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Summary of Contents for GERATHERM Ergostik Blueflow
- Page 1 Ergostik Blueflow Serial numbers: xx|8|201|yyy and 2203xxxxx Instruction for Use Version: 6 Release date: 02 August 2022 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 2203xxxxx 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...
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Page 3: Table Of Contents
Consumable Items / Auxilary Materials ......... 35 Safety in Handling ..............37 General Safety at Work and Personnel Qualification ..... 38 The Technical State of Ergostik Blueflow and System Construction39 Operation / Servicing and Maintenance ........41 Electromagnetic Compatibility (EMC) ..........42 Cleaning and Disinfection ............. - Page 4 Operating Instructions ............59 Checking for Worn Parts .............. 59 7.1.1 Minifilter / Permapure Check ............59 Establishing Operational Readiness ..........60 Switching Ergostik Blueflow On / Off ..........60 Inserting the Flow Sensor ............. 61 7.4.1 Assembly Face Mask ..............62 7.4.2 Assembly Blueflow Mouthpiece ............
- Page 5 Technical Data ................83 12.2 Installation and Operating Conditions ........... 85 12.3 Electrical Safety Concept .............. 86 12.3.1 Ergostik Blueflow with Medical Device Cart and Isolation Transformer ..................... 86 12.3.2 Ergostik Blueflow without Medical Device Cart and without Isolation Transformer .................. 87 12.4 Electromagnetic Compatibility / EMC Guidelines ......
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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 Blueflow, 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
Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx Please refer to the separate IFU of the BLUE CHERRY® software platform for pulmonary function diagnostics. If, in spite of careful reading of this IFU, you require more information, please contact your specialist retail partner on site. - 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 Blueflow or may indicate that Attention something in its environment may be damaged.
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Page 9: Symbols
Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx 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 Blueflow 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 Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx 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 Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx Symbol Explanation Atmospheric pressure limitation The product can be safely transported, stored or operated within the permissible atmospheric pressure. Page 12 Version: 6 | Release date: 02 August 2022...
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Page 13: Copyright
Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx 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 14: Conditions Of Use
Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx Conditions of Use Any other use of Ergostik Blueflow which is not described in this IFU is deemed improper use. The responsible organisation of Ergostik Blueflow alone is liable for any direct or indirect damage resulting from not adhering to these conditions. - Page 15 Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx 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 •...
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Page 16: Indication
Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx 2.1.1 Indication The Ergostik Blueflow 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 17: Contraindication And Side Effect
Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx 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 18 Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx 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 19 Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx Contraindications • Sinus surgery or middle ear surgery or infection within 1 week Due to increases in intrathoracic and intraabdominal pressure • Presence of pneumothorax • Thoracic surgery within 4 weeks •...
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Page 20: Side Effects
Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx 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 21 Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx 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...
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Page 22: Definition Of The Groups Of People
Groups of people named in this IFU are defined as follows: Manufacturer specifies all measures to ensure the safe and proper handling and application of Ergostik Blueflow. They are responsible for instructing the operator in relation to this via the corresponding specialist retail partner. -
Page 23: Intended Use
Respiratory GmbH products via the universal software BLUE CHERRY®. (See chap. 4.1.3 “System Construction and Electrical Safety”). In all cases, the Ergostik Blueflow is only intended for use in closed, pleasantly temperature-controlled (19 °C – 25 °C) rooms in a clinical area. - Page 24 Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx The Ergostik Blueflow 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.
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Page 25: Original Spare Parts / Accessories / Optional Expansions
The installation or use of other products can, under certain circumstances, negatively change constructive prescribed properties of Ergostik Blueflow 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 26: Original Spare Parts / Accessories
Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx 2.2.1.1 Original Spare Parts / Accessories The following components can be purchased via specialist retail partners. You will find: • A list of specialist retail partners as an insert in this IFU... - Page 27 Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx Component Description / name Supply scope in units Blueflow, Disposable 523557 Single-use flow sensor. Sensor codes validated during production ensure measurement quality and avoid frequent calibrations. Exercise Mask...
- Page 28 Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx Component Description / name Supply scope in units Ergostik Blueflow 240903 Tube set, 2 m Flow and gas connection tube set with permapure tube for moisture equilibration, hydrophobic minifilter and Blueclip adapter for Blueflow.
- Page 29 Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx Component Description / name Supply scope in units Silicone Adapter, Small 919774 28 mm x 2 mm x 50 mm [old:10.831] Silicone adapter size small used for Ergoflow and Blueflow to connect to calibration syringe.
