GERATHERM Ergostik Instructions For Use Manual
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GERATHERM Ergostik Instructions For Use Manual

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Ergostik
Serial numbers: xx|8|201|yyy and 2201xxxxx
Instruction for Use
Version: 7
Release date: 02. August 2021
Please read carefully and store in a place which is always accessible for future
consultation!

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Summary of Contents for GERATHERM Ergostik

  • Page 1 Ergostik Serial numbers: xx|8|201|yyy and 2201xxxxx Instruction for Use Version: 7 Release date: 02. August 2021 Please read carefully and store in a place which is always accessible for future consultation!
  • Page 2 Language: English Affected serial numbers: xx|8|201|yyy and 2201xxxxx Software version: valid from 1.1.0 Geratherm® Respiratory GmbH Kasernenstraße 4 97688 Bad Kissingen, GERMANY Tel.: +49 971 7857043-0 Fax: +49 971 7857043-30 info@geratherm-respiratory.com 0494 www.geratherm-respiratory.com EUDAMED SRN: © Geratherm® Respiratory GmbH DE-MF-000006818...

  • Page 3: Table Of Contents

    Consumable Items / Auxilary Materials ......... 32 Safety in Handling ..............33 General Safety at Work and Personnel Qualification ..... 34 The Technical State of Ergostik and System Construction .... 35 Operation / Servicing and Maintenance ........37 Electromagnetic Compatibility (EMC) ..........38 Cleaning and Disinfection .............
  • Page 4 Operating Instructions ............55 Checking for Worn Parts .............. 55 7.1.1 Minifilter / Permapure Check ............55 Establishing Operational Readiness ..........56 Switching Ergostik On / Off ............56 Inserting the Flow Sensor ............. 57 7.4.1 Assembly Face Mask ..............58 7.4.2 Assembly Silicone Mouthpiece .............
  • Page 5 12.2 Installation and Operating Conditions ........... 81 12.3 Electrical Safety Concept .............. 82 12.3.1 Ergostik with Medical Device Cart and Isolation Transformer ..82 12.3.2 Ergostik without Medical Device Cart and without Isolation Transformer .................. 83 12.4 Electromagnetic Compatibility / EMC Guidelines ......84 12.4.1...

  • Page 6: General Information

    This IFU is a component of the product in accordance with DIN EN ISO 60601-1. It should make it easier to familiarise yourself with Ergostik, as well as give you instructions about its intended use and safe operation. This IFU has been written for healthcare professionals who are qualified to perform cardiopulmonary exercise tests.

  • Page 7: Abbreviations

    If, in spite of careful reading of this IFU, you require more information, please contact your specialist retail partner on site. You can obtain the contact details via a form provided by the manufacturer at www.geratherm-respiratory.com/login/. Abbreviations The following simplified style of writing and abbreviations are used hereinafter to make this IFU easier to read.
  • Page 8 Not observing and not avoiding the situation may lead to minor or moderate injuries. Not observing this warning information may lead to faults or malfunctions of the Ergostik or may indicate that something in Attention its environment may be damaged.

  • Page 9: Symbols

    Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx Symbols Symbols displayed in this IFU, on the medical device itself and/or on its packaging are standardised symbols. Symbol Explanation Follow the instructions for use! Applied part from type BF corresponding to...
  • Page 10 For single use only! This symbol does not refer to the Ergostik itself, but to the consumable items used in connection with it. This is applied to the respective packaging and must be observed.
  • Page 11 Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx Symbol Explanation Conformity mark This symbol indicates conformity with health, safety and environmental protection standards for products sold 0494 within the European Economic Area (EEA). The additional four-digit number identifies the Notified Body involved in the conformity evaluation procedure of this product.

  • Page 12: Copyright

    Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx Copyright The manufacturer reserves all rights to this document and the information contained therein. No part of this document or the information contained herein may be reproduced or transmitted without the written consent of the manufacturer. All information or brand names of a third party contained in this document are subject to the copyright of that third party.

  • Page 13: Conditions Of Use

    Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx Conditions of Use Any other use of Ergostik which is not described in this IFU is deemed improper use. The responsible organisation of Ergostik alone is liable for any direct or indirect damage resulting from not adhering to these conditions.
  • Page 14 Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx Examination Required option Bronchoprovokation Provokation ( 403680) Resting Energy Expenditure / REE ( 526143) Resting Metabolic Rate You can find more information in: • IFU Spirometry for carrying out the examination •...

