BIOTRONIK Reocor S Technical Manual
Reocor S
Cardiac Rhythm Management
External Devices
Technical manual
Technická příručka
Gebrauchsanweisung
Manual técnico
Manuel technique
Használati utasítás
Manuale tecnico
Technische handleiding
Instrukcja obsługi
Manual técnico
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External pacemaker
Externí kardiostimulátor
Externer Herzschrittmacher
Marcapasos externo
Stimulateur cardiaque externe
Külső pacemaker
Pacemaker esterno
Externe pacemaker
Zewnętrzny stymulator serca
Marcapasso externo
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394270--J
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Contents
General Description .................................................................................3
Product Description ...................................................3
Indications ..................................................................3
Contraindications .......................................................4
Potential Side Effects .................................................4
Handling Instructions .................................................4
Visual and Acoustic Signals .......................................8
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
Pacing Modes and Parameters ...............................................................22
Pacing Modes ...........................................................22
Rate ..........................................................................22
Pulse Amplitude and Pulse Width ........................... 23
Sensitivity ................................................................. 23
Interference interval ................................................ 23
Burst .........................................................................23
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
Scope of Delivery and Accessories .........................................................36
Legend for the Label ..............................................................................38
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General Description
Product Description
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 connec
tion is made directly or via a separate patient cable and
adapter, if necessary.
There are three pacing modes available: SSI, S00, SST as well
as a burst function.
Pacing mode, rate, sensitivity, pulse amplitude and burst rate
are adjustable.
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.
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.
The safety features of Reocor S 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, 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.
Indications
Temporary pacing with Reocor S 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
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• Termination of supraventricular tachyarrhythmias
• Prophylactic pacing for prevention of arrhythmias
•Emergency pacing
• Checking the pacing thresholds
Contraindications
•Reocor S cannot be sterilized and is therefore not suit-
able for use within the sterile field.
• 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 •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 •Reocor S interacts with the human heart. There is also an
interaction with the patient's skin and blood vessels.
Intended use •Reocor S and the cables and accessories approved along
with the device may only be used in accordance with this
technical manual.
•Reocor S must not be connected to other electromedical
devices.
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•Reocor S 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.
Replacement parts
and accessories
• To ensure safety compliance, use only original replace-
ment 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 equip-
ment and emergency drugs on hand.
Behavior
before
use
• Before use, Reocor S 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 S, the patient cable or leads, the
user should touch the patient to equalize electrical
potentials.
• It is strongly recommended to examine all set para-
meters before the leads are connected to Reocor S.
• Even though Reocor S is protected from dripping water,
the device and all plugs should be kept clean and dry.
•Reocor S cannot be sterilized.
Lead connection • The connections of Reocor S and the temporary pacing
leads must be secured and checked regularly.
• The patient cable must first be connected to Reocor S
and then to the leads.
• The temporary leads, to which the Reocor S is connected,
represent a low-impedance conductor to the myocar
dium 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 S, it must be
reconnected immediately and the security of the connec
-
tion has to be examined.
• When using unipolar leads, two unipolar leads must be
used for effective pacing.
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Behavior
during
use
• During use of Reocor S, the protective cover must be
completely closed to prevent accidental resetting of the
programmed parameters.
• 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.
•Reocor S must not be worn directly on the skin.
• During use of Reocor S, the heart rate of the patient must
be monitored with an ECG monitor with alarm function.
• 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
• Pacing the heart with rates higher than 180 ppm over a
long period of time can cause severe hemodynamic com
plications. 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
according to page
25.
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
1)
time, resulting in sud-
den cessation of pacing.
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).
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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 pace
-
maker 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 S is protected from the shock
energy that can be induced by a defibrillation. Nonethe
less, 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 defi-
brillator 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.
Additionally, after defibrillation the pacemaker function
and pacing threshold must be checked and monitored for
a sufficient period of time.
Interference
resistance
•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, transform
ers, 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.
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— 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
in
terference cannot have an affect on the Reocor S.
— If safe to do: Switch Reocor S off and on again to
r
eset the pacemaker to interference-free operation.
— If the technical failure persists, please contact
BI
OTRONIK.
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.
• If the self-test does not find any errors, the LEDs and
war
ning signals turn off.
• When the self-test finds a defect, all LEDs flash continuously and warning signals sound.
• A required battery replacement is indicated by the flashing red Low battery LED.
• The Sense (green) LED signals sensing of a P wave or
R wave.
• The Pace (yellow) LED signals pulse delivery.
• The LEDs and acoustic signals also provide the following
war
nings during operation:
Warning Meaning Error correction
Acoustic signal for
tw
o seconds
A pulse amplitude of < 1 V or a rate of
> 180 ppm is programmed.
Check whether the set values
are suitable for the patient.
Fast sequence of sounds Impedance outside of the permissi-
ble range
Check whether all connectors
ar
e securely plugged in.
Check whether the leads have
the des
ired position.
Acoustic signal and flashing of the Pace and Sense
LE
Ds
High rate protection has been
tri
ggered; self-test failed.
Turn the device off and return
it to BIOTRONIK.
Low battery LED flashes. ERI has been reached. Replace the battery; and about
36 hour
s
a)
a) When using the battery type MN 1604 Duracell®, Procell
®
of service time
remain.
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Operating Notes
General Remarks
Caution! The connections of Reocor S and the temporary pacing leads
must be secured and checked regularly.
Self-test 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
•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 pace
-
maker 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 nega
tive 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 cor
rectly.
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 flash-
ing 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 sec
-
onds 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
two seconds.
• 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.
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Operating Devices and LEDs
Figure 1: Reocor S operating panel
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