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Sentec LuMon Service Manual Download Page 32

Part I of II 

 

32 of 33 

Service Manual for the LuMon™ System 

 

Protocol for Safety  & Functionality Test  –  LuMon™ 

Sytstem 

 

 

The LuMon™ System has been designed to comply with the IEC 60601-1 standard. For safety reasons it is recommended that the 

LuMon™ System undergoes a technical safety check once a year (but every two years the latest) and after repair. Please fill in this 

form (one form per monitor). 

Record the serial number and the hard-  and software specific information of the tested items. You will find this information in 

ScoutView ‘system settings’ area. 

The LMS safety and functionality test consists of several tests of the following equipment: 

•

 

LuMon™ Monitor 

•

 

SensorBeltConnector / LuMon™ Connector 

T

EST SUMMARY

: 

Product identification 

 

 

 

 

☐

 LuMon™ Monitor - Adult 

SN: 

           

  

 

☐

 LuMon™ Monitor - Neo 

 

SW version: 

           

TIC version:   

           

 

 

 

 

 

☐

  SensorBeltConnector 

SN: 

           

  

 

☐

  LuMon™ Connector 

Version 

           

 

 

 

Test tools 

☐

 EIT Advanced Interface 

SN: 

           

  

 

☐

 Safety analyzer 

 

 

 

 

☐

 Other:  

           

 

 

 

 

LuMon™ Monitor 

 

 

 Not passed 

☐

 

Passed* 

☐

 

SensorBeltConnector/LuMon™ Connector 

 Not passed 

☐

 

Passed* 

☐

 

*all test items passed 

 

Safety & Functionality test: 

 

 Not passed 

☐

 

Passed 

☐

 

Date of the next safety related test: 

 

 

           

Organization: 

           

Location: 

           

Qualified technician (name): 

           

Place, date: 

           

Signature: 

 

           

 

 

 

 

 

 

 

Summary of Contents for LuMon

Page 1: ...Service Manual for the LuMon System 2ST200 199 Rev002 04 2021 Service Manual For the LuMon System GUI software 1 0 x x TIC software 1 6 x xxx LuMon Belts sizes 47 and smaller SensorBelts ...

Page 2: ...on sheets for the LuMon System www sentec com education eit plpm eit Trademarks SenTec Advancing Noninvasive Patient Monitoring LuMon and sentec eit are trademarks of SenTec AG Terms of use of software components SenTec devices that use software may use SenTec third party and or open source software depending on their setup SenTec third party and or open source software may be subject to different...

Page 3: ...ITOR 13 4 TROUBLESHOOTING 18 4 1 HOW TO USE THE TROUBLESHOOTING LIST 18 4 2 TROUBLESHOOTING LIST 19 5 REPAIRS OF THE LUMON MONITOR 24 5 1 PRIOR TO REPAIR 24 5 2 REPLACEMENT SUPPORT FOOT 24 5 3 REPLACEMENT MAIN FUSES 25 6 SOFTWARE UPDATES UPGRADES 26 7 DISPOSAL 27 7 1 LUMON MONITOR 27 7 2 BELT CONNECTORS 27 7 3 BELTS 27 7 4 CONTACT MEDIUM 27 8 APPENDIX I 28 8 1 SPARE PARTS AND MAINTENANCE TOOLS 28 ...

Page 4: ...nformation on the LuMon System for health care practitioners It is available in several languages and can be downloaded from SenTec s webpage www sentec com education eit plpm eit 2 The Service Manual for the LuMon System 1 1 is available in English and can be downloaded from SenTec s webpage www sentec com education eit plpm eit 3 The Repair Manual for the LuMon Monitor describes repair procedure...

Page 5: ...used in this Service Manual refer to the User s Guide for the LuMon System 1 SenTec EIT related terms are described in the User s Guide 1 Notice that those terms being italicized and or capitalized in section terminology of the User s Guide 1 are italicized and or Capitalized throughout the entire Service Manual 1 4 Safety information A comprehensive list of warnings and cautions is provided in th...

Page 6: ... of the belt best fitting the respective patient The LuMon System is available in two configurations for adults and children illustrated in Table 2 1 with a family of belts supporting an underbust girth range of approximately 76 to 128 cm abbreviated as LMS A for neonates and infants illustrated in Table 2 2 with a family of belts supporting an underbust girth range of approximately 17 to 52 cm ab...

Page 7: ...GUI B Support foot indicating the LuMon Monitor s configuration LuMon ADULT identifies the LuMon Monitor Adult LuMon NEO identifies the LuMon Monitor Neo NOTE The LuMon Monitor performs a calibration of its touch screen after it is switched on To not disturb the calibration of the touch screen do not touch the screen the first few seconds after startup Figure 2 2 LuMon Monitor rear panel ...