  • Page 15: Indication

    Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx 2.1.1 Indication The Ergostik can be used for cardio-pulmonary (exercise) tests for diagnosis, follow-up, screening and severity assessment of pulmonary diseases. These include in particular: Evaluation of exercise intolerance Unexplained dyspnea...

  • Page 16: Contraindication And Side Effect

    Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx 2.1.2 Contraindication and Side Effect 2.1.2.1 Contraindications The following contraindications apply to ergometric examinations: Contraindications Absolute Relative Acute myocardial infarction (3–5 days) Unstable angina Uncontrolled arrhythmias Syncope Active endocarditis Acute myocarditis or pericarditis...
  • Page 17 Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx High-degree atrioventricular block Hypertrophic cardiomyopathy Significant pulmonary hypertension Advanced or complicated pregnancy Electrolyte abnormalities Orthopedic impairment that compromises exercise performance As the transitions between absolute and relative contraindication can be fluid in the assessment, the assertion of a physician should be regarded as binding.

  • Page 18: Side Effects

    Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx 2.1.2.2 Side Effects If there are no contraindications and the examination is carried out in accordance with the descriptions in the IFU, cardio- pulmonary exercise testing is a safe examination, but in rare cases (1 per 10,000 examinations) serious cardiac incidents and death (2-5 per 100,000 examinations) can occur.
  • Page 19 Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx Syncope / Rare Treatment and initiation of emergency medical measures if necessary. Cancellation Criterion Absolute Relative ST-Depression ≥ 3 mm ST-Elevation ≥ 1 mm Blood pressure drop > 10 mmHg (compared to initial...

  • Page 20: Definition Of The Groups Of People

    Responsible Organisation is any natural or legal person who is responsible for the operation of the health institution where Ergostik is used by their employees (users). User is a medically trained specialist who is familiar with cardio-...

  • Page 21: Intended Use

    11.1 "Expected Service Life") and the maintenance work required for this (see chap. 8 "Servicing / Maintenance"). The Ergostik may only be used for the duration of its service life if the specifications are observed. Any changes to Ergostik, in particular unauthorised modifications, are prohibited.
  • Page 22 Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx The Ergostik is not intended for the control of vital physiological parameters where the nature of the change could lead to immediate danger to the patient, e.g. changes in heart function, respiration or central nervous system activity.

  • Page 23: Original Spare Parts / Accessories / Optional Expansions

    The installation or use of other products can, under certain circumstances, negatively change constructive prescribed properties of Ergostik and, in the worst case, impair the safety of the patient, operator and / or third parties. The manufacturer assumes no liability for such consequences.

  • Page 24: Original Spare Parts / Accessories

     Installation CD for intuitive [old:10.500] Windows based diagnostic software platform BLUE CHERRY®. Ergoflow 139094  Re-useable lightweight [old:10.600] Flow Sensor for use with Ergostik, PFTstik, Bodystik and Diffustik device. Page 24 Version: 7 | Release date: 02. August 2021...
  • Page 25 Ergoclip adapter for Ergoflow. Calibration Tube 862229  Tube 1,5 m with black [old:40.421] Luer connector for gas calibration of Ergostik.  Outer diameter 4 mm. Power Supply, 12 V 628020  Medical grade 12 V [old:10.841] power supply.
  • Page 26 Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx Component Description / name Supply scope in units Power Cord, CEE 7/16, C7 142297 (IEC 60320, EU) [old:10.838]  Power cord with European plug for use with power supply (12 V).

  • Page 27: Optional Expansions

    Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx 2.2.1.2 Optional Expansions The following add-ons can be purchased via specialist retail partners. You will find: • A list of specialist retail partners as an insert in this IFU or in your medical device book, as well as the most updated version at www.geratherm-respiratory.com/login/...
  • Page 28 2 liter / min.  For bottles with connector DIN 477-1:1990 No. 6. (External thread, right-hand thread, W 21.80 x 1/14”) Accessory Pack for Ergostik 852153 Standard accessory pack containing: [old:10.904]  2 x Exercise mask, (S and XS)  2 x Headgear, (M and S) ...
  • Page 29 Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx Component Description / name Exercise Mask, Pediatric (S) 838093 [old: 10.827]  Translucent silicon rubber exercise (L) 220830 mask for children and adolescents. [old: 10.828] Two sizes available. Headgear Small for Exercise Mask (XS) 380816 [old: 10.829]...
  • Page 30 Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx Component Description / name Polar® H3 Heart Rate Sensor 187078 [old:10.809]  Polar® H3 Heart Rate Sensor to measure heart rate and transmit to Pulstik. WristOx2® Model 3150 with BLE 816016 ...
  • Page 31 Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx Component Description / name Software option: BGA-Interface 131393  Imports results from blood gas [old:10.534] analyzers via ASTM or HL7. Software option: REE Software 526143  Software option for BLUE CHERRY®...

