GERATHERM 40600 страница 2 Скачать руководство пользователя

Страница: 2 / 111

Version:

Release date:

02. August 2021

Filename:

TDOBOD0121R7

Language:

English

Affected serial numbers:

xx|8|301|yyy and 2301xxxxx

Software version:

valid from 1.2.0

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

0494

Содержание 40600

Страница 1: ...dystik Serial numbers xx 8 301 yyy and 2301xxxxx Instructions for Use Version 7 Release date 02 August 2021 Please read carefully and store in a place which is always accessible for future consultatio...

Страница 2: ...s xx 8 301 yyy and 2301xxxxx 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...

Страница 3: ...al Expansions 28 2 2 2 Consumable Items Auxilary Materials 30 3 Safety in Handling 32 3 1 General Safety at Work and Personnel Qualification 33 3 2 The Technical State of Bodystik and System Construct...

Страница 4: ...2 3 Assembly Flow Measuring System 61 6 2 3 1 Assembly Shutter System 65 6 2 3 2 Inserting the Flow Sensor 67 6 2 3 3 Connection Power Supply and PC 68 7 Operating Instructions 70 7 1 Checking for Wo...

Страница 5: ...ifications 96 12 1 Technical Data 96 12 2 Installation and Operating Conditions 98 12 3 Electrical Safety Concept 99 12 3 1 Bodystik with Medical Device Cart and Isolation Transformer 99 12 4 Electrom...

Страница 6: ...Instructions for Use Bodystik Serial no xx 8 301 yyy and 2301xxxxx Page 6 Version 7 Release date 02 August 2021 Attachment Declaration of Conformity 111...

Страница 7: ...d quality standards This means that Bodystik fulfills 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 m...

Страница 8: ...ified style of writing and abbreviations are used hereinafter to make this IFU easier to read Instructions for Use IFU Geratherm Respiratory GmbH Manufacturer Medical specialist personnel User s Perso...

Страница 9: ...ituation 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 mo...

Страница 10: ...rotection 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 f...

Страница 11: ...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...

Страница 12: ...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...

Страница 13: ...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 ina...

Страница 14: ...dical electrical device As a PC connected bodyplethysmograph it is mainly intended to determine lung volumes and airway resistance in lung function diagnostics in the clinical sector and by general pr...

Страница 15: ...ndication With the Bodystik bodyplethysmographic examinations can be performed for diagnosis follow up screening and severity assessment of pulmonary diseases In particular this includes Obstructive d...

Страница 16: ...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 X A...

Страница 17: ...ccur 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 performed i...

Страница 18: ...responsible organisation and or is responsible for rectifying faults to the Bodystik as well as its calibration Users must be aware of the clinical meaning and for example be a physician physician s...

Страница 19: ...out in accordance with the details in chap 12 2 Installation and Operating Conditions The responsible organisation must ensure that only medically trained specialist personnel see chap 2 1 3 Definitio...

Страница 20: ...is deemed improper use The responsible organisation of Bodystik alone is liable for any damage resulting from not adhering to these conditions Intended use also includes complying with all further in...

Страница 21: ...ructive prescribed properties of Bodystik 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 All warr...

Страница 22: ...m construction in chap 4 1 3 of this IFU Component Description name Supply scope in units Bodystik Comfortable USB 2 0 Bodyplethysmograph with 5 glass sides electro magnetic door lock electronic heigh...

Страница 23: ...0 630 Shutter Drive Electromagnetic shutter drive for shutter system 01 122919 old 40 610 Shutter Block Shutter block for shutter system for fast occlusion of breathing path For connection of shutter...

Страница 24: ...n CO Diffusion demand valve Replaced by shutter block 40 620 01 until 11 2018 without Add on CO Diffusion 40 612 Shutter Head CO For connecting shutter system with flow unit with Add on CO Diffusion d...

Страница 25: ...testing 03 199479 old 10 003 Medical Power Supply 24 V Medical grade 24 V power supply Recognisable by the manufacturer Bicker and the model name BET 1024M 1 8 m connection cable Replaces power suppl...

Страница 26: ...10 838 1 Can be retrofitted to all systems 01 from 08 2015 142297 old 10 838 Power Cord CEE 7 7 C13 IEC 60320 EU Power cable 2 m with European plug earth contact For connecting the power supply unit X...

Страница 27: ...Ring Set Shutter Head O Ring Set 2 x 23 52 x 1 78 mm and 2 x 30 x 2 mm for shutter head and shutter head CO 01 until 11 2018 952017 old 40 616 Rubber Seal Flow Unit 2 Rubber seal plates for flow unit...

Страница 28: ...login Instructions 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 TLco measurement to Bodystik or PFTstik...

Страница 29: ...of flow or volume based systems 3 liter volume nonadjustable Comes together with adapter for Spiraflow and Ergoflow 608220 old 10 801 MIP MEP Software option for BLUE CHERRY to add measurement of o m...

Страница 30: ...nt properties is deemed improper use 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 res...

Страница 31: ...GmbH SprayIn Dr Deppe GmbH depend ing on provider For disinfection bath with low chloride concentration InstruPlus Dr Deppe GmbH Bomix Plus BODE Chemie GmbH Desinfektion N ANTISEPTICA Dr Hans Joachim...

Страница 32: ...rsonnel Maintained or serviced improperly In order for Bodystik or the complete system to be operated in accordance with its intended use the safety information and procedures in this IFU must be unde...

