Device Description and Operating Instructionsactivecare.se/files/bruksanv/weinmann/somnocheck_manual_gb.pdf · Device Description and Operating Instructions SOMNO check SOMNO check

Device Description

and Operating Instructions

SOMNO

check

SOMNO

check

effort

SOMNO

check

Sleep Apnea Diagnosis Set

WM 94100

SOMNO

check


(without Sensors)

WM 94101

SOMNO

check

effort


WM 94200

SOMNO

check

effort


(without Sensors)

WM 94201

Contents

1.

Description

. . . . . . . . . . . . . . . . . .

3

1.1

Purpose of Use

. . . . . . . . . . . .

3

1.2

Functional description

. . . . . . . .

5

1.3

Symbols on the system

. . . . . . .

9

1.4

Signals and Alarms

. . . . . . . .

10

1.5

Measurement requirements

. . . .

12

–

Pulsoximetric sensors

–

Respiratory Flow / Snore Sensor

–

Respiratory flow snore nasal

cannula

–

Position sensor in the

SOMNO

check

basic unit

–

Thorax and Abdomen sensor

(only SOMNO

check

effort

)

–

Pressure measurement tube

2.

Safety Instructions

. . . . . . . . . . . .

16

–

SOMNO

check

basic unit

–

SOMNO

check

Software

3.

Combination with Therapy

Systems

19

3.1

Devices

. . . . . . . . . . . . . . . .

19

3.2

Masks

. . . . . . . . . . . . . . . . .

19

4.

Installation

. . . . . . . . . . . . . . . . . .

20

4.1

System Requirements

. . . . . . . .

20

4.2

Software Installation

. . . . . . . .

21

4.3

Preparation of

SOMNO

check

connection

. . .

24

5.

Operation

. . . . . . . . . . . . . . . . . .

26

5.1

Starting SOMNO

check

. . . . . .

26

–

Starting in Windows 3.1 and

3.11,

Windows NT Workstation

3.51

–

Starting in Windows 95/98/

ME, Windows

NT Workstation

4.0, Windows

2000,

Windows

XP

–

Language selection

5.2

Menus and Symbols

. . . . . . . .

28

5.3

Online Help and Tutorial

. . . . .

29

5.4

Measurement preparation

. . . .

31

– Configure SOMNOcheck– Time comparison

5.5 Charging the rechargeable power pack . . . . . . . . . . . . . 34

5.6 Attaching the SOMNOcheck system . . . . . . . . . . . . . . . . 35

– Attaching SOMNOcheck– Attaching SOMNOcheck effort

(only SOMNOcheck effort )– Attaching the Respiratory Flow /

Snore Sensor– Putting on respiratory flow nasal

cannula– Attaching the pressure

measurement tube– Attaching the pulsoximetric sensor– Carrying out the sensor test– Measurement start and end

5.7 Important tips for your patient . 455.8 Analyzing patient data. . . . . . 47

– Reading patient data– Change signal display– Display analysis– Print report– Print screen image– Exit the program

6. Using the rechargeable power pack . . . . . . . . . . . . . . . . . . . . . . .52

7. Hygienic preparation . . . . . . . . . . 557.1 Before each use and when

changing patients . . . . . . . . . 557.2 As required . . . . . . . . . . . . . 56

8. Functional checks . . . . . . . . . . . . . 579. Errors and their correction . . . . . . 58

9.1 SOMNOcheck Basic Unit . . . 589.2 SOMNOcheck-Software . . . . 599.3 Charger . . . . . . . . . . . . . . . 60

10. Maintenance, Service . . . . . . . . . 6111. Disposal. . . . . . . . . . . . . . . . . . . . 6112. Supply Range . . . . . . . . . . . . . . . 62

12.1 Standard supply range. . . . . . 6212.2 Replacement parts. . . . . . . . . 6412.3 Accessories . . . . . . . . . . . . . 66

13. Technical Data . . . . . . . . . . . . . . . 6714. Warranty. . . . . . . . . . . . . . . . . . . 70

OverviewSOMNOcheckFront k

1 CPAP connection with cover

Bac

2 Port
3 Yellow LED 4 Green LED 5 Button6 Power pack
k

7 Holster with strap
8 Outlet for thorax sensor
9 Outlet for connector

10 Holster with abdomen and chest straps and effort sensors

Sensors

12 Sensor nodu11 Respiratory flow / Snore sensor

les13 Sleeve

17 R

14 Microphon
e15 Carrying platform 16 Sensor plug
espiratory flow nasal cannula18 Sleeve

2

19 Cannulas

2 Vario a

20 Tab21 Connection

dapter

23 Pressure measurement tube
24 Connector25 Connection
hose

27 Synthetic hose26 Threaded joint for

CPAP connection

28 Pulsoximeter Clip Sensor Envitec

30 Cb29 Sensor plug

ombo-plug (com-ination plug)

31 Finger clip

32 Pulsoximeter Clip Sensor BCI

bination plug)33 Sensor plug

34 Combo-plug (com-35 Finger clip

37Eff36 Pulsoximeter Clip

Sensor Envitec
Thorax sensor 38 Coort Sensors (only SO
nnector 39 AbdomMNOcheck effort)

en sensor 40
Protective cover for abdomen sensor
SOMNOcheck effortFront
Bac
1 CPAP connection with cover

2 Port
3 Yellow LED 4 Green LED 5 Button6 Power pack

OverviewPC Elements

41 CD-ROM

2

SOMNOcheck

42 Charger with PC-data exchange cable

43 PC plug
44 Combo-plug
45 Charger

S

46 Galvanic isolation for PC 9-pin/9-pin (only for SOMNOcheck effort )

OMNOcheck effort

1. Description

1.1 Purpose of Use

SOMNOcheck and SOMNOcheck effort are meas-urement and control systems for the diagnosis and ther-apy monitoring of sleep apnea. They consist of the basic unit recording and storing the signals, plus the sensors and the software for analysis.

Note: These Instructions for Use describe the devices SOMNOcheck as well as SOMNOcheck effort.

All descriptions for SOMNOcheck apply also to SOMNOcheck effort. The additional functions of SOMNOcheck effort are noted.

The following parameters are recorded by the SOMNOcheck system:

• Oxygen saturation (SpO2; pulsoximetric)

• Pulse rate (pulsoximetric)

• Respiratory flow (via thermistors or pressure sensor)

• Snoring sounds (via microphone or pressure sensor)

• CPAP, BiLevel pressure or SmartPAP pressure

• Patient’s position

The additional measurements of thoracic and abdom-inal effort are registered by SOMNOcheck effort.

Description 3

The analysis software graphically depicts all measured signals, analyzes the data and documents the results.

On the basis of the results and the graphic portrayal of the signals, you can now decide:

• whether your patient suffers from respiration disrup-tions during the night;

• whether the therapy pressure used to treat your patient has to be changed.

Note: Please note that SOMNOcheck was designed for adult patients.

The SOMNOcheck system was designed for adult persons with a minimum weight of 45 kg.

Qualified personnel prepare the measurement, oper-ate the SOMNOcheck software and charge the pow-er pack.

Shortly before measurement begins, the patient can attach the device and sensors by himself if he has been trained by qualified personnel and has received a copy of the Instructions for Use for Patients.

4 Description

1.2 Functional description

The SOMNOcheck system consists of several sensors, the basic unit SOMNOcheck and the analysis soft-ware.

Function of the sensors

Respiratory Flow - Snore sensor 11

With the Respiratory Flow - Snore sensor you can reg-ister the patient’s nasal and oral respiratory flow and any snoring sounds.

• The sensor nodules 12 are made up of thermistors. They record the respiratory flow by means of the temperature of the inhaled and exhaled air.

• The microphone 14 registers the patient’s snoring sounds.

The sensor is reusable.

The nasal cannula can be used as an alternative to the thermistor with microphone:

Respiratory Flow Snore Nasal Cannula 17

• The nasal cannula is used as an alternative to the thermistor with microphone (Respiratory Flow Snore Sensor WM 94010) – i.e. not simultaneously.

• Nasal cannulas are disposable articles which are thrown away after use and do not have to be cleaned.

• In conjunction with the pressure sensor in the diag-nostic device the nasal cannula registers respiratory flow and snoring via pressure fluctuations in the na-sal openings (inspiration creates underpressure, ex-piration creates overpressure, snoring creates pressure oscillations).

Description 5

• While the mouth remains closed, pressure measure-ment reacts more sensitively to slight flow limitations than thermal measurement, is indpendent of the am-bient temperature and also permits a visual assess-ment of the flow contour over time, but the signals are more strongly affected by breathing through the mouth.

• The sensitivity of the Somnocheck device is matched to the original Weinmann nasal cannula No. 94043.

CPAP pressure measurement tube 23

Use the CPAP pressure measurement tube together with a CPAP mask for therapy control. The hose regis-ters your patient’s respiratory flow and snoring during CPAP therapy and measures CPAP pressure in the mask.

• Inhalation and exhalation pressure fluctuations are directed via the pressure measurement tube from the mask to the SOMNOcheck / SOMNOcheck effort basic unit. Inspiration creates underpressure, expiration creates overpressure, snoring creates pressure oscillations.

6 Description

Pulsoximetric sensors 28/32 and vario adapter 22

Pulsoximetric signals, oxygen saturation of blood andpulse rate of your patient can be measured by the pul-soximetric sensor.

