GERATHERM 503678 Instructions For Use Manual Download Page 2

Page: 2 / 88

Version:

Release date:

14. July 2021

Filename:

TDOSPC0069R7

Language:

English

Affected serial numbers:

xx|8|102|yyy and 2103xxxxx

Software version:

valid from 1.1.0

Geratherm® Respiratory GmbH

Kasernenstraße 4
97688 Bad Kissingen, GERMANY

Tel.: +49 (0)971 7857043-0

Fax: +49 (0)971 7857043-30
[email protected]
www.geratherm-respiratory.com

EUDAMED SRN:

DE-MF-000006818

0494

Summary of Contents for 503678

Page 1: ...tik Complete Serial numbers xx 8 102 yyy and 2103xxxxx Instructions for Use Version 7 Release date 14 July 2021 Please read carefully and store in a place which is always accessible for future consult...

Page 2: ...x 8 102 yyy and 2103xxxxx Software version valid from 1 1 0 Geratherm Respiratory GmbH Kasernenstra e 4 97688 Bad Kissingen GERMANY Tel 49 0 971 7857043 0 Fax 49 0 971 7857043 30 info geratherm respir...

Page 3: ...1 2 Optional Expansions 23 2 2 2 Consumable Items Auxiliary Materials 24 3 Safety in Handling 25 3 1 General Safety at Work and Personnel Qualification 26 3 2 The technical state of Spirostik Complet...

Page 4: ...to Operation after Servicing Cleaning Work 49 7 Operating Instructions 51 7 1 Checking for Worn Parts 51 7 2 Establish operational readiness 52 7 3 Inserting the Flow Sensor 54 7 4 Calibrating Spiros...

Page 5: ...ce s 76 12 3 3 Spirostik Complete without Medical Device Cart and without Isolation Transformer 77 12 4 Electromagnetic Compatibility EMC Guidelines 78 12 4 1 Emitted Interference Guideline and Manufa...

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 C...

Page 7: ...d hereinafter 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 Ope...

Page 8: ...on 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 moderate...

Page 9: ...0 Protection 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 wit...

Page 10: ...urer Catalog 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...

Page 11: ...e Keep 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 w...

Page 12: ...ment 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...

Page 13: ...and assumes complete product liability for the whole system 2 1 Intended Purpose The Spirostik Complete is an electric medical device It is designed as a desktop spirometer for determining dynamic lun...

Page 14: ...ation 2 1 1 Indication With Spirostik Complete pulmonary function examinations can be carried out for diagnosing monitoring of process screening and assessing the severity of pulmonary diseases In par...

Page 15: ...e ascending 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...

Page 16: ...y occur in pulmonary function examinations These can be described as follows Side effect Frequency Rules of conduct Dizziness syncope on a case by case basis Examinations should preferably be performe...

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

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

Page 19: ...such consequences 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 exp...

Page 20: ...rm respiratory com login Instructions on safe system construction in chap 4 1 4 of this IFU Further information on PC systems approved by the manufacturer in chap 12 1 Technical Data Component Descrip...

Page 21: ...ular and intuitive Windows based diagnostic software platform for pulmonary function 01 598197 old 10 500 Spiraflow Softclip Set Single use disposable flow sensor with low deadspace and Softclip nosec...

Page 22: ...omponent Description name Supply scope in units Guide Rolls for Paper Roll Set of 2 guide rolls for proper positioning and easy unrolling of paper roll in Spirostik Complete 01 191465 old 10 808 01 Qu...

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

Page 24: ...geratherm respiratory com login Component Description name Spiraflow Softclip Set Single use disposable flow sensor with low deadspace and Softclip noseclip for use with the Spirostik and Spirostik Co...

Page 25: ...cted personnel Maintained or serviced improperly In order for Spirostik Complete or the total system to be operated in accordance with its intended use the safety information and procedures in this IF...

Page 26: ...t be 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...

Page 27: ...t any devices systems equipment and other products that are not part of the total system This also includes only peripherals components approved by the manufacturer Ensure that in the patient environm...

Page 28: ...mponents add ons and auxiliary materials Check that the components are in a functional and safe condition Reason Electric shock and or misdiagnosis due to loss of electrical safety caused by exceeding...

Page 29: ...irostik Complete if there are flammable or explosive gases in the room Do not operate Spirostik Complete near the magnetic field of an MRT system Possible danger to life Reason Electric shock Cross co...

Page 30: ...s 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 i...

Page 31: ...turer at regular intervals as specified Possible severe physical injury Reason Contamination with transferable germs during improper disposal Therefore Dispose single use items disposable flow sensors...

Page 32: ...ee also chap 4 1 3 2 4 Type label on the bottom of the device see also chap 14 5 Connection panel power switch status display Status LED see also chap 4 1 3 1 6 Double tube of the handle with luer con...

