5392 Checkout Manual Sept 2013

Returning a Temporary Pacemaker to Medtronic To return a damaged or malfunctioning Model 5392 Dual Chamber Temporary Pacemaker to Medtronic for evaluation and repair, fill out the information requested on the Returned Product Information Report at the back of this manual. Send this information and the temporary pacemaker to: Medtronic, Inc. 7000 Central Avenue, NE Dock B Minneapolis, MN 55432-3576 Attention: Instrument Service Department For questions please call 1 (800) 638-1991 and ask for Instrument Technical Services or email [email protected]. 1 DOO/Emergency key

PACE

A

SENSE

PACE

V

SENSE

RATE

30

200

min-1 ppm

A OUTPUT

0

mA

20

V OUTPUT

0

25

mA

Mode Selection

Back

2 On/Off key 3 Pacing and sensing status bar indicators 4 Rate dial 5 A (Atrial) Output dial 6 V (Ventricular) Output dial 7 Lock/Unlock key 8 Enter key 9 Selection indicator 10 Up/Down arrow keys 11 Menu Parameter dial 12 Pause key 13 Lower screen 14 Lock indicator 15 Pacing Mode indicator 16 Battery indicator 17 V (Ventricular) Output scale 18 A (Atrial) Output scale 19 Rate scale 20 Upper screen

Figure 1. The Model 5392 Temporary Pacemaker

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Test Parameter Definitions The following paragraphs define each of the test parameters covered by the checkout procedures in this manual. 1) Rate – Rate is the number of output pulses per minute (ppm). It is the inverse of the time interval between output pulses, measured from leading edge to leading edge at the half-peak amplitude points. The rate control knob sets the atrial and the ventricular rates. Pulse rate is measured as average rate over more than 1 pulse. 2) Rapid Atrial Pacing Rate – High rate is delivered only to the atrium and is measured in the same manner as the rate. 3) Pulse Width – Pulse width is the time interval in milliseconds (ms) between the leading and trailing edges of the output pulse measured at the half-peak amplitude points. In this pacemaker, the Atrial Pulse Width is fixed at 1.0 ms and the Ventricular Pulse Width is fixed at 1.5 ms. Pulse widths are measured at 33% of peak amplitude. 4) AV Interval – AV interval is the interval between the atrial and ventricular output pulses. It is measured from leading edge of the atrial output to leading edge of the ventricular output at the half-peak amplitude points. 5) Output – Output is in milliamps (mA) and is equal to the amplitude of the output pulse in volts, measured at the mid-width point, divided by the load resistance in ohms (500 ohms is the nominal load resistance). 6) D  irect Current Leakage – When the device is on, this test measures the DC leakage current in the time interval between output pulses. 7) Sensitivity – This parameter represents the signal level that the amplitude of an intrinsic atrial or ventricular depolarization signal must exceed to be detected as a sensed event. Sensitivity is tested by determining the amplitude of sine-squared pulses (simulated P- or R- waves) that will inhibit pacing. This test first injects a sub-threshold signal (the device paces), then the amplitude is slowly increased until it is above threshold (the device senses). Valid Sensing occurs when the DUT detects 5 out of 5 inputs. Valid No Sense when the DUT detects 0 out of 5 inputs. 8) Emergency – The test verifies maximum atrial and ventricular output in mA at the current Rate setting, when the Emergency key is depressed. If the 5392 is in an “off” state, pressing the Emergency key will automatically turn the device “on.” 9) Operation after Battery Removal – Medtronic does not recommend replacing the batteries while the pacemaker is turned on or actively pacing the patient. The 5392 will operate after battery removal for a minimum 30 s (typical) under the following conditions: RATE of 80 ppm or less, A OUTPUT and V OUTPUT of 10 mA or less, backlight off, and lower screen blank.

