CR><LF> 5 Clarity:EEEEEEEEEE<CR><LF> 6 GLU*FFFFFFFFFFFFFF<CR><LF> 7 BIL*FFFFFFFFFFFFFF<CR><LF> 8 KET*FFFFFFFFFFFFFF<CR><LF> 9 SGFFFFFFFFFFFFFF<CR><LF> 10 BLO*FFFFFFFFFFFFFF<CR><LF> 11 pHFFFFFFFFFFFFFF<CR><LF> 12 URO*FFFFFFFFFFFFFF<CR><LF> 13 NIT*FFFFFFFFFFFFFF<CR><LF> 14 LEU*FFFFFFFFFFFFFF<CR><LF> 15 PRO*FFFFFFFFFFFFFF<CR><LF> 16 CREFFFFFFFFFFFFFF<CR><LF> 17 P:C*IIIIIIIIIIIII,JJJJJJJJJJJJJJ<CR><LF> 18 Ck1Ck2<ETX> D–12 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A Table D-15 Multistix PRO 6B, 6K NOTE:Lines 3, 4, and 5 are eliminated if the Specimen ID option is set to NO. When the Specimen ID option is set to YES, but the Color and/or Clarity options are set to NO, the Color value field and/or the Clarity value field are filled with the space character. NOTE:If the P:C result is Normal or Normal Dilute, there is no quantitative (I) result

Line # Line Content 1 <STX><CR><LF> 2 #A-AAABB-BB-BB<CR><LF> 3 ID=CCCCCCCCCCCCC<CR><LF> 4 Color:DDDDDDDDDD<CR><LF> 5 Clarity:EEEEEEEEEE<CR><LF> 6 GLU*FFFFFFFFFFFFFF<CR><LF> 7 KET*FFFFFFFFFFFFFF<CR><LF> 8 BLO*FFFFFFFFFFFFFF<CR><LF> 9 pHFFFFFFFFFFFFFF<CR><LF> 10 PRO*FFFFFFFFFFFFFF<CR><LF> 11 ALBFFFFFFFFFFFFFF<CR><LF> 12 CREFFFFFFFFFFFFFF<CR><LF> 13 A:C*GGGGGGGGGGGGGGGG,HHHHHHHHHHHHHHHHH<CR><LF> 14 P:C*IIIIIIIIIIIII,JJJJJJJJJJJJJJ<CR><LF> 15 Ck1Ck2<ETX> Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–13 04826807 Rev. A

Result Value Conversions from Clinitek Advantus and Clinitek 500 to Clinitek 200 English Conventional with PLUS System set to OFF Supports Clinitek 200 Program Card A40100 Test Clinitek Advantus or 500 Clinitek 200 Glucose (GLU) NEGATIVE 100 mg/dL 250 mg/dL 500 mg/dL ≥1000 mg/dL NEGATIVE 100 mg/dL 250 mg/dL 500 mg/dL ≥1000 mg/dL Bilirubin (BIL) NEGATIVE SMALL MODERATE LARGE NEGATIVE SMALL MODERATE LARGE Ketone (KET) NEGATIVE TRACE 15 mg/dL 40 mg/dL ≥80 mg/dL NEGATIVE TRACE 15 mg/dL 40 mg/dL ≥80 mg/dL Specific Gravity (SG) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025

≥1.030 Blood (BLO) NEGATIVE TRACE-INTACT TRACE-LYSED SMALL MODERATE LARGE NEGATIVE TRACE TRACE SMALL MODERATE LARGE pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) NEGATIVE TRACE 30 mg/dL 100 mg/dL ≥300 mg/dL NEGATIVE TRACE 30 mg/dL 100 mg/dL ≥300 mg/dL Urobilinogen (URO) 0.2 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL 0.2 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL Nitrite (NIT) NEGATIVE POSITIVE NEGATIVE POSITIVE Leukocytes (LEU) NEGATIVE TRACE SMALL MODERATE LARGE NEGATIVE TRACE SMALL MODERATE LARGE D–14 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A English Conventional with PLUS System set to ON Supports Clinitek 200 Program Card A40100 Test

Clinitek Advantus or 500 Clinitek 200 Glucose (GLU) NEGATIVE TRACE 1+ 2+ 3+ NEGATIVE 100 mg/dL 250 mg/dL 500 mg/dL ≥1000 mg/dL Bilirubin (BIL) NEGATIVE 1+ 2+ 3+ NEGATIVE SMALL MODERATE LARGE Ketone (KET) NEGATIVE TRACE 1+ 2+ 3+ NEGATIVE TRACE 15 mg/dL 40 mg/dL ≥80 mg/dL Specific Gravity (SG) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (BLO) NEGATIVE TRACE-INTACT TRACE-LYSED 1+ 2+ 3+ NEGATIVE TRACE TRACE SMALL MODERATE LARGE pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5

≥9.0 Protein (PRO) NEGATIVE TRACE 1+ 2+ 3+ NEGATIVE NEGATIVE 30 mg/dL 100 mg/dL ≥300 mg/dL Urobilinogen (URO) 0.2 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL 0.2 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL Nitrite (NIT) NEGATIVE POSITIVE NEGATIVE POSITIVE Leukocytes (LEU) NEGATIVE TRACE 1+ 2+ 3+ NEGATIVE TRACE SMALL MODERATE LARGE Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–15 04826807 Rev. A English Nordic with PLUS System set to OFF Supports Clinitek 200 Program Card A40101 Test Clinitek Advantus or 500 Clinitek 200 Glucose (GLU) NEGATIVE 1+ 2+ 3+ 4+ NEGATIVE TRACE + ++ +++ Bilirubin (BIL) NEGATIVE 1+ 2+ 3+ NEGATIVE + ++ +++ Ketone (KET) NEGATIVE 1+ 2+ 3+ 4+ NEGATIVE TRACE + ++ +++

Specific Gravity (SG) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (BLO) NEGATIVE +/- INTACT +/- 1+ 2+ 3+ NEGATIVE TRACE TRACE + ++ +++ pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) NEGATIVE +/- 1+ 2+ 3+ NEGATIVE TRACE + ++ +++ Urobilinogen (UBG) 3.2 umol/L 16 umol/L 33 umol/L 66 umol/L ≥131 umol/L NORMAL NORMAL + ++ +++ Nitrite (NIT) NEGATIVE POSITIVE NEGATIVE POSITIVE Leukocytes (LEU) NEGATIVE 1+ 2+ 3+ 4+

NEGATIVE TRACE + ++ +++ D–16 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A English Nordic with PLUS System set to ON Supports Clinitek 200 Program Card C40103 Test Clinitek Advantus or 500 Clinitek 200 Glucose (GLU) NEGATIVE TRACE 1+ 2+ 3+ NEGATIVE TRACE + ++ +++ Bilirubin (BIL) NEGATIVE 1+ 2+ 3+ NEGATIVE + ++ +++ Ketone (KET) NEGATIVE TRACE 1+ 2+ 3+ NEGATIVE TRACE + ++ +++ Specific Gravity (SG) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (BLO) NEGATIVE +/- INTACT +/- 1+ 2+ 3+ NEGATIVE TRACE TRACE + ++ +++ pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5

8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) NEGATIVE TRACE 1+ 2+ 3+ NEGATIVE TRACE + ++ +++ Urobilinogen (URO) 3.2 umol/L 16 umol/L 33 umol/L 66 umol/L ≥131 umol/L NORMAL NORMAL + ++ +++ Nitrite (NIT) NEGATIVE POSITIVE NEGATIVE + Leukocytes (LEU) NEGATIVE TRACE 1+ 2+ 3+ NEGATIVE TRACE + ++ +++ Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–17 04826807 Rev. A English S.I. with PLUS System set to OFF Supports Clinitek 200 Program Card C40104 Test Clinitek Advantus or 500 Clinitek 200 Glucose (GLU) NEGATIVE 5.5 mmol/L 14 mmol/L 28 mmol/L ≥55 mmol/L NEGATIVE 5.5 mmol/L 14 mmol/L 28 mmol/L ≥55 mmol/L Bilirubin (BIL) NEGATIVE SMALL MODERATE LARGE NEGATIVE SMALL MODERATE

LARGE Ketone (KET) NEGATIVE TRACE 1.5 mmol/L 3.9 mmol/L ≥7.8 mmol/L NEGATIVE TRACE 1.5 mmol/L 3.9 mmol/L ≥7.8 mmol/L Specific Gravity (SG) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (BLO) NEGATIVE TRACE-INTACT TRACE-LYSED Ca 25 Ery/uL Ca 80 Ery/uL Ca 200 Ery/uL NEGATIVE TRACE TRACE SMALL MODERATE LARGE pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) NEGATIVE TRACE 0.3 g/L 1.0 g/L ≥3.0 g/L NEGATIVE TRACE 0.3 g/L 1.0 g/L ≥3.0 g/L Urobilinogen (URO) 3.2 umol/L 16 umol/L 33 umol/L 66 umol/L ≥131 umol/L 3.2 umol/L 16 umol/L 33 umol/L

66 umol/L ≥131 umol/L Nitrite (NIT) NEGATIVE POSITIVE NEGATIVE POSITIVE Leukocytes (LEU) NEGATIVE Ca 15 Leu/uL Ca 70 Leu/uL Ca 125 Leu/uL Ca 500 Leu/uL NEGATIVE TRACE SMALL MODERATE LARGE D–18 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A English S.I. with PLUS System set to ON Supports Clinitek 200 Program Card C40102 Test Clinitek Advantus or 500 Clinitek 200 Glucose (GLU) NEGATIVE TRACE 1+ 2+ 3+ NEGATIVE + ++ ++ +++ Bilirubin (BIL) NEGATIVE 1+ 2+ 3+ NEGATIVE SMALL MODERATE LARGE Ketone (KET) NEGATIVE TRACE 1+ 2+ 3+ NEGATIVE ++ ++ +++ Specific Gravity (SG) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (BLO) NEGATIVE TRACE-INTACT TRACE-LYSED 1+ 2+ 3+ NEGATIVE +++

++ +++ pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) NEGATIVE TRACE 1+ 2+ 3+ NEGATIVE NEGATIVE + ++ +++ Urobilinogen (URO) 3.2 umol/L 16 umol/L 33 umol/L 66 umol/L ≥131 umol/L 3.2 umol/L 16 umol/L 33 umol/L 66 umol/L ≥131 umol/L Nitrite (NIT) NEGATIVE POSITIVE NEGATIVE + Leukocytes (LEU) NEGATIVE TRACE 1+ 2+ 3+ NEGATIVE ++ ++ +++ Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–19 04826807 Rev. A French Conventional with PLUS System set to OFF Supports Clinitek 200 Program Card G40100 Test Clinitek Advantus or 500 Clinitek 200 Glucose (GLU) NEGATIF TRACES 2.5 g/L 5.0 g/L ≥10.0 g/L NEGATIF 100 mg/dL 250 mg/dL 500 mg/dL ≥1000 mg/dL

Bilirubin (BIL) NEGATIF FAIBLE MOYEN FORT NEGATIF FAIBLE MOYEN FORT Ketone (CET) NEGATIF TRACES 0.15 g/L 0.4 g/L ≥0.8 g/L NEGATIF TRACE 15 mg/dL 40 mg/dL ≥80 mg/dL Specific Gravity (DEN) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (SNG) NEGATIF TRACES-INTACT TRACES-LYSE env. 25 GR/uL env. 80 GR/uL env. 200 GR/uL NEGATIF TRACE TRACE FAIBLE MOYEN FORT pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) NEGATIF TRACES 0.3 g/L 1.0 g/L ≥3.0 g/L NEGATIF TRACE 30 mg/dL 100 mg/dL ≥300 mg/dL Urobilinogen (URO) 0.2 mg/dL

1.0 mg/dL 2.0 mg/dL 4.0 mg/dL ≥8.0 mg/dL 0.2 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL Nitrite (NIT) NEGATIF POSITIF NEGATIF POSITIF Leukocytes (LEU) NEGATIF env. 15 GB/uL env. 70 GB/uL env. 125 GB/uL env. 500 GB/uL NEGATIF Ca 15 cells/uL Ca 70 cells/uL Ca 125 cells/uL Ca 500 cells/uL D–20 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A French Conventional with PLUS System set to ON Supports Clinitek 200 Program Card G40100 Test Clinitek Advantus or 500 Clinitek 200 Glucose (GLU) NEGATIF TRACES 1+ 2+ 3+ NEGATIF 100 mg/dL 250 mg/dL 500 mg/dL ≥1000 mg/dL Bilirubin (BIL) NEGATIF 1+ 2+ 3+ NEGATIF FAIBLE MOYEN FORT Ketone (CET) NEGATIF TRACES 1+ 2+ 3+ NEGATIF TRACE 15 mg/dL 40 mg/dL ≥80 mg/dL Specific Gravity (DEN) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030

Blood (SNG) NEGATIF TRACES-INTACT TRACES-LYSE 1+ 2+ 3+ NEGATIF TRACE TRACE FAIBLE MOYEN FORT pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) NEGATIF TRACES 1+ 2+ 3+ NEGATIF TRACE 30 mg/dL 100 mg/dL ≥300 mg/dL Urobilinogen (URO) 0.2 mg/dL 1.0 mg/dL 2.0 mg/dL 4.0 mg/dL ≥8.0 mg/dL 0.2 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL Nitrite (NIT) NEGATIF POSITIF NEGATIF POSITIF Leukocytes (LEU) NEGATIF TRACES 1+ 2+ 3+ NEGATIF Ca 15 cells/uL Ca 70 cells/uL Ca 125 cells/uL Ca 500 cells/uL Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–21 04826807 Rev. A French S.I. with PLUS System set to OFF Supports Clinitek 200 Program Card H40100 Test Clinitek Advantus or

500 Clinitek 200 Glucose (GLU) NEGATIF 5.5 mmol/L 14 mmol/L 28 mmol/L ≥55 mmol/L NEGATIF 5.5 mmol/L 14 mmol/L 28 mmol/L ≥55 mmol/L Bilirubin (BIL) NEGATIF FAIBLE MOYEN FORT NEGATIF FAIBLE MOYEN FORT Ketone (CET) NEGATIF TRACES 1.5 mmol/L 3.9 mmol/L ≥7.8 mmol/L NEGATIF TRACES 1.5 mmol/L 3.9 mmol/L ≥7.8 mmol/L Specific Gravity (DEN) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (SNG) TRACES-INTACT TRACES-LYSE FAIBLE MOYEN FORT NEGATIF ENV. 10 GR/uL ENV. 10 GR/uL ENV. 25 GR/uL ENV. 80 GR/uL ENV. 200 GR/uL pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) NEGATIF

TRACES 0.3 g/L 1.0 g/L ≥3.0 g/L NEGATIF TRACES 0.3 g/L 1.0 g/L ≥3.0 g/L Urobilinogen (URO) 3.2 umol/L 16 umol/L 33 umol/L 66 umol/L ≥131 umol/L 3.2 umol/L 16 umol/L 33 umol/L 66 umol/L ≥131 umol/L Nitrite (NIT) NEGATIF POSITIF NEGATIF POSITIF Leukocytes (LEU) NEGATIF TRACES FAIBLE MOYEN FORT NEGATIF ENV. 15 LEU/uL ENV. 70 LEU/uL ENV. 125 LEU/uL ENV. 500 LEU/uL D–22 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A French S.I. with PLUS System set to ON Supports Clinitek 200 Program Card H40100 Test Clinitek Advantus or 500 Clinitek 200 Glucose (GLU) NEGATIF TRACES 1+ 2+ 3+ NEGATIF 5.5 mmol/L 14 mmol/L 28 mmol/L ≥55 mmol/L Bilirubin (BIL) NEGATIF 1+ 2+ 3+ NEGATIF FAIBLE MOYEN FORT Ketone (CET) NEGATIF TRACES 1+ 2+ 3+ NEGATIF TRACES 1.5 mmol/L 3.9 mmol/L ≥7.8 mmol/L Specific Gravity (DEN) ≤ 1.005 1.010

