EDP 20/B Technical Manual

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Inhalt

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Contents

Contents General Description ...41 Device Description ... 41 Contraindications ... 42 Warnings and Precautions ... 42 Potential Adverse Events ... 47 Operating Instructions ...48 General Remarks ... 48 Controls and LEDs ... 49 Plastic Cover ... 50 Lead Connections ... 50 Operating Procedure ... 55 Battery Replacement ... 56 Pacing Modes and Parameters ...58 Pacing Modes ... 58 Rate ... 60 Pulse Amplitude ... 60 Sensitivity ... 60 Interference Interval ... 61 Handling and Maintenance ...62 Reusable Patient Cables ... 63 Disposal ... 63 Technical Safety ...64 Technical Data ...65 Compliance with IEC 60601-1-2 ... 67 Supplied Equipment and Accessories ...72

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Indications ... 42

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Contents

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General Description

General Description Sales in the USA: Federal (US) law restricts this device to sale by, or in the order of, a physician or properly licensed practitioner!

Device Description The EDP 20/B is a battery-powered, single-chamber, external cardiac pacemaker that is designed to be attached to the patient‘s temporary pacing leads (includes myocardial heart wires and transvenous catheters). This connection is facilitated through a separate patient cable between the pacing leads and the EDP 20/B. The three pacing modes available include •

demand mode (VVI; also functions as AAI in the atrium)

•

asynchronous mode (VOO; also functions as AOO in the atrium)

•

rapid pacing at rates up to 1000 ppm (atrial application only)

Rate and rapid pacing rate have a continuous range of settings. Sensitivity and output voltage are separately adjustable. Flashing lights indicate sensing and pacing as well as battery depletion. Safety features of the EDP 20/B include: •

visual control of sensed and paced events

•

microprocessor controlled stimulation parameters

•

lead impedance monitoring

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visual EOS warning

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a transparent sliding cover to protect the dials and unintentional changing of the parameters

The EDP 20/B is connected to the PK-83-B or PK-67 patient cable with touch-proof connectors. This system provides a secure connection of transvenous

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Caution!

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General Description

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catheters or myocardial heart wires applied either in the unipolar or bipolar version. Handles on the sides of the unit allow it to be strapped to the arm, chest, or waist of the patient, or attached with a separate holder card to the patient's bed or infusion stand.

Indications Temporary pacing as provided by the EDP 20/B is indicated for: •

temporary treatment of arrhythmias and heart block

•

the termination of certain supraventricular tachyarrhythmias

•

pre-, intra- and postoperative temporary stimulation of patients undergoing cardiac surgery

•

prophylactic pacing for prevention of arrhythmias

•

emergency pacing

Contraindications The use of an external pacemaker is contraindicated in the presence of a working, implanted cardiac pacemaker. Single chamber atrial pacing is contraindicated for patients with impaired AV nodal conduction. Single chamber atrial pacing is contraindicated for patients with chronic refractory atrial tachyarrhythmias.

Warnings and Precautions Depending on the pacing protocol and the underlying disease of the patient, pacing may induce arrhythmias. To secure patient safety certain procedures should be observed and precautions taken, e.g. continuous ECG monitoring of the patient as well as keeping an external defibrillator, oxygen, intubation equipment and emergency drugs on hand. For detailed

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General Description

information on recommended procedures and precautions to be taken, reference should be made to pertinent publications in the medical literature. •

The EDP 20/B may only be used by medically skilled personnel familiar with the device. The patient’s heart rate must be monitored with an ECG monitor with alarm function when using the EDP 20/B.

•

The EDP 20/B should only be used in accordance with the operating instructions contained in this manual.

•

Never use a damaged device or a device which exhibits anomalies, especially if the device has been dropped or might be damaged by radio frequency or defibrillation current.

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The EDP 20/B must not be connected to other (electromedical) devices.

•

The device should not be used in areas where there is danger of explosion.

•

All pulse generators can be affected by external stimuli including magnetic, electrical, and electromagnetic signals that closely resemble cardiac signals. Depending on the type of signal, the pulse generator may pace asynchronously, inhibit, or pace synchronously. The susceptibility of a particular unit depends on the type of lead used, the distance of the unit from the disturbance, the nature of the disturbance, and the selected parameters.

•

Before handling EDP 20/B, patient cables or leads the user should touch the patient to equalize electric potentials.

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The patient cables must be connected first to the EDP 20/B and then to the lead.

•

Prior to connection of the lead, it is highly recommended that the user reconfirms each selected parameter.

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General Description

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When using cables for dual chamber applications (PK-67 with patient adapters, PK-175 or for the US only: ADAP 2R), confirm that the lead is connected to the ventricular channel of the cable (see Fig. 2).

•

When using harness EDP-A, do not wear the device directly on the skin.

