Tip Booklet
13 Pages
Preview
Page 1
1
External surfaces of unit can be cleaned using a sponge or cloth moistened with water or 70% isopropyl alcohol. For internal surfaces, send to Medtronic for cleaning, safety, and technical check.
Send to Medtronic for safety and technical check.
Do NOT attempt to clean any internal surfaces, including battery compartment. Do NOT immerse the device in water or cleaning agents; do NOT expose the unit to ethers, acetone, or chlorinated solvents. Do NOT ignore; the device may appear to work appropriately immediately after being dropped or mishandled, but operational damage may have occurred. Do NOT ignore; the temporary pacemaker was designed to minimize leakage, but fluid incursion may still occur.
* Should service or repair be necessary, contact your local Medtronic representative. ** Disposable Pouch available for the Model 5392 Temporary Pacemaker; Model #5409. Safety and technical checks should be carried out at least once every 12 months and after any malfunction or accident.
If spilled on
What NOT to do ... Do NOT reuse battery. Do NOT ignore visible physical damage; the device may appear to work properly immediately after being dropped or mishandled, but operational damage may have occurred. Do NOT use damaged leads or cables. Improper connection, displacement, or fracture may result in pacemaker failure. Do NOT reuse single-use cables.
Do not place the temporary pacemaker in any area outside of the Do NOT place the device in any area where the patient may interact with it. direct observation by medical staff. If necessary, insert into a Disposable Pouch** (see-through plastic pocket) with an attachment panel (to hang from IV pole) that protects and holds the temporary pacemaker. Place the temporary pacemaker in an area that minimizes access to the controls by unauthorized personnel, such as patients and visitors.
If dropped/Visible Send to Medtronic for safety and technical check. exterior damage
POST-USE Clean
IN USE Placement
Cables
What to do ... Replace the battery for each new patient. Check case for cracks/damage.* Check battery drawer for closure.* Check display for cracks/damage.* Inspect cables and leads for possible defects, and secure connection before each use.
PRE-USE
Battery Physical Condition*
Medtronic Model 5392
Basic Operation – Lower Screen Pacing Parameters for DDD mode.
Medtronic Model 5392 Basic Operation
Connector Setup 1. Verify that the temporary pacemaker is turned off. 2. Plug the Model 5433A and Model 5433V patient cables or a pair of 5832 or 5832S surgical cables into appropriate sockets on the connector block on top of the temporary pacemaker. One socket is marked A (atrium); the other is marked V (ventricle). 3. Verify that each patient cable clicks when it is inserted into the temporary pacemaker connector receptacle. Note: The audible click verifies that the plug is completely inserted into the receptacle.
4. Pull gently on the patient cables after insertion to ensure a good connection. 5. Connect the leads to the appropriate cable. Match positive (+) and negative (–) leads to positive (+) and negative (–) sockets or clips for the atrium and ventricle (not shown). The sockets are also color-coded blue for atrium and white for ventricle.
Note: To disconnect the patient cables from the temporary pacemaker, do the following: 1. Press the connector release button on the patient cable plug. 2. Gently pull the plug from the receptacle.
2
3
Medtronic Model 5392 Basic Operation To Turn On • Press and hold the On/Off key momentarily to turn on the temporary pacemaker The upper screen and the backlight illuminate, a self-test is initiated, and the temporary pacemaker first paces, and then begins sensing and pacing in both chambers (DDD mode).
Medtronic Model 5392 Basic Operation Lock/Unlock The locK/unlocK key locks the temporary pacemaker to prevent inadvertent adjustment of the parameters, or unlocks the temporary pacemaker when it is locked. When Locked: • The Rate, A Output, and V Output parameter values lock and cannot be adjusted • Pacing therapy continues to be delivered at the currently selected values • The Lock indicator appears in the status bar
PACE
A
SENSE
PACE
V
SENSE
RATE
30
200
min-1 ppm
A OUTPUT Note: Pressing a key while the self-test is in process can cause the device to fail the self-test, and display error code, “0004.” The device may interpret mA the pressed key as being “stuck” and,V OUTPUT therefore, malfunctioning. If a key is pressed during the self-test, remove and reinsert the battery to clear the error code. mA 0
20
0
25
To Turn Off 1. Unlock the temporary pacemaker, if it is locked (see following section). 2. Press the On/Off key once. A message is displayed in the lower screen to confirm temporary pacemaker shutdown (see Figure below).
