BIOTRONIK Reocor D Technical Manual

External pacemaker

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Reocor D

External Pacemaker

Technical Manual

394271

Revision: R (2022-04-26)

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Page 1 Reocor D External Pacemaker Technical Manual 394271 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
Pulse Amplitude - Atrium/Ventricle....................Sensitivity – Atrium ........................... Sensitivity - Ventricle ........................Cross Channel Blanking........................Interference Interval ......................... Burst..............................Handling, Maintenance, and Care................Reocor D............................Reusable Patient Cables ........................Maintenance, Service, Inspections....................Disposal............................. Technical Safety......................Technical Data ......................Package Contents and Accessories................
Page 4: General Description
General Description Product Description Reocor D is a battery-powered, external dual-chamber pacemaker, which can be used in conjunction with temporary pacemaker leads (including endocardial leads and transvenous implantable catheters) for temporary atrial, ventricular, and AV sequential pacing in clinical settings. 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. • The atrially triggered pacing modes (DDD and VDD) are contraindicated for atrial fibrillation, atrial flutter and other fast atrial rhythms. •...
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 The device must not be worn directly on the skin. • In case of disturbances caused by electromagnetic interference (EMI), Reocor D will switch to asynchronous pacing when certain limits are exceeded. Depending on whether the interference was sensed in the atrium or in the ventricle, the following pacing modes will result for the duration...
Page 10 (20 ± 2°C) for at least 30 seconds. For safety reasons, the patient should be paced by another source during the battery replacement. Reocor D reminds you to replace the battery with the ERI signal (Low battery LED flashes). Electrocautery •...
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 D operating panel Name Function Atrial channel connection For cables and leads with 2-mm connectors or for Redel adapters (red = plus; blue = minus) Ventricular channel connection Channel Battery magazine For 9 V block battery...
Page 16 Selection of the pacing operating mode and off switch Control dial Rate Setting the pacing rate Tab. 1: Description of elements in Figure Reocor D 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 D [Page 16]. The Redel adapter is mounted to the correct side if it can be screwed on to the device.
Page 19 Operating Notes Lead Connection Fig. 6: Patient Cable PK-82 • Patient cable PK-83-B for single-chamber pacing with two screw terminals for temporary leads on the patient side and a Redel plug on the Reocor side (use the Redel adapter). Temporary leads that are connected with the PK-83-B are connected to the ventricular channel of the device.
Page 20 Direct connection If Reocor D 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 A+, A- and V+, V-.
Page 21 Patient-side BIOTRONIK cable Device-side Connection connection connection Reocor D Recommended connections Direct connection (without BIOTRONIK cables) 2-mm connector ports 2 mm PK-67-S/L with PA-1-B Redel plug Redel adapter Screw terminals PK-175 with TC Adapt Redel plug...
Page 22 Operating Notes Lead Connection Implanted lead with IS-1 connector Patient-side BIOTRONIK cable Device-side Connection connection connection Reocor D Recommended connections IS-1 connector port PK-67-S/L with PA-2 Redel plug Redel adapter Possible connections Alligator clips PK-141 Redel plug Redel adapter Alligator clips...
Page 23: Start-Up
Start-up Start-up The operation of Reocor D 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 D 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 43]), external pacing is possible for at least 500 hours at 20 ± 2°C before the battery must be replaced. Battery replacement during operation is possible. When the battery is removed, Reocor D remains ready for use at an ambient temperature (20 ± 2°C) for at least 30 seconds.
Page 26: Pacing Modes And Parameters
Like VVI, but immediate pulse delivery upon sensing of a ventricular event outside the refractory period In case of disturbances caused by electromagnetic interference (EMI), Reocor D will switch to asynchronous pacing when certain limits are exceeded. Depending on whether the interference was...
Page 27: Refractory Periods
Fig. 14: Reaction of the upper rate during atrial tachycardia (basic rate 72 bpm) The total atrial refractory period (TARP) of Reocor D is calculated by the sum of 175 ms and the set AV delay; however, its minimum value is 400 ms below a pacing rate of 120 bpm. Above this rate, the minimum TARP is reduced to 240 ms.
Page 28: Rate
Pacing Modes and Parameters Rate Rate The rate can be continuously adjusted from 30 bpm to 250 bpm with the Rate control dial (18). 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 29: Av Delay
The AV delay can be continuously adjusted from 15 ms to 400 ms with the AV delay control dial (15). A short AV delay may be selected for special indications, e.g., in case of recurring tachycardias. Reocor D limits the AV delay upwards to half the basic interval.
Page 30: Pulse Amplitude - Atrium/Ventricle
Pacing Modes and Parameters Pulse Amplitude - Atrium/Ventricle Pulse Amplitude - Atrium/Ventricle The pulse amplitudes for the atrium and ventricle can be adjusted with the Ampl. control dials (10), (6) in the 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 31: Sensitivity - Atrium
Pacing Modes and Parameters Sensitivity – Atrium Sensitivity – Atrium The sensitivity can be adjusted with the Atrium Sens. control dial (11) between 0.2 mV and 10 mV. It should be checked regularly to ensure that correct sensing takes place and that a sufficient safety margin has been set.
Page 32: Sensitivity - Ventricle
Pacing Modes and Parameters Sensitivity - Ventricle Sensitivity - Ventricle The sensitivity can be adjusted with the Ventricle 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 33: Cross Channel Blanking
Pacing Modes and Parameters Cross Channel Blanking Cross Channel Blanking After a stimulus has been delivered, sensing is suppressed for 80 ms ± 5 ms in the opposite channel to prevent far-field sensing.
Page 34: Interference Interval
Pacing Modes and Parameters Interference Interval Interference Interval The interference interval is started both by atrial and ventricular paced and sensed events. The interval is reset by noise sensed in any channel during the interval length of 80 ms, leading to asynchronous pacing at the programmed rate for as long as the interference lasts.
Page 35: Burst
Pacing Modes and Parameters Burst Burst The rate of the atrial burst rate function can be selected with the control dial (14) between 60 bpm and 1000 bpm. This function is activated with 2 keys: First the Select burst key (16) must be pressed and then, within 2 seconds, the Start burst key (12).
Page 36: 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 41]).
Page 37: 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 38: 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 39: 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 40: Technical Safety
The closed protective cover protects the pacemaker against dripping water. WARNING The temporary leads that are connected to Reocor D 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 41: 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 42 Technical Data Fixed parameters TARP minimum for (30 ... 120) bpm 400 ms ± 5 ms/± 3% for (121 ... 250) bpm 240 ms ± 5 ms/± 3% Refractory period (V) (30 ... 150) bpm 225 ms ± 5 ms (151 ... 200) bpm 200 ms ± 5 ms (201 ... 250) bpm 175 ms ±...
Page 43 30% ... 75%, no condensation Atmospheric pressure 700 hPa ... 1060 hPa Noise level 50 dB Dimensions, weight, material Reocor D Dimensions 160 mm x 75 mm x 35 mm (without Redel adapter) Weight With battery, with Redel adapter: 325 g ± 10% Without battery, with Redel adapter: 280 g ± 10% Without battery, without Redel adapter: 240 g ±...
Page 44: Package Contents And Accessories
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 D 365529 Battery – Armband Short 391843 – for Japan – for all other countries...
Page 45: 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 46: 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 47: Legend For The Label
Legend for the Label Legend for the Label The label icons symbolize the following: Symbol Meaning Reocor D 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 48 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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