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Application Notes: Sigmapace 1000: Medtronic Temporary External Pacemaker Model 5388 Checkout Procedure

The document provides instructions for testing the rate, pulse width, AV interval, output, emergency operation mode, and direct current leakage of the Medtronic Temporary External Pacemaker Model 5388 using a SigmaPace 1000 analyzer. Key steps include connecting the pacemaker to the analyzer, selecting test modes and settings on both devices, and verifying that pacemaker readings for various parameters fall within specified tolerances.

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Marielena Zabala
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69 views10 pages

Application Notes: Sigmapace 1000: Medtronic Temporary External Pacemaker Model 5388 Checkout Procedure

The document provides instructions for testing the rate, pulse width, AV interval, output, emergency operation mode, and direct current leakage of the Medtronic Temporary External Pacemaker Model 5388 using a SigmaPace 1000 analyzer. Key steps include connecting the pacemaker to the analyzer, selecting test modes and settings on both devices, and verifying that pacemaker readings for various parameters fall within specified tolerances.

Uploaded by

Marielena Zabala
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Application Notes

SigmaPaceTM 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 SigmaPace 1000 F1: PULSE OUTPUT, F3: DUAL A+V Screen)
Operational Mode: AAI
Atrial Channel: ON and Ventricular Channel: OFF by pressing the key
button on the 5388 and setting the V output to zero.
Atrial Channel Output @ 10 mA
Press the key button on the 5388 and check the rate settings.

Rate Setting Specified Tolerance Specified SigmaPace 1000 Status


(PPM) Tolerance (mS) Reading Pass / Fail?
30 PPM ± 5 % (28.5 – 31.5) 1900 – 2100 PPM
80 PPM ± 5 % (76 – 84) 712 – 788 PPM
120 PPM ± 5 % (114 – 126) 475 – 525 PPM
200 PPM ± 5 % (190 – 210) 285 – 315 PPM

Fluke Biomedical
6045 Cochran Road, Cleveland, OH 44139-3303 U.S.A.
Tel: 440.248.9300, Toll free: 800.850.4608, Fax: 440.349.2307
Email: [email protected]
www.flukebiomedical.com
Application Notes
b. VENTRICULAR RATE
(Use SigmaPace 1000 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
Ventricular Channel Output @ 10 mA
Press the key button on the 5388 and check the rate settings.

Rate Setting Specified Tolerance Specified SigmaPace 1000 Status


(PPM) Tolerance (mS) Reading Pass / Fail?
30 PPM ± 5 % (28.5 – 31.5) 1900 – 2100 PPM
80 PPM ± 5 % (76 – 84) 712 – 788 PPM
120 PPM ± 5 % (114 – 126) 475 – 525 PPM
200 PPM ± 5 % (190 – 210) 285 – 315 PPM

c. RAPID ATRIAL RATE (RAP)


(Use SigmaPace 1000 F1: PULSE OUTPUT, F3: DUAL A+V Screen)
Operational Mode: AOO (Access RAP feature via the Medtronic 5388
Menu #3).
Atrial Channel: ON and Ventricular Channel: OFF
Atrial Channel Output @ 10 mA

Rate Setting Specified Tolerance Specified SigmaPace 1000 Status


(PPM) Tolerance (mS) Reading Pass / Fail?
350 PPM ± 5 % (285 – 367.5) 163 – 180 PPM

3. PULSE WIDTH
a. ATRIAL PULSE WIDTH
(Use SigmaPace 1000 F1: PULSE OUTPUT, F3: DUAL A+V Screen)
Operational Mode: AAI
Atrial Channel: ON and Ventricular Channel: OFF
Atrial Channel Output @ 10 mA

