S5 Compact Anesthesia and Critical Care Monitor Technical Reference Manual March 2006

Intended purpose (Indications for use) The Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE05 or L-CANE05A software is intended for multiparameter patient monitoring with optional patient care documentation. The S/5 Compact Anesthesia Monitor with L-CANE05 or L-CANE05A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), Entropy (State Entropy and Response Entropy) and neurophysiological status of all hospital patients. The S/5 Compact Anesthesia Monitor with L-CANE05 and L-CANE05A software when using BIS is for monitoring the state of the brain by data acquisition and processing of electroencephalograph signals and may be used as an aid in monitoring the effects of certain anesthetic agents. The S/5 Compact Anesthesia Monitor with L-CANE05 or L-CANE05A software is also indicated for documenting patient care related information. The S/5 Compact Anesthesia Monitor with L-CANE05 or L-CANE05A software is indicated for use by qualified medical personnel only. The Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU05 or L-CICU05A software is intended for multiparameter patient monitoring. The S/5 Compact Critical Care Monitor with L-CICU05 and L-CICU05A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS) and neurophysiological status of all hospital patients. The S/5 Compact Critical Care Monitor with L-CICU05 and L-CICU05A software when using BIS is for monitoring the state of the brain by data acquisition and processing of electroencephalograph signals and may be used as an aid in monitoring the effects of certain anesthetic agents. The S/5 Compact Critical Care Monitor with L-CICU05 and L-CICU05A software 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 Compact Anesthesia Monitor 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 safety, reliability and performance of the product only if:

• modifications, service and repairs are carried out by personnel authorized by GE. • the electrical installation of the room complies with appropriate requirements. • the equipment is used in accordance with the User's Guide and serviced and maintained in accordance with the Technical Reference Manual.

Trademarks Datex, Ohmeda, S/5, D-lite, D-lite+, Pedi-lite, Pedi-lite+, Mini D-fend, D-fend, D-fend+, OxyTip+, MemCard, ComWheel, EarSat, FingerSat, FlexSat, PatientO2, Entropy, Patient Spirometry and Tonometrics are trademarks of GE Healthcare Finland Oy. All other product and company names are property of their respective owners. A portion of the Entropy software is derived from the RSA Data Security, Inc. MD5 Message-Digest Algorithm.

Master table of contents

Datex-Ohmeda S/5TM Compact Anesthesia Monitor S/5TM Compact Critical Care Monitor Technical Reference Manual, Order code: M1021567 Part I, General Service Guide Document No.

Updated

Description

M1031517-02

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

1

M1031518-02

Planned Maintenance Instructions

2

Part II, Product Service Guide Document No.

Updated

Description

M1031519-01

CAM, CCCM Service Menu

1

M1031520-02

Display Unit for F-CM1, F-CMC1 rev. 00...04 F-CMREC1, F-CMCREC1 rev .00...02 Software Licenses L-CANE05(A), L-CICU05(A)

2

M1044470-01

Frame Unit for F-CM1, F-CMC1 rev. 00...04 F-CMREC1, F-CMCREC1 rev. 00...02 AC/DC Power Supply Unit

3

Spare parts

4

M1031521

Table of contents

Table of contents Table of contents

i

Table of figures

iv

List of tables

vi

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

Symbols... 5 1.1.1 Symbols on transport packaging... 5 1.1.2 Symbols on equipment... 5 1.1.3 Equipment safety symbols... 6 1.1.4 Other symbols... 7 Safety...10 1.2.1 Safety precautions...10 1.2.2 ESD precautionary procedures...13 1.2.3 Disposal...13 Introduction...14 Bus structure...14 Distributed processing...15 Module communication...15 Software loading...16 Parameter modules...16

