ERGOMETRICS ER900 PC User manual

Operation Manual
ergometrics er900 PC
Art-Nr: 475.156 !Version: 12/01

Version: 12/01 er900 PC Operation Manual
Art-Nr: 475.156
Operation Manual for Bicycle Ergometer er900 PC
Printed in Germany.
We reserve the right of modifications due to technical development at any time and without prior notice.
Reprinting, translation and copying in any form - also in parts - is only permitted after prior written consent
by the manufacturer.
This Operation Manual is not registered for automatic update in case of eventual alterations.
Information regarding the latest version is available from the manufacturer.
This Operation Manual Ergometer ergometrics 900 PC
Version: 12/01
is valid for following Software-Versions:
V.752
ergoline GmbH
Lindenstraße 5
D-72475 Bitz
Tel.: +49 7431 98 94 - 0
Fax: +49 7431 98 94 - 127
e-mail: [email protected]
internet: http://www.ergoline.com


Version: 12/01 er900 PC Operation Manual
Art-Nr: 475.156

Operation Manual
Version: 12/01 1er900 PC Operation Manual
Art-Nr: 475.156
Ergometer
Type er900 PC
Contents
Table of Contents
EC Declaration of Conformity
Table of Contents.............................................................................................. 1
Foreword:............................................................................................................ 3
1. Introduction ....................................................................................................... 5
1.1 Comments by the Manufacturer for the Operating Company ................................. 5
1.2 Product Relevant Regulations .............................................................................. 6
1.3 Warranty Regulation ............................................................................................ 6
2 Safety Notices ................................................................................................... 7
2.1 Safety .................................................................................................................. 7
2.2 Application as directed ........................................................................................ 7
2.3 Fundamental Safety Comments ........................................................................... 7
2.4 Normative Notices ............................................................................................... 8
2.4.1 Notice for EMC (electromagnetic compatibility) ................................................... 8
2.5 Requirements for Operating Personnel ................................................................ 8
2.6 Safety and Device Protecting Features................................................................ 9
2.7 Measurement Accuracy Verification ..................................................................... 9
2.7.1 Routine Control of the Blood Pressure Measurement Unit .................................... 9
2.7.2 Periodic Accuracy Verification for Blood Pressure Unit ........................................ 9
2.7.3 Load Unit Inspection ............................................................................................ 9
2.8 Identification plate, Labelling .............................................................................. 10
3. Installation ....................................................................................................... 11
3.1 Installation steps ................................................................................................ 11
3.2 Scope of Delivery .............................................................................................. 11
3.3 Accessories ...................................................................................................... 12
3.4 Transport ........................................................................................................... 12
4 Putting into Operation .................................................................................... 13
4.1 Operating elements and Connections ................................................................ 13
4.2 Measurement head............................................................................................ 14
4.2.1 Keyboard .......................................................................................................... 14
4.3 Connectors and Interfaces ................................................................................. 15
4.3.1 Power Connection ............................................................................................. 15
4.3.2 Connector for Blood Pressure Cuff .................................................................... 15
4.3.3 Signal Connections ........................................................................................... 16
4.4 Power on Sequence .......................................................................................... 17
5 Operation ......................................................................................................... 18
5.1 The Computer - Your Helper............................................................................... 18
5.2 The Display Unit ................................................................................................ 19
5.2.2 Displayed Parameters and their Meanings ........................................................ 19

Operation Manual
er900 PC Operation Manual 2Version: 12/01
Art-Nr: 475.156
Ergometer
Type er900 PC Contents
6 Ergometry Process......................................................................................... 21
6.1 General Preparations ........................................................................................ 21
6.2 Preparations for External Control via ECG or PC ............................................... 22
6.3 Start of the Ergometry Session .......................................................................... 22
6.4 Manual Operation of Ergometry Session ........................................................... 22
6.5 Operational Panel for Manually Controlled Ergometry ........................................ 23
7. Cleaning .......................................................................................................... 24
7.1 Cleaning the Unit ............................................................................................... 24
7.2 Cleaning the Blood Pressure Cuff ...................................................................... 24
Annex A: Technical Data ............................................................................................ 25

