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ergoselect 4
Operator's Manual
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ergoline ergoselect 4, ergoselect 5 Operator's Manual

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ergoselect 4 / 5
Ergometer
Operator‘s Manual
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 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.: +49-(0)-7431 - 9894 - 0 Fax: +49-(0)-7431 - 9894 - 128 e-mail: info@ergoline.com http: www.ergoline.com
ergoselect 4 / 5 1
2 ergoselect 4 / 5

Contents

Contents
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1
2 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
4 Setup and Mains Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
4.1 Controls and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
4.2 Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
4.3 Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
4.4 Mounting the Control Terminal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4.5 Connecting the Power Cord . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4.6 Connecting the ECG Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
4.7 Connecting ECG Leadwires . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
4.8 Connecting the Blood Pressure Cu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
4.9 Connecting the SpO2 Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
5 Preparing the Patient for Blood Pressure Measurements . . . . . . . . . . . . .15
5.1 Cu Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
5.2 Microphone Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
5.3 Applying the Cu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
5.4 Checking the Cu Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
6 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
6.1 Speed Readout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
6.2 Handlebar Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
6.3 Saddle Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
7 Control Terminal M . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
7.1 Turning the System On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
7.2 Operating Mode with Control Terminal M . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
8 Control Terminal P . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
8.1 Turning the System On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
8.2 Operating Modes with Control Terminal P . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
8.2.1 PC Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
8.2.2 Ergometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
8.2.3 Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
8.2.4 Settings with Control Terminal P . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
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9 Control Terminal T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
9.1 Turning the System On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
9.2 Operating Modes with Control Terminal T . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
9.2.1 PC Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
9.2.2 Ergometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
9.2. 3 Training / Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
9.2.4 Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
9.2.5 Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
10 Cleaning, Maintenance, Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46
10.1 General Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46
10.1.1 Cleaning the Saddle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
10.1.2 Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
10.2 Cleaning the Blood Pressure Cu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
10.2.1 Removing the Microphone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47
10.2.2 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
10.2.3 Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
10.2.4 Inserting the Microphone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
10.3 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
10.3.1 Checks before each use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
10.3.2 Technical Safety Inspections, Inspections of the Measuring System . . . 48
10.4 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
11 Technical Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
11.1 Ergometer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
11.2 Blood Pressure Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
11.3 Exercise Test Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52
11.4 Test Protocols (control terminal T only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
11.5 Family of characteristics of the braking torque control range . . . . . . . . . . . .53
11.6 Family of characteristics of the load periods according to IEC 60601-1 . . . . . . 53
12 Electromagnetic Compatibility EN 60601-1-2 . . . . . . . . . . . . . . . . . . . .54
4 ergoselect 4 / 5

1 General Information

1 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 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 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 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 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 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 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 — 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.
• 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.
ergoselect 4/5 5
ergoline GmbH Lindenstraße 5 72475 Bit z 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

2 Safety Information

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 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 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.
• 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 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 electri­cal 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 require­ments .
If in doubt, please consult your local dealer or ergoline GmbH.
• 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
6 ergoselect 4/5
2 Safety Information
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 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 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 precau­tion 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 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 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, 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11.5 on page53.
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, 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 Symbole
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3 Symbols

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!
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. Notiedbody: TÜV SÜD Product Service GmbH, Ridlerstr. 65, 80339 München, Germany.
Nationally Recognized Testing Laboratory NRTL label for the USA and Canada.
Manufacturer’s identication.
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.
Dierent connection cables are available to support dierent 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
USB Port 1USB Port 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
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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
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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, ifrequired. The red tab identies 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, 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. 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 cus will cause erroneous measurements; overtight cus 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 deate correctly.
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6 Operation

The ergometer is available with dierent control terminals which dier to some extent in terms of their functionality.
The following sections describe the control and congura­tion 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 chapter11 “Technical Specications” on page49).
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 30RPM, theload 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.
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6 Operation
Optionally, the height of the handlebar can be adjusted by means of a motor, that is controlled via the toggle switch on the handlebar.

6.3 Saddle Adjustment

Figure 6 – 3: Toggle switch for adjusting the height of the
handlebar
On the dierent ergometer models, the saddle height is adjusted in dierent ways:
— with a clamping lever (mechanical) — with a gas pressure spring — with a motor.
When adjusting the height at the display, press the appro­priate arrow key on the right to raise or lower the saddle. The RPM display shows the actual saddle hight.
Note
Press the [Saddle] or the key to enable the adjustment of the saddle: the adjustment keys will be displayed (or via the
and buttons on the control terminal).
1 2
Saddle
0
Figure 6 – 4: Saddle adjustment at the control terminal 1 Saddle up 2 Saddle down
1
Figure 6 – 5: Saddle adjustment at the display 1 Saddle up
2
2 Saddle down
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7 Control Terminal M

7.1 Turning the System On

You turn the ergometer on by pressing the power switch. The ergometer runs a self-test. Subsequently, the start screen displays.
7 Control Terminal M
Figure 7 – 1: Control Terminal Type „M“
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 ergometer has been turned on and the self-test completed.
Control terminals M are entirely operated by remote control (e.g., from an ECG recorder or a PC).
With this key you initiate a blood pressure measure­ment. Pressing the key a second time during a measure­ment will stop the measurement.
Figure 7 – 2: Start screen

