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), 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
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 high-
             frequency 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                                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   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
     All patient cables can be sterilized as follows unless
     otherwise stated in the patient cables' documents:
      •	 Steam sterilization at 121 °C and 1.1 bar for 20 min.
     PK-175 and PK-83-B patient cables can also be sterilized as follows:
      •	 Steam sterilization at 134 °C and 3.0 bar for 18 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                      -
     Reocor D*:
      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 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
                                         Remington Medical Inc.
                                         Reusable adapter for cable models
     ADAP-2R
                          343 588        FL-601-97 and ADAP 2000
     (0.24 m)
                                         Redel adapter for connection to
                                         ADAPT D or ADAPT S
                                         For connection to 2-mm adapter
     PA-1-B               123 751        for heart wires, can be resterilized.
                                         Used with PK-67-S/L
     Cables            Order no.         Details
                                         Patient cable, with 4 screw
                                         connections for connection of
                                         temporary pacing wires, can be
     PK-175               333 959
                                         resterilized.
                                         Redel adapter for connection to
                                         ADAPT D or ADAPT S
                                         Patient cable, can be resterilized, for
                                         combination with PA-1-B adapter
     PK-67-L              123 672
                                         Redel adapter for connection to
                                         ADAPT D or ADAPT S
                                         Patient cable, can be resterilized, for
                                         combination with PA-1-B adapter
     PK-67-S              128 085
                                         Redel adapter for connection to
                                         ADAPT D or ADAPT S
                                         Remington Medical Inc.
     Model FL-601-        394 141
                                         Patient cable, 2-wire with screw
     97 (2.0 m)
                                         terminals for single use
                                         Remington Medical Inc.
     ADAP 2000
                          344 025        Adapter cable, for connection to
     (2.0 m)
                                         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-C 03/15
© 2015 BIOTRONIK, Inc.
All rights reserved. MN016r3 3/9/15