BIOTRONIK Reocor S Technical Manual
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BIOTRONIK Reocor S Technical Manual

BIOTRONIK Reocor S Technical Manual

External pacemaker
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Reocor S
External pacemaker
Externí kardiostimulátor
Externer Herzschrittmacher
Marcapasos externo
Stimulateur cardiaque externe
Külső pacemaker
Pacemaker esterno
Externe pacemaker
Zewnętrzny stymulator serca
Marcapasso externo
Cardiac Rhythm Management
External Devices
Technical manual
Technická příručka
Gebrauchsanweisung
Manual técnico
Manuel technique
Használati utasítás
Manuale tecnico
Technische handleiding
Instrukcja obsługi
Manual técnico
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Summary of Contents for BIOTRONIK Reocor S

  • Page 1 Reocor S Cardiac Rhythm Management External Devices External pacemaker Technical manual Externí kardiostimulátor Technická příručka Externer Herzschrittmacher Gebrauchsanweisung Marcapasos externo Manual técnico Stimulateur cardiaque externe Manuel technique Külső pacemaker Használati utasítás Pacemaker esterno Manuale tecnico Externe pacemaker Technische handleiding Zewnętrzny stymulator serca Instrukcja obsługi...
  • Page 2 394270--J...

  • Page 4: Table Of Contents

    Pulse Amplitude and Pulse Width ......23 Sensitivity ..............23 Interference interval ..........23 Burst ................. 23 Handling, Care and Maintenance ............25 Reocor S ..............25 Reusable Patient Cables .......... 26 Maintenance, Service, Inspections ......26 Disposal ..............27 Technical Safety ..................28 Technical Data ..................29...

  • Page 6: General Description

    This system offers a secure connection of transvenous catheters and myocardial leads, which are applied either as unipolar or bipolar. Indications Temporary pacing with Reocor S is suitable for the following applications for patients of any age: • Treatment of arrhythmias and heart block •...

  • Page 7: Contraindications

    Users • Reocor S 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.
  • Page 8 • Reocor S must not be used in areas with a danger of explosion. Changes not • Only the manufacturer or a party expressly authorized by BIOTRONIK may perform corrective maintenance, permitted enhancements or modifications to the device. Replacement parts •...
  • Page 9 (20 ± 2°C) when the battery is removed. 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 — The set energy should not be higher than necessary for defibrillation. — The distance between the leads of the cardiac defi- brillator and the leads of Reocor S should be at least 10 cm. — After a defibrillation, Reocor S must be switched off and then on again so that the device can perform a complete self-test.

  • Page 11: Visual And Acoustic Signals

    — Move the interference source to a location where the interference cannot have an affect on the Reocor S. — If safe to do: Switch Reocor S off and on again to reset the pacemaker to interference-free operation. — If the technical failure persists, please contact BIOTRONIK.

  • Page 12: Operating Notes

    The connections of Reocor S and the temporary pacing leads must be secured and checked regularly. Self-test After the device is switched on, Reocor S performs a self-test for a few seconds. This includes: • Check of the program code and the microprocessor •...

  • Page 13: Operating Devices And Leds

    Operating Devices and LEDs Figure 1: Reocor S operating panel...

  • Page 14: Protective Cover

    Sens. control dial Setting the sensitivity Start burst Starting the burst function Velcro harness Secures Reocor S to patient, bed or infusion stand Burst rate control dial Setting the burst rate Select burst Selection of the burst function Rate control dial...

  • Page 15: Lead Connection

    Push the cover all the way down to the stop and then remove Caution! During use of Reocor S, the protective cover must be locked to prevent inadvertent resetting of the rotary switch and con- trol dial, and thus of the programmed parameters.
  • Page 16 Figure 4: Redel adapter for Reocor S Reocor S can be used with the following patient cables and adapters: • Patient cable PK-83-B with two screw terminals for tem- porary leads on the patient side and Redel plug on the Reocor S side (use the Redel adapter).
  • Page 17 Patient cable PK-67-L and PK-67-S Patient cable PK-67-L (2.6 m) and PK-67-S (0.8 m) differ only in length. On the Reocor S side you have a Redel plug (use the Redel adapter) and on the patient side a connection for the adapter according to Figure 13 and for the single-use cable according to Figure 9.
  • Page 18 Reocor S can also be used with patient cables with 4 connec- tions for dual-chamber pacemakers. Reocor S only uses the ventricular channel of these cables. The following cables are possible: • Patient cable PK-141 with 4 alligator clips on the patient side and Redel plug on the Reocor S side (use the Redel adapter).
  • Page 19 • Adapter Figure 13 shows adapters for connection of temporary leads to Reocor S through the dual-chamber patient cable PK-67- L/S. The leads should be connected with the ventricular con- nection of the adapter (labeled V). Figure 13: Adapters for the patient cables PK-67-L and PK-67-S...
  • Page 20 Temporary catheters with 2-mm plugs or heart wire with 2-mm adapter You have the option to connect Reocor S directly to a tempo- rary catheter with touch-proof 2-mm plug or to a heart wire with 2-mm adapter, without any other cables or adapters. All...
  • Page 21 For dual-chamber cables (PK-141, PK-175, PK-67-S/L), Reocor S uses only the ventricular channel! Polarity Reocor S principally paces in bipolar mode, but it can be used with bipolar or unipolar temporary pacing leads. If unipolar leads are used, two leads must be connected.

  • Page 22: Start Up

    Monitor the ECG of the patient and adjust amplitude and/or sensitivity, if necessary. Caution! During use of Reocor S, the heart rate of the patient must be monitored with an ECG monitor with alarm function. Attachment Reocor S must be operated either horizontally on a non-slip...

