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3 Maintenance/Safety & Functionality Tests

SenTec Digital Monitoring System

3.1.12

Function Test: SpO2 + PR

Apply the sensor to the earlobe of a healthy person: Compare SpO2 and PR readings
against the readings of a reference pulse oximeter (e.g. N595 with Durasensor 100
from Nellcor). The SpO2 and PR reading should be within ± 3% SpO2

and ± 3 bpm,

respectively.
If this requirement is not met refer to

section

4.2.1

“Troubleshooting SpO2 / PR

monitoring” to further evaluate the problem.

Содержание SDM

Страница 1: ...For the SenTec Digital Monitoring System Software Version SMB V08 02 MPB V06 02 ...

Страница 2: ... Patents Trademarks Copyright International Industrial Design No DM 054179 Japanese Design No 1137696 U S Design Patent No D483488 Canadian Patent No 2466105 European Patent No 1335666 German Patent No 50111822 5 08 Spanish Patent No 2278818 Hongkong Patent No HK1059553 U S Patent No 6760610 Chinese Patent No ZL02829715 6 European Patent No 1535055 German Patent No 50213115 2 Spanish Patent No 231...

Страница 3: ...REPAIRS OF THE SDM 73 5 1 Prior to Repair 74 5 2 Replacement Tip up Foot 74 5 3 Replacement Silicon Foot 75 5 4 Replacement main fuses 75 5 5 Replacement Docking Station Door 76 5 6 Replacement Docking Station Gasket 77 6 SOFTWARE UPDATES 79 7 DISPOSAL 80 7 1 SenTec Digital Monitor 80 7 2 Cables 80 7 3 SenTec TC Sensors 80 7 4 Service Gas Bottle 80 7 5 Consumables 80 8 APPENDIX 81 8 1 Protocol for...

Страница 4: ...ents of the SDMS 11 Table 3 Connections for the High Potential Test AP 31 Table 4 Connections for the High Potential Test PC 32 Table 5 Example of a Troubleshooting Procedure 45 Table 6 Troubleshooting PCO2 PO2 Monitoring 47 Table 7 Troubleshooting SpO2 PR Monitoring 53 Table 8 Sensor specific troubleshooting 54 Table 9 SDM specific troubleshooting 59 Table 10 Docking Station specific troubleshoot...

Страница 5: ...onitoring System SpO2 Functional oxygen saturation of arterial hemoglobin as measured with a pulse oximeter TC Transcutaneous tcPCO2 Transcutaneous carbon dioxide partial pressure i e an estimate of PaCO2 calculated from the measured PcCO2 and displayed labeled on the SDM and unless explicitly stated otherwise throughout this manual as PCO2 tcPO2 Transcutaneous oxygen partial pressure i e an estim...

Страница 6: ......

Страница 7: ...he SDM intended for qualified personnel only see section 5 Note Repairs that require opening the SDM cover are described within SenTec s Repair Manual for the SDMS which is distributed to SenTec authorized service personnel only Within this manual activities described as for SenTec authorized service technicians only refer to activities described in detail within the Repair Manual for the SDMS HB ...

Страница 8: ... can be performed by the operator SDM Technical Manual for the SDM HB 005752 The Technical Manual for the SDM provides detailed information on the SenTec Digital Monitor SDM SDMS Service Manual for the SDMS present manual Provides information on maintenance safety and functionality tests troubleshooting and repair procedures that do not require opening the cover of the SDM as well as on service ma...

Страница 9: ...for the SDMS in all available languages can also be downloaded from SenTec s Webpage https www sentec com education customer portal Information Instructions about the Digital Sensor Adapter Cable the Contact Gel and the Service Gas are provided in the Instruction Manual for the SDMS and the Technical Manual for the SDM Note SDMS related tutorials are available for online viewing at http www sentec...

Страница 10: ...vironment Cautions This symbol identifies a CAUTION statement Cautions alert users to exercise appropriate care for safe and effective use of the product and the care necessary to avoid damage to the product that may occur as a result of use or misuse Carefully read all safety information in this Manual and in the Technical Manual for the SDM HB 005752 before operating the device or performing ser...

Страница 11: ...o ensure patient safety do not place the SDM in any position that might cause it to fall on the patient WARNING Do not lift the SDM by the sensor cable or the AC power cord because they could disconnect from the SDM causing the SDM to fall on the patient WARNING Do not spray pour or spill any liquid on the SDM its accessories connectors switches or openings in the chassis If the SDM has been wette...

