MAGLIFE light
Contents
1. Alarm field mT Shutdown field mT AA DU A Alarm limits Releases Reserved SCHILLER i i Device OFF Download Connect the USB PEN DRIVE to the DEVICE DEVICE WILL SHUTDOWN AT THE END OF THE PROCESS Part number 0 48 0080 Page 41 MAGLIFE light 4 9 Alarms 4 9 1 Screen alarm symbols S1 S2 S3 S4 Audible alarms enabled Alarm sound disabled Displayed when at least one monitoring threshold is disabled OFF Technical alarms will go off all the same X Alarm sound disabled for 2 minutes Displayed when you press key 9 for less than three amin seconds The remaining time is displayed under the symbol 1 44 y a mer T Alarm sound disabled permanently Displayed when the alarm off key 9 is held down for more than three seconds 3 DK Alarm muting function Key 9 is used to mute the alarms e When this key is pressed briefly alarms stay disabled for two minutes and the symbol 3 shows the time remaining in Minutes up the end of the disabling of the alarm e f you press key 9 for three seconds or more alarm sounds remain disabled permanently or until the key 9 is pressed again Symbol S4 is displayed the symbol co flashes and a beep is emitted once in every two minutes to remind the user Audible alarm enabling disabling The permanent disabling of audible alarms is not permitted in some medical facilities That is why that function2. 3 1 MAGLIFE light symbols Main device on off key FX 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 A 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 E Notified body for CE certification G MED 0459 3 2 Power symbols Power connected Power input Part number 0 48 0080 Page 10 MAGLIFE light 4 Use of MAGLIFE ight 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
3. 0 48 0080 Page 23 MAGLIFE light e Use the Alarm limits tab to manage thresholds For more details refer to section 4 7 1 3 Alarm limits and 4 9 Alarms On Off Average Patient type Alarms limit Exit e SPO2 alarm limits setting Select a limit by rotating the navigation knob 6 press to confirm High SpO2 Low p02 High Pulse Low Pulse Select the limit value by rotating the navigation knob 6 again press to confirm the selected value High SpO2 Low SpO2 High Pulse Low Pulse 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 MAGLIFE light 4 7 1 3 Alarm limits menu The Alarm limits menu is used to set the thresholds for triggering alarms relating to the different parameters Caution The Thresholds menu only displays the thresholds for the parameters present in the configuration Caution If one or more alarms have been disabled an icon with a crossed out bell and the word OFF is displayed in the upper right hand corner of the screen The following submenus are available Alarms limit Neonate Spor Pulse 90 fo 85 NIBP SYS 49 DIA 30 MAP 39 Operator 1 Operator 2 Default 200 100 140 100 120 p min When the device is powered up and when it
4. Fichier 21 12 2005 18 25 E update_files 1 Ko Fichier 21 12 2005 18 26 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 Download Connect the USB PEN DRIVE to the DEVICE DEVICE WILL SHUTDOWN AT THE END OF THE PROCESS Note The procedure has been described in detail in the Service Manual of the device For more information please contact the technical service network of Schiller Medical Part number 0 48 0080 Page 37 MAGLIFE light 4 7 2 5 Version submenu The Version tab will show detailed info about used software versions and releases in MAGLIFE ight 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 MAGLIFE light 4 8 Structure of menus 4 8 1 User menus NIBP Menu Alarm limits menu BO display Trend Menu Settings menu 138 82 102 59 as 136 78 un 1028 ro se 438 77 os 40 28 6 oF 138 82 402 7030 o m yo 10 32 5 oF 142 88 404 ag s ss 1m oo 40 36 60 98 138 77 86 Part number 0 48 0080 Page 39 MAGLIFE light NIBP Menu 16 39 poa al Part number 0 48 0080 Page 40 MAGLIFE light 4 8 2 Configuration Menus Same for Child Same for Adult