System installation 3.1 3.2 3.3

3.4 3.5 3.6 3.7

14

17

Unpacking instructions...17 Choosing location...17 S/5 Frame for Compact Monitor...17 3.3.1 Compact Monitor connections...18 3.3.2 Connecting to mains...20 3.3.3 Connecting to Network...20 3.3.4 Connecting to Wireless Network...20 3.3.5 Inserting the parameter modules...21 3.3.6 Downloading Monitor Software...21 3.3.7 Performing Factory Reset...22 3.3.8 Installing the Datex-Ohmeda Network and MemCard Upgrade, U-CMMEM...22 3.3.9 Installing the Datex-Ohmeda Network Upgrade, U-CMNET...23 3.3.10 Installing the S/5 Wireless LAN Upgrade, U-CMW...23 3.3.11 Installing the S/5 Recorder Upgrade, U-CMREC1...24 S/5 Remote Controller, K-CREMCO...25 Anesthesia Record Keeping Keyboard, K-ARKB...25 ARK Barcode Reader, N-SCAN (optional)...25 3.6.1 Connection to Compact Monitor...25 S/5 Compact Airway Modules, E-xxxx / M-xxxxx...26

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4

3.7.1 3.7.2

Sample gas exhaust...26 Troubleshooting...29

Interfacing

31

4.1

4.2

4.3

4.4

4.5

4.6 4.7

5

Interfacing external monitors via Interface Module, E-INT / M-INT...31 4.1.1 Connection to external Datex-Ohmeda monitors...32 4.1.2 Connection to Critikon Dinamap 1846SX, Abbott Oximetrix 3 and Baxter Explorer...33 4.1.3 Connection to Baxter Vigilance...33 4.1.4 Connection to Nellcor N-100 and N-1000...33 4.1.5 Connection to Nellcor N-200...33 Interfacing external bedside devices via S/5 Device Interfacing Solutions, N-DISxxx...34 4.2.1 Device Interfacing Solution components...35 4.2.2 Connections...35 4.2.3 Mounting...36 4.2.4 Selecting the external device...37 4.2.5 Functional check...38 4.2.6 Selecting the parameter data source...38 Interfacing Datex-Ohmeda Anesthesia Delivery Unit...39 4.3.1 Interconnection...39 4.3.2 Setting interfacing parameters on the S/5 Anesthesia Delivery Unit...39 4.3.3 Setting interfacing parameters on the S/5 Compact Anesthesia Monitor...39 Interfacing Dräger Cicero, Cato, Julian and Narkomed 2C (by NAD)...40 4.4.1 Interconnection...41 4.4.2 Setting communication parameters...41 4.4.3 Setting interfacing parameters on the S/5 Compact Anesthesia or Compact Critical Care Monitor41 Interfacing printer...42 4.5.1 Setting S/5 Compact Monitor interface for printers...42 4.5.2 Connection to serial printers...42 4.5.3 Connection to parallel printers...43 4.5.4 Installing the Serial-to-Parallel Converter...43 4.5.5 Connection to printer...44 Interfacing computer...44 Output signals...45 4.7.1 Digital outputs...45 4.7.2 Analog outputs...46 4.7.3 S/5 Pressure Temp Module, E-PT or M-PT, output signals...46

Functional check 5.1 5.2 5.3

47

Recommended tools...47 5.1.1 Hemodynamic patient simulators...49 Visual inspection...50 Functional inspection...51 5.3.1 General...51 5.3.2 Display...52 5.3.3 Keyboard(s)...52 5.3.4 Frame unit...52 5.3.5 Display unit...52 5.3.6 Compact Airway Module, E-CXXXXX/ M-CXXXXX...53 5.3.7 Single width Airway Module, E-miniC/ M-miniC...53

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Table of contents 5.3.8 5.3.9 5.3.10 5.3.11 5.3.12 5.3.13 5.3.14 5.3.15 5.3.16 5.3.17 5.3.18 5.3.19 5.3.20 5.3.21 5.3.22 5.3.23 5.3.24

6

Tonometry Module, E-TONO/ M-TONO...53 Multiparameter Hemodynamic Modules...54 Pressure/Pressure Temp Modules, E-P, E-PT, M-P, M-PT...54 Dual pressure Module, E-PP/ M-PP...55 Cardiac Output Modules, E-COP/ M-COP, E-COPSv/ M-COPSv...55 NIBP module, M-NIBP...55 Nellcor Compatible Saturation module, E-NSAT/ M-NSAT...56 Datex-Ohmeda Oxygen Saturation module, M-OSAT...56 BIS Module, E-BIS/ M-BIS...56 Entropy Module, E-ENTROPY/ M-ENTROPY...56 Data Card and Menu Card function...56 Recorder...57 Network connection...57 Wireless Network Option...57 Interface Module, E-INT/ M-INT...57 Device Interfacing Solution, N-DISxxx...57 General...58