1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (SNG) NEGATIF TRACES-INTACT TRACES-LYSE 1+ 2+ 3+ NEGATIF ENV. 10 GR/uL ENV. 10 GR/uL ENV. 25 GR/uL ENV. 80 GR/uL ENV. 200 GR/uL pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) NEGATIF TRACES 1+ 2+ 3+ NEGATIF TRACES 0.3 g/L 1.0 g/L ≥3.0 g/L Urobilinogen (URO) 3.2 umol/L 16 umol/L 33 umol/L 66 umol/L ≥131 umol/L 3.2 umol/L 16 umol/L 33 umol/L 66 umol/L ≥131 umol/L Nitrite (NIT) NEGATIF POSITIF NEGATIF POSITIF Leukocytes (LEU) NEGATIF TRACES 1+ 2+ 3+ NEGATIF ENV. 15 LEU/uL

ENV. 70 LEU/uL ENV. 125 LEU/uL ENV. 500 LEU/uL Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–23 04826807 Rev. A German Conventional with PLUS System set to OFF Supports Clinitek 200 Program Card F40100 Test Clinitek Advantus or 500 Clinitek 200 Glucose (GLU) NEGATIV 100 mg/dL 250 mg/dL 500 mg/dL ≥1000 mg/dL NEGATIV 100 mg/dL 250 mg/dL 500 mg/dL ≥1000 mg/dL Bilirubin (BIL) NEGATIV SCHWACH MAESSIG STARK NEGATIV SCHWACH MAESSIG STARK Ketone (KET) NEGATIV SPUR 15 mg/dL 40 mg/dL ≥80 mg/dL NEGATIV SPUR 15 mg/dL 40 mg/dL ≥80 mg/dL Specific Gravity (SG) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (OBL) 0 Ery/uL Ca 10 Ery/uL Ca 10 Ery/uL Ca 25 Ery/uL Ca 80 Ery/uL Ca 200 Ery/uL 0 rbc/uL Ca 10 rbc/uL Ca 10 rbc/uL Ca 25 rbc/uL Ca 80 rbc/uL Ca 200 rbc/uL pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5

≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) NEGATIV SPUR 30 mg/dL 100 mg/dL ≥300 mg/dL NEGATIV SPUR 30 mg/dL 100 mg/dL ≥300 mg/dL Urobilinogen (UBG) 0.2 mg/dL 1.0 mg/dL 2.0 mg/dL 4.0 mg/dL ≥8.0 mg/dL 0.2 mg/dL 1.0 mg/dL 2.0 mg/dL 4.0 mg/dL ≥8.0 mg/dL Nitrite (NIT) NEGATIV POSITIV NEGATIV POSITIV Leukocytes (LEU) 0 Leu/uL Ca 15 Leu/uL Ca 70 Leu/uL Ca 125 Leu/uL Ca 500 Leu/uL 0 cells/uL Ca 15 cells/uL Ca 70 cells/uL Ca 125 cells/uL Ca 500 cells/uL D–24 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A German Conventional with PLUS System set to ON Supports Clinitek 200 Program Card F40100 Test Clinitek Advantus or 500 Clinitek 200 Glucose (GLU) NEGATIV SPUR 1+ 2+ 3+ NEGATIV 100 mg/dL 250 mg/dL 500 mg/dL ≥1000 mg/dL Bilirubin (BIL) NEGATIV 1+ 2+ 3+ NEGATIV SCHWACH MAESSIG STARK Ketone (KET) NEGATIV

SPUR 1+ 2+ 3+ NEGATIV SPUR 15 mg/dL 40 mg/dL ≥80 mg/dL Specific Gravity (SG) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (OBL) NEGATIV SPUR-ZELLEN SPURLYSE 1+ 2+ 3+ 0 rbc/uL Ca 10 rbc/uL Ca 10 rbc/uL Ca 25 rbc/uL Ca 80 rbc/uL Ca 200 rbc/uL pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) NEGATIV SPUR 1+ 2+ 3+ NEGATIV SPUR 30 mg/dL 100 mg/dL ≥300 mg/dL Urobilinogen (UBG) 0.2 mg/dL 1.0 mg/dL 2.0 mg/dL 4.0 mg/dL ≥8.0 mg/dL 0.2 mg/dL 1.0 mg/dL 2.0 mg/dL 4.0 mg/dL ≥8.0 mg/dL

Nitrite (NIT) NEGATIV POSITIV NEGATIV POSITIV Leukocytes (LEU) NEGATIV SPUR 1+ 2+ 3+ 0 cells/uL Ca 15 cells/uL Ca 70 cells/uL Ca 125 cells/uL Ca 500 cells/uL Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–25 04826807 Rev. A German S.I. with PLUS System set to OFF Supports Clinitek 200 Program Card C40104 Test Clinitek Advantus or 500 Clinitek 200 Glucose (GLU) NEGATIV 5.5 mmol/L 14 mmol/L 28 mmol/L ≥55 mmol/L NEGATIV 100 mg/dL 250 mg/dL 500 mg/dL ≥1000 mg/dL Bilirubin (BIL) NEGATIV SCHWACH MAESSIG STARK NEGATIV SCHWACH MAESSIG STARK Ketone (KET) NEGATIV SPUR 1.5 mmol/L 3.9 mmol/L ≥7.8 mmol/L NEGATIV SPUR 15 mg/dL 40 mg/dL ≥80 mg/dL Specific Gravity (SG) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (OBL) 0 Ery/uL Ca 10 Ery/uL Ca 10 Ery/uL Ca 25 Ery/uL Ca 80 Ery/uL Ca 200 Ery/uL 0 rbc/uL Ca 10 rbc/uL Ca 10 rbc/uL

Ca 25 rbc/uL Ca 80 rbc/uL Ca 200 rbc/uL pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) NEGATIV SPUR 0.3 g/L 1.0 g/L ≥3.0 g/L NEGATIV SPUR 30 mg/dL 100 mg/dL ≥300 mg/dL Urobilinogen (UBG) 3.2 umol/L 16 umol/L 33 umol/L 66 umol/L ≥131 umol/L 0.2 mg/dL 1.0 mg/dL 2.0 mg/dL 4.0 mg/dL ≥8.0 mg/dL Nitrite (NIT) NEGATIV POSITIV NEGATIV POSITIV Leukocytes (LEU) NEGATIV Ca 15 Leu/uL Ca 70 Leu/uL Ca 125 Leu/uL Ca 500 Leu/uL 0 cells/uL Ca 15 cells/uL Ca 70 cells/uL Ca 125 cells/uL Ca 500 cells/uL D–26 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A German S.I. with PLUS System set to ON Supports Clinitek 200 Program Card c40104 Test Clinitek Advantus or 500 Clinitek 200 Glucose (GLU) NEGATIV SPUR 1+ 2+ 3+ NEGATIV 100 mg/dL 250 mg/dL

500 mg/dL ≥1000 mg/dL Bilirubin (BIL) NEGATIV 1+ 2+ 3+ NEGATIV SCHWACH MAESSIG STARK Ketone (KET) NEGATIV SPUR 1+ 2+ 3+ NEGATIV SPUR 15 mg/dL 40 mg/dL ≥80 mg/dL Specific Gravity (SG) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (OBL) NEGATIV SPUR-ZELLEN SPUR-LYSE 1+ 2+ 3+ 0 rbc/uL Ca 10 rbc/uL Ca 10 rbc/uL Ca 25 rbc/uL Ca 80 rbc/uL Ca 200 rbc/uL pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) NEGATIV SPUR 1+ 2+ 3+ NEGATIV SPUR 30 mg/dL 100 mg/dL

≥300 mg/dL Urobilinogen (UBG) 3.2 umol/L 16 umol/L 33 umol/L 66 umol/L ≥131 umol/L 0.2 mg/dL 1.0 mg/dL 2.0 mg/dL 4.0 mg/dL ≥8.0 mg/dL Nitrite (NIT) NEGATIV POSITIV NEGATIV POSITIV Leukocytes (LEU) NEGATIV SPUR 1+ 2+ 3+ 0 cells/uL Ca 15 cells/uL Ca 70 cells/uL Ca 125 cells/uL Ca 500 cells/uL Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–27 04826807 Rev. A Italian with PLUS System set to OFF Supports Clinitek 200 Program Card E40100 Test Clinitek Advantus or 500 Clinitek 200 Glucose (GLU) NEGATIVO 1.0 g/L 2.5 g/L 5.0 g/L ≥10.0 g/L NEGATIVO 0.1 g/dL 0.25 g/dL 0.50 g/dL ≥1.0 g/dL Bilirubin (BIL) NEGATIVO LEGGERO MEDIO FORTE NEGATIVO LEGGERO MEDIO FORTE Ketone (KET) NEGATIVO TRACCE 15 mg/dL 40 mg/dL ≥80 mg/dL NEGATIVO TRACCE 15 mg/dL 40 mg/dL ≥80 mg/dL Specific Gravity (PS) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020

1.025 ≥1.030 Blood (SAN) NEGATIVO TRACCE(INT.) TRACCE(LIS.) LEGGERO MEDIO FORTE NEGATIVO TRACCE TRACCE LEGGERO MEDIO FORTE pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) NEGATIVO TRACCE 30 mg/dL 100 mg/dL ≥300 mg/dL NEGATIVO TRACCE 30 mg/dL 100 mg/dL ≥300 mg/dL Urobilinogen (URO) 0.2 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL 0.2 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL Nitrite (NIT) NEGATIVO POSITIVO NEGATIVO POSITIVO Leukocytes (LEU) NEGATIVO Ca 15 Cel/uL Ca 70 Cel/uL Ca 125 Cel/uL Ca 500 Cel/uL NEGATIVO Ca 15 cells/uL Ca 70 cells/uL Ca 125 cells/uL Ca 500 cells/uL D–28 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A Italian with PLUS System set to ON Supports Clinitek 200 Program Card E40100

Test Clinitek Advantus or 500 Clinitek 200 Glucose (GLU) NEGATIVO TRACCE 1+ 2+ 3+ NEGATIVO 0.1 g/dL 0.25 g/dL 0.50 g/dL ≥1.0 g/dL Bilirubin (BIL) NEGATIVO 1+ 2+ 3+ NEGATIVO LEGGERO MEDIO FORTE Ketone (KET) NEGATIVO TRACCE 1+ 2+ 3+ NEGATIVO TRACCE 15 mg/dL 40 mg/dL ≥80 mg/dL Specific Gravity (PS) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (SAN) NEGATIVO TRACCE(INT.) TRACCE(LIS.) 1+ 2+ 3+ NEGATIVO TRACCE TRACCE LEGGERO MEDIO FORTE pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0

8.5 ≥9.0 Protein (PRO) NEGATIVO TRACCE 1+ 2+ 3+ NEGATIVO TRACCE 30 mg/dL 100 mg/dL ≥300 mg/dL Urobilinogen (URO) 0.2 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL 0.2 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL Nitrite (NIT) NEGATIVO POSITIVO NEGATIVO POSITIVO Leukocytes (LEU) NEGATIVO TRACCE 1+ 2+ 3+ NEGATIVO Ca 15 cells/uL Ca 70 cells/uL Ca 125 cells/uL Ca 500 cells/uL Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–29 04826807 Rev. A Japanese Conventional with PLUS System set to OFF Supports Clinitek 200 Program Card B40101 Test Clinitek Advantus or 500 Clinitek 200 Glucose (GLU) - 0.1 g/dL 0.25 g/dL 0.5 g/dL ≥1.0 g/dL - 0.1 g/dL 0.25 g/dL 0.5 g/dL ≥1.0 g/dL Bilirubin (BIL) - 1+ 2+ 3+ - 1+ 2+ 3+ Ketone (KET) - +/- 1+ 2+ 3+ - +/- 1+ 2+

3+ Specific Gravity (SG) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (OB) - +/-INTACT +/-LYSED 1+ 2+ 3+ - +/- +/- 1+ 2+ 3+ pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) - +/- 30 mg/dL 100 mg/dL ≥300 mg/dL - +/- 30 mg/dL 100 mg/dL ≥300 mg/dL Urobilinogen (URO) 0.1 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL 0.1 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL Nitrite (NIT) -+- + Leukocytes (WBC) - +/- 1+ 2+ 3+ -

+/- 1+ 2+ 3+ D–30 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A Japanese Conventional with PLUS System set to ON Supports Clinitek 200 Program Card B40101 Test Clinitek Advantus or 500 Clinitek 200 Glucose (GLU) - +/- 1+ 2+ 3+ - 0.1 g/dL 0.25 g/dL 0.5 g/dL ≥1.0 g/dL Bilirubin (BIL) - 1+ 2+ 3+ - 1+ 2+ 3+ Ketone (KET) - +/- 1+ 2+ 3+ - +/- 1+ 2+ 3+ Specific Gravity (SG) ≤1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (OB) - +/-INTACT +/-LYSED 1+ 2+ 3+ - +/- +/- 1+ 2+ 3+ pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0

8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) - +/- 1+ 2+ 3+ - +/- 30 mg/dL 100 mg/dL ≥300 mg/dL Urobilinogen (URO) 0.1 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL 0.1 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL Nitrite (NIT) -+ - + Leukocytes (WBC) - +/- 1+ 2+ 3+ - +/- 1+ 2+ 3+ Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–31 04826807 Rev. A Japanese JCCLS with PLUS System set to OFF Supports Clinitek 200 Program Card B40101 Test Clinitek Advantus or 500 Clinitek 200 Glucose (GLU) - 100 mg/dL 250 mg/dL 500 mg/dL ≥1000 mg/dL - 100 mg/dL 250 mg/dL 500 mg/dL ≥1000 mg/dL Bilirubin (BIL) - 1+ 2+ 3+ - 1+ 2+ 3+ Ketone (KET) -

+/- 1+ 2+ 3+ - +/- 1+ 2+ 3+ Specific Gravity (SG) ≤1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (OB) - +/-LYSED +/-INTACT 1+ 2+ 3+ - +/- +/- 1+ 2+ 3+ pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) - +/- 30 mg/dL 100 mg/dL ≥300 mg/dL - +/- 30 mg/dL 100 mg/dL ≥300 mg/dL Urobilinogen (URO) 0.1 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL 0.1 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL

Nitrite (NIT) -+- + Leukocytes (WBC) - +/- 1+ 2+ 3+ - +/- 1+ 2+ 3+ D–32 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A Japanese JCCLS with PLUS System set to ON Supports Clinitek 200 Program Card B40101 Test Clinitek Advantus or 500 Clinitek 200 Glucose (GLU) - 1+ 2+ 3+ 4+ - 1+ 2+ 3+ 4+ Bilirubin (BIL) - 1+ 2+ 3+ - 1+ 2+ 3+ Ketone (KET) - +/- 1+ 2+ 3+ - +/- 1+ 2+ 3+ Specific Gravity (SG) ≤1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (OB) - +/-LYSED +/-INTACT 1+ 2+ 3+ - +/- +/- 1+ 2+

3+ pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) - +/- 1+ 2+ 3+ - +/- 30 mg/dL 100 mg/dL ≥300 mg/dL Urobilinogen (URO) 0.1 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL 0.1 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL Nitrite (NIT) -+ - + Leukocytes (WBC) - +/- 1+ 2+ 3+ - +/- 1+ 2+ 3+ Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–33 04826807 Rev. A Spanish with PLUS System set to OFF Supports Clinitek 200 Program Card D40100 Test Clinitek Advantus or 500 Clinitek 200 Glucose (GLU) NEGATIVO 100 mg/dL 250 mg/dL 500 mg/dL ≥1000 mg/dL NEGATIV 100 mg/dL 250 mg/dL 500 mg/dL ≥1000 mg/dL Bilirubin (BIL) NEGATIVO