5. Special displays ES Pulse pimin Spo 4h NIBP mmHg se a a ons oo 1387 82 102 Technical alarm w20 s o8 138782 102 o 10 22 1601 o9 maz s8 10 nos ten o 138 77 9 mos 60 o 138 82 102 T ctl 4 7 1 6 Edit menu To be written Part number 0 48 0080 Page 31 MAGLIFE light 4 7 1 7 Settings menu The Settings menu is used to set the general parameters of 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 Alarms sound Pulse sound Keyboard sound Sounds may be High Medium Low or Off with the exception of alarms which can never be Off Alarms sound High Medium Pulse sound Low Keyboard sound Part number 0 48 0080 Page 32 MAGLIFE light 4 7 1 7 2 Clock submenu The various buttons are used to set the date and time The daylight saving option can be disabled The clock change date is pre set Day el Summerfainter time 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 MAGLIFE light 4 7 2 Device configuration menu The configuration menus are hidden during normal operation Access is initiated by pressing the navigation button 6 when
6. can be configured See Permanent muting section 4 7 2 2 4 9 2 Physiological alarms Part number 0 48 0080 If the measured value of a parameter exceeds a threshold for over three seconds an alarm goes off and the display of the measured value flashes in red an intermittent audible alarm sounds sequence of four digital sounds that is repeated the window of the parameter over the threshold flashes on a red background and the display colour are inversed Depending on the choice made while configuring See section 4 7 2 2 the alarm stops As soon as its cause stops non latched After the causes disappears and key 9 is pressed latched Page 42 MAGLIFE light 4 9 3 Technical alarms When a technical alarm is triggered an error message is displayed in the display field of the parameter in question an intermittent audible alarm goes off sequence of two audible signals that is repeated it depends on the audible alarm configuration criteria a question mark is displayed instead of the measured value Note going beyond of the measurement limits of the device In this case no error message is displayed e technical alarm sounds e 3 fixed indents are displayed in the place of the measured value These alarms go off automatically when their causes disappear 5 Technical specifications 9 1 Manufacturer Device name Dimensions main unit power supply Weight main unit power supply Prot
7. connect a device that simulates a physiological signal to the device e g SPO wait for the value to stabilise and take the reading e select the corresponding parameter with button 6 and select the Thresholds button e modify one of the threshold values so that the value of the physiological parameter read earlier exceeds it e confirm by pressing button 6 After 3 seconds an alarm will go off Part number 0 48 0080 Page 48 MAGLIFE light 9 Additional accessories and indications MAGMOVE light Amagnetic trolley with storage basket for MAGLIFE light 0 13 0010 Adult finger SpO sensor 5 2 m fibre optic 0 13 0011 Child finger SpO2 sensor 5 2 m fibre optic 0 13 0012 Universal Y SpO2 sensor 5 2 m fibre optic 0 13 0008 Adult finger SpO2 sensor 4 2 m fibre optic 0 13 0002 Child finger SpO2 sensor 4 2 m fibre optic 0 13 0001 Universal Y SpO2 sensor 4 2 m fibre optic 0 13 0009 Adult finger SpO2 sensor 3 5 m fibre optic 0 13 0004 Child finger SpO2 sensor 3 5 m fibre optic 0 13 0003 Universal Y SpO2 sensor 3 5 m fibre optic 0 22 0003 5 m cuff tube W1404413 3 5m m cuff tube U50143 2 5 cm neonate cuff U50142 4 cm neonate cuff U50130 6 cm child cuff U50129 7 cm child cuff U50140 9 cm child cuff 0 40 0002 12 cm adult cuff U50128 14 cm adult cuff U50141 16 cm adult cuff 3 10 0118 Shielded MAGLIFE ight power cable 10 Disposal 10 1 Battery disposal Important In normal use the battery requires no
8. 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 Part number 0 48 0080 Page 14 MAGLIFE light Warning Warning Caution Caution Warning Warning Warning Warning Warning Caution Part number 0 48 0080 Remove nail polish or false nails before placing the sensor on the patients finger as they could lead to inaccurate oximeter measurements Cut long nails as they could hinder the placing of the sensor 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 Do not place the sensor on an extremity with an invasive probe or a blood pressure cuff 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 The oximeter measurement may be modified by the presence of strong ambient light Cover the sensor e g with a surgical sheet if
