Download pdf - Temporary Pacemaker 5391 - CHI Saint Joseph Health...On the 5391 there is no specific VOO or AOO mode to select. Asynchronous pacing results when the sensitivity is set to an inf\൩nitely

$Page 1: Temporary Pacemaker 5391 - CHI Saint Joseph Health...On the 5391 there is no specific VOO or AOO mode to select. Asynchronous pacing results when the sensitivity is set to an inf\൩nitely$
Temporary Pacemaker 5391 In-Service

This presentation is provided for general educational purposes only and should not be considered the exclusive source for this type of information. At all times, it is the professional responsibility of the practitioner to exercise independent clinical judgment in a particular situation.

The device functionality and programming described in this module are based on Medtronic products and can be referenced in the device manuals.

Disclosures

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Presenter

Presentation Notes

This presentation is provided for general educational purposes only and should not be considered the exclusive source for this type of information. At all times, it is the professional responsibility of the practitioner to exercise independent clinical judgment in a particular situation. The device functionality and programming described in this module are based on Medtronic products and can be referenced in the device manuals.

Objectives • Identify the function dials on the 5391 • Describe the features of the 5391 • Describe basic use instructions • Describe different NGB codes • List steps to identify correct sensitivity setting • List steps to identify correct output setting • Review available cables, temporary heart wires, leads and

accessories • Present troubleshooting scenarios

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5391 Overview 5391 (SSI) PACEMAKER

1 Lead Terminals

2 Green LED – Sensed Event

3 Yellow LED – Paced Event

4 Pulse Output Amplitude (0.3 … 12 V)

5 Mode Selector

6 Button to activate high-rate stimulation

7 Sensitivity Control

8 Stimulation Rate, ppm (Basic Rate)

9 Red LED – Errors, Low Battery

10 Cover

11 Ridge for Arm Strap

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Presenter

Presentation Notes

Identification of the controls and connectors on the 5391. Single chamber pacing: AOO, VOO, AAI, VVI Constant voltage Bipolar or unipolar configuration 9 volt alkaline or lithium battery Four-dial operation Rapid Atrial Pacing (High Rate Pacing)

5391 Controls Pulse Amplitude (0.3 – 12 Volts)

Mode: OFF / VVI / High Rate

Sensitivity (1 – 20 mV, f=asynchronous)

Rate (30-180 ppm)

Blinks green when sensing

5

f

Blinks yellow when pacing

Presenter

Presentation Notes

Overview of 5391 Controls. Starting in lower right – moving clockwise. MODE: OFF, VVI , VVI with acoustic tone (beep), 2x and 4x Basic Rate delivered when High Rate button depressed. (Used for RAP = Rapid Atrial Pacing) RATE: Basic Rate 30-180 ppm SENSITIVITY: 1 – 20 mV, f (f=Asynchronous). Sense LED blinks green when sensing. PULSE AMPLITUDE: Set voltage 2-3x the capture threshold. Range 0.3 – 12 Volts. Stim LED blinks yellow when pacing stimulus delivered. To quickly provide asynchronous pacing support, move clockwise through controls pictured above. Starting with ON/OFF: OFF VVI (Note: There is no VVI vs. VOO mode to select. Synchronous versus asynchronous is defined by the sensitivity setting.) How Fast?: Rate (p/min or ppm) Sensitivity: Set to f. (f = infinite sensitivity value; Asynchronous pacing.) Infinite sensitivity means the “fence” for sensing is infinitely high such that no signal can be seen. How Much? Increase voltage until capture identified on ECG. Keep Amplitude 2-3X capture threshold.

5391 Features

• Constant voltage output • Easy-to-use for single chamber pacing

(demand or asynchronous) • High-rate function (rapid atrial pacing) • Long battery life

(38 days @72 ppm, 8 V with a 9 V Alkaline battery) • Small form factor and low weight • Sensed intrinsic activity and pacing pulses indicated

optically by LED • Audible tone available when pacing stimulus delivered • Low battery condition

(audible tone and flashing red LED)

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Presenter

Presentation Notes

Constant voltage output. The 5391 is a light-weight and easy to use single chamber external cardiac pacemaker. High Rate Function (RAP=Rapid Atrial Pacing) set to 2x or 4x Basic Rate. Delivered when High Rate button depressed. Audible tone always occurs with pacing in this mode. Sensed intrinsic activity will illuminate GREEN Sense LED. Pacing pulses will illuminate YELLOW Stim LED. Low Battery Condition met when red LED flashes and acoustic tone sounds. Battery Life: Alkaline - 38 days 72ppm at 8V; Lithium – 53 days 72ppm at 8V.