BAJO MODERADO ALTO NEGATIVO BAJO MODERADO ALTO Ketone (CET) NEGATIVO INDICIOS 15 mg/dL 40 mg/dL ≥80 mg/dL NEGATIVO INDICIOS 15 mg/dL 40 mg/dL ≥80 mg/dL Specific Gravity (DEN) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (SAN) NEGATIVO IND.INTACTOS IND.HEMOLIZ. Apr 25 Hem/uL Apr 80 Hem/uL Apr 200 Hem/uL NEGATIVO Apro 10 ERI/uL Apro 10 ERI/uL Apro 25 ERI/uL Apro 80 ERI/uL Apro 200 ERI/uL pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) NEGATIVO INDICIOS 30 mg/dL 100 mg/dL ≥300 mg/dL NEGATIVO INDICIOS 30 mg/dL 100 mg/dL ≥300 mg/dL Urobilinogen (URO) 0.2 E.U./dL 1.0 E.U./dL

2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL 0.2 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL Nitrite (NIT) NEGATIVO POSITIVO NEGATIVO POSITIVO Leukocytes (LEU) NEGATIVO Apr 15 Leu/uL Apr 70 Leu/uL Apr 125 Leu/uL Apr 500 Leu/uL NEGATIVO Apro 15 cel/uL Apro 70 cel/uL Apro 125 cel/uL Apro 500 cel/uL D–34 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A Spanish with PLUS System set to ON Supports Clinitek 200 Program Card D40100 Test Clinitek Advantus or 500 Clinitek 200 Glucose (GLU) NEGATIVO INDICIOS 1+ 2+ 3+ NEGATIVO 100 mg/dL 250 mg/dL 500 mg/dL ≥1000 mg/dL Bilirubin (BIL) NEGATIVO 1+ 2+ 3+ NEGATIVO BAJO MODERADO ALTO Ketone (CET) NEGATIVO INDICIOS 1+ 2+ 3+ NEGATIVO INDICIOS 15 mg/dL 40 mg/dL ≥80 mg/dL Specific Gravity (DEN) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (SAN) NEGATIVO

IND.INTACTOS IND.HEMOLIZ. 1+ 2+ 3+ NEGATIVO Apro 10 ERI/uL Apro 10 ERI/uL Apro 25 ERI/uL Apro 80 ERI/uL Apro 200 ERI/uL pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) NEGATIVO INDICIOS 1+ 2+ 3+ NEGATIVO INDICIOS 30 mg/dL 100 mg/dL ≥300 mg/dL Urobilinogen (URO) 0.2 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL 0.2 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL Nitrite (NIT) NEGATIVO POSITIVO NEGATIVO POSITIVO Leukocytes (LEU) NEGATIVO INDICIOS 1+ 2+ 3+ NEGATIVO Apro 15 cel/uL Apro 70 cel/uL Apro 125 cel/uL Apro 500 cel/uL Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–35 04826807 Rev. A

Result Value Conversions from Clinitek Advantus and Clinitek 500 to Clinitek 200+ English Conventional with PLUS System set to OFF Supports Clinitek 200+ Program A4

Test Clinitek Advantus or 500 Clinitek 200+ Glucose (GLU) NEGATIVE 100 mg/dL 250 mg/dL 500 mg/dL ≥1000 mg/dL NEGATIVE 100 mg/dL 250 mg/dL 500 mg/dL ≥1000 mg/dL Bilirubin (BIL) NEGATIVE SMALL MODERATE LARGE NEGATIVE SMALL MODERATE LARGE Ketone (KET) NEGATIVE TRACE 15 mg/dL 40 mg/dL ≥80 mg/dL NEGATIVE TRACE 15 mg/dL 40 mg/dL ≥80 mg/dL Specific Gravity (SG) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (BLO) NEGATIVE TRACE-LYSED TRACE-INTACT SMALL MODERATE LARGE NEGATIVE TRACE TRACE SMALL MODERATE LARGE pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0

8.5 ≥9.0 Protein (PRO) MULTISTIX Family of Test Strips NEGATIVE TRACE 30 mg/dL 100 mg/dL ≥300 mg/dL NEGATIVE TRACE 30 mg/dL 100 mg/dL ≥300 mg/dL MULTISTIX PRO® 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NEGATIVE 15 mg/dL 30 mg/dL 100 mg/dL 300 mg/dL NEGATIVE 15 mg/dL 30 mg/dL 100 mg/dL 300 mg/dL MULTISTIX PRO 6B MULTISTIX PRO 6K NEGATIVE 30 mg/dL 100 mg/dL 300 mg/dL NEGATIVE 30 mg/dL 100 mg/dL 300 mg/dL D–36 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A Test Clinitek Advantus or 500 Clinitek 200+ Urobilinogen (URO) 0.2 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL 0.2 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL Nitrite (NIT) NEGATIVE POSITIVE NEGATIVE POSITIVE Leukocytes (LEU) NEGATIVE TRACE SMALL MODERATE LARGE NEGATIVE TRACE SMALL MODERATE LARGE

Albumin (ALB) 10 mg/L 30 mg/L 80 mg/L 150 mg/L 10 mg/L 30 mg/L 80 mg/L 150 mg/L Creatinine (CRE) 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL A:C Ratio (A:C) <30 mg/g NORMAL 30-300 mg/g ABNORMAL >300 mg/g HIGH ABNORMAL <30 mg/g NORMAL 30-300 mg/g ABNORMAL >300 mg/g HIGH ABNORMAL P:C Ratio (P:C) MULTISTIX PRO 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NORMAL DILUTE NORMAL 150 mg/g ABNORMAL 300 mg/g ABNORMAL >500 mg/g ABNORMAL NORMAL DILUTE NORMAL 150 mg/g ABNORMAL 300 mg/g ABNORMAL >500 mg/g ABNORMA MULTISTIX PRO 6B MULTISTIX PRO 6K NORMAL 300 mg/g ABNORMAL >500 mg/g ABNORMAL NORMAL 300 mg/g ABNORMAL >500 mg/g ABNORMAL Invalid Result Value ERROR ERROR Color (COL) LT. YELLOW YELLOW DK. YELLOW LT. ORANGE ORANGE DK. ORANGE LT. RED RED DK. RED LT. GREEN GREEN DK. GREEN LT. BLUE BLUE DK. BLUE LT. BROWN BROWN DK. BROWN STRAW YELLOW

DK YELLOW AMBER ORANGE ORANGE RED RED RED GREEN GREEN GREEN OTHER OTHER OTHER OTHER OTHER OTHER Clarity (CLA) CLEAR SL CLOUDY CLOUDY TURBID OTHER CLEAR SL CLOUDY CLOUDY TURBID OTHER Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–37 04826807 Rev. A English Conventional with PLUS System set to ON Supports Clinitek 200+ Program A4 Test Clinitek Advantus or 500 Clinitek 200+ Glucose (GLU) NEGATIVE TRACE 1+ 2+ 3+ NEGATIVE TRACE 1+ 2+ 3+ Bilirubin (BIL) NEGATIVE 1+ 2+ 3+ NEGATIVE 1+ 2+ 3+ Ketone (KET) NEGATIVE TRACE 1+ 2+ 3+ NEGATIVE TRACE 1+ 2+ 3+ Specific Gravity (SG) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015

1.020 1.025 ≥1.030 Blood (BLO) NEGATIVE TRACE-LYSED TRACE-INTACT 1+ 2+ 3+ NEGATIVE TRACE TRACE 1+ 2+ 3+ pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) MULTISTIX Family of Test Strips NEGATIVE TRACE 1+ 2+ 3+ NEGATIVE TRACE 1+ 2+ 3+ MULTISTIX PRO 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NEGATIVE LOW 1+ 2+ 3+ NEGATIVE LOW 1+ 2+ 3+ MULTISTIX PRO 6B MULTISTIX PRO 6K NEGATIVE 1+ 2+ 3+ NEGATIVE 1+ 2+ 3+

Urobilinogen (URO) 0.2 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL 0.2 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL D–38 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A Test Clinitek Advantus or 500 Clinitek 200+ Nitrite (NIT) NEGATIVE POSITIVE NEGATIVE POSITIVE Leukocytes (LEU) NEGATIVE TRACE 1+ 2+ 3+ NEGATIVE TRACE 1+ 2+ 3+ Albumin (ALB) 10 mg/L 30 mg/L 80 mg/L 150 mg/L 10 mg/L 30 mg/L 80 mg/L 150 mg/L Creatinine (CRE) 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL A:C Ratio (A:C) <30 mg/g NORMAL 30-300 mg/g ABNORMAL >300 mg/g HIGH ABNORMAL <30 mg/g NORMAL 30-300 mg/g ABNORMAL >300 mg/g HIGH ABNORMAL P:C Ratio (P:C) MULTISTIX PRO 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NORMAL DILUTE NORMAL 150 mg/g ABNORMAL 300 mg/g ABNORMAL >500 mg/g ABNORMAL NORMAL DILUTE NORMAL 150 mg/g ABNORMAL 300 mg/g ABNORMAL >500 mg/g ABNORMAL

MULTISTIX PRO 6B MULTISTIX PRO 6K NORMAL 300 mg/g ABNORMAL >500 mg/g ABNORMAL NORMAL 300 mg/g ABNORMAL >500 mg/g ABNORMAL Invalid Result Value ERROR ERROR Color (COL) LT. YELLOW YELLOW DK. YELLOW LT. ORANGE ORANGE DK. ORANGE LT. RED RED DK. RED LT. GREEN GREEN DK. GREEN LT. BLUE BLUE DK. BLUE LT. BROWN BROWN DK. BROWN STRAW YELLOW DK YELLOW AMBER ORANGE ORANGE RED RED RED GREEN GREEN GREEN OTHER OTHER OTHER OTHER OTHER OTHER Clarity (CLA) CLEAR SL CLOUDY CLOUDY TURBID OTHER CLEAR SL CLOUDY CLOUDY TURBID OTHER Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–39 04826807 Rev. A English Nordic with PLUS System set to OFF Supports Clinitek 200+ “For Finland” Option Test Clinitek Advantus or 500 Clinitek 200+ Glucose (GLU) NEGATIVE 1+ 2+ 3+ 4+ NEGATIVE 1+ 2+

2+ 3+ Bilirubin (BIL) NEGATIVE 1+ 2+ 3+ NEGATIVE 1+ 2+ 3+ Ketone (KET) NEGATIVE 1+ 2+ 3+ 4+ NEGATIVE 1+ 1+ 2+ 3+ Specific Gravity (SG) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (BLD) NEGATIVE +/- +/- INTACT 1+ 2+ 3+ NEGATIVE 1+ 1+ 1+ 2+ 3+ pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) MULTISTIX Group of Test Strips NEGATIVE +/- 1+ 2+ 3+ NEGATIVE

NEGATIVE 1+ 2+ 3+ MULTISTIX PRO® 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NEGATIVE 0.15 g/L 0.3 g/L 1.0 g/L 3.0 g/L NEGATIVE LOW 1+ 2+ 3+ MULTISTIX PRO 6B MULTISTIX PRO 6K NEGATIVE 0.3 g/L 1.0 g/L 3.0 g/L NEGATIVE 1+ 2+ 3+ Urobilinogen (UBG) 3.2 umol/L 16 umol/L 33 umol/L 66 umol/L ≥131 umol/L NORMAL NORMAL 1+ 2+ 3+ D–40 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A Test Clinitek Advantus or 500 Clinitek 200+ Nitrite (NIT) NEGATIVE POSITIVE NEGATIVE POSITIVE Leukocytes (LEU) NEGATIVE 1+ 2+ 3+ 4+ NEGATIVE 1+ 1+ 2+ 3+ Albumin (ALB) 10 mg/L 30 mg/L 80 mg/L 150 mg/L 10 mg/L 30 mg/L 80 mg/L 150 mg/L Creatinine (CRE) 0.9 mmol/L 4.4 mmol/L 8.8 mmol/L 17.7 mmol/L 26.5 mmol/L

0.9 mmol/L 4.4 mmol/L 8.8 mmol/L 17.7 mmol/L 26.5 mmol/L A:C Ratio (A:C) < 3.4 mg/mmol NORMAL 3.4-33.9 mg/mmol ABNORMAL > 33.9 mg/mmol HIGH ABNORMAL < 3.4 mg/mmol NORMAL 3.4-33.9 mg/mmol ABNORMAL > 33.9 mg/mmol HIGH ABNORMAL P:C Ratio (P:C) MULTISTIX PRO 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NORMAL DILUTE NORMAL 17.0 mg/mmol ABNORMAL 33.9 mg/mmol ABNORMAL >56.6 mg/mmol ABNORMAL NORMAL DILUTE NORMAL 17.0 mg/mmol ABNORMAL 33.9 mg/mmol ABNORMAL >56.6 mg/mmol ABNORMAL MULTISTIX PRO 6B MULTISTIX PRO 6K NORMAL 33.9 mg/mmol ABNORMAL >56.6 mg/mmol ABNORMAL NORMAL 33.9 mg/mmol ABNORMAL >56.6 mg/mmol ABNORMAL Invalid Result Value ERROR ERROR Color (COL) LT. YELLOW YELLOW DK. YELLOW LT. ORANGE ORANGE DK. ORANGE LT. RED RED DK. RED LT. GREEN GREEN DK. GREEN LT. BLUE BLUE DK. BLUE LT. BROWN BROWN DK. BROWN STRAW YELLOW DK YELLOW AMBER ORANGE ORANGE RED RED RED GREEN GREEN GREEN OTHER

OTHER OTHER OTHER OTHER OTHER Clarity (CLA) CLEAR SL CLOUDY CLOUDY TURBID OTHER CLEAR SL CLOUDY CLOUDY TURBID OTHER Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–41 04826807 Rev. A English Nordic with PLUS System set to ON Supports Clinitek 200+ “For Finland” Option Test Clinitek Advantus or 500 Clinitek 200+ Glucose (GLU) NEGATIVE TRACE 1+ 2+ 3+ NEGATIVE 1+ 2+ 2+ 3+ Bilirubin (BIL) NEGATIVE 1+ 2+ 3+ NEGATIVE 1+ 2+ 3+ Ketone (KET) NEGATIVE TRACE 1+ 2+ 3+ NEGATIVE 1+ 1+ 2+ 3+ Specific Gravity (SG) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (BLD) NEGATIVE +/- +/- INTACT 1+ 2+ 3+ NEGATIVE 1+

1+ 1+ 2+ 3+ pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) MULTISTIX Group of Test Strips NEGATIVE TRACE 1+ 2+ 3+ NEGATIVE NEGATIVE 1+ 2+ 3+ MULTISTIX PRO® 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NEGATIVE LOW 1+ 2+ 3+ NEGATIVE LOW 1+ 2+ 3+ MULTISTIX PRO 6B MULTISTIX PRO 6K NEGATIVE 1+ 2+ 3+ NEGATIVE 1+ 2+ 3+ Urobilinogen (UBG) 3.2 umol/L 16 umol/L 33 umol/L 66 umol/L ≥131 umol/L NORMAL NORMAL 1+ 2+ 3+ D–42 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode

