504DX_Monitor criticacre.pdf

504DX / 504DXP Operator’s Manual

Cat. No. 1029 Part No. 39109B001Date 10/04 Revision 3

Page ii 504DX / 504DXP Operator’s Manual Criticare Systems, Inc.

Copyright

COPYRIGHT © CRITICARE SYSTEMS, INC. 1999, 2004

CRITICARE SYSTEMS, INC. (Criticare) owns all rights to this unpublished work and intends to maintain this work as confidential. Criticare may also seek to maintain this work as an unpublished copyright. This publication is to be used solely for the purposes of reference, operation, maintenance, or repair of Criticare equipment. No part of this publication may be reproduced in any manner or disseminated for other purposes.

In the event of inadvertent or deliberate publication, Criticare intends to enforce its rights to this work under copyright laws as a published work. Those having access to this work may not copy, use, or disclose the information in this work unless expressly authorized by Criticare to do so.

All product specifications, as well as information contained in this publication, are subject to change without notice.

All information contained in this publication is believed to be correct. Criticare Systems, Inc. shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing, performance, or use of this material.

This publication may refer to information and products protected by copyrights or patents and does not convey any license under the patent rights of Criticare Systems, Inc., nor the rights of others. Criticare Systems, Inc. does not assume any liability arising out of any infringements of patents or other rights of third parties.

PROPERTY OF CRITICARE SYSTEMS, INC.ALL RIGHTS RESERVED

Contents

Copyright................................................................................................................ iiContents................................................................................................................ iiiWarranty............................................................................................................... viiService Return Policy.......................................................................................... viiiEC Declaration of Conformity................................................................................ ix

Section 1 - Introduction

Intended Use................................................................................................................. 1-1Description .................................................................................................................... 1-1

Pulse Oximetry Measurement (SpO2)................................................................ 1-1Calibration .......................................................................................................... 1-2

Specifications................................................................................................................ 1-3Safety............................................................................................................................ 1-5

Symbols ............................................................................................................. 1-5Warnings, Cautions, and Notes ......................................................................... 1-6General Safety ................................................................................................... 1-6General Safety ................................................................................................... 1-7Electrical Safety ................................................................................................. 1-7Battery Safety..................................................................................................... 1-7Pulse Oximeter................................................................................................... 1-8

Potential Interference.................................................................................................... 1-9Software-Error-Related Hazard Mediation.................................................................... 1-9Biocompatibility ............................................................................................................. 1-9Operating Environment ................................................................................................. 1-9

Section 2 - Controls, Displays, and Connectors

Front Panel ................................................................................................................... 2-1Fixed Keys ......................................................................................................... 2-2Numeric Displays ............................................................................................... 2-3LCD Display Screen........................................................................................... 2-3LED Indicators.................................................................................................... 2-3

Connectors.................................................................................................................... 2-4Patient Connector .............................................................................................. 2-4Power Connector ............................................................................................... 2-4Data Connector .................................................................................................. 2-5

Section 3 - Monitor Setup Procedure

Initiating Power ............................................................................................................. 3-1Setting the Language.................................................................................................... 3-1Upon Power Off ............................................................................................................ 3-1The LCD Message Bar ................................................................................................. 3-2Using the Keys.............................................................................................................. 3-2

ON/OFF.............................................................................................................. 3-2ALARM SET/Alarm Menu .................................................................................. 3-3MONITOR SET .................................................................................................. 3-4ALARM SILENCE .............................................................................................. 3-6UP/DOWN Arrow Keys (Select) ......................................................................... 3-6PRINT ................................................................................................................ 3-7FEED.................................................................................................................. 3-7

Criticare Systems, Inc. 504DX series Operator’s Manual Page iii

Section 4 - Patient Setup

General..........................................................................................................................4-1Pulse Oximeter Setup ...................................................................................................4-1

Before You Begin ...............................................................................................4-1Sensor Selection ................................................................................................4-1Sensor Placement ..............................................................................................4-2Pulse Oximetry Finger Sensor Placement..........................................................4-2Multi-Site™ Sensor Placement...........................................................................4-3Disposable Sensor Placement ...........................................................................4-3

Section 5 - Patient Monitoring

General..........................................................................................................................5-1Monitoring the Patient ...................................................................................................5-1

SpO2 Monitoring .................................................................................................5-1Pulse Rate Monitoring ........................................................................................5-1Pulse Tone .........................................................................................................5-1Auto Shutoff........................................................................................................5-1

Section 6 - Alarms and Status Messages

General..........................................................................................................................6-1Visible System Status Messages ..................................................................................6-1Alert Indicators ..............................................................................................................6-2

Low Battery.........................................................................................................6-2AC Power ...........................................................................................................6-2Neonatal Mode ...................................................................................................6-2Alarm Silence .....................................................................................................6-2SpO2 Sensor ......................................................................................................6-2

Parameter Alarms .........................................................................................................6-2Triggering an Alarm.......................................................................................................6-2Alarms Testing ..............................................................................................................6-3Alarm Characteristics ....................................................................................................6-3

High Priority ........................................................................................................6-3Medium Priority...................................................................................................6-3System Status Alarms ........................................................................................6-3

Silencing the Alarms......................................................................................................6-4Two-minute Alarm Silence..................................................................................6-4Alarm Disable .....................................................................................................6-4Restoring the Alarms ..........................................................................................6-4

Section 7 - Trends

General..........................................................................................................................7-1Capacity..............................................................................................................7-1

Clearing the Trend Memory...........................................................................................7-1Printing Trends ..............................................................................................................7-1Serial Communications .................................................................................................7-2

Tabular Mode .....................................................................................................7-2CSV Mode ..........................................................................................................7-2CUSP Mode........................................................................................................7-2

Page iv 504DX series Operator’s Manual Criticare Systems, Inc.

Section 8 - Periodic Maintenance

Customer Service ......................................................................................................... 8-1Technical Support ......................................................................................................... 8-1Maintenance Schedule ................................................................................................. 8-1Cleaning and Disinfecting ............................................................................................. 8-2

Exterior Surfaces................................................................................................ 8-2Display ............................................................................................................... 8-2Pulse Oximeter Sensors .................................................................................... 8-2

Annual Safety Tests...................................................................................................... 8-3System Testing .................................................................................................. 8-3

Service Checks ............................................................................................................. 8-3Accidental Wetting ........................................................................................................ 8-3Battery Maintenance ..................................................................................................... 8-4Long-Term Storage....................................................................................................... 8-4Replacing the Battery.................................................................................................... 8-4Disposal ........................................................................................................................ 8-4Calibration..................................................................................................................... 8-4

Section 9 - Printer

Description .................................................................................................................... 9-1Definitions ..................................................................................................................... 9-1

Graphical Trend Interval..................................................................................... 9-1Graphical Trend Resolution ............................................................................... 9-1Tabular Trend Interval........................................................................................ 9-1

Printer Operation........................................................................................................... 9-2Tabular Print Mode............................................................................................. 9-2Date Change ...................................................................................................... 9-2Graphic Print Mode ............................................................................................ 9-3Histograms (Sleep Summary Mode) .................................................................. 9-4

Loading the Paper......................................................................................................... 9-7

Appendix A — Accessories

Pulse Oximeter Sensors ...............................................................................................A-1Multi-Site™ Sensors ..........................................................................................A-1Reusable Finger Sensors...................................................................................A-1Disposable Sensors ...........................................................................................A-1

Simulator.......................................................................................................................A-2Printer ...........................................................................................................................A-2

Interface Cables .................................................................................................A-2Chargers .......................................................................................................................A-2Carry Bag......................................................................................................................A-2

Appendix B — Profox Serial Communications

504DX Configuration for Profox ....................................................................................B-1PROFOX Serial Setting ................................................................................................B-2

Criticare Systems, Inc. 504DX series Operator’s Manual Page v

Appendix C — 504DX Data Connector

Description ................................................................................................................... C-1Downloading................................................................................................................. C-2

Terminal Configuration ...................................................................................... C-2External Serial Printer .................................................................................................. C-3

Communications................................................................................................ C-3

Page vi 504DX series Operator’s Manual Criticare Systems, Inc.

Warranty

Workmanship & Materials

Criticare Systems, Inc. (CSI) warranties new equipment other than the 940 Series Multi-SiteTM Sensor to be free from defects in workmanship and materials for a period of one (1) year from date of shipment under normal use and service. The 940 Series Multi-SiteTM Sensor carries a six-month warranty. CSI’s obligation under this warranty is limited to repairing or replacing, at CSI’s option, any part which upon CSIís examination proves defective.

EXCEPT AS DESCRIBED IN THE PARAGRAPH ABOVE, CSI MAKES NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

Exemptions CSI’s obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect, or consequential damages or delay resulting from the improper use or application of the product; or the substitution upon it of parts or accessories not approved by CSI; or repair by anyone other than a CSI authorized representative.

This warranty shall not extend to any instrument which has been subjected to misuse, negligence, or accident; any instrument from which CSI’s original serial number tag or product identification markings have been altered or removed; or any product of anyother manufacturer.

