Schiller MAGLIFE LIGHT User manual

MAGLIFE light
User manual
Version 1.2 / October 2006
Part No. 0-48-0080

MAGLIFE light
Part number: 0-48-0080 Page 2
Revision history
Version Date Comments
V1.0 June 2006 First edition
V1.1 July 2006 First release, Soft 3
V1.2 October 2006 Revision
Note: Distribution and maintenance information
SCHILLER has an international network of customer service, sales and consulting
agencies. For details about your local representative, please contact the SCHILLER
subsidiary near you. You will find a complete list of all the representatives and
subsidiaries on our website at http://www.schiller.ch
Sales information is also available from [email protected]
Manufacturer
SCHILLER Medical S.A.S. Tel: [phone]
4, rue Louis Pasteur Fax: [phone]
F- 67162 Wissembourg Email: [email protected]
Website: www.schiller.fr
Registered office
SCHILLER AG Tel: [phone]
Altgasse 68 Fax: [phone]
CH-6341 Baar, Switzerland Email: [email protected]
Website: www.schiller.ch

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WARNINGS
This manual shall be deemed to be an integral part of the
described unit.
Compliance with its content is a prerequisite for proper device
performance and for patients and operators safety .
The manufacturer disclaims all responsibility for the safety,
reliability and performance of the device if:
- assembly, extensions, adjustments, modifications and
repairs are not performed by the manufacturer or by
manufacturer authorised persons.
- the electrical installation of the premises does not comply
with locally applicable requirements.
- the device is not used in compliance with this instructions
for use.
This manual describes the device at the printing time.
Upon request, the supplier will provide circuit diagrams, lists of
components, descriptions, calibration instructions or any other
information required by the user’s qualified technical personnel
to repair those parts of the device that have been stated as
“repairable” by the device manufacturer. The supply of such
information shall not in any event constitute permission or
approval to modify or repair a device.
All rights reserved for the devices, circuits, processes and
names appearing in this manual.
The device is not designed for any use that is not specifically
provided in this manual, which may be hazardous.
Foreword

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Part number: 0-48-0080 Page 4
This MAGLIFE light manual provides the information required for proper device performance.
Knowledge of monitoring and the understanding of the characteristics and functions of MAGLIFE light are
required for proper use of the device.
Do not use the monitor before you read these instructions.
Device maintenance information is provided in the service manual of the MAGLIFE light.For more
information, please contact your nearest SCHILLER representative.
MAGLIFE light bears the CE-0459 mark in accordance with directive 93/42/EEC relating to medical devices
and fulfils the essential requirements of annex I of that directive.
This product complies with the electromagnetic immunity requirements of standard EN 60601-1-2
"Electromagnetic Compatibility-Medical Electrical Equipment » .
The radio interference emitted by this device is within the limits specified in the standard EN 55011, class B.
When the device is connected to a printer, it is within the limits specified in the standard EN 55011 – class A.

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WARNINGS, PRECAUTIONS AND NOTES
Please read and adhere to the following list of warnings, precautions and notes. Some of them have been
repeated at appropriate areas throughout this manual.
Follow the warnings and precautions stated on the labels affixed on the monitor. Throughout this manual we
have added specific notifications that offer additional information. These notations are designated as:
A Note is provided when extra general information is applicable.
A Caution is provided when special care is to be exercised by the user and/or patient, to avoid injury to the
patient, damage to the device or damage to other property.
A Warning is provided when actions may result in a serious outcome (i.e. injury, serious adverse effect,
death) to the patient or user.
Caution: MAGLIFE light is a monitor designed solely for use close to Magnetic
Resonance Imagers of 0.2 to 3 T for monitoring of patients undergoing an MRI
examination.
Caution: The continuous presence of a qualified person is imperative throughout the
examination.
Warning: Before using the MAGLIFE light monitor, follow the safety instructions below:
 MAGLIFE light may only be used by trained healthcare workers who are
familiar with its instructions for use.
 Make sure that the voltage and frequency of the electricity system match
those stated on the identification plate.
Warning: Because the device is a class I device, it may only be used in premises with
an electrical system comprising an earth connection.
Warning: Connecting other devices or sensors to the patient could lead to leakage
currents that may be harmful to the patient. Consult SCHILLER before
interconnecting with other equipment.
Warning: Take account of the physiological effect of the other devices connected to the
patient.
Warning: This device may not be installed or operated in explosive environment.
Warning: This device is not designed for use with inflammable anaesthetic agents.
Caution: Use only sensors supplied by SCHILLER. They have been designed specially
for use in MRI environments.
Warning: MAGLIFE light is designed for use with MRI systems with a magnetic field
between 0.2 and 3 Tesla. Contact SCHILLER for use beyond that magnetic
field range.
Warning: It is imperative the MAGLIFE light be installed in the area around the magnet
where the magnetic leakage field is less than or equal to 40 mT (400 Gauss)
(see typical installation drawings and labels on the device).