7.2 Operating Mode with Control Terminal M

Ergometers with the control terminal M support the fol­lowing operating mode:
PC Mode
An external device (e.g., an ECG recorder, a PC-based ECG system) controls the ergometer – no intervention at all is required at the ergometer.
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7 Control Terminal M
The display changes – the ergometer is waiting for com­mands from the external ECG 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 corre­sponding command from the controlling ECG unit.
Figure 7 – 3: Start screen
Note
• During an exercise test, the saddle height can be adjusted with
and .
Figure 7 – 4: Display during exercise test 1
1 current load in watts 2 most recent BP value (systolic/diastolic values or cuff pressure during inflation and bar graph indicating microphone signal strength (see below) 3 duration of exercise test (min) 4 heart rate at the time of the BP measurement (BPM) 5 pedal speed (RPM)
Figure 7 – 5: Display during exercise test 2
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8 Control Terminal P

8.1 Turning the System On

You turn on the ergometer by pressing the power switch (toggle switch [I / 0] ). The ergometer runs a self-test. Subsequently, the main menu displays.
8 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 ergometer has been turned on and the self-test completed.
• The device can be configured to default to one of the operating modes. If this option is selected, the start screen of the selected operating mode (e.g., Ergometry) will be displayed instead of the main menu. With the
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 measure­ment. A measurement in progress can be aborted with the same key.
key, you can display the main menu.
Figure 8 – 1: Control Terminal P
Figure 8 – 2: Main Menu
The functions of these three softkeys chan ge with the displayed menu – the key label describing the function is shown on the display.
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Figure 8 – 3: Keypad P
8 Control Terminal P

8.2 Operating Modes with Control Terminal P

Ergometers with control terminal P support the following operating modes:
PC Mode
An external device (e.g., an ECG recorder, a 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gurable and stored in the system. (see chapter8.2.4 “Settings with Control Terminal P” on page26)
Manual The ergometer is controlled manually, i.e., the user per­forms all load changes via the keypad.
Settings Used to congure the ergometer.

8. 2.1 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 com­mands from the external ECG unit.
Figure 8 – 4: Main Menu
Figure 8 – 5: Start screen
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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 corre­sponding command from the controlling ECG unit.
8 Control Terminal P
Figure 8 – 6: Display during exercise test 1
1 current load in watts 2 most recent BP value (systolic/diastolic values) or cuff pressure during inflation and bar graph indicating microphone signal strength (see below) 3 duration of exercise test (min) 4 heart rate at the time of the BP measurement (BPM) 5 pedal speed (RPM)
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
.

8.2.2 Ergometry

Use the softkeys on the right and on the left (↑↓) to position the bar cursor on Ergometry and conrm the selection with Select.
Figure 8 – 7: Display during exercise test 2
Figure 8 – 8: Main Menu
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8 Control Terminal P
The stored test protocols available for selection will be displayed. There are ve xed protocols (protocols 1 – 5, see chapter11.3 “Exercise Test Protocols” on page52), whereas protocols 6 – 15 are user-pro grammable.
The protocol menu provides an overview of the test phases. Example: 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 selec­tion with Select.
The exercise test is started with the “Start” key, a blood pressure measurement at rest may precede the test (depending on selected ergometry protocol).
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.
Figure 8 – 9: Selecting an exercise test protocol
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 (in increments of +/–1 W up to +/–25 W, as con­gured).
Note
• The saddle height can be adjusted during an exercise test.
• To activate the saddle height adjustment, press thearrow keys will be displayed then.
• Additional blood pressure measurements can be initiated with
.
:
Figure 8 – 10: Initial exercise test screen
Figure 8 – 11: Screen display during the test
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Terminating an Exercise Test
The exercise phase can be terminated manually at any time with the Recovery key.
The load will immediately be reduced to 25 watts, but a higher or lower value can be selected manually.
It is recommended that the patient continue to pedal in the recovery phase.
The End key in the middle will terminate the test. Figure 8 – 12: Recovery phase

8.2.3 Manual

Use the softkeys on the right and left (↑↓) to position the bar cursor on Manual and conrm the selection with Select.
8 Control Terminal P
In this operating mode the user controls the entire exercise test by selecting the loads, stage times and by initiating blood pressure measurements.
The exercise test is started with the “Start” key, afterwards the load can be set and changed with the +5 W and –5 W keys (in increments of +/–1 W up to +/–25 W, as congured).
Blood pressure measurements can be initiated with .
Terminating an Exercise Test
The exercise test can be terminated manually at any time with the End key located in the middle.
The load will immediately drop to 0 watt.
Figure 8 – 13: Main menu
Figure 8 – 14: Initial screen of a manual exercise test
There is no recovery phase in the manual mode.
Figure 8 – 15: Screen display during the test
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8 Control Terminal P

