Model 510-511 Preventative Maintenance Test Procedure
Contents
1. Pass Pass Pass Pass Pass Pass Pass Pass Completed Completed Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass Page 12 of 14 Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail N Nek Rar Nat a Nat weer wv wee w a w w CAS MEDICAL SYSTEMS INC MAINTENANCE Page 13 of 14 PROCEDURES TECHNOLOGY APPLIED TO MEDICINE Part Number 510 511 21 02 0170 Preventative Maintenance Test Procedure 1 6 Respiration Response Test A Set the simulator to the following settings a _ Set the HEART Rate to 120 Completed b Set the BREATH Rate to 15 Completed B Verify monitor counts rates set on simulator with no alarms Pass Fal C Set the BREATH Rate to 40 Verify the monitor counts rate set on simulator with no alarms Pass Fail D Set the BREATH Rate to 60 Verify the monitor counts rate set on simulator with no alarms Pass Fail E Set the BREATH Rate to 80 Verify the monitor counts rate set on simulator with no alarms Pass Fal 1 7 Improper Shutoff Test Sibling Protection Alarm A Depress the front panel DISPLAY ON OFF pushbutton switch Verify 1 _ al2. a LEAD CHANGE OFF Completed b TEST SIMULATE ELECTRODE TEST Completed c HEART BPM 120 Completed d BREATH BPM 15 Completed B Turn the simulator ON Completed C Verify one of the following conditions 1 Simulator displays a 1 at the far left of the LCD display Pass Fail 2 _ Simulator displays BAT in the upper left corner of the LCD display Pass Fail D Verify the red APNEA indicator is not lit Pass Fal 2 Monitor Setup A Power up the monitor Completed B Access the Configuration Menus Completed C At PRESS ANY KEY press any key to enter the Configuration Menus Completed D At ALARM LIMITS press the pushbutton switch to select Completed E Set the APNEA Alarm Limit to 20 SEC Completed F _ Set the LOW HR Alarm Limit to 40 BPM Completed G Set the HIGH HR Alarm Limit to 200 BPM Completed H Set the LOW SPO2 to 88 Completed CAS MEDICAL SYSTEMS INC MAINTENANCE Page 11 of 14 TECHNOLOGY APPLIED TO MEDICINE PROCEDURES Part Number 510 511 21 02 0170 Preventative Maintenance Test Procedure I Set the HIGH SPO2 to 96 511 only Completed J Set the PB to OFF Completed K Press the pushbutton switch to EXIT the ALARM LIMITS Completed L Press the pushbutton switch and select the SETUP MENU Completed M At SETUP MENU press the pushbutton switch to select Completed N Set the ALARM VOLUME to 1
3. 1 0 seconds If the monitor is a Model 511 also verify the RESPIRATION numeric value is flashing Press the APNEA button on the simulator Verify 1 the red APNEA indicator on the simulator is not lit 2 the RESPIRATION indicator is flashing at the rate set on the simulator 3 the monitor audible alarm silences and 4 the APNEA visual indicator on the monitor remains on If the monitor is a Model 511 also verify the RESPIRATION numeric value is no longer flashing Press the RESET RESET MUTE pushbutton switch on the monitor Verify the APNEA visual indicator clears and the HEART RATE and RESPIRATION indicators are flashing at the rates set on the simulator Proceed to Heart Beat Respiration Test 1 4 Heart Rate Respiration Test A Set the simulator to the following settings a Set the HEART Rate to 60 BPM b Set the BREATH Rate to 60 BrPM Verify 1 the HEART RATE indicator continues to flash at the rate set on the simulator 2 the RESPIRATION indicator is no longer flashing and 3 the monitor audible alarm and APNEA visual indicator are activated after 20 seconds If the monitor is a Model 511 also verify the RESPIRATION numeric value is flashing Set the simulator BREATH Rate to 40 BrPM Verify 1 the monitor audible alarm silences 2 the HEART RATE and RESPIRATION indicators are flashing at the rates set on the simulator and 3 the APNEA visual indicator remains on If the monitor is a Model 511 also verify the RESPI
