Sentec-Digital-Monitor-Service-Manual
Contents
1. P0305 SDM defective If the problem does not persist refer to section 4 2 6 Docking Station page 31 to further evaluate the problem P0306 V Sign Sensor Shield V Sign Sensor from heat lotto temperature is enhanced If the problem persists contact qualified service personnel TONA iS because of warming lamps displayed or electric blankets If the problem persists test the same sensor connected to another SDM in a room within the specified operating temperatures 10 40 C V Sign Sensor defective If the problem persists send the V Sign Sensor back to your local SenTec representative according to section 5 10 Instructions for Shipment page 41 SDM defective If the problem does not persist refer to section 4 2 5 SDM page 28 to further evaluate the problem P0307 Membrane change tool is Open the Membrane Change Tool as described in section Sensor is blocked 5 8 Breaking up the V Sign Disposable Set page 1 blocked in the Membrane change tool If the problem persists contact qualified service personnel Table 7 Sensor specific troubleshooting SenTec Digital Monitoring System 2 4 Troubleshooting 4 2 4 Sensor Application specific troubleshooting P0400 This problem has no reference to this manual V Sign Sensor cannot be applied correctly at the inside of the earlobe P0401 This problem has no reference to this manual Adhesive tape of Ear2. known calibrated reference barometer by more than 5 mmHg 0 7 kPa Otherwise contact qualified service personnel PCO sensitivity of the Test the PCO2 sensitivity as follows sensor too low Activate the display of the PCO calibration curve Following a calibration expose the sensor for approximately three minutes to ambient air Reinsert the sensor into the Docking Station The first displayed PCO value should be at least 30 mmHg 4 0 kPa lower than after calibration If this difference is not reached remembrane the sensor and repeat the test After a renewed missing of this difference consult qualified service personnel Clean the sensor as described in section 5 2 Cleaning the sensor without membrane page 35 and perform the sensitivity test as described in section 3 1 6 PCO2 Sensitivity Test page 10 If problem persists contact SenTec authorized service personnel Table 4 Example of a Troubleshooting Procedure SenTec Digital Monitoring System 23 4 Troubleshooting 4 2 Troubleshooting List This section describes problems possible causes and recommended actions for troubleshooting at service level 4 2 1 Troubleshooting PCO Monitoring P0100 Sensor too slow Refer to P0304 PCO2 values increase very slowly not stable 20 minutes after sensor application P0101 Wrong instable barometric Verify that the barometric pressure reading of the SDM is PCO too low pressure during calibration s
3. printed circuit boards a display cables and lithium batteries Do not incinerate equipment or gas bottles 6 1 SenTec Digital Monitor Return the SDM to your local SenTec representative or dispose it according to local regulations WEEE Disposal European consumers are obliged by law to dispose Waste Electrical and Electronic Equipment WEEE according to the WEEE Directive 1 All electrical and electronic waste must be stored collected treated recycled and disposed of separately from other waste 2 Consumers are obliged by law to return electrical and electronic devices at the end of their service lives to the public collection points set up for this purpose or point of sale Details to this are defined by the national law of the respective country Note By recycling materials or other forms of utilizing old devices you are making an important contribution to protecting our environment 6 2 Cables Dispose the cables according to local regulations The copper contained can be recycled 6 3 V Sign Sensor Return the V Sign Sensor to your local distributor 6 4 Service Gas Bottle Dispose the gas bottles according to local regulations Make sure that only empty gas bottles are disposed WARNING Pressurized container Protect from sunlight and do not expose to temperatures exceeding 50 C 122 F Do not pierce or burn even after use Do not spray on a naked flame or any incandescent material 6 5 C
4. shipment costs and costs for repair and service work will be billed to the sender The following instructions apply to all shipments of SDMS or any part of it e g for service or repair to qualified SenTec authorized service personnel or your local SenTec representative 1 Please return only the SDM and or V Sign Sensor with Extension Cable but without power cord and without any disposables such as the V Sign Disposable Set the Sensor Gel the Ear Clip or the Service Gas Important do not ship Service Gas bottles together with the SDM Gas bottles have to be declared as dangerous goods a special IATA form is required and special packing instructions apply 2 Devices must be properly disinfected For disinfection instructions please refer to the directions for use of the V Sign Sensor and the sub section Cleaning and Disinfection in the SDM s Technical Manual The Certificate of Disinfection and if applicable the Repair Form are to be completed by the responsible person and have to be shipped together with the SDMS 3 If you send back electronic parts make sure to follow applicable ESD precautions 4 Items must be shipped in the original packaging or in other packing providing the same degree of protection Use sanitized packing material only 5 Pack the components as shown in Figure 14 BE VER E e T Rn eee _ e i ty iF Figure 14 Packing in the Original Box 6 The completel
5. Apply the sensor to the earlobe of a healthy person Compare SpO gt and PR readings against the readings of a reference pulse oximeter e g N595 with Durasensor 100 from Nellcor The SpO 2 and PR reading should be within 3 SpO2 and 3 bpm respectively If these requirements are not fulfilled refer to section 4 2 3 Sensor specific troubleshooting page 26 to further evaluate the problem 3 1 5 Function Test PCO Calibrate the sensor and apply it to the ear of a healthy person Verify that the PCO2 readings equilibrate stabilize within 3 to 10 minutes and are within 33 to 47 mmHg after stabilization If this requirement is not fulfilled refer to section 4 2 1 Troubleshooting PCO2 Monitoring page 24 to further evaluate the problem For testing the PCO functionality sensor test equipment is available for SenTec authorized service personnel 3 1 6 PCO Sensitivity Test Test the PCO sensitivity as follows 1 Following a calibration expose the sensor for approximately 3 minutes to ambient air 2 Reinsert the sensor into the Docking Station The first displayed PCO2 value should be at least 30 mmHg 4 0 kPa lower than after calibration 3 If this difference is not reached exchange the membrane of the sensor and repeat the test 4 If there is no improvement clean the sensor following the instructions provided in section 5 2 Cleaning the sensor without membrane page 35 and repeat the test After a renewed
6. SDM If problem persists send the V Sign Sensor back to your V Sign Sensor defective local SenTec representative according to section 5 10 Instructions for Shipment page 41 SDM defective If problem does not persist refer to section 4 2 5 SDM page 28 to further evaluate the problem This problem has no reference to this manual P0302 White spots on the membrane P0303 After each calibration the SDM requests to exchange the membrane No membrane Change the sensor membrane and confirm as requested by Defective membrane the SDM After having changed the membrane calibrate holes or scratches the sensor Old membrane If the problem persists contact qualified service personnel Clean the sensor as described in section 5 2 Cleaning the sensor without membrane page 35 Then calibrate the sensor If the problem persists test the same sensor connected to another SDM V Sign Sensor defective If the problem persists send the V Sign Sensor back to your local SenTec representative according to section 5 10 Instructions for Shipment page 41 SDM defective If the problem does not persist refer to section 4 2 5 SDM page 28 to further evaluate the problem Docking Station door is Close Docking Station door properly not closed properly If the problem persists contact qualified service personnel 26 4 Troubleshooting Docking Station door Replace Docking Station door a
7. Spare Parts 42 6 DISPOSAL 44 6 1 SenTec Digital Monitor 44 6 2 Cables 44 6 3 V Sign Sensor 44 6 4 Service Gas Bottle 44 6 5 Consumables 44 7 APPENDIX 45 7 1 Pin Assignment 45 7 2 Technical Specifications 48 7 3 Contact 48 7 4 Protocol for Safety Related Test 49 7 5 Order Form for Service Technician 52 7 6 Repair Form 53 7 7 Repair Reporting Form 54 7 8 Certificate of Disinfection 55 SenTec Digital Monitoring System Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Figure 8 Figure 9 Figure 10 Figure 11 Figure 12 Figure 13 Figure 14 Figure 15 Figure 16 Figure 17 Front Panel of the SDM Rear Panel of the SDM Connections for the Safety Test Connections for the High Potential Test AP Connections for the High Potential Test PC Removal of the Membrane from the Sensor Replacement Tip up Foot Replacement Silicon Foot Replacement Main Fuses Docking Station Door Insertion Replacement Docking Station Gasket Positioning of the Docking Station Gasket Breaking up the V Sign Disposable Set Packing in the Original Box Sensor Connection Port Serial Data Port RS 232 Multipurpose I O Port Tables Table 1 Related Documents Table 2 Connections for the High Potential Test AP Table 3 Connections for the High Potential Test PC Table 4 Example of a Troubleshooting Procedure Table 5 Troubleshooting PCO Monitoring Table 6 Troubleshooting SpO and PR Monitoring Table 7 Sensor speci
