201000433000 • Version 2017-01-12 / Rev 01 • English
ergoselect 4 / 5
Ergometer
Operator‘s Manual
201000433000 • Version 2017-01-12 / Rev 01 • English
This manual was written with the utmost care. Should you still nd details that do not correspond
with the system, please letus 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.
• The product ergoselect bears the CE marking CE-0123
(Notied Body: TÜV), indicating its compliance with the
provisions of the Council Directive 93/42/EEC about
medical devices and fullls 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 fullls the requirements of standard
EN 60601-1 “Medical electrical equipment, Part 1:
General Requirements for Safety” as well as the
in terference protection requirements of standard
EN 60601-1-2 “Electromagnetic Compatibility –
Medical Electrical Devices”.
The radio-interference emitted by this product is within
the limits specied 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
isaprerequisite for proper device performance and
correct operation and ensures patient and operator
safety. Please note that information pertinent to several 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 symbols are of particular importance.
• 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 classied
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 specied measuring
accuracy, and interference-free operation, we recommend 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
— modications 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.
• 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 device is not designed for use in areas where an explosion
hazard may occur.
Explosion hazards may result from the use of ammable anesthetics, 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). 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 functions.
The ergoselect may only be used in combination with accessories approved by ergoline GmbH.
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 fulll 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.
• 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 frequently even though the speed is above 30 RPM, this may be
due to electro magnetic interference.
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 equipment must comply with the respective IEC or ISO standards
(e.g., IEC 60950 for data processing equipment).
Furthermore all congurations 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 electrical equipment congures 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, please consult your local dealer or ergoline GmbH.
Safety Information for
Non‑Invasive Blood Pressure Measurement
Warning
• Patient Hazard •
Do not take blood pressure measurements with a cuff on
patients suering 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 measurements .
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 circumstances.
Electromagnetic elds are also capable of impairing the measuring accuracy.
Note
• If the cuff pressure exceeds the maximum value of
300 mmHg during ination, the ination procedure will
be aborted and the cu deated. As a redundant safety
precaution, the cu is immediately deated when the cu
pressure exceeds 320 mmHg.
You can check the proper functioning of this safety precaution by abruptly bending your arm while the cu is being
inated, causing a brief overpressure in the cu. The cu
must deate immediately.
• Measurements that do not yield a valid measurement will
not be repeated during the exercise test.
• If the ination 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 deated.
• If a valid measurement cannot be completed within
120 seconds, the measurement will be aborted and the cu
deated.
• If the cu pressure remains constant for some time, the
measurement will also be aborted and the cu deated.
Intended Use
The ergoselect 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 section11.5 on
page53.
The ergoselect 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
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).
Note ‑ Stability
• Ensure the stability of the ergometer. If the maximum permitted patient weight is exceeded by 10%, 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, fulll the biocompatibility requirements
of the applicable standards if applied as intended.
If you have questions in this matter, please contact ergoline
or a representative.
• EN 1060-1 Non-invasive sphygmomanometers, Part1:
General requirements
• EN 1060-3 Non-invasive sphygmomanometers, Part3:
Supplementary requirements for electro-mechanical
blood pressure measuring systems Symbole
ergoselect 4/5 7
3 Symbols
3 Symbols
Symbol ’type B applied part’.
Type B applied parts have no direct contact with
patients and oer 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!
Order number.
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.
18
17
01
gemäss MPBetreibV
02
03
19
nächster
Prüftermin
04
05
Serial number.
20
21
Scheduled date of the next inspection
22
12
(e.g., March 2017).
11
10
09
08
07
06
Toggle switch ON (voltage).
Toggle switch OFF (voltage).
CE mark per the Medical Device
Directive 93/42/EEC of the European Union.
Notiedbody: TÜV SÜD Product Service GmbH,
Ridlerstr. 65, 80339 München, Germany.
Nationally Recognized Testing Laboratory
NRTL label for the USA and Canada.
Manufacturer’s identication.
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.
