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.: [phone] - 0
Fax: [phone] - 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
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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
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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
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Ergometer
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Operation Manual
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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

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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

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Type er900 PC
2 Safety Notices
2.1 Safety
Complying to the safety comments protects from potential injuries and prevents im-
proper application of the ergometer. Each operator of this ergometer as well as per-
sonnel which is in charge of installation, maintenance, examination or repair of this
ergometer, must have read and fully understood the contents of this Operation Manual
prior to operating or do any work on this device.
Special attention is required at sections labelled with additional symbols .
2.2 Application as directed
a) The ergometer ergometrics 900 must only used for precise Cardio- Vascular tests
under resting and stress test conditions.
b) Special test methods, e.g. Echo-Cardiography or other high-risk test methods must
not be performed by using the bicycle ergometer. For such purpose special leaning
ergometer or offered by ergoline.
c) Application under outdoor conditions is not permitted.
d) In case the ergometer is not being used according to above conditions, and if be-
cause of that any injuries or serious impact on individuals, or if damage of property
is caused, then from this no liability of the manufacturer can be derived.
2.3 Fundamental Safety Comments
Note: We herewith notify that this manual is in accordance with regulations set forth by
the EC-Directive 93/42 EEC and the standards IEC601-1 (1996) and EN60601-
1-2 (1993). These regulations are however, not contained within this handbook.
The ergometer must only be operated in perfect working order in techni-
cal respect.
Despite of the precautions, the operation of the ergometer may involve certain
risk or danger, especially if
- improper application or,
- application is not as directed
are the cause.
There is the hazard of injuries or of property damage, in case of Nonconformance to
the Operation Manual, especially to the S a fe t y N o t e s
Safety Notices

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Type er900 PC
It is necessary to ensure that no dangerous ground currents occur as a
result of attaching the ergometer to other devices. Device specifications
of the ergometrics er900 are in the appendix to this manual. Direct your
questions to your dealer or to ergoline’s service department. Especially
at the coupling of several devices to a measurement system is has to
be taken care, that proper grounding is achieved via a single power
supply, e.g. wall socket.
The ergometrics er900 ergometer should only be operated where elec-
trical requirements meet IEC 601-1.
This device is not suitable for use in rooms or areas where there is dan-
ger of explosion. .
Always observe accident prevention precautions when operating this
device.
In the event that the pressure in the blood pressure cuff is too high,
remove the cuff from the patient's arm immediately.
"This unit may only be operated for therapy or diagnosis purposes under
the supervision of qualified personal.
2.4 Normative Notices
2.4.1 Notice for EMC (electromagnetic compatibility)
- The EMC test was done with a interference level of 3V/m. The device should not be
used in areas with a higher level.
- The device should not be used beside a high voltage system.
- To connect the device with other devices it's only allowed to use special shielded
cable provided by ergoline.
- Strong transmitting equipment may not be operated in the immediate vicinity of this
device..
- Electromagnetic interferences will appear first by a instable value of load in the dis-
play. If the value will change without reason while the speed is >30 1/min. It may be
that this is caused by an electromagnetic interference.
2.5 Requirements for Operating Personnel
The operating personnel of this ergometer have to be :
- properly instructed and trained regarding the operation of the ergometer,
- have to have full command regarding the handling of the device,
- have to aware of the applicable relevant safety requirements for the operation of
such devices, and act accordingly (see Chap. „Introduction“),
- have to be informed regarding additional regulations, e.g. safety regulations,
- have to be informed regarding potential hazard and risk arising from the operation of
such devices.
Safety Notices

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Type er900 PC
2.6 Safety and Device Protecting Features
The device is equipped with following safety and device protecting features :
- High current protection which prevents damage to the device and potential danger to
person, e.g. in case of short circuit.
2.7 Measurement Accuracy Verification
Maintenance: The ergometrics 900 bicycle ergometer must be regularly inspected
and maintained, in time intervals of two years, in accordance with lawful regulations.
Alterations to the ergometer’s measurement capabilities are cause for re-certification.
2.7.1 Routine Control of the Blood Pressure Measurement Unit
The automatic blood pressure measurement unit in the console of the ergometer must
be approved and recalibrated every two years by personnel authorized by ergoline.
2.7.2 Periodic Accuracy Verification for Blood Pressure Unit
EC-Directive 93/42/EEC operator regulations stipulate that the automatic blood pres-
sure unit in the ergometer´s console must undergo a routine technical inspection every
two years. (see page II in this operators Manual)
2.7.3 Load Unit Inspection
EC-Directive 93/42/EEC operator regulations requires qualified technical maintenance
of the load unit at two years intervals. This is to be performed by an ergoline authorized
service technician.
Safety Notices