Страница 12: ... diathermy electro surgery cables manufactured by SenTec AG must be used WARNING During normal operation except transport it is recommended that the monitor is always connected to the AC power outlet WARNING Do not connect the SDM to an electrical outlet controlled by a wall switch because the SDM may be accidentally turned off once the battery is depleted WARNING To avoid risk of electric shock t...

Страница 13: ...nd the accessory equipment must be connected to a grounded AC outlet In case of doubt consult qualified technicians WARNING Accessory equipment e g a PC connected to the SDM s data ports must be certified according to the IEC 60950 standard All resulting combinations of equipment must be in compliance with the IEC standard 60601 1 systems requirements Anyone who connects accessory equipment to the...

Страница 14: ...ss than or equal to 302968 provided that the open thread has not been replaced by a blind thread already or is not sealed with slotted setscrew and thread locking adhesive A screw entering 17 mm 0 67 inches into one of the SDM s screw holes may touch the primary part of the SDM s power supply If this screw is electrically conducting the resulting short circuit may cause an electrical isolation fai...

Страница 15: ...let is properly grounded disconnect the SDM from the outlet and use the battery power Contact a qualified electrician to examine the outlet for ground connections CAUTION When installing setting up the SDM ensure that the SDM can easily be disconnected from the AC power source at any given time CAUTION Use only hospital grade power cords provided by SenTec CAUTION Ensure to always use the correct ...

Страница 16: ...in physical injury inaccurate measurements and or damage to the device WARNING Chemicals from a broken LCD display panel are toxic when ingested Use caution when handling a SDM with a broken display panel Electronic components may content toxic chemicals Do not ingest chemicals from a broken electronic component WARNING Dispose of battery in accordance with local requirements and regulations CAUTI...

Страница 17: ...achment Ring MAR MI to apply SenTec TC Sensors to patients with mature intact skin MAR SF Multi Site Attachment Ring MAR SF to apply SenTec TC Sensors to patients with sensitive fragile skin SA MAR Staysite Adhesive for the Multi Site Attachment Rings attaches complementary the MAR SF MI to the skin with an additional adhesive film GEL 04 Contact Gel contact liquid to apply SenTec TC Sensors to th...

Страница 18: ...f door indicates the SDM s PO2 activation status blue if activated orange otherwise 8 Enter Button 9 Display Button 10AC Power Battery Indicator green yellow LED 11UP DOWN Buttons 12ON OFF Indicator green LED 13Status Bar 14Speaker on the side Figure 1 Front Panel of the SDM Note SDMs with firmware version SMB SW V08 00 MPB SW V06 00 are available with and without activated PO2 option If the PO2 o...

Страница 19: ...Power Connector 24ON OFF Switch Figure 2 Rear Panel of the SDM WARNING Refer to section 1 2 1 for warnings related to connecting mounting the SDM to accessory equipment CAUTION Ensure to always use the correct type and rating of live and neutral fuses Otherwise you risk damage or malfunction of the SDM CAUTION Ensure that the fan of the SDM is clear of any obstructions and that the SDM is located ...

Страница 20: ...aintenance to be performed by the operator the SenTec form HB 007601 SDMS Maintenance Checklist see section 8 7 is available refer to the Manual CD It is recommended that qualified service personnel performs the maintenance and a complete safety and functionality test as specified in this Manual at regular intervals recommended every 12 month but at least every 24 months Use the HB 005638 Protocol...

Страница 21: ...he sensor to a SDM switch the monitor on read the sensor s serial number in the menu System information and write it on the plug of the sensor cable 3 1 4 Sensor LEDs Connect the sensor to the SDM and switch on the monitor Verify that the sensor emits red light and is recognized by the SDM When using an OxiVenT Sensor additionally verify that the sensor also emits green light Note In order to be a...

Страница 22: ... the SDM to reset the message Do not use the sensor if the message Sensor Fault xx is not reset by power cycling the SDM Instead contact qualified service personnel or your local SenTec representative Do not use the sensor if the test fails CAUTION Ensure that the temperature of the water bath is 50 C Temperatures above 50 C may damage the sensor 3 1 7 Cleaning Inspecting without Membrane 1 Remove...

Страница 23: ... parts of it are missing the brown color is lost or the ring has a metallic luster then replace the sensor with a new SenTec TC Sensor The sensor has an intact brown ring around the pH glass The ring around the pH glass is intact but has a metallic luster this sensor needs to be replaced Figure 4 Top view of the V Sign Sensor 7 Inspect the sensor to ensure that the grooves on the sensor circumfere...

