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Summary of Contents for GERATHERM Bodystik
- Page 1 Bodystik Serial numbers: xx|8|301|yyy and 2301xxxxx Instructions 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|301|yyy and 2301xxxxx Software version: valid from 1.2.0 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 ......... 30 Safety in Handling ..............32 General Safety at Work and Personnel Qualification ..... 33 The Technical State of Bodystik and System Construction ... 34 Operation / Servicing and Maintenance ........36 Electromagnetic Compatibility (EMC) ..........38 Cleaning and Disinfection ............. - Page 4 Setting up the Cabin ..............72 7.4.1 Height-Adjustable Arm ..............72 7.4.2 Patient Chair ................. 73 Using Bodystik / Performing Measurements ......... 74 Exchange of Disposable Products / Disinfection ......77 7.6.1 Bacteria- and Virus Filter / Noseclip ..........77 7.6.2 Bodystik / Cabin ................
- Page 5 Installation and Operating Conditions ........... 98 12.3 Electrical Safety Concept .............. 99 12.3.1 Bodystik with Medical Device Cart and Isolation Transformer ..99 12.4 Electromagnetic Compatibility / EMC Guidelines ......100 12.4.1 Emitted Interference Guideline and Manufacturer Declaration ..100 12.4.2...
- Page 6 Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Attachment – Declaration of Conformity ........ 111 Page 6 Version: 7 | Release date: 02. August 2021...
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Page 7: General Information
This IFU is a component of the product in accordance with DIN EN ISO 60601-1. It should make it easier to familiarize yourself with Bodystik, 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 spirometric examinations. -
Page 8: 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 9 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 Bodystik or may indicate that something in Attention its environment may be damaged.
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Page 10: Symbols
Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx 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 11 Serial no.: xx|8|301|yyy and 2301xxxxx Symbol Explanation For single use only! This symbol does not refer to the Bodystik itself, but to the consumable items used in connection with it. This is applied to the respective packaging and must be observed.
- Page 12 Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Symbol Explanation Fragile, handle with care The package contains a product that must be handled with appropriate care to prevent damage during transport and storage. Keep away from rain The package contains a product that must be protected from moisture during transport and storage.
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Page 13: Copyright
Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx 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
Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Conditions of Use Any other use of Bodystik which is not described in this IFU is deemed improper use. The responsible organisation of Bodystik alone is liable for any direct or indirect damage resulting from not adhering to these conditions. They are then... -
Page 15: Indication
IFU BLUE CHERRY® for the general operation of the software and carrying out the examination. 2.1.1 Indication With the Bodystik bodyplethysmographic examinations can be performed for diagnosis, follow-up, screening and severity assessment of pulmonary diseases. In particular, this includes: Obstructive diseases •... -
Page 16: Contraindications And Side Effects
Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx 2.1.2 Contraindications and Side Effects 2.1.2.1 Contraindications The following contraindications apply for body-plethysmographic examinations: Contraindications Absolute Relative Patients with a new (< 1 month old) myocardial infarction Aneurysm of the ascending aorta... -
Page 17: Side Effects
Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx 2.1.2.2 Side Effects If there are no contraindications and the examination is carried out in accordance with the descriptions in this IFU, side effects rarely occur in pulmonary function examinations. These can be described as follows:... -
Page 18: 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 Bodystik is used by their employees (users / operators). User is a medically trained specialist who is familiar with spirometry... -
Page 19: Intended Use
11.1 "Expected Service Life") and the maintenance work required for this (see chap. 8 "Servicing / Maintenance"). The Bodystik may only be used for the duration of its service life if the specifications are observed. Version: 7 | Release date: 02. August 2021... - Page 20 Any changes to Bodystik, in particular unauthorised modifications, are prohibited. The Bodystik 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 21: Original Spare Parts / Accessories / Optional Expansions
The installation or use of other products can, under certain circumstances, negatively change constructive prescribed properties of Bodystik and, in the worst case, impair the safety of the patient, user / operator and / or third parties. The manufacturer assumes no liability for such consequences. -
Page 22: Original Spare Parts / Accessories
Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx 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 23 Supply scope in units Ergoflow 139094 [old:10.600] Re-useable lightweight flow sensor for use with Ergostik, PFTstik, Bodystik and Diffustik device. Flow Unit 983244 [old:40.630] Flow unit for PFTstik, Bodystik and Diffustik. Including flow electronic and rubber seal plates.