8.2.4 Settings with Control Terminal P

Some of the device settings are congurable to meet spe­cic requirements. The settings will be saved and remain stored even when the ergometer is switched o.
Use the softkeys on the right and left (↑↓) to position the bar cursor on Settings and confirm the selection with Select. The conguration menu displays.
When all changes have been made, you can exit the con­guration menu with the key.
Use the softkeys on the right and left (↑↓) to position the bar cursor on the parameter to change and conrm the selection with Select.
Default Mode
In this menu you choose the default mode activated when the ergometer is turned on. When rst turned on after delivery, the ergometer will display this menu.
Use the softkeys on the right and left (↑↓) to position the bar cursor on your preferred default mode and save the selection with Select.
Figure 8 – 16: Main Menu
Figure 8 – 17: Settings Menu
Figure 8 – 18: Selecting the default mode
Protocols
Protocols 6 – 15 are user-programmable (protocols 1 – 5 are xed, see chapter11.3 “Exercise Test Protocols” on page52 for protocol parameter details). Default values can be entered for the following parameters:
— protocol type (Step/Ramp) — basic load — stage time — load stage (load increase with each stage)
Figure 8 – 19: Selecting the exercise test protocol to edit
Use the softkeys on the right and left (↑↓) to position the bar cursor on the protocol to change (No. 6 – 15) and conrm the selection with Select.
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Use the right and left softkeys (↑↓) to select the parameter to edit.
At Select, for example, you can choose the protocol type:
— Step (load increase in steps) or — Ramp (continuous load increase).
Press Select to save the selected protocol type.
To cancel the selection, press the
All other parameters are edited in the same way.
Using the arrow keys (↑↓), highlight a parameter and conrm the selection with Select: the corresponding value appears in reverse video and can be changed with the arrow keys ↑↓.
Pressing Select will save the new value. You exit the conguration with .
key.
8 Control Terminal P
Figure 8 – 20: Selecting the parameter to edit
Figure 8 – 21: Editing the parameter value
Contrast
The display contrast is adjustable in the range from 0 to 100%.
Load Change
Here you determine the increments for each load change. Depending on your choice, each key press will change the load by +/– 1, 5, 10 und 25 Watts.
Figure 8 – 22: Adjusting the display contrast
Figure 8 – 23: Selecting the increment for manual load changes
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8 Control Terminal P
Language
The texts can be displayed in dierent languages.
Beep
The audio signal emitted during blood pressure measure­ments can be turned on and o.
Figure 8 – 24: Language menu
Software Version
Select this option to view the installed software version.
Date / Time
To begin with, you select Date and conrm the selection. Then the value displayed in reverse video can be edited with the ↑ ↓ keys and saved with Select.
The time is adjusted in the same way. You exit the conguration with .
Figure 8 – 25: Beep during BP measurements
Figure 8 – 26: Setting the date
Figure 8 – 27: Setting the day
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EKG Type
The selected EKG Type determines the communication method with the ECG recorder, PC-based ECG system, etc.
To prevent an accidental change of this setting, the menu is protected with a password. Using the arrow keys, enter 003 and conrm the entry with Select.
All ergometers support the following communication modes:
• Analog with pulse Remote start mode; before advancing to the next load level, the ergometer generates a control pulse and sends the corresponding data via the interface.
8 Control Terminal P
Figure 8 – 28: Entering the EKG Type password
• Analo g / Digital An analog voltage controls the load – blood pressure measurements can be initiated with digital commands.
• Digital (default) The communication with the ergo meter is entirely controlled with digital commands.
• Analog IN-OUT The entire communication (load control and BP mea­surements) is controlled with analog signals. No digital data will be sent.
Select the communication mode and conrm with Select.
Note
• The EKG Type needs to be selected only when the ergometer is connected to an ECG unit. The selection is part of the installation procedure.
• The “Analog/Digital” and “Digital” communication is only possible when PC Mode is selected from the main menu or when this is the default mode.
Figure 8 – 29: Selecting the ergometer communication mode
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8 Control Terminal P
RPM
Here you determine the RPM limits. When these limits are exceeded, the LEDs for high or low speed (RPM) will illuminate.
Select the value to change (Min. or Max.) and conrm with Select.
Using the arrow keys, change the value and save the new value with Select.
Note
The limits selected in this menu only apply to the load range between 6 and 150 watts. At higher loads the RPM limits auto­matically adapt to the respective loads:
Load (watts) Green RPM range (1/min)
6 – 150 54 – 64 (adjustable) 151 – 250 58 – 65 251 – 350 68 – 75 351 – 450 78 – 85 451 – 550 88 – 95 551 – 650 98 – 105 651 – 750 108 – 115 751 – 850 118 – 125 851 – 950 >125 951 – 999 >130
Figure 8 – 30: Setting the RPM limit values
Pulse Display
The pulse readout on the display can be turned o.
Figure 8 – 31: Setting the Pulse Display
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9 Control Terminal T

9.1 Turning the System On

You turn on the ergometer by pressing the power switch (toggle switch [I / 0] ).
Note
• Instruct the patient not to pedal while the ergometer is being turned on and during the self-test.
• Apply the blood pressure cuff to the patient AFTER the ergometer 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 start screen of the selected operating mode (e.g., Ergometry) will be displayed instead of the main menu.
9 Control Terminal T
The ergometer runs a self-test. Subsequently, the main menu displays.
The ergometer software is controlled from the touch panel.
Figure 9 – 1: Control Terminal T
Figure 9 – 2: Self-test screen
Figure 9 – 3: Main Menu
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9 Control Terminal T

