GE Healthcare

MRI Monitor Users Guide May 2005

Users Guide

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File Name: GE Healthcare - MRI Monitor Users Guide May 2005 - 2005-05.pdf

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MRI Monitor User’s Guide

MRI Monitor User’s Guide Related to software licenses L-CANE04 and L-CANE04A 053 7

Conformity according to the Council Directive 93/42/EEC concerning Medical Devices CAUTION: U.S. Federal law restricts this device to sale by or on the order of a licensed medical practitioner. Outside the USA, check local laws for any restriction that may apply. All specifications are subject to change without notice. Document no. M1033895 30 May 2005 GE Healthcare Finland Oy Helsinki, Finland P.O. Box 900

Datex-Ohmeda Inc. P.O. Box 7550 Madison, WI 53707-7550, USA

FI-00031 GE

Tel: +1-608-221 1551

Tel: +358 10 39411, Fax: +358 9 1463310

Fax: +1-608-222 9147

www.datex-ohmeda.com www.gehealthcare.com

1 The NIBP measurement is indicated for patients who weigh 5kg (11 lb) and up. Gas exchange status monitoring is not indicated in the presence of N2O+O2 mixtures. The MRI Monitor with L-CANE04 or L-CANE04A software is also indicated for documenting patient care related information. The MRI Monitor with L-CANE04 or L-CANE04A software, module options E-MRIPSN, E-MRICAiOVX, 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-CANE04 or L-CANE04A software is indicated for use by qualified medical personnel only.

About this guide This User’s Guide describes the most common features and functions offered by the MRI Monitor. Descriptions refer to software licenses L-CANE04 and L-CANE04A. If you are a new user of the monitor, we suggest you begin with sections "Safety precautions,” "System introduction,""Monitor introduction " and "Monitoring basics." The following conventions are used: − Names of the hard keys on the Command Board/Bar, Remote Controller and side panel are written in the following way: ECG. − Menu items are written in bold italic typeface: ECG Setup. − Menu access is described from top to bottom. For example, the selection of the Screen 1 Setup menu item and the Waveform Fields menu item would be shown as Screen 1 Setup - Waveform Fields. − Messages (alarm messages, informative messages) displayed on the screen are written inside single quotes: ‘Learning’. − When referring to other manuals or different sections in this manual, the manual names and section names are enclosed in double quotes: “Cleaning and care.” − In this manual, the word “select” means choosing and confirming.

Classifications In accordance with IEC 60601-1: − −

Related documentation

−

Clinical aspects, basic methods of measurement and technical background: MRI Monitor User's Reference Manual Installation, technical solutions and servicing: MRI Monitor Technical Reference Manual Datex-Ohmeda Network Installation Guide Supplies and accessories: Section "MRI accessories," Supplies and Accessories catalog Options and selections of the software: MRI Monitor Default Configuration Worksheet Other devices closely related to the MRI Monitor: iCentral User's Reference Manual, Aestiva/5 MRI user documentation

−

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 is 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: IIb In accordance with CISPR 11: −

Group 1, Class B; see page 5 of this User's Guide.

Responsibility of the manufacturer GE Healthcare Finland Oy (GE) is responsible for the safety, reliability and performance of the equipment only if: − assembly, extensions, readjustments, modifications, service and repairs are carried out by personnel authorized by GE. − electrical installation complies with appropriate requirements. − the equipment is used in accordance with this User’s Guide.

Intended purpose (Indications for use) The MRI Monitor with L-CANE04 or L-CANE04A software, module options E-MRIPSN, E-MRICAiOVX, 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), ventilatory (comprising airway pressure, volume and flow) and gas exchange status (comprising Oxygen Consumption VO2, Carbon Dioxide production VCO2, Respiratory Quotient RQ, and Energy Expenditure, EE) of hospital patients during magnetic resonance scanning.

