S5 FM Technical Reference Manual Dec 2004

Intended purpose (Indications for use) The Datex-Ohmeda S/5 FM is intended for multiparameter patient monitoring. The S/5 FM with L-FICU04 or L-FICU04A software is indicated for monitoring of hemodynamics (including arrhythmia and ST-segment analysis) and respiratory status of all hospital patients. Impedance respiration measurement is indicated for patients three years old and up. NIBP and CO2 (using option N-FCREC or N-FC) measurements are indicated for patients weighing over 5 kg (11lb). The S/5 FM is indicated for use by qualified medical personnel only.

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 B

• 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 B equipment is suitable for use in domestic establishments and in establishments directly connected to a low voltage power supply network which supplies buildings used for domestic purposes.

Responsibility of the manufacturer Datex-Ohmeda Division, Instrumentarium Corporation 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 Datex-Ohmeda.

• the electrical installation of the monitor room complies with appropriate requirements. • the equipment is used in accordance with the “User's Guide.” Trademarks Datex®, Ohmeda®, and other trademarks S/5, D-lite, D-lite+, Pedi-lite, Pedi-lite+, D-fend, D-fend+, Mini D-fend, OxyTip+, MemCard, ComWheel, ComBar, EarSat, FingerSat, FlexSat, PatientO2, Patient Spirometry, Entropy and Tonometrics are property of Instrumentarium Corp. or its subsidiaries. All other product and company names are property of their respective owners.

Master table of contents

Datex-Ohmeda S/5TM FM Technical Reference Manual, Order code: M1037383 Part I, General Service Guide Document No.

Updated

Description

M1024149-4

Introduction, System description, Installation, Interfacing, Functional check, General troubleshooting

1

M1022497-3

Planned Maintenance Instructions

2

Part II, Product Service Guide Document No.

Updated

Description

M1022499-3

S/5TM FM Service Menu

1

M1018511-5

S/5TM Frame for FM

2

M1024662-3

S/5TM Patient Side Module, E-PSM, E-PSMP

3

M1022498-3

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

4

M1027838-3

S/5TM Remote Controller, K-REMCO, K-CREMCO

5

S/5TM Device Interfacing Solution, N-DIS

6

S/5TM FM Spare Parts

7

M1038658 M1022500-4

Document No. M1037383

Datex-Ohmeda S/5TM FM

Document No. M1037383

Table of contents

Table of contents Table of contents

i

Table of figures

iii

List of tables

iv

About this manual

1

1

3

Introduction 1.1

1.2

2

System description 2.1 2.2 2.3 2.4 2.5 2.6

3

3.4 3.5 3.6

16

Unpacking instructions...16 Choosing location...16 Mounting the S/5 FM...16 3.3.1 Monitor connections...17 3.3.2 Connection to mains...18 3.3.3 Connection to Network...19 3.3.4 Connection to Wireless Network...19 3.3.5 Inserting and removing the parameter modules...20 3.3.6 Downloading Monitor Software...20 3.3.7 Installing the S/5 Wireless Network Upgrade, U-FMW...21 3.3.8 Installing the S/5 Wireless Network Service Option, N-FMWS...24 S/5 Remote Controller, K-CREMCO...25 Visual indicators...25 Troubleshooting...25

Interfacing 4.1

12

Introduction...12 Bus structure...12 Distributed processing...13 Module communication...13 Software loading...14 Parameter modules...14

System installation 3.1 3.2 3.3

4

Symbols... 4 1.1.1 Symbols on transport packaging... 4 1.1.2 Symbols on equipment... 4 1.1.3 Equipment safety symbols... 4 1.1.4 Other symbols... 6 Safety... 8 1.2.1 Safety precautions... 8 1.2.2 ESD precautionary procedures...11 1.2.3 Disposal...11

27

Interfacing external bedside devices via S/5 Device Interfacing Solutions, N-DISxxx...27 4.1.1 Interfaced devices and parameters...27 4.1.2 Device Interfacing Solution components...28

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4.2

4.3 4.4

5

Functional check 5.1 5.2 5.3

6

4.1.3 Connections...28 4.1.4 Mounting...29 4.1.5 Selecting the external device...29 4.1.6 Functional check...30 4.1.7 Selecting the parameter data source...30 Interfacing printer...30 4.2.1 Setting S/5 FM interface for printers...30 4.2.2 Connection to serial printers...31 4.2.3 Connection to parallel printers...31 4.2.4 Installing the Serial-to-Parallel Converter, order code 78030...31 4.2.5 Connection to printer...32 Interfacing computer...32 Output Signals...32 4.4.1 Digital outputs...33 4.4.2 Analog outputs...33

35

Recommended tools...35 Visual inspection...36 Functional inspection...36 5.3.1 General...36 5.3.2 Display...37 5.3.3 Keyboard(s)...37 5.3.4 Frame unit...37 5.3.5 Extension Module with CO2 measurement...38 5.3.6 Hemodynamic Modules...38 5.3.7 Data Card and Menu Card function...39 5.3.8 Recorder...39 5.3.9 Network connection...39 5.3.10 Wireless Network Option...39 5.3.11 Device Interfacing Solution, N-DISxxx...39 5.3.12 General...40

