Datex-Ohmeda S-5 FM Technical Reference Manual

GE Healthcare

Datex-Ohmeda S/5 FM

Technical Reference Manual

Conformity according to the Council Directive 93/42/EEC concerning Medical Devices amended by 2007/47/EC

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 M1181261 3rd edition

10 February, 2012

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

www.gehealthcare.com

Indications for use

The S/5 FM with L-FICU06 and L-FICU06A and N-FCREC Module are intended for multiparameter patient monitoring. The S/5 FM with L-FICU06 or L-FICU06A software is indicated for monitoring of hemodynamics (including arrhythmia and ST-segment analysis) and respiratory status of all hospital patients. Extension module N-FCREC (option N-FCREC or N-FC) is indicated for monitoring CO2 and respiration rate of all hospital patients. CO2 measurements are indicated for patients weighing over 5kg (11lbs). The S/5 FM Monitor and N-F(C)(REC) Extension Module are indicated for use by qualified medical personnel only.

The Datex-Ohmeda S/5 PSM module (consisting of E-PSM, E-PSMP and E-INTPSM Modules) and accessories is intended for monitoring hemodynamic parameters of hospitalized patients. The Datex-Ohmeda S/5 PSM module (consisting of E-PSM, E-PSMP and E-INTPSM Modules) and accessories are indicated for monitoring of hemodynamic parameters of all hospital patients. The hemodynamic parameters of the module comprise ECG (including ST-segment and arrhythmia), Impedance respiration, NIBP, Temperature, SpO2 (including monitoring during conditions of clinical patient motion), and invasive blood pressure. Impedance Respiration measurement is indicated for patients ages 3 and up. The NIBP measurement is indicated for patients who weigh 5 kg (11 lbs.) and up. The device is indicated for use by qualified medical personnel only.

NOTE: E-INTPSM Module is not in use with the S/5 FM.

Classifications

In accordance with IEC 60601-1

CLASS I AND INTERNALLY POWERED EQUIPMENT – the type of protection against electric shock. TYPE BF or CF equipment. The degree of protection against electric shock is indicated by a symbol on

each parameter module. EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANESTHETIC MIXTURE WITH AIR OR

WITH OXYGEN OR NITROUS OXIDE. CONTINUOUS OPERATION according to the mode of operation.

In accordance with IEC 60529

IPX1 - degree of protection against harmful ingress of water.

In accordance with EU Medical Device Directive

The Datex-Ohmeda S/5 FM is classified as IIb. In accordance with CISPR 11: Group 1, Class A

• Group 1 contains all ISM (Industrial, scientific and medical) equipment in which there is intentionally generated and/or used conductively coupled radio-frequency energy which is necessary for the internal functioning of the equipment itself.

• Class A equipment is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

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.”

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. 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.

Technical Reference Manual, Order code: M1181261

Document No. Updated Description

Master Table of Contents

Datex-Ohmeda S/5 FM

3rd edition

Part I, General Service Guide

M1187317-009 Introduction, System description, Installation,

Interfacing, Functional check, General

troubleshooting

M1187318-003 Planned Maintenance Instructions 2

Part II, Product Service Guide

Document No. Updated Description

M1187329-003 S/5 FM Service Menu 1

M1187335-004 Frame for FM 2

M1215098-002 Patient Side Module, E-PSM, E-PSMP 3

M1187338-003 S/5 Extension Module for FM, N-FC, N-FCREC, N-FREC 4

M1187342-004 S/5 Remote Controller, K-REMCO, K-CREMCO 5

M1187344-003 Device Interfacing Solution, N-DIS 6

M1187346-007 S/5 FM Spare Parts 7

Document no. M1187317-009

Datex-Ohmeda S/5 FM

Document no. M1187317-009

Table of contents

Table of contents i

Table of figures iii

List of tables iv

About this manual 1

1Introduction 3

1.0.1 Compatibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

1.1 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1.1.1 Symbols on transport packaging. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1.1.2 Symbols on equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1.1.3 Equipment safety symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