04826807 Rev. A Test Clinitek Advantus or 500 Clinitek 200+ Nitrite (NIT) NEGATIVE POSITIVE NEGATIVE POSITIVE Leukocytes (LEU) NEGATIVE TRACE 1+ 2+ 3+ NEGATIVE 1+ 1+ 2+ 3+ Albumin (ALB) 10 mg/L 30 mg/L 80 mg/L 150 mg/L 10 mg/L 30 mg/L 80 mg/L 150 mg/L Creatinine (CRE) 0.9 mmol/L 4.4 mmol/L 8.8 mmol/L 17.7 mmol/L 26.5 mmol/L 0.9 mmol/L 4.4 mmol/L 8.8 mmol/L 17.7 mmol/L 26.5 mmol/L A:C Ratio (A:C) < 3.4 mg/mmol NORMAL 3.4-33.9 mg/mmol ABNORMAL > 33.9 mg/mmol HIGH ABNORMAL < 3.4 mg/mmol NORMAL 3.4-33.9 mg/mmol ABNORMAL > 33.9 mg/mmol HIGH ABNORMAL P:C Ratio (P:C) MULTISTIX PRO 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NORMAL DILUTE NORMAL 17.0 mg/mmol ABNORMAL 33.9 mg/mmol ABNORMAL >56.6 mg/mmol ABNORMAL NORMAL DILUTE NORMAL 17.0 mg/mmol ABNORMAL 33.9 mg/mmol ABNORMAL >56.6 mg/mmol ABNORMAL MULTISTIX PRO 6B MULTISTIX PRO 6K NORMAL 33.9 mg/mmol ABNORMAL >56.6 mg/mmol ABNORMAL NORMAL 33.9 mg/mmol ABNORMAL >56.6 mg/mmol ABNORMAL Invalid Result Value ERROR ERROR

Color (COL) LT. YELLOW YELLOW DK. YELLOW LT. ORANGE ORANGE DK. ORANGE LT. RED RED DK. RED LT. GREEN GREEN DK. GREEN LT. BLUE BLUE DK. BLUE LT. BROWN BROWN DK. BROWN STRAW YELLOW DK YELLOW AMBER ORANGE ORANGE RED RED RED GREEN GREEN GREEN OTHER OTHER OTHER OTHER OTHER OTHER Clarity (CLA) CLEAR SL CLOUDY CLOUDY TURBID OTHER CLEAR SL CLOUDY CLOUDY TURBID OTHER Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–43 04826807 Rev. A English S.I. with PLUS System set to OFF Supports Clinitek 200+ Program C4 Test Clinitek Advantus or 500 Clinitek 200+ Glucose (GLU) NEGATIVE 5.5 mmol/L 14 mmol/L 28 mmol/L ≥55 mmol/L NEGATIVE 5.5 mmol/L 14 mmol/L 28 mmol/L ≥55 mmol/L Bilirubin (BIL) NEGATIVE SMALL MODERATE LARGE NEGATIVE SMALL MODERATE

LARGE Ketone (KET) NEGATIVE TRACE 1.5 mmol/L 3.9 mmol/L ≥7.8 mmol/L NEGATIVE TRACE 1.5 mmol/L 3.9 mmol/L ≥7.8 mmol/L Specific Gravity (SG) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (BLD) NEGATIVE TRACE-LYSED TRACE-INTACT Ca 25 Ery/uL Ca 80 Ery/uL Ca 200 Ery/uL NEGATIVE TRACE TRACE SMALL MODERATE LARGE pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) MULTISTIX Group of Test Strips NEGATIVE TRACE 0.3 g/L 1.0 g/L ≥3.0 g/L NEGATIVE TRACE 0.3 g/L 1.0 g/L ≥3.0 g/L MULTISTIX PRO® 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G

NEGATIVE 0.15 g/L 0.3 g/L 1.0 g/L 3.0 g/L NEGATIVE 0.15 g/L 0.3 g/L 1.0 g/L 3.0 g/L MULTISTIX PRO 6B MULTISTIX PRO 6K NEGATIVE 0.3 g/L 1.0 g/L 3.0 g/L NEGATIVE 0.3 g/L 1.0 g/L 3.0 g/L Urobilinogen (UBG) 3.2 umol/L 16 umol/L 33 umol/L 66 umol/L ≥131 umol/L 3.2 umol/L 16 umol/L 33 umol/L 66 umol/L ≥131 umol/L D–44 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A Test Clinitek Advantus or 500 Clinitek 200+ Nitrite (NIT) NEGATIVE POSITIVE NEGATIVE POSITIVE Leukocytes (LEU) NEGATIVE Ca 15 Leu/uL Ca 70 Leu/uL Ca 125 Leu/uL Ca 500 Leu/uL NEGATIVE Ca 15 Cells/uL Ca 70 Cells/uL Ca 125 Cells/uL Ca 500 Cells/uL Albumin (ALB) 10 mg/L 30 mg/L 80 mg/L 150 mg/L 10 mg/L 30 mg/L 80 mg/L 150 mg/L Creatinine (CRE) 0.9 mmol/L 4.4 mmol/L 8.8 mmol/L 17.7 mmol/L 26.5 mmol/L 0.9 mmol/L 4.4 mmol/L 8.8 mmol/L 17.7 mmol/L 26.5 mmol/L A:C Ratio (A:C) < 3.4 mg/mmol NORMAL 3.4-33.9 mg/mmol ABNORMAL > 33.9 mg/mmol HIGH

ABNORMAL < 3.4 mg/mmol NORMAL 3.4-33.9 mg/mmol ABNORMAL > 33.9 mg/mmol HIGH ABNORMAL P:C Ratio (P:C) MULTISTIX PRO 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NORMAL DILUTE NORMAL 17.0 mg/mmol ABNORMAL 33.9 mg/mmol ABNORMAL >56.6 mg/mmol ABNORMAL NORMAL DILUTE NORMAL 17.0 mg/mmol ABNORMAL 33.9 mg/mmol ABNORMAL >56.6 mg/mmol ABNORMAL MULTISTIX PRO 6B MULTISTIX PRO 6K NORMAL 33.9 mg/mmol ABNORMAL >56.6 mg/mmol ABNORMAL NORMAL 33.9 mg/mmol ABNORMAL >56.6 mg/mmol ABNORMAL Invalid Result Value ERROR ERROR Color (COL) LT. YELLOW YELLOW DK. YELLOW LT. ORANGE ORANGE DK. ORANGE LT. RED RED DK. RED LT. GREEN GREEN DK. GREEN LT. BLUE BLUE DK. BLUE LT. BROWN BROWN DK. BROWN STRAW YELLOW DK YELLOW AMBER ORANGE ORANGE RED RED RED GREEN GREEN GREEN OTHER OTHER OTHER OTHER OTHER OTHER Clarity (CLA) CLEAR SL CLOUDY CLOUDY TURBID

OTHER CLEAR SL CLOUDY CLOUDY TURBID OTHER Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–45 04826807 Rev. A English S.I. with PLUS System set to ON Supports Clinitek 200+ Program C4 Test Clinitek Advantus or 500 Clinitek 200+ Glucose (GLU) NEGATIVE TRACE 1+ 2+ 3+ NEGATIVE TRACE 1+ 2+ 3+ Bilirubin (BIL) NEGATIVE 1+ 2+ 3+ NEGATIVE 1+ 2+ 3+ Ketone (KET) NEGATIVE TRACE 1+ 2+ 3+ NEGATIVE TRACE 1+ 2+ 3+ Specific Gravity (SG) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (BLD) NEGATIVE TRACE-LYSED TRACE-INTACT 1+ 2+ 3+ NEGATIVE TRACE TRACE 1+ 2+ 3+ pH (pH) 5.0 5.5 6.0 6.5 7.0

7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) MULTISTIX Group of Test Strips NEGATIVE TRACE 1+ 2+ 3+ NEGATIVE TRACE 1+ 2+ 3+ MULTISTIX PRO® 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NEGATIVE LOW 1+ 2+ 3+ NEGATIVE LOW 1+ 2+ 3+ MULTISTIX PRO 6B MULTISTIX PRO 6K NEGATIVE 1+ 2+ 3+ NEGATIVE 1+ 2+ 3+ Urobilinogen (UBG) 3.2 umol/L 16 umol/L 33 umol/L 66 umol/L ≥131 umol/L 3.2 umol/L 16 umol/L 33 umol/L 66 umol/L ≥131 umol/L D–46 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A Test Clinitek Advantus or 500 Clinitek 200+ Nitrite (NIT) NEGATIVE POSITIVE NEGATIVE POSITIVE Leukocytes (LEU) NEGATIVE

TRACE 1+ 2+ 3+ NEGATIVE TRACE 1+ 2+ 3+ Albumin (ALB) 10 mg/L 30 mg/L 80 mg/L 150 mg/L 10 mg/L 30 mg/L 80 mg/L 150 mg/L Creatinine (CRE) 0.9 mmol/L 4.4 mmol/L 8.8 mmol/L 17.7 mmol/L 26.5 mmol/L 0.9 mmol/L 4.4 mmol/L 8.8 mmol/L 17.7 mmol/L 26.5 mmol/L A:C Ratio (A:C) < 3.4 mg/mmol NORMAL 3.4-33.9 mg/mmol ABNORMAL > 33.9 mg/mmol HIGH ABNORMAL < 3.4 mg/mmol NORMAL 3.4-33.9 mg/mmol ABNORMAL > 33.9 mg/mmol HIGH ABNORMAL P:C Ratio (P:C) MULTISTIX PRO 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NORMAL DILUTE NORMAL 17.0 mg/mmol ABNORMAL 33.9 mg/mmol ABNORMAL >56.6 mg/mmol ABNORMAL NORMAL DILUTE NORMAL 17.0 mg/mmol ABNORMAL 33.9 mg/mmol ABNORMAL >56.6 mg/mmol ABNORMAL MULTISTIX PRO 6B MULTISTIX PRO 6K NORMAL 33.9 mg/mmol ABNORMAL >56.6 mg/mmol ABNORMAL NORMAL 33.9 mg/mmol ABNORMAL >56.6 mg/mmol ABNORMAL Invalid Result Value ERROR ERROR Color (COL) LT. YELLOW YELLOW DK. YELLOW LT. ORANGE ORANGE DK. ORANGE LT. RED RED DK. RED LT. GREEN

GREEN DK. GREEN LT. BLUE BLUE DK. BLUE LT. BROWN BROWN DK. BROWN STRAW YELLOW DK YELLOW AMBER ORANGE ORANGE RED RED RED GREEN GREEN GREEN OTHER OTHER OTHER OTHER OTHER OTHER Clarity (CLA) CLEAR SL CLOUDY CLOUDY TURBID OTHER CLEAR SL CLOUDY CLOUDY TURBID OTHER Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–47 04826807 Rev. A French Conventional with PLUS System set to OFF Supports Clinitek 200+ Program G4 Test Clinitek Advantus or 500 Clinitek 200+ Glucose (GLU) NEGATIF TRACES 2.5 g/L 5.0 g/L ≥10.0 g/L NEGATIF 1.0 g/L 2.5 g/L 5.0 g/L ≥10.0 g/L Bilirubin (BIL) NEGATIF FAIBLE MOYEN FORT NEGATIF FAIBLE MOYEN FORT Ketone (CET) NEGATIF TRACES 0.15 g/L 0.4 g/L ≥0.8 g/L NEGATIF TRACE 0.15 g/L 0.4 g/L

≥0.8 g/L Specific Gravity (DEN) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (SNG) NEGATIF TRACES-LYSE TRACES-INTACT env. 25 GR/uL env. 80 GR/uL env. 200 GR/uL NEGATIF env. 10 GR/uL env. 10 GR/uL env. 25 GR/uL env. 80 GR/uL env. 200 GR/uL pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) MULTISTIX Group of Test Strips NEGATIF TRACES 0.3 g/L 1.0 g/L ≥3.0 g/L NEGATIF TRACES 0.3 g/L 1.0 g/L ≥3.0 g/L MULTISTIX PRO 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NEGATIVE 0.15 g/L 0.3 g/L 1.0 g/L 3.0 g/L NEGATIF 0.15 g/L 0.3 g/L 1.0 g/L 3.0 g/L

MULTISTIX PRO 6B MULTISTIX PRO 6K NEGATIVE 0.3 g/L 1.0 g/L 3.0 g/L NEGATIF 0.3 g/L 1.0 g/L 3.0 g/L Urobilinogen (URO) 0.2 mg/dL 1.0 mg/dL 2.0 mg/dL 4.0 mg/dL ≥8.0 mg/dL 0.2 mg/dL 1.0 mg/dL 2.0 mg/dL 4.0 mg/dL ≥8.0 mg/dL D–48 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A Test Clinitek Advantus or 500 Clinitek 200+ Nitrite (NIT) NEGATIF POSITIF NEGATIF POSITIF Leukocytes (LEU) NEGATIF env. 15 GB/uL env. 70 GB/uL env. 125 GB/uL env. 500 GB/uL NEGATIF env. 15 GB/uL env. 70 GB/uL env. 125 GB/uL env. 500 GB/uL Albumin (ALB) 10 mg/L 30 mg/L 80 mg/L 150 mg/L 10 mg/L 30 mg/L 80 mg/L 150 mg/L Creatinine (CRE) 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL A:C Ratio (A:C) <30 mg/g NORMAL 30-300 mg/g ANORMAL >300 mg/g ANORMAL ELEVE <30 mg/g NORMAL 30-300 mg/g ANORMAL >300 mg/g ANORMAL ELEVE P:C Ratio (P:C) MULTISTIX PRO 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G

NORMAL, DILUEE NORMAL 150 mg/g ANORMAL 300 mg/g ANORMAL >500 mg/g ANORMAL NORMAL, DILUEE NORMAL 150 mg/g ANORMAL 300 mg/g ANORMAL >500 mg/g ANORMAL MULTISTIX PRO 6B MULTISTIX PRO 6K NORMAL 300 mg/g ANORMAL >500 mg/g ANORMAL NORMAL 300 mg/g ANORMAL >500 mg/g ANORMAL Invalid Result Value ERREUR ERREUR Color (COL) JAUNE CLR. JAUNE JAUNE FONC. ORANGE CLR. ORANGE ORANGE FONC. ROUGE CLR. ROUGE ROUGE FONC. VERT CLR. VERT VERT FONC. BLEU CLR. BLEU BLEU FONC. MARRON CLR. MARRON MARRON FONC. PAILLE JAUNE JAUN FONCE AMBRE ORANGE ORANGE ROUGE ROUGE ROUGE VERT VERT VERT AUTRE AUTRE AUTRE AUTRE AUTRE AUTRE Clarity (ASP) LIMPIDE LEG TROUB TROUBLE OPAQUE AUTRE LIMPIDE LEG TROUB TROUBLE OPAQUE AUTRE Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–49 04826807 Rev. A French Conventional with PLUS System set to ON Supports Clinitek 200+ Program G40100 Test

Clinitek Advantus or 500 Clinitek 200+ Glucose (GLU) NEGATIF TRACES 1+ 2+ 3+ NEGATIF TRACES 1+ 2+ 3+ Bilirubin (BIL) NEGATIF 1+ 2+ 3+ NEGATIF 1+ 2+ 3+ Ketone (CET) NEGATIF TRACES 1+ 2+ 3+ NEGATIF TRACES 1+ 2+ 3+ Specific Gravity (DEN) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (SNG) NEGATIF TRACES-LYSE TRACES-INTACT 1+ 2+ 3+ NEGATIF TRACES TRACES 1+ 2+ 3+ pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5

