Download Reocor D/S External Pacemaker

Cardiac Rhythm Management
External Devices
User's Guide
Reocor D/S
External Pacemaker
1
Table of Contents
Indications and Contraindications for Use............................................. 3
Product Description............................................................................. 14
Protective Cover for Reocor D/S........................................................... 14
Safety................................................................................................... 16
Connecting to Reocor D/S.................................................................... 17
Reusable Patient Cables....................................................................... 19
Start-Up............................................................................................... 20
Programming Reocor D/S.................................................................... 21
Burst Pacing......................................................................................... 23
Visual and Audible Signals................................................................... 24
Common Interference Sources and Recommendations....................... 27
Battery Information.............................................................................. 28
Care and Maintenance.......................................................................... 30
Supplementary Information................................................................. 31
Symbols on the Components................................................................ 33
2
3
Indications 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.
4
Indications 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), atriumcontrolled 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
5
Indications 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.
оо The 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.
оо Various 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 highfrequency pacing are other possible problems.
6
Indications and Contraindications for Use
• 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.
7
Indications and Contraindications for Use
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.
8
Indications and Contraindications for Use
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.
9
Indications and Contraindications for Use
• 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
10
Indications and Contraindications for Use
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
1) Reocor reminds you to replace the battery with the ERI signal (low battery
LED flashes).
11
Indications and Contraindications for Use
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.
12
Indications and Contraindications for Use
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.
13
Indications and Contraindications for Use
-- 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.
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
Figure 4: Correct positioning of the protective cover
Incorrect
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
Connecting to Reocor D/S
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.
19
Reusable Patient Cables
Reusable Patient Cables
Prior to opening, the package of a sterile cable must be
inspected for damage to determine whether sterility has been
compromised.
Cleaning
The reusable patient cables can be cleaned and disinfected
with hospital cleaning agents following many different
methods. However, aggressive chemicals (such as acetone)
may never be used.
The use of a wiping cloth with regular, alcohol-free hand
soap or the cleaning agent Stabimed by Braun is the
recommended cleaning method for the cables. Subsequently,
the cables must be cleaned from cleaning agent residue with
electrolyte-free water and then wiped with a clean, dry cloth.
Disinfection
For disinfection in a disinfectant bath, an aldehyde-based
(e.g. Lysoformin 3000) or alcohol-based (e.g. Aerodesin 2000)
disinfectant agent must be used in accordance with the
manufacturer information and in accordance to the respective
hospital guidelines.
After disinfection, the cable must be cleaned from residues of
the disinfectant by rinsing it in electrolyte-free water.
Sterilization
A steam sterilization can be carried out at 121°C and 1.1 bar
for 20 min.
20
Start-Up
Start-Up
Before connecting Reocor D/S to the patient cables, program
the device. Refer to “Programming Reocor D/S” on page 21
for further instructions. Selecting the mode will initiate a
self test. The self test is an automatic test that lasts a few
seconds. During the test, the device checks the program
code, memory, LEDs and audible signals, pacing and sensing
capability, and efficacy of high rate protection.
If the self test detects an error, LEDs will light up and audible
signals will sound. Also, if an error is detected, pacing will
be disabled. If this occurs, the device must be turned off and
returned to BIOTRONIK.
If the self test does not detect any errors, Reocor D/S will
begin pacing and sensing as programmed. Once the self test
is finished, connect the device to adapter cables, and then
patient leads. Monitor for proper operation per ECG.
21
Programming Reocor D/S
Programming Reocor D/S
The following parameters are programmable in Reocor D/S:
• Mode (NBG code)
оо DDD, DOO, VVI, VOO, VDD, VVT (Reocor D)
оо SSI, SOO, SST (Reocor S)
• Rate (ppm)
оо 30, 40... (20) ... 140, 170, 200, 250
• Burst rate (ppm, for use in the atrium only)
оо 60, 100 ... (100) ... 800, 1000
• Sensitivity (mV)
оо A: 0.2, 0.3, 0.5, 0.7, 1, 2, 3, 5, 7, 10 (Reocor D)
оо V: 1, 2, 3, 4, 5, 8, 11, 14, 17, 20 (Reocor D)
оо S: 1, 2, 3, 4, 5, 8, 11, 14, 17, 20 (Reocor S)
• Pulse amplitude (V)
оо 0.1, 0.5, 1, 2, 3, 5, 7, 10, 12, 17
• AV delay (ms, Reocor D only)
оо 15, 25, 50, 75, 100, 180, 200, 250, 350, 400
22
Programming Reocor D/S
The following parameters are fixed and non-programmable
in Reocor D/S:
•
•
•
•
•
Pulse width (1 ms)
Noise interval (80 ms)
Cross channel blanking (110 ms)
Total Atrial Refractory Period (AV delay + 175 ms)
Ventricular Refractory Period (Rate adaptive, see Table 1)
When initially programming the device, it is recommended
that the mode is programmed last. Switching the mode from
OFF to a specific mode activates Reocor D/S and initiates the
self test and subsequent pacing.
