FM Light Technical Reference Manual 1st edition June 2007

Intended purpose (Indications for use) The Datex-Ohmeda FM Light is intended for multiparameter patient monitoring. The FM Light with L-FICU05L 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 is indicated for patients who weigh over 5 kg (11 lbs). The FM Light and N-F(C)(REC) Extension Module are indicated for use by qualified medical personnel only. The patient side module E-PSMP (consisting E-PSM and E-PSMP 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 arrythmia), 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 NIPB measurement is indicated for patients who weigh 5 kg (11 lb) and up.

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 FM Light 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 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 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 GE Healthcare Finland Oy. 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.

Master Table of Contents

Datex-Ohmeda FM Light Technical Reference Manual, Order code: M1056768 Part I, General Service Guide Document No.

Updated

Description

M1090671

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

1

M1090673

Planned Maintenance Instructions

2

Part II, Product Service Guide Document No.

Updated

Description

M1056769

L-FICU05L, Service Menu

1

M1090675

Frame for FM Light, F-FML

2

M1090677

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

3

M1022498-5

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

4

M1027838-6

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

5

FM Light, F-FML Spare Parts

6

M1090680

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Table of contents

Table of contents Master Table of Contents

1

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

17

Unpacking instructions... 17 Choosing location... 17 Mounting the FM Light... 17 3.3.1 E-PSM(P) Mounting Accessories... 17 3.3.2 Monitor connections... 19 3.3.3 Connection to mains... 20 3.3.4 Connection to Network... 21 3.3.5 Inserting and removing the parameter modules... 21 3.3.6 Monitor software installation... 22 Remote Controller, K-CREMCO... 24 Visual indicators... 25 Troubleshooting... 25

Interfacing 4.1 4.2

13

Introduction... 13 Bus structure... 13 Distributed processing... 14 Module communication... 14 Software loading... 15 Parameter modules... 15

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... 5 1.1.4 Other symbols... 6 Safety... 9 1.2.1 Safety precautions... 9 1.2.2 ESD precautionary procedures... 12 1.2.3 Disposal... 12

27

Interfacing computer... 27 Output signals... 27 i Document no. M1090671

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4.2.1 Digital outputs... 28 4.2.2 Analog outputs... 28

5

Functional check 5.1 5.2 5.3

6

Recommended tools... 29 Visual inspection... 30 Functional inspection... 31 5.3.1 General... 31 5.3.2 Display... 31 5.3.3 Keyboard(s)... 32 5.3.4 Frame unit... 32 5.3.5 Extension Module with CO2 measurement... 32 5.3.6 Multiparameter Hemodynamic Modules... 32 5.3.7 Recorder... 33 5.3.8 Network connection... 33 5.3.9 General... 34

General troubleshooting 6.1

29

35

Software troubleshooting chart... 36

Appendix A:

Functional check form, Datex-Ohmeda FM Light

A-1

Appendix B:

ElectroMagnetic Compatibility

B-1

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List 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

Datex-Ohmeda FM Light with N-FCREC (1) and E-PSMP (2) modules ... 3 General bus structure of FM Light...13 Principle of UPI section operation ...14 General structure of parameter modules with patient isolation...15 E-PSM(P) mounting accessories ...18 FM Light font panel...19 Rear panel connections ...20 Software installation...22 FM Light general troubleshooting flowchart...35 Software troubleshooting ...36

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List of tables Table 1 NET ID connector, X8 on Multi I/O adapter ... 27 Table 2 Defib & IABP sync connector, X5... 27 Table 3 Patient simulators’ compatibility with each hemodynamic module... 30 Table 4 Adapter cables for hemodynamic patient simulators... 30 Table 5 Guidance and manufacturer’s declaration – electromagnetic emissions... 1 Table 6 Guidance and manufacturer’s declaration – electromagnetic immunity... 2 Table 7 Guidance and manufacturer’s declaration – electromagnetic immunity... 3 Table 8 Recommended separation distances between portable and mobile RF communications equipment and the S/5™ FM /Datex-Ohmeda FM Light ... 5

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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 FM Light running the software license L-FICU05L.

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 manual is M1056768. The manual includes Technical Reference Manual Slots and every slot has an individual document number. M1090671 is the document number of this first slot. This is the first edition of the manual.

•

Part I gives the reader an overview of the FM Light. 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 FM Light, Monitor, such as frame unit, parameter modules and Remote Controller. 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.

