MAGLIFE C Plus / MAGSCREEN
Contents
1. MAGSCREEN Item code W1404827 Page 10 1 PRESENTATION 1 1 MAGLIFE C Plus PRESENTATION MAGLIFE C Plus is a monitor designed solely for monitoring vital patient parameters during MRI Magnetic Resonance Imaging examinations Dependingon the configuration MAGLIFE C Plus is used to monitor the following parameters ECG rythmology for rate only pulsed arterial oxygen saturation by transcutaneous means SpO2 pulse blood pressure NIBP partial CO2 pressure at the end of expiration EtCO2 inspired nitrous oxide concentration N20 partial pressure of inspired CO2 min inspired CO2 respiratory rate RR fraction of inspired oxygen FiO2 concentration of anaesthetic gas inspired and expired AGENTS isoflurane halothane enflurane desflurane sevoflurane Invasive Blood Pressure IBP Temperature skin MAGLIFE C Plus is fitted with internal batteries to follow the patient when moved e g transfer to and from the examination room and the adjacent preparation room MAGLIFE C Plus can be configured with any combination of options the basic configuration being E S N i e ECG SPO2 Pulse and NIBP 1 2 MAGSCREEN PRESENTATION Part Number W1411675 MAGSCREEN is a remote control display unit for use with the surveillance monitor MAGLIFE C Plus MAGLIFE C Plus is placed in the MRI examination room whilst MAGSCREEN is used to monitor the patient from outside the Faraday cage an2. instructions inherent to MRI environments must be followed during any work on the unit installation operation servicing etc All work on MAGLIFE C Plus e g servicing shall be done imperatively outside the Faraday cage CAUTION Strict compliance with the safety instructions relating to ECG measurement see 4 2 is an essential requirement However the potential risk of heating at the ECG electrodes cannot be ruled out completely see article page 1226 Vol 2 of Proceedings of the S M R and E S M R M B meeting held jointly Nice France August 19 25 1995 Real Time Evaluation of ECG Electrode Heating during MRI at 1 5 T CAUTION No system which hampers the blood flow e g use of a cuff type sphygmomanometer may be used on patients limbs undergoing oxygen saturation measurement such systems may disrupt the accurate determination of data CAUTION Electrodes probes and sensors must not touch other conductive parts or ground CAUTION The ECG function must not be used on patients carrying a pacemaker the monitoring function can be inhibited Don t defibrillate on electrodes and accessories Place the defibrillation electrodes as far as possible from the other electrodes and accessories ECG etc CAUTION The monitor is adapted for the MRI configuration when it is started up Any subsequent change in the MRI system can alter the performance of the MAGLIFE C Plus monitor Please call SCHILLER WARNING the
3. line isolation monitor transients may resemble actual cardiac waveforms and thus inhibit heart rate alarms Item code W1404827 Page 6 MAGLIFE C Plus MAGSCREEN This symbol indicates in the manual that the text or paragraph which follows it relates to MAGLIFE C Plus This symbol indicates in the manual that the text or paragraph which follows it relates to MAGSCREEN Item code W1404827 Page 7 MAGLIFE C Plus MAGSCREEN CONTENTS HISTORY OF THE REVISIONS OF THE OPERATION MANUAL nnssssnnnrnmennnennennte 2 WARNING 2555 sent cpaccde ence eeh ce ere ee EE 3 FOREWORD RER EE EES EE eege SE A WARNINGS CAUTIONS AND NOTES ii nnennernmennnnnnnnnenennennennnnnenenennnnnennnneenenes 4 GENERAL WARNINGS CAUTIONS AND NOTES nes ranrrannemeeneenennemennnenenennenneneennenennenes 5 PRESENTATION 1 1 MAGLIFE C Plus presentation 0 cccccceceeeeeeeeeceeeeeeeaeeeeeaeeeeneeseaeeesaaeseseeeeseaeeesaeeseaeeeeaes 11 1 2 MAGSCREEN presentation AA 11 REFERENCES AND DESCRIPTION OF DISPLAY AND CONTROLS 2 1 MAGLIFE C Plus Front cca cee tenn Ann A eee Audierne 12 2 2 MAGLIFE C Plus Reat ai niidi i eee eves ceed vee dete area a 13 2 3 MAGLIFE C Plus Right side view 13 2 4 MAGSGREEN FOE eg erter ne ne ta tn ent MU Enr er nets 14 2 5 MAGSCREEN Reare tienne ta er he hr eme LE and mer fe le 14 IDENTIFICATION OF UNIT SYMBOLS 3 1 MAGLIFE GPiusg Zavmbole Seat geet e ENEE EE le 15 3 2 MAGSGREEN S YMbOls 2