- Page 24 Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Component Description / name Supply scope in units Shutter Cage 01* until 40.611 11 / 2018 For fast occlusion of breathing path. Replaced by shutter block (40.620). Shutter Head 01* until 40.612...
- Page 25 Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Component Description / name Supply scope in units Neumofilt 199479 Single use [old:10.003] disposable bacterial and viral filter for use in pulmonary function testing Medical Power Supply, 24 V 01*from 290495 ...
- Page 26 Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Component Description / name Supply scope in units Power Cord, CEE 7 / 16, C7 01*from 142297 (IEC 60320, EU) 08 / 2015 [old:10.838] Power Cord with European plug for use with Power...
- Page 27 Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Component Description / name Supply scope in units O-Ring Set, Shutter Head 01*from 40.623 2 x 23 x 2 mm for shutter 11 / 2018 head (outside). O-Ring, Demand Valve...
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Page 28: Optional Expansions
Component Description / name Add-on CO Diffusion 259149 Single breath CO Diffusion option adds [old:40.702] TLco measurement to Bodystik or PFTstik. Includes: Fast NDIR CO / CH Analyzer (CO: 0 – 3000 ppm, CH : 0 – 3000 ppm), ... - Page 29 Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Component Description / name Calibration Syringe 608220 Precision calibration instrument for [old:10.801] calibration of flow or volume-based systems. 3 liter volume (nonadjustable). Comes together with adapter for Spiraflow and Ergoflow.
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Page 30: Consumable Items / Auxilary Materials
Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx 2.2.2 Consumable Items / Auxilary Materials The following items were tested by the manufacturer for Bodystik. The use of other consumable items as well as auxiliary materials with different properties is deemed improper use. - Page 31 Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Description / name Component For wipe disinfection, alcoholic quick-acting Bacillol Tissues (BODE Chemie GmbH) SprayIn (Dr. Deppe GmbH) For disinfection bath with low chloride concentration InstruPlus (Dr. Deppe GmbH) Disinfectant ...
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Page 32: Safety In Handling
In spite of this, dangers of injury to users / operators, patients and third parties as well as damage to Bodystik or other materials may occur if this is: •... -
Page 33: 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 Bodystik may not be altered or removed! Have missing or not readable information replaced immediately! • When working with auxiliary materials, always... -
Page 34: The Technical State Of Bodystik And System Construction
Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx The Technical State of Bodystik and System Construction Possible danger to life. Reason: Electrical shock. Cross-contamination or misdiagnosis. For this: Only use Bodystik within its performance limits! Therefore: • Do not overstress Bodystik Use with care! •... - Page 35 Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx • Ensure that the users or third party persons do not touch the patient and any conductive connections or parts of the device that are located outside the patient environment at the...
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Page 36: Operation / Servicing And Maintenance
• Do not operate Boystik if there are flammable or explosive gases in the room! • Do not operate Bodystik near the magnetic field of an MRT system! Possible danger to life. Reason: Electric shock. Cross-contamination. Misdiagnosis caused by measurement error. Device damage. - Page 37 • Do not leave the patient unattended in the cabin! Possible severe physical injury. Reason: Bodystik can tilt over. Therefore: • Observe the maximum weight of the person on the chair when chair is swivelled outwards. It is...