4. s Manual for assistance At PRESS ANY KEY press any key to enter the Configuration Menus At ALARM LIMITS press the pushbutton switch to select If the monitor is a Model 510 or if Sibling Protection is enabled enter the password Set the APNEA Alarm Limit to 20 SEC Set the LOW HEART RATE LOW HR Alarm Limit to 40 BPM Set the HIGH HEART RATE HIGH HR Alarm Limit to 200 BPM Set the LOW SPO2 to 88 Set the HIGH SPO2 to 96 Model 511 only Set PB Periodic Breathing to OFF Press the pushbutton switch to EXIT the ALARM LIMITS Press the 1 pushbutton switch and select the SETUP MENU At SETUP MENU press the pushbutton switch to select If the monitor is a Model 510 or if Sibling Protection is enabled enter the password Set the ALARM VOLUME to 1 Set the QRS VOLUME to 1 Model 511 only Set the PATIENT MODE to INFANT At CLEAR MEMORY press the TO SELECT pushbutton switch Set the DATE TIME to the current Day Month Year Hour and Minute If the unit has a Memory Card installed set the ECG Trace Storage to OFF If the unit has a Memory Card installed set the SPO2 Trace Storage to OFF If the unit has a Memory Card installed set the Auxiliary Trace Storage to OFF Set the ID Number to 000001234 Press the pushbutton switch to EXIT the SETUP MENU Turn the Model 51X monitor OFF If Sibling Protection is not enabled Press the front panel DISPLAY ON OFF pushbutt
5. Heart Rate Respiration Test A Set the simulator to the following settings a _ Set the HEART Rate to 60 b Set the BREATH Rate to 60 Verify 1 the HEART RATE indicator continues to flash at the rate set on the simulator 2 the RESPIRATION indicator is no longer flashing 3 the monitor audible alarm and APNEA visual indicator are activated after 20 seconds For Model 511 Verify RESPIRATION numeric value is flashing Set the simulator BREATH Rate to 40 Verify 1 the monitor audible alarm silences 2 the HEART RATE and RESPIRATION indicators flash at the rates set on the simulator 3 the APNEA visual indicator remains on For Model 511 Verify RESPIRATION numeric value is no longer flashing Press RESET Verify APNEA visual clears and the monitor counts rates set on simulator 1 5 Lead Off Alarm Test A Disconnect a lead wire from the simulator Verify 1 the HEART RATE and RESPIRATION indicators are no longer flashing 2 LEAD OFF visual and audible alarms For Model 511 Verify HEART RATE and RESPIRATION numeric values are dashes Reconnect the lead wire to the simulator Verify 1 audible alarm silences 2 the HEART RATE and RESPIRATION indicators flash at the rates set on the simulator 3 LEAD OFF visual remains on For Model 511 Verify both numeric values are correctly displayed Press RESET Verify LEAD OFF visual clears and monitor counts rates set on simulator Pass
6. a Set the HEART Rate to 120 BPM b Set the BREATH Rate to 15 BrPM Verify the HEART BEAT and RESPIRATION indicators are flashing at the rate set on the simulator with no other Human Alarm visual indicators or audible alarms active Set the BREATH Rate to 40 BrPM Verify the HEART RATE and RESPIRATION indicators are flashing at the rate set on the simulator with no other Human Alarm visual indicators or audible alarms active Set the BREATH Rate to 60 BrPM Verify the HEART RATE and RESPIRATION indicators are flashing at the rate set on the simulator with no other Human Alarm visual indicators or audible alarms active Set the BREATH Rate to 80 BrPM Verify the HEART RATE and RESPIRATION indicators are flashing at the rate set on the simulator with no other Human Alarm visual indicators or audible alarms active Proceed to Improper Shutoff Test U cas MEDICAL SYSTEMS INC MAINTENANCE Page 9 of 14 TECHNOLOGY APPLIED TO MEDICINE PR O CEDURE S Part Number Rev 510 511 21 02 0170 00 Preventative Maintenance Test Procedure 1 7 Improper Shutoff Test Sibling Protection Alarm Model 510 or Model 511 if enabled A Depress the front panel DISPLAY ON OFF pushbutton switch Verify 1 all the front panel visual indicators are turned ON 2 an audible alarm is active If the monitor is a Model 511 also verify the HEART RATE numerics indicate 888 the RESPIRATION and SpO if installed numerics indicate 188 B Depr
