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Instructions for Use

Safestik

Serial no.: 2011xxxxx

Version: 4 | Release date: 14. July 2021

Page 57

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

Содержание 180384

Страница 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...

Страница 2: ...ial numbers 2011xxxxx Software version valid from 1 3 2 Geratherm Respiratory GmbH Kasernenstra e 4 97688 Bad Kissingen GERMANY Tel 49 971 7857043 0 Fax 49 971 7857043 30 info geratherm respiratory co...

Страница 3: ...k and Personnel Qualification 18 3 2 Storage Conditions stipulated by the Manufacturer 19 3 3 The Technical State of Safestik and System Construction 19 3 4 Operation Servicing and Maintenance 21 3 5...

Страница 4: ...cal 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 Emitted Interf...

Страница 5: ...standards This means that Safestik fulfills the regulatory requirements for medical devices class I These IFU is a component of the product in accordance with DIN EN ISO 60601 1 It should make it eas...

Страница 6: ...tion 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 1 1 Abbreviations The foll...

Страница 7: ...ates a directly hazardous situation Not observing and not avoiding the situation will lead to death or severe injuries The signal word DANGER is only used for extreme situations Indicates a possibly h...

Страница 8: ...protection of enclosure against harmful ingress of water Do not dispose of the device along with general household waste It must be disposed of in a proper and correct manner via the specialist retail...

Страница 9: ...A Caution non ionizing electromagnetic radiation Precautions must be taken to avoid an unexpected effect of non ionizing radiation Fragile handle with care The package contains a product that must be...

Страница 10: ...rmation or brand names of a third party contained in this document are subject to the copyright of that third party 1 5 Limitation of Liability The manufacturer emphasises the creation of accompanying...

Страница 11: ...irect damage resulting from not adhering to these conditions They are then solely responsible for the fulfillment of the basic requirements of the medical device and assumes complete product liability...

Страница 12: ...familiar with lung function examinations who uses Safestik after verifiable instruction by the responsible organisation and or is responsible for rectifying faults to the Safestik Users must be aware...

Страница 13: ...Conditions The responsible organisation must ensure that only medically trained specialist personnel see chap 2 1 1 Definition of the Groups of People operates Safestik Personnel must demonstrably ha...

Страница 14: ...the patient user operator and or third parties The manufacturer assumes no liability for such consequences All warranty claims shall expire See also chap 15 2 Warranty Exemption Possible physical inj...

Страница 15: ...in your medical device book as well as the most updated version at www geratherm respiratory com login Instructions on safe system construction in chap 4 1 3 of this IFU Component Description name Sup...

Страница 16: ...d 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 Component Description name Dis...

Страница 17: ...aintained or serviced improperly In order for Safestik or the complete system to be operated in accordance with its intended use the safety information and procedures in this IFU must be understood En...

Страница 18: ...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 observe the safety informat...

Страница 19: ...ik Use with care Do not modify or use product Safestik or complete system contrary to the respective manufacturer s specification When connecting Safestik to other devices make sure that all connectio...

Страница 20: ...re that in the patient environment a distance of 1 5 meters to the patient there are no accessible electrical parts interfaces plugs etc that are not isolated from the mains with an isolation voltage...

Страница 21: ...l and safe condition Reason Ignorance of safety instructions Therefore The assembler of a system must provide the user operator with all separate instructions for use applicable for the complete syste...

Страница 22: ...ble for any resulting injuries to persons and or damages to Safestik Possible danger to life Reason Electric shock Cross contamination Misdiagnosis caused by measurement error Therefore Ensure that th...

Страница 23: ...iquid Uncleanliness External exposure Therefore Do not use any liquids near Safestik Do not expose Safestik or the entire system to dust or other contamination Do not drop any objects on Safestik Do n...

Страница 24: ...m that exceed the immunity levels as specified in the EMC guidelines Ask your authorised specialist retail partner about this Reason Misdiagnosis caused by uncontrollable electromagnetic fields Trigge...

Страница 25: ...ason Improperly treated components Therefore For cleaning and disinfection only use those active substances that are approved by the manufacturer see chap 9 Cleaning and Disinfection Follow the instru...

Страница 26: ...Safestik Serial no 2011xxxxx Page 26 Version 4 Release date 14 July 2021 4 Structure and General Function of Safestik 4 1 Hardware 4 1 1 Overview 1 Safestik 2 USB extension cable 30 cm 3 Type label se...

Страница 27: ...not connected Connect the Safestik to the computer s USB 2 0 port GREEN flashing Safestik connected to USB no communication with BLUE CHERRY Start BLUE CHERRY GREEN permanent Safestik ready for opera...

Страница 28: ...ts spare parts consumables with existing medical electrical equipment or systems and this combination is used by third parties or this combination is placed on the market will legally become a produce...

Страница 29: ...estik or complete system contrary to the respective manufacturer s specification Under no circumstances use or connect any devices systems equipment and other products that are not part of the complet...

Страница 30: ...ctrical shock and or misdiagnosis due to loss of electrical safety caused by exceeding the recommended maintenance schedule Therefore Regularly check the specified maintenance schedules If a maintenan...

