Reocor D Technical Manual Rev J Jan 2015

394271--J

Português

Polski

Nederlands

Italiano

Magyar

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Deutsch

Česky

English

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English

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1

Handling, Care and Maintenance ...26 Reocor D ... 26 Reusable Patient Cables ... 27 Maintenance, Service, Inspections ... 27 Disposal ... 28

Deutsch Español Français Magyar Italiano

Pacing Modes and Parameters ...22 Pacing Modes ... 22 Refractory Periods ... 22 Rate ... 23 AV Delay ... 24 Pulse Amplitude – Atrium/Ventricle ... 24 Sensitivity – Atrium ... 24 Sensitivity – Ventricle ... 24 Cross Channel Blanking ... 24 Interference interval ... 24 Burst ... 25

Nederlands

Operating Notes ...10 General Remarks ... 10 Operating Devices and LEDs ... 11 Protective Cover ... 13 Lead Connection ... 14 Start Up ... 19 Attachment ... 20 Battery Exchange ... 20

Polski

General Description ...3 Product Description ...3 Indications ...3 Contraindications ...4 Potential Side Effects ...4 Handling Instructions ...4 Visual and Acoustic Signals ...9

Česky

Contents

Technical Data ...30

Português

Technical Safety ...29

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2 Conformity According to IEC 60601-1-2 ...33 Scope of Delivery and Accessories ...37 Legend for the Label ...39

English

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3

The safety features of Reocor D include: •

Visual display of sensed and paced events

•

Microprocessor-controlled pacing parameters

•

Lead impedance monitoring

•

Visual warning when the battery is almost depleted

•

A movable, transparent cover of the controls to prevent accidental changes of the programmed parameters

Temporary catheters, heart wires and leads with 2-mm plugs can be connected directly to Reocor D. Additional patient cables and adapters are available, too. This system offers a secure connection of transvenous catheters and myocardial leads, which are applied either as unipolar or bipolar.

Indications Temporary pacing with Reocor D is suitable for the following applications for patients of any age: •

Treatment of arrhythmias and heart block

•

Symptomatic sinus bradycardia

Deutsch Español Français

A defect of the device (failed self-test after the device was switched on) is indicated by continuously lit LEDs and an intermittent acoustic signal. If the self-test does not find any errors, the acoustic and visual signals will turn off after a few seconds.

Magyar

LEDs display the sense (Sense), pace (Pace) and battery status (Low battery). An acoustic signal sounds when a very high frequency or very low sensitivity value is set and when the lead impedance is not optimal.

Italiano

The pacing mode, rate, sensitivity and pulse amplitude, AV delay and burst rate are adjustable.

Nederlands

There are six pacing modes available: DDD, D00, VDD, VVI, V00 and VVT, as well as an atrial burst function.

Polski

Reocor D is a battery-powered, external dual-chamber pacemaker, which can be used in conjunction with temporary pacemaker leads (including endocardial leads and transvenous implantable catheters) for temporary atrial, ventricular and AV sequential pacing in clinical settings. The connection is made directly or via a separate patient cable and adapter, if necessary.

Português

Product Description

Česky

General Description

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4 •

Sick sinus syndrome

•

Pre-, intra- and postoperative pacing of patients with heart surgery

•

Termination of supraventricular tachyarrhythmias

•

Prophylactic pacing for prevention of arrhythmias

•

Emergency pacing

•

Checking the pacing thresholds

Contraindications •

Reocor D cannot be sterilized and is therefore not suitable for use within the sterile field.

•

The atrially triggered pacing modes (DDD and VDD) are contraindicated for atrial fibrillation, atrial flutter and other fast atrial rhythms.

•

When high ventricular rates are not well tolerated by the patient (e.g., in the presence of angina pectoris), atriumcontrolled modes can be contraindicated.

•

If retrograde conduction is encountered after ventricular pacing, extending the atrial refractory period and/or shortening the AV delay may be necessary programming options to prevent pacemaker-mediated tachycardia. It may be necessary in such cases to program a VVI mode.

•

Atrial single-chamber pacing is contraindicated for patients with existing AV conduction disturbances.

•

The use of an external pacemaker is contraindicated in the presence of an active, implanted pacemaker.