Page 8: ...lt The position sensor embedded in its MatchBox permits the LuMon System to measure and display the patient s position rotation and inclination If the SensorBeltConnector is properly connected to a LuMon Monitor in on state the status indicator LED of its MatchBox continuously lights green if a SensorBelt is connected Figure 2 3 SensorBeltConnector A MatchBox includes a position sensor and a statu...

Page 9: ...BR Breath Rate D BA control BA Breath Amplitude E Voltage in Connection for external AC DC Power Supply F EIT 1 Fault G EIT 7 Fault H Too many failing electrodes SensorBeltConnector only I Modes Switch J Manual breathing control RL Right lung LL Left lung K Matchbox for SensorBeltConnector Use with LuMon Connector only L LuMon EIT Advanced Interface Adapter M Ribbon Cable Medium 10 cm AC Adapter 1...

Page 10: ...ent your test results To perform a complete safety and functionality test all tests described in this chapter MUST be performed NOTE If safety or functionality test fail the respective problem must be fixed before the equipment is returned to the user NOTE Prior to maintenance service or repair all components of the LuMon System must be cleaned and disinfected More details can be found in section ...

Page 11: ...Européene label and notified body number G UDI data matrix code H UDI human readable I Follow instruction for use J K Dispose of according to Council Directive 2012 19 EU symbol The EU Authorized Representative EC REP label can be found on the cable close to the Redel connector Figure 2 2 Figure 2 2 A B C A Symbol for manufacturing date and manufacturing date B Symbol for EC Representative and the...

Page 12: ... indicating that the belt detection works properly Verify that the serial lot no B Figure 3 1 on patient belt area on ScoutView 1 is displayed e g ETAV50200311 000129 numbers may vary 3 Rotate the EIT Advanced Interface left or right and verify on ScoutView that the displayed rotation changes accordingly Figure 3 1 Function Test Belt connector 3 1 7 Function Test LuMon Connector 1 Connect the LuMo...

Page 13: ... connectors and ON OFF switch and the marking plate Example labels are shown below Figure 3 2 Labeling LuMon Monitor A SenTec logo B Product name C Manufacturer symbol and address D EU Authorized Representative E Reference symbol and number F UDI data matrix code and human readable G Serial number symbol and number H Cut out window for battery status LED I Battery symbol J Follow instructions for ...

Page 14: ...an your local SenTec representative or SenTec AG please refer to section instructions for repackaging and shipping of the User s Guide for the LuMon System 1 A complete Certificate of Disinfection 6 and if applicable the Repair or Investigation Request Form 7 must be provided NOTE Prior to maintenance service or repair all components of the LuMon System must be cleaned and disinfected More details...

Page 15: ... needs to be repaired Refer to section 4 2 4 to further evaluate the problem Check the AC power cord for damages of the isolation Check the belt connectors for damages The AC power cord must be tested when connected to the AC power outlet Thereby the cable must be swayed to detect potential cable breaks or loose contacts The AC power cord must be tested together with the Ground Integrity NOTE If t...

Page 16: ...y full 2 Enter VentView and check the readability of the following critical areas AC Power Battery icon on status bar Plethysmogram and Global Dynamic Image RRi numerical display NOTE If the above described functions do not operate properly the LuMon Monitor needs to be repaired Refer to section 4 2 4 to further evaluate the problem 3 2 8 Fan The fan should briefly activate during Power on Self te...

Page 17: ...ry was full and Time2 corresponds to the time when the battery was empty leading to the shutdown The run time of the battery can be computed as the difference between Time2 Time1 The quality of the rechargeable Lithium Ion battery is still acceptable if the LuMon Monitor runs for at least 1 hour before the battery management switches off the monitor automatically or the last entry of the QCount va...

Page 18: ...quest Form 7 to a SenTec Authorized LuMon Technician your local SenTec EIT representative or SenTec AG 4 1 How to use the troubleshooting list The troubleshooting list describes problems possible causes and recommended actions for troubleshooting of the system The problems are numbered EITXXXX unambiguously Please reference the respective EITXXXX code whenever applicable This section describes pro...

Page 19: ...e DockingStation Position sensor placed behind the bear in the LMB not placed close to the midline of the patient Verify belt positioning and a snug fit of the belt on the skin 1 section checking the proper setup Consider to adjust the LuMon Belt positioning the bear on the sternum In such case the belt displacement needs to be measured and entered to patient data on monitor again EIT0102 Status i...

Page 20: ...eshooting Table 4 2 Belt specific troubleshooting Problem Possible cause s Recommended action s EIT0200 Despite a belt is connected to SBC LMC and LMM the status message connect belt is displayed Bad contact SBC LMC not properly connected Verify connections disconnect and reconnect belt connector and if necessary power cycle the monitor SB LMB defective To identify the defective part exchange the ...