7. numeric value is no longer flashing Press the RESET RESET MUTE pushbutton switch on the monitor Verify the HIGH visual indicator clears and the HEART RATE and RESPIRATION indicators are flashing at the rates set on the simulator Proceed to Low Heart Rate Alarm Test 1 2 Low Heart Rate Alarm Test A Set the simulator HEART Rate to 30 BPM Verify the monitor s HEART RATE LOW visual indicator and audible alarm activate If the monitor is a Model 511 also verify the HEART RATE numeric value is flashing Set the simulator HEART Rate to 60 BPM Verify the monitor audible alarm silences and the HEART RATE LOW visual indicator remains on If the monitor is a Model 511 also verify the HEART RATE numeric value is no longer flashing Press the RESET RESET MUTE pushbutton switch on the monitor Verify the LOW visual indicator clears and the HEART RATE and RESPIRATION indicators are flashing at the rates set on the simulator Proceed to Apnea Alarm Test TECHNOLOGY APPLIED TO MEDICINE U cas MEDICAL SYSTEMS INC MAINTENANCE Page 7 of 14 PROCEDURES Part Number Rev 510 511 21 02 0170 00 Preventative Maintenance Test Procedure 1 3 Apnea Alarm Test A Press the APNEA button on the simulator Verify 1 the red APNEA indicator on the simulator is lit 2 Begin timing for apnea with the last Respiration pulse Stop timing when the monitor s APNEA visual and audio alarm activates Verify the time is 20
8. value is no longer flashing Pass Fail E Press RESET Verify HIGH visual clears and monitor counts rates set on simulator Pass Fail 1 2 Low Heart Rate Alarm Test A Set the simulator HEART Rate to 30 Verify LOW visual and audible alarms Pass Fail For Model 511 Verify HEART RATE numeric value is flashing Pass Fail B Set the simulator HEART Rate to 60 Verify audible stops and LOW visual remains on Pass Fail For Model 511 Verify HEART RATE numeric value is no longer flashing Pass Fail C Press RESET Verify LOW visual clears and monitor counts rates set on simulator Pass Fal CAS MEDICAL SYSTEMS INC TECHNOLOGY APPLIED TO MEDICINE Part Number MAINTENANCE PROCEDURES 510 511 Preventative Maintenance Test Procedure 21 02 0170 1 3 Apnea Alarm Test A Press the APNEA button on the simulator and verify 1 the red APNEA indicator on the simulator is lit 2 Verify the time to be 20 1 0 seconds For Model 511 Verify RESPIRATION numeric value is flashing Press the APNEA button on the simulator Verify 1 the red APNEA indicator on the simulator is not lit 2 the RESPIRATION indicator is flashing at rate set on simulator 3 the audible stops 4 the APNEA visual remains on For Model 511 Verify RESPIRATION numeric value is no longer flashing Press RESET on monitor Verify APNEA visual clears and monitor counts rates set on simulator 1 4
9. your records and mail the original sign off sheet to CAS Medical Systems Inc 203 488 6056 800 227 4414 US only phone 44 E Industrial Rd 203 488 9438 fax Branford CT 06405 www casmed com U S A ATTN Product Support Manager This Sign Off Sheet may be copied if additional individuals will be certified
10. CAS MEDICAL SYSTEMS INC 510 511 Cardiorespiratory Monitor Preventative Maintenance Test Procedure using the 2301 Multi Function Tester CAS Meo Systems INC TECHADLDOY AMLEDD TO MEDICIRB 44 Eas oie 2A o a www techsrv casmed com www casmed com 21 02 0170 Rev 00 07 02 U cas MEDICAL SYSTEMS INC MAINTENANCE Page 2 of 14 TECHNOLOGY APPLIED TO MEDICINE PROCEDURES Part Number Rev 510 511 21 02 0170 Preventative Maintenance Test Procedure TABLE OF CONTENTS I COPS s ER SR SR a R 3 ll Maintenance Intervals 222222nnaaaasnnnnana 3 lll Equipment Required cccceeeeeeeeeeeeeeeeeees 3 IV Initial Setup