Operation Manual
Version: 12/01 3er900 PC Operation Manual
Art-Nr: 475.156
Ergometer
Type er900 PC
Foreword
Foreword:
We are pleased with your decision to purchase our computerized ergometer er900 PC. This
unit gives you and your patients the benefits of a new dimension of precision in heart/circula-
tion testing.
The computerized ergometer 900 PC has been specially designed with the medical and
ergonomic requirements in mind for quick and definitive stress analysis of the heart/circula-
tion system.
The built-in automatic blood pressure meter was especially designed for ergometrics. It
assures that systole, diastole and heart rate limits are continuously, automatically,
monitored even under extreme stress. The computer controlled execution of all
measurements and analysis of results markedly simplifies the work of operating personnel.
Accordingly, the patient can be more closely observed and instructed. This allows the
ergometric process to be performed with the highest level of safety.
The display integrated into the console provides the operator continuously with current
measurement data. The continuous documentation of all measurements resulting from the
ergometric process will be done at your ECG device.
This handbook is intended for operators of the unit. It explains all the functions of the er-
gometer in detail and in such a manner that operation of the unit can be learned through its
use. It can also be used as a reference.
We hope that you are successful in your work with the 900 PC ergometer. We always
welcome your constructive remarks and improvement suggestions with regard to the unit
as well as to this handbook.
Your ergoline Team
Attention !
This Operation Manual is a part of the unit in accordance with EN 60601-1:1990. It
should always be kept close to the unit. The necessary safety considerations, con-
forming to EC Guideline 93/42 EC are in chapter 2 of this manual.
Complying to the Safety Considerations is protecting against danger and risk for
life and limb, and prevents from improper application of the Ergometer.
Please comply with all sign of danger at the Ergometer. Replace lacking or damaged
sign immediately.
Familiarize yourself with the appropriate handling of the ergometer and all its con-
trol facilities prior to operating the equipment.
While being at work, it is too late !
Never allow that a person without the necessary expert knowledge is operating the
equipment.
By above guidelines, a save and smooth operation is achieved, delays due to repairs are
avoided, and the requirements for the optimal employment of the equipment is fulfilled.

Operation Manual
er900 PC Operation Manual 4Version: 12/01
Art-Nr: 475.156
Ergometer
Type er900 PC

Operation Manual
Version: 12/01 5er900 PC Operation Manual
Art-Nr: 475.156
Ergometer
Type er900 PC
1. Introduction
Within this Operation Manual, important comments to ensure the safety and to avoid
potential damage are labelled with following symbols:
Warning !
Describes a potential dangerous situation.
Failure to comply may lead to death or serious injuries, or may cause dam-
age to the equipment or to the environment.
"Important !
Application hints to achieve an optimal application of the device and further
helpful information.
This Operation Manual is an integral part of the device, and has to be available at the
equipment at any time.
This Operation Manual is designed by the manufacturer according to his best knowl-
edge and experience in the construction, production and operation of the device.
The Operation Manual may be extended via special statements by the operating com-
pany, e.g. for supervision and obligatory registrations, internal maintenance plans, test-
ing intervals.
1.1 Comments by the Manufacturer for the Operating Company
As operating company, you are responsible for :
- The professional and application as directed via expert personnel which has been
instructed into the correct operation of the equipment,
- Compliance to the safety relevant information and maintenance comments,
- Compliance to the safety regulations, safety comments as well as the precautions in
respect to vocational safety and accident prevention.
- The technical instruction of the operating personnel at the device and for having taken
notice of the Operation Manual.
- The Operation Manual is accessible for the operating personnel.
Following guidelines and regulations apply to the operation of the ergometer:
- EN 60601-1 (1996) „Medical electrical equipment; General requirements for
safety“
- EN 60601-1-2 (1993) „Medical electrical equipment; General requirements for
safety; 2.“
Introduction

Operation Manual
er900 PC Operation Manual 6Version: 12/01
Art-Nr: 475.156
Ergometer
Type er900 PC
1.2 Product Relevant Regulations
- EC-Directive 93/42/EEC concerning medical products of June, the 14th 1993
- EC-Directive 89/336/EEC concerning „Electromagnetic compatibility“
1.3 Warranty Regulation
ergoline GmbH is only then, responsible for the safety and reliability of this
device when:
#all revisions, enhancements, repairs and service to the device are carried out by
ergoline authorized personnel, e.g. an ergoline dealer,
#ambient electrical service where the device is installed conform to IEC 601-1 and
#the device is operated in accordance with the Operation Manual.
Introduction
Table of contents

