• The lower screen does not appear. The Mode Selection options and pacing parameters cannot be adjusted. • The pause key is locked • Press locK/unlocK key to unlock the 5392 before adjusting parameters • Press locK/unlocK key to lock the 5392 after adjusting parameters Notes • The doo/emergencY key does not lock. If pressed while the temporary pacemaker is locked, the temporary pacemaker begins asynchronous pacing. • The temporary pacemaker locks under one of the following conditions: – 60 s after the last parameter adjustment is made – When the locK/unlocK key is pressed If any parameter dials are adjusted or any keys are pressed while the temporary pacemaker is locked (other than the doo/emergencY key), the Lock indicator flashes, and the lower screen displays the Locked message for approximately 30 s.
3. Press the Enter key once to confirm temporary pacemaker shutdown.
4
5
Medtronic Model 5392 Basic Operation
Medtronic Model 5392 Lower Screen Pacing Parameter Adjustments
Rate and Output Adjustments 1. If the Lock indicator appears in the status bar, press locK/unlocK key. 2. To adjust rate, a (Atrial) output, or V (Ventricular) output, turn the dials clockwise to increase their values; turn the dials counterclockwise to decrease their values, or to set the outputs to off. Rate and output values appear on upper screen. Viewing Patient’s Intrinsic Rhythm • Reduce the rate gradually, while watching the ECG, until the patient’s intrinsic rhythm takes over • Press and hold pause key to suspend pacing and sensing up to 10 seconds Note: To pause again up to 10 seconds, release pause key; then press and hold the pause key again.
EMERGENCY Pacing • Press doo/emergencY key to initiate high-output, dualchamber asynchronous pacing (DOO for emergency) Note: Press the enter key to return to synchronous (demand) pacing, or select the modes with synchronized pacing from the Mode Selection menu and adjust A Sensitivity and/or V Sensitivity.
After a pacing mode has been selected, the Pacing Parameters menu for that pacing mode is displayed and the parameters can be adjusted. Screen 1: Mode Selection screen Screen 2: V Sensitivity selected on the DDD pacing parameters screen Screen 3: Upper Rate selected on the DDD pacing parameters screen Screen 4: RAP screen Note: Parameters displayed on menus are based on currently programmed pacing mode and rate. Parameters that do not apply to the current chambers being paced and sensed are not displayed. Parameters that did not apply in the previous mode are set to nominal values in the new mode.
6
7
Medtronic Model 5392 Lower Screen Pacing Parameter Adjustments To Adjust Atrial/Ventricular Sensitivity 1. Press menu key until Menu 1 is displayed. 2. Press select key until A Sensitivity or V Sensitivity is highlighted. 3. Turn menu parameter dial clockwise to increase sensitivity; counterclockwise to decrease sensitivity or set to ASYNC. • A Sensitivity range: 0.4 mV - 10 mV and ASYNC • V Sensitivity range: 0.8 mV - 20 mV and ASYNC
Medtronic Model 5392 Lower Screen Pacing Parameter Adjustments Rate-Dependent Parameters Upper Rate, PVARP, and A-V Interval are automatically set whenever rate is adjusted, but can be manually adjusted from lower screens. Note: An asterisk (*) next to the value of each setting that is manually adjusted.
Notes • Setting A SENSITIVITY or V SENSITIVITY to ASYNC turns sensing off and starts asynchronous pacing • The highest number (in mV) for SENSITIVITY is the least sensitive setting; the lowest number (in mV) is the most sensitive setting
To Turn Atrial Tracking Off or On (Set to DDI or DDD mode) 1. Press menu key until Menu 1 is displayed. 2. Press select key until A Tracking is highlighted. 3. Turn menu parameter dial counterclockwise to display OFF (DDI mode); clockwise to display ON (DDD mode) Note: Atrial tracking can be set to OFF only from DDD mode and set to ON only from DDI mode.