Safety, Reliability, and Performance

Criticare Systems, Inc., is not responsible for the effects on safety, reliability, and performance of the 504DX monitor if:

• assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons other than those authorized by Criticare Systems, Inc.; or,

• the 504DX is not used in accordance with the instructions for use; or,

• the electrical installation of the relevant room does not comply with NFPA 70: National Electric Code, or NFPA 99: Standard for Health Care Facilities. (Outside the United States, the relevant room must comply with all electrical installation regulations mandated by the local and regional bodies of government.)

In Case of Emergency, Contact

CSI - USA 20925 Crossroads Circle Waukesha, WI 53186 Telephone: (262) 798-8282 Fax: (262) 798-8290 Orders: (800) 458-4615 Tech Support: (800) 458-2697

Internet: www.csiusa.com

Criticare Systems, Inc. 504DX series Operator’s Manual Page vii

Service/Return Policy

In the event that it becomes necessary to return a unit toCriticare Systems, Inc., the following procedure should befollowed:

1. Obtain return authorization. Contact the CSI Service Department at 800-458-2697 to obtain a Customer Service Authorization (CSA) number. (Outside the U.S., call 001-262-798-8282.) The CSA number must appear on the outside of the shipping container. Return shipments will not be accepted if the CSA number is not clearly visible. Please provide the model number, serial number, and a brief description of the reason for return.

1. Freight policy. The customer is responsible for freight charges when equipment is shipped to CSI for service (this includes customs charges).

1. Loaner service.

a. In the U.S. If it is necessary to provide a loaner system, CSI will ship a loaner by overnight courier. The loaner system must be returned to CSI at the customer's expense within one week after receipt of the repaired goods. If the unit is not returned to CSI within that time, the customer will be invoiced for the full purchase price of the equipment.

b. Outside the U.S. No loaners are available from CSI internationally. Please call your distributor.

Page viii 504DX series Operator’s Manual Criticare Systems, Inc.

Latex Content Statement

All Criticare Systems, Inc., products, including patient monitors and accessories, are free from latex in any location that may result in patient contact.

Criticare Systems, Inc. 504DX series Operator’s Manual Page ix

EC Declaration of Conformity

To view the Declaration of Conformity, visit the Criticare website at www.csiusa.com. A copy of the Declaration can also be faxed. Contact Criticare’s customer service department at (262) 798-8282 to obtain a faxed copy of the Declaration.

European Community Representative Frank Henaghan Frank Henaghan Criticare Systems Inc. Fax: 44 151 342 7208 P.O. Box 48 [email protected] Heswall CH616TZ - England

Year 2000 Compliance

20 October 1999

We have tested the following Criticare Systems, Inc. devices and found them to operate properly over the year 2000 transition.

Devices TestedFamily Covered Actual Device (and Software Revision) Tested501 Oximeter; 913 Sim Accessory No internal date or clock501+, 503 w/550 printer 503 w/printer (13.3F) {Monitor w/o printer has no date / clock} *503S w/562 printer {SpOT} 503S w/printer (1.4) {Monitor w/o printer has no date / clock} *503DX {mini SpOT} All Versions {Not Date / Time Sensitive; No internal clock hardware}502/504/P/US/USP 504USP (3.9.1) *504O/OP {PONI} 504OP (2.03) *504DX/DXP All Versions500 (1.2) *506, 507/S/SD, 508/I 507SD (2.5) *, 508 (1.2)!506DXN/T/P/TP {VitalCare} 506DXNTP (1.5) !507N/O/NP/OP 507OP (M1.4) *507E/EP {Scholar II} 507EP (2.7) !507ER {Scholar II} 507ER (2.7) !507NJ/NJC {ComfortCuff NIBP} All Versions {Not Date / Time Sensitive; No internal clock hardware}2200EL/R/I {Scholar I} 2200EL Scholar EL Recorder w/ 4 IBP (E1.28) *602-10/11/13 {POET TE/TE+} 602-13 POET TE+ (M1.1 S1.0) *601, 602-1/2/3/4/6 A/B {POET, POET II, POET IQ} 602-4B POET IQ 5 Agent w/ECG (M B1.1) *1100-3/4, 1120 1100-4 (2.5) w/1120 *507MV {MicroView} 507MV MicroView (1.1) {4 digit year} *507VV {VitalView} 507VV VitalView (2.0) {4 digit year} !507MP {MPT} 507MP MPT (1.2) {4 digit year} !820 {Maestro} 820 Maestro (2.204L-N & .264) !

NOTE:• Unless otherwise noted, all of the above devices use a two-digit year value internally.• Year 2000 - 2009 will usually be displayed as 00 - 09 but may be displayed and printed as

0 - 9.

* - No changes were necessary to ensure proper operation of these devices over the 1999 to 2000 demarcation. Therefore, we are confident that previous versions and earlier product family devices will not experience any problems.

! - Earlier versions of these devices are not new millennium compliant and must be updated to ensure proper operation. Please contact CSI Customer Service, at one of the numbers below, to arrange an appropriate media update for these devices. Depending upon the date of your request, please note that you may receive a more current revision than those listed here.

800-458-2697 North America only262-798-8282 USA / International

Incremental revisions above and beyond those listed here will be verified for proper Year 2000 operation. Please contact me directly if you have any further questions.

Best Regards,

Mike Larsen VP - Quality

Criticare Systems, Inc. 504DX series Operator’s Manual Page xi

Section 1 — Introduction

Intended Use This equipment is intended for use only by qualified medical providers in conjunction with established medical protocols.

Description The 504DX series SpO2 monitor is a compact pulse oximeter that provides continuous monitoring of oxygen saturation (SpO2) and pulse rate. In the manual, the term “504DX series” refers to both the 504DX monitor and the 504DXP monitor, unless otherwise specified.

Pulse Oximetry Measurement (SpO2)

The 504DX series monitor uses Digital Oximetry (DOX™) technology to measure blood oxygen saturation (SpO2).

DEFINITIONHemoglobin exists in the blood in several forms:

• Oxygenated (Oxyhemoglobin)

• Reduced (Deoxyhemoglobin)

• Dyshemoglobins (carboxyhemoglobin and methemoglobin.)

In the 504DX series monitor, SpO2 (pulse arterial oxygen saturation) is the ratio of oxygenated hemoglobin to the sum of oxygenated hemoglobin plus hemoglobin which is available for binding to oxygen, as expressed in the following formula:

Dyshemoglobins, such as carboxyhemoglobin and methemoglobin, are not directly measured and therefore are not factored into the measurement.

METHODThe 504DX series digital pulse oximeter measures oxygen saturation and pulse rate using the principles of spectrophotometry and plethysmography. The sensor is completely noninvasive, and there is no heat source that could burn the patient.

The pulse oximeter sensor contains two types of LEDs; each type emits a specific wavelength of light. Since oxygenated hemoglobin and deoxygenated hemoglobin absorb light selectively and predictably, the amounts of these two compounds can be determined by measuring the intensity of each wavelength that passes through the measuring site.

% oxygen saturation = Oxyhemoglobin

Oxyhemoglobin + Deoxyhemoglobinx 100

Criticare Systems, Inc. 504DX series Operator’s Manual Page 1-1

Section 1 —Introduction

The light from the LEDs shines into a pulsating vascular bed. A photodetector located opposite or alongside the LEDs measures the intensity of each wavelength transmitted through the monitoring site. The light intensity is converted to an electrical signal which is input to the monitor. The effects of skin pigmentation, venous blood, and other tissue constituents are eliminated by separating out the pulsating absorption data.

Calibration All Criticare Systems, Inc., oximeters have SpO2 calibration tables which were originally generated by monitoring desaturated human patients or volunteers and matching their displayed SpO2 value to the value determined by sampling arterial blood and measuring functional SaO2 with a clinical laboratory grade multiwavelength optical oximeter (i.e. CO-oximeter). The final SpO2 calibration curve was then generated based upon numerous patients' data over the range of 40 to 99% SaO2. All accepted data were taken from patients with dyshemoglobin (i.e., carboxyhemoglobin, methemoglobin) concentrations near zero.

• This oximeter is a two-wavelength device which is calibrated to measure functional SpO2 only when dyshemoglobin concentrations are near zero. The accuracy specifications of this device will not be met with high concentrations of dyshemoglobins. Significant concentrations of carboxyhemoglobin will result in a higher displayed SpO2 value than is actually present in the patient.

Page 1-2 504DX series Operator’s Manual Criticare Systems, Inc.