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Note: The ambient temperature must be located within the following limits:
15°C ≤Amb. T ≤35°C
60°F ≤Amb. T ≤96°F
Note: The instructions specific to the installation and use of the MAGLIFE light
monitor have been provided in section 4 of this manual, which must be read
carefully before initial use of the monitor.
Caution: The safety instructions relating to the MRI environment must be followed at all
times (during installation, use, repairs etc.). Any work on MAGLIFE light (e.g.
repairs) must be done outside the area where the risk of magnetic attraction is
non-existent.
Caution: No equipment that hampers blood flow (e.g. use of a cuff type
sphygmomanometer) may be used on the limb of a patient undergoing oxygen
saturation monitoring (SpO2), as it could disrupt the correct determination of
the data.
Caution: Sensors and probes may not come in contact with conductive parts, including
the earth.
Caution: Do not defibrillate on the accessories. Place the defibrillation electrodes as far
away from the other accessories as possible.
Caution: The monitor is adapted for the MRI configuration upon power up. Any
subsequent change in the MRI system can alter the performance of the
MAGLIFE light monitor. Inform SCHILLER of any such change.
Caution: The device is designed to operate with electrosurgical devices. Place the
accessories as far away from the electrodes of the electrosurgical device.
That device must be installed and used in accordance with the manufacturer’s
instructions.
Caution: The device is designed to operate without any equipotential connection.