Страница 24: ... Sensor problem 72 PO2 sensitivity will only reset if the test was successful Note If a V Sign Sensor is connected to the SDM the function Sensitivity Test will test the sensor s PCO2 sensitivity If an OxiVenT Sensor is connected to the SDM the function Sensitivity Test will test the sensor s PCO2 and PO2 sensitivity in parallel Test the PCO2 PO2 sensitivity as follows 1 Verify that the sensor SET...

Страница 25: ...the screen until Leak test in progress see step 8 is displayed on the screen 8 After sensor calibration a leak test of the Docking Station is automatically performed In the Status Bar the Status Message Sensitivity Test is displayed while Leak test in progress is displayed on the screen If the Sensitivity Test for PCO2 failed Sensor problem 12 will display when the sensor is in the Docking Station...

Страница 26: ...lly activate the display of the calibration curve by using V STATS PC Software for the SDM 2 Verify proper function of the SenTec Sensor Tester ST DSU In particular verify the integrity of the Docking Station Verify the expiration date of the test gas bottles 3 Power cycle the SDM before starting the Slope Test i e turn the SDM off and on again to ensure that the next calibration is a so called In...

Страница 27: ...age Sensor Problem 73 will disappear from the SDM s display at this stage 9 Insert the test bottle with 30 CO2 and 21 O2 into the Sensor Tester Use the menu function PCO2 Settings Calibrate Sensor or press the ENTER Button twice to start a calibration Wait until calibration is finished and record PCO2 30 and PO2 21 i e the PCO2 value just before termination of the calibration Note If you are using...

Страница 28: ...3 Maintenance Safety Functionality Tests HB 005615 j 22 Figure 6 Examples PCO2 and PO2 Slope Test ...

Страница 29: ...145 156 655 36 8 21 0 21 9 23 3 135 146 157 660 37 1 21 2 22 1 23 5 136 147 159 665 37 4 21 4 22 3 23 7 137 148 160 670 37 7 21 6 22 5 23 9 138 150 161 675 38 0 21 8 22 7 24 1 139 151 162 680 38 3 21 9 22 9 24 3 140 152 163 685 38 6 22 1 23 0 24 5 141 153 165 690 38 9 22 3 23 2 24 7 142 154 166 695 39 2 22 5 23 4 24 9 143 155 167 700 39 5 22 7 23 6 25 1 144 156 168 705 39 8 22 9 23 8 25 3 145 157 ...

Страница 30: ...9 5 21 0 88 0 4 95 2 83 2 95 3 13 18 1 19 6 21 1 88 7 4 99 2 85 2 97 3 16 18 3 19 8 21 3 89 3 5 03 2 88 3 00 3 18 18 4 19 9 21 5 90 0 5 07 2 90 3 02 3 21 18 6 20 1 21 6 90 7 5 11 2 93 3 05 3 24 18 7 20 2 21 8 91 3 5 15 2 95 3 07 3 26 18 8 20 4 22 0 92 0 5 19 2 98 3 10 3 29 19 0 20 5 22 1 92 7 5 23 3 00 3 12 3 32 19 1 20 7 22 3 93 3 5 27 3 02 3 15 3 34 19 3 20 8 22 4 94 0 5 31 3 05 3 17 3 37 19 4 2...

Страница 31: ...9 41 127 135 144 650 78 0 37 39 41 128 137 145 655 78 6 37 39 41 129 138 146 660 79 2 38 40 42 130 139 147 665 79 8 38 40 42 131 140 148 670 80 4 38 40 42 132 141 149 675 81 0 38 41 43 133 142 150 680 81 6 39 41 43 134 143 151 685 82 2 39 41 43 135 144 152 690 82 8 39 41 43 136 145 154 695 83 4 40 42 44 137 146 155 700 84 0 40 42 44 138 147 156 705 84 6 40 42 44 139 148 157 710 85 2 40 43 45 140 1...

