Datex-Ohmeda MRI Technical reference manual

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MRI Monitor

Technical Reference Manual

CAUTION: U.S. Federal law restricts this device to sale by or on the order of a licensed medical practitioner.

Datex-Ohmeda Inc.

P.O. Box 7550

Madison, WI 53707-7550, USA

Tel: +1 608 221 1551

Fax: +1 608 222 9147

All specifications are subject to change without notice.

Outside the USA, check local laws for any restriction that may apply.

Order Code M1079546

September, 2006

GE Healthcare Finland Oy

FI-00031 GE, FINLAND

Tel: +358 10 39411

Fax: +358 9 1463310

www.gehealthcare.com

edition

Helsinki, Finland

P.O. Box 900

Page 2

Intended purpose (Indications for use)

The MRI Monitor with L-CANE05 or L-CANE05A software, module options E-MRIPSN, E-MRICAiOV, E-MRICAiO, E-MRICO and accessories is indicated for monitoring of hemodynamic (comprising ECG (including heart rate, ST-segment and arrhythmia), NIBP, SpO

agents, anesthetic agent identification, and respiration rate) and ventilatory (comprising airway pressure, volume and flow) status of hospital patients during magnetic resonance scanning. The NIBP measurement is indicated for patients who weigh 5kg (11 lb) and up. The MRI Monitor with L-CANE05 or L-CANE05A software is also indicated for documenting patient care related information. The MRI Monitor with L-CANE05 or L-CANE05A software, module options E-MRIPSN, E-MRICAiOV, E-MRICAiO, E-MRICO and accessories is indicated for use in the MR environment up to 300 Gauss with static magnets up to

3.0 Tesla. SpO environment.

The MRI Monitor with L-CANE05 or L-CANE05A software is indicated for use by qualified medical personnel only.

and ECG monitoring is indicated only with accessories specifically designed for the MR

, and invasive blood pressure), respiratory (CO2, O2, N2O, anesthetic

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 MRI 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 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."

• manufacturer approved MRI Monitor system components are used.

Trademarks

Datex, Ohmeda, S/5, D-lite, D-lite+, Pedi-lite, Pedi-lite+, D-fend, D-fend+, Mini D-fend, OxyTip+, MemCard, ComWheel, ComBar, EarSat, FingerSat, FlexSat, PatientO

trademarks of GE Healthcare Finland Oy. All other product and company names are property of their respective owners.

, Patient Spirometry, Entropy and Tonometrics are

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Technical Reference Manual, Order code: M1079546

Document No. Updated Description

Master table of contents

MRI Monitor

edition

Part I, General Service Guide

M1041746-2 Introduction, System description, Installation,

Interfacing, Functional check, General troubleshooting

M1041747-1 Planned Maintenance Instructions 2

Part II, Product Service Guide

Document No. Updated Description

M1056423 MRI Service Menu 1

M1084164-1 MRI Shield N-MRI2 Rev. 01, incl. ECG measurement

unit, Network option for MRI Monitor, N-MRINET,

Active Remote Screen Option, N-MRIREMOTE

Command Bar for MRI2, K-MRIANEB,

LCD Display, D-LCC19-01,

Remote screen and sound converter

M1056422-2 MRI Monitor Frame F-MRICM1, Display Unit

Software Licenses, L-CANE05, L-CANE05A

MRI Monitor Frame F-MRICM1, Frame Unit,

AC/DC Power Supply Unit

Options N-CMMEM, N-CMW and N-MRIREC1

M1041750-1 Hemodynamic MRI Module, E-MRIPSN 4

M1041752-2 Airway Gas Module, E-MRICAiOV 5

M1027838-5 S/5 Remote Controller, K-CREMCO 6

M1072254-1 Recordkeeping keyboard, K-ARKB 7

M1056425-1 S/5 Device Interfacing Solution, N-DISVENT 8

M1041753-2 Spare parts 9

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Table of contents

Table of contents i

Table of figures iii

List of tables iv

About this manual 1

1Introduction 3

1.1 System introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

1.1.1 MRI Monitor system components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3

1.1.2 Monitoring in MR room . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1.1.3 Monitoring in control room . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5

1.1.4 MR monitoring in network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

1.1.5 Monitoring in wireless network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7

1.2 MRI Monitor introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

1.2.1 MRI Monitor parts and connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8

1.2.2 MRI Monitor frame options and modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

1.2.3 Connector panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9

1.2.4 MRI Cart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10

1.3 Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

1.3.1 Symbols on transport packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

1.3.2 Symbols on equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

1.3.3 Equipment safety symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

1.3.4 Other symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12

1.4 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15

1.4.1 Safety precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15

1.4.2 ESD precautionary procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

1.4.3 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

2 System description 20

2.1 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20

2.2 Bus structure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20

2.3 Distributed processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

2.4 Module communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

2.5 Software loading. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22

2.6 Parameter modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22

2.7 High magnetic field alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23

3 System installation 24

3.1 Unpacking instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24

3.2 Choosing location. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24

3.3 Installing and mounting the monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25

3.3.1 MRI Monitor parts and connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27

3.3.2 Monitor distance from the magnet bore. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28

3.3.3 Connecting to mains . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28

3.3.4 Mounting the MRI Monitor to MRI Cart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29

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3.3.5 Connecting to Datex-Ohmeda Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31

3.3.6 Connecting to Wireless LAN network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33

3.3.7 Device Interfacing Solution, N-DISVENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34

3.3.8 Remote Screen installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

3.3.9 Parameter modules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37

3.3.10 Downloading Monitor Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38

3.3.11 Performing Factory Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39

3.3.12 Performing Service Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39

3.4 S/5 Remote Controller, K-REMCO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40

3.5 Anesthesia Record Keeping Keyboard, K-ARKB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40

3.5.1 Connection to MRI Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40

3.6 MRI Airway Module gas scavenging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40

3.6.1 Sample gas exhaust . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40

3.7 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42

4 Interfacing 43

4.1 Interfaced parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43

4.2 Interfacing external bedside devices via Device Interfacing Solutions, N-DISxxx . . . . . . . . . . . . . . . . .43

4.2.1 Device Interfacing Solution components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43

4.2.2 Connections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43

4.2.3 Mounting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44

4.2.4 Selecting the external device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45

4.2.5 Functional check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45

4.2.6 Selecting the parameter data source. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46

4.3 Interfacing printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46

4.4 Interfacing computer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47

4.5 Output signals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47

5 Functional check 48

5.1 Recommended tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48

5.2 Visual inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49

5.3 Functional inspection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50

6 General troubleshooting 55

Appendix A: Functional check form, MRI Monitor A-1

Appendix B: 1ElectroMagnetic Compatibility B-1

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Table of figures

Figure 1 MRI monitoring system components in MR room ...................................................................................4

Figure 2 MRI monitoring system components when using Active Remote Screen..................................................5

Figure 3 MR monitoring in network ..................................................................................................................... 6

Figure 4 MRI monitoring in wireless network .......................................................................................................7

Figure 5 MRI Monitor parts and connections.......................................................................................................8

Figure 6 MRI Cart.............................................................................................................................................10

Figure 7 General bus structure of MRI Monitor ..................................................................................................20

Figure 8 Principle of UPI section operation........................................................................................................21

Figure 9 General structure of parameter modules with patient isolation ............................................................. 22

Figure 10 Example of 300 Gauss line distance with a MR scanner. ......................................................................25

Figure 11 MRI Monitor parts and connections.....................................................................................................27

Figure 12 Field strength in MR room ...................................................................................................................28

Figure 13 MRI Cart............................................................................................................................................. 29

Figure 14 ‘Do not place any non-MR compatible items’ symbol ...........................................................................30

Figure 15 MRI Monitor connected to network......................................................................................................31

Figure 16 WLAN Acces Point in Control room ......................................................................................................33

Figure 17 MRI Monitor connected to wireless network .........................................................................................34

Figure 18 Control room installation ....................................................................................................................35

Figure 19 Exhaust to reservoir tube.....................................................................................................................41

Figure 20 Connection cables and LED indicators ................................................................................................44

Figure 21 An example of interfacing external devices with Device Interfacing Solution ..........................................45

Figure 22 MRI general troubleshooting flowchart ................................................................................................56

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MRI Monitor

List of tables

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

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

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

Table 4 Recommended separation distances between portable and mobile RF communications equip-

ment and the MRI Monitor......................................................................................................................... 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 MRI Monitor running the software license L-CANE05 or L-CANE05A.

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 M1079546. This is the second edition.

• Part I gives the reader an overview of the MRI 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 MRI Monitor system, such as

MRI Monitor frame, shield, parameter modules and Active Remote Screen. Service check for each product, service menus and all the spare parts information for MRI 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.

1 Introduction

1.1 System introduction

The MRI Monitor is a modular multiparameter patient monitor. The monitor is especially designed for multiparameter patient monitoring in MR environment. It can also be used during transportation within the hospital, for example, when transporting the patient from induction to the MR environment.

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. Your system may also include Active Remote Screen allowing full remote control over the MRI Monitor. 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.

1.1.1 MRI Monitor system components

Options for the MRI Monitor system

− Built-in recorder, N-CMREC1

− Wireless network option, N-CMW

− Active Remote Screen, N-MRIRemote (includes a fiber optic cable and Remote screen

converter)

− Network option, N-MRINET (includes a fiber optic Network cable and a fiber optic converter board, B-FOC)

Introduction

Possible software options for the MRI Monitor

− MemCard option, N-CMMEM

MRI Monitor frame options

− N-SN (for ECG, SpO2, NIBP)

− N-PSN (for ECG, SpO2, NIBP, InvBP)

− N-PSNG (for ECG, SpO2, NIBP, InvBP, CO2, Patient O2 and N2O)

− N-SNG (for ECG, SpO2, NIBP, CO2, Patient O2 and N2O)

− N-PSNGV (for ECG, SpO2, NIBP, InvBP, CO2, Patient O2, N2O, anesthetic agents, agent

identification and patient spirometry)

− N-SNGV (for ECG, SpO2, NIBP, InvBP, CO2, Patient O2, N2O, anesthetic agents, agent identification and patient spirometry)

MR compatible modules

− Hemodynamic MRI Module E-MRIPSN

− MRI Compact Airway Modules E-MRICO, E-MRICAiO and E-MRICAiOV

Active Remote Screen display option with built-in loudspeakers

− 19" LCD display, D-LCC19 - 01

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1.1.2 Monitoring in MR room

The MRI Monitor system in the MR room may consist of the elements shown in the picture below.

Figure 1 MRI monitoring system components in MR room

(1) MRI Monitor with MR compatible modules inside

(2) MRI Cart. You can also use a wall mount.

(3) Device Interfacing Solution, DIS

(4) Active Remote Screen fiber optic cable

(5) Fiber optic network cable

(6) Remote Controller, K-CREMCO

(7) MR scanner specific cardiac gating cable

(8) Anesthesia record keeping keyboard

(9) Mains power cable

(10) MR-specific SpO2 accessories (OXY-FMR, OXY-WMR)

(11) MR-specific ECG cable

(12) Datex-Ohmeda Wireless Network (WLAN) Access

Point, N-WAP, and WLAN antenna

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1.1.3 Monitoring in control room

Active Remote Screen is an external surveillance monitor for MRI Monitor. While the MRI Monitor is placed inside the MR examination room, the Active Remote Screen is used outside the MR environment in the control room to monitor the patient. The connection between the MRI Monitor and Active Remote Screen is done over on fiber optic cable, which ensures safe and undisturbed data transmission. The Active Remote Screen has the same functionality as the MRI Monitor and it allows full remote control over the MRI Monitor. However, the MRI Monitor can not be turned on or to standby through the Active Remote Screen.

The possible components are described below.

Introduction

Figure 2 MRI monitoring system components when using Active Remote Screen

(1) Active Remote Screen with built-in loudspeakers.

(2) Remote screen converter. Contains connectors for Active Remote Screen and anesthesia record

keeping keyboard or Command Bar K-MRIANEB.

(3) Fiber optic cable

(4) MRI Monitor

(5) Command Bar

(6) Anesthesia record keeping keyboard K-ARKB

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1.1.4 MR monitoring in network

Figure 3 MR monitoring in network

(1) MRI Monitor

(2) Fiber optic Network cable

(3) Fiber optic converter, N-FOC, which connects the monitor to the Datex-Ohmeda Network (wired

or wireless)

(4) Network printer

(5) Monitor-Network cable

Communication between monitors

You can use the MRI Monitor as a stand-alone monitor or for

− viewing and receiving data (alarms, vital signs) from other patient monitors

− gathering and storing data during intrahospital transportation.