MAGLIFE light
Contents Page
Revision history..................................................................................................................................... 2
WARNINGS............................................................................................................................................. 3
Foreword ................................................................................................................................................ 3
WARNINGS, PRECAUTIONS AND NOTES.......................................................................................... 5
Contents................................................................................................................................................. 7
1. Description of MAGLIFE light ............................................................................................ 8
2. Location and description of displays and controls......................................................... 9
2.1 Front of MAGLIFE light..................................................................................................................... 9
2.2 Rear of MAGLIFE light...................................................................................................................... 9
2.3 Mains power unit................................................................................................................................. 9
3. Device symbol identification............................................................................................ 10
3.1 MAGLIFE light symbols .................................................................................................................. 10
3.2 Power symbols.................................................................................................................................. 10
4. Use of MAGLIFE light........................................................................................................ 11
4.1 Installation......................................................................................................................................... 11
4.2 Display screens.................................................................................................................................. 13
4.2.1 SPO2option only........................................................................................................................... 13
4.2.2 NIBP option only .......................................................................................................................... 13
4.2.3 SPO2and NIBP options................................................................................................................. 14
4.3 Placing of probes and sensors ........................................................................................................... 14
4.3.1 Absolute rule................................................................................................................................. 14
4.3.2 Probes and sensors to be used and positioning instructions.......................................................... 14
4.3.2.1 SpO2 sensor .............................................................................................................................. 14
4.3.2.2 Sphygmomanometer cuffs (Non-Invasive Blood Pressure) ...................................................... 16
4.4 Start up.............................................................................................................................................. 17
4.5 Battery charge ................................................................................................................................... 17
4.5.1 Operating during a mains failure................................................................................................... 17
4.6 Use of the menu ................................................................................................................................ 18
4.7 Description of menus ........................................................................................................................ 18
4.7.1 Main menu .................................................................................................................................... 18
4.7.1.1 NIBP (Non Invasive Blood Pressure) menu.............................................................................. 19
4.7.1.2 Oximeter (SpO2) submenu........................................................................................................ 23
4.7.1.3 Alarm limits menu..................................................................................................................... 25
4.7.1.3.1 Power up and standby mode................................................................................................ 27
4.7.1.4 Magnetic field display............................................................................................................... 28
4.7.1.5 Trends menu.............................................................................................................................. 28
4.7.1.5.1 Trend graph submenu.......................................................................................................... 29
4.7.1.5.2 Trend table submenu........................................................................................................... 30
4.7.1.6 Edit menu.................................................................................................................................. 31
4.7.1.7 Settings menu............................................................................................................................ 32
4.7.1.7.1 Sound submenu................................................................................................................... 32
4.7.1.7.2 Clock submenu.................................................................................................................... 33
4.7.1.7.3 Screen brightness setting..................................................................................................... 33
4.7.2 Device configuration menu........................................................................................................... 34
4.7.2.1 Alarm limits submenu............................................................................................................... 34
4.7.2.2 Monitor submenu ...................................................................................................................... 35
4.7.2.3 Options submenu....................................................................................................................... 37
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4.7.2.4 Software update submenu ......................................................................................................... 37
4.7.2.5 Version submenu....................................................................................................................... 38
4.7.2.6 Reserved SCHILLER submenu................................................................................................. 38
4.8 Structure of menus ............................................................................................................................ 39
4.8.1 User menus.................................................................................................................................... 39
4.8.2 Configuration Menus .................................................................................................................... 41
4.9 Alarms............................................................................................................................................... 42
4.9.1 Screen alarm symbols.................................................................................................................... 42
4.9.2 Physiological alarms ..................................................................................................................... 42
4.9.3 Technical alarms ........................................................................................................................... 43
5. Technical specifications................................................................................................... 43
5.1 System specifications........................................................................................................................ 43
5.2 Technical specifications of modules ................................................................................................. 44
5.2.1 Pulse oximeter............................................................................................................................... 44
5.2.2 NIBP Non-Invasive Blood Pressure.............................................................................................. 44
5.3 Threshold ranges............................................................................................................................... 45
6. Cleaning ............................................................................................................................. 46
7. Troubleshooting................................................................................................................ 47
7.1 General errors.................................................................................................................................... 47
7.2 Errors of modules.............................................................................................................................. 48
8. Maintenance....................................................................................................................... 48
8.1 Alarm simulation............................................................................................................................... 48
9. Additional accessories and indications.......................................................................... 49
10. Disposal.............................................................................................................................. 49
10.1 Battery disposal................................................................................................................................. 49
10.2 Device disposal ................................................................................................................................. 49
11. Front ................................................................................................................................... 50
12. Rear and power supply..................................................................................................... 51
1. Description of MAGLIFE light
MAGLIFE light is a monitor designed solely for monitoring vital patient parameters during MRI
(Magnetic Resonance Imaging) examinations.
Depending on the selected version, MAGLIFE light will monitor the following parameters:
․ transcutaneous measurement of arterial oxygen saturation, SpO2 (pulse oximeter)
․ pulse rate
․ blood pressure (NIBP)
MAGLIFE light may be configured with all combinations of the above parameters
MAGLIFE light is fitted with batteries as standard and can move with the patient (e.g. to and
from the examination room and the adjacent preparation room).
MAGLIFE light is designed to be placed on a non-magnetic mobile stand.
.

