temporary pacemaker 5391 · are based on medtronic products and can be referenced in the device...
TRANSCRIPT
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Temporary Pacemaker 5391 In-Service
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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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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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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
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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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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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Rate
Basic Rate Range: 30-180 p/min (ppm) High Rate Pacing Range: 2x: 60-360 ppm 4x: 120-720 ppm
Basic Use Instructions
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Sensitivity Sensitivity Range: 1-20 mV, f (= Asynchronous)
Basic Use Instructions
Sense LED illuminates GREEN
when intrinsic activity sensed.
1 mV
5 mV
20 mV
f (infinite) Asynchronous pacing
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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
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Review of Sensitivity
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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
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Review of Sensitivity
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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
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Pulse Amplitude
Pulse Amplitude/Output: 0.3-12 Volts • Constant voltage output • Determine amplitude capture threshold
Basic Use Instructions
Stim LED illuminates YELLOW when
pacing pulse delivered.
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Knowledge Check Explain how to turn the device “ON”?
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Basic Use Instructions
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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Basic Use Instructions
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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Basic Use Instructions
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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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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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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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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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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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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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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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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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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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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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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Knowledge Check
Explain the steps necessary to deliver high rate atrial pacing at 400 ppm.
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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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Basic Use Instructions
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
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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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Basic Use Instructions
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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
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Basic Use Instructions Connecting Leads/Cable
IS-1 or unipolar lead
5391
53912 Adapter/Extensi
on Cable
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Basic Use Instructions
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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Basic Use Instructions
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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Basic Use Instructions
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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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
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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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Troubleshooting
Scenario #2
Failure of pacemaker to sense intrinsic R-waves
Gather information and identify the problem
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Troubleshooting
Scenario #2
Identify the problem and solution
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
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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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Troubleshooting
Scenario #3
Gather information and identify the problem
Low Batt/Error LED is flashing red every 5 seconds and beeping every 5 minutes.
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Troubleshooting
Scenario #3
Identify the problem and solution
Possible Causes Corrective Measures • Battery is getting low • Replace battery
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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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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
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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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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)
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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
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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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