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Page 38: Electromagnetic Compatibility (Emc)
Therefore: • While using Bodystik, do not use any transmitting devices (e.g. mobile phones, portable phones, power lines …) within close proximity (< 30 cm) that exceed the immunity levels as specified in the EMC guidelines! •... -
Page 39: Cleaning And Disinfection
Possible danger to life. Reason: Cross-contamination. For this: Observe the general medical principles! Therefore: • Clean and disinfect the Bodystik 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: Structure And General Function Of Bodystik
Patient panel on the inside of the cabin with loudspeaker and door opener (see also chap. 4.1.2.2 and chap. 4.2.2) Type label (see also chap. 14) [10] Connection panel for Bodystik (see also chap. 4.1.3.1) Page 40 Version: 7 | Release date: 02. August 2021... -
Page 41: Operating Elements
Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx 4.1.2 Operating Elements 4.1.2.1 User Panel User panel on the front right-hand side of the cabin EMERGENCY OFF button To disconnect the cabin from the power Supply in case of emergency (see also chap. -
Page 42: Patient Panel
Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx 4.1.2.2 Patient Panel Patient panel on the inside of the cabin to the right of the door. Speaker To reproduce the commands to the patient during the measurement by the user... -
Page 43: Connections / Interfaces Of The Bodystik
Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx 4.1.3 Connections / Interfaces of the Bodystik 4.1.3.1 Connection Panel Connection panel to the right of the door on the lower right-hand side of the cabin. Power supply unit LED-Indicator Power Supply... -
Page 44: Connectors On The Height-Adjustable Arm
Adjustable Arm. Flow unit Gas sample (CO Diffusion connection) Gas supply CO Diffusion The connection of the components for extending the Bodystik with the CO Diffusion option is described in the separate IFU: • Add-on Co-Diffusion 4.1.3.3 Sensors Bodystik could be damaged. - Page 45 Calibration Flow Sensor and Calibration Bodyplethysmograph Pressure Sensor The Bodystik has a highly sensitive pressure sensor which is able to precisely resolve even the slightest pressure changes in the cabin. It must be calibrated before the first examination of the day.
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Page 46: Pressure Reducer (Optional With Extension „Diffusion Measurement")
Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx 4.1.3.4 Pressure Reducer (optional with Extension „Diffusion Measurement“) The Bodystik provides the option of extension for CO Diffusion measurement. A suitable pressure reducer for the Diffusion gas bottle is required for safe application. If you are planning the extension with Diffusion measurement, please note: Danger to life. -
Page 47: System Construction And Electrical Safety
System Construction and Electrical Safety The following instructions are intended for safe handling of the entire system, taking into account the electrical safety concept of the Bodystik. The system may be set up only by an authorised specialist retail partner. - Page 48 Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Possible danger to life. Reason: Electric shock due to lack of galvanic separation with composition of non-approved components. Therefore: • Only use the power supply and USB connection cable supplied by the manufacturer as spare...
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Page 49: Equipment Cart With Isolating Transformer
• Do not install any further software! • Ask your authorised specialist retail partner which devices are approved by the manufacturer! Bodystik 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! 4.1.4.1 Equipment Cart with Isolating Transformer... -
Page 50: Data Connection
Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx 4.1.4.2 Data Connection The hardware connection between the device and computer is established via an integrated USB interface and USB cable. This is considered to be a spare part approved by the manufacturer and can be obtained from an authorised specialist retail partner. -
Page 51: Power Supply
Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx 4.1.4.3 Power Supply The power supply is provided by an external desktop power supply Unit. Only this is considered a spare part approved by the manufacturer and can be obtained from an authorised specialist retail partner (see also chap. -
Page 52: Technical Protection Measures
Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Technical Protection Measures Bodystik has been designed and built in accordance with the recognised state of technology and the requirements of the applicable, safety-relevant regulations. This chapter of the IFU only describes the operation of protective... -
Page 53: Emergency Stop
EMERGENCY OFF button is unlocked and ready for operation again. The Bodystik can only be operated again after unlocking the EMERGENCY STOP. For more detailed information, please see: • Chap. 6.2 "Recommissioning after Servicing / Cleaning Work". -
Page 54: Door-Opener Patient Panel
Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx 4.2.2 Door-Opener Patient Panel With the door opener, the cabin door can be opened any time by the patient sitting in the cabin in case of emergency. Danger to life possible. -
Page 55: Software
For a more detailed description see IFU BLUE CHERRY® Software The measurement device (Bodystik) is supplied with BLUE CHERRY® software. This serves to manage patient and examination data as well as carry out, depict, process and record measurements with the devices of the manufacturer. -
Page 56: 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 Bodystik is solely in charge of compliance with these requirements. For storage and transport conditions, see chap. 12 "Technical Specifications". -
Page 57: Assembly
Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Assembly Installation or assembly for the first commissioning of the Bodystik 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 58: Operation
(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. Bodystik is only completely ready to function after calibration and once the initial operation is complete. Recommissioning after Servicing / Cleaning Work... - Page 59 • The Cabin is restarted (audible by the "click"). • The Bodystik is ready for operation and function again. Possible severe physical injury. Reason: Crushing by unintentional height-adjustable stand movements. Patient collapses because the cabin door is firmly closed. Therefore: •...