9. 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 of in an approved disposal facility or sent back to SCHILLER 10 2 Device disposal The device components must be disposed of separately and the relevant parts must be sent to appropriate recovery and disposal centres If you do not know of such a recovery and disposal system you may return the device to the distributor or manufacturer who will take charge of disposing of the device in accordance with applicable regulations In that way you will contribute to the recycling and recovery of old electrical and electronic devices and their reuse in other forms 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 Part number 0 48 0080 Page 49 11 Front o s 1 82 10 11 Part number 0 48 0080 Page 50 IEE 12 12 Rear and power supp lt Part number 0 48 0080 Page 51
10. required 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 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 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 The temperature of the patient and the room must not be too low since it will affect the measurement outcome Do not use the oximeter alone while monitoring vital parameters Page 15 MAGLIFE light 4 3 2 2 Sphygmomanometer cuffs Non Invasive Blood Pressure 1 Make sure that the NIBP function is on and
11. se tesama Waynes eta tonewe A 39 CORSA or Men s orrasa a E E ana atelanes 41 A A 42 Screen ala DOS ica 42 WSI 42 Technical SITE 43 Tecnnicalsbecificatiohms ai a 43 Ne AAA A O ERE DEDE sstaceuiearanta 43 Technical specitications 0t Moquies sensitivity oe 44 A II O SN DST ES YTRET ERE ES SENDE 44 NIBP Nom Invasive EGR 44 Threshold anges A A A td 45 CIC ANIIAG aa 46 TFOUDIESMOOUIG aid aci n 47 General CHO al ao aitor 4 A ERE SEERE REESE ERE ESSEN ERE RER ERE ES teenies 48 Maintenance siii ii PEGE NE BES OSS Ea 48 Alaris HALLS OD ane PPPoE EE A rer cer ere 48 Additional accessories and indicatiONS ooooccccccccccccnnononancnannnnnnnnnnn cnn rr rn cnn 49 DISDSa iiccsuAmctesthacce SVERRE NS e TEE SR SER ER SBE SN aa Aaa a i 49 Bat ISDN 49 Device disposi is 49 ON 50 Rear nd POWer SUD aiii is 51 1 Description of MAGLIFE light MAGLIFE ight is a monitor designed solely for monitoring vital patient parameters during MRI Magnetic Resonance Imaging examinations Depending on the selected version MAGLIFE ight will monitor the following parameters transcutaneous measurement of arterial oxygen saturation SpO2 pulse oximeter pulse rate blood pressure NIBP MAGLIFE ight may be configured with all combinations of the above parameters MAGLIFE flight 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 ight is desig
12. 0459 SCHILLER MEDICAL S A S MAGLIFE ight User manual Version 1 2 October 2006 Part No 0 48 0080 The Art of Diagnostics MAGLIFE light Revision history Versi n mte Commens June 2006 First edition July 2006 First release Soft 3 October 2006 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 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 Registered office SCHILLER AG Tel 41 0 41 766 42 42 Altgasse 68 Fax 41 0 41 761 08 80 CH 6341 Baar Switzerland Email sales schiller ch Website www schiller ch Part number 0 48 0080 Page 2 MAGLIFE light 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 adjustme
13. 5 20 220 MAP 25 235 Part number 0 48 0080 Page 45 MAGLIFE light 6 Cleaning MAGLIFE light can be cleaned with common cleaning and disinfecting agents BURATON INCIDIN GG KORSOLIN or LYSO FORMIN 2000 Follow the manufacturer s instructions for use Switch the device off and disconnect 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 disposed of using a special procedure and not merely scrapped Part number 0 48 0080 Page 46 MAGLIFE light 7 Troubleshooting 7 1 General errors Check and correct the connections LED 3 must be on The screen does not activate Battery discharged Connect the mains LED when the device is switched on 4 flashes e Magnetic field too great e Place the device outside the e Device faulty field lt 40mT e Replace the device leal E O Acc device initialise sequence is not e Device faulty e Replace the device carried out The device shuts off e Battery discharged e Connect the mains automatically e Magnetic field too great o er the device outside the le e Non specific printer e Replace the printer with a printer speci
