ergoline ers2 System Manual
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ergoline ers2 System Manual

ergoline ers2 System Manual

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

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Summary of Contents for ergoline ers2

  • Page 1 – 1-Channel ECG Telemetry System System Manual 201000401000 • Version 2020-09-24 / Rev 04 • English...
  • Page 3 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.
  • Page 4 Manufacturer Distributor 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 2 | 2 201000401000 /Rev 04...

  • Page 5: Table Of Contents

    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 ers2 – 1-Channel ECG Telemetry System 201000401000 /Rev 04...
  • Page 6 Application Software ers2 ........
  • Page 7 Revision Software Version Comment/Note 2015-02-15 – initial release 2015-10-22 – ers2 software version 1.4 and later – general adaptations – telemetry firmware version < 5.0 2016-07-19 – ers2 software version 1.4 and later – added ECG system information – telemetry firmware version < 5.0 –...
  • Page 8 6 | 6 201000401000 / Rev 04...

  • Page 9: General Notes

    Please note that US Federal Law restricts this ECG system to be used by a physician or on the order of a physician. 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.
  • Page 10 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 verifi- cation of compliance with the requirements for electrical safety and of the essential performance.

  • Page 11: Definitions

    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. ers2 – 1-Channel ECG Telemetry System 201000401000 / Rev 04...

  • Page 12: Intended Use

    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 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.

  • Page 13: Patient Characterization

    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. ers2 – 1-Channel ECG Telemetry System 201000401000 / Rev 04...

  • Page 14: Provisions And Safety Information

    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.
  • Page 15 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.
  • Page 16 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.

  • Page 17: System And Data Security

    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.

  • Page 18: 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.

  • Page 19: Symbols

    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. ers2 – 1-Channel ECG Telemetry System 201000401000 / Rev 04...
  • Page 20 2 Definitions 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.
  • Page 21 (EU) 2017/745 of the European Parliament and the Council, and with Annex 2 in particular. On/Off button Pressing the On/Off button switches the 1-channel transmitter on and off in the current operating mode. ers2 – 1-Channel ECG Telemetry System 201000401000 / Rev 04...

  • Page 22: Components

    Spare part; if a defect is identified during visual inspection. Replacement by primary user. 3.1 Information on Product and Packaging This section describes the labels and type plates used on the device and its packaging. Each ergoline device has a type plate that bears the product designation, part number, manufacturer informa- tion, and unique serial number or batch number.
  • Page 23 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...
  • Page 24 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 pack- aged adapter (within kit) Label of individually pack- aged chest belt (within kit) 22 | 22 201000401000 / Rev 04...

  • Page 25: Unique Device Identification (Udi)

    Via the applied part, the 1-channel transmitter acquires a single-channel, bipolar raw ECG signal and sends it to a medical application software or other ME equipment by radio transmission. The 1-channel transmitter is a type CF, defibrillation-proof applied part. ers2 – 1-Channel ECG Telemetry System 201000401000 / Rev 04...

  • Page 26: Normal Operation Mode

    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: Operation LED Status Operating Status Switching ON to normal LED is illuminated while button Transmitter ON, initializing...

  • Page 27: Receiver

    A receiver can connect to a maximum of six 1-channel transmitters. Operating controls • USB cable port Front view • Indicator LED: ON/OFF – status • Function LEDs S1 and S2 Rear view • Threaded inserts for installation ers2 – 1-Channel ECG Telemetry System 201000401000 / Rev 04...

  • Page 28: Chest Belt

    3 Components Function LEDs LED Indicator Operating Status Power supply LED on = receiver ON, powered via USB LED off = receiver OFF, no power supply via USB LED on = receiver ready for connection to transmitter LED off = receiver not ready for connection LED on = receiver is connected to at least one transmitter LED off = receiver is not connected to any transmitter 3.4 Chest Belt...

  • Page 29: Adapter

    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-chan- nel transmitter. The adapter is intended for use on intact skin of adult patients for an extended period of time.

  • Page 30: Start-Up And Preparation

    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.

  • Page 31: 1-Channel Transmitter

    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.

  • Page 32: Replacing The Battery Of The 1-Channel Transmitter

    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 conduc- tive materials. It is not permitted to replace the battery of the 1-channel transmitter while the transmitter is applied to the patient.

  • Page 33: Battery Management Of The 1-Channel Transmitter

    If you follow this advice, you will not have to replace the battery between training units. We recommend replacing a battery with a charged battery after 5 to 6 operating hours. ers2 – 1-Channel ECG Telemetry System 201000401000 / Rev 04...

  • Page 34: Attaching The Ecg System To The Patient

    ECG system must be repaired before it can be used again. Follow the instructions for visual inspection given in this manual. Visually inspect the ECG system before each use. If one of the checks fails, please contact your ergoline service partner for further information. Visual Inspection Pass...