To view other patient monitors, the monitor needs to be connected to network. To gather, store, and transfer data between different monitors, use the Data Card or network communication.

NOTE: You cannot transfer data to the MRI Monitor from the Data Card; use network for this purpose. The Data Card is for storage and transfer of patient data from the MRI Monitor. The Menu Card is used for storing the anesthesia record keeping menus and configurations, and for loading and storing user modes.

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1.1.5 Monitoring in wireless network

Introduction

Figure 4 MRI monitoring in wireless network

(1) Antennas

(2) Network cable

(3) Access point.

NOTE: Before installing the wireless monitoring network in the MR environment, the system must be tested to avoid all the interference that it may cause to the MR pictures.

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1.2 MRI Monitor introduction

1.2.1 MRI Monitor parts and connections

Figure 5 MRI Monitor parts and connections

(1) Frame for MRI Monitor, F-MRICM1

(2) MRI Shield for MRI Monitor, N-MRI2

(3) Hemodynamic MRI module, E- MRIPSN

(4) Slot for memory cards (PCMCIA)

(5) D-fend

(6) Spirometry connectors

(7) NIBP connector

(8) ECG connector

(9) InvBP connector

(10) SpO2 connector

(11) Air filter

(12) MRI Compact Airway Module E-MRICxx

(13) Air filter

(14) Recorder, N-CMREC1

(15) Connectors for Active Remote Screen

(16) Connector for Device Interfacing Solution, DIS

(17) Cardiac (ECG) gating connector

(18) Network connectors

(19) Mains power inlet

(20) Connector for anesthesia record keeping keyboard

or K-CREMCO

(21) Side panel keys

(22) ComWheel

(23) Command Board

(24) High magnetic field alarm led

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1.2.2 MRI Monitor frame options and modules

The MRI Monitor has the following frame and module options available.

Parameter Frame options and modules

Introduction

ECG, SpO2 and NIBP

• N-SN, N-SNG, N-SNGV, N-PSN, N-PSNG or N-PSNGV

• E-MRIPSN module

InvBP (up to 2)

• N-PSN, N-PSNG or N-PSNGV

• E-MRIPSN module

, Patient O2 and N2O

• N-PSNG, N-SNG, N-PSNGV or N-SNGV

• E-MRICO, E-MRICAiO or E-MRICAiOV

Anesthetic agents, agent identification

• N-PSNG, N-SNG, N-PSNGV or N-SNGV

• E-MRICAiO or E-MRICAiOV

Spirometry

• N-PSNGV or N-SNGV

• E-MRICAiOV

− Hemodynamic MRI Module E-MRIPSN measures ECG, SpO2, NIBP and InvBP (two pressures, optional).

− MRI Compact Airway Modules E-MRICO, E-MRICAiO and E-MRICAiOV measure CO2 (C), O2 (O), Spirometry (V), anesthetic agents (A) and agent identification (i).

NOTE: The modules are preinstalled inside the shield and they can only be changed by authorized service personnel.

1.2.3 Connector panel

The connectors for the different parameter accessories are located on the connector panel on the left side of the shield. The frame option determines the connectors included in the panel. Below is an example of the connector panel in the frame option N-PSNGV.

3 4 5

(1) Spirometry connectors (optional)

(2) D-Fend with sampling line connector (optional)

(3) ECG connector

(4) NIBP connector

(5) InvBP connector (optional)

(6) SpO2 connector

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MRI Monitor

1.2.4 MRI Cart

MRI Cart has been designed for MR environment. It allows you to move the monitor around the MR room, if necessary.

Figure 6 MRI Cart

(1) Mounting plate for the MRI Monitor

(2) Drawer for small MR compatible accessories

NOTE: The maximum load of the MRI Cart drawer is 400 g (0.9 lb).

(3) Compartment for the manuals

(4) Caster brakes

NOTE: The maximum load of the MRI Cart monitor arm is 25 kg (55.12 lb).

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1.3 Symbols

1.3.1 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.

Introduction

1.3.2 Symbols on equipment

1.3.3 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%.

- On the connector panel this symbol indicates that for pulse oximetry (SpO invasive pressures (P1-P2), the patient isolation and protection against cardiac

defibrillator discharge are based on the SpO accessories.

- On the rear 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.

and invasive blood pressure

) and

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MRI Monitor

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) 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 “1.4.2. ESD precautionary procedures”.

1.3.4 Other symbols

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

Symbol on the led on the front panel of the shield. The led indicates if the magnetic field is too strong.

Symbol on the MRI Cart drawer cover. Do not place any non-MR-compatible items in the MRI Cart.

Equipotentiality. Monitor can be connected to potential equalization conductor.

Alternating current

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

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Introduction

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.

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

The monitor is connected to the Datex-Ohmeda 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.

Do not reuse.

Use by. Indicates the last use day.

Date of manufacturer

Does not contain Latex.

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MRI Monitor

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

1.4 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.

1.4.1 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.

• The Active Remote Screen and printer must be supplied from an additional transformer

providing at least basic isolation (isolating or separating transformer).

• 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 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.

• 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

The monitor contains some ferromagnetic material.

•

• Do not install or use the monitor inside the 300 Gauss line. Verify the 300 G line from the safety

instructions of the MRI imaging equipment.

• Inside the 300 G line the monitor is subject to the attraction of the magnetic field.

• The MRI Monitor has been designed for MR environment. The MR scanners, however, may be

capable of causing injury if the given instructions are not followed, especially with respect to electrically conducting lead positioning and safety distance from the magnet.

• The MRI Monitor has been designed to tolerate high magnetic field strengths over short-term

periods. High magnetic field strengths may, however, be destructive to the MRI Monitor electronics. Always keep the MRI Monitor outside the 300 G line.

• The MRI Monitor parameters will be shut down if MRI Monitor is taken to higher magnetic field

strengths than 400 G to protect the MRI Monitor electronics. No parameter information can be seen on the monitor screen during this time.

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MRI Monitor

• The MRI Monitor has been validated to tolerate up to 300 G magnetic field strength. Higher field

strengths may interfere with the MRI Monitor parameter measurements. Always keep the MRI Monitor outside the 300 G line.

• Use the monitor during Magnetic Resonance Imaging (MRI) only together with MR compatible

modules E-MRIPSN, E-MRICO, E-MRICAiO, and E-MRICAiOV.

• Only personnel who are aware of possible risks involved with patient monitoring in the MR

environment should perform the monitoring.

• Do not use the system with the MRI devices with static magnetic field stronger than 3 T.

• Do not place the system closer than the 300 G line to the MRI device.

• MRI Monitor is intended to be mounted to a fixed structure if the MRI Cart is not used. Do not

use the monitor without manufacturer approved mounting attached.

• Do not tilt the MRI Cart more than 10°.

• The MRI Cart is intended to be used only for the MRI Monitor (labeled as N-MRI2) that can

tolerate 300 G magnetic field or less.

• Do not place any non-MR-compatible items in the MRI Cart and not more than 400 g (0.9 lb) of

weight in the MRI Cart drawer.

• Keep the MRI Cart outside 300 G line.

• Always keep the caster breaks locked when you are not moving the MRI Cart.

• MRI Cart has been designed for MR environment. The MRI Cart allows you to move the monitor

around the MRI room, if necessary. Tie the cart with an inelastic, strong rope to the MR room wall to avoid moving the MRI Monitor unintentionally too close to the magnet.

• 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 “1.4.2. 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.

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

service personnel prior to clinical use.

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. The

•

monitor measures only non-flammable anestethics.

Patient safety

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

•

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Introduction

• 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.

• Never turn the volume off from Active Remote Screen display. If the volume is silenced from the

display, all patient alarms will be silenced and there will be no visible indication of the silenced state.

• If you are using a display that does not have built-in speakers, use external loudspeakers.

• If you are using external loudspeakers, always make sure that audio cables are properly

connected.

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 “1.4.2. ESD precautionary procedures”.

• 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. Infectous hazard may be

present.

Accessories

Use only approved cables, mounts, batteries, invasive pressure transducers and MR

•

compatible accessories. For a list of approved supplies, accessories and mounts, see section “MRI accessories” in the User’s Guide or User’s Refence Manual and the "Supplies and Accessories" catalog. Other cables, transducers and accessories may cause a safety hazard, damage the equipment or system, result in increased emissions or decreased immunity of the equipment or system or interfere with the measurement.

• ECG and SpO

made of non-metallic materials, either fiber optic or silicon plastic, and can safely be used in MR environment. All other listed accessories are non-ferrous and designed so that they can be safely used in MR environment. The accessories designed for use with this device are made of biocompatible materials conforming to requirements of the standard EN 30993 Biological Evaluation of Medical Devices and therefore do not contain toxic ingredients or primary skin irritants. The conformity is based either on laboratory testing or material knowledge and the long history of the materials used. Please note that some products are not available worldwide. You can check the availability with your local GE Healthcare representative.

monitoring requires specific MR compatible accessories. These accessories are

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

and/or affect the measurement accuracy.

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MRI Monitor

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.

• Various MRI systems and RF coils feature significant differences in their technical design. The

ability of the RF coil and MRI system to tolerate external RF interference may differ from that of the environment where the MRI Monitor was tested. Thus it is recommended that the users run interference tests before taking the MRI Monitor in use to recognize the potential RF interference caused by the MRI Monitor.

Before use

Allow two minutes for warm-up and note any error messages or deviations from normal

•

operation.

MRI Cart

Rough use of the MRI Cart may cause damage to the Cart. If damage is found, the Cart must be

•

removed from use until it has been serviced by authorized service personnel.

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.

• 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.

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

• 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.

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Introduction

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

local regulations.

Batteries

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.

1.4.2 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 giv en o f m e th o ds to p re v en t b u il d -u p o f 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.

1.4.3 Disposal

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

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MRI Monitor

2 System description

2.1 Introduction

MRI Monitor is based on the same system architecture as other modular Datex-Ohmeda monitors. 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

Patient

Modules

Module

MODULE-BUS

PCMCIA Serial

Non-

Volatile

Memory

Reset

Logic

Boot

Memory

Ethernet Sound UPI

ISA-BUS

Code

Memory

Display

Controller

Chipset

486 LOCAL BUS

DRAM

486

Processor

cam_p1_gnrl_bus_strctr_cm.vsd

Figure 7 General bus structure of MRI Monitor

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.

The RS-485 type of serial communication supports so-called multidrop or party line connections. This means that all parameter modules connected to the module bus use exactly the same lines for communication.

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2.3 Distributed processing

The system 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

Voltage

Temp

Meas

Shared

SRAM

Control

ISA-BUS

Logic

Processor

UPI

Analog & Digit al outputs

Module Bus

ComWheel I nterface

Keypad Interface

cam_p1_prncpl_UPI_operation.vsd

Figure 8 Principle of UPI section operation

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.

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MRI Monitor

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. For service and upgrade procedures, the CPU board is fitted with a PCMCIA card drive through which new software can be loaded.

2.6 Parameter modules

PATIENT

Module

keys

Analog

electronics

Peripheral

drivers

A/D

converter

RAM

EEPROM

+5 V

+12 V

CPU

Isolation

transformer

Patient isolation

Opto

isolation

+13...16 V

VMOD

Data

RS485 drivers

Module Bus

Figure 9 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.

eneral_struct_of_parm_mod.vsd

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2.7 High magnetic field alarm

When the magnetic field where the MRI Monitor is located gets stronger than 150 G, yellow light is lit in the high magnetic field alarm led on the front panel of the shield. When the magnetic field gets stronger than 250 G, the led starts blinking red and an audible alarm is triggered.

When the monitor is turned on, the high magnetic field alarm alarms once.

NOTE: Noise in the MR Room may be very high. Due to this reason, the MRI Monitor's high magnetic field alarm sound volume is intentionally set very high being more than 80 dB. The alarm sound can only be silenced by moving the MRI Monitor outside the high magnetic field of 250 G.

NOTE: The high magnetic field alarm does not work if the monitor is turned off.

System description

High magnetic field alarm led

Meaning Tone pattern Front panel LED

Magnetic field >

250 G Triple + double beep every 5 seconds or

continuous beep

-- -- -- 5 -- --/ -----

150 G No tone yellow LED lit

red LED blinking

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MRI Monitor

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 are damaged, contact the shipper.

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

3.2 Choosing location

Consider the following aspects:

• lighting

• space

• connections

• electromagnetic and radio frequency interference, see Appendix B. ElectroMagnetic

Compatibility

• environment

WARNING The monitor contains some ferromagnetic material.

