Datex-Ohmeda E-Modules Technical reference manual

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Datex-Ohmeda

E-Modules

Technical Reference Manual

Conformity according to the Council Directive 93/42/EEC concerning Medical Devices amended by 2007/47/EEC. CAUTION: U.S. Federal law restricts this device to sale by or on the order of a licensed medical practitioner. Outside the USA, check local laws for any restriction that may apply. All specifications subject to change without notice.

Order code for the Datex-Ohmeda E-Modules Technical Reference Manual, paper: M1065282 Order code for the S/5 Technical Reference Manuals CD: M1220141

edition

November 19, 2012

GE Healthcare Finland Oy Kuortaneenkatu 2, FI-00510 Helsinki Finland Tel: +358 10 39411 Fax: +358 9 1463310

www.gehealthcare.com

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Responsibility of the manufacturer

GE Healthcare Finland Oy (GE) is responsible for the effects on safety, reliability and performance of the equipment only if:

• assembly, extensions, readjustments, modifications, servicing and repairs are carried out by personnel authorized by GE.

• the electrical installation of the monitor room complies with appropriate requirements.

• the equipment is used in accordance with the "User's Guide" and serviced and maintained in accordance with the “Technical Reference Manual”.

The manufacturer reserves the right to change product specifications without prior notice. Although the information in this manual is believed to be accurate and reliable, the manufacturer assumes no responsibility for its use.

Trademarks

S/5, D-lite, D-lite+, Pedi-lite, Pedi-lite+, Mini D-fend, D-fend, D-fend+, MemCard, ComBar, ComWheel, EarSat, FingerSat, FlexSat, PatientO2, Entropy and Patient Spirometry are trademarks of GE Healthcare Finland Oy.

Datex, Ohmeda, and OxyTip+ are trademarks of GE Healthcare Finland Oy and Datex-Ohmeda, Inc. A portion of the Entropy software is derived from the RSA Data Security, Inc. MD5 Message-Digest

Algorithm.

Masimo SET

Masimo SET is a licensed trademark of Masimo Corporation.

All other product and company names are property of their respective owners.

Product availability

Some of the products mentioned in this manual may not be available in all countries. Please, consult your local representative for the availability.

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Description

Master Table of Contents

Datex-Ohmeda E-Modules

M1065282

Respiratory Modules, E-sCAiOV, E-sCAiO, E-sCOV and E-sCO 1

Compact Airway Modules, E-CAiOVX, E-CAiOV,

E-CAiO, E-COVX, E-COV and E-CO

PRESTN Modules, E-PRESTN, E-RESTN, E-PRETN 3

Patient Side Modules, E-PSM, E-PSMP rev. 01 4

Cardiac Output Modules E-COP rev. 01 and E-COPSv rev. 01 5

Pressure Module, E-P, Pressure Temp Module, E-PT 6

Dual Pressure Module, E-PP 7

Masimo Module, E-MASIMO 8

Nellcor Compatible Saturation Module, E-NSAT, E-NSATX 9

Single-width Airway Module, E-miniC 10

Tonometry Module, E-TONO 11

Entropy Module, E-ENTROPY 12

EEG Module, E-EEG rev.00 and EEG Headbox, N-EEG rev. 01

BIS Module, E-BIS rev. 01

NeuroMuscular Transmission Module, E-NMT

Device Interfacing Solution, N-DISxxx rev. 01

Interface Module, E-INT 17

Recorder Module, E-REC 18

Memory Module, E-MEM 19

Remote Controllers, K-REMCO rev. 01, K-CREMCO 20

Anesthesia record keeping keyboard, K-ARKB, Keyboard Interface Board,

B-ARK and ARK Barcode Reader, N-SCAN

E-Modules, Spare Parts 22

Document no. M1181405B

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Datex-Ohmeda E-Modules

Document no. M1181405B

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About this manual

Notes to the reader

This Technical Reference Manual is intended for service personnel and engineers who will service and maintain the Datex-Ohmeda E-Modules as well as the anesthesia record keeping keyboard, K-ARKB, remote controllers, K-REMCO and K-CREMCO, Device Interfacing Solution, N-DISxxx, keyboard interface board, B-ARK, and ARK barcode reader, N-SCAN.

This Technical Reference Manual completes the S/5 Anesthesia Monitor and S/5 Critical Care Monitor Technical Reference Manual and the S/5 Compact Anesthesia Monitor and

S/5 Compact Critical Care Monitor Technical Reference Manual. Later in this manual, the monitors may be referred to as AM, CCM, CAM and CCCM.

The order code for the Datex-Ohmeda E-Modules Technical Reference Manual is M1065282. The order code for the S/5 Technical Reference Manuals CD is M1220141. S/5 AM, CCM

Technical Reference Manual, S/5 CAM, CCCM Technical Reference Manual and Datex-Ohmeda E-Modules Technical Reference Manual are included on the CD.

Each manual on the CD has an individual document number and is available for downloading from GE Common Document Library in Adobe Acrobat PDF format.

• This Technical Reference Manual contains the information needed to maintain, service

and troubleshoot these products. Instructions for visual and functional inspection, disassembly and reassembly as well as calibration of the modules are included. A service check form for each product is included in the slots.

• In addition, this Technical Reference Manual contains detailed module specifications and

descriptions on the technical performance and functioning of the modules.

• Read the manual through and make sure that you understand the procedures described

before servicing the modules. To avoid risks concerning safety or health, strictly observe the warning indications. If you need any assistance concerning the service, please do not hesitate to contact your authorized distributor.

For information on safety precautions and symbols on equipment, installation, planned maintenance and interfacing, refer to the AM and CCM Technical Reference Manual or the CAM and CCCM Technical Reference Manual.

GE Healthcare assumes no responsibility for the use or reliability of its software in equipment that is not furnished by GE Healthcare.

GE Healthcare

Respiratory Modules, E-sCAiOV, E-sCAiO, E-sCOV, E-sCO

Technical Reference Manual Slot

Document number M1214853C

June 21, 2012

GE Healthcare Finland Oy Kuortaneenkatu 2, FI-00510 Helsinki Finland Tel: +358 10 39411 Fax: +358 9 1463310

www.gehealthcare.com

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Table of contents

Introduction 1

1 Technical specifications 3

1.1 Physical characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

1.2 Operating characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

1.3 Airway gases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

1.3.1 General characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

1.3.2 Respiration rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

1.3.3 Carbon dioxide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1.3.4 Oxygen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1.3.5 Nitrous oxide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1.3.6 Anesthetic agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

1.3.7 Non-disturbing gases. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

1.3.8 Gas cross effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

1.4 Patient Spirometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

1.4.1 General characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

1.4.2 Airway pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

1.4.3 Airway gas flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

1.4.4 Tidal volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

1.4.5 Minute volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

1.4.6 Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

1.4.7 Airway resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

1.4.8 Inspiration to expiration ratio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

2 Functional description 8

2.1 Measurement principle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

2.1.1 CO2, N2O, and agent measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

2.1.2 O2 measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

2.1.3 Patient spirometry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

2.2 Main components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

2.2.1 Controls and connectors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

2.2.2 Gas sampling system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

2.2.3 MiniTPX measuring unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

2.2.4 MiniOM Oxygen sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

2.2.5 MiniPVX measuring unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

2.2.6 CPU board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

2.2.7 MiniOM board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

2.2.8 MiniPVX board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

2.2.9 Main Component Interactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

3 Service Procedures 22

3.1 Replacement of planned maintenance parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

3.1.1 Required parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

3.1.2 Planned Maintenance Kits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

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3.1.3 Replacement procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

3.2 Visual inspections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

3.3 Functional check. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

3.3.1 Test setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

3.3.2 Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

3.3.3 Test completion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

3.4 Disassembly and reassembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

3.4.1 Disassembly guidelines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

3.4.2 Disassembly and reassembly procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

3.5 Adjustments and calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

3.5.1 Sample Flow Rate Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

3.5.2 Gas Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

3.5.3 Spirometry Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

4Troubleshooting 47

4.1 Visual inspection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

4.2 Troubleshooting checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

4.2.1 Gas sampling system troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

4.2.2 MiniOM Measuring unit troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

4.2.3 MiniTPX Measuring unit troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

4.2.4 MiniPVX Measuring unit troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

4.2.5 CPU board troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

4.3 Service Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

4.4 Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

4.4.1 Gas measurements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

4.4.2 Spirometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

4.5 Troubleshooting charts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

4.5.1 CO2 measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

4.5.2 Patient spirometry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

5Spare parts 56

5.1 Ordering parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

5.1.1 Planned Maintenance Kits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

5.2 Spare parts for E-sCAiOV, E-sCAiO, E-sCOV, E-sCO. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

5.2.1 Front covers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

6 Earlier revisions 61

Appendix A: Service check form A-1

Document no. M1214853C

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Introduction













This document provides information for the maintenance and service of the CARESCAPE

Respiratory modules, E-sCO, E-sCOV, E-sCAiO and E-sCAiOV. The CARESCAPE Respiratory

modules are single width plug-in modules.

The CARESCAPE Respiratory modules provide airway and respiratory measurements.

Letters in the module name stand for:

C = CO

identification

Table 1 Options for CARESCAPE Respiratory modules

and N2O, O = patient O2, V = patient spirometry, A = anesthetic agents, and i = agent

Modules Parameters / measurements

Respiratory Modules, E-sCAiOV, E-sCAiO, E-sCOV, E-sCO

N2OO2Anesthetic

Agent ID Spirometry

agents

E-sCOV X X X X

E-sCO X X X

E-sCAiOV X X X X X X

E-sCAiO X X X X X

NOTE: Anesthetic agents and N2O values are not displayed with ICU and ED software packages,

but when present in the module they are calculated for compensation of CO

and O2.

Figure 1 Airway gases measurement setup

(1) CARESCAPE Respiratory Module

(2) Gas sample, gas sampling line connector on the water trap

(3) Gas sampling line

(4) Gas sampling line connector on the airway adapter; place the connector upwards

(5) Airway adapter with sampling line connector

(6) Heat and moisture exchanger with filter (HMEF) (optional)

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Datex-Ohmeda E-Modules

System compatibility

The CARESCAPE Respiratory Modules can be used for respiratory monitoring

in the following S/5 monitors:

 S/5 Anesthesia Monitor, software versions L-ANE06(A) 24.1 or later

 S/5 Critical Care Monitor, software versions L-ICU06(A) 24.1 or later

 S/5 Compact Anesthesia Monitor, software versions L-CANE05(A) 19.6 or later

 S/5 Compact Critical Care Monitor, software versions L-CICU05(A) 19.6 or later

NOTE: Low sample gas flow situation is indicated with the message Replace D-Fend in the

L-xxx06(A) software versions 24.1 and L-xxx05(A) software versions 19.6.

NOTE: The CARESCAPE Respiratory Modules cannot be used in the S/5 Extension Frame.

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Respiratory Modules, E-sCAiOV, E-sCAiO, E-sCOV, E-sCO

1 Technical specifications

1.1 Physical characteristics

Size (H x W x D) 112 x 37 x 205 mm ( 4.4 x 1.5 x 8.7 in)

Weight 0.75 kg (1.5 lb)

Power consumption 3.9 W

1.2 Operating characteristics

Warm-up time

- CO2, O2 and N2O measurements: 1 minute

-Anesthetic agent measurement

and identification: 5 minutes Gas sampling rate: 120 ±20 ml/min Automatic compensation for ambient pressure.

Operating conditions

Ambient temperature: +10°C to +40°C

Ambient pressure: 660 mbar to 1060 mbar

Ambient humidity: 10%RH to 98%RH, non-condensing

1.3 Airway gases

1.3.1 General characteristics

Specifications are valid at the following normal operating conditions: Ambient temperature: +18°C to +28°C, within ±5°C of calibration

Ambient pressure: 660 mbar to 1060 mbar, ±67 mbar of calibration Ambient humidity: 20%RH to 80%RH, non-condensing, ±20%RH of calibration Sampling line length: 2, 3 and 6 meters Respiration rate: 4 to 70 breaths/minute

Airway pressure: -20 mbar to +100 mbar Module operating time: >20 minutes continuously

NOTE: The displayed ranges of parameter values depend on the host device. For more information, refer to the host device’s user documentation.

1.3.2 Respiration rate

Breath detection: 1 vol% change in CO2 level Measurement range: 4 to 100 breaths/min

Accuracy

at 4 to 20 breaths/min: ±1 breath/min

at 20 to 100 breaths/min: ±5% RR value is updated breath-by-breath.

(Halothane 4 to 50 breaths/minute)

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Datex-Ohmeda E-Modules

1.3.3 Carbon dioxide

Measurement range: 0 vol% to 15 vol%, 0 kPa to 15 kPa,

Accuracy: ±(0.2 vol% +2% of reading) Total system response time: < 3.0 s Rise time: < 260 ms

drift: < 0.1 vol%

EtCO2 and FiCO2 values are updated breath-by-breath.

Description of test method, data rate, and method of ET-calculation

The module uses gas concentration waveforms with data rate of 25Hz to calculate end-tidal (ET) gas readings.

The module finds the time instant of the highest CO2 concentration in each breath. Concentration at that instant is the ET CO2 reading. Because nitrous oxide and anesthetic agents are measured by the same sensor as CO2, the ET-readings of those gases are obtained directly at the time instant of ET CO2. For calculating ET-readings of oxygen, the module synchronizes the O2-waveform with the CO2 waveform. The ET-reading of O2 is then determined as O2-concentration at the time instant of ET CO2. If no breaths are detected for a given time (20s, for example), an apnea situation is triggered. During apnea, the ET values are updated every two seconds to the current concentration of each gas.

The rated respiration rate range and the corresponding end-tidal gas reading accuracy were tested with reference gases of known concentrations. The test gases were fed to the gas sampling system of the module through an electrically actuated valve with very low internal volume. Depending on its actuation status, the valve directed either room air or a test gas to the gas sampling line. The desired respiration rates were set by the electrical actuating times of the valve.

The measurement accuracy of the end-tidal gas readings was tested using gas sampling lines of 3 meter length, connected to the gas sample port on the D-fend Pro water trap. The gas sampled to the sampling line was switched from room air to the test gases using an electrically actuated valve with low internal dead space to generate step changes in the gas concentrations. The electric actuating signal of the valve was generated using a higly accurate signal generator to accurately control the simulated respiration rate.

The electronic sampling rate of the gas sensor signals is 25Hz, equaling a new data point on the gas waveform traces every 40 milliseconds.

0 mmHg to 113 mmHg

1.3.4 Oxygen

Measurement range: 0 vol% to 100 vol% Accuracy: ±(1 vol% +2% of reading) Total system response time: < 3.0 s Rise time: < 260 ms

drift: < 0.3 vol%

and FiO2 values are updated breath-by-breath.

EtO

1.3.5 Nitrous oxide

Measurement range: 0 vol% to 100 vol% Accuracy:

N2O < 85 vol%) ±(2 vol% +2% of reading)

at (0 < Total system response time: < 3.0 s

Rise time: < 320 ms

O drift: < 0.3 vol%

O and FiN2O values are updated breath-by-breath.

EtN

Document no. M1214853C

Page 15

1.3.6 Anesthetic agents

Measurement range:

Sevoflurane: 0 vol% to 8 vol%

Desflurane: 0 vol% to 20 vol%

Isoflurane, enflurane, halothane: 0 vol% to 6 vol% Accuracy: ±(0.15 vol% +5% of reading) Total system response time: < 3.1 s (< 3.5 s for Halothane) Rise time: < 420 ms (< 800 ms for Halothane) Hal drift: < 0.1 vol% Enf drift: < 0.1 vol% Iso drift: < 0.1 vol% Sev drift: < 0.1 vol% Des drift: < 0.3 vol% EtAA and FiAA values are updated breath-by-breath.