• The main portions of the sensor are two LEDs and one receptor diode.

• Several SpO2 values (Split Pulse Wave Algorithm) are determined for each pulse wave.

Note: The measured pulse rate changes correspond with sufficient accuracy to heart rate changes triggered by a sleep-related apnea syndrome.

SOMNOcheck and SOMNOcheck effort work out a quality value for each registered oxygen sat-uration value, which identifies the quality or the ac-curacy of the measured SpO2 values.

If the signal is disrupted by movements, the number of values is small. Undisrupted signals result in a high number of values. Accordingly, a disrupted measurement signal produces a low quality value while an undisrupted measurement signal results in a higher quality value.

The quality signal takes on a value between 0 and 10.

For the evaluation of SpO2 long-term measure-ments, the quality signal can be helpful because it indicates artefacts that occur during measurement.

Instead of the 94034 or 94032 it is alternatively possible to use a vario adapter 94036 together with the pulsoximetric sensor 94037 or 90326.

Description 7

Function of the sensors with SOMNOcheck effortThorax sensor 37 and Abdomen sensor 39

The thorax sensor and abdomen sensor register thoracic and abdominal effort.

• Measurement of effort takes place with the help of the thorax and abdomen sensors. Via the fixing straps, effort transfers the changing pressure or tension to the measurement recorder, which, as a result of the piezoelectric effect, converts the changes in effort into electric signals.

SOMNOcheck Basic Unit Function

SOMNOcheck carries out the following tasks:

• It processes and stores all measured signals. Pow-ered by a replaceable power pack, it can operate without a network. The data are stored until you pre-pare SOMNOcheck for the next measurement.

• SOMNOcheck has a built-in sensor for body posi-tion. The sensor registers whether and when your patient lies on his stomach, back or side.

• If you like, SOMNOcheck can wake your patient with an alarm if the sensors fall off or slip out of place. The alarm ends automatically or can be turned off by your patient. (For more information see “1.4 Signals and Alarms” on page 10).

• Furthermore, SOMNOcheck shows you by means of a yellow LED 3 next to the battery symbol that the power pack has to be charged or that it is currently being charged.

8 Description

• You can check the positioning of the sensors by means of a function test.

SOMNOcheck Software FunctionData read after the measurement are automatically analyzed according to time and value criteria and the occurrences of respiratory disruptions are registered. On the basis of the analysis results and the depicted signals, you can evaluate the results according to your own criteria.

1.3 Symbols on the system

The symbols on the back of the device have the follow-ing meanings:

Date of manufacture

Direct current

Be careful. Observe accompanyingdocumentation.

Be careful. Observe accompanyingdocumentation.

Type B application parts

Protected from water splashes

SN: Device number (e.g., SN: 2546)

Power pack

Power packs should not be put intohousehold trash!

IPX4

Description 9

Do not dispose of the unit in domestic waste!.

Protection class II

Protect from high and low temperatures

Performance data, mains (input) side

Performance data, output side

Use indoors only

1.4 Signals and Alarms

So that you can always be sure that the measurement proceeds without problems, SOMNOcheck has visual and acoustic signals. They consist of two LEDs and an acoustic signal emitter.

Green LED next to the curve symbol• Illuminated constantly:

– either no signal can be received or – a sensor has slipped out of place or has fallen

off.

• Blinks during measurement in rhythm with pulse rate:

– all bio signals are being received.

• Blinks when it is connected to PC:

– SOMNOcheck is being configured, or– data are being transferred from SOMNOcheck

basic unit to a PC.

10 Description

Yellow LED next to the battery symbol• Illuminated constantly or blinks; SOMNOcheck is

turned on:

– the power pack has to be charged.

• Illuminated constantly; SOMNOcheck has been turned off; the charger is connected:

– the power pack is being charged.

• Blinks; SOMNOcheck has been turned off; the charger is connected:

– The power pack is fully charged. The charger is in top-up mode with low charging current.

• Blinks irregularly:

– a power pack has not been inserted or – the power pack is discharged and

SOMNOcheck is being operated by the charg-er (e.g., data transfer).

Acoustic Signal• A brief tone:

– SOMNOcheck has been turned on or– SOMNOcheck is starting to measure.

Alarms

Alarms in the form of a sequence of notes are triggered if they have been set up during the programming of SOMNOcheck and the device is in measurement mode.

• An alarm sequence is triggered:

– the combo-plug 30/34 has been removed from the SOMNOcheck basic unit or

– at least one of the bio signals has not been received (i.e., loss of sensor).

Description 11

The triggered alarm automatically ends after approx-imately 30 seconds. Furthermore, the alarm can be turned off by pressing the green button 5 on the SOMNOcheck basic unit. The measurement will not be interrupted by the alarm.

1.5 Measurement requirements

• Please observe the user tips for the fastening of sen-sors or accessories.

• Soiling of the sensors, such as with secretions or moisture, can lead to incorrect measurements.

Pulsoximetric sensors• Please be sure that the LEDs and the receiver in the

sensor are not dirty or wet.

• The pulsoximetric sensor is calibrated with refer-ence measurements by means of fractional satura-tion measurement to pulsoximetric hemoglobin oxygen saturation with dyshemoglobin-free blood. If the portion of dysfunctional hemoglobin (e.g., carboxyhemoglobin or methemoglobin) is high, the accuracy of the measurement can be im-paired. Similarly, the use of intravascular dyes or colored fingernail polish can compromise the ac-curacy of the measurement. Since this also applies to artificial acrylic finger nails, these should be re-moved.

Respiratory Flow / Snore Sensor• The measurement of the respiratory flow curve is

based on a temperature difference between the in-haled and exhaled air flow. For this reason, an un-satisfactory signal will be registered if the ambient temperature exceeds 33° C. This can also occur if

12 Description

the sensor 11 is covered by a blanket, causing the ambient temperature to increase to body tempera-ture.

• The sensor nodules 12 have to lie directly in the nasal and oral air flow.

• The sensor nodules cannot be allowed to become soiled (for example, covered with secretions) be-cause that could cause an incorrect measurement.

• The membrane over the microphon 14 must not be damaged.

• In addition to recording your patient’s snoring sounds, the microphone in the respiratory flow /snore sensor registers noises in the surrounding area that have the same frequency as snoring. Loud street noises can therefore falsify the measurement results as can the snoring sounds from the person sleeping next to your patient. Make sure that the volume for the surrounding area is considerably lower than the volume caused by snoring sounds.

• The respiratory flow snore sensor is used for diag-nostic measurements only; do not use it at the same time as the pressure measurement tube WM 94040 for CPAP or BiLevel pressure therapy control. During therapy control measurements the signals of the thermistor with microphone are not registered.

• The sensor can be used again after it has dried completely.

Respiratory flow snore nasal cannula• The nasal cannula is used as an alternative to the

thermistor with microphone (respiratory flow snore sensor WM 94010) – but not simultaneously. SOMNOcheck automatically recognizes the sen-sor type at the start of the measurement (diagnostic measurement takes place via the pressure connec-

Description 13

tion when the thermistor with microphone is not connected).

• The nasal cannula is used for diagnostic measure-ment only; it cannot be used at the same time as the pressure measurement tube WM 94040 for CPAP or BiLevel pressure therapy control.

• The difference between nasal pressure and ambi-ent pressure is registered, so changes in ambient pressure during measurement are immaterial.

• Large quantities of secretion (colds) or blood (nose-bleed) may affect the measurement of respiratory flow and snoring.

• Extraneous noises (e.g. traffic noise, snoring of partner) may affect the snoring measurements.

• The nasal cannula must be connected directly to the pressure measurement port of the diagnostic device.

• Do not used damaged nasal cannnulas.

• The tube must not be jammed or pinched during measurement.

Position sensor in the SOMNOcheck basic unit• The position sensor integrated in the device functions

properly when the SOMNOcheck basic unit has been attached with help from the holster and strap 7 according to the instructions for use. Otherwise in-correct measurements can result.

Thorax and Abdomen sensor (only SOMNOcheck effort )• Please be sure that the strap is sufficiently snug when

attaching the sensors. A strap that is loose can lead to a loss of the signal amplitude or to a complete loss of signal.

14 Description

• Use the washable protective cover for the abdomen sensor in order to prevent soiling of the sensor.

Pressure measurement tube• must be clean and free from liquid.

• must not be kinked.

• must be securely and tightly attached to the mask.

Description 15

2. Safety Instructions

For your own safety please observe the following points.

SOMNOcheck basic unit • Please read these Instructions for Use and the In-

structions for Use for the Patient thoroughly. They are a part of the device and must be available at all times.

• Each operation on the device requires detailed knowledge and observation of the Instructions for Use. The device is intended only for the described purpose.

• Observe also the Instructions for Use for certain ac-cessories for SOMNOcheck/SOMNOcheck effort.

• Please comply with section “7. Hygienic prepara-tion” on page 55 to prevent infection or bacterial contamination.

• Always use the galvanic isolation for the transfer of data with SOMNOcheck effort.

• Malfunctions and a lack of biocompatibility may result if third-party articles are used. Please bear in mind that in these cases any warranty entitlement and liability shall lapse where the accessories rec-ommended in the instructions for use or original spare parts are not utilised.

• Charge the power pack only with the Weinmann charger supplied.