Potential Side Effects Potential complications associated with the application of temporary external pacing include asystole after abrupt cessation of pacing (e.g., if the patient cable is inadvertently disconnected, the leads are loosened or the settings are incorrect) or pacemaker dependency. Complications when inserting transvenous leads include: Wound infection, arterial puncture, pericardial friction, cardiac perforation and dysrhythmia after lead insertion.

Handling Instructions Depending on the pacing settings and the patient's underlying illness, pacing can induce arrhythmias. To ensure the patient's safety, certain procedures should be observed and

Intended use

•

Reocor D and the cables and accessories approved along with the device may only be used in accordance with this technical manual.

•

Reocor D must not be connected to other electromedical devices.

•

Reocor D must not be used in areas in which there is a danger of explosion.

Changes not permitted

•

Only the manufacturer or a party expressly authorized by BIOTRONIK may perform corrective maintenance, enhancements or modifications to the device.

Replacement parts and accessories

•

To ensure safety compliance, use only original replacement parts and accessories authorized by BIOTRONIK. Using any other parts voids the manufacturer's liability for any consequences, guarantee and warranty.

Devices on hand

•

In case of pacemaker dependency of the patient, an emergency pacemaker should be kept on hand.

•

Keep an external defibrillator, oxygen, intubation equipment and emergency drugs on hand.

•

Before use, Reocor D should be visually inspected for damages and dirt.

•

Never use a device that is damaged or shows abnormal behavior. Replace any cable that shows even slight damage.

•

Before using Reocor D, the patient cable or leads, the user should touch the patient to equalize electrical potentials.

•

It is strongly recommended that users examine all set parameters before the leads are connected to Reocor D.

•

Even though Reocor D is protected from dripping water, the device and all plugs should be kept clean and dry.

•

Reocor D cannot be sterilized.

Behavior before use

Deutsch

Reocor D interacts with the human heart. There is also an interaction with the patient's skin and blood vessels.

Español

•

Français

Mode of action

Magyar

Reocor D may only be used by persons with knowledge of cardiology who were trained in the handling of the device. Potential users are technical and medical hospital staff and physicians.

Italiano

•

Nederlands

Users

Polski

the precautionary measures listed below taken. Please read about additional procedures and precautionary measures in appropriate medical publications.

Português

5

Česky

English

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6 Lead connection

Behavior during use

Pacing with high rates

•

The connections of Reocor D and the temporary pacing leads must be secured and checked regularly.

•

The patient cable must first be connected to Reocor D and then to the leads.

•

The temporary leads, to which the Reocor D is connected, represent a low-impedance conductor to the myocardium for electric current. Therefore line-powered devices that are operated in the patient's vicinity must be grounded in accordance with established guidelines.

•

When handling already implanted leads, their connector pins and metal contact surfaces must not touch or come into contact with electrically conductive or wet surfaces.

•

If the cable has become disconnected from the Reocor D, it must be reconnected immediately and the security of the connection inspected.

•

When using unipolar leads, two unipolar leads must be used for each chamber for effective pacing.

•

During use of Reocor D, the protective cover must be completely closed to prevent inadvertent resetting of the programmed parameters.

•

Secure Reocor D either horizontally on a non-slip surface or on the patient with an armband, or operate it from a hanging position on the infusion stand using the hanger on the back of the device.

•

Reocor D must not be worn directly on the skin.

•

During use of Reocor D, the heart rate of the patient is to be monitored with an ECG monitor with alarm function.

•

For disturbances caused by electromagnetic interference (EMI), Reocor D will trigger asynchronous pacing when certain limits are exceeded. Depending on whether the interference was sensed in the atrium or in the ventricle, the following operating modes will result for the duration of the interference:

•

Undisturbed operating mode

Interference by EMI

SSI, SST

S00

VDD

VAT, VVI, V00

DDD

DAD, DVI, D00

Pacing the heart with rates higher than 180 ppm over a long period of time can cause severe hemodynamic complications. Pacing with high rates should only be performed when continuous monitoring is ensured.

•

Inspection and maintenance work should be performed according to page 26.