Page 33: ...tion Display Explanation Action NONE LED off Device switched off Switch on the power supply button No electricity supply Connecting the power supply unit PC system off or in standby mode Switch on the...

Page 34: ...plete and the display thereof Possible states Display Explanation Action NONE LED off Device switched off Switch on the power supply button PC system switched off Switch on the PC system with the LED...

Page 35: ...ostic software platform can be operated directly with the integrated touch screen BLUE CHERRY has an integrated On Screen Keyboard for data input The screen also serves to display all relevant informa...

Page 36: ...3 1 Handle Peripherals Power At the backside of the device you will find Status LED For status indication of the power suppy Socket for medical power supply unit Power supply system USB 2 0 Interfaces...

Page 37: ...and 2103xxxxx Version 7 Release date 14 July 2021 Page 37 4 1 3 2 Network Peripherals Display Sound On the left side of the device you will find Micro phone Line Out HDMI Port USB 3 0 Interfaces 2 pie...

Page 38: ...e preserved Therefore Exactly follow instructions for cleaning disinfection and calibration The heart of the Spirostik Complete is the Spiraflow flow sensor The Spiraflow is a disposable sensor and th...

Page 39: ...the system should be constructed by a specialist retail partner but may also be carried out by the responsible organisation of Spirostik Complete themselves It is essential to note Anyone who combines...

Page 40: ...Ensure 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 vol...

Page 41: ...0 is required 4 1 4 1 Data Connection Computer Printer The data connection between measuring electronics and computer is already integrated in the Spirostik Complete The integrated Windows 10 PC syste...

Page 42: ...danger to life Reason Electric shock due to lack of galvanic separation with composition of non approved components Therefore Only use the medical power supply unit with power cord supplied by the ma...

Page 43: ...and examination data as well as carry out depict process and record measurements with the devices of the manufacturer The communication between the BLUE CHERRY software and a practice computer system...

Page 44: ...tail partner authorised by the manufacturer is responsible for supplying Spirostik Complete to the responsible organisation Unpacking and transport to the actual place of use are the responsibility of...

Page 45: ...operation of Spirostik Complete as this is supplied in a ready for operation state As a consumable the flow sensor must be replaced constantly which is therefore not considered assembly For further i...

Page 46: ...sation see 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 6 1 Initial Operating 6 1...

Page 47: ...e Handle 1 Connecting the handle on the rear connection panel of the Complete For this Connect the luer connections 1 of the double tube to the connection socket 2 observe color coding Lock the luer c...

Page 48: ...residue if necessary 3 upwards 3 Insert guide rollers 4 on both sides of the new paper roll 4 Load the paper roll into the tray For this Turn the paper roll so that the paper rolls off in the directi...

Page 49: ...Maintenance 6 2 Returning to Operation after Servicing Cleaning Work The responsible organisation is responsible for returning the device to operation after servicing cleaning work for which the oper...

Page 50: ...to leakage caused by the incorrect assembly of components Therefore Carefully observe the assembly instructions Attention Spirostik Complete could be damaged Reason Careless operation Therefore Assure...

Page 51: ...o not expose Spirostik Complete or the entire system to dust or other contamination Do not drop any objects on Spirostik Complete Do not lay any objects on it Never push foreign objects into the housi...

Page 52: ...ervicing Maintenance and chap 9 Cleaning and Disinfection 7 2 Establish operational readiness As soon as the medical power supply is connected to the Spirostik Complete the device can be put into stan...

Page 53: ...sec PC starts with a short delay Windows interface including symbol for BLUE CHERRY appears Spirostik Complete is ready for use Status LED on the back of the device lights up green LED standby button...

Page 54: ...the 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 App...

Page 55: ...measurement Insert the flow sensor as described in chap 7 3 Inserting the Flow Sensor Connect the calibration pump to the flow sensor on the mouthpiece The required frequency is shown in the tables be...

Page 56: ...ommendations 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...

Page 57: ...regulatory requirements for biologically hazardous materials Clean and disinfect Spirostik Complete and its reusable components as instructed by the manufacturer at regular intervals as specified The...

Page 58: ...stik Complete remains connected to the power supply it is recommended to select the energy saving mode with the Windows menu for shutting down the PC LED Standby Button flashes white Status LED on the...

Page 59: ...lete 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 Only a little work is necessary to guarantee a fault free ope...

Page 60: ...tor In order to ensure a flawless operation of Spirostik Blue over its whole service life regular servicing and repairs if applicable are required Interval Servicing work Once per day Visual checks of...

Page 61: ...way Therefore Prior to each use visually inspect the total system housing connectors etc for any damages If there are any damages do not operate the system The damaged parts must be replaced or repair...

