ergoline ers2 User manual

Manual
ers. 2
ergoline Rehabilitation System
Operator‘s Manual
201000414000 • Version 2014-04-15 / Rev 00 • English

ergoline GmbH
Lindenstrasse 5
72475 Bitz
Germany
Phone: [phone] - 0
Fax: [phone] - 128
e-mail: [e-mail]
http: www.ergoline.com
This manual was written with the utmost care. Should you still find details that do
not correspond with the system, please let us know and we will correct the issue
as soon as possible.
We reserve the right to modify the design and technical features of the device
and are not bound by the information and illustrations provided in this manual. All
trademarks appearing in this document are trademarks of their respective owners.
Their protection is acknowledged.
No part of this manual may be reprinted, translated, or reproduced without the
manufacturer's written permission.
This manual is not subject to any change order service.
Please contact the manufacturer for the most recent version.

ergoline GmbH
Lindenstrasse 5
72475 Bitz
Germany
Phone: [phone] - 0
Fax: [phone] - 128
e-mail: [e-mail]
http: www.ergoline.com
This manual was written with the utmost care. Should you still find details that do
not correspond with the system, please let us know and we will correct the issue
as soon as possible.
We reserve the right to modify the design and technical features of the device
and are not bound by the information and illustrations provided in this manual. All
trademarks appearing in this document are trademarks of their respective owners.
Their protection is acknowledged.
No part of this manual may be reprinted, translated, or reproduced without the
manufacturer's written permission.
This manual is not subject to any change order service.
Please contact the manufacturer for the most recent version.
|3
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
CE Marking Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
License Terms ........................................................ 7
Revision History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Intended Audience .................................................... 8
Stylistic Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Safety Information .................................................... 8
General Information .................................................. 8
Denitions .......................................................... 9
Safety Notices ....................................................... 9
System Requirements .................................................11
Equipment Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Intended Use ....................................................... 12
Ers 2 System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
An overview of the key performance features of the software ............... 13
System Conguration ................................................ 14
Starting the Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Patient Data > General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Personal Data ....................................................... 19
Contact Data ....................................................... 21
Physician ...........................................................21
Patient Data > Medical .......................................22
Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Examinations .......................................................23
Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Findings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Patient Data > Protocols
Bicycle ....................................................26
Creating a Protocol ..................................................26
Selecting the Protocol Type ...........................................27
Protocol Type ‘SpO2-controlled’. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Protocol Type ‘Interval HR-controlled‘ ...................................28
Protocol Type ‚Custom‘ ...............................................29
Editing a Protocol ...................................................30
Activating a Protocol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Deleting a Protocol ..................................................30
Saving a Protocol as Default ........................................... 31
Loading a Default Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Contents

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Patient Data > Protocols
Treadmill. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Creating a Protocol ..................................................32
Selecting the Protocol Type ...........................................33
Protocol Type ‘HR-controlled’. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Protocol Type ‚Custom‘ ...............................................34
Editing a Protocol ...................................................35
Activating a Protocol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Deleting a Protocol ..................................................35
Saving a Protocol as Default ........................................... 36
Loading a Default Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Management
Groups ....................................................37
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Creating Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Selecting the Group Type .............................................38
Adding Patients to a Group. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Deleting Patients from a Group ........................................39
Editing a Group .....................................................39
Management > Protocols
Bicycle ....................................................40
Saving the Default Protocol ...........................................40
Selecting the Protocol Type ...........................................40
Protocol Type ‘SpO2-controlled‘. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Protocol Type ‘Interval HR-controlled‘ ...................................42
Protocol Type ‚Custom‘ ...............................................43
Editing the Default Protocol ...........................................44
Activating the Default Protocol ........................................44
Deleting the Default Protocol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Management > Protocols
Treadmill. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Saving the Default Protocol ...........................................45
Selecting the Protocol Type ...........................................45
Protocol Type ‘HR-controlled‘. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Protocol Type ‚Custom‘ ............................................... 47
Editing the Default Protocol ...........................................48
Activating the Default Protocol ........................................48
Deleting the Default Protocol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