14. LIFE 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 Part number 0 48 0080 Page 5 MAGLIFE light Note Note Caution Caution Caution Caution Caution Caution Caution The ambient temperature must be located within the following limits 15 C lt Amb T lt 35 C 60 F lt Amb T lt 96 F 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 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 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 Sensors and probes may not come in contact with conductive parts including the earth Do not defibrillate on the accessories Place the defibrillation electrodes as far away from the other accessories as possible The monitor is adapted for the MRI configuration upon power up Any subsequent change in the MRI system c
15. LLER representative MAGLIFE ight bears the CE 0459 mark in accordance with directive 93 42 EEC relating to medical devices and fulfils the essential requirements of annex 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 Part number 0 48 0080 Page 4 MAGLIFE light Please read and adhere to the following list of warnings precautions and notes Some of them have been WARNINGS PRECAUTIONS AND NOTES 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 Caution Warning Warning Warnin
16. an alter the performance of the MAGLIFE ight monitor Inform SCHILLER of any such change 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 The device is designed to operate without any equipotential connection Part number 0 48 0080 Page 6 MAGLIFE light Contents Page Revision NISTON se 2 WARNINGS osia EO E E EEE EEA RE 3 TOIAN OMG iaa ii 3 WARNINGS PRECAUTIONS AND NOTES ooonccocccccconnnccnnnnnncconnnnccnnonnnnnnnnnnonennnnnnnnnnnnrnnnnnnrennnnnrrnnannenenzns 5 nn elec aaa a aaa ENa a a E EE 7 1 Description of MAGLIFE GME icsi eaa aaa E aaa a ed lse le 8 2 Location and description of displays and controls ne 9 2 1 Frontor MAG ERE Meta dai 9 22 Re 9 Zo Mains POW Cl TI 9 3 Devicessymbolidenilication ae 10 3 1 MAGLE ERE SVIMDOIS errre que saseumensmedevesnnswa patents vioastaanteemadinecauoumialaneswinacteepenend delicada 10 3 2 J Wai 10 4 USC 0t MAGUIEE MOP ese ssivenosececsveszeaveandoxss o 11 4 1 A eines ual EEE NES arte celal tenet act x Magne ata telat ce AT Bagatelles 11 4 2 DR 13 4 2 1 SEO OP COMO Ly POR ORCATOS OO TE BESAD EGE TEE RENSE TESS S 13 4 2 2 NIBP OPUOR ON aaben ad 13 4 2 3 SEOs and NTE Prop ON 14 4 3 Placing of probes amd Sensors ri iii date dedo ii 14 4 3 1 So 14 4 3 2 Probes and sensors to be used and positioning
17. ast 75 cl and a pressure measuring device If required add an inflating bulb with a deflating valve Activate 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 password is communicated to the people who followed the technical training Myx 111 Patient type A B C D E F G H I J Ax c m njo a r s T u Guy iw x Y Z Alarms limit jop1f2 3 4 5 6 7 8 9 Calibration Page 22 MAGLIFE light 4 7 1 2 Oximeter SpO2 submenu Windows displayed with the SpO2 parameter disabled select SpO2 On Off to enable with the SpO2 parameter enabled select SpO2 On Off to disable On f Off Average Patient type Alarms limit Exit e 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 16s is made by activating the Average tab On Off Average Patient type Alarms limit Exit e Patient type selection The patient type selection only affects the thresholds On Off Average Patient type Neonate Child Alarms limit Adult Exit Part number
18. 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 each type of patient These values can be set from the Device configuration menu see section 4 7 2 Part number 0 48 0080 Page 25 MAGLIFE light The Operator 1 choice gives access to the following submenu which is used to set the thresholds from the values selected by the operator when the function was last accessed Alarms limit Adult Operator 1 spO Pulse A5 75 p min 50 99 di NIBP SYS 30 155 mmHg DIA 15 220 to MAP 20 235 mmHg Exit Quick Default gt e The Quick selection is used to set all the values in 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 e The Default selection is used to go back to the default values for the selected patient type e gt provides access to the following submenu Alarms limit Adult Operator 1 spO Pulse A5 75 p min Lo 50 99 NIBP SYS 30 455 mmHg DIA 15 220 to MAP 20 235 mmHg OFF Operator 2 Exit a Is used to go back to the previous submenu e OFF is used to disable all the audio and visual physiological alarms Part number 0 48 0080 Page 26 MAGLIFE light Caution Fai