The module automatically identifies the anesthetic agent present in the sampled gas and measures the concentration of the identified agent.

Identification threshold: 0.15 vol% Identification time: < 20 s The module automatically identifies mixtures of two anesthetic agents present in the sampled gas and

measures the concentrations of the two identified agents.

Identification threshold for the 2

at 1 MAC of the 1

Respiratory Modules, E-sCAiOV, E-sCAiO, E-sCOV, E-sCO

agent

agent: 0.2 vol% +10% of the concentration of the 1st agent

1.3.7 Non-disturbing gases

A gas is considered non-disturbing if its effects to the measured gas are as follows: CO

:< 0.2 vol%

O2, N2O: < 2 vol% Anesthetic agents: < 0.15 vol%

The following gases are non-disturbing when tested according to ISO21647(2004B): ethanol, acetone, isopropanol, methane, nitrogen, carbon monoxide, nitric oxide, freon R134A (for CO

O), water vapor.

and N

The effects caused by N2O to the measurement of CO2, O2 and anesthetic agents are automatically compensated for.

The effects caused by anesthetic agents to the measurement of CO2 and N2O are automatically compensated for.

1.3.8 Gas cross effects

Helium (50 vol%): Decreases CO2 readings by less than 0.5 vol% at 5 vol% of CO

Xenon (80 vol%): Decreases CO2 readings by less than 0.5 vol% at 5 vol% of CO

Decreases O2 readings by less than 2 vol% at 50 vol% of O

Decreases O2 readings by less than 1.5 vol% at 14 vol% of O

, O2

Document no. M1214853C

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Datex-Ohmeda E-Modules

1.4 Patient Spirometry

1.4.1 General characteristics

These specifications are valid in the following operating conditions: The module has been operating continuously for 10 minutes

Airway adapter, adult: D-lite Airway adapter, pediatric: Pedi-lite Respiration rate

- adults: 4 to 35 breaths/min

- pediatric patients: 4 to 70 breaths/min I:E ratio: 1:4.5 to 2:1 Airway humidity: 10 %RH to 100 %RH Ambient temperature: +10°C to +40°C Ambient pressure: 660 mbar to 1060 mbar Ambient humidity: 10 %RH to 98 %RH (non-condensing) NOTE: The displayed ranges of parameter values depend on the host device. For more information, refer

to the host device’s user documentation.

1.4.2 Airway pressure

Measurement range: -20 cmH2O to +100 cmH2O Accuracy: ±1 cmH Time resolution: 10 ms

Values calculated from the measured airway pressure data:

Peak pressure (Ppeak) Plateau pressure (Pplat) Mean pressure (Pmean) Positive end expiratory pressure (PEEPtot, or PEEPi and PEEPe) Static positive end expiratory pressure (static PEEPe and static PEEPi)

1.4.3 Airway gas flow

Measurement range

- adults: -100 l/min to +100 l/min

- pediatic patients: -25 l/min to +25 l/min Time resolution: 10 ms Flow measurement has automatic compensation for airway pressure and effects caused by variation in

the concentrations of the gas components measured by the module.

1.4.4 Tidal volume

The module calculates the volume by integrating the measured gas flow over time. Tidal volumes (TVinsp and TVexp) are obtained as the change of volume during inspiration and expiration.

Measurement range

- with D-lite: 150 ml to 2000 ml

- with Pedi-lite: 5 ml to 300 ml Accuracy

- with D-lite: ±6% or 30 ml (whichever is greater)

- with Pedi-lite: ±6% or 4 ml (whichever is greater)

Document no. M1214853C

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1.4.5 Minute volume

The module calculates the inspired and expired minute volumes as the sum of inspired (MVinsp) and expired (MVexp) gas volume during one minute.

Measurement range

- with D-lite: 2 l to 20 l

- with Pedi-lite: 0.5 l to 5 l

1.4.6 Compliance

The module calculates both the compliance (Compl) and static compliance (static Compl). Compliance is calculated by dividing the expired gas volume (TVexp) by the change in the airway pressure (Pplat PEEPtot). Static compliance is calculated by dividing TVexp by the difference of static Pplat and static PEEPtot.

Measurement range

- adults: 4 ml/cmH2O to 100 ml/cmH2O

- pediatric patients: 1 ml/cmH2O to 100 ml/cmH2O

1.4.7 Airway resistance

The module calculates the airway resistance (Raw) by solving the lung model equation P(t) = Raw * F(t) + V(t) / Compl + PEEPtot

where: P(t), F(t) and V(t) are the time dependent waveforms of pressure, flow, and volume, respectively. Measurement range: 0 cmH

Respiratory Modules, E-sCAiOV, E-sCAiO, E-sCOV, E-sCO

O/l/s to 40 cmH2O/l/s

1.4.8 Inspiration to expiration ratio

The module measures ratio of the inspiratory and expiratory time (I:E). The inspiratory time is the time from the start of inspiration to the start of expiration. The end inspiratory pause, if one exists, is included in the inspiration. Accordingly, expiratory time is the time from the start of expiration to the start of the next inspiration.

Document no. M1214853C

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Datex-Ohmeda E-Modules

2 Functional description

2.1 Measurement principle

2.1.1 CO2, N2O, and agent measurement

MiniTPX is a side stream gas analyzer, measuring real time concentrations of CO2, N2O, and anesthetic agents (Halothane, Enflurane, Isoflurane, Desflurane, and Sevoflurane).

Figure 2 MiniTPX sensor principle

Anesthetic agents or mixtures of two anesthetic agents are automatically identified, and concentrations of the identified agents are measured. MiniTPX also detects mixtures of more than two agents and issues an alarm.

MiniTPX is a non-dispersive infrared analyzer, measuring absorption of the gas sample at seven infrared wavelengths, which are selected using optical narrow band filters.

The infrared radiation detectors are thermopiles. Concentrations of CO

and N2O are calculated from absorption measured at 3-5 m.

Document no. M1214853C

Page 19

Respiratory Modules, E-sCAiOV, E-sCAiO, E-sCOV, E-sCO

Figure 3 Absorbance of N2O and CO

Identification of anesthetic agents and calculation of their concentrations is performed by measuring absorptions at five wavelengths in the 8-9 m band and solving the concentrations from a set of equations.

Figure 4 Infrared absorbance of AAs

The measuring accuracy is achieved utilizing numerous software compensations. The compensation parameters are determined individually for each MiniTPX during the factory calibration.

Document no. M1214853C

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Datex-Ohmeda E-Modules

2.1.2 O2 measurement

The differential oxygen measuring unit uses the paramagnetic principle in a pneumatic bridge configuration. The signal picked up with a differential pressure transducer unit is generated in a measuring cell with a strong magnetic field that is switched on and off at a main frequency of 164 Hz. The output signal is a DC voltage proportional to the O

between the gas to be measured and the air reference.

concentration difference

Figure 5 O2 measurement principle

2.1.3 Patient spirometry

In mechanical ventilation, breaths are delivered to the patient by a ventilator with a proper tidal volume (TV), respiration rate (RR), and inspiration / expiration ratio in time (I:E) determined by the settings of the ventilator.

The Patient Spirometry monitors patient ventilation.

The following volume parameters are displayed:

 Expiratory and inspiratory tidal volume (TV) in ml  Expiratory and inspiratory minute volume (MV) in l/min  Expiratory spontaneous minute volume in l/min  Inspiration/expiration ratio (I:E)

The following airway pressure parameters are displayed:

 Peak pressure (P  Mean airway pressure (P

monitors

 End inspiratory pressure (P  PEEPi, PEEPe; available only in S/5 Critical Care and Compact Critical Care monitors

 Total positive end expiratory pressure (PEEP

Compact Anesthesia monitors

 Real time airway pressure waveform (P  Static Positive end expiratory pressures (Static PEEPi and Static PEEPe); available only in

S/5 Critical Care and Compact Critical Care monitors

 Static Plateau pressure (Static Pplat); available only in S/5 Critical Care and Compact

Critical Care monitors

 Static Compliance (Static Compl); available only in S/5 Critical Care and Compact Critical

Care monitors

peak

)

); available only in S/5 Critical Care and Compact Critical Care

mean

)

plat

; available only in S/5 Anesthesia and

tot)

)

Document no. M1214853C

Page 21

Respiratory Modules, E-sCAiOV, E-sCAiO, E-sCOV, E-sCO

PEEP, P

peak

, P

mean

, and P

are measured by a pressure transducer on the MiniPVX board.

plat

Ambient pressure is used as a reference in measurement. The pressure measurement is made from the airway part that is closest to the patient between the patient circuit and intubation tube.

PEEP

=intrinsic PEEP, PEEP

-PEEP

tot

Static pressure measurement maneuvers are automatically identified based on an increased zero flow period at the end of the inspiration or expiration.

Static Compliance is calculated, if Static PEEP and Static P

measurements were made within

plat

a 2 minute period.

The following airway flow parameters are displayed:

 Real time flow waveform (V')  Compliance (Compl)  Airway resistance (Raw)  Pressure volume loop  Flow volume loop

The measurement is based on measuring the kinetic gas pressure and is performed using the Pitot effect. A pressure transducer is used to measure the Pitot pressure. The pressure signal obtained is linearized and corrected according to the density of the gas. Speed of flow is calculated from these pressure values and the TV value is then integrated. The MV value is calculated and averaged using TV and RR (respiratory rate) values.

D-lite

Patient Spirometry uses specific sensors called D-lite+/D-lite and Pedi-lite+/Pedi-lite flow sensors. Different types of sensors are available: adult sensor for measuring adults and pediatric sensor for children. Both are available as reusable and disposable versions.

D-lite and Pedi-lite adapters are designed to measure kinetic pressure by a two-sided Pitot tube. Velocity is calculated from pressure difference according to Bernoulli's equation. Flow is then determined using the calculated velocity.

(from Bernoulli's equation) Formula 1

where:

V’ = flow (l/min), v = velocity (m/s), A = cross area (m



= density (kg/m3)

), dP = pressure difference (cmH2O),

Finally, the volume information is obtained by integrating the flow signal.

Compliance and airway resistance

Compliance is calculated for each breath from the equation

Formula 2

Compliance describes how large a pressure difference is needed to deliver a certain amount of gas to the patient.

The airway resistance, Raw, is calculated using an equation that describes the kinetics of the gas flow between the lungs and the D-lite. The equation states that the pressure at the D-lite can at any moment of the breath be approximated using the equation

Document no. M1214853C

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Datex-Ohmeda E-Modules







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where P(t), V’(t) and V(t) are the pressure, flow and volume measured at the D-lite at a time t, Raw is the airway resistance, Compl is the compliance and PEEP

expiratory pressure (PEEP

2.2 Main components

The respiratory modules consist of:

• Gas sampling system

• MiniTPX measuring unit

• MiniOM measuring unit

• MiniPVX measuring unit

• CPU board

2.2.1 Controls and connectors

Formula 3

+PEEPi is the total positive end

tot

Figure 6 Front of CARESCAPE Respiratory Module, E-sCAiOV, and the back of

the module

(1) D-fend Pro water trap

Document no. M1214853C

(2) Gas sample, sampling line connector on the water trap (3) Water trap container (4) Connectors for Patient Spirometry (5) Gas exhaust, connector for the gas exhaust line (sampling gas out

Page 23

Module keys Module Description

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Change Loop E-sCOV, E-sCAiOV Change Loop changes a

Connector Module Description

D25 connector all modules Module bus connector

2.2.2 Gas sampling system

The gas sampling system draws a 120ml/min sample from the patient's airway to the module. The sampling system also takes about 30ml/min flow of room air to the oxygen sensor. When the gas sensors are zeroed, room air is taken through the CO

the gas sensors instead of the sampled gas from the patient's breathing. The gas sampling line is connected between the patient circuit and the Gas Sample port

on the water trap. The water trap protects the sampling system and gas sensors from liquids and dust.

The diagram of the gas sampling system is shown in the figure below:

Respiratory Modules, E-sCAiOV, E-sCAiO, E-sCOV, E-sCO

loop.

pressure/volume loop to a flow/volume loop or vice versa.

-absorber to

Figure 7 Gas sampling system

Document no. M1214853C

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Datex-Ohmeda E-Modules

The sampling system has a self diagnostics that detects disturbances in the gas flow, reveals the most common reasons for disturbances, such as occluded sampling line or blocked gas exhaust line, and communicates relevant status messages to the patient monitor.

The system is designed so that gas the sampled gas will not flow from the sampling line back to the patient circuit. The parts and connections of the sampling system are streamlined for minimal dead spaces and turbulences in gas flows.

All gas inputs of the module have dust filters protecting the sampling system and gas sensors. The water trap acts as a dust filter for the sampled gas and the module should always have the water trap connected.

NOTE: It is very important to prevent dust from entering the open gas connections during service operations.

D-fend Pro(+) water trap

The gas sampling line is connected to the input of the water trap where a special membrane passes gases and vapors but stops liquids. The gas flowing through the membrane continues via the main flow connector of the water trap to the module. The main flow is about 90% of the sample flow.

Liquids stopped below the membrane are moved to the water container by a side flow that goes through the water container and the water separation membrane before entering the side flow connector of the water trap. Thus, the side flow also is free of liquids when it gets into the module. In the module, the side flow is connected directly to the pump input and it does not enter the gas sensors.

NOTE: The water trap acts as a dust filter for the sampling system and gas sensors. Thus, the module should always have the water trap connected.

Zero valve and CO2 absorber

The zero valve is activated during gas sensor zeroing. Room air is drawn through the CO

-absorber and the zero valve to the gas sensors, and the main flow of sample gas is

stopped. The zero gas comes to the sensors through the CO

. The side flow of the water trap flows in the gas sampling line even during zeroing.

During normal monitoring, the zero valve is not activated and the sampled gas gets through the zero valve to the gas sensors.

Figure 8 Absorber

Nafion tubes

The Nafion tube between the water trap and the zero valve equalizes the humidity of the sampled gas to ambient level. This will prevent calibration errors caused by the difference in humidities in the sampled breathing gas and the totally dry calibration gas.

Another Nafion tube is used between the CO condensation of water generated in the CO

1 Nafion is a registered trademark of Perma Pure Inc.

-absorber that chemically absorbs

absorber and the zero valve to prevent

absorber as by-product of CO2-absorption.

Document no. M1214853C

Page 25

Respiratory Modules, E-sCAiOV, E-sCAiO, E-sCOV, E-sCO

Gas sensors

After the zero valve, the gas flows trough the MiniTPX sensor that measures the concentrations of all gases but oxygen.

The oxygen concentration is measured in the MiniOM sensor that has two inputs. One input draws in a part of the main flow and the other draws in room air as reference gas for the O

measurement.

Sample flow differential pressure transducer

The module measures total flow at the input of the gas pump and reference flow at the OM reference line. The sample flow is the difference of these two flows.

Working pressure transducer

The working pressure transducer measures absolute working pressure near the MiniTPX unit and MiniOM unit. It is used for messages: ‘Sample line blocked’, ‘Check D-fend’, ‘Replace D-fend’ and ‘Check sample gas out’.

Pneumatics unit

The pneumatics unit contains the zero valve, the occlusion valve and the pneumatics block with tubing connections.

The zero valve is activated during the zero level calibrations of gas sensors. The occlusion and zero valves are activated when the sampling line or water trap is occluded. With the activated valves, the gas pump generates maximal suction trough the “side flow” connector of the water trap, thus maximizing the transfer of liquids from the wet side of the water trap to the container.

