ergoline ers2 User guide

System Manual
201000401000 • Version 2020-09-24 / Rev 04 • English
ers2 – 1-Channel ECG Telemetry System

ers2 – 1-Channel ECG Telemetry System 1
201000401000 /Rev 04
ers2 – 1-Channel ECG Telemetry System
System Manual
201000401000 • Version 2020-09-24 / Rev 04 • English
This manual contains the instructions for use and the technical specifications of the
ers2 – 1-Channel ECG Telemetry System. It was written with the utmost care. Should you
nonetheless find details that do not correspond with the hardware or software, 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 manufac-
turer‘s written permission.
This manual will not be automatically updated. Please contact the manufacturer for the
latest document revision.

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Manufacturer Distributor
ergoline GmbH
Lindenstrasse 5
72475 Bitz
Germany
Tel.: [phone] - 9894 - 0
Fax: [phone] - 9894 - 128
e-mail: [email protected]m
http: www.ergoline.com

ers2 – 1-Channel ECG Telemetry System 1
201000401000 /Rev 04
Contents
1General Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.1 General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.1 Meaning of the Signal Words . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.2 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.2.1 User Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.2.2 Patient Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.2.3 Characterization of the Environment of Use . . . . . . . . . . . . . . . . . . . . . 11
2.2.4 Essential Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.3 Provisions and Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
2.3.1 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
2.3.2 System and Data Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2.3.3 EMS/EMC/RF Warning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2.3.4 Biocompatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
2.4 Responsibility of the Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
2.5 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3.1 Information on Product and Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3.1.1 Unique Device Identification (UDI) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
3.2 1-Channel Transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
3.2.1 Normal Operation Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
3.2.2 Firmware Update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
3.3 Receiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
3.4 Chest Belt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
3.5 Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
4Start-up and Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
4.1 Receiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
4.2 1-Channel Transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
4.2.1 Replacing the Battery of the 1-Channel Transmitter . . . . . . . . . . . . . . . 30
4.2.2 Battery Management of the 1-Channel Transmitter . . . . . . . . . . . . . . . 31
5Attaching the ECG System to the Patient . . . . . . . . . . . . . . . . . . . . . . . . 32
5.1 Visual Inspection of the ECG System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
5.2 Applying the 1-Channel Transmitter and Chest Belt . . . . . . . . . . . . . . . . . . . . . 33
5.2.1 Applying the Chest Belt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
5.2.2 Attaching and Switching On the 1-Channel Transmitter . . . . . . . . . . . 35
5.2.3 Removing the 1-Channel Transmitter and Chest Belt . . . . . . . . . . . . . . 36
5.3 Applying the 1-Channel Transmitter and Adapter . . . . . . . . . . . . . . . . . . . . . . . 36
5.3.1 Attaching and Switching On the 1-Channel Transmitter . . . . . . . . . . . 37
5.3.2 Applying Adhesive Electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
5.3.3 Attaching the Adapter with the 1-Channel Transmitter to the Patient . . . 37
5.3.4 Removing the Adapter with the 1-Channel Transmitter from the Patient . 38

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6Cleaning and Disinfection Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . 39
6.1 1-Channel Transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
6.1.1 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
6.1.2 Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
6.2 Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
6.2.1 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
6.2.2 Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
6.3 Chest Belt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
6.3.1 Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
6.4 Receiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
6.4.1 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
7Maintenance Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
7.1 Maintenance Requirement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
7.1.1 Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
7.2 Functional Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
7.3 Firmware Update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
7.4 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
8Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
9Technical Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
9.1 1-Channel Transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
9.1.1 General Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
9.1.2 Electronic System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
9.1.3 Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
9.1.4 Bluetooth Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
9.1.5 Mechanical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
9.2 Application Software ers2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
9.3 Receiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
9.3.1 Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
9.4 Chest Belt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
9.4.1 Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
9.4.2 Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
9.5 Adaptor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
9.5.1 Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
9.5.2 Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
10 Electromagnetic Compatibility (EMC) DIN EN 60601-1-2 . . . . . . . . 52