≥9.0 Protein (PRO) MULTISTIX Group of Test Strips NEGATIF TRACES 1+ 2+ 3+ NEGATIF TRACES 1+ 2+ 3+ MULTISTIX PRO® 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NEGATIF FAIBLE 1+ 2+ 3+ NEGATIF FAIBLE 1+ 2+ 3+ MULTISTIX PRO 6B MULTISTIX PRO 6K NEGATIF 1+ 2+ 3+ NEGATIF 1+ 2+ 3+ Urobilinogen (URO) 0.2 mg/dL 1.0 mg/dL 2.0 mg/dL 4.0 mg/dL ≥8.0 mg/dL 0.2 mg/dL 1.0 mg/dL 2.0 mg/dL 4.0 mg/dL ≥8.0 mg/dL D–50 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A Test Clinitek Advantus or 500 Clinitek 200+ Nitrite (NIT) NEGATIF POSITIF NEGATIF POSITIF Leukocytes (LEU) NEGATIF TRACES 1+ 2+ 3+ NEGATIF TRACES 1+ 2+ 3+ Albumin (ALB) 10 mg/L 30 mg/L 80 mg/L

150 mg/L 10 mg/L 30 mg/L 80 mg/L 150 mg/L Creatinine (CRE) 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL A:C Ratio (A:C) <30 mg/g NORMAL 30-300 mg/g ABNORMAL >300 mg/g ABNORMAL ELEVE <30 mg/g, NORMAL 30-300 mg/g, ANORMAL >300 mg/g, HIGH ANORMAL ELEVE P:C Ratio (P:C) MULTISTIX PRO 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NORMAL, DILUEE NORMAL 150 mg/g ANORMAL 300 mg/g ANORMAL >500 mg/g ANORMAL NORMAL, DILUEE NORMAL 150 mg/g ANORMAL 300 mg/g ANORMAL >500 mg/g ANORMAL MULTISTIX PRO 6B MULTISTIX PRO 6K NORMAL 300 mg/g ANORMAL >500 mg/g ANORMAL NORMAL 300 mg/g, ANORMAL >500 mg/g, ANORMAL Invalid Result Value ERREUR ERREUR Color (COL) JAUNE CLR. JAUNE JAUNE FONC. ORANGE CLR. ORANGE ORANGE FONC. ROUGE CLR. ROUGE ROUGE FONC. VERT CLR. VERT VERT FONC. BLEU CLR. BLEU BLEU FONC. MARRON CLR. MARRON MARRON FONC. PAILLE JAUNE JAUN FONCE AMBRE ORANGE

ORANGE ROUGE ROUGE ROUGE VERT VERT VERT AUTRE AUTRE AUTRE AUTRE AUTRE AUTRE Clarity (ASP) LIMPIDE LEG TROUB TROUBLE OPAQUE AUTRE LIMPIDE LEG TROUB TROUBLE OPAQUE AUTRE Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–51 04826807 Rev. A French S.I. with PLUS System set to OFF Supports Clinitek 200+ Program H4 Test Clinitek Advantus or 500 Clinitek 200+ Glucose (GLU) NEGATIF 5.5 mmol/L 14 mmol/L 28 mmol/L ≥55 mmol/L NEGATIF 5.5 mmol/L 14 mmol/L 28 mmol/L ≥55 mmol/L Bilirubin (BIL) NEGATIF FAIBLE MOYEN FORT NEGATIF FAIBLE MOYEN FORT Ketone (CET) NEGATIF TRACES 1.5 mmol/L 3.9 mmol/L ≥7.8 mmol/L NEGATIF TRACES 1.5 mmol/L 3.9 mmol/L ≥7.8 mmol/L Specific Gravity (DEN) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030

Blood (SNG) NEGATIF TRACES-INTACT TRACES-LYSE FAIBLE MOYEN FORT NEGATIF TRACE TRACE FAIBLE MOYEN FORT pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) MULTISTIX Group of Test Strips NEGATIF TRACES 0.3 g/L 1.0 g/L ≥3.0 g/L NEGATIF TRACE 0.3 g/L 1.0 g/L ≥3.0 g/L MULTISTIX PRO® 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NEGATIF TRACES 0.15 g/L 0.3 g/L 1.0 g/L 3.0 g/L NEGATIF TRACE 0.15 g/L 0.3 g/L 1.0 g/L 3.0 g/L Protein (PRO) MULTISTIX PRO 6B MULTISTIX PRO 6K NEGATIF 0.3 g/L 1.0 g/L 3.0 g/L NEGATIF 0.3 g/L 1.0 g/L 3.0 g/L

Urobilinogen (URO) 3.2 umol/L 16 umol/L 33 umol/L 66 umol/L ≥131 umol/L 3.2 umol/L 16 umol/L 33 umol/L 66 umol/L ≥131 umol/L D–52 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A Test Clinitek Advantus or 500 Clinitek 200+ Nitrite (NIT) NEGATIF POSITIF NEGATIF POSITIF Leukocytes (LEU) NEGATIF TRACES FAIBLE MOYEN FORT NEGATIF TRACE FAIBLE MOYEN FORT Albumin (ALB) 10 mg/L 30 mg/L 80 mg/L 150 mg/L 10 mg/L 30 mg/L 80 mg/L 150 mg/L Creatinine (CRE) 0.9 mmol/L 4.4 mmol/L 8.8 mmol/L 17.7 mmol/L 26.5 mmol/L 0.9 mmol/L 4.4 mmol/L 8.8 mmol/L 17.7 mmol/L 26.5 mmol/L A:C Ratio (A:C) < 3.4 mg/mmol NORMAL 3.4-33.9 mg/mmol ANORMAL > 33.9 mg/mmol ANORMAL ELEVE < 3.4 mg/mmol NORMAL 3.4-33.9 mg/mmol ANORMAL > 33.9 mg/mmol ANORMAL ELEVE P:C Ratio (P:C) MULTISTIX PRO 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NORMAL, DILUEE NORMAL 17.0 mg/mmol ANORMAL 33.9 mg/mmol ANORMAL >56.6 mg/mmol ANORMAL NORMAL, DILUEE NORMAL

17.0 mg/mmol ANORMAL 33.9 mg/mmol ANORMAL >56.6 mg/mmol ANORMAL MULTISTIX PRO 6B MULTISTIX PRO 6K NORMAL 33.9 mg/mmol ANORMAL >56.6 mg/mmol ANORMAL NORMAL 33.9 mg/mmol ANORMAL >56.6 mg/mmol ANORMAL Invalid Result Value ERREUR ERREUR Color (COL) CLR. JAUNE JAUNE FONC. JAUNE CLR. ORANGE ORANGE FONC. ORANGE CLR. ROUGE ROUGE FONC. ROUGE CLR. VERT VERT FONC. VERT CLR. BLEU BLEU FONC. BLEU CLR. MARRON MARRON FONC. MARRON PAILLE JAUNE JAUN FONCE AMBRE ORANGE ORANGE ROUGE ROUGE ROUGE VERT VERT VERT AUTRE AUTRE AUTRE AUTRE AUTRE AUTRE Clarity (ASP) LIMPIDE LEG TROUB TROUBLE OPAQUE AUTRE LIMPIDE LEG TROUB TROUBLE OPAQUE AUTRE Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–53 04826807 Rev. A French S.I. with PLUS System set to ON Supports Clinitek 200+ Program H4 Test Clinitek Advantus or 500 Clinitek 200+ Glucose (GLU) NEGATIF TRACES 1+ 2+ 3+

NEGATIF TRACE 1+ 2+ 3+ Bilirubin (BIL) NEGATIF 1+ 2+ 3+ NEGATIF 1+ 2+ 3+ Ketone (CET) NEGATIF TRACES 1+ 2+ 3+ NEGATIF TRACE 1+ 2+ 3+ Specific Gravity (DEN) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (SNG) NEGATIF TRACES-LYSE TRACES-INTACT 1+ 2+ 3+ NEGATIF TRACES TRACES 1+ 2+ 3+ pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) MULTISTIX Group of Test Strips NEGATIF TRACES 1+

2+ 3+ NEGATIF TRACE 1+ 2+ 3+ MULTISTIX PRO® 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NEGATIVE FAIBLE 1+ 2+ 3+ NEGATIF FAIBLE 1+ 2+ 3+ MULTISTIX PRO 6B MULTISTIX PRO 6K NEGATIF 1+ 2+ 3+ NEGATIF 1+ 2+ 3+ Urobilinogen (URO) 3.2 umol/L 16 umol/L 33 umol/L 66 umol/L ≥131 umol/L 3.2 umol/L 16 umol/L 33 umol/L 66 umol/L ≥131 umol/L D–54 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A Test Clinitek Advantus or 500 Clinitek 200+ Nitrite (NIT) NEGATIF POSITIF NEGATIF POSITIF Leukocytes (LEU) NEGATIF TRACES 1+ 2+ 3+ NEGATIF TRACE 1+ 2+ 3+ Albumin (ALB) 10 mg/L 30 mg/L 80 mg/L 150 mg/L 10 mg/L 30 mg/L 80 mg/L 150 mg/L Creatinine (CRE) 0.9 mmol/L 4.4 mmol/L

8.8 mmol/L 17.7 mmol/L 26.5 mmol/L 0.9 mmol/L 4.4 mmol/L 8.8 mmol/L 17.7 mmol/L 26.5 mmol/L A:C Ratio (A:C) < 3.4 mg/mmol NORMAL 3.4-33.9 mg/mmol ANORMAL > 33.9 mg/mmol ANORMAL ELEVE < 3.4 mg/mmol NORMAL 3.4-33.9 mg/mmol ANORMAL > 33.9 mg/mmol ANORMAL ELEVE P:C Ratio (P:C) MULTISTIX PRO 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NORMAL, DILUEE NORMAL 17.0 mg/mmol ANORMAL 33.9 mg/mmol ANORMAL >56.6 mg/mmol ANORMAL NORMAL, DILUEE NORMAL 17.0 mg/mmol ANORMAL 33.9 mg/mmol ANORMAL >56.6 mg/mmol ANORMAL MULTISTIX PRO 6B MULTISTIX PRO 6K NORMAL 33.9 mg/mmol ANORMAL >56.6 mg/mmol ANORMAL NORMAL 33.9 mg/mmol ANORMAL >56.6 mg/mmol ANORMAL Invalid Result Value ERREUR ERREUR Color (COL) CLR. JAUNE JAUNE FONC. JAUNE CLR. ORANGE ORANGE FONC. ORANGE CLR. ROUGE ROUGE FONC. ROUGE CLR. VERT VERT FONC. VERT CLR. BLEU BLEU FONC. BLEU CLR. MARRON MARRON FONC. MARRON PAILLE JAUNE JAUN FONCE AMBRE ORANGE ORANGE ROUGE ROUGE ROUGE VERT VERT VERT

AUTRE AUTRE AUTRE AUTRE AUTRE AUTRE Clarity (ASP) LIMPIDE LEG TROUB TROUBLE OPAQUE AUTRE LIMPIDE LEG TROUB TROUBLE OPAQUE AUTRE Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–55 04826807 Rev. A German Conventional with PLUS System set to OFF Supports Clinitek 200+ Program F4 Test Clinitek Advantus or 500 Clinitek 200+ Glucose (GLU) NEGATIV 100 mg/dL 250 mg/dL 500 mg/dL ≥1000 mg/dL NEGATIV 100 mg/dL 250 mg/dL 500 mg/dL ≥1000 mg/dL Bilirubin (BIL) NEGATIV SCHWACH MAESSIG STARK NEGATIV SCHWACH MAESSIG STARK Ketone (KET) NEGATIV SPUR 15 mg/dL 40 mg/dL ≥80 mg/dL NEGATIV SPUR 15 mg/dL 40 mg/dL ≥80 mg/dL Specific Gravity (SG) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (OBL) 0 Ery/uL Ca 10 Ery/uL Ca 10 Ery/uL Ca 25 Ery/uL Ca 80 Ery/uL Ca 200 Ery/uL 0 Ery/uL

Ca 10 Ery/uL Ca 10 Ery/uL Ca 25 Ery/uL Ca 80 Ery/uL Ca 200 Ery/uL pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) MULTISTIX Group of Test Strips NEGATIV SPUR 30 mg/dL 100 mg/dL ≥300 mg/dL NEGATIV SPUR 30 mg/dL 100 mg/dL ≥300 mg/dL MULTISTIX PRO® 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NEGATIV 15 mg/dL 30 mg/dL 100 mg/dL 300 mg/dL NEGATIV 15 mg/dL 30 mg/dL 100 mg/dL 300 mg/dL MULTISTIX PRO 6B MULTISTIX PRO 6K NEGATIV 30 mg/dL 100 mg/dL 300 mg/dL NEGATIV 30 mg/dL 100 mg/dL 300 mg/dL Urobilinogen (UBG) 0.2 mg/dL 1.0 mg/dL 2.0 mg/dL 4.0 mg/dL ≥8.0 mg/dL 0.2 mg/dL 1.0 mg/dL 2.0 mg/dL 4.0 mg/dL ≥8.0 mg/dL

D–56 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A Test Clinitek Advantus or 500 Clinitek 200+ Nitrite (NIT) NEGATIV POSITIV NEGATIV POSITIV Leukocytes (LEU) 0 Leu/uL Ca 15 Leu/uL Ca 70 Leu/uL Ca 125 Leu/uL Ca 500 Leu/uL 0 Leu/uL Ca 15 Leu/uL Ca 70 Leu/uL Ca 125 Leu/uL Ca 500 Leu/uL Albumin (ALB) 10 mg/L 30 mg/L 80 mg/L 150 mg/L 10 mg/L 30 mg/L 80 mg/L 150 mg/L Creatinine (CRE) 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL A:C Ratio (A:C) <30 mg/g NORMAL 30-300 mg/g ABNORMAL >300 mg/g STARK ABNORMAL <30 mg/g NORMAL 30-300 mg/g ABNORMAL >300 mg/g STARK ABNORMAL P:C Ratio (P:C) MULTISTIX PRO 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G P OK/ K GERING NORMAL 150 mg/g ABNORMAL 300 mg/g ABNORMAL >500 mg/g ABNORMAL P OK/ K GERING NORMAL 150 mg/g ABNORMAL 300 mg/g ABNORMAL >500 mg/g ABNORMAL MULTISTIX PRO 6B MULTISTIX PRO 6K NORMAL 300 mg/g ABNORMAL >500 mg/g ABNORMAL NORMAL 300 mg/g ABNORMAL >500 mg/g ABNORMAL Invalid Result Value FEHLER FEHLER Color (COL) HELL GELB

GELB DUNK. GELB HELL ORANGE ORANGE DUNK. ORANGE HELL ROT ROT DUNK. ROT HELL GRUEN GRUEN DUNK. GRUEN HELL BLAU BLAU DUNK. BLAU HELL BRAUN BRAUN DUNK. BRAUN HELL GELB DUNKEL BRAEUNL. ORANGE ORANGE ROT ROT ROT GRUEN GRUEN GRUEN ANDERS ANDERS ANDERS ANDERS ANDERS ANDERS Clarity (ASP) KLAR FLOCKIG S. FLOCKIG TRUEB ANDERS KLAR FLOCKIG S. FLOCKIG TRUEB ANDERS Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–57 04826807 Rev. A German Conventional with PLUS System set to ON Supports Clinitek 200+ Program F4 Test Clinitek Advantus or 500 Clinitek 200+ Glucose (GLU) NEGATIV SPUR 1+ 2+ 3+ NEGATIV SPUR 1+ 2+ 3+ Bilirubin (BIL) NEGATIV 1+ 2+ 3+ NEGATIV 1+ 2+ 3+

Ketone (KET) NEGATIV SPUR 1+ 2+ 3+ NEGATIV SPUR 1+ 2+ 3+ Specific Gravity (SG) ≤1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (OBL) NEGATIV SPUR-LYSE SPUR-ZELLEN 1+ 2+ 3+ NEGATIV SPUR SPUR 1+ 2+ 3+ pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) MULTISTIX Group of Test Strips NEGATIV SPUR 1+ 2+ 3+ NEGATIV SPUR 1+ 2+ 3+ MULTISTIX PRO® 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NEGATIV