1.1.4 Other symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

1.2 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

1.2.1 Safety precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

1.2.2 ESD precautionary procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

2 System description 14

2.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

2.2 Bus structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

2.3 Distributed processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

2.4 Module communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

2.5 Software loading. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

2.6 Parameter modules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

3 System installation 18

3.1 Unpacking instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

3.2 Choosing location. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

3.3 Mounting the S/5 FM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

3.3.1 E-PSM(P) Mounting Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

3.3.2 Monitor connections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

3.3.3 Connection to mains . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

3.3.4 Connection to Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

3.3.5 Connection to Wireless Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

3.3.6 Inserting and removing the parameter modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

3.3.7 Downloading Monitor Software F-FM(W)-00 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

3.3.8 Downloading Monitor Software, F-FM(W)-01 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

3.3.9 Performing Factory Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

3.3.10 Installing the Datex-Ohmeda Wireless Network Upgrade, U-FMW (F-FM-00). . . . . . 25

3.3.11 Installing the Datex-Ohmeda Wireless Network Service Option,

N-FMWS (F-FM-00) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

3.3.12 Installing the S/5 Wireless Network Upgrade, U-FMW-01 . . . . . . . . . . . . . . . . . . . . . . . . 28

3.4 Remote Controller, K-CREMCO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

3.5 Visual indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

3.6 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

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4Interfacing 32

4.1 Interfacing external bedside devices via Device Interfacing Solutions, N-DISxxx. . . . . . . . . 32

4.1.1 Device Interfacing Solution components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

4.1.2 Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

4.1.3 Mounting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

4.1.4 Selecting the external device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

4.1.5 Functional check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

4.1.6 Selecting the parameter data source. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

4.2 Interfacing printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

4.2.1 Setting S/5 FM interface for printers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

4.2.2 Connection to serial printers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

4.2.3 Connection to parallel printers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

4.2.4 Installing the Serial-to-Parallel Converter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

4.2.5 Connection to printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

4.3 Interfacing computer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

4.4 Output signals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

4.4.1 Digital outputs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

4.4.2 Analog outputs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

5 Functional check 40

5.1 Recommended tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

5.2 Visual inspection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

5.3 Functional inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

5.3.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

5.3.2 Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

5.3.3 Keyboard(s) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

5.3.4 Frame unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

5.3.5 Extension Module with CO

5.3.6 Multiparameter Hemodynamic Modules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

5.3.7 Data Card and Menu Card function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

5.3.8 Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

5.3.9 Network connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

5.3.10 Wireless Network Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

5.3.11 Device Interfacing Solution, N-DISxxx . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

5.3.12 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

6 General troubleshooting 47

Appendix A: Functional check form, Datex-Ohmeda S/5 FM A-1

Appendix B: ElectroMagnetic Compatibility B-1

Appendix C: Channel Mask Selections for S/5 FM C-1

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Table of figures

Figure 1 S/5 FM with N-FCREC (1) and E-PSM (2) modules.......................................................................................................... 3

Figure 2 General bus structure of S/5 FM ........................................................................................................................................14

Figure 3 Principle of UPI section operation ......................................................................................................................................15

Figure 4 General structure of parameter modules with patient isolation.........................................................................17

Figure 5 E-PSM(P) mounting accessories ..........................................................................................................................................19

Figure 6 S/5 FM front panel .....................................................................................................................................................................20

Figure 7 Rear panel connections ..........................................................................................................................................................21

Figure 8 Connection cables and LED indicators ............................................................................................................................33

Figure 9 An example of interfacing external devices with Device Interfacing Solution..............................................34

Figure 10 Connecting S/5 FM monitor to printer, converter model PI130-R2....................................................................37

Figure 11 S/5 FM general troubleshooting flowchart ....................................................................................................................47

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Datex-Ohmeda S/5 FM

List of tables

Table 1 DIS modules and interfaced devices............................................................................................................. 32

Table 2 NET ID connector, X8 on Multi I/O adapter ............................................................................................... 38

Table 3 Defib & IABP sync connector, X5 .................................................................................................................... 38

Table 4 Patient simulators’ compatibility with each hemodynamic module.............................................. 41

Table 5 Adapter cables for hemodynamic patient simulators .......................................................................... 42

Table 6 Guidance and manufacturer’s declaration – electromagnetic emissions................................ B-1

Table 7 Guidance and manufacturer’s declaration – electromagnetic immunity................................. B-2

Table 8 Guidance and manufacturer’s declaration – electromagnetic immunity................................. B-3

Table 9 Recommended separation distances between portable and mobile

RF communications equipment and the S/5 FM .................................................................................. B-4

Document no. M1187317-009

About this manual

Intended audience

This Technical reference manual is meant for service representatives and technical personnel who install, configure, maintain, administer, troubleshoot or repair Datex-Ohmeda S/5 FM.