Rate Setting Pulse Width Specified Tolerance SigmaPace 1000 Status


(mS) Reading Pass / Fail?
80 PPM 1.0 mS ± 5 % (0.95 – 1.05) mS

Fluke Biomedical
6045 Cochran Road, Cleveland, OH 44139-3303 U.S.A.
Tel: 440.248.9300, Toll free: 800.850.4608, Fax: 440.349.2307
Email: [email protected]
www.flukebiomedical.com
Application Notes
b. VENTRICULAR PULSE WIDTH
(Use SigmaPace 1000 F1: PULSE OUTPUT, F3: DUAL A+V Screen)
Operational Mode: VVI
Atrial Channel: OFF and Ventricular Channel: ON
Ventricular Channel Output @ 10 mA

Rate Setting Pulse Width Specified Tolerance SigmaPace 1000 Status


(mS) Reading Pass / Fail?
80 PPM 1.5 mS ± 5 % (1.425 – 1.575) mS

4. AV INTERVAL
(Use SigmaPace 1000 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
Atrial Channel Output @ 10 mA
Ventricular Channel Output @ 10 mA

Rate Setting AV Interval Specified Tolerance (mS) SigmaPace 1000 Status


Setting Reading Pass / Fail?
80 PPM 20 mS ± 5 mS (15 – 25) mS

80 PPM 150 mS ± 5 % (142 – 158) mS

80 PPM 300 mS* ± 5 % (285 – 315) mS

*To set the Medtronic 5388 AV interval @ 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.

Fluke Biomedical
6045 Cochran Road, Cleveland, OH 44139-3303 U.S.A.
Tel: 440.248.9300, Toll free: 800.850.4608, Fax: 440.349.2307
Email: [email protected]
www.flukebiomedical.com
Application Notes
5. OUTPUT
a. VENTRICULAR CHANNEL
(Use SigmaPace 1000 F1:PULSE OUTPUT, F2: VENT ONLY Screen)
Operational Mode: VVI
Rate @ 80 PPM
Atrial Channel: OFF and Ventricular Channel: ON
Ventricular Channel @ 10 mA

Output Setting Specified Tolerance (mA) SigmaPace 1000 Status


Reading Pass / Fail?
0.2 mA ± 0.1 mA (0.1 – 0.3) mA
5.0 mA ± 10 % (4.5 – 5.5) mA
25.0 mA ± 10 % (22.5 – 27.5) mA

b. ATRIAL CHANNEL
(Use SigmaPace 1000 F1: PULSE OUTPUT, F1: ATR ONLY Screen)
Operational Mode: AAI
Rate @ 80 PPM
Atrial Channel: ON and Ventricular Channel: OFF
Atrial Channel @ 10 mA

Output Setting Specified Tolerance (mA) SigmaPace 1000 Status


Reading Pass / Fail?
0.2 mA ± 0.1 mA (0.1 – 0.3) mA
5.0 mA ± 10 % (4.5 – 5.5) mA
20.0 mA ± 10 % (18.0 – 22.0) mA

Fluke Biomedical
6045 Cochran Road, Cleveland, OH 44139-3303 U.S.A.
Tel: 440.248.9300, Toll free: 800.850.4608, Fax: 440.349.2307
Email: [email protected]
www.flukebiomedical.com
Application Notes
6. EMERGENCY OPERATION MODE
(Use SigmaPace 1000 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)
Rate @ 80 PPM
Atrial Channel: ON and Ventricular Channel: ON
Atrial Channel @ 10 mA (Initial Setting) to 20 mA with EMERGENCY
pushbutton depressed
Ventricular Channel @ 10 mA (Initial Setting) to 25 mA with EMERGENCY
pushbutton depressed.

Output Setting Specified Tolerance (mA) SigmaPace 1000 Status


Reading Pass / Fail?
ATRIAL @ 20 mA ± 10 % (18 – 22) mA
VENT @ 25 mA ± 10 % (22.5 – 27.5) mA
Return to Synchronous Pacing by pressing the pacemaker’s “ON” power key.