8. any environment which has increased oxygen content WARNING The SDM must be connected to a grounded 3 wire AC power outlet Ensure that power and protective ground lines are connected correctly WARNING For US respectively Japan Grounding reliability can only be achieved when the SDM is connected to an equivalent receptacle marked HG Hospital Grade respectively HGJ Hospital Grade Japan WARNING To ensure protection of patient operator and equipment from the effects of defibrillation and diathermy electro surgery cables manufactured by SenTec AG must be used WARNING Equipment is protected against electrostatic discharge The display may be temporarily affected during discharge to chassis ground but will rapidly recover WARNING This device has been tested and found to comply with the requirements for medical devices according to the TEC 60601 1 2 second edition and the Medical Device Directive 93 42 FEC These requirements are designed to provide reasonable protection against harmful interference in a typical medical installation WARNING Certain types of mobile telecommunication equipment could potentially interfere with SDM operation Mobile telecommunication equipment should not be used within five meters 16 4 feet of the SDM WARNING Keep the SDM as well as any discarded parts out of reach of children under the age of 5 years Some parts of the SDM are small enough to be swallowed and may block the t
9. switch the SDM ON 2 Insert the sensor in the Docking Station and verify that the 100 gas icon displays in the status bar 3 Remove the gas bottle from the SDM and verify that the yellow 0 gas icon displays in the status bar If the expected result is not observed refer to section 4 2 5 SDM page 28 to further evaluate the problem 3 4 Digital Monitor Extension Cable 3 4 1 Visual Inspection Check the Digital Monitor Extension Cable for breaks or damages of the isolation Check the Digital Monitor Extension Cable connectors for damages If you detect a damage the Digital Monitor Extension Cable needs to be replaced by a new Digital Monitor Extension Cable see section 5 11 1 Accessories and Spare Parts List page 42 SenTec Digital Monitoring System 21 4 Troubleshooting 4 Troubleshooting This section describes problems possible causes and recommended corrective actions Together with the troubleshooting list located in the Technical Manual for the SDM it helps to pinpoint errors from the symptoms they cause Repairs are described in section 5 Repairs page 33 4 1 How to use the troubleshooting list The troubleshooting list in the Technical Manual for the SDM describes problems that are primarily caused by handling errors The troubleshooting list in this Manual complements the troubleshooting list of the Technical Manual for the SDM It describes possible defects of the device The problems are numbered unam
10. the SDM dark SDM defective Switch the SDM off and on again If the problem persists contact qualified service personnel P0505 POST screen does not disappear POST i e Power On Self Write down the Error code switch the SDM off and on Test failed failed is again displayed If the problem persists contact qualified service personnel SDM defective Contact SenTec authorized service personnel P0506 SDM is blocked Switch the monitor off and on again SDM does not If problem persists contact qualified service personnel dese abs SDM defective Contact SenTec authorized service personnel button is pressed P0507 Low internal battery Contact qualified service personnel Clock shows SDM defective Contact SenTec authorized service personnel wrong time and date after each restart P0508 Verify the SDM s barometric pressure with a known Barometric calibrated reference barometer The difference should be pressure is to within 5 mmHg 0 7 kPa low high If the problem persists contact qualified service personnel Verify the SDM s barometric pressure with a known calibrated reference barometer The difference should be within 5 mmHg 0 7 kPa SDM defective Contact SenTec authorized service personnel P0509 Fan defective or polluted Contact qualified service personnel Fan is noisy SDM defective Contact SenTec authorized service personnel P0510 Fan is blocked Barometer chip defective Fan d
11. to document your test results The system MUST pass all tests mentioned in this protocol Note If any of the tests specified below fails the respective problem must be fixed before the equipment is returned to the user 3 Maintenance Safety amp Functionality Tests 3 1 V Sign Sensor 3 1 1 Visual Inspection Visually inspect the membrane of the sensor If you suspect a damage of the membrane exchange the membrane of the sensor Visually inspect the sensor body for damages Check the sensor cable for breaks or damages of the isolation Check the sensor cable plug and its connectors for damages If any of the components of the sensor is irreversibly damaged replace the sensor with a new V Sign Sensor 3 1 2 Labeling Check presence legibility of the serial number label on the plug of the sensor cable If the serial number can not be found or read read the serial number of the V Sign Sensor out of the SDM sub menu System Information and write it on the plug of the sensor cable 3 1 3 Sensor LEDs Switch on the sensor and verify that the sensor emits red light Then insert the sensor into the Docking Station and verify that the calibration display activates If these requirements are not fulfilled refer to section 4 2 3 Sensor specific troubleshooting page 26 to further evaluate the problem SenTec Digital Monitoring System 9 3 Maintenance Safety amp Functionality Tests 3 1 4 Function Test SpO PR
12. 1 2 2 Safety Information regarding Repair and Service Operations WARNING Maintenance and repair requiring removal of the case or covers must be performed by SenTec authorized service personnel WARNING Before attempting to open or disassemble the SDM disconnect the device from the AC power outlet WARNING Before replacing fuses of the SDM disconnect the device from the AC power outlet WARNING Use only accessories and spare parts supplied or recommended by SenTec AG Use of other parts may result in injury inaccurate measurements and or damage to the device WARNING Electronic components may content toxic chemicals Do not ingest chemicals from a broken electronic component CAUTION Follow ESD Electrostatic discharge precautions when working with the SDM especially when disassembling and reassembling the SDM and when handling any of its components CAUTION When reassembling the SDM tighten the screws to a torque of 5 Nm Over tightening could strip out the screw holes rendering the part unusable 2 The SenTec Digital Monitoring System SDMS 2 The SenTec Digital Monitoring System SDMS 2 1 Components The SDMS consists of the following components accessories and disposables SenTec Digital Monitor REF SDM V Sign Sensor REF VS A P V Sign Disposable Set REF VS DSET Ear Clip REF EC A P Multi Site Attachment Rings for Adults Pediatrics Neonates REF MAR A P N Multi Site Attachment Ri
13. 15 No communi cation over RS 232 P0516 No alarm on speaker nurse call P0518 Gas Level Indicator shows wrong indication SDM defective Contact qualified service personnel SDM defective Contact SenTec authorized service personnel j Q D o SDM specific troubleshooting 30 4 Troubleshooting 4 2 6 Docking Station specific troubleshooting P0600 Mechanical defect of the Contact qualified service personnel Docking Station Docking Station door door does not close properly Gasket not placed Place gasket correctly in the chamber in the Docking correctly Station according to section 5 7 Replacement Docking Station Gasket page 38 Docking Station door Replace Docking Station door according to section mechanically defective 5 6 Replacement Docking Station Door page 37 P0601 Docking Station Fault is displayed Clean Docking Station and V Sign Sensor as described in the corresponding section of the Technical Manual for the SDM If the problem persists contact qualified service personnel SDM defective Contact SenTec authorized service personnel Docking Station defective Contact SenTec authorized service personnel Docking station and or Clean Docking Station and V Sign Sensor as described sensor contaminated with in the corresponding section of the Technical Manual for gel residues causing a the SDM If the problem persists contact qualified service per
14. Clip or Multi Site Attachment Ring does not attach properly Table 8 Sensor Application specific troubleshooting 4 2 5 SDM specific troubleshooting P0500 SDM defective Switch the SDM off and on again SDM not If problem persists contact qualified service personnel operational Main fuses defective Replace main fuses according to section SDM LEDs not 5 5 Repl t Hf n 37 omine eplacement main fuses page 37 SDM defective Contact SenTec authorized service personnel P0501 SDM switched off Switch on SDM Display is If problem persists contact qualified service personnel dark AC Power Battery SDM defective Contact SenTec authorized service personnel indicator green yellow LED illuminated ON OFF indicator green LED dark P0502 Battery defective Contact qualified service personnel 100 charged SDM defective Contact SenTec authorized service personnel Battery is discharged after less than 3h 28 4 Troubleshooting SDM in Sleep mode Press any button If the problem persists switch the SDM off and on again P0503 Display is dark ON OFF If the problem persists contact qualified service indicator is personnel illuminated SDM defective Contact SenTec authorized service personnel P0504 Brightness not adjusted Switch the monitor off and on again Readjust the Display is not correctly brightness as described in the corresponding section of readable the Technical Manual for