To Adjust A-V Interval 1. Navigate to the Pacing Parameters menu. 2. Press the up or down arrow key to highlight A-V Interval. 3. Turn the menu parameter dial clockwise to lengthen the A-V Interval, or counterclockwise to shorten the A-V Interval. Range: 20 ms - 300 ms To Adjust Upper Rate 1. Navigate to the Pacing Parameters menu. 2. Press the up or down arrow key to highlight Upper Rate. 3. Turn the menu parameter dial clockwise to increase the upper rate, or counterclockwise to decrease the upper rate. The Upper Rate parameter is only adjustable in DDD mode. Range: 80 min-1 - 230 min-1
8
9
Medtronic Model 5392 Lower Screen Pacing Parameter Adjustments To Adjust PVARP 1. Navigate to the pacing parameters menu. 2. Press the up or down arrow key to select PVARP.
Medtronic Model 5392 Sensing Thresholds Note: The sensing threshold is the least sensitive setting at which the pacemaker can detect a heartbeat. To find the atrial and ventricular thresholds, monitor the patient’s ECG as you follow the procedure below. Caution: Pacemaker-dependent patients will have limited or no intrinsic rate/rhythm.
3. Turn the menu parameter dial clockwise to increase the PVARP, or counterclockwise to decrease the PVARP. Range: 150 ms - 500 ms
To Find Atrial or Ventricular Sensing Threshold
To Reset Rate-Dependent Values to Automatic Settings 1. Navigate to the pacing parameters menu.
Caution: Do not connect the temporary pacemaker to the patient lead system until step 4.
1. Turn on the temporary pacemaker without connecting it to the patient lead system.
2. Select Settings.
2. Set Rate to at least 10 min–1 (ppm) under the patient’s intrinsic rate. This adjustment ensures non-pacing.
3. Turn the menu parameter dial either clockwise or counterclockwise until Automatic replaces Manual.
3. Adjust the atrial or ventricular output to prevent the risk of competitive pacing.
4. Use the menu parameter dial to alternate between Automatic and Manual parameter settings, as long as Settings remains selected. Previous Manual settings are lost when Automatic is selected for Upper Rate, PVARP, and A-V Interval.
• Atrial: Set A Output to 0.1 mA. • Ventricular: Set V Output to 0.1 mA. 4. Connect the temporary pacemaker to the patient lead system. 5. Navigate to the mode selection menu and select the appropriate pacing mode for the patient leads that are connected to the patient. • Select DDD mode if both channels are connected • Select AAI mode if only the atrial channel is connected • Select VVI mode if only the ventricular channel is connected 6. Navigate to the Sensitivity settings. a. Complete steps 7 thru 9 for the A Sensitivity setting, if the atrial channel is connected. b. Complete steps 7 thru 9 for the V Sensitivity setting, if the ventricular channel is connected.
10
11
Medtronic Model 5392 Sensing Thresholds 7. Decrease Sensitivity: Slowly turn the menu parameter dial counterclockwise (increase mV value) until the sense indicator stops flashing. The pace indicator flashes continuously, but capture is not likely because the output value is set to minimum.
Medtronic Model 5392 Stimulation Thresholds Note: The stimulation threshold is the minimum output pulse needed to consistently capture the heart. To find this threshold, monitor the ECG as you follow the procedure below. To reduce the risk of competitive pacing, find the sensing threshold first (if the patient’s intrinsic rate is adequate).
To Find Atrial or Ventricular Stimulation Threshold 1. Verify that the patient is connected to the temporary pacemaker and is being monitored on the ECG. 2. Set Rate at least 10 min–1 (ppm) above the patient’s intrinsic rate. This adjustment ensures pacing. The pace indicator flashes.
