BIOTRONIK Reocor S Technical Manual
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BIOTRONIK Reocor S Technical Manual

External pacemaker
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Reocor S
External Pacemaker
Technical Manual
394270
Revision: R (2022-04-26)

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  • Page 1 Reocor S External Pacemaker Technical Manual 394270 Revision: R (2022-04-26)
  • Page 2 BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin / Germany ® All product names in use may be trademarks or Tel +49 (0) 30 68905-0 registered trademarks held by BIOTRONIK or the Fax +49 (0) 30 6852804 sales@biotronik.com respective owner. www.biotronik.com...

  • Page 3: Table Of Contents

    Table of Contents Table of Contents General Description....................Product Description .......................... Indications ............................Contraindications..........................Potential Side Effects........................Handling Instructions ........................Electromagnetic Interference ......................Visual and Acoustic Signals......................Operating Notes......................General Remarks..........................Operating Elements and LEDs ......................Protective Cover..........................Lead Connection ..........................Start-up .............................

  • Page 4: General Description

    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 connection is made directly or via a separate patient cable and adapter if necessary.

  • Page 5: Indications

    General Description Indications Indications Temporary pacing 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 •...

  • Page 6: Contraindications

    General Description Contraindications Contraindications • The device cannot be sterilized and is therefore not suitable for use within the sterile patient environment. • Atrial single-chamber pacing is contraindicated for patients with existing AV conduction disorders. • The use of an external pacemaker is contraindicated in the presence of an active, implanted pacemaker.

  • Page 7: Potential Side Effects

    General Description Potential Side Effects Potential Side Effects Potential complications associated with the application of temporary external pacing include asystoles 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 frictions, cardiac perforation and dysrhythmia after lead insertion.

  • Page 8: Handling Instructions

    Spare Parts and Accessories • To ensure safety compliance, use only original replacement parts and accessories authorized by BIOTRONIK. The use of any other parts voids the warranty and eliminates the manufacturer's liability for any consequences. Keep the Devices Ready •...
  • Page 9 (20 ± 2°C) for at least 30 seconds. For safety reasons, the patient should be paced by another source during the battery replacement. Reocor S reminds you to replace the battery with the ERI signal (Low Battery LED flashes).
  • Page 10 General Description Handling Instructions Electrocautery • Electrocautery should in no case 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.

  • Page 11: Electromagnetic Interference

    General Description Electromagnetic Interference Electromagnetic Interference This device is protected against electromagnetic interference and electrostatic discharges in the specialized environment in the vicinity of high-frequency surgical instruments. At the same time, the emitted interference is reduced to a minimum. The device thus conforms to all requirements of EN 60601-1-2 (in its current version at the time of delivery).
  • Page 12 WARNING Risk of electromagnetic interference through the use of unauthorized accessories The use of accessories, transducers, or cables unlisted by BIOTRONIK or of accessories other than those specified by BIOTRONIK can produce elevated electromagnetic emissions or cause degradation in the device's resistance to electromagnetic interference. Such effects can lead to the faulty operation of the device.

  • Page 13: Visual And Acoustic Signals

    Acoustic signal and flashing High rate protection has been Turn the device off and return it of the Pace and Sense LEDs triggered; self-test failed to BIOTRONIK. Low battery LED flashes ERI has been reached Replace the battery. About 36 hours of service time remain.

  • Page 14: Operating Notes

    When the self-test finds a defect, all LEDs flash permanently and acoustic warning signals sound. In this case, the pacemaker must be turned off and sent to BIOTRONIK. If the self-test did not find any error, the LEDs and warning signals go out and the device starts to deliver pacing pulses in accordance with the set parameters.

  • Page 15: Operating Elements And Leds

    Operating Notes Operating Elements and LEDs Operating Elements and LEDs Fig. 1: Reocor S operating panel Name Function Patient connection INDIFF.+; DIFF.- For cables with 2-mm connector or for Redel adapters (red = plus; blue = minus) Battery magazine For 9 V block battery...
  • Page 16 Setting the pacing rate Rotary switch Mode Selection of the pacing mode and off switch Tab. 1: Description of elements in Figure Reocor S operating panel [Page 13]. Bold labeling of the operating elements indicates safe values for the intended use of the device.