15. Functionality Tests 3 Maintenance Safety amp Functionality Tests To guarantee continuous performance safety and reliability of the equipment maintenance procedures and checks have to be performed regularly The maintenance of the SDMS is subdivided into Cleaning and Disinfection Routine Checks and Safety amp Functionality Tests Note Prior to maintenance service or repairs all components of the SDMS must be cleaned and disinfected If equipment is send to service personnel a local SenTec representative or to SenTec AG a completed Certificate of Disinfection see page 55 must be attached Cleaning and disinfection procedures are described in the Technical Manual for the SDM and in the Directions for use of the V Sign Sensor Routine Checks that can be performed by the user are described in the Instruction Manual for the SDMS and in the Technical Manual for the SDM The Safety and functionality tests specified in the present paragraph must be performed annually by qualified service personnel If any of the tests specified below fails the respective problem must be fixed before the equipment is returned to the user Note To perform a complete Safety amp functionality test all tests described in this chapter MUST be performed Note Use the Protocol Safety Related Test see 7 4 Protocol for Safety Related Test page 49 to guide you through the complete Safety amp Functionality test and
16. Power Connector by compressing the two tabs on both sides of the lid and pulling out the fuse holder according to Figure 9 11 Replace the defective fuses with time delay high breaking capacity fuses T 630mMA H 250V see section 5 11 1 Accessories and Spare Parts List page 42 12 Reinsert the holder into the AC Power Connector Fuse drawer Figure 9 Replacement Main Fuses 5 6 Replacement Docking Station Door 1 Follow the procedure described in section 5 1 Prior to Repair page 35 13 0pen the Docking Station Door to an angle of approximately 120 see Figure 10 14 Lift the mounting link for the hinge and remove the Docking Station Door by pulling it out and pressing it down at the same time 15 Insert the new Docking Station Door parallel to the case with an aperture angle of the door of 45 see section 5 11 1 Accessories and Spare Parts List page 42 The door must not be closed further as this could damage the pressure spring First press on the bottom then on the top of the door to insert the hinge into the mounting link 16 Switch on the monitor and check if POST is passed without an error After maximum one minute the measuring display will appear 17 Put the sensor into the Docking Station a calibration will start after maximum two minutes Ten minutes after calibration no message Docking Station Fault or Clean Docking Station should appear If the sensor membrane needs to be changed
17. Service Manual sentec CER PR 2006 12 24 for the SenTec Digital Monitoring System Software Version SMB V06 20 MPB V04 04 Warranty The manufacturer warrants to the initial purchaser that each new component of the SenTec Digital Monitoring System see list of components will be free from defects in workmanship and materials The manufacturer s sole obligation under this warranty is to replace any component for which the manufacturer acknowledges the warranty cover with a replacement component Warranty Exclusions SenTec AG can neither guarantee or verify instrument performance characteristics nor accept warranty claims or product liability claims if the recommended procedures are not carried out if the product has been subject to misuse neglect or accident if the product has been damaged by extraneous causes if accessories other than those recommended by SenTec AG are used or if instrument repairs are not carried out by SenTec authorized service personnel CAUTION Federal law U S restricts this device to sale by or on the order of a physician Patents Trademarks Copyright International Industrial Design No DM 054179 Japanese Design No 1137696 U S Patent No D483488 U S Patent No 6760610 European Patent No 1335666 SenTec V Sign and V STATS are trademarks of SenTec AG 2007 SenTec AG All rights reserved The contents of this document may not be reproduced in any form or communicated to
18. additional 2 3 hours If the problem persists contact qualified service personnel 24 4 Troubleshooting V Sign Sensor defective If the problem persists end the V Sign Sensor back to your local SenTec representative according to section 5 10 Instructions for Shipment page 41 P0102 Docking Station gas leak Insert the sensor into the Docking Station and observe the PCO2 too high system during 20 minutes When the sensor is in the Docking Station the SDM evaluates the integrity of the Docking Station system If a failure occurs a low priority alarm sounds and the message Clean DS is displayed In this case carefully inspect the door and gasket Clean the Docking Station gasket and sensor with a cotton swab Remove any residual threads and fibers then reinsert the sensor to calibrate it Observe the system during 20 minutes to detect any reoccurrence If the problem persists contact qualified service personnel Docking Station door Replace Docking Station door according to section mechanically defective 5 6 Replacement Docking Station Door page 37 Gasket defective Replace gasket according to section 5 7 Replacement Docking Station Gasket page 38 SDM defective Contact SenTec authorized service personnel Wrong instable barometric Refer to P0101 pressure during calibration PCO sensitivity of the eim to P0101 sensor too low Significant PCO drift O to P0101 P0103 This problem has no referen
19. ae cesseccceceesseeeeeceeessseeceeeseeeaseeessseeagsseeeeeseeens Sensor hardware Version arara aaa aaa aaa aaa arara Sensor software version arara arara Organization ete te eeeeeecaeeuceeeaeeueeeeecaeeeeeesauauseeeaeaeseeeeeaeaees Location _ _ incu nuuausuuausuuaucuuauacuneausueausuesusunausneatsnsungnsneas Service technician name _ ____aaavesensvecsecusuuccecusueveeseeuseeeneeuseenseusuerseneeuars Place dale ii me ee a JOME o e 54 7 Appendix 7 8 Certificate of Disinfection All items must be disinfected before shipment This certificate serves as proof of disinfection Any items arriving at qualified SenTec authorized service personnel or your local SenTec representative lacking this certificate or being accompanied by an improperly issued certificate will be disinfected at the sender s expense without prior notice The sender will be held liable for any harm attributed to improper disinfection For disinfection instructions please refer to the directions for use of the V Sign Sensor and the sub section Cleaning and Disinfection in the SDM s technical manual Items in shipment SenTec Digital Monitor Serial no erre label on rear panel V Sign Sensor serial NO hh esceesseccesscesseeeeecscesssseeenceseessersecnscgsussersessiens label on connector Complete this table to identify the items that have been disinfected tem mabipment Disinfected _ semeogtamentor 1 DO SOM Dock
20. any third party without the prior written consent of SenTec AG While every effort is made to ensure the correctness of the information provided in this document SenTec AG assumes no responsibility for errors or omissions This document is subject to change without notice Patient Monitor WITH RESPECT TO ELECTRICAL SHOCK FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601 1 CAN CSA C22 2 No 601 1 IEC 60601 1 4 IEC 60601 2 23 20LW 0120 SenTec AG Ringstrasse 39 CH 4106 Therwil Switzerland www sentec ch HB 005615 d Contents Contents Contents Figures ji Tables ii Abbreviations ii 1 INTRODUCTION 1 1 Related Documents 1 2 Safety Information 1 1 1 2 THE SENTEC DIGITAL MONITORING SYSTEM SDMS gt 5 6 8 2 1 Components 2 2 The SenTec Digital Monitor SDM 3 MAINTENANCE SAFETY amp FUNCTIONALITY TESTS 3 1 V Sign Sensor 9 3 2 SenTec Digital Monitor 11 3 3 Docking Station 21 3 4 Digital Monitor Extension Cable 21 4 TROUBLESHOOTING 22 4 1 How to use the troubleshooting list 22 4 2 Troubleshooting List 24 5 REPAIRS 33 5 1 Prior to Repair 35 5 2 Cleaning the sensor without membrane 35 5 3 Replacement Tip up Foot 36 5 4 Replacement Silicon Foot 36 5 5 Replacement main fuses 37 5 6 Replacement Docking Station Door 37 5 7 Replacement Docking Station Gasket 38 5 8 Breaking up the V Sign Disposable Set 40 5 9 Firmware Updates 40 5 10 Instructions for Shipment 41 5 11 Accessories and
21. apacity of a new fully charged battery is about 6 hours of monitoring time The quality of the Rechargeable Lithium Battery is still acceptable when the SDM runs for at least 4hours before the battery management switches off the monitor automatically If the specification above is not met the SDM needs to be repaired Refer to section 4 2 5 SDM page 28 to further evaluate this problem SenTec Digital Monitoring System 15 3 Maintenance Safety amp Functionality Tests 3 2 13 Display Alarm Initiate a low priority alarm e g by disconnecting the V Sign Sensor from the SDM Verify that the corresponding status message is displayed in the status bar If the above specification is not met the SDM needs to be repaired Refer to section 4 2 5 SDM page 28 to further evaluate the problem 3 2 14 Speaker Alarm Initiate a low priority alarm e g by disconnecting the V Sign Sensor from the SDM Verify that the audible component of a low priority alarm is audible 1 single pulse of low pitch repeated every 10 seconds If the specification above is not met the SDM needs to be repaired Refer to section 4 2 5 SDM page 28 to further evaluate the problem 3 2 15 Nurse Call Alarm Initiate a low priority alarm e g by disconnecting the V Sign Sensor from the SDM The Nurse Call feature is relay based and can be tested with the SenTec Test Connector Multipurpose I O see section 5 11 1 Accessories and Spare Parts Li