5391 Features Overview Function Operation Output Constant Voltage Mode(s) VVI/VOO, AAI, AOO, (with or without beep) Rate Control 30-180 ppm Output Amplitude 0.3-12 Volts Sensitivity 1-20 mV, f (= Async) Runaway Rate Limit Yes

High Rate Atrial Stimulation 60-720 ppm Battery 9 V alkaline or lithium Low Battery Indicator LED/acoustic Pacing Continuation at Battery Removal NO Dimensions 2.3” x 4.5” x 0.8” Weight (including battery) 6.5 oz. (185 g)

Warranty 1 year

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Basic Use Instructions • On/Off process • Rate control • Pacing mode adjustments (sensitivity) • Output stimulation control • Battery • Pacing and sensing threshold procedure • Cables and Wires/Leads

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Mode

• Off

• VVI: (or AAI) without sound

• VVI Beep: (or AAI) audible signal during sensing and pacing (two different tones)

• X2: stimulation delivered at twice the basic rate when High Rate button depressed

• X4: stimulation delivered at four times the basic rate when High Rate button depressed

Basic Use Instructions

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Presenter

Presentation Notes

Even though the mode indicator only shows VVI or VVI beep, if wires/leads are in the atrium, the mode would be AAI. Asynchronous pacing (VO/AOO) is determined by sensitivity setting. The 2x and 4x High Rate is intended to be used for Rapid Atrial Overdrive Pacing.

Rate

Basic Rate Range: 30-180 p/min (ppm) High Rate Pacing Range: 2x: 60-360 ppm 4x: 120-720 ppm


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Presenter

Presentation Notes

Select the desired pacing rate (basic rate) by rotating the dial (30-180 ppm). High Rate Pacing Range applies when Mode selector is either 2x or 4x and High Rate button is held down. Mode will be asynchronous and device will automatically deliver acoustic signal during this operation.

Sensitivity Sensitivity Range: 1-20 mV, f (= Asynchronous)


Sense LED illuminates GREEN

when intrinsic activity sensed.

1 mV

5 mV

20 mV

f (infinite) Asynchronous pacing

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Presenter

Presentation Notes

The sensitivity range is from 1-20 mV and f. The f setting is basically an infinitely large number for sensitivity. The f sensitivity threshold is so high that no intrinsic signal can be seen, and therefore results in asynchronous pacing (VOO/AOO). The Sense LED will illuminate green when intrinsic activity is sensed. Therefore, asynchronous pacing will result in no green light being seen.

Review of Sensitivity

1 mV

5 mV

20 mV

f (infinite) – Asynchronous pacing Least sensitive

Most sensitive

Signals greater than 1 mV will be sensed and inhibit pacing

Intrinsic signal

Sens

itivi

ty S

ettin

g

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Example: Sensitivity set to 1 mV

Presenter

Presentation Notes

The next three slides provide a review of sensitivity operation. In VVI (AAI) mode, the pacing output will be inhibited when an intrinsic signal is sensed. As the sensitivity NUMBER gets BIGGER, the device is LESS sensitive and sees less of the intrinsic signal and therefore is inhibited less.


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1 mV

5 mV

20 mV

f (infinite) – Asynchronous pacing Least sensitive

Less sensitive

Intrinsic signal

Sens

itivi

ty S

ettin

g

Signals greater than 5 mV will be sensed and inhibit pacing

Example: Sensitivity set to 5 mV

Presenter

Presentation Notes

The next three slides provide a review of sensitivity operation. In VVI (AAI) mode, the pacing output will be inhibited when an intrinsic signal is sensed. As the sensitivity NUMBER gets BIGGER, the device is LESS sensitive and sees less of the intrinsic signal and therefore is inhibited less.


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1 mV

5 mV

20 mV

f (infinite) – Asynchronous pacing

f setting: Results in asynchronous pacing

(AOO/VOO)

Sens

itivi

ty S

ettin

g

Sensing threshold is so high that no intrinsic signal can be seen

Example: Sensitivity set to “f” Least sensitive

Presenter

Presentation Notes

On the 5391 there is no specific VOO or AOO mode to select. Asynchronous pacing results when the sensitivity is set to an infinitely large number such that no signal is seen (sensed). That is the f setting on the 5391.

Pulse Amplitude

Pulse Amplitude/Output: 0.3-12 Volts • Constant voltage output • Determine amplitude capture threshold


Stim LED illuminates YELLOW when

pacing pulse delivered.

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Presenter

Presentation Notes

Output amplitude is 0.3-12 Volts + 5%. Pulse width is 0.75 ms + 0.002 ms. Since the 5391 is a constant voltage device, the capture threshold is determined in volts and subsequently set at an output of 2-3X the capture threshold.

Knowledge Check Explain how to turn the device “ON”?

