S5 Extension Module for FM, N-FC, N-FCREC, N-FREC Technical Reference Manual Slot July 2004

Table of contents

Table of contents Introduction 1

Specifications 1.1 1.2

1.3

2

2.2

2.3

3.2 3.3 3.4

4

4.3 4.4

11

General service information... 11 3.1.1 MiniCO2 measuring unit... 11 3.1.2 Recorder unit... 11 Service check... 11 3.2.1 Recommended tools... 12 3.2.2 Recommended parts... 12 S/5 N-FCREC disassembly and reassembly... 19 3.3.1 Instructions after replacing MiniC unit... 19 3.3.2 Before disassembly... 19 Adjustments and calibrations... 25 3.4.1 Calibrating... 25 3.4.2 Gas sampling system adjustment... 27 3.4.3 Flow rate measurement... 27 3.4.4 Flow rate adjustment... 27 3.4.5 Gas calibration... 28

Troubleshooting 4.1 4.2

5

Measurement principle... 5 2.1.1 CO2 measurement... 5 Main components... 5 2.2.1 Gas sampling system... 5 2.2.2 MiniCO2 measuring unit... 8 2.2.3 CPU board... 9 2.2.4 Recorder board... 9 Connectors and signals... 10

Service procedures 3.1

2

General specifications... 2 1.1.1 Environmental specifications... 2 CO2 measurement... 2 1.2.1 Typical performance... 2 1.2.2 Technical specifications... 2 1.2.3 Normal conditions... 3 1.2.4 Conditions exceeding normal... 3 Recorder... 4 1.3.1 Typical performance... 4

Functional description 2.1

3

1

29

Troubleshooting chart for recorder unit... 29 Troubleshooting chart for CO2 measurement... 29 4.2.1 CO2 measurement... 31 Gas sampling system troubleshooting... 31 4.3.1 Sampling system leak test... 32 MiniC unit troubleshooting... 32 i Document No. M1022498-2

Datex-Ohmeda S/5™ FM

4.5

Error messages... 32

Appendix A: Service check form

ii Document No. M1022498-2

A-1

S/5 Extension Module for FM, N-FC, N-FCREC, N-FREC

Introduction This Technical Reference Manual Slot provides information for the maintenance and service of the Datex-Ohmeda S/5 Extension Module for FM, N-FC, N-FCREC and N-FREC. The Extension Modules for FM are designed for use with the S/5 FM Monitor. Later in this manual the module can be called w/o the system name Datex-Ohmeda S/5. Please also refer to the Part I sections of the manual for information regarding system specific information e.g. related documentation, conventions used, symbols on equipment, safety precautions, system description, system installation, interfacing, functional check and planned maintenance. N-FREC and N-FCREC provide real time printing of waveform and numerical data, and trend data. NOTE: Printings on thermal paper may be destroyed when exposed to light, heat, alcohol etc. Take a photocopy for archive. N-FCREC and N-FC provide CO2 airway and respiratory measurements. NOTE: The Extension Modules for FM provide airway and respiratory measurements intended for patients weighing over 5kg (11lb).

Figure 1

F-FCREC side and front views

Parameters Module

CO2

N-FC

X

N-FCREC

X

N-FREC

Recorder X X

Compatibility NOTE: The Extension Modules for FM are designed for use with L-FICU03(A) software. NOTE: The Extension Modules for FM are compatible with S/5 FM monitor only.

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1

Specifications

1.1

General specifications N-FCREC Module size, W × D× H Module weight Power consumption N-FREC Module size, W × D× H Module weight Power consumption N-FC Module size, W × D× H Module weight Power consumption

1.1.1

90 × 169 × 191 mm, 3.54 × 6.65 × 7.51 in 1.0 kg/2,2 lb. 2.7 W standby, 11.5 W printing 90 × 169 × 191 mm, 3.54 × 6.65 × 7.51 in 0.8 kg/1,7 lb. 1.2 W standby, 10 W printing 46 × 169 × 191 mm, 1.81 × 6.65 × 7.51 in 0.5 kg/1,1 lb. 1.5 W typical