22. are version arara rara aaa V SIGN Sensor serial NO ae seesssccceceeesseeeeeceessseeceeeeeeeaeeesseeeagsseeeeeseeens Sensor hardware Version arara aaa aaa aaa aaa rena Sensor software version aaa aaa aaa aaa aaa aaa SenTec Digital Monitoring System Not passed Date of the next safety related test erre O goi 4 E pp pe POCO ri EE Ri Service technician name a aaaccceceeeeeeeteeeceeeteeeseeeeeteeeueeeteaeseeseeanaeseeeneags TAG So Fo ee ee roe eer eee AONE ebecieece scractetseieero sce cts ett sue q areautacdes This document must be filed until at least the next safety related test is performed Page 1 of 3 SenTec Digital Monitoring System 49 7 Appendix Test tools MEME OT RSNA AC High potential tester ec eeecccccccesseecceeeeeseseeeeeeeeeeeeeeeeeeeeeeeseeeeeeeaens Barely ciaiyZel iii DAS anneRORGen Reference barometer aauacecccssucccssseeeececseeceueceseeeeeeeeseeeegssdsenereeeeeess Fill in the tables bellow to confirm that the tests have been performed successfully see manual for details Vewingecton beng i ET Function test SpoO2 PR Function test PCO PCO Sensitivity Test Sensor Temperature Surveillance SenTec Digital Monitor Analog output Serial data port RS 232 Rechargeable Lithium Battery capacity 50 7 Appendix SenTec Digital Monitor Display alarm Speaker alarm Nurse Call alarm Safety test IEC UL 60601 1 Ground integrity i
23. ay not be reproduced in any form or communicated to any third party without the prior written consent of SenTec AG 1 1 Related Documents To perform service or repairs you must know how to operate the SDMS Refer to the following Manuals and Directions for Use System component senTec Digital Instruction Manual for the SDMS Getting started Using the SDMS Monitoring System eae Technical Manual for the SDM Detailed information on the SDM Sentec Diaital Provides information on repair and sick aed System Service Manual for the SDMS service procedures that do not require g gt Y to open the cover of the SDMS Sentec Digital Repair and Service Manual for the Provides information on repair and Monitoring System SDMS service procedures of the SDMS Table 1 Related Documents 1 2 Safety Information Warnings This symbol identifies a WARNING statement Warning statements refer to conditions that may lead to risk or injury to the patient or user Cautions This symbol identifies a CAUTION statement Caution statements refer to conditions that may lead to damage or malfunction of the equipment Carefully read all safety information in this Manual and in the Technical Manual for the SDM before operating the device or performing service repairs SenTec Digital Monitoring System 1 Introduction 1 2 1 General Safety Information WARNING Explosion hazard Do not use the SDM in the presence of flammable anesthetics gases or in
24. biguously throughout all documents The example in Table 4 explains how to work with the troubleshooting list a Along with the defective part service personnel should receive the SenTec repair form from the customer sender On the repair form the problem and its possible cause should be described and referenced with the PXXXX number b Look up the PXXXX number in the troubleshooting list of this Manual The possible cause and the last action implemented by the user are shaded in dark grey a c If the problem cannot be solved continue with lines b troubleshooting at service level If the problem persist forward the equipment to a SenTec authorized service technician Take into account that the user might not have performed the corrective actions recommended at user level might not have identified the problem correctly and therefore check other possible causes and problems Note Areas shaded in dark grey correspond to that part of the troubleshooting list which is also provided in the Technical manual for the SDM Note The troubleshooting list in the Technical Manual for the SDM provides additional recommended corrective actions that can be carried out by the user and therefore have no reference to this Manual 22 4 Troubleshooting P0101 Wrong instable barometric Verify that the barometric pressure reading of the SDM is PCO too low pressure during calibration stable during calibration and does not deviate from a
25. ccording to section mechanically defective 5 6 Replacement Docking Station Door page 37 Gasket defective Replace gasket according to section 5 7 Replacement Docking Station Gasket page 38 SDM defective Contact SenTec authorized service personnel Change the sensor membrane and confirm as requested by the SDM After having changed the membrane calibrate P0304 V Sign Sensor too slow Calibration takes very the sensor long or is If the problem persists contact qualified service personnel aporte O alter Clean the sensor as described in section 5 2 Cleaning the 14 min i 1 sensor without membrane page 35 V Sign Sensor defective If the problem persists send the V Sign Sensor back to your local SenTec representative according to section 5 10 Instructions for Shipment page 41 SDM defective If the problem does not persist refer to section 4 2 5 SDM page 28 to further evaluate the problem V Sign Sensor Wait until the sensor temperature is less than 0 5 C below V Sign M temperature is too low the SET temperature Sensor If the problem persists contact qualified service personnel Fanoranon If the problem persists test the same sensor connected to does not start l another SDM using another extension cable V Sign Sensor defective If the problem persists send the V Sign Sensor back to your local SenTec representative according to section 5 10 Instructions for Shipment page 41
26. ce to this manual PCO suddenly changes Table 5 Troubleshooting PCO Monitoring 4 2 2 Troubleshooting SpO and PR Monitoring P0200 This problem has no reference to this manual SpO and or pulse rate too low or too high Table 6 Troubleshooting SpO2 and PR Monitoring SenTec Digital Monitoring System 25 4 Troubleshooting 4 2 3 Sensor specific troubleshooting Shield V Sign Sensor from heat source Switch the SDM off and on again P0300 Sensor Fault is displayed Sensor temperature too high e g caused by heat sources such as warming lamps blankets Verify that the temperature of the V Sign Sensor deviates less than 0 2 C from the SET temperature ey Repeat the test with the same sensor connected to another SDM V Sign Sensor defective If the problem persists send the V Sign Sensor back to If problem persists contact qualified service personnel your local SenTec representative according to section 5 10 Instructions for Shipment page 41 SDM defective If problem does not persist refer to section 4 2 5 SDM page 28 to further evaluate the problem P0301 V Sign Sensor or SDM Switch the SDM off and on again Sensor LEDs defective If problem persists contact a qualified service personnel not luminated _ 7 l Digital Monitor Extension Replace the Digital Monitor Extension Cable Cable defective If problem persists test the same sensor connected to another
27. d 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 If the above specifications are not met then the AC power cord needs to be replaced by a new AC power cord from SenTec AG see section 5 11 1 Accessories and Spare Parts List page 42 SenTec Digital Monitoring System 17 3 Maintenance Safety amp Functionality Tests Figure 3 Connections for the Safety Test Setup with 601PROx International Safety Analyzer from BIO TEK 18 3 Maintenance Safety amp Functionality Tests 3 2 16 2 High potential test according to IEC UL 60601 1 e AC High potential tester e g Model 7530DT HypoULTRAQII Tools from Associated Research Inc WARNING Before performing the safety test read the operating instructions of the safety analyzer WARNING Never touch the equipment under test or anything connected to it while high voltage is applied during the high potential test High voltage can lead to injury or death The sensor is an applied part of Type BF The interface ports of the SDM meet the same requirements as the sensor port and are tested in an analogous manner The high potential test for accessible parts is performed with a voltage of 1500 VAC during 60 seconds between the following connections of the SDM High Potential Test Accessible Parts AP Phase connected to neu
28. dware Version aaa aaa aaa aaa arara Sensor software version aaa aaa aaa aaa aaa arara oana O iai road as tada oras baba Location delivery address ccueseceusseeeesseeeseeeesseeeeeeseeeeseeeuseeegsseeeeeuseeens Ordered by name tratar ra tear tear tear trace narra Place o F lt A E EEEE Enna Signature ett e ce eeeecceeceeceeeeesaeeeeeesaeeeesseaeeesaeueeeesaaeeeeaas 52 7 Appendix 7 6 Repair Form Send this document together with any defective part Describe the problem and possible causes you found during your tests Use the troubleshooting list provided in the manuals to identify the problem PXXXX number and the possible cause Fill in the serial number and the hard and software specific information of the complete SDMS Monitor and Sensor to be repaired even if you send back only one component of the system You will find this information in the SDM menu System information SenTec Digital Monitor Serial nO erre SMB hardware version arara rara SMB software version arara arara arara rara MPB hardware version arara MPB software version arara rara aaa V Sign Sensor serial NO he esccsseecesscesseeeeenseessseeeenceseessersecnsegsaesereesniens Sensor hardware Version aaa aaa aaa aaa aaa aaa Sensor software version aaa aaa aaa aaa aaa ana Part designation Comment problem PXXXX possible cause Date of installation or acceptance into service GANZER E A OCO O aiii nantes talciuluatnceden