  • Page 35: Applying The 1-Channel Transmitter And Chest Belt

    If the chest belt is not properly applied, the ECG data may be incorrect or missing, which may lead to inadequate therapy and/or over-exertion. Check the 1-channel transmitter for correct application to the chest belt and patient according to the instructions in this manual. ers2 – 1-Channel ECG Telemetry System 201000401000 / Rev 04...

  • Page 36: Applying The Chest Belt

    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 repro- cessed according to the instructions in this manual and if used on the same patient.

  • Page 37: Attaching And Switching On The 1-Channel Transmitter

    • 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. • Check that the ergoline logo on the 1-channel transmitter and on the chest belt is presented in the proper orientation. (Figure 3) Figure 3 •...

  • Page 38: Removing The 1-Channel Transmitter And Chest Belt

    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.

  • Page 39: Attaching And Switching On The 1-Channel Transmitter

    Check that the battery cover of the 1-channel transmitter rests in the corresponding groove in the cradle. • Check that the ergoline logo on the 1-channel transmitter is presented in the proper orientation. • After attaching the 1-channel transmitter to the adapter, switch it on.

  • Page 40: Removing The Adapter With The 1-Channel Transmitter From The Patient

    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. •...

  • Page 41: Cleaning And Disinfection Instructions

    Clean and disinfect the devices before their first use, before applying them to a patient, and after removing them from a patient. Clean and disinfect the devices when sending them to ergoline or a certified ergoline service partner. Observe the following information for cleaning and disinfection.

  • Page 42: Disinfection

    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. •...

  • Page 43: Chest Belt

    • Dampen a clean cloth with distilled water. • Wring excess liquid from the cloth. • Wipe the exterior surfaces of the receiver. • Use another clean cloth to dry the surface of the receiver. ers2 – 1-Channel ECG Telemetry System 201000401000 / Rev 04...

  • Page 44: Maintenance Information

    The user is responsible for informing ergoline or one of the authorized representatives of any required maintenance. 42 | 42...

  • Page 45: Warranty Information

    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 recom- mend performing the following functional tests within the application software.

  • Page 46: Firmware Update

    The secondary user can obtain the firmware version of the 1-channel trans- mitter using the maintenance software. Please contact your ergoline service partner for more information.

  • Page 47: Disposal

    If you have questions regarding the disposal, please contact ergoline or its representatives. The batteries have to be taken to a collection point. They need to be recycled.

  • Page 48: Technical Specifications

    9 Technical Specifications Technical Specifications 9.1 1-Channel Transmitter 9.1.1 General Data Description Data Classification Device with internal power supply; type CF, defibrilla- tion-proof applied part; class IIa Number of ECG channels Operating mode Continuous operation Operating time on battery power Approx.

  • Page 49: Environment

    Dimensions length: 84 mm width: 48 mm depth: 17.5 mm Weight 44 g (w/o. battery) 56 g (with battery) Material ABS (housing) Degree of protection IP 42 10.75 44.5 16.75 ers2 – 1-Channel ECG Telemetry System 201000401000 / Rev 04...

  • Page 50: Application Software Ers2

    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 <= 0.8 mV, the heart rate indication is within the specified error limits (+/–...

  • Page 51: Chest Belt

    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 ers2 – 1-Channel ECG Telemetry System 201000401000 / Rev 04...

  • Page 52: Dimensions

    9 Technical Specifications 9.4.2 Dimensions Reference Description Dimension Permitted Letter Deviation Length of chest belt 880 mm +/– 20 mm Width of chest belt 30 mm +/– 1 mm Distance between snap fastener contacts from 44.5 mm +/– 0.5 mm center to center Length of sensor module 270 mm...

  • Page 53: Dimensions

    Length of cradle 87 mm +/– 1 mm Distance between snap fastener contacts from center to center 44.5 mm +/– 0.5 mm 75.74 44.5 15.3 31.63 15.72 47.5 87.01 115.16 ers2 – 1-Channel ECG Telemetry System 201000401000 / Rev 04...

  • Page 54: Electromagnetic Compatibility (Emc) Din En 60601-1-2

    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.
  • Page 55 (> 95 % dip in UT) a typical commercial or hospital environ- supply input lines to EN 61000-4-11 for 0.5 cycles ment. If the user of the ergoline ECG telemetry system requires continued opera- 40 % UT tion during power mains interruptions, it is...
  • Page 56 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. Immunity Test IEC 60601 Test Level Compliance...
  • Page 57 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 affected by absorption and reflection from structures, objects, and people. ers2 – 1-Channel ECG Telemetry System 201000401000 / Rev 04...
  • Page 58 10 Electromagnetic Compatibility (EMC) DIN EN 60601-1-2 201000401000 • Version 2020-09-24 / Rev 04 • English 56 | 56...
  • Page 60 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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