Страница 32: ... 2 5 5 17 2 18 3 19 4 88 0 10 6 5 0 5 3 5 5 17 4 18 5 19 6 88 7 10 6 5 1 5 3 5 6 17 5 18 6 19 7 89 3 10 7 5 1 5 4 5 6 17 6 18 8 19 9 90 0 10 8 5 1 5 4 5 7 17 8 18 9 20 0 90 7 10 9 5 2 5 4 5 7 17 9 19 0 20 2 91 3 11 0 5 2 5 5 5 8 18 0 19 2 20 3 92 0 11 0 5 2 5 5 5 8 18 2 19 3 20 5 92 7 11 1 5 3 5 6 5 8 18 3 19 5 20 6 93 3 11 2 5 3 5 6 5 9 18 4 19 6 20 8 94 0 11 3 5 4 5 6 5 9 18 6 19 7 20 9 94 7 11 ...

Страница 33: ...ormed as follows Open the Docking Station Door in order to expose the sensor to ambient air Then enable the Enforced Sensor On Patient Mode in order to start measuring PO2 i e by entering the Quick Access Menus and selecting Start Monitoring Wait until PO2 readings equilibrate stabilize usually within 2 to 10 minutes Check the atmospheric pressure Patm and verify that PO2 readings are within the r...

Страница 34: ...141 86 7 16 8 17 8 18 8 655 127 135 142 87 3 17 0 18 0 18 9 660 128 136 143 88 0 17 1 18 1 19 1 665 129 137 144 88 7 17 3 18 3 19 2 670 130 138 145 89 3 17 4 18 4 19 3 675 132 139 146 90 0 17 5 18 5 19 5 680 133 140 147 90 7 17 7 18 7 19 6 685 134 141 148 91 3 17 8 18 8 19 8 690 135 142 149 92 0 18 0 19 0 19 9 695 136 143 150 92 7 18 1 19 1 20 0 700 137 144 151 93 3 18 2 19 2 20 2 705 138 145 152 ...

Страница 35: ...be of a healthy person Compare SpO2 and PR readings against the readings of a reference pulse oximeter e g N595 with Durasensor 100 from Nellcor The SpO2 and PR reading should be within 3 SpO2 and 3 bpm respectively If this requirement is not met refer to section 4 2 1 Troubleshooting SpO2 PR monitoring to further evaluate the problem ...

Страница 36: ...presentative or send back the monitor according to section 8 6 Instructions for Shipment For SenTec authorized service technicians only If the above requirements for the front panel are not fulfilled then replace the SDM Case upper part according to the Repair Manual for the SDMS HB 005755 3 2 4 Electrical Safety Check The SenTec Digital Monitoring System SDMS has been designed to comply with the ...

Страница 37: ... 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 Table 3 Connect...

Страница 38: ...onnected to neutral of the AC power cord Ground of the Serial Data Port 4 Measurement Ground of the Sensor connection port Ground of the Serial Data Port Figure 8 Connections for the High Potential Test PC Setup with Model 7530DT HypoULTRA II from Associated Research Inc If a disruptive discharge occurs refer to section 4 2 4 SDM specific troubleshooting to further evaluate the problem 3 2 4 2 Saf...

Страница 39: ...istance Test AC Power Connector housing equipotential terminal The resistance must be more than 2 MΩ Patient Insulation Resistance Sensor Connection Port Ground housing equipotential terminal The resistance must be more than 2 MΩ Earth Leakage Current The current must be below 500 A Enclosure Leakage Current The current must be below 100 A Patient Leakage Current Test Sensor Connection Port Ground...

Страница 40: ...he message failed is displayed 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 Note The message LAN Interface supported is displayed on the POST screen if the hardware version of the SDM supports the LAN interface Note The message LED Backlight is displayed on the POST screen if the backlight is a LED...

Страница 41: ...set to OFF pressing the AUDIO PAUSED OFF Button has no function If the above described functions do not operate properly contact your local SenTec representative or return the monitor according to section 8 6 Instructions for Shipment For SenTec authorized service technicians only If the above requirements for the Keyboard are not fulfilled then replace the SDM Case upper part according to the Rep...

Страница 42: ... indicator LED s 2 Control the readability of the following critical areas graph window numerical displays status bar may be accepted If the above described functions do not operate properly contact your local SenTec representative or send back the monitor according to section 8 6 Instructions for Shipment For SenTec authorized service technicians only If the above requirements for the LEDs are no...

Страница 43: ...Pa the SDM has to be repaired Refer to section 4 2 4 SDM specific troubleshooting to further evaluate the problem 3 2 12 Analog Output Tools Multimeter 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 Rear Panel of the SDM Measure the Analog Output vol...