WARNING Do not install or use the monitor inside the 300 Gauss line. Verify the 300 Gauss

line from the safety instructions of the MRI imaging equipment.

WARNING Inside the 300 Gauss line the monitor is subject to the attraction of the magnetic

field.

WARNING The MRI Monitor has been designed for MR environment. The MR scanners,

however, may be capable of causing injury if the given instructions are not followed, especially with respect to electrically conducting lead positioning and safety distance from the magnet.

WARNING Do not place the system closer than the 300 Gauss line to the MR scanner.

WARNING Do not use the system with the MR scanners with static magnetic field stronger

than 3 T.

The allowed cables, transducers, mounts and accessories for the monitor are listed in section “MRI accessories” in the User’s Guide and in the User’s Reference Manual.

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3.3 Installing and mounting the monitor

The MRI Monitor is designed to operate with max 3 T MR device. The MRI Monitor is designed to operate as close to the patient as possible. The minimum distance from the magnet must be maintained. The minimum distance depends on the magnetic field and the type of the magnet used. The monitor must be kept outside the 300 Gauss line. The 300 G line should be verified from the safety instructions of the MR scanner.

The built-in magnetic field detector sets a yellow alarm at 150 G and a red alarm at 250 G. Beyond the 300 G line the monitor may be subject to force attraction of the magnetic field.

Mount the monitor to a fixed structure such as a wall mount or MRI compatible cart. If you are using an MRI Cart, make sure to maintain the minimum distance from the magnet.

For a list of mounts, see section “MRI accessories” in the User’s Guide or in the User’s Reference Manual.

System installation

3 T

Figure 10 Example of 300 Gauss line distance with a MR scanner.

WARNING Do not place the MRI Monitor closer than the 300 G line to the MR scanner. Mark

the 300 G line on the floor.

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.

WARNING MRI Monitor is intended to be mounted to a fixed structure if MRI Cart is not

used. Do not use the monitor without manufacturer approved mounting attached. Mount the monitor to some fixed structure such as a wall mount or MRI Cart.

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MRI Monitor

WARNING 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.

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 Use only MR compatible accessories.

CAUTION The LCD displays used in the control room are fragile. Ensure that they are not placed

near a heat source or exposed to mechanical shocks, pressure, moisture or direct sunlight.

CAUTION Rough use of the MRI Cart may cause damage to the Cart. If damage is found, the Cart

must be removed from use until it has been serviced by authorized service personnel.

CAUTION Various MRI systems and RF coils feature significant differences in their technical

design. The ability of the RF coil and MRI system to tolerate external RF interference may differ from that of the environment where the MRI Monitor was tested. Thus it is recommended that the users run RF interference tests before taking the MRI Monitor in use to recognize the potential RF interference caused by the MRI Monitor.

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3.3.1 MRI Monitor parts and connections

System installation

Figure 11 MRI Monitor parts and connections

(1) Frame for MRI Monitor, F-MRICM1

(2) MRI Shield for MRI Monitor, N-MRI2

(3) Hemodynamic MRI module, E- MRIPSN

(4) Slot for memory cards (PCMCIA)

(5) D-fend

(6) Spirometry connectors

(7) NIBP connector

(8) ECG connector

(9) InvBP connector

(10) SpO2 connector

(11) Air filter

(12) MRI Compact Airway Module E-MRICxx

(13) Air filter

(14) Recorder, N-CMREC1

(15) Connectors for Active Remote Screen

(16) Connector X1 for Device Interfacing

Solution, N-DIS

(17) ECG gating connector X2

(18) Network connectors

(19) Mains power inlet

(20) Connector X3 for anesthesia record keeping

keyboard or K-CREMCO

(21) Side panel keys

(22) ComWheel

(23) Command Board

(24) High magnetic field alarm led

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MRI Monitor

3.3.2 Monitor distance from the magnet bore

SAFETY PRECAUTION: The strength of the magnetic field increases exponentially causing a sudden

strong attraction on metallic components. The field strength increases hundreds of Gauss in a very short distance. To ensure safe and reliable monitoring in MR room, it is important to keep the MRI Monitor outside the 300 G line all the time.

Figure 12 Field strength in MR room

3.3.3 Connecting to mains

Connect the power cord to the mains power inlet of the MRI Monitor and to the wall socket.

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

receptacle.

WARNING 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.

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3.3.4 Mounting the MRI Monitor to MRI Cart

System installation

Figure 13 MRI Cart

(1) Mounting plate for the MRI Monitor

(2) Arm

(3) Place for K-ARKB

(4) Drawer for small MR compatible accessories

(5) Front door

(6) Monitor holding bar

(7) Wheels with caster brakes

NOTE: The maximum load for the MRI Cart drawer is 400 g (0.9 lb).

NOTE: The maximum load for the MRI Cart monitor arm is 25 kg (55.12 lb).

WARNING Do not place any non-MR-compatible items in the MRI Cart.

WARNING Do not tilt the MRI Cart more than 10°.

WARNING The MRI Cart is intended to be used only for the new MRI Monitor that can

tolerate 300 G magnetic field or less.

WARNING Keep the MRI Cart outside 300 G line.

WARNING Keep the caster breaks always locked when you are not moving the MRI Cart.

WARNING MRI Monitor is intended to be mounted to a fixed structure if MRI Cart is not

used. Do not use the monitor without manufacturer approved mounting attached.

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MRI Monitor

WARNING The MRI Cart has been designed for MR environment. The MRI Cart allows you to

move the monitor around the MRI room, if necessary. Tie the cart with an inelastic, strong rope to the MR room wall to avoid moving the MRI Monitor unintentionally too close to the magnet.

CAUTION Rough use of the MRI Cart may cause damage to the Cart. If damage is found, the Cart

must be removed from use until it has been serviced by authorized service personnel.

Before mounting the monitor to the cart

Figure 14 ‘Do not place any non-MR compatible items’ symbol

1. Open the drawer. Check that a label “Do not place any non-MR-compatible items” is attached to the plastic cover of the drawer. Close the drawer again.

NOTE: If the label is missing, the cart must be removed from usage until a new label can be attached.

2. Open the front door. Check that a label “Do not place any non-MR-compatible items” is attached to the inner surface of the door. Close the door again.

NOTE: If the label is missing, the cart must be removed from usage until a new label can be attached.

3. Check that the wheels are clean and intact. Check that the brakes function normally.

NOTE: If any of the brakes is not functioning, the cart must be removed from use until the cart has been serviced.

4. Check that the monitor holding bar is properly tightened. If necessary, open the rear panel of the cart and fix the bar holding screws inside. Check also the screws holding the bar from underneath.

5. Check the arm holding the mounting plate. The arm must be mounted to the upper end of the bar. The arm must be properly tightened. If the arm is loose, tighten the screws holding the bar.

6. Check that the black cover at the upper end of the bar is intact.

Mounting the MRI Monitor to the cart

1. Slide the monitor on the mounting plate and secure it. Check that the locking screw locks properly.

2. Check that the mounting plate tilts properly, and that the monitor can be rotated freely.

CAUTION Pay attention to the attached cables and tubes when tilting or rotating the monitor.

The cables and tubes can be damaged if kinked during monitor movement.

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Mounting the Anesthesia Record Keeping Keyboard (K-ARKB) to the cart

1. Open the drawer completely and remove it by loosing the 4 screws holding it.

2. Insert the K-ARKB sliding system, and insert the screws holding it. The screws are inserted from inside the cart.

3. Attach the keyboard holder on the sliding system, and secure it with 3 screws.

4. Snap the keyboard to the holder.

5. Connect the keyboard cable to the MRI Monitor connector X3 on the connector panel.

3.3.5 Connecting to Datex-Ohmeda Network

System installation

Figure 15 MRI Monitor connected to network

(1) MRI Monitor

(2) Fiber optic Network cable

(3) Fiber optic converter, N-FOC, which connects the monitor to the Datex-Ohmeda Network (wired

or wireless)

(4) Network printer

(5) Monitor-network cable

Use the fiber optic network cable and the monitor-network cable to connect the monitor to the network as follows:

1. Make sure that the power to the monitor is turned off. Connect the fiber optic network cables to the MRI Monitor connectors (see Figure 11).

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MRI Monitor

NOTE: The monitor with N-MRINET option already contains the ID plug connected.

2. Connect the other end of the fiber optic network cable to the Fiber Optical Converter (N-FOC) outside the MRI room.

3. Connect the RJ-45 connector of the monitor-network cable to the N-FOC.

NOTE: The ID plug possibly attached to the cable need not be connected.

4. Connect the other RJ-45 connector to the corresponding connector on the wall box.

5. Turn on the power to the MRI Monitor. Enter the Network service menu:

Monitor Setup - Install/Service (password 16-4-34) Service (password 26-23-8) Frame – Network

Make sure that the monitor's network communication has been set according to the used network software:

Network software S-CNET99 -> DRI Level = 1999

Network software S-CNET01 -> DRI Level = 2001

Network software S-CNET02 -> DRI Level = 2001 or 2002 (WLAN)

Network software L-NET03 -> DRI Level = 2003

Network software L-NET05 -> DRI Level = 2005

If necessary, change the monitor's network communication by selecting DRI Level and turning the ComWheel.

NOTE: The DRI Level 1999 is not selectable in all monitor software versions.

NOTE: If you change the DRI level, the monitor will restart automatically.

6. Confirm that the network symbol and ‘Connected to Network’ message are displayed in the upper part of the screen.

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3.3.6 Connecting to Wireless LAN network

Make sure that the Datex-Ohmeda Wireless LAN Option, N-CMW is installed. Use the wireless LAN antenna card to connect the monitor to the network.

NOTE: The N-CMW option requires also that either N-CMNET or N-CMMEM option is installed.

1. Make sure that the power is switched off.

2. Connect the wireless LAN antenna card into a free, typically backmost, card drive slot.

3. Switch on the power. Confirm that the wireless LAN network symbol and the wireless LAN signal strenght symbol are displayed in the upper part of the screen.

Recommended installation

System installation

To Acces Point

Copper Pile

High-pass filter

RF shield

WLAN

antenna

Figure 16 WLAN Acces Point in Control room

(1) Antennas

(2) Network cable

(3) Access point.

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MRI Monitor

Use an appropriate high-pass filter and copper pile for the antenna wire in the wall throughput, if the WLAN access point is located outside the MRI room.

Use high-pass filter that passes through the WLAN signal but attenuates lower frequency noise (for example Mini-Circuits VHP-16 (15542 High Pass Filter w/ cut off frequency 1.9GHz).

NOTE: Required cable adapters must be supplied locally.

Alternative installation

Figure 17 MRI Monitor connected to wireless network

(1) Network cable

(2) Fiber optic converter

(3) Fiber optic cable

(4) Access point. Install the access point in the MR room as far from the magnet as possible.

(5) Antennas

WARNING The fiber optic converter contains ferrous material. Install it outside the 5 G line.

NOTE: Before installing the wireless monitoring network in the MR environment, the system must be tested to avoid all the interference that it may cause to the MR pictures. If problems exist, use wired networking.

3.3.7 Device Interfacing Solution, N-DISVENT

Follow the instruction in chapter 4, and in the N-DISVENT Installation Guide.

NOTE: When installing N-DISVENT, make sure to locate the DISVENT module outside 5G line.

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3.3.8 Remote Screen installation

The connection between the MRI Monitor and Active Remote Screen is accomplished with a fiber optic cable, which ensures safe and undisturbed data transmission. The available components are described below.

System installation

Figure 18 Control room installation

(1) Active Remote Screen with built-in loudspeakers.

(2) Remote screen converter, N-KVM, includes Sound

converter, connectors for Active Remote Screen and Command Bar or anesthesia record keeping keyboard.

(3) Fiber optic cable

(4) MRI Monitor

(5) Command Bar K-MRIANEB

(6) Anesthesia record keeping keyboard

Fiber optic cable installation

1. Route the fiber optic cable appropriately from the MR room to the Control room.

2. Connect the fiber optic cable connectors 1,2,3,4 and 5 to the connectors X, Y, B, G and R on the MRI Monitor.

3. Ensure that the fiber optic cable connectors are connected to corresponding connectors on the Remote screen converter, N-KVM.

NOTE: The connecotrs of color signals are marked with R, G and B and the digital signal connectors are marked with X and Y on monitor and on the N-KVM.

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MRI Monitor

Connecting the Command Bar, K-MRIANEB

Connect the command bar to the cable at the back of the Remote screen converter, N-KVM.

NOTE: K-MRIANEB has a special cable that enables the connection to Active Remote Screen converter, K-ANEB cannot be used.