  • Page 17: Protective Cover

    Operating Notes Protective Cover 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 Correct fit of the protective cover [Page 15]. Fig. 2: Correct fit of the protective cover To release the protective cover, see Figure Release the protective cover [Page 15]: •...

  • Page 18: Lead Connection

    To connect cables with Redel plugs, the Redel adapter must be mounted on the correct side and screwed in, Figure Redel adapter for Reocor S [Page 16]. The Redel adapter is mounted to the correct side if it can be screwed on to the device.
  • Page 19 Figure Adapters for the patient cables PK-67-L and PK-67-S [Page 18] shows adapters for connection of temporary leads to Reocor S through the dual-chamber patient cable PK-67-L/S. The leads must be connected with the ventricular connection of the adapter (labeled V).
  • Page 20 Operating Notes Lead Connection Fig. 12: 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 connectors or MHW adapters (adapters for heart wires) PA-2 IS-1 PA-4 with alligator clips Connecting WARNING Danger to patient by damaged cables Damaged cables are limited in functionality and pose a danger to the patient.
  • Page 21 Operating Notes Lead Connection 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 device.
  • Page 22 PK-82 2-mm connectors 2-mm connector ports Note For dual-chamber cables (PK-141, PK-175, PK-67-S/L), Reocor S only uses the ventricular channel! Polarity The device principally paces in bipolar mode, but it can be used with bipolar or unipolar temporary pacing leads.

  • Page 23: Start-Up

    Start-up Start-up The operation of Reocor S is identical for all operating modes. The operating steps should be carried out in the following order (the numbers in parentheses refer to Figure Reocor S operating panel [Page 13] of this technical manual).

  • Page 24: Attachment

    Operating Notes Attachment Attachment The device must be operated either horizontally on a nonslip surface or affixed to the patient with an armband, or from a hanging position on the infusion stand using the hanger on the back of the device. To attach the device to an infusion stand, unscrew the hanger from the back of the device.

  • Page 25: Battery Replacement

    (see Accessories [Page 39]), external pacing is possible for at least 600 hours at 20 ± 2°C before the battery must be replaced. Battery replacement during operation is possible. When the battery is removed, Reocor S remains ready for use at an ambient temperature (20 ± 2°C) for at least 30 seconds.

  • Page 26: Pacing Modes And Parameters

    There are three pacing modes available: S00, SSI, SST as well as high-rate pacing (burst). In case of disturbances caused by electromagnetic interference (EMI), Reocor S will switch to pacing mode S00 for the duration of the disturbance when certain limits are exceeded.

  • Page 27: Rate

    Pacing Modes and Parameters Rate Rate The rate can be continuously adjusted from 30 bpm to 250 bpm with the Rate control dial (12). If a value greater than 180 bpm is set, the device will sound a warning signal for 2 seconds. WARNING Pacing the heart with rates higher than 180 bpm over a long time period can cause severe hemodynamic complications.

  • Page 28: Pulse Amplitude And Pulse Width

    Pacing Modes and Parameters Pulse Amplitude and Pulse Width Pulse Amplitude and Pulse Width The pulse amplitude can be set with the Ampl. control dial (6) within a range from 0.1 V to 17 V. If a value less than 1 V is set, the device will sound a warning signal for 2 seconds. The pulse width is 1 ms.

  • Page 29: Sensitivity

    Pacing Modes and Parameters Sensitivity Sensitivity The sensitivity can be adjusted with the Sens. control dial (7) between 1 mV and 20 mV. It should be checked regularly to ensure that correct sensing takes place and that a sufficient safety margin has been set.

  • Page 30: Interference Interval

    Pacing Modes and Parameters Interference Interval Interference Interval The interference interval is started both by paced and sensed events. The interval is reset if noise is sensed during the interval length of 80 ms, leading to asynchronous pacing at the programmed rate for as long as the interference lasts.

  • Page 31: Burst

    Pacing Modes and Parameters Burst Burst The rate of the atrial burst rate function can be selected with the control dial (10) between 60 bpm and 1000 bpm. This function is activated with 2 keys: First the Select burst key (11) must be pressed and then, within 2 seconds, the Start burst key (8).