4. 4 MAGSCREEN FRONT see photo page 102 27 28 29 30 31 32 33 34 Device On indicator Key for displaying and accessing the main menu or quitting a menu from any location when MAGLIFE C Plus is controlled by MAGSCREEN Control knob for remote menu selection Waveform parameter menu and message display screen Key for starting or stopping blood pressure measurement by means of a cuff Remote starting and stopping the freeze function of all physiological waveforms Key for starting or stopping printing if recorder option installed Key for enabling physiological and technical audio alarms or disabling them for 2 minutes 2 5 MAGSCREEN REAR see photo page 103 35 36 37 38 39 Item code W1404827 Identification label Loudspeaker output Optical connector for connecting to MAGFILE DC Power input Optical connector for connecting to MAGLIFE C Plus Page 14 3 IDENTIFICATION OF UNIT SYMBOLS 3 1 MAGLIFE C Plus SYMBOLS Ge Item code W1404827 Main unit On Off button Mains on Battery being charged Access to main menu or exiting any menu Trace freeze 2 minutes sound alarm disabling Electrocardiogram Non Invasive Blood Pressure Temperature Invasive Blood Pressure CF type device protected against defibrillation shock device designed for direct applications on heart Print Attention Refer to the operating manual of t
5. SCHILLER MEDICAL S A S MAGLIFE C Plus MAGSCREEN User s Manual Version 3 1 February 2005 SCHILLER MAGUFE C Plus SCHILLER MEDICAL S A S ZAE SUD 4 rue Louis Pasteur BP 90050 F 67162 WISSEMBOURG CEDEX T l phone 33 0 3 88 63 36 00 T l copie 33 0 3 88 94 12 82 Internet http www schiller medical com E mail info schiller fr THE ART OF DIAGNOSTICS Part No W1404827 History of User s Manual revisions Revision 1 November 1998 Revision 2 August 2002 Revision 3 September 2003 Revision 3 1 February 2005 Item code W1404827 Page 2 WARNING This manual shall be deemed to be an integral part of the described unit Compliance with its contents is a preliminary condition for correct unit operation as well as for the safety of the patient and the operator The manufacturer may not be held responsible for the safety reliability and specifications of the unit if assembly extensions adjustments and repairs are not performed by the manufacturer or by personnel authorised by the manufacturer the electrical installation of the premises does not comply with locally applicable requirements the unit is not used in compliance with the instructions for use This manual describes the units as they are at the time of printing On request the manufacturer shall supply circuit diagrams lists of components descriptions calibrating instructions and any other informat
6. d remote control the monitor An optical fibre link between the MAGLIFE C Plus monitor and MAGSCREEN ensures safe and interference free data transmission An optional wireless link is available MAGSCREEN can also transmit data from MAGLIFE C Plus to MAGFILE data storage system using a PC e g for computerised anaesthesia records Item code W 1404827 Page 11 2 REFERENCES AND DESCRIPTION OF DISPLAY AND CONTROLS 2 1 MAGLIFE C Plus FRONT see photo page 99 1 2 3 4 5 6 7 8 9 9 10 11 12 13 14 15 16 17 18 Item code W1404827 Main unit ON OFF switch Unit ON indicator Indicator showing that the unit is connected to the mains Indicator showing that the battery is being charged Key for displaying and accessing the main menu or quitting a menu from any location Control knob for menu selection Waveform parameter menu and message display screen Key for starting and stopping blood pressure measurement via a cuff Key for starting and stopping the freeze function for all physiological waveforms Key for starting a recorder sequence Key for disabling and enabling audible alarms for 2 minutes physiological and technical alarms Connector for the fiber optic ECG sensor Connector for the fiber optic SpO2 sensor Connector for the aspiration tube for CO2 N20 and anaesthetic agents Connector for the NIBP cuff Connector for the fiber optic temperatu
7. dical Electrical Equipment The radio interference emitted by this device is within the limits specified in the sandarts CISPR11 EN 55011 class B 1 1 WARNINGS CAUTIONS and NOTES Please read and adhere to the following list of warnings precautions and notes some of which are repeated in the appropriate areas throughout this manual Observe all CAUTION and WARNING labels on the monitor A warning is provided when actions may result in a serious outcome i e injury serious adverse effect death to the patient or user A caution is provided when any special care is to be exercised by the practitioner and or patient to avoid injury to the patient damage to the device or damage to other property A note is provided when extra general information is applicable This manual shall be deemed to be an integral part of the described unit Compliance with its contents is a preliminary condition for correct unit operation as well as for the safety of the patient and the operator The manufacturer may not be held responsible for the safety reliability and specifications of the unit if e assembly extensions adjustments and repairs are not performed by the manufacturer or by personnel authorised by the manufacturer e the electrical installation of the premises does not comply with locally applicable requirements e the unit is not used in compliance with the instructions for use This manual describes the units as they are at the