cessvicseveccerccieetenteeicncceestevenecensdach 4 V Equipment Set p v200smssssnssnananieksskunnsnaaannaka 4 1 Simulator Setup aaaaanaaaaanvaaa annnunnnana 4 2 Monitor SetU ssst sssska ndl vbkasaan aka kun 5 VI Preventative Maintenance Test 1 Functional Test aanaaaanaaasnnnnnnnnnununa 6 1 1 High Heart Rate Alarm Test 6 1 2 Low Heart Rate Alarm Test 6 1 3 Apnea Alarm Test 2222asnnvaaaaii 7 1 4 Heart Rate Respiration Test 7 1 5 Lead Off Alarm Test aaa22nnnanns nni 8 1 6 Respiration Rate Test 8 1 7 Improper Shutoff Test 9 VII Test Data Sheet 2aa2anaaaaaannaaasnnn nunnnnnnnnnnnn 10 Vill Certification Acknowledgement Sign
11. Completed O Set the QRS VOLUME to 1 Completed P Set the PATIENT MODE to INFANT Completed Q At CLEAR MEMORY press the TO SELECT pushbutton switch Completed R Set the DATE TIME to the current Day Month Year Hour and Minute Completed S _ If the unit has a Memory Card installed set the ECG Trace Storage to OFF Completed T _ If the unit has a Memory Card installed set the SPO2 Trace Storage to OFF Completed U If the unit has a Memory Card installed set the Auxiliary Trace Storage to OFF Completed V Set the ID Number to 000001234 Completed W Press the pushbutton switch to EXIT the SETUP MENU Completed X Turn the Model 51X monitor OFF Completed VI Preventative Maintenance Test 1 Functional Test 1 1 High Heart Rate Alarm Test A Turn the monitor ON Verify the visual indicator is lit Pass Fal B Verify monitor counts rates set on simulator with no alarms Pass Fal For Model 511 verify 1 the numeric values for HEART RATE and RESPIRATION are correct Pass Fal 2 an audible beep is heard with each heartbeat Pass Fal C Set the simulator HEART Rate to 240 Verify HIGH visual and audible alarms Pass Fail For Model 511 Verify HEART RATE numeric value is flashing Pass Fail D Set the simulator HEART Rate to 120 Verify audible stops and HIGH visual remains on Pass Fail For Model 511 Verify HEART RATE numeric
12. Off Sheet 14 TECHNOLOGY APPLIED TO MEDICINE U cas MEDICAL SYSTEMS INC MAINTENANCE Page 3 of 14 PROCEDURES Part Number Rev 510 511 21 02 0170 00 Preventative Maintenance Test Procedure Note Scope The purpose of this procedure is to provide a means by which a qualified person can perform a Preventative Maintenance Test to a Model 510 or Model 511 Cardiorespiratory Monitor Maintenance Intervals CAS Medical Systems Inc recommends the following Maintenance Intervals for the Model 510 or Model 511 monitor e Preventative Maintenance In Between Patients e Bench Testing Once every year e Battery and Audio Indicator Replacement Every 3 three years performed at CAS Medical Systems Equipment Required To perform this procedure you will need the following Model 510 or 511 monitor hereafter referred to as 51X Power Supply Charger p n 01 04 0004 AC Power Cord p n 01 04 0016 Model 2301 Multi Function Tester p n 01 05 0025 Patient Cable p n 01 04 0106 Lead Wires p n 01 04 0110 Stopwatch or equivalent Model 510 and 511 Operator s Manual reference material p n 21 02 0062 Model 2301 User s Manual reference material p n 21 02 0102 Simulator This procedure is based on the CAS Medical System s Model 2301 Multi Function Tester Should one not be available a compatible fully calibrated simulator with similar settings will be acceptable The simulator s Make Model and Calibr