  • Page 23: Battery Exchange

    , external pacing is possible for at least 600 hours at 20 ± 2°C before the battery must be replaced. It is possible to exchange a battery while Reocor S is in use. The device remains ready for use for at least 30 s at the ambi- ent temperature (20 ±...
  • Page 24 Insert the new battery with the bottom (Figure 14) down first into the battery compartment. Figure 14: Inserting the battery Close the drawer and press the blue slider down until it snaps in place with an audible click. Note: If the pacemaker is stored or will not be used for a long period of time, it is recommended to remove the battery to prevent damage due to leakage.

  • Page 25: Pacing Modes And Parameters

    There are three pacing modes available: S00, SSI, SST as well as high-frequency pacing (Burst). For disturbances caused by electromagnetic interference (EMI), after certain limits are exceeded Reocor S will switch to operating mode S00 for the duration of the disturbance. Mode S00 The pacemaker sends pulses with a constant rate.

  • Page 26: 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 two seconds. The pulse width is 1 ms.
  • Page 27 Various risks have to be considered in association with high- frequency atrial pacing. The risks 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 atrio- ventricular stimulus conduction (e.g.

  • Page 28: Handling, Care And Maintenance

    After cleaning or disinfection, Reocor S must not be used for one hour. Sterilization Reocor S cannot be sterilized. If the device needs to be used in a sterile environment, it can be packed into a sterile cover. Annual checks of the device by manufacturer-authorized technicians are recommended.

  • Page 29: 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.

  • Page 30: Disposal

    Disposal Reocor S is marked with the symbol of a crossed-out garbage can on its type plate. The symbol indicates that the European guideline 2002/96/EC on waste electrical and electronic equipment (WEEE directive) applies to the disposal method of the device.

  • Page 31: Technical Safety

    The closed protective cover protects the pacemaker against dripping water. WARNING! The temporary leads that are connected to Reocor S repre- sent a low-impedance conductor to the myocardium for elec- tric current. Therefore line-powered devices that are oper- ated in the patient's vicinity must be grounded in accordance with established guidelines.

  • Page 32: Technical Data

    Technical Data Symbols Follow the instructions for use in the technical manual. Indication of the placement of the battery in the compartment Disposal according to the WEEE directive Applied part classification: CF (cardiac floating), defibrillation pro- tected IP31 Water-repellent, protection degree IP31 Off (on the Mode dial) Adjustable parameters Pacing modes...
  • Page 33 Fixed parameters High rate protection 1 … 180 ppm 286 ms ± 10% 286 ms = 210 ppm, does not apply for Burst 181 … 250 ppm 214 ms = 280 ppm, does not apply 214 ms ± 10% for Burst Pulse waveform Asymmetric, biphasic Lead impedance monitoring...
  • Page 34 Without battery, with Redel adapter: 260 g ± 10% Without battery, without Redel adapter: 225 g ± 10% Dimensions of the Redel 76 mm x 35.5 mm x 29.4 mm adapter for Reocor S Weight of Redel adapter for 35 g ± 10% Reocor S...

  • Page 35: Conformity According To Iec 60601-1-2

    Conformity According to IEC 60601-1-2 Manufacturer guidelines and declaration - electromagnetic radiation (IEC 60601-1-2: Table 1) The device is intended for use in an electromagnetic environ- ment as described below. The user should make sure that the device is used in such an environment. Emissions test Compliance level Guidelines for the electromagnetic environment HF emission...
  • Page 36 Test of resistance Test level according to Compliance Guidelines for the electro- to interference IEC 60601 level magnetic environment Voltage drops, Not applicable brief interrup- tions and fluctua- tions in the supply voltage according to IEC 61000-4-11 Magnetic field at 3 A/m 30 A/m The magnetic field strength should...
  • Page 37 Test of resistance Test level according to Compliance Guidelines for the electromagnetic to interference IEC 60601 level environment P is the maximum rated power of the transmitter in watts [W] accord- ing to the information from the transmitter manufacturer and d is the recommended safe distance in meters [m] The field strength of stationary...
  • Page 38 Recommended safe distances to portable and mobile RF communications equipment (IEC 60601-1-2: Table 5) The device is intended for use in an electromagnetic environ- ment, in which the RF interference is controllable. The user of the device can help to prevent electromagnetic interference by maintaining the safe distance to mobile RF communication equipment (transmitters) - depending on the power output of the communication equipment.

  • Page 39: Scope Of Delivery And Accessories

    Artigo Nº para Descrição Conexão pedido PK-141 (2,8 m) 353181 Cabo do paciente, reesterilizável, com quatro Adaptador clipes jacaré com proteção contra contato Redel Braçadeira Reocor 103704 Braçadeira padrão – padrão Braçadeira Reocor 391843 Braçadeira com circunferência reduzida. – Apropriada para braços mais finos. curta Apenas para os EUA Artigo...
  • Page 40 Os símbolos na etiqueta têm o seguinte significado: Símbolo Significado Reocor S Adaptador Redel Número para pedido BIOTRONIK Número de série do aparelho Data de fabricação do aparelho Variação de temperatura de armazenamento permitida Variação de pressão atmosférica de armazenamento permitida Variação de umidade do ar de armazenamento permitida...
  • Page 42 Técnico Responsável: Eng. Zolmo de Oliveira Jr. - CREA/SP nº: 060 1869029 Eng. Rogério Quiarim Zarza - CREA/SP nº: 060 1812032 Marcapasso Externo Reocor S - Reg. ANVISA nº: 80224390178 Fabricante / Distribuidor: Fornecedor: BIOTRONIK SE & Co. KG BIOTRONIK Comercial Médica Ltda.

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