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Page 60: Recommissioning After Termination By Patient
USB connection to the computer must be established, and the Bodystik must be connected to the power supply and calibrated. Calibration also fulfils the regulatory requirements for functional testing after maintenance work. -
Page 61: Assembly Flow Measuring System
Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx 6.2.3 Assembly Flow Measuring System Possible physical injury. Reason: Measurement error due to leakage caused by incorrect assembly of components. Therefore: • Carefully observe the assembly instructions! Functional disorders possible. Reason: Components and e.g. plug connections can be damaged. - Page 62 Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Height-adjustable arm with flow measuring system and shutter system incl. connection sockets From Prod. 11 / 2018 Mounting plate Shutter block [1] with Shutter plug [2] and Shutter drive [3] Flow unit Connection cable Until Prod.
- Page 63 Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx 1. Attach the mounting plate [1] to the height-adjustable arm [3]. For this: Insert the stand holding plate on the bolt of the height-adjustable arm tighten the knob [2] until the mounting plate remains movable.
- Page 64 Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx 4. Insert the flow unit [6] into the connection socket of the shutter 4a/b block or shutter head [4a / b] For this: Push the flow unit with the fixed side slightly to the stop and simultaneously turn it back and forth.
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Page 65: Assembly Shutter System
Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx 6.2.3.1 Assembly Shutter System Height-adjustable arm with shutter system including connection sockets. (detailed overview see chap. 4.1.3.2) 1. From prod. 11 / 2018: Screw shutter drive [3] to shutter block [1a] until stop 2. - Page 66 Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx 4. Connect the connector cable of the shutter drive [3] with three-pole socket on the flow unit – central. If possible, observe the sequence of the work steps, because otherwise it is more difficult to assemble! Page 66 Version: 7 | Release date: 02.
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Page 67: Inserting The Flow Sensor
Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx 6.2.3.2 Inserting the Flow Sensor 1. Open the closing cap [2] on the flow unit For this: Turn the screw lock [1] on the left and right side open the closure cap [2] upwards. -
Page 68: Connection Power Supply And Pc
• The device may only be operated in conjunction with the equipment cart (ergoline ergocar PC) offered by the manufacturer! The Bodystik is activated by establishing the power supply. To do this, connect the power supply: 1. USB-connection cable •... - Page 69 The LED Display "Power Supply" on the connection panel lights up. • Bodystik is ready for operation. Only after a new calibration is the Bodystik ready to operate again. see also: • Chap. 7.3 "Calibrating Bodystik". • Separate IFU Flow Sensor Calibration Calibration Bodyplethysmograph Version: 7 | Release date: 02.
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Page 70: Operating Instructions
Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Operating Instructions Checking for Worn Parts The Bodystik should be checked for defective wearing parts each day before beginning treatments. You can get a description in: • Chap. 8 “Servicing / Maintenance And: Possible danger to life. -
Page 71: Switching Bodystik On
The Bodystik is designed for permanent operation and doesn't need to be switched on and off daily. But there are different ways to finish the work with the Bodystik. Therefore the Bodystik is "switched on" again in different ways. For descriptions of "Recommissioning after Servicing / Cleaning Work"... -
Page 72: Setting Up The Cabin
Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Setting up the Cabin The correct sitting position of the patient is decisive for the success of the examination. This must always be individually adjusted. • Make sure that the patient is sitting upright, and the back of the chair doesn't touch the back wall of the cabin. -
Page 73: Patient Chair
Therefore: • Observe the maximum weight of the person on the chair. It is 150 kg! Possible severe physical injury. Reason: Bodystik can tilt over. Therefore: Version: 7 | Release date: 02. August 2021 Page 73... -
Page 74: Using Bodystik / Performing Measurements
Serial no.: xx|8|301|yyy and 2301xxxxx • Observe the maximum weight of the person on the chair when chair is swivelled outwards. It is 125 kg! Using Bodystik / Performing Measurements Descriptions of the applications can be found in the separate IFU: • Spirometry •... - Page 75 Therefore: • While using Bodystik, do not use any transmitting devices (e.g. mobile phones, portable phones, power lines …) within close proximity (< 30 cm) that exceed the immunity levels as specified in the...