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Page 30: Optional Expansions
Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx 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 31 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 Blueflow 650202 with: 2 x Exercise mask, (S and XS) 2 x Headgear, (M and S)
- Page 32 Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx Component Description / name Exercise Mask, Pediatric (S) 838093 [old: 10.827] Translucent silicone 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 33 Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx Component Description / name WristOx2® Model 3150 Activation Key 220553 Activation Key for the use of the [old:10.532] WristOx2® Model 3150 with Bluetooth. Soft Finger Sensor 318808 Soft finger sensor for WristOx2® Model [old:10.877]...
- Page 34 Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx Component Description / name Software option: Training Planer Software 551941 Software option for BLUE CHERRY® [old:40.451] to create individual exercise training plans based on the results of a CPET test.
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Page 35: Consumable Items / Auxilary Materials
Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx 2.2.2 Consumable Items / Auxilary Materials The following items were tested by the manufacturer for Ergostik Blueflow. The use of other consumable items as well as auxiliary materials with different properties is deemed improper use. - Page 36 Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx Komponente Description / name CPET Oxygen Sensor II 318415 Oxygen (O ) measurement cell with fast [old:40.404] response time. Measurement range 0 – 100 % O for wipe disinfection, alcoholic quick-acting ...
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Page 37: Safety In Handling
In spite of this, dangers of injury to operators / users, patients and third parties as well as damage to Ergostik Blueflow or other materials may occur if this is: •... -
Page 38: General Safety At Work And Personnel Qualification
Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx General Safety at Work and Personnel Qualification Possible danger to life. Reason: Not complying with health and safety regulations. Ignoring essential preventive measures. Therefore: • Always comply with general national regulations... -
Page 39: The Technical State Of Ergostik Blueflow And System Construction39
Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx The Technical State of Ergostik Blueflow and System Construction Possible danger to life. Reason: Electric shock. Cross-contamination. Misdiagnosis caused by measurement error. Therefore: • Do not overstress Ergostik Blueflow! Use with care! •... - Page 40 Serial no.: xx|8|201|yyy and 2203xxxxx located outside the patient environment at the same time! • Ensure that the Ergostik Blueflow 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.
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Page 41: Operation / Servicing And Maintenance
Therefore: • In principle, observe chap. 12 “Technical Specifications"! • Do not operate Ergostik Blueflow if there are flammable or explosive gases in the room! • Do not operate Ergostik Blueflow near the magnetic field of an MRT system! Possible danger to life. -
Page 42: Electromagnetic Compatibility (Emc)
Therefore: • While using Ergostik Blueflow, 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 43: Cleaning And Disinfection
Possible danger to life. Reason: Coss-contamination. For this: Observe general medical principles! Therefore: • Clean and disinfect Ergostik Blueflow 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 44 Ergostik Blueflow could be damaged. Reason: Penetrating liquids into electronic components. Therefore: • Disconnect the Ergostik Blueflow 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...
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Page 45: Structure And General Function Of Ergostik Blueflow
Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx Structure and General Function of Ergostik Blueflow Hardware 4.1.1 Overview Ergostik Blueflow Medical power supply unit (see also chap. 4.1.3) Ergostik Blueflow tube set Blueflow Disposable flow sensor (see also chap. 7.4) Ambistik Type label on the bottom of the case (see also chap. -
Page 46: Connections / Interfaces Of The Ergostik Blueflow
Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx 4.1.2 Connections / Interfaces of the Ergostik Blueflow 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... -
Page 47: Sensors
• The separate IFU Volume Calibration Flow Sensor The heart of the Ergostik Blueflow for accurate flow measurement is the Blueflow Disposable flow sensor. Since the flow sensor is used for precise flow measurement, it is essential to comply with the cleaning and calibration instructions. -
Page 48: 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 Blueflow could be damaged Reason: Working pressure too high. Therefore: • Only use a pressure reducer that meets the... - Page 49 Reason: Electric shock due to lack of galvanic separation with composition of non-approved components. Therefore: • Do not modify or use Ergostik Blueflow 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.
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Page 50: Data Connection
Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx Ergostik Blueflow 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... -
Page 51: Power Supply
See also chap. 2.2.1.1 "Original Spare Parts / Accessories" Technical Protection Measures Ergostik Blueflow 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 52 Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx For further information see the separate IFU of BLUE CHERRY® − information on the configuration and use of the software BLUE CHERRY®. Page 52 Version: 6 | Release date: 02 August 2022...
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Page 53: 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 Blueflow is solely in charge of compliance with these requirements. For storage and transport conditions see chap. 12 "Technical Specifications". -
Page 54: Assembly
Serial no.: xx|8|201|yyy and 2203xxxxx Assembly Installation or assembly for the first commissioning of the Ergostik Blueflow 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 55: Operation
Serial no.: xx|8|201|yyy and 2203xxxxx Operation Initial Operating The first commissioning of the Ergostik Blueflow and its recommissioning after maintenance work in accordance with the operator's obligations (see chap. 8 "Servicing / Maintenance"), which is carried out by qualified personnel of the specialist retail partner, is also only carried out by these qualified personnel. -
Page 56: Assembly Calibration Tube
Before the Ergostik Blueflow can be used to perform measurements again, all components must be properly reconnected, the USB connection to the computer must be established, and the Ergostik Blueflow 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 57 Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx 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.
