ergoline ergoselect 100 User manual

Manual
ergoselect 100 / 200
Bicycle Ergometer
Operator's Manual
2010000134000 • Version 04/2011 • 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.: [phone] - 0
Fax: [phone] - 128
e-mail: [email protected]
http: www.ergoline.com
Printed in Germany

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Declaration of Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Setup and Mains Connection . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Controls and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Mounting the Control Terminal (P or K) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Connecting the Power Cord . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Connecting the Blood Pressure Cu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Preparing the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Adjusting the Saddle and the Handlebar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Preparing the Patient for Blood Pressure Measurements . . . . . . . . . . . . . . 18
Checking the Cu Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
Control terminal P . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
Turning the System On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Operating Modes with Control Terminal P . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
PC Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Ergometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Settings with Control Terminal P . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Control Terminal K . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Turning the System On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Operating Modes with Control Terminal K . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Speed readout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
PC Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Ergometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Training with Chip Card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Settings for Control Terminals K . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Cleaning, Maintenance, Disposal . . . . . . . . . . . . . . . . . . . . . . . . . 48
Technical Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51
Electromagnetic Compatibility EN 60601-1-2 . . . . . . . . . . . . . . . . . . 55
Contents

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DeClaration of Conformity

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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
within the limits specied in EN 55011, class B.
• 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.
It indicates points which 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 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 Field Service
Manual.
• The ERGOLINE quality management system complies
with the standards ISO 9001: 2000 and EN ISO 13485:
2003.
• The safety information given in this manual is classi‑
ed as follows:
• To ensure patient safety, the specied measuring ac‑
curacy, 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: [phone] - 9894 -0
Fax: [phone]
e-mail: [email protected]
http: www.ergoline.com / www.ergoline.eu
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.

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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 sys-
tem 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 electro magnetic 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 regu-
lations (e.g. safety features)
• must be informed about the potential hazards arising from
the use of this type of equipment.
safety information
Hint
Removing the power cord results in complete disconnection
from mains (all poles)..
Danger
Additional equipment connected to medical electrical
equipment 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 re‑
quirements 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
electrical 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 93142lEEC: Annex I clause 13.6.c

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safety information for
non‑invasive BlooD Pressure
measurement
Warning
• Patient Hazard •
Do not take blood pressure measurements with a cu on
patients 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 measure-
ments.
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 mea-
suring accuracy.
Note
• The blood pressure module and the approved accessories
are debrillation-proof and may remain attached to the
patient during debrillation.
• 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 inju‑
ries or property damage resulting from the unintended use
of the equipment.
BioComPatiBility
The parts of the product described in this manual, includ‑
ing 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
• 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

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Additional equipment connected to medical electrical
equipment 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 re‑
quirements 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
electrical equipment cong ures a medical system and is
therefore responsi ble 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.“
(Standard / directive references:
· 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 93142lEEC: Annex I clause 13.6.c

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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

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levelling feet of the ergoselect ergometer
Caution
• Equipment Damage •
Avoid strong vibrations of the ergoselect during transport.
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 level oor.
The ergoselect must be set up in a secure and stable posi‑
tion ‑ the two levelling feet at the back make for easy
adjustment to uneven oor surfaces. Extend the foot
concerned 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

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mountinG the Control terminal (P or K)
The control terminal can be installed with the display
either facing the patient or the operator.
It is recommended to install the terminal with the display
and control keys towards the operator and the speed
display towards the patient.
ConneCtinG the Power CorD
Set the handlebar to the front upper position and secure.
Tilt the ergoselect carefully towards you until it rests on
the handlebar.
assembly position of the ergoselect ergometer
different orientations of the control terminal
Caution
• Equipment Damage •
Before connecting the ergometer to the power line, check that
the line voltage corresponds to the ratings on the type plate.
The type plate is located on the back of the ergometer, at the
bottom.

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b
a
connection panel
a Power input
b Lock
Hint
• disconnection •
Removing the power cord results in complete disconnection
from mains (all poles).
Danger
• Patient Hazard •
To insure a safe connection to the protective ground system,
power cords of type „hospital only“ or „hospital grade“ have to
be used!
power cord with installed strain relief
The connection panel is located on the underside of the
ergometer.
• Plug the power cord into socket (a) and use the sup‑
plied lock (b) to secure it against disconnection.
• Using the supplied strain relief, attach the cable to the
metal frame.