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Atr Conn

500Ω

1%

+

A -

5392

Transvenous Analyzer Vent Conn

500Ω

1%

+

V -

Test Function Rate Output Pulse Width A/V Interval Sensitivity DC Current Leakage

Figure 2. Setup for Testing 5392 Note: Transvenous analyzers have a built-in 500 ohm load on the inputs

Analyzer Transvenous Pacemaker Analyzer DC millivolt meter/analyzer

Test Conditions For accurate measurement of device parameters, test instrument inaccuracy should not exceed 10 percent of the tolerance for that particular parameter. An oscilloscope may be used, but due to instrument tolerances, measured values should be considered relative rather than exact. Measurements are to be made under the following conditions and at the specified parameter settings. • All unspecified tolerances ± 5% • Temperature 70 ± 10 °F • Relative humidity 80% or less • Normal output load 500 ohms ± 1% • Battery voltage 3.0 ± 0.5% DC (1.5 ± 5% per AA cell) • Battery type Two IEC type LR6-sized (AA-sized) 1.5 V alkaline batteries (Duracell MN1500, Eveready E91 or equivalent) • Simulated P-wave 20 ms, sine2 pulse at 400 ms intervals • Simulated R-wave 40 ms, sine2 pulse at 400 ms • Device settings shall be the default settings in the DDD mode, unless otherwise specified: MODE LOWER RATE UPPER RATE A OUTPUT V OUTPUT A SENSITIVITY V SENSITIVITY A PULSE WIDTH V PULSE WIDTH AV INTERVAL

DDD 80 ppm 110 ppm (base rate + 30 ppm) 10.0 mA 10.0 mA 0.4 mV 2.0 mV 1.0 ms 1.5 ms 170 ms

Test Equipment Medtronic recommends only the use of a transvenous external pacemaker analyzer for testing the Model 5392. For all tests use a 500 ohm load. The external transvenous pacemaker analyzer may require the selection of type which is “invasive.”

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Test Procedures GENERAL To change a parameter value, adjust the appropriate control knob for the required parameter value while observing the LCD numeric value displayed. The pacing load for this device consists of a 499 ohm, ± 1% resistor, in parallel or installed across the atrial and/or ventricular outputs. 1) Rate a) Test Setup Connect the temporary pacemaker to a transvenous external pacemaker analyzer; select “Invasive” (if required) and 500 ohms for the load, and then proceed to test. b) On the 5392 change the mode to AAI by setting the V OUTPUT to 0 mA (OFF). Adjust the A OUTPUT to 10 mA. Set the Atrial Rate to the values listed below, and verify that the measured atrial pulse intervals are within specified tolerances. Rate Setting 30 ppm 80 ppm 120 ppm 200 ppm

Specified Tolerance ± 2% ± 2% ± 2% ± 2%

Pulse Range 29 – 31 ppm 78 – 82 ppm 117 – 123 ppm 196 – 204 ppm

c) On the 5392 change the mode to VVI by setting the A OUTPUT to 0 mA (OFF). Adjust the V OUTPUT to 10 mA. Set Ventricular Rate to the values listed above, and verify that the measured ventricular pulse rates are within specified tolerance. 2) Rapid Atrial Pacing Test (RAP) a) Test Setup Connect the temporary EPG to a transvenous external pacemaker analyzer. The RAP test is performed using the Rate test on the analyzer. b) Select the RAP mode from 5392 Lower Screen, Menu Screen 4. Set the RAP rate to 800 ppm with the “Menu Parameter Dial.” To deliver RAP, depress and hold the “ENTER” key. The A Pace LED will flash at the RAP rate. The V Pace LED will stop flashing, indicating no V Pace. Verify on the analyzer that the atrial rate is 800 ppm ± 4% (768 – 832 ppm). Release the “ENTER” key to discontinue RAP. RAP Setting 180 ppm 250 ppm 360 ppm 800 ppm

Specified Tolerance ± 2% ± 2% ± 2% ± 2%

RAP Range 176 – 184 ppm 245 – 255 ppm 353 – 367 ppm 768 – 832 ppm

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3) Output a) Setup Connect the temporary pacemaker to a transvenous pacemaker analyzer. Set the mode to VVI mode by turning the A OUTPUT to 0 mA (OFF). Adjust the V OUTPUT to 10 mA. Select from the test analyzer the “Pulse Output” or “Output” test. This output test is measuring the ventricular output amplitude at the 50% point of the output pulse and dividing this value by the load resistance (500 ohms) to get the value for output current which will verify that the measured outputs are within specified limits. Ventricular Current Output Specifications Output 1.0 mA 5.0 mA 10.0 mA 25.0 mA