NOTE: If Command Bar is used, the anesthesia record keeping keyboard cannot be used at the same time because they use the same connector.

Display installation

The LCD display (D-LCC19 - 01) is a 19” active matrix LCD display, which is equipped with loudspeakers.

NOTE: As a safety feature the audio volume is set to maximum, and the volume adjustment wheel is disabled from the D-LCC19-01 (M1057466).

NOTE: Please pay attention to any additional instructions that may accompany the displays and / or their installation equipment. The instructions described below in this manual may not contain all the necessary information.

NOTE: When using the display with the desk stand option, it must be placed on a flat surface.

WARNING The Active Remote Screen must be supplied from an additional transformer

providing at least basic isolation (isolating or separating transformer).

WARNING Never turn the volume off from the alarm loudspeakers on the display. If the

volume is silenced from the display, all patient alarms will be silenced and there will be no visible indication of the silenced state. The volume should only be adjusted through the Alarm Options page.

WARNING If you are using a display that does not have built-in speakers, use external

loudspeakers.

WARNING If you are using external loudspeakers, always make sure that audio cables are

properly connected.

WARNING Always make sure that the audio alarm volume level is adequate in your care

environment.

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System installation

WARNING After cleaning or if liquid has accidentally entered the display, ensure that every

part of the display is dry before reconnecting it to the power supply.

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

CAUTION The LCD display is fragile. Ensure that the display is not placed near a heat source or

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

CAUTION Make sure that the power adapter of the display is plugged into a grounded power

outlet. Do not use the power adapter in the presence of flammable anesthetics.

Display mounting

Mount the LCD Display to a pedestal, wall or ceiling mount, or display arm with appropriate parts. Connect the video cable to the display and tighten the video cable finger screws.

Connection to Remote Screen Converter

1. Make sure that power to the Remote Screen Converter is turned off.

2. Connect the video cable to the the appropriate connector on the Remote Screen Converter. Tighten the finger screws.

3. Connect the display loudspeaker cable to the Remote Screen Converter.

4. Connect the display power cord to the mains outlet.

WARNING The display must be used only together with the original type of power adapter.

WARNING Always make sure that the whole combination complies with the international

safety standard IEC 60601-1-1 for medical electrical systems and with the requirements of local authorities.

Adjustments

Adjust the brightness and contrast using the control keys on the display housing. To perform needed adjustments, please refer to the operations manual of the display.

3.3.9 Parameter modules

The modules are pre-installed inside the MRI Monitor.

Hemodynamic MRI Module E-MRIPSN is needed for measuring ECG, SpO2, NIBP and InvBP (two pressures, optional).

MRI Compact Airway Modules E-MRICO, E-MRICAiO and E-MRICAiOV measure CO2 (C), O2 (O), Spirometry (V), anesthetic agents (A) and agent identification (i).

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MRI Monitor

3.3.10 Downloading Monitor Software

The following instructions apply to downloading of new monitor software in case of upgrade or service. Detailed instructions for downloading software are supplied with software PCMCIA cards.

NOTE: When a new monitor software is downloaded, all user settings will be lost.

NOTE: When a new monitor software is downloaded, the WLAN encryption key will be lost. Rewrite the encryption key in the WLAN Config service menu if needed.

NOTE: During the downloading of software, the serial number of the monitor is written on the software card. The software can then be downloaded again in the same monitor, but not in another monitor.

1. Make sure the monitor is switched to standby.

2. Insert the software card into the card drive slot and press the card firmly into its place.

3. Switch the monitor on.

4. Wait for approximately 80 seconds. When the normal screen is displayed, enter the service menu and make sure that the information regarding monitor software has been updated. Memorize the serial number of the new software.

sec

5. Remove the software card.

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System installation

6. Replace the original device plate for monitor software with the new one supplied with the software card.

7. Perform Factory Reset. Make sure that the monitor functions normally after the restart.

8. Set the time and date.

9. Set the monitor’s network communication according to the network software in use, if necessary.

The communication is set in the monitor’s Network service menu.

Network software S-CNET99 -> DRI Level = 1999

Network software S-CNET01 -> DRI Level = 2001

Network software S-CNET02 -> DRI Level = 2001 or 2002 (WLAN)

Network software L-NET03 -> DRI Level = 2003

Network software L-NET05 -> DRI Level = 2005

NOTE: The DRI Level 1999 is not selectable in all monitor software versions.

NOTE: If you change the DRI level, the monitor will restart automatically.

10. Fill out all necessary documentation regarding the new monitor software.

NOTE: The license agreement of the monitor software needs to be in accordance with the monitor software serial number. Make sure you archive the license agreement in a secure location.

NOTE: The first start-up after software loading takes considerably longer than usually.

3.3.11 Performing Factory Reset

NOTE: The factory reset is necessary after downloading of monitor software and after replacing the CPU board or SRAM/Timekeeper battery.

NOTE: The factory reset will restore all customized defaults, including language selection, to factory defaults.

1. Press the

2. Select Install/Service and password (16-4-34).

3. Select Service and password (26-23-8).

4. Select Set/Test and perform a Factory Reset.

5. The monitor will perform an automatic restart. After the restart is completed, restart the monitor also manually by pressing the

Monitor Setup key.

3.3.12 Performing Service Reset

Perform the service reset always before disassembling or service checking the monitor.

NOTE: The service reset will erase all the trend information.

1. Disconnect the mains power cord.

2. Press the

ON/Standby key for 10 seconds.

On/Standby key.

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MRI Monitor

3.4 S/5 Remote Controller, K-REMCO

To connect Remote Controller to MRI Monitor

1. Make sure that the monitor is switched to standby.

2. Connect the Remote Controller cable to the 5 pin connector X3 on the right side of the MRI Monitor.

CAUTION Ensure that the Remote controller is outside the 300Gauss line and that the cable is

not in contact with the patient.

3.5 Anesthesia Record Keeping Keyboard, K-ARKB

3.5.1 Connection to MRI Monitor

To connect the K-ARK to MRI Monitor you need ARK Keyboard-LCD Cable 1.5 m/5ft, 881154 or ARK Keyboard-LCD Cable 2.5 m/ 8 ft, 889340.

1. Make sure that the power to the MRI Monitor is turned off.

2. Connect the ARK Keyboard-LCD Cable to the connector X3 on the MRI Monitor, and to the connector on the rear of the keyboard. Alternatively you can connect the cable to a Remote Screen Converter in Control room. Secure the connection with the thumbscrew and slip the cable beneath the fasteners.

CAUTION If you use the anesthesia record keeping keyboard inside the MR scanning room,

place the between the keyboard and the monitor outside the 300 Gauss line.

3.6 MRI Airway Module gas scavenging

3.6.1 Sample gas exhaust

Preventing MR room pollution

When N2O or volatile anesthetics are used, pollution of the MR room by these gases should be prevented. Connect the sample gas outlet of the monitor to the scavenging system.

Connect the sample gas outlet of the monitor to the scavenging system either

• through the ventilator, or

• directly to the scavenging system.

CAUTION Strong scavenging suction may change the operating pressure of the monitor and

cause inaccurate readings or internal damage. To prevent this, there must for example be an opening to room air.

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System installation

Scavenging through the ventilator reservoir

Connect the sample gas outlet only to open scavenging system where gas is removed in room pressure.

1. Connect the exhaust line to the sample gas outlet on the connector panel of the MRI Monitor shield.

Figure 19 Exhaust to reservoir tube

2. Attach the other end of the line to the ventilator reservoir. Make sure that the reservoir tube diameter is at least 2 - 3 times larger than the exhaust line.

Scavening through the anesthesia gas scavennging system

Anesthesia machines are equipped with an anesthesia gas scavenging system (AGSS), and in some machines you can connect the sample gas outlet directly to that. Refer to the anesthesia machines’s user documentation to find out where and how the the sample gas can be connected.

Connecting directly to the scavenging system

1. Connect the exhaust line to the monitor's sample gas outlet.

2. Connect the exhaust line only to an open scavenging system where gas is removed at room pressure.

NOTE: Do not connect the monitor directly to a vacuum scavenging system.

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MRI Monitor

3.7 Troubleshooting

If a problem occurs during a functional examination, check the components of the monitor according to the following troubleshooting chart. If the problem persists, please refer to “6. General

troubleshooting” section.

Trouble Treatment

The MRI Monitor does not function.

The remote display does not function.

A parameter module does not function.

The MRI Compact Airway Module does not function.

Printer error. Printer is not working properly.

Unplug the power cord. Check that the cord is intact, then reconnect the cord.

Unplug the display power cord and the display cable. Check that the cord and cable are intact, then reconnect the cord and cable.

Unplug the Remote Screen Converter-LCD Display cable. Check that the cable is intact and reconnect the cable. Check that the display brightness is adjusted properly.

Check that the parameters displayed are configured correctly.

Check that the ‘Occlusion’ or ‘Calibrating Gas Sensor’ messages are not displayed.

Check that a D-fend water trap and a sampling line are attached.

Check that the parameters displayed are configured correctly.

Check that the local or network printer is operational. Central can also start snapshot printing, please refer to the "iCentral User's Reference Manual" for details.

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4 Interfacing

The MRI Aestiva/5 can be interfaced with the Device Interfacing Solution.

Printers and computers cannot be directly connected to the MRI monitor, but can be interfaced through the network.

NOTE: The N-DISVENT module must be mounted outside 5G line.

4.1 Interfaced parameters

When you interface Aestiva/5 MRI to the MRI Monitor you will get the following parameters:

Device set values for trends Measured numeric values Waveforms Supported versions

Interfacing

Vent. mode, I:E ratio, RR, TV, PEEP, Pinsp, Insp.pause, Pmax

, TVexp, MV, RR, Pmean,

FiO

Ppeak

Paw, Flow, Vol Loops

with SmartVent 7900: software versions 3.5 and 4.5

4.2 Interfacing external bedside devices via Device Interfacing Solutions, N-DISxxx

The Device Interfacing Solution, N-DISxxx provides means for transferring physiological, waveform and event data from various bedside patient care devices to the Datex-Ohmeda monitoring system. The real-time and trended data can be displayed on the monitor screen and used for record keeping purposes. The interfacing module reads the data coming from the external device, converts it to a suitable format and sends it to the monitor.

4.2.1 Device Interfacing Solution components

The Device Interfacing Solution consists of:

− a device specific interfacing module

− a device specific cable

− a bus cable

− a connector for another bus cable

− label specifying the external device

4.2.2 Connections

Connect the device specific cable to the external device and the bus cable to the monitor's DIS connector or to another interfacing module.

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MRI Monitor

(1) label specifying the external device

(2) LED indicators

(3) black bus cable from another interfacing

module, if needed

(4) grey device specific cable to the

communication port of the external device

(5) black bus cable to the monitor’s DIS

connector (or to another interfacing module)

Figure 20 Connection cables and LED indicators

WARNING The MRI Monitor, interfacing modules and interfaced devices must be situated in

the same patient environment (as defined in IEC 60601-1-1).

WARNING Connecting electrical equipment together or using the same extension cord for

more than one device may cause their leakage currents to exceed the limits specified in relevant safety standards. Always make sure that the combination complies with the international safety standard IEC 60601-1-1 for medical electrical systems and with the requirements of local authorities.

WARNING The manufacturer guarantees a reliable functioning of the devices with tested

software versions only. Always refer to the Installation guide accompanying the DIS module and verify the compatibility before use.

4.2.3 Mounting

The DIS module can be mounted on the side panel of the external device. Also IV pole placement is possible.

NOTE: As the Device Interfacing Solution works only with the device specified in the label of the interfacing module, it is recommended that the interfacing module always travels along with the external device.

For mounting accessories, please refer to the “Supplies and Accessories” catalog. See the following figure for an example of a device interfacing.

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Interfacing

Figure 21 An example of interfacing external devices with Device Interfacing Solution

(1) MRI Monitor (with L-CANE05 or L-CANE05A software license)

(2) Aestiva/5 MRI anesthesia machine

(3) Device specific interfacing module, N-DISVENT

CAUTION Make sure that the interfacing module is always used in vertical position to prevent

water from entering the module.

CAUTION Make sure that you are connecting the interfacing module to the device specified in

the label.

NOTE: If DIS is used, keep it connected to the MRI Monitor at all times. If the DIS is already connected to the Aestiva/5 MRI that is on, do not connect the DIS to the MRI Monitor that is on.