  • Page 32: Consumable Items / Auxilary Materials

    Consumable Items / Auxilary Materials The following items were tested by the manufacturer for Ergostik. The use of other consumable items as well as auxiliary materials with different properties is deemed improper use. You will find a list of specialist retail partners as an insert in this...

  • Page 33: Safety In Handling

    In spite of this, dangers of injury to operators / users, patients and third parties as well as damage to Ergostik or other materials may occur if this is: •...

  • Page 34: General Safety At Work And Personnel Qualification

    Always comply with general national regulations on accident prevention! Instruct users / operators accordingly! • Safety and warning information on Ergostik may not be altered or removed! Have missing or not readable information replaced immediately! • When working with auxiliary materials, always...

  • Page 35: The Technical State Of Ergostik And System Construction

    Misdiagnosis caused by measurement error. Therefore: • Do not overstress Ergostik! Use with care! • Do not modify or use product Ergostik or total system contrary to the respective manufacturer's specification! • Only use Ergostik within its expected service life, determined by the manufacturer! •...
  • Page 36 Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx • Ensure that the Ergostik cannot fall down! Otherwise, the functionality must be checked properly before putting it into operation! Reason: Electrical shock and / or misdiagnosis due to loss of electrical safety caused by exceeding the recommended maintenance schedule.

  • Page 37: Operation / Servicing And Maintenance

    Therefore: • In principle, observe chap. 12 “Technical Specifications"! • Do not operate Ergostik if there are flammable or explosive gases in the room! • Do not operate Ergostik near the magnetic field of an MRT system! Possible danger to life.

  • Page 38: Electromagnetic Compatibility (Emc)

    Therefore: • While using Ergostik, do not use any transmitting devices (e.g. mobile phones, portable phones, power lines …) that exceed the immunity levels as specified in the EMC guidelines! •...

  • Page 39: Cleaning And Disinfection

    Possible danger to life. Reason: Coss-contamination. For this: Observe general medical principles! Therefore: • Clean and disinfect Ergostik and its reusable components as instructed by the manufacturer at regular intervals as specified! Possible severe physical injury. Reason: Contamination with transferable germs during improper disposal.
  • Page 40 Ergostik could be damaged. Reason: Penetrating liquids into electronic components. Therefore: • Disconnect the Ergostik from the power supply before cleaning and disinfecting! • (When switching off via the On / Off switch of the equipment cart), shut down the PC completely before...

  • Page 41: Structure And General Function Of Ergostik

    Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx Structure and General Function of Ergostik Hardware 4.1.1 Overview Ergostik Medical power supply unit (see also chap. 4.1.3) Exercise tube set Ergoflow flow sensor (see also chap. 7.4) Ambistik Type label on the bottom of the case (see also chap. 14) Type label on the bottom of the Ambistik (see also chap.

  • Page 42: Connections/ Interfaces Of The Ergostik

    Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx 4.1.2 Connections/ Interfaces of the Ergostik 4.1.2.1 Ergostik Device and Connections Device front view Flow - Connection Flow + Connection Gas-Connection to show the power supply Device rear view Power-LED Calibration gas connection...

  • Page 43: Sensors

    • The separate IFU Volume Calibration Flow Sensor The heart of the Ergostik for precise flow measurement is the Ergoflow flow sensor. It must be calibrated after every cleaning and before the first examination of a day. As the flow sensor ensures the precise flow measurements, the cleaning and calibration requirements must absolutely be adhered to, regardless of the version selected.

  • Page 44: Pressure Reducer

    4.1.2.3 Pressure Reducer For safe use, a suitable pressure reducer for the calibration gas cylinder is required. Please note the following: Ergostik could be damaged Reason: Working pressure too high. Therefore: • Only use a pressure reducer that meets the...
  • Page 45 Reason: Electric shock due to lack of galvanic separation with composition of non-approved components. Therefore: • Do not modify or use Ergostik or total system contrary to the respective manufacturer's specification! Reason: Electrical shock and/or misdiagnosis due to loss of electrical safety caused by exceeding the recommended maintenance schedule.

