GERATHERM 455713 Instructions For Use Manual Download Page 103

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Instructions for Use

Diffustik / Variant PFTstik

Serial no.: xx|8|401|yyy and 2401xxxxx

Version: 8 | Release date: 16. August 2021

Page 103

Attachment – Declaration of Conformity

The Diffustik resp. the variant PFTstik declaration of conformity is
enclosed with each device by the manufacturer.

Summary of Contents for 455713

Page 1: ...ystem variant PFTstik Serial numbers xx 8 401 yyy and 2401xxxxx Instructions for Use Version 8 Release date 16 August 2021 Please read carefully and store in a place which is always accessible for fut...

Page 2: ...s xx 8 401 yyy and 2401xxxxx Software version valid from 1 2 0 Geratherm Respiratory GmbH Kasernenstra e 4 97688 Bad Kissingen GERMANY Tel 49 971 7857043 0 Fax 49 971 7857043 30 info geratherm respira...

Page 3: ...2 Consumable Items Auxilary Materials 29 3 Safety in Handling 31 3 1 General Safety at Work and Personnel Qualification 33 3 2 The Technical State of Diffustik Variant PFTstik and System Construction...

Page 4: ...2 Assembly Shutter System 58 6 2 3 Inserting the Flow Sensor 60 6 2 4 Power Supply and Computer Connection 61 7 Operating Instructions 63 7 1 Checking for Worn Parts 63 7 2 Switching Diffustik Varian...

Page 5: ...fety Concept 90 12 3 1 Variant Diffustik with Medical Device Cart and Isolation Transformer 90 12 3 2 Variant PFTstik with Medical Device Cart and Isolation Transformer91 12 4 Electromagnetic Compatib...

Page 6: ...ory 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 Diffustik resp the var...

Page 7: ...used 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...

Page 8: ...rving 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 injuries I...

Page 9: ...Body Floating In order to comply with the limit value for the patient leakage current the applied part is insulated from earth Only use indoors IP20 Protection type safe environmental conditions IP2x...

Page 10: ...must be taken to a central collection point for used batteries or to the manufacturer For single use only This symbol does not refer to the Diffustik resp the variant PFTstik itself but to the consuma...

Page 11: ...ing 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 handled with approp...

Page 12: ...document 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 error...

Page 13: ...dditionally intended for the following purposes The Diffustik resp the variant PFTstik is a medical electrical device As a PC linked PFT system it is mainly intended to determine lung volumes and airw...

Page 14: ...e separate IFU Add on CO Diffusion Examination Required option CO Diffusion Variant Diffustik Included Variant PFTstik Add on CO Diffusion 259149 MIP MEP MIP MEP 250798 P0 1 MIP MEP 250798 Breathing P...

Page 15: ...nosing monitoring of process screening and assessing the severity of pulmonary diseases In particular this includes Obstructive diseases Complaints such as dyspnea shortness of breath or coughing when...

Page 16: ...X Aneurysm of the 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...

Page 17: ...effects rarely 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 preferabl...

Page 18: ...onsible organisation and or is responsible for rectifying faults to the Diffustik resp the variant PFTstik as well as its calibration Users must be aware of the clinical meaning and for example be a p...

Page 19: ...ation with the Add on CO Diffusion extension the room must always be well ventilated to protect users and third parties from continuous exposure to harmful carbon monoxide CO The following applies in...

Page 20: ...thorised modifications are prohibited The Diffustik resp the variant PFTstik is not intended for the control of vital physiological parameters where the nature of the change could lead to immediate da...

Page 21: ...ange constructive prescribed properties of Diffustik resp the variant PFTstik and in the worst case impair the safety of the patient user operator and or third parties The manufacturer assumes no liab...

Page 22: ...Instructions on safe system construction in chap 4 1 4 of this IFU The list of original spare parts and the scope of supply described in the separate IFU Add on CO Diffusion also applies to the Diffus...

Page 23: ...Clamp Arm Table Clamp to mount arm of PFTstik or Diffustik to a suitable table Can be ordered instead of Adapter Stand Clamp 420241 old 10 906 BLUE CHERRY Media Pack Installation CD for intuitive Wind...

Page 24: ...ik device 01 139094 old 10 600 Flow Unit Flow unit for PFTstik Bodystik and Diffustik Including flow electronic and rubber seal plates 01 40 630 Shutter Drive Electromagnetic shutter drive for shutter...

Page 25: ...cclusion of breathing path Replaced by shutter block 40 620 1 until 11 2018 40 611 Shutter Head For connection of shutter system with flow unit without Add on CO Diffusion demand valve Replaced by shu...