WENIG 1+ 2+ 3+ NEGATIV WENIG 1+ 2+ 3+ MULTISTIX PRO 6B MULTISTIX PRO 6K NEGATIV 1+ 2+ 3+ NEGATIV 1+ 2+ 3+ Urobilinogen (UBG) 0.2 mg/dL 1.0 mg/dL 2.0 mg/dL 4.0 mg/dL ≥8.0 mg/dL 0.2 mg/dL 1.0 mg/dL 2.0 mg/dL 4.0 mg/dL ≥8.0 mg/dL D–58 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A Test Clinitek Advantus or 500 Clinitek 200+ Nitrite (NIT) NEGATIV POSITIV NEGATIV POSITIV Leukocytes (LEU) NEGATIV SPUR 1+ 2+ 3+ 0 Leu/uL SPUR 1+ 2+ 3+ Albumin (ALB) 10 mg/L 30 mg/L 80 mg/L 150 mg/L 10 mg/L 30 mg/L 80 mg/L 150 mg/L Creatinine (CRE) 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL A:C Ratio (A:C) <30 mg/g NORMAL 30-300 mg/g ABNORMAL >300 mg/g STARK ABNORMAL <30 mg/g NORMAL

30-300 mg/g ABNORMAL >300 mg/g STARK ABNORMAL P:C Ratio (P:C) MULTISTIX PRO 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G P OK/ K GERING NORMAL 150 mg/g ABNORMAL 300 mg/g ABNORMAL >500 mg/g ABNORMAL P OK/ K GERING NORMAL 150 mg/g, ABNORMAL 300 mg/g, ABNORMAL >500 mg/g, ABNORMAL MULTISTIX PRO 6B MULTISTIX PRO 6K NORMAL 300 mg/g ABNORMAL >500 mg/g ABNORMAL NORMAL 300 mg/g, ABNORMAL >500 mg/g, ABNORMAL Invalid Result Value FEHLER FEHLER Color (COL) HELL GELB GELB DUNK. GELB HELL ORANGE ORANGE DUNK. ORANGE HELL ROT ROT DUNK. ROT HELL GRUEN GRUEN DUNK. GRUEN HELL BLAU BLAU DUNK. BLAU HELL BRAUN BRAUN DUNK. BRAUN HELL GELB DUNKEL BRAEUNL. ORANGE ORANGE ROT ROT ROT GRUEN GRUEN GRUEN ANDERS ANDERS ANDERS ANDERS ANDERS ANDERS Clarity (ASP) KLAR FLOCKIG S. FLOCKIG TRUEB ANDERS KLAR FLOCKIG

S. FLOCKIG TRUEB ANDERS Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–59 04826807 Rev. A German S.I. with PLUS System set to OFF Supports Clinitek 200+ Program F4 Test Clinitek Advantus or 500 Clinitek 200+ Glucose (GLU) NEGATIV 5.5 mmol/L 14 mmol/L 28 mmol/L ≥55 mmol/L NEGATIV 100 mg/dL 250 mg/dL 500 mg/dL ≥1000 mg/dL Bilirubin (BIL) NEGATIV SCHWACH MAESSIG STARK NEGATIV SCHWACH MAESSIG STARK Ketone (KET) NEGATIV SPUR 1.5 mmol/L 3.9 mmol/L ≥7.8 mmol/L NEGATIV SPUR 15 mg/dL 40 mg/dL ≥80 mg/dL Specific Gravity (SG) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (OBL) 0 Ery/uL Ca 10 Ery/uL Ca 10 Ery/uL Ca 25 Ery/uL Ca 80 Ery/uL Ca 200 Ery/uL 0 Ery/uL Ca 10 Ery/uL Ca 10 Ery/uL Ca 25 Ery/uL Ca 80 Ery/uL Ca 200 Ery/uL pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5

≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) MULTISTIX Group of Test Strips NEGATIV SPUR 0.3 g/L 1.0 g/L ≥3.0 g/L NEGATIV SPUR 30 mg/dL 100 mg/dL ≥300 mg/dL MULTISTIX PRO® 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NEGATIV 0.15 g/L 0.3 g/L 1.0 g/L 3.0 g/L NEGATIV 15 mg/dL 30 mg/dL 100 mg/dL 300 mg/dL MULTISTIX PRO 6B MULTISTIX PRO 6K NEGATIV 0.3 g/L 1.0 g/L 3.0 g/L NEGATIV 30 mg/dL 100 mg/dL 300 mg/dL D–60 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A Test Clinitek Advantus or 500 Clinitek 200+ Urobilinogen (UBG) 3.2 umol/L 16 umol/L 33 umol/L 66 umol/L ≥131 umol/L 0.2 mg/dL 1.0 mg/dL 2.0 mg/dL 4.0 mg/dL ≥8.0 mg/dL Nitrite (NIT) NEGATIV POSITIV NEGATIV POSITIV Leukocytes (LEU) 0 Leu/uL Ca 15 Leu/uL Ca 70 Leu/uL Ca 125 Leu/uL

Ca 500 Leu/uL 0 Leu/uL Ca 15 Leu/uL Ca 70 Leu/uL Ca 125 Leu/uL Ca 500 Leu/uL Albumin (ALB) 10 mg/L 30 mg/L 80 mg/L 150 mg/L 10 mg/L 30 mg/L 80 mg/L 150 mg/L Creatinine (CRE) 0.9 mmol/L 4.4 mmol/L 8.8 mmol/L 17.7 mmol/L 26.5 mmol/L 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL A:C Ratio (A:C) < 3.4 mg/mmol NORMAL 3.4-33.9 mg/mmol ABNORMAL > 33.9 mg/mmol STARK ABNORMAL <30 mg/g NORMAL 30-300 mg/g ABNORMAL >300 mg/g STARK ABNORMAL P:C Ratio (P:C) MULTISTIX PRO 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G P OK/ K GERING NORMAL 17.0 mg/mmol ABNORMAL 33.9 mg/mmol ABNORMAL >56.6 mg/mmol ABNORMAL P OK/ K GERING NORMAL 150 mg/mmol ABNORMAL 300 mg/mmol ABNORMAL >500 mg/mmol ABNORMAL MULTISTIX PRO 6B MULTISTIX PRO 6K NORMAL 33.9 mg/mmol ABNORMAL >56.6 mg/mmol ABNORMAL NORMAL 300 mg/g ABNORMAL >500 mg/g ABNORMAL Invalid Result Value FEHLER FEHLER Color (COL) HELL GELB GELB DUNK. GELB HELL ORANGE ORANGE DUNK. ORANGE HELL ROT ROT DUNK. ROT HELL GRUEN GRUEN DUNK. GRUEN HELL BLAU

BLAU DUNK. BLAU HELL BRAUN BRAUN DUNK. BRAUN HELL GELB DUNKEL BRAEUNL. ORANGE ORANGE ROT ROT ROT GRUEN GRUEN GRUEN ANDERS ANDERS ANDERS ANDERS ANDERS ANDERS Clarity (CLA) KLAR FLOCKIG S. FLOCKIG TRUEB ANDERS KLAR FLOCKIG S. FLOCKIG TRUEB ANDERS Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–61 04826807 Rev. A German S.I. with PLUS System set to ON Supports Clinitek 200+ Program F4 Test Clinitek Advantus or 500 Clinitek 200+ Glucose (GLU) NEGATIV SPUR 1+ 2+ 3+ NEGATIV SPUR 1+ 2+ 3+ Bilirubin (BIL) NEGATIV 1+ 2+ 3+ NEGATIV 1+ 2+ 3+ Ketone (KET) NEGATIV SPUR 1+ 2+ 3+ NEGATIV SPUR 1+ 2+ 3+ Specific Gravity (SG) ≤1.005 1.010

1.015 1.020 1.025 ≥1.030 ≤1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (OBL) NEGATIV SPUR-LYSE SPUR-ZELLEN 1+ 2+ 3+ NEGATIV SPUR SPUR 1+ 2+ 3+ pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) MULTISTIX Group of Test Strips NEGATIV SPUR 1+ 2+ 3+ NEGATIV SPUR 1+ 2+ 3+ MULTISTIX PRO® 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NEGATIV WENIG 1+ 2+ 3+ NEGATIV WENIG 1+ 2+ 3+ MULTISTIX PRO 6B MULTISTIX PRO 6K NEGATIV

1+ 2+ 3+ NEGATIV 1+ 2+ 3+ D–62 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A Test Clinitek Advantus or 500 Clinitek 200+ Urobilinogen (UBG) 3.2 umol/L 16 umol/L 33 umol/L 66 umol/L ≥131 umol/L 0.2 mg/dL 1.0 mg/dL 2.0 mg/dL 4.0 mg/dL ≥8.0 mg/dL Nitrite (NIT) NEGATIV POSITIV NEGATIV POSITIV Leukocytes (LEU) NEGATIV SPUR 1+ 2+ 3+ NEGATIV SPUR 1+ 2+ 3+ Albumin (ALB) 10 mg/L 30 mg/L 80 mg/L 150 mg/L 10 mg/L 30 mg/L 80 mg/L 150 mg/L Creatinine (CRE) 0.9 mmol/L 4.4 mmol/L 8.8 mmol/L 17.7 mmol/L 26.5 mmol/L 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL A:C Ratio (A:C) < 3.4 mg/mmol NORMAL 3.4-33.9 mg/mmol ABNORMAL > 33.9 mg/mmol STARK ABNORMAL <30 mg/g, NORMAL 30-300 mg/g, ABNORMAL >300 mg/g, STARK ABNORMAL P:C Ratio (P:C) MULTISTIX PRO 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G P OK/ K GERING NORMAL

17.0 mg/mmol ABNORMAL 33.9 mg/mmol ABNORMAL >56.6 mg/mmol ABNORMAL P OK/ K GERING NORMAL 150 mg/g, ABNORMAL 300 mg/g, ABNORMAL >500 mg/g, ABNORMAL MULTISTIX PRO 6B MULTISTIX PRO 6K NORMAL 33.9 mg/mmol ABNORMAL >56.6 mg/mmol ABNORMAL NORMAL 300 mg/g, ABNORMAL >500 mg/g, ABNORMAL Invalid Result Value FEHLER FEHLER Color (COL) HELL GELB GELB DUNK. GELB HELL ORANGE ORANGE DUNK. ORANGE HELL ROT ROT DUNK. ROT HELL GRUEN GRUEN DUNK. GRUEN HELL BRAUN BRAUN DUNK. BRAUN HELL BLAU BLAU DUNK. BLAU HELL GELB DUNKEL BRAEUNL. ORANGE ORANGE ROT ROT ROT GRUEN GRUEN GRUEN ANDERS ANDERS ANDERS ANDERS ANDERS ANDERS Clarity (ASP) KLAR FLOCKIG S. FLOCKIG TRUEB ANDERS KLAR FLOCKIG S. FLOCKIG TRUEB ANDERS Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–63 04826807 Rev. A Italian Conventional with PLUS System set to OFF Supports Clinitek 200+ Program E4 Test Clinitek Advantus or 500 Clinitek 200+

Glucose (GLU) NEGATIVO 1.0 g/L 2.5 g/L 5.0 g/L ≥10.0 g/L NEGATIVO 0.1 g/dL 0.25 g/dL 0.50 g/dL ≥1.0 g/dL Bilirubin (BIL) NEGATIVO LEGGERO MEDIO FORTE NEGATIVO LEGGERO MEDIO FORTE Ketone (KET) NEGATIVO TRACCE 15 mg/dL 40 mg/dL ≥80 mg/dL NEGATIVO TRACCE 15 mg/dL 40 mg/dL ≥80 mg/dL Specific Gravity (PS) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (SAN) NEGATIVO TRACCE (LIS.) TRACCE (INT.) LEGGERO MEDIO FORTE NEGATIVO TRACCE TRACCE LEGGERO MEDIO FORTE pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO)

MULTISTIX Group of Test Strips NEGATIVO TRACCE 30 mg/dL 100 mg/dL ≥300 mg/dL NEGATIVO TRACCE 30 mg/dL 100 mg/dL ≥300 mg/dL MULTISTIX PRO® 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NEGATIVO 15 mg/dL 30 mg/dL 100 mg/dL 300 mg/dL NEGATIVO 15 mg/dL 30 mg/dL 100 mg/dL 300 mg/dL MULTISTIX PRO 6B MULTISTIX PRO 6K NEGATIVO 30 mg/dL 100 mg/dL 300 mg/dL NEGATIVO 30 mg/dL 100 mg/dL 300 mg/dL D–64 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A Test Clinitek Advantus or 500 Clinitek 200+ Urobilinogen (URO) 0.2 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL 0.2 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL Nitrite (NIT) NEGATIVO POSITIVO NEGATIVO POSITIVO Leukocytes (LEU) NEGATIVO Ca 15 Cel/uL Ca 70 Cel/uL Ca 125 Cel/uL Ca 500 Cel/uL NEGATIVO Ca 15 Cells/uL Ca 70 Cells/uL Ca 125 Cells/uL Ca 500 Cells/uL Albumin (ALB) 10 mg/L 30 mg/L 80 mg/L 150 mg/L 10 mg/L

30 mg/L 80 mg/L 150 mg/L Creatinine (CRE) 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL A:C Ratio (A:C) <30 mg/g NORMALE 30-300 mg/g ABNORMALE >300 mg/g MOLTO ABNORMALE <30 mg/g NORMALE 30-300 mg/g ABNORMALE >300 mg/g MOLTO ABNORMALE P:C Ratio (P:C) MULTISTIX PRO 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G URINA DILUITA NORMALE 150 mg/g ABNORMALE 300 mg/g ABNORMALE >500 mg/g ABNORMALE URINA DILUITA NORMALE 150 mg/g ABNORMALE 300 mg/g ABNORMALE >500 mg/g ABNORMALE MULTISTIX PRO 6B MULTISTIX PRO 6K NORMALE 300 mg/g ABNORMALE >500 mg/g ABNORMALE NORMALE 300 mg/g ABNORMALE >500 mg/g ABNORMALE Invalid Result Value ERRORE ERRORE Color (COL) CHIA. GIALLO GIALLO SCUR. GIALLO CHIA. ARANCIONE ARANCIONE SCUR. ARANCIONE CHIA. ROSSO ROSSO SCUR. ROSSO CHIA. VERDE VERDE SCUR. VERDE CHIA. AZZURO AZZURO SCUR. AZZURO CHIA. MARRONE MARRONE SCUR. MARONE PAGLIER. GIALLO GIALLO SC. AMBRA ARANCIO

ARANCIO ROSSO ROSSO ROSSO VERDE VERDE VERDE ALTRO ALTRO ALTRO ALTRO ALTRO ALTRO Clarity (ASP) LIMPIDA LEG. TORB TORBIDA MOL.TORB ALTRO LIMPIDA LEG. TORB TORBIDA MOL.TORB ALTRO Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–65 04826807 Rev. A Italian Conventional with PLUS System set to ON Supports Clinitek 200+ Program E40100 Test Clinitek Advantus or 500 Clinitek 200+ Glucose (GLU) NEGATIVO TRACCE 1+ 2+ 3+ NEGATIVO TRACCE 1+ 2+ 3+ Bilirubin (BIL) NEGATIVO 1+ 2+ 3+ NEGATIVO 1+ 2+ 3+ Ketone (KET) NEGATIVO TRACCE 1+ 2+ 3+ NEGATIVO TRACCE 1+ 2+ 3+ Specific Gravity (PS) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030

Blood (SAN) NEGATIVO TRACCE (LIS.) TRACCE (INT.) 1+ 2+ 3+ NEGATIVO TRACCE TRACCE LEGGERO MEDIO FORTE pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) MULTISTIX Group of Test Strips NEGATIVO TRACCE 1+ 2+ 3+ NEGATIVO TRACCE 1+ 2+ 3+ MULTISTIX PRO® 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NEGATIVO BASSO 1+ 2+ 3+ NEGATIVO BASSO 1+ 2+ 3+ MULTISTIX PRO 6B MULTISTIX PRO 6K NEGATIVO 1+ 2+ 3+ NEGATIVO 1+ 2+ 3+ D–66 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A Test

