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BIOTRONIK Reocor D User Manual

BIOTRONIK Reocor D
38 pages
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ardac Rhythm Management
External Devces
User's ude
Reocor D/S
External Pacemaker
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BIOTRONIK Reocor D Specifications

General IconGeneral
Device TypeImplantable Cardioverter Defibrillator (ICD)
ManufacturerBIOTRONIK
ModelReocor D
Therapy OptionsCardioversion, Defibrillation
MRI CompatibilityMR conditional
Battery LongevityApproximately 7-10 years depending on usage

Summary

Indications and Contraindications for Use

Indications for Use

Lists applications for Reocor temporary pacing for patients of any age.

Intended Use

Describes Reocor as a battery-powered external pacemaker for temporary atrial, ventricular, or AV-sequential stimulation.

Contraindications

Lists situations where Reocor use is not recommended or prohibited.

Potential Side Effects

Details potential complications from temporary external pacing and lead insertion.

Warnings

Highlights dangers associated with damaged/damp cables and electrical currents.

Precautions

Outlines necessary steps to ensure safe operation and patient care during use.

General Safety Instructions

Provides overarching safety guidance for users and device operation.

Authorized Users

Specifies that only trained personnel with cardiology knowledge should operate the device.

Device Interaction

Explains the device's interaction with the human heart, skin, and blood vessels.

Usage Restrictions

Reaffirms device usage guidelines and restrictions with other electromedical devices or hazardous areas.

Maintenance and Modifications

States that only the manufacturer or authorized parties can perform maintenance or modifications.

Replacement Parts and Accessories

Advises using only original BIOTRONIK parts to maintain warranty and safety compliance.

Emergency Equipment

Recommends keeping emergency equipment and pacemakers readily available for dependent patients.

Pre-Use Checks

Details pre-operation checks including visual inspection and lead connection procedures.

Lead Connection Sequence

Specifies the correct sequence for connecting patient cables and leads to the device.

In-Use Best Practices

Covers securing the device, monitoring heart rate, and avoiding direct skin contact.

Reocor S EMI Handling

Describes how Reocor S handles electromagnetic interference by switching to operating mode S00.

Reocor D EMI Handling

Explains Reocor D's response to EMI, triggering asynchronous pacing.

High Rate Pacing Risks

Warns about potential hemodynamic complications from prolonged high-rate pacing, requiring monitoring.

Post-Use Procedures

Guides on post-use actions like function tests, battery removal for storage, and cleaning procedures.

Battery Specifications and Indicators

Discusses battery types, service life, and low battery indicators.

Electrocautery Guidelines

Provides recommendations for using electrocautery to minimize interference and protect the device.

Defibrillation Precautions

Details precautions for defibrillation, including energy settings, lead distance, and post-defibrillation checks.

Electromagnetic Interference Resistance

Explains the device's protection against EMI and potential errors caused by strong electromagnetic fields.

Device Self-Test Procedure

Describes the automatic self-test procedure performed upon device activation and error handling.

Product Description and Features

Device Overview

Introduces Reocor D/S as a temporary pacing device and differentiates between Reocor D and Reocor S.

Protective Cover Operation

Explains how to release and lock the protective cover to prevent accidental parameter changes.

Safety Precautions

General Safety Precautions

Lists essential precautions for device and patient safety, including emergency preparedness and inspection.

Connecting Reocor D/S and Accessories

Connection Procedure

Details how to connect lead adapters and patient cables to the Reocor D/S device.

Available Adapters and Cables

Lists and describes various adapters and patient cables for Reocor D/S, including order numbers.

Reusable Patient Cables

Cleaning and Disinfection

Provides instructions for cleaning, disinfecting, and sterilizing reusable patient cables.

Sterilization Method

Specifies steam sterilization parameters for reusable patient cables.

Device Start-Up

Start-Up Procedure

Outlines the steps to program the device, initiate a self-test, and connect patient leads.

Reocor D/S Programming Details

Programmable Parameters

Lists the adjustable parameters for Reocor D/S, including mode, rate, sensitivity, and AV delay.

Fixed Parameters

Details parameters that are fixed and non-programmable in Reocor D/S, such as pulse width and blanking periods.

Burst Pacing Functionality

Performing Burst Pacing

Explains the step-by-step process for initiating and maintaining atrial burst pacing.

Device Signals and Indicators

Reocor D LED Indicators

Describes the function of various LEDs on the Reocor D, including low battery, sense, and pace indicators.

Reocor S LED Indicators

Details the LEDs present on the Reocor S model and their meanings.

Audible Signal Explanations

Explains the two distinct audible signals indicating lead impedance issues or specific parameter settings.

Interference Sources and Mitigation

Electrocautery Guidelines

Provides recommendations for using electrocautery to minimize interference and protect the device.

Defibrillation Precautions

Details precautions for defibrillation, including energy settings, lead distance, and post-defibrillation checks.

Other Interference Sources

Discusses electromagnetic interference (EMI) and troubleshooting steps for unexpected device behavior.

Battery Management

Battery Specifications and Indicators

Specifies required battery type (9V) and expected battery life, including low battery indication.

Battery Replacement Procedure

Provides a step-by-step guide for replacing the battery in the Reocor D/S device.

Care and Maintenance Guidelines

Cleaning and Disinfection

Instructs on proper cleaning methods using mild soap and disinfectant solutions, with a usage restriction after cleaning.

Supplementary Information

Scope of Delivery and Accessories

Lists the items included in the delivery for Reocor S and Reocor D, along with their order numbers.

Available Adapters and Cables

Details various adapters and patient cables available for Reocor D/S, including order numbers and descriptions.

System Messages and Component Symbols

System Warnings and Errors

Lists potential warnings and error indicators during device use, such as low battery or lead impedance issues.

Label Symbol Explanations

Explains the meaning of icons found on the device labels, such as order number and manufacturing date.

Component Symbol Guide

Illustrates and defines symbols related to storage conditions, patient connection, and regulatory warnings.

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