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Monitor the patient's heart rate with an ECG monitor with alarm function when using the EDP 20/B.

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Connections of EDP 20/B and pacing leads should be secured and checked regularly.

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The temporary leads to which the EDP 20/B is connected provide a direct, low resistance path to the myocardium for electrical current. Proper grounding of line-powered devices used in the vicinity of the patient is essential.

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When handling indwelling leads, the terminal pins or exposed metal are not to be touched nor to be allowed to contact electrically conductive or wet surfaces.

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If the cable becomes disconnected from the EDP 20/B, immediately reattach the cable to the EDP 20/B and ensure the cable connector is tightened more securely.

•

When leads are attached to the patient and connected to the EDP 20/B the battery compartment may not be open, so that the connectors in the battery compartment cannot be touched. Touching can induce current leakage that could mediate lethal arrhythmias.

•

Proper use of unipolar heart wires is essential. Two unipolar leads must be used in combination to ensure effective pacing.

•

The device will discontinue operating upon battery removal. If the battery needs to be replaced while the device is in use, disconnect the device and connect the patient cables to another device.

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General Description

•

During use, the plastic cover should be closed completely to cover the dials, thereby preventing unintentional changing of the operating parameters.

•

Although the device is protected against dripping water, all connections and the EDP 20/B itself should be kept clean and dry. The EDP 20/B pulse generator cannot be sterilized.

•

Electrocautery should never be performed within 15 cm (6 inches) of the leads because of the danger of inducing ventricular fibrillation and/or damaging the pacemaker. The EDP 20/B should be programmed to an asynchronous mode to avoid inhibition by interference signals. The patient’s peripheral pulse should be continuously monitored throughout the treatment. The EDP 20/B function must be checked after the treatment.

•

The circuitry of the EDP 20/B is protected against the energy normally induced by defibrillation. Nevertheless, complete protection is not possible. Circumstances permitting, the following precautions should be taken: - The energy setting should not be higher than necessary for defibrillation. - The distance between the paddles and the lead should be at least 10 cm (4 inches). - If the EDP 20/B has been exposed to defibrillation type current, it should be powered OFF and ON to allow performance of the complete self-test. After defibrillation, pacemaker function and the pacing threshold must be checked and monitored for a sufficient time period.

•

Rapid ventricular pacing may induce dangerous arrhythmias and is, therefore, generally contraindicated. The rapid pacing mode should be considered for atrial applications only. Rapid atrial pacing is intended for the termination of certain supraventricular tachycardias (SVT). The application of asynchronous rapid stimuli may interrupt an SVT by depolarizing portions of a reentry path-

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General Description

way. Also, when an ectopic atrial focus is responsible for an SVT, application of rapid stimuli to the atrium may result in overdrive suppression of the ectopic focus. Several potential risks related to rapid atrial stimulation should be considered. They include possible ventricular stimulation and/or ventricular tachycardia or fibrillation. This could result from poor lead placement or the existence of anomalous conduction pathways bypassing normal atrioventricular conduction (e.g. Wolff-ParkinsonWhite Syndrome). Other considerations include patient discomfort and asystole following rapid pacing.

•

If the device is to be stored and not used for a long period of time, it is strongly recommended to remove the battery.

•

The EDP 20/B is protected against incidental electromagnetic radiation, electrostatic discharge, and interference from other sources including conducted interference. The emitted radiation from the EDP 20/B has also been minimized. The EDP 20/B thus fulfills the requirements of IEC 60601-12:2001. However, it is possible that strong electromagnetic interferences such as that which can occur in the immediate vicinity of electric motors, power lines, PCs, monitors, or other electrical appliances (if defective), may impair the function of the EDP 20/B under certain circumstances.

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•

The following may result from electromagnetic interference: - unexpected reset (self-test is performed). - cardiac events are sensed, but do not appear on the ECG monitor. - the EDP 20/B displays other unexplainable behavior. •

To restore proper function of the EDP 20/B: - Verify correct cable connection between the device and the pacing leads.

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- Adjust the sensitivity of the EDP 20/B. (Sensitivity settings are often appropriate if the selected value is half of the mean measured amplitude of the intrinsic signal.) - Power off all unnecessary EMI-producing electrical equipment in close proximity to the EDP 20/B. - Relocate the source of interference to a place where the interference does not occur. - Switch the EDP 20/B OFF and ON again to reset the device if this can be done safely. - Contact BIOTRONIK‘s customer service if the interference continues.

Potential Adverse Events Potential complications related to the use of temporary external pacing include, but are not limited to, asystole following abrupt cessation of pacing (e.g. unintentional patient cable disconnection, lead dislocation or inappropriate settings) or pacemaker dependency. Complications of transvenous lead insertion include, but are not limited to: wound infection, arterial puncture, pericardial rubs, cardiac perforation, and dysrhythmia secondary to electrode insertion.