13. RATION numeric value is no longer flashing Press the RESET RESET MUTE pushbutton switch on the monitor Verify the APNEA visual indicator clears and the HEART RATE and RESPIRATION indicators are flashing at the rates set on the simulator Proceed to the Lead Off Alarm Test TECHNOLOGY APPLIED TO MEDICINE U cas MEDICAL SYSTEMS INC MAINTENANCE Page 8 of 14 PROCEDURES Part Number Rev 510 511 21 02 0170 00 Preventative Maintenance Test Procedure 1 5 Lead Off Alarm Test A Disconnect a lead wire from the simulator Verify 1 the HEART RATE and RESPIRATION indicators are no longer flashing and 2 the monitor LEAD OFF visual indicator and audible alarm activate If the monitor is a Model 511 verify both the HEART RATE and RESPIRATION numeric values indicate dashes Reconnect the lead wire to the simulator Verify 1 the monitor audible alarm silences 2 the HEART RATE and RESPIRATION indicators are flashing at the rates set on the simulator and 3 the LEAD OFF visual indicator remains on If the monitor is a Model 511 verify the HEART RATE and RESPIRATION numeric values are correctly displayed Press the RESET RESET MUTE pushbutton switch on the monitor Verify the LEAD OFF visual indicator clears and the HEART RATE and RESPIRATION indicators are flashing at the rates set on the simulator Proceed to Respiration Rate Test 1 6 Respiration Rate Test A Set the simulator to the following settings
14. TEST SIMULATE ELECTRODE TEST c HEART BPM 120 Beats Per Minute d BREATH BPM 15 Breaths Per Minute Turn the Simulator ON Once the Simulator has completed its power on sequence verify one of the following 1 Ifthe simulator displays a 1 at the far left of the LCD the value is meaningless and should be disregarded 2 Ifthe simulator displays BAT in the upper left corner of the LCD the 9 Volt battery needs to be replaced Verify the red APNEA indicator is not lit TECHNOLOGY APPLIED TO MEDICINE U cas MEDICAL SYSTEMS INC MAINTENANCE Page 5 of 14 PROCEDURES Part Number Rev 510 511 21 02 0170 00 Preventative Maintenance Test Procedure vo Z o g SP AR R Oo Z Q gt NOTE KESAJINDOVTOZ Monitor Setup Power up the monitor To power up the monitor depress the front panel DISPLAY ON OFF pushbutton switch Access the Configuration Menus To access the Configuration Menus The LCD Control Panel access door located on the bottom of the monitor must be opened to gain access and view the Configuration Menus Once the monitor is turned ON and completes its Initialization the LCD control panel defaults to a status screen where messages can be viewed The and pushbutton switches are used to enter exit and make selections within the Configuration Menus provided Alarm Limits Setup Menu and Other Refer to Section 3 Configuration Menus in the Operator
15. ation Date should be noted on the Data Sheet The Data Sheet should also be marked with the values that were used during the procedure for each step Data Sheet Requirement This procedure uses a Data Sheet as the record for verifying monitor performance Once the procedure is completed CAS recommends the Data Sheet be kept with the respective monitor s Device History Record should verification of monitor performance be questioned TECHNOLOGY APPLIED TO MEDICINE CAS MEDICAL SYSTEMS INC MAINTENANCE Page 4 of 14 45 PROCEDURES Part Number Rev 510 511 21 02 0170 00 Preventative Maintenance Test Procedure IV Initial Setup A B Connect the 6 six pin Power Supply Charger connector to its mating receptacle located on the rear panel of the monitor Connect the power cord to the power input receptacle on the Power Supply Charger Plug the other end of the power cord into a properly grounded A C outlet of the appropriate voltage Verify the green CHARGING visual indicator located on the front panel of the monitor is lit Connect the Patient lead wires to the Patient Cable white to RA black to LA Plug the male end of the lead wires into the Simulator white to white jack black to black jack Connect the Patient Cable to the ECG RESP input receptacle located on the front panel of the monitor Equipment Setup 1 A Simulator Setup Set the switches on the Model 2301 as follows a LEAD CHANGE OFF b