Page 26: ...monary function testing 03 199479 old 10 003 Power Cord CEE 7 7 C13 IEC 60320 EU Power cord with European plug with protective earth 01 719626 old 10 838 01 USB Connection Cable USB connection cable m...

Page 27: ...2 Rubber seal plates for flow unit 01 885146 old 40 630 05 Retaining Ring 10 mm Retaining ring to fix the mounting plate on the height adjustable arm 01 292655 old 40 702 08 PFT Cart Consisting of Ca...

Page 28: ...ions on safe system construction in chap 4 1 4 of this IFU Component Description name Add on CO Diffusion Single breath CO Diffusion option adds DLco measurement to Bodystik or Diffustik Variant PFTst...

Page 29: ...ware option for BLUE CHERRY to add measurement of o Maximum inspiratory pressure MIP o Maximum expiratory pressure MEP o P0 1 250798 old 10 525 2 2 2 Consumable Items Auxilary Materials The following...

Page 30: ...0 Neumofilt Single use disposable bacterial and viral filter for use in pulmonary function testing 199479 old 10 003 Disinfectant For wipe disinfection alcoholic quick acting Bacillol Tissues BODE Che...

Page 31: ...f this dangers of injury to users operators patients and third parties as well as damage to Diffustik resp the variant PFTstik or other materials may occur if this is Not used in accordance with the c...

Page 32: ...d Otherwise in the worst case death or severe injuries are the consequence resulting from the risks described in more detail in the respective chapters Therefore Read this IFU carefully and in its ent...

Page 33: ...y not 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 W...

Page 34: ...PFTstik within its expected service life determined by the manufacturer Under no circumstances use or connect any devices systems equipment and other products that are not part of the total system Ne...

Page 35: ...sis due to loss of electrical safety caused by exceeding the recommended maintenance schedule Therefore Regularly check the specified maintenance schedule If a maintenance schedule is exceeded do not...

Page 36: ...ion Do not operate Diffustik resp the variant PFTstik if there are flammable or explosive gases in the room Do not operate Diffustik resp the variant PFTstik near the magnetic field of an MRT system P...

Page 37: ...resp the variant PFTstik Never push foreign objects into the housing Reason Disregard of a contraindication Misdiagnosis caused by measurement error Cross contamination For this Observe the general me...

Page 38: ...nt error caused by a system failure due to uncontrollable electromagnetic fields of inadmissible transmitting devices Therefore While using Diffustik resp the variant PFTstik do not use any transmitti...

Page 39: ...ble Flow Sensors Mouthpieces and Noseclips after each use For this observe the applicable regulatory requirements for biologically hazardous materials Observe regulations on wearing personal protectiv...

Page 40: ...s added to the PFTstik variant the complete system also includes the components described in the separate IFU Add on CO Diffusion 4 1 1 Overview of the Complete System of the Diffustik Variant 1 Movab...

Page 41: ...ew of the Complete System of the PFTstik Variant 1 Movable arm for connection of 2 2 Flow measuring and shutter system see also chap 6 2 1 und 6 2 2 3 Connections for gas sample and gas supply CO Diff...

Page 42: ...able Arm with Flow Measurement Shutter System Variant Diffustik Height adjustable arm Connection sockets see photo below Demand valve see also chap 6 2 3 Shutter drive with shutter cage see also chap...

Page 43: ...t adjustable arm Lever for height regulation and for moving see also chap 7 4 Shutter drive with shutter block and shutter plug see alo chap 6 2 2 Flow unit see also chap 6 2 3 Connecting cable see al...

Page 44: ...hen the CO Diffusion option is added to the PFTstik variant the connection of the relevant components is described in the separate IFU Add on CO Diffusion 4 1 3 3 Diffustik Device Connections Device f...

Page 45: ...on of the relevant components is described in the separate IFU Add on CO Diffusion 4 1 3 4 Connection on the Height Adjustable Arm Connection sockets on the height adjustable arm Gassample Connection...

Page 46: ...etailed description in Chap 9 Cleaning and Disinfection The separate IFU Volume Calibration Flow Sensor The heart of the Diffustik resp the variant PFTstik for precise flow measurement is the Ergoflow...

Page 47: ...t of leakage Reason damage to the CO Analyzer because of excessive working pressure on the demand valve Therefore Only use a pressure reducer that complies with the specifications defined by the manuf...

Page 48: ...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 producer of a system or a procedu...

Page 49: ...electrical safety 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 th...

Page 50: ...l Expansions Respectively consult with your authorised specialist retail partner 4 1 4 2 Data Connection All measurement results and graphical data can be displayed on the screen as well as printed ou...

Page 51: ...ustik resp the variant PFTstik 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...

Page 52: ...e The specialist retail partner authorised by the manufacturer is responsible for supplying Diffustik resp the variant PFTstik to the responsible organisation 5 2 Storage Requirements regarding space...