Страница 44: ...tion with SDM via Serial Interface this opens dialog Communication with SDM via Serial Interface with the Connection Status indicator showing the status of the communication between V STATS and the SDM for detail description see V STATS Instruction Manual Verify that data transmission between V STATS and the SDM works properly The Connection Status indicator lights green if the connection is estab...

Страница 45: ...bar of the window corresponds to the time of the SDM lagging no more than 5 seconds and that the serial number in the Monitor Configuration Status Information field corresponds to the serial number of the device under test LAN test 2 3 2 15 Capacity of Rechargeable Lithium Battery Tools A PC with a terminal emulation software Test using a PC 1 Connect the SDM to AC power and wait until the battery...

Страница 46: ...properly the SDM needs to be repaired Refer to section 4 2 4 SDM specific troubleshooting to further evaluate the problem 3 2 17 Speaker Alarm Initiate a low priority alarm e g by disconnecting the SenTec TC Sensor from the SDM Verify that the audible component of a low priority alarm is audible one burst of two pulses 1 dyad repeated every 15 seconds If the above described functions do not operat...

Страница 47: ...eplace the defective part according to section 5 Repairs Note We recommend changing the gasket of the Docking Station annually Figure 10 Correct orientation of the Docking Station Gasket 3 3 3 Gas Level Indicator Tools 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 switch the SDM ON 2 Insert the sensor in the Dockin...

Страница 48: ...tional ordinances recommended weekly For cleaning and disinfection instructions refer to the Technical Manual for the SDM HB 005752 3 4 2 Visual Inspection Check the Digital Sensor Adapter Cable for damages of the isolation Check the Digital Sensor Adapter Cable connectors for damages If you detect damages the Digital Sensor Adapter Cable needs to be replaced by a new Digital Sensor Adapter Cable ...

Страница 49: ... together top and bottom part of the Membrane Changer together see Figure 11 Opening the Membrane Changer Insert a screwdriver behind the latches and use it as leverage to break out the 6 latches WARNING Wear protective goggles while breaking out the 6 latches CAUTION This procedure will irreversibly destroy the Membrane Changer but not harm the sensor if executed with care latches removed latches...

Страница 50: ...ive The Repair or Investigation Request Form may be copied from section 8 3 Repair or Investigation Request Form 4 1 How to use the troubleshooting list The troubleshooting list describes possible defects of the device The problems are numbered PXXXX unambiguously Please reference the respective PXXXX code whenever applicable The trouble shooting list comprises up to three levels of recommended ac...

Страница 51: ...ing to section 5 16 To be performed by SenTec authorized service technicians only c SenTec authorized technician PCO2 sensitivity of the sensor too low Test the PCO2 sensitivity see section 3 1 8 PCO2 PO2 Sensitivity Calibration Duration If the test is not passed remembrane the sensor and repeat the test After a renewed missing of this difference consult qualified service personnel a operator Clea...

Страница 52: ... state conditions The PaCO2 PaO2 value obtained from ABG analysis should be compared to the SDM s PCO2 PO2 reading at the time of blood sampling In patients with functional shunts the sensor application site and the arterial sampling site should be on the same side of the shunt If the menu parameter Severinghaus Correction Mode is set to Auto the PCO2 values displayed by the SDM are automatically ...

Страница 53: ...te Typically PaCO2 is 25 mmHg in humans and PCO2 of ambient air 0 5 mmHg If the contact between the sensor and skin is not hermetically sealed PCO2 readings consequently may increase slowly after sensor application or a TC artifact and be too low thereafter Note Typically PaO2 is 100 mmHg in humans and PO2 of ambient air 130 mmHg If the contact between the sensor and skin is not hermetically seale...

Страница 54: ...e causing drift Allow the sensor to stabilize for an additional 1 2 hours i e store the sensor in the Docking Station with the monitor being switched on refer to the Technical Manual for the SDM for additional sensor stabilization related information Note After switching on the monitor or after membrane change it is recommended to store the sensor in the Docking Station with the monitor being swit...

Страница 55: ...e fit of the membrane trapped air under the membrane If needed perform an unrequested membrane exchange activate the menu Membrane Change After membrane exchange calibrate the sensor and allow the PCO2 part of the sensor to stabilize for 4 hours If no remembraning is needed allow the sensor to stabilize for an additional 2 3 hours SDM defective Contact SenTec authorized service personnel or our lo...

