Ergoline Ergoselect 100 Manuale utente

Manual

ergoselect 100 / 200

Bicycle Ergometer

Operator’s Manual

201000134000 • Version 2016-03-15 / Rev 02• English

This manual was written with the utmost care. Should you still nd details that do not correspond with the system, please

let us know and we will correct the issue as soon as possible.

We reserve the right to modify the design and technical features of the device and are not bound by the information and

illustrations provided in this manual.

All trademarks appearing in this document are trademarks of their respective owners. Their protection is acknowledged.

No part of this manual may be reprinted, translated or reproduced without the manufacturer's written permission.

This manual is not subject to any change order service. Please contact the manufacturer for the latest document revision.

ergoline GmbH

Lindenstraße 5

72475 Bitz

Germany

Tel.: +49-(0) 7431 98 94 - 0

Fax: +49-(0) 7431 98 94 - 128

e-mail: info@ergoline.com

http: www.ergoline.com

Printed in Germany

- 3 -

General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Setup and Mains Connection. . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Controls and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Mounting the Control Terminal (P or K) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Connecting the Power Cord. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Connecting the ECG Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Connecting the Blood Pressure Cu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Preparing the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15

Adjusting the Saddle and the Handlebar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Preparing the Patient for Blood Pressure Measurements . . . . . . . . . . . . . . .16

Checking the Cu Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18

Control terminal P . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18

Turning the System On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Operating Modes with Control Terminal P . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

PC Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Ergometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Settings with Control Terminal P . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Control Terminal K. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Turning the System On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Operating Modes with Control Terminal K . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Speed readout. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

PC Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Ergometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Training with Chip Card. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Settings for Control Terminals K . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Cleaning, Maintenance, Disposal . . . . . . . . . . . . . . . . . . . . . . . . . 45

Technical Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

Electromagnetic Compatibility EN 60601-1-2 . . . . . . . . . . . . . . . . . . . 52

CONTENTS

- 4 -

- 5 -

GENERAL INFORMATION

• The product ergoselect bears the CE marking CE-0123

(Notied Body: TÜV), indicating its compliance with the

provisions of the Council Directive 93/42/EEC about

medical devices and fullls the essential requirements

of Annex I of this directive.

The CE marking covers only the accessories listed in

the Order Information chapter.

The ergometer is an MDD class IIa product.

• The device fullls the requirements of standard

EN 60601-1 "Medical Electrical Equipment, Part 1:

General Requirements for Safety" as well as the

interference protection requirements of standard

EN 60601-1-2 "Electromagnetic Compatibility –

Medical Electrical Devices".

The radio-interference emitted by this product is with-

in the limits specied in EN 55011, class B.

• The symbol means: protection class II

• This manual is an integral part of the equipment. It

should be available to the equipment operator at all

times. Close observance of the information given in

the manual is a prerequisite for proper device perfor-

mance and correct operation and ensures patient and

operator safety. Please note that information pertinent

to several chapters is given only once. Therefore, read

the manual once carefully in its entirety.

• The symbols mean:

Consult accompanying documents.

They indicate points which are of particular impor-

tance in the operation of the device.

• Observance of the safety information protects from

injuries and prevents inappropriate use of the device.

All equipment users and persons responsible for

assembly, maintenance, inspection and repair of the

device must read and understand the content of this

manual, before using or work on it.

Paragraphs with special symbols are of particular

importance.

• If unauthorized individuals open the control terminal,

damaging the calibration sticker, any warranty claim

shall become void.

• This manual reects the equipment specications

and applicable safety standards valid at the time of

printing. All rights are reserved for devices, circuits,

techniques, software programs, and names appearing

in this manual.

• On request ERGOLINE will provide a Service Manual.

• The ERGOLINE quality management system complies

with the standards ISO 9001: 2008 and EN ISO 13485:

2003-AC2007.

• The safety information given in this manual is classi-

ed as follows:

• To ensure patient safety, the specied measuring

accuracy, and interference-free operation, we recom-

mend using only original ERGOLINE accessories. The

user is responsible if non-ERGOLINE accessories are

used.

• ERGOLINE is responsible for the safety, reliability, and

performance of the equipment, only if

- modications and repair are carried out by

ergoline GmbH or by an organization expressly

authorized by ergoline GmbH

- the equipment is used in accordance with the

instructions given in this operator's manual.

ergoline GmbH

Lindenstrasse 5

72475 Bitz

Germany

Phone: +49-(0)-7431 - 9894 -0

Fax: +49-(0)-7431 - 9894 -128

e-mail: info@ergoline.com

http: www.ergoline.com

Danger

indicates an imminent hazard. If not avoided, the hazard will

result in death or serious injury.

Caution

indicates a potential hazard. If not avoided, the hazard may

result in minor injury and/or product/property damage.

Warning

indicates a hazard. If not avoided, the hazard may result in

minor injury and/or product/property damage.

