Specified Tolerance (ms)
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1 SigmaPace TM 1000: Medtronic Temporary External Pacemaker Model 5388 Checkout Procedure 1. PRELIMINARY SET UP a. Connect the pacemaker output to the analyzer s ATRIAL and VENTRICULAR 4 mm interface jacks using the supplied (red and black) test leads. b. Turn on power on both the pacemaker and the analyzer. From the main (power-up) menu on the analyzer: Press F2: INVasive pacemakers Press F1: NEXT (Tests pacemaker using the default 500 Ω test load.) Remaining menu navigation directions are given from this Ext-Invasive Pacer SELECT TEST screen. Note: Use the F1: HOLD/RELEASE key feature to freeze test results on the analyzer s screen. Use the analyzer s ESCape key to EXIT out of specific test modes. 2. RATE TEST a. ARTRIAL RATE (Use F1: PULSE OUTPUT, F3: DUAL A+V Screen) Operational Mode: AAI by pressing the key button on the 5388 and setting the V output to zero. Press the key button on the 5388 and check the rate settings. Rate Setting Specified Tolerance (PPM) Specified Tolerance (ms) 30 PPM ± 5 % ( ) PPM 80 PPM ± 5 % (76 84) PPM 120 PPM ± 5 % ( ) PPM 200 PPM ± 5 % ( ) PPM
2 b. VENTRICULAR RATE (Use F1: PULSE OUTPUT, F3: DUAL A+V Screen) Operational Mode: VVI Atrial Channel: OFF by pressing the key button on the 5388 and setting the A output to zero. and Ventricular Channel: ON Press the key button on the 5388 and check the rate settings. Rate Setting Specified Tolerance (PPM) Specified Tolerance (ms) 30 PPM ± 5 % ( ) PPM 80 PPM ± 5 % (76 84) PPM 120 PPM ± 5 % ( ) PPM 200 PPM ± 5 % ( ) PPM c. RAPID ATRIAL RATE (RAP) (Use F1: PULSE OUTPUT, F3: DUAL A+V Screen) Operational Mode: AOO (Access RAP feature via the Medtronic 5388 Menu #3). Rate Setting Specified Tolerance Specified (PPM) Tolerance (ms) 350 PPM ± 5 % ( ) PPM 3. PULSE WIDTH a. ATRIAL PULSE WIDTH (Use F1: PULSE OUTPUT, F3: DUAL A+V Screen) Operational Mode: AAI Rate Setting Pulse Width Specified Tolerance (ms) 80 PPM 1.0 ms ± 5 % ( ) ms
3 b. VENTRICULAR PULSE WIDTH (Use F1: PULSE OUTPUT, F3: DUAL A+V Screen) Operational Mode: VVI Atrial Channel: OFF and Ventricular Channel: ON Rate Setting Pulse Width Specified Tolerance (ms) 80 PPM 1.5 ms ± 5 % ( ) ms 4. AV INTERVAL (Use F1: PULSE OUTPUT, F3: DUAL A+V Screen) Operational Mode: DDD (Access this feature via the Medtronic 5388 Menu #1 or use it s power up default output settings.) Atrial Channel: ON and Ventricular Channel: ON Rate Setting AV Interval Specified Tolerance (ms) Setting 80 PPM 20 ms ± 5 ms (15 25) ms 80 PPM 150 ms ± 5 % ( ) ms 80 PPM 300 ms* ± 5 % ( ) ms *To set the Medtronic 5388 AV 300 ms, first decrease the PVARP to minimum (150 ms) on MENU #2 and then go to Menu #1 to access the AV interval function.