Page 21: ...ding to 5 LMM defective Contact SenTec Authorized LuMon Technicians AC DC Power Supply not connected Connect AC DC Power Supply according to the Repair Manual 3 To be performed by SenTec Authorized LuMon technicians only AC DC Power Supply defective Replace AC DC Power Supply according to the Repair Manual 3 To be performed by SenTec Authorized LuMon technicians only EIT0401 Display is dark AC Pow...

Page 22: ...nTec Authorized LuMon Technicians LMM defective Contact SenTec Authorized LuMon Technicians Internal battery on LM MIO low Replace internal battery on LM MIO according to the Repair Manual 3 To be performed by SenTec Authorized LuMon technicians only LM MIO PC Board defective Replace LM MIO according to the Repair Manual 3 To be performed by SenTec Authorized LuMon technicians only EIT0408 Fan is ...

Page 23: ...ir Manual 3 To be performed by SenTec Authorized LuMon technicians only TIC Module defective Replace TIC Module according to the Repair Manual 3 To be performed by SenTec Authorized LuMon technicians only EIT0413 Message Tech Error 0001 Invalid measurements due to excessive patient movement or insufficient skin contact If the message is displayed intermittently than verify belt positioning and a s...

Page 24: ...re versions of all components of the LuMon System This means if you replace parts of the LuMon System or if you perform a software update you must report the serial number of the respective LuMon Monitor and the serial and LOT numbers of the replaced parts to your local distributor using the Technical Service Report Form 8 For spare parts and test tools refer to section 8 1 Tools T10 Torx screwdri...

Page 25: ...e procedure described in section 5 1 Before replacing the fuses of the LuMon Monitor switch the LuMon Monitor off and disconnect the LuMon Monitor from AC mains power To replace the fuses open the fuse holder Figure 5 2 with a screwdriver and replace the fuses with specified fuses only 8 1 Figure 5 2 Main fuses ...

Page 26: ... Module EIT image calculation and signal analysis algorithm 2 GUI software Embedded PC user interface memory and interface management The TIC and GUI software can be updated over the USB port using an installer software Detailed instructions are included in separate documents 10 NOTE Software updates must be reported to SenTec AG by using the Technical Service Report Form 8 to ensure traceability ...

Page 27: ...erials that could be harmful to the environment if disposed of incorrectly Use of such materials is essential to performing the functions of the product and to meeting statutory and other requirements 7 1 LuMon Monitor Return the LuMon Monitor to your local SenTec representative or dispose it according to local regulations NOTE If equipment is send to a SenTec Authorized LuMon Technician local Sen...

Page 28: ... LuMon Monitor are not separated from each other If at a time accessory equipment is connected to only one of the interface connectors no additional safety measures are necessary to comply with the requirements of IEC 60601 1 If however accessory equipment is simultaneously connected to two or more of the LuMon Monitor s interface connectors additional safety measures may be required to be complia...

Page 29: ...gnal ground 6 UI CH3 Digital 0V 3 3V I O reserved 7 12V 12V max 0 4A for sensor supply only controlled by LuMon Monitor 8 UI CH2 Digital 0V 3 3V I O reserved 9 SYNC IN Digital 0V 5V eit frame synchronization input with built in pull up resistor NOTE The current software does not support any functionality over this interface This interface is reserved for factory use only 8 2 4 Serial port 2 RS 232...

Page 30: ...or connection of the monitor to a network hub or switch You may also use a cross over Ethernet cable for direct connection of the monitor to a computer without a hub or switch NOTE The current software does not support any functionality over this interface This interface is reserved for factory use only 8 3 Technical specification See the corresponding section of the User s Guide for the LuMon Sys...

Page 31: ...Appendix II Protocol for Safety Functionality Test Service Manual for the LuMon System 31 of 33 9 APPENDIX II PROTOCOL FOR SAFETY FUNCTIONALITY TEST See next page ...

Page 32: ...tems You will find this information in ScoutView system settings area The LMS safety and functionality test consists of several tests of the following equipment LuMon Monitor SensorBeltConnector LuMon Connector TEST SUMMARY Product identification LuMon Monitor Adult SN LuMon Monitor Neo SW version TIC version SensorBeltConnector SN LuMon Connector Version Test tools EIT Advanced Interface SN Safet...

Page 33: ...e or a check mark BELT CONNECTOR Test Results Passed Visual inspection Labeling Indicator LED Function test Other observations LUMON MONITOR Test Results Passed Visual inspection Labeling Safety test according to IEC 62353 According to Service Manual for the LuMon System Touchscreen Clock settings Display and AC Power Battery indicator Fan Capacity of rechargeable Lithium Ion battery Runtime until...

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