Specifications Pulse Oximetry (SpO2)Averaging Time: Selectable, 3, 6, 9, 12, 15, 18, or 21

secondsSearch Time: Selectable, 10, 20, 30, or 40 secondsSensor Type: Reusable or disposable

Range: 0-99%Resolution: 1%

Accuracy: ± 2% (70-99%); ±3% (40-69%);unspecified below 39%, statistical, representsone st. dev. (~66%) of clinical samples

Method: Dual-wavelength LEDSensor Wavelength: 660nm/905nm

Sensor Power: <80mw

Heart Rate (Pulse)Source: SpO2Range: 20 to 300 BPM

Resolution: 1 BPMAccuracy: ±1% or ± 1 BPM (whichever is greater)

DisplayType: LCD, LED

Parameters: SpO2; pulse; rate; pulse barStatus: Alarm Silence; Sensor; Low Battery;

External Power; Neonatal ModeText: Alphanumeric LCD

Languages: Selectable; English, French, German, Italian, Portuguese, Spanish

Display Update Period: 0.5 sec. (pulse bar updates with every pulse)

Data StorageCapacity: 24 hr at 4 sec intervals

System OutputCom Port: RS 232-compatible: digital or analog;

Mini-DIN8Serial Interfaces ASCII, text, or CSV; Profox compatible

PrinterType: Thermal line printer; optional

Tabular Mode: 5, 15, 30 sec intervals; 1, 2, 3, 5, 10, 15, 30, 60 min intervals; Off

Graphical Mode: 5, 15, 30 sec; 1, 2 minSpan: 1, 4, 8, 12, 24 hr



Power RequirementsCharger/Transformer,Charger Input Rating: (Cat. No. 908) 120 VAC, 60Hz

(Cat. No. 908U) 120/240 VAC, 50/60 Hz.Class Rating: Class II

BatteryType: Rechargeable lead-acid (sealed)

Rating: 6V, 3.8 A-HLife: 6 hours, typical

Recharge Time: 8 hours to 100% capacity

Operating EnvironmentTemperature: 0° to 45° C (32° to 113° F)

Humidity: 15 to 90% (non-condensing)

Storage EnvironmentTemperature: -5° to 55° C (23° to 131°F)

Humidity: 15 to 90% (non-condensing)Atmospheric Pressure: 619 to 775 mmHg (825 to 1033 kPa)

Altitude: -1,280 ft to 12,000 ft(-390m to 3,658m)

PhysicalSize: 5.6" H x 7" W x 4.81" D

(14.2cm. H x 17.8cm. W x 12.2cm. D)Weight: 3.34 lbs. (1.51 kg)

Type of Protection: Class II EquipmentDegree of Protection: Type CF Equipment

Protection Against Liquids: IPX 1 rating, Drip-Proof Equipment (monitor)IPX 0 rating (power supply)

Degree of safety of applicationin the presence of a flammable Equipment not suitable for use in the presence

anesthetic mixture with air or of a flammable anesthetic mixture with airwith nitrous oxide: or with oxygen or nitrous oxide.

Mode of operation: Continuous operation

NOTE: All specifications are subject to change without notice.



Safety

Symbols The following table explains the meaning of safety-related symbols that are used on the 504DX series monitor.

Symbol Means

Refer to Operator’s Manual for information

Alternating current

Power ON/OFF switch

ON/OFF switch (Alternate)

Alarms ON/OFF key

Sensor OFF

Neonatal mode

Battery charge low

AC power on

Do not connect any sensor to this connector

Print

Paper feed

Type CF equipment; Defibrillator proof

Electrical Testing Laboratories (ETL) Mark

European Community Mark of Approval

!

REVIEW



Warnings, Cautions, and Notes

Special statements are preceded by the Warning, Caution, or Note heading. These statements contain important instructions which often relate to safety.

indicates possible personal injury to you or others if instructions are not followed.

indicates possible damage to the equipment if instructions are not followed.

NOTE is used to emphasize important information.

General Safety

• Read this manual entirely before attempting clinical use of the 504DX series SpO2 monitor.

• A possible explosion hazard exists. Do not use the 504DX series SpO2 monitor in the presence of flammable anesthetics. The 504DX series is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.

• Do not store equipment at extreme temperatures. The storage temperature should be between -5° and 55° C (23° to 131° F). Temperatures exceeding these limits may damage the system.

• Do not stretch sensor cables. Store cables carefully after forming them into loose loops. If cables are stretched, electrical failures could result.

• Changes or modification not expressly approved by Criticare Systems, Inc., may void the warranty.

• Use of this device in an MRI environment may result in distortion of MRI images.

• Cables, cords, and leadwires may present a risk of entanglement or strangulation. Verify safe and proper positioning of these items after patient application.

• Federal (USA) law restricts this device to sale by or on the order of a physician.

CAUTION ! !



General Safety .

• Performance of the monitor may be adversely affected by exposure to high levels of electrostatic discharge. NOTE: The amplitude of the audible pulse tone remains constant regardless of changes in patient parameter measurements.

Electrical Safety

• All accessories (charger, SpO2 sensor, etc.) connected to the 504DX series monitor must meet applicable IEC standards. Accessories not meeting these standards can endanger the safety of the patient and the operator.

• Do not attempt to ground the 504DX series monitor.

• The 908U power supply input voltage is set at the factory and should not be changed.

• Do not connect the monitor directly to any external power source!

• In order to ensure compliance with applicable IEC standards, use only the CSI cat. nos. 908U or 908 charger.

Battery Safety

• Do not short circuit the battery terminals! The resulting high-current discharge can cause burns.

• Charge the battery completely following extended battery use to ensure a fully-charged battery is available for the next use.

• Explosion hazard! Keep lighted cigarettes, sparks, and flames away from the battery.

• The battery contains sulfuric acid electrolyte which can cause severe burns and eye damage, as well as illness from sulfur oxide fumes.

• Do not crack, cut, burn, or dissolve (with solvents) the battery case. Damaging the battery case can cause the release of sulfuric acid. If sulfuric acid is released from the battery, wear eye protection and rubber gloves to handle the battery, and use a solution of baking soda in water to neutralize the sulfuric acid.

• The used battery is a potential environmental hazard and must be disposed of properly. Dispose the old battery in accordance with local and federal laws. Do not incinerate.

CAUTION ! !



Pulse Oximeter

• The pulse oximeter sensor may cause skin irritation and pressure necrosis. Inspect the pulse oximeter sensor site every two to four hours or per hospital protocol. Move the sensor to a different location if skin irritation is present.

• Excessive amounts of motion at the sensor sites may cause errors in reading. Attempt a reading when motion has stopped, or move the sensor to another site.

• The cable used in CSI reusable sensors and patient cables has a minimum acceptable bend radius of 0.75 inches (19mm). The sensors must not be tightly wound around fingers or any other object with a lesser radius on a regular basis. For short term storage, the sensor shuld be loosely looped over the palm of an open hand and stored; in a basket, on a flat surface, or hung on a large diameter hook

• All accessories connected to the 504DX series monitor, including SpO2 sensors or any other accessories, must comply with all applicable UL (Underwriterís Laboratories) standards and IEC standards for such products.

• The 504DX series is intended for use with Criticare pulse oximeter sensors only. Substitution of other sensors may cause inaccurate measurements and degrade patient safety, and may damage the monitor.

• Do not tape over the pulse oximeter sensor housing. Taping over the housing may cause injury and sensor failure due to excessive pressure. If the sensor needs to be secured, place tape over the cable, immediately behind the sensor. NOTE: If possible, do not place the pulse oximeter sensor on the same extremity as the blood pressure cuff or an arterial line. Place the pulse oximeter sensor on the side of the patient opposite the blood pressure cuff or an arterial line. The occlusion of the blood flow during blood pressure determinations could affect saturation readings.

• The pulse oximeter sensor is light sensitive. Too much ambient light makes it difficult for the system to provide accurate readings. The system provides a high ambient light alarm message (SPO2: HI AMBIENT) when it is necessary to shield the sensor from extraneous light sources such as phototherapy light or infrared heating lamps. NOTE: Extreme temperature may affect equipment accuracy. Operating environment should have a room temperature of 0 to 45° C (32 to 113° F) and a relative humidity of 15 to 90% (noncondensing).

CAUTION ! !



PROTECTION AGAINST DEFIBRILLATORThe 504DX series monitor is protected against the effects of a defibrillator for the SpO2 input.

REPLACEMENT OF CONSUMABLE MATERIALSDisposable pulse oximeter sensors are intended for single-patient use only. Other pulse oximeter sensors may be replaced if they fail or become excessively worn. Replacement sensors may be ordered from Criticare Systems, Inc., at telephone number 262-798-8282. (In the United States and Canada, call 1-800-458-4615.) (See “Accessories” in Appendix A.)

Potential Interference This device has been successfully tested to IEC 60601-1-2 specified levels for emissions of and resistance to electromagnetic energy fields. External disturbances which exceed these levels may cause operational issues with this device. Other devices which are sensitive to a lower level of emissions than those allowed by IEC 60601-1-2 may experience operational issues when used in proximity to this device.

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:

• This device may not cause harmful interference; and,

• This device must accept any interference received, including interference that may cause undesired operation.

Software-Error-Related Hazard Mediation

Criticare Systems, Inc., has quality control practices and procedures in place to review hazards as they relate to software and has implemented appropriate controls.