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Presenter

Presentation Notes

Turn the Mode (white) dial to VVI or VVI beep.


Battery • Use a fresh battery with

each patient • Projected longevity 72 ppm

at 8 Volts: - 9 V alkaline battery: 38 days - 9 V lithium battery: 53 days

• Monitor battery status - Low battery LED blinks red and

the device will beep when battery is getting low

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Presenter

Presentation Notes

Even though the projected longevity with a fresh battery, is longer than the time the EPG is typically used, it is still important to monitor the battery status. The Low Batt/Error LED will blink red when the battery is getting low.


Low Battery Warning • The Low Batt/Error LED will flash red

(every 5 s) and device will beep (every 5 min)

• Replace battery when possible

• If device turned off after the low battery warning begins, the battery must be replaced before the device can be turned on again

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Presenter

Presentation Notes

Assuming a constant pacing at 72 ppm and 8V, the 5391 can operate approximately 2 days after the first low battery indication (beep repeating every 5min and a lit red LED every 5 sec.) With increasing discharge of the battery the interval of blinking decreases from 5 s at first to 1 s. At the same time the acoustic warning tone decreases from 5 min to 1 min. Note: If the device is turned off after the battery warning signal begins, the battery must be replaced before the pacemaker can be turned on again.


Replacing the Battery • Do not replace battery while connected to

patient • Slide the compartment lid (12) to the side • Remove the battery from the

compartment and disconnect from the battery clip

• Connect new battery with correct polarity to the battery clip

* 5391 DOES NOT PROVIDE PACING WHEN BATTERY IS REMOVED

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Presenter

Presentation Notes

Since the 5391 does not provide pacing when the battery is removed, it is imperative to have a back-up pacing system available.

Knowledge Check

Which statements are true? (select all that apply)

1. The 5391 will provide backup pacing for up to 15 sec with the battery removed.

2. Replace the battery when the first low battery warning (LED flash/ beep) is observed/noted.

3. Projected longevity for a fresh 9 V alkaline battery at 72 ppm and 8 V is 38 days.

4. The Low Battery LED only flashes if the battery is low.

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Presenter

Presentation Notes

All are true except #1. No pacing occurs with the battery removed. The Low Batt/Error LED may illuminate for a malfunction but it will be constant, not flashing. The error/malfunction will be discussed later.

NBG Codes

Chamber(s) Paced A = atrium V = ventricle D = dual (both atrium

and ventricle)

1st Letter Chamber(s) Sensed A = atrium V = ventricle D = dual O = none

2nd Letter Response to Sensing I = inhibit

(Demand mode) T = triggered D = dual O = none (Asynch)

3rd Letter

V V I

Chamber paced

Chamber sensed

Action or response to a sensed event

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Basic Use Instructions: Pacing Setup Table AOO VOO AAI VVI RAP

Rapid Atrial Pacing

MODE VVI* VVI* VVI* VVI* x2 or x4

RATE 30-180 ppm

30-180 ppm

30-180 ppm

30-180 ppm

30-180 ppm

SENSITIVITY f f 1-20 mV 1-20 mV NA

Asynchronous during RAP

OUTPUT 0.3-12 V 0.3-12 V 0.3-12 V 0.3-12 V 0.3-12 V

Depress and hold High Rate button to

deliver 2x or 4x RATE

* Selected MODE can be VVI or VVI Beep (audible tone)

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Presenter

Presentation Notes

AOO /AAI pacing occurs when leads/wires are in atrium. VOO/VVI pacing occurs when leads/wires are in ventricle.

Basic Use Instructions: Sensing Threshold Set Mode VVI and Rate ~ 10 bpm slower than intrinsic

Allows sensing

Rotate sensitivity dial to ‘larger’ number (less sensitive) until Sense LED stops blinking

At this point, device will asynchronously pace

Rotate sensitivity dial to ‘smaller’ number (more sensitive) until stim stops and Sense LED blinks

This is the sensing threshold

Set Sensitivity = Sensing threshold 2

Provides 2:1 safety margin

Ex: If sensing threshold equals 5 mV, set sensitivity to 2.5 mV

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Presenter

Presentation Notes

Monitor the patient’s ECG and blood pressure during the procedure. Determine the sensing threshold before the stimulation (capture) threshold to reduce the risk of competitive pacing. If desired, the output can be set to the lowest voltage so that asynchronous pacing is ineffective. Set Mode to VVI Set Rate ~10 bpm slower than patient’s intrinsic rate (this will allow sensing). The Sense LED blinks green on every sensed signal. Rotate the sensitivity dial (mV) to a LARGER number until the green Sense LED stops flashing. At this point, the device does not sense any intrinsic activity and begins asynchronously pacing. Rotate the sensitivity dial to a SMALLER number until the pacing stimulation stops and the Sense LED begins blinking again. This is the sensing threshold. A 2:1 safety margin is usually set so consistent sensing occurs. A 2:1 safety margin is determined by dividing the sensing threshold in half. In the above example, if the sensing threshold is 5mV (which means at values greater than 5mV, intrinsic signals are not seen), the sensitivity would be set to 2.5mV to provide a 2:1 safety margin.