4.2.4 Selecting the external device

1. Turn off the monitor.

2. Turn off the external device.

3. Connect the interfacing module to the monitor’s connector for N-DIS or to another interfacing module.

4. Connect the device specific cable to the external device and turn the external device on.

5. Turn the monitor on. The monitor identifies the connected device automatically.

4.2.5 Functional check

There are two ways to check the function of the Device Interfacing Solution:

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1. Press the Monitor Setup key.

2. Select Interfacing and open the Status Page menu. The status page shows you the current communication status of the interfacing module (1 - ).

NOTE: The status message ‘Connected’ appears on the Status Page after you have connected the external device to the interfacing module and turned it on. Note also that the monitor and the interfacing module must be operational.

• Check the LED indicators on the interfacing module (the green LED indicates physical

connections, the yellow LED software selections)

GREEN YELLOW INDICATION

lit dark

Physical connections between the monitor, interfacing module and external device are in order and the device has been selected in the menu.

dark

lit lit

lit

There is something wrong with the physical connections between the monitor, interfacing module and external device. The external device has not been selected in the menu.

Physical connections between the monitor, interfacing module and external device are in order but the external device has not been selected in the menu.

dark dark

The interfacing module is not connected to the monitor.

4.2.6 Selecting the parameter data source

Select the external device via Monitor Setup - Interfacing menu:

NOTE: The name of the device is visible on the list only if the device is correctly connected.

NOTE: Detailed information about interfacing module related mountings, connections and settings is included in the installation guides that are delivered with the interfacing modules.

4.3 Interfacing printer

The printer can be used through the Central. At the Central you can print patient information, real-time ECG waveforms strips, trends, event history waveforms strips and full disclosure data from the selected monitor location to a . to the network. You can also print the anesthesia records and critical care reports. For details please refer to "iCentral and iCentral Client" manuals.

WARNING Always make sure that the combination complies with the international safety

standard IEC 60601-1-1 for medical electrical systems and with the requirements of local authorities.

WARNING Connecting the power supply cord of the printer to the wall power outlet may

cause the printer leakage current to exceed the limit specified for medical

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Interfacing

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

4.4 Interfacing computer

Contact your authorized GE Healthcare distributor for further advice on computer interface.

WARNING Always make sure that the combination complies with the international safety

standard IEC 60601-1-1 for medical electrical systems and with the requirements of local authorities.

WARNING Connecting the power supply cord of the computer to the wall power outlet may

cause the computer leakage current to exceed the limit specified for medical equipment. A computer must be supplied from an additional transformer providing at least basic isolation (isolating or separating transformer).

4.5 Output signals

Cardiac (ECG) Gating connector X2

Connector Pin Signal

Cardiac Gating

The ECG hardware has an electric output providing analog ECG and QRS triggering pulses.

Analog ECG

Gain 1mV ECG signal is 1 V ± 10 % at the analog output

Delay < 10 ms

Range ± 8 V

Bandwith 0.5 to 40 Hz

QRS triggering pulse

Pulse width 10 ms positive pulse

Delay -15 to 15 ms

ECG out

QRS pulse OUT

Reserved for future use

+15 VDC

GND

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5 Functional check

These instructions include procedures for a functional check for MRI Monitor. The functional check is recommended to be performed after any monitor installation, either a new monitor or a serviced monitor.

These instructions include a “Functional check form, MRI Monitor” to be filled in when performing the

procedures. The symbol

signed in the check form. The procedures should be performed in ascending order, by passing those that are not applicable for a particular monitor.

All menu selections related to MRI Monitor are written in following typeface: e.g. Parameters - Gas Unit.

As you enter the service menus, you need the following passwords:

" in the instructions means that the performed procedure should be

Monitor Setup - Install/Service (password 16-4-34) - Service (password 26-23-8)

In case you evaluate the measurement accuracy with a patient simulator, add simulator’s accuracy specification to the one of the monitor.

An electrical safety check and a leakage current test are recommended to be performed prior to the monitor installation.

5.1 Recommended tools

For product(s) Tool Order No.

Airway Modules

All MRI Airway modules Sampling line, 6 m/19.7 ft 73306

All MRI Airway modules w/ (V) Spirometry tube, 6 m/19.7 ft 891191

D-lite 733910

Hemodynamic module, E-MRIPSN

for InvBP InvBP transducer 70077-001

for ECG MRI ECG 3-lead set, 6.5 m/20 ft, IEC 897987

MRI ECG 3-lead set, 6.5 m/20 ft, AAMI

for SpO

for NIBP Adult NIBP cuff hose, 6 m/19.7 ft 2020980-002

for InvBP and NIBP Pressure manometer

Finger MRI sensor for adults OXY-FMR

Wrap MRI sensor for pediatrics OXY-WMR

Infant NIBP cuff hose, 6 m/19.7 ft 2017009-004

897986

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For product(s) Tool Order No.

Data Card option MemCard – Data or Menu

Network or WLAN option Datex-Ohmeda Network connection

Screwdrivers See “3.4.2. Tools needed” for the

tools needed during the dis-/reassembly.

NOTE: Ensure that the calibrating gas and regulator are functioning properly before calibration. Perform annual maintenance on the regulator as required. For more information see “Calibration gas

regulator flow check” in the “Gas calibration” chapter.

Patient simulators’ compatibility with MRI hemodynamic module

Patient simulator

Functional check

Module Parameter

E-MRIPSN ECG

InvBP

M1010831 MedSim 874027

Not compatible

with adapter cable M1010858

Not compatible

Adapter cables for hemodynamic patient simulators

Patient simulator Adapter cables for simulators

Hemodynamic patient simulator - Dual Inv.BP adapter cable 2005772-001

Medsim - Inv.BP adapter cable M1010858

Lionheart & MPS450 - Inv.BP adapter cable M1010862

5.2 Visual inspection

• Make sure that the monitor is switched to standby.

Disconnect the mains power cord from the monitor. If the monitor is connected to the Datex-Ohmeda Network, disconnect the fiber optic Network cables from the monitor. If the MRIRemote option is connected, disconnect the fiber optic cables from the monitor.

1. External parts and connectors

Check that all the parts and the connectors are intact. Especially check that:

− all the screws are tightened properly.

− the patient cable connectors in the connector panel are intact.

Connect the sampling line to the connector panel.

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5.3 Functional inspection

General

1. Connect the mains power cord.

2. Switch the monitor on. Check that the monitor starts up properly, i.e. normal start-up sound is heard, the alarm LEDs turn on and off, also the magnetic field alarm LEDs, and the monitoring screen appears. No error messages should appear on the screen. Magnetic Field alarm test sound should be heard.

3. Check that the clock on the screen shows correct time. Readjust the time and date, if necessary.

4. Enter the Service Menu.

When applicable, check from the corresponding Parameters submenu that the Timeouts, Bad checksums and Bad c-s by mod values of inserted modules are not increasing faster than by 5 per second. Check also that the module memories have passed the internal memory test, i.e. RAM, ROM and EEPROM all state OK. If connected, the recorder should record two lines of start-up information.

Display(s)

1. Check that the picture on the monitor screen is correct and the monitor screen configuration is appropriate for the parameters in use.

Keyboard(s)

1. Press the Monitor Setup key. Turn the ComWheel in both directions and check that the cursor in the menu moves correspondingly. Select Normal Screen and check that the menu disappears from the screen.

MRI Monitor frame

1. Check that all the monitor fans are running.

MRI Compact Airway Module, E-MRICXXXXX

Wait until the message ‘Calibrating gas sensor’ disappears from the screen.

Perform the sampling system leak test.

Prevent the module from performing the normal occlusion functions, such as controlling the valves, by turning the pump first off, then on again from the menu.

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Functional check

Block the reference gas connector at the module front panel.

Connect a flow cassette with high flow resistance value (50/1.1) to the end of the sampling line and start following the Amb-Work value in the service menu. When the value exceeds 170 mmHg, connect the other port of the flow cassette to the sample gas out connector and switch the pump off.

Wait until pressure inside the sampling system is stabilized, then notice the shown Amb-Work value. The value, i.e. the pressure inside the sampling system, should not drop more than 6 mmHg in one minute.

If the pressure drops more, first check the connections and then repeat the test.

2. Flow rates

Wait until the Sample Flow value in the service menu is back near 200 ml/min.

Connect the flowmeter to the reference gas connector, check that the flowmeter reading is within the following range:

Reference flow (ml/min) 30 to 45

MRI Compact Airway Modules with the Patient Spirometry option

3. Flow waveform

Connect a clean spirometry tube to the module and a clean D-lite to the other end of the tube. Connect the sampling line. Breathe through the wider side of the D-lite. Check that the flow waveform moves downwards when you breathe in and upwards when you breathe out.

4. Spirometry system leak test

Enter the service menu Spirometry:

Gas Unit - Spirometry

Block the D-lite’s sampling line port, for example with a Luer stopper.

NOTE: Make sure that the date marking on the D-lite is 10/94 or newer.

Take the D-lite in your hand and occlude both ends tightly with your fingers (or with both hands). Pressing creates a pressure inside the D-lite. Check that a pressure near 5 cmH

(the Aw Pressure value in the service menu).

If the system leaks heavily, no pressure will be generated.

If there is a small leak in the connections, the monitor will measure a pressure difference, which is then interpreted as flow and seen on the monitor screen. The pressure waveform (and the Aw Pressure value) decreases slowly and the flow waveform (the Flow value) either goes above or below the zero line, depending on which of the connectors is leaking.

In case of leakage, first check all the connections and try again.

O is generated

Document no. M1041746 -1

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MRI Monitor

For all MRI Compact Airway Modules

5. Occlusion detection

Block the tip of the sampling line with your finger and check that the message ‘Sample line blocked’ is displayed on the monitor screen within 30 seconds.

6. D-fend detection

Detach the D-fend and check that the message ‘Check D-fend’ is displayed on the monitor screen within 30 seconds. Attach the D-fend back to the patient connector panel.

7. CO2 information

Breathe to the sampling line briefly. Check that the CO

8. Apnea detection

Check that the ‘Apnea’ message is displayed on the screen within 30 seconds after you have stopped breathing in the sampling line.

Hemodynamic measurements, E-MRIPSN

ECG measurement

1. Connect an ECG cable to the connector panel. Connect the cable leads to a patient simulator. Check that all ECG information is shown on the monitor screen as configured on the simulator.

Turn the simulator off. Check that the ‘Asystole’ and ‘Apnea’ messages are displayed.

information is updated on the screen.

Invasive blood pressure measurement

1. Check the InvBP channels with a patient simulator.

2. Zero the InvBP channels and check that the values and waveforms correspond to the simulator settings.

Document no. M1041746 -1

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SpO2 measurement

3. Connect an SpO2 finger probe to the module. Check that the message ‘Probe off’ is shown when

4. Attach the SpO

Non-invasive blood pressure measurement

5. Attach an adult NIBP cuff on your arm and perform one NIBP measurement. Check that the

Data Card function

1. Insert a Data Card in the slot.

Functional check

the probe is not connected to a finger.

probe to your finger. Check that a reading of 95 to 99 and a pleth waveform are

displayed on the screen.

module identifies the cuff, i.e. the text ‘Adult’ is displayed in the NIBP digit field for a short time.

Check that the module gives a reasonable measured result.

Check that the corresponding symbol appears on the monitor screen.

Recorder

1. Press the Record Wave side panel key and check that the recorder starts recording the selected waveforms. Press the

2. Check that the quality of the recordings is acceptable.

Active Remote Screen Option

Reconnect the fiber optic cable to the MRI Monitor. Make sure that the fiber optic cables are connected to the Remote screen converter and this to the remote screen and to the MRI Command Bar or to the Anesthesia record keeping keyboard, K-ARK, if included.

Turn the monitor on.

1. Check that the picture on the remote screen is correct.

2. Press the in the menu moves correspondingly. Select Normal Screen and check that the menu disappears from the screen.

3. Create an alarm and check that this alarm is correctly displayed on the remote screen and an alarm sound is heard from the remote screen.

Monitor Setup key. Turn the ComWheel in both directions and check that the cursor

Stop side panel key to stop recording.

Network connection

1. Reconnect the fiber optic Network cable to the MRI Monitor. Make sure that the fiber optic

cables are connected to the Fiber optic converter, N-FOC, and this to the network.

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MRI Monitor

Check that the monitor connects to the network, i.e. the network symbol is displayed under the clock in the upper right-hand corner of the screen. Also a message regarding the connected Central should appear in the message field on the screen.

Wireless Network Option

1. Check that the WLAN signal strength symbol scrolls between zero and full or stays fixed on the monitor screen.

2. Check that the wireless LAN network symbol is displayed in the upper right-hand corner of the screen when the monitor connects to the Datex-Ohmeda Network.