Related documentation For instructions for daily use including cleaning and daily maintenance, clinical aspects and basic methods of measurement see: FM Light, User’s Guide FM Light, User’s Reference Manual For more information about the iCentral, see the “Technical Reference Manuals” and ”User’s Reference Manual” for this product. Software options and default settings are described in the “Default Configuration Worksheet” delivered with each monitor. Available accessories are described in the “Supplies and Accessories” catalog delivered with each monitor.

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Conventions used To help you find and interpret information easily, the manual uses consistent text formats:

"

Sign the check form after performing the procedure.

Hard Keys

Names of the hard keys on the Remote Controller, Command Board, side panel and modules are written in the following way: Others.

Menu Items

Software terms that identify window parts or menu items are written in bold italic: ECG Setup. Menu access is described from top to bottom. For example, the selection of the Monitor Setup hard key, the Screen 1 Setup menu item and the Waveform Fields menu item would be shown as Monitor Setup - Screen 1 Setup - Waveform Fields.

‘Messages’

Messages (alarm messages, informative messages) displayed on the screen are written inside single quotes: ‘Please wait’.

“Sections”

When referring to different sections in this manual or to other manuals, manual names and section names are enclosed in double quotes: See section "Cleaning and care." Please refer to "User's Reference Manual: Alarms."

Hypertext links Hypertext links on PDF versions are written in blue color. WARNING

Warnings are written in the following way:

WARNING

This is a WARNING.

CAUTION

Cautions are written in the following way:

CAUTION

This is a CAUTION.

NOTE

Notes are written in the following way: NOTE: This is a NOTE. In this manual, the word “select” means choosing and confirming.

Illustrations and names All illustrations in this manual are only examples, and may not necessarily reflect your system settings or data displayed in your system. If a particular selection is not available in your system, the selection is shown grayed.

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Introduction

1

Introduction The Datex-Ohmeda FM Light 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. NOTE: Your system may not include all these components. Consult your local representative for the available components.

1 2

Figure 1

Datex-Ohmeda FM Light with N-FCREC (1) and E-PSMP (2) modules

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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

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Introduction

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 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 this symbol 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.

-

Do not touch a battery-operated monitor during defibrillation procedure.

-

Disconnect from the power supply before servicing.

-

Do not use the monitor without manufacturer approved mounting attached.

-

Lithium battery on the CPU board: follow the regional regulations for disposal.

-

Do not touch the monitor during defibrillation procedure.

-

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 electric 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 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.

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 Network (Local Area Network, LAN). 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.

Date of manufacturer

Does not contain Latex.

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Do not immerse the sensor in liquids. Degree of protection against harmful ingress of water as detailed in the IEC 60529:

IPX class: IPX0 IPX1 IPX2 IPX3 IPX4 IPX7 IPX8

- 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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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. Power connection

•

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

•

When detaching Patient Side 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.

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.

Installation

• •

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

•

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.

• • •

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

•

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

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.

Never install the monitor so that it is above the patient. If you accidentally drop the monitor, modules or frames, have them checked by authorized service personnel prior to clinical use.

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•

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

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

•

To avoid 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 so that it is above the patient. The monitor must not be used without manufacturer approved mounting attached. Operation of the monitor outside the specified values may cause inaccurate results.

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.

•

Handle the water trap and its contents as you would any body fluid. Infectous hazard may be present.

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 GE Healthcare. 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

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Introduction

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 reused. Reuse may cause a risk of contamination and/or affect the measurement accuracy.

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 connecting the power cord to the power supply, check that the local voltage and frequency correspond with the rating stated on the device plate.

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 pressurized air to any outlet or tubing connected to the 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. If liquid has accidentally entered the system or its parts, disconnect the power cord from the power supply and have the equipment serviced by authorized service personnel.

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.

• 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. Refresh the batteries completely every six months. To replace the batteries safely, please refer to the service instructions in this manual.

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•

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, pressure and humidity ranges: Temperature Atmospheric pressure Relative humidity

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

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 wrist strap intended for use with ESD sensitive equipment should be worn. Refer to the 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 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 wrist strap to the equipment or the earth prior to making a connection.

1.2.3 Disposal Dispose of the whole device, parts of it and its packing material and manuals in accordance with local environmental and waste disposal regulations.

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