Reocor J Technical Manual Rev J Jan 2015

394270--J

Português

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Handling, Care and Maintenance ...25 Reocor S ... 25 Reusable Patient Cables ... 26 Maintenance, Service, Inspections ... 26 Disposal ... 27 Technical Safety ...28 Technical Data ...29 Conformity According to IEC 60601-1-2 ...32

Deutsch Español Français Magyar Italiano

Pacing Modes and Parameters ...22 Pacing Modes ... 22 Rate ... 22 Pulse Amplitude and Pulse Width ... 23 Sensitivity ... 23 Interference interval ... 23 Burst ... 23

Nederlands

Operating Notes ...9 General Remarks ...9 Operating Devices and LEDs ... 10 Protective Cover ... 11 Lead Connection ... 12 Start Up ... 19 Attachment ... 19 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 ...8

Česky

Contents

Legend for the Label ...38

Português

Scope of Delivery and Accessories ...36

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Reocor S is a battery-powered, external single-chamber pacemaker for in-clinic use. The pacemaker is connected to temporary pacemaker leads (including myocardial heart wires and transvenous implantable catheters). The connection is made directly or via a separate patient cable and adapter, if necessary.

Deutsch

Product Description

Česky

General Description

The safety features of Reocor S include: •

Visual display of sensed and paced events

•

Microprocessor-controlled pacing parameters

•

Lead impedance monitoring

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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, leads with 2-mm plugs can be connected directly to Reocor S. 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.

Français Magyar

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.

Italiano

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.

Nederlands

Pacing mode, rate, sensitivity, pulse amplitude and burst rate are adjustable.

Español

There are three pacing modes available: SSI, S00, SST as well as a burst function.

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Treatment of arrhythmias and heart block

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Symptomatic sinus bradycardia

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Sick sinus syndrome

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

Português

Temporary pacing with Reocor S is suitable for the following applications for patients of any age:

Polski

Indications

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4 •

Termination of supraventricular tachyarrhythmias

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Prophylactic pacing for prevention of arrhythmias

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Emergency pacing

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Checking the pacing thresholds

Contraindications •

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

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

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Reocor S 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.

Mode of action

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

Intended use

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

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Reocor S must not be connected to other electromedical devices.

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

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

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

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

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

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

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

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

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Reocor S cannot be sterilized.

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

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

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The temporary leads, to which the Reocor S 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.

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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.

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If the cable is disconnected from the Reocor S, it must be reconnected immediately and the security of the connection has to be examined.

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

Behavior before use

Lead connection

Deutsch

•

Español

Replacement parts and accessories

Français

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

Magyar

•

Italiano

Changes not permitted

Nederlands

Reocor S must not be used in areas with a danger of explosion.

Polski

•

Português

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Česky

English

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6 Behavior during use

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

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Secure Reocor S 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.

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Reocor S must not be worn directly on the skin.

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During use of Reocor S, the heart rate of the patient must be monitored with an ECG monitor with alarm function.

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In case of disturbances caused by electromagnetic interference (EMI), Reocor S will switch to operating mode S00 when certain limits are exceeded.

Pacing with high rates

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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.

Behavior after use

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

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

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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.

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Inspection and maintenance work should be performed according to page 25.

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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.

Battery operation

Only 9-volt batteries with the international code IEC 6LR61 must be used. When using the battery type MN 1604 Duracell® Procell®, external pacing is possible for at least 600 hours before the battery must be replaced. It is possible to exchange a battery while Reocor S 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. 1)

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

Additionally, after defibrillation the pacemaker function and pacing threshold must be checked and monitored for a sufficient period of time. Interference resistance

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Reocor S is protected against interference due to electromagnetic radiation, electrostatic discharge and transferred interference. The radiation emitted by Reocor S has also been minimized. Thus, the device meets the requirements of IEC 60601-1-2. However, it is still 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 S. 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 S exhibits unexpected behavior. Measures to restore proper function of Reocor S: - Check the connection between device and temporary pacing leads and adjust, if necessary. - Correctly adjust the sensitivity of the Reocor S: Often, the sensitivity safety margin is half the average intrinsic signal amplitude.

