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GERATHERM 820658, Instructions For Use Manual

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GERATHERM 820658 Instructions For Use Manual Download Page 2

 

 

 

 

Version: 

 

 

6 

Release date:   

 

14. July 2021 

Filename: 

 

 

TDOSPI0085R6 

Language: 

 

 

English 

Affected serial numbers: 

xx|8|001|yyy and 2001xxxxx 

Software version: 

 

valid from 1.0.1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 

Geratherm® Respiratory GmbH 

Kasernenstraße 4 
97688 Bad Kissingen, GERMANY 

Tel.: +49 971 7857043-0 

Fax: +49 971 7857043-30 
[email protected] 
www.geratherm-respiratory.com 
 

 

 

 

EUDAMED SRN: 

DE-MF-000006818

 

© Geratherm® Respiratory GmbH

 

 

 

0494 

Summary of Contents for 820658

Page 1: ...pirostik Serial numbers xx 8 001 yyy and 2001xxxxx Instructions for Use Version 6 Release date 14 July 2021 Please read carefully and store in a place which is always accessible for future consultatio...

Page 2: ...xx 8 001 yyy and 2001xxxxx Software version valid from 1 0 1 Geratherm Respiratory GmbH Kasernenstra e 4 97688 Bad Kissingen GERMANY Tel 49 971 7857043 0 Fax 49 971 7857043 30 info geratherm respirat...

Page 3: ...s Accessories 20 2 2 1 2 Optional Expansions 23 2 2 2 Consumable Items Auxiliary Materials 25 3 Safety in Handling 27 3 1 General Safety at Work and Personnel Qualification 28 3 2 The Technical State...

Page 4: ...ing the Flow Sensor 49 8 Servicing Maintenance 51 8 1 Duties of the Responsible Organisation 51 8 2 Servicing Maintenance by the User Operator 52 8 2 1 Checking for Damage 53 8 2 1 1 General 53 8 2 1...

Page 5: ...ference Resistance for all ME Systems Guideline and Manufacturer Declaration 68 12 4 3 Interference Resistance for Non Life Supporting ME Systems Guideline and Manufacturer Declaration 69 12 4 4 Recom...

Page 6: ...the regulatory requirements for medical devices class IIa 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 Spirostik a...

Page 7: ...einafter to make this IFU easier to read Instructions for Use IFU Geratherm Respiratory GmbH Manufacturer Medical specialist personnel User s Personnel instructed in cleaning maintenance work Operator...

Page 8: ...tuation Not observing and not avoiding the situation may lead to death or severe injuries Indicates a possibly hazardous situation Not observing and not avoiding the situation may lead to minor or mod...

Page 9: ...otection type safe environmental conditions IP2x Protection of enclosure against ingress of solid foreign objects with a diameter greater than or equal to 12 5 mm and access to hazardous parts with fi...

Page 10: ...log number This symbol identifies the catalog number given by the manufacturer Manufacturer This symbol identifies the manufacturer of a product Date of manufacture This symbol indicates the date on w...

Page 11: ...ep away from rain The package contains a product that must be protected from moisture during transport and storage Temperature limitation The product can be safely transported stored or operated withi...

Page 12: ...are subject to the copyright of that third party 1 5 Limitation of Liability The manufacturer emphasises the creation of accompanying documents for his products Despite careful checking errors or inac...

Page 13: ...m 2 1 Intended Purpose Spirostik is an electric medical device It is a PC connected spirometer intended to identify the static and dynamic lung volume in pulmonary function testing in a clinical setti...

Page 14: ...ostik pulmonary function examinations can be carried out for diagnosing monitoring of process screening and assessing the severity of pulmonary diseases In particular this includes Obstructive disease...

Page 15: ...ending aorta X X Pulmonary embolism X X Tension pneumothorax X Acute internal bleeding X Recent eye operations X Recent thorax abdominal operations X Hemoptysis X Acute diarrhea X Angina X Severe hype...

Page 16: ...onary function examinations These can be described as follows Side effect Frequency Rules of conduct Side Effect Frequency Dizziness syncope on a case by case basis Examinations should preferably be p...

Page 17: ...onsible organisation and or is responsible for rectifying faults to the Spirostik as well as its calibration Users must be aware of the clinical meaning and for example be a physician physician s assi...

Page 18: ...ist personnel see chap 2 1 3 Definition of the Groups of People operates Spirostik Personnel must demonstrably have been given training in the function of Spirostik This also includes a complete study...

Page 19: ...onsequences All warranty claims shall expire Possible danger to life Reason Cross contamination Therefore Do not use consumable articles with a limited life span after their use by date has expired Po...

Page 20: ...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 Instructions on safe system construction in chap 4 1...

Page 21: ...rivers Comes together with intuitive Windows based diagnostic software platform BLUE CHERRY 01 361333 old 40 001 BLUE CHERRY Media Pack Modular and intuitive Windows based diagnostic software platform...

