ers2 – 1-Channel ECG Telemetry System System Manual 201000401000 • Version 2020-09-24 / Rev 04 • English
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.
Manufacturer Distributor ergoline GmbH Lindenstrasse 5 72475 Bitz Germany Tel.: Fax: e-mail: http: +49-(0)-7431 - 9894 - 0 +49-(0)-7431 - 9894 - 128 info@ergoline.com www.ergoline.
Contents 1 General Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 1.1 2 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 2.1 2.2 2.3 2.4 2.5 3 3.2 3.3 3.4 3.5 Information on Product and Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.1.1 Unique Device Identification (UDI) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-Channel Transmitter .
Cleaning and Disinfection Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . 39 6.1 6.2 6.3 6.4 7 7.2 7.3 7.4 9 39 39 40 40 40 40 41 41 41 41 Maintenance Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 7.1 8 1-Channel Transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.1.1 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.1.
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.
66 | 201000401000 / Rev 04
1 General Notes 1 General Notes 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.
1 General Notes 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 verification of compliance with the requirements for electrical safety and of the essential performance.
2 Definitions 2 Definitions The following terms are used in this document. ergoline English ETS ECG system ETS1 1-channel system ETS1 Transmitter 1-channel transmitter ETS1 Adapter adapter ETS1 Chestbelt chest belt ETS Receiver receiver 2.1 Meaning of the Signal Words Risk is defined as a source of potential injury to a person or property damage.
2 Definitions 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 medical 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.
2 Definitions Equipment (typically used to perform the tasks): Application software, ECG maintenance software, ECG simulator Expected training (related to the medical device): One 1-hour training session by manufacturer 2.2.2 Patient Characterization Indications • Adult patients whose electrical activity of the heart needs to be continuously monitored to control the training sessions.
2 Definitions 2.3 Provisions and Safety Information This section contains information on the safe use of the system and on observance of legal regulations. 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.
2 Definitions 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.
2 Definitions 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 reliability of the ECG system.
2 Definitions 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 cybersecurity can result in compromised device functionality, loss of data (medical or personal) availability or integrity, or expose other connected devices or networks to security threats. 2.3.
2 Definitions NOTICE 2.3.4 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 radiate radiofrequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.
2 Definitions 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.
2 Definitions This side up Indicates the correct position of the 1-channel transmitter on the adapter. MR 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.
2 Definitions Temperature limits Indicates the temperature limits for transport, storage, and handling of the package. The limit values are indicated next to the upper and lower horizontal lines. Disposal of electric devices Indicates that this system contains electric or electronic components that must be collected and disposed of separately from household waste. For information about disposal of the device, please contact an authorized representative of the manufacturer.
3 Components 3 Components 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. The ECG system is provided as 1-channel transmitter kits with different contents. If a packaging unit is damaged, please inform your ergoline service partner.
3 Components Picture Label Location Type plate Back of the 1-channel transmitter Type plate Inside of the adapter Type plate Sewed on elastic chest belt Type plate Underside of the receiver ers2 – 1-Channel ECG Telemetry System 201000401000 / Rev 04 21
3 Components Label Package containing 1-channel transmitter kit (chest belt) Label Package containing 1-channel transmitter kit (adapter) Label Package containing receiver Label of individually packaged adapter (within kit) Label of individually packaged chest belt (within kit) 2222 | 201000401000 / Rev 04
3 Components 3.1.1 Unique Device Identification (UDI) The Unique Device Identification (UDI) system is a globally harmonized system for the identification of medical devices in machine-readable form. The following UDI information for each component of the ECG system is saved in the form of a bar code on the respective type plates. This bar code can be read with an appropriate reading device (e.g., a cell phone).
3 Components 3.2.1 Normal Operation Mode The primary user operates the 1-channel transmitter in normal mode. On/Off button and function indicator LED These are the functions of the button and function indicator LED in normal mode: 3.2.
3 Components These are the functions of the button and function indicator LED in the firmware update mode: Operation LED Status Operating Status Switching on to firmware update mode • Press On/Off button for more than 30 seconds and release LED is illuminated while button is held down Initializing Wait for connection LED continuously flashing (3 short blinks and 2 long blinks) Transmitter waiting for connection in firmware update mode Firmware update mode LED continuously flashing (3 short blinks
3 Components Function LEDs LED Indicator Operating Status 1 Power supply LED on = receiver ON, powered via USB LED off = receiver OFF, no power supply via USB 2 S1 LED on = receiver ready for connection to transmitter LED off = receiver not ready for connection 3 S2 LED on = receiver is connected to at least one transmitter LED off = receiver is not connected to any transmitter 3.
3 Components Back 3.5 Adapter Intended use The adapter is used to conduct the ECG signal via two ECG leadwires connected to commercially available ECG monitoring electrodes from the surface of the skin to the attached ergoline 1-channel transmitter. The adapter is intended for use on intact skin of adult patients for an extended period of time. It is used for ECG monitoring in rehabilitation programs. The device is non-critical and supplied non-sterile.
