ergoline ergoselect 50 User manual

Manual
ergoselect 50
Bicycle Ergometer
Operator's Manual
201000147000 • Version 03/2010 • 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
Mounting the Control Terminal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Connecting the Power Cord . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Connecting the ECG Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Preparing the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Adjusting the Saddle and the Handlebar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Operation Control terminal P . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Turning the System On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Operating Modes with Control Terminal P . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
PC Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Ergometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Settings with Control Terminal P . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Cleaning, Maintenance, Disposal . . . . . . . . . . . . . . . . . . . . . . . . . 29
Technical Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
Electromagnetic Compatibility EN 60601-1-2 . . . . . . . . . . . . . . . . . . 35
Contents

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- 5 -
DeClaration of Conformity

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- 7 -
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 symbol means:
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)..

- 9 -
intenDeD Use
The optibike is a computer‑controlled medical ergometer.
At pedal speeds between 30 and 130 RPM and loads
between 6 and 400 watt, the ergometer operates
independent of the pedal speed.
The speed‑independent range is shown in the Appendix
(Technical Specications).
The optibike ergometer may only be used in exercise test‑
ing as well as for rehabilitation of cardiac and cardiovas‑
cular 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.
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)

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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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4
6
1
2
3
5
8
7
setUp anD mains ConneCtion
Controls anD inDiCators
1 Control terminal model P
2 Adjustment of the handlebar angle
3 Castors
4 Speed display (RPM) for patient
5 Adjustment of the saddle height
6 Power switch (green button)
7 Levelling devices to adjust the ergometer to uneven
oors
8 Sockets for power cord and connection cables
(underside of ergometer)
ergoselect 50 - controls, connections and indicators

- 12 -
Caution
• Equipment Damage •
Avoid strong vibrations of the ergoselect 50 during transport.
moUntinG the Control terminal
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.
transport
For short distances, the ergoselect 50 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 50, grasp the handle‑
bar and tilt the ergoselect 50 towards you until it is
standing on the castors only and is balanced.
• It is now possible to transport the ergoselect 50.
• When you have reached the new location, lower the
ergoselect 50 very carefully to avoid damage.
transporting the ergoselect 50
Mounting options for control terMinal

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setUp
Place the ergoselect 50 on a level oor.
The ergoselect 50 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 50 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.
The ergometer can be transported by means of the 2 front
castors.
ConneCtinG the power CorD
• Rotate the handlebar towards the front.
• Tilt the ergometer carefully towards you all the way
until it rests on the handlebar.
levelling feet of the ergoselect 50 ergoMeter
asseMbly position of the ergoselect 50 ergoMeter

- 14 -
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!
Note
• Disconnection from Mains •
Removing the power cord results in complete disconnection
from mains (all poles).
• Plug in the power cord on the underside of the
ergometer.
• Guide the power cord under the strain relief and screw
the strain relief to the frame: the plastic pin must lock
into place in the boring provided.
• Put the ergometer back on its feet and set the handle‑
bar to the correct position.
• Connect the power cord to a wall outlet.
power cord with installed strain relief
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.

- 15 -
Hint
• connecting cables •
Only use connecting cables released by ergoline.
Use of the USB connection requires a special PC driver software
(available from ergoline).
ecg / pc-ecg connection
USB PC connection via USB (virtual COMx)
PORT 1 Digital interface connector
(remote control through PC or ECG)
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, Port 3 or Analog)
and secured with the strain relief.

- 16 -
preparinG the patient
aDjUstinG the saDDle anD the hanDleBar
On the ergoselect 50, you adjust the saddle height manu‑
ally with a clamping lever.
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.
adjusting saddle and handlebar
1 Adjustment of the handlebar angle
2 Adjustment of the saddle height
Note
• Tighten the clamping levers only as far as necessary, NOT
with maximum force.
• Lubricate the clamping lever threads quarterly at mini-
mum, using a suitable lubricant (e.g. OKS470).

