Sentec tCOM+ Service Manual

Transcutaneous monitor & sensors

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Instruction manual (124 pages)

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SERVICE MANUAL

tCOM+ Transcutaneous

Monitor & Sensors

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Troubleshooting

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Summary of Contents for Sentec tCOM+

Page 1 SERVICE MANUAL tCOM+ Transcutaneous Monitor & Sensors...
Page 2: Warranty
Sentec are used, if the warranty seal on the lower side of the monitor is broken, or if instrument repairs are not carried out by Sentec authorized service personnel.
Page 3: Table Of Contents
Figures Tables Abbreviations INTRODUCTION Related Documents Safety Information WARNINGS CAUTIONS THE SENTEC DIGITAL MONITORING SYSTEM (SDMS) The tCOM+ Patient Monitor MAINTENANCE/SAFETY & FUNCTIONALITY TESTS Sentec TC Sensors The tCOM+ Patient Monitor Docking Station Sensor Adapter Cable Opening the Membrane Changer...
Page 4 Contents Forms Interfaces - Pin Assignment Technical Specifications Contact HBQ-197-V1...
Page 5: Figures
1 Introduction Figures Figure 1 Front Panel Figure 2 Left Panel Figure 3 Right Panel Figure 4 Rear Panel Figure 5 Removal of the Membrane from the TC Sensor Figure 6 Top view of the V-Sign™ Sensor Figure 7 Top view of the OxiVenT™ Sensor Figure 8 Inspection after re-membraning the sensor Figure 9...
Page 6: Introduction
(* Qualified personnel should have obtained a relevant technical education/degree, e.g., medical or maintenance technicians.) Note: Repairs that require opening the tCOM+ cover must be done by Sentec only. This manual must be read carefully prior performing service. Section "Safety Information"...
Page 7: Related Documents
Related Documents System Manual Content component Getting started / Using the SDMS: The Instruction Manual for the tCOM+ and the Sentec HBQ-179 Instruction Transcutaneous Sensors highlights the essential Manual for the tCOM+ SDMS points when using the SDMS. To ensure proper...
Page 8: Safety Information
Safety Information Note: The Sentec Digital Monitoring System (SDMS) is to be operated by qualified personnel only. Read this manual, accessory Directions for Use, all precautionary information, and specifications before use. Warnings This symbol identifies a WARNING statement. A warning alerts the reader about a situation which, if not avoided, could result in death or serious injury to the patient, user, or serious adverse events on the environment respectively.
Page 9 CAUTION: Do not sterilize any parts of the SDMS by irradiation, steam, ethylene oxide, or plasma. CAUTION: Use only the external power supplies provided by Sentec and described in the tCOM+ Instruction Manual. CAUTION: Do not connect the tCOM+ to an electrical outlet controlled by a wall switch, because the tCOM+ may be accidentally turned off once the battery is depleted.
Page 10 Use only accessories and spare parts supplied or recommended by Sentec. Do not perform other service and repair activities than specified and described by Sentec. Failure to comply may result in physical injury, inaccurate measurements, and/or damage to the device.
Page 11: The Sentec Digital Monitoring System (Sdms)
2 The Sentec Digital Monitoring System (SDMS) 2 The Sentec Digital Monitoring System (SDMS) The tCOM+ Patient Monitor 2.1.1 Front Panel Figure 1 - Front Panel LED Bar Touchscreen Handle Service Manual tCOM+...
Page 12: Side Panels
2.1.2 Side Panels Figure 2 - Left Panel Gas Bottle DATA/SERVICE USB Port (USB C) ON/OFF Button Figure 3 - Right Panel Docking Station HBQ-197-V1...
Page 13: Rear Panel
2 The Sentec Digital Monitoring System (SDMS) 2.1.3 Rear Panel Figure 4 - Rear Panel Cable Holder Slots Sensor Connection Port DC Power Connector Serial Data Port (RS-232) Isolated Connectivity Port (USB C) Network Port (LAN) Analog Output Port Battery Cover...
Page 14 2.1.4 Top View HBQ-197-V1...
Page 15: Maintenance/Safety & Functionality Tests
Prior to maintenance or service all components of the SDMS must be cleaned and disinfected. If equipment is sent to service personnel, a local Sentec representative or to Sentec a completed “Certificate for Disinfection” (see section 8.1) must be attached.
