Subscribe to Our Youtube Channel
Related Manuals for GERATHERM Safestik
Summary of Contents for GERATHERM Safestik
- Page 1 Safestik Serial numbers: 2011xxxxx Instructions for Use Version: 4 Release date: 14. July 2021 Please read carefully and store in a place which is always accessible for future consultation!
- Page 2 14. July 2021 Filename: TDOSAF0007R4 Language: English Affected serial numbers: 2011xxxxx Software version: valid from 1.3.2 Geratherm® Respiratory GmbH Kasernenstraße 4 97688 Bad Kissingen, GERMANY Tel. +49 971 7857043-0 Fax +49 971 7857043-30 info@geratherm-respiratory.com www.geratherm-respiratory.com EUDAMED SRN: © Geratherm® Respiratory GmbH DE-MF-000006818...
-
Page 3: Table Of Contents
Safety in Handling ..............17 General Safety at Work and Personnel Qualification ..... 18 Storage Conditions stipulated by the Manufacturer ...... 19 The Technical State of Safestik and System Construction .... 19 Operation / Servicing and Maintenance ........21 Electromagnetic Compatibility (EMC) ..........24 Cleaning and Disinfection ............. - Page 4 12.2 Installation and Operating Conditions ........... 45 12.3 Electrical Safety Concept .............. 46 12.3.1 Safestik with Medical Device Cart and Isolation Transformer ..46 12.3.2 Safestik without Medical Device Cart and without Isolation Transformer .................. 47 12.4 Electromagnetic Compatibility / EMC Guidelines ......48 12.4.1...
-
Page 5: General Information
Serial no.: 2011xxxxx Foreword Thank you for purchasing a medical device from Geratherm® Respiratory GmbH. Safestik is a part of our product family with solutions for cardiopulmonary function diagnostics which are operated using the common software platform BLUE CHERRY®. This means that you have the option of optimising the working processes in your practice using the networked application of further products from Geratherm®... -
Page 6: Abbreviations
If, in spite of careful reading of this IFU, you require more infor- mation, please contact your specialist retail partner on site. You can obtain the contact details via a form provided by the manu- facturer 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 7: Explanations
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 Safestik or may indicate that something in Attention its environment may be damaged. -
Page 8: Symbols
Instructions for Use Safestik Serial no.: 2011xxxxx 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! Only use indoors! IP20 Protection type (safe environmental conditions) - Page 9 Instructions for Use Safestik Serial no.: 2011xxxxx Symbol Explanation Manufacturer This symbol identifies the manufacturer of a product. Date of manufacture This symbol indicates the date on which a product is manufactured. Conformity mark This symbol indicates conformity with health, safety and environmental protection standards for products sold within the European Economic Area (EEA).
-
Page 10: Copyright
Instructions for Use Safestik Serial no.: 2011xxxxx Symbol Explanation Atmospheric pressure limitation The product can be safely transported, stored or operated within the permissible atmospheric pressure. 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. -
Page 11: Conditions Of Use
Safestik Serial no.: 2011xxxxx Conditions of Use Any other use of Safestik which is not described in this IFU is deemed improper use. The responsible organisation of Safestik alone is liable for any direct or indirect damage resulting from not adhering to these conditions. They are then... -
Page 12: 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 Safestik is used by their employees (users / operators). User is a medically trained specialist who is familiar with lung function... -
Page 13: Intended Use
11.1 "Expected Service Life") and the maintenance work required for this (see chap. 8 "Servicing / Maintenance"). The Safestik may only be used for the duration of its service life if the specifications are observed. Any changes to Safestik, in particular unauthorised modifications, are prohibited. -
Page 14: Original Spare Parts / Accessories / Optional Expansions
The installation or use of other products can, under certain circumstances, negatively change constructive prescribed properties of Safestik 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 15: Original Spare Parts / Accessories
Instructions for Use Safestik Serial no.: 2011xxxxx 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 or in your medical device book, as well as the most updated version at www.geratherm-respiratory.com/login/... -
Page 16: Auxiliary Materials
Instructions for Use Safestik Serial no.: 2011xxxxx 2.2.2 Auxiliary Materials 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 17: Safety In Handling
In spite of this, dangers of injury to operators / users, patients and third parties as well as damage to Safestik or other materials may occur if this is: •... -
Page 18: 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 Safestik may not be altered or removed! Have missing or not readable information replaced immediately! • When working with auxiliary materials, always... -
Page 19: Storage Conditions Stipulated By The Manufacturer
/ contamination due to improper handling of components. Therefore: • Observe the storage conditions stipulated by the manufacturer! The Technical State of Safestik and System Construction Possible danger to life. Reason: Electric shock. Cross-contamination. Misdiagnosis caused by measurement error. Therefore: •... - Page 20 Instructions for Use Safestik Serial no.: 2011xxxxx respective manufacturer of the individual devices must be carried out before putting into operation! • Under no circumstances use or connect any devices, systems, equipment and other products that are not part of the complete system!