ers2 – 1-Channel ECG Telemetry System 5
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Revision History
The part number of the document and the revision code are indicated in the footer of each page.
The revision code identifies the revision status of the document. The table below provides a summary
of the document revision history.
Publication Date Revision Software Version Comment/Note
2015-02-15 00 – initial release
2015-10-22 01 – ers2 software version 1.4 and later
– telemetry firmware version < 5.0
– general adaptations
2016-07-19 02 – ers2 software version 1.4 and later
– telemetry firmware version < 5.0
– added ECG system information
– added information to technical data
– update of intended use information
2019-02-19 03 – ers2 software version 2.00 and later
– telemetry firmware version 5.0 and later
– ECG telemetry transmitter hardware
version STR12 and later
– added new firmware functionalities
– added ECG chest belt information
– added ECG system maintenance information
– update of intended use information
– added ECG use warning
– added cybersecurity information
– added ECG electrode adapter information
2020-09-24 04 – ers2 software version 2.00 and later
– telemetry firmware version 5.0 and later
– ECG telemetry transmitter hardware
version STR12 and later
– implementation of MDR compliant content and design

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1 General Notes
ers2 – 1-Channel ECG Telemetry System 7
201000401000 / Rev 04
1 General Notes
This manual describes the ers2 ECG system and is geared for the primary and secondary users of these
devices. The ECG system is intended for use with a medical application software or ME equipment.
The ECG system is intended for use with the ergoline rehabilitation software (ers2) among others.
The software processes the acquired ECG signal, saves it, and uses it to continuously monitor and
document the heart rate and the cardiac rhythm and to control the training load for rehabilitation
or preventive training activities of adult patients. For the relevant wireless connections and special
functional tests, refer to the instructions for use of the application software.
If you intend to use the ECG system with a software not expressly approved by ergoline, please
contact the manufacturer of this software for information on installation, configuration, and pos-
sible restrictions.
1.1 General Information
This manual is an integral part of the device. It should be kept near the device at all times.
This manual provides the necessary information for safe transport and storage, setup and safe
operation in compliance with its function and as defined by its intended use. This system man-
ual is not a substitute for in-depth product training, it should rather be considered as a supple-
ment.
The symbol means: Follow instructions in accompanying documents.
It indicates points that are of particular importance in the application of the device.
The 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.
The CE mark and the CE approval number 0123 indicate that the device is in conformity with the
applicable rules and requirements set out in Regulation (EU) 2017/745.
It is an active class IIa device for "transient" use on patients.
The device has been certified with respect to electric shock, fire, mechanical hazards, electromag-
netic compatibility, and signal accuracy in accordance with IEC 60601-1, IEC 60601-1-2, and IEC
60601-2-27.
WARNING No pacemaker detection
There is a risk of inadequate therapy and/or over-exertion.
The 1-channel system may continue to count the pacemaker rate during cardiac arrest or some
arrhythmias. Do not rely entirely upon rate meter alarms.
The 1-channel transmitter has no pacemaker pulse rejection capability.
Keep pacemaker patients under close surveillance. The primary user is required to periodically assess
the current exertion level by referring to independent, subjective parameters (e.g., the RPE value).
CAUTION Prescription device
Please note that US Federal Law restricts this ECG system to be used by a physician or on the order
of a physician.

1 General Notes
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The implemented quality management system covers all aspects of the ergoline GmbH operations
as per EN ISO 13485.
All the cleaning and disinfection procedures described in this manual need to be carried out.
The assembly of ME systems and modifications during their actual operating life require the verifi-
cation of compliance with the requirements for electrical safety and of the essential performance.
The manufacturer and the competent authority of the member state where this ECG system is
used must be notified of all serious incidents involving the system which directly or indirectly led
or may lead to death or serious deterioration in the health of a patient.