• While charging, protect the device from direct sunlight or other heat sources, and do not cover the charger.

16 Safety Instructions

• While the device is charging or is connected to the PC, it must not be in the vicinity of the patient (1.5 m according to IEC 60601-1-1), and it must not be touched at the same time as the patient. The connecting cable without device must similarly not be in the vicinity of the patient and must not be touched at the same time as the patient.

• SOMNOcheck and the charger must not be oper-ated in atmospheres where there is a risk of explo-sion or which contain concentrations of combustible gases.

• SOMNOcheck and the charger must not be im-mersed in liquids or have liquids poured over them.

• Please be sure to replace all parts that are broken, worn out or contaminated before you use SOMNOcheck.

• Do not use the charger if the cable is damaged.

• Please observe the maintenance schedule. Allow only authorized specialists to carry out mainte-nance.

• Maintenance measures such as inspection and maintenance work can be carried out only by the manufacturer Weinmann or by expert personnel.

• SOMNOcheck should be opened only by expert personnel. Do not open the charger. Unauthorised opening of the devices makes the guarantee void.

• Weinmann is not liable for the function of SOMNOcheck if the owner or the operator of the device improperly maintains it or if an operation takes place that does not correspond to the agreed purpose according to these Instructions for Use.

• Any additional equipment connected to the analog and digital ports of the device must demonstrably comply with the relevant EN specifications (e.g.

Safety Instructions 17

EN 60950-1 for data processing devices or EN 60601-1 for electromedical devices). All con-figurations must furthermore comply with the valid version of the system norn EN 60601-1-1. Anyone who connects additional equipment to the signal input or output unit is a system configurer and is hence responsible for compliance with the valid version of the system norm EN 60601-1-1. If you have any queries please contact your local dealer or our Technical Service.

SOMNOcheck Software• Please note that the software for determining sleep-

related respiratory disruptions offers a possible analysis. The evaluation of the automatically gen-erated analytical results is left to the doctor.

• Please observe the system requirements. Install the software only on a computer that fills the system requirements.

• Do not place the CD in direct sunlight. This can cause data to be lost.

• The CD should not be bent.

• Please observe the Online Help contained in the software.

18 Safety Instructions

3. Combination with Therapy Systems

3.1 Devices

Note: The measurement function may be restricted when SOMNOcheck up to device number 3000 is used with an auto-CPAP device. Please contact Technical Service.

As a control system, SOMNOcheck can be combined with commercially available CPAP, nCPAP, BiLevel pressure therapy systems and SOMNOsmart. Connect-ing the two systems is quick and easy. SOMNOcheck is connected to the mask via the CPAP pressure meas-urement tube 23.

3.2 Masks

Important! Please observe the Instruc-tions for Use for the mask.

You can use SOMNOcheck with all commercially available masks that are utilized in the treatment of sleep apnea.

If you would like to connect a mask to SOMNOcheck, please choose, according to the type of mask, one of the three following aspects:

• Masks with recessed outlet:Place the white connector with the Luer connector 24 on the CPAP pressure measurement tube 23 into the outlet.

• Masks with protruding outlet:Push the connection hose 25 that fits an external diameter of four to six mm onto the white connector 24 of the CPAP pressure measurement tube 23 and onto an outlet or Luer connector on the mask.

Important! When using masks with two connections, make sure that the spare connection is kept closed.

Combination with Therapy Systems 19

4. Installation

4.1 System Requirements

In order to be able to install SOMNOcheck software without any trouble, you will need an IBM-compatible computer that fills the following requirements:

• Processor: 80386 or higher• Available memory: at least 25 MB on the hard

disk• Main memory: at least 16 MB (RAM)• Port: an available serial interface

(COM port) RS232• Drive: CD drive• Graphics card: supported by Microsoft

Windows, VGA- or higher resolution

• a mouse or other pointing device• Printer: supported by Microsoft

Windows• Operating system: Microsoft Windows 3.1

or 3.11, Microsoft Windows 95, 98, ME, Microsoft Win-dowsNT Workstation 3.51 (SP5 or higher), Microsoft WindowsNT Workstation 4.0 (SP3 or higher), Microsoft Windows 2000, Microsoft Windows XP.

System recommendationWe recommend a Pentium processor with a clock frequency of at least 133 MHz and main memory of 32 MB as well as a 17-inch VGA monitor.

20 Installation

4.2 Software Installation

Windows 3.1 or 3.11, Windows NT Workstation 3.51

1. Start Windows.

If you have already started Windows 3.11, please close all open programs before you install SOMNOcheck software.

2. Place the CD in the CD drive.

3. Choose Open from the File menu.

Note: “d:” is the designation for the CD drive. If this does not apply to your compu-ter, enter the correct desig-nation for your drive.

4. Enter the following d:\setup in the command field of the dialog that appears.

5. Click OK.

Your computer will begin the installation.

6. All further installation steps will be displayed to you in various dialog windows (see „During the Installation“ on page 22).

You can stop the installation at any time.

Windows 95/98/ME, Windows NT Workstation 4.0, Windows 2000, Windows XP

1. Start Windows.If you have already started Windows, please close all open programs before you install SOMNOcheck software.

2. Place the CD in the CD drive.Your computer will automatically begin the installation.

Installation 21

3. All further installation steps will be displayed to you in various dialog windows (see „During the Installation“).You can stop the installation at any time.

During the Installation

Note: Our hotline is available if you have questions or problems of any kind. Tel.: 0800/78 52 190 or Somnocheck.hotline@ weinmann.de

• It is recommended that you close all applications during the installation. If you have not done that, cancel the Setup (Cancel), close the programs that are running and start again at Step 3. To continue the installation, click Next.

• The next message tells you that SOMNOcheck software will be automatically installed in the des-tination folder C:\SOMNO. If you accept this path, click Next. If you would like a different path, click Browse. . . and enter the new path.

22 Installation

Note: The tutorial can be run under Microsoft Windows 95/98/ME/NT Worksta-tion 3.51, NT Workstation 4.0, Windows 2000 and Windows XP.

• Under setup type Custom, you can choose whether you want to install a tutorial and the desired ver-sion. The tutorial is an interactive on-line training program that provides a quick introduction to all program options. If you would like to work through the program without installing it, close the installa-tion. Start the tutorial by choosing Open from the Start menu and enter ”d:\Tutorial\Tutorial English“ in the dialog that opens.

• In the following installation steps, you can choose in which folder the SOMNOcheck symbol should be placed.

Installation 23

Note: You can drag the SOMNOcheck symbol from the window to your desktop when using Microsoft Windows 95/98/ME, Workstation 4.0, Windows 2000 or Windows XP. The symbol can be used to start the program.

Leave the folder SOMNOcheck or choose a dif-ferent folder and click Next.

• At the end, you will be informed of the current set-tings. Click Next to continue or Back to change the settings.

• At the end of the installation you can start the pro-gram by highlighting the option box. Click Finish.

4.3 Preparation of SOMNOcheck connection

1. Check whether the charger is fitted with the appro-priate mains plug adapter for your country. If not, you can slide the mains plug adapter off the charg-er in the direction of the arrow, i.e. along the charger, and then fit the mains plug adapter re-quired.

2. Plug the charger 45 into an electrical outlet.

3. Place the PC plug 43 into an available serial port on the PC, which has been turned off. (only SOMNOcheck effort )

The galvanic isolation for SOMNOcheck effort is to be placed in the serial port between PC and PC plug 43. It provides a galvanic separation between PC and SOMNOcheck effort. No other external provision is required. This galvanic isola-tion can also be used with Multibase or other serial connections (e.g., between two PCs) that require three wires (GND, RxD and TxD).

24 Installation

Tip: Save yourself some work. Leave the charger plugged into the electrical outlet and the PC plug in your PC at all times. The combo-plug should be kept ready for use on your desk.

The standard setting in the software expects a COM 2 port. If the COM 2 port on your computer is not already in use, connect your SOMNOcheck there. If the port is already in use, choose a different COM port. The change will take place automati-cally within the software.

Installation 25

26

Op

5.

O

5.1 St

peration

In this section you will find all the information you need for simple utilization of the SOMNOcheck system. All the applications and explanations within the SOMNOcheck software can also be found in the printable Online Help, whose structure is equal to standard Windows help. To find out how you can print the help text or the entire Online Help text, read the section

“5.3

Online Help and Tutorial

” on

page

29

.

arting SOMNO

check

Starting in Windows 3.1 and 3.11,

Windows NT Workstation 3.51

1.

Start Windows.

2.

The installation program displays a window on the

screen which contains the symbol for the

SOMNO

check

program. Start the program by

double-clicking the symbol.

Another way to start the program is via the menu bar:

1.

Choose

Window

and then

SOMNOcheck

from the

menu.

2.

A window with the above-mentioned symbol for

the

SOMNO

check

program will appear. Click

twice on the symbol in order to start the program.

eration

Starting in Windows 95/98/ME,

Windows

NT Workstation 4.0,

Windows

2000, Windows

XP

1.

Start Windows.

2.

The installation program displays a window on the

screen which contains the symbol for the

SOMNO

check

program.

–

Start the program by clicking the symbol twice.

–

If the

SOMNO

check

symbol is on your desktop

(you moved it by dragging the symbol from the

window to the desktop), click it twice to start the

program.

If the

SOMNO

check

symbol is not on the desktop, you

can also start the program via several menu selections:

1.