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2. Location and description of displays and controls
2.1 Front of MAGLIFE light
(see photo in section 11 )
1. Main device on/off key.
2. Device “ON” indicator.
3. “MAINS” connection indicator.
4. “BATTERY” Indicator, showing that the battery is being charged (flashing), or is fully charged
(steady).
5. Main “MENU” key. Access to the main menu and for exiting a menu from any other place.
6. Navigation button for menu selection.
7. Display for curves, parameters, menus and messages.
8. “NIBP” key, for starting up or stopping a measurement or a series of measurements of the
blood pressure via a cuff.
9. “Alarm silence” key, enables or disables the two-minute or permanent audio alarm function
(physiological and technical alarms).
10. Device “STANDBY” key.
11. SPO2 optical oximeter sensor connector.
12. NIBP cuff connector.
2.2 Rear of MAGLIFE light
(see photo in section 12 )
13. Connector for the low voltage cord for connecting to the mains power unit.
14. Loudspeaker
15. USB connector
16. RS 232 connector
17. Auxiliary connector compartment cover.
18. Identification label.
2.3 Mains power unit
(see photo in section 12 )
19. Mains plug.
20. Low voltage plug for connecting the MAGLIFE light.

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3. Device symbol identification
3.1 MAGLIFE light symbols
Main device on/off key
Mains power on
Battery charge
Entry into main menu or exit from any menu
Audio alarm enable/disable
Non-invasive blood pressure start/stop
CF type device, is protected against defibrillation shocks (device designed
for direct heart applications).
Caution! Read the instructions for use of the device.
Electrical and electronic device identification symbol. The device
components must be disposed of separately and the relevant parts must be
sent to available recycle centres. Inappropriate disposal may be harmful to
the environment and to public health as a result of the presence of
hazardous materials in electrical and electronic devices.
Notified body for CE certification (G-MED)
3.2 Power symbols
Power connected
Power input

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4. Use of MAGLIFE light
4.1 Installation
MAGLIFE light has been designed to operate at the patient’s bedside. It is installed in the
Faraday cage, i.e. in the room with the MRI system.
Minimum distances must be kept in relation to the measuring tunnel entrances. These
depend on the magnetic field of the magnet and the type of magnet.
As a result, it is imperative the MAGLIFE light be kept outside the area
around the magnet demarcated by the 40 mT (400 G) line. A magnetic field
detector sets off an alarm if that value is reached. Beyond the 40 mT limit, the
monitor is exposed to a force of attraction (due to the magnetic field) that
rises rapidly as the distance from the magnet decreases. This area must
be indicated by markings on the floor.
Caution: The monitor may be installed on a non-magnetic trolley supplied as
an option by SCHILLER. The trolley has wheels for turning and
moving the monitor. If the minimum distance is not kept, the
performance of the device may be disrupted. The trolley bearing
the monitor may not be placed in or moved to an area where the
field is greater than 40 mT (400G), regardless of whether the
monitor is on or off. The force of attraction of the magnet could pull
the monitor against the walls of the tunnel.
The wheels of the trolley can be locked when the trolley is installed
in the permitted area.
Important note: The magnetic field is always present, even when the imager is not
being used for an examination.