2 Definitions
ers2 – 1-Channel ECG Telemetry System 9
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2 Definitions
The following terms are used in this document.
2.1 Meaning of the Signal Words
Risk is defined as a source of potential injury to a person or property damage.
The terms "Danger", "Warning", Caution", and "Notice" are used throughout this manual to point
out risks and to designate a degree or level of seriousness. Familiarize yourself with the following
definitions:
ergoline English
ETS ECG system
ETS1 1-channel system
ETS1 Transmitter 1-channel transmitter
ETS1 Adapter adapter
ETS1 Chestbelt chest belt
ETS Receiver receiver
Signal Word Meaning
DANGER Indicates an imminent risk that, if not avoided, can result in death or seri-
ous injury. (Not used in this manual.)
WARNING Indicates a potential risk or unsafe practice that, if not avoided, can result
in death or serious injury.
CAUTION Indicates a potential risk or unsafe practice that, if not avoided, can result
in minor or moderate injury.
NOTICE Indicates a potential risk or unsafe practice that, if not avoided, can result
in product or property damage or loss of data.

2 Definitions
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2.2 Intended Use
The 1-channel system is a device for recording of a single-channel, bipolar surface ECG (frontal
plane) acquired with two ECG electrodes. The ECG is transmitted to another ME device or a medi-
cal application software that processes it to continuously monitor and document the heart rate
and the cardiac rhythm and to control the training load for rehabilitation or preventive training
activities.
The signal is acquired on the intact skin of adult patients.
The medical device is intended for use in professional healthcare institutions for inpatient and
outpatient care.
2.2.1 User Characterization
2.2.1.1 Primary Users
2.2.1.2 Secondary Users
User Group: Primary Users
Typical professional title(s): Cardiologist, sports therapist, physiotherapist,
nurse
Expected education (formation, degree, training): Three-year professional education and training
Expected professional experience (related to
the product, similar products or IT in general):
No product-specific professional experience
required, specified education is sufficient
Core task (related to the medical device): Prepare patient for ECG monitoring, perform
follow-up tasks (cleaning, disinfection)
Replace battery of 1-channel transmitter
Equipment (typically used to perform the tasks): Application software, ECG system, ECG elec-
trodes
Expected training (related to the medical device): Approx. 30 minutes of training encompassing
application of the device and patient prepa-
ration
User Group: Secondary Users
Typical professional title(s): Biomedical technician, application specialist
Expected education (formation, degree, training): Three-year professional education and train-
ing, training by manufacturer
Expected professional experience (related to
the product, similar products or IT in general):
No product-specific professional experience
required, specified education is sufficient
Core tasks (related to the medical device): Training of primary users, firmware update of
the 1-channel transmitter, functional and
safety checks

2 Definitions
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2.2.2 Patient Characterization
Indications
• Adult patients whose electrical activity of the heart needs to be continuously monitored to control
the training sessions.
Contraindications
• The general, absolute contraindications to cardiac stress testing (according to the ergometry
guidelines, DGSP (German Sports Physicians Association)) apply.
Acute myocardial infarction
Unstable angina
Cardiac arrhythmia causing symptoms and/or hemodynamic instability
Symptomatic severe aortic stenosis
Decompensated heart failure
Acute pulmonary embolism
Acute myocarditis
Acute pericarditis
Acute aortic dissection
• Patients with physical, psychological, or mental afflictions who cannot be mobilized and are
therefore not capable of using rehabilitation facilities.
Application
• Applied parts are only used on healthy, intact skin.
• The application is transient (less than 60 minutes under normal conditions), cumulative use for
20 training sessions.
2.2.3 Characterization of the Environment of Use
The ECG system is intended for use in medical training therapy for inpatient and outpatient care in
professional healthcare institutions.
2.2.4 Essential Performance
The 1-channel system fulfills the applicable requirements of IEC 60601-2-27 for the essential perfor-
mance of electrocardiographic monitoring equipment regarding signal accuracy and protection against
the effects of defibrillation. As defined by its intended purpose, the device can be used to monitor the
cardiac rhythm and calculate the heart rate during training units in rehabilitation therapy.
Equipment (typically used to perform the tasks): Application software, ECG maintenance soft-
ware, ECG simulator
Expected training (related to the medical device): One 1-hour training session by manufacturer