Example

PACE SENSE SENSE

PACE

This is an example of sensed events appropriately inhibiting the pacemaker. Each time the device senses the intrinsic R-wave, the pacing stimulus is inhibited.

Device Programmed VVI 70 ppm

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Presenter

Presentation Notes

Sensing-The pacemaker detects patient’s heartbeat and does not deliver a pacing stimulus. Undersensing-The pacemaker does not detect intrinsic activity and thus paces on or between beats. Sensing Threshold-Least sensitive setting at which the pacemaker can detect a heartbeat. Safety Margin-Ensures sensing and accommodates a changing threshold. Provide a 2:1 margin by�setting sensitivity to a value that is half the sensing threshold value.

Knowledge Check

The ventricular sensing threshold was determined to be 10 mV.

• What sensitivity setting should be set to provide a 2:1 safety margin for VVI pacing?

• What sensitivity setting should be set to deliver asynchronous pacing (VOO)?

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Presenter

Presentation Notes

With 10mV sensing threshold, the sensitivity setting should be 10/2 or 5mV to provide a 2:1 safety margin. Independent of the sensing threshold, a sensitivity setting of “f” will provide asynchronous pacing.

Definitions

CAPTURE Depolarization of

cardiac tissue after a pacing pulse. ECG

shows a p-wave or QRS after the pacing pulse.

LOSS of CAPTURE ECG shows no heart

response as a result of the pacing pulse.

Pacing Pulse

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Pacing Threshold (Ventricular)

The minimum output needed to consistently capture the heart

2.5 V 2 V 1.5 V

Set output to 2-3 times stimulation threshold Ex: Threshold = 2 V; Output set to 4-6 V

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Presenter

Presentation Notes

Synonymous terms: Pacing Threshold ~ Capture Threshold ~ Stimulation Threshold Depending on the device, these thresholds are either determined in volts (constant voltage device) or mAmps (constant current device). In the above example, 1.5 V fails to capture, therefore the “pacing threshold” is 2V. In order to provide a safety margin to ensure consistent capture and accommodate a changing threshold, the output is set to 2-3 times the pacing threshold.

Pacing Threshold (Atrial) QRS QRS QRS QRS

Atrial pacing pulse

Atrial pacing pulse

Atrial pacing pulse

Atrial pacing pulse

Each atrial pacing pulse results in a QRS with a consistent AV interval

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Presenter

Presentation Notes

The 5391 can be used to pace either the ventricle or the atrium, depending on where the wire or lead is placed. Usually if only atrial pacing is desired, the patient has intact atrium to ventricle conduction (AV conduction). Since it is sometimes difficult to observe a p-wave on the ECG, look for conduction to the ventricle to determine if the atrium was captured. In the above example, each atrial pacing pulse results in a QRS at a consistent AV interval.

Basic Use Instructions: Pacing Threshold Set Mode VVI and Rate ~ 10 bpm faster than intrinsic Avoid inhibition

Decrease Voltage until stimulation is no longer effective

No Capture; ECG flat or ECG morphology like intrinsic

Increase Voltage until stimulation pulse “captures” the heart

This is the pacing or Capture Threshold

Set Voltage significantly higher than Capture Threshold

Safety margin: 2x, 3x… Capture Threshold

Ex: If Capture Threshold equals 4 V, set voltage to 8-12 V

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Presenter

Presentation Notes

Set the Mode to VVI. Set rate ~10bpm above the intrinsic rate (if intrinsic activity is sensed, the output is inhibited). Observing the ECG on a monitor, decrease the voltage until the stimulation is no longer effective. When there is loss of capture (LOC), the ECG will either be flat or the patient’s intrinsic rhythm and rate will take over. Increase the voltage until the pacing pulse consistently captures the heart. This is the pacing threshold. Set voltage output 2-3 times the pacing threshold. Note: Constant voltage devices (5391) remain at the same output regardless of the impedance, therefore, the threshold should be periodically checked (few hours post implant, then daily).

Knowledge Check

Given a sensing threshold of 4 mV and a capture threshold of 3 V, is this device set properly to deliver VVI pacing at 70 ppm?

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Presenter

Presentation Notes

No, the device is OFF. If it was programmed VVI or VVI Beep, it would be correct.