29. efective or polluted The fan has to be able to rotate freely If you blow into the fan slits on the rear panel of the SDM the fan has to rotate If the problem persists contact qualified service personnel SDM defective Contact SenTec authorized service personnel SenTec Digital Monitoring System 29 4 Troubleshooting P0511 Volume is on minimum Regulate the volume in the menu Alarm Settings to a No sound higher level If the problem persists contact qualified service personnel SDM defective Contact SenTec authorized service personnel P0512 Power Entry Module Contact qualified service personnel Tt is not defective possible to connect the Fuse Holder not mounted Mount Fuse Holder correctly according to section AC power cord correctly 5 5 Replacement main fuses page 37 a AC SDM defective Contact SenTec authorized service personnel connector P0513 Disruptive discharges during the high tension test SDM defective Contact SenTec authorized service personnel P0514 Wrong or no analog output SDM defective Contact qualified service personnel SDM defective Contact SenTec authorized service personnel SDM defective Contact qualified service personnel SDM defective Contact SenTec authorized service personnel SDM defective Contact qualified service personnel SDM defective Contact SenTec authorized service personnel SDM defective Contact SenTec authorized service personnel P05
30. epaired Refer to section 4 2 5 SDM page 28 to further evaluate the problem 3 2 12 Capacity of Rechargeable Lithium Battery Tools e A PC with a terminal emulation software Test using a PC 1 Connect the SDM to AC power and wait until the battery is completely charged AC Power Battery Indicator on the front panel of the SDM see Figure 1 page 6 lits green Adjust the brightness in the menu General Systems Settings to 100 Activate the communication protocol SenTecLink in the menu Interfaces Serial Interfaces 4 Connect the Serial Data Port RS 232 of the SDM to an external PC and record the on line data using a terminal program 5 Activate data recording using a terminal program and disconnect the SDM from AC power 6 When the battery capacity is below 10 the status message Battery Low displays and the status code LB is recorded The time stamp of the last data set recorded on the PC corresponds to the time when the battery was empty and the SDM switched off automatically With the first and last time stamps of the recorded data set you can calculate the running time Alternatively the capacity of the rechargeable battery can be tested using the following procedure 1 See step 1 and 2 above 2 Disconnect the SDM from AC power and write down the time 3 Once the battery capacity is below 10 check the SDM every 5 minutes Record the time when the SDM was switched off by the battery management The c
31. fic troubleshooting Table 8 Sensor Application specific troubleshooting Table 9 SDM specific troubleshooting Table 10 Docking Station specific troubleshooting Table 11 Accessories and Spare Parts List Table 12 Pin Assignment Sensor Connection Port Table 13 Pin Assignment Serial Data Port RS 232 Table 14 Pin Assignment Multipurpose I O Port Abbreviations CO Carbon dioxide DS Docking Station O Oxygen PaCO gt Arterial carbon dioxide partial pressure PCB Printed circuit board PcCO gt Cutaneous carbon dioxide partial pressure PCO PaCO calculated from the measured PcCO cutaneous blood gas measurement POST Power On Self Test PR Pulse rate SaO Arterial oxygen saturation SDM SenTec Digital Monitor SDMS SenTec Digital Monitoring System SpO gt Functional oxygen saturation of arterial hemoglobin pulse oximeter measurement 1 Introduction 1 Introduction This Manual is intended to provide information on the service and repair of the SenTec Digital Monitoring System SDMS The SenTec Digital Monitoring System consists of the Sentec Digital Monitor SDM the V Sign Sensor and accessories This Manual is to be used by qualified service personnel only The service personnel should read this Manual carefully before performing any service or repairs In particular the section 1 2 Safety Information must be read and understood This Manual contains confidential information The contents of this document m
32. follow the instructions in the Instruction Manual of the SDM SenTec Digital Monitoring System 37 5 Repairs pressure spring Ca 120 Ut link for the hinge Figure 10 Docking Station Door removal mounting link for the hinge Figure 10 Docking Station Door Insertion 5 7 Replacement Docking Station Gasket 1 2 3 38 Follow the procedure described in section 5 1 Prior to Repair page 35 Open the Docking Station door Remove the defective gasket using tweezers Take care not to damage the lining groove Clean the lining groove using a cotton soaked with 70 isopropanol allow to dry Insert the new gasket see Figure 11 by pressing it with a cotton swab soaked with 70 isopropanol into the lining groove Make sure that no cotton wool remains on the gasket as it may cause leak problems Place the asymmetric gasket as shown in Figure 12 Allow to dry 5 Repairs 7 Switch on the monitor and check if POST is passed without any error After one minute max the measuring display will appear 8 Put the sensor into the Docking Station a calibration will start after maximum two minutes max Ten minutes after calibration no message Docking Station Fault or Clean Docking Station should appear If the sensor membrane needs to be changed follow the instructions in the Instruction Manual of the SDM gasket Figure 11 Replacement Docking Station Gasket gasket Figure 12 Positioning of the D
33. g Station of another SDM switched on V Sign Sensor defective If the problem persists send back V Sign Sensor to your local distributor according to section 5 10 Instructions for Shipment page 41 SDM defective If the problem doesn t persist contact SenTec authorized service personnel Table 10 Docking Station specific troubleshooting 32 5 Repairs 5 Repairs Repairs shall be carried out by qualified service personnel only Repairs which require the opening of the case shall only be carried out by SenTec authorized service personnel trained by SenTec AG or accredited partners If you need to return devices for service or repair follow the shipment instructions in section 5 10 Instructions for Shipment page 41 Send defective parts together with the completed Repair form to your local SenTec representative The Repair Form may be copied from section 7 6 Repair Form page 53 For orders please use the Order Form for Service Technician Record the serial and LOT number and the hard and software specific information of the SDMS you order parts for The Order Form for Service Technician may be copied from section 7 5 Order Form for Service Technician page 52 To ensure traceability a regulatory requirement SenTec needs to know the serial and LOT numbers as well as software versions of all components of the SDMS If you replace a part in the SDM out of your stock then you have to feedbac
34. iddle of the sensor surface To change the sensor membrane activate the menu item Membrane Change and confirm the membrane change as requested by the monitor Refer to the Directions for Use of the V Sign Disposable Set SON Figure 6 Removal of the Membrane from the Sensor SenTec Digital Monitoring System 35 5 Repairs 5 3 Replacement Tip up Foot 1 Follow the procedure described in section 5 1 Prior to Repair page 35 2 Fold out the tip up foot Expand it on one side to release the first pin from the positioning hole Then remove the whole Tip up foot 3 Fix the new tip up foot see section 5 11 1 Accessories and Spare Parts List page 42 by inserting one pin into the positioning hole on one side Enlarge the tip up foot and engage the second pin on the other side Figure 7 Replacement Tip up Foot 5 4 Replacement Silicon Foot 1 Follow the procedure described in section 5 1 Prior to Repair page 35 2 Clean the groove for the silicon foot with a cotton soaked with 70 isopropanol 3 Put one drop of silicon glue see section 5 11 1 Accessories and Spare Parts List page 42 in the groove 4 Insert the new silicon foot into the groove by pressing firmly Allow the glue to dry Figure8 Replacement Silicon Foot 36 5 Repairs 5 5 Replacement main fuses 1 Follow the procedure described in section 5 1 Prior to Repair page 35 10 Remove the fuse holder from the AC
35. ing Staton ne gose D j O vs Digital Monitor Extension Cable PF oO O Sender rdan kadom O ad OCC O ei Disinfected by name a eececeteaeeeeeeeeeeeeeseseeeeeeeaeeeceeeeeaaeneeseeeenenegs Bd Fe 6 A Fo e ee ne eee JONS oe e ne Important This document has to remain with the disinfected items until returned to the sender SenTec Digital Monitoring System 55