Deutsch

The circuitry of Reocor S is protected from the shock energy that can be induced by a defibrillation. Nonetheless, the following precautionary measures should be taken, if possible: - 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 S should be at least 10 cm. - After a defibrillation, Reocor S must be switched off and then on again so that the device can perform a complete self-test.

Español

•

Français

Defibrillation

Magyar

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.

Italiano

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.

Nederlands

•

Polski

Electrocautery

Português

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Česky

English

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8 - Turn off all electric devices in the vicinity of Reocor S 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 S. - If safe to do: Switch Reocor S off and on again to reset the pacemaker to interference-free operation. - If the technical failure persists, please contact BIOTRONIK.

Visual and Acoustic Signals •

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

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

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

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

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The Sense (green) LED signals sensing of a P wave or R wave.

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The Pace (yellow) LED signals pulse delivery.

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

Warning

Meaning

Acoustic signal for two seconds

A pulse amplitude of < 1 V or a rate of Check whether the set values > 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 flash- High rate protection has been ing of the Pace and Sense triggered; self-test failed. LEDs

Turn the device off and return it to BIOTRONIK.

Low battery LED flashes.

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

a)

ERI has been reached.

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

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

Check of the program code and the microprocessor

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Memory test

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Function test of the LEDs and the acoustic signals

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Test of the pacing and sensing capability

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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, the LEDs and warning signals turn off and Reocor S starts to deliver 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.

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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.

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

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If the rate is too high (see page 30 “High rate protection”) or if the self-test has not passed, a continuous acoustic signal sounds and the Pace and Sense LEDs flash.

Nederlands

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

Polski

•

Italiano

The following warnings can appear during use:

Português

Warning messages

Deutsch

Self-test

Español

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

Français

Caution!

Magyar

General Remarks

Česky

Operating Notes

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10 Operating Devices and LEDs

Figure 1: Reocor S operating panel

11 Function

Patient connection INDIFF.+; DIFF.-

For cables with 2-mm plug or for Redel adapters (red = plus; blue = minus)

2

Battery compartment

For 9-V block battery

3

Low battery LED

Provides a warning when the battery voltage is too low

4

LED Pace

Yellow display for stimulated event

5

LED Sense

Green display for sensed event

6

Ampl. control dial

Setting the pulse amplitude

7

Sens. control dial

Setting the sensitivity

8

Start burst

Starting the burst function

9

Velcro harness

Secures Reocor S to patient, bed or infusion stand

10

Burst rate control dial

Setting the burst rate

11

Select burst

Selection of the burst function

12

Rate control dial

Setting the pacing rate

13

Mode dial

Selection of the pacing mode and off switch

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Deutsch

Designation 1

Česky

English

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

Français

Table 1: Description of elements in Figure 1

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). False:

Polski Português

Figure 2: Correct positioning of the protective cover

Nederlands

Italiano

Correct:

Magyar

Protective Cover

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12 To release the protective cover (see Figure 3): Push the release lever up with one hand. At the same time, use your other hand to slide down the protective cover.

Figure 3: Unlocking the protective cover To lock the protective cover: Slide the protective cover upwards along the rail until it locks into place (see Figure 2). 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 S, the protective cover must be locked to prevent inadvertent resetting of the rotary switch and control dial, and thus of the programmed parameters.

Lead Connection Reocor S has two 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 S. Note:

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

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Reocor S can be used with the following patient cables and adapters: Patient cable PK-83-B with two screw terminals for temporary leads on the patient side and Redel plug on the Reocor S side (use the Redel adapter).

Figure 5: Patient cable PK-83-B Patient cable PK-83 with two insulated screw terminals for temporary leads on the patient side and two touchproof 2-mm plugs on the Reocor S side.