9.2 Operating Modes with Control Terminal T

Ergometers with control terminal T support the following operating modes:
PC Mode
An external device (e.g., an ECG recorder, a PC-based ECG system) controls the ergometer – no intervention at all is required at the ergometer. Figure 9 – 4: Operating mode „PC Mode“
Ergometry The ergometer runs an automatic exercise test – the available protocols (5 precongured, editable protocols and 5 user­congurable protocols) are saved in the ergometer (see chapter “Settings” on page34).
Training / Test Ten user-congurable training/test protocols are available (see chapter9.2.3 “Training / Test” on page36). A POLAR receiver is integrated in the ergometer and pro­vides the relevant data for heart-rate controlled training sessions. The test subject’s performance can be assessed on the basis of these protocols.
Figure 9 – 5: Operating mode „Ergometry“
Figure 9 – 6: Operating mode „Training / Test“
Manual The ergometer is controlled manually, i.e., the user per­forms all load changes via the touch panel.
Setup Used to congure the ergometer.
Figure 9 – 7: Operating mode „Manual“
Figure 9 – 8: Operating mode „Setup“
32 ergoselect 4/5
9.2.1 PC Mode
When the [PC Mode] key has been pressed, the screen appears as shown at right. The ergometer is waiting for commands from the external ECG 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 display shows heart rate (1/min), blood pressure (mmHG), oxygen saturation in percent (%), duration of the exercise test (min:ss), pedal speed (1/min) and current load (W).
9 Control Terminal T
The exercise test can only be terminated with the corre­sponding command from the controlling ECG unit.
A blood pressure measurement can be initiated with the [RR] key. Pressing the [RR] key a second time during a measurement will stop the measurement.
When you press the [ECG] key, the display will change. Theacquired, electrical signals will be displayed. The amplitude (gain) can be adjusted with the arrow keys [ ] and [ ].
The pump for the electrode suction system can be switched on and o with the [I / 0] key.
You can change the vacuum intensity between low, medi­um and high by touching the [I] key.
To switch off the pump, press the [0] key for about 3seconds.
Conrm all inputs with the [ ] key.
Figure 9 – 9: PC mode screen
Figure 9 – 10: ECG screen
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9 Control Terminal T

9.2.2 Ergometry

Pressing the [Ergometry] key in the main menu activates the ergometry mode.
The dierent exercise test protocols will be displayed (5pre­congured, editable and 10user-congurable protocols).
All exercise test protocols (including the 5 precongured protocols) are editable.
Figure 9 – 11: Ergometry Menu
Settings
When you touch a protocol, the dierent parameters will be displayed.
With the [Edit] key, you can modify each protocol para­meter. The new inputs overwrite the existing values.
All protocols can be edited during operation (except for the PC mode).
User-programmed protocols must be saved with the [Setup] key in the main menu.
In the conguration menu, the following parameters can be edited:
• the basic load (from 6 to 100 W),
• the stage time (form 1 to 30 min),
• the stage rate (increment, from 1 to 400 W).
Figure 9 – 12: Exercise test protocol 1
Figure 9 – 13: Exercise test protocol 2
34 ergoselect 4/5
With the [  2.] key, you proceed to the next menu level where you can edit these parameters:
• the recovery load (from 6 to 100 W) and
• the recovery time (from 1 to 30 min).
With the [ 1.] key, you return to the previous screen.
Touch the light gray eld, e.g., at Basic Load: a submenu with input eld and numeric keypad opens. You can enter numeric values directly via the keypad.
Conrm your inputs with the [ ] key. To cancel the input, press the [ ] key.
9 Control Terminal T
Figure 9 – 14: Basic load of the exercise test 1
The other parameters can be edited in the same way, they will overwrite the current values.
Figure 9 – 15: Basic load of the exercise test 2
When you touch the [ ] key again after conrming, the display will change. Touching the [Start] key on the display will initiate the training session. The session is entirely controlled by the protocol. The display indicates the current values.
When you press the [const.] key, the current load will be maintained for the rest of the session.
To change the load, press the [+ 5 W] and [– 5 W] keys (the increments can be congured from +/– 1 W up to +/– 25 W as needed). See section9.2.5 “Setup with Control Terminal”, section “Load Change” on page41. Figure 9 – 16: Starting an exercise test
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9 Control Terminal T
Terminating the Program
Once the full protocol has been completed, it terminates automatically.
The program can be terminated manually before the end of the protocol with [Stop]. First, you enter the recovery phase.
When you touch [Stop] again, the training will be termi­nated.
Figure 9 – 17: Terminating an exercise test 1

9.2.3 Train ing / Test

Ten dierent protocols are available in the Training/Test menu.
To edit the protocol parameters, rst touch the Training/ Test protocol you want to edit.
Figure 9 – 18: Terminating an exercise test 2
Figure 9 – 19: Training/Test setup
36 ergoselect 4/5
Then press the [Edit] key.
The individual parameters (light gray elds) can now be edited by touching the display or by repeatedly tapping [ ]. If you need to input characters (numbers or letters), an (alpha-) numeric keypad will be displayed.
The options for Type are [Pulse ], [Constant ], [Interval ], [Ramp Test ], [PWC Test 1 ], [PWC Test 2 ], [PWC Test 3 ] and [Inactive ]. You scroll through the Type options by tapping the [ ] key. Congure the parameters as required by the selected type.
9 Control Terminal T
Figure 9 – 20: Modify Training/Test
With the [ ] key (arrow down, [  2.] or [  3.]), you access the next menu level where more parameters can be congured. With the [ ] key (arrow up, [  1.] or [  2.], you return to the previous screen.
Inputs are conrmed with the [ ] key.
Figure 9 – 21: Modify parameters 1
Figure 9 – 22: Modify parameters 2
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9 Control Terminal T