Page 53: ...or Therefore Prevent improper assembly installation Diffustik resp the variant PFTstik should only be assembled and installed by officially trained personnel authorised by the manufacturer For further...

Page 54: ...partner is also only carried out by these qualified personnel Diffustik resp the variant PFTstik is only completely ready to function after calibration and once the initial operation is complete 6 2 R...

Page 55: ...ust be established and the Diffustik resp the variant PFTstik must be connected to the power supply and calibrated Calibration also fulfils the regulatory requirements for functional testing after mai...

Page 56: ...made carefully and without too much force Flow measuring system and shutter system on the height adjustable arm Mounting plate Shutter block and shutter plug from prod 11 2018 Flow unit Connection cab...

Page 57: ...il prod 11 2018 By pressing in the dovetail of the shutter block into the appropriate groove 5 of the mounting plate 2 3 Connect the flow unit 6 to the connection socket of the shutter block or shutte...

Page 58: ...nnect shutter plug 7 to shutter block 4a For the Diffustik variant resp when the CO Diffusion option is added to the PFTstik variant the connection of the relevant components is described in the separ...

Page 59: ...b By slight rotation to protect the O Rings until stop 2 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...

Page 60: ...and Open the closure cap 2 upwards 2 Insert flow sensor 3 For this Carefully press the patient far side with connection piece 3b into the holder with silicone seal 4 Press the patient close side 3a i...

Page 61: ...ys part of the medical device The device may only be operated in conjunction with the equipment cart ergoline ergocar PC offered by manufacturer To make the Diffustik resp the variant PFTstik ready fo...

Page 62: ...e variant PFTstik is only ready for operation again after a new calibration See also Chap 7 3 Calibrating Diffustik Variant PFTstik Separate IFU Volume Calibration For the Diffustik variant resp when...

Page 63: ...resp the variant PFTstik 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 Reason...

Page 64: ...on and off daily For descriptions of Recommissioning after Servicing and Cleaning Work see Chap 6 2 Recommissioning after Servicing Cleaning Work 7 3 Calibrating Diffustik Variant PFTstik There are v...

Page 65: ...e Arm Lever 1 for height regulation and 2 to swivel to the side horizontal 7 4 1 Height Adjustment 1 Hold the height adjustable arm 2 Move the lever 1 counterclockwise Locking of the height adjustable...

Page 66: ...is released 2 Swivel the height adjustable arm into the desired position infinitely variable 3 Move the lever 2 counterclockwise Height adjustable arm is locked again 4 Check secure locking 7 5 Using...

Page 67: ...uidelines Reason Misdiagnosis due to measurement error caused by a system failure due to uncontrollable electromagnetic fields of inadmissible transmitting devices Therefore While using Diffustik resp...

Page 68: ...r Therefore Never change pre assembled height adjustable arm Do not attach any other components to the device Do not lean on the height adjustable arm or hold on to it Reason Skin burn caused by short...

Page 69: ...ispose of bacteria virus filter and noseclip after each use The bacteria and virus filters provided by the manufacturer are optimally adapted to the measuring systems and due to the very high filtrati...

Page 70: ...carrying out regular and proper servicing as well as safety checks at intervals recommended by the manufacturer carried out by specialist personnel who have been authorised by the manufacturer for the...

Page 71: ...ndependent of this the user operator must carry out regular checks during day to day operation see also the following chap 8 2 Servicing Maintenance by the User Operator 8 2 Servicing Maintenance by t...

Page 72: ...each use visually inspect the total system housing cables connectors tubings pneumatic connections etc for any damages If there are any damages do not operate the system The damaged parts must be rep...

Page 73: ...g components see Chap 4 1 3 3 Diffustik Device Connections Chap 4 1 4 System Construction and Electrical Safety Chap 6 2 Recommissioning after Servicing Cleaning Work 8 2 2 Checking Replacing O Rings...

Page 74: ...Slightly screw in 2c Press the second side into the groove 2d Press all around To remove the rings proceed in reverse order Attention SI094 The unit may be damaged Therefore Do not use any pointed sh...

Page 75: ...lean Cleaning and disinfection may cause discolouration of the components but without impairing their function The following intervals apply Component Interval Method Bacteria and virus filter After e...

Page 76: ...l Reason Penetrating liquid into electrical components Therefore Disconnect the Diffustik device before cleaning and disinfecting When switching off via the On Off switch of the equipment cart shut do...

Page 77: ...rface disinfection Otherwise these can be wiped with a soft cloth using a weak soap solution When using a disinfectant that has not been tested and approved by the manufacturer the following steps mus...

