BIOTRONIK Reocor S User 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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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
•Emergencypacing
• Checking the pacing thresholds
Contraindications
•ReocorS 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 under-
lying 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 •ReocorS 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 •ReocorS interacts with the human heart. There is also an
interaction with the patient's skin and blood vessels.
Intended use •ReocorS and the cables and accessories approved along
with the device may only be used in accordance with this
technical manual.
•ReocorS must not be connected to other electromedical
devices.
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•ReocorS 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.
•ReocorS 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.
•ReocorS 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 inter-
ference (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 per-
formed 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 ERI1) 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
•ReocorS is protected against interference due to electro-
magnetic radiation, electrostatic discharge and trans-
ferred 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 possi-
ble 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.
—ReocorS 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
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 self-
test is finished after a few seconds.
• If the self-test does not find any errors, the LEDs and
warning signals turn off.
• When the self-test finds a defect, all LEDs flash continu-
ously and warning signals sound.
• A required battery replacement is indicated by the flash-
ing 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
warnings during operation:
Warning Meaning Error correction
Acoustic signal for
twoseconds 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 are securely plugged in.
Check whether the leads have
the desired position.
Acoustic signal and flash-
ing of the Pace and Sense
LEDs
High rate protection has been
triggered; 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 hoursa)
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
•Memorytest
• 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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Table 1: Description of elements in Figure 1
Designation Function
1Patient connection
INDIFF.+; DIFF.- For cables with 2-mm plug or for Redel adapters (red = plus; blue = minus)
2Battery compartment For 9-V block battery
3Low battery LED Provides a warning when the battery voltage is too low
4LED Pace Yellow display for stimulated event
5 LED Sense Green display for sensed event
6Ampl. control dial Setting the pulse amplitude
7Sens. control dial Setting the sensitivity
8Start burst Starting the burst function
9Velcro 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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Bold labels of the operating devices indicate safe values for
the intended use of the device.
Protective Cover
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:
Figure 2: Correct positioning of the protective cover
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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 con-
trol 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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Figure 4: Redel adapter for Reocor S
Reocor S can be used with the following patient cables and
adapters:
•Patient cable PK-83-B with two screw terminals for tem-
porary 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 touch-
proof 2-mm plugs on the Reocor S side.
Figure 6: Patient cable PK-83
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•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
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Reocor S can also be used with patient cables with 4 connec-
tions 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.
Figure 12: Patient cable PK-175
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•Adapter
Figure 13 shows adapters for connection of temporary leads
to Reocor S through the dual-chamber patient cable PK-67-
L/S. The leads should be connected with the ventricular con-
nection 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.
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Note: 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.
Fit the Redel adapter to Reocor S.
Screw the adapter in tight.
Insert the Redel plug of the patient cable into the Redel
port of the adapter.
Connection Variants
Temporary catheters with 2-mm plugs or heart wire with
2-mm adapter
You have the option to connect Reocor S directly to a tempo-
rary 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:
Patient-side
connection
BIOTRONIK cable Device-side
connection
Reocor S connection
Recommended connections
Direct connection (without BIOTRONIK cables) 2-mm connector port
2 mm 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
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