The pneumatics block contains a network of constrictions to divide the sampled gas in correct proportions to different parts in the module. The first branching takes place in the water trap where incoming flow is divided to the “main flow” and “side flow”. The second branching takes place before the MiniOM sensor.

The pneumatics block also contains a pneumatic low pass filter between gas sensors and gas pump. The filter consists of constrictions (resistors) and volumes (capacitors) and it attenuates the pressure pulsation generated in the gas pump so that they do not disturb the operation of the gas sensors.

Gas pump unit

The gas pump is a membrane pump run by a brushless DC-motor. The pump is adjusted so that the sample gas flow is kept close to its nominal value even when the flow resistances in the sampling line of water trap change.

Document no. M1214853C

Page 26

Datex-Ohmeda E-Modules

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The pump is in a plastic enclosure to minimize the operating noise and mechanical vibration of the pump unit. A pneumatic damping chamber is integrated to enclosure to attenuate the pressure pulsation and noise conducted to the gas exhaust port.

Pressure measurements

The four pressure sensors on the CPU board are used to measure ambient pressure, working pressure of the MiniTPX and MiniOM sensors and pressure of the reference gas flow to the MiniOM sensor.

Sample flow control

The gas flow in the sampling line is monitored by measuring the gas flow at the input of the gas pump and the reference flow to the oxygen sensor is estimated by measuring the pressure in the reference gas flow branch. The sample flow is calculated by subtracting the reference flow from the total gas flow. A control loop adjusts the rotation speed of the pump motor so that the gas flow is kept close to 120ml/min.

Gas sampling self-diagnostics

The sample flow and the vacuum in the sampling system are used for continuous monitoring of the gas sampling system. The vacuum is calculated in real time as difference of the measured ambient and working pressures.

The self-diagnostics of the gas sampling system sends the following status data to the patient monitor when specific triggering conditions are met: ‘Check water trap’, ‘Check sample gas out’, ‘Replace water trap’, ‘Sample line blocked’ and ‘Continuous blockage’.

The gas pump is stopped when the 'Sample line blocked' has lasted for more than 1 minute. The module automatically restarts the pump to check whether the abnormal situation has been resolved so that normal gas sampling operation is possible.

The gas pump repeats 1 minute full pump, 30 seconds pump off when the ‘Continuous blockage’ message is shown.

Figure 9 Gas tubing layout

2.2.3 MiniTPX measuring unit

The MiniTPX unit is a non dispersive infrared analyzer, measuring the absorption of the gas sample at seven infrared wavelengths, which are selected using optical narrow band filters. The IR source is a micro-machined heating element with an integrated collimator. From the output of the source, the radiation is passed to a flow optimized measuring chamber.

Document no. M1214853C

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Respiratory Modules, E-sCAiOV, E-sCAiO, E-sCOV, E-sCO

From the sample chamber, radiation goes via a specially designed beam splitter to two detector units, each with four thermopile detectors and integrated optical filters. The miniTPX measuring unit has two detector units for redundancy purposes. A more detailed description of the measuring principle can be found in section “2.1.1. CO2, N2O, and agent measurement”.

Each detector unit also measures the unit's temperature. The module CPU uses it for further processing and temperature compensation of the measured raw signals.

The miniTPX unit includes an amplifier board with the following functions:

• On-board 5V regulator and 2.5V reference source.

• Preamplifiers for the eight thermopile detectors and for the two temperature sensors.

A 16 channel buffered multiplexer is used to transfer the signals to the CPU board.

• PWM controlled power for the IR source.

• An EEPROM memory for storing factory calibration coefficients of the sensor.

The input to the amplifier board comprises a 7V DC feed and CPU control signals for the PWM, the multiplexer and the EEPROM. When the module starts up, the calibration coefficients are read to the module CPU and then used for calculating the gas concentrations from the raw data received from the sensor multiplexer.

Figure 10 MiniTPX measuring unit

2.2.4 MiniOM Oxygen sensor

The miniOM sensor measures the concentration of Oxygen in the gas sample. The measurement is based on the magnetic properties of oxygen. The sensor measures the

sound pressure generated in the air gap of the magnet at the 164Hz operating frequency. Two microphones are used for detection and the Oxygen concentration is calculated from the RMS value of the difference of the microphone outputs. The measurement principle is described in more detail in section ”2.1.2. O2 measurement”.

The sensor consists of the following functional parts

• Pneumatic system

• Amplifier board

• MiniOM board

• Magnet

Document no. M1214853C

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Datex-Ohmeda E-Modules

The sensor is shown in the picture below.

Figure 11 MiniOM oxygen sensor

NOTE: The sensor is assembled in the module using flexible suspension to prevent the mechanical vibrations of the gas pump and cooling fan from disturbing the Oxygen measurement. All gas lines to the sensor must also be carefully assembled so that they do not pick up mechanical vibrations of the module mechanics.

Pneumatic System

The pneumatic system, together with the gas sampling system of the module creates the gas flows and pressures needed for the oxygen measurement and protection of the microphones from excessive pressure. About 30 ml/min flow of sampled gas comes to the In connector on the MiniOM sensor. Room air is drawn to the Ref input of MiniOM also at 30 ml/min rate. About 75% of these flows are conducted to a pressure equalization chamber so that only about a 8 ml/min flow of the two gas streams continue into the air gap of the magnet. All the internal gas flows finally get to a volume enclosed by the sensor board and the sensor body, and then flow out through the Out connection of the sensor. Some of the gas channels and flow restrictors are integrated into the preamplifier electronics board utilizing the multi-layer structure of the LTCC (Low Temperature Co-fired Ceramics) circuit board technology.

NOTE: It is very important to prevent dust or liquids from getting into the pneumatic circuit of MiniOM and thus, the gas connections should always be closed with a protecting cap when the sensor is not connected to the module pneumatics.

Amplifier Board

The amplifier board located in the sensor has two electric microphones for the differential detection of pressure pulses generated in the magnet's air gap. The microphone signals are fed to two identical signal conditioning channels with a band-pass filter and a digitally controlled amplifier. The voltage gains of the amplifiers are set during factory calibration so that the responses of the microphone channels match in spite of differences in microphone's sensitivities. The amplifier board also has an amplifier for the thermistor measuring the temperature of the magnet.

MiniOM Board

The MiniOM board has five functions

• Drive the magnet coil.

• Convert the microphone and temperature signals into digital format.

• Filter digitally the microphone signals and perform the RMS-conversion.

• Communicate digitally with the module CPU.

Document no. M1214853C

Page 29

• Store factory calibration data in permanent memory and communicate them to the

module CPU.

The module CPU provides the coil drive and communication enabling signals and also clock signal for MiniOM board. The FPGA takes care of the coil drive and has also back-up clock in case of CPU clock does not work. The FPGA takes care of the A/Dconversions which are performed with a serial controlled SAR A/D-converter.

The digital band pass filtering and RMS conversion of the microphone signals is made with FPGA circuit controlled by the VHDL code stored in the circuit. In order to filter out the disturbances caused by acoustic noise, mechanical vibration and amplifier noise, the band pass filters are designed to have as narrow a pass band as possible without slowing down the filter's response to changes in the amplitude of the 164 Hz signal.

The FPGA circuit takes care of the digital communication between the miniOM sensor and the module CPU.

The factory calibration coefficients of the sensor are stored in an EEPROM memory on the miniOM board. When the module starts up, the calibration coefficients are read to the module CPU and then used for calculating the O2 concentration from the Oxygen raw data received from the sensor.

2.2.5 MiniPVX measuring unit

Respiratory Modules, E-sCAiOV, E-sCAiO, E-sCOV, E-sCO

NOTE: Never apply the overpressure or negative pressure of more than 300 cmH2O to the flow and volume tubing. Differential pressure max 25 cmH when connecting tubes.

When Patient Spirometry is used, a special sensor, D-lite, replaces the normal airway adapter in the patient circuit. A double lumen tubing is attached to the two connectors on the adapter and on the module front panel.

The Patient Spirometry provides patient respiration monitoring capabilities using the D-lite and Pedi-lite flow sensors.

O is allowed on one port at a time e.g.

Figure 12 MiniPVX measuring unit

The measurement is based on measuring the kinetic gas pressure and is performed using the Pitot effect. A pressure transducer is used to measuring the Pitot pressure. The signal is then linearized and corrected according to the density of the gas. Speed of the flow is calculated from the pressure and TV is integrated from it.

Document no. M1214853C

Page 30

Datex-Ohmeda E-Modules

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Patient Spirometry consists of airway connections, two pressure transducers, valves and preamplifiers. The preamplifiers are connected to the A/D-converter on the module main CPU.

The patient’s breathing flow passing through the D-lite adapter creates a pressure difference. This pressure difference is measured by a pressure transducer, B1. Overpressure and negative pressure in airways are measured by another pressure transducer, B2.

2.2.6 CPU board

The CPU board contains the processor, memories and an A/D-converter that is common to the whole module.

The CPU board also contains sensors for pressure, temperature and humidity as well as drivers for valves, the fan and the pump. The module is connected to the module bus through an RS-485 serial channel.

Figure 13 Signal processing on CPU board

2.2.7 MiniOM board

Document no. M1214853C

The miniOmM board contains electronics specific to the MiniOM sensor: FPGA circuit, coil drive, A/D-converter etc. It also contains EEPROM memory that stores calibration data of the oxygen measurement.

Page 31

2.2.8 MiniPVX board

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The MiniPVX board contains pressure sensors for airway pressure and flow measurement and preamplifiers for those. It also contains EEPROM memory that stores calibration data of the spirometry measurement.

2.2.9 Main Component Interactions

The figure below describes the functionality of the module and the division of tasks between different components.

Respiratory Modules, E-sCAiOV, E-sCAiO, E-sCOV, E-sCO

Figure 14 Block diagram

Document no. M1214853C

Page 32

Datex-Ohmeda E-Modules

3 Service Procedures

To help ensure the equipment remains in proper operational and functional order, adhere to a good maintenance schedule.

WARNING Only perform maintenance procedures specifically described in the manual. WARNING Planned maintenance should be carried out annually. Failure to implement

the recommended maintenance schedule may cause equipment failure and possible health hazards.

CAUTION Do not apply pressurized air to any outlet or tubing connected to the module.

NOTE: The manufacturer does not, in any manner, assume the responsibility for performing the recommended maintenance schedule, unless an Equipment Maintenance Agreement exists. The sole responsibility rests with the individuals, hospitals, or institutions utilizing the device.

Corrective maintenance

Service personnel shall perform the following checkout procedure after any corrective maintenance, before taking the module back into clinical use:

Required checkout procedure

Performed service activity

Front panel replacement All steps Check “Module Keys” only

OM Reference gas filter assembly

Module case opened either for troubleshooting purpose or for replacing any of the internal parts.

Visual inspections (section 3.2)

All steps Check “Sample Flow Rate Check”

All steps All steps

Functional check (section 3.3)

Planned maintenance

Service personnel shall perform the following checkout procedure completely every 12 months after installation:

1. 3.1. Replacement of planned maintenance parts

2. 3.2. Visual inspections

3. 3.3. Functional check

Document no. M1214853C

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Respiratory Modules, E-sCAiOV, E-sCAiO, E-sCOV, E-sCO

3.1 Replacement of planned maintenance parts

3.1.1 Required parts

Replace the following parts that wear in use at the recommended interval.

Description Pieces Replacement interval

Nafion Tube, 230 mm (mainflow) 1 Once a year

OM Reference gas filter assembly including O-ring

PM sticker 1 Once a year

Nafion tube, 85 mm (zero line) 1 Once every 4 years

absorber 1 Once every 4 years

It is also recommended to replace the D-fend Pro water trap, the gas sampling line and the spirometry tube as part of the planned maintenance procedure.

NOTE: See compatible accessories.

the supplies and accessories document delivered with the manual for

3.1.2 Planned Maintenance Kits

The required planned maintenance parts are included in a PM kit.

Part number Description

M1206554 Planned Maintenance Kit for CARESCAPE E-sCxxx Respiratory modules.

The PM kit includes the required Nafion tubes, the OM reference gas filter assembly with an O-ring and a PM sticker.

NOTE: The PM kit does not include the CO

1 Once a year

absorber. Order it separately.

3.1.3 Replacement procedures

Replace the specified planned maintenance parts according to the chapter “3.4. Disassembly

and reassembly”.

1. Replace the CO

2. Replace the special tubes (Nafion) and check the condition of the internal tubing.

absorber every 4 years.

• Check that the tubing inside the module is not contaminated. Any contamination

inside the tubing may indicate that the valves or sensors are contaminated, too. This can increase a risk of faulty operation in valves or sensors. The valves or gas sensors

Document no. M1214853C

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Datex-Ohmeda E-Modules

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are not possible to clean in the field. Therefore, if you noticed any contamination in the module tubing, send the module to GE Healthcare for factory service.

NOTE: The nafion tubes do not include the silicon fittings they connect to. Use the original silicon fittings unless they are damaged or leaking.

3. Replace the OM reference gas filter assembly.

4. Check that the fan and ventilation hole are not covered in dust.

3.2 Visual inspections

Detach the module from the module slot and check that:

• the front cover is intact

• all connectors are intact and are attached properly

• the module box and latch are intact

• the D-fend Pro and its connectors are clean and intact

• the module and the applied parts are clean

The cleaning precautions, cleaning requirements, cleaning procedures, and recommended cleaning solutions for the monitor are described in the S/5 monitor user’s manual. For details about cleaning, disinfecting and sterilizing the accessories, see the instructions for use in the accessory package.

Document no. M1214853C

Page 35

3.3 Functional check

Turn the monitor on. Wait until the normal monitoring screen appears.

3.3.1 Test setup

Required tools

 A barometer  A mass flowmeter for measuring air flow, minimum measurement range from 0 to

200ml/min, accuracy 5% or better in the 0 to 200 ml/min range.

 P/N: 755534-HEL Calibration Gas Regulator  P/N: 755583-HEL Calibration gas, CO2, O2, N2O, DESF, package of 1 can (with E-sCAiO,

E-sCAiOV modules)

 P/N: 755581-HEL QUICK CAL calibration gas, CO2, O2, N2O, package of 4 cans (with

E-sCO, E-sCOV modules)

 P/N: M1006864, Calibration Gas Regulator, US only  P/N: 755571-HEL, Calibration Gas, 5% CO2, 54.5% O2, 36.0% N2O, 2.0% DESFLURANE,

BAL N2 (with E-sCAiO, E-sCAiOV modules) US only

 P/N: 755587, Calibration Gas, CO2, O2, Balance, 4 cans/pkg (with E-sCO, E-sCOV modules)

US only

 D-fend Pro water trap  3 m / 10 ft anesthesia gas sampling line  Spirometry tube, 3 m/10 ft (with E-sCOV and E-sCAiOV modules)  Adult D-Lite sensor  A pressure manometer with either an integrated or a separate pressure pump  Tubing for spirometry leak tests  Forceps

Respiratory Modules, E-sCAiOV, E-sCAiO, E-sCOV, E-sCO

NOTE: See the supplies and accessories document delivered with the manual for compatible accessories.

Connections

•

Monitor configuration

1. Configure the CO2, O2, AA, and Flow waveform fields to the monitor screen.

2. Configure the Spiro 1 split screen to the monitor screen.

3. Select the Spirometry Setup in the Airway Gas menu and configure:

3.3.2 Procedure

Mark each task as complete on the checkout form.

1. Gas Sampling System Leak Test

NOTE: The gas module shall be disconnected from the monitor during the leak test.

Disconnect the module from the monitor, if connected.