19. 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 ight 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 Operating during a mains failure MAGLIFE ight 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 Part number 0 48 0080 Page 17 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
20. 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 lt 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 NIBP Menu Alarm limits menu BO display Trend Menu Edition menu Settings menu It is used to select submenus Note Only the labels corresponding to the installed parameters are displayed The main menu contains the following submenus Part number 0 48 0080 Page 18 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 Calibration e Cycle selection to select a cycle value from 1 minute to 90 minutes activate symbol 3 then select the appropriate value by rotating button 6 and confirm by pressing the button On Off a Patient type Alarms limit Calibration Part number 0 48 0080 Page 19 MAGLIFE light e 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 Fo
21. e Connection Class SPO2 accuracy SPO display range Pulse accuracy Pulse display range Blocking by defibrillator shock HF protection BCI Fibre optic CF 2 from 70 to 99 3 from 50 to 69 0 99 5 b min 30 250 b min 10 seconds maximum protection from electro surgery devices 5 2 2 NIBP Non Invasive Blood Pressure OEM module Connection Class Measuring principle Mode Part number 0 48 0080 CAS Fast snap CF Oscillometric Manual Automatic Continuous Page 44 MAGLIFE light Types of patient Neonate Child Adult Sensor accuracy 3mmHg or 2 Pulse accuracy 5 b min Display range Adult Child systolic 30 255 mmHg diastolic 15 220 mmHg mean 20 235 mmHg Pulse 30 240 P min Neonate systolic 30 135 mmHg diastolic 15 110 mmHg mean 20 125 mmHg Pulse 40 240 P min RF protection protection from electro surgery devices 5 3 Threshold 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 Saturation 50 98 51 99 SYS 30 130 35 135 DIA 15 105 20 110 MAP 20 120 25 125 Child patient Pulse 30 245 35 250 Saturation 50 98 51 99 SYS 30 250 35 255 DIA 15 115 20 220 MAP 20 230 25 235 Adult patient Pulse 35 250 Saturation 91 99 SYS 35 25
22. ection class of the enclosure Electricity supply Power consumption Fuses Battery Autonomy System specifications SCHILLER Medical S A S MAGLIFE ight 2 0 x 216 x 116 mm 10 6 x 8 5 x 4 6 180 x 84 x 68 mm 7 x 3 3 x 2 7 6 Kg 1 3 Kg IP 21 100 115 230 VAC 50 60Hz Factory defined voltage 25 VA 2 x 100 mA T 230 VAC 2 x 200 mA T 100 115 VAC 12 V 2 Ah Lead 2 hours Environmental conditions Operating Temperature Relative humidity Pressure Magnetic field Storage Temperature Relative humidity Pressure Magnetic field Part number 0 48 0080 15 35 C 60 F 96 F 30 95 non condensing 500 1060 hPa lt 40mT 10 C 50 C 13 124 F 30 95 non condensing 500 1060 hPa lt 40mT Page 43 MAGLIFE light Display Connections Interfaces Safety standards EMC CE marking Protection class Colour TFT screen 6 8 98 x 132mm 480 x 640 dots SPO and NIBP RS232 USB 1 1 for connecting the equipment specified by SCHILLER IEC 60601 1 IEC 60601 1 2 CISPER 11 Class B with printer connected class A The device may be subject to the following interference without being affected Static discharge up to 8 kV Radio frequency 10 V m 80 2500 MHz 5 Hz modulating According to directive 93 42 EEC class Ilb Class according to IEC 60601 1 5 2 Technical specifications of modules 5 2 1 Pulse oximeter OEM modul
23. fied by SCHILLER No printing e No power to printer e Connect the printer to the e Connecting cable loose power source and switch on e Check and remedy the connections Part number 0 48 0080 Page 47 MAGLIFE light 7 2 Errors of modules Error No SPO2 measurement SPO2 signal disturbed The cuff will not inflate Doubtful NIBP measurements Cause Optical probe faulty Ambient light artefacts No perfusion Module faulty no light in the SPO2 connector Incorrect sensor installation Compression of the measurement location Poor perfusion Pump motor magnetised because the device has been subject to an excessive magnetic field Faulty cuff or tube Incorrect cuff installation Inappropriate cuff System not airtight Remedy Replace the probe Cover the sensor holder on the finger Change the signal taking location Replace the device Move the sensor Remove the compression Move the sensor Replace the device Replace and check tightness Check and adjust the cuff Replace with an appropriate cuff Replace the leaking part Not locatable Replace the device 8 Maintenance e Before each use check all the device functions simulate an alarm check if all the connectors and cable insulators are in good condition e Once a year check the leakage current according to paragraph 19 of standard IEC 601 1 8 1 Alarm simulation To simulate an alarm for verification proceed as follows e