8. Increase Sensitivity: Slowly turn the menu parameter dial clockwise (decrease mV value) until the sense indicator starts flashing. • The pace indicator stops flashing • This value is the sensing threshold
3. Decrease Output: Slowly turn the output dial counterclockwise until ECG shows loss of capture. • Pace and sense indicators flash intermittently. 4. Increase Output: Slowly turn the output dial clockwise until ECG shows consistent capture. • The pace indicator flashes continuously; the sense indicator stops flashing • This value is the stimulation threshold 5. Set Output to a value at least 2 to 3 times greater than the stimulation threshold value. This setting provides at least a 2:1 safety margin. 6. Restore Rate to the previous value.
9. Set Sensitivity to half (or less) the threshold value. This setting provides at least a 2:1 safety margin. 10. Restore Rate, A Output, or V Output to previous values.
12
13
Off
On
On
On
DDI
Notes • The Pacing Setup Table on the other side of this card provides a reference to output and sensitivity settings for each available pacing mode. 1. Verify Output.
On
Medtronic Model 5392 Pacing Setup
On
On
On
4. Verify Pacing Setup Indicators.
On
DDD
3. Verify Atrial Tracking.
On
2. Verify Sensitivity.
14
15
NA
NA
ASYNC
NA NA NA A Tracking
3. Set
ASYNC NA
On NA
On NA
NA
ASYNC
ASYNC A Sensitivity
V Sensitivity
2. Set Sensitivity
On
On On
Off On
Off On
DOO VVI AAI
Off On
Off
Note: Manually-set pacing parameter values are not retained when the temporary pacemaker is turned off, and then turned back on.
A Output
Rate, Output, and Sensitivity values are set to the nominal values when a pacing mode is selected, unless they have been manually adjusted before the pacing mode was selected. If they have been manually adjusted before the pacing mode was selected, the new pacing mode retains these values.
V Output
Pacing in the selected mode begins as follows:
1. Set Output
3. Press the enter key select the pacing mode.
Instructions
2. Press the up or down arrow keys to highlight a pacing mode.
VOO
1. Navigate to the mode selection menu.
AOO
To Dial-A-Mode (DDD, DDI, DOO, AAI, AOO, VVI, or VOO pacing modes, or OOO for no pacing therapy)
Setup Indicators
• The Pacing Parameter Adjustments card describes how to manually adjust pacing parameters
Temporary External Pacemaker 5392 Setup Table
• The RAP (Rapid Atrial Pacing) card describes how to deliver rapid atrial pacing
Medtronic Model 5392 RAP (Rapid Atrial Pacing) RAP can be used to interrupt some types of atrial tachycardias or to induce an atrial tachycardia. Caution: RAP is for atrial use only. Be sure that the atrial leads are connected to the atrium, not the ventricle, before enabling RAP.
Medtronic Model 5392 RAP (Rapid Atrial Pacing) Adjusting Rate or Atrial Output during RAP Delivery The RAP rate and A Output can be adjusted during RAP delivery by turning the menu parameters dial. To adjust A Output, do the following: 1. Continue to press and hold the enter key. 2. Turn the menu parameter dial clockwise or counterclockwise to adjust RAP rate. 3. Turn the a output dial clockwise or counterclockwise to adjust atrial output.
Caution: RAP may result in tachycardia, acceleration of existing tachycardia, or fibrillation. Apply high rates under careful patient monitoring and control. Monitor the patient’s ECG and blood pressure, and ensure that defibrillation equipment is immediately available.
To Deliver RAP: 1. Navigate to the Pacing Parameters menu. 2. Press the up or down arrow key to highlight Rapid Atrial Pacing (RAP). 3. Verify that the leads are in contact with the atrium and are connected to the atrial channel of the temporary pacemaker through a patient or surgical cable. 4. Press the enter key to open the RAP screen. The RAP screen displays the RAP rate [initially the rate of 250 min–1 (ppm)]. Pacing continues at currently displayed settings. 5. Adjust RAP rate as needed. Turn the menu parameter dial clockwise to increase rate, or counterclockwise to decrease rate.