Basic Use Instructions Atrial High Rate Pacing

• Ensure leads/wires in atrium

• Set Basic Rate: 30-180 ppm

• Set Mode: x2 or x4

• Press and hold High Rate to deliver RAP

x2 = Basic Rate x2 Range = 60 - 360 ppm

x4 = Basic Rate x4 Range = 120 - 720 ppm

• Release High Rate button to stop

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Presenter

Presentation Notes

When the mode select dial is rotated to the x2 or x4 position, the 5391 will continue operating as a pacemaker without any change in the set parameters. However, once the High Rate button is activated, the pacemaker automatically switches to an asynchronous mode and stimulates at twice or four times the basic rate. The 5391 will also automatically emit beeps during stimulation in this mode

Knowledge Check

Explain the steps necessary to deliver high rate atrial pacing at 400 ppm.

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Presenter

Presentation Notes

Ensure lead is the atrium. Set output to 2-3x atrial capture threshold, if known, otherwise set at 12V. Set rate to 100 ppm. Set mode to x4. Press and hold High Rate button to deliver AOO pacing at 400ppm.

Basic Use Instructions Low Battery/Error LED • When a malfunction occurs the Low

Batt/Error LED will be constantly lit red and a repeating beep will sound

• Turn the device off and on again – If the red LED is not lit, the device can

be used – If the red LED remains constantly lit,

return the device for service

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Presenter

Presentation Notes

When a malfunction occurs, an error message is given by means of a constantly lit red LED. At the same time a repeating acoustic warning signal is given. The error is confirmed by turning the device off and on. If the error was not eliminated, the red LED remains constantly lit and additional warning tones will be given. The device needs to be returned for service. Example for a continuously lit red LED would be a device which showed ingress of liquids which caused a short in some electrical circuitry. The device shall not be used (in any mode) upon showing a continuously lit red LED.


5391 EPG

DIRECT connection of heart wire or lead

(exposed or shrouded pin) Medtronic Patient or Surgical Cables (e.g., 5433)

Heart wire or lead 53912 Adapter

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Connections Overview

Presenter

Presentation Notes

Overview schematic of available connections to the 5391 EPG. Any heart wire or lead (pin diameter < 2mm) can be directly connected to the 5391. If the Medtronic Patient or Surgical cables are used, the 53912 adapter is required to connect to the 5391.

53912 Adapter

30 cm

Necessary to connect ANY Medtronic Patient and Surgical Safety Cables (D01 Style Connector) Model 53912 – Reusable Model 53912D – Disposable (sold separate in box of 5)

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Presenter

Presentation Notes

The new 53912 is a 30cm adapter/extension cable which accepts the male end of the Medtronic Patient and Surgical Safety Cables. The other end bifurcates into 2mm male shrouded pins (black/red) which connect directly to the red(+) and black (-) connector posts on top of the 5391. A 53912 is included with a new 5391 EPG. The Medtronic 53912 is equivalent to the Oscor ATAR TM extension cable.


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Connecting Leads/Cable Direct connect or use Adapter/Extension

5391

DIRECT connection of heart wires or lead pins

(up to 2 mm diameter)

53912 Adapter/Extension required when using Medtronic

Patient or Surgical Cables

Ex: 5433V

Patient or Surgical Cables

Presenter

Presentation Notes

Connections: The 5391 has protected safety connectors for shrouded pins with a diameter of 0.9-2.0mm. Polarity is clearly marked with (-)/black for the Different pole and (+)/red for the Indifferent pole. Rotate the 5391 connectors to close the ‘jaw’ and clamp down on the wire/lead to secure it. The 5391 requires the use of the 53912 Adapter (30cm) when using patient/surgical cables such as 5433, 5846, 5833, 5832 and 5487.

Basic Use Instructions Connecting Leads/Cable

IS-1 or unipolar lead

5391

53912 Adapter/Extensi

on Cable

37

Presenter

Presentation Notes

On the right, is a list of the available Medtronic Surgical and Patient cables. Refer to Tip Card UC200005190eEN for more in-depth descriptions of these EPG accessories. Reminder that 53912 Adapter is required whenever the Medtronic Surgical and Patient cables are used.


Connecting Leads/Cable • Connector pins on the lead(s) must

be fully inserted in the patient connector block

• Observe polarity – Black to negative – Red to positive

• Finger tighten only (no tools required)

5433 Patient Cable

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Presenter

Presentation Notes

Up close diagram of the commonly used 5433 Patient Cable.