24. g Warning Warning Warning Caution Warning Warning 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 The continuous presence of a qualified person is imperative throughout the examination Before using the MAGLIFE light monitor follow the safety instructions below e 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 Because the device is a class device it may only be used in premises with an electrical system comprising an earth connection 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 Take account of the physiological effect of the other devices connected to the patient This device may not be installed or operated in explosive environment This device is not designed for use with inflammable anaesthetic agents Use only sensors supplied by SCHILLER They have been designed specially for use in MRI environments 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 It is imperative the MAG
25. g 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 Part number 0 48 0080 Page 16 MAGLIFE light 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 4 5 1 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
26. in Quality of a SPO2 signal Plethysmogram SPO2 area F 60 Pulse rate value SPO2 value N Pulse area Alarm Thresholds 4 2 2 NIBP option only Status area a 29 06 2006 14 27 ADULTE NIBP area NIBP values Unit 9 POULS pimin Mode N 7 7 Previous measurements BER 13 min Piletas 14 24 125 80 94 9 2 14 24 Part number 0 48 0080 Page 13 MAGLIFE light 4 2 3 SPO and NIBP options SPO2 9 POULS p min A 100 SPO2 area _J9 8 7 0 a 60 29 06 2006 ER 725114 25 NIBP area N Status area 69 39 PNI mmHg 094 en 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
27. instructions et 14 4 3 2 1 SPOOZ A iaa 14 4 3 2 2 Sphygmomanometer cuffs Non Invasive Blood Pressure pe 16 4 4 A O eas ea cate aN ane E ESS R RES A BER ETS 17 4 5 JU 17 4 5 1 Operans dunne mamis ii 17 4 6 U eor CMa encanta A A A RE EE 18 4 7 DESC POON OF Menis a it S 18 4 7 1 is o FEED EI PE ER FEED E OEE SER E E SETE V VEDDET 18 4 7 1 1 NIBP Non Invasive Blood Pressure menu pp 19 4 7 1 2 Oximeter Sp OF SED MAC TAU on ns mene Re naa lain arom cen tee valse aes aaruiaeen sl Meiamnee 23 4 7 1 3 ES 25 4 7 1 3 1 Power up and standby Mode 27 4 7 1 4 Niasnete ed 28 4 7 1 5 Trends Ml dolo 28 4 7 1 5 1 Frend erapa Submit 29 4 7 1 5 2 Trend table UD Neco cccrcuecadice spececicetasdceaceeacevene tedden scatterer cd essens lad Salen dadtanersdibauntsteracdeest 30 4 7 1 6 de 31 4 7 1 7 SSL HEB SR 32 4 7 1 7 1 Sound Soc Deia pisito pilar on EEE BESES TERESE SER 32 4 7 1 7 2 ARA A A TES ERNE GS ER ESENER ERE DETS 33 4 7 1 7 3 Screen Driohthess setin Tienie e a EE ce dehctuse Weksaterushes dean ace uuels 33 4 7 2 DENCE CONT SUT ALON A eS 34 4 7 2 1 SO 34 4 7 2 2 UA OR 35 4 7 2 3 Opos SUDINCHU iia sd adas 37 Part number 0 48 0080 Page 7 MAGLIFE light 4 7 2 4 4 7 2 5 4 7 2 6 4 8 4 8 1 4 8 2 4 9 4 9 1 4 9 2 4 9 3 5 1 3 2 5 2 1 I2 5 3 7 1 1 2 8 1 10 10 1 10 2 11 12 SOtLWare 1pdate Su DML de 37 38 Reserved SCHILLER SUD e ici 38 SE UCTUNE Ol Menus sica ip ira 39 Eer MEAS pi a EAA
28. 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 Important note Part number 0 48 0080 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 The magnetic field is always present even when the imager is not being used for an examination Page 11 MAGLIFE light Typical plan of an MRI system with a MAGLIFE ight monitor 1 Faraday cage 2 MAGLIFE fight monitor 3 Mains connector 4 Marking on the floor 40 mT line 40 mT 400G line Forbidden area Authorised area Figure 1 Part number 0 48 0080 Page 12 MAGLIFE light 4 2 Display screens 4 2 1 SPO option only Patient type Time Miscellaneous Date j Batterv status S Sound alarm status 29 06 2006 14 26 DENG O a ADULTE Status area SPO2 POULS 99 p m