Notes to the reader

As the monitor setup may vary, some functions described may not be available in the monitor you are using.

• The order code for the entire printed manual is M1181261. The manual includes Technical

Reference Manual Slots and every slot has an individual document number.

• Part I gives the reader an overview of the S/5 FM. It contains the information needed to

install, interface and troubleshoot the monitors. Instructions for functional check and planned maintenance are also included. Read the manual through and make sure that you understand the procedures described before the installation of the monitor. To avoid risks concerning safety or health, strictly observe the warning indications. If you need any assistance concerning the installation, please do not hesitate to contact your authorized distributor.

• Part II contains detailed descriptions of each component of the S/5 FM, such as frame

unit, parameter modules Remote Controller and Device Interfacing Solution. Service check for each product, service menus and all the spare parts information for the Monitor is included.

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.

Installation and service are allowed by authorized service personnel only. GE Healthcare Finland Oy (GE) assumes no responsibility for the use or reliability of its software

in equipment that is not furnished by GE.

Ordering manuals

A paper copy of this manual will be provided upon request. Contact your local GE representative and request the part number on the cover page of the manual.

1 Introduction

The Datex-Ohmeda S/5 FM is a modular multiparameter patient monitor. The monitor is

especially designed for monitoring in intensive care units. It can also be used during

transportation within the hospital.

The modular design makes the system flexible and easy to upgrade. In addition to patient

parameter modularity and easy upgrades, the monitor can be upgraded to wireless

networking. External devices can be interfaced to the monitor with interface modules.

NOTE: Your system may not include all these components. Consult your local representative for

the available components.

Introduction

Figure 1 S/5 FM with N-FCREC (1) and E-PSM (2) modules

1.0.1 Compatibility

S/5 FM is compatible with:

S/5 L-FICU04/A S/5 L-FICU06/A

Patient Side Modules, S/5 E-PSM and E-PSMP

Extension Module S/5 F-FC x x

Extension Modules, S/5 N-FCREC, and N-FREC

Device Interfacing Solution S/5 N-DISxxx, rev. 01 and later

S/5 Network and iCentral x x

Wireless LAN is available with WLAN option F-FMW

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Datex-Ohmeda S/5 FM

Pb/Cd/Hg

1.1 Symbols

1.1.1 Symbols on transport packaging

The contents of the transport package are fragile and must be handled with care.

Indicates the correct upright position of the transport package.

The transport package must be kept in a dry environment.

Indicates the temperature limitations within which the transport package should be stored.

This package can be recycled.

1.1.2 Symbols on equipment

This battery contains lead and can be recycled.

Dangerous voltage.

The separate collection symbol is affixed to a battery, or its packaging, to advise you that the battery must be recycled or disposed of in accordance with local or country laws. The letters below the separate collection symbol indicate whether certain elements (Pb=Lead, Cd=Cadmium, Hg=Mercury) are contained in the battery. To minimize potential effects on the environment and human health, it is important that all marked batteries that you remove from the product are properly recycled or disposed. For information on how the battery may be safely removed from the device, please consult the technical or service manual, or equipment instructions. Information on the potential effects on the environment and human health of the substances used in batteries is available at this url: http://www.gehealthcare.com/euen/weee-recycling/index.html

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1.1.3 Equipment safety symbols

- Attention, consult accompanying documents.

- When displayed next to the HR value, indicates that the pacer is set on R.

- On the N-FC(REC) module indicates that the airway gases should be calibrated every 6 months in normal use and every two months in continuous use to ensure that the measurement accuracy remains within specifications.