Page 16 If the message “Sensor Fault xx” or “SFxx” was triggered, you must restart the tCOM+ to reset the message. Do not use the sensor if the message “Sensor Fault xx” or “SFxx” is not reset by power cycling the tCOM+. Instead contact qualified service personnel or your local Sentec representative.
Page 17 Membrane Changer as shown in the figure below (note that the Membrane Changer is shown upside down). Step 1: Slide the Sentec TC Sensor into the membrane remover with its membrane facing the bottom of the Membrane Changer. Step 2: Lift the Sentec TC Sensor up to remove the membrane from the sensor body.
Page 18 If the grooves on the sensor circumference are damaged replace the sensor with a new Sentec TC Sensor. Do not use the sensor if there is any visible damage to/trapped air underneath the membrane, or if the sensor’s red LED does not light when the sensor is connected to the tCOM+.
Page 19 3 Maintenance/Safety & Functionality Tests Test the PCO sensitivity as follows: Make sure the Monitor used for the test has no gas leak in Docking station. Insert the sensor into the Docking Station. Open the Sensor Maintenance menu (e.g. by tapping on the Sensor icon in the status bar) and select Sensitivity Test.
Page 20 Function Test Control Table PO – in mmHg and kPa ranges are valid for ambient temperatures between 18 °C and 28 °C and relative humidity between 30% r.H. and 60% r.H. Patm ambient_ ambient ambient_ Patm ambient_ ambient ambient_ [mmHg] [kPa] 80.0 15.4...
Page 21: The Tcom+ Patient Monitor
3.2.3 Labeling Check the tCOM+ for presence and legibility of the following labels and symbols. If the below requirements are not met contact your local Sentec representative or send back the monitor according to section "Instructions for Shipment”. 3.2.3.1...
Page 22: Electrical Safety Check
Requirements: The tCOM+ was not opened before and the safety seal is intact. Otherwise contact your local Sentec representative. Tools: Electrical safety analyzer for tests according to IEC 60601-1 / IEC 62353 (e.g., Gossen Metrawatt Seculife ST Pro). If the required equipment is not available, contact your local Sentec representative. Note: Before performing the safety test, read the operating instructions and make sure you are familiar with the usage of your safety analyzer.
Page 23 The following connections must be tested. If the specifications are not met, the tCOM+ needs to be taken out of service. Contact your local Sentec representative. Note: Due to the Class II design with the external power supply unit protective earth resistance is not applicable.
Page 24: Power Button
Press the power button on the left of the monitor. The menu "Shut Down" will appear on the screen. Close this screen by selection X on the top right corner. If the above-described process does not operate properly, contact your local Sentec representative. 3.2.7 Clock Settings Verify that the clock settings are correct.
Page 25 3 Maintenance/Safety & Functionality Tests Channel Wire label (Default signal) CH 0 Pleth CH 1 CH 2 CH 3 Signal Ground In the menu "Advanced Settings > Interfaces > Analog / PSG” (a password may be required) tap on Calibrate Channels. Output: 1.0 V ...
Page 26: Docking Station
3.2.13 Alarm by Display Initiate a low priority alarm (e.g., by disconnecting the Sentec TC Sensor from the tCOM+). Verify that the corresponding status message is displayed in the status bar. If the above-described functions do not operate properly, the tCOM+ needs repair. Refer to section 4.3.4...
Page 27: Sensor Adapter Cable
3 Maintenance/Safety & Functionality Tests Note: Replacement of both gaskets is recommended annually. 3.3.3 Gas Level Indicator Tools • 1 full Calibration Gas bottle Check the functionality of the gas level indicator using a new gas bottle. 1. Fit a new gas bottle and switch the tCOM+ ON. 2.
Page 28 latches removed latches Figure 12 Opening the Membrane Changer HBQ-197-V1...
Page 29: Troubleshooting
Replacement of Service Parts (without opening the tCOM+ cover) are described in section 5. Repairs that require opening the cover of the tCOM+ are to be performed by Sentec only. Prior to maintenance or service or all components of the SDMS must be cleaned and disinfected.