Tolerance ± 10% ± 10% ± 10% ± 10%

Range mA 0.9 – 1.1 mA 4.5 – 5.5 mA 9.0 – 11 mA 22.5 – 27.5 mA

b) Setup Connect the temporary pacemaker to a transvenous pacemaker analyzer. Set the mode to AAI mode by turning the V OUTPUT to 0 mA (OFF). Adjust the A OUTPUT to 10 mA. Select from the test analyzer the “Pulse Output” or “Output” test. This output test is measuring the atrial output amplitude at the 50% point of the output pulse and dividing this value by the load resistance (500 ohms) to get the value for output current which will verify that the measured outputs are within specified limits. Atrial Current Output Specifications Output 1.0 mA 5.0 mA 10.0 mA 20.0 mA

Tolerance ± 10% ± 10% ± 10% ± 10%

Range mA 0.9 – 1.1 mA 4.5 – 5.5 mA 9.0 – 11.0 mA 18.0 – 22.0 mA

Figure 3: Left – Ventricular Waveform, Right – Atrial Waveform

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4) Pulse Width a) T est Setup Connect the temporary pacemaker to a transvenous external pacemaker analyzer using a 500 + 1% ohm load across each output, per figure 2. Using the Pulse Width Test function of analyzer to measure the period of time between the leading edge of the pulse to the negative edge of the pulse measured at 33% peak amplitude. b) Set the mode to AAI by turning the V OUTPUT to 0 mA (OFF). Adjust the A OUTPUT to 10 mA. Connect the analyzer test lead to the atrial output. The Atrial Pulse Width is fixed at 1.0 ms ± 10% (0.90 - 1.10 ms). Verify the Atrial Pulse Width on the transvenous external pacemaker analyzer. c) C  hange the mode to VVI mode by setting the A OUTPUT to 0 mA (OFF). Adjust the V OUTPUT to 10 mA. Connect the analyzer test lead to the ventricular output. The Ventricular Pulse Width is fixed at 1.5 ms ± 10% (1.35 - 1.65 ms). Verify the Ventricular Pulse Width on the transvenous external pacemaker analyzer. 5) A/V Interval a) T est Setup With the temporary pacemaker in the DDD mode, connect the temporary pacemaker according to the setup shown in Figure 2.  ption A) Using a transvenous analyzer, select the “Pulse Interval” test, using a 500 ohm load. O Use the default settings of the 5392 for testing. On the lower screen select Menu Screen 3, A – V Interval by pressing the DOWN arrow until A – V Interval is selected. Increase or decrease the A – V Interval by turning “Menu Parameter Dial” (refer to page 3). Test per settings below in b.  ption B) Using a scope, trigger on the leading edge of the pulse for channel A (connected to O the atrial output), and on the leading edge of channel B, pulse (connected to the ventricular output) at the half-peak (pulse) points. Measure the time interval between an atrial output pulse and the following ventricular output pulse. Alternatively, a scope may be used by setting the sensitivities to ASYNC and parallel the outputs across a single 500 ohm resistor load. Adjust the time base of the scope to observe the interval between the leading edge of the atrial pulse to the leading edge of the ventricular pulse. b) Set the device to the following AV intervals and verify that the readings meet the specifications. Rate 30 ppm 80 ppm 120 ppm 200 ppm