Page 22: ...cope in units Silicon Adapter Large Silicon adapter size large used for Spiraflow to connect to calibration syringe 01 158822 old 10 805 USB Extension Cable 30 cm 30 cm extension cable to connect USB...

Page 23: ...tem construction in chap 4 1 3 of this IFU Further information on Ambistik in the separate Ambistik IFU Component Description name Calibration Syringe Precision calibration instrument for calibration...

Page 24: ...14 July 2021 Component Description name Provocation For performing bronchial provocation tests with BLUE CHERRY diagnostic platform Offers pre defined and user configurable protocols with timers for...

Page 25: ...ook as well as the most updated version at www geratherm respiratory com login Component Description name Spiraflow Softclip Set Single use disposable flow sensor with low deadspace and Softclip nosec...

Page 26: ...isinfectant For wipe disinfection alcoholic quick acting Bacillol Tissues BODE Chemie GmbH SprayIn Dr Deppe GmbH depend ing on provider For disinfection bath with low chloride concentration Korsolex p...

Page 27: ...personnel Maintained or serviced improperly In order for Spirostik or the total system to be operated in accordance with its intended use the safety information and procedures in this IFU must be und...

Page 28: ...altered or removed Have missing or not readable information replaced immediately When working with auxiliary materials always observe the safety information from the respective manufacturer Wear suita...

Page 29: ...quipment and other products that are not part of the total system This also includes only components approved by the manufacturer such as connection cables and computers that are not permitted by the...

Page 30: ...caused by exceeding the recommended maintenance schedule Therefore Regularly check the specified maintenance schedule If a maintenance schedule is exceeded do not continue to use the total system Req...

Page 31: ...ases in the room Do not operate Spirostik near the magnetic field of an MRT system Possible danger to life Reason Electric shock Cross contamination Misdiagnosis caused by measurement error Device dam...

Page 32: ...cts more than once 3 4 Electromagnetic Compatibility EMC Possible danger to life Reason Misdiagnosis due to measurement error caused by a system failure due to uncontrollable electromagnetic fields of...

Page 33: ...the Spirostik and its reusable components as instructed by the manufacturer at regular intervals as specified Possible severe physical injury Reason Contamination with transferable germs during impro...

Page 34: ...ly 2021 4 Structure and General Function of Spirostik 4 1 Hardware 4 1 1 Overview 1 Easy to use snap in handle 2 Spirostik see also chap 7 6 3 Spiraflow flow sensor see also chap 4 1 2 1 4 Type label...

Page 35: ...e cleaning and calibration requirements must absolutely be adhered to For further information see Chap 9 Cleaning and Disinfection The separate manual Calibration flow sensor 4 1 3 System Construction...

Page 36: ...the relevant harmonised standards and the additional national and international standards and guidelines in the currently valid versions You will find a detailed description of the correct system for...

Page 37: ...cables to the system Do not connect any additional USB devices except mouse keyboard and printer Do not install any further software Ask your authorised specialist retail partner which Devices are ap...

Page 38: ...via the Windows printer interface Any printer compatible with Windows can be used for this 4 1 3 2 Power Supply The Spirostik is powered directly via the 5 V of the USB interface 4 2 Technical Protect...

Page 39: ...uter system or hospital 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 s...

Page 40: ...list retail partner authorised by the manufacturer is responsible for supplying Spirostik to the responsible organisation Unpacking and transport to the actual place of use are the responsibility of t...

Page 41: ...For further information see Chap 4 1 3 System Construction and Electrical Safety safe installation Assembly work is not required for the initial operation of Spirostik as this is supplied in a ready...

Page 42: ...nger to life Reason Electric shock Therefore After assembly or modification of a system a test of the electrical safety of the total system as well as all tests required by the respective manufacturer...

Page 43: ...fall down Before the Spirostik can be used for measurements again all components must be properly connected mounted and calibrated Calibration also fulfils the regulatory requirement of MPBetreibV 7 f...

Page 44: ...objects on Spirostik Do not lay any objects on it Never push foreign objects into the housing 7 1 Checking for Worn Parts The Spirostik should be checked for defective wearing parts each day before be...

Page 45: ...Calibrate Spirostik Set up funtional Operations 7 3 Switching Spirostik On Off As soon as the Spirostik is connected to the PC by the USB interface the device is automatically detected and started It...

Page 46: ...interrupted guide rib 2a and the nose on the handle are on the same side and the pressure tapping holes 2b show in the direction of the handle 2 Snap the Spiraflow 2 into the handle 1 For this Apply...

Page 47: ...sert the flow sensor as described in chap 7 4 Inserting the Flow Sensor Connect the calibration pump to the flow sensor on the mouthpiece The required frequency is shown in the tables below For detail...

Page 48: ...ndations e g ATS ERS Guidelines Replace the Flow Sensor immediately in case of saliva or moisture inside the Flow Sensor Reason Misdiagnosis due to measurement error caused by a system failure due to...

