MRI Monitor Technical Reference Manual 2nd edition Sept 2006

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, SpO2, and invasive blood pressure), respiratory (CO2, O2, N2O, anesthetic 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. SpO2 and ECG monitoring is indicated only with accessories specifically designed for the MR environment. The MRI Monitor with L-CANE05 or L-CANE05A software is indicated for use by qualified medical personnel only.

Classifications In accordance with IEC 60601-1 Class I and internally powered equipment – the type of protection against electric shock. Type BF or CF equipment. The degree of protection against electric shock is indicated by a symbol on each parameter module. Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. Continuous operation according to the mode of operation. In accordance with IEC 60529 IPX1 - degree of protection against harmful ingress of water. In accordance with EU Medical Device Directive The 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, PatientO2, Patient Spirometry, Entropy and Tonometrics are trademarks of GE Healthcare Finland Oy. All other product and company names are property of their respective owners.

Master table of contents

MRI Monitor Technical Reference Manual, Order code: M1079546 2nd edition Part I, General Service Guide Document No.

Updated

Description

M1041746-2

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

1

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

2

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

3

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

Table of contents

Table of contents Table of contents

i

Table of figures

iii

List of tables

iv

About this manual

1

1

3

Introduction 1.1

1.2

1.3

1.4

2

System description 2.1 2.2 2.3 2.4 2.5 2.6 2.7

3

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 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 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 Safety...15 1.4.1 Safety precautions...15 1.4.2 ESD precautionary procedures...19 1.4.3 Disposal...19

System installation 3.1 3.2 3.3

20

Introduction...20 Bus structure...20 Distributed processing...21 Module communication...21 Software loading...22 Parameter modules...22 High magnetic field alarm...23

24

Unpacking instructions...24 Choosing location...24 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 i Document no. M1041746 -1

MRI Monitor

3.4 3.5 3.6 3.7

4

Interfacing 4.1 4.2

4.3 4.4 4.5

5

43

Interfaced parameters...43 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 Interfacing printer...46 Interfacing computer...47 Output signals...47

Functional check 5.1 5.2 5.3

6

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 S/5 Remote Controller, K-REMCO...40 Anesthesia Record Keeping Keyboard, K-ARKB...40 3.5.1 Connection to MRI Monitor...40 MRI Airway Module gas scavenging...40 3.6.1 Sample gas exhaust...40 Troubleshooting...42

48

Recommended tools...48 Visual inspection...49 Functional inspection...50

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

Table of figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Figure 8 Figure 9 Figure 10 Figure 11 Figure 12 Figure 13 Figure 14 Figure 15 Figure 16 Figure 17 Figure 18 Figure 19 Figure 20 Figure 21 Figure 22

MRI monitoring system components in MR room ... 4 MRI monitoring system components when using Active Remote Screen... 5 MR monitoring in network ... 6 MRI monitoring in wireless network ... 7 MRI Monitor parts and connections... 8 MRI Cart... 10 General bus structure of MRI Monitor ... 20 Principle of UPI section operation... 21 General structure of parameter modules with patient isolation ... 22 Example of 300 Gauss line distance with a MR scanner. ... 25 MRI Monitor parts and connections... 27 Field strength in MR room ... 28 MRI Cart... 29 ‘Do not place any non-MR compatible items’ symbol ... 30 MRI Monitor connected to network ... 31 WLAN Acces Point in Control room ... 33 MRI Monitor connected to wireless network ... 34 Control room installation ... 35 Exhaust to reservoir tube... 41 Connection cables and LED indicators ... 44 An example of interfacing external devices with Device Interfacing Solution ... 45 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 equipment 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.

Related documentation For instructions for daily use including cleaning and daily maintenance, clinical aspects and basic methods of measurement see: MRI Monitor, User’s Guide MRI Monitor, User’s Reference Manual For more information about the iCentral and anesthesia record keeping solution, see the “Technical Reference Manuals” and “User’s Reference Manuals” for these products. Software options and default settings are described in the “Default Configuration Worksheet” delivered with each monitor. Available accessories are described in the User’s Guide in “MRI accessories” section.