2 Definitions
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2.3 Provisions and Safety Information
This section contains information on the safe use of the system and on observance of legal regula-
tions. Familiarize yourself with this information. Read and understand all instructions before
attempting to use this system.
Any failure to observe the safety information contained herein is considered improper use of the
system, which may lead to injuries, loss of data and may render the warranty null and void.
2.3.1 Safety Information
The following safety information refers to the system as a whole. Specific safety information may
be presented in other sections of this manual.
Safety Text
WARNING No monitoring device
There is a risk of life-threatening patient conditions going unnoticed.
The ECG system is not suitable for the electrocardiographic monitoring of critical care patients.
WARNING No pacemaker detection
There is a risk of inadequate therapy and/or over-exertion.
The 1-channel system may continue to count the pacemaker rate during cardiac arrest or some
arrhythmias. Do not rely entirely upon rate meter alarms.
The 1-channel transmitter has no pacemaker pulse rejection capability.
Keep pacemaker patients under close surveillance. The primary user is required to periodically assess
the current exertion level by referring to independent, subjective parameters (e.g., the RPE value).
WARNING Conductive materials
Electric shocks or malfunction of the ECG system may result from contact with conductive mate-
rials.
Conductive parts of the ECG system must not touch other conductive parts, including ground,
during application to or removal from the patient.
Follow the sequence of steps for application and removal of the ECG system described in this
manual.
WARNING Visual inspection before use
Before each use, visually inspect the ECG system for signs of damage. If you detect damage that
may result in a hazard to the patient or the operator, the ECG system must be repaired before it
can be used again. Follow the instructions for visual inspection given in this manual.
WARNING Defibrillation protection
To ensure defibrillation protection, use only the electrodes, leadwires, and patient cables with the
1-channel transmitter specified by the manufacturer.
When a defibrillation shock was delivered, all components must be inspected by a certified
ergoline service partner for possible damage.
WARNING Compatibility
Safe and reliable operation of the ECG system is only possible when ergoline has declared the
devices connected to the ECG system to be part of the ECG system or compatible with the ECG
system.
CAUTION Incorrect application
The ECG system is not intended for long-term monitoring. Skin irritation and/or allergies may occur.
Apply the ECG system only as described in this manual.

2 Definitions
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CAUTION Insufficient ECG transmission quality
Line isolation monitor transients may resemble actual cardiac waveforms and thus inhibit heart
rate alarms. This problem can be largely avoided by correct application of the chest belt and/or
adapter.
Regularly check the 1-channel transmitter for correct application to the chest belt or adapter and
patient according to the instructions in this manual.
CAUTION Risk of infection
After use, the ECG system may be contaminated with bacteria or viruses.
Clean and disinfect the 1-channel transmitter and the applied parts according to the cleaning and
disinfection instructions in this manual.
CAUTION Prescription device
Please note that US Federal Law restricts this ECG system to be used by a physician or on the order
of a physician.
CAUTION Risk of infection
The ECG system may only be applied on intact skin (e.g., not over open wounds, lesions, infected or
inflamed areas).
CAUTION Wet environment
There is a risk of burn injuries and insufficient ECG transmission quality.
The ECG system is not suitable for use in highly wet environments. Do not wear it in the shower or
when swimming.
CAUTION MR Unsafe
• There is a risk of injuries from ferromagnetic objects being attracted by the magnetic core of
the MRI system (missile effect).
• Thermal injury and burns may occur due to metal components of the device heating up during
MR scanning.
• The system may generate artifacts in the MR image.
• The system may not function properly due to the strong magnetic and radiofrequency fields
generated by the MR scanner.
• It is not permitted to use the ECG system in the vicinity of an MR scanner.
CAUTION Electrosurgery
There is a risk of skin burns and patient injuries.
It is not permitted to use the ECG system during electrosurgery.
CAUTION No diagnostic device
There is a risk of inadequate or wrong therapy.
The ECG system is not intended for use as a tool to diagnose cardiac conditions (e.g., arrhythmias,
ST elevation, etc.).
Apply the ECG system only as described in this manual.
CAUTION Compulsory presence of a primary user
There is a risk of wrong or missing ECG data leading to inadequate therapy and/or over-exertion.
The ECG system may only be used with patients when the primary user is present. The primary user
is required to periodically assess the current exertion level by referring to independent, subjective
parameters (e.g., the RPE value).
CAUTION Installation and instruction obligation
Incorrect installation or training may lead to wrong application of the ECG system.
The ECG system may only be used if properly installed by a certified ergoline partner and after the
user has been instructed by the certified ergoline partner.