Biocompatibility All portions of this product that routinely contact the patient have passed biocompatibility tests.

Operating Environment This equipment is designed to operate under normal environmental conditions in hospitals and non-hospital settings, as well as conditions expected in outdoor use by EMS personnel. Environmental limits are listed in the specifications section of this manual. It is not intended for use in an MRI environment, or in an air transport environment.


Section 2 — Controls, Displays, and Connectors

This section provides an overview of the 504DX monitor’s operator controls, displays, and external connectors. It shows the location of each control and explains each control’s purpose and operation.

Front Panel All operator controls are on the front panel of the Model 504DX Patient Monitor. Figure 2-1 illustrates the components of the front panel.

Figure 2-1: Model 504DX, Front Panel


Section 2 —Controls, Displays, and Connectors

Fixed Keys The fixed keys are hard keys which can perform one or more functions. The fixed keys and their functions are listed in the following table:

Key Function

(Select or Up/Down) Permits adjustment of alarm values and monitor settings.

(Monitor Set) Selects one of the following settings for adjustment:• Pulse volume• Monitoring mode• Print format:

• Tabular interval• Graphic interval• Sleep Summary

• Print Interval• Trend Resolution• Alarm Print• SpO2 Search• SpO2 Average

NOTE: Some menu items may not display due to settings of other menu items.

If pressed and held for 2 seconds, also permits the following parameters to be accessed for adjustment:• Contrast, time, date, serial data, baud

rate, analog out A, analog out B.

If pressed and held for 2 seconds, after a config default reset, also permits the following parameters to be accessed for adjustment:• Language• Alarm warning• Line frequency

(Alarm Set) Selects one of the following parameters for adjustment:• Alarm volume• High saturation limit• Low saturation limit• High pulse rate limit• Low pulse rate limit

(Print) Activates the printer.

(Feed) Advances paper through the printer.

(Silence) Permits operator to temporarily suspend audible alarms or turn audible tone off until manually re-enabled.

or (On/Off) Toggles monitor power OFF and ON.Hold for 2 seconds to turn OFF.



Numeric Displays PULSE RATEThe pulse rate is displayed in amber LEDs on the front panel. The pulse rate is derived from the SpO2 measurement.

SPO2 % VALUEThe SPO2 % value is displayed in green LEDs.

LCD Display Screen The LCD (liquid crystal display) screen displays menu options, monitor status messages, and alarm messages.

LED Indicators The LED indicators illuminate under the following conditions (the indicators are called out in “Figure 2-1: Model 504DX, Front Panel” on page 2-1.):

Icon LED Indicator Illuminates to indicate:

Low battery Less than 1 hour of battery charge remaining

AC power The monitor is connected to AC power

Alarm SILENCE Audible alarms have been turned off (red indicator at upper left of SILENCE key)

SpO2 sensor off The SpO2 sensor is not attached to the patient

Neonate The monitor is in neonate mode

PULSE BARA pulse bar display indicates the rate and relative strength of the plethysmographic signal.



Connectors

• All accessories (charger, SpO2 sensor, etc.) connected to the 504DX monitor must meet applicable IEC standards. Accessories not meeting these standards may endanger the safety of the patient and the operator.

Patient Connector The patient connector is shown in “Figure 2-2: Patient Connector (504DX, Side View)” on page 2-4. This DB-9 connector allows the use of any current CSI oximeter sensor with a DB-9 connector.

Connector Function

SENSOR Receptacle for CSI oxygen saturation (SpO2) sensor

Figure 2-2: Patient Connector (504DX, Side View)

Power Connector The power connector is on the rear panel. This connector is shown in “Figure 2-3: 504DX, Rear View.” on page 2-4.

Connector Function

POWER Provides power to the unit and to charge the internal battery

Figure 2-3: 504DX, Rear View.

SpO2 sensor connector

dataconnector

powerconnector



Data Connector The serial data connector is shown in “Figure 2-3: 504DX, Rear View.” on page 2-4.

Connector Function

DATA To provide digital or analog data to external devices


Section 3 — Monitor Setup Procedure

This section describes setting up the 504DX monitor, including initiating power and using the setup menus to adjust parameter and system setup items.

Initiating Power The 504DX monitor can be powered from the external AC charger or from the internal lead-acid battery.

To operate the 504DX monitor from AC power:

1. Connect the external charger/transformer to the POWER INPUT connector on the monitor's rear panel.

2. Connect the AC charger power plug to the AC power outlet. A

green indicator ( ) illuminates when AC power is supplied to the monitor.

3. Press the power ON/OFF key on the lower left corner of the front panel of the monitor.

The 504DX monitor is equipped with an internal battery that, when fully charged, will operate the monitor for 6 hours. The indicator does not illuminate when the monitor is operating from internal battery power. A flashing yellow low battery indicator ( ) will illuminate when approximately 1 hour of battery life remains.

The following actions always occur upon power up:

• The monitor goes through the power cycle sequence, which is described later in this section under “Using the Keys.”

• If the Low SpO2 % alarm limit was set below 85%, the limit will be reset to 85%.

• If a patient signal is present, SpO2 and pulse rate parameter monitoring begins.

Setting the Language Hold down the MONITOR SET key while powering up the monitor. Press and hold the MONITOR SET key to enter the configuration menu. Language selection is now be available as an option. Choose from English, French, German, Italian, Portuguese, and Spanish.

Upon Power Off All settings except Low SpO2 values below 85% are stored in memory when the 504DX monitor is powered off. If the Low SpO2% alarm limit was set below 85%, the limit will be reset to 85% when the 504DX monitor is powered off and then on again.

- +


Section 3 —Monitor Setup Procedure

The LCD Message Bar The message bar consists of a two-line LCD screen for the display of all system messages and menu items and adjustments. The LCD message bar display and backlight automatically turn on whenever the menu is accessed or a system message is displayed. When no activity occurs on the LCD message bar, it remains blank and unlit.

Using the Keys

ON/OFF If pressed when the unit is off, turns unit on. If pressed for 2 seconds when the unit is on, turns unit off.

AUTO POWER OFFIf the monitor receives neither parameter data nor key press data for 30 minutes, the monitor will automatically turn off. All settings and data are retained.

POWER CYCLEWhen power is turned on, there is an immediate indication to the user that the key has been activated. The unit performs the following power up sequence:

1. lluminate all segments of each 7-segment LED, all segments of pulse bar, and each indicator light for a period of 8 seconds; then blank all displays for one second.

2. Display current software revision on the LCD message bar for 2 seconds.

3. Perform an internal self-test and, if no errors are detected, revert to dashes on the 7-segment displays to signify operational readiness.

If an error is detected during power-up, an error message displays to assist in troubleshooting.

ON/OFF WITH ALARM SET (ALARMS DEFAULT RESET)If power is applied while holding down the ALARM SET key, alarm limits are restored to factory defaults. The message ALARMS DEFAULT appears in the LCD message bar during the power-up cycle.

ON/OFF WITH PRINT (TRENDS RESET)If power is applied while holding down the PRINT key, all trend information stored in memory will be erased. The message TRENDS RESET appears in the LCD message bar during the power-up cycle.



ON/OFF WITH MONITOR SET (CONFIG DEFAULT RESET)If power is applied while holding down the MONITOR SET key, the monitor configuration is restored to factory defaults. The message CONFIG DEFAULT appears in the LCD message bar during the power up cycle. Note that a config default reset must be performed in order to access the language, alarm warning, and line frequency menu items.

ALARM SET/Alarm Menu Upon the first key press, LCD message bar displays:

ALARM MENU ALARM VOLUME=xxx

The value may be adjusted using the UP/DOWN keys. Subsequent presses will bring up the following selections (listed in order). All may be adjusted using the UP/DOWN keys. Possible settings and factory defaults for each of these menu items are as follows:

Menu Item Range Increments Factory Default

ALARM VOLUME=XXX 1-10, Off 1 3

LOW SPO2=XXX Off, 30-99% 1% 85%(adult) 90% (neonate)

HIGH SPO2=XXX 70-98%, Off 1% Off

LOW PULSE=XXXbpm 20-150 bpm 2 bpm 50 bpm (adult) 90 bpm (neonate)

HIGH PULSE=XXXbpm 80-250 bpm 2 bpm 150 bpm (adult) 200 bpm (neonate)

All settings made in this manner are nonvolatile with the exception of low SpO2 which, if it is set lower than 85%, will return to 85% when power is cycled. If Low SpO2 is turned off, the message Low Sat Off appears in the LCD message bar, but the Low SpO2 alarm setting returns to 85% upon power-up.

The unit automatically exits the ALARM MENU if there is no user interaction for 20 seconds. The user may manually exit the ALARM MENU by pressing and holding the ALARM SET key for two seconds.



MONITOR SET The MONITOR SET key can be used in three ways:

• A momentary press,

• Press and hold for 3 seconds, and

• Press and hold for three seconds following a configuration default reset (powering the monitor up while pressing the MONITOR SET key).

These functions are described in the following paragraphs.