From the menu select

Start

,

Program

,

SOMNO

check

one after the other

.

2.

Click the

SOMNOcheck

submenu to start the

program.

Operation 27

28 Op

5.2 M

Language selection

The

SOMNO

check

program works in various lan

-

guages. When you start the program the first time, the

English version is automatically selected. In order to

switch to the English version, please follow these step:

1.

Chose

Language

from the

Settings

menu.

2.

Click

English

.

The program will run in English from now on. The next time you start the program, it will automatically open the English version. This setting will remain until you choose a different language.

enus and Symbols

The main menu bar is at the upper edge of the screen. As in standard Windows software, you will find sub-menus under the individual menus on the bar. All the important menu selections are explained in this section „Operation“.

Under the menu bar you will see various symbols. By clicking these symbols, you can open some of the sub-menus directly. The following tells you what is behind the individual symbols:

: “New”: New entry of patient data.

: “Data import from SOMNOcheck”: Reading of data from the SOMNOcheck basic unit, execution of automatic analysis.

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: “Open file”.

: “Store file“.

: “Print“: print what is currently on the screen.

5.3 O

: “Display measurement data“.

: “Event list“: Select events to be depicted. (Possible only for a time period up to one hour, see “ Change signal display” on page 48)

: “Statistic“: Display statistics.

: “Report“: Display report.

: “Analysis“: Setting of analysis criteria.

: End the display of measurement data.

: Open Online Help.

nline Help and Tutorial

Open Help Text

1. First open the Online Help. You have three choices of method here:

– press the F1 key,

– click on the field or

– choose Help from the Help menu.

In the Online Help under Content, you will see an over-view of all the help subjects and menus. By choosing Search you can enter a word or choose a subject from a list.

2. Open the help text:

– Under Content: click on a subject in order to open the help text.

Operation 29

– Under Search: Open the help text either with a double click or highlight the subject you would like to see and choose Display.

30 Op

Printing a help text

1. Open the help text you would like.

2. From the File menu, choose the menu selection Print subject.

3. Click OK in the print dialog in order to start printing.

The Online Help will be printed.

Printing the entire Online Help text

The Online Help text is about 20 pages long.

1. Open the help text Manual.

2. Choose Print subject from the File menu.

3. Click OK in the print dialog in order to start printing.

The Online Help will be printed.

Interactive Tutorial

If you would like to learn how to use SOMNOcheck / SOMNOcheck effort software with the interactive

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online program, install it as described on page 22.

5.4 M

Note: Data can (e.g., undname) wiSOMNOcFile manaHelp).

easurement preparation

Configure SOMNOcheck 1. If you haven’t already done so, please connect the

combo-plug 44 of the PC transfer cable 42 to SOMNOcheck.

Before you enter the measurement period, type of measurement and alarm settings, create a file for patient data. Later your patient’s data will be automat-ically read into this file.

2. In the File menu choose New or click on the field .

3. In the window that opens please enter the data about the examiner and patient. Then click on Create file.

be easily found er patient’s th the help of the

4. Another window will open in which you can change the file name. The suggested data name is composed of the patient’s initials and the pro-gram date. For a patient whose name is Diana

Operation 31

heck software ger (see Online

Prodomo and whose examination took place on January 11, 2000, the file name PD110100 will be suggested automatically.

5. Click OK.

32 Op

Note: You can ctime for thbegin. SOstarts to myour patiethe senso

6. If the selected file name has not yet been used, the name will appear in a message window so that you can confirm it. Click OK.

The next window serves to configure SOMNOcheck. Enter here the measurement period, type of measurement and alarm settings for sensor loss.

hoose an early e recording to MNOcheck first easure after nt has attached

rs.

7. If you would like to change the set measurement period ex works, click on the corresponding place, delete the old measurement period and enter a new period. If you click Standard, SOMNOcheck measures from 10 p.m. to 6 a.m.

SOMNOcheck effortSOMNOcheck

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Important To be abldifferent ptions corrcheck neesetting ofment modthat the tyment perfwith the s

Important Each timeSOMNOcthe SOMNunit will byour PC’sThereforethat the tiset on youthe recordat the wro

! e to interpret the ressure condi-

ectly, Somno-ds the correct the measure-e. Make sure pe of measure-ormed agrees etting.

8. By clicking you can choose to carry out a diagno-sis, a CPAP or BiLevel pressure therapy check. For APAP/SmartPAP therapy controls, use the CPAP set-ting.

9. Under Effort, you can suppress the graphics for the thoracic and abdominal effort channels when you use SOMNOcheck effort without effort sensors.

10. If your patient should be awakened by an alarm if a sensor is lost, click on the field next to the sensors and choose (by pressing the arrow keys) how much time should pass before the alarm is trig-gered.

11.Click Configure SOMNOcheck.

12. If SOMNOcheck has not yet been turned on, you will be asked to turn it on. Press the green key 5 on the SOMNOcheck basic unit and click OK.

13. The system will issue a response about the measure-ment period, type of measurement and alarm selec-tion. Please check that everything has been set up correctly and then click OK.

SOMNOcheck is now programmed and ready to begin measuring.

Time comparison! you program heck, the time in Ocheck basic e compared to system clock. , please be sure

Before you send your patient home with the SOMNOcheck system, you can once again make sure that all the settings and the current time of SOMNOcheck are correct.

1. Choose SOMNOcheck Status from the Options menu.

2. Check all the settings and click OK.

Operation 33

me is correctly r PC. Otherwise, ing could begin ng time.

3. If you find an incorrect setting, reprogram SOMNOcheck according to the instructions in section “Configure SOMNOcheck” on page 31.

34 Op

5.5 Ch

Note: Please obInstructionMULTIBASlike to recpack with

Note: For a longplease obs“6. Using power pa

arging the rechargeable power pack

serve the s for Use for E 2 if you would harge the power that device.

Before you use SOMNOcheck, please be sure to charge the power pack.

You can charge the power pack with the accompany-ing charger 45 or with MULTIBASE 2.

1. Plug the charger 45 into a mains socket. If the sock-et has a switch, switch it on. The LED on the charg-er lights up orange for a few seconds and then turns to yellow.

2. Make sure that the rechargeable power pack 6 is already fitted in the SOMNOcheck basic unit. Connect the combo-plug 44 to the port 2 on the SOMNOcheck basic unit. After a few seconds, the yellow LED 3 next to the battery symbol comes on. If the green LED is illuminated instead of the yellow one, the device is on. Please turn off the device by pressing the green key 5.

3. Keep charging the SOMNOcheck until the yellow lamp on the SOMNOcheck goes out or starts flashing. During the charging process the LED on the charger is continuously orange.

There may be a delay of about 10 minutes before charging starts. The other possible LED signals can be found in the table in Chapter “13. Technical Data” on page 67.

4. Charging takes between 10 and 120 minutes, depending on the actual charging status of the power pack.

5. Before unplugging the charger from the mains, dis-connect the compo-plug 44 from port 2 on the SOMNOcheck unit.

power pack life, erve the section the rechargeable ck” on page 52.

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• If additional power packs are to be charged after a charging operation, let the charger run with no load for 15 seconds to ensure that it is reset to its initial values. This is indicated by the LED on the

5.6 At

Tip: Your patiethe sensoryour direc

Note: The powecharged fput SOMNoperation

charger changing to yellow. A new charging cycle can now begin.

Note: In rare cases it is possible that battery charging is interrupted through access to the serial PC interface by non-system software or internal processes involving the operating system. This may cause measurement to end prematurely. If this problem occurs, SOMNOcheck should be disconnected from the PC following data transmission to the PC to ensure that the battery is fully charged. The device should be switched off following disconnection if still switched on.

taching the SOMNOcheck system

nt should attach s himself under tion.

Make this as easy for your patient as possible. Attach the SOMNOcheck system to your patient only as a “try out”. Show him and explain to him clearly how he can attach the sensors without your help and how he can check the positioning of the sensors with a test.

r pack has to be ully before you Ocheck into

.

Loosen only the colored Velcro closures on the side of the strap to remove the SOMNOcheck system from your patient. Give your patient the SOMNOcheck sys-tem in its carrying case. It protects the device and the sensors and also contains in its cover an information page about attaching the system.

Please be sure that the power pack has been charged before you attach the SOMNOcheck system to your patient and before you give it to your patient to take home.

Attaching SOMNOcheck Attach the SOMNOcheck basic unit to your patient’s

Operation 35

body with the holster and a three-point fixing strap (WM 94053 or WM 94054).

1. Two straps are included in the supply range. The strap marked with yellow corresponds to normal

36 Op

Note: Please becolored enon the rigthe body.

c

sizes and the green strap for extra-large sizes. Choose the appropriate strap for your patient.

2. Put the SOMNOcheck into the holster 7 so that the operating buttons are visible through the plastic window.

3. Place the holster with the strap on your patient.

– Pull the strap first through the upper tab a and then through the tab on the side b of the holster.

– Hang the resulting loop in the strap over your patient’s shoulder.

– Now pull the third colored end of the strap through the free tab c and close the strap.

– All the ends of the straps have Velcro closures. By adjusting the Velcro closures, you can adapt the straps to the circumference of your patient’s body. The straps should sit snugly but comforta-bly on the body.

sure that the d of the strap is

ht-hand side of

– Please make sure that the device is firmly at-tached. It should be in the middle of the chest (on the breastbone).