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Patient Data > Protocols
Treadmill. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Creating a Protocol ..................................................32
Selecting the Protocol Type ...........................................33
Protocol Type ‘HR-controlled’. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Protocol Type ‚Custom‘ ...............................................34
Editing a Protocol ...................................................35
Activating a Protocol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Deleting a Protocol ..................................................35
Saving a Protocol as Default ........................................... 36
Loading a Default Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Management
Groups ....................................................37
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Creating Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Selecting the Group Type .............................................38
Adding Patients to a Group. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Deleting Patients from a Group ........................................39
Editing a Group .....................................................39
Management > Protocols
Bicycle ....................................................40
Saving the Default Protocol ...........................................40
Selecting the Protocol Type ...........................................40
Protocol Type ‘SpO2-controlled‘. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Protocol Type ‘Interval HR-controlled‘ ...................................42
Protocol Type ‚Custom‘ ...............................................43
Editing the Default Protocol ...........................................44
Activating the Default Protocol ........................................44
Deleting the Default Protocol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Management > Protocols
Treadmill. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Saving the Default Protocol ...........................................45
Selecting the Protocol Type ...........................................45
Protocol Type ‘HR-controlled‘. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Protocol Type ‚Custom‘ ............................................... 47
Editing the Default Protocol ...........................................48
Activating the Default Protocol ........................................48
Deleting the Default Protocol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
|5
Training ...................................................49
Monitoring .........................................................49
Assigning a Patient ..................................................49
Removing a Patient ..................................................50
Assigning a Device ...................................................50
Removing a Device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Switching Devices ...................................................50
Starting a Training Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Ending a Training Session ............................................. 51
Changing from the Training Phase to the Recovery Phase (RP) ............... 51
Suspending Heart-Rate Control during a Training ......................... 51
Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Patient Analysis .....................................................52
Editing the Borg Value. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Editing Eort .......................................................52
ECG Display ........................................................53
Measuring Blood Pressure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Adding Blood-Pressure Readings .......................................53
Marking the ECG ....................................................54
Turning the ECG Pump On. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Turning the ECG Pump O ............................................54
Training View .......................................................54
Selecting the Training Protocol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Management .......................................................56
Patients. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Analysis ...................................................57
Patient Analysis .....................................................57
Overview - Trend ....................................................58
Analyzing the Training Sessions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Editing / Deleting a Training Session ....................................59
Training Details. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Overview - Compare .................................................60
Training - Single . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Analyzing the Training Sessions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Training - Compare ..................................................63
Analyzing the Training Sessions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Tools ......................................................64
Karvonen Formula ...................................................64
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

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|7
CE Marking inforMation
The product ERS 2 system bears the CE marking CE-0123 (notified body TÜV SÜD
Produkt Service GmbH, Ridlerstrasse 65, 80339 München, Germany) indicating its
compliance with the provisions of the Council Directive 93/42/EEC about medical
devices and fulfills the essential requirements of Annex I of this directive.
The product ERS 2 system has been assigned to class IIa in accordance with Annex
IX of the Directive 93/42/EEC.
The product fulfills the requirements of the standard EN 60601-1 “Medical Electri-
cal Equipment, Part 1: General Requirements for Safety“ as well as of the standard
DIN EN 62304 “Medical Device Software“.
Magnetic and electrical fields are capable of interfering with the proper perfor-
mance of the device. For this reason make sure that all external devices operated
in the vicinity of the equipment comply with the relevant EMC requirements.
X-ray equipment, MRI devices, radio systems, cellular telephones, etc. are possible
sources of interference as they may emit higher levels of electromagnetic radi-
ation. Keep the equipment away from these devices and verify its performance
before use.
LiCEnsE tErMs
By installing the software, you accept the following terms:
Subject of this agreement is the granting of a license to use the software program
and the product documentation.
Ergoline GmbH grants you the personal, non-exclusive and non-transferable right
to use the software and documentation. The software and the accompanying
documentation are protected by copyright. The licensee shall comply with the
provisions of copyright law.
Ownership and all other rights to the software are retained by Ergoline GmbH. You
are not entitled to transfer the software to another computer via network or data
channel. The program and the accompanying product documentation shall not be
modified, copied or, in an altered version, merged with other software and made
accessible to third parties.
The licensee is liable to the licenser for any damage arising from the breach of the
copyright or infringement of the conditions of this agreement.
Introdu CtIon

8|
rEvision History
Revision: 1.0
Date: 2014-04-15
Comments: Applies to software version 1.0 and later
intEndEd audiEnCE
This manual is geared for clinical professionals. Clinical professionals are expected
to have working knowledge of medical procedures, practices, and terminology as
required for completing these examinations.
styListiC ConvEntions
Control keys (soft keys and hard keys) are emphasized by different styles, e.g.,
Start training or [ Create ].
safEty inforMation
General Information
This manual is an integral part of the device. It should be available to the equip-
ment operator at all times. Close observance of the information given in the man-
ual is a prerequisite for proper equipment performance and correct operation and
ensures patient and operator safety. Please note that information pertinent to
several chapters is given only once. Therefore, read the manual once in its entire-
ty. Also observe the information given in the enclosed separate user manuals (e.g.,
the PC and ergometer user manuals).
To ensure maximum patient safety, the specified measuring accuracy, and inter-
ference-free operation, we recommend using only original accessories available
through Ergoline GmbH. The user is responsible if accessories from other manu-
facturers are used.
Ergoline GmbH is responsible for the effects on safety, reliability, and perfor-
mance of the equipment, only if
· assembly operations, extensions, readjustments, modifications, or repairs are
carried out by Ergoline GmbH or persons authorized by Ergoline GmbH
· the device is used in accordance with the instructions given in this manual.
The warranty does not cover damage resulting from the use of unsuitable acces-
sories and consumables from other manufacturers.
Always consult with Ergoline GmbH if you intend to connect equipment not men-
tioned in this manual.
Parts and accessories must comply with the applicable IEC 60601 safety stan-
dards and/or the configured system must comply with the collateral standard IEC
60601-1-1 "Safety requirements for medical electrical systems".