- On the E-PSM(P) module:

WARNING Protection against cardiac defibrillator discharge is

- On the rear or bottom panel:

WARNING Electric shock hazard. Do not open the cover or the

WARNING Do not touch the monitor during defibrillation

WARNING Disconnect from the power supply before servicing. WARNING When using the monitor with mounting attached,

CAUTION For continued protection against fire hazard, replace the

CAUTION Lithium battery on the CPU board. Dispose of the battery

Introduction

due in part to the accessories for pulse oximetry (SpO

), temperature (T) and invasive pressure (P)

measurement.

back. Refer servicing to qualified service personnel.

procedure.

make sure that the mounting is manufacturer approved.

fuse only with one of the same type and rating.

in accordance with local environmental and waste disposal regulations.

- On top of the monitor beside the battery cover:

WARNING Use manufacturer recommended batteries only.

Dispose of the batteries in accordance with local environmental and waste disposal regulations.

Type BF (IEC 60601-1) protection against electric shock.

Type BF (IEC 60601-1) defibrillator-proof protection against electric shock.

Type CF (IEC 60601-1) protection against electric shock.

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1.1.4 Other symbols

Type CF (IEC 60601-1) defibrillator-proof protection against electric shock.

When displayed in the upper left corner of the screen, indicates that the alarms are silenced. When displayed in the menu or digit fields, indicates that the alarm source has been turned off or alarm does not meet the alarm-specific activation criteria.

ESD warning symbol for electrostatic sensitive devices. Pins of connectors identified with the ESD warning symbol should not be touched. Connections should not be made to these connectors unless ESD precautionary procedures are used. For details, see section “1.2.2. ESD precautionary procedures”.

Symbol for non-ionizing electromagnetic radiation. Interference may occur in the vicinity of equipment marked with this symbol.

SN, S/N

Equipotentiality. Monitor can be connected to potential equalization conductor.

Alternating current

Fuse. Replace the fuse only with one of the same type and rating.

Serial Number

Submenu. Selecting an alternative marked with this symbol in a menu opens a new menu.

Battery operation and remaining capacity. The height of the green bar indicates the charging level.

Battery (A) charging (white bar)

Battery (A) failure

Both batteries have failed

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Introduction

Battery (A) is missing

In the front panel: mains or external DC power. (External DC power for future use.)

The monitor is connected to the Datex-Ohmeda Network (Local Area Network, LAN).

The monitor is connected to the Datex-Ohmeda S/5 Network (Wireless Local Area Network, WLAN).

Data Card (green) or Menu Card (white) is inserted.

WLAN signal strength. The number of segments corresponds to the signal strength: four segments indicate strong signal, one segment weak signal. When connection to access point is being searched, the segments scroll from zero to four and back.

Ethernet connector

A blinking heart next to the heart rate or pulse rate value indicates the beats detected.

A lung next to the respiration rate value indicates that respiration rate is calculated from the impedance respiration measurement.

Gas inlet

Gas outlet

Do not reuse.

Use by. Indicates the last use day.

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Datex-Ohmeda S/5 FM

Date of manufacturer

Manufacturer name and address

Does not contain Latex.

Do not immerse the sensor in liquids.

IPX class:

IPX0 IPX1 IPX2 IPX3 IPX4 IPX7 IPX8

Degree of protection against harmful ingress of water as detailed in the IEC 60529:

- Ordinary equipment

- Protection against vertically falling water drops.

- Protection against vertically falling water drops when enclosure tilted

up to 15 °.

- Protected against spraying water.

- Protected against splashing water.

- Protected against the effects of temporary immersion in water.

- Protected against the effects of continuous immersion in water.

This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.

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Introduction

1.2 Safety

The following list contains general warnings and cautions you should know before installing, maintaining or servicing the system. Warnings and cautions specific to the use of the system can be found in the User’s Guide and User’s Reference Manual.

1.2.1 Safety precautions

Warnings

WARNING A WARNING indicates a situation in which the user or the patient may be in

danger of injury or death.

• The device is not able to withstand unpacked drops from a height of 1 m. If the device is

dropped, please service the device before taking it back into use.

Power connection

• Always check that the power cord and plug are intact and undamaged.

• Do not use the power cord delivered with this product for any other product or purpose.

• Use only hospital-grade grounded power outlets and power cord. Do not remove the

grounding pin from the power plug.

• Use only an intact and undamaged power cord. Replace the power cord if it is cracked,

frayed, broken or otherwise damaged.

• All system devices must be connected to the same power supply circuit.