NOTE: If the monitor does not connect to the Datex-Ohmeda Network, check the WLAN configuration in the monitor and in the network.

Device Interfacing Solution, N-DISVENT

1. Make sure that the monitor receives all necessary parameter data from the connected devices. Check the screen configuration and the related interfacing settings, if necessary.

Monitor Setup - Interfacing - Status Page

General

Test the MRI monitor system to avoid all the interference that it may cause to the MR pictures.

•

• Switch the monitor to standby

• Perform final cleaning

• Fill in all necessary documents

Document no. M1041746 -1

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6 General troubleshooting

oub

oot

Monitor not f unctioning

General troubleshooting

On/Stby

switch "ON"?

Yes

Ma in s

pow er c ord connec ted?

Connect pow er cord

Monitor s tar ts

functioning

Yes

Press the On/Stby key less than

10 s.

Monitor s tar ts

functioning?

Disconnect and reconnect the

pow er cord.

Yes

Monitor s tar ts

functioning?

Yes

The monitor is w orking OK.

The batteries w ere empty.

The pow er supply unit w as shut

dow n by instant over voltage in the

mains and the batteries w ere empty.

Stby- led lit

or blinks?

Yes

Fr ame

unit fan

running?

Yes

Go to the next

page to continue

Pos sible AC/DC unit

failure.

Pos si b l e PMB f a i l u r e.

Document no. M1041746 -1

See troubleshooting in the

"MRI Monitor Frame slot".

-1.v in

h l

r l r

MRI

Page 64

MRI Monitor

Continuing f rom previous

page. (Is the frame unit fan

running?)

Yes

Start-up

texts appear on

screen?

Yes

Cloc k etc.

data appears on

the screen?

Yes

Module data

appears on the

screen?

Is o n ly the

MRIPSN data

missing?

Yes

Mov e

the monitor

further off from

the magnet.

OK?

Yes

Faulty Display unit.

See troubleshooting in

"MRI Monitor Frame slot".

Monitor w orks.

The module may be loosen or the internal

parameter cables or tubes are not proper ly

connected.

See troubleshooting in the

"MRI Monitor Shield slot".

Yes

The monitor w orks.

It w as too close to the

magnet.

Figure 22 MRI general troubleshooting flowchart

Document no. M1041746 -1

MR I_General troubl eshooti ng-1.vsd

Page 65

Appendix A, Functional check form, MRI Monitor

APPENDIX A Functional check form, MRI Monitor

Customer

Service

Service engineer Date

Monitor Installation

Frame: N- System options N- Modules

Active Remote Screen N- N- E-MRIPSN

D- N- N- E-MRIC_____

K- K- N-

OK = Test OK N.A. = Test not applicable Fail = Test failed

Visual Inspection OK N.A. Fail

1External parts and connectors

Functional Inspection OK N.A. Fail

General S/N

Display(s) S/N

Keyboard(s) S/N

MRI Monitor frame

Notes

MRI Compact Airway Module, E-MRICXXXXX S/N

MRI Compact Airway Modules with the Patient Spirometry option

For all MRI Compact Airway Modules

S/N

Notes

Hemodynamic measurements, E-MRIPSN S/N

A-1(2)

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MRI Monitor

Functional Inspection OK N.A. Fail

ECG measurement

Invasive blood pressure measurement

SpO2 measurement

Non-invasive blood pressure measurement

Notes

Data Card function S/N

Recorder S/N

Active Remote Screen Option S/N

Network connection S/N

Wireless Network Option S/N

Notes

Device Interfacing Solution, N-DISVENT S/N

General S/N

Notes

Signature

A-2(2)

Document no. M1041746 -1

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Appendix B, 1ElectroMagnetic Compatibility

APPENDIX B 1ElectroMagnetic Compatibility

Table 1 Guidance and manufacturer’s declaration – electromagnetic emissions

Guidance and manufacturer’s declaration – electromagnetic emissions

The MRI Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the MRI Monitor should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions

Group 1 The MRI Monitor uses RF energy only for its internal function.

CISPR 11

RF emissions

Group 2

CISPR 11

RF emissions

Class B

CISPR 11

Harmonic emissions

Class A

IEC 61000-3-2

Voltage fluctuations/

Complies

flicker emissions

IEC 61000-3-3

1. MRI Monitor equipped with N-CMW option

Therefore, its RF emissions are very low and are not likely to cause any interference in the nearby electronic equipment.

The MRI Monitor

must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.

The MRI Monitor

is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

B-1(6)

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MRI Monitor

Table 2 Guidance and manufacturer’s declaration – electromagnetic immunity

Guidance and manufacturer’s declaration – electromagnetic immunity

The MRI Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the MRI Monitor should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance

Electrostatic discharge (ESD) IEC 61000-4-2

Electrical fast transients/bursts IEC 61000-4-4

Surge IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply lines IEC 61000-4-11

±6 kV contact

±8 kV air

±2 kV for power supply lines ±1 kV for input/output lines

±1 kV differential mode ±2 kV common mode

<5 % U

(>95 % dip in UT) for 0.5 cycle

40 % U

(60 % dip in UT) for 5 cycles

70 % U

(30 % dip in UT) for 25 cycles

±6 kV contact

±8 kV air

±2 kV for power supply lines ±1 kV for input/output lines

±1 kV differential mode ±2 kV common mode

<5 % U

(>95 % dip in UT) for 0.5 cycle

40 % U

(60 % dip in UT) for 5 cycles

70 % U

(30 % dip in UT) for 25 cycles

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If user of the MRI Monitor requires continued operation during power mains interruptions, it is recommended that the MRI Monitor be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

NOTE U

is the a.c. mains voltage prior to application of the test level.

B-2(6)

Document no. M1041746 -1

<5 % U

(>95 % dip in UT) for 5 sec

<5 % U

(>95 % dip in UT) for 5 sec

3 A/m 10 A/m Power frequency magnetic field should be at

levels characteristic of a typical location in a typical commercial or hospital environment.

Page 69

Appendix B, 1ElectroMagnetic Compatibility

Table 3 Guidance and manufacturer’s declaration – electromagnetic immunity

Guidance and manufacturer’s declaration – electromagnetic immunity

The MRI Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the MRI Monitor should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance

level

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

3 Vrms

3 V/m

Electromagnetic environment - guidance

Portable and mobile RF communications equipment should be used no closer to any part of the MRI Monitor including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

d 1.2 P=

80 MHz to 800 MHz

d 2.3 P=

800 MHz to 2.5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined

by an electromagnetic site survey, the compliance level in each frequency range.

should be less than

Interference may occur in the vicinity of equipment marked with the following symbol:

Document no. M1041746 -1

B-3(6)

Page 70

MRI Monitor

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption

and reflection from structures, objects and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicated theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the MRI Monitor is used exceeds the applicable RF compliance level above, the MRI Monitor should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the MRI Monitor.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

B-4(6)

Document no. M1041746 -1

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Appendix B, 1ElectroMagnetic Compatibility

Table 4 Recommended separation distances between portable and mobile RF

communications equipment and the MRI Monitor

Recommended separation distances between portable and mobile RF communications equipment and the MRI Monitor.

The MRI Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the MRI Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the MRI Monitor as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output

power of transmitter

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflection from structures, objects and people.

150 kHz to 80 MHz

d 1.2 P= d 1.2 P= d 2,3 P=

Separation distance according to frequency of transmitter

80 MHz to 800 MHz

800 MHz to 2.5 GHz

B-5(6)

Document no. M1041746 -1

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MRI Monitor

For your notes:

B-6(6)

Document no. M1041746 -1

Page 73

Datex-Ohmeda

MRI Monitor

Planned Maintenance Instructions

CAUTION: U.S. Federal law restricts this device to sale by or on the order of a licensed medical practitioner.

Datex-Ohmeda Inc.

P.O. Box 7550

Madison, WI 53707-7550, USA

Tel: +1 608 221 1551

Fax: +1 608 222 9147

All specifications are subject to change without notice.

Outside the USA, check local laws for any restriction that may apply.

M1041747-1

September, 2006

GE Healthcare Finland Oy

Helsinki, Finland

P.O. Box 900

FI-00031 GE, FINLAND

Tel: +358 10 39411

Fax: +358 9 1463310

www.gehealthcare.com

Page 74

Page 75

Table of contents

Table of contents i

1 Planned maintenance instructions 1

1.1 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1

1.2 Recommended tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

1.3 Recommended parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3

1.4 Recommended parts for MRI compact airway module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3

2 Planned maintenance check list 5

2.1 Visual inspection/preparation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5

2.1.1 General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5

2.1.2 MRI Compact Airway Module, E-MRICXXXXX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5

2.1.3 Hemodynamic MRI module, E-MRI(P)SN. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

2.1.4 Recorder Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

2.1.5 Monitor reassembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

2.2 Functional inspection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7

2.2.1 General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7

2.2.2 Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

2.2.3 Keyboard(s) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7

2.2.4 Display Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

2.2.5 MRI Monitor Frame Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

2.2.6 MRI Compact Airway Module, E-MRICXXXXX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8

2.2.7 Hemodynamic measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9

2.2.8 Magnetic field alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

2.2.9 Data Card function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

2.2.10 Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

2.2.11 Electrical safety check. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

2.2.12 Active Remote Screen Option. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12

2.2.13 Network Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12

2.2.14 Wireless Network Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12

2.2.15 Device Interfacing Solution, N-DISVENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13

2.2.16 General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13

Appendix A: Planned maintenance check form, MRI Monitor A-1

Document no. M1041747-1

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MRI Monitor

Document no. M1041747-1

Page 77

1 Planned maintenance instructions

1.1 Introduction

These instructions include procedures for planned maintenance (PM) for the MRI Monitor. The Planned maintenance should be performed once a year.

These instructions include “Planned maintenance check form, MRI Monitor” to be filled in when performing the corresponding procedures.

Planned maintenance instructions

The symbol

check form.

The procedures should be performed in ascending order, bypassing those that are not applicable for a particular monitor.

If you need further information on how to perform a certain Planned maintenance procedure, please refer to the corresponding slot in the Technical Reference Manual.

All menu selections related to the Datex-Ohmeda monitors are written in the following typeface:

e.g. Parameters - Gas Unit

As you enter the service menus, you need following passwords:

Monitor Setup - Install/Service (password 16-4-34) - Service (password 26-23-8)

NOTE: In case you evaluate the measurement accuracy with a patient simulator, add the simulator’s accuracy specification to the one of the monitor.

" in the instructions means that the procedure performed should be signed in the

CAUTION Failure on the part of all responsible individuals, hospitals or institutions, employing

the use of this device, to implement the recommended maintenance schedule may cause equipment failure. The manufacturer does not, in any manner, assume the responsibility for performing the recommended maintenance schedule, unless an equipment maintenance agreement exists. The sole responsibility rests with the individuals, hospitals, or institutions utilizing the device.

CAUTION Only trained personnel with appropriate equipment should perform the tests and

repairs outlined in this section. Unauthorized service may void warranty of the unit.

WARNING Planned maintenance requires using tools like calibration gas bottles, that

contain ferrous metal, perform the procedure outside the MR environment.

CAUTION Wear a static control wrist strap when handling PC boards. Electrostatic discharge

may damage components on the board.

Document no. M1041747-1

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MRI Monitor

1.2 Recommended tools

For product(s) Tool Order No.

Airway Modules

MRI Compact Airway Module,

Calibrating gas and regulator 755583/755534*

E-MRICAiO(V)

MRI Compact Airway Module,

Calibrating gas and regulator 755581/755534*

E-MRICO

All MRI Airway modules Sampling line, 6 m/19.7 ft 73306

All MRI Airway modules w/ (V) Spirometry tube, 6 m/19.7 ft 891191

D-lite 733910

Hemodynamic module, E-MRIPSN

for InvBP InvBP transducer 70077-001

for ECG MRI ECG 3-lead set, 6.5 m/20 ft, IEC 897987

MRI ECG 3-lead set, 6.5 m/20 ft,

897986

AAMI

for SpO

Finger MRI sensor for adults OXY-FMR

Wrap MRI sensor for pediatrics OXY-WMR

for NIBP Adult NIBP cuff hose, 6 m/19.7 ft 2020980-002

Infant NIBP cuff hose, 6 m/19.7 ft 2017009-004

for InvBP and NIBP Pressure manometer

Data Card option MemCard – Data or Menu

Network or WLAN option Datex-Ohmeda Network connection

Active Remote Screen option Control room setup

Screwdrivers See “3.4.2. Tools needed” for the

NOTE: Ensure that the calibrating gas and regulator are functioning properly before calibration. Perform annual maintenance on the regulator as required. For more information see “Calibration gas

regulator flow check” in the “Gas calibration” chapter.

tools needed during the dis-/reassembly.