•

Do not use rechargeable batteries. The service time of these batteries is difficult to estimate, making it possible to inadvertently exceed the ERI1 time, resulting in sudden cessation of pacing. Only 9-volt batteries with the international code IEC 6LR61 may be used. When using the battery type MN 1604 Duracell® Procell®, external pacing is possible for at least 500 hours before the battery must be replaced. It is possible to exchange a battery while Reocor D is in use. The device remains ready for use for at least 30 s at the ambient temperature (20 ± 2°C) when the battery is removed. For safety reasons, the patient should be paced by another source during the battery replacement.

Electrocautery

•

Electrocautery should definitely not be performed at a distance less than 15 cm from the leads, as it is possible that ventricular fibrillation will be induced or the pacemaker could be damaged. The pacemaker should be set to asynchronous pacing to avoid pacemaker inhibition due to interference signals. During treatment, the peripheral pulse of the patient should be continuously monitored. After treatment, the pacemaker function must be inspected.

Defibrillation

1

•

The circuitry of Reocor D is protected from the shock energy that can be induced by a defibrillation. Nonetheless, the following precautionary measures should be taken, if possible:

Reocor D reminds you to replace the battery with the ERI signal (Low battery LED flashes).

Deutsch

A damp cloth and mild soap can be used for cleaning. Strong cleaning agents or organic solvents should be avoided, as these can corrode the plastic housing.

Español

•

Français

If the device will be stored for a long period of time, the battery should be removed to prevent damage due to leakage.

Magyar

•

Italiano

After a defibrillation or cauterization, the device should be subjected to a function test.

Nederlands

Battery operation

•

Polski

Behavior after use

Português

7

Česky

English

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8 - The set energy should not be higher than necessary for defibrillation. - The distance between the leads of the cardiac defibrillator and the leads of Reocor D should be at least 10 cm. - After a defibrillation, Reocor D must be switched off and then on again so that the device can perform a complete self-test. Additionally, after defibrillation the pacemaker function and pacing threshold must be checked and monitored for a sufficient period of time. Interference resistance

•

Reocor D is protected against interference due to electromagnetic radiation, electrostatic discharge and against transferred interference. The radiation emitted by Reocor D has also been minimized. Thus, the device meets the requirements of IEC 60601-1-2. However, it still is possible that strong electromagnetic fields which can occur (e.g., in the direct vicinity of electric motors, transformers, power lines, and other electric devices) may impair the function of Reocor D. Electromagnetic interference can lead to the following errors: - Unexpected reset (self-test is executed). - Cardiac events are sensed but do not appear on the ECG monitor. - Reocor D exhibits unexpected behavior. Measures to restore proper function of Reocor D: - Check the connection between device and temporary pacing leads and adjust, if necessary. - Correctly adjust the sensitivity of the Reocor D: Often, the sensitivity safety margin is half the average intrinsic signal amplitude. - Turn off all electric devices in the vicinity of Reocor D if they can cause electromagnetic interference and their operation is not absolutely necessary. - Move the interference source to a location where the interference cannot have an affect on the Reocor D. - If safe to do: Switch Reocor D off and then on again to reset the pacemaker to interference-free operation. - If the technical failure persists, please contact BIOTRONIK.

•

If the atrial sensitivity is set to a value less than 1 mV, interference from electromagnetic fields could result. Thus, if possible sensitivity values higher than 1 mV should be programmed. Programming sensitivity values to less than 1 mV requires explicit medical necessity. Values like this can only be set and retained with physician supervision.

English

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9

•

The Sense (green) LEDs signal sensing of a P wave or R wave.

•

The Pace (yellow) LEDs signal pulse delivery.

•

The LEDs and acoustic signals also provide the following warnings during operation:

Warning

Meaning

Acoustic signal for 2 s

A pulse amplitude of < 1 V or a rate Check whether the set values of > 180 ppm is programmed. are suitable for the patient.

Error correction

Fast sequence of sounds

Impedance outside of the permissible range

Check whether all connectors are securely plugged in. Check whether the leads have the desired position.

Acoustic signal and flashing High rate protection has been of the Pace and Sense LEDs triggered; self-test failed.

Turn the device off and return it to BIOTRONIK.

Low battery LED flashes.

Replace the battery; about 36 hoursa) of service time remain.

a)

ERI has been reached.

When using the battery type MN 1604 Duracell®, Procell®

Deutsch

A required battery replacement is indicated by the flashing red Low battery LED.

Español

•

Français

When the self-test finds a defect, all LEDs flash continuously and warning signals sound.