AV Interval 250 ms 170 ms 100 ms 50 ms

Spec. ± 5% ± 5% ± 5% ± 5%

Range 237.5 – 262.5 ms 161.5 – 178.5 ms 95.0 – 105.0 ms 47.5 – 52.5 ms

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6) Sensitivity a) Test Setup Connect the device according to the test setup shown in Figure 2. Connect the 5392 to a transvenous pacemaker analyzer. Select “Sense Amp” or “Sensitivity” and then select atrial or ventricular test. • For measuring atrial sensitivity, use a simulated P-wave input (20 ms sine2 pulse at 400 ms intervals) • For measuring ventricular sensitivity, use a simulated R-wave input (40 ms sine2 pulse at 400 ms intervals) Atrial Sensitivity Set the sensitivity control, via Lower Display of 5392, to the values listed in the table, below. For measuring atrial sensitivity, set the device to AAI mode by setting the Ventricular output to 0 mA (OFF). At each test setting, increase the output (simulated P wave or R wave) of the analyzer, either manually or automatically, from below sensing threshold (device paces) to above threshold (device senses a minimum of five consecutive input signals). The sensing threshold must fall within the range specified for each setting. Sensitivity Atrial 1.0 mV 2.0 mV 5.0 mV 10.0 mV

Tolerance ± 60% ± 40% ± 40% ± 40%

Threshold 0.4 – 1.6 mV 1.20 – 2.80 mV 3.00 – 7.0 mV 6.0 – 14.0 mV

Ventricular Sensitivity Set the sensitivity control, via Lower Display of the 5392, to the values listed in the table, below. For measuring ventricular sensitivity, set the device to VVI mode by setting the Atrial output to 0 mA (OFF). At each test setting, increase the output (simulated P wave or R wave) of the analyzer, either manually or automatically, from below sensing threshold (device paces) to above threshold (device senses a minimum of five consecutive input signals). The sensing threshold must fall within the range specified for each setting. Sensitivity Ventricular 1.0 mV 3.0 mV 10.0 mV 20.0 mV

Tolerance

Threshold

± 55% ± 55% ± 55% ± 55%

0.45 – 1.55 mV 1.35 – 4.65 mV 4.50 – 15.50 mV 9.0 – 31.0 mV

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7) Emergency (Optional) a) Test Setup Set the temporary pacemaker to the DDD mode. The test is conducted using the setup in Figure 2. Connect the 5392 to a transvenous analyzer. Depress the DOO key. Refer to Figure 1. b) Using the analyzer, measure the Atrial Output and verify output current as 20 mA ± 10% (18 - 22 mA). c) Using the analyzer, measure the Ventricular Output and verify the output current as 25 mA ± 10% (22.5 - 27.5 mA).  Note: When the DOO/Emergency key is pressed, the current rate setting (or 80 ppm if the temporary pacemaker was off before the DOO/Emergency key was pressed), will be measured through the analyzer. 8) Inactive Current Drain (Optional) a) Test Setup Connect the temporary pacemaker according to the setup shown in Figure 2 with the monitor being a DC voltmeter, micro amp meter or transvenous analyzer, (determine if this function is available with the analyzer). b) With the 5392 turned “OFF,” measure the DC voltage across the 500 ohm atrial load resistor, then across the 500 ohm ventricular load resistor. Verify that the value is as specified below. Note: The 5392 must be in an “OFF” state a minimum of 1 minute before measurement. If it can be determined that the device has been powered on for at least 1 minute during previous tests, proceed to the next step. If the 5392 has been turned “OFF” for this test, wait a minimum of 1 minute before proceeding. Specification

≥ 0 and ≤ 10 μA

9) Active Current Drain (Optional) Connect the temporary pacemaker according to the setup shown in Figure 2 with the monitor being a DC voltmeter, micro amp meter or transvenous analyzer, (determine if this function is available with the analyzer). Backlight OFF a) Turn the 5392 “ON “and wait a minimum 1 minute to allow the pacing capacitors to fully charge. Verify default settings: rate = 80 bpm, Atrial Output = 10 mA, Ventricular Output = 10 mA. b) Turn the Backlight and Menu screen OFF by pressing the “Lock” key. c) Verify that the DC current drawn by the 5392 is > 9 mA and < 18 mA. Backlight and Menu ON a) Turn the 5392 “ON” and verify default settings of: rate = 80 bpm, Atrial Output = 10 mA, Ventricular Output = 10 mA. b) Turn the Backlight and Menu ON by pressing the “Lock” key. c) Verify that the DC current drawn by the 5392 is > 13 mA and < 24 mA.