9.2.4 Manual

In this operating mode the user has complete control over the ergometer and initiates blood pressure measurements.
Pressing the [Start] key initiates the exercise test, the [+ 5 W] and [– 5 W] keys are used to control the load. Theincrements for the load change can be dened in the setup menu.
A blood pressure measurement is initiated with the [RR] key.
Figure 9 – 23: Starting a manual test
Terminating an Exercise Test
The exercise test can be terminated manually at any time with the [Stop] key.
The load will immediately drop to 0 watt.
There is no recovery phase in the manual mode.
9.2.5 Setup
The [Setup] key opens the conguration menu where various program functions can be dened.
To access a menu, touch the corresponding key on the display.
Figure 9 – 24: Terminating a manual test
Conrm inputs with the [ ] key and exit menus with the [ ] key.
Figure 9 – 25: Setup menu
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Default Mode
Select the operating mode to be activated when the ergometer is turned on:
• PC Mode
• Ergometry
• Training/Test
• Manual
Conrm the selection with the [ ] key.
Protocols
The 5 ve exercise test protocols (WHO, BAL, Hollm, Std Fr and Standard) are precongured, but all protocols in the list are editable.
9 Control Terminal T
Figure 9 – 26: Default mode setup
To reach the level for editing of the individual protocol parameters, rst touch the protocol that you want to modify (e.g., [5. Program 6]), and then touch the [Edit] key.
To change the name of a protocol, touch the name and enter the new name from the keypad. Conrm your inputs with the [ ] key.
Figure 9 – 27: Protocol configuration 1
Figure 9 – 28: Protocol configuration 2
Figure 9 – 29: Protocol configuration 3
ergoselect 4/5 39
9 Control Terminal T
At Type, you can choose [Step ], [Ramp ] or [Inactive ]. You scroll through the Type options with the [ ] key.
When choosing the Step type (load increase in steps), dene the basic load (from 6 to 100 W), the stage time (from 1 to 30min) and the stage rate (increment, from 1 to 400 W). When choosing the Ramp type (continuous load increase), define the basic load (from 6 to 100 W) and the load increase (from 1 to 50 W).
To congure the protocol parameters (light gray elds), touch one of the parameters. Edit the parameter as appropriate and conrm the modi­cation with the [ ] key.
Touch the Cancel key [ ] to conclude the parameter change.
Figure 9 – 30: Protocol configuration 4
With the [  2.] and [  1.] keys, you toggle between the dierent screens.
EKG Type
The selected EKG Type determines the communication method with the ECG recorder, PC-based ECG system, etc.
To prevent an accidental change, this setting is protected with a password.
A submenu opens when you touch EKG Type on the display. Enter the code number “3” via the numeric keypad and conrm with the [ ] key.
Figure 9 – 31: Protocol configuration 5
Figure 9 – 32: Setup menu
40 ergoselect 4/5
The following communication modes are supported:
• Analog with pulse Remote start mode; before advancing to the next load level, the ergometer generates a control pulse and sends the corresponding data via the interface.
• Analo g / Digital An analog voltage controls the load – blood pressure measurements can be initiated with digital commands.
• Digital (default) The communication with the ergometer is entirely controlled with digital commands.
• Analog IN-OUT The entire communication (load control and BP mea­surements) is controlled with analog signals. No digital data will be sent.
9 Control Terminal T
Figure 9 – 33: EKG type setup
Choose the appropriate communication mode and conrm with the [ ] key.
Load Change
With this function, you select the increments for load changes.
Figure 9 – 34: Load change setup
ergoselect 4/5 41
9 Control Terminal T
HR Belt Number
If, during the training, the test subject wears a chest belt to measure the heart rate, the corresponding chest belt number must be entered. You will nd the number on the back of the housing. It is the unique identier for this particular belt.
With the [ screen displays.
2.] and [ 1.] keys, you toggle between the
Date / Time
Touch the respective elds to adjust date and time.
Figure 9 – 35: HR Belt Number setup 1
Figure 9 – 36: HR Belt Number setup 2
Enter day, month, year as well as hours, minutes and seconds via the numeric keypad.
Inputs are conrmed with the [
] key.
Figure 9 – 37: Date/Time setup 1
Figure 9 – 38: Date/Time setup 2
42 ergoselect 4/5
Regulation
At Regulation, you can specify the load details:
• load control (at, normal, steep)
• duration: load + (0 min … 15 min) and
• duration: load – (0 min … 15 min).
You scroll through the load control options (at, normal, steep) by tapping the light gray text eld.
When you touch the light gray elds to the right of ‘Dura­tion: load +’ or ‘Duration: load –’, the time can be entered via the numeric keypad.
9 Control Terminal T
Figure 9 – 39: Control setup 1
Inputs are conrmed with the [ ] key.
RPM
In this menu, you determine the limits for the RPM indica­tion.
The three LEDs on the control panel show the patient whether the pedal speed is high, low or correct.
Figure 9 – 40: Control setup 2
Figure 9 – 41: RPM setup 1
ergoselect 4/5 43
9 Control Terminal T
Touch the light gray eld to the right of Min. or Max. and enter the value via the numeric keypad.
Conrm the input with the [ ] key or cancel the input with the [ ] key.
Beep
A short beep conrms each key press. The audible feedback can be enabled and disabled.
Figure 9 – 42: RPM setup 2
Software Version
This menu shows the software version and the date of the technical inspection of the measuring system (MTK).
Figure 9 – 43: Beep setup
Figure 9 – 44: Software Version setup
44 ergoselect 4/5
Language
Here you choose the language for the user interface.
Display
Press the [ 2.] key to display the next screen and touch Display.
9 Control Terminal T
Figure 9 – 45: Language setup
Switch the pulse readout on or o.
Select the blood pressure unit: mmHg (millimeter of mercury) or kPa (kilopascal).
Figure 9 – 46: Setup screen 1
Figure 9 – 47: Setup screen 2
ergoselect 4/5 45

10 Cleaning, Maintenance, Disposal

10 Cleaning, Maintenance, Disposal

10.1 General Cleaning

Wipe the device surface down with a cloth moistened with soap water or a disinfectant.
The cloth should not be dripping wet; do not allow liquids to enter the device.