Magyar

•

Italiano

If the self-test does not find any errors, the LEDs and warning signals turn off.

Nederlands

•

Polski

During the self-test after switching on Reocor D, all LEDs light up and brief acoustic signals can be heard. The selftest is completed after a few seconds.

Português

•

Česky

Visual and Acoustic Signals

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Operating Notes General Remarks Caution!

The connections of Reocor D and the temporary pacing leads must be secured and checked regularly.

Self-test

After the device is switched on, Reocor D executes a self-test for a few seconds. This includes: •

Check of the program code and the microprocessor

•

Memory test

•

Function test of the LEDs and the acoustic signals

•

Test of the pacing and sensing capability

•

Test of the efficacy of high rate protection

When the self-test finds a defect, all LEDs flash continuously and acoustic warning signals sound. In this case, the pacemaker must be turned off and sent to BIOTRONIK. If the self-test did not find any errors, Reocor D begins delivering pacing pulses in accordance with the programmed parameters. The negative electrode (cathode) should therefore only be connected when it has been ensured that the pacing mode, pacing rate, pulse amplitude and sensitivity have been programmed correctly. Setting the rotary switch for the operating mode to OFF prevents pacing pulses from being delivered to the patient immediately after connecting the leads. Warning messages

The following warnings can appear during use: •

A required battery replacement is indicated by the flashing Low battery LED.

•

If the lead impedance is not within a permissible range (e.g. due to a fractured lead or a loose contact), a rapid sequence of sounds can be heard no earlier than 5 seconds after activation.

•

If the pulse amplitude is set to values <1 V or the rate to values >180 ppm, an acoustic signal sounds for about 2 seconds.

•

If the rate is too high (see page 31 “High rate protection”) or if the self-test has not passed, an acoustic signal sounds and the Pace and Sense LEDs flash.

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11

17

D

0

30 0

10

80

60

10

7

0,1

3

0,5 3

2

1

3

10 5 3

0 ,5

Magyar

1

7

8 14 11

20

17

0,1

2

4

5 5

5

1

12

10

17

7

2

Français

2

0, 3 0, 2

Español

0

40

20 0

0, 5

300

0 25 20 0 18 0

1

12

0, 7

0

17

4 00 35 0

10

0

0 10 75

50

0

60 0

60

50

V0 0

80 0 1000

70

VV I

T

25 15

12 0

VV

40

Deutsch

14 0

DD

20 0 250

D VD D0 0

Česky

Operating Devices and LEDs

Nederlands

Italiano

b

DIFF.-

Polski

INDIFF.+

Português

Figure 1: Reocor D operating panel

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12

Designation 1a

Function

Atrial channel connection

1b

For cables and leads with 2-mm plugs or for Redel adapters Ventricular channel connec- (red = plus; blue = minus) tion

2

Battery compartment

For 9-V block battery

3

Low battery LED

Provides a warning when the battery voltage is too low

4

Ventricle Pace LED

Yellow display for ventricular stimulated event

5

Ventricle Sense LED

Green display for sensed R wave

6

Ventricle Ampl. control dial

Setting the ventricular pulse amplitude

7

Ventricle Sens. control dial

Setting the ventricular sensitivity (cannot be used in D00 and V00 operating modes)

8

Atrium Pace LED

Yellow display for atrial stimulated event

9

Atrium Sense LED

Green display for sensed P wave

10

Atrium Ampl. control dial

Setting the atrial pulse amplitude (cannot be used in VDD operating mode)

11

Atrium Sens. control dial

Setting the atrial sensitivity (cannot be used in D00 operating mode)

12

Start burst

Starts the atrial burst function

13

Velcro harness and hanger (on back)

Securing Reocor D to patient, bed or infusion stand

14

Burst rate atrium control dial Setting the atrial burst rate

15

AV delay control dial

Setting the AV delay

16

Select burst

Selection of the atrial burst function

17

Mode dial

Selection of the pacing operating mode and off switch

18

Rate control dial

Setting the pacing rate

Table 1: Description of elements in Figure 1

Bold labels of the operating devices indicate safe values for the intended use of the device.

English

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13

Figure 2: Correct positioning of the protective cover

Español

Deutsch

The protective cover is locked when the cover has been pushed to the stop, passing two snap-in points and when the lever is resting on the rail (see Figure 2). Correct: False:

Česky

Protective Cover

Push the release lever up with one hand.