General troubleshooting

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41

Table of figures

Table of figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Figure 8 Figure 9 Figure 10

S/5 FM with N-FCREC (1) and E-PSM (2) modules ... 3 General bus structure of S/5 FM ... 11 Principle of UPI section operation... 12 General structure of parameter modules ... 13 S/5 FM front panel... 15 Rear panel connections... 16 Connection cables and LED indicators ... 22 An example of interfacing external devices with Device Interfacing Solution ... 23 Connecting S/5 FM monitor to printer ... 25 S/5 FM general troubleshooting flowchart... 34

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List of tables Table 1 Monitor interfaces... 27 Table 2 Blood gas analyzers ... 27 Table 3 NET ID connector, X8 on Multi I/O adapter ... 32 Table 4 Defib & IABP sync connector X5 ... 33 Table 5 Guidance and manufacturer’s declaration – electromagnetic emissions ...B-1 Table 6 Guidance and manufacturer’s declaration – electromagnetic immunity ...B-2 Table 7 Guidance and manufacturer’s declaration – electromagnetic immunity ...B-3 Table 8 Recommended separation distances between portable and mobile RF communications equipment and the S/5™ FM ...B-5

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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 Datex-Ohmeda S/5 FM. This Technical Reference Manual is divided into two parts in one folder:

•

The order code for the entire printed manual is M1021563. The manual includes Technical Reference Manual Slots and every slot has an individual document number. M1027807 is the document number of this slot.

•

Part I gives the reader an overview of the S/5 FM monitor and all monitor specific components. This part of the manual contains the information needed to install, interface and troubleshoot 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 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 gives detailed descriptions of each component of the S/5 FM monitor, such as frame unit and parameter modules, Remote Controller and Device Interfacing Solution. Service check for each product is included in these slots. Service Menu slot contains all the service menus and Spare Parts slot all the spare parts information for this monitor. 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. Datex-Ohmeda assumes no responsibility for the use or reliability of its software in equipment that is not furnished by Datex-Ohmeda.

Related documentation S/5 FM For more specific information about the clinical aspects and technical background refer to: S/5 FM, User’s Guide S/5 FM, User’s Reference Manual For more specific information about other devices closely related to the S/5 FM refer to: GE Datex-Ohmeda S/5 iCentral, User’s Reference Manual

Conventions used Throughout this manual, the following conventions are used to distinguish procedures or elements of text:

"

Sign the check form after performing the procedure.

Hard Keys

Hard key names on the Command Board, the Remote Controller and modules are written in the following way: ECG.

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Datex-Ohmeda S/5TM FM Menu Items ‘Messages’ “Sections”

Menu items are written in bold italic: ECG Setup. Messages displayed on the screen are written inside single quotes: ‘Please wait’. When referring to different sections in the same manual, the section name is enclosed in double quotes: section “Cleaning and Service.” “Other documents” When referring to different documents, the document name is enclosed in double quotes: refer to “User’s Reference Manual”. Hypertext links Hypertext links on PDF versions are written in blue color. WARNING Warnings are written in the following way:

WARNING

Use only hospital-grade grounded electrical outlets and power cord.

CAUTION

Cautions are written in the following way:

CAUTION

The circuit boards contain sensitive integrated circuits that can be damaged by an electrostatic discharge. Careful handling of the boards is therefore essential.

NOTE

Notes are written in following way: NOTE: Only one E-PSM(P) module and one N-F(C)(REC) module can be attached to S/5 FM.

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Introduction

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.

1 2

Figure 1

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

Compatibility S/5 FM is compatible with: S/5 L-FICU03/A

S/5 L-FICU04/A

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

x

x

Extension Module S/5 F-FC

x

x

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

x

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

x

S/5 Network and iCentral Wireless LAN is available with WLAN option F-FMW

x

x x

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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.

1.1.2

Symbols on equipment This battery contains lead and can be recycled.

Pb

1.1.3

Equipment safety symbols -

-

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Attention, consult accompanying documents. When displayed next to the HR value, indicates that there is a risk that the monitor counts * pacemaker spikes because the pacer is set on R. * T-waves because a wide QRS is selected.

Introduction

-

On the E-NMT, M-NMT module indicates the following warnings: * Do not place the NMT stimulating electrodes on the patient’s chest. * Always stop the NMT measurement before handling the stimulating electrodes. * Never subject a patient with an implanted electronic device to electrical stimulation without consulting a medical specialist first.