MAGLIFE light
Typical plan of an MRI system with a MAGLIFE light monitor
1) Faraday cage
2) MAGLIFE light monitor
3) Mains connector
4) Marking on the floor (40 mT line)
Forbidden area
Authorised area
40 mT(400G) line
2
1
34
Figure 1
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MAGLIFE light
4.2 Display screens
4.2.1 SPO2option only
Status area
SPO2 area
Pulse area
Sound alarm
status
Miscellaneo
us
Patient t
yp
e
Plethysmogram
Quality o
f
SPO2 si
g
nal
SPO2 value
Pulse rate value
Battery status
Date
Time
Alarm Thresholds
4.2.2 NIBP option only
Status area
N
IBP are
a
P
u
l
se
a
r
ea
Uni
t
Mode
Previous measurements
N
IBP values
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MAGLIFE light
4.2.3 SPO2and NIBP options
SPO2 are
a
N
IBP are
a
Status area
4.3 Placing of probes and sensors
Warning: The recommendations relate to the type of sensors and probes to be
used, the positioning of the sensors and probes on the patient and the
placing of the cables that connect the sensors and probes on the
patient and the device.
The following rules must be followed precisely to avoid the problems described below:
4.3.1 Absolute rule
Use only the cables, sensors and cuffs supplied by SCHILLER.
4.3.2 Probes and sensors to be used and positioning instructions
4.3.2.1 SpO2 sensor
1. Make sure that the Oximeter function is on and that the oximeter
parameters are set correctly.
Caution: Use only the sensors from the list of accessories supplied by
SCHILLER.
2. Connect the oximeter patient cable to the oximeter connector and
give the connector a quarter turn to the right-hand side to lock it in
place (to disconnect, turn the connector to the left and pull it out).
3. Place the sensor over the nail of the index finger or equivalent site;
place the cable on the top of the hand and fix it using Velcro™ strap
or secure to the patient’s wrist without tightening it.
Warning: Be cautious in placing the cable correctly so as to prevent damage
or injury (tangling and/or strangulation).
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Warning: Remove nail polish or false nails before placing the sensor on the
patient’s finger, as they could lead to inaccurate oximeter
measurements. Cut long nails, as they could hinder the placing of
the sensor.
Warning: If the sensor is secured with tape, do not tighten the tape
excessively. If the tape is too tight, it may affect the measurement
accuracy of the device and blisters may form on the patient’s skin
(due to the lack of circulation in the skin and not because of a
source of heat).
Caution: Do not place the sensor on an extremity with an invasive probe or
a blood pressure cuff.
Caution: Do not place the cuff on the same limb that the oxygen saturation
is being measured, as it could disrupt the correct determination of
the data (resistance that hinders the blood flow).
Warning: The oximeter measurement may be modified by the presence of
strong ambient light. Cover the sensor (e.g. with a surgical sheet) if
required.
Warning: The incorrect application or improper use of the sensor can lead to
measurement inaccuracies, as can the presence of significant
levels of dysfunctional haemoglobins (e.g. carboxyhaemoglobin or
methaemoglobin) or intravascular dyes such as indocyanine green
or methylene blue, the exposure to excessive light such as with
surgical lamps (especially lamps with xenon sources), bilirubin
lights, fluorescent lamps, infrared heating lamps or direct sunlight,
excessive movement by the patient, vein pulsations, the installation
of a sensor on a limb with a blood pressure cuff, an arterial probe
or an intravascular line.
Warning: In some cases, when the perfusion and signal are weak, e.g. with
patients with a thick or dark skin, the device may produce
abnormally low oximeter readings. Oxygenation should be verified
before starting therapies and interventions, especially in preterm
babies and patients with chronic lung diseases.
Warning: It often happens that patients suffer from low peripheral perfusion
due to hypothermia, hypovolaemia, serious vasoconstriction or
reduced cardiac output etc. These symptoms may lead to a loss in
the oximeter readings.
Warning: The temperature of the patient and the room must not be too low
since it will affect the measurement outcome.
Caution: Do not use the oximeter alone while monitoring vital parameters.

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4.3.2.2 Sphygmomanometer cuffs (Non-Invasive Blood Pressure)
1. Make sure that the NIBP function is on and that the NIBP
parameters are set correctly.
2. Connect the NIBP tube connector to the NIBP measurement
connector (12). Use only the cuffs listed in section 8.
Warning: If the cuff is placed too tightly on the limb, the results will be
excessively high readings. Among other considerations, the use of
a cuff suited to the patient has a direct bearing on the accuracy of
the NIBP measurements obtained. Select the cuff according to the
circumference of the patient’s limb.
Warning: Cuffs can soften over time and get permanent creases that may
mark the limb temporarily. Replace any cuffs which have that
characteristic.
Caution: Make sure that the pressure connectors are not flattened or
blocked.
Caution: Position the cuff slightly above the elbow, the Velcro™ turned up.
Since the cuff does not contain a microphone, specific positioning
is not necessary.
Warning: The cuff must be tightened around the arm, but must not apply
pressure on the blood vessels before the measurement. Roll the
cuff around the arm and close the Velcro™.
Caution: Check to ensure the hose is not tangled (check any incorrect
placement of the arms, legs or body of the patient, any clamps
etc.), as device operation will be disrupted by a flattened or
restricted hose.
Warning: Check that the blood is flowing correctly in the relevant limb (arm,
leg) (except during the measurement).
Caution: A cuff type sphygmomanometer must not be used on the patient’s
limb undergoing oxygen saturation measurement as it could disrupt
the correct determination of the data.
Several cuff models are available, including:
- Adult cuff
- Child cuff
- Neonate cuff
Extension hoses are also available.