Page 49: ...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 T...

Page 50: ...ock the handle For this Slightly bend up the locking device 1 by pressure from below 2 Remove the flow sensor 2 from the handle towards mouthpiece side 3 Dispose the flow sensor 4 Insert a new flow se...

Page 51: ...8 years In its development a great deal of value was placed on making the servicing of all device components as simple as possible Only a little work is necessary to guarantee a fault free operation...

Page 52: ...the device and its components for damage and replacing them if necessary see chap 8 2 1 Checking for Damage Once per day Checking the sealing rubber of the head for tears wear and replacing the head...

Page 53: ...aintenance and servicing work may only be performed by specialised personnel who have been authorised by the manufacturer 8 2 1 Checking for Damage 8 2 1 1 General All parts of Spirostik should be che...

Page 54: ...n general this should be replaced once per year To do this proceed as follows 1 Remove the used handle 1 For this Carefully remove both tubes blue white off the Spirostik connector 1 2 Mount a new han...

Page 55: ...cleaning and disinfection This is why just a few tasks are necessary to keep Spirostik functional and clean The following intervals apply Component Interval Method Single use flow sensor After each pa...

Page 56: ...agents The composition is available on data sheets which we can provide on request Check bactericidal and virucidal effect suitable for the intended use Use only disinfectants listed in public databas...

Page 57: ...pirostik in the cleaning and disinfection solutions The device contains electrical components that will be damaged by doing so Reason Avoid penetration of liquid into electrical components Therefore R...

Page 58: ...observe Chap 2 2 2 Consumable Items Auxiliary Materials For selection of suitable disinfectants for surface wipe disinfection also note The separate IFU Cleaning and Disinfection Information on the ap...

Page 59: ...Danger to life Reason Unauthorised work carried out by the user to troubleshoot and rectify an error Therefore Users may only carry out work which is described and permitted by the manufacturer In ca...

Page 60: ...3 Disposal In general the applicable national laws and regulations stipulated by the local authority should be complied with for disposal 11 3 1 Transport Packaging The transport packaging should be...

Page 61: ...eces and noseclips must be disposed of via hospital or medical practice waste Possible severe physical injuries Reason Contamination with transferable germs during improper disposal Therefore Dispose...

Page 62: ...rotection class 1 or 2 depending on the PC system Protection type IP20 Application component BF corresponding DIN EN 60601 1 PC interface USB 2 0 Power supply 5 V via USB Power consumption Max 2 5 VA...

Page 63: ...e 0 20 l Accuracy 3 oder 50 ml Minimum PC system requirements Standard at least EN 62368 1 EN 60950 recommended EN 60601 Processor X86 amd64 compatible 1 GHz or higher RAM storage 1 GB or higher Hard...

Page 64: ...orage Transport min max Temperature 10 C 60 C Relative air humidity 0 95 non condensing Atmospheric pressure 700 hPa 1100 hPa Operation min max Environmental temperature 0 C 40 C Avoid extreme fluctua...

Page 65: ...uctions for Use Spirostik Serial no xx 8 001 yyy and 2001xxxxx Version 6 Release date 14 July 2021 Page 65 12 3 Electrical Safety Concept 12 3 1 Spirostik with Medical Device Cart and Isolation Transf...

Page 66: ...Instructions for Use Spirostik Serial no xx 8 001 yyy and 2001xxxxx Page 66 Version 6 Release date 14 July 2021 12 3 2 Spirostik without Medical Device Cart and without Isolation Transformer...

Page 67: ...in an electromagnetic environment as specified below The user operator of the Spirostik should ensure that it is operated in this environment Measurement of electromagnetic emissions Compliance Elect...

Page 68: ...d ensure that it is operated in this environment Measurement of interference immunity IEC 60601 test level Compliance level Electromagnetic environment Guideline Electrostatic discharge ESD according...

Page 69: ...e level Electromagnetic enviroment Guidline Portable and mobile RF communication devices should not be used at a shorter distance from the Spirostik as the recommended safety distance calculated accor...

Page 70: ...of electromagnetic 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 bas...

Page 71: ...ower of the 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...

Page 72: ...e carefully 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...

Page 73: ...erial number 5 Catalog number 6 Manufacturer details 7 Do not dispose of the device along with general household waste 8 Input power 9 Type label revision indication 10 Follow the IFU 11 Conformity ma...

Page 74: ...you purchased 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 warran...

Page 75: ...amage 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 packin...

Page 76: ...yyy and 2001xxxxx Page 76 Version 6 Release date 14 July 2021 16 Authorised Specialist Retail Partner You can reach your responsible specialist retail partner via a contact form of the manufacturer w...

Page 77: ...e Spirostik Serial no xx 8 001 yyy and 2001xxxxx Version 6 Release date 14 July 2021 Page 77 Attachment Declaration of Conformity The Spirostik declaration of conformity is enclosed with each device b...

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