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Schiller MAGLIFE LIGHT, User Manual

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MAGLIFE light

 

 

 

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. 
 

Summary of Contents for MAGLIFE LIGHT

Page 1: ...MAGLIFE light User manual Version 1 2 October 2006 Part No 0 48 0080 ...

Page 2: ...lease 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 sales schiller ch Manufacturer SCHILLER Medical S A S Tel 33 0 3 88 63 36 00 4 rue Louis Pasteur Fax 33 0 3 88 94 12 82 F 67162 Wissembourg Email tech support schiller fr Website www schiller fr Regi...

Page 3: ...cable 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 repair...

Page 4: ...t 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 ...

Page 5: ...he 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 Conne...

Page 6: ... 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 t...

Page 7: ...itioning 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 standb...

Page 8: ...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 followin...

Page 9: ...essages 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 ...

Page 10: ...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 ...

Page 11: ...n 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 ...

Page 12: ...f 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 3 4 Figure 1 Part number 0 48 0080 Page 12 ...

Page 13: ...area Sound alarm status Miscellaneous Patient type Plethysmogram Quality of SPO2 signal SPO2 value Pulse rate value Battery status Date Time Alarm Thresholds 4 2 2 NIBP option only Status area NIBP area Pulse area Unit Mode Previous measurements NIBP values Part number 0 48 0080 Page 13 ...

Page 14: ...ng 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 ...

Page 15: ...ement 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 pat...

Page 16: ...e 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 ensur...

Page 17: ...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...

Page 18: ...h 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...

Page 19: ...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 Part number 0 48 0080 Page 19 ...

Page 20: ... 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 Part number 0 48 0080 Page 20 ...

Page 21: ...ng the navigation knob 6 press to confirm Select the limit value by rotating the navigation knob 6 again press to confirm the selected value Note At the switch on time the alarm levels corresponds to the standard values of the selected patient The operator selection is done in general alarm limit management window refer to section 4 7 1 3 Alarm limits Part number 0 48 0080 Page 21 ...

Page 22: ...vate Calibration the display on the screen will show the pressure value measured by the NIBP module Make several comparisons between the measurements by MAGLIFE light and those by the external measuring device over the entire measurement range Note Calibration is regulated in some countries Comply with applicable laws and regulations Note The Calibration submenu is locked by a password The passwor...

Page 23: ...rameter enabled select SpO2 On Off to disable Select the averaging time to be taken into account while calculating the SpO2 value and the pulse rate The choice between the two values 8 s and 16 s is made by activating the Average tab Patient type selection The patient type selection only affects the thresholds Part number 0 48 0080 Page 23 ...

Page 24: ...ng the navigation knob 6 press to confirm Select the limit value by rotating the navigation knob 6 again press to confirm the selected value Note At the power up time the alarm levels corresponds to the standard values of the selected patient The operator selection is done in general alarm limit management window refer to section 4 7 1 3 Alarm limits Part number 0 48 0080 Page 24 ...

Page 25: ...d out bell and the word OFF is displayed in the upper right hand corner of the screen The following submenus are available When the device is powered up and when it comes out of the standby mode the threshold values are the default values for the type of patient selected Adult Child or Neonate See section 4 7 1 3 1 Power up and standby mode Three different sets of default values are available for ...

Page 26: ...relation to the measured physiological values of the patient The upper values are set to 20 above and the lower values are set to 20 below those physiological values The Default selection is used to go back to the default values for the selected patient type provides access to the following submenu Is used to go back to the previous submenu OFF is used to disable all the audio and visual physiolog...

Page 27: ... when the device was last used for monitoring The default thresholds are factory set and can be adapted from the configuration menu Patient type selection is offered for 12 seconds after device power up and also when the device comes out of standby mode If the operator does not select the patient type the default values of the neonatal type are selected automatically The possibility to select the ...

Page 28: ...Bz show the value of the magnetic field in mT along the three orthogonal directions in space The B value shows the corresponding vector modulus 4 7 1 5 Trends menu The Trends menu contains two main submenus Graphs and Tables and two options It enables the user to erase the trends and select the period for trend tables Part number 0 48 0080 Page 28 ...

Page 29: ...displayed and contains the following tabs Note Only two waveforms can be shown at the same time Navigation buttons Back one page Forward one page Reduce time line from 24 hours to 1 hour Increase time line from 1 hour to 24 hours Adapt graph scale Exit the trend graphs display Part number 0 48 0080 Page 29 ...

Page 30: ...he display varies according to the selected parameters Navigation buttons Forward to the end of the table most recent value Forward to next line Back to previous line Back to the start of the table oldest value Exit the trend tables display Note If a non invasive pressure measurement does not strictly follow the table frequency rules it is inserted at the appropriate location Part number 0 48 0080...

Page 31: ...MAGLIFE light Special displays Patient change Technical alarm Physiological alarm 4 7 1 6 Edit menu To be written Part number 0 48 0080 Page 31 ...

Page 32: ... MAGLIFE light and to access the demonstration mode 4 7 1 7 1 Sound submenu The sound submenu is used to set the level of the sound for alarm signals pulse bip or keyboard clics Sounds may be High Medium Low or Off with the exception of alarms which can never be Off Part number 0 48 0080 Page 32 ...

