Cardioline xr100+ User manual

User’s manual
xr100+ / xr100BP+

User Manual: xr100+_eng 1
Cardioline S.p.A. Via Linz,151 38121 Trento (TN) [e-mail] www.cardioline.com
Sales ofce: Via F.lli Bronzetti, 8 20129 Milano (MI) Italy tel.[phone] fax [phone]
xr100+
User’s manual
xr100+ / xr100BP+
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 will not be automatically updated. Please contact the manufacturer for the
latest document revision.
ergoline GmbH
Lindenstrasse 5
72475 Bitz
Germany
Tel.: [phone] - 9894 - 0
Fax: [phone] - 9894 - 128
e-mail: [e-mail]
http: www.ergoline.com

2 User Manual: xr100+_eng
Cardioline S.p.A. Via Linz,151 38121 Trento (TN) [e-mail] www.cardioline.com
Sales ofce: Via F.lli Bronzetti, 8 20129 Milano (MI) Italy tel.[phone] fax [phone]
xr100+

User Manual: xr100+_eng 3
Cardioline S.p.A. Via Linz,151 38121 Trento (TN) [e-mail] www.cardioline.com
Sales ofce: Via F.lli Bronzetti, 8 20129 Milano (MI) Italy tel.[phone] fax [phone]
xr100+
Contents
1General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
2Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
4Setup and Mains Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
4.1 Controls and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
4.2 Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
4.3 Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
4.4 Connecting the Power Cord . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4.5 Connecting the ECG Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4.6 Connecting ECG Leadwires . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
4.7 Connecting the Blood Pressure Cu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
4.8 Connecting the SpO2 Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
5Preparing the Patient for Blood Pressure Measurements . . . . . . . . . . . . .14
5.1 Cu Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
5.2 Microphone Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
5.3 Applying the Cu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
5.4 Checking the Cu Tubing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
6Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
6.1 Speed Readout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
6.2 Handlebar Adjustment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
6.3 Saddle Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
6.3.1 Motor-Assisted Saddle Adjustment. . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
6.3.2 Mechanical Saddle Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
6.3.3 Saddle Adjustment with Gas Pressure Spring. . . . . . . . . . . . . . . . . . . . . 18
7Control Terminal P . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
7.1 Turning the System On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
7.2 Operating Modes with Control Terminal P . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
7.2.1 PC Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
7.2.2 Ergometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
7.2.3 Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
7.2.4 Settings with Control Terminal P . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
Inhalt
Contents

4 User Manual: xr100+_eng
Cardioline S.p.A. Via Linz,151 38121 Trento (TN) [e-mail] www.cardioline.com
Sales ofce: Via F.lli Bronzetti, 8 20129 Milano (MI) Italy tel.[phone] fax [phone]
xr100+
8Cleaning, Maintenance, Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29
8.1 General Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29
8.1.1 Cleaning the Saddle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
8.1.2 Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
8.2 Cleaning the Blood Pressure Cu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
8.2.1 Removing the Microphone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
8.2.2 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
8.2.3 Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
8.2.4 Inserting the Microphone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
8.3 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
8.3.1 Checks before each use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
8.3.2 Technical Safety Inspections, Inspections of the Measuring System . . . . . 31
8.4 Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
9Technical Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
9.1 Ergometer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
9.2 Blood Pressure Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
9.3 Exercise Test Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
9.4 Family of characteristics of the braking torque control range. . . . . . . . . . . . . . . 35
9.5 Family of characteristics of the load periods according to IEC 60601-1 . . . . . . . . 36
10 Electromagnetic Compatibility EN 60601-1-2 . . . . . . . . . . . . . . . . . .37