General troubleshooting

59

Appendix A: Functional check form, Datex-Ohmeda S/5 CAM, CCCM

A-1

Appendix B: ElectroMagnetic Compatibility

B-1

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Table of figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Figure 8 Figure 9 Figure 10 Figure 11 Figure 12 Figure 13 Figure 14 Figure 15 Figure 16 Figure 17

S/5 Compact Anesthesia Monitor system ... 3 General bus structure of S/5 system... 14 Principle of UPI section operation ... 15 General structure of parameter modules with patient isolation... 16 External connections of Compact Monitor frame F-CM(C)1 rev.04 ... 18 External connections of Compact Monitor frame F-CM(C)1 rev.00...03... 19 Installation of the U-CMREC1 ... 24 ARK Barcode Reader, N-SCAN connected to Compact Monitor ... 25 Compact Airway Module, E-XXXX... 26 Scavenging through ventilator reservoir... 27 Connecting the gas module to the scavenging connector of S/5 Avance ... 27 Sample gas returned to patient circuit in ADU ... 28 Connection cables and LED indicators ... 36 An example of interfacing external devices with Device Interfacing Solution... 37 Connecting S/5 Compact Monitor to printer, converter model PI130-R2 ... 43 Connecting S/5 Compact Monitor to printer, converter model PI 1115A... 44 S/5 Compact Monitor general troubleshooting flowchart... 59

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Table of figures

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List of tables Table 1 Table 2 Table 3 Table 4 Table 5 Table 6 Table 7 Table 8 Table 9 Table 10 Table 11 Table 12 Table 13 Table 14 Table 15 Table 16

Transference of parameters, Datex-Ohmeda monitors ... 32 Transference of parameters, external monitors ... 32 DIS modules and interfaced devices... 34 Parameters transferred from S/5 Compact Anesthesia Monitor to S/5 Anesthesia Delivery Unit ... 39 Events transferred from S/5 Anesthesia Delivery Unit to the S/5 Compact Anesthesia Monitor 40 Parameters transferred from Dräger Cicero monitor to S/5 Compact Anesthesia Monitor or S/5 Compact Critical Care Monitor ... 41 Parameters transferred from Dräger Cato, Julian and Narkomed 2C (NAD) monitor to the S/5 Compact Anesthesia Monitor or S/5 Compact Critical Care Monitor ... 42 Coding element connector, X4... 45 Synchronization connector, X8 ... 45 Signal output connector pin assignments ... 46 Patient simulators’ compatibility with each hemodynamic module... 49 Adapter cables for hemodynamic patient simulators ... 50 Guidance and manufacturer’s declaration – electromagnetic emissions ...B-1 Guidance and manufacturer’s declaration – electromagnetic immunity ...B-2 Guidance and manufacturer’s declaration – electromagnetic immunity ...B-3 Recommended separation distances between portable and mobile RF communications equipment and the S/5™ CAM/ CCCM...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 install, service and maintain Datex-Ohmeda S/5 Compact Anesthesia Monitors running the software license L-CANE05 or L-CANE05A and S/5 Compact Critical Care Monitors running the software license L-CICU05 or L-CICU05A. 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 M1021567. The manual includes Technical Reference Manual Slots and every slot has an individual document number.