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2.8 Identification plate, Labelling
Safety Notices
label with serial number

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Ergometer
Type er900 PC
3. Installation
This section describes the required installation steps in order to establish operational
readiness. The steps described are also required at initial installation after delivery of
the device.
3.1 Installation steps
1) Loosen screws and clamp lever for clamp fixture, and remove upper clamp jaw;
Insert handlebar, secure, and screw tight with screws and clamp lever.
Adjust appropriate handlebar position and fix position with clamp lever.
2) Insert measurement head with the tin flaps into the handlebar pipe;
Attach grounding cable, connection cable and tubing.
3) Adjust black rear cover onto the measurement head and tighten with screw.
4) Insert saddle pipe into the guidance and tighten with clamp lever.
5) Feed saddle bellows into the saddle pipe, and put on to the intended notch .
6) Connect blood pressure cuff according to 4.3.2 at the measurement head.
7) Connect mains cable according to 4.3.1 at the power inlet.
3.2 Scope of Delivery
The standard scope of delivery consists of :
Installation
1 blood pressure cuff
3 handle bar
4 Measurement head with rear cover
5 saddle bar with saddle
not in picture:
mains cable, 5 m
Final test protocol
Operation Manual
optional :
connecting cable to ECG (not in picture)
1
3
4
5

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3.3 Accessories
Order No. Description
200.194 Cuff for ergometry, adults
200.199 Cuff for ergometry, adults (connecting hose 2 m)
200.230 Cuff for ergometry, long version for strong arms
200.231 Cuff for ergometry, special (strong arms/connecting hose2 m)
200.200 Cuff for ergometry, children
313.420.9 Polar Receiver er900
424.016 Polar chest belt
501.026 Triathlon handle bar er900, incl. Polar Receiver cable extension
300.937 adjustable cranks, pediatric size
200.850 saddle for children, incl saddle pipe and sadle bellows
475.156 er900PC Operation Manual
475.190 er900 Service-Unterlagen
3.4 Transport
""
""
"Please ensure that the mains cable is removed prior to transporting the device.
During transport within the same room respectively within the same building, hold onto
the ergometer such that the measurement head is pointing towards you.
Take hold of the handle bar at both sides, and pull the ergometer towards yourself, so
that it is resting on the casters only , and is in balance too. Now you may pull the ergom-
eter easily to the working space within the room.
Please be careful at touching down the ergometer. Otherwise the WSG (= wire
string gauge) of the driving unit may be damaged.
Installation

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4 Putting into Operation
Check the mains fuse at the respective workstation prior to putting into operation the
device. Minimal fuse value: 16A.
4.1 Operating elements and Connections
Putting into Operation
1 power connector, fuse
2 main power switch
3 clamp handle for seat adjustment
4 clamp handle for handlebar angle adjustment
5 console with keypad, display
6 blood pressure cuff
7 clamp handle for handlebar height adjustment
8 transport casters
9 leveling feet for optimal stability
1
2
3
4
5
6
7
89

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4.2 Measurement head
4.2.1 Keyboard
Putting into Operation
1
LCD-Display
Enable blood pressure measurement
Initiate or stop blood pressure measurement
Increase load level in 5 Watt steps
Decrease load level in 5 Watt steps
1
2
3
4
5
4
5
32

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4.3 Connectors and Interfaces
4.3.1 Power Connection
1) Make sure that the unit power switch is in
the off position (not depressed).
"
When using an ergoline utility cart with suction device, connect the unit’s power
plug to one of the white outlets on the utility cart. The ergometer can then be switched
on and off together with the suction device.
4.3.2 Connector for Blood Pressure Cuff
The cuff tube is to be connected
via Luer-Lok to J16 with the measure-
ment head .
The microphone cable is to be
connected via RCA-Jack to J12
2) Connect the unit’s power plug via the sup-
plied mains cable to power outlet with same
voltage as indicated at the indication label
Putting into Operation

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4.3.3 Signal Connections
1
23
1) Digital RS-232 interface connector for PC or ECG
2) Analog interface for analog control and analog data transfer to ECG.
3) Fiber-optic connector for ear/finger clip or HR input from and ECG
"The interface pin configuration as well as related technical data are in the
appendix of this Operation Manual.
Putting into Operation