Apnea Monitor Preventative Maintenance Test Procedure
Contents
1. Pass Fail C Press RESET Verify HEART SLOW visual clears Pass Fait 1 3 Heart Fast Alarm Test A Set the simulator HEART Rate to 240 Verify HEART FAST visual and audible alarms Pass Fait B Set the simulator HEART Rate to 120 Verify audible stops and HEART FAST visual remains on Pass Fail C Press RESET Verify HEART FAST visual clears Pass Fait 1 4 Loose Lead Alarm Test A Disconnect a lead wire from the simulator Verify LOOSE LEAD visual and audible alarms Pass Fait B Reconnect the lead wire to the simulator Verify the audible stops and LOOSE LEAD visual remains on Pass Fait C Press RESET Verify LOOSE LEAD visual clears Pass Fait CAS MEDICAL SYSTEMS INC TECHNOLOGY APPLIED TO MEDICINE Part Number 21 02 0162 Ami 1 5 Respiration Rate Test A amon D 1 6 Set the simulator to the following settings a Set the HEART Rate to 120 b Set the BREATH Rate to 15 Verify the monitor counts rate set on simulator with no alarms Set the BREATH Rate to 40 Verify the monitor counts rate set on simulator with no alarms Set the BREATH Rate to 60 Verify the monitor counts rate set on simulator with no alarms Set the BREATH Rate to 80 Verify the monitor counts rate set on simulator with no alarms Set the simulator BREATH Rate to 15 Heart Beat Respiration Test A Set the simulator to the following settings a Set the HEART Rate to 60 b Set the B2. 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 Fait 2 Ami Monitor Setup A Hmommoo w Power up the monitor in the Setup Mode Completed At NEW PATIENT select YES Completed At ARE YOU SURE select YES Verify monitor displays CLEARING MEMORY Pass Fait At PATIENT NAME enter your initials Completed At PATIENT NUMBER enter 1234 Completed Set BRADYCARDIA OPTION to 3 BEAT 6 SECOND MAX Completed Set AUX PORT 1 to O2 SAT Completed Set OXIMETER CHOICE to NPB 290 295 395 Completed Set AUX PORT 2 to 02 PR Completed CAS MEDICAL SYSTEMS INC MAINTENANCE Page 10 of 12 TECHNOLOGY APPLIED TO MEDICINE PROCEDURES Part Roi art Number 21 02 0162 _ Ami Ami Plus Preventative Maintenance Test Procedure J Ser AUX PORT 3 to AIR FLOW Completed K Set PRIORITY FIFO CONTINUE to FIFO Completed L Set FIXED FULL LENGTH to FIXED 2 MINUTE Completed M Set APNEA MONITOR ALARM LIMIT to 10 SEC Completed N Set HEART FAST MONITOR ALARM LIMIT to 125 BPM Completed O Set HEART SLOW MONITOR ALARM LIMIT to 40 BPM Completed P Set APNEA EVENT LOG LIMIT to 10 SEC Complet
3. Ao art Number 21 02 0162 ev o1 _ Ami Ami Plus Preventative Maintenance Test Procedure Vill Certification Acknowledgement Sign Off Sheet Home Care Dealer Hospital Address City ss Staten Zip Phone Fax Phone By signing below I have read and understood the Ami Ami Plus 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 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 USA www casmed com ATTN Anthony F Cop Product Support Manager acop casmed com This Sign Off Sheet may be copied if additional individuals will be certified
4. CAS MEDICAL SYSTEMS INC Ami Ami Plus Infant Apnea Monitor Preventative Maintenance Test Procedure using the 2301 Simulator TECHNOLOGY ANLEO TS MEDITI 44 Fast Industrial Road Branford CT 06405 USA www techsry casmed com 21 02 0162 Rev 01 12 01 Ca MEDICAL SYSTEMS INC MAINTENANCE Page 2 of 12 TECHNOLOGY APPLIED TO MEDICINE PR O CEDURE S Part Number 91 02 0162 Rev 9 l Ami Ami Plus Preventative Maintenance Test Procedure TABLE OF CONTENTS I e EE 3 Il Maintenance Intervals cceceeseeeeeeeeeeeeees 3 lll Equipment Required nen 3 DN Initial Setup eege eege 4 V Eguipment Set p cicceiccectcsndscssvcecstasseectecenniens 4 1 Simulator Setup ve esbe eege 4 2 Ami Monitor Setup sek 5 VI Preventative Maintenance Test 1 Functional Test oessegetuggggegkbes stenge eege 6 1 1 Apnea Alarm Test EE 6 1 2 Heart Slow Alarm Test ENEE 6 1 3 Heart Fast Alarm Test ENEE 6 1 4 Loose Lead Alarm Test EEN 7 1 5 Respiration Rate Test cseceseeees 7 1 6 Heart Beat Respiration Test 8 Vil Fest Data Sheet onbe seg ie eege 9 Vill Acknowledgement Sign Off Sheet 12 TECHNOLOGY APPLIED TO MEDICINE Q cas MEDICAL SYSTEMS INC MAINTENANCE Page 3 of 12 PROCEDURES Part Number 91 02 0162 Rev o l Ami Ami Plus Preventative Maintenance Test Procedure L Scope The purpose of this procedure is to provide a means by which a qualified person can perform a Pre