MONITOR SET MENU (MOMENTARY PRESS)Momentarily pressing MONITOR SET while in the normal operating mode will access the Monitor Set menu.

Upon the first key press, the LCD message bar will display:

MONITOR SET PULSE VOL=xxx

The value may be adjusted using the UP/DOWN arrow keys. Subsequent presses of the MONITOR SET key will bring up the following menu items (listed in order). All may be adjusted using the UP/DOWN arrow keys. Possible settings and factory defaults for each of these menu items are as follows:

Menu Item Possible Settings Factory Default

PULSE VOL=XXX 1-10, Off 2

MODE=XXXXXXXX Adult, Neonatal Adult

PRINTER=XXXXXXXXX Off, Tabular, Graphic, Tabular Slp Sum

INTERVAL=XXX 5, 15, 30 sec.;1, 2, 3, 5, Off 10, 15, 30, 60M; Off

NOTE: If Tabular Print is selected, the next menu selection is:

ALARM PRNT=XXX On, Off Off(When ALARM PRNT is set to ON and an alarm is triggered, the monitor prints a tabular printout.)

NOTE: If Graphic Print or Sleep Summary is selected as the print mode, the next two menu selections will be:

TREND RES=XX XXX 5, 15, 30 SEC, 1, 2 MIN 30 SEC

GRAPH INT=XXHR 1, 4, 8, 12, 24 HR 8 HR




SPO2 SEARCH=XX 10, 20, 30, 40 sec. 10 sec.

SPO2 AVERAGE=XX 3, 6, 9, 12, 15, 18, 21 sec. 12 sec.

NOTE: SPO2 SEARCH sets the time interval from the time the pulse signal is lost until the SPO2 SEARCH message appears. SPO2 AVERAGE sets the duration of the interval over which the SpO2 value is averaged.

If MONITOR SET is pressed again after SPO2 AVERAGE, PULSE VOLUME reappears.

All values set in this manner are nonvolatile.

The unit automatically exits the MONITOR SET mode if there is no user interaction for 20 seconds. The user may manually exit MONITOR SET mode by pressing and holding the MONITOR SET key for two seconds.

CONFIGURATION MENU (PRESS AND HOLD)If the MONITOR SET key is pressed and held for two seconds, the following menu item settings may be viewed and changed.


CONTRAST 5-95 (increments of 5) 50

HOUR 0-23 Current Hour

MINUTE 0-59 Current Minute

DAY 1-31 Current Date

MONTH JAN-DEC Current Date

YEAR 00-99 Current Date

SERIAL OUT PROFOX, CUSP†, CSV, TABULAR, Off OFF

BAUD RATE* 19200, 9600, 4800, 2400 19200

ANALOG A Pleth, SPO2 50-100, SPO2 0-100, SPO2 0-100 Pulse Rate, Alarm

ANALOG B Pleth, SPO2 50-100, SPO2 0-100, Pulse Rate Pulse Rate, Alarm

* Baud rate settings can be changed only when Serial Out is set to CSV or Tabular.

† CUSP is intended for future use.



CONFIGURATION MENU FOLLOWING CONFIG DEFAULT (PRESS AND HOLD FOLLOWING A CONFIG DEFAULT RESET)If the MONITOR SET key is pressed and held for two seconds following a Configuration Default Reset, the following menu item settings may be viewed and changed in addition to the menu items listed previously for the PRESS AND HOLD function.


LANGUAGE English, French, German, Italian, English Portuguese, Spanish

ALARM WARN Off, 1, 2, 4, 5 min Off

LINE FREQ 50, 60 Hz 60Hz

ALARM WARNINGWhen turned on, the Alarm Warning (Alarm Warn) function generates an a low-pitched double “beep” audible tone at the selected interval to remind the user that the audible alarms have been turned off. (This function is active only when the audible alarms are off, not when the alarms are suspended for two minutes.) Note that the factory default for this menu item is “off.”

LINE FREQUENCYThe line frequency menu item should be set to match the line frequency of the AC (mains) power at the location where the monitor is used.

ALARM SILENCE If pressed momentarily, the ALARM SILENCE key suspends audible alarms for a period of two minutes. The Alarm Silence LED indicator illuminates during this period. When actively monitoring a patient, the message ALARM SILENCE appears in the LCD message bar.

If the ALARM SILENCE key is pressed and held for two seconds, the audible alarms sound for one second, then are turned OFF. The Alarm Silence LED indicator flashes on and off while the audible alarms are turned off. When actively monitoring a patient, the message AUDIO OFF appears in the LCD message bar. The unit remains in this state until the user manually changes the alarm volume or power is cycled. Pressing the Alarm SILENCE key while in the AUDIO OFF state returns the monitor to audio-on condition and removes all AUDIO OFF messages.

NOTE: The AUDIO OFF and ALARM SILENCE messages do not display if one or more higher-priority (i.e., alarm) messages are displaying.

UP/DOWN Arrow Keys (Select)

These keys permit adjustment of selected parameters in the ALARM or MONITOR SET menus. UP increments the value; DOWN decrements the value.



PRINT On units with a printer, this key initiates a printout of information as specified in the monitor setup (See “Alarms and Status Messages” in Section 6) and sends data to the serial port in the format selected. On non-printer units, initiates a serial data output in the format selected. Print to: is OFF by default.

FEED Advances the printer paper through the printer.


Section 4 — Patient Setup

General This section describes step-by-step procedures for preparing the patient for monitoring.

Pulse Oximeter Setup

Before You Begin The following special notices warn or caution of avoidable conditions. Read and follow these warnings and cautions to protect yourself and your patient.

• Pulse oximeter sensors may cause skin irritation. Inspect the pulse oximeter sensor site every 2 to 4 hours or per hospital protocol. Move sensor to a different location if any skin irritation is present.

• The pulse oximeter sensor is light sensitive. Too much ambient light makes it difficult for the system to provide accurate readings. The system provides a high ambient light alarm when it is necessary to shield the sensor from extraneous light sources such as phototherapy light or infrared heating lamps.

• Do not stretch sensor cables. Store cables carefully after forming them into loose loops. If cables are stretched, electrical failures may result.

Sensor Selection Select a sensor based on patient size and monitoring conditions. For optimum results, refer to the following table regarding sensor selection for various patient monitoring applications.

NOTE: The 570, 571, 572, and 573 sensors are disposable. The 940 and 511 are reusable.

CAUTION ! !

Patient Size Duration Activity Suggested Sensor

>40kg Short/long term Low/High 511LD reusable

>30kg Long term High 940SD Multi-Site™ reusable 570SD disposable (adult)

10-50kg Short/long term High 940SD Multi-Site™ reusable 571SD disposable (pediatric)

1-20kg Short/long term High 572SD disposable (infant) 940SD Multi-Site™ reusable 573SD (neonate)


Section 4 —Patient Setup

Sensor Placement Once the sensor is selected, follow the sensor placement procedure in this section for the type of sensor you are using.

• Read the pulse oximetry safety information in this section before applying sensors OR attempting use of the pulse oximeter function.

GENERAL GUIDELINESThe following are some general guidelines for sensor placement:

• Inspect the pulse oximeter application site every 2 to 4 hours or per hospital protocol. If there is any redness or skin irritation caused by the sensor, remove the sensor and apply it to a different location.

• Use tape to secure the sensor cable as needed. Avoid applying excessive pressure to the monitoring site.

• If tape is required to secure the sensor to the patient, wrap the tape around the cable, not around the sensor itself. Do not strain the sensor cable.

• Apply the sensor with the LED lights positioned on the nail side of the finger and the detector on the fleshy portion of the finger.

Pulse Oximetry Finger Sensor Placement

Place the finger sensor on the patientís finger with the LEDs positioned on the nail side, and, if necessary, apply tape as shown in “Figure 4-1: Finger Sensor Placement.” on page 4-2.

NOTE: The sensor must be properly positioned for a plethysmographic waveform to appear. Placing tape too tightly around an extremity will reduce blood flow, thus diminishing the amplitude of the plethysmographic waveform.

Figure 4-1: Finger Sensor Placement.

CAUTION ! !


Section 4 —Patient Setup

Multi-Site™ Sensor Placement

“Figure 4-2: Attaching the Multi-Site™ Sensor.” on page 4-3 illustrates some typical sensor locations for the Multi-Site Sensor.

NOTE: When using the disposable sensors (cat. no. 570SD, 571SD, 572SD, and 573SD), see the instruction sheet that comes with the package.

Figure 4-2: Attaching the Multi-Site™ Sensor.

Disposable Sensor Placement

Refer to each sensor's accompanying instruction sheet for placement information.

LEDs ( )

Photodetector ( )

Headband

Tape

Foot

Finger

Forehead

Foreheadadapter

Ear Clip


Section 5 — Patient Monitoring

General This section describes step-by-step procedures for monitoring the patient.

Monitoring the Patient Turn on the 504DX monitor, then perform the following procedure to monitor the patient.