– Attach the holster snugly but comfortably to your patient. Only then can the device’s integrated position sensor function reliably. Otherwise in-correct measurements can result.

• The strap is made of skin-sensitive elastic fleece.

• The holster is made of Cambrelle+.

Attaching SOMNOcheck effort (only SOMNOcheck effort )

a

b

eration

Two additional fixing straps for abdomen are included in the supply range of SOMNOcheck effort along with an abdomen sensor, a thorax sensor and a con-nector for connection of the thorax sensor and for con-tact of the abdomen sensor.

Connector 38

Use the connector together with the holster WM 94052 and the fixing straps (WM 94053 or WM 95054).

The connector transfers the measurement values of the abdomen sensor WM 94080 to the basic unit of SOMNOcheck effort.

The connector is made of a skin-sensitive elastic material.

• Make sure that the connector is fastened with the wire made as short as possible.

• Make sure that the connections (snaps) to fasten the thorax sensor are facing outwards.

• Make sure that the sensor cable is directed toward the top and the cable outlet faces toward the holster.

Thorax sensor 37

Use the thorax sensor with the holster WM 94052 and the fixing straps (WM 94053 or WM 95054).

The thorax sensor registers thoracic efforts.

The sensor is made of a skin-sensitive elastic material.

Fixing strap for abdomen

The fixing strap for abdomen serves to fasten the abdo-men sensor WM 98080 to your patient’s body.

• The fixing strap for abdomen marked in yellow is for normal sizes and the green strap for extra-large sizes. Choose the appropriate strap for your patient.

• Make sure that the strap is snug on the body. Otherwise effort cannot be registered.

black

blue

black

Operation 37

• However, the strap should not be too tight. Your patient has to be able to breathe easily.

The strap is made of skin-sensitive elastic fleece.

38 Op

gh

Abdomen sensor 39

Use the abdomen sensor with the fixing strap for abdo-men (WM 94082 or WM 94083).

The abdomen sensor registers abdominal effort.

The sensor is made of a skin-sensitive elastic material.

1. Place the SOMNOcheck effort in the holster 7 so that you can see the operating buttons through the plastic window.

2. Open the tab on the back of the holster.

3. Pull the thorax sensor f with the cable connection toward the top – through the tab on the holster so that the sensor lies behind the holster. When doing this, make sure that only the sensor part without the cable connection is pulled through the loops of the bag. Establish contact between the plug h and the device.

4. Fasten the connector on the tab of the thorax sen-sor. The connector’s ports should face toward the operating keys.

5. Establish contact between the plug g on the connector and the device.

6. Close the tabs on the holster.

Note: Give your patient the SOMNOcheck effort prepared in this way. This guarantees that your patient will be able to attach the device quickly and properly.

7. Now place the holster with the chest strap on your patient’s body.

– Pull the strap first through the upper tab a and then through the side tab b of the sensors.

blue

f

a

b

eration

– Hang the resulting loop in the strap over your patient’s shoulder.

– Make sure that the connections (snaps) to fasten the abdomen sensor are facing outwards.

Note: Please macolored enon the rigyour patie

ik

– Now pull the third colored end of the strap through the free tab of the connector and close the strap.

ke sure that the d of the strap is

ht-hand side of nt’s body.

– All ends of the straps have Velcro closures. By adjusting the Velcro closures, you can adapt the straps to the circumference of your patient’s body. The straps should sit snugly but comforta-bly on the body.

– Please make sure that SOMNOcheck effort is placed on the breastbone.

8. Finally, attach the fixing strap for abdomen with the abdomen sensor.

– Put the washable protective cover 40 around the abdomen sensor and secure the Velcro clo-sures. This guarantees that the sensor will not get soiled.

– Pull the fixing strap for abdomen through the tab i of the sensors and place the fixing strap for ab-domen around your patient’s abdomen.

– Pull the free end of the strap through tab k and close the strap.

– Be sure that the strap is snug on the body, but that the patient’s air is not cut off. Your patient has to be able to breathe easily.

– Attach the blue plug on the abdomen sensor to the connector and close the blue tab on the connector over the plug.

Operation 39

40 Op

Important Do not usflow snorsame timemeasuremCPAP or Btherapy cnasal can

Attaching the Respiratory Flow / Snore Sensor1. Unwrap the sensor 11 from around the carrying

platform 15. Place the sensor on the patient’s upper lip. Make sure the microphone 14 is facing away from the skin, i.e it must remain visible.

2. Pull the cable over the patient‘s ears and tighten it under the chin by pushing the adjuster 13 up along the cable.

3. Connect the round plug 16 of the Respiratory Flow/Snore Sensor to the round socket on the Finger Clip.

:e the respiratory e sensor at the as the pressure ent tube for iLevel pressure

ontrol or with the nula.

4. When you have finished measuring, place the sen-sor on the carrying platform 15 to protect it from kinks and wrap the cable around the sensor and platform.

• Carrying platform 15, like the sensor, can be cleaned and disinfected.

• Because the sensor no longer needs a fastening belt, the fixing strap for respiratory flow/snore sen-sor WM 94009 cannot be used together with this sensor.

5. Place the combo-plug 30/34 of the pulsoxymetric sensor into the port 2 on the SOMNOcheck basic unit. Make sure that the plug is tight. Both side clips should snap into place.

6. Close the pressure connection 1 with the enclosed cover.

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Important Do not usnula at ththe respirsnore sen

Tip: Ask your along his

Putting on respiratory flow nasal cannula! e the nasal can-e same time as atory flow / sor.

1. Remove (if present) the protective cap from the pressure connection of the diagnostic device and screw the tube on the nasal cannula (1/2 turn).

2. Hold the double tube on left and right so that the cannulas point upwards and the semicircular tab faces towards the patient’s face.

3. Now place the cannulas in the patient’s nostrils and run the tubes over the ears and down under the chin. Adjust the sleeve at the bifurcation so that the tube remains loosely in place without slipping.

Tip: Slightly lubricating the nostrils, e.g. with Vaseline, improves wearing comfort and prevents drying out.

Attaching the pressure measurement tube

patient to bring mask.

If you would like to carry out a therapy check on your patient, attach the pressure measurement tube 23 as follows:

1. Turn the threaded joint onto the pressure connec-tion on the SOMNOcheck. One turn is enough!

2. Attach the other end of the pressure measurement tube to the mask.

Operation 41

42 Op

For masks with two connections:

– the unused connection must be kept closed!

Masks with protruding outlet:

– Push the connection hose 25 suitable for an exterior diameter of four to six mm onto the white connector 24 of the pressure measurement tube 23 and onto an outlet or Luer connector on the mask.

Masks with recessed outlet:

– Place the white connector 24 with Luer connec-tor on the pressure measurement tube 23 into the outlet.

• The pressure measurement tube for CPAP pressure measurement is to be thrown away after one use.

• Do not use the pressure measurement tube simulta-neously with the respiratory flow / snore sensor WM 94010.

Attaching the pulsoximetric sensorIf you use a pulsoxymetric sensor WM 94034, be sure to note the following points. If you use a different pulsoximetric sensor from the Weinmann program in combination with the vario adapter WM 94036, you should also consult the rele-vant operating instructions for the sensor. In this case the vario adapter is connected to port 2 instead of the pulsoximetric sensor WM 94034, and the sensor is connected to the other end of the vario adapter. The connection between sensor and vario adapter is fixed by closing the securing bar.

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• Use the pulsoximetric sensor only in connection with SOMNOcheck/SOMNOcheck effort.

• If you are simultaneously monitoring your patient’s blood pressure with a blood pressure cuff, do not attach the finger clip to the same arm on which the cuff has been placed.

1. Attach the pulsoximetric sensor 28/32 to your patient’s index finger.

Please be sure that the finger marking points up-wards. The sensor should sit firmly and comforta-bly. It should not squeeze the finger.

The sensor cable should lie under the finger.

2. Attach the sensor if necessary by fastening the sensor cable onto the finger with tape.

Note: You should not allow any bandage or tape to touch the sensor case.

3. Put the plug 30/34 into the port on SOMNOcheck. Please make sure that the plug is tight. Both side clamps should snap into place.

4. If you would also like to use the respiratory flow/snore sensor during your measurement, please connect the round sensor port 29 of the pulsoxi-metric sensor to the sensor plug of the respiratory flow/snore sensor.

Carrying out the sensor testSo that you and your patient can be sure that all the sensors are properly connected, show your patient how to carry out a test after attaching the sensors and the SOMNOcheck basic unit.

Press the green key 5 on the SOMNOcheck basic unit. If everything is OK, the following will occur:

Test

Operation 43

• The green LED 4 next to the curve symbol will begin to light up.

44 Op

Note: The depicsymbol fobio signaldoes not m

ted curve is a r the registered s. SOMNOcheck easure ECG.

• Within one minute this LED will blink in rhythm with the patient’s pulse rate for a certain amount of time.

If the LED goes out without flashing, check the connec-tions and the seating of the pulsoximetric sensor (e.g. 28/32), the respiratory flow / snore sensor 11 or the respiratory flow / snore nasal cannula 17. Then repeat the test.