Contents Safety precautions ... 3 Symbols... 7 System introduction ... 9 Monitor introduction ... 19 Monitoring basics... 21 Setting up the monitor before use... 23 Starting and ending ... 27 Entering and loading patient data... 28 Screen setup... 29 Alarms... 31 Trends and snapshots ... 35 Recording and printing ... 37 Anesthesia record keeping... 41 Laboratory data and calculations ... 43 Interfacing external devices ... 45

ECG ...47 Pulse oximetry (SpO2) ...57 Non-invasive blood pressure (NIBP) ...59 Invasive blood pressure ...61 Airway gases ...65 Patient Spirometry...67 Gas exchange...69 Cleaning and care...71 Troubleshooting...75 Messages...77 Abbreviations ...81 Performance ...87 MRI accessories ...93 End User License Agreement ...95 Warranty ...97 Trademarks Datex, Ohmeda, S/5, D-lite, D-lite+, Pedi-lite, Pedi-lite+, D-fend, D-fend+, Mini D-fend, OxyTip+, MemCard, ComWheel, EarSat, FingerSat, FlexSat, PatientO2, Entropy, Patient Spirometry and Tonometrics are trademarks of GE Healthcare Finland Oy. All other product and company names are property of their respective owners. © 2005 General Electric Company. All rights reserved.

Safety precautions These precautions refer to the entire system. Warnings and cautions specific to parts of the system can be found in the relevant section. • To avoid explosion hazard, do not use the monitor in the presence of flammable anesthetics. The monitor measures only nonflammable anesthetics. • Use the monitor during MR scanning only together with MR compatible modules E-MRIPSN, E-MRICO, E-MRICAiO, E-MRICAiOV and E-MRICAiOVX. • 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 MR scanners with static magnetic field stronger than 3.0 T. • Do not connect any external devices to the system other than those specified. • Before starting to use the system, ensure that the whole combination complies with the international standard IEC 606011-1 and the requirements of the local authorities. Do not connect any external devices to the system other than those specified. • Do not place the MRI Monitor closer than the 300 G line to the MR scanner. • Use only approved mounts, batteries, invasive pressure transducers and MR compatible accessories. For a list of approved supplies, accessories and mounts, see section "MRI accessories." Other transducers, supplies 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. • Single-use accessories are not designed to be reused. Reuse may cause a risk of contamination and affect the measurement accuracy.

Warnings

A WARNING indicates a situation in which the user or the patient may be in danger of injury or death. • 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. • 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. • 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. • 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. • Connect only one patient to the monitor at a time. • Do not open the cover or the back. Refer servicing to qualified personnel. Disconnect power supply before servicing. • Use only hospital-grade grounded power outlets and power cord. • 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. • Some equipment malfunctions may not generate a monitor alarm. Always keep the patient under close surveillance.

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

• Keep the monitor horizontal when the Compact Airway Module is used. Tilting the monitor may cause erroneous results in the Compact Airway Module’s readings and damage the module. • If the integrity of the external protective earth conductor arrangement is in doubt, use the monitor with battery operation. • 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. • Do not touch the patient, table, instruments, modules or the monitor during defibrillation. • 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. See "Safety precautions: ESD precautionary procedures" in the "User’s Reference Manual" for details. • Always unplug the monitor before cleaning. After cleaning, ensure that every part of the monitor is dry before reconnecting it to the power supply. • If liquid has accidentally entered the equipment, disconnect the power cord from the power supply and have the equipment serviced by authorized service personnel. • Other equipment may interfere with the system, even if that other equipment complies with CISPR emission requirements. • Vibrations during intrahospital transportation may disturb SpO2, ECG, NIBP and invasive blood pressure measurements. • If the unit fails to respond as described, do not use the monitor until tested and repaired by authorized service personnel. • 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°.