Scaling: Auto Sensor Type: Adult

TV or MV: TV

Document no. M1214853C

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Datex-Ohmeda E-Modules

Check the gas sampling system for possible leakages.

a. Disconnect the module from the monitor. b. Detach the module front cover and casing, see chapters“Detaching the Front Cover”

c. Block the OM reference tube with the forceps. Correct positioning of the forceps is

on page 33 and “Detaching the Module Casing” on page 34.

indicated by the figure below. NOTE: Be careful when attaching the forceps to the tube and avoid stretching the tube. Short pieces of silicone tubing on the forcep jaws can be used to protect the tube from breaks that may appear when the tube is compressed between the jaws.

d. Connect a new D-fend Pro water trap to the module. e. Connect a new gas sampling line to the sampling line connector in the water trap. f. Connect the other end of the gas sampling line to a pressure manometer and a

pressure pump. g. Block the sample gas out (gas exhaust) connector. h. Carefully pump 80 mmHg 20 mmHg pressure to the gas sampling system. Let the

pressure stabilize for 10 - 20 seconds. i. Check that the pressure reading does not drop more than 2 mmHg during 25

seconds. j. Release the forceps, and reassemble the module casing. Make sure that the tubing

fits nicely into the module casing.

2. Spirometry System Leak Test

NOTE: Perform this test only for E-sCOV and E-sCAiOV modules.

NOTE: The gas module shall be disconnected from the monitor during the leak test.

NOTE: The spirometry pressure transducers are very sensitive for differential overpressure. A momentary differential pressure between the two spirometry connectors exceeding 25 cmH

(18 mmHg) may damage the pressure sensors. To ensure that both pressure channels are equally pressurized, make sure that the tubing between the manometer and the two spirometry connectors is connected tightly, the tubes are equally long and thick and not kinked.

NOTE: Do not overpressure the spirometry sampling system. A static pressure exceeding 300 cmH

O (220 mmHg) may damage the pressure sensor.

Check the spirometry sampling system for possible leakages.

Document no. M1214853C

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Respiratory Modules, E-sCAiOV, E-sCAiO, E-sCOV, E-sCO

a. Ensure the module is disconnected from the monitor. b. Connect a pressure manometer to the spirometry connectors.

c. Pump ~68 cmH

O (50 mmHg ±10 mmHg) pressure to the Spirometry sampling

system. Let the pressure stabilize for approximately 10 seconds. d. Verify that the pressure reading does not drop more than 4 cmH

O (3 mmHg) during

one minute.

3. Sample Flow Rate Check Check the sample flow rate. Connect the module to the monitor.

NOTE: Anesthetic gas measurement is not available during the first 1 to 5 minutes after the module is connected due to warming up. A message 'Calibrating Gas Sensor' is shown in the waveform field. Wait until warm-up is completed before proceeding with the next steps.

NOTE: The ambient temperature and air pressure influence the flow rate measured by the flow meter. A flow meter, which has been calibrated at 21.11 °C (70 °F) and 760 mmHg (1033 cmH2O), measures the flow rate correctly under the same conditions, i.e. in room temperature at sea level. A flow rate correction as instructed by the manufacturer of the flow meter needs to be performed when measuring flow rate under other conditions, for example in high altitude.

a. Connect the gas sampling line (3 m / 10 ft with E-sCO, E-sCOV, E-sCAiO and

E-sCAiOV) to the Sampling line connector. b. Connect the other end of the gas sampling line to a flowmeter. c. Check the sample flow rate reading from the flowmeter. The flow rate shall be within

the specification limit 120 ± 20 ml/min.

NOTE: Readjustment is needed, if the measured value is not within the specification limit. Adjust the sample gas flow rate according to the instructions in section “3.5.1. Sample Flow Rate

Adjustment”.

Document no. M1214853C

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Datex-Ohmeda E-Modules

4. Reference Gas Flow Rate Check Check the flow rate in reference gas inlet:

a. Connect the module to the monitor. b. Leave the other end of the gas sampling line open to room air. c. Connect the flowmeter to the OM reference gas inlet on the side of the module with

d. Check that the Reference Flow is within the following range:

e. Detach the water trap. f. Attach the front cover.

5. Fan a. Check that the gas module's fan is running behind the D-fend Pro water trap.

b. Attach the water trap.

6. Module Keys

NOTE: Perform this test only for E-sCOV and E-sCAiOV modules.

a piece of tubing.

10 - 50 ml/min with E-sCO, E-sCOV, E-sCAiO and E-sCAiOV modules

a. Press the b. Check that the spirometry loop is changed from Flow / Vol loop to Paw/Vol loop, or

vice versa.

c. Leave the Flow / Vol loop on the screen.

7. Zero Valve Operation

Test the zero valve functionality:

a. Connect the gas regulator to the calibration gas container. b. Connect the end of the gas sampling line to the regulator on the gas container.

Leave the regulator overflow port open to room air. c. Select d. Start feeding the specified calibration gas. Wait until the gas values shown in the

Gas calibration menu rise approximately to the level indicated in the labelling of the

calibration gas container.

NOTE: The gas values in the Gas Calibrations menu is in percentages (%).

e. Open the zero valve to room air by selecting Zero valve Ctrl > Zero (zero position). f. Check that the CO2, N2O and anesthesia agent values drop back near 0% and the

O2 reading near 21% (room air). g. Stop feeding the calibration gas. h. Turn the zero valve back to the normal measurement position by selecting Zero

valve Crtl > Meas (measurement position).

Change Loop module key.

Monitor Setup> Install/Service >Service > Parameters > Gas out > Gases

8. Gas Calibration Perform gas calibration according to the instructions in section “3.5.2. Gas Calibration”.

9. Agent Identification

NOTE: Perform this test only for E-sCAiO and E-sCAiOV modules.

Check agent ID unreliability:

Document no. M1214853C

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Respiratory Modules, E-sCAiOV, E-sCAiO, E-sCOV, E-sCO

a. Feed the specified calibration gas for at least 30 seconds. b. Check that the anesthesia agent is identified as Desflurane and the ID unrel value

(=agent ID unreliability) shown in the

Parameters > Gas Unit > Gases menu is lower than 75.

If the value is higher, repeat the gas calibration and check the value again.

10. Ambient Pressure Use a barometer to check the operation of the absolute pressure sensor.

Monitor Setup > Install / Service > Service >

• Check that the ambient pressure value shown in the Gas Calibrations menu does not

differ more than ± 10 mmHg from the value shown by the barometer.

NOTE: The ambient pressure value in the Gas Calibrations menu is in mmHg.

11. Occlusion detection a. Block the tip of the sampling line by your finger.

b. Check that a 'Sample line blocked' and a ‘Low sample flow’ message appear on the

screen within 30 seconds.

12. Air Leak detection a. Detach the D-fend Pro water trap.

b. Check that the message 'Check Water Trap' appears on the screen within 30

seconds.

c. Attach the water trap.

13. Gas exhaust blockage a. Block the gas exhaust connector with your finger.

b. Check that the message 'Sample gas out' appears on the screen within 30

seconds.

14. Airway Gases a. Breathe a minimum of 5 times to the tip of the sampling line. b. Check that a normal CO2 waveform appears and the EtCO2 and FiCO2 values are

updated on the screen .

15. Apnea detection a. Stop breathing to the gas sampling line.

b. Check that an 'Apnea' alarm appears on the screen within 30 seconds.

16. Flow waveform

NOTE: Perform this test only for E-sCOV and E-sCAiOV modules.

a. Connect a clean spirometry tube and D-lite to the module. b. Breathe through the wider side of the D-lite. c. Check that the flow waveform responds when you breathe in and out. The setting of

the inspiratory flow may be positive or negative.

Document no. M1214853C

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Datex-Ohmeda E-Modules

3.3.3 Test completion

Select Discharge patient or Reset case to discard any changes made to the monitor

•

configuration during checkout.

• Disconnect and reconnect the module before starting a new case.

• Complete the “Appendix A. Service check form”.

3.4 Disassembly and reassembly

3.4.1 Disassembly guidelines

WARNING Disconnect the module from any monitoring system before performing any

repair.

WARNING Always perform gas sampling system leak test after the module cover is

reassembled.

WARNING Always perform gas calibration after any planned or corrective

maintenance.

Field service of the module is limited to replacing the serviceable parts listed below (see also chapter ”5. Spare parts”). Attempting a field repair on any other parts could jeopardize the safe and effective operation of the module, and void the warranty.

NOTE: Only a qualified service technician should perform field replacement procedures.

NOTE: Perform the checkout procedure described in chapter ”3. Service Procedures” after you have disassembled and reassembled the module.

Serviceable parts

CO2 Absorber

•

• D-fend Pro

• Nafion tubes

• Front chassis unit

• MiniPVX Unit

• Pump

• OM reference filter

• Latch and spring

• Mechanical parts listed in chapter ”5. Spare parts”

Service limitations

The following parts are not serviceable:

• MiniOM Measuring unit

• MiniTPX measuring unit

NOTE: Due to the complicated and sensitive mechanical construction of the oxygen measuring unit, no repairs should be attempted inside the unit. Instead, if the fault has been found in the

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measuring unit itself, the entire module should be replaced and the faulty module be sent to GE Healthcare for repair.

NOTE: The MiniTPX measuring unit can only be repaired and calibrated at the factory. In case of failure, the entire module should be replaced and the faulty module be sent to GE Healthcare for repair.

ESD precautions

WARNING Protect module from electrostatic discharge.

All external connectors of the module are designed with protection from ESD damage. However, if the module requires service, exposed components and assemblies inside are susceptible to ESD damage. This includes human hands, non-ESD protected work stations or improperly grounded test equipment. The following guidelines may not guarantee a 100% static-free workstation, but can greatly reduce the potential for failure of any electronic assemblies being serviced:

• Discharge any static charge you may have built up before handling semiconductors or

assemblies containing semiconductors.

• A grounded, antistatic wristband or heel strap should be worn at all times while handling

or repairing assemblies containing semiconductors.

• Use properly grounded test equipment.

• Use a static-free work surface while handling or working on assemblies containing

semiconductors.

• Do not remove semiconductors or assemblies containing semiconductors from antistatic

containers until absolutely necessary.

• Do not slide semiconductors or electrical/electronic assemblies across any surface.

• Do not touch semiconductor leads unless absolutely necessary.

• Semiconductors and electronic assemblies should be stored only in antistatic bags or

boxes.

• Handle all PCB assemblies by their edges.

• Do not flex or twist a circuit board.

Protection from dust

WARNING Module must be handled to prevent dust from entering the gas sampling

system.

The gas sampling system must be protected from dust entering the tubes, valves and other components. In order to achieve this goal, the following measures must be taken:

• Have the D-fend Pro water trap always connected to the module.

• Clean and dust free working environment during all service procedures.

• Minimize the times with any open connections in the gas sampling system.

• Always close the open tube connections of the sampling system when not working on the

module.

• Remove the protective caps on the gas pump only immediately before assembling it to

the module

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• Take the CO

the module.

-absorber out from the plastic bag only immediately before assembling it to

• The clothing of the service person must be such that the dust risk is taken into account.

Before disassembly

Note the positions of any sampling tubes, wires or cables. Mark them if necessary to

•

ensure that they are reassembled correctly.

• Save and set aside all hardware for reassembly.

Required tools

- Torx T8 and T10 screwdrivers

- flat blade screwdriver

-forceps

- antistatic wristband

3.4.2 Disassembly and reassembly procedure

Disassembling the module (see the exploded view of the module in chapter ”5. Spare parts”: Reassembling the module: reverse the order of the disassembly steps. Check that:

• 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

NOTE: Make sure that the Nafion tubes are routed in such a way that they don’t come near the fan, and there is no risk of the fan being obstructed by the tubes. An obstructed fan will result in degraded ventilation inside the module, and a ‘Sensor inop’ message being displayed.

• there are no loose objects inside the module

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Disassembly workflow

Use this workflow diagram to find the simplest way to disassemble the required parts of the module. Follow the arrows from the top down to the required part and disassemble the module by following the steps in between.

Detaching the Front Cover

1. Remove the D-fend Pro.

2. Release the two snaps on both sides of the module by using a flat blade screwdriver.

3. Detach the front cover.

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Detaching the Module Casing

1. Remove the two T8 screws mounting the D25 connector shield.

2. Detach the connector shield.

3. Remove the two T8 screws to detach the module casing.

4. Push the latch and pull the module casing.

NOTE: When reassembling ensure that the module casing does not damage the conductive sealings on the front chassis unit.

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Replacement of Planned Maintenance Parts

1. Carefully remove the main flow nafion tube and every 4

year the shorter zero line nafion tube.

NOTE: Remember the route of the tubes and reassemble correctly.

NOTE: The nafion tubes do not include the silicon fittings they are connected to. Use the original silicon fittings unless they are not damaged or leaking.

2. Pull out the OM reference filter assembly with forceps.

3. Push the new filter assembly until it is on the same level with the front chassis.

Replacement of CO

Absorber

1. Lift the CO

absorber from the slot.

2. Detach the tubes from the absorber.

3. Connect the tubes to a new CO

absorber and

place it to the slot.

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Detaching the Latch

1. Pull the latch from the front chassis. NOTE: Remember to detach the front cover first.

2. Remove the spring by squeezing it.

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Detaching the Front Chassis Unit

1. Remove the two T8 screws which fasten the PVX

2. Remove the two T10 screws.

unit to the front chassis.

3. Carefully detach the three tubes.

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4. Disconnect the fan and keypad cables.

5. Detach the front chassis unit.

NOTE: When reassembling insert the pump silicone tube in the front chassis connector.

Detaching the Main Flow Connector

Original Main Flow Connector is required to maintain proper gas flow restriction in the module. When the Front Chassis Unit is replaced move the original connector to the new unit.

1. Carefully detach the lock pin holding the main flow connector.

2. Carefully attach the main flow connector to the new front chassis unit.

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Detaching the PVX Unit

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1. Carefully disconnect the PVX connector.

2. Detach the PVX Unit.

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Detaching the Pump

1. Carefully detach the tube from the pump.

2. Disconnect the pump cable from the CPU board.

3. Lift the pump from the metal brackets.

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Detaching the OM holder

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1. Carefully detach the three tubes from the OM unit.

2. Carefully disconnect the OM flex cable from the CPU board.

3. Carefully pass the flex cable through metal frame.

4. Lift the OM unit with the holder from the metal brackets.

5. Detach the holder.

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3.5 Adjustments and calibration

3.5.1 Sample Flow Rate Adjustment

Sample flow rate shall be adjusted:

• if the sample flow rate check in section “3.3.2. Procedure” failed.

Calibration setup

Required tools

 A mass flowmeter for measuring air flow, minimum measurement range from 0 to

200ml/min, accuracy 5% or better in the 0 to 200 ml/min range.

 3 m / 10 ft anesthesia gas sampling line.

NOTE: See the supplies and accessories document delivered with the manual for compatible accessories.

NOTE: Use only accurate, properly maintained, calibrated and traceable calibration tools for the parameter calibration to ensure measurement accuracy.

NOTE: If the flow meter unit is not ml/min, it shall be converted to ml/min according to the instructions of the flow meter manufacturer.

NOTE: Gas module sample flow rate is calibrated in the factory to ambient air conditions corresponding the flow at the end of 3 m sampling line. Make sure that your meter is also showing the flow at ambient conditions (= ATP).

NOTE: Refer to the flowmeter documentation for user instructions.

Connections

1. Ensure that the module is connected to the monitor.

2. Ensure that you have a new D-fend Pro water trap in use.

3. Connect a new gas sampling line to the sampling line connector in the water trap.

4. Connect the other end of the gas sampling line to the flow meter.

NOTE: Before checking or adjusting the sample flow, make sure there is no leakage in the sampling system.