Страница 31: ...a Bluetooth connection to the permanently dedicated Bluetooth device and transmits data between BLUE CHERRY and the Bluetooth device To protect against cyber attacks neither the Safestik or the associ...

Страница 32: ...ospital information system is supported by standardised software interfaces e g HL7 GDT Paid software options are necessary for this if applicable A modular and flexible hardware and software concept...

Страница 33: ...festik to the responsible organisation Unpacking and transport to the actual place of use are the responsibility of the responsible organisation 5 2 Storage The Safestik is a mobile portable device Re...

Страница 34: ...ee chap 8 Servicing Maintenance may be carried out by the responsible organisation s own authorised specialist personnel This can also be the operator user themselves Possible danger to life Reason El...

Страница 35: ...oth device 1 The Safestik is connected directly to the PC via the USB interface 1 Alternatively the USB extension cable 2 can be placed between the PC and the Safestik increasing the range of the Safe...

Страница 36: ...erefore Do not use any liquids near the Safestik Do not expose Safestik or the entire system to dust or other contamination Do not drop any objects on Safestik Do not lay any objects on it Never push...

Страница 37: ...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 3 Once the Safestik ha...

Страница 38: ...ended by the manufacturer carried out by specialist personnel who have been authorised by the manufacturer for the respective tasks The expected service life of Safestik is 8 years In its development...

Страница 39: ...c shock and or misdiagnosis due to loss of electrical safety caused by exceeding the recommended maintenance schedule Therefore Regularly check the specified maintenance schedule If a maintenance sche...

Страница 40: ...ufacturer 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 C...

Страница 41: ...ose active substances that are approved by the manufacturer see chap 2 2 2 Auxiliary Materials Follow the instructions on the concentration and dwell time stated by the cleanser and disinfectant manuf...

Страница 42: ...er via contact form on the manufacturer s website www geratherm respiratory com login Danger to life Reason Unauthorised work carried out by the user to troubleshoot and rectify an error Therefore Use...

Страница 43: ...gulations stipulated by the local authority should be complied with for disposal 11 2 1 Transport Packaging The transport packaging should be reused or sent for material recycling Before doing so you...

Страница 44: ...0 PC interface USB 2 0 Bluetooth interface 4 0 2 400 2 4835 GHz GFSK PI 4 DQPSK 8DPSK Transmitter with Output Power 8 dBm Power supply 5 V via USB Power consumption 100 mA EMC Group 1 Class B Minimum...

Страница 45: ...nufacturer and for the safety of the patient and operator Storage Transport min max Temperature 10 C 50 C Relative air humidity 10 95 non condensing Operation min max Environmental temperature 10 C 35...

Страница 46: ...Instructions for Use Safestik Serial no 2011xxxxx Page 46 Version 4 Release date 14 July 2021 12 3 Electrical Safety Concept 12 3 1 Safestik with Medical Device Cart and Isolation Transformer...

Страница 47: ...Instructions for Use Safestik Serial no 2011xxxxx Version 4 Release date 14 July 2021 Page 47 12 3 2 Safestik without Medical Device Cart and without Isolation Transformer...

Страница 48: ...lectromagnetic environment as specified below The user operator of the Safestik should ensure that it is operated in this environment Measurement of electromagnetic emissions Compliance Electromagneti...

Страница 49: ...hat it is operated in this environment Measurement of interference immunity IEC 60601 test level Compliance level Electromagnetic environment Guideline Electrostatic discharge ESD according to IEC 610...

Страница 50: ...ectromagnetic enviroment Guidline Portable and mobile RF communication devices should not be used at a shorter distance from the Safestik as the recommended safety distance calculated according to the...

Страница 51: ...ctromagnetic parameters is influenced by absorptions and reflections from buildings objects and people a The field strengths of stationary transmitters such as base stations and mobile land based radi...

Страница 52: ...communication device as indicated below Power rating of the transmitter W Safety distance depending on the transmitter frequency m 150 kHz to 80 MHz 1 17 80 MHz to 800 MHz 1 17 800 MHz to 2 7 GHz 2 3...

Страница 53: ...lly selected and correspond to the biocompatibility requirements in accordance with ISO 10993 1 ff and those of the RoHS directive 2011 65 EU RoHS II All materials in contact with the patient were eva...

Страница 54: ...Manufacturer details 7 Do not dispose of the device along with general household waste 8 Input power 9 Type label revision edition 10 Follow the IFU 11 Conformity mark in accordance with the Medical D...

Страница 55: ...hased the device via a specialist retail partner All repairs to products which are covered by the warranty must be carried out by the manufacturer or by a specialist retail partner All warranty claims...

Страница 56: ...ing 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...

Страница 57: ...2011xxxxx Version 4 Release date 14 July 2021 Page 57 16 Authorised Specialist Retail Partner You can reach your responsible specialist retail partner via a contact form of the manufacturer www gerath...

Страница 58: ...ons for Use Safestik Serial no 2011xxxxx Page 58 Version 4 Release date 14 July 2021 Attachment Declaration of Conformity The Safestik declaration of conformity is enclosed with each device by the man...

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