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Page 58: Power Supply And Pc-Connection
(See chap. 2.2.1.1 “Original Spare Parts/ Accessories“) Connect the Ergostik Blueflow in order to make it ready for operation: 1. USB- connection cable [1] to the USB socket of the Ergostik Blueflow. -
Page 59: Operating Instructions
Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx Operating Instructions Checking for Worn Parts The Ergostik Blueflow should be checked for defective wearing parts each day before beginning treatments. You can get a description in: • Chap. 8 “Servicing / Maintenance”... -
Page 60: Establishing Operational Readiness
After switching on the Ergostik Blueflow needs a warm-up time of 15 minutes. Only after this time is the Ergostik Blueflow ready for operation. Detailed information on how to establish operational readiness you will find here: •... -
Page 61: Inserting The Flow Sensor
Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx Inserting the Flow Sensor 1. Connect the exercise tube set [1] with the Ergostik Blueflow [2] For this: Screw the flow- [1a] and gas tubes [1b] clockwise to the color- coded connections on the front of the Ergostik Blueflow. -
Page 62: Assembly Face Mask
Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx 7.4.1 Assembly Face Mask 1. a) Assemble the exercise mask adapter Blueflow [5] to the face mask [6].For this: Press the mask adapter Blueflow through the round opening of the... -
Page 63: Assembly Blueflow Mouthpiece
Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx 7.4.2 Assembly Blueflow Mouthpiece 1. Attach the Blueflow mouthpiece [1] to the flow sensor [2]. For this: Orient the Blueflow mouthpiece [1] in such a way that the arrow symbols on the... -
Page 64: Calibrating Ergostik Blueflow
Once per week Flow linearity test After Maintenance / Cleaning Volume calibration Using Ergostik Blueflow / Performing Measurements Descriptions of the individual examinations can be found in the separate IFU: • CPET And for general use of the software: •... - Page 65 Therefore: • While using Ergostik Blueflow, 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 66 Reason: Penetrating liquid. Uncleanliness. External exposure. Therefore: • Do not use any liquids near Ergostik Blueflow! • Do not expose Ergostik Blueflow or the entire system to dust or other contamination! • Do not drop any objects on Ergostik Blueflow! Attention •...
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Page 67: Exchange Of Disposable Products / Disinfection
Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx Exchange of Disposable Products / Disinfection 7.7.1 Noseclip / Blueflow Disposable / Exercise Mask Adapter Blueflow Possible danger to life. Reason: Cross-contamination. For this: Observe the general medical principles! Therefore: •... -
Page 68: Mask
Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx 7.7.2 Mask All parts which have come into contact with the patient or patient breathing during the examination must be disinfection. For further weekly cleaning and disinfection tasks, please see: •... -
Page 69: Servicing / Maintenance
The expected service life of Ergostik Blueflow 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 70: 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 Blueflow over its whole service life, regular servicing and repairs, if applicable, are required. -
Page 71: Checking / Exchanging Of Tubes And Cables
8.2.1 Checking / Exchanging of Tubes and Cables All parts of Ergostik Blueflow 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 72: Cleaning And Disinfection
Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx 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 Blueflow functional and clean. -
Page 73: Single Use
Chap. 7.7 “Exchange of Disposable Products / Disinfection” Disinfection All parts of the Ergostik Blueflow can be cleaned of dirt with a soft cloth using a cleaning solution / weak soapy water. All parts of Ergostik Blueflow which come into contact, or could come into contact, with the patient must be treated with a surface disinfection. - Page 74 Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx 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 75 • Do not place Ergostik Blueflow 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: •...
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Page 76: Ergostik Blueflow
Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx 9.2.1 Ergostik Blueflow All parts of the Ergostik Blueflow which come or could come into contact with the patient must be treated with surface disinfection. 9.2.2 Blueflow Flow Sensor- / Blueclip Removal 1. -
Page 77: Removing The Silicone Mask / Adapter
Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx 9.2.3 Removing the Silicone Mask / Adapter 1. Remove the Exercise Mask Adapter Blueflow. (In reserve order as described in chap. 7.4.1 “Assembly Face Mask“) 2. Dispose of the Exercise Mask Adapter Blueflow (see chap. -
Page 78: Fault Indication And Repair
Serial no.: xx|8|201|yyy and 2203xxxxx Fault Indication and Repair Simple errors which occur when using Ergostik Blueflow 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 79 Check for moisture in the tube / connection piece of the Blueflow Perform gas calibration Drift on gas signal Note the warm-up time of the Ergostik Blueflow (15 minutes) Check for moisture in the tube / connection piece of the Blueflow...