The Reocor D also has a non-programmable ventricular
refractory period when programmed to a tracking mode. The
refractory period is rate adaptive and the following refractory
periods are applied:
Atrial Rate (bpm)
Ventricular Refractory Period (ms)
Under 150
225 ms
150 to 200
200 ms
Over 200
175 ms
Table 1: Ventricular Refractory Period at various rates
When in a tracking mode, the upper tracking rate for Reocor D is
determined by the total atrial refractory period. When the atrial
rate is above the upper tracking rate, the device will exhibit a 2:1
block, calculated by adding 175 ms to the AV delay.
The Reocor D also has a non-programmable cross channel
blank in both the atrial and ventricular channel. After a
pacing stimulus is delivered, a 110 ms blank occurs in the
opposite channel to prevent far-field oversensing.
23
Burst Pacing
Burst Pacing
The following steps describe how to perform atrial burst
pacing with this device:
• Program the mode, rate, and amplitude for back up
pacing in the ventricle (Reocor D only).
• Select the burst rate.
• Push the Select burst button.
• Within two seconds of pushing the Select burst button,
press and hold the Start burst button.
• Continue to hold the Start burst button for as long as
burst pacing is needed.
Burst pacing will occur as long as the Start burst button is
pressed. During burst pacing, the ventricular channel will
continue to provide back up pacing at the programmed rate.
Note: Because of the cross channel blanking in Reocor D,
ventricular intrinsic events may be blanked; therefore, burst
pacing may cause asynchronous pacing in the ventricle.
24
Visual and Audible Signals
Visual and Audible Signals
Figure 7: Reocor D LEDs.
1: Low battery LED.
2: Ventricular green sense LED.
3: Atrial green sense LED.
4: Atrial yellow pace LED.
5: Ventricular yellow pace LED.
25
Visual and Audible Signals
Figure 8: Reocor S LEDs.
1: Low battery LED. 2: Green sense LED. 3: Yellow pace LED.
The Reocor D has five LEDs and the Recor S has three, as
shown in Figure 7 and Figure 8. The green LED indicates
sensed events (in both chambers for Reocor D) and the yellow
LED indicates paced events (in both chambers for Reocor D).
Also, a flashing red LED indicates low battery. When the red
LED begins flashing, approximately 36 hours of battery life
remain except in the instance of battery removal. (See Battery
Information on page 28.)
26
Visual and Audible Signals
The device also has two distinct audible signals:
• A fast sequence of sounds indicates lead impedance
measurements have been taken out of range. To correct
this error, check all cable connections and lead positions.
• An audible signal lasting two seconds indicates a pulse
amplitude that has just been set to <1 V or a rate of
>180 ppm. When this occurs, confirm the device is
programmed appropriately for the patient.
When the audible signals sound and the pace/sense LEDs
flash, high rate protection has been triggered or the self
test has failed. The device should not be used and should be
returned to BIOTRONIK.
27
Common Interference Sources and Recommendations
Common Interference Sources and
Recommendations
Electrocautery: To minimize interference, it is recommended
that the electrocautery is kept at least 15 cm from the leads.
Also, programming the device to an asynchronous mode when
electrocautery is used will prevent the possibility of inhibition.
Defibrillation: Reocor D/S is a Cardiac Floating device and
is protected against external defibrillation. However, some
precautions should be made to ensure device and patient
safety. If possible, perform the defibrillation at the lowest
possible energy. Maintain a distance of at least 10 cm between
the leads and defibrillator. After defibrillation, the device
should be turned off then on to perform a complete self-test.
Other: The device is protected against electromagnetic
interference. Reocor D/S has a noise interval of 80 ms.
Signals within this noise interval will result in asynchronous
pacing at the programmed rate. However, strong
electromagnetic fields may interfere with the device. In the
presence of EMI, the device may experience an unexpected
reset (device restarts self-test), oversensing, or other
unexpected behavior. If this occurs, check the connection
between Reocor and leads, adjust the sensitivity of Reocor,
turn off all electrical devices in the vicinity, move the
interference source, or, if safe, restart the Reocor.
28
Battery Information
Battery Information
Figure 9: Battery insertion in Reocor S
Reocor D/S requires 9 volt batteries with international
code IEC 6LR61 MN1604 Duracell® Procell®. These
batteries provide at least 5001 hours of pacing at ambient
temperature. When there is approximately 36 hours of
battery life remaining, the Low battery LED will begin
flashing. When the battery is removed for replacement,
Reocor D/S can pace for approximately 30 seconds at
ambient temperature (20 ± 2°C) without battery support.