8|
rEvision History
Revision: 1.0
Date: 2014-04-15
Comments: Applies to software version 1.0 and later
intEndEd audiEnCE
This manual is geared for clinical professionals. Clinical professionals are expected
to have working knowledge of medical procedures, practices, and terminology as
required for completing these examinations.
styListiC ConvEntions
Control keys (soft keys and hard keys) are emphasized by different styles, e.g.,
Start training or [ Create ].
safEty inforMation
General Information
This manual is an integral part of the device. It should be available to the equip-
ment operator at all times. Close observance of the information given in the man-
ual is a prerequisite for proper equipment performance and correct operation and
ensures patient and operator safety. Please note that information pertinent to
several chapters is given only once. Therefore, read the manual once in its entire-
ty. Also observe the information given in the enclosed separate user manuals (e.g.,
the PC and ergometer user manuals).
To ensure maximum patient safety, the specified measuring accuracy, and inter-
ference-free operation, we recommend using only original accessories available
through Ergoline GmbH. The user is responsible if accessories from other manu-
facturers are used.
Ergoline GmbH is responsible for the effects on safety, reliability, and perfor-
mance of the equipment, only if
· assembly operations, extensions, readjustments, modifications, or repairs are
carried out by Ergoline GmbH or persons authorized by Ergoline GmbH
· the device is used in accordance with the instructions given in this manual.
The warranty does not cover damage resulting from the use of unsuitable acces-
sories and consumables from other manufacturers.
Always consult with Ergoline GmbH if you intend to connect equipment not men-
tioned in this manual.
Parts and accessories must comply with the applicable IEC 60601 safety stan-
dards and/or the configured system must comply with the collateral standard IEC
60601-1-1 "Safety requirements for medical electrical systems".
|9
safEty inforMation
General Information
Operate the equipment only with power cords certified for the country of use.
All publications reflect the equipment specifications and standards on the safety
of medical electrical equipment valid at the time of printing. All rights are re-
served for devices, circuits, techniques, software programs, and names appearing
in this manual.
No part of this manual may be reprinted without written permission from
Ergoline GmbH.
© 2013 Ergoline GmbH, Lindenstrasse 5, 72475 Bitz, Germany.
Definitions
The safety information in this manual is classified as follows:
Danger
indicates an imminent hazard. If not avoided, the hazard will result in death or se-
rious injury.
Warning
indicates a hazard. If not avoided, the hazard can result in death or serious injury.
Caution
indicates a potential hazard. If not avoided, the hazard may result in minor injury
and/or product/property damage.
Safety Notices
Explosion Hazard
The ERS 2 system is not designed for use in areas of rooms used for medical purpos-
es where an explosion hazard may occur. Potentially explosive atmospheres may
result from the use of flammable anesthetics, skin cleansing agents or disinfec-
tants. Furthermore, great care must be exercised when the system is used in an
oxygen-enriched atmosphere. The atmosphere is considered to be oxygen-enriched
when the room air contains more than 25% of oxygen or nitrous oxide.
Shock Hazard
Before use, verify that the equipment is in correct working order and operating
condition. Check the cables and connectors, in particular, for signs of damage. Re-
place damaged cables and connectors immediately, before use.
Do not expose the equipment to direct sunlight to prevent system components from
reaching inadmissible, high temperatures. The equipment has no additional protec-
tion against the ingress of humidity.

10 |
safEty inforMation
Safety Information
Shock Hazard
When disconnecting the device from the power line, remove the plug from the wall
outlet first, before disconnecting the cable from the device.
Do not use multiple portable socket outlets (MPSO) to connect devices to the power
line.
If a printer is operated in the patient environment, the printer must comply with
IEC 60601 requirements or it must be a modified printer with additional protective
earth conductor (potential equalization).
All devices of a system must be connected to the same electric circuit. Devices that
are not connected to the same circuit must be electrically isolated when operated,
e.g., by means of an isolated RS232 interface (not required in the USA).
Devices may be connected to other devices or to parts of systems only when it has
been made certain that there is no danger to the patient, the operators, or the en-
vironment as a result.
In those instances where there is any element of doubt concerning the safety of
connected equipment, the user must contact the manufacturers concerned or oth-
er informed experts as to whether there is any possible danger to the patient, the
operator, or the environment as a result of the proposed combination of equipment.
Standard IEC 60601-1-1/EN60601-1-1 must be complied with in all cases.
All bicycle ergometers and treadmills connected to the system must meet
IEC60601-1 requirements.
Liquids must not be allowed to enter the devices. If liquids have entered the devices,
the ERS 2 system must be checked by a service technician before being used again
Do not open any of the devices. There are no user-replaceable components inside
the devices.
Do not insert objects of any kind into the device. They may touch live components
and you might suffer an electric shock, cause fire, or damage the device.
Warning
Patient Hazard — For stress-test examinations, a defibrillator and a pacemaker,
regularly checked for proper functioning, must be readily accessible at all times.
Patient Hazard, Interpretation Hazard — A qualified physician must overread all
computer-generated records.
Patient Hazard — The operator must be trained in the use of the device.
Patient Hazard, Equipment Damage — Do not modify the ERS 2 system in any way.