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4.4 Start up
Connect the mains cord to the mains connector (19) and the low-voltage connecting
cord to connectors (20) and (13). Indicator (3) will light up to show that the device is
connected to the mains.
Caution: Indicator (4) will illuminate and the battery will be charge automatically
while the device is connected to the mains, even if it is not in operation.
Press key (1); the associated indicator (2) will illuminate.
After a few seconds, the screen will activate and the system initialised. The initialisation
sequence will last about 10 seconds. After that time, the parameters will be displayed.
For battery operation (with the mains cord disconnected), just press key (1) (the battery
is integrated in the device). If the battery is charged, associated indicator (2) illuminate
and the device will start up. With a fully charged battery, the device can operate for at
least two hours.
Note: The operating of key (1) is disabled during the initialisation phase.
4.5 Battery charge
MAGLIFE light may be powered by the internal battery to accompany the patient as the
patient is moved, or if the mains power is absent. The battery charges automatically
whenever the device is connected to the mains, whether or not it is operating. While the
battery is charging, indicator (4) flashes. Once the battery is fully charged, it stays on
and steady.
MAGLIFE light can operate on the battery (new battery, fully charged) for two hours
(one hour if intensive use is made of the NIBP function).
An alarm message is displayed about 5 to 10 minutes before the battery is completely
discharged and the automatic device shutdown occurs,
4.5.1 Operating during a mains failure
MAGLIFE light manages its power supply automatically. If the mains supply fails or is
of poor quality, the battery will automatically start supplying power to the device
regardless of the duration of the disruption.
Indicators (3) and (4) will go off and the mains present indicator (see section 4.2 ) and
the battery charge indicator will reflect the new situation in the Status zone after three
seconds.

MAGLIFE light
4.6 Use of the menu
All the functions other than those accessible via the controls on the unit are selected
from the menus displayed on the screen.
You can enter the main menu in two ways:
− by pressing rotary button (6) or
− by pressing key (5).
Caution: The displayed menus depend on the parameters defined as active in the
configuration (see paragraph 4.7.2 ).
The rotary button is used to:
− confirm a choice in the menu (when the line is highlighted in blue)
− make a choice
− switch to the digital entry mode by making the cursor flash
− move from one selected field to another without making any change
− select a status in a toggle function
Double clicking (two clicks in rapid succession) is used to exit any menu. It has the
same function as key (5).
Button rotation is used to:
− move in a menu
− increase or decrease the value of an entry field
Caution: Menus disappear if no action is taken for more than 10 seconds.
4.7 Description of menus
4.7.1 Main menu
The main menu is as follows:
It is used to select submenus.
Note: Only the labels corresponding to the installed parameters are displayed.
The main menu contains the following submenus:
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MAGLIFE light
4.7.1.1 NIBP (Non Invasive Blood Pressure) menu
Windows displayed
− with the NIBP parameter disabled (select NIBP On/Off to enable)
− with the NIBP parameter enabled (select NIBP On/Off to disable)
• Cycle selection
to select a cycle value from 1 minute to 90 minutes, activate symbol ,
then select the appropriate value by rotating button (6) and confirm by
pressing the button.
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MAGLIFE light
• Patient type selection
Depending on the type of patient, the initial inflating pressure is
automatically selected (180mmHg for Adult/Child and 120mmHg for
Neonate.
Note: For subsequent measurements, the inflating pressure is automatically
selected (about 50mmHg above the measured systolic pressure for
Adult/Child and 30mmHg for Neonate.
• Measuring unit selection
The Unit button is used to switch between the two units - kPa and mmHg.
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