8. his device for instructions Page 15 3 IDENTIFICATION OF UNIT SYMBOLS EZ 3 2 MAGSCREEN SYMBOLS L __ Power on Entering the main menu or quitting any menu Trace freeze function Two minute alarm disable function Non invasive blood pressure Print EG a Connection with MAGLIFE C Plus 00000000 E Connection with MAGFILE Power input connector Item code W1404827 Page 16
9. ion for use by qualified personnel of the user in charge of repairing the parts of the unit which have been stated by the manufacturer to be repairable Such supply shall in no event constitute permission to modify or repair the units or approval of the same All rights reserved for the units circuits processes and appellations mentioned herein This unit is not designed for any type of use which is not specifically described in this manual Such use may be hazardous Item code W1404827 Page 3 MAGLIFE C Plus MAGSCREEN FOREWORD The MAGLIFE C Plus Operating Instructions Manual is intended to provide information for proper operation General knowledge of monitoring and an understanding of the features and functions of the MAGLIFE C Plus are prerequisites for its proper use Do not operate this monitor before reading these instructions Information for servicing this instrument is contained in the SCHILLER MAGLIFE C Plus Service Manual Part No W1404434 For additional information or assistance please contact an authorized SCHILLER representative in your area MAGLIFE C Plus MAGSCREEN bears the CE mark CE 0459 indicating its compliance with the provisions of the Council Directive 93 42 EEC about medical devices and fulfills the essential requirements of Annex of this directive The product complies with the electromagnetic immunity requirements of standart IEC 60601 1 2 EN 60601 1 2 Electromagnetic Compatibility Me
10. not protected from pacing pulses or from HF currents Specially electrosurgery and diathermy devices NOTE MAGLIFE C Plus recognizes variations in the ECG electrode offset with its ECG amplifier system but not to saturation Considering that the electrodes are made from carbon are slightly charged and are intended for the exclusive use in the MRI environment it is nonessential that saturation be detected WARNING This unit is not designed for installation and use in explosive environments WARNING This unit is not designed for use with flammable anesthetic agents CAUTION Use only SCHILLER supplied electrodes and probes They have been designed specially for use in an MRI environment CAUTION MAGLIFE C Plus is designed for use with MRI units with a magnetic field between 0 2 and 2 Tesla Consult SCHILLER for use with units with greater magnetic field values WARNING MAGLIFE C Plus must necessarily be installed in the area around the magnet where the leakage magnetic field is less than or equal to 40 mT 400 G see typical layout drawing and warning labels on the monitor NOTE The ambient temperature must be between the following limits 19 C lt Tamb lt 25 NOTE Specific instructions for the installation and operation of the MAGLIFE C Plus monitor have been described in chapter 4 Read chapter 4 carefully before starting up the monitor Item code W1404827 Page 5 MAGLIFE C Plus MAGSCREEN CAUTION Safety
11. ntaine nr tt te ne EE EE dee 56 Automatic tests ni tentent men ite md retro het ates ety 57 Waveform and parameter display cccceeseeceeeeeceneeeceaeeceeeeeceaeeecaaeeeeaaeeeeeessaeeeeeaaeeenees 58 4 10 1 Distribution of waveforms and parameters on the screen 58 4 10 2 Date and time display EE 61 4 10 3 Software release display mrena a eaa naaa aa eiaa ARa a AE eRe 61 4 10 4 Trend waveform display 62 Alarm te EE 65 RR elle EE Eu 66 Magnetic field monitoring 69 Recorder Ee 70 4 14 1 ee 70 Item code W1404827 Page 9 MAGLIFE C Plus MAGSCREEN 4 14 2 Launching the recording sus 73 4 14 3 Leaders ss thins tte ata ee ee te 74 4 14 4 ANNOtAUION EE 75 4 14 5 HRH WE 76 4 14 6 Printer paper replacement cc ceeeececeeeeeneeeeeenneeeeeeaeeeeeeaaeeeeeeaeeeesenaeeeeneaaes 76 4 15 ECG Gating Module rh dne menait ened beeing othewedauenefaadeavedt evans 78 MAGSCREEN OPERATION 5 1 df ET ten EE 79 5 1 1 FIDGr Optic EE 79 5 1 2 Wireless linK 5 5 8 E TET E AER Repair RER Sege 80 5 2 Sarting up and screen display 81 5 3 Transfer of control to MAGSCHREEN 82 5 4 Connection AUS ni sn ace er aaa 82 5 5 MAGLIFE C Plus MAGSCREEN MAGFILE status indication symbols 008 82 5 6 Turning MAGSCREEN off ir 84 SPECIFICATIONS CLEANING MAINTENANCE ADDITIONAL INFORMATION AND ACCESSORIES FRONT PANEL MAGLIFE C Plus REAR PANEL MAGLIFE C Plus FRONT PANEL MAGSCREEN REAR PANEL