  • Page 46: Data Connection

    Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx Ergostik could be damaged. Reason: Electrostatic discharges. Therefore: • Preferably no floor made of synthetic material! Attention • Otherwise a relative air humidity of at least 30 % is required! 4.1.3.1 Data Connection The hardware connection between the device and computer is established via an integrated USB interface and USB cable.

  • Page 47: Power Supply

    See also chap. 2.2.1.1 "Original Spare Parts / Accessories" Technical Protection Measures Ergostik has been designed and built in accordance with the recognised state of technology and the requirements of the applicable, safety-relevant regulations. The technical safety condition is checked by the authorised...
  • Page 48 Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx For further information see the separate IFU of BLUE CHERRY® − information on the configuration and use of the software BLUE CHERRY®. Page 48 Version: 7 | Release date: 02. August 2021...

  • Page 49: Transport, Storage And Assembly

    Requirements regarding space requirements, media connections and operating conditions can be found in chap. 12 "Technical Specifications". The responsible organisation of the Ergostik is solely in charge of compliance with these requirements. For storage and transport conditions see chap. 12 "Technical Specifications".

  • Page 50: Assembly

    Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx Assembly Installation or assembly for the first commissioning of the Ergostik may only carried out by qualified personnel of the manufacturer's specialist retail partners. Possible danger to life. Reason: Electric shock. Misdiagnosis caused by measurement error.

  • Page 51: Operation

    Ergostik is only completely ready to function after calibration and once the initial operation is complete. Recommissioning after Servicing / Cleaning Work...

  • Page 52: Assembly Calibration Tube

    USB connection to the computer must be established, and the Ergostik must be connected to the power supply and calibrated. Calibration also fulfils the regulatory requirements of MPBetreibV §7 for functional testing after maintenance work.
  • Page 53 Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx 1. Remove the red protective caps from the calibration gas connection [1] and gas exhaust [2]. For this: Unscrew the protective caps counterclockwise so that the white marked connections [3] are accessible.

  • Page 54: Power Supply And Pc-Connection

    (See chap. 2.2.1.1 “Original Spare Parts / Accessories“) Connect the Ergostik in order to make it ready for operation: 1. USB- connection cable [1] to the USB socket of the Ergostik.

  • Page 55: Operating Instructions

    Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx Operating Instructions Checking for Worn Parts The Ergostik should be checked for defective wearing parts each day before beginning treatments. You can get a description in: • Chap. 8 “Servicing / Maintenance”...

  • Page 56: Establishing Operational Readiness

    Otherwise, the On / Off switch on the back of the Ergostik must be activated. To extend the life of the gas sensors, the Ergostik should be switched off if there are long intervals between measurements. After switching on the Ergostik needs a warm-up time of 15 minutes.

  • Page 57: Inserting The Flow Sensor

    Ergostik [2] For this: Screw the flow- [1a] and gas tubes [1b] clockwise to the color- coded connections on the front of the Ergostik. 2. Insert the Ergoflow flow sensor [3]. For this: Press the side with the connection pins [3a]...

  • Page 58: Assembly Face Mask

    Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx 7.4.1 Assembly Face Mask 1. a) Assemble the mask adapter [5] to the face mask [6]. For this: Press the adapter through the round opening of the silicone mask so that the lower...

  • Page 59: Assembly Silicone Mouthpiece

    Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx 7.4.2 Assembly Silicone Mouthpiece 1. Assemble the flow sensor in the Ergoclip adapter to the silicone mouthpiece. For this: Press the flow sensor with the patient close side into the receptacle provided on the adapter.

  • Page 60: Calibrating Ergostik

    Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx Calibrating Ergostik There are various processes to be carried out for Ergostik in order to calibrate or validate the volume and gas measurement. The required intervals can be found in the tables below. For details on individual calibrations, please read: •...
  • Page 61 Therefore: • While using Ergostik, do not use any transmitting devices (e.g. mobile phones, portable phones, power lines …) that exceed the immunity levels as specified in the EMC guidelines! •...

  • Page 62: Exchange Of Disposable Products / Disinfection

    Ergostik could be damaged. Reason: Penetrating liquid. Uncleanliness. External exposure. Therefore: • Do not use any liquids near Ergostik! • Do not expose Ergostik or the entire system to dust or other contamination! • Do not drop any objects on Ergostik! Attention •...