- Page 76 Bodystik could be damaged. Reason: Penetraiting liquid. Uncleanliness. External exposure Therefore: • Do not use liquids near the Bodystik! • Do not expose the Bodystik to excessive temperature fluctuations during operation! • Do not drop any objects on the device! Attention •...
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Page 77: Exchange Of Disposable Products / Disinfection
The same applies to the noseclip. 7.6.2 Bodystik / Cabin Parts of the cabin which have come into contact with the patient during the treatment must be treated with surface disinfection. For further weekly cleaning and disinfection tasks, please see: •... -
Page 78: Switching Off Bodystik
Serial no.: xx|8|301|yyy and 2301xxxxx Switching off Bodystik Switching off the Bodystik can be done by disconnecting the power supply. If an equipment cart is used, it can be switched on by using the On / Off switch on the equipment cart (see chap. -
Page 79: Servicing / Maintenance
The expected service life of Bodystik 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 80: Servicing / Maintenance By The User / Operator
8.2 “Servicing / Maintenance by the User / Operator”! Servicing / Maintenance by the User / Operator In order to ensure a flawless operation of Bodystik over its whole service life, regular servicing and repairs, if applicable, are required. -
Page 81: Checking / Exchange Of Tubes And Cables
8.2.1 Checking / Exchange of Tubes and Cables All parts of Bodystik 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 82: Checking / Replacing O-Rings And Sealing Rubbers
Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx 8.2.2 Checking / Replacing O-Rings and Sealing Rubbers During the daily inspection of the O-Rings and sealing rubbers, attention must be paid to mechanical damage or signs of abrasion. If necessary, any affected parts must be replaced. -
Page 83: Care Of Door Rubbers
Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Sealing Rubber Flow Unit When ordering new O-rings and sealing rubbers, please note • Chap 4.1.4 "System Construction and Electrical Safety" • Chap 6.2.2 "Recommissioning after Maintenance / Cleaning Work by the Operator"... -
Page 84: 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 Bodystik functional and clean. Cleaning and disinfection may cause discolouration of the components, but without impairing their function. -
Page 85: Single Use
This applies to the flow unit, Ergoflow, shutter cage and shutter head or shutter block. All parts of the Bodystik can be cleaned from dirt with a soft cloth using a cleaning solution / weak soap suds. - Page 86 Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx 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 87 Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Bodystik could be damaged. Reason: Improperly treated components. Therefore: • For cleaning and disinfection only use those active substances that are approved by the manufacturer (see chap. 2.2.2 "Consumable Items / Auxilary Materials")!
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Page 88: Flow Unit
For this: Wipe all accessible surfaces with a wet disinfecting cloth. 9.2.2 Ergoflow / Flow Sensor Bodystik could be damaged. Reason: destruction of the orifice. Therefore: • Do not clean the interior of the sensor, mechanical or with hard water jet! Attention •... -
Page 89: Shutter System
Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx 9.2.3 Shutter System 9.2.3.1 Shutter Cage or Shutter Block 1. Disassemble the shutter system For this: Procced in reverse order as described in chap. 6.2.3.1 ”Assembly Shutter System“. 2. a) Until product. 11 / 2018:... -
Page 90: Shutter Drive
Bodystik could be damaged. Reason: Penetrating liquid into electrical components. Therefore: • Disconnect the Bodystik from the power supply before cleaning and disinfecting! (When switching off via the Attention On / Off switch of the equipment cart), shut down the PC completely before doing so! •... -
Page 91: Fault Indication And Repair
Serial no.: xx|8|301|yyy and 2301xxxxx Fault Indication and Repair Simple errors which occur when using Bodystik 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 92 Flow Unit (see chap. 6.2.3) of the valid range". Checking the connection of the flow unit and the Height-Adjustable Arm (see chap. 6.2.3.2) System restart – Computer and Bodystik (see chap. 6.2) Error message: Checking the ambient conditions "Temperature out of valid System reboot - PC and Bodystik range"...