Lead Types • Endocardial/Transvenous lead

– Transvenous lead is introduced into a vein and advanced into the heart

• Epicardial/Myocardial lead – An epicardial lead is attached to the outside of the

heart and is introduced through the chest wall, usually done after cardiac surgery

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Temporary Pacing Wires/Leads

• Model 6500 Unipolar Temporary Myocardial Pacing lead

• Model 6495 Bipolar Coaxial Myocardial Temporary Pacing Lead

• Model 6494 Unipolar Myocardial Temporary Pacing Lead

• Model 6492 Unipolar Atrial Temporary Pacing Lead

• Model 6491 Pediatric Unipolar Temporary Pacing Lead

• Model 6416 Bipolar Temporary Transvenous Pacing Lead (active fix)

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Presenter

Presentation Notes

These are the temporary leads and wires available from Medtronic. The 6500, 6495, 6494, 6492 and 6491 are the Streamline heart wires. The 6416 is a bipolar, active fix, temporary transvenous pacing lead. All of these leads/wires can connect directly to 5391 without an adaptor.


Connecting Leads/Cable •Make sure MODE is set to OFF when connecting lead, patient cable and adapter •Connect patient cable and adapter to EPG before connecting lead/wire to patient cable •Ensure correct polarity (+/-) is observed •When using bipolar lead, connect:

- Distal electrode (-/black) - Proximal electrode (+/red)

•When using unipolar lead, connect: - Lead/wire (-/black) - Indifferent electrode (+/red); large surface area electrode

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Additional Accessories • 5409: Disposable Pouch

for EPGs

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Knowledge Check Which of the following statements are true?

1. The 53912 Adapter/Extension cable is always required when using

Medtronic Patient and Surgical cables.

2. Leads with shrouded pins cannot directly connect to the 5391.

3. Keep 5391 off when connecting leads and cables.

4. The 5391 has protected safety connectors for direct connection of leads/wires with a diameter ≤ 2.0 mm.

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Presenter

Presentation Notes

#1, #3 and #4 are correct. Shrouded pins can be directly connected provided the diameter is < 2mm.

Troubleshooting Pacemaker Performance

1. Gather information

2. Identify the problem and possible cause

3. Identify the solution and carry out corrective procedures

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Troubleshooting

Scenario #1

Electrical stimulation delivered by the pacemaker does not initiate depolarization of the atria or ventricle.

Gather information and identify the problem

45

Troubleshooting

Scenario #1

Identify the problem and solution

Possible Causes • Threshold rise • Fractured/dislodged lead • Battery depletion • QRS not visible • Tissue is refractory • Faulty cable connections

Corrective Measures • Increase output (V)/check thresholds • Replace/reposition lead • Replace battery • Adjust ECG • Assess mode selection • Check connections • Switch polarity (epicardial system)

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Troubleshooting

Scenario #1

Carry out corrective procedures 1. Increase RATE at least 10 ppm above patient’s intrinsic rate.

2. Increase the OUTPUT (voltage) until ECG shows consistent

capture. • This is the capture threshold

3. Set the OUTPUT to a value 2 to 3 times greater than the

capture threshold. • This provides a 2:1 or 3:1 safety margin

4. Restore RATE to clinical setting.

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Presenter

Presentation Notes

One possible problem/solution could be that the threshold has increased and the output needs to be increased. Perform a pacing threshold and reset the output based on the new capture threshold.

Troubleshooting

Scenario #2

Failure of pacemaker to sense intrinsic R-waves


48

Presenter

Presentation Notes

Note on this strip there are R-waves that are not being sensed and subsequently a pacing pulse is inappropriately delivered.

Troubleshooting

Scenario #2


Possible Causes Corrective Measures • Decreased QRS voltage • Increase sensitivity • Fractured/dislodged lead • Replace/reposition lead • Battery depletion • Replace battery • Inappropriate sensitivity setting • Sensing test/increase sensitivity • Fusion beat

49

Presenter

Presentation Notes

These are the possible causes for failure to sense intrinsic R-waves. Let’s address the ventricular undersensing by performing a sensing threshold and making the device more sensitive.

Troubleshooting

Scenario #2

Carry out corrective procedures 1. Set RATE at least 10 ppm below patient’s intrinsic rate. 2. Adjust OUTPUT to prevent competitive pacing. 3. Rotate the SENSITIVITY dial (mV) to a larger number (less

sensitive) until the Stim LED flashes continuously. 4. Rotate the SENSITIVITY dial (mV) to a smaller number (more

sensitive) until the Sense LED flashes and the Stim LED stops flashing.

• This is the sensing threshold 5. Set SENSITIVITY dial (mV) to half the sensing threshold.

• This provides a 2:1 safety margin 6. Restore RATE and OUTPUT to clinical setting.

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Presenter

Presentation Notes

This describes the sensing threshold procedure which determines the least sensitive setting the pacemaker can detect a heartbeat.

Troubleshooting

Scenario #3


Low Batt/Error LED is flashing red every 5 seconds and beeping every 5 minutes.