  • Page 63: Ergoflow / Mask / Mouthpiece

    Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx For further weekly cleaning and disinfection tasks, please see: • Chap. 9 “Cleaning and Disinfection” Information about disposal of the disposable products can be found in: • Chap. 11.3 "Disposal" 7.7.2...

  • Page 64: Servicing / Maintenance

    The expected service life of Ergostik is 8 years. In its development, a great deal of value was placed on making the servicing of all device components as simple as possible.

  • Page 65: Servicing / Maintenance By The User / Operator

    Attention chap. 8 “Servicing / Maintenance by the User”! Servicing / Maintenance by the User / Operator In order to ensure a flawless operation of Ergostik over its whole service life, regular servicing and repairs, if applicable, are required. Intervall...

  • Page 66: Checking / Exchanging Of Tubes And Cables

    8.2.1 Checking / Exchanging of Tubes and Cables All parts of Ergostik should be checked for visible mechanical damage (cracks, tears) each day. If damage is ascertained, the corresponding component must be replaced. For replacing components see: •...

  • Page 67: Cleaning And Disinfection

    The devices of the manufacturer were designed in such a way that minimal effort is required for cleaning and disinfection. This is why just a few tasks are necessary to keep Ergostik functional and clean. Cleaning and disinfection may cause discolouration of the components, but without impairing their function.

  • Page 68: Single Use

    Chap. 7.7 “Exchange of Disposable Products / Disinfection” Disinfection All parts of the Ergostik can be cleaned of dirt with a soft cloth using a cleaning solution / weak soapy water. All parts of Ergostik which come into contact, or could come into contact, with the patient must be treated with a surface disinfection.
  • Page 69 Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx When using a disinfectant that has not been tested and approved by the manufacturer, the following steps must be observed: • Preferably use agents that correspond in composition to the approved agents. The composition is available on data sheets, which we can provide on request.
  • Page 70 Follow the instructions on the concentration and dwell time stated by the cleanser and disinfectant manufacturer! • Do not place Ergostik in the cleaning and disinfection solutions! The device contains electrical components that will be damaged by doing so! For the selection of suitable disinfectants please note: •...

  • Page 71: Ergostik

    Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx 9.2.1 Ergostik All parts of the Ergostik which come or could come into contact with the patient must be treated with surface disinfection. 9.2.2 Flow Sensor- / Ergoclip Removal 1. Remove Ergoflow.
  • Page 72 Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx Ergostik could be damaged Reason: destruction of the orifice. Therefore: • Do not clean the interior of the sensor, mechanical or with hard water jet! • Do not use any disinfectants which contain high chloride concentrations! Reason: Improper treated components.

  • Page 73: Removing The Silicone Mask / Adapter

    Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx 9.2.3 Removing the Silicone Mask / Adapter 1. Remove the adapter. (In reserve order as described in chap. 7.4.1 “Assembly Face Mask“) 2. Wipe off visible contamination. with a soft cloth.

  • Page 74: Fault Indication And Repair

    Serial no.: xx|8|201|yyy and 2201xxxxx Fault Indication and Repair Simple errors which occur when using Ergostik can be recognised quickly and rectified using the following table. If you cannot find the error in the table or the problem cannot be rectified using the method described, please contact your specialist retail partner.
  • Page 75 Check for moisture in the tube / connection piece of the Ergoflow Perform gas calibration Drift on gas signal Note the warm-up time of the Ergostik (15 minutes) Check for moisture in the tube / connection piece of the Ergoflow...
  • Page 76 Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx Software error message Check tube connection between Ergoclip and "O out of measuring Ergostik range“ Check for moisture in the tube / connection piece of the Ergoflow Check gas outlet for blockage...

  • Page 77: Decommissioning / Disposal

    11.3.2 Ergostik Ergostik is an active medical device and is thus subject to the WEEE directive 2012 / 19 / EU and the German law on electrical and electronic devices (ElektroG) for the disposal for old electrical items.

  • Page 78: Infectious / Contaminated Single Use Items

    Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx 11.3.3 Infectious / Contaminated Single Use Items All contaminated items such as mouthpieces and noseclips must be disposed of trough the hospital or medical practice waste. Possible severe physical injury. Reason: Contamination with transferable germs during improper disposal.

