EasyManua.ls Logo

OSYPKA PACE 203H User Manual

OSYPKA PACE 203H
139 pages
To Next Page IconTo Next Page
To Next Page IconTo Next Page
Page #1 background imageLoading...
Page #1 background image
5I-17-016X-B-20 Osypka Medical 2013©
Instructions for Use
P A C E 2 0 3 H
Dual-Chamber (DDD) Temporary Pacemaker
Distributor
OSYPKA AG
Earl-H.-Wood-Strasse 1
D-79618 Rheinfelden, Germany
Phone: +49 (7623) 7405 - 0
Fax: +49 (7623) 7405 - 160
E-Mail: mail@osypka.de
M a n u f a c t u r e r
Osypka Medical GmbH
Albert
-Einstein-Strasse 3
D-12489 Berlin, Germany
Phone: +49 (30) 6392 8300
Fax: +49 (30) 6392 8301
E-Mail: mail@osypkamed.com

Table of Contents

Other manuals for OSYPKA PACE 203H

Question and Answer IconNeed help?

Do you have a question about the OSYPKA PACE 203H and is the answer not in the manual?

OSYPKA PACE 203H Specifications

General IconGeneral
BrandOSYPKA
ModelPACE 203H
CategoryMedical Equipment
LanguageEnglish

Summary

1 Preface

General Information and Manual Conventions

Provides general information, contact details, and explains manual conventions for keys and displays.

2 Product Description

3 Indication

4 Contraindication

5 Possible Complications

6 Precautionary Measures and Warnings

General Safety and Handling Precautions

Lists essential safety measures for using the PACE 203H, emphasizing personnel experience and proper grounding.

7 Patient Safety

International Safety Standards Compliance

Lists international standards met by PACE 203H for patient safety and electromagnetic compatibility.

8 Electromagnetic Compatibility

EMC Guidelines and Precautions

Details EMC standards compliance, potential interference sources, and necessary precautions.

9 Use and Application of PACE 203H

9.1 Device Design Overview

Introduces the device's displays, keys, and terminals, referencing Figure 1.

9.2 Display, Dials, and Keys Overview

Provides an overview of the device's displays, dials, and keys, referencing figures.

9.3 Powering On PACE 203H

Guides on how to power on the device, including self-test and stand-by modes.

9.4 Locking/Unlocking PACE 203H

Explains how to lock and unlock the device to prevent accidental parameter changes.

9.5 Powering Off PACE 203H

9.6 Modes of Operation

Key Pacing Terms and Definitions

Defines key terms related to pacing operation like beat-to-beat interval, A-V Delay, and PVARP.

Asynchronous and Inhibited Pacing Modes

Describes asynchronous (V00, A00, D00) and inhibited (VVI, AAI) pacing modes.

Dual-Chamber and Sequential Pacing Modes

Explains dual-chamber (DDD) and sequential (VDD, DAI, DVI) pacing modes.

Other Pacing Modes and Triggering

Covers VAT, 0D0 (Pause) mode, and Atrial Trigger modes.

9.7 Changing the Mode of Operation

9.8 Parameter Adjustment Overview

Adjusting Rate, Amplitude, Sensitivity, A-V Delay

Details how to adjust key pacing parameters using the device's rotary dials.

9.9 Using the Automatic Features

9.9.1 Auto A-V Delay and 9.9.2 Auto PVARP

Explains automatic settings for A-V Delay and PVARP based on rate.

9.9.3 Auto MTR and 9.9.4 Auto Sense

Details automatic settings for Maximum Tracking Rate and Sensitivity.

9.10 High-Rate / Overdrive Stimulation

Atrial High-Rate and Ventricular Rapid Pacing

Covers standby modes for atrial high-rate stimulation and ventricular rapid pacing.

9.11 Standard Programs

Managing Standard Programs

Explains how to store, recall, and manage standard pacing programs and defaults.

9.12 Parameters/Options Setting

Adjusting PVARP, MTR, Pulse Duration, ARP/VRP

Guides on adjusting refractory periods, MTR, and pulse durations.

Setting Options: Beep, Alarms, Language

Details how to configure beep, alarms, language, and interface settings.