8 ergoselect 4/5
4 Setup and Mains Connection
4.1 Controls and Indicators
4 Setup and Mains Connection
1
Control terminal M
2
Speed readout for patient
3
Connectors (e.g., for blood pressure cu, SpO2)
4
Adjustment of handlebar angle
5
Castors
6
Baseplate (small)
7
Leveling feet to adjust the ergometer to uneven oors
8
Sockets for power cord and connection cables
(underside of ergometer)
9
Power switch (toggle switch [I / 0])
10
Saddle adjustment with clamping lever
1
3
2
4
6
5
Figure 4 – 1: ergoselect 4 M
10
9
8
7
1
Control terminal T
2
Speed readout for patient
3
Connectors (e.g., for blood pressure cu, SpO2)
4
Adjustment of handlebar angle
5
Height adjustment for handlebar
(by means of toggle switch, option)
6
Castors
7
Baseplate (large)
8
Leveling feet to adjust the ergometer to uneven oors
9
Sockets for power cord and connection cables
(underside of ergometer)
10
Power switch (toggle switch [I / 0])
11
Saddle adjustment
(optionally with gas pressure spring or motor)
1
3
5
2
4
7
6
Figure 4 – 2: ergoselect 5 T
11
10
9
8
ergoselect 4/5 9
4 Setup and Mains Connection
4.2 Transport
For short distances, the ergometer 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 and the connection cables.
• Rotate the handlebar towards the front and tighten the
clamping lever.
• Stand in front of the ergometer, grasp the handlebar
and tilt the ergometer towards you until it is standing
on the castors only and is balanced.
• It is now possible to transport the ergometer.
• 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.
Figure 4 – 3: Transporting the ergoselect
4.3 Setup
Place the ergometer on a horizontal level oor.
The ergometer must be set up in a secure and stable
position; the two leveling feet at the back make for easy
adjustment to uneven oors. An optional stabilizer plate is
available to enhance the stability.
Extend the foot concerned until the ergometer 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.
Figure 4 – 4: Levelling feet of the ergoselect ergometer
10 ergoselect 4/5
4.4 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 readout towards the patient.
4.5 Connecting the Power Cord
Stand in front of the ergometer (looking at the control
panel) and rmly grasp the handlebar with both hands.
4 Setup and Mains Connection
Figure 4 – 5: Different orientations of the control terminal
Then tilt the ergometer carefully to one side (it is recommended to do this with the help of a second person) and
place it on the oor so that it rests on the handlebar.
Figure 4 – 6: Assembly position
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.
ergoselect 4/5 11
4 Setup and Mains Connection
The connection panel is located on the underside of the
ergometer.
• Connect the power cord to socket (a).
• Using the supplied strain relief, attach the cable to the
metal frame (b).
Return the ergometer carefully to its upright position and
make sure that it is not standing on the power cord.
b
a
Figure 4 – 7: Underside of the Ergometer
b
a
Figure 4 – 8: Connecting the power cord
a Power input
b Strain relief
Note
• Disconnection from Power Supply •
Pressing the power switch or removing the power cord disconnects the device from the power supply.
Removing the power cord results in a complete disconnection
of the device from the power supply (all poles).
Ensure that the power plug is readily accessible at all times.
12 ergoselect 4/5
4.6 Connecting the ECG Cable
The ergometers can be connected to electrocardiographs
and PC-based ECG systems of most manufacturers.
Dierent connection cables are available to support dierent
communication modes (digital, analog, remote start, etc.).
All ergometers are equipped with a digital interface. (Special adapters are needed for analog control or the remote
start capability. Please contact ergoline for these adapters.)
The connection cable is plugged into the 9-pole socket of
the connection panel (Port 1) or the USB port and secured
at the metal frame with an additional strain relief.
4 Setup and Mains Connection
USBPort 1USBPort 1
Figure 4 – 9: Connection to electrocardiograph/PC-based ECG system
USB PC connection via USB (virtual COM)
PORT 1 Digital connection (remote control from
PC or ECG recorder), connection for cable
adapter (analog interface + remote start)
Note
• Connection Cables •
Use only connection cables approved by ergoline.
A special PC driver software, which can be obtained from
ergoline, is required for operation via the USB port.
4.7 Connecting ECG Leadwires
Plug the ECG leadwires (L, R, N) into the appropriate
sockets (1) in the control terminal.
N
L
R
1
Figure 4 – 10: ECG leadwire connections
ergoselect 4/5 13
4 Setup and Mains Connection
4.8 Connecting the Blood Pressure Cu
• Connect the microphone cable for blood pressure measurement to the intended port (2) so that it clicks into
place.