Document no. M1041747-1

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Planned maintenance instructions

Patient simulators’ compatibility with MRI hemodynamic module

Patient simulator

Module Parameter

E-MRIPSN ECG

InvBP

M1010831 MedSim 874027

Not compatible

with adapter cable M1010858

Not compatible

Adapter cables for hemodynamic patient simulators

Patient simulator Adapter cables for simulators

Hemodynamic patient simulator - Dual Inv.BP adapter cable 2005772-001

Medsim - Inv.BP adapter cable M1010858

Lionheart & MPS450 - Inv.BP adapter cable M1010862

1.3 Recommended parts

For Part Order No.

MRI Shield and MRI Monitor Frame Fan filters, 2 pcs 896085

CPU Board,every 8 years Battery for SRAM/Timekeeper 197230

Recorder Recorder paper 74205

E-MRI(P)SN NIBP pump filter 57142-HEL

1.4 Recommended parts for MRI compact airway module

Part Order No. Notes

Fan filter M1028983

D-fend O-ring (2 pcs) 653125 Replace annually the ones in the Patient

connector panel.

Filter (3 pcs) 886136 Replace the occlusion filter annually.

D-fend 876446

Sampling line, 6 m/19.7 ft 73306

Nafion tubes (2 pcs) 733382 Replace annually.

Zero Absorber 895933 Replace once every four years.

Document no. M1041747-1

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MRI Monitor

D-lite / Pedi-lite 733910/73393

Spirometry tube, 6 m/ 19.7 ft 891191

Filter assembly 896025-HEL

For details on recommended accessories see the “Supplies and Accessories” catalog.

Document no. M1041747-1

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2 Planned maintenance check list

2.1 Visual inspection/preparation

2.1.1 General

Make sure that the monitor is switched to standby.

•

• Disconnect the mains power cord and all the other external cables connected to the monitor. If

the monitor is connected to the Datex-Ohmeda Network, disconnect the fiber optic network cable from the monitor.

• Disconnect all the patient connectors.

• Disassemble the MRI Monitor far enough to be able to remove the MRI Monitor frame from the

shield. See MRI Shield slot for the disassembly instructions.

• Remove both modules from the monitor.

• Remove the WLAN antenna card, if the Wireless LAN option is installed. Remove any data cards

and the PCMCIA Extender Unit.

Planned maintenance check list

1. Replace the SRAM/Timekeeper battery on the CPU board, if necessary. See MRI Monitor frame slot for the disassembly instructions.

The manufacturer recommendation is to replace the SRAM/Timekeeper battery every 8 years.

NOTE: The Factory Reset must be performed if the SRAM/Timekeeper battery is replaced.

2. Check all the units visually. Check that all the parts are intact and the cables and screws are connected and tightened properly.

Especially check the following parts:

− the display unit locking screw is in a locking position.

Insert the WLAN antenna card back into the foremost card slot, if the Wireless LAN option is installed.

3. Clean or replace the fan filters in MRI Shield.

4. Check that the fuses are of the correct rating.

5. Check the ventilation holes of the MRI Monitor Shield and clean of dust if necessary.

2.1.2 MRI Compact Airway Module, E-MRICXXXXX

Detach the module box. See MRI Compact Airway Modules slot for the disassembly instructions.

1. Check that all cables and tubes are connected properly and that there are no loose objects inside the module.

NOTE: The tubes connected to the Oxygen board pressure transducers should not be pressed too deep.

NOTE: Make sure that the tubes are not in contact with the sampling pump or the O its springs.

sensor, or

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2. Planned maintenance parts

− Clean or replace the fan filter.

− Replace the special tubes (Nafion™).

− Replace the reference gas filter in the patient connector panel and, if necessary, in the

module front cover.

− Replace the occlusion filter in the pneumatic unit.

− Check the dummy D-fend O-rings.

− Check the D-fend O-rings located in the patient connector panel and replace them, if

necessary.

− Replace the old D-fend and the sampling line.

NOTE: Use only approved sampling lines to ensure proper functioning.

3. CO

absorber

The manufacturer recommendation is to replace the CO absorber, if necessary.

absorber every 4 years. Replace the

Insert the MRI Compact Airway Module in to the gas module slot in the MRI Monitor frame.

2.1.3 Hemodynamic MRI module, E-MRI(P)SN

Detach the module box. See Hemodynamic MRI Module slot for the disassembly instructions.

1. Check the NIBP pump filter. Replace the filter, if necessary.

Reassemble the module and insert it back in to the monitor frame.

2.1.4 Recorder Unit

1. Clean the recorder.

− Open the paper compartment hatch and remove the paper roll, if installed.

− Remove any paper chaff from the paper compartment.

− Clean the thermal printhead and the small glass window in front of the static brush with a

cotton swab dipped in isopropyl alcohol, if necessary.

NOTE: Avoid contact with the rubber paper roller. Be careful to limit the application of alcohol to the thermal printhead and the window.

− Reinstall the paper roll.

2.1.5 Monitor reassembly

Reassemble the MRI Monitor far enough to be able to connect all the tubes and cables to the MRI Monitor frame, see ”Disassembly and reassembly” in the MRI Shield slot.

NOTE: Leave the MRI Shield front cover still open.

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2.2 Functional inspection

2.2.1 General

1. Connect the mains power cord to the MRI Monitor. Check that the LED above the mains switch is lit continuously (full charged batteries) or periodically (charging batteries).

2. Switch the monitor on.

Check that the monitor starts up properly, i.e. the alarm LEDs turn on shortly, normal start-up sound is heard from the loudspeaker and the monitoring screen appears.

No error messages should appear on the screen.

3. Configure the screen for the parameters that are connected. Check that all the connected modules are recognized, i.e. the required parameter information is shown on the screen.

If installed, the recorder should record two lines of start-up information.

Preset the measurement settings for those parameters that are connected.

Planned maintenance check list

2.2.2 Display

1. Check that the picture on the screen is adjusted correctly.

2.2.3 Keyboard(s)

1. Tests with the Command Board:

2.2.4 Display Unit

1. Check that the clock on the screen shows correct time.

2. Enter the Service Log service menu.

− Press the

cursor in the menu moves correspondingly. Select Normal Screen and check that the menu disappears from the screen. Check the rest of the menu keys by pressing them one by one.

Tests with the Remote Controller:

− Enter the Keyboard service menu.

− Check the function of the ComWheel.

− Press all keys. Check that each key produces a sound from the loudspeaker, or the

Message count value in the service menu increases.

Readjust the time and date, if necessary.

Check the content of the Service Log for possible problems.

Monitor Setup key. Turn the ComWheel in both directions and check that the

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2.2.5 MRI Monitor Frame Unit

1. Check that the Monitor frame unit fan is running.

2.2.6 MRI Compact Airway Module, E-MRICXXXXX

1. Check that the fan is running.

2. Wait until the message ‘Calibrating gas sensor’ disappears from the screen, then enter the Compact Airway Module General service menu.

Check that the module configuration displayed corresponds to the Compact Airway Module type being used.

3. Check that the Time-outs, Bad checksums and Bad c-s by mod values are not increasing faster than by 5 per second.

4. Enter the Gases service menu: Check that the ‘Ambient’ value displayed corresponds with the current ambient pressure (±20 mmHg).

5. Check that the flow measurement offset, i.e. the sample ‘Zero’ value displayed is within ±10 ml/min.

6. Perform a sampling system leak test.

7. Check the flow rates. Adjust the sampling flow, if necessary.

8. Perform a gas calibration:

NOTE: For maximum accuracy, a warm-up time of 30 minutes is recommended.

NOTE: For correct measurement values, modules need different amounts of oxygen in the calibration. If you do not use the recommended calibrating gases, the calibration does not succeed.

Anesthesia Agent

MRI Compact Airway Modules w/ the option

9. Enter the Gases service menu.

Feed calibrating gas (order code 755583) continuously for at least 30 seconds and check that the ‘ID’ in the service menu shows ‘DES’ and that the value for ‘ID unrel.’ is lower than 50.

Patient Spirometry

Compact Airway Modules w/ the option

10. Enter the Spirometry service menu.

Connect a clean spirometry tube and a D-lite to the module.

Perform the spirometry leak test.

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11. Connect the sampling line. Breathe through the wider side of the D-lite. Check that the flow waveform moves downwards when you breathe in, and upwards when you breathe out.

General

For all MRI Compact Airway Modules [General]

Switch the monitor to standby and reassemble the module.

•

NOTE: Attach the plastic cover to the CPU Board before fitting the module box. Make sure that the grounding claws in the front panel frame make good contact with the module box.

NOTE: When reassembling the module, make sure that the tubes are not pinched between the module box and internal parts.

Reassemble the MRI Compact Airway Module back to the monitor frame. Replace the dummy D-fend to the module and the D-fend to the patient connector panel.

Reassemble the MRI Monitor far enough to be able to connect all the tubes and cables to the MRI Monitor frame.

NOTE: Leave the MRI Shield front cover still open.

Planned maintenance check list

Switch the monitor back on and wait until the message ‘Calibrating gas sensor’ disappears from the screen.

12. Block the tip of the sampling line with your finger and check that the message ‘Sample line blocked’ appears on the monitor screen within 30 seconds.

13. Detach the D-fend and check that the message ‘Check D-fend’ appears on the monitor screen within 60 seconds.

2.2.7 Hemodynamic measurements

ECG measurement

1. Enter the ESTP: ECG service menu.

Check that the Time-outs, Bad checksums and Bad c-s by mod values are not increasing faster than by 5 per second. Check that the ECG board memories have passed the internal memory test, i.e. RAM, ROM and EEPROM all state OK.

2. Check that the ‘Power Freq’ value is set according to the mains power frequency. Correct the setting, if necessary.

3. Connect a 3-lead ECG cable to the monitor. Check that the message 'Leads off' is displayed on the screen.

4. Connect the cable leads to a patient simulator. Disconnect one of the leads and check that the corresponding electrode in the service menu shows OFF within 10 seconds from the disconnection, then reconnect the lead.

Check the rest of the leads using the same method.

NOTE: The asystole and different leads off messages are shown using certain priority. Even though one of the leads is disconnected, the related leads off message may not appear on the screen.

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5. Check that all ECG information is shown on the monitor screen as configured on the simulator.

Turn the simulator off. Check that the ‘Asystole’ and ‘Apnea’ messages are displayed.

Invasive blood pressure measurement

6. Check the InvBP channels with a patient simulator.

Zero the InvBP channels, then check that the values and waveforms correspond to the simulator settings.

SpO2 measurement

7. Check that the message ‘No probe’ is shown, when no SpO2 sensor is connected.

Connect an SpO when the probe is not connected to a finger.

8. Attach the SpO appear on the screen.

finger probe to the module. Check that the message ‘Probe off’ is shown,

probe to your finger. Check that a reading of 95 to 99 and a pleth waveform

Non-invasive blood pressure measurement

9. Enter the NIBP module service menu. Check that the Time-outs, Bad checksums and Bad c-s by mod values are not increasing faster than by 5 per second. Check that the NIBP board memories have passed the internal memory test, i.e. RAM, ROM and EEPROM all show OK.

10. Check the NIBP tubing system for leakages by performing Calibrations - Active leak test.

11. Perform NIBP calibration by selecting Calibration.

12. Enter the Pneumatics service menu. Check the NIBP watchdog timer activation pressure with a pressure manometer.

13. Check the safety valve by performing Safety Valve – Adult and Infant.

14. Attach an adult NIBP hose and cuff on your arm and perform one NIBP measurement. Check that the module identifies the cuff, i.e. the text ‘Adult’ appears in the NIBP digit field for a short time.

Check that the module gives a reasonable measurement result.

15. Attach a NIBP cuff hose without cuff identification and check that the module identifies the hose:

− The message ‘Select inflation limits’ appears in the NIBP digit field.

− When you try to start the measurement, the monitor automatically opens the selections

NIBP Setup - Inflation Limits.

MRI Shield reassembly

Turn the monitor off and disconnect the power cord.

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Close the MRI Shield front cover.

NOTE: Remember to reconnect the Alarm board cable.

2.2.8 Magnetic field alarm

1. Connect the mains power cable and other external cables.

2. Turn the monitor ON and check that the Magnetic field alarm LED is lit and the alarm sound is heard for a moment.

2.2.9 Data Card function

1. Enter the MemCards service menu:

Check that the Data Card is recognized properly, i.e. Present and Active state YES.