29. lure to monitor the condition of the patient may lead to death e Selection Operator 2 provides access to the second set of values defined by the operator when the function was last accessed The values can then be edited e Exitis used to close this submenu 4 7 1 3 1 Power up and standby mode When the device is powered up the threshold values are the default values for the type of patient selected and therefore not necessarily the values used 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 values used last is available with the Previous button NEONATE Patient in a Child Note Selecting the Previous option makes it possible to obtain trend continuity as all the other selections result in the insertion of a separating mark between patients in the trends Part number 0 48 0080 Page 27 MAGLIFE light 4 7 1 4 Magnetic field display The BO display button is used to display the magnetic field measurement on the screen Values Bx By and Bz show the value of the magnetic field in mT along the three orthogonal directions in space The B value shows the corresponding vecto
30. ned to be placed on a non magnetic mobile stand Part number 0 48 0080 Page 8 MAGLIFE light 2 Location and description of displays and controls 2 1 Front of MAGLIFE light see photo in section 11 1 2 10 11 12 Main device on off key Device ON indicator MAINS connection indicator BATTERY Indicator showing that the battery is being charged flashing or is fully charged steady Main MENU key Access to the main menu and for exiting a menu from any other place Navigation button for menu selection Display for curves parameters menus and messages NIBP key for starting up or stopping a measurement or a series of measurements of the blood pressure via a cuff Alarm silence key enables or disables the two minute or permanent audio alarm function physiological and technical alarms Device STANDBY key SPO optical oximeter sensor connector NIBP cuff connector 2 2 Rear of MAGLIFE light see photo in section 12 13 14 15 16 17 18 Connector for the low voltage cord for connecting to the Mains power unit Loudspeaker USB connector RS 232 connector Auxiliary connector compartment cover Identification label 2 3 Mains power unit see photo in section 12 19 20 Mains plug Low voltage plug for connecting the MAGLIFE ight Part number 0 48 0080 Page 9 MAGLIFE light 3 Device symbol identification
31. ntinuous mode Caution To ensure the correct vascularization of the member on whom the blood pressure is measured the repetition of the continuous mode is not advised Is used to select the frequency of Cycle after CONT mode automatic measurements after the end of the continuous mode Caution These configuration settings must be in accordance with the laws applicable in the country of use Page 36 MAGLIFE light 4 7 2 3 Options submenu The Options menu is used to enable or disable one or both parameters of MAGLIFE ight 5p02 SM Non Invasive Blood Pressure das 4 7 2 4 Software update submenu The person performing the update must have the requisite skills to make the relevant functional and safety checks and is entirely responsible for such checking The software is updated by means of a USB key 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 Adresse ES G maglight update Dossiers x Nom Taille Type Date de modification S Disque amovible G A El analog bin 20Ko Fichier BIN 20 12 2005 10 47 2 E madlight El boot script 1 Ko Fichier 21 12 2005 18 22 a update ES dear boot script 1 Ko Fichier 21 12 2005 18 22 E hardware compatibility 1 Ko Fichier 21 12 2005 18 22 E kernel bin 1401 Ko Fichier BIN 21 12 2005 18 05 COScHILLER tar 1670Ko Winzip File 21 12 2005 18 23 soft 1 Ko
32. nts 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 Part number 0 48 0080 Page 3 MAGLIFE light 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 SCHI