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Operating Instructions

Operating Instructions General Remarks

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After the EDP 20/B has been switched ON, a self-test routine is performed. In addition to the initial self-test, a ROM test is repeated every 15 minutes. The initial self-test includes a RAM test, a ROM test and a test of the run-away-protection and the watchdog timer. During the self-test all LEDs, including the one indicating battery replacement, light up. If the self-test detects a defect, all LEDs will start blinking and the buzzer will hum. If this happens, the device should then be switched OFF and returned to the manufacturer. The EDP 20/B emits pulses according to the set parameters as soon as the self-test is completed. The different (cathode) lead terminal should therefore be connected only after verification that the pacing mode, pacing rate, pulse amplitude and sensitivity parameters are set appropriately. Caution!

Connections of EDP 20/B and pacing leads should be secured and checked regularly. Upon connecting the leads, pacing will be initiated immediately at the selected parameters. The EDP 20/B is turned OFF by dialing the mode selection dial to the „O“ setting. Need for battery replacement is indicated by the red flashing BATTERY CONDITION LED after starting or during use. With every stimulation pulse, the EDP 20/B monitors the lead impedance. If the measured impedance does not lie within the specified acceptable range (e.g. due to broken lead, loose contact or insulation failure), an audible warning signal is generated with every stimulation pulse.

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Operating Instructions

Controls and LEDs

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1

2 3 4

5

6 7

8 9 10 11

Fig. 1:

Operating Controls and LEDs of EDP 20/B

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Operating Instructions

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Function

Description

1

Cable connector

Redel connector

2

PACE LED

Yellow indicator for paced event

3

Power and MODE dial

Dial to switch the EDP 20/B ON and OFF and to select the stimulation mode

4

RATE dial

Dial for setting pacing rate

5

SENSITIVITY dial

Dial for continuously adjustable sensivity

6

START RAPID button

Start button to activate the rapid pacing

7

SENSE LED

Green indicator for sensed event

8

RAPID RATE dial

Dial for continuously adjustable rate for rapid pacing

9

AMPLITUDE dial

Dial for continuously adjustable pulse amplitude

10 BATTERY CONDITION LED

Yellow or red indicator flashes to warn of low battery power

11 Handles

For attaching the device to the patient, bed or stand

Table 1: Description of Numbered Items in Fig. 1

Plastic Cover The controls for the device are accessible when the transparent plastic cover is slid down completely to the base of the unit. The cover will slide down to the top of the EDP 20/B label. The plastic cover can be removed for cleaning by pulling it down more forcefully. Caution!

During use, the plastic cover should be closed completely to cover the dials, thereby preventing unintentional changing of the operating parameters.

Lead Connections Cables and adapters to connect temporary leads to the EDP 20/B are presented in table 2 - table 7.

Cable with Two Connectors The EDP 20/B can be used with patient cable PK-83-B designed with two screw terminals on one end that attach to temporary pacing leads, and a Redel plug on the other end that connects to the EDP 20/B.

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Operating Instructions

For the CE-market only: the EDP 20/B can also be used with Patient Cables PK-67 plus Patient Adapter PA-1-C.

Cable with Four Connectors The EDP 20/B can also be used with the ventricular channel of the following cables: •

Patient cable PK-67-L or PK-67-S with one of the following patient adapters: - PA-1-B to connect with 2 mm cable adapters or MHW Adapt (heart wire adapter) - PA-2 to connect to IS-1 connectors - PA-4 with alligator forceps - PK-155 with alligator forceps (only PK-67-S) - US only: Remington Model 301-CG with alligator forceps (only PK-67-S)

•

For the US only: Adapter cable ADAP-2R with any combination of two of the following patient cables: - Remington Model S-101-97 - Remington Model FL-601-97

Note:

Do not attach the patient cable to the patient‘s temporary pacing lead until all other connections have been completed.

Note:

The PK-83-B and the Patient Adapter PA-1-C have been designed for use with the EDP 20/B. If cables are used which have been designed for dual chamber pacing (PK-67 and PK-175) the temporary lead must be connected to the ventricular terminals of the cable (see fig. 2).

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To connect temporary leads with touch-proof 2 mm pins to PK-83-B use cable adapters TC Adapt (121 340).