- 17 -
ergoline
GmbH
 
ergoline
GmbH
operation Control terminal p
tUrninG the system on
You turn the ergometer on by pressing the power switch ‑
the green indicator in the switch lights up.
The ergometer runs a self‑test. Subsequently, the main
menu displays.
Control terminal P
Note
• Instruct the patient not to pedal while the ergometer is
being turned on and during the self-test.
• Apply the blood pressure cu to the patient AFTER the er-
gometer has been turned on and the self-test completed.
• The device can be congured to default to one of the
operating modes.
If this option is selected, the initial screen of the selected
operating mode (e.g. Ergometry) will be displayed instead
of the main menu.
With the key, you can display the main menu.
• If an error message (e.g. E:01) appears immediately after
the self-test, please refer to the "Troubleshooting" section
for advice.
self-test screen
 Selftestrunning
Main Menu
PCMode
Ergometry
Manual
Settings
 Select
The ergometer software is controlled with 5 keys:
With this key you display the main menu or
return to the previous menu level.
With this key you initiate a blood pressure mea‑
surement. A measurement in progress can be aborted with
the same key.
The functions of these three softkeys
change with the displayed menu ‑ the key label describing
the function is shown on the display.
Keypad p

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operatinG moDes with Control terminal
p
An ergoselect ergometer with a control terminal P sup‑
ports the following operating modes:
PC MODE
An external device (e.g. stand‑alone electrocardio‑
graph, PC‑based ECG system) controls the ergometer ‑
no intervention at all is required at the ergometer.
ERGOMETRY
The ergometer runs an automatic exercise test ‑ some
of the corresponding test protocols are user‑congu‑
rable and stored in the system (see chapter "Settings").
MANUAL
The ergometer is controlled manually, i.e., the user
performs all load changes via the keypad.
SETTINGS
Used to congure the ergometer.
speeD reaDoUt
At the top of the control terminal, there is a speed readout
for the patient as well as three LEDs that inform the
patient of the speed: too slow, too fast or correct.
The ranges for the respective speed ratings depend on the
selected load (see "Technical Specications"). speed readout
1 speed low (patient should pedal faster)
2 correct speed
3 speed high (= patient should pedal slower)
Note
• If, during an exercise test, the speed drops below 30 RPM,
the load readout starts blinking on the display.
• To reactivate the saddle height adjustment function, press
and the arrow keys will again be displayed.
• Additional blood pressure measurements an be initiated
with .

- 19 -
↑  ↓
 
PCMode
Ergometry
Manual
Settings
 Select
 Saddle
Main Menu
initial screen
pC moDe
Use the softkeys on the right and left (↑↓) to position the
bar cursor on PC MODE and conrm the selection with
SELECT.
The display changes ‑ the ergometer is waiting for com‑
mands from the external ECG unit.
With the arrrow keys, the saddle height can be electrically
adjusted on the ergoselect 200 (on the ergoselect 400,
these keys adjust the height of the drive unit).
As soon as the ergometer receives commands from the
controlling ECG unit or PC, the exercise test will start and
the corresponding values will be displayed.
The exercise test can only be terminated with the corre‑
sponding command from the controlling ECG unit.
Note
• All functions are locked while the ergometer is operating
in PC mode, except for the saddle height adjustment and
the blood pressure key .
• To reactivate the saddle height adjustment function, press
and the arrow keys will again be displayed.
• Additional blood pressure measurements can be initiated
with .
 PCMode
display during exercise test
1 current load in watts
2 most recent BP value (systolic/diastolic values) or cu
pressure during ination
3 duration of exercise test (min)
4 heart rate at the time of the BP measurement (BPM)
5 pedal speed (RPM)

- 20 -
 
 
+5W  -5W
erGometry
Use the softkeys on the right and left (↑↓) to position the
bar cursor on ERGOMETRY and conrm the selection with
SELECT.
The stored test protocols available for selection will be
displayed. There are ve xed protocols (protocols 1 to
5, see Appendix) , whereas protocols 6 to 15 are user‑
programmable.
The protocol menu provides an overview of the test
phases:
e.g.: 50 W / 2 min / 25 W
means: initial (basic) load 50 watts
stage time 2 minutes
load increment 25 watts
Use the softkeys on the right and left (↑↓) to position the
bar cursor on one of the protocols and conrm the selec‑
tion with SELECT.
The exercise test is started with the "Start" key, a blood
pressure measurement at rest may precede the test (see
"Settings").
When the basic load appears on the display (after approx.
15 seconds or upon termination of the blood pressure
measurement) and the patient's RPM indicator blinks, the
patient should start pedalling.
The internal protocol will now control the entire exercise
test ‑ the display always indicates the current values.
With the +5 W and ‑5 W keys, the current load can be
changed at any time (in increments of +/‑1 W up to
+/‑25 W, as congured).
screen display during the test
PCMode
Ergometry
Manual
Settings
 Select
Protocols
1.WHO
2.BAL
3.Hollmann
4.STD.France
5.Standard
 Select
Main Menu
selecting an exercise test protocol
initial exercise test screen
 Start
 Recovery