Страница 56: ...res than PCO2 monitoring In newborns PO2 correlates with PaO2 almost in a one to one relationship at a sensor temperature of 43 to 44 C whereby the accuracy of PO2 compared to PaO2 is best up to PaO2 80 mmHg 10 67 kPa above which it increasingly tends to read lower than PaO2 especially in adults Sensor applied to a measurement site that is inadequate not recommended for PCO2 monitoring Refer to id...

Страница 57: ...or as described in section 3 1 7 Cleaning Inspecting without Membrane and perform the Sensitivity Test as described in section 3 1 8 PCO2 PO2 Sensitivity Calibration Duration If problem persists contact SenTec authorized service personnel Docking Station door mechanically defective Replace Docking Station door according to section 5 5 Replacement Docking Station Door Gasket defective Replace gaske...

Страница 58: ...DMS Consider to use the Staysite Adhesive model SA MAR to complementary attach Multi Site Attachment Rings if more secure sensor attachment is required e g in high humidity environments for patients who perspire profusely and or in challenging patient motion conditions Electrocautery HF surgery defibrillation mainly PCO2 specific The values will come back to normal after electrocautery HF surgery ...

Страница 59: ...erify the sensor application and the appropriateness of the monitoring site Avoid any mechanical pressure stress on the sensor or measurement site Secure the sensor cable with adhesive tape and a clothing clip Note Refer to the Status Message SpO2 low signal see Technical Manual for the SDM Electrocautery HF surgery defibrillation The values will come back to normal after electro cautery HF surger...

Страница 60: ...medium etc may absorb light at the same wavelength as the one used for pulse oximetry measurements 4 2 3 Sensor specific troubleshooting Table 8 Sensor specific troubleshooting Problem Possible Cause s Recommended action s P0300 Despite a SenTec TC Sensor is connected to the SDM the message Connect sensor displays Bad contact cables not properly connected Verify connections disconnect and reconnec...

Страница 61: ...LED does not light message Connect sensor not displayed As a safety precaution sensor or SDM did switch off all power consuming parts Refer to Status Messages Temp limiter active Sensor problem 38 Sensor problem 42 Sensor fault 39 Sensor fault 43 see Technical Manual for the SDM Red LED defective Refer to messages Sensor problem 20 Sensor fault 20 and Sensor fault 21 see Technical Manual for the S...

Страница 62: ...akes almost 14 minutes or cannot be completed within 14 minutes Note If the PCO2 calibration takes 14 minutes the message PCO2 slow displays and PCO2 subsequently will be flagged as questionable Note If the PCO2 calibration cannot be finished within 14 minutes the message Sensor problem 11 displays and PCO2 subsequently will be flagged as invalid Note If the calibration cannot be finished within a...

Страница 63: ...ls contact qualified service personnel to clean the sensor without membrane Clean Inspect the sensor as described in section 3 1 7 Cleaning Inspecting without Membrane and perform the Sensitivity Test as described in section 3 1 8 PCO2 PO2 Sensitivity Calibration Duration If problem persists contact SenTec authorized service personnel SenTec TC Sensor defective If the problem persists the SenTec T...

Страница 64: ...fic troubleshooting to further evaluate the problem P0309 OxiVenT Sensor connected to SDM but PO2 measurement flagged to be invalid or not available PO2 option of the SDM not activated or if activated PO2 not enabled in the menu of the SDM Ensure that PO2 option of the SDM is activated and PO2 is enabled in the menu of the SDM After doing so verify that the off centered white spot is illuminated i...

Страница 65: ...minated SDM switched off Switch on SDM SDM not connected to mains and battery depleted Connect the SDM to the mains Allow battery to charge Mains power supply defective Choose another mains power supply for connecting the SDM SDM defective Switch the SDM off and on again If problem persists contact qualified service personnel Main fuses defective Replace main fuses according to section 5 4 Replace...

Страница 66: ...nual for the SDMS To be performed by SenTec authorized service technicians only SMBC Controller Board defective Replace SMBC according to the Repair Manual for the SDMS To be performed by SenTec authorized service technicians only SMBM Motherboard defective Replace SMBM according to the Repair Manual for the SDMS To be performed by SenTec authorized service technicians only P0402 fully charged Bat...

Страница 67: ...ective Replace Display Module according to the Repair Manual for the SDMS To be performed by SenTec authorized service technicians only P0403 P0504 Display is dark ON OFF indicator is illuminated OR Display is not readable dark SDM in Sleep Mode Press any button If the problem persists switch the SDM off and on again If problem persists contact qualified service personnel Brightness not adjusted c...