Sample Flow Rate Adjustment

1. Select Monitor Setup > Install / Service > Service > Parameters > Gas Unit > Gases

2. Select Sample gain adj.

3. Adjust the sample flow to the nominal value 120 ml/min by increasing or decreasing the

Sample Flow Gain:

NOTE: On S/5 monitor screen the 120 ml/min flow rate is shown as 200 ml/min to be compatible with the old S/5 monitors.

• To decrease the sample flow rate measured by the flow meter by approximately

7,5 ml / min, add gain value by 0.05.

• To increase the sample flow rate measured by the flow meter by approximately

4. Press Confirm to check the effect of the gain adjustment. Wait until the sample flow value shown in the Calibration menu returns near to the nominal value 120 ml/min and then check the actual measured flow rate from the flow meter.

5. Repeat steps 3 and 4 until the flow meter shows a 120 ± 20 ml /min flow rate.

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7,5 ml / min, lower the gain value by 0.05.

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NOTE: Adjust the flow rate according to the reading in the flow meter. The flow rate reading in the Calibration menu is measured by the internal electronics and settles always back to the nominal 120 ml /min independent on the real flow rate.

3.5.2 Gas Calibration

WARNING Failure in zeroing or calibrating gases might cause inaccurate readings. WARNING Since calibration gas contains anesthetic agents, always ensure sufficient

ventilation of the room during calibration.

Gas calibration shall be performed:

• each time planned maintenance is performed.

• each time corrective maintenance is performed.

NOTE: Gas calibration is a normal user action. Refer to the monitor user’s manual for the recommendation for gas calibration interval in clinical use.

Calibration setup

Required tools

 P/N: 755534-HEL Calibration Gas Regulator  P/N: 755583-HEL Calibration gas, CO2, O2, N2O, DESF, package of 1 can (with E-sCAiO,

E-sCAiOV modules)

 P/N: 755581-HEL QUICK CAL calibration gas, CO2, O2, N2O, package of 4 cans (with

E-sCO, E-sCOV modules)

 P/N: M1006864, Calibration Gas Regulator, US only  P/N: 755571-HEL, Calibration Gas, 5% CO2, 54.5% O2, 36.0% N2O, 2.0% DESFLURANE,

BAL N2 (with E-sCAiO, E-sCAiOV modules) US only

 P/N: 755587, Calibration Gas, CO2, O2, Balance, 4 cans/pkg (with E-sCO, E-sCOV modules)

US only

 3 m / 10 ft anesthesia gas sampling line

NOTE: Use only the specified GE Healthcare calibration gas for the gas calibration to ensure measurement accuracy. Do not use any other calibration gases. Check the calibration gas container's labelling to ensure that the calibration gas has not expired.

NOTE: Ensure that the gas regulator is functioning properly before gas calibration. Refer to the gas regulator's "Instructions for Use" letter for the annual maintenance instructions.

Connections

1. Ensure that the module is connected to the monitor.

2. Ensure that you have a new D-fend Pro water trap in use.

3. Connect the gas regulator to the calibration gas container.

4. Connect a new gas sampling line to the sampling line connector in the water trap.

5. Connect the other end of the gas sampling line to the regulator on the gas container. Leave the regulator overflow port open to room air.

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Figure 15 Connecting a gas regulator to the calibration gas container and

Procedure

NOTE: Gas calibration is not available during the first 5 minutes after the module is connected. A message 'Gas calibration is not available during first 5 minutes' is shown in the lower left corner of the Calibration menu. For maximum accuracy, let the monitor to warm up for 30 minutes before starting calibration.

NOTE: Gas calibration is not available during a 'Sample line blocked', 'Check Dfend' and 'Check

sample gas out’ alarm condition. A message 'Gas calibration is not available during gas sampling warning' is shown in the lower left corner of the calibration menu. Resolve the alarm

condition before starting calibration.

connecting a sampling line to the gas regulator.

1. Select Airway Gas > Gas Calibration

2. The monitor will start automatic zeroing of the gas sensors. Wait until the message 'Zeroing' is replaced by a message 'Zero Ok' for all measured gases.

3. Open the regulator after a message 'Feed gas' is shown for all measured gases. The measured gas concentrations are shown in real-time in the gas calibration menu. Continue feeding the calibration gas until the measured gas concentrations are stabilized and a message 'Adjust' is shown for all measured gases. Close the regulator.

4. Adjust the gas readings shown in the Calibration menu to match with the gas readings in the labelling of the calibration gas container. Select Accept to accept the adjusted values when the gas readings match each other.

5. Wait until a message 'Ok' is shown for all measured gases.

NOTE: A message 'Zero Error' is shown in case the zeroing fails.

NOTE: A message 'Calibration Error' is shown, if you do not start feeding gas within 1 minute after the automatic zeroing is completed, or if the calibration fails due to too large gain adjustment.

NOTE: If zeroing or calibration failed, select the procedure from the beginning.

Recalibrate button to restart the calibration

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3.5.3 Spirometry Calibration

Patient spirometry does not require regular service calibration during planned maintenance, or after the MiniPVX unit has been replaced. Calibration is only needed if there is a permanent difference between the measured inspiratory and expiratory volumes.

The MiniPVX measuring unit is calibrated at the factory and due to the unit's design, spirometry calibration is not regularly needed in the field. The calibration data is saved into the board's EEPROM.

If calibration is desired, it is recommended to perform the calibration both with adult values using the D-lite, and with pediatric values using the Pedi-lite.

Calibration setup

Required tools

 P/N 884202-HEL Spirometry tester  D-Lite and Pedi-lite sensors  Spirometry tube  Ventilator

NOTE: See the supplies and accessories document delivered with the manual for compatible accessories.

Respiratory Modules, E-sCAiOV, E-sCAiO, E-sCOV, E-sCO

Connections

• Refer to the "Instructions for Use" -letter of the spirometry tester to see the setup.

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Monitor configuration

$GXOW

• Configure the Flow waveform field to the monitor screen with adequate priority.

• Select the Spirometry Setup in the Airway Gas menu and configure:

Scaling: Auto Sensor Type: Adult TV or MV: TV

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Ventilator configuration

• Configure the ventilator to use air as fresh gas.

• Set the Tidal Volume (TV) to 500 ml/min when doing calibration check and calibration with

adult sensor and 100 ml/min with pediatric sensor.

• Set the RR =15, I/E =1/2 and PEEP 0cmH2O.

Calibration check

1. Perform the calibration check according to the steps 1 through 12a in the "Instructions for Use" -letter of the spirometry tester.

NOTE: Let the gas module to warm up at least for 10 minutes before performing the calibration check or flow calibration.

2. The measured flow values are shown in real-time in the TV Insp and TV Exp fields in the Flow parameter window. Compare these measured values to the TV value reading (highest water level) in the spirometry tester.

Acceptance criteria:

• If the TV Insp and TV Exp values differ less than ± 6% of the value read from the

spirometry tester, flow calibration is not needed.

• If the TV Insp and TV Exp values differ more than ± 6% of the value read from the

spirometry tester, perform flow calibration according to section “Flow calibration”.

Flow calibration

1. Select Monitor Setup > Install /Service > Service > Parameters > Gas Unit > Spirometry

2. Ensure that the Sensor Type is correct and that Spirometry Zeroing is Enabled.

3. Wait until the MiniPVX sensor performs an automatic zeroing. It will show a message ‘zeroing’ in the Flow parameter window when zeroing takes place.

4. Adjust the Exp Flow Gain and/or Insp Flow Gain separately to calibrate the measured TV Exp ml and TV Insp ml values:

 To increase the TV Exp ml flow value, increase the Exp Flow Gain.  To decrease the TV Exp ml flow value, lower the Exp Flow Gain.  To increase the TV Insp ml flow value, increase the TV Flow Gain.  To decrease the TV Insp ml flow value, lower the TV Flow Gain.

5. Press Confirm to check the effect of the gain adjustment to the flow readings.

6. Repeat steps 3 and 4 until the flow values are within the specification.

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4Troubleshooting

The problems and solutions in this chapter represent only a few of the faults that you may encounter and are not intended to cover every possible problem that may occur.

This chapter focuses on troubleshooting technical problems. Refer also to the troubleshooting hints on the S/5 monitor user’s manual for troubleshooting monitoring problems, performance issues and clinical configuration issues.

NOTE: Perform the checkout procedure described in chapter “3. Service Procedures” each time after you have opened the module casing.

4.1 Visual inspection

Before beginning any detailed troubleshooting, complete thorough visual inspection to be sure that:

• the front cover is intact

• the water trap connection and disconnection functions properly

• all connectors are intact, clean and are attached properly

Respiratory Modules, E-sCAiOV, E-sCAiO, E-sCOV, E-sCO

• the module box and latch are intact

• the metal D-fend Pro connectors are clean and intact

If in doubt of having any loose parts or cable connections inside the module, detach the module box by removing the four screws from the back of the module and check that:

• 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

• there are no loose objects inside the module

4.2 Troubleshooting checklist

The following simple troubleshooting hints may help you to localize and isolate a functional problem to the correct unit. Ensure that the monitor is turned on and all modules are connected:

• Check if there are any messages shown in the message field. Find the possible cause and

solution from the “Messages” section later in the chapter.

• Check that the module in doubt is compatible with the monitor. Compatibility information

can be found from the Carescape Respiratory Modules User’s Manual.

• Check that there are no duplicate modules connected to the monitor. List of identical

modules can be found from the Carescape Respiratory Modules User’s Manual.

• Connect the accessories to the module in doubt. Check that the parameters measured by

the module are configured to the display (

Monitor Setup > Screen 1 Setup).

• Do a visual check to the accessories used with the module. If in doubt, replace the

accessories with known good ones.

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After troubleshooting if the problem remains, contact service. Make sure you have all necessary information of the product at hand. Describe the problem and the troubleshooting done so far. Provide Webmin Device Information and Service logs, if requested.

4.2.1 Gas sampling system troubleshooting

Faults which can occur in the sampling system are: leaks or blockages in the tubing,

•

failure of the sampling pump or the magnetic valves, or diminishing of the flow rates because of dirt or other matter accumulating in the internal tubing or failure of pressure sensors.

• Whenever suspecting the sampling system and always after having done any work on

the sampling system, check the sampling system for leakages and check the flow rate.

• The D-fend Pro water trap should be replaced, when the 'REPLACE D-FEND' message

appears.

• If any liquid has entered the MiniTPX measuring unit due to water trap filter failure,

contact GE Healthcare service.

• Check that the tubing inside the module is not contaminated.

Any contamination inside the tubing may indicate that the valves or sensors are contaminated, too. This can increase a risk of faulty operation in valves or sensors. The valves or gas sensors are not possible to clean in the field. Therefore, if you noticed any contamination in the module tubing, send the module to GE Healthcare for factory service.

NOTE: All internal tubes are mechanically fragile. Sharp bends may cause leaks and occlusions.

4.2.2 MiniOM Measuring unit troubleshooting

Due to the complicated and sensitive mechanical construction of the oxygen measuring

•

unit, no repairs should be attempted inside the unit. Instead, if the fault has been found in the measuring unit itself, the entire module should be replaced and the faulty module be sent to GE Healthcare for repair.

• In cases of no response to O

blockages, and leaks.

or strong drift, check the tubing for loose connections,

• Check also the OM reference gas filter assembly, and replace if needed.

• If the O

has tension.

NOTE: Never apply overpressure to the O permanently damaged.

signal is noisy, check the measurement unit suspension and if the MiniOM tubing

measuring unit, as the pressure transducer may be

4.2.3 MiniTPX Measuring unit troubleshooting

The MiniTPX measuring unit can only be repaired at the factory. In case of failure, the

•

entire module should be replaced and the faulty module be sent to GE Healthcare for repair.

4.2.4 MiniPVX Measuring unit troubleshooting

In case of failure, the MiniPVX unit can be replaced.

•

• Perform spirometry system leak test to check if there is any leakages in the internal or

external spirometry tubing.

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4.2.5 CPU board troubleshooting

Due to the complexity of the large scale integrated circuitry, there are few faults in the

•

CPU digital electronics that can be located without special equipment.

• Check that all connectors and screws are properly installed.

• In case of failure, the entire module should be replaced and the faulty module be sent to

GE Healthcare for repair.

4.3 Service Interface

The monitor has a service menu, which is a useful tool to examine monitor functions and troubleshoot it in case a fault occurs.

To enter to the service menu see instructions in chapter Service Menu in the S/5 monitor’s technical reference manual.

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4.4 Messages

4.4.1 Gas measurements

Message Possible causes Possible solutions

Check water trap Check water trap and sample

gas out. Wait for 30 sec. and press

Normal screen to

continue.

Sample line blocked Continuous blockage. Check

sampling line and water trap.

Check sampling gas out Check water trap and sample

gas out. Wait for 30 seconds and press to continue.

Normal screen

Water trap is not connected.

Air leak inside the internal tubing.

Gas sampling line is blocked.

Water trap container is full. Water trap is occluded. Internal tubing is blocked.

The sample gas outflow is blocked.

Internal tubing is blocked.

Pump failure.

Connect the water trap and sampling line to the module.

Check the internal tubing for leakages.

Check the external gas sampling line for blockages. Replace, if needed.

Empty the water trap container. Replace the water trap. Check the internal tubing for

blockages.

Check the sample gas out connector in the front panel and the exhaust line for gas return or scavenging for blockages.

- If the sample gas is returned to the patient circuit, check that there is no occlusion in the tubing.

- If the sample gas outlet is connected to a scavenging system, make sure an open system is used where gas is removed in room pressure.

Check the internal tubing for blockages.

Check sample pump operation by measuring the sample gas flow rate. Replace pump, if needed.

Replace water trap Defective or contaminated D-fend Pro.

Occlusion in internal tubing.

Calibrating Gas calibration is in progress. Wait until the calibration is

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Replace the D-fend Pro water trap.

Check sample and reference flows. Perform a visual check for the internal tubing. Remove the cause for occlusion.

completed successfully.

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Message Possible causes Possible solutions

Failure in Agent ID Agent ID has failed. Perform gas calibration. Check

agent ID unreliability (see functional check). If it does not help, send the module to GE Healthcare for factory repair.

Zeroing Zeroing is in progress. Wait until zeroing is completed

successfully.

Zero error Autozeroing during the measurement or in

the beginning of the gas calibration failed.

Calibrating error Feeding the calibration gas was not started

within 1 minute after the automatic zeroing was completed.

Calibration was failed due to too large gain adjustment.

Wrong calibration gas is used.

Over range Measured FiO2>103% Perform gas calibration.

Apnea deactivated Apnea alarm start-up conditions are not

reached.

Sensor INOP IR Lamp failure.

Ambient pressure is too high or low.

CPU failure. No response from the gas module, high

temperature inside the module, or EEPROM checksum failure.

Check the zero valve operation. Replace the zero absorber and Nafion tube in zero line. If it does not help, send the module to GE Healthcare for factory repair.

Recalibrate.

Use the specified calibration gas.

Apnea alarm detection is activated after the 3 breaths are detected.

Check miniTPX flex cable connection.

Check the ambient pressure from the Gas Calibrations menu.

Replace CPU. Return the module to GE

Healthcare for service.