5. R Set the HEART SLOW EVENT LOG LIMIT to 40 BPM Press ENTER Set the O2 SAT EVENT LOG LIMIT to 85 Press ENTER followed by MODE Scroll past AUX PORT 1 2 and 3 test screens no selections are available Press MODE 4 times Set TIME DATE to current date and time Use the UP and DOWN Arrows and the ENTER buttons to make changes when completed press MODE V At SETUP COMPLETE select YES by pressing the ENTER button W At ARE YOU SURE select YES by pressing the DOWN Arrow button m OZEMrACET EO Ciao NOTE Wait for the monitor to complete its power down sequence approximately 25 35 seconds which will be distinguished by an audio sound Ca MEDICAL SYSTEMS INC MAINTENANCE Page 6 of 12 TECHNOLOGY APPLIED TO MEDICINE PROCEDURES Part Number 91 02 0162 Rev o l Ami Ami Plus Preventative Maintenance Test Procedure Vi Preventative Maintenance Test 1 Functional Test 1 wh Apnea Alarm Test A Press the POWER button on the monitor Once the monitor has completed its power up sequence approximately 45 seconds verify Good Connection Best Signal or Best Connection Best Signal on the monitor LCD B 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 C Press the APNEA button on the simulator Verify 1 the red APNEA indicator on the simulator is lit 2 Begin timing for apne
6. REATH Rate to 40 Verify the monitor counts rate set on simulator with no alarms Set the simulator HEART Rate and BREATH Rate to 60 Verify 1 the HEART BEAT 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 10 seconds Set the simulator BREATH Rate to 40 Verify 1 the monitor audible alarm silences 2 the HEART BEAT and RESPIRATION indicators flash at the rate set on the simulator 3 the APNEA visual indicator remains on Press RESET Verify APNEA visual clears Turn the Ami monitor OFF Verify proper monitor power down MAINTENANCE PROCEDURES Ami Plus Preventative Maintenance Test Procedure Completed Completed Pass Pass Pass Pass Completed Completed Completed Pass Completed Pass Pass Pass Passt Pass Pass Pass Pass Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail Fail 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 Ami Ami Plus Test Data Sheet Page 11 of 12 Se ot Ree Seet Sec rer Ree Set AS Ca MEDICAL SYSTEMS INC MAINTENANCE Page 12 of 12 TECHNOLOGY APPLIED TO MEDICINE PR O CEDURE S Part Rev
7. URES Part Number 91 02 0162 Rev o l Ami Ami Plus Preventative Maintenance Test Procedure 1 4 Loose Lead Alarm Test A Disconnect a lead wire from the simulator Verify the monitor LOOSE LEAD visual indicator and audible alarm activate B Reconnect the lead wire to the simulator Verify the monitor audible alarm silences and the LOOSE LEAD visual indicator remains on C Press the RESET button on the monitor Verify the LOOSE LEAD visual indicator clears Proceed to Respiration Rate Test 1 5 Respiration Rate Test A Set the simulator to the following settings a Set the HEART Rate to 120 BPM b Set the BREATH Rate to 15 BrPM B 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 C Set the BREATH Rate to 40 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 D Set the BREATH Rate to 60 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 E Set the BREATH Rate to 80 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 F Set the simulator BREATH Rate