Environmental specifications Operating temperature Storage temperature Atmospheric pressure

Humidity Protection against electrical shock

1.2

CO2 measurement

1.2.1

Typical performance

+10...+40 °C (+50 to 104 °F) -20...+60 °C (-4 to +140 °F) 666...1060 hPa / (67...106 kPa) (500...800 mmHg) (666...1060 mbar) 10...95% non-condensing (in airway 0...100%, condensing) Type BF

Measurement range 0...20 vol% (0...20 kPa, 0...150 mmHg) Measurement rise time < 300 ms with nominal flow Accuracy (0…15 vol%) ±(0.2 vol% +2% of reading) (15…20 vol%) ±(0.7 vol% +2% of reading) If CO2 concentration is below 0.1%, 0.0% is displayed.

1.2.2

Technical specifications Airway humidity Sampling rate Sampling delay Total system response time

0...100%, condensing 150 ±25ml / min. (sampling line 2 to 3 m, normal conditions) 2.1 seconds typical with a 3-m sampling line 2.4 seconds typical with a 3-m sampling line, including sampling delay and rise time (typically 3.7 seconds with a 6-m sampling line). Automatic compensation for pressure, CO2-NO2 and CO2-O2 collision broadening effect compensation selectable from menu. Warm up time 1 min for operation with CO2 2 Document No. M1022498-2

S/5 Extension Module for FM, N-FC, N-FCREC, N-FREC

Zeroing interval

1.2.3

4, 15, 30,and 60 minutes after start-up, then every 60 minutes.

Normal conditions Accuracy specifications apply in normal conditions (after 30 minutes warm-up period): Ambient temperature 18...28 °C, within ±5°C of calibration Ambient pressure 500...800mmHg, ±50mmHg of cal. Ambient humidity 20...80% RH, ±20% RH of cal. Non-disturbing gases are those with a maximum effect on the CO2 reading <0.2 vol%. The effect is valid for specific concentrations shown in parentheses of the non-disturbing gas: − Ethanol C2H5OH (<0.3%) − Acetone (<0.1%) − Methane CH4 (0.2%) − Nitrogen N2 − water vapor − Trichloromonofluoromethane (<1%) − Dichlorotetrafluroethane (<1%) − Dichlorofluromethane (<1%) Disturbing gases and their effect on the CO2-reading at 5.0 vol% CO2 are shown below. Errors listed reflect the effect of specific concentrations (shown in parentheses) of an individual disturbing gas and should be combined when estimating the effect of gas mixtures: − Halotane (4%) increases < 0.3 vol% − Isoflurane (5%) increases < 0.4 vol% − Enflurane (5%) increases < 0.4 vol% − Desflurane (24%) increases < 1.2 vol% − Sevoflurane (6%) increases < 0.4 vol% − Helium (50%) decreases < 0.3 vol% − If O2 compensation is not activated:Oxygen (40 … 95%) decreases < 0.3 vol%

1.2.4

−

If O2 compensation is activated: Oxygen (40 … 95%) error < 0.15 vol%

−

If N2O compensation is not activated:N2O (40%) increases < 0.4 vol%

−

N2O (40 to 80%) increases < 0.8 vol%

−

If N2O compensation is activated: N2O (40 to 80%) error < 0.3 vol%

Conditions exceeding normal Accuracy specifications under the following conditions nop: n Ambient temperature 10...40 °C, within ±5 °C of calibration Ambient pressure 500...800 mmHg, ±50 mmHg of calibration Ambient humidity 10...98% RH, ±20% RH of calibration o During warm-up 1 to 10 minutes, under normal conditions p During warm-up 10 to 30 minutes, under normal conditions

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Accuracy under different conditions (see above) Conditions n and p

Condition o

CO2 (0 … 15 vol%)

±(0.3 vol% + 4% of reading) (at 5 vol% error ±0.5 vol%)

±(0.4 vol% + 7% of reading) (at 5 vol% error ±0.75 vol%)

CO2 (15 … 20 vol%)

±(0.8 vol% + 4% of reading) (at 5 vol% error ±0.5 vol%)