• Do not apply tension to the power cord otherwise the cord may get damaged.

• Do not use an additional multiple socket outlet, extension cord or adapters of any kind.

• Before starting to use the system, ensure that the whole combination complies with the

international standard IEC 60601-1-1 and with the requirements of the local authorities. Do not connect any external devices to the system other than those specified.

• When detaching modules, be careful not to drop them. Always support with one hand

while pulling out with the other.

• If the integrity of the external protective earth conductor arrangement is in doubt, use the

monitor with battery operation.

• To avoid the risk of electric shock, this equipment must only be connected to a supply

mains with protective earth.

Installation

• Do not incinerate a battery or store at high temperatures as it will explode.

• The monitor or its components should not be used adjacent to or stacked with other

equipment. If adjacent or stacked use is necessary, the monitor and its components should be observed to verify normal operation in the configuration in which it will be used.

• Pins of connectors identified with the ESD warning symbol should not be touched.

Connections should not be made to these connectors unless ESD precautionary procedures are used. For details, see section “1.2.2. ESD precautionary procedures.”

• After transferring or reinstalling the monitor, always check that it is properly connected

and all parts are securely attached. Pay special attention to this in case of stacked mounting.

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Datex-Ohmeda S/5 FM

• Do not use the monitor in high electromagnetic fields (for example, during MRI.)

• A printer or computer must be supplied from an additional transformer providing at least

• If you accidentally drop the monitor, modules or frames, have them checked by

• To avoid explosion hazard, do not use the monitor in presence of flammable anesthetics.

• Do not touch the patient, table, instruments, modules or the monitor during defibrillation.

• Other transmitting radio devices using the same radio frequency band (Industrial

External connection

• Do not connect any external devices to the monitor other than those specified.

Explosion hazard

• To avoid explosion hazard do not use the monitor in the presence of flammable

• Do not incinerate a battery or store at high temperatures as it will explode.

basic isolation (isolating or separating transformer).

authorized service personnel prior to clinical use.

Scientific and Medical 2.45 GHz band) may degrade or disturb the wireless network communication.

anesthetics.

Patient safety

• Do not perform any testing or maintenance on the monitor while it is being used on a

patient.

• PACEMAKER PATIENTS: The impedance respiration measurement may cause rate

changes in Minute Ventilation Rate Responsive Pacemakers. In this case, set the pacemaker rate responsive mode off or turn the monitor impedance respiration measurement off.

• Never install the monitor so that it is above the patient.

• When using the monitor with mounting attached, make sure that the mounting is

manufacturer approved.

• Operation of the monitor outside the specified values may cause inaccurate results.

Autoclaving and sterilizing

• Do not autoclave any part of the system with steam or sterilize with ethylene oxide.

Cleaning and service

• Only trained personnel with proper tools and test equipment should perform the tests

and repairs described in this manual. Unauthorized service may void the monitor warranty.

• Always unplug the monitor before cleaning or service. After cleaning or service ensure

that every part of the monitor is dry before reconnecting it to the power supply.

• Do not touch any exposed wire or conductive surface while any cover is removed and the

monitor is energized. The voltages present can cause injury or death.

• Pins of connectors identified with the ESD warning symbol should not be touched.

Connections should not be made to these connectors unless ESD precautionary procedures are used. For details, see section “1.2.2. ESD precautionary procedures”.

• NOTE! The monitor is always internally powered when the batteries are connected.

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Introduction

• Electrostatic discharge through the PC boards may damage the components. Before

handling PC boards, wear a grounded antistatic wristband. Handle all PC boards by their non-conductive edges and use antistatic containers when transporting them.

• Do not break or bypass the patient isolation barrier when testing PC boards.

• Always perform an electrical safety check and a leakage current test on the monitor after

service.

• Handle the water trap and its contents as you would any body fluid. Infectious hazard

may be present.

• Do not immerse any part of the device in any liquid, or allow liquid to enter the monitor or

modules.

• If liquid has accidentally entered the system or its parts, disconnect the power cord from

the power supply, remove the batteries from the monitor and have the equipment serviced by authorized service personnel.

• Since calibration gas contains anesthetic agents, always ensure sufficient ventilation of

the room during calibration.