• Slip the cu tubing onto the tting (3) 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, 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 it around the
handle bar.
• Secure the cu tubing with the small Velcro tape, but
do not exert pressure on the tubing.
4.9 Connecting the SpO2 Sensor
Connect the sensor cable to the corresponding socket (4)
on the underside of the control terminal.
2
3
Figure 4 – 11: Blood pressure cuff connections
2 Microphone connection
3 Fitting for connection of cuff tubing
Figure 4 – 12: Velcro tape to secure the cuff tubing
Insert the index nger into the SoftTip sensor. The cable
should run over the back of the hand.
Within a few seconds the current oxygen saturation in
percent (%) will be indicated on the display.
4
Figure 4 – 13: SpO2 sensor connection
4 SpO2 connection
Figure 4 – 14: SpO2 SoftTip
14ergoselect 4/5
5 Preparing the Patient for Blood Pressure Measurements
5 Preparing the Patient for Blood Pressure Measurements
5.1 Cu Size
Always choose the cu size suitable for the patient’s arm.
The maximum arm circumference is indicated on the cu.
Figure 5 – 1: Correct cuff size
When you close the Velcro strap, check that the metal clasp
(a) is inside the marked index range (b), and not outside.
5.2 Microphone Position
Before applying the cu, check the position of the microphone inside the red pocket (on the inside of the cu):
When the microphone is inside the pocket, its metal side must face the arm.
Figure 5 – 2: Wrong cuff size
Figure 5 – 3: Correct microphone position
ergoselect 4/5 15
5 Preparing the Patient for Blood Pressure Measurements
5.3 Applying the Cu
The center of the microphone must be located exactly
on the brachial artery. Locate the artery by palpation,
ifrequired.
The red tab identies the position of the microphone.
The accurate placement of the microphone is the primary
condition for reliable pressure measurement during exercise tests. The cu must be applied directly on the skin,
itmay 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. Make sure that the cu cannot shift when the
patient moves during the exercise test.
The cu tab must be located below the metal clasp (see
illustration at right).
Figure 5 – 4: Microphone placement on the artery
5.4 Checking the Cu 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.
Caution
• Patient Hazard •
Apply the cuff directly on the skin. Make sure that rolled up
sleeves do not impede blood circulation in the upper arm.
Loose cus will cause erroneous measurements; overtight cus
may constrict blood vessels or cause skin lesions and hematomas.
• Incorrect Measurements •
A loose cu would degrade the accuracy of the measurement.
Therefore, the computer aborts the measurement, if a minimum pressure is not attained within a few seconds.
Figure 5 – 5: Correct cuff position (tab)
Figure 5 – 6: Distance between knee and tubing
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
deate correctly.
16 ergoselect 4/5
6 Operation
The ergometer is available with dierent control terminals
which dier to some extent in terms of their functionality.
The following sections describe the control and conguration of the ergometer.
6.1 Speed Readout
A speed readout as well as three LEDs on the control terminal inform the patient of the speed: too slow, too fast
or correct (this readout is located at the top of the P and T
versions of the control terminal and on the side of control
terminal M).
The ranges for the respective speed ratings depend on the
selected load (see chapter11 “Technical Specications” on
page49).
6 Operation
1
2
3
Figure 6 – 1: 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 30RPM,
theload readout starts blinking on the display and the load is
reduced to zero.
6.2 Handlebar Adjustment
Set the handlebar to a position where it is comfortable to
reach while sitting upright.
Fold up the clamping lever to unlock the handlebar.
When the handlebar is in the correct position, fold down
the clamping lever to lock the handlebar and check that the
lever is tightened.
With the ergometer standing rmly, check that the handlebar is tight. Adjust the clamping force of the clamping lever
if necessary.
Adjust the clamping force by opening the clamping lever
and turning the setting screw clockwise about a quarter
revolution with a at-blade screwdriver. Then check the
clamping force. Repeat these steps if necessary. When the
clamping force is appropriate, lock the clamping lever by
folding it down.
1
Figure 6 – 2: Handlebar adjustment
1 Clamping lever
Note
• Lock the clamping levers only as tight as necessary, NOT
with maximum force.
• Lubricate the thread of the saddle clamping lever periodically with a suitable lubricant (e.g., OKS470).
The handlebar is not designed to support the full body
weight.
ergoselect 4/5 17
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