- Page 80 Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx Error Rectification Check for moisture in the tube / connection piece of the Blueflow Software error message Check tube connection between Blueclip and "O out of measuring Ergostik Blueflow range“...
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Page 81: Decommissioning / Disposal
Decommissioning / Disposal 11.1 Expected Service Life The expected service life of Ergostik Blueflow has been stated by the manufacturer as 8 years. This applies provided the operating conditions, the prescribed servicing intervals, taking into account and complying with all safety information such as is described in this IFU as well as other technical standard regulations are adhered to. -
Page 82: Infectious / Contaminated Single Use Items
Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx 11.3.3 Infectious / Contaminated Single Use Items All contaminated items such as flow sensors, mouthpieces and noseclips must be disposed of via hospital or practice waste. Possible severe physical injury. -
Page 83: Technical Specifications
Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx 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 84 Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx Accuracy: ±3 % or 50 ml/s 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: <...
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Page 85: Installation And Operating Conditions
Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx 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 Blueflow guaranteed by the manufacturer and for the safety of the patient and operator. -
Page 86: Electrical Safety Concept
Serial no.: xx|8|201|yyy and 2203xxxxx 12.3 Electrical Safety Concept 12.3.1 Ergostik Blueflow with Medical Device Cart and Isolation Transformer External Medical Power Supply for Ergostik Blueflow (Protection Class 2) Communication with PC via USB-Interface USB/PC Galvanic Isolation in Ergostik Blueflow... -
Page 87: Ergostik Blueflow Without Medical Device Cart And Without Isolation Transformer
Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx 12.3.2 Ergostik Blueflow without Medical Device Cart and without Isolation Transformer External Medical Power Supply for Ergostik Blueflow (Protection Class 2) Communication with PC via USB-Interface USB/PC Galvanic Isolation in Ergostik Blueflow... -
Page 88: Electromagnetic Compatibility / Emc Guidelines
Guidelines and manufacturer’s declaration – electromagnetic emissions The Ergostik Blueflow is determined for operation in an electromagnetic environment as specified below. The user / operator of the Ergostik Blueflow should ensure that it is operated in this environment. Measurement of Compliance Electromagnetic environment –... -
Page 89: Interference Resistance For All Me Systems Guideline And Manufacturer Declaration
Guidelines and manufacturer’s declaration – electromagnetic interference immunity The Ergostik Blueflow is determined for operation in an electromagnetic environment as specified below. The user / operator of the Ergostik Blueflow should ensure that it is operated in this environment. Measurement of IEC 60601 –... -
Page 90: Interference Resistance For None-Life-Supporting Me Systems Guideline And Manufacturer Declaration
Guidelines and manufacturer’s declaration – electromagnetic interference immunity The Ergostik Blueflow is determined for operation in an electromagnetic environment as specified below. The user / operator of the Ergostik Blueflow should ensure that it is operated in this environment. Measurement of... - Page 91 Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx 10.1 MHz to 10.15 MHz 14 MHz to 14.2 MHz 18.07 MHz to 18.17 MHz 21.0 MHz to 21.4 MHz 24.89 MHz to 24.99 MHz 28.0 MHz to 29.7 MHz 50 MHz to ����...
- Page 92 If the measured field strength at the site where the Ergostik Blueflow is used exceeds the abovementioned compliance levels, the Ergostik Blueflow should be observed to demonstrate its intended function.
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Page 93: Recommended Safety Distances For Non-Life-Supporting Me Systems
Ergostik Blueflow The Ergostik Blueflow is determined for operation in an electromagnetic environment in which the RF disturbances are controlled. The user/operator of the Ergostik Blueflow may help to avoid electromagnetic interference by keeping the minimum distance between portable and... -
Page 94: Safety Of Product And Material
DIN EN ISO 10993- 1:2017-04 "Biological evaluation of medical devices" (biocompatibility). Ergostik Blueflow 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 95: Product Labeling / Type Label
93 / 42 / EEC with identification of the involved notified body [13] Date of manufacture Safety symbols have been applied to the Ergostik Blueflow type label. It may not be changed or removed. If information should become unreadable, the type label should be replaced immediately. -
Page 96: Warranty And Service
Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx 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 97: Packaging And Shipping
Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx 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. -
Page 98: Authorised Specialist Retail Partner
Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx 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 Page 98 Version: 6 | Release date: 02 August 2022... -
Page 99: Attachment - Declaration Of Conformity
Instructions for Use Ergostik Blueflow Serial no.: xx|8|201|yyy and 2203xxxxx Attachment – Declaration of Conformity The Ergostik Blueflow declaration of conformity is enclosed with each device by the manufacturer. Version: 6 | Release date: 02 August 2022 Page 99...
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