Accessories

• Use only accessories, including mounts, and batteries, and defibrillator-proof cables and

invasive pressure transducers approved by GE Healthcare. For a list of approved supplies and accessories, see the “Supplies and Accessories” catalog. Other cables, batteries, transducers and accessories may cause a safety hazard, damage the equipment or the system, result in increased emissions or decreased immunity of the equipment or system or interfere with the measurement. (Protection against cardiac defibrillator discharge is due in part to the accessories for pulse oximetry (SpO2), temperature (T) and invasive pressure (P) measurement.)

• Single-use products are not designed to be reused. Reuse may cause a risk of

cross-contamination, affect the measurement accuracy and/or system performance, or cause a malfunction as a result of the product being physically damaged due to cleaning, disinfection, re-sterilization and/or reuse.

Special components

Special components are used in these monitors that are vital to assure reliability and safety. GE Healthcare assumes no responsibility for damage, if replacement components not approved by GE Healthcare are used.

Batteries

The Lithium Ion batteries are recyclable. Follow your local recycling guidelines. Refresh the batteries completely every six months. To replace the batteries safely, please refer to the service instructions in this manual.

• Do not short-circuit the battery terminals, this may produce a very high current, which will

damage the battery.

• Do not dispose of the battery into open flame, nor put the battery near fire, as it may

explode.

• Do not dismantle the battery.

• After replacing a battery, always make sure to close the battery compartment by sliding

the lid back to the right until it clicks.

1.2.2 ESD precautionary procedures

•

To avoid electrostatic charges building up, it is recommended to store, maintain and use the equipment at a relative humidity of 30% or greater. Floors should be covered by ESD

dissipative carpets or similar. Non-synthetic clothing should be used when working with the component.

• To prevent applying a possible electrostatic discharge to the ESD sensitive parts of the

equipment, one should touch the metallic frame of the component or a large metal object located close to the equipment. When working with the equipment and specifically when the ESD sensitive parts of the equipment may be touched, a grounded antistatic wristband intended for use with ESD sensitive equipment should be worn. Refer to the documentation provided with the wristbands for details of proper use.

ESD precautionary procedure training

It is recommended that all potential users receive an explanation of the ESD warning symbol and training in ESD precautionary procedures.

The minimum contents of an ESD precautionary procedure training should include an introduction to the physics of electrostatic charge, the voltage levels that can occur in normal practice and the damage that can be done to electronic components if they are touched by an operator who is electrostatically charged. Further, an explanation should be given of methods to prevent build-up of electrostatic charge and how and why to discharge one’s body to earth or to the frame of the equipment or bond oneself by means of a wristband to the equipment or the earth prior to making a connection.

Introduction

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Datex-Ohmeda S/5 FM

486

Processor

CMCIA

Serial Ether

net

Sound UPI

Chip

set

Displ

Controller

486 LOCAL BUS

ISA-BUS

DRAM

Reset Logic

Non-

Volatile

Memory

Boot

Memory

Code

Memory

Patient

Modules

Fm_p1_gnrl_bus_strctr_cm.vsd

MODULE-BUS

2 System description

2.1 Introduction

Datex-Ohmeda monitors build up a freely configurable modular system. The architecture is designed to enable different module combinations so that the user is able to get the desirable parameter and feature set. This modular approach makes it possible to add new features when they are needed.

2.2 Bus structure

The operation of Datex-Ohmeda FM is based on two communication channels, the CPU bus and module bus. All units, including the modules, receive power from the same power supply, which is an integral part of the monitor frame.

Figure 2 General bus structure of S/5 FM

The CPU bus is a communication channel used only for internal data transfer. It is based on the ISA bus used in IBM PC computers. Data is transferred on this 16 bit wide bus using the CPU

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clock frequency. The module bus is for the parameter modules. The bus is based on the industry standard

RS-485, which uses a differential serial method to transfer data. This type of bus is robust and it allows parameter modules to be inserted or removed while the power is on. The module bus uses a 500 kbps data transfer rate.

The RS-485 type of serial communication supports so-called multidrop or party line

UPI

Processor

Shared

SRAM

Control

Logic

ISA-BUS

Voltage

Meas

Temp

Meas

Keypad Interface

ComWheel I nterface

Module Bus

Analog & Digit al outputs

cam_p1_prncpl_UPI_operation.vsd

connections. This means that all parameter modules connected to the module bus use exactly the same lines for communication. The advantage of this is that all bus connectors are identical and the modules can be connected in any order and position.