9.13 Statistics

Statistics Overview and Navigation

Explains how to view and navigate through statistical data on pacing performance.

9.14 Emergency Stimulation

9.15 Pause Function

9.16 Connecting the Leads to PACE 203H

Lead Types and Connection Configurations

Describes compatible lead types and various connection configurations.

9.16.3 Lead Connection Procedure

Provides step-by-step instructions for safely connecting stimulation leads.

9.17 Determining the Sensitivity Threshold

9.18 Determining the Cardiac Capture Threshold

9.19 AC Power Supply (Option)

9.20 Controlling an Intra-Aortic Balloon Pump (Option)

9.21 Interfacing with Electrical Cardiometry™ Monitors (Option)

9.22 Internal Surveillance and Safety Features

9.22.1 Battery Surveillance

Details how the device monitors battery voltage and indicates low battery status.

9.22.2 Lead Surveillance

Explains the lead surveillance system that checks for interruptions or short circuits.

9.22.3 Interference and Mode Switching

Discusses how the device handles interference and switches modes to maintain optimal sensing.

9.22.4 Crosstalk and Ventricular Safety Pacing

Explains crosstalk and how the device uses ventricular safety pacing to prevent asystole.

9.22.5 Premature Ventricular Contraction (PVC)

PVC Detection and Response

Describes how the device detects and responds to premature ventricular contractions.

9.22.7 Protection Against Abnormal Settings

Possible Conflicts Overview

Discusses potential conflicts during parameter changes and how the device resolves them.

9.22.9 Summary of Text Messages

9.22.9.1 Conflicting Parameter Settings Warnings

Explains warning messages related to unusual or conflicting parameter settings.

9.22.9.2 Application Errors Messages

Explains warning messages for application-related errors and how users can solve them.

9.22.9.3 Device Errors Messages

Describes device-related errors caused by potential malfunctions and their troubleshooting.

9.22.9.4 Informative Messages

Explains informative messages that alert users to actions that must be taken.

10 Storage

11 Care and Maintenance

11.1 Care and Cleaning

Details how to clean and disinfect the device, emphasizing what not to do.

11.2 Battery Changing

Guides on when and how to change the device's battery, including operational continuity.

11.3 Safety Check-Ups

Lists essential check-ups to ensure safe operation, including visual inspection and functional tests.

11.4 Product Return Policy

Explains the policy for returning devices for disposal according to WEEE guidelines.

12 Customer Service

13 Technical Data

Classification and Regulatory Information

Lists classification details like Safety Class, Protection Degree, and conformity to standards.

Device Parameters and Specifications

Details measurement conditions, pacing modes, and various parameter ranges.

Battery Performance and Environment

Provides battery lifespan, power reserve, depletion indications, and operating environment.

Device Dimensions and Weight

Lists physical specifications of the device, including dimensions, weight, and terminals.

14 Delivery Unit

15 Conditions of Guarantee and Liability

16 Appendix A: Glossary

Glossary Terms A-B

Defines pacing-related terms starting with A and B.

Glossary Terms C-P

Defines pacing-related terms starting with C through P.

Glossary Terms P-S

Defines pacing-related terms starting with P through S.

Glossary Terms U-V

Defines pacing-related terms starting with U and V.

17 Appendix B: Menu Tree

Menu Tree Part 1

Shows the first part of the device's menu tree, illustrating navigation paths.

Menu Tree Part 2

Displays the second part of the device's menu tree, continuing the navigation paths.

18 Appendix C: Conformity to IEC 60601-1-2

Electromagnetic Radiation Emissions

Details guidance and manufacturer declarations regarding electromagnetic radiation emissions.

Electromagnetic Immunity to Interference

Provides guidance on electromagnetic immunity levels and corresponding environmental guidelines.

RF Interference Immunity Guidelines

Details immunity levels for conducted and radiated RF interference.

RF Safety Distances and Guidelines

Explains recommended safety distances for portable and mobile RF equipment.

19 Appendix D: List of Figures

20 Appendix E: List of Tables

21 Appendix F: PACE 203H Accessories

22 Appendix G: Declaration of Conformity