- 6 -

Danger

• Explosion Hazard •

The device is not designed for use in areas where an explosion

hazard may occur.

Explosion hazards may result from the use of ammable anes-

thetics, skin cleansing agents or disinfectants.

Warning

• Patient Hazard, Equipment Damage •

Do not expose the ergoselect to direct sunlight to prevent system

components from reaching inadmissible high temperatures.

Do NOT use the ergoselect outdoors (medical device). Further-

more the device has no additional protection against the ingress

of humidity. Humidity inside the device may cause equipment

malfunctions and increases the risk of an electric shock.

Additionally, the device should not be operated in the vicinity

of electric power plants, because they may impair equipment

functions.

The ergoselect ergometer may only be used in combination with

accessories approved by ergoline GmbH.

• Risk to Persons •

Before using the ergometer, the operator must ascertain that it is

in correct working order and operating condition. The cables and

connectors, in particular, must be checked for signs of damage.

Damaged parts must be replaced immediately, before use.

• Equipment Malfunction •

Only the special shielded cables supplied by ERGOLINE may be

used to connect the device to other pieces of equipment.

• Equipment Malfunction •

Cellular telephones may not be used in the immediate vicinity

of the ergometer, because they might interfere with the proper

functioning of the ergometer.

Electromagnetic interference most probably exists when the

watt reading is unstable. If the displayed value changes fre-

quently even though the speed is above 30 RPM, this may be due

to electromagnetic interference.

Warning

• Shock Hazard •

When the ergometer is connected to other equipment or if a

medical system is created, it must be ensured that the added

leakage currents do not present a hazard.

In case of questions, please contact your ERGOLINE dealer or the

ergoline GmbH Service Department.

For use, the ergometer must always be connected to electric

installations that fulll the local requirements.

• Patient Hazard •

The German Medical Device Operator Ordinance (MPBetreibV,

§ 5) demands that users

• must be trained in the use of the ergometer

• must be familiar with the routines for handling and

assembly of the ergometer

• must be familiar with and observe the safety rules and

regulations for operation of this type of equipment

• must be informed about any other pertinent rules and

regulations (e.g. safety features)

• must be informed about the potential hazards arising from

the use of this type of equipment.

• make sure that no unauthorised changes are carried out.

SAFETY INFORMATION

Hint

Removing the power cord results in complete disconnection

from mains (all poles).

Caution

Additional equipment connected to medical electrical equip-

ment must comply with the respective IEC or ISO standards

(e.g. IEC 60950 for data processing equipment). Furthermore all

congurations shall comply with the requirements for medical

electrical systems (see IEC 60601-1-1 or clause 16 of the 3Ed. of

IEC 60601-1, respectively).

Anybody connecting additional equipment to medical electri-

cal equipment cong ures a medical system and is therefore

responsible that the system complies with the requirements for

medical electrical systems. Attention is drawn to the fact that

local laws take priority over the above mentioned requirements.

If in doubt, consult your local representative or the technical

service department.

• IEC 60601-1+Al +A2:1995: 6.8.2.c, 19.2.b, 19.2.c,

• IEC 60601-1:2005: 7.9.2.5, 8.1, 16.2.d,

• MDD 93/42/EEC: Annex I clause 13.6.c

- 7 -

SAFETY INFORMATION FOR

NON-INVASIVE BLOOD PRESSURE

MEASUREMENT

Warning

• Patient Hazard •

Do not take blood pressure measurements with a cu on pa-

tients suering from sickle cell anemia or where skin lesions are

likely to occur.

The cu may cause hematomas in patients with severe blood

coagulation disease. In these instances, the user must take a

decision for or against automatic blood pressure measurements.

Caution

• Compromised Measuring Accuracy •

Arrhythmias occurring frequently during a measurement may

compromise the accuracy of the measurement.

In certain cases, a valid measurement will not be possible.

Electromagnetic elds are also capable of impairing the measur-

ing accuracy.

Note

• If the cu pressure exceeds the maximum value of

300 mmHg during ination, the ination procedure will be

aborted and the cu deated.

As a redundant safety precaution, the cu is immediately

deated when the cu pressure exceeds 320 mmHg.

You can check the proper functioning of this safety precau-

tion by abruptly bending your arm while the cu is being

inated, causing a brief overpressure in the cu. The cu

must deate immediately.

• Measurements that did not yield a valid measurement will

not be repeated during the exercise test.

• If the ination phase takes longer than 40 seconds or if an

adequate pressure does not build up in the cu within a

reasonable period of time, the measurement will be aborted

and the cu deated.

• If a valid measurement cannot be completed within

120 seconds, the measurement will be aborted and the cu

deated.

• If the cu pressure remains constant for some time, the

measurement will also be aborted and the cu deated.

INTENDED USE

The ergoselect is a computer-controlled medical ergometer.

At pedal speeds between 30 and 130 RPM and loads

between 6 and 999 watt, the ergometer operates indepen-

dent of the pedal speed.