±(0.9 vol% + 7% of reading) (at 5 vol% error ±0.75 vol%)

1.3

Recorder

1.3.1

Typical performance Principle Print resolution Vertical Horizontal Paper width Print speed Waveform printout Numerical printout Tabular Trend printout

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Thermal array 8 dots/mm (200 dots/inch) 32 dots/mm (800 dots/inch) at a speed of 25 mm/s and slower 50 mm, printing width 48 mm 1, 6.25, 12.5, 25 mm/s selectable 1, 2, or 3 waveforms HR, NIPBP, P1, P2, T1, T2, Tblood, Et/FiCO2, RR HR, SpO2, P1, NIBP, EtCO2

S/5 Extension Module for FM, N-FC, N-FCREC, N-FREC

2

Functional description

2.1

Measurement principle

2.1.1

CO2 measurement MiniC is a side stream gas analyzer, measuring real time concentrations of CO2. It is a non dispersive infrared analyzer, measuring absorption of the gas sample using optical narrow band filter. The infrared radiation detector is thermopile. Concentration of CO2 is calculated from absorption measured at 4.2 to 4.3 µm.

Figure 2

2.2

Absorbance of CO2

Main components The miniC unit in N-FC and N-FCREC modules consists of: − Gas sampling system − MiniCO2 measuring unit − CPU board The recorder unit in N-FREC and N-FCREC consists of: − Recorder board − Thermal printer

2.2.1

Gas sampling system The sampling system draws a gas sample to the analyzer at a fixed rate.

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The gas sampling system samples the measured air to the module, and removes water and impurities from it. A sampling line is connected to the water trap. The pump draws gas through the sampling line to the gas measuring unit. After the measurement, the gas is exhausted from the sample gas out connector. The sample flow is nominally 150 ml/min.

Figure 3

MiniC block diagram

Mini D-fendTM The sample is drawn through the sampling line. The gas then enters the module through the water trap, where it is divided into two flows, a main flow and a side flow. The main flow goes into the analyzer. This flow is separated from the patient side by a hydrophobic filter. The side flow creates a slight subatmospheric pressure within the Mini D-fend water trap which causes fluid removed by the hydrophobic filter to collect in the bottle.

Zero valve The main flow passes through a magnetic valve before proceeding to the analyzer. This valve is activated to establish the zero point for the MiniCO2 measuring unit. When the valve is activated, room air is drawn through a filter into the internal system and the gas sensor.

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NafionTM tube 1) A nafion tube is used between the water trap and the zero valve to balance the sample gas humidity with that of ambient air. The tube prevents errors caused by the effect of water vapor on gas partial pressure when humid gases are measured after calibration with dry gases.

Gas analyzers After the zero valve and nafion tube the gas passes through miniCO2 measuring unit.

Sample flow differential pressure transducer The sample flow differential pressure transducer measures pressure drop across a restrictor and calculates the sample flow from the pressure difference.

Working pressure transducer The working pressure transducer measures differential pressure between tubing and ambient air near the miniCO2 measuring unit.

Atmospheric pressure transducer The atmospheric pressure transducer measures real-time atmospheric pressure. The following messages are based on the obtained pressure values: ‘sample line blocked’, ‘check D-fend’, ‘replace D-fend’ and ‘check sample gas outlet’.

Sampling pump and damping chamber The gas sampling pump is a membrane pump run by a DC-motor. Sample flow is measured with a differential pressure transducer across a known restriction. The motor is automatically controlled to maintain a constant flow even when the D-fend water trap ages and starts to get occluded. It also enables use of sample tubes with varying lengths and diameters. NOTE: In no occasion is the flow reversed towards patient.

1.

1)

Nafion is a trademark of Perma Pure Inc.