  • Page 32: Handling, Maintenance, And Care

    This is a highly developed precision device that must be treated with care. Mechanical impact, e.g., by dropping the device, can impair its function. Please return the device to BIOTRONIK in case of damage or impaired function. Prior to use, the pacemaker should be stored at least 2 hours under the ambient conditions specified for operation (see Technical Data [Page 37]).

  • Page 33: Reusable Patient Cables

    The cleaning, disinfection, and sterilization are described in the following technical manual: Information on Reprocessing of Medical Products: Patient Cable and Patient Adapter. This technical manual is either included in hard copy form in the storage package or available in digital form on the internet at: https://manuals.biotronik.com...

  • Page 34: Maintenance, Service, Inspections

    Handling, Maintenance, and Care Maintenance, Service, Inspections Maintenance, Service, Inspections The only required maintenance action is the replacement of the battery (see Battery Replacement [Page 23]). No other maintenance work is required. Test before Use A short test should be performed prior to each use of the device. It consists of a visual inspection and a simple function test.

  • Page 35: Disposal

    (WEEE 2) applies to the disposal method of the device. Old devices and accessories that are no longer needed, such as patient cables and adapters, should be returned to BIOTRONIK. This ensures that proper disposal will be carried out in accordance with the national implementations of the WEEE directive.

  • Page 36: Technical Safety

    The closed protective cover protects the pacemaker against dripping water. WARNING The temporary leads that are connected to Reocor S 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.

  • Page 37: Technical Data

    Technical Data Technical Data Symbols Observe the technical manual Indication of the placement of the battery in the battery magazine Disposal according to the WEEE 2 directive Applied part classification: CF (cardiac floating), defibrillation protected IP31 Water-repellent, degree of protection IP31 Off (on the Mode rotary switch) Adjustable parameters Pacing modes...
  • Page 38 Technical Data Fixed parameters Refractory period (30 ... 150) bpm 225 ms ± 5 ms (151 ... 200) bpm 200 ms ± 5 ms (201 ... 250) bpm 175 ms ± 5 ms High rate protection 1 ... 180 bpm 286 ms ± 10% 286 ms = 210 bpm, does not apply for burst 181 ...
  • Page 39 30% ... 75%, no condensation Atmospheric pressure 700 hPa ... 1060 hPa Noise level 50 dB Dimensions, weight, material Reocor S Dimensions 160 mm x 75 mm x 35 mm ± 2 mm (without Redel adapter) Weight With battery, with Redel adapter: 305 g ± 10% Without battery, with Redel adapter: 260 g ±...

  • Page 40: Package Contents And Accessories

    Package Contents and Accessories Package Contents Package Contents and Accessories Note The device may only be used with the accessories developed and tested for this pacemaker. Package Contents Item Quantity Remark Order number Reocor S 365528 Battery – Armband Short 391843 –...

  • Page 41: Accessories

    Package Contents and Accessories Accessories Accessories Not all accessory products are available in every country. Item Order number Description Connection PK-82 (1.5 m) 128564 Patient cable with two insulated alli- Direct connection gator clips, can be resterilized PK-83 (2.5 m) 128563 Patient cable with two insulated screw Direct connection...

  • Page 42: Adapters For Pk-67-S And Pk-67-L

    Package Contents and Accessories Adapters for PK-67-S and PK-67-L Adapters for PK-67-S and PK-67-L Not all accessory products are available in every country. Item Order number Description PA-1-B 123751 For connection to 2-mm adapter or MHW adapter (adapter for heart wires), can be re-sterilized PA-1-C 349723 For connection to 2-mm adapter or MHW adapter...

  • Page 43: Legend For The Label

    Legend for the Label Legend for the Label The label icons symbolize the following: Symbol Meaning Reocor S Redel adapter BIOTRONIK order number Serial number Manufacturing date Storage temperature Air pressure limit Humidity Patient with implanted lead Contents Device contains materials that must be correctly disposed of in accor- dance with environmental protection regulations.
  • Page 44 Legend for the Label Symbol Meaning manuals.biotronik.com Follow the instructions for use! Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. CE mark...

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