Clinitek Advantus or 500 Clinitek 200+ Urobilinogen (URO) 0.2 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL 0.2 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL Nitrite (NIT) NEGATIVO POSITIVO NEGATIVO POSITIVO Leukocytes (LEU) NEGATIVO TRACCE 1+ 2+ 3+ NEGATIVO TRACCE 1+ 2+ 3+ Albumin (ALB) 10 mg/L 30 mg/L 80 mg/L 150 mg/L 10 mg/L 30 mg/L 80 mg/L 150 mg/L Creatinine (CRE) 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL A:C Ratio (A:C) <30 mg/g NORMALE 30-300 mg/g ABNORMALE >300 mg/g MOLTO ABNORMALE <30 mg/g NORMALE 30-300 mg/g ABNORMALE >300 mg/g MOLTO ABNORMALE P:C Ratio (P:C) MULTISTIX PRO 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G URINA DILUITA NORMALE 150 mg/g ABNORMALE 300 mg/g ABNORMALE >500 mg/g ABNORMALE URINA DILUITA NORMALE 150 mg/g ABNORMALE 300 mg/g ABNORMALE >500 mg/g ABNORMALE MULTISTIX PRO 6B

MULTISTIX PRO 6K NORMALE 300 mg/g ABNORMALE >500 mg/g ABNORMALE NORMALE 300 mg/g, ABNORMALE >500 mg/g, ABNORMALE Invalid Result Value ERRORE ERRORE Color (COL) CHIA. GIALLO GIALLO SCUR. GIALLO CHIA. ARANCIONE ARANCIONE SCUR. ARANCIONE CHIA. ROSSO ROSSO SCUR. ROSSO CHIA. VERDE VERDE SCUR. VERDE CHIA. AZZURO AZZURO SCUR. AZZURO CHIA. MARRONE MARRONE SCUR. MARONE PAGLIER. GIALLO GIALLO SC. AMBRA ARANCIO ARANCIO ROSSO ROSSO ROSSO VERDE VERDE VERDE ALTRO ALTRO ALTRO ALTRO ALTRO ALTRO Clarity (ASP) LIMPIDA LEG. TORB TORBIDA MOL.TORB ALTRO LIMPIDA LEG. TORB TORBIDA MOL.TORB ALTRO Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–67 04826807 Rev. A Japanese Conventional with PLUS System set to OFF Supports Clinitek 200+ Program B40101 Test Clinitek Advantus or 500 Clinitek 200+ Glucose (GLU) - 0.1 g/dL 0.25 g/dL 0.5 g/dL ≥1.0 g/dL - 0.1 g/dL 0.25 g/dL 0.5 g/dL

≥1.0 g/dL Bilirubin (BIL) - 1+ 2+ 3+ - 1+ 2+ 3+ Ketone (KET) - +/- 1+ 2+ 3+ - +/- 1+ 2+ 3+ Specific Gravity (SG) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (OB) - +/-LYSED +/-INTACT 1+ 2+ 3+ - +/- +/- 1+ 2+ 3+ pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) MULTISTIX Group of Test Strips - +/- 30 mg/dL 100 mg/dL ≥300 mg/dL - +/-

30 mg/dL 100 mg/dL ≥300 mg/dL MULTISTIX PRO®11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G - 15 mg/dL 30 mg/dL 100 mg/dL 300 mg/dL - 15 mg/dL 30 mg/dL 100 mg/dL 300 mg/dL MULTISTIX PRO 6B MULTISTIX PRO 6K - 30 mg/dL 100 mg/dL 300 mg/dL - 30 mg/dL 100 mg/dL 300 mg/dL D–68 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A Test Clinitek Advantus or 500 Clinitek 200+ Urobilinogen (URO) 0.1 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL 0.1 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL Nitrite (NIT) -+ - + Leukocytes (WBC) - +/- 1+ 2+ 3+ - +/- 1+ 2+ 3+ Albumin (ALB) 10 mg/L 30 mg/L 80 mg/L 150 mg/L 10 mg/L 30 mg/L 80 mg/L 150 mg/L Creatinine (CRE) 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL 10 mg/dL 50 mg/dL

100 mg/dL 200 mg/dL 300 mg/dL A:C Ratio (A:C) <30 mg/g NORMAL 30-300 mg/g ABNORMAL >300 mg/g HIGH ABNORMAL <30 mg/g, NORMAL 30-300 mg/g, ABNORMAL >300 mg/g, HIGH ABNORMAL P:C Ratio (P:C) MULTISTIX PRO 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NORMAL DILUTE NORMAL 150 mg/g ABNORMAL 300 mg/g ABNORMAL >500 mg/g ABNORMAL NORMAL DILUTE NORMAL 150 mg/g, ABNORMAL 300 mg/g, ABNORMAL >500 mg/g, ABNORMAL MULTISTIX PRO 6B MULTISTIX PRO 6K NORMAL 300 mg/g ABNORMAL >500 mg/g ABNORMAL NORMAL 300 mg/g, ABNORMAL >500 mg/g, ABNORMAL Invalid Result Value ERROR ERROR Color (COL) LT. YELLOW YELLOW DK. YELLOW LT. ORANGE ORANGE DK. ORANGE LT. RED RED DK. RED LT. GREEN GREEN DK. GREEN LT. BLUE BLUE DK. BLUE LT. BROWN BROWN DK. BROWN STRAW YELLOW DK YELLOW AMBER ORANGE ORANGE RED RED RED GREEN GREEN GREEN OTHER OTHER OTHER OTHER OTHER

OTHER Clarity (CLA) - +/- 1+ 2+ 3+ - +/- 1+ 2+ 3+ Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–69 04826807 Rev. A Japanese Conventional with PLUS System set to ON Supports Clinitek 200+ Program B40101 Test Clinitek Advantus or 500 Clinitek 200+ Glucose (GLU) - +/- 1+ 2+ 3+ - +/- 1+ 2+ 3+ Bilirubin (BIL) - 1+ 2+ 3+ - 1+ 2+ 3+ Ketone (KET) - +/- 1+ 2+ 3+ - +/- 1+ 2+ 3+ Specific Gravity (SG) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (OB) - +/-LYSED +/-INTACT 1+ 2+ 3+ - +/- +/- 1+ 2+ 3+ pH (pH) 5.0

5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) MULTISTIX Group of Test Strips - +/- 1+ 2+ 3+ - +/- 1+ 2+ 3+ MULTISTIX PRO® 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G - LOW 1+ 2+ 3+ - LOW 1+ 2+ 3+ MULTISTIX PRO 6B MULTISTIX PRO 6K - 1+ 2+ 3+ - 1+ 2+ 3+ D–70 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A Test Clinitek Advantus or 500 Clinitek 200+ Urobilinogen (URO) 0.1 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL 0.1 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL Nitrite (NIT) -+

- + Leukocytes (WBC) - +/- 1+ 2+ 3+ - +/- 1+ 2+ 3+ Albumin (ALB) 10 mg/L 30 mg/L 80 mg/L 150 mg/L 10 mg/L 30 mg/L 80 mg/L 150 mg/L Creatinine (CRE) 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL A:C Ratio (A:C) <30 mg/g NORMAL 30-300 mg/g ABNORMAL >300 mg/g HIGH ABNORMAL <30 mg/g, NORMAL 30-300 mg/g, ABNORMAL >300 mg/g, HIGH ABNORMAL P:C Ratio (P:C) MULTISTIX PRO 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NORMAL DILUTE NORMAL 150 mg/g ABNORMAL 300 mg/g ABNORMAL >500 mg/g ABNORMAL NORMAL DILUTE NORMAL 150 mg/g, ABNORMAL 300 mg/g, ABNORMAL >500 mg/g, ABNORMAL MULTISTIX PRO 6B MULTISTIX PRO 6K NORMAL 300 mg/g ABNORMAL >500 mg/g ABNORMAL NORMAL 300 mg/g, ABNORMAL >500 mg/g, ABNORMAL Invalid Result Value ERROR ERROR Color (COL) LT. YELLOW YELLOW DK. YELLOW LT. ORANGE ORANGE DK. ORANGE LT. RED RED

DK. RED LT. GREEN GREEN DK. GREEN LT. BLUE BLUE DK. BLUE LT. BROWN BROWN DK. BROWN STRAW YELLOW DK YELLOW AMBER ORANGE ORANGE RED RED RED GREEN GREEN GREEN OTHER OTHER OTHER OTHER OTHER OTHER Clarity (CLA) - +/- 1+ 2+ 3+ - +/- 1+ 2+ 3+ Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–71 04826807 Rev. A Japanese JCCLS with PLUS System set to OFF Supports Clinitek 200+ Program B4 Test Clinitek Advantus or 500 Clinitek 200+ Glucose (GLU) - 100 mg/dL 250 mg/dL 500 mg/dL ≥1000 mg/dL - 100 mg/dL 250 mg/dL 500 mg/dL ≥1000 mg/dL Bilirubin (BIL) - 1+ 2+ 3+ - 1+ 2+ 3+ Ketone (KET) - +/- 1+ 2+ 3+ - +/-

1+ 2+ 3+ Specific Gravity (SG) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (OB) - +/-INTACT +/-LYSED 1+ 2+ 3+ - +/- +/- 1+ 2+ 3+ pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) MULTISTIX Group of Test Strips - +/- 30 mg/dL 100 mg/dL ≥300 mg/dL - +/- 30 mg/dL 100 mg/dL ≥300 mg/dL MULTISTIX PRO® 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G - 15 mg/dL 30 mg/dL 100 mg/dL 300 mg/dL - 15 mg/dL 30 mg/dL

100 mg/dL 300 mg/dL MULTISTIX PRO 6B MULTISTIX PRO 6K - 30 mg/dL 100 mg/dL 300 mg/dL - 30 mg/dL 100 mg/dL 300 mg/dL Urobilinogen (URO) 0.1 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL 0.1 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL Nitrite (NIT) -+ - + Leukocytes (WBC) - +/- 1+ 2+ 3+ - +/- 1+ 2+ 3+ D–72 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A Test Clinitek Advantus or 500 Clinitek 200+ Albumin (ALB) 10 mg/L 30 mg/L 80 mg/L 150 mg/L 10 mg/L 30 mg/L 80 mg/L 150 mg/L Creatinine (CRE) 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL A:C Ratio (A:C) <30 mg/g NORMAL 30-300 mg/g ABNORMAL >300 mg/g HIGH ABNORMAL <30 mg/g, NORMAL 30-300 mg/g, ABNORMAL >300 mg/g, HIGH ABNORMAL MULTISTIX PRO 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G

NORMAL DILUTE NORMAL 150 mg/g ABNORMAL 300 mg/g ABNORMAL >500 mg/g ABNORMAL NORMAL DILUTE NORMAL 150 mg/g, ABNORMAL 300 mg/g, ABNORMAL >500 mg/g, ABNORMAL MULTISTIX PRO 6B MULTISTIX PRO 6K NORMAL 300 mg/g ABNORMAL >500 mg/g ABNORMAL NORMAL 300 mg/g, ABNORMAL >500 mg/g, ABNORMAL Invalid Result Value ERROR ERROR Color (COL) LT. YELLOW YELLOW DK. YELLOW LT. ORANGE ORANGE DK. ORANGE LT. RED RED DK. RED LT. GREEN GREEN DK. GREEN LT. BLUE BLUE DK. BLUE LT. BROWN BROWN DK. BROWN STRAW YELLOW DK YELLOW AMBER ORANGE ORANGE RED RED RED GREEN GREEN GREEN OTHER OTHER OTHER OTHER OTHER OTHER Clarity (CLA) - +/- 1+ 2+ 3+ - +/- 1+ 2+ 3+ Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–73 04826807 Rev. A Japanese JCCLS with PLUS System set to ON Supports Clinitek 200+ Program B40101 Test

Clinitek Advantus or 500 Clinitek 200+ Glucose (GLU) - 1+ 2+ 3+ 4+ - 1+ 2+ 3+ 4+ Bilirubin (BIL) - 1+ 2+ 3+ - 1+ 2+ 3+ Ketone (KET) - +/- 1+ 2+ 3+ - +/- 1+ 2+ 3+ Specific Gravity (SG) ≤1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (OB) - +/-LYSED +/-INTACT 1+ 2+ 3+ - +/- +/- 1+ 2+ 3+ pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5

≥9.0 Protein (PRO) MULTISTIXÒ Group of Test Strips - +/- 1+ 2+ 3+ - +/- 1+ 2+ 3+ MULTISTIX PRO® 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G - LOW 1+ 2+ 3+ - LOW 1+ 2+ 3+ MULTISTIX PRO‘ 6B MULTISTIX PRO‘ 6K - 1+ 2+ 3+ - 1+ 2+ 3+ D–74 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A Test Clinitek Advantus or 500 Clinitek 200+ Urobilinogen (URO) 0.1 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL 0.2 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL Nitrite (NIT) -+ -+ Leukocytes (WBC) - +/- 1+ 2+ 3+ - +/- 1+ 2+ 3+ Albumin (ALB) 10 mg/L 30 mg/L 80 mg/L 150 mg/L

10 mg/L 30 mg/L 80 mg/L 150 mg/L Creatinine (CRE) 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL A:C Ratio (A:C) <30 mg/g NORMAL 30-300 mg/g ABNORMAL >300 mg/g HIGH ABNORMAL <30 mg/g, NORMAL 30-300 mg/g, ABNORMAL >300 mg/g, HIGH ABNORMAL P:C Ratio (P:C) MULTISTIX PRO 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NORMAL DILUTE NORMAL 150 mg/g ABNORMAL 300 mg/g ABNORMAL >500 mg/g ABNORMAL NORMAL DILUTE NORMAL 150 mg/g, ABNORMAL 300 mg/g, ABNORMAL >500 mg/g, ABNORMAL MULTISTIX PRO 6B MULTISTIX PRO 6K NORMAL 300 mg/g ABNORMAL >500 mg/g ABNORMAL NORMAL 300 mg/g, ABNORMAL >500 mg/g, ABNORMAL Invalid Result Value ERROR ERROR Color (COL) LT. YELLOW YELLOW DK. YELLOW LT. ORANGE ORANGE DK. ORANGE LT. RED RED DK. RED LT. GREEN GREEN DK. GREEN LT. BLUE BLUE DK. BLUE LT. BROWN BROWN DK. BROWN STRAW YELLOW DK YELLOW AMBER ORANGE ORANGE

RED RED RED GREEN GREEN GREEN OTHER OTHER OTHER OTHER OTHER OTHER Clarity (CLA) - +/- 1+ 2+ OTHER - +/- 1+ 2+ 3+ Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–75 04826807 Rev. A Portuguese Conventional with PLUS System set to OFF Test Clinitek Advantus or 500 Clinitek 200+ Glucose (GLU) NEGATIVO 100 mg/dL 250 mg/dL 500 mg/dL ≥1000 mg/dL NEGATIVE 100 mg/dL 250 mg/dL 500 mg/dL ≥1000 mg/dL Bilirubin (BIL) NEGATIVO PEQUENO MODERADO GRANDE NEGATIVE SMALL MODERATE LARGE Ketone (KET) NEGATIVO INDICIO 15 mg/dL 40 mg/dL ≥80 mg/dL NEGATIVE TRACE 15 mg/dL 40 mg/dL ≥80 mg/dL Specific Gravity (SG) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (BLO) NEGATIVO INDICIO-LISADO