Page 30 Verify proper operation of the blood gas analyzer. Periodically compare the blood gas • analyzer’s barometric pressure against a known calibrated reference barometer. Note: This section only is applicable for Sentec TC Sensors with PCO and/ or PO enabled. Table 2...
Page 31 ‘Remaining Recommended Sensor Stabilization’ on the “Ready for use” screen (see tCOM+ instruction manual). Wrong / expired Verify that Sentec Calibration Gas is used. If calibration gas was expired replace with a new gas bottle! used during last...
Page 32 Problem Possible Cause(s) Recommended corrective action(s) If 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 exchange (activate the menu “Membrane Change”).
Page 33 Refer to P0305 sensitivity of the sensor low/ deteriorated Measurement is Shield Sentec TC Sensor from strong ambient light. Note: influenced by high Refer to Status Message ‘High ambient light’ ambient light levels (with Status Code ‘SA’) (see tCOM+ instruction manual).
Page 34 Refer to P0304. of the sensor is slow 4.3.2 Troubleshooting SpO / PR monitoring Note: This section is applicable for Sentec TC Sensors (if SpO / PR are enabled) and for Sentec’s oximetry sensors. Table 3 Troubleshooting SpO / PR Monitoring...
Page 35: Sensor-Specific Troubleshooting
'Connect sensor' displays In case of damage of the Sentec TC Sensor replace it by original replacement parts. In case of damage of the 'Sensor Adapter Cable' replace it by original replacement parts. tCOM+ defective If problem persists, contact qualified service personnel.
Page 36 Problem Possible Cause(s) Recommended action(s) P0303 Sentec TC Sensor The Sentec TC Sensor is defective. Replace it with a defective/ low voltage new one. Message 'SP10: potential is detected Contact Service' P0304 Membrane related Change the membrane: (defective or dried up...
Page 37 / lamps or electric Message 'Sensor blankets problem 38-42' Sentec TC Sensor If the problem persists, the Sentec TC Sensor is defective defect. Replace it with a new one. tCOM+ defective Refer to section 4.3.4 “tCOM+ specific troubleshooting"...
Page 38 3.1.7 "Cleaning / Inspecting without Membrane" and perform the 'Sensitivity Test' as described in section 3.1.8 "PCO / PO Sensitivity & Calibration Duration". Sentec Sensor If the problem persists, contact qualified service defective personnel. 4.3.4 tCOM+ specific troubleshooting Table 5...
Page 39 4 Troubleshooting Problem Possible Cause(s) Recommended action(s) LED bar not tCOM+ defective Contact your local Sentec Representative. illuminated P0402 Insufficient capacity Contact qualified service personnel. of the rechargeable Fully charged Lithium Battery Battery is Insufficient capacity Replace battery according to section...
Page 40 3 mmHg (0.4 kPa). Otherwise contact qualified service personnel. Note: The ‘Barometer Icon’ only displays if PCO enabled, and the Sentec TC Sensor is connected to the tCOM+ and inside the Docking Station. Note: Also refer to Status Messages ‘Atm. P.
Page 41: Docking Station-Specific Troubleshooting
Possible Cause(s) Recommended action(s) No communi- wrong / defective Contact qualified service personnel. cation over RS- cable tCOM+ defective Contact your local Sentec representative. tCOM+ defective Contact your local Sentec representative. P0417 Safety test does not comply P0418 Gas Bottle empty or Replace gas bottle by a fresh one.
Page 42 Station Gasket”. tCOM+ defective Contact your local Sentec representative. P0501 Contaminations (e.g., Clean Docking Station and Sentec TC Sensor and gel residues) disturb then insert the sensor into the Docking Station. Message the gas flow If problem persists, contact qualified service ‘Docking...
Page 43: Replacement Of Service Parts
Use only accessories and spare parts supplied or recommended by Sentec. Do not perform other service and repair activities than specified and described by Sentec. Failure to comply may result in physical injury, inaccurate measurements, and/or damage to the device.
Page 44: Spare Parts
Prior to maintenance or service all components of the SDMS must be cleaned and disinfected. If equipment is sent to service personnel, a local Sentec representative or to Sentec a completed “Certificate for Disinfection” (see section 8.1) must be attached.