Page 33: ...daylight saving option can be disabled The clock change date is pre set Example of date setting Only plausible values can be selected Note A time or date setting will erase all trends 4 7 1 7 3 Screen brightness setting You can set the screen brightness from 50 to 100 Part number 0 48 0080 Page 33 ...

Page 34: ...submenu The default thresholds are set for the three type of patients Adult Child and Neonate Select one type of patient press button 6 and make the setting in the following tab Select the parameter by navigation button 6 counter clockwise and confirm by pressing button 6 The first value will flash Turn as required to modify the value Save the value by pressing button 6 The next value is automatic...

Page 35: ...for information only and cannot be modified by the user A certain number of languages are available The language selection does not affect the operating of MAGLIFE light The screen colour combination can be selected with button You cannot define a customised colour combination The allowed patient selection button is used to restrict or extend the patient selection list Part number 0 48 0080 Page 3...

Page 36: ...the sensors for the measured values to stabilise This button is used to permit or prevent the ability to mute audible alarms permanently with key 9 If the alarms are permanently muted a reminding audio signal double beep is emitted after every two minutes Button is used to define the parameters of the NIBP measurement in the continuous mode Is used to select the duration of the continuous mode Cau...

Page 37: ...y standard 1 1 or above Make sure that the software on the USB key in the root directory only that software is compatible with the device you want to update Insert the USB key in the connector 15 provided select the update button and loading will start automatically Follow the instructions At the end of the loading process the device will go off automatically Note The procedure has been described ...

Page 38: ...e Version tab will show detailed info about used software versions and releases in MAGLIFE light 4 7 2 6 Reserved SCHILLER submenu This submenu is only for technical purpose and is described in a separate manual Part number 0 48 0080 Page 38 ...

Page 39: ...MAGLIFE light 4 8 Structure of menus 4 8 1 User menus Part number 0 48 0080 Page 39 ...

Page 40: ...MAGLIFE light Part number 0 48 0080 Page 40 ...

Page 41: ...MAGLIFE light 4 8 2 Configuration Menus Same for Child Same for Adult Part number 0 48 0080 Page 41 ...

Page 42: ...bled permanently or until the key 9 is pressed again Symbol S4 is displayed the symbol flashes and a beep is emitted once in every two minutes to remind the user Caution Audible alarm enabling disabling The permanent disabling of audible alarms is not permitted in some medical facilities That is why that function can be configured See Permanent muting section 4 7 2 2 4 9 2 Physiological alarms If ...

Page 43: ...f automatically when their causes disappear 5 Technical specifications 5 1 System specifications Manufacturer SCHILLER Medical S A S Device name MAGLIFE light Dimensions main unit 270 x 216 x 116 mm 10 6 x 8 5 x 4 6 power supply 180 x 84 x 68 mm 7 x 3 3 x 2 7 Weight main unit 6 Kg power supply 1 3 Kg Protection class IP 21 of the enclosure Electricity supply 100 115 230 VAC 50 60Hz Factory defined...

Page 44: ...V m 80 2500 MHz 5 Hz modulating CE marking According to directive 93 42 EEC class IIb Protection class Class I according to IEC 60601 1 5 2 Technical specifications of modules 5 2 1 Pulse oximeter OEM module BCI Connection Fibre optic Class CF SPO2 accuracy 2 from 70 to 99 3 from 50 to 69 SPO2 display range 0 99 Pulse accuracy 5 b min Pulse display range 30 250 b min Blocking by defibrillator shoc...

Page 45: ...d ranges The upper and lower alarm thresholds are adjustable according to the values in the table below The lower limit setting may never be greater than the upper limit setting and vice versa Parameter Lower limit Upper limit Neonate patient Pulse 30 245 35 250 SPO2 Saturation 50 98 51 99 SYS 30 130 35 135 DIA 15 105 20 110 NIBP MAP 20 120 25 125 Child patient Pulse 30 245 35 250 SPO2 Saturation ...

Page 46: ...ect from the mains before cleaning Do not remove any covers If any liquid does penetrate into the device the device must be cleaned completely and inspected Do not expose the device to temperatures above 50 C The use of an autoclave is not permitted The device and its accessories need to be decontaminated risk of pathological contamination before disposal The batteries of MAGLIFE light must be dis...

Page 47: ...s Place the device outside the field 40mT Replace the device The screen activates but the device initialise sequence is not carried out Device faulty Replace the device The device shuts off automatically Battery discharged Magnetic field too great Connect the mains Place the device outside the field No printing Non specific printer No power to printer Connecting cable loose Replace the printer wit...

Page 48: ...ts Incorrect cuff installation Inappropriate cuff System not airtight Not locatable Check and adjust the cuff Replace with an appropriate cuff Replace the leaking part Replace the device 8 Maintenance Before each use check all the device functions simulate an alarm check if all the connectors and cable insulators are in good condition Once a year check the leakage current according to paragraph 19...

Page 49: ... Disposal 10 1 Battery disposal Important In normal use the battery requires no maintenance After five years the battery must be replaced whether or not the device has been used Caution Explosion hazard The battery may not be incinerated or disposed of with household waste Caution Acid burn hazard Never open or overheat the battery In accordance with national law the battery may only be disposed o...

Page 50: ...11 Front 5 1 3 4 2 6 7 8 9 10 11 12 Part number 0 48 0080 Page 50 ...

Page 51: ...12 Rear and power supply 13 15 16 17 18 14 19 20 Part number 0 48 0080 Page 51 ...

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