•

Part I gives the reader an overview of the monitor. 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 CAM, CCCM Monitor,

For information of parameter modules, Remote Controller and Device Interfacing Solution refer to the “S/5 E-Modules, Technical Reference Manual”. Service check for each of these products is included in these slots. 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 S/5 Modules S/5 E-Modules, Technical Reference Manual S/5 M-Modules, Technical Reference Manual

S/5 Compact Anesthesia Monitor For instructions for daily use including cleaning and daily maintenance, clinical aspects and basic methods of measurement see: S/5 Compact Anesthesia Monitor, User’s Guide S/5 Compact Anesthesia Monitor, User’s Reference Manual

S/5 Compact Critical Care Monitor For instructions for daily use including cleaning and daily maintenance, clinical aspects and basic methods of measurement: S/5 Compact Critical Care Monitors, User’s Guide S/5 Compact Critical Care Monitors, User’s Reference Manual For more information about the iCentral, S/5 Arrhythmia Workstation and anesthesia record keeping solution, see the “Technical Reference Manuals” and “User’s Reference Manuals” for these products.

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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.

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

Hypertext links WARNING

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 (alarm messages, informative messages) displayed on the screen are written inside single quotes: ‘Please wait’. 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 "iCentral User's Reference Manual: Alarms." Hypertext links on PDF versions are written in blue color. 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:

‘Messages’ “Sections”

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 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 anesthesia record keeping, wired and wireless networking and memory card operation. Additionally, 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.

1

5

Figure 1 (1) (2) (3) (4) (5)

3

2

4

S/5 Compact Anesthesia Monitor system

S/5 Compact Anesthesia Monitor with modules inside Remote Controller, K-CREMCO Printer Wireless Network (WLAN) Access Point, N-WAP Network (LAN)

Optional components Optional components are:

• • • •

Built-in recorder, N-CMREC1 Remote controller Keyboard for anesthesia record keeping solution, barcode reader Wireless network option, N-CMW

Possible software options are:

•

MemCard option, N-CMMEM

NOTE: Insert the WLAN PC card in the first slot from the front. NOTE: Memory Module, M-MEM/ E-MEM, is not compatible with the S/5 Compact Monitors.

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Communication between monitors You can use the Compact Monitor as a stand-alone monitor or for − viewing and receiving data (alarms, vital signs) from other patient monitors − gathering and storing data during transportation. To view other patient monitors, the monitor needs to be connected to the network (LAN or WLAN). To gather, store, and transfer data between different Datex-Ohmeda monitors, use memory cards or connect the monitor to the network. NOTE: With WLAN, use only Data Card.

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Introduction

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 Ni-MH and can be recycled. Ni-MH Pb

Dangerous voltage.

When using the ARK Barcode Reader, N-SCAN, do not stare into beam. The N-SCAN Barcode Reader is a Class 2 laser product.

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1.1.3

Equipment safety symbols -

Attention, consult accompanying documents. When displayed next to the O2 value, indicates that the FiO2 low alarm limit is set below 21%. - When displayed next to the HR value, indicates that the pacer is set on R. -

On the modules or frames indicates that modules with identical measurements should not be used in the same monitor. If such modules have been inserted, remove the module that has been most recently connected. You can also remove both modules and re-connect the new module after five seconds.

-

On the Interface Module E-INT, M-INT, indicates that it is for connecting external devices. Do not connect patient cables to the module. - On the E-TONO, M-TONO module indicates that the module should only be used with Tonometrics catheters. - On the E-miniC module indicates that airway gases should be calibrated every six months in normal use and every two months in continuous use.

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-

BIS: On the Aspect DSC indicates that the converter must not be opened for any reason or autoclaved.

-

On the E-PRESTN, E-PRETN, E-RESTN, E-PSM, E-PSMP, E-P, E-PP, E-PT, E-COP and E-COPSv 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 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 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.

Introduction

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. 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 Battery operation and remaining capacity (green bar)

Battery charging (white bar) Submenu. Selecting an alternative marked with this symbol in a menu opens a new menu.

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The monitor is connected to the network (LAN). The monitor is connected to the wireless network (WLAN).

Data Card (green) and/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.

Date of manufacture

Do not immerse the sensor in liquids.

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Introduction

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.

Ethernet connector

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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.

• • •

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. Do not connect any external devices to the system other than those specified. 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 or extension cord.

Installation • Keep the monitor horizontal when the Compact Airway Module is used. Tilting the monitor may cause erroneous results in the Compact Airway Module’s readings and damage the module.

• • •

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.

• •

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.

A printer or computer must be supplied from an additional transformer providing at least basic isolation (isolating or separating transformer).

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