10.1.1 Cleaning the Saddle

Clean the saddle with a soft and dry or moist cloth (Disin­fectants used should not contain any alcohol).

10.1.2 Disinfection

Only the following disinfectants are approved for disinfec­tion:
Schülke & Mayr GmbH:
• Antifect ® AF, FF, FD 10
• Terralin ® (0,5 %)
• Quartamon Med ®
B. Braun Melsungen AG:
• Hexaquart plus ® (0,5 % / 5,0 %)
• Hexaquart S ® (1,5 % / 5,0 %)
• Meliseptol ®
• Melsept SF ® (0,5 % / 5,0 %)
Warning
• Shock Hazard •
• Disconnect the device from the power line before cleaning.
• Equipment Damage •
• Do not allow liquids to enter the equipment. Devices into which liquids have entered must be immedi­ately cleaned and checked by a service technician, before they can be reused.
• Do not use acids, alkaline solutions (household cleaners) or caustic disinfectants.
Hint
The use of cleaning agents and disinfectants containing alco­hol is not permitted!
Hint
Strictly observe the manufacturer’s instructions for use.
ECOLAB:
• Incidin Foam ®
46 ergoselect 4/5
10.2 Cleaning the Blood Pressure Cu

10. 2.1 Removing the Microphone

Pull the end of the cu through the metal clasp and fold out the cu.
Pull on the short Velcro tab to open the microphone pocket and carefully remove the microphone.

10.2.2 Cleaning

10 Cleaning, Maintenance, Disposal
Figure 10 – 1: Removing the Microphone
Clean the cu and tubing with a moist cloth. You can use a dishwashing liquid or mild soap water (no cleaning agents containing alcohol).
Clean the microphone with a cloth moistened with alcohol or soap water.
Allow the microphone to dry before reinserting it in its pocket.

10.2.3 Disinfection

For disinfection, spray a disinfectant sparingly on the cu, the tubing and the microphone. After the contact time indicated by the manufacturer, wipe all components dry.
Only the following disinfectants are approved for disinfec­tion:
Schülke & Mayr GmbH:
• Antifect ® AF, FF, FD 10
• Terralin ® (0,5 %)
• Quartamon Med ®
Warning
• Equipment Damage •
• Cu, microphone and tubing may not under any circum­stances: —be immersed in liquids —be cleaned in a water bath or in running water.
Hint
Strictly observe the manufacturer’s instructions for use.
B. Braun Melsungen AG:
• Hexaquart plus ® (0,5 % / 5,0 %)
• Hexaquart S ® (1,5 % / 5,0 %)
• Meliseptol ®
• Melsept SF ® (0,5 % / 5,0 %)
ECOLAB:
• Incidin Foam ®
ergoselect 4/5 47
10 Cleaning, Maintenance, Disposal

10.2.4 Inserting the Microphone

Slip the microphone into the pocket, the metal side facing the arm.
Guide the microphone cable out of the pocket and to the right of the Velcro tab. Then close the tab.
Fold the end of the cu over and introduce it into the metal clasp.

10.3 Maintenance

10.3.1 Checks before each use

Before each use, visually inspect the device for signs of damage. If you detect damages or impaired functions which may result in a hazard to the patient or the operator, the device must be repaired before it can be used again.
Figure 10 – 2: Inserting the Microphone

10.3.2 Technical Safety Inspections, Inspections of the Measuring System

The technical safety inspections and the inspections of the measuring system must be completed every two years according to the rules of the art by a Service Engineer authorized by ergoline.
Similarly, the automatic sphygmomanometer in the control terminal must be checked and calibrated by an authorized specialist every two years to fulll legal requirements.
The date of the next inspection is indicated on the inspection sticker attached next to the type plate on the ergometer.

10.4 Disposal

The product described in this operator manual must not be disposed of as unsorted municipal waste and must be collected separately.
Please contact your authorized manufacturer ergolineGmbH for information concerning the disposal of your equipment. There is no waste approval. Proper disposal is documented by ergoline GmbH. Consult Operator’s Manual!
48 ergoselect 4/5
11 Technical Specications
11 Technical Specications