2.3 Distributed processing

A system assembled from Datex-Ohmeda products is a multiprocessor system. All parameter modules have their own microprocessor, which performs functions such as module key control, waveform filtering, parameter related computing and pneumatic control, etc. At the same time the main CPU performs higher level tasks such as trending and alarm control. While the parameter modules and CPU are performing their tasks, the UPI (Universal Peripheral Interface) microprocessor handles all functions needed to transfer data between the parameter modules and the CPU.

This kind of parallel processing gives one major advantage to centralized processing. When new parameter modules are added to the system, the processing power is increased. As a result, the system does not slow down when new features are added.

2.4 Module communication

The communication master controlling data transfers between the CPU and parameter modules is called UPI processor. It sends data to each connected module 100 times a second. Modules respond to each data request immediately by sending a data package, whose length depends on the type of the module. This communication protocol ensures that each module receives and sends data every 10 ms. If a module does not respond to data requests, the UPI processor presumes that the module is disconnected.

Parameter modules may hold a static (fixed) or dynamic address, which the UPI processor uses when sending out data. Two parameter modules of the same type must not be fitted onto the same monitor since they might reply to a data request simultaneously, thus causing communication errors.

System description

Figure 3 Principle of UPI section operation

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The UPI processor collects and stores all data that is received from the parameter modules into a shared SRAM, which is mapped directly to the address space of the main CPU. The main CPU reads data from the memory while the UPI processor guarantees that the data is up to date. This operation also works in the other direction. In this the main CPU fills the shared SRAM with data and the UPI processor distributes it to the parameter modules.

2.5 Software loading

The program memory on the CPU board is loaded with monitor software at the factory. The software is used for running all the functions that are integrated into the PC board.

F-FM(W)-00

For service and upgrade procedures, the software loading is done by using a PCMCIA card or the SWDL Tool.

F-FM(W)-01

For service and upgrade procedures, the software loading is done by using the SWDL Tool only.

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2.6 Parameter modules

Module Bus

Isolation

transformer

RS485 drivers

Peripheral

drivers

A/D

converter

CPU

Analog

electronics

Opto

isolation

RAM

EEPROM

Patient isolation

PATIENT

Module

keys

Data

+13...16 V

VMOD

+5 V

+12 V

System description

Figure 4 General structure of parameter modules with patient isolation

The detailed structure of a parameter module depends on the specific needs for each individual parameter. However, some common parts are used in the parameter modules. The electronics inside the module is usually divided into isolated (floating) and non-isolated sections. Typically, the non-isolated section consists of buffers to interface the parameter module to the module bus while the rest of the electronics is located in the isolated section. The isolated section includes the microcontroller together with memory components, the front-end analog electronics (amplifiers, etc.) and sensor drivers.

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3 System installation

3.1 Unpacking instructions

1. Confirm that the packing box is undamaged. If the box is damaged, contact the shipper.

2. Open the top of the box and carefully unpack all components.

3. Confirm that all components are undamaged. If any of the components is damaged, contact the shipper.

4. Confirm that all components are included. If any of the components is missing, contact your GE Healthcare distributor.

3.2 Choosing location

Consider the following aspects:

• lighting

• space

• connections

• electromagnetic and radio frequency interference. For details see Appendix B.

ElectroMagnetic Compatibility

• environment

WARNING The monitor or its components should not be used adjacent to or stacked

with other equipment. If adjacent or stacked use is necessary, the monitor and its components should be observed to verify normal operation in the configuration in which it will be used.

CAUTION The monitor display is fragile. Ensure that it is not placed near a heat source or

exposed to mechanical shocks, pressure, moisture or direct sunlight.

3.3 Mounting the S/5 FM

Mounting of S/5 FM to the Wall Mount, Rollstand, Wall Mount with standard arm or Counter Top Mount is described in a separate instruction sheet delivered with each mount.

WARNING After transferring or reinstalling the monitor, always check that it is

properly connected and all parts are securely attached. Pay special attention to this in case of stacked mounting.

WARNING The monitor must not be used without a manufacturer approved mounting

attached.