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Troubleshooting

Scenario #3


Possible Causes Corrective Measures • Battery is getting low • Replace battery

52

Presenter

Presentation Notes

The only possible cause for this is a low battery. When this occurs, the battery has an estimated 2 days remaining at 8V at 72 ppm. However, it is recommended that the battery be replaced when the low battery warning is first given.

Troubleshooting

Scenario #3

Carry out corrective procedures 1. Patient should be connected to another device to provide pacing

while the battery of the 5391 is replaced. - There is no pacing support when the battery is removed

2. Slide the compartment lid (12) to the side.

3. Remove the battery from the compartment and disconnect from the battery clip.

4. Connect new battery with correct polarity to the battery clip.

5. Reconnect the patient to the 5391.

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Presenter

Presentation Notes

Patient should not be connected to the 5391 when replacing the battery. Since there is no pacing when the battery is removed from the 5391, some other means of pacing the patient must be provided.

Key Learning Points • It is important to understand the temporary pacemaker equipment

(constant voltage) and programming options before attempting operation.

• Sensing and pacing thresholds should be measured at the time of implant and checked regularly.

• Adequate sensing and threshold safety margins should be maintained.

• Backup batteries should be available for replacement. • Backup external pacing should be available for battery replacement

(no pacing when battery removed) and in the event that an issue occurs with the temporary pacemaker or lead.

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General Information Precautions External Interference

•The 5391 and leads should be at minimum 6 inches away from any source of interference •The 5391 may be inhibited by strong external interference resembling the signal the pacer is designed to sense. Such interference signals may be produced by a variety of sources including electrocautery, diathermy, and other devices. The 5391 will not be damaged by such interferences and will resume its function as soon as the interference source is removed. •In the presence of interference to the leads or 5391, sensitivity should be turned to “f” for asynchronous pacing •Defibrillation equipment should be on hand while the 5391 and its leads are being introduced into and connected to the patient

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General Information Care and Handling •Inspect device and accessories for visible damage •Inspect mechanical operation of connectors •Check battery cover for closure •External surface of unit can be cleaned using sponge/cloth with 70% alcohol or alhydex or Cidex®

- Do not sterilize with steam, ethylene oxide or gamma rays •Yearly safety check-ups and functional inspection by the manufacturer or authorized personnel is recommended

56

Presenter

Presentation Notes

Yearly check-up to include: Measuring the differential or auxiliary currents. Measuring the stimulation parameters Measuring the stimulation rate Measuring the sensing sensitivity Measuring the refractory period Inspecting the interference behavior Inspecting the battery surveillance

General Information Service and Repair

• New Product Warranty is 1 year • Service Warranty is 90 days • The Medtronic 5391 is not field serviceable

– No parts can be repaired or calibrated by anyone other than Medtronic or an authorized representative

• Refer to 5391 Checkout Manual for periodic testing of device • For repairs, return to Medtronic

– Information is available at: https://wwwp.medtronic.com/mdtConnectPortal/registration/index.jsp

• Technical Support/Contact Information - Instrument Technical Services 800-638-1991 or email [email protected]

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https://wwwp.medtronic.com/mdtConnectPortal/registration/index.jsp

mailto:[email protected]

General Information Additional Resources

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1. 5391 Tip Card (UC201304829EN) 2. Care and Use Care (UC201304828EN) 3. Cable Reference Guide (UC201305502EN) 4. Spec Sheet (UC201304831EN)

General Information Technical Specifications

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• Stimulation frequency: Variable from 30 ppm to 180 ppm Tolerance of setting: ± 10%

• High Rate stimulation: Async., freq. ×2, ×4, with acoustic signals • P-/R-waves Sensitivity: Variable from 1 mV to 20 mV, ∝

Tolerance of settings: ± 20 % • Input resistance: 24 kOhm ± 10 % • Output resistance: < 20 Ohm; for load resistance > 150 Ohm • Defibrillation protection: Suppression diode built in • Output impulse: Polarity: cathodic, capacitive coupled

Form: biphasic, asymmetric Duration: 0.75 ms ± 0.05 ms

• Output impulse amplitude: Variable from 0.3 V - 12 V Tolerance of setting: ± 10 % ±0.1V

• Run Away-Protection: 200 ppm ± 10 ppm • Refractory period: 250 ms ± 5 % • Interference recognition: Interference frequencies >283 ppm ± 5

Technical Support

World Headquarters Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432-5604 USA www.medtronic.com Tel. +1-763-514-4000 Fax +1-763-514-4879 Medtronic USA, Inc. Toll-free in the USA (24-hour technical consultation for physicians and medical professionals) Instruments: 1-800-638-1991 Bradycardia: 1-800-505-4636 Tachycardia: 1-800-723-4636