Страница 68: ...ce SMBC according to the Repair Manual for the SDMS To be performed by SenTec authorized service technicians only SMBM Motherboard defective Replace SMBM according to the Repair Manual for the SDMS To be performed by SenTec authorized service technicians only P0406 SDM does not react if any button is pressed Menu Access disabled Refer to P0420 SDM firmware is not responding firmware has crashed Sw...

Страница 69: ...y on SMBC according to the Repair Manual for the SDMS To be performed by SenTec authorized service technicians only SMBC Controller Board defective Replace SMBC according to the Repair Manual for the SDMS To be performed by SenTec authorized service technicians only P0408 Wrong unstable barometric pressure Barometer chip defective Verify that the barometric pressure reading of the SDM is stable du...

Страница 70: ...10 Fan is blocked Fan defective or polluted The fan has to be able to rotate freely Check ventilation slots if something is blocking the fan If problem persists contact qualified service personnel SDM defective Contact SenTec authorized service personnel Fan not connected Connect Fan according to the Repair Manual for the SDMS To be performed by SenTec authorized service technicians only Fan pollu...

Страница 71: ...according to the Repair Manual for the SDMS To be performed by SenTec authorized service technicians only Speaker defective Replace Speaker according to the Repair Manual for the SDMS To be performed by SenTec authorized service technicians only SMBC Controller Board defective Replace SMBC according to the Repair Manual for the SDMS To be performed by SenTec authorized service technicians only SMB...

Страница 72: ...ble Contact qualified service personnel SDM defective Contact SenTec authorized service personnel SMBC Controller Board defective Replace SMBC according to the Repair Manual for the SDMS To be performed by SenTec authorized service technicians only SMBM Motherboard defective Replace SMBM according to the Repair Manual for the SDMS To be performed by SenTec authorized service technicians only P0415...

Страница 73: ...o be performed by SenTec authorized service technicians only SMBM Motherboard defective Replace SMBM according to the Repair Manual for the SDMS To be performed by SenTec authorized service technicians only P0417 Safety test does not comply SDM defective Contact SenTec authorized service personnel Protective Earth Resistance is more than 0 2 Ω Control the Protective Earth wiring between the AC Pow...

Страница 74: ...ait 5 seconds Contact qualified service personnel if the problem persists SDM defective Contact SenTec authorized service personnel DS Module defective Replace DS Module according to the Repair Manual for the SDMS To be performed by SenTec authorized service technicians only P0419 Despite a SenTec TC Sensor is connected to the SDM the message Connect sensor displays Refer to P0300 P0420 SDM Menu c...

Страница 75: ...nically defective Replace Support for Docking Station Door according to the Repair Manual for the SDMS To be performed by SenTec authorized service technicians only P0501 Message Docking Station Fault is displayed Contaminations e g gel residues disturb the gas flow Clean Docking Station and SenTec TC Sensor and then insert the sensor into the Docking Station If problem persists contact qualified ...

Страница 76: ...ion door according to section 5 5 Replacement Docking Station Door Gasket defective missing Place gasket correctly in the chamber in the Docking Station according to section 5 6 Replacement Docking Station Gasket SDM defective Contact SenTec authorized service personnel Calibration Module defective Replace Calibration Module according to the Repair Manual for the SDMS To be performed by SenTec aut...

Страница 77: ...whether DP01 status code is flagged Contact qualified service personnel High pressure part of the Docking Station Module is leaky Contact qualified service personnel Unstable sensor requiring too many calibrations Remembrane sensor and observe gas consumption If problem persists contact qualified service personnel SDM defective Contact SenTec authorized service personnel Gasket in the Docking Stat...

Страница 78: ...ooting HB 005615 j 72 Problem Possible Cause s Recommended action s P0505 Sensor calibration does not start Sensor LED is illuminated Refer to P0308 P0506 Gas Level Indicator shows wrong indication Refer to P0418 ...

Страница 79: ...r Investigation Request Form may be copied from section 8 3 Repair or Investigation Request Form To ensure traceability a regulatory requirement SenTec AG needs to know the serial and LOT numbers as well as software versions of all components of the SDMS This means if you replace parts of the SDM of if you perform a software update you must report the serial number of the respective SDM and the se...

Страница 80: ...that the sender completed and enclosed the Disinfection Certificate see section 8 7 2 If necessary clean and disinfect the device as described in the corresponding section of the Technical Manual for the SDM 3 Set the ON OFF Switch of the SDM to OFF 4 Disconnect all connections on the rear panel of the device 5 2 Replacement Tip up Foot 1 Follow the procedure described in section 5 1 Prior to Repa...