2 Definitions
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NOTICE Cleaning and disinfection
Wrong cleaning agents or disinfectants or wrong application of these substances may damage the
ECG system.
Use the recommended cleaning agents and disinfectants for cleaning and disinfection.
Clean and disinfect your ECG system according to the instructions in this manual.
NOTICE Maintenance
Proper maintenance by the secondary user is a primary condition for long-term safety and reliabil-
ity of the ECG system.
Observe the maintenance information in this manual.
NOTICE Damage to device and accessories
Unauthorized personnel is not adequately trained and educated to properly maintain the device.
Repairs carried out by unauthorized personnel may damage the ECG system.
Inform your ergoline service partner when you identify or suspect a malfunction.
NOTICE Safety only with approved accessories/applied parts
Safe and reliable operation of the ECG system is only possible when the supplied or approved
applied parts or accessories are used. Observe the appropriate instructions in this manual and
the instructions supplied with the applied parts and accessories.
NOTICE Environmental impact
Electronic devices and the accessories contain metal and plastic parts. After the expiration of their
useful life, the parts must be disposed of in compliance with the valid waste regulations to pre-
vent any environmental impact.
Once the service life of the ECG system has expired, it must be disposed of in compliance with the
applicable local and national provisions. If you have any questions about the disposal of the device,
please contact ergoline or one of the authorized ergoline representatives.

2 Definitions
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2.3.2 System and Data Security
Medical device security is a shared responsibility between all stakeholders. These are healthcare
facilities, patients, employees, and manufacturers of medical devices. Failure to maintain cyber-
security can result in compromised device functionality, loss of data (medical or personal) avail-
ability or integrity, or expose other connected devices or networks to security threats.
2.3.3 EMS/EMC/RF Warning
The ECG system is designed to comply with applicable regulations regarding EMC (electromagnetic
compatibility). Its compliance with these requirements has been verified. Changes or modifications
to this system not expressly approved by ergoline could cause EMC issues with this or other equip-
ment. RF devices may adversely affect the usability or accuracy of the device or system. During
installation and use of the device or system, known RF sources in the vicinity need to be taken into
account. These sources include:
• Radio and TV stations
• Portable and mobile radio communication equipment (cell phones, radios)
• X-ray, CT, or MRI equipment
These devices are possible sources of interference as they may emit higher levels of electromagnetic
radiation.
NOTICE Protection from unauthorized access
Lock the 1-channel transmitter in a cabinet when not in use.
NOTICE Protection from unauthorized access
Switch off the 1-channel transmitter if not used for long periods of time.
NOTICE Protection from unauthorized access
Inform your ergoline service partner if a 1-channel transmitter is stolen or lost.
WARNING Malfunction of the ECG system
Use of portable telephones or other RF devices near the ECG system may cause unexpected or
adverse operation.
Do not use portable telephones or other RF devices near the ECG system.
WARNING Accessories or components
Adding accessories or components to the ECG system or modifying the device or system may result
in increased emissions or decreased electromagnetic immunity of the device or system.
More information on EMS/EMC and RF can be obtained from these sources:
Appendix "Electromagnetic Compatibility" in this system manual.
NOTICE This device complies with part 15 of the FCC rules
Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that may cause unde-
sired operation.
NOTICE Changes or modifications made to this device not expressly authorized by ergoline GmbH may void
the FCC authorization to operate this device.
NOTICE Information about exposure to radiofrequency emitted by radiation
The radiated output power of the device is far below the FCC limits for RF emissions. However, any
potential human contact during normal operation of the device should be considered and reduced
to a minimum.