7. DIRECT CURRENT LEAKAGE


a. STATIC TESTS (PACEMAKER POWER OFF)
(Use SigmaPace 1000 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 Specified MAXIMUM SigmaPace 1000 Status


Leads Tolerance (μA) Reading Pass / Fail?
A+ to A- 10.0 μA
V+ to V- 10.0 μA

Fluke Biomedical
6045 Cochran Road, Cleveland, OH 44139-3303 U.S.A.
Tel: 440.248.9300, Toll free: 800.850.4608, Fax: 440.349.2307
Email: [email protected]
www.flukebiomedical.com
Application Notes
b. DYNAMIC TEST-A CHANNEL (PACEMAKER POWER ON)
(Use SigmaPace 1000 F4: >>> [Press 2X], F1: DC LEAK, F2: ON
(Dynamic), F1: ATRIAL Screen), F1: NEXT

TURN PACEMAKER POWER ON

Operational Mode: AAI


Rate @ 80 PPM
Atrial Channel: ON and Ventricular Channel: OFF
Atrial Channel @ 10 mA

Tested Pacemaker Specified MAXIMUM SigmaPace 1000 Status


Leads Tolerance (μA) Reading Pass / Fail?
A+ to A- 10.0 μA

c. DYNAMIC TEST-V CHANNEL (PACEMAKER POWER ON)


(Use SigmaPace 1000 F4: >>> [Press 2X], F1: DC LEAK, F2: ON
(Dynamic), F2: VENTricular Screen), F1: NEXT

TURN PACEMAKER POWER ON

Operational Mode: VVI


Rate @ 80 PPM
Atrial Channel: OFF and Ventricular Channel: ON
Ventricular Channel @ 10 mA

Tested Pacemaker Specified MAXIMUM SigmaPace 1000 Status


Leads Tolerance (μA) Reading Pass / Fail?
V+ to V- 10.0 μA

Fluke Biomedical
6045 Cochran Road, Cleveland, OH 44139-3303 U.S.A.
Tel: 440.248.9300, Toll free: 800.850.4608, Fax: 440.349.2307
Email: [email protected]
www.flukebiomedical.com
Application Notes
d. DYNAMIC TEST-A+V CHANNELS (PACEMAKER POWER ON)
(Use SigmaPace 1000 F4: >>> [Press 2X], F1: DC LEAK, F2: ON
(Dynamic), F3: A+V Screen), F1: NEXT

TURN PACEMAKER POWER ON

Operational Mode: DDD


Rate @ 80 PPM
Atrial Channel: ON and Ventricular Channel: ON
Atrial Channel @ 10 mA
Ventricular Channel @ 10 mA
(Third Test Load @ 500 Ω across A+ to V+ terminals)

Tested Pacemaker Specified MAXIMUM SigmaPace 1000 Status


Leads Tolerance (μA) Reading Pass / Fail?
A+ to V+ 10.0 μA

8. SENSITIVITY
a. ATRIAL CHANNEL
(Use SigmaPace 1000 F4: >>>, F2: SENSE AMP, F1: ATRial, F1: NEXT,
F1: NEXT (DEFAULT SETTING: SSQ WAVE @ 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: SSQ @ 30 mS
Rate @ 80 PPM
Atrial Channel: ON and Ventricular Channel: OFF
Atrial Channel Output @ 10 mA

Sensitivity Setting Specified Tolerance and SigmaPace 1000 Status


Range (mV) Reading Pass / Fail?
0.4 mV* ± 0.25 mV (0.15 – 0.65) mV
1.6 mV ± 25 % (1.2 – 2.0) mV
3.0 mV ± 25 % (2.25 – 3.75) mV
5.0 mV ± 25 % (3.75 – 6.25 mV
10.0 mV ± 25 % (7.5 – 12.5) mV
*Note: Once you have entered the SENSITIVITY TEST, use F1: RESTART then F1: START to check the remaining settings.