8. Verify the green CHARGING visual indicator on the monitor is lit B 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 C Connect the Patient Cable to the PATIENT CABLE input receptacle located on the front panel of the Ami monitor V Equipment Setup 1 Simulator Setup A Set the switches on the Model 2301 as follows a LEAD CHANGE OFF b TEST SIMULATE ELECTRODE TEST c HEART BPM 120 Beats Per Minute d BREATH BPM 15 Breaths Per Minute B Turn the Simulator ON C 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 D Verify the red APNEA indicator is not lit TECHNOLOGY APPLIED TO MEDICINE Q cas MEDICAL SYSTEMS INC MAINTENANCE Page 5 of 12 PROCEDURES Part Number 91 02 0162 Rev o l Ami Ami Plus Preventative Maintenance Test Procedure 2 AMI Monitor Setup A Power up the Ami monitor in the Setup mode To get into Setup Mode On the bottom of the Ami apnea monitor press the UP Arrow and the ENTER buttons and hold them At the same time press the POWER button on the front of the monitor release the POWER butt
9. a with the last Respiration pulse Stop timing when the apnea visual and audio alarm activates Verify the time is 10 1 0 seconds D 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 E Press the RESET button on the monitor Verify the APNEA visual indicator clears Proceed to Heart Slow Alarm Test 1 2 Heart Slow Alarm Test A Set the simulator HEART Rate to 30 BPM Verify the monitor HEART SLOW visual indicator and audible alarm activates B Set the simulator HEART Rate to 120 BPM Verify the monitor audible alarm silences and the HEART SLOW visual indicator remains on C Press the RESET button on the monitor Verify the HEART SLOW visual indicator clears Proceed to Heart Fast Alarm Test 1 3 Heart Fast Alarm Test A Set the simulator HEART Rate to 240 BPM Verify the monitor HEART FAST visual indicator and audible alarm activates B Set the simulator HEART Rate to 120 BPM Verify the monitor audible alarm silences and the HEART FAST visual indicator remains on C Press the RESET button on the monitor Verify the HEART FAST visual indicator clears Proceed to Loose Lead Alarm Test TECHNOLOGY APPLIED TO MEDICINE Q cas MEDICAL SYSTEMS INC MAINTENANCE Page 7 of 12 PROCED
10. ed Q Set HEART FAST EVENT LOG LIMIT to 125 BPM Completed R Set HEART SLOW EVENT LOG LIMIT to 40 BPM Completed S Set O2 SAT EVENT LOG LIMIT to 85 Completed T Scroll past AUX PORT 1 2 and 3 test screens Completed U Set TIME and DATE information Completed __ V At SETUP COMPLETE select YES Completed W At ARE YOU SURE select YES Verify proper monitor power down Pass Fail VI Preventative Maintenance Test 1 Functional Test 1 1 Apnea Alarm Test A Press the POWER button on the monitor Verify Good Connection Best Signal or Best Connection Best Signal on LCD Pass Fail B Verify monitor counts rate set on simulator with no alarms Pass Fal C Press the APNEA button on the simulator and verify 1 the red APNEA indicator on the simulator is lit Pass Fal 2 Verify the time to be 10 1 0 seconds Pass Fail D Press the APNEA button on the simulator Verify 1 the red APNEA indicator on the simulator is not lit Pass Fait 2 the RESPIRATION indicator is flashing at rate set on simulator Pass Fait 3 the audible stops Pass Fait 4 the APNEA visual remains on Pass Fait E Press RESET on monitor Verify APNEA visual clears Pass Fait 1 2 Heart Slow Alarm Test A Set the simulator HEART Rate to 30 Verify HEART SLOW visual and audible alarms Pass Fail B Set the simulator HEART Rate to 120 Verify audible stops and HEART SLOW visual remains on
11. on after the alarm then release the UP Arrow and ENTER buttons While in the Setup Mode use the UP and DOWN Arrow keys to select a setting Use the ENTER key to lock in the setting and move to the next selection Use the MODE key to finish and move to the next screen Refer to the Setting Parameters section in the Clinician s Manual for assistance B At NEW PATIENT select YES by pressing the DOWN Arrow button C At ARE YOU SURE select YES by pressing the ENTER button Verify the monitor displays CLEARING MEMORY D At PATIENT NAME enter your initials Use the UP and DOWN Arrows to change the letter after each letter press ENTER when completed press MODE At PATIENT NUMBER enter 1234 Use the UP and DOWN Arrows to change the number after each number press ENTER when completed press MODE Set BRADYCARDIA OPTION to 3 BEAT 6 SECOND MAX Press MODE Set AUX PORT 1 to O2 SAT Press MODE Set OXIMETER CHOICE to NPB 290 295 395 Press MODE Set AUX PORT 2 to O2 PR Press MODE Set AUX PORT 3 to AIR FLOW Press MODE Set PRIORIT Y FIFO CONT to FIFO Press MODE Set FIXED FULL LENGTH to FIXED 2 MINUTE Press MODE Set APNEA MONITOR ALARM LIMIT to 10 SEC Press ENTER Set HEART FAST MONITOR ALARM LIMIT to 125 BPM Press ENTER Set the HEART SLOW MONITOR ALARM LIMIT to 40 BPM Press ENTER followed by MODE Set the APNEA EVENT LOG LIMIT to 10 SEC Press ENTER Set the HEART FAST EVENT LOG LIMIT to 125 BPM Press ENTE
