BIOTRONIK Reocor D User manual

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

1
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

2

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.

6
• 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

7
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

8
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

9
• The temporary leads, to which the Reocor 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 is disconnected from the Reocor, it must
be reconnected immediately and the security of the
connection has to be examined.
• When using unipolar leads, two unipolar leads must be
used for effective pacing.
Behavior during use
• During use of Reocor, the protective cover must be
completely closed to prevent accidental resetting of the
programmed parameters.
• Secure Reocor 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 must not be worn directly on the skin.
• During use of Reocor, the heart rate of the patient must
be monitored with an ECG monitor with alarm function.
Reocor S:
• In case of disturbances caused by electromagnetic
interference (EMI), Reocor will switch to operating mode
S00 when certain limits are exceeded.
Reocor D:
• For disturbances caused by electromagnetic interference
(EMI), Reocor D will trigger asynchronous pacing when
certain limits are exceeded. Depending on whether the
Indications and Contraindications for Use

10
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 with high rates
• 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
• After a defibrillation or cauterization, the device should
be subjected to a function test.
• If the device will be stored for a long period of time, the
battery should be removed to prevent damage due to
leakage.
• 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.
• Inspection and maintenance work should be performed.
Battery operation
• Do not use rechargeable batteries. The service time of
these batteries is difficult to estimate, making it possible
to inadvertently exceed the ERI time1, resulting in sudden
cessation of pacing.
• Only 9-volt batteries with the international code IEC
6LR61 must be used. When using the battery type MN
Indications and Contraindications for Use
1) Reocor reminds you to replace the battery with the ERI signal (low battery
LED flashes).

11
1604 Duracell®Procell®, external pacing is possible for
at least 600 hours (Reocor S) and 500 hours (Reocor D)
before the battery must be replaced.
• It is possible to exchange a battery while Reocor 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
• The circuitry of Reocor 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 should be at
least 10 cm.
-After a defibrillation, Reocor must be switched off
and then on again so that the device can perform a
complete self-test.
Indications and Contraindications for Use

12
Additionally, after defibrillation the pacemaker function
and pacing threshold must be checked and monitored for
a sufficient period of time.
Interference resistance
• Reocor is protected against interference due to
electromagnetic radiation, electrostatic discharge and
transferred interference. The radiation emitted by Reocor
has also been minimized. However, it is still possible that
strong electro-magnetic 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.
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 exhibits unexpected behavior.
Measures to restore proper function of Reocor:
-Check the connection between device and
temporary pacing leads and adjust, if necessary.
-Correctly adjust the sensitivity of the Reocor:
Often, the sensitivity safety margin is half the
average intrinsic signal amplitude.
-Turn off all electric devices in the vicinity of Reocor
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.
-If safe to do: Switch Reocor off and on again to reset
the pacemaker to interference-free operation.
Indications and Contraindications for Use

13
-If the technical failure persists, please
contact BIOTRONIK.
• For Reocor D: If atrial sensitivity is set to a value <1 mV,
interference from electromagnetic fields could result.
Thus, if possible sensitivity values higher than 1 mV
should be programmed. Programming sensitivity values
to <1 mV requires explicit medical necessity. Values
like this can only be set and retained with physician
supervision.
Self-test
After the device is switched on, Reocor performs 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 audible 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 audible 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 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.
Indications and Contraindications for Use

14 Product Description / Protective Cover for Reocor D/S
Product Description
Figure 1: Reocor D Figure 2: Reocor S
Reocor D/S is a battery-powered external pacemaker used to
provide temporary pacing support in a clinical setting.
Reocor D, as shown in Figure 1, is a dual-chamber device,
providing temporary atrial, ventricular, or A-V sequential
pacing. Reocor S, as shown in Figure 2, is a single-chamber
device, providing temporary atrial or ventricular pacing.
Protective Cover for Reocor D and Reocor S
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.
To lock the protective cover:
• Slide the protective cover upwards along the rail until it
locks into place (see Figure 4).
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 3). Make sure that the

15 Protective Cover for Reocor D/S
protective cover is locked in place while the device is in use
to avoid accidental resetting of the rotary switches and the
control dial, as this would affect the program parameters.
Figure 3: Protective cover for Reocor D and Reocor S
Correct Incorrect
Figure 4: Correct positioning of the protective cover

16 Safety
Safety
Figure 5: Reocor D safely secured to IV stand.
The following precautions can be taken to ensure device
and patient safety:
• Have an alternative emergency external pacemaker
available if the patient is pacemaker dependent.
• Before use, inspect the device visually for dirt or damage.
• Never use a device that is damaged or shows
abnormal behavior.

17 Connecting to Reocor D/S
• Keep the transparent cover closed during use to prevent
accidental reprogramming.
• Place the device on a horizontal, non-slip surface, on
an IV stand using the hanger on the back of the device,
as shown in Figure 5, or affixed to the patient with an
armband. If an armband is used, Reocor D/S must not be
attached directly to the skin.
• During use of Reocor, the heart rate of the patient is to be
monitored with an ECG monitor with alarm function.
Connecting to Reocor D/S
Figure 6: ADAPT D adaptor for Reocor D
Reocor D/S comes with an ADAPT D or ADAPT S adapter that
has a Redel connector, which must be fitted on and screwed
in, as seen in Figure 6. When connecting lead adapters to the
Reocor, the patient cables should be connected to Reocor D/S
first, then the patient leads.

18
Reocor D/S can be used with the following adapters:
Redel plug
• ADAP-2R: This adapter has a Redel plug and connects to
single-use cables, ADAP 2000 and FL-601-97.
Redel plug
• PK-67-L/S: These patient cable adapters differ only in
length and have a Redel plug. These cables are used with
the PA-1-B adapter.
Redel plug
• PK-175: This patient cable has a Redel plug and four
screw terminals for open heart wires.
Connecting to Reocor D/S