Page 62: ...hap 4 1 4 System Construction and Electrical Safety Chap 6 2 Returning to Operation after Servicing Cleaning Work 8 2 1 2 Checking Replacing the Handle During the daily inspection of the sealing rubbe...

Page 63: ...ls apply Component Interval Method Single use flow sensor After each patient Dispose of Noseclip After each patient Dispose of Spirostik Complete Device Weekly Surface Wipe disinfection All other touc...

Page 64: ...sinfectants listed in public databases e g RKI Check data sheet for material compatibility with plastics especially polyoxymethylene polystyrene acrylonitrile butadiene styrene Makrolon as well as met...

Page 65: ...Dispose single use items bacteria virus filter and noseclips after each use For this observe the applicable regulatory requirements for biologically hazardous materials Clean and disinfect Spirostik C...

Page 66: ...nser and disinfectant manufacturer Do not place Spirostik Complete in the cleaning and disinfection solutions The device contains electrical components that will be damaged by doing so Reason Penetrat...

Page 67: ...t 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 Users may only c...

Page 68: ...lete Serial no xx 8 102 yyy and 2103xxxxx Page 68 Version 7 Release date 14 July 2021 For other error conditions and their correction please refer to this IFU Chap 4 1 2 1 Display Status LED Chap 4 1...

Page 69: ...o decommission the Spirostik Complete remove any contaminated material from it 11 3 Disposal In general the applicable national laws and regulations stipulated by the local authority should be complie...

Page 70: ...Contaminated Single Use Items All contaminated items such as single use flow sensors and noseclips must be disposed of via hospital or medical practice waste Possible severe physical injuries Reason...

Page 71: ...n class I protective conductor system Device with additional internal electrical power source Protection type IP20 Application component BF according to DIN EN 60601 1 PC interfaces Bluetooth 4 0 2 40...

Page 72: ...ection Internal 4 5 A fuse EMC Group 1 Class B Noise emission 80 dB A Flow measurement Flow sensor Spiraflow Measuring principle Differential pressure Measuring range 16 l s Ventilation measuring rang...

Page 73: ...103xxxxx Version 7 Release date 14 July 2021 Page 73 Minimum PC system requirements Processor Quad Core Intel Prozessor max 2 4 GHz RAM storage 4 GB DDR 3 Hard drive storage 128 GB SSD Monitor 10 1 in...

Page 74: ...f the patient and operator Storage Transport min max Temperature 10 C 50 C Relative air humidity 0 95 non condensing Operation min max Environmental temperature 10 C 35 C Avoid extreme fluctuations in...

Page 75: ...or Use Spirostik Complete Serial no xx 8 102 yyy and 2103xxxxx Version 7 Release date 14 July 2021 Page 75 12 3 Electrical Safety Concept 12 3 1 Spirostik Complete with Medical Device Cart and Isolati...

Page 76: ...pirostik Complete Serial no xx 8 102 yyy and 2103xxxxx Page 76 Version 7 Release date 14 July 2021 12 3 2 Spirostik Complete without Medical Device Cart and without Isolation Transformer combined with...

Page 77: ...ructions for Use Spirostik Complete Serial no xx 8 102 yyy and 2103xxxxx Version 7 Release date 14 July 2021 Page 77 12 3 3 Spirostik Complete without Medical Device Cart and without Isolation Transfo...

Page 78: ...n in an electromagnetic environment as specified below The user operator of the Spirostik Complete should ensure that it is operated in this environment Measurement of electromagnetic emissions Compli...

Page 79: ...propriate for a typical business or hospital environment Surges according to IEC 61000 4 5 1 kV Voltage outer conductor outer conductor 2 kV Voltage outer conductor end 1 kV Voltage outer conductor ou...

Page 80: ...ould ensure that it is operated in this environment Measurement of interference immunity IEC 60601 level Compliance level Electromagnetic enviroment Guidline Portable and mobile RF communication devic...

Page 81: ...sorptions and reflections from buildings objects and people a The field strengths of stationary transmitters such as base stations and mobile land based radios amateur radio stations AM and FM radio a...

Page 82: ...ending on the emitted power 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 8...

Page 83: ...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 84: ...al 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 mark...

Page 85: ...n if 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 wa...

Page 86: ...id 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 pa...

Page 87: ...102 yyy and 2103xxxxx Version 7 Release date 14 July 2021 Page 87 16 Authorised Specialist Retail Partner You can reach your responsible specialist retail partner via a contact form of the manufactur...

Page 88: ...ik Complete Serial no xx 8 102 yyy and 2103xxxxx Page 88 Version 7 Release date 14 July 2021 Attachment Declaration of Conformity The Spirostik Complete declaration of conformity is enclosed with each...

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