4 Start-up and Preparation 4 Start-up and Preparation 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. The 1-channel ECG system is, among other options, operated with the ergoline ers2 application software. It is not possible to operate the system without software.
4 Start-up and Preparation 4.2 1-Channel Transmitter During commissioning, an ergoline service partner needs to configure the 1-channel transmitter in the application software. • Clean and disinfect the 1-channel transmitter according to the instructions in this manual. • Insert the AAA battery into the 1-channel transmitter according to the instructions in this manual. • Switch on the 1-channel transmitter according to the instructions in this manual for the normal operation mode.
4 Start-up and Preparation 4.2.1 Replacing the Battery of the 1-Channel Transmitter WARNING Remove transmitter from patient before battery replacement Electric shocks or malfunction of the 1-channel transmitter may result from contact with conductive materials. It is not permitted to replace the battery of the 1-channel transmitter while the transmitter is applied to the patient. Replace the battery according to the instructions in this manual.
4 Start-up and Preparation The 1-channel transmitter is powered from a commercially available, rechargeable AAA battery. • Open the battery compartment of the 1-channel transmitter by turning the cover counterclockwise. • To remove a battery, hold the 1-channel transmitter in one hand and tilt it a bit, allowing the battery to slide out of the compartment. • For insertion of a charged battery, hold the 1-channel transmitter upright in one hand or place it vertically on a table.
5 Attaching the ECG System to the Patient 5 Attaching the ECG System to the Patient 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. CAUTION Insufficient ECG transmission quality Line isolation monitor transients may resemble actual cardiac waveforms and thus inhibit heart rate alarms.
5 Attaching the ECG System to the Patient Check the contact spring in the battery compartment for wear due to improper battery replacement. Expected result: spring not bent Check the rechargeable batteries for wear (e.g., legibility of labeling, intact insulation). Expected result: no signs of wear, insulation intact Check the chest belt: Strap as elastic as it used to be, ECG electrodes not protruding, no loose stitching.
5 Attaching the ECG System to the Patient CAUTION Risk of infection Using the chest belt on another patient may cause cross-infections. The chest belt is intended for use on a single patient only. The product can be reused if reprocessed according to the instructions in this manual and if used on the same patient. NOTICE Damaged chest belt A damaged chest belt may adversely affect the ECG transmission quality. To avoid damage, do not kink or coil the chest belt or bend it sharply.
5 Attaching the ECG System to the Patient Figure 2 • Check that the ergoline logo on the chest belt is presented in the proper orientation. 5.2.2 Attaching and Switching On the 1-Channel Transmitter The 1-channel transmitter and the chest belt are connected to each other by means of the integrated snap fasteners. • Press the studs of the two snap fasteners on the 1-channel transmitter into the sockets of the snap fasteners on the chest belt until you feel them engage.
5 Attaching the ECG System to the Patient 5.2.3 Removing the 1-Channel Transmitter and Chest Belt After use, please remove the chest belt with the 1-channel transmitter from the patient. • Adjust the chest belt with the 1-channel transmitter to a position where the clasp is directly below the sternum. • Open the chest belt by lifting the belt loop out of the clasp. • Pull the side of the chest belt with the belt loop around the patient's upper body and towards you.
5 Attaching the ECG System to the Patient NOTICE Damaged adapter A damaged adapter may adversely affect the ECG transmission quality. To avoid damage, do not kink or coil the adapter and its cables or bend them sharply. Apply and secure the adapter according to the instructions in this manual. • Make sure that the adapter and the 1-channel transmitter are dry. • The ECG telemetry electrode adapter is worn underneath clothing; the adhesive ECG electrodes must be attached directly on the patient's skin.
5 Attaching the ECG System to the Patient 5.3.4 Removing the Adapter with the 1-Channel Transmitter from the Patient • • • • Carefully disconnect the leadwires from the ECG electrodes. Remove the adapter with the 1-channel transmitter from the patient. Carefully remove the ECG electrodes from the patient following the manufacturer's instructions.
6 Cleaning and Disinfection Instructions 6 Cleaning and Disinfection Instructions 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. NOTICE Cleaning and disinfection Wrong cleaning agents or disinfectants or wrong application of these substances may damage the ECG system.
6 Cleaning and Disinfection Instructions 6.1.2 Disinfection Clean the 1-channel transmitter before disinfecting it. Recommended disinfectant: Isopropyl alcohol (IPA), 70 % solution, spray • • • • • • • Apply IPA spray to the surface from a distance of 15 to 20 cm until the entire surface is wet. Allow the solution to remain on the treated surface for at least 1 minute. Dry the treated surface with a clean cloth. Dampen a clean cloth with distilled water. Wring excess liquid from the cloth.
6 Cleaning and Disinfection Instructions 6.3 Chest Belt CAUTION Risk of infection Using the chest belt on another patient may cause cross-infections. The chest belt is intended for use on a single patient only. The product can be reused if reprocessed according to the instructions in this manual and if used on the same patient. Recommended cleaning agent and disinfectant: Ecolab Eltra 40 Extra 6.3.1 Cleaning and Disinfection • Put the chest belt into a laundry bag or mesh bag.