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Connecting the ECG Cable
ergoselect ergometers can be connected to electrocardio‑
graphs and PC‑based ECG systems of most manufacturers.
Dierent connection cables are available to support dier‑
ent communication modes (digital, analog, remote start,
etc.).
The appropriate cable is plugged into the corresponding
socket on the connection panel (Port 1, USB) and secured
with the strain relief.
Hint
• connecting cables •
Only use connecting cables released by ergoline.
To use the integrated USB connector, a special driver is required
- contact ergoline.
eKg / pc connection
USB PC connection via USB (virtual COM)
PORT 1 Digital connection RS232 (remote control
by PC or ECG recorder,

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ConneCtinG the BlooD Pressure Cuff
• Connect the microphone at (1).
• Slip the cu tubing onto the tting (2) and engage.
To disconnect, push back the connector's knurled
sleeve.
Artifacts that may be caused by patient movements during
the exercise test, must be avoided if possible, while the
blood pressure is being taken.
Therefore, do not forget to attach the cu tubing to the
handlebar with the supplied Velcro tape:
• Open the large Velcro tape and wrap around
handlebar.
• Secure the cu tubing with the small Velcro tape, but
do not exert pressure on the tubing.
transPort
• Disconnect the power cord and the connection cables.
• Stand in front of the ergometer, grasp the handlebar
and tilt the ergometer towards you until it is standing
on the castors only and balanced.
• When you have reached the new location, lower the
ergometer very carefully to avoid damage.
Caution
• Equipment Damage •
Avoid strong vibrations of the ergometer during transport.
blood pressure cuff connections
1 Microphone connection
2 Cu tubing
velcro tape to secure the cuff tubing

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PreParinG the Patient
aDjustinG the saDDle anD the hanDleBar
On the ergoselect 100, you adjust the saddle height manu‑
ally with a clamping lever. On the ergoselect 200, the
saddle height is electrically adjusted with the correspond‑
ing keys on the control terminal (the display below the
saddle indicates the saddle height).
With the pedal in the bottom position, the angle between
the axis formed by the upper body and the thigh should be
approximately 10°.
Set the handlebar to a position where the patient sitting
upright on the saddle can reach it easily.
To do so, open clamping lever 1 and set the handlebar to a
suitable angle.
On the ergoselect 200, the height of the handlebar can ad‑
ditionally be adjusted with clamping lever 2 ‑ the horizon‑
tal bar should be approximately at the samel level as the
saddle.
adjusting saddle and handlebar
1 Adjustment of the handlebar angle
2 Adjustment of the handlebar height
(ergoselect 200 only)
3 Adjustment of the saddle height (ergoselect 100 only)
4 Saddle height display (ergoselect 200 only)
Note
• Tighten the clamping levers only as far as necessary, NOT
with maximum force.
• Lubricate the clamping lever threads quarterly at minimum,
using a suitable lubricant (e.g. OKS470).

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PreParinG the Patient for BlooD
Pressure measurements
Cuff size
Always choose the cu size suitable for the patient's arm.
The maximum arm circumference is indicated on the cu.
miCroPhone Position
Before applying the cu, check the position of the micro‑
phone inside the red pocket (on the inside of the cu):
When the microphone is inside the pocket, its metal side
must face the arm.
aPPlyinG the Cuff
The center of the microphone must be located exactly
on the brachial artery. Locate the artery by palpation, if
required. The red tab identies the position of the micro‑
phone.
The accurate placement of the microphone is the primary
condition for reliable pressure measurement during exer‑
cise tests.
The cu must be applied directly on the skin, it may not
be applied on top of clothing, paper, etc. Apply the cu
approx. 2 cm above the bend of the elbow. The cu
should be tight, but it should not constrict blood vessels.
The cu may not move during the exercise test.
correct microphone position
wrong cuff size
microphone placement on the artery
correct cuff size

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correct cuff position (tab)
Caution
• Patient Hazard •
Apply the cu directly on the skin. Make sure that rolled up
sleeves do not impede blood circulation in the upper arm.
Loose cus will cause erroneous measurements; overtight cus
may constrict blood vessels or cause skin lesions and hemato-
mas.
• Incorrect Measurements •
A loose cu would degrade the accuracy of the measurement.
Therefore, the computer aborts the measurement, if a mini-
mum pressure is not attained within a few seconds.
Warning
• Patient Hazard •
If, by accident, an excessive pressure builds up inside the cu ,
either remove the cu immediately from the arm or disconnect
the cu tubing from the control terminal.
The same measures are recommended, if the cu does not
deate correctly.
When you close the Velcro strap, check that the metal
clasp (a) is inside the marked index range (b), and not
outside.
The cu tab must be located below the metal clasp (see
illustration at right).
CheCKinG the Cuff tuBinG
Check that the cu tubing does not knock against the
patient's knee, when the patient is pedalling and the hand
is on the handlebar.
Secure the cu tubing with the Velcro tape attached to the
handlebar.
Instruct your patient to move as little as possible during
a blood pressure measurement and, in particular, to avoid
excessive contractions of the muscles in the upper arm.
distance between Knee and tubing

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