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Message Possible causes Possible solutions

Sensor INOP MiniOM unit failure

- temperature

- internal supply voltages

- other internal failure MiniTPX unit failure

- temperature

- internal supply voltages

- IR lamp failure MiniPVX unit failure

- pressure sensor failure

- internal supply voltages CPU failure

- internal supply voltages

- pressure sensor failure

- a/d-converter system failure Other failure

- Fan failure

- Pump failure

- Valve (Zero, Occlusion) failure

- Zeroing fails too many times

-CO

Calibrating gas sensor O

reference signal differs too much

from CO

, CO2 and N2O measurements are not

signal

available during the first minute after the module is connected due to warm-up. Anaesthesia agent measurement is not available during the first 5 minutes after the module is connected due to warm-up.

Check flex cable connection.

Check that fan can rotate freely. Check fan, pump or valve wire

connection.

Wait until the warm-up is completed.

Over Scale Incorrect waveform scale for the parameter.

The waveform clipped because measured gas concentration exceeds the upper limit of the current scale.

Low gas sample flow Sample flow deviates to less than 80% of the

module specific nominal flow value. Gas sampling line, gas output, water trap, or

internal tubing is blocked. Pump failure.

Change to the appropriate waveform scale. For detailed instructions refer to the S/5 monitor user’s manual.

Check sample flow rate. Adjust, if needed.

Check or replace the gas sampling line, water trap, or internal tubing.

Replace the pump unit.

Incompatible gas module Incompatible gas module detected by the

monitor.

Check the compatibility of the gas module.

Gas measurements removed The module is disconnected. Reconnect the module.

Identical gas modules The monitor detects gas measurement from

two or more modules.

Remove excess modules providing gas measurement.

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4.4.2 Spirometry

Message Possible causes Possible solutions

MVexp<<MVinsp Expired volume is much smaller (70% or less)

Replace the spirometry tube. than inspired volume due to a leak in the spirometry system.

A leaking or occluded spirometry tube. Water in tubing.

Perform spirometry leak test.

Replace MiniPVX, if needed.

Clean the tubing.

Low volumes I:E detection does not work.

Water trap may not be properly connected, or there may be a leak in the breathing circuit.

All following conditions are true for 20 s. No apnea, Ppeak - PEEP <2cmH

O, TVinsp and

TVexp are DATA_INVALID.

Zeroing error Zero valve leaking or internal damage in the

flow sensor.

Check the water trap and its

connection.

Check the breathing circuit for

leaks.

Check the loops on screen to

locate the problem.

Perform spirometry leakage test.

Replace MiniPVX sensor, if

needed. MiniPVX flex cable loose.

Check MiniPVX flex cable.

Zeroing Zeroing is in progress. Wait until zeroing is completed

successfully.

Sensor INOP There is no response from the MiniPVX

Replace MiniPVX unit. measurement board or there is an EEPROM checksum failure.

MiniPVX flex cable loose. Zero valve is broken.

Check MiniPVX flex cable.

Return the module to GE

Healthcare for service.

Over scale Flow or Paw waveform signal exceeds the

upper limit of the current scale.

Change Flow/Paw waveform

scale or use autoscaling. For

detailed instructions refer to the

S/5 monitor user’s manual.

Scale changed Displayed for 10 seconds after autoscaling

N/A mode has changed Flow, Paw, or Vol scale.

Saving loop Spirometry loop is being saved. N/A

Printing loop Spirometry loop is being printed. N/A

Spirometry measurements

The module is disconnected. Reconnect the module.

removed

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4.5 Troubleshooting charts

4.5.1 CO2 measurement

Problem Possible clinical cause Possible technical cause What to do

too low EtCO

value - sudden decrease in

circulation

- pulmonary embolism

- hyperventilation

- leak in sampling system

- calibration error

- high by-pass flow from ventilator

- check all connections

- check calibration

- very large dead-space

- large shunting

too high EtCO

- hypoventilation

- increased metabolism

- D-fend Pro contaminated

- calibration error

- change D-fend Pro

- check calibration

waveform clipped - incorrect scaling - change scale

For detailed instructions refer to the S/5 monitor user’s manual.

no response to breathing

- apnea

- (disconnection)

- sampling line or water trap loose or blocked (air

- check all connections

leak)

- sample gas out blocked

- check that outlet is open

EtCO

overscale

>15% (>20%)

- abnormally high EtCO2 (permissive hypercapnia)

-CO2 sensor contaminated

- D-fend Pro malfunction

- call service technician

- change D-fend Pro

Shown until 32%, specified range

0...15%

EtCO

>PaCO

- unit is mmHg or kPa and EtCO

is close to arterial

PCO

- Dry gas as default - change to Wet gas by

4.5.2 Patient spirometry

Problem Possible clinical cause Possible technical cause What to do

insp TV>exp TV - leak in lungs

- ET tube cuff leak

Document no. M1214853C

- spirometry tube leak

- water inside D-lite or tubings

- another side stream gas sampling between D-lite and patient

- D-fend Pro leaks

- check leakages — perform leak test

- change tubings and D-lite

- do not use active humidification

- connect gas sampling only and always to D-lite

- check D-fend Pro

using Default Setup/

Care unit Settings / Parameters menu

Page 65

Respiratory Modules, E-sCAiOV, E-sCAiO, E-sCOV, E-sCO

Problem Possible clinical cause Possible technical cause What to do

exp TV> insp TV - spirometry tube leak

- water inside D-lite or tubings

Loop overscale Monitored volumes <

set volumes

Strongly vibrating loop

Too large or too small volumes

Fluctuating Raw - mucus in airways or

- mucus in ET tube - water or secretions in

tubings

- breathing effort against the ventilator

- patient triggered breathes

- wrong scale selected

- wrong TV base selected

- leak between ventilator and D-lite

hoses or D-lite

- wrong mode vs. sensor selection

- incorrect sensor type selection

- ventilator exp. valve causes fluctuations during exp. flow

- check leakages — perform leak test

- change tubings and D-lite

- do not use active humidification

- change scaling

- Select correct TV base (ATPD / BTPS / NTPD/ STPD)

- check ventilator connections

- check the patient status

- change dry D-lite and/or empty the water from hoses

- check mode and sensor

- D-lite for adult

- Pedi-lite for pediatric

- check the tubings and D-fend Pro

- check the patient status

Too high Raw

Raw value invalid

Too high Ppeak - bronchospasm

Compl value invalid - spontaneous breaths - compliance cannot be

- kink in tubing

- mucus

- asthmatic patient

- bronchospasm

- spontaneous breaths

- breathing efforts against the ventilator

- patient triggered breaths

- patient is coughing

- patient breaths against the ventilator

- obstruction in airways

-HME obstructed

- check the tubing

- check the patient status

- check the patient circuit status

calculated

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Datex-Ohmeda E-Modules

5 Spare parts

5.1 Ordering parts

To order parts, Contact GE Healthcare. Contact information is available at

www.gehealthcare.com. Make sure you have all necessary information at hand.

NOTE: Perform the checkout procedure described in chapter “3. Service Procedures” after you have disassembled and reassembled the module.

5.1.1 Planned Maintenance Kits

The required planned maintenance parts are included in a PM kit.

Part number Description

M1206554

Planned Maintenance Kit for CARESCAPE E-sCxxx Respiratory modules. The PM kit includes the required Nafion tubes, OM reference filter assembly with O-ring and PM Sticker.

NOTE: The PM kit does not include the CO

absorber. Order it separately.

Document no. M1214853C

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Respiratory Modules, E-sCAiOV, E-sCAiO, E-sCOV, E-sCO







5.2 Spare parts for E-sCAiOV, E-sCAiO, E-sCOV, E-sCO

FRU# FRU/ Item description FRU / Item part

1 FRU, Front Chassis Unit, E-sCAiO, E-sCO

number

M1206530

- Front Chassis Assembly

2 FRU, Front Chassis Unit, E-sCAiOV, E-sCOV

M1206529

- Front Chassis Assembly including Membrane Keyboard

3 FRU, HW Kit, E-sCxxxx

M1206533

- All Mounting Screws

- All Conductive Sealings

- Pump Connector Silicone Tube

- D25 Connector Shield

- Latch

-Torsion Spring

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













FRU# FRU/ Item description FRU / Item part

number

4 FRU, Pump Unit, E-sCxxxx M1206290

5 FRU, OM Holder, E-sCxxxx M1206531

6 FRU, PVX Unit, E-sCAiOV, E-sCOV M1206528

7 CO2 Absorber, E-sCxxxx M1206555

Document no. M1214853C

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5.2.1 Front covers





Respiratory Modules, E-sCAiOV, E-sCAiO, E-sCOV, E-sCO

FRU# FRU/ Item description FRU / Item part number

8 FRU, Front Cover, E-sCAiO M1206538

8 FRU, Front Cover, US, E-sCAiO M1206558

8 FRU, Front Cover, E-sCO M1206539

8 FRU, Front Cover, US, E-sCO M1206559

9 FRU, Front Cover, EN, E-sCAiOV M1207033

9 FRU, Front Cover, CS, E-sCAiOV M1207034

9 FRU, Front Cover, DA, E-sCAiOV M1207035

9 FRU, Front Cover, ES, E-sCAiOV M1207036

9 FRU, Front Cover, FI, E-sCAiOV M1207037

9 FRU, Front Cover, FR, E-sCAiOV M1207038

9 FRU, Front Cover, HU, E-sCAiOV M1207039

9 FRU, Front Cover, IT, E-sCAiOV M1207040

9 FRU, Front Cover, JA, E-sCAiOV M1207041

9 FRU, Front Cover, NL, E-sCAiOV M1207042

9 FRU, Front Cover, NO, E-sCAiOV M1207043

9 FRU, Front Cover, PL, E-sCAiOV M1207044

9 FRU, Front Cover, PT, E-sCAiOV M1207045

9 FRU, Front Cover, SV, E-sCAiOV M1207046

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Datex-Ohmeda E-Modules

FRU# FRU/ Item description FRU / Item part number

9 FRU, Front Cover, DE, E-sCAiOV M1207047

9 FRU, Front Cover, RU, E-sCAiOV M1213759

9 FRU, Front Cover, ZH, E-sCAiOV M1213760

9 FRU, Front Cover, EN, E-sCOV M1207048

9 FRU, Front Cover, CS, E-sCOV M1207049

9 FRU, Front Cover, DA, E-sCOV M1207051

9 FRU, Front Cover, ES, E-sCOV M1207053

9 FRU, Front Cover, FI, E-sCOV M1207055

9 FRU, Front Cover, FR, E-sCOV M1207057

9 FRU, Front Cover, HU, E-sCOV M1207059

9 FRU, Front Cover, IT, E-sCOV M1207062

9 FRU, Front Cover, JA, E-sCOV M1207064

9 FRU, Front Cover, NL, E-sCOV M1207067

9 FRU, Front Cover, NO, E-sCOV M1207069

9 FRU, Front Cover, PL, E-sCOV M1207071

9 FRU, Front Cover, PT, E-sCOV M1207073

9 FRU, Front Cover, SV, E-sCOV M1207075

9 FRU, Front Cover, DE, E-sCOV M1207077

9 FRU, Front Cover, RU, E-sCOV M1213757

9 FRU, Front Cover, ZH, E-sCOV M1213758

Document no. M1214853C

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6 Earlier revisions

There are no earlier revisions of the CARESCAPE Respiratory Modules E-sCAiOV, E-sCAiO, E-sCOV, E-sCO.

Respiratory Modules, E-sCAiOV, E-sCAiO, E-sCOV, E-sCO

Document no. M1214853C

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Datex-Ohmeda E-Modules

For your notes:

Document no. M1214853C

Page 73

Appendix A, Service check form

APPENDIX A: Service check form

CARESCAPE Respiratory Modules, EsCAiOV, E-sCAiO, E-sCOV, E-sCO

Customer Monitor S/N

Service S/N

Service engineer Software

Planned maintenance Corrective maintenance

Prior to testing verify all equipment is calibrated via “Cal” labeling and record Cal Due Dates

Measuring equipment / test gases used:

Equipment / tool / gas: Manufacturer: Model/Type/Part No: Serial Number/ID: Cal Due Date:

Module type S/N

PASS = Test passed N.A. = Test not applicable FAIL = Test failed

PASS N.A. FAIL PASS N.A. FAIL

3.2. Visual inspections

3.3. Functional check

3.3.2. Procedure

1. Gas Sampling System Leak Test

3. Sample Flow Rate Check

5. Fan

7. Zero Valve Operation

9. Agent Identification

11. Occlusion detection

13. Gas exhaust blockage

15. Apnea detection

3.3.3. Test completion

2. Spirometry System Leak Test

4. Reference Gas Flow Rate Check

6. Module Keys

8. Gas Calibration

10. Ambient Pressure

12. Air Leak detection

14. Airway Gases

16. Flow waveform

Notes

Used service parts

Signature Date

Document no. M1214853C

A-1(2)

Page 74

Datex-Ohmeda E-Modules

For your notes:

A-2(2)

Document no. M1214853C

Page 75

Compact Airway Modules

S/5 Compact Airway Module, E-CAiOVX (Rev. 00) S/5 Compact Airway Module, E-CAiOV (Rev. 00) S/5 Compact Airway Module, E-CAiO (Rev. 00) S/5 Compact Airway Module, E-COVX (Rev.00) S/5 Compact Airway Module, E-COV (Rev. 00) S/5 Compact Airway Module, E-CO (Rev. 00)

Technical Reference Manual Slot

All specifications subject to change without notice.

Document number M1027822-02

May 2, 2011

GE Healthcare Finland Oy Kuortaneenkatu 2, FI-00510 Helsinki Finland Tel: +358 10 39411 Fax: +358 9 1463310

www.gehealthcare.com

Page 76

Page 77

Table of contents

Table of contents i

Table of figures iii

Introduction 1

1 Specifications 2

1.1 General specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

1.2 Typical performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

1.3 Gas specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

1.3.1 Normal conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

1.3.2 Conditions exceeding normal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1.4 Patient spirometry specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1.4.1 Normal conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1.4.2 Conditions exceeding normal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

1.5 Gas exchange specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

2 Functional description 7

2.1 Measurement principle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

2.1.1 CO2, N2O, and agent measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

2.1.2 O2 measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

2.1.3 Patient spirometry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

2.1.4 Gas exchange measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

2.2 Main components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

2.2.1 Controls and connectors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

2.2.2 Gas sampling system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

2.2.3 TPX measuring unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

2.2.4 PVX measuring unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

2.2.5 CPU board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

2.2.6 OM board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

3 Service procedures 19

3.1 General service information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

3.1.1 OM measuring unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

3.1.2 TPX measuring unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

3.1.3 OM, TPX, and PVX measuring unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

3.1.4 Serviceable parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

3.2 Service check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

3.2.1 Recommended tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

3.2.2 Recommended parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

3.2.3 Planned Maintenance Kits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

3.2.4 Replacement procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

3.2.5 Visual inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

3.2.6 Functional inspection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

3.3 Disassembly and reassembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

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3.3.1 Before disassembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

3.3.2 Required tools. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

3.3.3 PVX unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

3.3.4 Pump unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

3.3.5 CPU board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

3.3.6 Software of CPU board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

3.3.7 Instructions after replacing software or CPU board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

3.4 Adjustments and calibrations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

3.4.1 Gas sampling flow rate measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

3.4.2 Gas sampling flow rate adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

3.4.3 Gas calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

4Troubleshooting 35

4.1 Troubleshooting charts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

4.1.1 CO2 measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

4.1.2 Patient spirometry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

4.1.3 Gas exchange. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

4.2 Gas sampling system troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

4.3 OM measuring unit troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

4.4 PVX measuring unit troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

4.5 CPU board troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

4.6 Error messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

5 Earlier revisions 42

Appendix A: Service check form, Compact Airway Modules A-1

Document no. M1027822-02

Page 79

List of figures

Table of figures

Figure 1 TPX sensor principle .................................................................................................................................................................... 7

Figure 2 Absorbance of N2O and CO2 ................................................................................................................................................. 7

Figure 3 Infrared absorbance of AAs .................................................................................................................................................... 8

Figure 4 O2 measurement principle...................................................................................................................................................... 8

Figure 5 Front of Compact Airway Module, E-CAiOVX, and the back of the module....................................................12

Figure 6 Absorber .........................................................................................................................................................................................13

Figure 7 Gas sampling system layout.................................................................................................................................................14

Figure 8 Gas tubing layout .......................................................................................................................................................................15

Figure 9 TPX measuring unit ...................................................................................................................................................................15

Figure 10 OM measuring unit....................................................................................................................................................................16

Figure 11 PVX measuring unit...................................................................................................................................................................16

Figure 12 Signal processing.......................................................................................................................................................................17

Figure 13 Control logic..................................................................................................................................................................................18

Figure 14 Calibration data stored in EEPROM....................................................................................................................................18

Figure 15 Pneumatic unit and reference gas connection block ..............................................................................................25

Document no. M1027822-02

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Document no. M1027822-02

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Introduction

This Technical Reference Manual slot provides information for the maintenance and service of the Datex-Ohmeda S/5 Compact Airway modules. The Compact Airway modules are double width plug-in modules. E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV, E-CAiOVX and E-CAiOVX/SERVICE/SERVICE are designed for use with the S/5 Monitors. Later in this manual modules may be referred to without S/5 for simplicity.