36. k the serial number of the SDM and the serial and LOT number of the replaced parts with the Repair Reporting Form on page 54 to your local distributor You can find the spare parts and test tools with their corresponding order number in section 5 11 1 Accessories and Spare Parts List page 42 Test Tools e Multimeter e SenTec Test connector Multipurpose I O e Screwdriver large slotted 3 Su du e A pair of pointed tweezers asia e A pair of normal tweezers SEE WARNING Maintenance and repairs requiring removal of the case or covers may only be carried out by SenTec authorized service personnel trained by SenTec AG or accredited partners WARNING Use only accessories and spare parts supplied or recommended by SenTec AG Use of other than supplied or recommended parts may result in physical injury inaccurate measurements and or damage to the device WARNING Before attempting to open or disassemble the SDM disconnect the device from the AC power SenTec Digital Monitoring System 33 5 Repairs WARNING Before replacing fuses of the SDM disconnect the device from the AC power CAUTION Observe the ESD Electrostatic discharge precautions when working with the SDM especially when disassembling and reassembling the SDM and when handling any of the components Use an ESD protective mat connected to Earth while working with the electronics 34 5 Repairs 5 1 Prior to Repair 1 Prior to repair all compone
37. l PCO Ground reserved Ground reserved 7 Ground reserved Ground 3 3 V max 15 mA Ground Common lead for Nurse Call relays 1 2 closes upon SDM rm 24 25 Nurse Call relay 1 audible ala open close opens upon SDM 24 26 audible alarm Nurse Call relay 2 close open Table 14 Pin Assignment Multipurpose I O Port N SenTec Digital Monitoring System 4 7 Appendix 7 2 Technical Specifications See the corresponding section of the Technical Manual for the SDM 7 3 Contact phone 41 61 726 97 60 Monday to Friday 08 30 12 00 und 14 00 17 00 GMT 01 00 eMail hotlineQsentec ch 48 7 Appendix 7 4 Protocol for Safety Related Test The SenTec Digital Monitoring System SDMS has been designed to comply with the standards IEC UL 60601 1 and CAN CSA C22 2 No 601 1 M90 For safety reasons it is strongly recommended that the SDMS undergoes a technical safety check at least once a year and after repair Please fill in this form one form per monitor This document must be filed until at least the next safety related test is performed Record the serial number and the hard and software specific information of the tested items You will find this information in the SDM menu System information SenTec Digital Monitor Serial nO errar SMB hardware version arara rara arara rara aaa SMB software version arara rara arara rara aaa MPB hardware version arara rara aaa MPB softw
38. missing of this difference send the V Sign Sensor to your local SenTec representative refer to section 5 10 Instructions for Shipment page 41 3 1 7 Sensor Temperature Surveillance Connect the sensor to the SDM and switch the monitor on Immerse the sensor into water of 45 C 50 C Verify that the red sensor LED switches off a low priority alarm starts to sound and that the message Sensor fault or Temp limiter active displays If the test fails send the V Sign Sensor to your local SenTec representative see section 5 10 Instructions for Shipment page 41 10 3 Maintenance Safety amp Functionality Tests 3 2 SentTec Digital Monitor 3 2 1 Visual Inspection Visually check the entire SDMS for possible damages If you detect a damage the SDM needs to be repaired according to section 5 Repairs page 33 3 2 2 Labeling Check the SDM for presence and legibility of the following labels and symbols Front panel Symbols for buttons and LED s see Figure 1 page 6 Rear panel Labels of all ports connectors and switches label with SN REF and m CE label UL label and WEEE Disposable label see Figure 2 page 7 If the requirements for the front or rear panel are not fulfilled contact your local SenTec representative or send back the monitor according to section 5 10 Instructions for Shipment page 41 3 2 3 POST After switching on the SDM initiates a Power On Self Test POST Some componen
39. n are not fulfilled then refer to section 4 2 5 SDM page 28 to further evaluate the problem 3 2 9 Barometric Pressure Tools e Reference Barometer Compare the barometric pressure measured by the SDM against a calibrated reference barometer The barometric pressure measured by the SDM is displayed in the status bar if PCO is enabled and if the sensor is in the docking station The unit mmHg or kPa depends on the setting of the menu parameter Pressure Unit If the difference between the two barometric pressure readings is bigger than 5 mmHg 0 7 kPa the SDM has to be repaired Refer to section 4 2 5 SDM page 28 to further evaluate the problem 3 2 10 Analog Output e Multimeter Tools e SenTec Test Connector Multipurpose I O For a detailed description of the analog output refer to the technical manual for the SDM The analog output is part of the Multipurpose I O Port see Figure 2 page 7 SenTec Digital Monitoring System 13 3 Maintenance Safety amp Functionality Tests Measure the Analog Output voltages for the Pleth Waveform Pin 1 2 for PR pin 3 4 for SpO Pin 5 6 and for PCO Pin 7 8 using a voltmeter To facilitate the connection of the lead of the voltmeter to the pins it is recommended to use the SenTec Test Connector Multipurpose I O see section 5 Repairs page 33 or a 26 pin Mini Delta Ribbon connector e g 3M part no 10126 3000VE In the menu Interfaces Analog Outputs the parameter ra
40. nclusive power cord max 0 20 Isolation resistance min 2MQ Patient isolation resistance min 2MQ Earth leakage current max 500uA Enclosure leakage current max 100uA Patient leakage current max 100uA AC power cord visual and safety test High tension test IEC UL 60601 1 No disruptive discharge accessible parts 1500VAC 1 minute 1 measurement uA _ No disruptive discharge High tension test IEC UL 60601 1 2 measurement uA patient circuits 3000VAC min 1 second 3 measurement uA 4 measurement uA SDM Docking Station Gas indicator Digital Monitor Extension Cable Results Page 3 of 3 SenTec Digital Monitoring System 51 7 Appendix 7 5 Order Form for Service Technician Please use this form to order original SenTec spare parts one form per monitor Send this document to your local distributor Record the serial number and the hard and software specific information of all components of the SDMS to be repaired even if you order only one component of the system You will find this information in the SDM menu System information SenTec Digital Monitor Serial nO errar SMB hardware version arara eae aaa arara SMB software version aaa aaa aerea rara aaa MPB hardware version arena aaa MPB software version arara rara aaa aaa V Sign Sensor serial NO ae seaeseccceccesseeeeeceeessseeceeeeeaeaeeeeseeeassseeeenseeens Sensor har
41. nge that is attributed to the O to 1 Volt output range can be changed for PCO2 SpOQ2 and PR During measurements on the patient the voltage differential varies proportionally from O to 1 Volt as the pin s parameter varies over the selected parameter range Activating the menu function Calibration Sequence in the menu Interfaces Analog Outputs causes for all parameters the output of 1 Volt during 60 seconds followed by the output of O Volt during another 60 seconds When the calibration sequence is running the current output voltage is indicated on the display Note By pressing ENTER it is possible a to change from 1 Volt to O Volt if output of 1 Volt is active b to stop the calibration sequence if output of O Volt is active If the above specifications are not met the SDM needs to be repaired Refer to section 4 2 5 SDM page 28 to further evaluate the problem 14 3 Maintenance Safety amp Functionality Tests 3 2 11 Serial Data Port RS 232 For a detailed description of the Serial Data Port RS 232 refer to the corresponding section of the Technical Manual for the SDM The Serial Data Port is located on the rear panel of the SDM see Figure 2 page 7 To verify the data transmission to an external device e g PC activate the protocol SenTecLink proceed as described in the Technical Manual for the SDM Check that data transmission works properly If the above specifications are not met the SDM needs to be r
42. ngs for Adults Pediatrics REF MAR A P Digital Monitor Extension Cable REF AC 150 Sensor Gel REF Gel 04 Service Gas REF Gas 0812 Mains Power Cord V STATS installation CD REF V STATS Instruction Manual for SDMS REF IM xx User Manual CD REF UMCD Quick Reference Guide REF QRG xx SenTec Digital Monitoring System 5 2 The SenTec Digital Monitoring System SDMS 2 2 The SenTec Digital Monitor SDM 2 2 1 Front Panel WOON A URW N Figure 1 1 D ODG TE in 100 9 6 85 9Sp02 in 161 84 bpm Trend Plethysmogramm 2006 12 21 15 28 31 Trend Display Area Numerical Display Area Select Button Alarm Mute Button Alarm Mute Indicator yellow LED Door Lock Docking Station Door Enter Button Display Button AC Power Battery Indicator green yellow LED UP DOWN Buttons ON OFF Indicator green LED Status Bar Speaker on the side panel Front Panel of the SDM 2 The SenTec Digital Monitoring System SDMS 2 2 2 Rear Panel 17 8 Efe e Ep A senteci I O lt gt LAN 15 Sensor Connection Port 16 Multipurpose I O Port Nurse call analog output 17 Serial Data Port RS 232 18 Network Port LAN 19 Gas Bottle Slot 20 Fan 21 Equipotential Terminal Connector ground 22 Fuse Holder 23 AC Power Connector 24 ON OFF Switch feature not currently available Figure 2 Rear Panel of the SDM SenTec Digital Monitoring System 3 Maintenance Safety amp