1. Make sure the 504DX battery is charged and/or the AC charger is plugged in before connecting the patient.

2. Check the menu items described in “Monitor Setup Procedure” in Section 3 to select appropriate settings for each alarm parameter and monitor parameter.

3. Follow the patient setup instructions in “Patient Setup” in Section 4.

4. Follow the patient instructions for each parameter as listed in this section.

5. If the unit fails to display data for a parameter, check the appropriate sensor and placement.

SpO2 Monitoring Connect the pulse oximetry sensor to the SpO2 connector on the right-side panel of the 504DX monitor. After several good pulses have been detected, the SpO2 value will appear on the display.

Pulse Rate Monitoring The pulse rate is monitored via the SpO2 connector. After several good pulses have been detected, the pulse rate value will appear on the Pulse display.

Pulse Tone The pulse tone pitch increases and decreases with increasing and decreasing oxygen saturation values. This allows the operator to audibly detect changes in saturation without observing the display.

Auto Shutoff If the finger is removed from the sensor for 30 minutes, the 504DX monitor automatically turns off.


Section 6 — Alarms and Status Messages

General The 504DX monitor provides both audible and visible alarm indicators to alert the operator of status alarms and parameter alarms.

Each parameter limit alarm condition triggers both audible and visible alarms until one of the following events occurs:

• The parameter value returns to within the alarm limit;

• The user sets the alarm limit beyond the present parameter value;

• The alarm SILENCE key is pressed.

Visible System Status Messages

The 504DX monitor provides visible alarms on its LCD message bar. LED alarm indicators are illuminated behind symbols for “Alarm Silence,” “Sensor,” and “Low Battery” where applicable. (See “Figure 2-1: Model 504DX, Front Panel” on page 2-1.)

A list of the status messages and the appropriate corrective action are provided in “Table 6-1: Status Messages” on page 6-1.

Table 6-1: Status Messages

Message Description/Corrective Action

SpO2: NO SENSOR The SpO2 sensor is not connected, or the SpO2 signal is not being detected due to possible sensor failure. Connect or replace the sensor.

SpO2: SENSOR The SpO2 sensor is not properly positioned, or is off site.

SpO2: SEARCH The SpO2 signal has disappeared. Move the sensor to a different site.

SpO2: SIGNAL The SpO2 signal is too weak to measure. Check the sensor site for low perfusion and reposition the sensor if necessary.

SpO2: HI AMBIENT The sensor is detecting excessive ambient light. Shield the sensor or reduce the amount of ambient light.

AUDIO OFF The audible alarms are turned off.

HIGH SCALE The incoming plethysmographic signal is outside the expected range. Reposition the sensor if necessary.

LOW BATTERY Approximately one hour of continuous operation (from battery) remains. Recharge the monitor battery. If battery power falls below levels needed for reliable operation, the unit automatically turns off. If this message appears, plug unit into AC power as soon as possible.


Section 6 —Alarms and Status Messages

Alert Indicators

Low Battery This indicator flashes when approximately one hour of battery life remains. The LCD message bar simultaneously displays the message LOW BATTERY.

AC Power This indicator illuminates when the unit is plugged into a line power source.

Neonatal Mode This indicator illuminates when the neonatal mode is enabled.

Alarm Silence This indicator will be steadily illuminated when alarms are temporarily suspended. It flashes when the alarm volume is set to the Off position either via the ALARM SET menu or the alarm SILENCE key.

SpO2 Sensor This indicator will be steadily illuminated during any of the SpO2 error conditions listed in “Table 6-1: Status Messages” on page 6-1.

Parameter Alarms When monitored values for SpO2 and pulse rate fall outside the limits specified in the Alarm Menu, the corresponding numeric LED display begins to flash and the appropriate message display on the LCD message bar:

“Low SpO2” “High SpO2” “Low Pulse Rate” “High Pulse Rate”

If the alarm condition persists for more than 5 seconds, the audible alarm will sound at the volume level selected in the Alarm Menu.

Triggering an Alarm A patient alarm is activated only when the value of one of the patient's parameters exceeds one of the alarm limits. For example, if the high saturation limit is set to 97%, the 504DX sounds an alarm when the patient’s SpO2 reaches 98%. It will not alarm at 97%.

Similarly, if the low saturation limit is set to 90%, the alarm sounds when the patient's SpO2 falls to 89% or below.

• To trigger an alarm, the patient's value must exceed the parameter's limit.



Alarms Testing To check and ensure that the audible and visual alarm limit settings are operating as expected, the user may do so by performing the following suggested procedure:

1. Apply power to the monitor. Observe that all displays and LEDs illuminate.

2. Place the SpO2 probe on your finger. Allow readings to stabilize.

3. Observe the pulse rate that is being displayed and adjust the low pulse rate limit to a value greater than the observed pulse rate value.

4. Verify that the low pulse rate violation message is displayed on the LCD message bar and that the alarm tone sounds.

5. Once verified, return the low pulse rate limit to the previously set value, or to one that is required for the patient to be monitored.

Alarm Characteristics

High Priority High-priority physiological alarms are signaled by three "beeps," a brief pause, then two “beeps,” a two-second pause, three “beeps,” a brief pause, then two “beeps.” After approximately four seconds, this sequence is repeated. The numeric SpO2 LED flashes. The only high-priority physiological alarm is Low SpO2.

Medium Priority Medium-priority physiological alarms are signaled by three “beeps” repeating after a pause of approximately 24 seconds. The numeric LED's for the parameter in alarm flashes. The medium-priority physiological alarms are High SpO2, High HR, and Low HR.

System Status Alarms System status alarms are signaled by two “beeps” repeating after a pause of approximately 14 seconds. The system status alarms are listed in “Table 6-1: Status Messages” on page 6-1.



Silencing the Alarms Alarms may be silenced for two minutes or may be disabled indefinitely.

Two-minute Alarm Silence To silence the alarms for two minutes, press the SILENCE key. The monitor generates a single “beep” tone. The alarm silence LED indicator illuminates continuously during the two minute silence period.

When the alarm silence period ends, the alarm SILENCE LED indicator turns off to indicate that the alarms are enabled again.

Alarm Disable To silence the alarms for an indefinite period of time, press and hold the SILENCE key for two seconds. The monitor generates a single "beep" tone, pause, and then generate a double “beep” tone. (If alarms are disabled while the two minute alarm silence is active, the monitor emits only a single “beep” tone.)

The alarm SILENCE LED indicator flashes on and off continuously during the time the alarms are disabled.

Restoring the Alarms To enable the alarms again, press the SILENCE key. The monitor generates a single “beep” tone. The alarm SILENCE LED indicator turns off.

NOTE: When the audible alarms are silenced, a “double beep” occurs the first time an alarm is violated. When the audible alarms are silenced and the 504DX is powered down and then up again, the alarm volume reverts to a value of 2.


Section 7 — Trends

General This section describes the use of the 504DX monitor's trend functions. The trend memory stores patient data at regular intervals for review at a later time. Trend data can be reviewed by printing it out on the monitor's built-in printer.

SpO2 and pulse rate trend data are stored every 5 seconds, except in Profox mode, which stores trend data every 4 seconds.

Capacity The trend memory can store up to 24 hours of trend data with 4-second intervals.

When the trend memory is filled to maximum capacity, the new trend data will begin to overwrite the oldest trend data in the memory, except in Profox mode. In Profox mode, data collection will stop when trend memory is filled to maximum capacity.

Clearing the Trend Memory

To clear the trend memory, turn the monitor off, then press and hold the PRINT key while pressing the power key. Trend memory is erased when the monitor turns on.

The trend memory is automatically cleared when the time and/or date are changed in the menu. The trend memory is also cleared when entering and leaving Profox mode, and when entering and leaving neonate mode.

Printing Trends Refer to “Printer” in Section 9 for information on trend printing.


Section 7 —Trends

Serial Communications When the serial port is activated with one of the following modes, data in the chosen format is routed to the serial port instead of the printer. (Use CSI Serial Cable cat. no. 931S.)

Tabular Mode Setup the interval in the Monitor Set menu. Choose the interval setting (5, 15, 30 seconds; 1, 2, 3, 5,10, 15, 30, 60 minutes).

In the Configuration menu, set the serial setting to Tabular. Data is now routed, at the interval specified, to the serial port instead of the printer.

To send a demand reading to the serial port, press the PRINT button.

The format of the serial tabular data is the same as the printed tabular data.

CSV Mode The CSV (comma separated variable) mode data format is similar to the printed tabular mode data format, except that the header is not sent. (See “Figure 9-1: Tabular Trend Printout (example).” on page 9-2 for an example of a tabular mode printout.) The parameter data is separated by commas.

CUSP Mode This mode is a serial communications protocol which is proprietary to Criticare Systems, Inc. It is reserved for future use.PROFOX mode

See “Profox Serial Communications” in Appendix B.


Section 8 — Periodic Maintenance

This section covers maintenance to the 504DX Patient Monitor and its sensors. There are no user-serviceable parts inside the monitor. For maintenance inside the monitor, call a CSI-authorized service center.