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Datex-Ohmeda S/5™ FM

Side flow Main flow

Mini D-fend

Filter

Room air

Zero valve

Mini CO2

Diff. Pressure Sensor

Abs. Pressure Sensor

Pump

Gas out

Figure 4

2.2.2

minic_fem_gastubing.vsd

Diff. Pressure Sensor

Gas tubing layout

MiniCO2 measuring unit The miniCO2 measuring unit is a non-dispersive infrared analyzer measuring absorption of the gas sample at 4.2 to 4.3 µm infrared wavelength, which is selected using an optical narrow band filter. The IR lamp is a filament surrounded by thermal isolation. There is a hole in the isolation, passing the radiation to a conical measuring chamber with 3 mm length. From the sample chamber, the radiation goes into a thermopile detector with an optical filter in front of it. The temperature sensor measures miniCO2 measuring unit's temperature and it is used for temperature compensation. The miniCO2 measuring unit includes miniCO2 flexible board which connects the thermopile signal and the temperature sensor signal to the CPU board.

Figure 5

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MiniCO2 measuring unit

S/5 Extension Module for FM, N-FC, N-FCREC, N-FREC

2.2.3

CPU board CPU board contains the processor, memories and all the analog signal processing needed. MiniCO2 measuring unit is attached to the board with a flexible PCB. Also supply voltage and RS485 serial channel are connected to the CPU board using another flexible PCB. Analog signals (CO2, temperature, absolute and differential pressure and lamp current signals) are fed to the 16-bit A/D-converter. The processor controls the A/D-converter and calculates the CO2 percentage and respiration rate from this data. The processor controls sample flow by adjusting pump voltage based on the differential pressure signal. The processor also controls the current of the IR source and keeps it constant. Calibration data is stored on the eeprom.

2.2.4

Recorder board The function of the recorder board is to establish an interface between the recorder unit and main CPU board in the monitor. The recorder unit related side panel key is connected to the recorder unit via the recorder board. The recorder unit and the recorder board are connected together with a special connector.The REC board controls the recorder unit communication and power. The REC board is grounded via the recorder unit. If the recorder unit is not installed, the REC board does not function.

.

N NV Memo V Memory ry

Dat Data a

RS48 RS485 Driv 5 Driver er

Figure 6

+15V_RE +15V_REC C

CP CPU U

REC Board

Reset Reset Communicati Communication on CT CTS S

Record Recorder Uni er Unit t

n-frec_block_brd_diag.vsd

MODULE BUS

Pow Power Suppl er Supply +15 y +15 V V

RE REC Ke C Key y

Recorder board block diagram

External Communication Communication with the main CPU board is via RS485. Supply voltage The recorder unit supply voltage, +15V_REC, is provided by the recorder board. Module Bus Flex board.

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Datex-Ohmeda S/5™ FM

Module Bus Flex board connects the CPU board of miniC unit and the recorder board to the module bus.

Figure 7

2.3

Module bus flex board

Connectors and signals Table 1

Module bus connector pin description

5 pin female connector

10 Document No. M1022498-2

Pin

Signal

1 2 3 4 5

GND Vmod 13.8 - 16 V Data + Data Shield

S/5 Extension Module for FM, N-FC, N-FCREC, N-FREC

3

Service procedures

3.1

General service information Field service of the Extension Modules for FM is limited to replacing faulty circuit boards or mechanical parts. The circuit boards should be returned to Datex-Ohmeda for repair. Datex-Ohmeda is always available for service advice. Please, provide the unit serial number, full type designation and a detailed fault description.

CAUTION

Only trained personnel with appropriate equipment should perform the tests and repairs outlined in this section. Unauthorized service may void warranty of the unit.

CAUTION

The module electronics can only be repaired and calibrated at the factory.

3.1.1

MiniCO2 measuring unit

CAUTION

The miniCO2 measuring unit and its components are repaired/calibrated at the factory. Attempts to repair/calibrate the unit elsewhere will adversely affect operation of the unit. The information provided is for reference only. Serviceable or exchangeable parts • Mini D-fend • Mini D-fend O-rings • Nafion tube • Air filter • Pump NOTE: After any component replacement see chapter Adjustments and calibrations.