-
Page 21: Operation / Servicing And Maintenance
Therefore: • In principle, observe chap. 12 “Technical Specifications”! • Do not operate Safestik if there are flammable or explosive gases in the room! • Do not operate Safestik near the magnetic field of an MRI system! Version: 4 | Release date: 14. July 2021... - Page 22 Ensure that the used components are undamaged and that you are working in a careful way! • Only use Safestik within its expected service life, determined by the manufacturer! • Prior to each use, visually inspect the complete system (housing, connectors, etc.) for any damages! •...
- Page 23 Safestik could be damaged. Reason: Penetrating liquid. Uncleanliness. External exposure. Therefore: • Do not use any liquids near Safestik! • Do not expose Safestik or the entire system to dust or other contamination! Attention • Do not drop any objects on Safestik! •...
-
Page 24: Electromagnetic Compatibility (Emc)
Therefore: • While using Safestik, 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 25: Cleaning And Disinfection
Attention • Do not place Safestik in the cleaning and disinfection solution! The device contains electrical components that will be damaged by doing this! Functional disorders possible. Reason: Components and e.g. plug connections can be damaged. -
Page 26: Structure And General Function Of Safestik
Instructions for Use Safestik Serial no.: 2011xxxxx Structure and General Function of Safestik Hardware 4.1.1 Overview Safestik USB extension cable, 30 cm Type label (see also chap. 14) Page 26 Version: 4 | Release date: 14. July 2021... -
Page 27: Leds For Status Indication
Instructions for Use Safestik Serial no.: 2011xxxxx 4.1.2 LEDs for Status Indication LEDs for status indication Shows the current status of the Safestik. Bluetooth connected Operational readiness Possible conditions: Display Explanation Action NONE Safestik not connected Connect the Safestik to the computer's USB 2.0 port... -
Page 28: 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 Safestik. It is essential to note: Anyone who combines additional devices or medical devices or unauthorised or non-original... - Page 29 Independent of this, the following should also be observed: Possible danger to life. Reason: Electric shock. Misdiagnosis. Therefore: • Do not modify or use the Safestik or complete system contrary to the respective manufacturer's specification! • Under no circumstances use or connect any...
- Page 30 • When connecting Safestik to other devices, make sure that all connections and cables are secured and cannot come loose by themselves! •...
-
Page 31: Computer / Printer Data Connection
The separate IFU BLUE CHERRY® The Safestik communicates with the BLUE CHERRY® software via the USB 2.0 interface. As long as the Safestik communicates with BLUE CHERRY®, it automatically establishes a Bluetooth connection to the permanently dedicated Bluetooth device and transmits data between BLUE CHERRY®... -
Page 32: Software
Safestik Serial no.: 2011xxxxx Software The measurement of the Safestik 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 33: 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 Safestik is solely in charge of compliance with these requirements. For storage and transport conditions, see chap.12 "Technical Specifications". -
Page 34: Operation
Safestik Serial no.: 2011xxxxx Operation The initial operation of Safestik, as well as any return to operation after service work in accordance with the duties of the responsible organisation (see chap. 8 “Servicing / Maintenance”), may be carried out by the responsible organisation's own authorised specialist personnel. -
Page 35: System Overview
Instructions for Use Safestik Serial no.: 2011xxxxx System Overview Safestik automatically establishes the Bluetooth connection to the dedicated device and carries out the data transfer between BLUE CHERRY® and the Bluetooth device. 1. The Safestik is connected directly to the PC via the USB interface [1]. -
Page 36: Operating Instructions
Reason: Penetrating liquid. Uncleanliness. External exposure. Therefore: • Do not use any liquids near the Safestik! • Do not expose Safestik or the entire system to dust or Attention other contamination! • Do not drop any objects on Safestik! •... -
Page 37: Initial Operating
Instructions for Use Safestik Serial no.: 2011xxxxx Initial Operating The measurements of the Safestik are processed by the diagnostic platform BLUE CHERRY®. 1. Start the PC and press the "BLUE CHERRY®" icon on the desktop to start the software. 2. Activate the Bluetooth communication of the dedicated Bluetooth device. -
Page 38: Servicing / Maintenance
The expected service life of Safestik 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 39 Instructions for Use Safestik Serial no.: 2011xxxxx Possible danger to life. Reason: Electric shock and / or misdiagnosis due to loss of electrical safety caused by exceeding the recommended maintenance schedule. Therefore: • Regularly check the specified maintenance schedule! •...
