BIOTRONIK Reocor D User Manual
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BIOTRONIK Reocor D User Manual

External pacemaker
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Reocor D/S
External Pacemaker
Cardiac Rhythm Management
External Devices
User's Guide

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Summary of Contents for BIOTRONIK Reocor D

  • Page 1 Cardiac Rhythm Management External Devices User's Guide Reocor D/S External Pacemaker...

  • Page 3: Table Of Contents

    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 ..................

  • Page 5: Indications And Contraindications For Use

    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...
  • Page 6 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-...
  • Page 7 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.
  • Page 8 • 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.
  • Page 9 • 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.
  • Page 10 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...
  • Page 11 • 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...
  • Page 12 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 VAT, VVI, V00 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...
  • Page 13 , 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 ±...
  • Page 14 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.
  • Page 15 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.

  • Page 16: Product Description

    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.
  • Page 17 Figure 3: Protective cover for Reocor D and Reocor S Correct Incorrect...

  • Page 18: Safety

    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.

  • Page 19: Connecting To Reocor D/S

    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.
  • Page 20 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.

  • Page 21: Reusable Patient Cables

    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 22: Start-Up

    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...

  • Page 23: Programming Reocor D/S

    о 60, 100 ... (100) ... 800, 1000 • Sensitivity (mV) о A: 0.2, 0.3, 0.5, 0.7, 1, 2, 3, 5, 7, 10 (Reocor D) о V: 1, 2, 3, 4, 5, 8, 11, 14, 17, 20 (Reocor D) о S: 1, 2, 3, 4, 5, 8, 11, 14, 17, 20 (Reocor S) • Pulse amplitude (V)
  • Page 24 175 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.

  • Page 25: Burst Pacing

    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.

  • Page 26: Visual And Audible Signals

    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.
  • Page 27 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).
  • Page 28 >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.

  • Page 29: Common Interference Sources And Recommendations

    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.

  • Page 30: Battery Information

    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. 70 ppm, 5 V, DDD (Reocor D) or VVI (Reocor S), 500 ohm...
  • Page 31 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.

  • Page 32: 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.

  • Page 33: Supplementary Information

    Reocor D 365 529 Battery Armband Reocor ADAPT D 371 262 Protective Cover 378 007 Technical Manual Quick Reference Guide Case * Reocor S and Reocor D may only be used with the accessories developed and tested for this pacemaker.
  • Page 34 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.

  • Page 35: Symbols On The Components

    • 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...
  • Page 36 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...
  • Page 38 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...

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