The protective cover can be removed completely for cleaning. Push the cover all the way down to the stop and then remove it. Caution!

During use of Reocor D, the protective cover must be locked to prevent inadvertent resetting of the rotary switch and control dial, and thus of the programmed parameters.

Nederlands

Slide the protective cover upwards along the rail until it locks into place (see Figure 2).

Polski

To lock the protective cover:

Português

Figure 3: Unlocking the protective cover

Italiano

Magyar

At the same time, use your other hand to slide down the protective cover.

Français

To release the protective cover (see Figure 3):

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14 Lead Connection Reocor D has four connector ports for direct connection of leads with touch-proof 2-mm plugs. To connect cables with Redel plugs, the Redel adapter must be fitted on the correct side and screwed in (Figure 4). The Redel adapter is attached to the correct side if it can be screwed on to the Reocor D. Note:

The function of the Redel adapter is only guaranteed if it is attached to the correct side!

Figure 4: Redel adapter for Reocor D Reocor D can be used with the following patient cables and adapters: •

Patient cable PK-175 with four screw terminals for temporary leads on the patient side and Redel plug on the Reocor D side (use the Redel adapter)

Figure 5: Patient cable PK-175

Patient cable PK-82 with two insulated alligator clips for temporary leads on the patient side and two touch-proof 2-mm plugs on the Reocor D side.

Figure 6: Patient cable PK-82 •

Patient cable PK-83-B for single-chamber pacing with two screw terminals for temporary leads on the patient side and a Redel plug on the Reocor D side (use the Redel adapter). Temporary leads that are connected with the PK-83-B are connected to the ventricular channel of Reocor D.

Deutsch

•

Español

15

Česky

English

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Français

Redel plug

Patient cable PK-83 for single-chamber pacing with two insulated screw terminals for temporary leads on the patient side and two touch-proof 2-mm plugs on the Reocor D side.

Patient cable PK-67-L, PK-67-S differ only in length.

Figure 9: Patient cable PK-67-L (2.6 m) and PK-67-S (0.8 m)

Polski

•

Português

Figure 8: Patient cable PK-83

Nederlands

Italiano

•

Magyar

Figure 7: Patient cable PK-83-B

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16 •

Adapters

The adapters from Figure 10 fit the patient cables PK-67 L/S (Figure 9):

Figure 10: Adapters for the patient cables PK-67-L and PK-67-S PA-1-B for the connection of touch-proof 2-mm plugs or MHW adapters (adapters for heart wires) PA-2 IS-1 PA-4 with alligator clips •

Patient cable PK-141 with four alligator clips on the patient side and Redel plug on the Reocor D side (use the Redel adapter).

Figure 11: Patient cable PK-141 •

Adapter cable ADAP-2R is a reusable cable to connect the single-use cables according to Figure 13 (for USA only) to Reocor D (use the Redel adapter).

Figure 12: Adapter cable ADAP-2R

English

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17 Cable for single use (USA only)

Danger to patient by damaged cables. Damaged cables are limited in functionality and pose a danger to patients. Do not use damaged cables.

WARNING!

Danger from loss of function. Damp cables have limited functionality and pose a danger to patients. Do not use damp cables.

WARNING!

Danger from electrical currents. Unused cable contacts can conduct electrical currents to patients. Adhere unused cable contacts close to the patient.

Caution!

Allergic reactions and inflammations. Prevent the cable from coming into contact with the patient's wounds or skin.

Note:

Ensure correct fitting of the insulators prior to using the cables.

Note:

Do not connect the patient cable to the temporary pacing lead of the patient before the connection has been established to the Reocor D. Direct connection If Reocor D is used without the Redel adapter, temporary catheters and heart wires can be connected to the patient cables PK-82 and PK-83 directly at the connector ports A+, Aand V+, V-.

Español Français

Connection WARNING!

Magyar

Figure 14: Cable PK-155

Italiano

The single-use cables PK-155 and Remington 301-CG (USA only) with alligator clips (Figure 14) are connected to the patient through the cable PK-67-S.

Nederlands

Cable for single use

Polski

•

Português

Figure 13: Single-use cable by Remington Medical Inc. (USA only)

Deutsch

Česky

•