11.1 Ergometer

Model modular ergometer system ergoselect 4 / 5
models ergoselect 4, M / P / T, ergoselect 5, M / P / T
Operating mode continuous operation
Power 100 – 240 V / 50 – 60 Hz (max. 60 VA or 90 VA)
specications of the US power cord:
SPT 2x18AWG 125 V / 10 A “hospital” or “hospital grade”
specications of the internal backup battery:
IEC: CR 2032 / 3 V 230 mAh
Braking principle computer-controlled eddy current brake
with torque measurement; speed independent to DIN VDE 0750-0238
Load range 6 … 999 Watt, speed (RPM)-independent
(see diagrams on page53)
Speed range 30 … 130 n/min
Load accuracy to DIN VDE 0750-0238
Load increments user programmable
Internal protocols control terminal P:
• 5 xed and 10 user-programmable protocols
• manual load control
control terminal T:
• 10 protocols (5precongured, editable and 5 user-pro­grammable protocols)
• 10 additional, user-programmable training/exercise test protocols
• manual load control
• 3 precongured performance tests
Permitted patient weight version 1: manual adjustment (standard), up to 160 kg
version 2: gas-spring assisted adjustment of the saddle
height (option), up to 200 kg
version 3: electrical adjustment of the saddle height with
digital indication of the current saddle height (option), up to 200 kg
Handlebar adjustment for patient heights between 120 cm and 210 cm
continuous handlebar adjustment over 350°
Handlebar height adjustment version 1: rigid steering column (standard)
version 2: electrical adjustment of the steering column
(option)
ergoselect 4/5 49
11 Technical Specications
Crank length 170 mm (cranks with adjustable length available as
optional accessories)
Displays version 1:
control terminal M with 93 x 70 mm LCD,
128 x 64 pixels and 7-segment RPM display
version 2: control terminal P with 93 x 70 mm LCD,
128 x 64 pixels and 7-segment RPM display
version 3: control terminal T with TFT LCD touch screen, 165 x 104mm,
800 x 480 pixels and 7-segment RPM display
Interfaces PORT 1 (DSUB-9-pole):
remote control from PC or ECG recorder remote start of an ECG recorder (option)
USB: remote control from PC (driver required)
option: Bluetooth / WLAN / CO M mo dule
Dimensions, weight length: 1030 mm
width: 490 mm (width of handlebar approx. 530 mm) height: 1140 to 1400 mm weight: approx. 66 kg
Safety standards DIN EN 60601-1, DIN EN 60601-1-2,
DIN VDE 0750-238
Protection class / degree of protection II / B (ergometer)
BF (blood pressure module)
MDD classication class IIa to 93/42 EEC
RF emission class B to DIN EN 55011 / 5.0
DIN EN 60601-1-2
Environment operation:
temperature: +10 to +40 °C rel. humidity 30 to 75 %, no condensation atmospheric pressure: 800 to 1060 hPa
transport and storage:
temperature: –20 to +70 °C rel. humidity 10 to 95 %, no condensation atmospheric pressure: 500 to 1060 hPa
50 ergoselect 4/5
11 Technical Specications

11. 2 Blood Pressure Module

Measuring method auscultatory method (Korotokov), oscillometric; for rest-
ing BP, the results from both measurements are compared for plausibility
Measuring range systolic pressure: 40 to 280 mmHg
diastolic pressure: 40 to 280 mmHg pulse rate: 35 to 230 bpm
Measurement error, systematic systolic pressure: +/– 3 mmHg
diastolic pressure: +/– 3 mmHg (temperature: +15 to +25 °C)
Standard deviation (clinical trial) systolic/diastolic pressure: 7 mmHg (max.)
Ination pressure 300mmHg max.; during ination the ination pressure
automatically adapts to patient’s BP
Ination rate between approx. 6 seconds (to 140 mmHg) and approx.
18seconds (to 300mmHg)
Max. cu pressure 300mmHg
Cu deation method pulse-dependent deation rate
approx. 3 mmHg/beat or approx. 3 mmHg/s
Calibration calibration with external pressure meter
Artifact rejection automatic artifact rejection
ergoselect 4/5 51
11 Technical Specications

11. 3 Exercise Test Protocols

Protocol Basic Load
[W]
1. WHO 25 2 25 25 99
2. BAL 50 3 50 25 99
3. Hollmann 30 3 40 25 99
4. STD France 30 3 30 25 99
5. Standard 20 1 25 25 99
6. – 15. (user programmable) 25 2 25 25 99
Adjustment Range 20 – 100 1 – 3 0 1 – 40 0 20 – 100 (*) 1 – 99
(*) With control terminal P, the recovery load is xed at 25 W.
Stage Time
[min]
Load Stage
[W]
Recovery Load
[W]
Recovery Time
[min]

11.4 Test Protocols (control terminal T only)

Protocol Basic Load
[W]
ramping protocol 0 120 25 10 25 99
PWC-130 (*) 25 0 25 120 25 99
PWC-150 (*) 50 0 25 120 25 99
PWC-170 (*) 50 0 50 120 25 99
(*) the protocol advances to the recovery phase as soon as the target heart rate (130/150/170) is reached
Duration
[sec]
Load Increment
[W]
Stage Time
[sec]
Recovery Load
[W]
Recovery Time
[min]
52 ergoselect 4/5
11 Technical Specications

11.5 Family of characteristics of the braking torque control range

rpm
1
min
130130
120
110
100
90
80
70
60
50
40
30
20
10
0
25 100 200 300 400 500 600 700 800 900 1000
Load
Figure 11 – 1: black: speed-independent range to DIN VDE 0750-0238
black + grey: speed-independent range of the ergoselect ergometer
Watt
11.6 Family of characteristics of the load periods according to IEC 60601‑1
Figure 11 – 2: Under permanent load, the load periods and pauses (white) shall be observed.
ergoselect 4/5 53