- Page 93 Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Error Rectification Resistance" and "TGV" Closing the cabin door measurements cannot be performed Obvious measuring error Checking the last calibration date and recalibrate if necessary (see chap. 7.3) Version: 7 | Release date: 02. August 2021...
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Page 94: Decommissioning / Disposal
11.3.2 Bodystik Bodystik 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 95: Patient Chair
Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx 11.3.3 Patient Chair The patient chair in the cabin is equipped with a gas pressure spring. This is filled with oil. Possible severe physical injury. Reason: Pressure unloading through damage of the gas pressure spring on the patient chair. -
Page 96: Technical Specifications
Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Technical Specifications 12.1 Technical Data Medical device: Class IIa (in accordance with MDD 93 / 42 Council Directive of 14 / 6 / 1993 annex IX) Cabin outer dimensions: (L) 950 mm x (W) 850 mm x (H) 1730 mm... - Page 97 Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Sample rate: 125 Hz Accuracy: ±3 % or 50 ml/s Volume: Measuring range: 0 –20 l Accuracy: ±3 % or 50 ml Cabin pressure: Measuring principle: Differential pressure / Thermal Microflow-...
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Page 98: 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 Bodystik guaranteed by the manufacturer and for the safety of the patient and user / operator. Storage / Transport: min. -
Page 99: Electrical Safety Concept
Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx 12.3 Electrical Safety Concept 12.3.1 Bodystik with Medical Device Cart and Isolation Transformer Version: 7 | Release date: 02. August 2021 Page 99... -
Page 100: Electromagnetic Compatibility / Emc Guidelines
12.4.1 Emitted Interference Guideline and Manufacturer Declaration Guidelines and manufacturer’s declaration – electromagnetic emissions The Bodystik is determined for operation in an electromagnetic environment as specified below. The user / operator of the Bodystik should ensure that it is operated in this environment. Measurement of Compliance Electromagnetic environment –... -
Page 101: Interference Resistance For All Me Systems Guideline And Manufacturer Declaration
Guidelines and manufacturer’s declaration – electromagnetic interference immunity The Bodystik is determined for operation in an electromagnetic environment as specified below. The user / operator of the Bodystik should ensure that it is operated in this environment. Measurement of IEC 60601 – test... -
Page 102: Interference Resistance For Non-Life-Supporting Me Systems Guideline And Manufacturer Declaration
Guidelines and manufacturer’s declaration – electromagnetic interference immunity The Bodystik is determined for operation in an electromagnetic environment as specified below. The user / operator of the Bodystik should ensure that it is operated in this environment. Measurement of IEC 60601 -level... - Page 103 Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx 7 MHz to 3 MHz 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...
- Page 104 If the measured field strength at the site where the Bodystik is used exceeds the abovementioned compliance levels, the Bodystik should be observed to demonstrate its intended function.
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Page 105: Recommended Safety Distances For Non-Life-Supporting Me Systems
Recommended safety distance between portable and mobile RF communication devices and the Bodystik The Bodystik is determined for operation in an electromagnetic environment in which the RF disturbances are controlled. The user / operator of the Bodystik may help to avoid... -
Page 106: Safety Of Product And Material
DIN EN ISO 10993-1:2017- 04 "Biological evaluation of medical devices" (biocompatibility). Bodystik 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 107: Product Labeling / Type Label
42 / EEC with identification of the involved notified body [12] Date of manufacture Safety symbols have been applied to the Bodystik type label. It may not be changed or removed. If information should become unreadable, the type label should be replaced immediately. -
Page 108: Warranty And Service
Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx 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 109: Packaging And Shipping
Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx 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 110: Authorised Specialist Retail Partner
Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx 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 110 Version: 7 | Release date: 02. August 2021... - Page 111 Instructions for Use Bodystik Serial no.: xx|8|301|yyy and 2301xxxxx Attachment – Declaration of Conformity The Bodystik declaration of conformity is enclosed with each device by the manufacturer. Version: 7 | Release date: 02. August 2021 Page 111...
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