-
Page 40: 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 Safestik functional and clean. The following intervals apply: Component... - Page 41 Attention time stated by the cleanser and disinfectant manufacturer! • Do not place Safestik in the cleaning and disinfection solutions! The device contains electrical components that will be damaged by doing so! When selecting a suitable disinfectant, please observe •...
-
Page 42: Fault Indication And Repair
Safestik Serial no.: 2011xxxxx Fault Indication and Repair Simple errors which occur when using Safestik 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 43: Decommissioning / Disposal
11.2.2 Safestik Safestik 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 44: Technical Specifications
Instructions for Use Safestik Serial no.: 2011xxxxx Technical Specifications 12.1 Technical Data Medical device: Class I (according to MDR 2017 / 745 EU, annex VIII) Dimensions: (L) 76.5 mm x (W) 30 mm x (H) 18.5 mm Weight: 20 g... -
Page 45: 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 Safestik guaranteed by the manufacturer and for the safety of the patient and operator. Storage / Transport: min. -
Page 46: Electrical Safety Concept
Instructions for Use Safestik Serial no.: 2011xxxxx 12.3 Electrical Safety Concept 12.3.1 Safestik with Medical Device Cart and Isolation Transformer Page 46 Version: 4 | Release date: 14. July 2021... -
Page 47: Safestik Without Medical Device Cart And Without Isolation Transformer
Instructions for Use Safestik Serial no.: 2011xxxxx 12.3.2 Safestik without Medical Device Cart and without Isolation Transformer Version: 4 | Release date: 14. July 2021 Page 47... -
Page 48: Electromagnetic Compatibility / Emc Guidelines
12.4.1 Emitted Interference Guideline and Manufacturer Declaration Guidelines and manufacturer’s declaration – electromagnetic emissions The Safestik is determined for operation in an electromagnetic environment as specified below. The user/operator of the Safestik should ensure that it is operated in this environment. Measurement of Compliance Electromagnetic environment –... -
Page 49: Interference Resistance For All Me Systems Guideline And Manufacturer Declaration
Guidelines and manufacturer’s declaration – electromagnetic interference immunity The Safestik is determined for operation in an electromagnetic environment as specified below. The user / operator of the Safestik should ensure that it is operated in this environment. Measurement of IEC 60601 – test... -
Page 50: Interference Resistance For Non-Life-Supporting Me Systems Guideline And Manufacturer Declaration
Guidelines and manufacturer’s declaration – electromagnetic interference immunity The Safestik is determined for operation in an electromagnetic environment as specified below. The user / operator of the Safestik should ensure that it is operated in this environment. Measurement of IEC 60601 -level... - Page 51 If the measured field strength at the site where the Safestik is used exceeds the abovementioned compliance levels, the Safestik should be observed to demonstrate its intended function.
-
Page 52: Recommended Safety Distances For Non-Life-Supporting Me Systems
Recommended safety distance between portable and mobile RF communication devices and the Safestik The Safestik is determined for operation in an electromagnetic environment in which the RF disturbances are controlled. The user / operator of the Safestik may help to avoid... -
Page 53: Safety Of Product And Material
DIN EN ISO 10993-1:2017- 04 "Biological evaluation of medical devices" (biocompatibility). Safestik is a class I 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 54: Product Labeling / Type Label
Instructions for Use Safestik Serial no.: 2011xxxxx Product Labeling / Type Label The type label can be found on the back of the Safestik. See chap. 1.3 “Symbols”. Manufacturer logo Product name Product application Serial number Catalog number Manufacturer details... -
Page 55: Warranty And Service
Instructions for Use Safestik Serial no.: 2011xxxxx 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 56: Packaging And Shipping
Instructions for Use Safestik Serial no.: 2011xxxxx 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 57: Authorised Specialist Retail Partner
Instructions for Use Safestik Serial no.: 2011xxxxx 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: 4 | Release date: 14. July 2021 Page 57... -
Page 58: Attachment - Declaration Of Conformity
Instructions for Use Safestik Serial no.: 2011xxxxx Attachment – Declaration of Conformity The Safestik declaration of conformity is enclosed with each device by the manufacturer. Page 58 Version: 4 | Release date: 14. July 2021...
Need help?
Do you have a question about the Safestik and is the answer not in the manual?
Questions and answers