The speed-independent range is shown in the Appendix

(Technical Specications).

The ergoselect ergometer may only be used in exercise

testing as well as for rehabilitation of cardiac and cardio-

vascular patients according to the instructions given in this

manual. If the ergometer is used for other purposes, the

manufacturer cannot be held liable for personal injuries or

property damage resulting from the unintended use of the

equipment.

Note - Applied Parts

• Applied parts are components that are directly in contact

with the human body (e.g., blood pressure measuring devices).

BIOCOMPATIBILITY

The parts of the product described in this manual,

including all accessories that come in contact with the

patient during the intended use, fulll the biocompatibil-

ity requirements of the applicable standards if applied as

intended.

If you have questions in this matter, please contact

ERGOLINE or a representative.

APPLICABLE LAWS, REGULATIONS AND

DIRECTIVES

• 93/42/EEC (Medical Device Directive of the EU)

• 89/336/EEC (Electromagnetic Compatibility Directive of the EU)

• EN 1060-1 Non-invasive sphygmomanometers, Part 1:

General requirements

• EN 1060-3 Non-invasive sphygmomanometers, Part 3:

Supplementary requirements for electro-mechanical blood

pressure measuring systems

Note - Stability

• Ensure the stability of the ergometer. If the maximum per-

mitted patient weight is exceeded by 10%, the stability of

the ergometer can no longer be guaranteed. It may become

unstable as a result.

- 8 -

SYMBOLS

Symbol ’type B applied part’.

Type B applied parts have no direct contact with

patients and oer the lowest protection against

electric shock.

Symbol ’type BF applied part’.

Type BF applied parts are connected to the body

of the patient and provide a higher degree of pro-

tection against electric shock. The applied parts

are isolated.

Caution, consult accompanying documents.

Protection class II equipment.

This symbol indicates that the waste of electrical

and electronic equipment must not be disposed as

unsorted municipal waste and must be collected

separately.

Consult operating instructions.

Catalog number.

Serial number.

Scheduled date of the next inspection

(e.g., March 2011).

On/O switch for pressure actuation

CE mark per the Medical Device

Directive 93/42/EEC of the European Union.

Notied body: TÜV SÜD Product Service GmbH,

Ridlerstr. 65, 80339 München, Germany.

Nationally Recognized Testing Laboratory

NRTL label for the USA and Canada.

Do not lean against the ergometer:

there is a risk of the ergometer tipping over.

REF

Manufacturer’s identication.

Date of manufacture.

The number found under this symbol is the year of

manufacture in the YYYY format.

PVC-free.

Latex-free.

Suitable for indicated arm circumference.

Small size.

Standard size.

Large size.

Transport and storage label:

top.

Transport and storage label:

keep dry.

Transport and storage label:

fragile.

Transport and storage label:

approved temperature range.

Transport and storage label:

approved humidity, non-condensing.

Transport and storage label:

approved pressure range.

Transport and storage label:

do not stack.

- 9 -

SETUP AND MAINS CONNECTION

CONTROLS AND INDICATORS

1 Control terminal (model P or model K)

2 Blood pressure cu connection (option)

3 Adjustment of the handlebar angle

4 Blood pressure cu

5 Adjustment of the handlebar height

(ergoselect 200 only)

6 Castors

7 Speed display (RPM) for patient

8 Adjustment of the saddle height (ergoselect 100 only)

9 Digital saddle height indication

(ergoselect 200 only)

10 Power switch (green button)

11 Sockets for power cord and connection cables

(underside of ergometer)

12 Levelling devices to adjust the ergometer to

uneven oors

ERGOSELECT 100 - CONTROLS, CONNECTIONS AND INDICATORS

ERGOSELECT 200 - CONTROLS, CONNECTIONS AND INDICATORS

- 10 -

LEVELLING FEET OF THE ERGOSELECT ERGOMETER

TRANSPORT

For short distances, the ergoselect can be lifted at the

saddle and rolled away on its castors.

To cover greater distances, however, we recommend the

following method:

• Disconnect the power cord from the wall outlet.

• Rotate the handlebar towards the front.

Tighten the clamping lever.

• Stand in front of the ergoselect, grasp the handlebar

and tilt the ergoselect towards you until it is standing

on the castors only and is balanced.

• It is now possible to transport the ergoselect.

• When you have reached the new location, lower the

ergoselect very carefully to avoid damage.

SETUP

Place the ergoselect on a horizontal level oor.

The ergoselect must be set up in a secure and stable

position - the two levelling feet at the back make for easy

adjustment to uneven oor surfaces. Extend the foot con-

cerned until the ergoselect no longer wobbles.

In case of delicate ooring, it is recommended to place

a mat under the ergometer to protect the ooring from

damage by the feet.

TRANSPORTING THE ERGOSELECT

Caution

• Equipment Damage •

Avoid strong vibrations of the ergoselect during transport.

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