12 Electromagnetic Compatibility EN 60601-1-2

12 Electromagnetic Compatibility EN 60601‑1‑2
Changes or modications to this system not expressly approved by ergoline may cause EMC issues with this or other equipment.
Use of portable telephones or other radio frequency (RF) emitting
This system is designed to comply with applicable regula­tions regarding EMC.
Its compliance with these requirements has been veried. Itneeds to be installed and put into service according to the EMC information stated as follows.
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The ergoselect ergometer is intended for use in the electromagnetic environment specied below. It is the responsibility ofthe customer or user to ensure that the ergoselect ergometer is used in such an environment.
equipment near the system may cause unexpected or adverse operation.
• Equipment Malfunction •
The equipment or system should not be used adjacent to, or stacked with, other equipment. If adjacent or stacked use is necessary, the equipment or system should be tested to verify normal operation in the conguration in which it is being used.
Warning
• RF Interference •
Caution
Emissions Test Compliance Electromagnetic Environment – Guidance
RF emissions to EN 55011 Group 1 The ergoselect ergometer uses RF energy only for its
internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions to EN 55011 Class B The ergoselect ergometer is suitable for use in all estab-
lishments, including domestic and those directly con-
Harmonic emissions to EN 61000-3-2 Class A
Voltage uctuations/icker emissions to EN 61000-3-3
Complies
nected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
54 ergoselect 4/5
12 Electromagnetic Compatibility EN 60601-1-2
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The ergoselect ergometer is intended for use in the electromagnetic environment specied below. It is the responsibility of the customer or user to ensure that the ergoselect ergometer is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment –
Guidance
Electrostatic discharge (ESD) to EN 61000-4-2
Electrical fast transient/ burst to EN 61000-4-4
Surge to EN 61000-4-5 ± 1 kV dierential mode
Voltage dips, short inter­ruptions and voltage variations on power supply input lines to EN61000-4-11
± 6 kV contact ± 8 kV air
± 2 kV for power supply lines ± 1 kV for input and output lines
± 2 kV common mode
< 5 % UT (> 95 % dip in UT) for 0.5 cycles
40 % UT (60 % dip in UT) for 5 cycles
70 % UT (30 % dip in UT) for 25 cycles
< 5 % UT (> 95 % dip in UT) for 5 s
± 6 kV ± 8 kV
± 2 kV passed Mains power should be that of
± 1 kV N/A
< 5 % UT Mains power should be that of a
40 % UT
70 % UT
< 5 % UT
Floors should be wood, concrete or ceramic tile. If oors are covered with synthetic material, the relative humidity should be at least 30%.
a typical commercial or hospital environment.
Mains power should be that of a typical commercial or hospital environment.
typical commercial or hospital envi­ronment. If the user of the ergose­lect ergometer requires continued operation during power mains interruptions, it is recommended that the ergoselect ergometer be powered from an uninterruptible power supply or a battery.
Power frequency (50/60Hz) magnetic eld to EN61000-4-8
NOTE: UT is the a.c. mains voltage prior to application of the test level.
3 A/m passed Power frequency magnetic elds
should be at levels characteristic of atypical location in a typical com­mercial or hospital environment. The ergoselect ergometer has no components susceptible to magnetic elds.
ergoselect 4/5 55
12 Electromagnetic Compatibility EN 60601-1-2
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The ergoselect ergometer is intended for use in the electromagnetic environment specied below. It is the responsibility of the customer or user to ensure that the ergoselect ergometer is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment –
Guidance
Portable and mobile RF communica­tions equipment should be used no closer to any part of the ergoselect ergometer, including cables, than the recommended separation dis­tance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance:
d = 1.2 √P d = 1.2 √P for 80 MHz to 800 MHz d = 2.3 √P for 800 MHz to 2.5 GHz
Conducted RF to EN61000-4-6
Radiated RF to EN61000-4-3
3 Vrms 150 kHz to 80 MHz
3 V/m 80 MHz to 2.5 GHz
3 V
3 V/m
where P is the rated output power of the transmitter in watts (W) accord­ing to the transmitter manufacturer and d is the recommended separa­tion distance in meters (m).
Field strengths from xed RF trans­mitters, as determined by an elec­tromagnetic site survey (a), should be less than the compliance level in each frequency range (b).
Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from
structures, objects, and people.
(a) Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radio, AM and FM
radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which the ergose­lect ergometer is used exceeds the applicable RF compliance level above, the ergoselect ergometer should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the ergoselect ergometer.
(b) Over the frequency range from 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
56 ergoselect 4/5
12 Electromagnetic Compatibility EN 60601-1-2
Recommended separation distances between portable and mobile RF communications equipment
and the ergoselect ergometer
The ergoselect ergometer is intended for use in an electromagnetic environment, as specied below, in which radiated RF disturbances are controlled. The customer or the user of the ergoselect ergometer can help prevent electromagnetic inter­ference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ergoselect ergometer as recommended below, according to the maximum output power of the communications equipment.
Rated Maximum Output
separation distance according to frequency of transmitter [m]
Power of Transmitter [W]
150 kHz to 80 MHz
d = 1.2 √P
80 MHz bis 800 MHz
d = 1,2 √P
800 MHz bis 2,5 GHz
d = 2,3 √P
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0 .74
1 1.17 1.17 2.33
10 3.7 3.7 7.37
100 11.7 11.7 23.3
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from
structures, objects, and people.
ergoselect 4/5 57
201000433000 • Version 2017-01-12 / Rev 01 • English
58 ergoselect 4/5
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
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