Cautions

A CAUTION indicates a situation in which the unit or devices connected to it may be damaged. • 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 on the rear panel of the monitor. • Leave space for circulation of air to prevent the monitor from overheating. • Refresh the batteries completely once a month (see “Cleaning and care”). • Do not store or use the monitor outside the temperature and humidity ranges specified in the "Performance" section of this manual. • Other transmitting radio devices using the same radio frequency band (Industrial Scientific and Medical 2.45 GHz band) may degrade or disturb the wireless network communication. • The eventual rough usage of the MRI Cart may cause damages on the Cart. If damages are found, the Cart must be removed from usage as long the damages have been serviced by authorized service personnel. 4

Points to note

Disposal

• Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the "Technical Reference Manual" by qualified personnel. • Portable and mobile RF communications equipment can affect the medical electrical equipment. • The allowed cables, transducers, accessories and mounts for the system are listed in section "MRI accessories." • Service and reparations are allowed for authorized service personnel only. • The equipment is suitable for use in the presence of electrosurgery. Please notice the possible limitations in the parameter sections. • The MRI Monitor software L-CANE04 and L-CANE04A contains some functions that are not available, for example temperature monitoring. These and other non-functional user interface functions have been reserved for future development. • In this manual, the concept MRI Monitor always refers to the MRI Monitor labeled as N-MRI2. • MRI Monitor CISPR 11 Classification: 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.

• Dispose of the whole device, or parts of it, in accordance with local environmental and waste disposal regulations.

For your notes:

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 15” LCD display, D-LCC15, indicates that the display must only be used together with the original type of D-LCC15 power adapter. − 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 personnel. - For continued protection against fire hazard, replace the fuse only with one of the same type and rating. - Disconnect from the power supply before servicing. - Do not touch battery-operated monitor during defibrillation. - Lithium battery on CPU board: follow the local regulations for disposal.

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. Equipotentiality. Monitor can be connected to potential equalization conductor. Alternating current Fuse. Replace the fuse only with one of the same type and rating. Battery operation and remaining capacity (green bar).

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

Battery charging (white bar).

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

Wireless LAN 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.

Data Card (green) and/or Menu Card (white) is inserted. A blinking heart next to the heart rate or pulse rate value indicates the beats detected. Symbol on the led on the front panel of the shield. The led indicates if the magnetic field is too strong.

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. See "Safety precautions: ESD precautionary procedures" in the "User’s Reference Manual" for details.

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

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

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.

Date of manufacture SN, S/N

Serial number Submenu. Selecting a menu item with this symbol opens a new menu. The monitor is connected to the Datex-Ohmeda Network (Local Area Network). The monitor is connected to the Datex-Ohmeda Network (Wireless Local Area Network).

System introduction NOTE: Your system may not include all the components described below.

Monitoring in MR environment 2

3 12

5 11 6 10

(1) MRI Monitor with modules inside (2) MRI Cart. You can also use a wall mount. (3) Device Interfacing Solution, DIS (4) Active Remote Screen cable (5) Network cable (6) Remote Controller, K-CREMCO (7) Magnet-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) Wireless Network (WLAN) Access Point, N-WAP, and WLAN antenna NOTE: Only one of the following can be connected to the MRI Monitor at a time: Remote Controller or anesthesia record keeping keyboard.

System possibilities Optional components for the MRI Monitor are: • Built-in recorder, N-MRIREC1 • Wireless network option, N-CMW • Active Remote Screen, N-MRIRemote (includes sound converter, fiber optical cable and Remote screen converter) • Network option, N-MRINET (includes an optical cable and a fiber optical converter board, N-FOC) Possible software options for the MRI Monitor are: • MemCard option, N-CMMEM MR compatible modules: • Hemodynamic MRI module E-MRIPSN • MRI gas modules E-MRICO, E-MRICAiO, E-MRICAiOV and E-MRICAiOVX

WARNING: 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.

Active Remote Screen display options with built-in loudspeakers: • 15" LCD display, D-CFLT15 • 17" LCD display, D-CFLT17 • 19" LCD display, D-LCC19

WARNING: Connect only one patient to the MRI Monitor at a time.

Interfacing other devices Aestiva/5 MRI anesthesia machine can be connected to the MRI Monitor, and the data it measures can be seen on the monitor screen. For more information, see section "Interfacing external devices" and the "User’s Reference Manual."