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

"

Sign the check form after performing the procedure.

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MRI Monitor

Hard Keys

Hypertext links WARNING

Names of the hard keys on the Remote Controller, Command Board, Active Remote Screen Command Bar and side panel are written in the following way: Others. Software terms that identify window parts or menu items are written in bold italic: ECG Setup. Menu access is described from top to bottom. For example, the selection of the Monitor Setup hard key, the Screen 1 Setup menu item and the Waveform Fields menu item would be shown as Monitor Setup - Screen 1 Setup - Waveform Fields. Messages (alarm messages, informative messages) displayed on the screen are written inside single quotes: ‘Please wait’. When referring to different sections in this manual or to other manuals, manual names and section names are enclosed in double quotes: See section "Cleaning and care." Please refer to "iCentral User's Reference Manual: Alarms." Hypertext links on PDF versions are written in blue color. Warnings are written in the following way:

WARNING

This is a WARNING.

CAUTION

Cautions are written in the following way:

CAUTION

This is a CAUTION.

NOTE

Notes are written in the following way:

Menu Items

‘Messages’ “Sections”

NOTE: This is a NOTE. In this manual, the word “select” means choosing and confirming.

Illustrations and names All illustrations in this manual are only examples, and may not necessarily reflect your system settings or data displayed in your system. If a particular selection is not available in your system, the selection is shown grayed. In this manual, the concept MRI Monitor always refers to the MRI Monitor labeled as N-MRI2.

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Introduction

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)

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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MRI Monitor

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. 2

3 12

1

4

5 11 6 10

9 8

Figure 1 (1) (2) (3) (4) (5) (6) (7)

MRI monitoring system components in MR room

MRI Monitor with MR compatible modules inside MRI Cart. You can also use a wall mount. Device Interfacing Solution, DIS Active Remote Screen fiber optic cable Fiber optic network cable Remote Controller, K-CREMCO MR scanner specific cardiac gating cable

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7

(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

Introduction

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.

4

3 1 2

6

5

Figure 2 (1) (2) (3) (4) (5) (6)

MRI monitoring system components when using Active Remote Screen

Active Remote Screen with built-in loudspeakers. Remote screen converter. Contains connectors for Active Remote Screen and anesthesia record keeping keyboard or Command Bar K-MRIANEB. Fiber optic cable MRI Monitor Command Bar Anesthesia record keeping keyboard K-ARKB

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MRI Monitor

1.1.4

MR monitoring in network

1 5 2

4

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

3

MR monitoring in network

MRI Monitor Fiber optic Network cable Fiber optic converter, N-FOC, which connects the monitor to the Datex-Ohmeda Network (wired or wireless) Network printer 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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Introduction

1.1.5

Monitoring in wireless network

1 1

2

3

Figure 4 (1) (2) (3)

MRI monitoring in wireless network

Antennas Network cable 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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MRI Monitor

1.2

MRI Monitor introduction

1.2.1

MRI Monitor parts and connections 4

3

2

1

5 6

13

15

7

16

14 8

17

9

18

10

19

11

20

12

21

22 24 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

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23

(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

Introduction

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

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

CO2, 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 • N-PSNGV or N-SNGV • E-MRICAiOV

Spirometry

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. 2

1

3

4

5

(1) (2) (3) (4) (5) (6)

Spirometry connectors (optional) D-Fend with sampling line connector (optional) ECG connector NIBP connector InvBP connector (optional) SpO2 connector

6

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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.

1

2

3

4

Figure 6 (1) (2)

MRI Cart

Mounting plate for the MRI Monitor Drawer for small MR compatible accessories

NOTE: The maximum load of the MRI Cart drawer is 400 g (0.9 lb). (3) (4)

Compartment for the manuals Caster brakes

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

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Introduction

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.

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 (SpO2) and invasive pressures (P1-P2), the patient isolation and protection against cardiac defibrillator discharge are based on the SpO2 and invasive blood pressure 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.

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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”. 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.

1.3.4

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

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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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