4 5. OUTPUT a. VENTRICULAR CHANNEL (Use F1:PULSE OUTPUT, F2: VENT ONLY Screen) Operational Mode: VVI Atrial Channel: OFF and Ventricular Channel: ON Ventricular 10 ma Output Setting Specified Tolerance (ma) 0.2 ma ± 0.1 ma ( ) ma 5.0 ma ± 10 % ( ) ma 25.0 ma ± 10 % ( ) ma b. ATRIAL CHANNEL (Use F1: PULSE OUTPUT, F1: ATR ONLY Screen) Operational Mode: AAI Atrial 10 ma Output Setting Specified Tolerance (ma) 0.2 ma ± 0.1 ma ( ) ma 5.0 ma ± 10 % ( ) ma 20.0 ma ± 10 % ( ) ma
5 6. EMERGENCY OPERATION MODE (Use F1: PULSE OUTPUT, F3: DUAL A+V Screen) Press pacemaker s top panel key EMERGENCY to begin test. Operational Mode: DDD + EMERGENCY = DOO (Asynchronous Dual Channel) Atrial Channel: ON and Ventricular Channel: ON Atrial 10 ma (Initial Setting) to 20 ma with EMERGENCY pushbutton depressed Ventricular 10 ma (Initial Setting) to 25 ma with EMERGENCY pushbutton depressed. Output Setting Specified Tolerance (ma) 20 ma ± 10 % (18 22) ma 25 ma ± 10 % ( ) ma Return to Synchronous Pacing by pressing the pacemaker s ON power key. 7. DIRECT CURRENT LEAKAGE a. STATIC TESTS (PACEMAKER POWER OFF) (Use F4: >>> [Press 2X], F1: DC LEAK, F1 OFF (Static), F1: ATRIAL Screen or F2: VENTricular Screen) TURN PACEMAKER POWER OFF Operational Mode: N/A Atrial Channel: N/A Ventricular Channel: N/A Tested Pacemaker Leads Specified MAXIMUM Tolerance (μa) A+ to A μa V+ to V μa
6 b. DYNAMIC TEST-A CHANNEL (PACEMAKER POWER ON) (Use F4: >>> [Press 2X], F1: DC LEAK, F2: ON (Dynamic), F1: ATRIAL Screen), F1: NEXT TURN PACEMAKER POWER ON Operational Mode: AAI Atrial 10 ma Tested Pacemaker Leads Specified MAXIMUM Tolerance (μa) A+ to A μa c. DYNAMIC TEST-V CHANNEL (PACEMAKER POWER ON) (Use F4: >>> [Press 2X], F1: DC LEAK, F2: ON (Dynamic), F2: VENTricular Screen), F1: NEXT TURN PACEMAKER POWER ON Operational Mode: VVI Atrial Channel: OFF and Ventricular Channel: ON Ventricular 10 ma Tested Pacemaker Leads Specified MAXIMUM Tolerance (μa) V+ to V μa
7 d. DYNAMIC TEST-A+V CHANNELS (PACEMAKER POWER ON) (Use F4: >>> [Press 2X], F1: DC LEAK, F2: ON (Dynamic), F3: A+V Screen), F1: NEXT TURN PACEMAKER POWER ON Operational Mode: DDD Atrial Channel: ON and Ventricular Channel: ON Atrial 10 ma Ventricular 10 ma (Third Test 500 Ω across A+ to V+ terminals) Tested Pacemaker Leads Specified MAXIMUM Tolerance (μa) A+ to V μa 8. SENSITIVITY a. ATRIAL CHANNEL (Use F4: >>>, F2: SENSE AMP, F1: ATRial, F1: NEXT, F1: NEXT (DEFAULT SETTING: SSQ 30.0 ms WIDTH), F1: START (+ POLarity and 2.00 mv AMPlitude) Set pacemaker sensitivity as indicated below for each test.) Analyzer auto-advances Operational Mode: AAI (Access this feature via the Medtronic 5388 Menu #1 or simply turn off the VENTRICULAR CHANNEL.) Waveform: 30 ms Sensitivity Setting Specified Tolerance and Range (mv) 0.4 mv* ± 0.25 mv ( ) mv 1.6 mv ± 25 % ( ) mv 3.0 mv ± 25 % ( ) mv 5.0 mv ± 25 % ( mv 10.0 mv ± 25 % ( ) mv *Note: Once you have entered the SENSITIVITY TEST, use F1: RESTART then F1: START to check the remaining settings.