Page 45: Replacement, Docking Station Gasket
5 Replacement of Service Parts Replacement, Docking Station Gasket In case of a Docking Station leak or a possible damage, qualified service personnel, e.g., medical technicians, should replace the Docking Station Gasket. Clean or disinfect hands. Open Docking Station. Remove the rubber ring (Gasket) as depicted.
Page 46 Open the Docking Station door for approx. 20mm and insert cutter knife between door and upper hinge. Carefully turn the cutter knife clockwise to bend the hinge slightly upwards and disengage the door at the same time. Pay attention not to damage the hinge. Insert the new Docking Station door by holding it vertically and 45°...
Page 47: Replacement, Ac Power Adapter
5 Replacement of Service Parts Replacement, AC Power Adapter Use only original AC power adapter type provided by Sentec. The power supply is available in two versions. Make sure to replace by respective version: Hospital Use - Class II with functional earth connection (Hospital use).
Page 48: Replacement, Battery
Replacement, Battery Only use the same type of battery as replacement (RRC2057, 7.2 V / 49.7 Wh). The performance and degradation of the battery highly depends on the usage scenario of the battery. Never let the battery fully discharge. Make sure to recharge it at least every 6 months. Perform the following steps to replace the battery: Open the battery cover on the back of the monitor by releasing two TX10 screws.
Page 49: Replacement, Handle
5 Replacement of Service Parts Replacement, Handle Follow the procedure described in section "Prior to Replacement ". Loosen both bolts of the handle by using a 2.5mm hex key and pull out the brass sleeves. Replace the defective handle by a new one. Insert the brass sleeves as far as possible and tighten the bolts until flush with the handle surface (0.2 Nm).
Page 50: Replacement, Cable Clip
5.10 Replacement, Cable Clip Follow the procedure described in section "Prior to Replacement" . Remove the defective cable clip by lifting and pulling out. Insert the new cable clip into the slot and lock by pushing down. Removing Cable clip 5.11 Replacement, Silicon Foot If the Silicon Foot got lost or extremely contaminated, perform the following steps to replace the Silicon Foot:...
Page 51: Software Updates
15 minutes. Ensure to check the software version for accuracy in the System Information menu once the software update is completed. Note: Software updates must be reported to Sentec by using the Software Update Reporting Form to ensure traceability. 7 Disposal The SDMS contains electronic printed circuit boards, a display, cables, and lithium batteries.
Page 52: Patient Monitor
Details to this are defined by the national law of the respective country. Patient Monitor Return the tCOM+ to your local Sentec representative or dispose it according to local regulations. Cables Dispose the cables according to local regulations. The copper contained can be recycled.
Page 53: Appendix
SDMS Maintenance Checklist To be used to schedule and keep track of cleaning/maintenance by the operator. HBQ-59 (HB-007601) 8.1.6 Device Service Request Country-/region-specific forms for submitting any warranty claims on Sentec products. FO-159 Interfaces - Pin Assignment 8.2.1 Sensor Connection Port...
Page 54 Pin(s) Signal Supply Ground 2, 8 Signal Ground (reserved) Received Data (RX, from Sensor) 5 V, for sensor supply only Transmitted Data (TX, to Sensor) 3.3 V, for sensor supply only 8.2.2 Serial Data Port (RS-232) Pin(s) Signal (reserved) Transmitted Data (TX, from tCOM+) Received Data (RX, to tCOM+) (reserved) Signal Ground...
Page 55: Technical Specifications
It is currently not in use. The Isolated Connectivity Port is located on the rear panel of the tCOM+. Technical Specifications See the corresponding section of the tCOM+ instruction manual. Contact Phone: +41 61 726 97 60 Monday to Friday, 08:30 - 12.00 und 14.00 - 17:00 (GMT +01:00) e-Mail: service@sentec.com Service Manual tCOM+...
Page 56 Sentec AG Ringstrasse 39 4106 Therwil HBQ-197-V1 Switzerland Date of release: 2024-09 www.sentec.com...