3.1.2

Recorder unit Serviceable or exchangeable parts • Recorder board • Thermal plotter

3.2

Service check These instructions include complete procedures for a service check. The service check is recommended to be performed after any service repair. However, the service check procedures can also be used for determining possible failures. The procedures should be performed in ascending order. The instructions include a check form, Service check FORM Appendix A, which should be filled in when performing the procedures. The mark

" in the instructions means that the check form should be signed after performing the

procedure.

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Datex-Ohmeda S/5™ FM

3.2.1

Recommended tools Tool

Order no.

Notes

Screwdrivers

Pozi-drive, Torx

Ambient pressure manometer

Amb. Press. can be checked from local meteorological station

Flowmeter

TSI model 4140 recommended

Flow cassette 50/1.1

873812

Calibration gas and the regulator

755580 (gas) 755534

Contains 5 CO2 and air

E-PSM / E-PSMP Patient simulator

3.2.2

Recommended parts Recorder paper

•

74205

Detach the module box cover by removing the five screws from the locking side of the module. Be careful with the flex cable when opening the cover. Remove the grey plastic shield over the miniC unit.

General 1.

Check internal parts: − all screws are tightened properly − all cables are connected properly − tubes are not pinched and there are no sharp bends on them − all tubes are connected properly − EMC covers are attached properly − there are no loose objects inside the module N-F(C)REC: Open the paper compartment hatch and take out the paper roll, if installed. Remove any paper chaff from the paper compartment. Clean the thermal printhead and the small glass window in front of the static brush with a cotton swab dipped in isopropyl alcohol. Avoid contact with the rubber paper roller. NOTE: Be careful to limit the application of alcohol to the thermal printhead and the window. Leave the paper compartment empty and close the hatch.

" 2.

12 Document No. M1022498-2

Check external parts: − all connectors are intact and are attached properly

S/5 Extension Module for FM, N-FC, N-FCREC, N-FREC −

the module box and the locking system are intact

" −

Reattach the module and check that the locking system moves properly

CO2 measurement 3.

Check Mini D-Fend. Detach the Mini D-fend. Check the condition of the rubber O-rings on the metal Mini D-fend connectors, located in the module front cover. If necessary, detach the connectors by first disconnecting the tubes, then removing the locking rings from the back of the front cover.

" Replace the Mini D-fend and sampling line with new ones. NOTE: Use only Datex-Ohmeda sampling lines in order to ensure proper functioning. Connect the Extension Module, N-FC or N-FCRE,C to the monitor. Turn on the monitor. Configure the monitor screen so that CO2 curve is shown, for example as follows:

Monitor Setup - Screen 1 Setup - Waveform fields Field 6 - CO2 Digit Fields Lower Field 1 - Gases 4.

Module software Wait until the message ‘Calibrating gas sensor’ disappears from the screen, then enter the Service menu. Monitor Setup - Install/Service (password 16-4-34) - Service (password 26-23-8). Write down the information regarding the Extension Module software.

" 5.

Module bus communication Enter the service menu General: Parameters - Gas Unit - General Check that the ‘Timeouts’, ‘Bad checksums’ and ‘Bad c-s by mod’ values are not increasing faster than by 5 per second. If one of the values is increasing faster, it indicates a failure in module bus communication.

" 6.

Flow measurement offset Enter the service menu Gases: Gas Unit - Gases Check that the flow measurement offset, i.e. the shown sample ‘Zero’ value is within ±10 ml/ min. 13 Document No. M1022498-2

Datex-Ohmeda S/5™ FM

" 7.

Ambient pressure Check that the shown ‘Ambient’ value corresponds with the current ambient pressure (±20 mmHg).

" 8.

Zero valve check Feed calibration gas and check that the gas readings in the service menu correspond with the values on the gas bottle sticker. Keep feeding gas, then activate the zero valve from the menu. The CO2 reading should drop back to near 0%.

" 9.

Nafion tube Replace the Nafion tube, if necessary. NOTE: The Nafion tube should be replaced annually.

" 10. Perform sampling system leak test. Connect a flow cassette with high flow resistance value (50/1.1) to the end of the sampling line and start following the ‘Amb-Work’ value in the service menu. When the value exceeds 130 mmHg connect the other port of the flow cassette to the sample gas out connector and switch off the pump. Wait until the pressure inside the sampling system is stabilized, then observe the shown ‘AmbWork’ value. The value, i.e. the pressure inside the sampling system should not drop more than 6 mmHg in 20 seconds. If the pressure drops more, first check connections and repeat the test.