-

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 indicates that protection against cardiac defibrillator discharge is due in part to the accessories for pulse oximetry (SpO2), temperature (T) and invasive pressure (P) measurement. - On the rear or bottom panel indicates the following warnings and cautions: - Electric shock hazard. Do not open the cover or the back. Refer servicing to qualified service personnel. - For continued protection against fire hazard, replace the fuse only with one of the same type and rating. - Disconnect from the power supply before servicing. - Do not touch the monitor during defibrillation procedure. - Do not use the monitor without manufacturer approved mounting attached. - Lithium battery on the CPU board: follow the regional regulations for disposal. On top of the monitor beside the battery cover - Use manufacturer recommended batteries only. Follow the regional regulations for disposal

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

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

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

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

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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 “ESD precautionary procedures” in the User’s Reference Manual. Symbol for non-ionizing electromagnetic radiation. Interference may occur in the vicinity of equipment marked with this symbol.

1.1.4

Other symbols Equipotentiality. Monitor can be connected to potential equalization conductor. Alternating current Fuse. Replace the fuse only with one of the same type and rating.

SN, S/N

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

A B

B

B

B

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

B

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Battery (A) is missing

Introduction

In the front panel: mains or external DC power

The monitor is connected to the Datex-Ohmeda S/5 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. 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.

Do not immerse the sensor in liquids.

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IPX class:

Degree of protection against harmful ingress of water as detailed in the IEC 60529: - Protection against vertically falling water drops

IPX1

Date of manufacture

Ethernet connector

1.2

Safety The following list contains general warnings and cautions you should know before installing, maintaining or servicing the system. Warnings and cautions spesific 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. Power connection • Before connecting the power cord to the mains outlet, check that the local voltage and frequency correspond with the rating stated on the device plate on the rear panel.

•

Connect the monitor to a three-wire, grounded, hospital grade power outlet. Do not remove the grounding pin from the power plug.

•

Use only an intact power cord. Replace the power cord if it is cracked, frayed, broken or otherwise damaged.

• • •

Do not apply tension to the power cord otherwise the cord may get damaged. Do not use extension cords or adapters of any type. 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.

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

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Introduction

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.External

connection • Do not connect any external devices to the monitor other than those specified. Fuse replacement • Replace a fuse only with one of the same type and rating. Explosion hazard • Do not use the monitor in the presence of flammable anesthetics. • Do not incinerate a battery or store at high temperatures as it will explode. 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 or the displays so that they are above the patient. The monitor must not be used without manufacturer approved mounting attached.

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.

•

Turn the power off and unplug the power cord before cleaning or service. Completely remove any moisture before reconnecting the power cord to the mains outlet.

•

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 1.2.2. ESD precautionary procedures

• •

NOTE! The monitor is always internally powered when the batteries are connected. Always perform an electrical safety check and a leakage current test on the monitor after service.

Accessories • Use only accessories, including mounts and batteries, and defibrillator-proof cables and invasive pressure transducers approved by Datex-Ohmeda. For a list of approved supplies and accessories, see the “Supplies and Accessories” catalog delivered with the monitor. 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 accessories are not designed to be re-used. Re-use may cause a risk of contamination and affect the measurement accuracy.

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Cautions CAUTION

A CAUTION indicates a condition that may lead to equipment damage or malfunction. Installation • Leave space for air circulation to prevent the monitor from overheating. Before use • Allow two minutes for warm-up and note any error messages or deviations from normal operation.

Autoclaving and sterilizing • Do not autoclave any part of the monitor. • Do not gas sterilize the modules. Cleaning and service • Do not use hypoclorite, ammonia-, phenol-, or acetone based cleaners. These cleaners may damage the monitor surface.

•

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

• •

Do not apply pressurezed air to any outlet or tubing connected to monitor.

•

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

Electrostatic discharge through the PC boards may damage the components. Before handling PC boards, wear a static control wrist strap. Handle all PC boards by their non-conductive edges and use anti-static containers when transporting them.

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

• A lithium battery on the CPU Board. Dispose of the faulty IC containing the battery according to local regulations.

Batteries The Lithium Ion batteries are recyclable. Follow your local recycling guidelines. To replace the batteries safely, please refer to the 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..

See also section “Symbols”.

Storage and transport Do not store or transport the monitor outside the specified temperature and pressure ranges: Temperature -10...+50 °C/14...122 °F

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Introduction

Temperature Atmospheric pressure Relative humidity

1.2.2

-20...+60 °C/-4...140 °F 660...1060 hPa/500...800 mmHg/660...1060 mbar 10...90% non-condensing

ESD precautionary procedures • •

To avoid electrostatic charges to build 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 to 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 wrist strap intended for use with ESD sensitive equipment should be worn. Refer documentation provided with the wrist straps 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 content 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 wrist strap to the equipment or the earth prior to making a connection.

1.2.3

Disposal Dispose of the whole device and parts of it according to local environmental and waste disposal regulations.

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2

System description

2.1

Introduction Datex-Ohmeda S/5 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 S/5 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.

Patient Patient Patient Modules Module Module

MODULE-BUS

PCMCIA

Serial

Ethernet

Sound

UPI

Code Memory

Chipset

DRAM

Display Controller

486 LOCAL BUS

NonVolatile Memory

Reset Logic

Figure 2

Boot Memory

486 Processor

cam_p1_gnrl_bus_strctr_cm.vsd

ISA-BUS

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 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 12 Document no. M1024149-4