Page 78: ...see chap 2 2 2 Consumable Items Auxilary Materials Follow the instructions on the concentration and dwell time stated by the cleanser and disinfectant manufacturer Do not put the flow unit and the shu...

Page 79: ...parts of the height adjustable arm which come or could come into contact with the patient must be treated with surface disinfection 9 2 2 Flow Unit 1 Remove the Ergoflow For this Proceed in reverse o...

Page 80: ...clean the interior of the sensor mechanical or with hard water jet Do not use any disinfectants which contain high chloride concentrations 1 Remove the flow sensor in reverse order as in chap 6 2 3 I...

Page 81: ...ck 1 from the shutter drive 2 by turning it counterclockwise Also separate the shutter block 1 from the shutter plug 3 by screwing and pulling it out b Until product 11 2018 disconnect the shutter cag...

Page 82: ...se Diffustik Variant PFTstik Serial no xx 8 401 yyy and 2401xxxxx Page 82 Version 8 Release date 16 August 2021 9 2 4 2 Shutter Drive Perform a wipe disinfection For this Wipe the surface with a wet d...

Page 83: ...cannot find the error in the table or the problem cannot be rectified using the method described please contact your specialist retail partner You will reach your authorised specialist retail partner...

Page 84: ...height adjustable arm see chap 4 1 3 3 Error message Pm No mouth pressure sensor detected Checking the connection between flow unit and height adjustable arm see chap 4 1 3 3 Error message Flow out o...

Page 85: ...on the Diffustik resp the variant PFTstik remove any contaminated material from it 11 3 Disposal In general the applicable national laws and regulations stipulated by the local authority should be com...

Page 86: ...inated Single Use Items All contaminated items such as single use flow sensors filters mouthpieces and noseclips must be disposed of trough the hospital or medical practice waste Possible severe physi...

Page 87: ...device Class IIa in accordance with MDD 93 42 Council Directive of 14 6 1993 annex IX Dimensions L 210 mm x W 175 mm x H 75 mm Weight 1120 g Electrical data Protection class Diffustik device II Prote...

Page 88: ...ow resolution 15 Bit Sample rate 125 Hz Accuracy 3 or 50 ml s Volume Measuring range 0 20 l Accuracy 3 or 50 ml Mouth pressure Measuring principle Semiconductor Measuring range 25 kPa Accuracy 0 25 FS...

Page 89: ...nsport 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 temperature Relative air humidity 20...

Page 90: ...se Diffustik Variant PFTstik Serial no xx 8 401 yyy and 2401xxxxx Page 90 Version 8 Release date 16 August 2021 12 3 Electrical Safety Concept 12 3 1 Variant Diffustik with Medical Device Cart and Iso...

Page 91: ...structions for Use Diffustik Variant PFTstik Serial no xx 8 401 yyy and 2401xxxxx Version 8 Release date 16 August 2021 Page 91 12 3 2 Variant PFTstik with Medical Device Cart and Isolation Transforme...

Page 92: ...d for operation in an electromagnetic environment as specified below The user operator of the Diffustik should ensure that it is operated in this environment Measurement of electromagnetic emissions C...

Page 93: ...output lines 2 kV for power cables 1 kV for input and output lines The quality of the supply voltage should be appropriate for a typical business or hospital environment Surges according to IEC 61000...

Page 94: ...ronment Measurement of interference immunity IEC 60601 level Compliance level Electromagnetic enviroment Guidline Portable and mobile RF communication devices should not be used at a shorter distance...

Page 95: ...z 50 MHz to 54 0 MHz Radiated HF distrubance according to IEC 61000 4 3 3 V m 80 MHz to 2 7 GHz 1 3 V m 3 5 1 from 80 MHz up to 800 MHz 7 1 from 800 MHz up to 2 7 GHz 27 V m PM 18 Hz 385 MHz 2 27 V m...

Page 96: ...opagation 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...

Page 97: ...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 800 MHz 1 17 80...

Page 98: ...refully 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...

Page 99: ...on 4 Serial number 5 Catalog number 6 Manufacturer details 7 Do not dispose of the device along with general household waste 8 Power input 9 Type label revision indication 10 Follow the IFU 11 Conform...

Page 100: ...lation 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 A...

Page 101: ...o 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 improp...

Page 102: ...8 401 yyy and 2401xxxxx Page 102 Version 8 Release date 16 August 2021 16 Authorised Specialist Retail Partner You can reach your responsible specialist retail partner via a contact form of the manuf...

Page 103: ...Tstik Serial no xx 8 401 yyy and 2401xxxxx Version 8 Release date 16 August 2021 Page 103 Attachment Declaration of Conformity The Diffustik resp the variant PFTstik declaration of conformity is enclo...

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