Measurement start and endAfter reaching the pre-set time for the start of the meas-urement, SOMNOcheck turns itself on for one minute. In this time it checks to see if the sensors are on hand. If this is not the case (for example, because your patient goes to bed later than planned), this sensor test is repeated every five minutes and is announced by a brief beeping sound. The measurement begins as soon as SOMNOcheck can receive signals.

During a proper measurement recording, the green LED 4 blinks in rhythm to the pulse rate.

SOMNOcheck turns itself off automatically at the programmed time. If your patient wants to interrupt the measurement before the scheduled time, he can simply remove the sensors and the SOMNOcheck basic unit. If you pre-set an alarm, the alarm will be triggered. Your patient can turn off the alarm with the green key 5.

After the measurement your patient takes off the sensors and the SOMNOcheck basic unit and packs all the parts into the transport case.

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5.7 Im

Important After confSOMNOcbe separarechargea

portant tips for your patient

You and your patient can prevent the annoyance resulting from incorrect measurements if you advise your patient of the following:

• Your patient should not open the SOMNOcheck basic unit under any circumstances.

!iguration, heck should not ted from the ble power pack.

• Your patient should not remove the rechargeable power pack from SOMNOcheck basic unit at any time. If the power supply is interrupted for longer than one minute, the entered measurement time will be deleted. SOMNOcheck would then carry out no measurement.

• Your patient should attach SOMNOcheck snugly but comfortably on his body so that body position will be registered correctly.

• The effort sensor has to be firmly attached so that ef-fort can be registered (only SOMNOcheck effort).

• When he looks in a mirror, your patient should be able to see the microphone 14 on the respiratory flow /snore sensor 11 after fastening it into place.

Operation 45

46 Op

Note: Your patiecable for 28/32 throf his pajaplaces thefinger.

• Your patient should attach the cable of the pulsox-imetric sensor 28/32 to his finger with a bandage. This does not disturb the cable and assures that the sensor cannot slip out of place.

• Your patient should sleep alone in a room with the windows closed in order to prevent an incorrect measurement due to snoring noises from another person or street noises.

• The sensors have to be clean and dry. Your patient should carefully wipe the secretions (for example after sneezing) from the sensors.

nt can put the the finger clip ough the sleeve mas before he sensor on his

• Make sure that your patient is aware of the need to avoid pulling the bedding or pillow over his head when using the respiratory flow/snore sen-sor (thermistor). The ambient temperature will in-crease greatly in this case, causing the respiratory flow/snore sensor 11 deliver incorrect measure-ment data.

• If your patient is uncertain about the positioning of the sensors, he can check them at any time by car-rying out a test (see “ Carrying out the sensor test” on page 43).

• Your patient should not wear colored fingernail polish on the index finger to which the pulsoximet-ric sensor is attached.

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5.8 An
alyzing patient data
Reading patient data1. Remove combo-plug 30/34 of pulsoximetric

sensor 28/32 from the SOMNOcheck.

2. Please connect the combo-plug 44 of the PC transfer cable 42 to SOMNOcheck.

3. Select Data import from Somnocheck from the File menu or click on the field .

4. If the SOMNOcheck is not yet turned on, you will be asked to turn it on. Press the green key 5 on the SOMNOcheck basic unit and click OK. The data will be automatically read into the correct file. During the data transfer the data will be processed and analyzed immedi-ately.

This action takes about two minutes with SOMNOcheck.

For SOMNOcheck effort, this action lasts about four minutes.

5. After the data have been processed, the measure-ment data will be depicted. When you trigger the data import by clicking the field , the report window will simultaneously open and the analysis results will be displayed. If you would like to have a closer look at the course of the signal, close the report window by clicking Cancel.

Operation 47

48 Op

Change signal displayThe signals will be displayed automatically in their complete length to give you an overview of the course of the measurement. As a result, the signals appear greatly compressed, which makes it difficult to recog-nize individual events. For this reason the program offers the chance to look at the signals with greater res-olution. You can choose among seven different set-tings. In order to „stretch“ the signal, please proceed as follow:

1. Click on the button bar, in order to allow one minute to be displayed , if you would like to see five minutes represent-ed, or

for the depiction of one hour. With the field you can display the entire measurement period again.

If you work with the menu or if you would like to display a different period resolution, choose Display measurement data from the Options menu.

Choose the appropriate time basis.

2. Click on the time line under the measurement curve window. By pressing the left or right arrow key, PageUp and PageDown or by clicking within the time line, you can see a different view of the meas-urement data.

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Display analysis1. Choose Report from the Options menu or click on

the symbol in order to redisplay the report.

2. You will receive a complete overview of the analysis results of the measurement. You can enter further patient data and your findings in the report. For data registered by SOMNOcheck effort, different analysis results will be displayed in the report.

11.01.2000

Operation 49

3. Click OK.

50 Op

Print reportYou can print the report either from the Report window or the menu bar. When you print via the Report win-dow, you will receive both report and the course of the curve of the entire measurement. Several different print options are available by means of the menu.

Printout via Report window:

Click on Print Report and Night Overview. The print task will start immediately.

Printout via the menu:

1. Select Print from the File menu.

2. In the window that opens, click to select what you want to print, which time period should be depicted in the measurement printout, which time interval should appear per page and how many copies you would like to print.

You can also set up via Options which channels and event markings should be printed.

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3. Click OK to start printing.

Print screen imageAt any time you can print what is displayed on the screen, for example, an interesting course of an event.

1. Click on the field .

2. In the dialog box for the printer click OK.

The screen image will be printed immediately.

Exit the program1. When you would like to leave the program, click

Exit in the File menu.

2. If you have already made changes in the Report, you will be asked if you would like to save the changes and if the analysis results should be calcu-lated again.

Choose Yes or No.

3. The program will then end.

Operation 51

52

Usi

6. U

sing the rechargeable power pack

Rechargeable power packs have a very long life. The typical life span of a rechargeable power pack is about 1.5 years or 500 charges, depending greatly on usage. If you handle the rechargeable power packs in a way that differs from the following descrip-tion, the life of the power packs can be shortened.

All rechargeable power packs lose their charge over time, even when the device is turned off. A fully-charged power pack is discharged after 90 days out of operation. If the power pack is not charged for a period of more than four months, it can enter a so-called deep discharge. A power pack that has gone through deep discharge, like an old, worn out power pack, can no longer be charged to its full capacity. After a short while it will be discharged again.

You should handle your power packs as follows:

• Be sure to recharge your power packs completely after a long measurement.

• If you do not use SOMNOcheck for more than three months, recharge the power packs every three months.

• If the power pack has been completely charged through the operation of the SOMNOcheck basic unit, another charge is unnecessary.

• If the fully charged power pack is topped up repeatedly within less than an hour, this can shorten the life of the power pack. In rare cases it can cause the power pack to overheat, thereby irreversibly triggering the power pack’s tempera-

ng the rechargeable power pack

ture cut-out. The power pack must be exchanged in this case.

• Change the power pack at the end of its useful life. You can remove the power pack by pressing together the snap mechanism on the power pack and by pulling the power pack toward the bottom of SOMNOcheck.

• Insert power pack: Simply push the power pack into place in SOMNOcheck. When you hear it snap into place, the connection to the device has been made (see illustration).

• To maximise the life of the power pack, it is advis-able not to leave the power pack permanently connected to the charger. Once charging is com-plete, you should therefore disconnect both power pack and SOMNOcheck from the charger.

When charging batteries the following should also be taken into account:

• The NiMH batteries must not be charged while ex-posed to an external source of heat, e.g. with so-lar radiation, electrical equipment, near radiators.

• The NiMH batteries must not be subjected to ex-ternal fluctuations in temperature exceeding 5°C during charging.

• The charger must be operated with a stable no-break power supply of 100 – 240V ±10% 50 – 60Hz in a temperature range between +5°C and +40°C.

• The charger should only be reconnected / pow-ered after disconnection of SOMNOcheck or SOMNOcheck effort or after disconnection of the power supply once the battery has cooled down fully.

• Note the instructions for charging the power pack as set out in Chapter “5.5 Charging the recharge-able power pack” on page 34.

Using the rechargeable power pack 53

• If additional power packs are to be charged after a charging operation, let the charger run with no load for 15 seconds to ensure that it is reset to its initial values. This is indicated by the LED on the charger changing to yellow. A new charging cycle can now begin.

54 Using the rechargeable power pack

7. Hygienic preparation

7.1 Before each use and when changing patients

Respiratory flow / Snore sensor

The respiratory flow / snore sensor 11 is covered with synthetic material. Please clean it with a mild deter-gent. To disinfect, we recommend a spray disinfectant with incidin-liquid spray. You are recommended to wear suitable gloves (e.g. household or disposable gloves) during disinfection procedures. Please make sure than no liquid is allowed to get into the plug. Al-low the sensor to air-dry completely before you use it again.

Respiratory flow / snore nasal cannulaThe nasal cannula is a disposable article. For hygiene reasons, do not reuse nasal cannulas, but dispose of used nasal cannulas as household garbage.

In sleep laboratories / clinical facilities, be sure to comply with the relevant hygiene regulations.

Thorax and abdomen sensors (only SOMNOcheck effort )Please clean the sensors with a disinfectant as de-scribed above or wipe the sensors with a damp cloth. After cleaning allow the sensors to dry completely.

The sensors should not be submerged in liquid nor placed in an autoclave.