16. ess the DISPLAY ON OFF pushbutton switch Verify 1 the audible alarm silences and 2 the monitor performs a reset and continues to count at the rates set on the simulator C Turn the monitor OFF Turn the simulator OFF Disconnect the simulator from the monitor This concludes the Model 510 511 Preventative Maintenance Test Procedure Should you have any questions do not hesitate to contact CAS Technical Support at 203 488 6056 800 227 4414 US only phone 203 488 9438 fax or www techsrv casmed com email CAS MEDICAL SYSTEMS INC MAINTENANCE Page 10 of 14 TECHNOLOGY APPLIED TO MEDICINE PROCEDURES Part Number 510 511 21 02 0170 Preventative Maintenance Test Procedure Date Vil Test Data Sheet Tested By 510 511 Monitor using the 2301 Multi Function Tester Home Care Dealer Hospital Monitor Type select one 510 0 511 Address Monitor Serial Number City Simulator Type Serial Number State CS Zipp2_ Simulator Calibration Date IV Initial Setup A Connect the 6 six pin charger cord to the monitor Completed B Connect the power cord to the Power Supply Charger Verify green CHARGING indicator is lit Pass Fail C Connect the Patient lead wires to the Patient Cable and Simulator Completed D Connect the Patient Cable to the ECG RESP input on the monitor Completed V Equipment Setup 1 Simulator Setup A Set the switches on the 2301 simulator
17. l front panel visual indicators are turned ON Pass Fal 2 an audible alarm is active Pass Fal For Model 511 HEART RATE numerics 888 RESPIRATION and SpO2 if installed numerics 188 Pass Fail B Depress the DISPLAY ON OFF pushbutton switch Verify 1 the audible alarm silences Pass Fail 2 the monitor performs a reset and continues to count at the rates set on the simulator Pass Fail C Turn the monitor OFF Pass Fal If the monitor fails to pass any part of this procedure please return a copy of this Data Sheet with the monitor when it is returned for service Comments This concludes the Model 510 511 Test Data Sheet U cas MEDICAL SYSTEMS INC MAINTENANCE Page 14 of 14 TECHNOLOGY APPLIED TO MEDICINE PROCEDURES Part Number Rev 510 511 21 02 0170 00 Preventative Maintenance Test Procedure Vill Certification Acknowledgement Sign Off Sheet Home Care Dealer Hospital Address City Sateen Zip Phone Fax Phone By signing below I have read and understood the Model 510 511 Preventative Maintenance Test Procedure and agree to adhere to it using the equipment required to the best of my ability Print Name as it would appear on the certificate of the individual being certified Signature Date Email Address Would you like to be contacted concerning any product updates improvements Yes No Once completed keep a copy for
18. on If the monitor is a Model 510 or if Sibling Protection is enabled Press and hold the RESET RESET MUTE pushbutton for at least 3 three seconds continue to hold the pushbutton and then push the DISPLAY ON OFF pushbutton U cas MEDICAL SYSTEMS INC MAINTENANCE Page 6 of 14 TECHNOLOGY APPLIED TO MEDICINE PROCEDURES Part Number Rev 510 511 21 02 0170 00 Preventative Maintenance Test Procedure Vi Preventative Maintenance Test 1 as Functional Test High Heart Rate Alarm Test Turn ON the monitor by pressing the front panel DISPLAY ON OFF pushbutton Verify the green visual indicator next to the DISPLAY ON OFF pushbutton switch is lit Once the monitor has completed its power up sequence verify the HEART RATE and RESPIRATION visual indicators are flashing at the rates set on the simulator with no Human Alarm visual indicators or audible alarms active If the monitor is a Model 511 verify 1 the numeric values for HEART RATE and RESPIRATION are correct and 2 an audible beep is heard with each heartbeat Set the simulator HEART Rate to 240 BPM Verify the monitor s HEART RATE HIGH visual indicator and audible alarm activate If the monitor is a Model 511 also verify the HEART RATE numeric value is flashing Set the simulator HEART Rate to 120 BPM Verify the monitor audible alarm silences and the HEART RATE HIGH visual indicator remains on If the monitor is a Model 511 also verify the HEART RATE
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