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2.3.4 Biocompatibility
The system components described in these instructions for use, including accessories, that come
into contact with the patient during the intended use, meet the biocompatibility requirements of
the applicable standards. If you have questions in this matter, please contact ergoline or one of
their representatives.
2.4 Responsibility of the Manufacturer
The manufacturer is responsible for the results with respect to safety, reliability and performance
only if the following conditions are met:
• Assembly operations, extensions, readjustments, modifications or repairs are carried out by per-
sons authorized by ergoline.
• The electrical installation of the relevant room complies with the requirements of the applica-
ble standards.
• The system is used in accordance with the operator's manual.
• Information is obtained from ergoline before any devices not recommended in this manual are
connected to the equipment.
NOTICE This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This device generates, uses and can radi-
ate radiofrequency energy and, if not installed and used in accordance with the instructions, may
cause harmful interference to radio communications. However, there is no guarantee that inter-
ference will not occur in a particular installation. If this device causes harmful interference to
radio or television reception, which can be determined by turning the device off and on, the user
is encouraged to try to correct the interference by one or more of the following measures
• Reorienting or relocating the receiving antenna.
• Increase the distance between the device and the receiver.

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2.5 Symbols
The following symbols may be used on the device or on the system packaging. Knowledge of these
symbols contributes to the safe application and disposal of the equipment.
Symbol Meaning
Catalog or part number
Indicates the manufacturer's catalog or part number.
Serial number
Indicates the manufacturer's serial number.
Batch code
Indicates products from the same delivery.
Manufacturer, name and address
Indicates the device manufacturer's name and address.
Date of manufacture (year)
Indicates the original year of manufacture of the device.
Type CF applied part, defibrillation-proof
Identifies a defibrillation-proof, type CF applied part of medical equipment that
meets the requirements of the standard EN IEC 60601–1. This device fulfills the
requirements for protection against electric shock for a non-grounded (floating)
applied part intended for direct cardiac application.
International Protection Code (Ingress Protection Rating)
Classifies and evaluates the protection of the 1-channel transmitter against
ingress of solid foreign objects (such as hands and fingers, dust, unintentional
contact) and liquids. The first digit (4) indicates the protection against solid for-
eign objects: in this case the protection against ingress of objects with a diame-
ter of 1.0 mm and more. The second digit (2) indicates the protection against
ingress of liquids: in this case the protection against vertically falling drops
when the enclosure is tilted at an angle up to 15° from its normal position.
ATTENTION
The protection rating applies only to the following condition:
IP42 applies only when the battery cover of the 1-channel transmitter is closed.
Before starting a recording and before cleaning and disinfecting the device,
make sure that the battery compartment is properly closed.
International Protection Code (Ingress Protection Rating)
Classifies and evaluates the protection of the receiver against ingress of solid
foreign objects (such as hands and fingers, dust, unintentional contact) and liq-
uids. The first digit (2) indicates the protection against solid foreign objects: in
this case the protection against ingress of objects with a diameter of 12.5 mm
and more. The second digit (0) indicates the protection against ingress of liq-
uids: in this case no protection.
Protection class II equipment.
Indicates that the receiver is a protection class II device.

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This side up
Indicates the correct position of the 1-channel transmitter on the adapter.
MR Unsafe
Indicates that the ECG system must not be used in the vicinity of MR scanners.
Correct washing at 40°C
Indicates that the maximum washing temperature for the chest belt is 40°C.
Do not tumble dry
Indicates that the chest belt must not be tumble dried after washing.
Do not bleach
Indicates that the chest belt must not be bleached.
Do not dry clean
Indicates that the chest belt must not be dry cleaned.
Do not iron
Indicates that the chest belt must not be ironed.
Indicates the size of the chest belt.
FCC Approval (USA only)
Indicates that the 1-channel transmitter and the receiver comply with part 15
of the FCC rules. Operation is subject to the following two conditions: (1) This
device may not cause harmful interference, and (2) this device must accept any
interference received, including interference that may cause undesired opera-
tion.
Follow instructions in accompanying documents
Read and understand the instructions for use before using the device or product.
This is a "mandatory sign" identified by a white symbol on a blue background.
Rx Only
Please note that US Federal Law restricts the device to be used by a physician or
on the order of a physician.
QR code
Readable with a QR code reader. Provides the following information: serial
number or lot (batch) number, UDI number, and date of manufacture.
Caution
Consult accompanying documents.
There may be special warnings or precautions for the device that are not printed
on the label. For further information on the safe use of the device, refer to the
supplied documentation.
MR