8 b. VENTRICULAR CHANNEL (Use F4: >>>, F2: SENSE AMP, F2: VENTricular, F1: NEXT, F1: NEXT (DEFAULT SETTING: SSQ 40.0 ms WIDTH), F1: START (+ POLarity and 2.00 mv AMPlitude) Set pacemaker sensitivity as indicated below for each test. Analyzer auto-advances Operational Mode: VVI (Access this feature via the Medtronic 5388 Menu #1 or simply turn off the ATRIAL CHANNEL.) Waveform: 40 ms Atrial Channel: OFF and Ventricular Channel: ON Sensitivity Setting Specified Tolerance and Range (mv) 0.8 mv* ± 0.25 mv ( ) mv 2.0 mv ± 25 % ( ) mv 4.0 mv ± 25 % ( ) mv 12 mv ± 25 % ( ) mv 20 mv ± 25 % (15 25) mv *Note: Once you have entered the SENSITIVITY TEST, use F1: RESTART then F1: START to check the remaining settings. 9. REFRACTORY PERIOD TEST a. ATRIAL CHANNEL (Use F4: >>>, F1: REFRACT DEMAND, F1: ATRial, F1: NEXT (DEFAULT SETTING = SQR WAVE and 1.00 ms WIDTH), F1: NEXT (DEFAULT SETTING = + POLarity and mv AMPlitude) Operational Mode: AAI Selected Waveform: Square 1.0 ms and 20 mv Atrial Sensitivity Setting: 0.5 mv Refractory Period (RP) Test Specified Setting and Tolerance (ms) Paced RP 250 ± 10 % ( ) ms Sensed RP 250 ± 10 % ( ) ms
9 b. VENTRICULAR CHANNEL (Use F4: >>>, F1: REFRACT DEMAND, F2: VENTricular, F1: NEXT (DEFAULT SETTING = SQR WAVE and 1.00 ms WIDTH), F1: NEXT (DEFAULT SETTING = + POLarity and mv AMPlitude) Operational Mode: VVI Selected Waveform: Square 1.0 ms and 20 mv Ventricular Sensitivity Setting: 2.0 mv Atrial Channel: OFF and Ventricular Channel: ON Refractory Period (RP) Test Specified Setting and Tolerance (ms) Paced RP 250 ± 10 % ( ) ms Sensed RP 250 ± 10 % ( ) ms 10. OFF CURRENT DRAIN (PACEMAKER POWER OFF) (Use F4: >>> (2X), F2: DC LOAD, F1: NEXT (Follow ON-SCREEN INSTRUCTIONS) TURN PACEMAKER POWER OFF Operational Mode: N/A Atrial Channel: N/A Ventricular Channel: N/A POWER Specified Tolerance (ma DC) Power OFF 0.15 Maximum ma DC
10 11. ON CURRENT DRAIN (PACEMAKER POWER ON) (Use F4: >>> (2X), F2: DC LOAD, F1: NEXT (Follow ON-SCREEN INSTRUCTIONS) TURN PACEMAKER POWER ON Operational Mode: DDD (Access this feature via the Medtronic 5388 Menu #1 or use it s power up default output settings.) Atrial Channel: ON and Ventricular Channel: ON POWER Specified Tolerance (ma DC) Power ON (Wait 5 minutes) 1.5 Maximum ma DC (Backlight OFF) Power ON (Wait 5 minutes) 20.0 Minimum ma DC (Backlight ON) NOTES: Note: This testing protocol is based upon the published Medtronic Model 5388 Temporary External Pacemaker checkout guide. Refer to the referenced Medtronic 5388 publication for additional details.
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