Europe/Africa/Middle East Headquarters Medtronic International Trading Sàrl Route du Molliau 31 Case Postale 84 CH-1131 Tolochenaz Switzerland www.medtronic.com Tel. +41-21-802-7000 Fax +41-21-802-7900 Medtronic E.C. Authorized Representative Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel. +31-45-566-8000 Fax +31-45-566-8668 Technical manuals: www.medtronic.com/manuals

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• Warning: The 5391 must not be connected to the patient during battery replacement • External Interference: The 5391 may be inhibited by strong external interference

resembling the signal the pacer is designed to sense. Such interference signals may be produced by a variety of sources including electrocautery, diathermy, and other devices. The 5391 will not be damaged by such interferences and will resume its function as soon as the interference source is removed.

• Defibrillation equipment should be at hand while the 5391 and its leads are being introduced into and connected to the patient

• Warning: MR unsafe - The temporary pacemaker is MR unsafe. Do not bring the temporary pacemaker into Zone 4 (magnet room), as defined by the American College of Radiology.

Operational failure of the temporary pacemaker can occur as the result of battery depletion, mishandling, or random component failure. Complications related to the use of temporary external pacemakers such as the Model 5391 include, but are not limited to asystole following abrupt cessation of pacing, inhibition, and reversion. Potential complications related to the use of pacing lead systems with the Model 5391 include, but are not limited to myocardial irritability resulting in fibrillation, infarction, pericarditis, rejection, muscle and nerve stimulation, and infection. Complication related to inhibition or reversion of the pacemaker in the presence of strong electromagnetic interference. Whenever possible, for the safety of the patient, disconnect the temporary pacemaker from the implanted lead system before defibrillating or cardioverting. Excessive defibrillation energy can damage the temporary pacemaker. This can result in a large current flowing through the implanted lead system and temporary pacemaker, which could reduce intended defibrillation energy delivered to the patient or cause myocardial damage. A lead with extension cable constitutes a direct, low-resistance current path to the myocardium. During connection and testing procedures, only battery-powered instrumentation should be used. Extreme caution must be taken to properly ground all line-powered equipment used in the vicinity of the patient. Electrosurgical units can cause tachyarrhythmias by inducing current on the leads. Improper connection, displacement or fracture of leads or cables may result in pacemaker system failure. Inspect leads and cables for damage before each use. The pacing lead system may cease to function at any time due to improper connections or lead-related problems such as displacement or fracture. Do not modify the temporary pacemaker. Modifications could impact the temporary pacemaker effectiveness and adversely affect patient safety. See the device manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1 (800) 328-2518 and/or consult Medtronic’s website at www.medtronic.com. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. UC201305408 EN

March 2013

Brief Statement: Model 5391 Single-Chamber Temporary Pacemaker Intended Use The Medtronic Model 5391 single-chamber temporary pacemaker is intended to be used in conjunction with a cardiac pacing lead system for temporary single chamber pacing in a clinical environment by trained personnel. The external pacemaker 5391 is designed for temporary stimulation of the heart in case of rhythm disturbances and conduction defects. According to present clinical experience, the instrument is especially suited for stimulation of the heart in the following cases: • treatment of patients before an operation, whereby an implantable pacemaker is being inserted

• treatment of tachyarrhythmia • treatment of special cases of acute myocardial infarction • treatment of patients after heart surgery The temporary pacemaker must be used in an environment where the patient is monitored continuously to ensure that it is operating properly and delivering appropriate therapy to the patient. Contraindications There are no contraindications with regards to the use of the 5391 for temporary cardiac stimulation for therapy and prevention of arrhythmia. The state of health of the patient, however, can restrict the choice of operational mode and stimulation parameters. For example, a mode of operation with atrial sensing is not suitable or appropriate when atrial fibrillation occurs. This is due to the excessive and chaotic frequency of detected fibrillation waves. Asynchronous pacing is contraindicated in the presence of intrinsic cardiac rhythms. Overdrive-stimulation therapy must only be used in the atrium. Overdrive-stimulation in the ventricle could cause life threatening ventricular fibrillation. Medtronic does not recommend high-rate pacing for the treatment of ventricular tachycardia. Warnings/Precautions Monitor the patient continuously while the temporary pacemaker is in use to ensure it is operating properly and delivering appropriate therapy to the patient. ECG monitoring should be in use and defibrillating equipment should be placed on standby and be kept immediately available during pacing lead insertion, pulse generator connection and adjustment, measurements of stimulation thresholds or sensed potentials, and application of antitachycardia burst therapy. Use of high rates in the atrium may result in accidental conduction to the ventricle. Defibrillation equipment should be kept immediately available during high-rate pacing. • Warning: The 5391 does not have pacing continuation when the 9 Volt battery is removed

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