Hygienic preparation 55

Pulsoximetric sensorClean the pulsoximetric sensor 28/32 with a disinfectant. You are recommended to wear suitable gloves (e.g. household or disposable gloves) during disinfection procedures.

Pressure measurement tubeThe pressure measurement tube 23 is intended for a single use only.

AccessoriesPlease follow the instructions included with each accessory.

7.2 As required

SOMNOcheck

Important! No liquids should get into the SOMNOcheck basic unit or the plug connec-tions. Make sure to close the CPAP port with the cover!

Clean the surface of SOMNOcheck with a dry or slightly damp cloth. If the device is very dirty, you can use weak soapsuds or a disinfectant with an alcohol agent. You are recommended to wear suitable gloves (e.g. household or disposable gloves) during disinfec-tion procedures. Do not allow any liquid to get into the device.

Please follow the Instructions for Use of the disinfection agents.

Holster and StrapsImportant! Holsters and straps cannot be dried in a tumble dryer!

The carrying case, the holster, the straps and the pro-tective cover for the abdominal sensor can be washed at 40°C in a washing machine. Please air-dry all parts. Do not use a tumble dryer!

56 Hygienic preparation

Functional checks 57

8. Functional checks

Please carry out the following functional checks before each use:

• Check all the sensor cables and plug connections. If a plug or the insulation on a sensor is damaged, replace the sensor before measurement.

Important! Soiled or wet sensors de-liver false measurement results.

• Please check the condition of the sensors. They should be clean and dry. If they are soiled, they have to be cleaned before measurement (see “7. Hygienic preparation” on page 55).

• Check the condition of the SOMNOcheck basic unit by carrying out the sensor test as described on page 43.

• Please check the sit of the sensors before measure-ment.

9. Errors and their correction

9.1 SOMNOcheck Basic Unit

Error Cause Correction

The green LED 4 does not illuminate during the test.

The power pack is not charged. Charge the power pack.SOMNOcheck or the power pack is defective.

Have SOMNOcheck or thepower pack put into working order.

The green LED 4 goes out during the test without first blinking.

The respiratory flow /snore sensor 11 and/or the pulsoximetric sensor 28/32 are not attached.

Attach the missing sensors.

The plug connections are notcorrectly put together.

Make sure the plugs are firmlyconnected.

The sensors are soiled, wet or defective.

Clean the sensors and wipethem dry.

The yellow LED 3 doesnot illuminate duringcharging.

The power pack has already been charged. You can cancel the charging step.

The electrical outlet is defective. Use a different electrical outlet.

SOMNOcheck is defective. Have SOMNOcheck put into working order.

The yellow LED 3 illum-inates or blinks during measurement.

The power pack has been discharged or depleted.

Repeat the measurement with a charged power pack. If this error occurs frequently, the power pack is probably depleted and should be replaced (see Seite 53).

The yellow LED 3 blinksirregularly.

The power pack has not been inserted. Place the power pack in the device.

The power pack has been discharged and SOMNOcheck is being operated on the charger (e.g., data transfer).

If this error occurs frequently, the power pack is probably depleted and should be replaced (see Seite 53).

The alarm sounds without interruption. The power pack is discharged. Repeat the measurement with

a recharged power pack.

58 Errors and their correction

9.2 SOMNOcheck-Software

A signal curve shows a non-physiological course.

The plug connections were not made correctly.

Repeat the measurement withclean or replacement sensors.

The sensor became soiled or slipped out of place during measurement.The measurement require-ments for the sensors werenot observed.


The program cannot produce a connection to the SOMNOcheck basic unit.

SOMNOcheck is not on. Press the green key 5 on the SOMNOcheck basic unit.

The PC transfer cable 42 is not connected to the SOMNOcheck basic unit.

Place the combo-plug 44 in the port on the SOMNOcheck basic unit.

The PC transfer cable 42 is not connected to a serial port on your PC.

Put the PC-plug 43 into a COM port.

The serial interface is set up incorrectly.

Turn on the SOMNOcheck and allow the software (after this error message)

to set up the interface automatically or set it up manually by using the menuentries Settings, Serial Interface.

The properties of your COM port have been set incorrectly.

Check the properties in the system folder and correct them.

Other applications are usingthe interface. Close other applications.


Errors and their correction 59

9.3 Charger


The LED flashes alternately orange and green.

A fault has been detected in the charger, e.g. if the power pack voltage is too low.

1. Disconnect the SOMNOcheck from the charger. Disconnect the charger from the mains. After a few seconds, connect the charger to the mains again, then reconnect the SOMNOcheck.

2. If the fault occurs again, change the power pack if there is a spare one available.

3. If the fault continues to occur, have the charger repaired together with the SOMNOcheck and the power pack.

60 Errors and their correction

Maintenance, Service 61

10. Maintenance, Service

SOMNOcheck should be serviced every two years by the manufacturer in order to assure its functional capacity.

At this time the internal sensor for pressure measure-ment is checked and if necessary recalibrated.

You can determine the calibration date in the SOMNOcheck software as follows:

• Select SOMNOcheck Status from the Options menu. The calibration date will be displayed here.

11. Disposal

Do not dispose of the unit with domestic waste. For proper disposal of the device and its components, please contact a certified waste disposal site for elec-tronic goods. Ask your Environmental Officer or local council for the address. The device packaging (card-board and inserts) can be disposed of in paper recy-cling facilities.

Electronic scrap mut not be disposed of as household waste! All consumers have a statutory obligation to de-liver all end-of-life devices containing electronic com-ponents, batteries and rechargeable power packs, whether or not they contain pollutants, to a local autho-rity collection centre or to the trade to ensure that they are sent for environmentally sound disposal. Please make sure batteries and rechargeable power packs are discharged when you hand them in!

12. Supply Range

12.1 Standard supply range

1. SOMNOcheck Sleep Apnea Diagnosis Set WM 941002. SOMNOcheck Sleep Apnea Diagnosis Set, no sensor system WM 941013. SOMNOcheck effort Sleep Apnea Diagnosis Set WM 942004. SOMNOcheck effort Sleep Apnea Diagnosis Set,

no sensor system WM 94201

Order Nr. Article WM 94100 WM 94101 WM 94200 WM 94201

WM 94050 SOMNOcheck basic unit • •

WM 94250 SOMNOcheck effort basic unit • •

WM 94051 Power pack, NiMH • • • •

WM 94052 Holster • • • •

WM 94053 Fixing strap 1.1 m (yellow end) • • • •

WM 94054 Fixing strap 1.5 m (green end) • • • •

WM 94055 Carrying case • • • •

WM 94010 Respiratory flow/snore sensor for adults, large • •

WM 94034Pulsoximeter Clip Sensor Envitec with connector respiratory flow / snore sensor

• •

WM 94040 Pressure measurement tube • • • •

WM 94042 Cap for pressure measurement connector • • • •

WM 94060 Charger with PC-data exchange cable • • • •

WM 94091 Software SOMNOcheck • • • •

WM 96267 Instructions for Use SOMNOcheck, German • • • •

WM 96272 Instructions for Use SOMNOcheck, English • • • •

WM 96273 Instructions for Use SOMNOcheck, French • • • •

62 Supply Range

WM 96269 Instructions for Use SOMNOcheck Patients, German • • • •

WM 96270 Instructions for Use SOMNOcheck Patients, English • • • •

WM 96271 Instructions for Use SOMNOcheck Patients, French • • • •

WM 94063 Module for galvanic isolation RS 232 / PC (9-pin/9-pin) • •

WM 94071

WM 94070WM 94080WM 94081

WM 94082

WM 94083

WM 94079

Set Effort Sensor system,comprising:– Effort sensor with black plug– Effort sensor with blue plug– Connector to effort sensor with blue

plug– Fixing strap for abdomen 1.5 m

(green end)– Fixing strap for abdomen 1.1 m

(yellow end)– Protective cover for abdomen sensor

o

•••

•

•

•


Supply Range 63

12.2 Replacement parts




WM 94050 SOMNOcheck basic unit • •

WM 94250 SOMNOcheck effort basic unit • •

WM 94051 Power pack, NiMH • • • •

WM 94052 Holster • • • •

WM 94053 Fixing strap 1.1 m (yellow end) • • • •

WM 94054 Fixing strap 1.5 m (green end) • • • •

WM 94055 Carrying case • • • •

WM 94010 Respiratory flow/snore sensor for adults, large1) • •

WM 94034Pulsoximeter Clip Sensor Envitec with connector respiratory flow / snore sensor

• •

WM 94040 Pressure measurement tube • • • •

WM 94042 Cap for pressure measurement connector • • • •

WM 94060 Charger with PC-data exchange cable • • • •

WM 94061 Charger with PC-data exchange cable/UK • • • •

WM 94091 Software SOMNOcheck • • • •

WM 96267 Instructions for Use SOMNOcheck, German • • • •

WM 96272 Instructions for Use SOMNOcheck, English • • • •

WM 96273 Instructions for Use SOMNOcheck, French • • • •

64 Supply Range

1) The respiratory flow/snore sensor is a part that is subject to wear and tear. Especially due to cleaning and disinfection, the elastic bands, the silicone covering on the sensors and the microphone membrane have a limited life. Due to its flexible construction, the relief piece joining the cable to the sensor is also subject to wear and tear.