Страница 81: ...he glue to dry Figure 13 Replacement Silicon Foot 5 4 Replacement main fuses 1 Follow the procedure described in section 5 1 Prior to Repair 2 Remove the fuse holder from the AC Power Connector by compressing the two tabs on both sides of the lid and pulling out the fuse holder according to Figure 14 Replacement Main Fuses 3 Replace the defective fuses with time delay high breaking capacity fuses ...

Страница 82: ...to the case with an aperture angle of the door of 45 see section 8 2 Testing Accessories and Spare Parts 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 5 Switch on the monitor 6 Put the sensor into the Docking Station to calibration the sensor After calibration wait 6 minu...

Страница 83: ...special carefully the lining groove as described above if grease or talcum powder has been used before 5 Insert a new asymmetric gasket see Figure 16 Replacement Docking Station Gasket and Figure 17 Positioning of the Docking Station Gasket by pressing it with a cotton swab soaked with 70 isopropanol into the lining groove Make sure that no cotton fibers remain on the gasket as this might cause le...

Страница 84: ...5 Repairs of the SDM HB 005615 j 78 Figure 17 Positioning of the Docking Station Gasket ...

Страница 85: ...e Signal Analysis Algorithm The SMBC and MPB software can be updated by trained and authorized personnel by flashing a new version in the flash memory of the existing boards note detailed instructions are included in separate documents WARNING Software updates of the SDM must be carried out by trained and authorized personnel Software updates must be reported to SenTec by using the Repair Reportin...

Страница 86: ...f the respective country Note By recycling materials or other forms of utilizing old devices you are making an important contribution to protecting our environment 7 1 SenTec Digital Monitor Return the SDM to your local SenTec representative or dispose it according to local regulations 7 2 Cables Dispose the cables according to local regulations The copper contained can be recycled 7 3 SenTec TC S...

Страница 87: ...nTec AG Use of other than supplied or recommended parts may result in physical injury inaccurate measurement and or damage to the device Contact SenTec authorized service personnel 8 3 Repair or Investigation Request Form Please refer to the document HB 005643 8 4 Repair Reporting Form Please refer to the document HB 005729 8 5 Customer Feedback Form Please refer to the document HB 006872 8 6 Inst...

Страница 88: ... The three interface connectors serial data port Multipurpose I O port analog outputs nurse call LAN port of the SDM are not separated from each other If at a time accessory equipment is connected to only one of the three interface connectors no additional safety measures are necessary to comply with the requirements of IEC 60601 1 If however accessory equipment is simultaneously connected to two ...

Страница 89: ...18 Sensor Connection Port Table 11 Pin Assignment Sensor Connection Port Pin s Signal 1 3 reserved 4 Signal Ground 5 Received Data RX from Sensor 6 Transmitted Data TX to Sensor 7 9 reserved 10 5 V for sensor supply only 11 Supply Ground 12 3 3 V for sensor supply only 13 14 reserved ...

Страница 90: ...6 9 Figure 19 Serial Data Port RS 232 Table 12 Pin Assignment Serial Data Port RS 232 Pin s Signal 1 reserved 2 Transmitted Data TX from SDM 3 Received Data RX to SDM 4 reserved 5 Signal Ground 6 9 reserved 8 9 3 Multipurpose I O Port Figure 20 Multipurpose I O Port ...

Страница 91: ...6 SpO2 Ground 7 PCO2 Signal Voltage 0 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 4 5 15 0 8 18 0 10 0 27 0 16 0 27 0 0 10 0 0 15 0 0 27 0 kPA 8 PCO2 Ground 9 13 reserved 14 Ground 15 16 reserved 17 Ground 18 19 reserved 20 21 Ground 22 3 3 V max 15 mA 23 Ground Nurse Call 24 Common lead for Nurse Call relays 1 2 24 25 Nurse Ca...

Страница 92: ...to a network hub or switch You may also use a cross over Ethernet cable for direct connection of the monitor to a computer without a hub or switch Note While trend data are downloaded via the LAN interface the serial interface of the SDM is inactivated Once data download via the LAN interface is completed the serial interface is reactivated 8 10 Technical Specifications See the corresponding secti...

Страница 93: ...8 Appendix SenTec Digital Monitoring System 87 HB 005615 j Date of release 02 2019 ...

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