12. re probe Connector for the 1st invasive blood pressure sensor Connector for the 2nd invasive blood pressure sensor Connector for the inspired oxygen fraction FiO2 sensor Page 12 2 REFERENCES AND DESCRIPTION OF DISPLAY AND CONTROLS 2 2 MAGLIFE C Plus REAR see photo page 100 and 101 19 20 21 22 23 24 25 26 40 41 Mains switch Mains socket Location of water trap for CO2 N20 and Agents functions Exhaust for CO2 N20 and Anesthetic Agents Exhaust 1 is used during calibration mode and Exhaust 2 is used during monitoring mode and are used for the purpose of recovering gases from the CO2 N20 and Anesthetic Agent monitoring system Warning The two exhaust ports must never be linked together using a T This can bring erroneous indications for halogen agents calibration CO2 N20 and Agents water trap inlet CO2 N20 and Agents filters connection Connection for the calibrating cylinder for the CO2 N20 and anaesthetic agents Identication label ECG optical signal output for MRI gating triggering purpose Optical connector for link to MAGSCREEN 2 3 MAGLIFE C Plus RIGHT SIDE VIEW Thermal strip chart printer optionnal with an internal paper spool Provides a permanent record of patient s vital signs waveforms and trended information Refer to section 4 14 Item code W1404827 Page 13 2 REFERENCES AND DESCRIPTION OF DISPLAY AND CONTROLS 2
13. time of printing All rights reserved for the units circuits processes and appellations mentioned herein This unit is not designed for any type of use which is not specifically described in this manual Such use may be hazardous Item code W1404827 Page 4 MAGLIFE C Plus MAGSCREEN GENERAL WARNINGS CAUTIONS AND NOTES WARNING Before using the Maglife C Plus surveillance monitor make sure that the following safety instructions are followed e MAGLIFE C Plus may only be used by personnel who are trained in the field of health and familiar with the instructions for use e The voltage and frequency of the facility shall be as stated on the identification label and in chapter 5 of this manual e The unit is manufactured as a class unit and may only be used in rooms fitted with electrical installations including an earth connection e Connecting other units or sensors to the patient may give rise to leakage currents harmful to the patient Consult SCHILLER before interconnecting with other units e Account must be taken on the physiological effect of any other units to which the patient may be connected CAUTION MAGLIFE C Plus is a monitor designed solely for use close to Magnetic Resonance Imagers of 0 2 to 2 0 T for the surveillance of patients undergoing MRI examinations CAUTION The continuous presence of a qualified person is imperative during the entire duration of the examination CAUTION MAGLIFE C Plus is
14. ver iert eene EE Ent A 16 MAGLIFE C Plus OPERATION 4 1 dE CT te IM 17 4 2 Placing probes and sensors oreas asiri iiaiai ate iiA EEEE ENAERE N 19 4 2 1 General rules heiren e a aa ee ege gg Aa AT ANa te Per AEDE AA 20 4 2 2 Probes and sensors used and positioning instructions 20 4 3 SUAMUIMG Kl le EE 27 4 4 Battery Charging WEE 27 4 5 Using the MN nie han Res ce te tt ee tirent runs 28 4 6 Description of MENUS Eden d troit unter 29 Item code W1404827 Page 8 MAGLIFE C Plus MAGSCREEN 4 7 4 8 4 9 4 10 4 12 4 13 4 14 4 6 1 Main MAU tytn ea Acta ti ete eth 29 4 6 2 BEER Dn EE E 29 4 6 3 NIBP ie En in teins evict deine ie Severe 31 4 6 4 UB Ped SUBS En E 33 4 6 5 lee En LE 34 4 6 6 SPO2 SUD ENEE 35 4 6 7 CO2 N20 SUB MENU iii 36 4 6 8 Anes Agent sub menu us 37 4 6 9 Ile DEn EE 38 4 6 10 Temperature SUB MENU issue 39 4 6 11 CO2 N20 calibration procedure ss 40 4 6 12 Anesthetic Agant calibration procedure 41 4 6 13 FiO2 calibration procedure cc ccccecceceeeeeseeeeeeeeceeeesaeeeeeeeeeeeeeseaeeeeaeeeeaes 42 4 6 14 Alarm RR ul Cu UE 43 4 6 15 Alarm Suspend menu iii 45 4 6 16 Tronds Mende Avi eles ied ee A en ne An Man 46 4 6 17 Configuration menu sis 50 4 6 18 Magtile ment 2 wech Red Aen ivi AN 53 Configuration of options sis 54 NIBP Module tester fo
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