The service menu is described in a separate “Service Menu“ slot and the spare part lists in the “E-Modules Spare Parts” slot.

The Compact Airway modules provide airway and respiratory measurements. Letters in the module name stand for: C = CO

agents, and i = agent identification

About E-CAiOVX/SERVICE module

The E-CAiOVX/SERVICE module is meant for service purposes only. It can be used as a loan module, if the module in the hospital should be sent to the factory for repair. The specifications that apply to the E-CAiOVX apply also to the E-CAiOVX/SERVICE module. Module differences: the color of the front mask is green, the front panel has a “SERVICE” text and there are no front panel keys equipped.

Table 1 Options for Compact Airway modules

and N2O, O = patient O2, V = patient spirometry, X = gas exchange, A = anesthetic

Compact Airway Modules

Modules Parameters / measurements

E-CAiOVX

E-CAiOV

E-CAiO

E-COV

E-COVX

E-CO

E-CAiOVX/SERVICE

N2OO2Anesthetic

agents

Agent ID SpirometryGas

exchange

XXX X X X X

XXX X X X

XXX X X

XXX X

XXX X X

XXX

XXX X X X X

NOTE: Do not use identical modules in the same monitor simultaneously. The E-miniC, E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV, E-CAiOVX and E-CAiOVX/SERVICE and the M-miniC, M-C, M-CO, M-COV, M-COVX, M-CAiO, M-CAiOV, M-CAiOVX and M-CAiOVX/SERVICE are considered identical modules.

NOTE: The Compact Airway Module or Single-Width Airway Module and Airway Module, G-XXXX, cannot be used simultaneously in the same monitor.

NOTE: The Compact Airway modules cannot be used in the Extension Frame, F-EXT4.

NOTE: Anesthetic agents and N but when present in the module they are calculated for compensation of CO

O values are not displayed with Critical Care main software,

and O2.

Document no. M1027822-02

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Datex-Ohmeda E-Modules

1Specifications

1.1 General specifications

Module size, W x D x H 75 x 228 x 112 mm / 3.0 x 9.0 x 4.4 in Module weight 1.6 kg / 3.5 lb. Operating temperature +10 to +40 °C Storage temperature -25 to +70 °C Atmospheric pressure 666 to 1060 hPa /

Relative humidity 10 to 95% non-condensing (in airway 0 to 100%, condensing)

Power consumption 12.6 W P

Protection against electrical shock Type BF

1.2 Typical performance

(67 to 106 kPa) (500 to 800 mmHg) (666 to 1060 mbar)

, 14.6 W momentary

rms

Measurement range 0 to 15 vol% (0 to 15 kPa, 0 to 113 mmHg) Measurement rise time < 400 ms typical Accuracy (0.2 vol% +2% of the reading)

Gas cross effects < 0.2 vol% (O

Measurement range 0 to 100 vol% Measurement rise time < 400 ms typical Accuracy ± (1 vol% + 2% of the reading) Gas cross effects < 1 vol%; anesthetic agents

Fi-Et difference resolution 0.1 vol%

N2O

Measurement range 0 to 100% Measurement rise time < 400 ms typical Accuracy ± (2 vol% + 2% of the reading) (0%<N2O<85%)

Gas cross effects < 2 vol%; anesthetic agents

Respiration Rate (RR)

Measurement range 4 to 60 breaths/min Detection criteria 1% variation in CO

e.g. Reading 5.0 % accuracy = ± (0.2 + 0.1); = ± 0.3 vol%

, N2O, anesthetic agents)

< 2 vol%; N

± (2 vol% + 8% of the reading) (85%<N2O<100%)

Document no. M1027822-02

Page 83

Anesthetic Agents (AA)

Measuring range Hal, Enf, Iso 0 to 6 vol% Sev 0 to 8 vol% Des 0 to 20 vol% Measurement rise time <600 ms typical (<1000 ms for Hal, typical) Gas cross effects < 0.15 vol% N

Resolution is two digits, when the AA concentration is below 1.0 vol%. If AA concentration is below 0.1 vol%, 0.0% is displayed.

Agent identification

Identification threshold 0.15 vol% typical Identification time < 20 s (for pure agents) Mixture identification threshold for 2. agent:

MAC

Range 0...9.9 MAC Equation:

0.2 vol% +10% of total conc.

Compact Airway Modules

where x(AA): Hal=0.75%, Enf=1.7%, Iso=1..15%, Sev=2.05%, Des=6.0%

1.3 Gas specifications

Airway humidity 0...100%, condensing Sampling rate 200 ±20 ml/min. (sampling line 2-3 m, normal conditions) Sampling delay 2.5 seconds typical with a 3 m sampling line

Total system response time 2.9 seconds typical with a 3 m sampling line, including

Display update rate breath-by-breath Warm up time 2 min. for operation with CO

Gas values are measured in ATPD conditions (ambient temperature and pressure, dry). When CO2 is displayed as a partial pressure (kPa, mmHg), the value can be alternatively shown as wet (BTPS, body temperature and pressure saturated).

Automatic compensation for barometric pressure , CO effect.

Auto zeroing interval Immediately after calibrating the gas sensor and 2, 5, 10, 15, 30,

Formula 1

sampling delay and rise time

, O2, and N2O

5 min. for operation of anesthetic agents 30 min. for full specifications

O and CO2-O2 collision broadening

2-N2

45, 60 minutes after start-up, then every 60 minutes

1.3.1 Normal conditions

Accuracy specifications apply in normal conditions (after 30 minutes warm-up period):

Ambient temperature 18 to 28 °C, within ±5 °C of calibration Ambient pressure 500 to 800 mmHg, ±50 mmHg of cal. Ambient humidity 20 to 80% RH, ±20% RH of cal.

Document no. M1027822-02

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Datex-Ohmeda E-Modules

Non-disturbing gases

Ethanol C Acetone < 0.3% Methane CH Freon 21 < 1% Freon R134A <1% Nitrogen N Carbon monoxide CO Nitric Oxide NO < 200 ppm water vapor

Maximum effect on readings

, N2O < 2 vol%

anesthetic agents < 0.15 vol%

Effect of Helium decreases CO

Effect of Xenon decreases CO

OH < 0.3%

2H5

< 0.3%

1.3.2 Conditions exceeding normal

< 0.2 vol%

decreases O

readings < 0.6 vol% typically

readings < 3 vol% typically

readings < 0.4 vol% typically

Accuracy specifications under the following conditions; nopq:

n Ambient temperature 10 to 40 °C, within ±5 °C of calibration Ambient pressure 500 to 800 mmHg, ±50 mmHg of calibration Ambient humidity 10 to 98% RH, ±20% RH of calibration

o During warm-up 2 to 10 minutes (anesthetic agents 5-10 minutes), under normal conditions p During warm-up 10 to 30 minutes, under normal conditions q N

O > 85%, under normal conditions

Accuracy under different conditions (see above)

Condition n and p Condition o Condition q

O ±(3 vol% + 3% of reading) ±(3 vol% + 5% of reading) ± (2vol% + 8% of reading)

Agents: Hal, Enf, Iso, Sev, Des

±(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%)

(2 vol% + 2% of reading) ±(3 vol% + 3% of reading)

±(0.2 vol% + 10% of reading) ±(0.3 vol% + 10% of

reading)

1.4 Patient spirometry specifications

1.4.1 Normal conditions

Accuracy specifications apply in normal conditions (after 10 minutes warm-up period):

Ambient temperature 10 to 40 °C Ambient pressure 500 to 800 mmHg Ambient humidity 10 to 98% RH Airway humidity 10 to 100% RH

Document no. M1027822-02

Page 85

Compact Airway Modules

Respiration rate 4 to 35 breaths/min (adults)

4 to 50 breaths/min (pediatric) I:E ratio 1:4.5 to 2:1 Intubation tube 5.5 to 10 mm (adults), 3...6 mm (pediatric)

Airway pressures (Paw, P

Measurement range -20 to +100 cmH2O Resolution 0.5 cmH Accuracy ±1 cmH

peak

, P

, PEEPe, PEEP

plat

, PEEP

iStat

iDyn

, P

mean

)

Airway flow

Measurement range 1.5 to 100 l/min (adults) (for both directions) 0.25 to 25 l/min (pediatric)

Tidal volume

Measurement range 150 to 2000 ml (adults), 15...300 ml (pediatric) Resolution 1 ml Accuracy ±6% or 30 ml (adult), ±6% or 4 ml (pediatric)

Minute volume

Measurement range 2 to 20 l/min (adults), 0.5...5 l/min (pediatric) Resolution 0.1 l/min

Compliance

Measurement range 4 to 100 ml/cmH2O (adult), 1...100 ml/cmH2O (pediatric) Resolution 1 ml/cmH

O (adult), 0.1 ml/cmH2O (pediatric)

Airway resistance

Measurement range 0 to 40 cmH2O/ l/s Resolution 1 cmH

O/ l/s

Other parameters

Specifications apply in conditions listed in patient spirometry specifications.

Dead space of the sensor

9.5 ml (adult), 2.5 ml (pediatric)

Resistance of the sensor

0.5 cmH2O at 30 l/min (adult), 1.0 cmH2O at 10 l/min (pediatric)

1.4.2 Conditions exceeding normal

Accuracy specifications under the following condition (during warm-up 2 to 10 minutes):

Airway Pressure (Paw)

Accuracy ±2 cmH2O

Tidal volume

Accuracy ±10% or 100 ml (adult), ±10% or 10 ml (pediatric)

1.5 Gas exchange specifications

Mathematical integration of airway flow and gas concentration for intubated, mechanically ventilated and/or partly spontaneously breathing patients. NOTE: These specifications apply only, when a 2 meter gas sampling line is used, and a Y-piece with a physical dead space less than 8 ml.

Document no. M1027822-02

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Datex-Ohmeda E-Modules

NOTE: These specifications only apply, if the FiO2 level delivered to the patient is varying by less

NOTE: than 0.2% at the measurement point during the inspiratory cycle.

VO2 and VCO

Measurement range 50 to 1000 ml/min Resolution 10 ml/min Accuracy ±10% or 10 ml/min; when FiO

±15% or 15 ml/min; when 65% < FiO

Measurement range 0.6...1.2 Resolution 0.05

< 65%

< 85%

Document no. M1027822-02

Page 87

2 Functional description

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2.1 Measurement principle

2.1.1 CO2, N2O, and agent measurement

TPX is a side stream gas analyzer, measuring real time concentrations of CO2, N2O and anesthetic agents (Halothane, Enflurane, Isoflurane, Desflurane, and Sevoflurane).

Compact Airway Modules

Figure 1 TPX sensor principle

Anesthetic agents or mixtures of two anesthetic agents are automatically identified and concentrations of the identified agents are measured. TPX also detects mixtures of more than two agents and issues an alarm.

TPX is a non dispersive infrared analyzer, measuring absorption of the gas sample at seven infrared wavelengths, which are selected using optical narrow band filters.

The infrared radiation detectors are thermopiles. Concentrations of CO

and N2O are calculated from absorption measured at 3-5 μm.

Figure 2 Absorbance of N2O and CO

Document no. M1027822-02

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Datex-Ohmeda E-Modules

absorbance_AA.vsd

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Identification of anesthetic agents and calculation of their concentrations is performed by measuring absorptions at five wavelengths in the 8-9 μm band and solving the concentrations from a set of five equations.

Figure 3 Infrared absorbance of AAs

The measuring accuracy is achieved utilizing numerous software compensations. The compensation parameters are determined individually for each TPX during the factory calibration.

2.1.2 O2 measurement

The differential oxygen measuring unit uses the paramagnetic principle in a pneumatic bridge configuration. The signal picked up with a differential pressure transducer is generated in a measuring cell with a strong magnetic field that is switched on and off at a frequency of 165 Hz. The output signal is a DC voltage proportional to the O

the two gases to be measured.

concentration difference between

Figure 4 O2 measurement principle

Document no. M1027822-02

Page 89

2.1.3 Patient spirometry

The Patient Spirometry monitors patient ventilation. The following parameters are displayed:

− Expiratory and inspiratory tidal volume (TV) in ml

− Expiratory and inspiratory minute volume (MV) in l/min

− Expiratory spontaneous minute volume in l/min

− Inspiration/expiration ratio (I:E)

Airway pressure

− Peak pressure (P

− Mean airway pressure (P

monitors

− End inspiratory pressure (P

− PEEPi, PEEPe; available only in S/5 Critical Care and Compact Critical Care monitors

− Total positive end expiratory pressure (PEEP

Compact Anesthesia monitors

− Real time airway pressure waveform (P

− Static Positive end expiratory pressures (Static PEEP

S/5 Critical Care and Compact Critical Care monitors

− Static Plateau pressure (Static Pplat); available only in S/5 Critical Care and Compact

Critical Care monitors

− Static Compliance (Static Compl); available only in S/5 Critical Care and Compact Critical

Care monitors PEEP, P Atmospheric pressure is used as a reference in measurement. The pressure measurement is

made from the airway part that is closest to the patient between the patient circuit and intubation tube.

PEEP

Static pressure measurement maneuvers are automatically identified based on an increased zero flow period at the end of the inspiration or expiration.

Static Compliance is calculated, if Static PEEP and Static P a 2 minute period.

, P

peak

mean

=intrinsic PEEP, PEEP

, and P

Compact Airway Modules

)

peak

are measured by a pressure transducer on the PVX board.

plat

tot

); available only in S/5 Critical Care and Compact Critical Care

mean

)

plat

); available only in S/5 Anesthesia and

tot

)

-PEEP

and Static PEEPe); available only in

measurements were made within

plat

Airway flow

− Real time flow waveform (V')

− Compliance (Compl)

− Airway resistance (Raw)

− Pressure volume loop

− Flow volume loop

Compliance and airway resistance

Compliance is calculated for each breath from the equation

Formula 2

Document no. M1027822-02

Page 90

Datex-Ohmeda E-Modules

Compliance describes how large a pressure difference is needed to deliver a certain amount of gas to the patient.

where P(t), V’(t) and V(t) are the pressure, flow and volume measured at the D-lite at a time t, Raw is the airway resistance, Compl is the compliance and PEEP

expiratory pressure (PEEP

D-lite

Formula 3

+PEEPi is the total positive end

tot

(from Bernoulli's equation) Formula 4

where:

F = flow (l/min), v = velocity (m/s), A = cross area (m

= density (kg/m3)

Finally the volume information is obtained by integrating the flow signal.