Customer Service To order a battery or any other part or accessory, call CSI Customer Service at 1-800-458-4615. Outside the U.S., call 262-798-8282.

Technical Support To obtain technical support for service or warranty-related problems, call CSI Technical Support at 1-800-458-2697. Outside the U.S., call 262-798-8282.

Maintenance Schedule

Every Patient • Clean and disinfect the sensor cable and sensor.

• Inspect the pulse oximeter and cables for damage.

• Inspect all cables and sensor for damage.

Every 3 Months • Clean the exterior of the unit (or clean as needed).

Every Year • Perform the annual safety tests described in this section.


Section 8 —Periodic Maintenance

Cleaning and Disinfecting

• Turn the power off before cleaning the monitor and sensor.

• Do not use abrasive cleaners on the monitor or on any sensors or probes. Abrasive cleaners can damage the monitor, sensors, and probes.

Exterior Surfaces The exterior surface of the 504DX monitor, EXCEPT FOR THE DISPLAY WINDOW, may be wiped clean with alcohol and dried with a soft, dry cloth.

Display Clean the display window by wiping it with a clean, soft, lint-free cloth sprayed with alcohol-free glass cleaner. DO NOT spray glass cleaner directly on the display window.

• Do not use alcohol or abrasive cleaners to clean the display window. Use of these cleaners may damage the display window. Use ordinary glass cleaners only.

• Use only a soft, clean, lint-free cloth. Paper towels or tissues can scratch the surface.

Pulse Oximeter Sensors NOTE: The standard CSI pulse oximeter probe is not a sterile product. If the probe or package is damaged and requires cleaning, perform the following procedure.

• Do not immerse any Criticare pulse oximeter sensor connector in any liquid. Doing so may damage the connector.

The SpO2 sensor may be wiped clean with alcohol. The SpO2 sensor may be disinfected by placing the paddles and cable in a 2% glutaraldehyde solution. Place only the sensor paddles and cable in the solution.

CAUTION ! !

CAUTION ! !

CAUTION ! !



Annual Safety Tests The monitor should be electrically tested annually as follows:

NOTE: Safety tests should be performed only by CSI-authorized service technicians.

System Testing The 504DX monitor has built-in system tests which should be performed regularly. However, the tests should be performed by authorized service personnel only. Refer to the 504DX Service Manual for additional information.

Service Checks If the monitor shows any signs of physical damage, return it to the CSI Service Department for repair.

Have a qualified service technician perform the following performance and safety checks annually.

Perform complete functional testing of the monitor as described in the test procedures in the 504DX Service Manual.

Test the monitor for electrical leakage current as described previously in this section.

NOTE: No user-serviceable parts exist inside the monitor. Do not remove the cover. Refer all servicing to a qualified technician.

Accidental Wetting The action to be taken following accidental wetting of the equipment is as follows:

1. IMMEDIATELY disconnect the charger from the 504DX monitor.

• After accidental wetting of the equipment, do not use the monitor for patient monitoring until it has been safety tested and has passed all applicable safety tests.

2. If monitoring a patient, transfer the patient to another monitor as quickly as possible.

3. Use a clean, dry towel or cloth to remove the liquid from the 504DX monitor housing.

4. The 504DX monitor should be inspected by an authorized Criticare Service Technician as soon as possible.

• Time is critical! The longer any liquid remains in the 504DX monitor, the more damage it can do. It is important to service the monitor immediately after any liquid is spilled into it.

CAUTION ! !



Battery Maintenance The battery requires no maintenance.

Long-Term Storage No special preparation is necessary for long term storage of the 504DX monitor.

Replacing the Battery Battery replacement is beyond the scope of this manual. If it becomes necessary to replace the battery, refer to the battery replacement procedure in the 504DX Service Manual, or contact the CSI Service Department.

Disposal At the end of its useful life, the monitor and its accessories may be disposed of according to your institution's policies and procedures for disposal of patient-contact medical waste.

Alternately, the monitor and its accessories may be returned to Criticare Systems, Inc. for safe disposal. The shipping address is:

Criticare Systems, Inc. 20925 Crossroads Circle Waukesha, WI 53186

Calibration No calibration is required for the 504DX monitor.


Section 9 — Printer

This section describes the integral printer in the 504DXP.

Description The 504DXP monitor is equipped with a thermal dot-matrix printer which is located on the top of the unit. It is capable of printing stored SpO2 and pulse rate data.

Definitions

Graphical Trend Interval The Graphical Trend Interval is the “window” of time that the trend printout represents. This is set in the MONITOR SET menu (represented as GRAPH INT) as described in “Monitor Setup Procedure” in Section 3.

Graphical Trend Resolution The Graphical Trend Resolution is the interval at which patient data is retrieved and displayed from trend memory. This is set in the MONITOR SET menu (represented as TREND RES) as described in “Monitor Setup Procedure” in Section 3.

Tabular Trend Interval The Tabular Trend Interval is the interval at which a data “snapshot” is printed or sent to the serial port. This is set in the MONITOR SET menu (represented as INTERVAL) as described in “Monitor Setup Procedure” in Section 3.


Section 9 —Printer

Printer Operation The optional thermal printer will generate documentation of saturation and pulse rate data in a variety of formats, selectable in the MONITOR SET menu.

Tabular Print Mode If Tabular printing is selected, the unit generates a time-stamped printout of SpO2 and pulse rate with status message automatically at the interval set in the Tabular Interval field. The first time the PRINT key is pressed after power up, a header prints which includes the Criticare name, Model Number, Software Revision, Date, and labeled spaces to manually write in patient name and identification number. The current time, SpO2 and pulse rate readings also are printed as shown in Figure 9-1.

Figure 9-1: Tabular Trend Printout (example).

In tabular mode, the first five characters of each line indicate the time of day for the data on that line. Two blank spaces follow, then the heart rate in BPM. Two more blank spaces are followed by the SpO2% value. The remaining area is used to indicate any alarm condition messages as they appear on the LCD display.

Parameters which are outside the specified limits for alarm values will be flagged by an asterisk (*), and an indication as to the alarm conditions.

Date Change If the date changes during the course of a printout (i.e., if the time of the printed data passes midnight), the monitor will record the new date on the printout between the last line of data for the old date and the first line of data for the new date.



Graphic Print Mode TREND RESOLUTION SETTINGS AT 5, 15, 30 SECONDS OR 1, 2 MINUTESGenerates a graphic record of data stored in trend memory with time appearing on the horizontal axis and SpO2 and pulse rate appearing on the vertical axis. The total time represented is dependent on the Graph Interval selected in the MONITOR SET menu, which is accessed via the MONITOR SET key. The resolution of the data (i.e., the number of seconds or minutes represented by each horizontal dot) is selected in the Trend Res field in the MONITOR SET menu.

During normal operation, the 504DX stores saturation and pulse rate values every five seconds for a total of 24 hours. Once the memory is filled, the most current data will be written over the oldest data stored. The data is written over in the order of oldest to newest (i.e., “first in, first out”). This information is accessed for printout as follows:

1. If trend resolution is set for 5, 15, or 30 seconds, the single value which was recorded at that time is plotted on the trend graph.

2. If trend resolution is set for 1 or 2 minutes, the unit plots a vertical line between the high and low values during that period to represent the range of measurements recorded over that time.

When Graphic mode is selected and the PRINT key is pressed, the unit prints a graphic record of the data currently in memory for the interval specified in GRAPHIC INT. in the MONITOR SET menu. (See Figure 9-2.)

Figure 9-2: Graphic Trend Printout (example).

NOTE: If the operator requests a trend printout for a longer interval than is stored in trend memory, the monitor prints out only the data available from memory. For example, if the patient has been monitored for 7 hours and the operator requests a 12-hour trend printout, the monitor only prints out 7 hours of trend data because no more data is available.



The format of the printout specifies the model (504DX), the time period and date represented on the printout, and the trend resolution. A thick vertical line is placed on the graph under two conditions:

1. To indicate when power is cycled; this usually indicates monitoring a new (different) patient.

2. When the PRINT key is pressed. Note that when printer mode is set to graphical or sleep summary, no trend data is recorded in trend memory during the time that the monitor is printing.

Histograms (Sleep Summary Mode)

If Print Select is set to SLP SUM (Sleep Summary Mode), then histograms are available. Sleep Summary Mode generates the same information as the Graphic Mode, but includes threshold levels for desat analysis (i.e., low saturation alarm setting), desaturation log, and histograms. The threshold level is the low alarm limit for saturation. This level defines what will be counted as an event in the desaturation summary. An example of a complete histogram printout is shown in Figure 9-3.

Figure 9-3: Histogram Graphic Trend Printout (example) (1 of 2).

HR alarm limits

SpO2 alarm limits

Time of reading

Pulse ratein beats per

minute (BPM)

(continuation of data on

previous strip)

SpO2%



Figure 9-4: Histogram Graphic Trend Printout (example) (2 of 2).