2. Check that the memories and the PCMCIA controller have passed the tests. The status for each should be OK.

3. Select Communication.

Check that the Interface status states Active continuously and the error counter values on the bottom part of the menu are stable.

4. Select Status.

Insert Data Card in the slot.

Wait until the information is fully updated in the service menu, then check that the Card types are correct and the ‘File system’ states ATA.

Check that the rest of the information is reliable and no errors have been detected.

Planned maintenance check list

2.2.10 Recorder

1. Open the paper compartment cover. Check that the message ‘Recorder: Cover open’ appears on the screen, then close the cover.

2. Press the waveforms. Press the

3. Check that the quality of the recordings is acceptable.

Record Wave key and check that the module starts recording the selected

2.2.11 Electrical safety check

1. Perform an electrical safety check and a leakage current test.

2. Check that the monitor and all connected units function normally after the performed test.

3. Switch the monitor to standby and perform a final cleaning.

Start/Stop key again to stop recording.

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MR room and control room installation

Return the monitor back to the MR room to perform the following checks for the whole MRI Monitor installation.

2.2.12 Active Remote Screen Option

Reconnect the fiber optic cable to the MRI Monitor. Make sure that the fiber optic cables are connected to the Remote screen converter and this to the remote screen and to the Command Bar, K-MRIANEB or to the Anesthesia record keeping keyboard, K-ARK, if included.

Turn the monitor on.

1. Check that the picture on the remote screen is correct.

2. Press the in the menu moves correspondingly. Select Normal Screen and check that the menu disappears from the screen.

3. Create an alarm and check the alarm is correctly displayed on the remote screen and an alarm sound is heard from the remote screen.

Monitor Setup key. Turn the ComWheel in both directions and check that the cursor

2.2.13 Network Option

1. Check that the network cable connector and the Identification plug are clean and intact, then connect them to the MRI Monitor . Check that the monitor connects to the Datex-Ohmeda Network, i.e. the network symbol is displayed on the upper right-hand corner of the screen. Also a message regarding the connected Central should be displayed in the message field on the screen.

NOTE: If necessary, reselect the monitor’s network communication according to the used network software in the Network service menu.

2. Enter the service menu:

Check that the counters for data errors (CRC, Frame, Transm.) are stable.

Check that the counters for hardware errors (Intern., Missed, FIFO, Overrun) all show 0.

2.2.14 Wireless Network Option

1. Check that the green LED on the wireless antenna card blinks and the WLAN signal strenght symbol scrolls between zero and full or stays stable on the monitor screen.

2. Check that the wireless LAN network symbol is displayed in the upper right-hand corner of the screen when the monitor connects to the Datex-Ohmeda Network,

NOTE: If the monitor does not connect to the Datex-Ohmeda Network, check the WLAN configuration on the monitor and on the network.

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2.2.15 Device Interfacing Solution, N-DISVENT

1. Enter the DIS Interfacing service menu:

Check that the DIS module ‘tout’ and ‘cse’ values do not increase faster than by 5 per second. Check also that the DIS module memories have passed the internal memory test, i.e. Ram, Rom and EEPROM state all OK.

2.2.16 General

1. Storing trend data

Check that the monitor is capable of storing the trend information and temporary settings in a short (max. 15 minutes) standby situation with no power cord.

2. Service reset

Check the Service Reset. Press the monitor back on and check that the monitor performs a Cold Start, i.e. all trend information is cleared.

Planned maintenance check list

ON/Standby key for at least 10 seconds. Switch the

3. Watchdog

Enter the Set/Test service menu and perform Watchdog.

Check that the monitor restarts.

4. Service Log reset

Enter the Service Log service menu.

Clear the content of the Service Log by selecting Reset Log from the menu. Turn the monitor to standby.

Fill in all necessary documents.

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APPENDIX A Planned maintenance check form, MRI Monitor

Customer

Service

Service engineer Date

Monitor Installation

F-MRICM1 N-MRI2 D- K-

S- L- E-MRIPSN E-MRIC_ _ _

N-

OK = Test OK N.A. = Test not applicable Fail = Test failed

Appendix A,

Visual Inspection

2.1.1. General

2.1.2. MRI Compact Airway Module, E-MRICXXXXX S/N

2.1.3. Hemodynamic MRI module, E-MRI(P)SN S/N

2.1.4. Recorder Unit

MRI Monitor reassembly

Notes

Functional Inspection

2.2.1. General

2.2.2. Display

2.2.3. Keyboard(s)

OK N.A. Fail

2.2.4. Display Unit

2.2.5. MRI Monitor Frame Unit

2.1.2. MRI Compact Airway Module, E-MRICXXXXX

A-1(4)

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Functional Inspection

. Anesthesia Agent

. Patient Spirometry

. General

Notes

2.2.7. Hemodynamic measurements

. ECG measurement

. Invasive blood pressure measurement

. SpO2 measurement

. Non-invasive blood pressure measurement

Notes

OK N.A. Fail

MRI Shield reassembly

. MRI Shield reassembly

2.2.8. Magnetic field alarm

2.2.9. Data Card function S/N

2.2.10. Recorder S/N

2.2.11. Electrical safety check

MR room installation

2.2.12. Active Remote Screen Option S/N

2.2.13. Network Option S/N

2.2.14. Wireless Network Option S/N

2.2.15. Device Interfacing Solution, N-DISVENT S/N

Notes

A-2(4)

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Appendix A,

Functional Inspection

2.2.16. General

1. Storing trend data

2. Service reset

3. Watchdog

4. Service Log reset

Notes

Used Spare Parts

OK N.A. Fail

Notes

Signature

A-3(4)

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MRI Monitor

For your notes:

A-4(4)

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Datex-Ohmeda

MRI Monitor

Monitor Software L-CANE05(A)

Service Menu

CAUTION: U.S. Federal law restricts this device to sale by or on the order of a licensed medical practitioner.

Datex-Ohmeda Inc.

P.O. Box 7550

Madison, WI 53707-7550, USA

Tel: +1 608 221 1551

Fax: +1 608 222 9147

All specifications are subject to change without notice.

Outside the USA, check local laws for any restriction that may apply.

Document no. M1056423

June, 2006

GE Healthcare Finland Oy

Helsinki, Finland

P.O. Box 900

FI-00031 GE, FINLAND

Tel: +358 10 39411

Fax: +358 9 1463310

www.gehealthcare.com

Page 96

Page 97

Table of contents

Table of contents i

Introduction 1

1Frame 3

1.1 Memory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3

1.2 Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

1.2.1 Network Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

1.2.2 Network Config. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

1.2.3 Ethernet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

1.2.4 WLAN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

1.3 MemCards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10

1.3.1 Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10

1.3.2 Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

1.4 Power supply. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12

1.4.1 Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13

1.5 PCMCIA Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13

2Display 14

3 Keyboard 15

3.1 Keyboard Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16

3.2 Keyboard Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16

4 Parameters 17

4.1 Gas Unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17

4.1.1 General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18

4.1.2 Gases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

4.1.3 Spirometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20

4.2 ECG Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22

4.2.1 ECG Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23

4.3 ESTP Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24

4.3.1 Calibrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26

4.4 NIBP Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27

4.4.1 NIBP Demo. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28

4.4.2 NIBP Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29

4.4.3 NIBP Safety Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30

4.4.4 NIBP Pulse Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31

4.4.5 NIBP Buttons/Leds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32

4.4.6 NIBP Pneumatics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33

4.4.7 NIBP Watchdog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34

4.5 DIS Interfacing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35

4.5.1 Interfacing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35

4.5.2 Status Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36

4.5.3 DIS Interfacing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36

5 Set/Test 38

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5.1 Country Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39

6Service Log 40

6.1 Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41

6.1.1 Planned Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41

6.1.2 Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42

6.1.3 Upgrade . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42

6.2 Error History. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43

6.3 Event History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43

6.4 Alarm History. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44

7Record Data 45

8 Remote Access 46

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Introduction

The monitor has a Service Menu, which is a useful tool to examine monitor functions and to troubleshoot in case a fault occurs.

Service Menu structure

The menus that are shown grayed are not in use in MRI Monitor.

Service M en u

Service Menu

Memo r y

Net w o rk

Frame

MemC ar ds

Power Supply

Dis pl ay

Keyboard

Parameters Gas Unit

Set/Test

Serv ic e Log

Rec or d Da t a

Remote Access

PCMCIA Board

Keyboard Log

Keyboard Type

ECG Module

EST P Mo d u le

P/ PT

COP

NIBP Module

NMT

M- SA T

Mor e .. .

Country Settings

Maintenance

Error history

Event history

Alarm history

Netw ork Status

Subnet Status

Net w o r k Co n f ig

Ethernet

WLA N

Socket s

Status

Communication

Batter y

General

Gas es

Spirometry

ECG Se tu p

Calibrations

NIBP demo

Calibrations

Safety v alve

Puls e v a lv e

Buttons/Leds

Pneumatics

Watchdog

NMT s et up

Int e rf a c e

TONO

EEG/ EP

BIS

ENTR OPY

DIS Inte r f ac in g

Planned Maint.

Repair

Upgrade

Gas es

SpO2

NIBP

Spirometry

SvO2/C.O.

Tonometr y

Press sensor

System test

CO2 sens or

Pneumatics

EEG/ EP se tu p

BIS setup

serv menu_str uct05_MR I.vsd

Document no. M1056423

Page 100

MRI Monitor

Service Menu

NOTE: The Service Menu pictures are for reference only. Details on the menu page can vary depending on the software version and the module type in use. If a particular selection is not available in your system, the selection is shown grayed.

In this manual, the concept MRI Monitor always refers to the MRI Monitor labeled as N-MRI2.

1. Press the Monitor Setup key.

2. Select Install/Service (password

16-4-34).

3. Select Service (password 26-23-8).

Document no. M1056423

Datex-Ohmeda MRI Technical reference manual

Specifications and Main Features

Frequently Asked Questions

User Manual

MRI Monitor

Technical Reference Manual

About this manual

1 Introduction

1.1 System introduction

1.1.1 MRI Monitor system components

1.1.2 Monitoring in MR room

1.1.3 Monitoring in control room

1.1.4 MR monitoring in network

1.1.5 Monitoring in wireless network

1.2 MRI Monitor introduction

1.2.1 MRI Monitor parts and connections

1.2.2 MRI Monitor frame options and modules

1.2.3 Connector panel

1.2.4 MRI Cart

1.3 Symbols

1.3.1 Symbols on transport packaging

1.3.2 Symbols on equipment

1.3.3 Equipment safety symbols

1.3.4 Other symbols

1.4 Safety

1.4.1 Safety precautions

1.4.2 ESD precautionary procedures

1.4.3 Disposal

2 System description

2.1 Introduction

2.2 Bus structure

2.3 Distributed processing

2.4 Module communication

2.5 Software loading

2.6 Parameter modules

2.7 High magnetic field alarm

3 System installation

3.1 Unpacking instructions

3.2 Choosing location

3.3 Installing and mounting the monitor

3.3.1 MRI Monitor parts and connections

3.3.2 Monitor distance from the magnet bore

3.3.3 Connecting to mains

3.3.4 Mounting the MRI Monitor to MRI Cart

3.3.5 Connecting to Datex-Ohmeda Network

3.3.6 Connecting to Wireless LAN network

3.3.7 Device Interfacing Solution, N-DISVENT

3.3.8 Remote Screen installation

3.3.9 Parameter modules

3.3.10 Downloading Monitor Software

3.3.11 Performing Factory Reset

3.3.12 Performing Service Reset

3.4 S/5 Remote Controller, K-REMCO

3.5 Anesthesia Record Keeping Keyboard, K-ARKB

3.5.1 Connection to MRI Monitor

3.6 MRI Airway Module gas scavenging

3.6.1 Sample gas exhaust

3.7 Troubleshooting

4 Interfacing

4.1 Interfaced parameters

4.2 Interfacing external bedside devices via Device Interfacing Solutions, N-DISxxx

4.2.1 Device Interfacing Solution components

4.2.2 Connections

4.2.3 Mounting

4.2.4 Selecting the external device

4.2.5 Functional check

4.2.6 Selecting the parameter data source

4.3 Interfacing printer

4.4 Interfacing computer

4.5 Output signals

5 Functional check

5.1 Recommended tools

5.2 Visual inspection

5.3 Functional inspection

6 General troubleshooting

APPENDIX A Functional check form, MRI Monitor

APPENDIX B 1ElectroMagnetic Compatibility

Datex-Ohmeda

MRI Monitor

Planned Maintenance Instructions