33. ou cannot define a customised colour combination e The allowed patient selection button is used to restrict or extend the patient selection list Part number 0 48 0080 Page 35 MAGLIFE light Button 2 is used for special alarm configuration It opens the following submenu 4 4 SpO2 alarm Physiological alarms 2 alarm rejection at start Fy 4 SpO2 alarm Enabling or disabling the alarm function if the SPO drops more than 4 Physiological alarms A physiological alarm may be latched i e confirmation by 2 alarm rejection at start E Part number 0 48 0080 pressing key 9 is required to stop it even when the value of the parameter has exceeded the threshold and is back in the non alarm range If the alarm is not latched it stops as soon as the value is back within the non alarm range This option is used to disable audio alarms for two minutes after the device is switched on allowing for time required to apply 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 lf the alarms are permanently muted a reminding audio signal double beep is emitted after every two minutes Button NIBP is used to define the parameters of the NIBP measurement in the continuous mode CONT mode length Cycle after CONT mode lect the duration of th CONT mode length S used to select the duration of the co
34. r modulus 4 7 1 5 Trends menu The Trends menu contains two main submenus Graphs and Tables and two options lt enables the user to erase the trends and select the period for trend tables Sampling rate Part number 0 48 0080 Page 28 MAGLIFE light 4 7 1 5 1 Trend graph submenu Part number 0 48 0080 pa a pa e The Trend graph menu is used to select the trend curves to be displayed and contains the following tabs Note Only two waveforms can be shown at the same time Pulse f SpO2 pimin th 60 50 10 46 00 10 53 25 BLU GR 0 10 08 30 10 16 00 10 23 30 10 31 00 10 38 30 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 Exit the trend graphs display Page 29 MAGLIFE light 4 7 1 5 2 Trend table submenu Part number 0 48 0080 Trend table show the numerical values of the physiological parameters according to the frequency that has been defined earlier from the trend type selection menu 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 If a non invasive pressure measurement does not strictly follow the table frequency rules it is inserted at the appropriate location Page 30 MAGLIFE light
35. r subsequent measurements the inflating pressure is automatically selected about 50mmHg above the measured systolic pressure for Adult Child and 30mmHg for Neonate Patient type Neonate Child Unit Adult Alarms limit Calibration e Measuring unit selection The Unit button is used to switch between the two units kPa and mmHg On Off a a Patient type Unit Alarms limit Calibration Part number 0 48 0080 Page 20 MAGLIFE light e Use the Alarm limits button to manage thresholds For more details refer to section 4 7 1 3 Alarm limits and 4 9 Alarms On f Off D Patient type Unit Alarms limit Calibration e NIBP alarm limit setting Select a limit by rotating the navigation knob 6 press to confirm High SYS Low SYS High DIA Low DIA High MAP Low MAP Select the limit value by rotating the navigation knob 6 again press to confirm the selected value High SYS Low SYS High DIA Low DIA High MAP Low MAP 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 MAGLIFE light Part number 0 48 0080 The Calibration submenu is used to check if the NIBP pressure module is measuring the pressure correctly Connect the external verification system with an expansion vessel of at le
36. 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 sohygmomanometer must not be used on the patient s limb undergoin
37. the device is switched on and keeping it pressed until the configuration menu is displayed Alarm limits e Releases Reserved SCHILLER Device OFF Note To exit the Device configuration mode the device must be switched off 4 7 2 1 Alarm limits 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 Neonat Child Adult Magnetic Field 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 automatically selected When the last parameter value has been entered the selection cursor goes back to the parameter selection column Part number 0 48 0080 Page 34 MAGLIFE light Alarms limit Neonate Default spO Pulse 90 200 p min 85 100 Ne SYS 49 140 o DIA 30 100 o MAP 39 120 o 4 7 2 2 Monitor submenu Note The Language Colour Alarms NIBP and Patients selection list buttons are used for settings whilst the Serial number and Hardware number buttons are provided for information only and cannot be modified by the user e A certain number of languages are available The language selection does not affect the operating of MAGLIFE ight e The screen colour combination can be selected with button Y
Download Pdf Manuals
Related Search