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Operating Instructions

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Fig. 2: Using dual chamber cable PK-67 with single chamber pacemaker EDP 20/B. Connect lead at ventricular terminal (see: <). PK-83-B (1.5 m or 2.5 m)

EDP 20/B

Insulated screw connectors for < 2.3 mm pins

Table 2: Patient Cables with Two Connectors

Ventricle only: PK-67 (-S: 0.8 m; -L: 2.6 m) EDP 20/B

-L : Connects to PA-1-B, PA-2, and PA-4 adapters -S: Connects additionally to PK-155 and (US only) to Remington Model 301-CG cable

Table 3: Patient Cables with Four Connectors

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Operating Instructions

PA-1-B, PA-2, PA-4 (0.31 m)

PK-67-L/S

PA-2: IS-1 PA-4: Alligator forceps

Table 4: Patient Adapters for PK-67

US only: Reusable Adapter ADAP-2R (0.24 m)

EDP 20/B

Remington disposable cables

Table 5: Reusable Adapters available from Remington Medical Inc. (For the US market)

Disposable Cables PK-155 (2.0 m) PK-67-S

Alligator forceps

Table 6: Disposable Cables

US only: Disposable Cables S-101-97 (2.5 m) ADAP-2R

Alligator forceps

Table 7: Cables Available from Remington Medical Inc. (For the US market only)

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PA-1-C and PA-1-B: Touch-proof 2mm pins and MHW-Adapt

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Operating Instructions

US only: Disposable Cables FL-601-97 (2.0 m) ADAP-2R

Screw terminals

301-CG (2.0 m)

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PK-67-S

Alligator forceps

Table 7: Cables Available from Remington Medical Inc. (For the US market only)

To connect: Caution!

Prior to connection of the lead, it is highly recommended that the user reconfirms each selected parameter.

Caution!

When using cables for dual chamber applications (PK67 with patient adapters, PK-175 or US only: ADAP 2R), confirm that the lead is connected to the ventricular channel of the cable (see fig. 2). PK-83-B Patient Cables 1

Attach the Redel plug of the PK-83-B patient cable to the Redel receptacle of the EDP 20/B.

2

Attach the patient cable to the patient‘s temporary pacing lead. To connect temporary leads with touch-proof 2 mm pins to PK-83-B use cable adapters TC Adapt (121 340).

PK-67 Patient Cables 1

Attach the patient adapter (PA-1-C, PA-1-B, PA-2, or PA-4) to the PK-67-L or-S, or PK-155 cable, or Remington 301-CG cable (US only) to the PK-67-S patient cable.

2

Attach the Redel plug of the PK-67 patient cable to the Redel receptacle of the EDP 20/B.

3

Attach the patient adapter to the patient‘s temporary pacing leads.

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Operating Instructions

US only: Remington Patient Cables 1

Attach Remington disposable cables (S-101-97, FL-601-97) to the ADAP-2R Remington reusable adapter.

2

Attach the Redel plug of the ADAP-2R to the Redel receptacle of the EDP 20/B.

3

Attach the patient cables to the patient‘s temporary pacing leads.

Polarity The EDP 20/B can be used with either bipolar or unipolar temporary pacing leads. If unipolar heart wires are used, connect one heart wire to the „-“ different cable connector (cathode) and one to the „+“ indifferent cable connector (anode) to form a bipolar configuration.

To remove: Disconnect the patient cable from the patient‘s temporary pacing leads.

Operating Procedure The use of the EDP 20/B is identical for all operating modes and the operation should be done in the following sequential steps (the numbers in brackets refer to fig. 1 on page 49 of this manual). •

Select the pacing rate with the RATE dial (4).

•

Select the pacing amplitude with the AMPLITUDE dial (9).

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Turn on the device by turning the MODE dial (3) to the selected pacing mode.

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If the BATTERY CONDITION LED (10) is flashing, the battery must be replaced. See "Battery Replacement", page 56 for details on battery replacement.

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Caution!

Operating Instructions

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Connect the lead. The yellow light, labeled PACE (2) will flash in synchrony with the stimulation pulses.

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Adjust the SENSITIVITY dial (5) so that the green light labeled SENSE (7) flashes synchronously with each sensed event. Allowance should be made for sufficient safety margin to ensure reliable sensing.

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Monitor the ECG of the patient and readjust amplitude and/or sensitivity, if necessary.

Monitor the patient's heart rate with an ECG monitor with alarm function when using the EDP 20/B.

Battery Replacement With the EDP 20/B, 9 volt batteries, international code IEC 6F 22, must be used. Only leak-proof, alkalinemanganese batteries should be used (e.g., type MN 1604 manufactured by Duracell® are recommended). With these batteries, external pacing will be available for approximately 900 hours before battery replacement is needed. A shorter lifetime or shorter service time after battery warning may be realized using other batteries. The EDP 20/B has a two-step battery depletion indication: 1

The BATTERY CONDITION LED will illuminate in yellow. This indicates that battery charge is decreasing, but there is still enough power to deliver every pacing pulse. The remaining operation time is at least 72 hours after the onset of the yellow LED warning.

2

The BATTERY CONDITION LED will illuminate in red. This indicates that battery voltage has seriously decreased, pulse amplitudes higher than 10 V can no longer be generated. If the pulse amplitude is at a setting > 10 V, an audible warning will be emitted with each pacing pulse. The remaining operation time is at least 24 hours after the onset of the red LED warning, but battery