INDICIO-INTACTO PEQUENO MODERADO GRANDE NEGATIVE TRACE TRACE SMALL MODERATE LARGE pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) MULTISTIX Group of Test Strip NEGATIVO INDICIO 30 mg/dL 100 mg/dL ≥300 mg/dL NEGATIVE TRACE 30 mg/dL 100 mg/dL ≥300 mg/dL MULTISTIX PRO® 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NEGATIVO 15 mg/dL 30 mg/dL 100 mg/dL 300 mg/dL NEGATIVE 15 mg/dL 30 mg/dL 100 mg/dL ≥300 mg/dL MULTISTIX PRO 6B MULTISTIX PRO 6K NEGATIVO 30 mg/dL 100 mg/dL 300 mg/dL NEGATIVE 30 mg/dL 100 mg/dL 300 mg/dL D–76 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A Test Clinitek Advantus or 500 Clinitek 200+

Urobilinogen (URO) 0.2 mg/dL 1.0 mg/dL 2.0 mg/dL 4.0 mg/dL ≥8.0 mg/dL 0.2 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL Nitrite (NIT) NEGATIVO POSITIVO NEGATIVE POSITIVE Leukocytes (LEU) NEGATIVO INDICIO PEQUENO MODERADO GRANDE NEGATIVE TRACE SMALL MODERATE LARGE Albumin (ALB) 10 mg/L 30 mg/L 80 mg/L 150 mg/L 10 mg/L 30 mg/L 80 mg/L 150 mg/L Creatinine (CRE) 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL A:C Ratio (A:C) <30 mg/g NORMAL 30-300 mg/g ABNORMAL >300 mg/g HIGH ABNORMAL <30 mg/g NORMAL 30-300 mg/g ABNORMAL >300 mg/g HIGH ABNORMAL P:C Ratio (P:C) MULTISTIX PRO 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NORMAL DILUTE NORMAL 150 mg/g ABNORMAL 300 mg/g ABNORMAL >500 mg/g ABNORMAL NORMAL DILUTE NORMAL 150 mg/g ABNORMAL 300 mg/g ABNORMAL >500 mg/g ABNORMAL MULTISTIX PRO 6B MULTISTIX PRO 6K NORMAL 300 mg/g ABNORMAL >500 mg/g ABNORMAL

NORMAL 300 mg/g ABNORMAL >500 mg/g ABNORMAL Invalid Result Value ERROR ERROR Color (COL) CL. AMERELO AMERELO ES. AMERELO CL. LARANJA LARANJA ES. LARANJA CL. VERMELHO VERMELHO ES. VERMELHO CL. VERDE VERDE ES. VERDE CL. AZUL AZUL ES. AZUL CL. MARROM MARROM ES. MARROM STRAW YELLOW DK YELLOW AMBER ORANGE ORANGE RED RED RED GREEN GREEN GREEN OTHER OTHER OTHER OTHER OTHER OTHER Clarity (CLA) CLARO POUCO NEBULOSO NEBULOSO TURVO OUTROS CLEAR SL CLOUDY CLOUDY TURBID OTHER Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–77 04826807 Rev. A Portuguese Conventional with PLUS System set to ON Test Clinitek Advantus or 500 Clinitek 200+ Glucose (GLU) NEGATIVO INDICIO 1+ 2+ 3+ NEGATIVE TRACE 1+ 2+ 3+ Bilirubin (BIL) NEGATIVO 1+ 2+ 3+

NEGATIVE 1+ 2+ 3+ Ketone (KET) NEGATIVO INDICIO 1+ 2+ 3+ NEGATIVE TRACE 1+ 2+ 3+ Specific Gravity (SG) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (BLO) NEGATIVO INDICIO-LISADO INDICIO-INTACTO 1+ 2+ 3+ NEGATIVE TRACE TRACE 1+ 2+ 3+ pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) MULTISTIX Group of Test Strips NEGATIVO INDICIO 1+ 2+ 3+ NEGATIVE TRACE 1+ 2+ 3+ MULTISTIX PRO® 11 MULTISTIX PRO 10LS

MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NEGATIVO BAIXO 1+ 2+ 3+ NEGATIVE LOW 1+ 2+ 3+ MULTISTIX PRO 6B MULTISTIX PRO 6K NEGATIVO 1+ 2+ 3+ NEGATIVE 1+ 2+ 3+ D–78 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A Test Clinitek Advantus or 500 Clinitek 200+ Urobilinogen (URO) 0.2 mg/dL 1.0 mg/dL 2.0 mg/dL 4.0 mg/dL ≥8.0 mg/dL 0.2 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL Nitrite (NIT) NEGATIVO POSITIVO NEGATIVE POSITIVE Leukocytes (LEU) NEGATIVO INDICIO 1+ 2+ 3+ NEGATIVE TRACE 1+ 2+ 3+ Albumin (ALB) 10 mg/L 30 mg/L 80 mg/L 150 mg/L 10 mg/L 30 mg/L 80 mg/L 150 mg/L Creatinine (CRE) 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL A:C Ratio (A:C) <30 mg/g NORMAL

30-300 mg/g ANORMAL >300 mg/g ANORMAL ALTO <30 mg/g NORMAL 30-300 mg/g ABNORMAL >300 mg/g HIGH ABNORMAL P:C Ratio (P:C) MULTISTIX PRO 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G DILUIDO NORMAL NORMAL 150 mg/g ANORMAL 300 mg/g ANORMAL >500 mg/g ANORMAL NORMAL DILUTE NORMAL 50 mg/g ABNORMAL 300 mg/g ABNORMAL >500 mg/g ABNORMAL MULTISTIX PRO 6B MULTISTIX PRO 6K NORMAL 300 mg/g ANORMAL >500 mg/g ANORMAL NORMAL 300 mg/g ABNORMAL >500 mg/g ABNORMAL Invalid Result Value ERROR ERROR Color (COL) CL. AMERELO AMERELO ES. AMERELO CL. LARANJA LARANJA ES. LARANJA CL. VERMELHO VERMELHO ES. VERMELHO CL. VERDE VERDE ES. VERDE CL. AZUL AZUL ES. AZUL CL. MARROM MARROM ES. MARROM STRAW YELLOW DK YELLOW AMBER ORANGE ORANGE RED RED RED GREEN GREEN GREEN OTHER OTHER OTHER OTHER OTHER OTHER Clarity (CLA) CLARO POUCO NEBULOSO NEBULOSO

TURVO OUTROS CLEAR SL CLOUDY CLOUDY TURBID OTHER Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–79 04826807 Rev. A Spanish with PLUS System set to OFF Supports Clinitek 200+ Program D4 Test Clinitek Advantus or 500 Clinitek 200+ Glucose (GLU) NEGATIVO 100 mg/dL 250 mg/dL 500 mg/dL ≥1000 mg/dL NEGATIVO 100 mg/dL 250 mg/dL 500 mg/dL ≥1000 mg/dL Bilirubin (BIL) NEGATIVO BAJO MODERADO ALTO NEGATIVO BAJO MODERADO ALTO Ketone (CET) NEGATIVO INDICIOS 15 mg/dL 40 mg/dL ≥80 mg/dL NEGATIVO INDICIO 15 mg/dL 40 mg/dL ≥80 mg/dL Specific Gravity (DEN) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (SAN) NEGATIVO IND.HEMOLIZ. IND.INTACTOS Apr 25 Hem/uL Apr 80 Hem/uL Apr 200 Hem/uL NEGATIVO Apr 10 eri/uL Apr 10 eri/uL Apr 25 eri/uL Apr 80 eri/uL Apr 200 eri/uL pH (pH) 5.0 5.5 6.0 6.5

7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) MULTISTIX Group of Test Strip NEGATIVO INDICIOS 30 mg/dL 100 mg/dL ≥300 mg/dL NEGATIVO INDICIO 30 mg/dL 100 mg/dL ≥300 mg/dL MULTISTIX PRO 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NEGATIVO 15 mg/dL 30 mg/dL 100 mg/dL 300 mg/dL NEGATIVO 15 mg/dL 30 mg/dL 100 mg/dL 300 mg/dL MULTISTIX PRO 6B MULTISTIX PRO 6K NEGATIVO 30 mg/dL 100 mg/dL 300 mg/dL NEGATIVO 30 mg/dL 100 mg/dL 300 mg/dL D–80 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A Test Clinitek Advantus or 500 Clinitek 200+ Urobilinogen (URO) 0.2 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL 0.2 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL Nitrite (NIT) NEGATIVO POSITIVO NEGATIVO POSITIVO

Leukocytes (LEU) NEGATIVO Apr 15 Leu/uL Apr 70 Leu/uL Apr 125 Leu/uL Apr 500 Leu/uL NEGATIVO Apr 15 cel/uL Apr 70 cel/uL Apr 125 cel/uL Apr 500 cel/uL Albumin (ALB) 10 mg/L 30 mg/L 80 mg/L 150 mg/L 10 mg/L 30 mg/L 80 mg/L 150 mg/L Creatinine (CRE) 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL A:C Ratio (A:C) <30 mg/g NORMAL 30-300 mg/g ANORMAL >300 mg/g ALTAMENTE ANORMAL <30 mg/g, NORMAL 30-300 mg/g, ANORMAL >300 mg/g, ALTAMENTE ANORMAL P:C Ratio (P:C) MULTISTIX PRO 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G DILUIDO NORMAL NORMAL 150 mg/g ANORMAL 300 mg/g ANORMAL >500 mg/g ANORMAL DILUIDO NORMAL NORMAL 150 mg/g ANORMAL 300 mg/g ANORMAL >500 mg/g ANORMAL MULTISTIX PRO 6B MULTISTIX PRO 6K NORMAL 300 mg/g ANORMAL >500 mg/g ANORMAL NORMAL 300 mg/g ANORMAL >500 mg/g ANORMAL Invalid Result Value ERROR ERROR Color (COL) CL. AMARILLO AMARILLO OSC. AMARILLO CL. NARANJA NARANJA OSC. NARANJA CL. ROJO ROJO OSC. ROJO CL. VERDE

VERDE OSC. VERDE CL. AZUL AZUL OSC. AZUL CL. MARRON MARRON OSC. MARRON COLURICA AMARILLO AM. OSCURO AMBAR ANARANJ ANARANJ ROJIZO ROJIZO ROJIZO VERDOSO VERDOSO VERDOSO OTROS OTROS OTROS OTROS OTROS OTROS Clarity (ASP) CLARO LIG. TURB TURBIA MUY TURB OTROS CLARO LIG. TURB TURBIA MUY TURB OTROS Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode D–81 04826807 Rev. A Spanish with PLUS System set to ON Supports Clinitek 200+ Program D40100 Test Clinitek Advantus or 500 Clinitek 200+ Glucose (GLU) NEGATIVO INDICIOS 1+ 2+ 3+ NEGATIVO INDICIO 1+ 2+ 3+ Bilirubin (BIL) NEGATIVO 1+ 2+ 3+ NEGATIVO 1+ 2+ 3+ Ketone (CET) NEGATIVO INDICIOS 1+ 2+ 3+ NEGATIVO INDICIO 1+ 2+

3+ Specific Gravity (DEN) ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 ≤ 1.005 1.010 1.015 1.020 1.025 ≥1.030 Blood (SAN) NEGATIVO IND.INTACTOS IND.HEMOLIZ. 1+ 2+ 3+ NEGATIVO INDICIO INDICIO 1+ 2+ 3+ pH (pH) 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0 Protein (PRO) MULTISTIX Group of Test Strips NEGATIVO INDICIOS 1+ 2+ 3+ NEGATIVO INDICIO 1+ 2+ 3+ MULTISTIX PRO® 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G NEGATIVO BAJO 1+ 2+ 3+ NEGATIVO BAJO 1+ 2+ 3+

MULTISTIX PRO 6B MULTISTIX PRO 6K NEGATIVO 1+ 2+ 3+ NEGATIVO 1+ 2+ 3+ D–82 Clinitek Advantus and Clinitek 500 Interface Specification: Clinitek 200/200+ Emulation Mode 04826807 Rev. A Test Clinitek Advantus or 500 Clinitek 200+ Urobilinogen (URO) 0.2 U.E./dL 1.0 U.E./dL 2.0 U.E./dL 4.0 U.E./dL ≥8.0 U.E./dL 0.2 E.U./dL 1.0 E.U./dL 2.0 E.U./dL 4.0 E.U./dL ≥8.0 E.U./dL Nitrite (NIT) NEGATIVO POSITIVO NEGATIVO POSITIVO Leukocytes (LEU) NEGATIVO INDICIOS 1+ 2+ 3+ NEGATIVO INDICIO 1+ 2+ 3+ Albumin (ALB) 10 mg/L 30 mg/L 80 mg/L 150 mg/L 10 mg/L 30 mg/L 80 mg/L 150 mg/L Creatinine (CRE) 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL 10 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL A:C Ratio (A:C) <30 mg/g NORMAL 30-300 mg/g ANORMAL >300 mg/g ALTAMENTE ANORMAL <30 mg/g NORMAL 30-300 mg/g ANORMAL >300 mg/g ALTAMENTE ANORMAL P:C Ratio (P:C) MULTISTIX PRO 11 MULTISTIX PRO 10LS MULTISTIX PRO 10LB MULTISTIX PRO 10SB MULTISTIX PRO 7G

DILUIDO NORMAL NORMAL 150 mg/g ANORMAL 300 mg/g ANORMAL >500 mg/g ANORMAL DILUIDO NORMAL NORMAL 150 mg/g ANORMAL 300 mg/g ANORMAL >500 mg/g ANORMAL MULTISTIX PRO 6B MULTISTIX PRO 6K NORMAL 300 mg/g ANORMAL >500 mg/g ANORMAL NORMAL 300 mg/g ANORMAL >500 mg/g ANORMAL Invalid Result Value ERROR ERROR Color (COL) CL. AMARILLO AMARILLO OSC. AMARILLO CL. NARANJA NARANJA OSC. NARANJA CL. ROJO ROJO OSC. ROJO CL. VERDE VERDE OSC. VERDE CL. AZUL AZUL OSC. AZUL CL. MARRON MARRON OSC. MARRON COLURICA AMARILLO AM. OSCURO AMBAR ANARANJ ANARANJ ROJIZO ROJIZO ROJIZO VERDOSO VERDOSO VERDOSO OTROS OTROS OTROS OTROS OTROS OTROS Clarity (CLA) CLARO LIG. TURB TURBIA MUY TURB OTROS CLARO LIG. TURB TURBIA MUY TURB OTROS 04826807 Rev. A

Appendix E: Glossary A:C albumin to creatinine ratio <ACK> Computer acknowledges that it received the data correctly,

analyzer to address the next data set. ALB albumin <BEL> single character request for identification message BIL bilirubin BLO blood CAN Resets the analyzer data transfer functions to the default values: XON, output buffer clear, input buffer clear Checksum Two hexidecimal digit checksum for verification of the data. <CR> control code for the carriage return character CRE creatinine DC1 Enables data transmission from the Clinitek 50 XON is in effect. DC2 Data prompt to transmit one data set. The Ready screen must be displayed. DC3 Stops data transmission within one character. Analyzer recognizes no input except DC1 (XON). XOFF <ENQ> Send instrument ID message. XOFF is in effect. <ETX> control code for the end of text character GLU glucose KET ketone LEU leukocyte <LF> control code for the line feed character Marking Transmit signal is at negative levels. Mpbs Megabytes bits per second <NAK> Computer did not receive the data correctly, analyzer not to address the next data set. NIT nitrate pH pH P:C protein to creatinine ratio PRO protein 2 CLINITEK Advantus and CLINITEK 500 Interface Specification: Glossary 04826807 Rev. A SG Specific Gravity Spacing Transmit signal is at positive levels. <STX> control code for the tart of text character URO Urobilinogen