User Manual: xr100+_eng 5
Cardioline S.p.A. Via Linz,151 38121 Trento (TN) [e-mail] www.cardioline.com
Sales ofce: Via F.lli Bronzetti, 8 20129 Milano (MI) Italy tel.[phone] fax [phone]
xr100+
1 General Information
• The product xr100+ 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 device 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 within
the limits specied in EN 55011, class B.
• The symbol means: protection class II.
• This manual is an integral part of the device. It should
be available to the device operator at all times. Close
observance of the information given in the manual
isaprerequisite for proper device performance and
correct operation and ensures patient and operator
safety. Please note that information pertinent to sever-
al chapters is given only once. Therefore carefully read
the manual once in its entirety.
• The symbols mean:
Consult accompanying documents.
They indicate points that are of particular importance
in the operation of the device.
• Observance of the safety information protects from
injuries and prevents inappropriate use of the device.
All device 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 working with it. Paragraphs with special sym-
bols are of particular importance.
• If unauthorized individuals open the control terminal,
damaging the calibration sticker, any warranty claim
shall become void.
• This manual reflects the device specifications 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 Field Service Manual.
• The ergoline quality management system complies with
the standard ENISO 13485: 2012.
• The safety information given in this manual is classied
as follows:
Danger
indicates an imminent hazard. If not avoided, the hazard will
result in death or serious injury.
Warning
indicates a hazard. If not avoided, the hazard may result in
minor injury and/or product/property damage.
Caution
indicates a potential hazard. If not avoided, the hazard may
result in minor injury and/or product/property damage.
• 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 accessories from other manufacturers
are used.
• ergoline is responsible for the safety, reliability, and
performance of the device, only if
— modications and repair are carried out by ergoline
GmbH or by an organization expressly authorized
by ergoline GmbH.
— the device is used in accordance with the instruc-
tions given in this operator’s manual.
ergoline GmbH
Lindenstraße 5
72475 Bitz
Germany
Tel.: [phone] - 9894 - 0
Fax: [phone] - 9894 - 128
e-mail: [e-mail]
http: www.ergoline.com

6 User Manual: xr100+_eng
Cardioline S.p.A. Via Linz,151 38121 Trento (TN) [e-mail] www.cardioline.com
Sales ofce: Via F.lli Bronzetti, 8 20129 Milano (MI) Italy tel.[phone] fax [phone]
xr100+
2 Safety Information
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 xr100+ to direct sunlight to prevent system
components from reaching inadmissible high temperatures.
Do NOT use the xr100+ outdoors (medical device). Furthermore
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 power systems, because they may impair equipment func-
tions.
The xr100+ 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.
• 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 instructions)
• 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.
Note
Only the removal of the power cord will result in an all pole
disconnection of the device from mains.
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 must meet the requirements of
the applicable medical systems standards (see 3rd edition of
IEC 60601-1).
Anybody connecting additional equipment to medical electri-
cal equipment congures 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 require-
ments.
If in doubt, please consult your local dealer or ergoline GmbH.

User Manual: xr100+_eng 7
Cardioline S.p.A. Via Linz,151 38121 Trento (TN) [e-mail] www.cardioline.com
Sales ofce: Via F.lli Bronzetti, 8 20129 Milano (MI) Italy tel.[phone] fax [phone]
xr100+
Safety Information for
Non‑Invasive Blood Pressure Measurement
Warning
• Patient Hazard •
Do not take blood pressure measurements with a cuff on
patients suering from sickle cell anemia or if 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 measure-
ments.
Caution
• Compromised Measuring Accuracy •
Arrhythmias occurring frequently during a measurement may
compromise the accuracy of the measurement.
Valid measurements may not be possible under certain circum-
stances.
Electromagnetic elds are also capable of impairing the mea-
suring accuracy.
Note
• If the cuff 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 pre-
caution by abruptly bending your arm while the cu is
being inflated, causing a brief overpressure in the cuff.
Thecu must deate immediately.
• Measurements that do 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 cuff 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 xr100+ is a computer-controlled medical ergometer,
which operates at pedal speeds between 30 and 130 RPM
and loads between 6 and 999 W.
The speed-independent range is shown in section9.4 on
page35.
The xr100+ ergometer may only be used in exercise testing
and for rehabilitation of cardiac and cardiovascular 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 dam-
age 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).
Note – Stability
• Ensure the stability of the ergometer. If the maximum
permitted patient weight is exceeded, the stability of the
ergometer can no longer be guaranteed. It may become
unstable as a result.
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 biocompatibility 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
If you have questions regarding laws, regulations or direc-
tives related to the product, please contact ergoline GmbH.

8 User Manual: xr100+_eng
Cardioline S.p.A. Via Linz,151 38121 Trento (TN) [e-mail] www.cardioline.com
Sales ofce: Via F.lli Bronzetti, 8 20129 Milano (MI) Italy tel.[phone] fax [phone]
xr100+
3 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 protection
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 of
as unsorted municipal waste and must be collected
separately.
Consult Operating Manual!
REF Order number.
SN Serial number.
nächster
Prüftermin
gemäss MPBetreibV
20
21
22
19
18
17
01
02
03
04
05
06
07
08
09
10
11
12
Scheduled date of the next inspection
(e.g., March 2017).
Toggle switch ON (voltage).
Toggle switch OFF (voltage).
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 device: tipping hazard.
Manufacturer’s identication.
Date of manufacture.
The number found under this symbol is the date of
manufacture in the YYYY-MM-DD 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.