Figure 6: Patient cable PK-83

Português

Polski

•

Nederlands

Italiano

•

Magyar

Figure 4: Redel adapter for Reocor S

Français

Español

Deutsch

Česky

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14 •

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 S side.

Figure 7: Patient cable PK-82 •

Patient cable PK-67-L and PK-67-S

Patient cable PK-67-L (2.6 m) and PK-67-S (0.8 m) differ only in length. On the Reocor S side you have a Redel plug (use the Redel adapter) and on the patient side a connection for the adapter according to Figure 13 and for the single-use cable according to Figure 9.

Figure 8: Patient cable PK-67-L and PK-67-S •

Cable for single use

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

Figure 9: Single-use cables PK-155 and 301-CG (USA only) Only for USA: The single-use cables S-101-97 and FL-601-97 by Remington Medical Inc. are connected via the reusable adapter cable ADAP-2R to the Reocor S (Figure 10).

Figure 10: USA only: Remington single-use cable and adapter

Reocor S can also be used with patient cables with 4 connections for dual-chamber pacemakers. Reocor S only uses the ventricular channel of these cables. The following cables are possible: Patient cable PK-141 with 4 alligator clips on the patient side and Redel plug on the Reocor S side (use the Redel adapter). The ventricular channel is indicated by the label Vent Diff/Indiff on the protective sleeves.

Figure 11: Patient cable PK-141 Patient cable PK-175 with four screw terminals on the patient side and Redel plug on the Reocor S side (use the Redel adapter). The ventricular channel is labeled with Ventricle.

Polski Português

Figure 12: Patient cable PK-175

Nederlands

Italiano

Magyar

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Français

Español

•

Deutsch

15

Česky

English

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16 •

Adapter

Figure 13 shows adapters for connection of temporary leads to Reocor S through the dual-chamber patient cable PK-67L/S. The leads should be connected with the ventricular connection of the adapter (labeled V).

Figure 13: Adapters for the patient cables PK-67-L and PK-67-S PA-1-B and PA-1-C 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

Connection WARNING!

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.

For use of cables or adapters for dual-chamber applications, the leads must be connected to the ventricular channel (labeled Ventricle or V).

Note:

Do not connect the patient cable to the temporary pacing lead of the patient before the connection has been established to the Reocor S. Direct connection If Reocor S 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 INDIFF.+ and DIFF.-. Patient cable The patient cable is connected via a Redel adapter to the Reocor S.

Deutsch

Note:

Español

17

Česky

English

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Screw the adapter in tight. Insert the Redel plug of the patient cable into the Redel port of the adapter.

Français

Fit the Redel adapter to Reocor S.

You have the option to connect Reocor S directly to a temporary catheter with touch-proof 2-mm plug or to a heart wire with 2-mm adapter, without any other cables or adapters. All other connection options are listed in the following table: Device-side connection

Reocor S connection

Recommended connections 2-mm connector port

PK-67-S/L with PA-1-C

Redel plug

Redel adapter

Screw terminals

PK-83B with TC Adapt

Redel plug

2-mm connector port

Screw terminals

PK-83 with TC Adapt

2-mm plug

2-mm connector port

Possible connections 2 mm

PK-67-S/L with PA-1-B

Redel plug

Redel adapter

Alligator clips

PK-141

Redel plug

Redel adapter

Alligator clips

PK-67-S/L with PA-4

Redel plug

Redel adapter

Alligator clips

PK-67-S/L with PK-155

Redel plug

Redel adapter

Alligator clips

PK-82

2-mm plug

2-mm connector port

Nederlands

Direct connection (without BIOTRONIK cables) 2 mm

Polski

BIOTRONIK cable

Português

Patient-side connection

Italiano

Temporary catheters with 2-mm plugs or heart wire with 2-mm adapter

Magyar

Connection Variants