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Low Voltage a) Turn the Backlight and Menu OFF by pressing the “Lock” key. b) The 5392 will need 2 AA batteries with a total voltage of 2.0 + 5%, or will need to be connected to a DC power supply. c) Set the voltage to 2.0 + 5% VDC, on the DC power supply. d) Verify that the DC current drawn by the 5392 is >13.5 mA and <27 mA. 10) Battery Removal – Pacing Continuation Test (Optional) Pacing Continuation Test a) Connect the 5392 to a transvenous test analyzer, using the output test function to complete this test. Or connect the 5392 to an oscilloscope for measuring and monitoring the Output. b) Verify the battery voltage is 3.0 + .5 VDC. c) Turn the 5392 “ON” and verify default settings of rate = 80 bpm, Atrial Output = 10 mA, Ventricular Output = 10 mA. (Wait a minimum of 1 minute to allow pacing capacitors to fully charge). d) Turn the Backlight and Lower Display OFF by pressing the “Lock” key. e) If it can be determined that the device has been powered on for at least 30 seconds during previous tests, wait a minimum of 1 minute, then proceed to the next step.  Or, wait for a minimum 1 minute (to allow for the capacitors to charge, if running tests out of order). f) Disconnect power from the 5392. g) Verify that the Atrial and Ventricular output amplitude is 10 mA + 10% after 30 seconds.

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Error Messages TYPES OF ERROR MESSAGES Note the ERROR Message and contact Medtronic Instrument Technical Services. Refer to page 2 for contact information. Recoverable Error Message

Button Press Detected Error Message

Non-Recoverable Error Message

If the temporary pacemaker displays the Recoverable error message (below) in the lower screen, press the Enter key. The temporary pacemaker restarts and performs the self-test.

If the temporary pacemaker displays the Button Press Detected error message in the lower screen, a button has been pressed while the temporary pacemaker is turning on. Release any pressed key and the temporary pacemaker continues to power on normally.

If the temporary pacemaker displays the Non-Recoverable error message (see below) in the lower screen, contact Medtronic Instrument Technical Services.

ERROR

ERROR

ERROR

Error {XXXX} occurred.

Button Press Detected

Error {XXXX} occurred.

Press

Release all buttons

to restart the device.

Contact Medtronic to service this device.

Product useful life The expected service life of the temporary pacemaker is five years. Medtronic will not service or repair the temporary pacemaker after five years. Contact your Medtronic representative to replace your temporary pacemaker after it has been in service for five years.

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Returned Instrument Report

RPR Number (Shaded area for Office use only)

Note: No RGR or RMA required for return. Important: Use one report for each device being returned. 2A. Received from Name and Address

1. Date 2B. Ship to Address

3A. Was a specific patient involved at the time of the device incident? Yes If Yes, note the contact name and telephone number for further questions:

No

Name: Telephone Number: 3B. If there were patient complications, please note the action(s) taken and the patient outcome to date. Attach any additional documentation, e.g. EKG.

3C. If this is a repair, please provide specific detail

Model

Serial Number

4. Refer to Medtronic Connect (www.medtronicconnect.com) for current pricing Contact Person:

MDT Field Employee Use ONLY:

Phone number:

District Manager:

5. Customer Purchase Order Number:

6. Reason for Return: (choose one) Repair Test and Calibration No longer needed (scrap) Medtronic, Inc. 7000 Central Avenue NE, DOCK B Minneapolis, MN 55432-3576 Attn: Instruments Service

7. Shipping directions A. No return authorization number is required B. Enclose this report with the device being returned and ship to the address shown (at right)

UC201104196c EN © Medtronic, Inc. 2010. Minneapolis, MN. All Rights Reserved. Printed in USA. 03/2011

World Headquarters Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432-5604 USA Tel: (763) 514-4000 Fax: (763) 514-4879 Medtronic USA, Inc. Toll-free: 1 (800) 328-2518 (24-hour technical support for physicians and medical professionals)

UC201402092 EN © Medtronic, Inc. 2013. Minneapolis, MN. All Rights Reserved. Printed in USA. 09/2013

www.medtronic.com

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