7 Maintenance Information 7 Maintenance Information 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. NOTICE Maintenance Proper maintenance by the secondary user is a primary condition for long-term safety and reliability of the ECG system.
7 Maintenance Information 7.1.1 Warranty Information Only authorized ergoline service partners are allowed to carry out maintenance. Improper repair of the device may render any existing warranty null and void. 7.2 Functional Test Functional tests can only be performed in conjunction with the application software. We recommend performing the following functional tests within the application software. For information on possible functional restrictions (e.g.
7 Maintenance Information FT1.4 Connect the 1-channel transmitter to the software. Expected result: Once the 1-channel transmitter is connected, a charging icon appears in the software. For charge levels above 40 % the icon is black. FT1.5 Connect the 1-channel transmitter to the software. Cover the 1-channel transmitter with your hand. Expected result: Once the 1-channel transmitter is connected, a connection icon appears in the software. The connection quality decreases.
8 Disposal 8 Disposal 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 prevent 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.
9 Technical Specifications 9 Technical Specifications 9.1 1-Channel Transmitter 9.1.1 9.1.2 General Data Description Data Classification Device with internal power supply; type CF, defibrillation-proof applied part; class IIa Number of ECG channels 1 Operating mode Continuous operation Operating time on battery power Approx. 6 hours of continuous operation Battery charging time 2.
9 Technical Specifications 9.1.3 Environment Description Data Operating conditions Temperature: +10 to +35 °C Rel. humidity: 30 to 75 % (no condensation) Atmospheric pressure: 700 to 1060 hPa Transport and storage conditions Temperature: –20 to +65 °C Rel. humidity: 10 to 95 % (no condensation) Atmospheric pressure: 500 to 1060 hPa 9.1.4 Bluetooth Module Description Data Transmission mode Bluetooth 2.1 + EDR, class 1 Frequency range 2402 – 2483.
9 Technical Specifications 9.2 Application Software ers2 Description Data Heart rate calculation The heart rate is calculated by the ers2 software which uses the Pan Tompkins algorithm for QRS detection. Tall T-wave rejection capability For T-waves <= 0.
9 Technical Specifications Antenna type integrated Maximum antenna gain 2.14 dBi Dimensions length: 11.3 cm width: 5.8 cm depth: 2.8 cm Weight 90 g Enclosure ABS Operating conditions Temperature: +10 to +35 °C Rel. humidity: 30 to 75 % (no condensation) Atmospheric pressure: 700 to 1060 hPa Transport and storage conditions Temperature: –20 to +65 °C Rel. humidity: 10 to 95 % (no condensation) Atmospheric pressure: 500 to 1060 hPa 9.4 Chest Belt 9.4.
9 Technical Specifications 9.4.2 Dimensions Reference Letter Description Dimension Permitted Deviation A Length of chest belt 880 mm +/– 20 mm B Width of chest belt 30 mm +/– 1 mm C Distance between snap fastener contacts from center to center 44.5 mm +/– 0.
9 Technical Specifications Biocompatibility ISO10993 Operating conditions Temperature: +10 to +35 °C Rel. humidity: 30 to 75 % (no condensation) Atmospheric pressure: 700 to 1,060 hPa Transport and storage conditions Temperature: –20 to +65 °C Rel. humidity: 10 to 95 % (no condensation) Atmospheric pressure: 500 to 1,060 hPa 9.5.2 Dimensions Description Dimension Permitted Deviation Length of silicone cord 1020 mm +/– 10 mm Length of ECG leadwire 250 mm +/– 15 mm Width of cradle 58.
10 Electromagnetic Compatibility (EMC) DIN EN 60601-1-2 10 Electromagnetic Compatibility (EMC) DIN EN 60601-1-2 Changes or modifications to this system not expressly approved by ergoline could cause EMC issues with this or other equipment. This system is designed to comply with applicable regulations regarding EMC. Its compliance with these requirements has been verified. It needs to be installed and put into service according to the EMC information stated as follows.
10 Electromagnetic Compatibility (EMC) DIN EN 60601-1-2 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The ECG system is intended for use in the electromagnetic environment specified below. It is the responsibility of the customer or user to ensure that the ECG system is used in such an environment.
10 Electromagnetic Compatibility (EMC) DIN EN 60601-1-2 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The ECG system is intended for use in the electromagnetic environment specified below. It is the responsibility of the customer or user to ensure that the ECG system is used in such an environment.
10 Electromagnetic Compatibility (EMC) DIN EN 60601-1-2 Recommended separation distances between portable and mobile RF communications equipment and the ergoline 1-channel transmitter The ECG system is intended for use in an electromagnetic environment, as specified below, in which radiated RF disturbances are controlled.
10 Electromagnetic Compatibility (EMC) DIN EN 60601-1-2 201000401000 • Version 2020-09-24 / Rev 04 • English 5656 |
ergoline GmbH Lindenstraße 5 72475 Bitz Germany Tel.: Fax: e-mail: http: +49-(0) 7431 98 94 - 0 +49-(0) 7431 98 94 - 128 info@ergoline.com www.ergoline.