2.1.4 Gas exchange measurement

The gas exchange measurement uses the D-lite flow sensor and the gas sampler. The basic data which is needed to obtain O

concentrations. Concentrations have been corrected for delay and deformation during the transport of the gas

sample in a sidestream gas measurement sensor. To obtain the amount of O

from the amount that is inhaled. To obtain the amount of CO

from the amount that is exhaled. These amounts can be obtained by multiplying each measured volume piece (dv) by the

corresponding gas concentration:

consumed in ml/min, the amount which is exhaled is subtracted

produced in ml/min, the amount which is inhaled is subtracted

), dP = pressure difference (cmH2O),

consumption and CO2 production are volumes and

and

Document no. M1027822-02

Formula 5

Page 91

Compact Airway Modules

Formula 6

Using inspiratory and expiratory minute volumes MVi and MVe and volume-weighted inspiratory concentrations fi and fe, these equations can be rewritten as:

Formula 7

Formula 8

To obtain results which are less sensitive to errors in volume measurements, the so-called Haldane transformation is used. This means taking advantage of the fact that the patient is not consuming nor producing nitrogen: the amount of nitrogen inhaled is equal to the amount exhaled fi

and VCO2 can then be written as:

× MVi=feN2×MVe.

Formula 9

with f

Hald

= (1-fi

– fiO2 – fi

CO2

N2O

with Un=Urea Nitrogen Excretion = 13 g/day (for adults only).

2.2 Main components

The compact airway modules consist of:

• Gas sampling system

• TPX measuring unit

• OM measuring unit

• PVX measuring unit

• CPU board

• OM board

• PVX board

- fi

Ane1

– fi

Ane2

) / (1-fe

– feO2 – fe

CO2

N2O

- fe

Ane1

– fe

Formula 10

)

Ane2

Formula 11

Document no. M1027822-02

Page 92

Datex-Ohmeda E-Modules



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2.2.1 Controls and connectors

Figure 5 Front of Compact Airway Module, E-CAiOVX, and the back of the

module

(1) D-fend water trap (2) Sampling line connector (3) Water trap latch (4) Oxygen reference gas inlet (5) Sample gas outlet (6) Cooling fan with dust filter

Module keys Module Description

Save Loop E-COV, E-COVX, E-CAiOV,

E-CAiOVX

Print Loop E-COV, E-COVX, E-CAiOV,

E-CAiOVX

Change Loop E-COV, E-COVX, E-CAiOV,

E-CAiOVX

Connector Module Description

D25 connector all modules Module bus connector

Save Loop saves a reference loop.

Print Loop prints the reference loop.

Change Loop changes a pressure/volume loop to a flow/volume loop or vice versa.

Document no. M1027822-02

Page 93

2.2.2 Gas sampling system

The sampling system takes care of drawing a gas sample into the analyzers at a fixed rate. 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 gas measuring units. After the measurements, the gas is exhausted from the sample gas out connector.

The E-COVX and E-CAiOVX modules have a different gas sampling system compared to the other modules. A number of flow restrictors have been changed to create a bigger pressure difference between ambient pressure and the gas sampling system in the gas sensors. The sample flow is, however, about the same (200 ml/min).

A larger pressure difference makes the deformations of the gas concentration curves less sensitive to high variations of the airway pressures, thus also meeting the accuracy requirements of gas exchange for these applications.

Compact Airway Modules

D-fend

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

Zero valve and absorber

Figure 6 Absorber

Nafion® tubes

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 will prevent errors caused by the effect of water vapor on gas partial pressure, when humid gases are measured after calibration with dry gases. Another Nafion tube is used between the absorber and the pneumatic unit to prevent humidity caused by the absorption of CO

The main flow passes through a magnetic valve before proceeding to the analyzers. This valve is activated to establish the zero points for the TPX and OM units. When the valve is activated, room air is drawn through the absorber into the internal system and the gas sensors. Paralyme is used as an absorbent.

Gas analyzers

After the zero valve and Nafion tube, the gas passes through the TPX and OM units. The oxygen sensor has two inputs. One input accepts the main flow and the other draws in room air for reference. Both gas flows exit from a single port.

Sample flow differential pressure transducer

The sample flow differential pressure transducer measures pressure drop across an OM inlet restrictor and calculates sample flow from the pressure difference.

1 Nafion is a registered trademark of Perma Pure Inc.

Document no. M1027822-02

Page 94

Datex-Ohmeda E-Modules

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Working pressure transducer

The working pressure transducer measures absolute working pressure between the TPX unit and OM unit. It is used for messages: ‘Sample line blocked’, ‘Check D-fend’, ‘Replace D-fend’ and ‘Check sample gas outlet’.

Pneumatic unit

The pneumatic unit contains a zeroing valve, occlusion valve and tubing connections. There is a series of restrictors and chambers forming a pneumatic filter to prevent pressure oscillations from the pump to reach the measuring units. The occlusion valve connection to room air includes a dust filter and the zero valve connection to room air includes an absorber.

Connection block

The connection block contains a sample gas outlet connector and an OM unit reference gas inlet. The inlet is equipped with a dust filter.

Occlusion valve

The valve is activated, when the sampling line gets occluded. The main flow is then diverted to the side flow of the D-fend water trap to faster remove the occlusion.

Sampling pump and damping chamber

The gas sampling pump is a membrane pump that is run by a brushless 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.

The damping chamber is used to even out the pulsating flow and silence the exhaust flow.

NOTE: In no occasion is the flow reversed towards the patient.

Document no. M1027822-02

Figure 7 Gas sampling system layout

Page 95

Compact Airway Modules

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Tubing marked with 1) is thinner in E-CAiOVX and E-COVX module.

Figure 8 Gas tubing layout

2.2.3 TPX measuring unit

The TPX unit is a non dispersive infrared analyzer, measuring absorption of the gas sample at seven infrared wavelengths, which are selected using optical narrow band filters. The IR lamp is a 4 W filament, surrounded by thermal isolation. There is a hole in the isolation, passing the radiation to a conical measuring chamber with 4 mm length.

From the sample chamber, radiation goes into seven tubular light guides with reflective inner surfaces. At the other end of each light guide, there is a thermopile detector with an optical filter in front of it.

The Temp sensor measures the TPX units’ temperature and it is used for temperature compensation.

The TPX unit includes a TPX board located at the end of the unit. Its function is to connect the 7 thermopile signals and the temperature sensor signal to the CPU board.

Figure 9 TPX measuring unit

Document no. M1027822-02

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Datex-Ohmeda E-Modules

PVX_meas_unit.vsd

OM measuring unit

The oxygen measurement is based on paramagnetic susceptibility. The gas and the reference gas, which usually is room air, are conducted into a gap in an electromagnet with a strong magnetic field switched on and off at a frequency of approximately 165 Hz.

An alternating differential pressure is generated between the sample and reference inputs due to forces acting to the oxygen molecules in a magnetic field gradient.

The pressure is measured with a sensitive differential transducer, rectified with a synchronous detector and amplified to produce a DC voltage proportional to the oxygen partial pressure difference of the two gases.

Figure 10 OM measuring unit

2.2.4 PVX measuring unit

NOTE: Never apply overpressure or negative pressure of more than 300 cmH2O to the flow and volume tubing. Differential pressure max 25 cmH tubes.

The Patient Spirometry provides patient respiration monitoring capabilities using the D-lite and Pedi-lite flow sensors.

O on one port at a time e.g. when connecting

Figure 11 PVX measuring unit

The measurement is based on measuring the kinetic gas pressure and is performed using the Pitot effect. A pressure transducer is used to measure the Pitot pressure. The signal is then linearized and corrected according to the density of the gas. Speed of the flow is calculated from the pressure and TV is integrated from it.

Document no. M1027822-02

Page 97

Compact Airway Modules

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Patient Spirometry consists of airway connections, two pressure transducers, valves and preamplifiers. The preamplifiers are connected to the A/D-converter on the module main CPU.

The breathing flow of a patient passing through the D-lite adapter creates a pressure difference. This pressure difference is measured by a pressure transducer, B1. Overpressure and negative pressure in airways are measured by another pressure transducer, B2.

Gas exchange

The gas exchange measurement uses the concentrations measured by the TPX measurement unit and the O

measurement unit, in combination with the flow from the PVX measurement

unit. The gas exchange calculation is done by software.

CAUTION The gas exchange measurement in the E-CAiOVX and E-COVX modules works

accurately only with 2-meter gas sampling lines.

2.2.5 CPU board

The CPU board contains the processor and memories and A/D-converters that are common to the whole module. The CPU board also contains preamplifiers of TPX-sensor and drivers for valves, fan, pump and lamp. The module is connected to the module bus through an RS-485 serial channel.

Figure 12 Signal processing

Document no. M1027822-02

Page 98

Datex-Ohmeda E-Modules

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Figure 13 Control logic

Figure 14 Calibration data stored in EEPROM

2.2.6 OM board

The Oxygen board contains the specific electronics for the oxygen sensor. Sample flow measurement and sampling system pressure sensors are on this board. It also contains EEPROMs that store calibration data of both TPX and OM sensors. The spirometry keyboard connection is on this board.

PVX board

The Spirometry board is connected to the oxygen board. It contains pressure sensors for airway pressure and flow measurement differential pressure and preamplifiers for those. Calibration data of spirometry is stored on its own EEPROM.

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Compact Airway Modules

3 Service procedures

3.1 General service information

The field service of the compact airway modules is limited to replacing faulty circuit boards or mechanical parts. The circuit boards should be returned to GE Healthcare for repair.

GE Healthcare is always available for service advice. Please provide the unit serial number, full type designation, and a detailed fault description.

WARNING Handle the water trap and its contents as you would any body fluid.

Infectious hazard may be present.

CAUTION Only trained personnel with appropriate equipment should perform the tests

and repairs outlined in this section. Unauthorized service may void the warranty of the unit.

NOTE: Wear a static control wrist strap when handling PC boards. Electrostatic discharge may damage components on the board.

3.1.1 OM measuring unit

CAUTION Due to the complicated and sensitive mechanical construction of the O2

measuring unit, no repairs should be attempted inside the unit.

3.1.2 TPX measuring unit

CAUTION The TPX photometer 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.

3.1.3 OM, TPX, and PVX measuring unit

CAUTION The OM, TPX, and PVX measuring units can be repaired only at the factory.

3.1.4 Serviceable parts

Absorber

•

• D-fend

• Nafion tubes

• Fan filter

• Fan

• CPU board

• CPU software

• PVX Unit including PVX board

• Pump

NOTE: After any component replacement, see chapter 3.4. Adjustments and calibrations.

Document no. M1027822-02

Page 100

Datex-Ohmeda E-Modules

3.2 Service check

These instructions include complete procedures for a service check. The service check is mandatory 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 (“APPENDIX A:”) which may be used when performing the

procedures.

The symbol

results of the particular procedure.

"in the instructions means that the check form contains space to record the

3.2.1 Recommended tools

NOTE: Use only calibrated and traceable measuring equipment.

− A barometer

− A mass flowmeter for measuring air flow, minimum measurement range 100-300ml/min,

accuracy 5% or better in the 100-300ml/min range.

− P/N: 755534-HEL Calibration Gas Regulator

− P/N: 755583-HEL Calibration gas, CO2, O2, N2O, DESF, package of 1 can (with E-CAiO,

E-CAiOV, E-CAiOVX modules)

− P/N: 755581-HEL QUICK CAL calibration gas, CO2, O2, N2O, package of 4 cans (with E-CO,

E-COV and E-COVX modules)

− P/N: M1006864, Calibration Gas Regulator, US only

− P/N: 755571-HEL, Calibration Gas, 5% CO2, 54.5% O2, 36.0% N2O, 2.0% DESFLURANE,

BAL N2 (with E-CAiO, E-CAiOV, E-CAiOVX modules) US only

− P/N: 755587, Calibration Gas, CO2, O2, Balance, 4 cans/pkg (with E-CO, E-COV and

E-COVX modules) US only

− D-Fend water trap

− 3 m / 10 ft anesthesia gas sampling line (with E-CO, E-COV, E-CAiO and E-CAiOV modules)

− 2 m / 7 ft anesthesia gas sampling line (with E-COVX and E-CAiOVX modules)

− Spirometry tube, 3 m/10 ft (with E-CO, E-COV, E-CAiO and E-CAiOV modules)

− Spirometry tube, 2 m/7 ft (with E-COVX and E-CAiOVX modules)

− Adult D-Lite sensor

− A pressure manometer with either an integrated or a separate pressure pump

− Tubing for spirometry leak tests

NOTE: Ensure that the calibration gas and the regulator are functioning properly before calibration. Perform annual maintenance on the regulator as required, see “Calibration gas

regulator flow check” page 33.

Document no. M1027822-02

Datex-Ohmeda E-Modules Technical reference manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Datex-Ohmeda

E-Modules

Technical Reference Manual

About this manual

GE Healthcare

Respiratory Modules, E-sCAiOV, E-sCAiO, E-sCOV, E-sCO

Technical Reference Manual Slot

Table of contents

Introduction

1 Technical specifications

1.1 Physical characteristics

1.2 Operating characteristics

1.3 Airway gases

1.3.1 General characteristics

1.3.2 Respiration rate

1.3.3 Carbon dioxide

1.3.4 Oxygen

1.3.5 Nitrous oxide

1.3.6 Anesthetic agents

1.3.7 Non-disturbing gases

1.3.8 Gas cross effects

1.4 Patient Spirometry

1.4.1 General characteristics

1.4.2 Airway pressure

1.4.3 Airway gas flow

1.4.4 Tidal volume

1.4.5 Minute volume

1.4.6 Compliance

1.4.7 Airway resistance

1.4.8 Inspiration to expiration ratio

2 Functional description

2.1 Measurement principle

2.1.1 CO2, N2O, and agent measurement

2.1.2 O2 measurement

2.1.3 Patient spirometry

2.2 Main components

2.2.1 Controls and connectors

2.2.2 Gas sampling system

2.2.3 MiniTPX measuring unit

2.2.4 MiniOM Oxygen sensor

2.2.5 MiniPVX measuring unit

2.2.6 CPU board

2.2.7 MiniOM board

2.2.8 MiniPVX board

2.2.9 Main Component Interactions

3 Service Procedures

3.1 Replacement of planned maintenance parts

3.1.1 Required parts

3.1.2 Planned Maintenance Kits

3.1.3 Replacement procedures

3.2 Visual inspections

3.3 Functional check

3.3.1 Test setup

3.3.2 Procedure

3.3.3 Test completion

3.4 Disassembly and reassembly

3.4.1 Disassembly guidelines

3.4.2 Disassembly and reassembly procedure

3.5 Adjustments and calibration

3.5.1 Sample Flow Rate Adjustment

3.5.2 Gas Calibration

3.5.3 Spirometry Calibration

4Troubleshooting

4.1 Visual inspection

4.2 Troubleshooting checklist

4.2.1 Gas sampling system troubleshooting

4.2.2 MiniOM Measuring unit troubleshooting

4.2.3 MiniTPX Measuring unit troubleshooting

4.2.4 MiniPVX Measuring unit troubleshooting

4.2.5 CPU board troubleshooting

4.3 Service Interface

4.4 Messages

4.4.1 Gas measurements

4.4.2 Spirometry

4.5 Troubleshooting charts

4.5.1 CO2 measurement