Fluke Biomedical
6045 Cochran Road, Cleveland, OH 44139-3303 U.S.A.
Tel: 440.248.9300, Toll free: 800.850.4608, Fax: 440.349.2307
Email: [email protected]
www.flukebiomedical.com
Application Notes

b. VENTRICULAR CHANNEL
(Use SigmaPace 1000 F4: >>>, F2: SENSE AMP, F2: VENTricular,
F1: NEXT, F1: NEXT (DEFAULT SETTING: SSQ WAVE @ 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: SSQ @ 40 mS
Rate @ 80 PPM
Atrial Channel: OFF and Ventricular Channel: ON
Ventricular Channel Output @ 10 mA

Sensitivity Setting Specified Tolerance and Range SigmaPace 1000 Status


(mV) Reading Pass / Fail?
0.8 mV* ± 0.25 mV (0.55 – 1.05) mV
2.0 mV ± 25 % (1.5 – 2.50) mV
4.0 mV ± 25 % (3.00 – 5.00) mV
12 mV ± 25 % (9.0 – 15.0) 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 SigmaPace 1000 F4: >>>, F1: REFRACT DEMAND, F1: ATRial,
F1: NEXT (DEFAULT SETTING = SQR WAVE and 1.00 mS WIDTH) ,
F1: NEXT (DEFAULT SETTING = + POLarity and 20.00 mV AMPlitude)
Operational Mode: AAI
Selected Waveform: Square Wave @ 1.0 mS and 20 mV
Rate @ 80 PPM
Atrial Sensitivity Setting: 0.5 mV
Atrial Channel: ON and Ventricular Channel: OFF
Atrial Channel Output @ 10 mA

Refractory Period (RP) Specified Setting and SigmaPace 1000 Status


Test Tolerance (mS) Reading Pass / Fail?
Paced RP 250 ± 10 % (225 – 275) mS
Sensed RP 250 ± 10 % (225 – 275) mS

Fluke Biomedical
6045 Cochran Road, Cleveland, OH 44139-3303 U.S.A.
Tel: 440.248.9300, Toll free: 800.850.4608, Fax: 440.349.2307
Email: [email protected]
www.flukebiomedical.com
Application Notes
b. VENTRICULAR CHANNEL
(Use SigmaPace 1000 F4: >>>, F1: REFRACT DEMAND, F2:
VENTricular,
F1: NEXT (DEFAULT SETTING = SQR WAVE and 1.00 mS WIDTH) ,
F1: NEXT (DEFAULT SETTING = + POLarity and 20.00 mV AMPlitude)
Operational Mode: VVI
Selected Waveform: Square Wave @ 1.0 mS and 20 mV
Rate @ 80 PPM
Ventricular Sensitivity Setting: 2.0 mV
Atrial Channel: OFF and Ventricular Channel: ON
Ventricular Channel Output @ 10 mA

Refractory Period (RP) Specified Setting and SigmaPace 1000 Status


Test Tolerance (mS) Reading Pass / Fail?
Paced RP 250 ± 10 % (225 – 275) mS
Sensed RP 250 ± 10 % (225 – 275) mS

10. OFF CURRENT DRAIN (PACEMAKER POWER OFF)


(Use SigmaPace 1000 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 Status Specified Tolerance (mA DC) SigmaPace 1000 Status


Reading Pass / Fail?
Power OFF 0.15 Maximum mA DC

Fluke Biomedical
6045 Cochran Road, Cleveland, OH 44139-3303 U.S.A.
Tel: 440.248.9300, Toll free: 800.850.4608, Fax: 440.349.2307
Email: [email protected]
www.flukebiomedical.com
Application Notes
11. ON CURRENT DRAIN (PACEMAKER POWER ON)
(Use SigmaPace 1000 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
Atrial Channel Output @ 10 mA
Ventricular Channel Output @ 10 mA

POWER Status Specified Tolerance (mA DC) SigmaPace 1000 Status


Reading Pass / Fail?
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:
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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.

Fluke Biomedical
6045 Cochran Road, Cleveland, OH 44139-3303 U.S.A.
Tel: 440.248.9300, Toll free: 800.850.4608, Fax: 440.349.2307
Email: [email protected]
www.flukebiomedical.com

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