  • Page 79: Technical Specifications

    Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx Technical Specifications 12.1 Technical Data Medical device: Class IIa (in accordance with MDD 93 / 42 Council Directive of 14/6/1993 annex IX) Dimensions: (L) 210 mm x (W) 175 mm x (H) 75 mm...
  • Page 80 Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx Volume: Measuring range: 0 – 20 l Accuracy: ±3 % or 50 ml Principle: Electrochemical cell Range: 1 - 100 % Accuracy: ± 0.1 vol% (13 % - 21 %) / ± 1 % FS t10-90: <...

  • Page 81: Installation And Operating Conditions

    12.2 Installation and Operating Conditions The following conditions supplement chap. 2.2 "Intended Use" and must be observed to maintain the properties of the Ergostik guaranteed by the manufacturer and for the safety of the patient and operator. Storage / Transport: min.

  • Page 82: Electrical Safety Concept

    Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx 12.3 Electrical Safety Concept 12.3.1 Ergostik with Medical Device Cart and Isolation Transformer Page 82 Version: 7 | Release date: 02. August 2021...

  • Page 83: Ergostik Without Medical Device Cart And Without Isolation Transformer

    Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx 12.3.2 Ergostik without Medical Device Cart and without Isolation Transformer Version: 7 | Release date: 02. August 2021 Page 83...

  • Page 84: Electromagnetic Compatibility / Emc Guidelines

    12.4.1 Emitted Interference Guideline and Manufacturer Declaration Guidelines and manufacturer’s declaration – electromagnetic emissions The Ergostik is determined for operation in an electromagnetic environment as specified below. The user / operator of the Ergostik should ensure that it is operated in this environment. Measurement of Compliance Electromagnetic environment –...

  • Page 85: Interference Resistance For All Me Systems Guideline And Manufacturer Declaration

    Guidelines and manufacturer’s declaration – electromagnetic interference immunity The Ergostik is determined for operation in an electromagnetic environment as specified below. The user/operator of the Ergostik should ensure that it is operated in this environment. Measurement of IEC 60601 – test...

  • Page 86: Interference Resistance For None-Life-Supporting Me Systems Guideline And Manufacturer Declaration

    Guidelines and manufacturer’s declaration – electromagnetic interference immunity The Ergostik is determined for operation in an electromagnetic environment as specified below. The user/operator of the Ergostik should ensure that it is operated in this environment. Measurement of IEC 60601 -level...
  • Page 87 If the measured field strength at the site where the Ergostik is used exceeds the abovementioned compliance levels, the Ergostik should be observed to demonstrate its intended function.

  • Page 88: Recommended Safety Distances For Non-Life-Supporting Me Systems

    Recommended safety distance between portable and mobile RF communication devices and the Ergostik The Ergostik is determined for operation in an electromagnetic environment in which the RF disturbances are controlled. The user/operator of the Ergostik may help to avoid electromagnetic...

  • Page 89: Safety Of Product And Material

    DIN EN ISO 10993- 1:2017-04 "Biological evaluation of medical devices" (biocompatibility). Ergostik is a class IIa active medical device. Conformity with the underlying standards and directives is certified in the declaration of conformity which is included in the documentation accompanying the device.

  • Page 90: Product Labeling / Type Label

    Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx Product Labeling / Type Label The type label can be found on the bottom of the Ergostik. • See chap. 4.1.1 “Overview” point [6]. For more information about the symbols: •...

  • Page 91: Warranty And Service

    Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx Warranty and Service 15.1 General Conditions The manufacturer guarantees that the products you have purchased fulfill the listed technical data and that the medical devices are free from technical material and production defects.

  • Page 92: Packaging And Shipping

    Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx 15.3 Packaging and Shipping To avoid damage during transport, devices must be sent along with the warranty claim in the original packaging. This also applies for defective devices being repaired. Transport damage arising from improper packing is the responsibility of the customer.

  • Page 93: Authorised Specialist Retail Partner

    Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx Authorised Specialist Retail Partner You can reach your responsible specialist retail partner via a contact form of the manufacturer www.geratherm-respiratory.com/login/ see depositors Version: 7 | Release date: 02. August 2021 Page 93...

  • Page 94: Attachment - Declaration Of Conformity

    Instructions for Use Ergostik Serial no.: xx|8|201|yyy and 2201xxxxx Attachment – Declaration of Conformity The Ergostik declaration of conformity is enclosed with each device by the manufacturer. Page 94 Version: 7 | Release date: 02. August 2021...

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