WARNING Never install the monitor so that it is above the patient.

3.3.1 E-PSM(P) Mounting Accessories

Intended use

The Module Bus Adapter for PSM is intended for connecting the Pole Mount for PSM to the Datex-Ohmeda S/5 FM monitor.

With Module Bus Adapter, the Pole Mount for PSM, short or long, can be connected to the Datex-Ohmeda S/5 FM monitor. The E-PSM(P) module can be removed from the FM monitor and docked to the Pole Mount for PSM, short or long.

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Figure 5 E-PSM(P) mounting accessories

1. M1051025 Module Bus Adapter for PSM

2. M1049197 Pole Mount for PSM, short

3. M1051023 Pole Mount for PSM, long

System installation

WARNING Make sure that the Pole Mount for PSM is always used in vertical position to

prevent water from entering the E-PSM(P) module.

Pole Mount for PSM – Instructions for connecting to an IV pole, vertical position

Fasten the Pole Mount for PSM with the fastening screw of the clamp and tighten properly to an IV pole.

Pole Mount for PSM - Instructions for installing in horizontal position.

Remove the 2 screws from the clamp, turn the clamp and insert and tighten the screws back. Fasten the Pole Mount for PSM with the fastening screw of the clamp and tighten properly to a horizontal tube or rail with a diameter of 10 mm*25 mm.

Pole mount for PSM – Instructions for connecting to monitor

1. Attach the E-PSM(P) module to the Pole Mount.

2. Connect the cable of the Pole Mount for PSM to the S/5 FM monitor with the Module Bus adapter for PSM (M1031025).

3. Check the module communication of the E-PSM(P) module.

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3.3.2 Monitor connections

Figure 6 S/5 FM front panel

(1) Battery compartment (2) Transportation handle (3) Alarm light (4) Alarm LED indicators (5) Side panel keys (6) The ComWheel (7) Command Board keys (8) Guide rail for GCX mounting (9) Mains power and battery LEDs (10) ON/standby key (11) Connector for the Device Interfacing Solution (X6) (12) Connector for defibrillator synchronization (X5) (13) Measurement modules (14) Slot for Data Card or Menu Card

You can use one E-PSM(P) and/or one N-F(C)(REC) module in the monitor at a time.

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System installation

Figure 7 Rear panel connections

(1) Slot for infusion pole mounting (2) Module connector (3) Guide rail for GCX mounting (4) Receptacle for power cord (5) Fuse holder (6) Serial port X9 (7) Network ID X8 (8) Connector for K-CREMCO X7 (9) Optional: Multi I/O adapter incorporating connectors 6 - 8 mentioned above (10) Network connector X1 (11) Equipotential connector (12) Slot for Data Card or Menu Card (13) Defibrillator & IABP sync connector X5 (14) Connector for the Device Interfacing Solution (X6)

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Battery charging

3.3.3 Connection to mains

Connect the power cord to the mains power inlet (4) at the back of the monitor and to the wall socket.

NOTE: Before taking the monitor into use for the first time, the batteries should be fully charged. Keep the monitor connected to the mains until the Battery charging symbol disappears, or in STBY mode the Orange Battery condition LED is off (may take up to 5 hours if the batteries are fully discharged).

WARNING The power cord may only be connected to a three-wire, grounded, hospital

grade receptacle.

3.3.4 Connection to Network

Use the Monitor-Network cable to connect the monitor to the network.

1. Make sure that the power is switched off.

2. Connect the Identification Plug and one RJ-45 connector to the connectors X8 and X1 at the back of the monitor.

3. Connect the other RJ-45 connector to the corresponding connector on the wallbox.

4. Switch on the power. Confirm that the network connection is indicated in the upper

part of the screen.

3.3.5 Connection to Wireless Network

Wireless LAN is available only with S/5 FM Wireless LAN option F-FMW.

1. Disconnect the network cable.

2. The monitor will automatically connect to the Wireless LAN.

3. Confirm that the wireless LAN network symbol and the wireless LAN signal strength symbol are displayed in the upper part of the screen.

NOTE: The WLAN configuration in the monitor has to be set to correspond to the hospital WLAN.

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+ 338 hidden pages

Datex-Ohmeda S-5 FM Technical Reference Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

GE Healthcare