43. nts of the SDMS must be cleaned and disinfected as described in the corresponding section of the Technical Manual for the SDM Check that the sender completed and enclosed the Disinfection Certificate If necessary clean and disinfect the device as described in the corresponding section of the Technical Manual for the SDM 4 Set the ON OFF Switch of the SDM to OFF 5 Disconnect all connections on the rear panel of the device 5 2 Cleaning the sensor without membrane Under certain circumstances sensor too slow bad sensitivity the sensor should be manually cleaned before applying a new membrane i The V Sign Sensor must be disinfected Check that the completed Disinfection protocol is enclosed If necessary clean and disinfect the V Sign Sensor as described in the V Sign Sensor Directions for Use Remove the sensor membrane using the membrane remover located at the bottom of the V Sign Disposable Set as shown in Figure 6 Step Slide the V Sign Sensor into the membrane remover with its membrane facing the bottom of the V Sign Disposable Set Step Lift up the V Sign Sensor to remove the membrane from the sensor body Clean the V Sign Sensor by immersing it for 5 minutes in clean water Then rinse it with running water Use demineralized or distilled water Dry the V Sign Sensor using a clean lint free towel Carefully pat it without rubbing Pay attention not to damage the glass membrane in the m
44. ocking Station Gasket SenTec Digital Monitoring System 39 5 Repairs 5 8 Breaking up the V Sign Disposable Set If the sensor is blocked at any position of the V Sign Disposable Set Tool then the Tool can be opened as follows Break off the 6 latches indicated in Figure 13 holding together top and bottom part of Tool by inserting a screwdriver WARNING Wear protective goggles while breaking out the 6 latches Note This procedure will irreversibly destroy the V Sign Disposable Set but not harm the sensor if executed with care latches removed latches Figure 13 Breaking up the V Sign Disposable Set 5 9 Firmware Updates The firmware of the SDMS consists of four items 1 2 3 4 SMBC Controllerboard software User Interface MPB Multiparameterboard software Measuring Algorithm Docking Station software Calibration Control Sensor software Measuring Algorithm Each software item can be updated independently Whereas the SMBC MPB and Docking Station software can be updated by flashing a new version in the flash memory of the existing boards the update of the sensor software requires the replacement of the sensor WARNING Firmware update of the SDM should be carried out only by SenTec authorized service personnel 40 5 Repairs 5 10 Instructions for Shipment Please contact SenTec AG before returning any material Unless otherwise expressly agreed
45. onsumables All material used is considered non critical The consumables may be disposed with the regular garbage collection 44 7 Appendix 7 Appendix 7 1 Pin Assignment 7 1 1 Sensor Connection Port a TEM 8 9 1011 1213 14 f if I ti Ff 1234567 Figure 15 Sensor Connection Port ES e smao 5 se a tom Su 6a a Ses ro e ERRO ER a bay trsesr ain ow a Table 12 Pin Assignment Sensor Connection Port SenTec Digital Monitoring System 45 7 Appendix 7 1 2 The Serial Data Port RS 232 Figure 16 Serial Data Port RS 232 Pings Sigma eme 2a baa tomo ERES a eme ERR eos eme Table 13 Pin Assignment Serial Data Port RS 232 7 1 3 Multipurpose I O Port faa 45 46 17 16 19 20 H 22 23 fa 25 BE 12 345 E F 8 8 10 11 12 13 Figure 17 Multipurpose I O Port 46 7 Appendix Voltage O 1 05 V Parameter Range min max not selectable Voltage O 1 05 V Parameter Range 30 80 30 125 50 120 100 250 30 250 bpm Voltage O 1 05 V Parameter Range 0 100 50 100 Pin s Pleth Signal Pleth Ground PR Signal PR Ground SpO2 Signal SpO gt Ground 70 100 85 100 Yo Voltage O 1 05 V Parameter Range 10 50 25 55 25 75 35 100 60 140 75 200 120 200 0 75 0 100 0 200 mmHg 1 5 7 3 5 7 5 3 5 10 0 0 15 0 8 18 0 10 0 27 0 16 0 27 0 0 10 0 0 15 0 0 27 0 KPA WI mec Ana on PCO Signa
46. plied during the high potential test High voltage can lead to injury or death The sensor is an applied part of Type BF The interface ports of the SDM meet the same requirements as the sensor port and are tested in an analogous manner The safety test is performed according to IEC UL 60601 1 The following connections must be tested while the SDM is switched on e Protective Earth Resistance Test Earth wire of the AC power cord equipotential terminal ground see Figure 2 page 7 gas bottle Caution the container might be insulated from the thread by the color The resistance between two of these must be less than 0 2 Q Minimum current USA 1 A Europe 5 A o Insulation Resistance Test AC Power Connector housing equipotential terminal The resistance must be more than 2 MQ e Patient Insulation Resistance Sensor Connection Port Ground housing equipotential terminal The resistance must be more than 2 MQ e Earth Leakage Current The current must be below 500 uA e Enclosure Leakage Current The current must be below 100 uA o Patient Leakage Current Test Sensor Connection Port Ground and interface Ground of the Serial Data Port all other connectors The current must be below 100 uA If the requirements are not met refer to section 4 2 5 SDM page 28 to further evaluate the problem Check the AC power cord for breaks or damages of the isolation Check the connectors for damages The AC power cor
47. rachea rr rrr rrr 1 Introduction WARNING Do not spray pour or spill any liquid on the SDM its accessories connectors switches or openings in the chassis WARNING If the SDM has been wetted accidentally it must be wiped dry externally allowed to dry thoroughly and be inspected by qualified service personnel before further use WARNING If connecting the SDM to any other equipment verify proper operation before clinical use Both the SDM and the equipment connected to it must be connected to a properly grounded AC power outlet Combinations of equipments must be in compliance with IEC UL 60601 1 systems requirements Anyone who configures a medical system by connecting additional equipment to the SDM is responsible for ensuring that the resulting system complies with the requirements of IEC 60601 1 1 and IEC 60601 1 2 WARNING During normal operation except transport it is recommended that the monitor is always connected to the AC power outlet WARNING To maintain monitor readiness ALWAYS clean the sensor before putting it into the Docking Station ALWAYS store the clean sensor in the Docking Station after monitoring ALWAYS keep the monitor switched on CAUTION Do not immerse the SDMS or the connectors of any connecting cables in liquid solution CAUTION Do not sterilize any parts of the SDMS by irradiation steam or ethylene oxide SenTec Digital Monitoring System 3 1 Introduction
48. sonnel Docking Station door Replace Docking Station door according to section mechanically defective 5 6 Replacement Docking Station Door page 37 Gasket defective Replace gasket according to section 5 7 Replacement Docking Station Gasket page 38 SDM defective Contact SenTec authorized service personnel P0603 SDM is defective Contact qualified service personnel VES SDM defective Contact SenTec authorized service personnel bottle cannot be installed properly P0604 High pressure part of the Contact qualified service personnel Consumption of the Service Contaminations e g gel residues disturb the gas flow leak Docking Station Module is leaky Gas is higher SDM defective Contact SenTec authorized service personnel than normally Gas lea in DS is not displayed SenTec Digital Monitoring System 31 4 Troubleshooting P0605 V Sign Sensor Wait until the sensor temperature is less than 0 5 C V Sign M temperature is too low below the SET temperature Sensor If the problem persists contact qualified service calibration personnel does not start V Sign Sensor LED is illuminated No communication Hold the V Sign Sensor with the sensor membrane face between the Docking in front of the Docking Station Calibration Module A red Station Module and the LED in the upper Window will flicker Monitor If the problem persists repeat the test with the same sensor but using the Dockin
49. st page 42 Note If the audible alarm signals of the SDM are silenced the nurse call function is not active If the specifications above are not met the SDM needs to be repaired Refer to section 4 2 5 SDM page 28 to further evaluate the problem 3 2 16 Electrical Safety Check The SenTec Digital Monitoring System SDMS has been developed to comply with the standards IEC UL 60601 1 and CAN CSA C22 2 No 601 1 M90 To ensure electrical safety reasons of the equipment the electrical safety check MUST be performed annually The electrical safety tests for the SDMS have to be performed in accordance with the standards IEC UL 60601 1 and CAN CSA C22 2 No 601 1 M90 for instruments classified as Class 1 and Type BF defibrillation proof Technicians must be familiar with these standards applicable to the institution and the country Test equipment and its application must comply with the applicable standard 3 2 16 1 Safety test according to IEC UL 60601 1 e Safety analyzer for tests according to IEC UL 60601 1 e g Tools 601PROXL International Safety Analyzer from BIO TEK If the required equipment is not available send the SDM to your local SenTec representative for testing 16 3 Maintenance Safety amp Functionality Tests WARNING Before performing the safety test read the operating instructions of your safety analyzer WARNING Never touch the equipment under test or anything connected to it while high voltage is ap