12. se the RESET button Wait for the monitor to complete its power down sequence approximately 25 35 seconds which will be distinguished by an audio sound Turn the simulator OFF Disconnect the monitor from the simulator This concludes the Ami Ami Plus Preventative Maintenance Test Procedure Should you have any questions do not hesitate to contact CAS Technical Support at 203 488 6056 800 581 7806 US only phone 203 488 9438 fax or email CAS MEDICAL SYSTEMS INC MAINTENANCE Page 9 of 12 TECHNOLOGY APPLIED TO MEDICINE Part Number PROCEDURES RS Ri 21 02 0162 Ami Ami Plus Preventative Maintenance Test Procedure Date Vil Test Data Sheet Tested By Ami Ami Plus Infant Apnea Monitor using the 2301 Simulator Home Care Dealer Hospital Address City State Ami Type selectone Ami AmiPlus _ Ami Serial Number Simulator Serial Number Zip Simulator Calibration Date IV Initial Setup A Connect the power cord to the Ami monitor Verify green CHARGING indicator is lit Pass Fait B Connect the Patient Leads to the Patient Cable and Simulator Completed C Connect the Patient Cable to the Patient Cable input on the Ami monitor Completed V Equipment Setup 1 Simulator Setup A Set the switches on the 2301 simulator a LEAD CHANGE OFF Completed b TEST SIMULATE ELECTRODE TEST Completed c HEART BPM 120 Completed
13. to 15 BrPM Proceed to Heart Beat Respiration Test TECHNOLOGY APPLIED TO MEDICINE Q cas MEDICAL SYSTEMS INC MAINTENANCE Page 8 of 12 PROCEDURES Part Number 91 02 0162 Rev o l Ami Ami Plus Preventative Maintenance Test Procedure 1 6 Heart Beat Respiration Test A Set the simulator to the following settings a Set the HEART Rate to 60 BPM b Set the BREATH Rate to 40 BrPM B 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 C Set the simulator to the following settings a Set the HEART Rate to 60 BPM b Set the BREATH Rate to 60 BrPM D Verify 1 the HEART BEAT 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 10 seconds E Set the simulator BREATH Rate to 40 BrPM Verify 1 the monitor audible alarm silences 2 the HEART BEAT and RESPIRATION indicators are flashing at the rate set on the simulator and 3 the APNEA visual indicator remains on F Press the RESET button on the monitor Verify the APNEA visual indicator clears G Turn the Ami monitor OFF To turn OFF the Ami Apnea Monitor Press and hold the RESET button then press the POWER button at the same time Release the POWER button while still pressing the RESET button Then relea
14. ventative Maintenance Test to an Ami or Ami Plus monitor ll Maintenance Intervals CAS Medical Systems Inc recommends the following Maintenance Intervals for the Ami or Ami Plus monitor e Preventative Maintenance In Between Patients e Bench Testing Once every year e Battery Replacement Every 2 two years lll Equipment Required To perform this procedure you will need the following Ami or Ami Plus monitor hereafter referred to as Ami Model 2301 Multi Function Tester Simulator p n 01 05 0025 AC Power Cord p n 01 05 0139 Patient Cable p n 01 05 0004 Lead Wires p n 01 05 0005 Stopwatch or equivalent Ami and Ami Plus Clinician s Manual reference material p n 21 02 0116 Model 2301 User s Manual reference material p n 21 02 0102 Note 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 Q cas MEDICAL SYSTEMS INC MAINTENANCE Page 4 of 12 PROCEDURES Part Number 91 02 0162 Rev o l Ami Ami Plus Preventative Maintenance Test Procedure IV Initial Setup A Connect the Ami power cord to the power receptacle on the rear panel of the monitor Plug the other end of the power cord into a properly grounded A C outlet
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