Resuming Pacing at Previous Settings • Release enter key to resume pacing at the previous settings. The temporary pacemaker stops delivering RAP and resumes operation at the non-RAP settings, within 3 s. If the A Output is adjusted during RAP, the new setting is retained when RAP is terminated. CAUTION: If the temporary pacemaker continues to deliver RAP after the enter key is released, press the on/oFF key or the doo/emergencY key to stop RAP. If RAP continues to be delivered, remove the batteries from the temporary pacemaker. Return the temporary pacemaker for service.
Note: The range for RAP is 80 min–1 (ppm) to 800 min–1 (ppm).
6. Press and hold the enter key to deliver RAP burst. AOO pacing begins at displayed RAP rate and current A Output. The A Pace LED flashes during delivery of RAP pulses. Note: RAP delivery stops when either the enter key is released, or after 1 min has passed.
To exit the RAP screen, use the up or down arrow key to select BacK, and then press the enter key.
16
17
Medtronic Model 5392 Battery Replacement Battery Installation and Replacement Note: Medtronic recommends disconnecting device from patient before replacing battery.
1. Press the battery drawer latch release button until the battery drawer opens.
2. Remove the old batteries. 3. Install two new LR6-sized (AA-sized) alkaline batteries. Verify that the batteries align with the polarity markings on the inside of the battery drawer. 4. Close the battery drawer firmly until the battery drawer is fully latched. Note: Failure to close the battery drawer completely can result in the battery drawer opening and the temporary pacemaker shutting down.
5. Discard the old batteries properly according to local regulations. Notes • Replace the temporary pacemaker batteries in the following situations: – Replace the batteries for each new patient – Replace the batteries when the low battery indicator appears during temporary pacemaker operation – Replace the batteries at least once every week when the temporary pacemaker is in continuous use • Install the batteries with proper polarity. The temporary pacemaker does not turn on or provide pacing therapy with incorrect battery polarity • If during an emergency situation the batteries must be replaced while the temporary pacemaker is in use, ensure that the temporary pacemaker is locked before replacing the batteries. Pacing is maintained at the current settings for 30 s, minimum, if the settings are at nominal values.
18
19
Brief Statement Model 5392 Dual Chamber Temporary Pacemaker Intended Use: The Medtronic Model 5392 dual chamber temporary pacemaker is intended to be used in conjunction with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment by trained personnel. The temporary pacemaker can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylactic, or diagnostic purposes. 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 known contraindications to the use of temporary pacing as a means to control the heart rate. The patient’s age and medical condition, however, may dictate the type of temporary pacemaker and lead system used by the physician. Pacing modes which allow sensing in the atrium to trigger a ventricular response are contraindicated in the presence of rapid atrial arrhythmias such as atrial fibrillation or atrial flutter. Atrial pacing is ineffective in the presence of atrial fibrillation or flutter. Single chamber atrial pacing is contraindicated in the presence of AV conduction disorders. Asynchronous pacing is contraindicated in the presence of intrinsic cardiac rhythms. Atrial high-rate burst pacing therapy is intended for use in the atrium only. High-rate burst pacing in the ventricle may result in life-threatening arrhythmias. The temporary pacemaker is MR Unsafe. 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. 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 5392 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 5392 include, but are not limited to, myocardial irritability resulting in fibrillation, infarction, pericarditis, rejection, muscle and never 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 batterypowered 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.
Australia Medtronic Australasia Pty Ltd ABN 47 001 162 661 97 Waterloo Road North Ryde NSW 2113 Toll Free 1800 668 670
New Zealand Medtronic New Zealand Limited 5 Gloucester Park Road Onehunga, Auckland NZ Toll Free 0800 377 807
UC201205013ANZ © Medtronic Australasia 2013. All Rights Reserved. Printed in Australia. 10/2013
www.medtronic.com.au www.medtronic.co.nz