50. stem Settings Date Time Power cycle the SDM and control the clock settings If the clock settings are wrong refer to section 4 2 5 SDM page 28 to further evaluate the problem 3 2 6 Display LED s Check indicator LED s and the display for defects 1 Connect the SDM to AC power Switch the SDM OFF and ON again During the POST first the Alarm Mute Indicator yellow LED and then the ON OFF Indicator green LED are activated The AC Power Battery Indicator LED is lit yellow battery charging or green battery full Refer to Figure 1 page 6 for location of the indicator LED s 2 Control the display for inactive pixels during the POST If the requirements for the display and or LED s are not fulfilled then contact your local SenTec representative or send back the monitor according to section 5 10 Instructions for Shipment page 41 12 3 Maintenance Safety amp Functionality Tests 3 2 7 Speaker POST Switch ON the SDM and verify three signal tones of 0 2 seconds each during the POST If the speaker does not sound during the POST refer to section 4 2 5 SDM page 28 to further evaluate the problem 3 2 8 Fan The fan is active if the battery is charging AC Power Battery Indicator lits yellow The fan has to be able to rotate freely and without causing unusual noises If you blow into the fan slits on the rear panel of the SDM when the fan is off the fan has to rotate If the requirements for the fa
51. table during calibration and does not deviate from a known calibrated reference barometer by more than 5 mmHg 0 7 kPa Otherwise contact qualified service personnel SDM defective If the problem persists contact SenTec authorized service personnel PCO sensitivity of the Test the PCO sensitivity as follows sensor too low Activate the display of the PCO calibration curve Following a calibration expose the sensor for approximately three minutes to ambient air Reinsert the sensor into the Docking Station The first displayed PCO value should be at least 30 mmHg 4 0 kPa lower than after calibration If this difference is not reached remembrane the sensor and repeat the test After a renewed missing of this difference consult qualified service personnel Clean the sensor as described in section 5 2 Cleaning the sensor without membrane page 35 and perform the sensitivity test as described in section 3 1 6 PCO2 Sensitivity Test page 10 If the problem persists contact SenTec authorized service personnel Significant PCO drift Verify that the sensor is not affected by loose fit of the membrane trapped air under the membrane If needed perform an unrequested membrane change activate the menu Membrane Change After having changed the membrane calibrate the sensor and allow the PCO part of the sensor to stabilize for 4 hours If no change of the sensor membrane is needed allow the sensor to stabilize for an
52. tral of the AC 1 Measurement Equipotential Terminal power cord Table 2 Connections for the High Potential Test AP Figure 4 Connections for the High Potential Test AP Setup with Model 7530DT HypoULTRA II from Associated Research Inc SenTec Digital Monitoring System 19 3 Maintenance Safety amp Functionality Tests The high potential test for patient circuits is performed with a voltage of 3000 VAC during at least 1 second between the following connections of the SDM High Potential Test Patient Circuits PC Phase connected to neutral of the AC Grounchor the Serial Data Port power cord Ground of the Sensor connection port Ground of the Serial Data Port Table 3 Connections for the High Potential Test PC Figure 5 Connections for the High Potential Test PC Setup with Model 7530DT HypoULTRA II from Associated Research Inc If a disruptive discharge occurs section 4 2 5 SDM page 28 will help you to evaluate the problem 20 3 Maintenance Safety amp Functionality Tests 3 3 Docking Station 3 3 1 Visual Inspection Inspect the Docking Station door and the gasket for mechanical damages The closing mechanism must lock properly If you detect a possible damage replace the defective part according to section 5 Repairs page 33 3 3 2 Gas Level Indicator Tools e Full Service Gas bottle Check the functionality of the gas level indicator using a new gas bottle 1 Screw in a new gas bottle and
53. ts of the SDM are checked The display as well as the visual and audible indicators i e LED s and speaker are shortly activated The result of the POST is indicated by a Y passed or x failed symbol Note The message FLASH Memory Inside is displayed on the POST screen if the hardware version of your monitor supports a non volatile FLASH memory If the POST fails an error message shows up at the bottom of the POST screen see section 4 Troubleshooting page 22 The SDM needs to be repaired according to section 5 Repairs page 33 SenTec Digital Monitoring System 11 3 Maintenance Safety amp Functionality Tests 3 2 4 Keyboard 5 Activate the Main Menu by pressing once 6 Select the menu System Settings by pressing three times 7 Activate the selection by pressing once 8 Select the item Key Click by pressing six times 9 Switch ON and OFF the Key Click by using the UP and DOWN Q Button When the Key Click is ON you hear a beep when pushing a button 10 Push the Display Button to exit the menus 11 If you push the Alarm Mute Button the Alarm Mute Indicator yellow LED should lit If the requirements for the Keyboard are not fulfilled then contact your local SenTec representative or send back the monitor according to section 5 10 Instructions for Shipment page 41 3 2 5 Clock Settings Verify that the clock settings are correct If necessary adjust the clock in the SDM Menu Sy
54. tutane ates Nee OD dA seen Pace dE E ODE A ae E EEEE SenTec Digital Monitoring System 53 7 Appendix 7 7 Repair Reporting Form To ensure traceability you must send back the following information to the authorized service center if any of the following items is repaired replaced or updated Record the new serial number the new LOT number and the new hard and software specific information of the repaired or updated SDMS one form per monitor You will find this information in the menu System information on the labels of the printed circuit boards or on the packing SenTec Digital Monitor serial nO errar SMBC Seal NOS DRDS Sos Did cece SMBC LOT no PR ADE ORNE ERRO EP antennas SMB software version _ _______haacaccacaccuceccecucaecuccsuccecucaucuceusucucaucutaueaueucanass MPB serial no an so doen nae vuteioedaceautenaoeecessientedieueaie MPB LOT no PA VD MPB software version arara SMBM Seta NO assi o ida ia SMBM LOT no DA ae nae Docking Station Module SC2A serial no aaa GOL ida Cr Raia SC2A LOT no PA ERRAR RR RD UR Rechargeable Li Battery Lot NO cccccccceecesssseeseeeeeeeeeeeeeeesseeeeeeseeeeesaeees AC DC Power Supply LOL NO insana iganniiosgis didi ii a Display Module Lot No saccceseceecccceeeeeesseeeeeeeeaeeseeeeeseeeneeeeeeeaeaaeseeeess SDM Case upper part LOL NO oo ee ceeeececeeeeteeeeeeeeeeeseeeeeseeeeteaseeeseeeees V SIGN Sensor serial no
55. unting Plate roll stands heads MP IW Mounting Plate infusion stands amp wall rails IM xx Instruction Manual for SDMS E100967 VueLink Adapter UMCD User Manual CD al 2 5 Repairs Accessories and Spare Parts List Order no Part designation LOT SN E100857 AC Power Connector E100858 Fuse Holder for AC Power Connector time delay high breaking E100838 capacity Fuse 250VAC T630mA H E100414 Mains Connecting Cable E100145 Docking Station Door E100380 Docking Station Gasket E100454 Silicon Feet Set 6 feet E100884 Silicone Glue omniVISC1050 E100171 Tip up Foot excl silicone feet E100463 lt Serrated lock washer E100451 AC Power Cord Europe E100452 AC Power Cord Switzerland E100693 AC Power Cord Italy E100694 AC Power Cord Australia E100695 AC Power Cord United Kingdom E100747 AC Power Cord Japan HGJ E100748 AC Power Cord USA Canada HGC E100795 AC Power Cord Denmark E100796 AC Power Cord China E100797 AC Power Cord Israel E100798 AC Power Cord Korea E100701 SenTec Test Connector Multipurpose I O Uses gas with 5 and ST DSU 30 CO Equipment for testing V Sign sensors S100005 Test gas for ST DSU 5 CO S100005 Test gas for ST DSU 30 CO PU Packaging Unit Table 11 Accessories and Spare Parts List SenTec Digital Monitoring System 43 6 Disposal 6 Disposal The SDMS is constructed with environment friendly material It contains electronic
56. y filled in forms Certificate of disinfection and if applicable Repair form must accompany the shipment and be accessible without opening up the packaging Insert them into the transparent envelope that holds the transportation documents and pack list or use a separate transparent envelope Important Any shipment to SenTec AG lacking this documentation or showing improperly filled in documentation will be returned immediately and unopened at the sender s expense SenTec Digital Monitoring System 41 5 Repairs 5 11 Accessories and Spare Parts WARNING Use only accessories and spare parts supplied or recommended by SenTec AG Use of other than supplied or recommended parts may result in physical injury inaccurate measurement and or damage to the device You will receive original SenTec spare parts from your local SenTec representative 5 11 1 Accessories and Spare Parts List Accessories and Spare Parts List Order no Part designation LOT SN Cp IJ 1 SenTec Digital Monitor VS A P V Sign Sensor VS DSET V Sign Disposable Set EC A P MAR A P N MAR A P N A Ear Clip Multi Site Attachment Ring Adults Pediatrics Neonates Multi Site Attachment Ring Adults Pediatrics N D Ul 150cm 250cm 750cm or customized length Digital Monitor Extension Cable Gel 04 Sensor Gel Gas 0812 Service Gas 5 71 9 5 bar VS TSET Training Set MP WR Mounting Plate wall rails MP RSH Mo
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