" 11. Check the flow rates. Wait until the ‘Sample Flow’ value returns close to 150 ml /min. Connect a flow meter to the 3 meter sampling line and check that the flow (the flow meter reading) is within the following range: Sampling flow (ml/min) 135...165 If necessary, readjust the sampling flow: Select ‘Sample gain adj’ from the menu. To increase the sampling flow, turn the ComWheel counterclockwise, to decrease the flow, turn the ComWheel clockwise. A change of 0.050 in the ‘Gain’ value changes the flow approximately 7.5 ml/min.

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After you have changed the gain, wait until the ‘Sample Flow’ value on the screen returns near to the original, then check the flow meter reading again.

"

12. Working pressure Check that the ‘Amb-Work’ value in the service menu is within the following range: Amb-Work (mmHg) 20...50

" 13. Gas calibration

Airway Gas - Gas Calibration NOTE: The calibration should not be performed before 30 minutes warm-up time. Use calibration gas 755580 (5% CO2, about 20% O2) for calibrating the module with CO2 measurement.

"

14. Occlusion detection Block the tip of the sampling line with your finger and check that the message ‘Sample line blocked’ appears on the monitor screen within 60 seconds.

" 15. Check D-fend Detach the mini D-fend and check that the message ‘Check D-fend’ appears on the monitor screen within 30 seconds.

" 16. Apnea detection Reattach the mini D-fend. Simulate at least 5 breaths by feeding calibration gas into the sampling line. Check that the shown gas information is correct. Check that the monitor shows the message ‘Apnea’ within 30 seconds after you have stopped feeding the gas.

" Recorder •

Configure the monitor screen so that all required parameters are shown, for example:

Monitor Setup - Screen 1 Setup - Waveform Fields - Field 1 - ECG1 Field 2 - ECG2 Field 3 - P1

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Field 4 - P2 Field 5 - PLETH Field 6 - OFF

•

Plug in the Hemodynamic Module. Connect a patient simulator to the module and check that all connected parameters are shown on the screen.

•

Preset recording settings:

•

Record/Print - Record Waveforms -

Waveform 1 - ECG1 Waveform 2 - P1 Waveform 3 - P2 Delay - Off Paper Speed - 6.25 Mm/S Length --> 30 S

Record Trends -

Graphic Trend 1 - Hr Graphic Trend 2 - P1

Monitor Setup - Install/Service (password 16-4-34) - Installation - Printer & Recorder - Default Trend - Graph. Display Trends - Time Scale - 2 h 17. Paper recognition Press the Start/Stop key on the monitor side panel. Check that the message “Recorder: Out of paper” appears on the screen.

"

18. Cover state recognition Open the paper compartment cover. Check that the previous message changes to “Recorder: Cover open”. Install a paper roll and close the cover. Check that the message “Recorder: Cover open” disappears from the screen.

" 19. Quality of recording Press the Start/ Stop key again and check that the quality of the recordings is acceptable.

"

20. Recording speed Press the RECORD WAVE key again and this time wait until the recording stops. Check that the length of the recorded waveform scale is 18.7 cm (±1.5 cm). Change the paper speed setting to 1 mm/s:

Record/Print - Record Waveforms - Paper Speed - 1 mm/s Press the RECORD WAVE key and wait until the recording stops. Check that the length of the scale is now 3.0 cm (±0.5 cm).

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S/5 Extension Module for FM, N-FC, N-FCREC, N-FREC

General 21. Electrical safety check Perform an electrical safety check and a leakage current test.

"

22. Functioning after electrical safety check Check that the module functions normally after performing the electrical safety check.

"

23. Final cleaning Turn off the monitor, disconnect and clean the module.

" • •

Fill in all necessary documents. It is recommended to fill in the PM sticker since the service check includes all the Planned Maintenance actions. Attach it to a suitable place on the module box.

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