While the battery is removed, the Low battery LED will flash.
1
70 ppm, 5 V, DDD (Reocor D) or VVI (Reocor S), 500 ohm
29
Battery Information
Rechargeable batteries should not be used with Reocor D/S
because the service time of these batteries is difficult to
estimate, possibly resulting in a sudden loss of pacing. Also,
if the device is not going to be used for an extended period
of time, it is recommended that the battery be removed to
prevent damage due to battery leakage.
To replace the battery, follow these steps:
• Locate the battery door, found on the lower right side
of the device.
• Push the blue slider upwards.
• Pull out the battery drawer.
• Remove the old battery.
• Position the new battery so the poles point to the middle
of the housing.
• Insert battery bottom down first, as shown in Figure 9.
• Close the drawer.
• While holding the drawer all the way in, push down the
blue slider until it clicks into place.
• Once the battery is properly placed, the Low Battery light
stops blinking.
30
Care and Maintenance
Care and Maintenance
Reocor D/S cannot be sterilized and therefore should not be
within the sterile field unless placed in a sterile cover. To clean
Reocor D/S, use a damp cloth and mild soap. Strong cleaning
agents can corrode the housing. For disinfection, wipe the
device with a cloth soaked with a disinfectant solution.
Note: After cleaning or disinfection, Reocor must not be
used for one hour.
Call Technical Services with any additional questions:
1 (800) 284-6689
31
Supplementary Information
Scope of Delivery and Accessories:
Reocor S*:
Name
Quantity
Order no.
Reocor S
1
365 528
Battery
1
-
Armband
1
-
Reocor ADAPT S
1
371 263
Protective Cover
1
378 007
Technical Manual
1
Quick Reference Guide
1
Case
1
-
Name
Quantity
Order no.
Reocor D
1
365 529
Battery
1
-
Armband
1
-
Reocor ADAPT D
1
371 262
Protective Cover
1
378 007
Technical Manual
1
Quick Reference Guide
1
Case
1
Reocor D*:
-
* Reocor S and Reocor D may only be used with the accessories developed and
tested for this pacemaker.
32
Supplementary Information
Available Adapters and Cables
Adapter
Order no.
Details
ADAP-2R
(0.24 m)
343 588
Remington Medical Inc.
Reusable adapter for cable models
FL-601-97 and ADAP 2000
Redel adapter for connection to
ADAPT D or ADAPT S
PA-1-B
123 751
For connection to 2-mm adapter
for heart wires, can be resterilized.
Used with PK-67-S/L
Cables
Order no.
Details
PK-175
333 959
Patient cable, with 4 screw
connections for connection of
temporary pacing wires, can be
resterilized.
Redel adapter for connection to
ADAPT D or ADAPT S
PK-67-L
123 672
Patient cable, can be resterilized, for
combination with PA-1-B adapter
Redel adapter for connection to
ADAPT D or ADAPT S
PK-67-S
128 085
Patient cable, can be resterilized, for
combination with PA-1-B adapter
Redel adapter for connection to
ADAPT D or ADAPT S
Model FL-60197 (2.0 m)
394 141
ADAP 2000
(2.0 m)
344 025
Remington Medical Inc.
Patient cable, 2-wire with screw
terminals for single use
Remington Medical Inc.
Adapter cable, for connection to
shrouded 2 mm pins for single use
Note: For dual-chamber cables (PK-175, PK-67-S/L), Reocor S uses only the
ventricular channel.
33
System Messages / Symbols on the Components
System Messages
The following warnings can appear during use:
• A required battery replacement is indicated by the
flashing Low battery LED.
• If the lead impedance is not within a defined tolerance
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.
• If the pulse amplitude is set to values < 1 V or the rate to
values > 180 ppm, an audible signal sounds for about two
seconds.
• If the rate is too high or if the self-test has not passed,
a continuous audible signal sounds and the Pace and
Sense LEDs flash.
Legend for the Label
The label icons symbolize the following:
Reocor D/S
ADAPT D or ADAPT S
BIOTRONIK order number
Serial number
Manufacturing date
34
Symbols on the Components
Acceptable temperature ranges for storage
Acceptable atmospheric pressure range for
storage
Acceptable relative humidity range for storage
Patient with implanted lead
Contents
Disposal sign
Follow the instructions in the technical manual
Caution: Federal (U.S.A.) law restricts this
device to sale by, or on the order of, a physician
BIOTRONIK, Inc.
6024 Jean Road
Lake Oswego, OR 97035-5369
(800) 547-0394 (24-hour)
(800) 291-0470 (fax)
www.biotronik.com
M4143-B 09/12
© 2012 BIOTRONIK, Inc.
All rights reserved. MN016r2 9/24/12