WM 96269 Instructions for Use SOMNOcheck Patient, German • • • •

WM 96270 Instructions for Use SOMNOcheck Patient, English • • • •

WM 96271 Instructions for Use SOMNOcheck Patient, French • • • •

WM 94063 Module for galvanic isolation RS 232 / PC (9-pin/9-pin) • •

WM 94071

WM 94070WM 94080WM 94081

WM 94082

WM 94083

WM 94079

Set Effort Sensor system,comprising:– Effort sensor with black plug– Effort sensor with blue plug– Connector to effort sensor with blue

plug– Fixing strap for abdomen 1.5 m

(green end)– Fixing strap for abdomen 1.1 m

(yellow end)– Protective cover for abdomen sensor

o

•••

•

•

•

o

•••

•

•

•

WM 94009 Fixing strap for respiratory flow/snore sensor • • • •

Supply Range 65

12.3 Accessories



1) The sensors WM 94037 and WM 90326 are to be connected to the SOMNOcheck with the pulsoximeter vario adapter WM 94036.


WM 96210 Instructions for Use SOMNOcheck Patient, Finnish • • • •

WM 96211 Instructions for Use SOMNOcheck Patient, Spanish • • • •

WM 96212 Instructions for Use SOMNOcheck Patient, Turkish • • • •

WM 96214 Instructions for Use SOMNOcheck Patient, Italian • • • •

WM 96215 Instructions for Use SOMNOcheck Patient, Norwegian • • • •

WM 96274 Instructions for Use SOMNOcheck Patient, Dutch • • • •

WM 96276 Instructions for Use SOMNOcheck Patien, Swedish • • • •

WM 94036 Pulsoximeter vario adapter • • • •

WM 94037 Pulsoximeter clip sensor Envitec with 40 cm cable1) • • • •

WM 94043 Respiratory flow / snore nasal cannula • • • •

WM 94044 Respiratory flow / snore nasal cannula, package of 10 • • • •

WM 94045 Respiratory flow / snore nasal cannula, package of 50 • • • •

WM 90326 Disposable sensor for adults, package of 10 • • • •

WM 94032 Pulsoximeter Clip Sensor BCI with connector respiratory flow / snore sensor • • • •

66 Supply Range

13. Technical Data

* Please note the temperature range of the respiratory flow/snore sensor (see page 69).

SOMNOcheck Basic Unit

Product class according to 93/42/EEC

IIa

Dimensions (W x H x D) 65 x 130 x 30 mm

Weight (SOMNOcheck with power pack)

approx. 240 g

TemperatureOperatingStorage

+5 °C to +40 °C*-10 °C to +60 °C

Power supply Power pack NiMH(WM 94051)

Average power consumption approx. 340 mW

Operating life of power pack approx. 13 hours

Classification according to EN 60601-1– Protection from

electric shock– Degree of

protection from electric shock

Protection class II

Type B

Protection from infiltration of water IPX 4

Electromagnetic tolerance (EMV) according to EN 60601-1-2– Static screen

– Interference resistance

EN 55011 (VDE 0875 T.11)

IEC 1000-4 Part 2-5

Relative humidity during operation and storage

0 to 95 %, no condensation

Air pressure during operation and storage

900 to 1100 mbar

Storage

integrated data storage with data retention even without power supply, capacity: 13 hours.

Data port RS232 to PC with charger (WM 94060)

Charger unit

Dimensions (W x H x D) 45 x 90 x 32 mm

Weight 225 g

TemperatureOperatingStorage

+5 °C to +40 °C*-10 °C to +60 °C

Input voltage 100–240V, 50–60Hz

Max. power output 16 W

Classification according to EN 60601-1– Protection from

electric shock

Protection class II

Protection from infiltration of water IPX0

Relative humidity during operation and storage

10 to 85 %, no condensation

Electrical safety EN 60601-1, EN 60950, EN 60335-2-29

Cable Charging and data transfer cable

Technical Data 67

68 Technical Data

Power pack

Charging

Fast charge within max. 2 hours. Typical charging time after eight hours measurement: about 1 hour; approx. 500 charges possible

Signals from SOMNOcheck

LED yellowContinuous (SOMNOcheck on)Flashing (SOMNOcheck on)Flashing (while charging)

Power pack empty or being chargedPower pack empty

Top -up mode with low charging current and full power pack

LED greenconstant

blinking

ready for operation,sensor testmeasurement, data transfer

Note at loss of sensor and ready to measure

Signals from charger

LED, yellow

– Power pack not connected– Power pack initialisation

and analysis– 10-minute wait before

charging starts

LED, flashing alternately orange and yellow

10-minute wait before charging starts with empty power pack

LED, green (for 8 s) Preparing fast charge (for test and service purposes)

LED, orange Fast charge

LED, green with flashing yellow light

Top-up mode with low charging current and full power pack (this charging phase does not necessarily occur).

LED, green Floating charge mode

Signals from charger

LED, flashes alternately orange and green

Fault

Position Sensor

Position Sensor position sensor integrated in device

Values right side, left side, stomach, back, standing

Position accuracy approx. 45° ± 15°

CPAP / BiLevel pressure /SmartPAP Pressure

Measurement range 0 to 20 mbar

Accuracy ±0,2 mbar

Pulsoximeter clip sensor

SpO2 measurement range 50 to 99 %

SpO2 accuracyat SpO2 above 85%at SpO2 between 75% and 85%at SpO2 between 50% and 75%

±1,5 %-Points±2,0 %-Points

±3,0 %-Points

Pulse rate measurement range 30 to 250 bpm

Pulse accuracy ±1 %

e reserve the right to change the design.

fort-Sensor

fortlue range

Piezo sensor8 Bit

alvanic isolation

ectrical isolation 4000 V

ud rate 9600 to 115200 Baud

tilized wires GND, TxD, RxD

imensions 63 x 33 x 17 mm

eight approx. 25 g

wer supply automatic via RxD

ectrical usage bei RxD=9 V: approx. 6 mAbei RxD=6 V: approx. 4 mA

Respiratory flow/Snore Sensor

Respiratory flow sensor

Value range

3 thermistors as total signal, no measurementfunction at ambient temperatures between 33°C and 38°C 8 bit

Snore sensor

Method

Value range

integrated microphone in respiratory flow/Snore sensorLog. average value of inspiratory snore sounds8 bit

Respiratory flow / snore nasal cannula

Respiratory flow

Method

Value range

Difference from ambient pressure, resolution up to 10 microbarFlow approximation by square root calculation8 bit

Snoring

Method

Value range

Difference from ambient pressure, bandpass filter 30-250 HzLogarithmic mean of inspiration signal8 bit

Service life 6 months (130 applications)

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Technical Data 69

14. Warranty

• Weinmann offers a warranty that the product, when used in accordance with requirements, will remain free from defects for a period of two years from date of pur-chase. For products whose durability is clearly indicated as less than two years, the warranty expires on the expi-ration date indicated on the packaging or in the user’s manual.

• Sensors and batteries are wear parts. For such parts Weinmann offers a warranty of 6 months.

• Claims against the warranty can be made only when accompanied by the sales receipt, which must show salesperson and date of purchase.

• We offer no warranty in the case of:– Disregard of usage instructions– Operating errors– Improper use or handling – Third-party intervention by non-authorized persons for

the purpose of device repair – Acts of God, e.g., lightning strikes, etc.– Transport damage as a result of improper packaging

of returned items– Lack of maintenance – Operational and normal wear and tear, which in-

cludes, for example, the following components. – Filter– Rechargeable and non-rechargeable batteries– Sensors– Electrodes– Articles for one-time usage, etc.

– Failure to use original spare parts

• Weinmann is not liable for consequential harm caused by a defect if it is not based on intention or gross negli-gence. Weinmann is also not liable for minor physical injury to life or limb resulting from negligence.

• Weinmann reserves the right to decide whether to elim-inate defects, to deliver a defect-free item or to reduce the purchase price by a reasonable amount.

70 Warranty

• If Weinmann rejects a claim against the warranty, it as-sumes no expense for transport between customer and manufacturer.

• Implied warranty claims remain unaffected by these changes.

• The guarantee is made invalid by the chemical ef-fects from leaking rechargeable batteries and by damages resulting from the use of unsuitable chargers.

• Devices to be repaired should be sent to:

Technischer Service Weinmann Geräte für Medizin GmbH + Co KG,Siebenstücken 14 D-24558 Henstedt-Ulzburg

Germany

• For questions or matters of urgency, please contact Weinmann Customer Service in Hamburg

Telephone: +49 40/547 02 - 0

For urgent questions: Our hotline

or use our Hotline:

[email protected]

Warranty 71

72 Warranty

Weinmann

Geräte für Medizin GmbH+Co. KG

P.O. Box 540268 · D-22502 Hamburg

Phone +49/40/5 47 02-0

Fax +49/40/5 47 02-461

E-Mail [email protected]

Internet www.weinmann.de

For decades Weinmann has been

developing, producing and marketing

medical devices for markets around

the world. In cooperation with our

partners we design economic health

systems for diagnosis and therapy in

Sleep Medicine, Home Mechanical

Ventilation, Oxygen Medicine

and Emergency Medicine.

WM

962

72i·

BD00

75i ·

11/

07

Device Description and Operating Instructionsactivecare.se/files/bruksanv/weinmann/somnocheck_manual_gb.pdf · Device Description and Operating Instructions SOMNO check SOMNO check

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