WARNING: Use only MR compatible accessories. WARNING: Do not use the system with the MR scanners with static magnetic field stronger than 3.0 T. WARNING: Do not place the MRI Monitor closer than the 300 G line to the MR scanner. 10

Monitoring in control room Active Remote Screen is an external surveillance monitor for the MRI Monitor. While the MRI Monitor is placed inside the MR scanning room, the Active Remote Screen is used outside the MR scanning room in the control room to monitor the patient. The connection between the MRI Monitor and Active Remote Screen is done over on fiber optical 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. The possible components are described below.

2 1 3

(1) Active Remote Screen, Command Bar MRI K-ANEB and built-in loudspeakers. NOTE: MRI K-ANEB has a special cable that enables the connection to Active Remote Screen converter, K-ANEB cannot be used. (2) Sound converter (3) Remote screen converter. Contains connectors for Active Remote Screen and anesthesia record keeping keyboard or Command Bar. NOTE: If Command Bar is used, the anesthesia record keeping keyboard cannot be used. (4) Fiber optical cable (5) MRI Monitor (6) Anesthesia record keeping keyboard K-ARKB

WARNING: Before starting to use the system, ensure that the whole combination complies with the international standard IEC 60601-1-1 and the requirements of the local authorities. Do not connect any external devices to the system other than those specified. 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 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. WARNING: Always make sure that the audio alarm volume level is adequate in your care environment. WARNING: If you are using a display that does not have built-in speakers, use external loudspeakers. WARNING: If your are using external loudspeakers, always make sure that audio cables are properly connected.

CAUTION: D-CFLT17: Do not force the display past its maximum extension (5° forward, 25° backward with desk stand option) in either direction. CAUTION: The displays must only be used together with the original type of power adapters. CAUTION: Display D-LCC19 does not have a top spill shielding. This display (and the power adapters) must be mounted at a height of 180 cm/71” or higher to prevent any liquid from entering the casing. CAUTION: The LCD displays are fragile. Ensure that they are not placed near a heat source or exposed to mechanical shocks, pressure, moisture, or direct sunlight.

Installing and mounting the monitor

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.

The MRI Monitor is designed to operate in the MR environment and 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 G line. The 300 G line shall be verified from the safety instructions of the MR scanner. The built-in magnetic field detector sets a yellow alarm at 150 G. At 250 G line, the red alarm with sound is set by the magnetic detector. Beyond the 250 G line the monitor may be subject to force attraction of the magnetic field. Mount the monitor to some fixed structure such as a wall mount or MR compatible cart. If you are using an MRI Cart, make sure to maintain the minimum distance from the magnet. For details about mounting and installing the MRI Monitor, see "Technical Reference Manual."

WARNING: Do not use the system with the MR scanners with static magnetic field stronger than 3.0 T. 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: 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.

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 the safe and reliable monitoring in MR room it is important to keep the MRI Monitor outside the 300 Gauss line all the time.

MRI Cart

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

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

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. 2

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

WARNING: MRI Monitor is intended to mounted to a fixed structure if MRI Cart is not used. Do not use the monitor without manufacturer approved mounting attached. WARNING: 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.

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

CAUTION: The eventual rough usage of the MRI Cart may cause damages on the Cart. If damages are found, the Cart must be removed from usage as long the damages have been serviced by authorized service personnel.

MR monitoring in network

(1) MRI Monitor (2) Fiber optical cable (3) Fiber optical converter, N-FOC, which connects the monitor to the Datex-Ohmeda Network (wired or wireless) (4) Network printer

Communication between monitors 4

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.

MR monitoring in wireless network (1) (2) (3) (4)

4 1

Network cable Fiber optical converter Fiber optical cable Access point. Install the access point in the MR room as far from the magnet as possible. (5) Antennas

WARNING: The fiber optical converter contains ferrous material. Install it outside the 5 G line. 1

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

2 3

For your notes:

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