BIOTRONIK Reocor D User manual

ardac Rhythm Management
External Devces
User's ude
Reocor D/S
External Pacemaker

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Table of Contents
Indcatons and ontrandcatons for Use ............................................3
Product Descrpton ............................................................................ 14
Protectve over for Reocor D/S.......................................................... 14
Safety................................................................................................... 16
onnectng to Reocor D/S....................................................................17
Reusable Patent ables...................................................................... 19
Start-Up............................................................................................... 20
Programmng Reocor D/S ................................................................... 21
Burst Pacng........................................................................................ 23
Vsual and Audble Sgnals.................................................................. 24
ommon Interference Sources and Recommendatons...................... 27
Battery Informaton............................................................................. 28
are and Mantenance......................................................................... 30
Supplementary Informaton ................................................................ 31
Symbols on the omponents............................................................... 33

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3Indications and Contraindications for Use
Note: Federal (USA) law restricts this device to sale by, or on
the order of, a physician (or properly licensed practitioner).
Indications for Use:
Temporary pacing with Reocor is suitable for the following
applications for patients of any age:
• Treatment of arrhythmias and heart block
• Symptomatic sinus bradycardia
• 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
Intended Use
Reocor is a battery powered external pacemaker, that is used in
combination with a lead system for temporal atrial, ventricular
and AV - sequential stimulation in a clinical environment. The
Reocor is a product family of external pacemakers. These
pacemakers are used for temporary pacing.
Contraindications:
Use of the Reocor Family of External Pacemakers is
contraindicated for:
• The Reocor external pacemaker family can not be
sterilized and is therefore not dedicated for the use in a
sterile patient environment.
• Atrial single chamber stimulation is contraindicated for
patient with AV conduction problems.
• The use of an external pacemaker is contraindicated in
the presence of an active, implanted pacemaker.

4Indications and Contraindications for Use
Use of the Reocor D External Pacemakers is
contraindicated for:
• 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), atrium-
controlled 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.
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.
Warnings:
• Danger to patient by damaged cables. Damaged cables
are limited in functionality and pose a danger to patients.
Do not use damaged cables.
• Danger from loss of function. Damp cables have limited
functionality and pose a danger to patients. Do not use
damp cables.
• Danger from electrical currents. Unused cable contacts
can conduct electrical currents to patients. Adhere

5Indications and Contraindications for Use
unused cable contacts close to the patient.
• After a burst stimulation in the atrium, the ventricular
blanking interval can prevent sensing of intrinsic signals
and lead to asynchronous pacing in the ventricle.
• After a burst stimulation in the atrium, the ventricular
blanking interval can prevent sensing of intrinsic signals
and lead to asynchronous pacing in the ventricle.
Pacing the heart with rates higher than 180 ppm over
a long time period can cause severe hemodynamic
complications. Pacing with high rates should only be
performed when continuous monitoring is ensured.
оThe mode for high-frequency pacing is used to
terminate certain supraventricular tachycardias
(SVT) and should only be considered for atrial
applications. The application of asynchronous
high-frequency stimuli can interrupt an SVT by
depolarizing portions of a reentry path. When an
ectopic atrial focus is responsible for an SVT, the
application of high-frequency stimuli in the atrium
can also lead to increased suppression of the
ectopic center.
оVarious risks have to be considered in association
with high-frequency atrial pacing. The risks
include possible ventricular pacing and ventricular
tachycardia or fibrillation. This can be caused
by poor placement of the leads or the presence
of anomalous stimulus conduction paths that
circumvent the normal atrioventricular stimulus
conduction (e.g. Wolff-Parkinson-White Syndrome).
Patient discomfort and asystole after high-
frequency pacing are other possible problems.

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• Never use a damaged device or a device that exhibits
abnormal behavior; especially if it has been dropped
or could have been damaged by high-frequency or
defibrillation voltage.
• The temporary leads that are connected to Reocor
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.
• The pacemaker must not be used in areas at risk
for explosion.
• All additional maintenance work and repairs should only
be performed by BIOTRONIK.
Precautions:
• The connections of Reocor and the temporary pacing
leads must be secured and checked regularly.
• During use of Reocor, the protective cover must be locked
to prevent inadvertent resetting of the rotary switch and
control dial, and thus of the programmed parameters.
• Allergic reactions and inflammations. Prevent the cable
from coming into contact with the patient's wounds or skin.
• During use of Reocor, the heart rate of the patient must
be monitored with an ECG monitor with alarm function.
• The preferred pole orientation is marked in the battery
compartment. When inserting the new battery you only
need to ensure that the battery poles point to the middle
of the housing. The position of the plus and minus pole
can be selected freely.
• If an armband is used, Reocor must not be worn directly
on the skin.
• Even though Reocor is protected from dripping water, the
device should be kept clean and dry.
Indications and Contraindications for Use

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General Safety 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
Reocor 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
Reocor interacts with the human heart. There is also an
interaction with the patient's skin and blood vessels.
Intended use
Reocor and the cables and accessories approved along with
the device may only be used in accordance with this technical
manual.
• Reocor must not be connected to other
electromedical devices.
• Reocor must not be used in areas with 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.
Indications and Contraindications for Use

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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.
Behavior before use
• Before use, Reocor 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, the patient cable or leads, the user
should touch the patient to equalize electrical potentials.
• It is strongly recommended to examine all set parameters
before the leads are connected to Reocor.
• Even though Reocor is protected from dripping water, the
device and all plugs should be kept clean and dry.
• Reocor cannot be sterilized. If the device needs to be
used in a sterile environment, it can be packed into a
sterile cover.
Lead connection
• The connections of Reocor and the temporary pacing
leads must be secured and checked regularly.
• The patient cable must first be connected to Reocor and
then to the leads.
Indications and Contraindications for Use