SpO2 Histogram

Percentage of total SpO2%

measurements

Percentage of total HR

measurements

SpO2%range

Indicates that about 60% of the SpO2 readings for this patient were between the range of 95% and 99%

HR Histogram

HRrange

Indicates that about 35% of the HR readings for this patient were between the range of 51 and 70 BPM

Start and stop times for event #1

Sum of lowest SpO2 values ÷ # of events

Pulse rate at timeof lowest SpO2% during event #1

Lowest SpO2% during entire desat log period

Pulse rate at timeof lowest SpO2%

Lowest SpO2% during event #1

Event #1

Event: Interval during which the Low SpO2 alarm is violated for

20 sec. or more



RECALCULATING AN ANALYSISUsing the information generated in the histograms, desaturation log, and summary, the user has the ability to change low saturation alarm settings and then recalculate and rerun an analysis based on those new settings by pressing PRINT again.



Loading the Paper Perform the following instructions to load the printer paper:

1. Cut the end of the paper roll to a point as shown in “Figure 9-5: Cutting the Printer Paper.”

Figure 9-5: Cutting the Printer Paper.

2. Open the paper access door. (See “Figure 9-6: Opening the Paper Access Door.”)

Figure 9-6: Opening the Paper Access Door.

3. Feed the end of the paper roll into the printer. (See “Figure 9-7: Feeding the Paper into the Printer.”)

Figure 9-7: Feeding the Paper into the Printer.

4. Press the FEED key to feed the paper through the printer.

5. Place the paper roll in the unit.

Cut paper to apoint as shown

Insert paper into printer here



6. Feed the paper through the slot in the paper access door. (See “Figure 9-8: Feeding the Paper Through the Slot.”)

7. Close the paper access door.

Figure 9-8: Feeding the Paper Through the Slot.

The printer paper is now ready for use.

Feed paperthroughslot in door


Appendix A — Accessories

Pulse Oximeter Sensors

Multi-Site™ Sensors Part No. Description

940-HP Multi-Site™ Package, Contains940-SD Multi-Site™ Sensor518-DD Patient Cable

914 Forehead Applicator and Headband514 Earclip525 Double-sided Adhesives526 Microfoam Tape508 Labels582 Instruction Book

NOTE: Items contained in the Multi-Site™ package may also be ordered separately.

Reusable Finger Sensors Part No. Description511HP Reusable Finger Sensor, 3' (~1m) cable, DB9

connector; includes separate 10' (~3m) Patient Cable, DB9 to DB9

511SD Reusable Finger Sensor, 3' (~1m) cable, DB9 connector511-10D Reusable Finger Sensor, 10' (~3m) cable, DB9

connector940SD Reusable Multi-Site Sensor, 3' (~1m) cable, DB9

connector w/accessories

PULSE OXIMETER CABLES518DD 10' (~3m) Patient Cable, DB9 to DB9

Disposable Sensors Part No. Description

570SD Adult Disposable Sensor (25mm) (box of 25) (PN 90356A002)

571SD Pediatric Disposable Sensor (20mm) (box of 25) (PN 90355A002)

572SD Infant Disposable Sensor (20mm) (box of 25) (PN 90353A002)

573SD Neonatal Disposable Sensor (25mm) (box of 25) (PN 90354A002)

574SD Disposable Sensor Variety Pack (10 adult, 5 pediatric, 5 infant, 5 neonatal)

Criticare Systems, Inc. 504DX series Operator Manual Page A-1

Appendix A —Accessories

Simulator Part No. Description

913AD SpO2/ECG Simulator

913A Adapter Cable (Required to use 913AD with 504DX Monitor)

Printer Part No. Description

553 5 Rolls (60mm) Thermal Paper (504DXP internal printer)

Interface Cables Part No. Description

931S Serial Cable 6' 8-pin DIN – DB9

931P Printer Cable 6’ 8-pin DIN – DB9

931A Analog Cable 6' 8-pin DIN – 2 BNCs

Chargers Part No. Description

908 120 V / 60 Hz Wall Mount, United States style plug

908U 220 V / 50 to 60 Hz Table Top, Universal

1046E 220 V / 50 Hz Wall Mount, Euro style plug

1046UK 220 V / 50 Hz Wall Mount, United Kingdom style plug

1046A 240 V / 50 Hz Wall Mount, Australia style plug

1062J 100 V / 50 to 60 Hz Wall Mount, Japanese style plug

Carry Bag Part No. Description

1013 Carry Bag for 504DX

Page A-2 504DX series Operator Manual Criticare Systems, Inc.

Appendix B — Profox Serial Communications

504DX Configuration for Profox

The CSI 504DX monitor can communicate with Profox Associates database sleep study software. To configure the monitor to collect data for Profox, do the following:

1. Power up the monitor.

2. Press and hold the MONITOR SET key. The CONFIGURATION menu displays.

3. Repeatedly press the MONITOR SET key until the serial setting is viewable.

4. Use the UP and DOWN arrow keys to set the serial setting to Profox.

5. Press and hold the MONITOR SET key for 2 seconds to exit the CONFIGURATION menu.

6. Press the MONITOR SET key. The MONITOR SET menu displays.

7. Repeatedly press the MONITOR SET key until the printer setting is available.

8. Use the UP and DOWN arrow keys to set the printer setting to OFF.

9. Press and hold the MONITOR SET key for 2 seconds to exit the MONITOR SET menu.

10.Collect data on the patient for the desired period of time.

11.When data collection concludes, plug the cable (CSI cat. no. 931S) into the serial/analog communications port of the monitor. Plug the other end of the cable into the device with the Profox database software. NOTE: The printer mode in the MONITOR SET menu must be set to OFF to allow trend data to be sent to the serial port.

12.When the Profox software is ready to receive the data, press the PRINT key to start the data transfer. NOTE: If the mode is changed from Profox, all trend data is lost.

Criticare Systems, Inc. 504DX series Operator Manual Page B-1

Appendix B —Profox Serial Communications

PROFOX Serial Setting If PROFOX is selected as the Serial setting, the unit stores data at four second intervals for a period of up to 24 hours. In this mode, data collection will stop when memory is filled. When the PRINT key is pressed in this mode, all data currently in memory is output through the serial port in ASCII format.

The operator needs to manually clear trends (hold PRINT during power up) prior to starting a new patient to ensure continuity of data.

For more detailed information on Profox database sleep study software, refer to the Profox User’s Manual.

Page B-2 504DX series Operator Manual Criticare Systems, Inc.

Appendix C — 504DX Data Connector

Description The 504DX supports the use of the serial port (8-pin DIN) for outputting trend data to an external serial printer or computer. Serial printer cable CSI Cat. No. 931S can be used for computer connection in order to capture this data. A modified null modem printer cable, CSI Cat. No. 931P can be used for the Seiko DPU-414 external printer. This connector also provides connections for two analog outputs, A and B.

The connector pinouts are shown in “Figure C-1: 504DX Data Connector Pinout, as Viewed from Rear of Monitor.”

Figure C-1: 504DX Data Connector Pinout, as Viewed from Rear of Monitor.

Criticare Systems, Inc. 504DX series Operator Manual Page C-1

Appendix C —504DX Data Connector

Downloading A serial download cable is available from CSI, use Cat. No. 931S to connect to standard male DB-9 computer serial ports. A common computer terminal program and an unused RS232 serial port will be need for downloading.

CSI recommends using the Windows HYPERTRM.EXE program provided with MS Windows 95/98. HYPERTRM.EXE can be found in the Windows accessory directory. For older computers using MS Windows 3.1, the communications program TERMINAL.EXE can be found in the Windows directory.

Use the serial communications instructions for the 504DX described in “Trends” in Section 7.

Terminal Configuration The cable connections should be completed and the terminal program should be configured before attempting to send data.

The required settings are as follows:

Baud Rate: 9600Parity: No Parity

Stop Bits: 1Data Bits: 8

Hardware Control: None

Page C-2 504DX series Operator Manual Criticare Systems, Inc.

Appendix C —504DX Data Connector

External Serial Printer The Seiko DPU-414 is pinned out as a modem would be (DCE - data communications equipment) rather than as a typical printer/computer (DTE - data terminal equipment). Use the serial communications instructionsfor the 504DX described in “Trends” in Section 7.

A standard DB-9 serial connector is located on the back of the DPU-414 thermal printer. Read the manual provided with the Cat. No. 680-5 printer kit for additional instructions.

To order ask for:

Seiko DPU-414 Thermal Printer Kit ................................. Cat. #680-5 Includes:

printer, manual, power adapter, 931P Serial Cable, 1 roll thermal printer paper

External Printer Thermal Paper, 5 rolls ................................Cat. #679 (This external printer paper does not fit the 504DXP internal printer)

Communications The selected external printer must be configured so that it can communicate with the 504DX. Follow the configuration instructions provided with your printer.

The required settings are as follows:

Baud Rate: 9600Parity: No Parity

Stop Bits: 1Data Bits: 8

Criticare Systems, Inc. 504DX series Operator Manual Page C-3

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