Страница 33: ...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 suit...

Страница 34: ...termined by the manufacturer Under no circumstances use or connect any devices systems equipment and other products that are not part of the complete system Never obstruct the access to the mains plug...

Страница 35: ...ent at the same time Reason Electric shock and or misdiagnosis due to loss of electrical safety caused by exceeding the recommended maintenance schedule Therefore Regularly check the specified mainten...

Страница 36: ...r explosive gases in the room Do not operate Bodystik near the magnetic field of an MRT system Possible danger to life Reason Electric shock Cross contamination Misdiagnosis caused by measurement erro...

Страница 37: ...e guidelines and recommendations e g ATS ERS Guidelines Reason Collapse of the patient due to claustrophobia For this Observe general medical principles Therefore Before examination inform the patient...

Страница 38: ...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 Ask your authorised specialis...

Страница 39: ...posable flow sensors mouthpieces and noseclips after each use For this observe the applicable regulatory requirements for biologically hazardous materials Observe regulations on wearing personal prote...

Страница 40: ...t adjustable and pivoting patient chair see also chap 7 4 2 4 Adjustable feet for a secure stand 5 Magnets top and bottom for secure door locking see also 2 6 User Panel incl EMERGENCY STOP see also c...

Страница 41: ...de of the cabin EMERGENCY OFF button To disconnect the cabin from the power Supply in case of emergency see also chap 4 2 1 LED for door status To indicate the door status Door open LED OFF Door close...

Страница 42: ...e date 02 August 2021 4 1 2 2 Patient Panel Patient panel on the inside of the cabin to the right of the door Speaker To reproduce the commands to the patient during the measurement by the user Door o...

Страница 43: ...4 1 3 Connections Interfaces of the Bodystik 4 1 3 1 Connection Panel Connection panel to the right of the door on the lower right hand side of the cabin Power supply unit LED Indicator Power Supply U...

Страница 44: ...n connection Gas supply CO Diffusion The connection of the components for extending the Bodystik with the CO Diffusion option is described in the separate IFU Add on Co Diffusion 4 1 3 3 Sensors Atten...

Страница 45: ...a day As the flow sensor ensures the precise flow measurements the cleaning and calibration requirements must absolutely be adhered to regardless of the version selected Mouth Pressure Sensor A preci...

Страница 46: ...ason 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 manufacturer and pro...

Страница 47: ...vices or unauthorised or non original components spare parts consumables with existing medical electrical equipment or systems and this combination is used by third parties or this combination is plac...

Страница 48: ...er as spare parts which are always part of the medical device The device may only be operated in conjunction with the equipment cart ergoline ergocar PC offered by manufacturer Reason Electrical shock...

Страница 49: ...Bodystik could be damaged Reason Electrostatic discharges Therefore Preferably no floor made of synthetic material Otherwise a relative air humidity of at least 30 is required 4 1 4 1 Equipment Cart w...

Страница 50: ...well as printed out via the Windows printer interface Any printer compatible with Windows can be used for this The hardware connection between the device and computer is established via an integrated...

Страница 51: ...cognisable bei the manufacturers information on the type label Deutronic Model ETC70G 24 The power supply is provided by an external desktop power supply Unit Only this is considered a spare part appr...

Страница 52: ...uirements of the applicable safety relevant regulations This chapter of the IFU only describes the operation of protective and safety equipment or safety systems that can be triggered by patients and...

Страница 53: ...utton engages Cabin door lock is deactivated door opens Height Adjustable Arm is no more height adjustable Communication with the PC no longer functions LED Power Supply on the connection panel turns...

Страница 54: ...For this Observe general medical principles Therefore Before examination inform the patient about the emergency opening of the door Do not leave the patient unattended in the cabin Door opener on the...

Страница 55: ...ict process and record measurements with the devices of the manufacturer The communication between the BLUE CHERRY software and a practice computer system or hospital information system is supported b...

Страница 56: ...rised specialist retail partner or manufacturer For further information see Chap 11 Decommissioning Disposal 11 3 1 Chap 15 Warranty and Service 15 3 The specialist retail partners authorised by the m...

Страница 57: ...retail partners Possible danger to life Reason Electric shock Misdiagnosis caused by measurement error Therefore Prevent improper assembly installation Bodystik should only be assembled and installed...

Страница 58: ...o only carried out by these qualified personnel Bodystik is only completely ready to function after calibration and once the initial operation is complete 6 2 Recommissioning after Servicing Cleaning...

Страница 59: ...abin is restarted audible by the click The Bodystik is ready for operation and function again Possible severe physical injury Reason Crushing by unintentional height adjustable stand movements Patient...

Страница 60: ...ed again If this is not done the BLUE CHERRY Software will inform you with the message Please close the door You can find more information on Resistance and TGV in chap 4 2 2 Door Opener Patient Panel...

Страница 61: ...ement error due to leakage caused by incorrect assembly of components Therefore Carefully observe the assembly instructions Attention Functional disorders possible Reason Components and e g plug conne...

Страница 62: ...Height adjustable arm with flow measuring system and shutter system incl connection sockets From Prod 11 2018 Mounting plate Shutter block 1 with Shutter plug 2 and Shutter drive 3 Flow unit Connectio...

Страница 63: ...e arm and tighten the knob 2 until the mounting plate remains movable 2 Connect the shutter block 4a to the mounting plate 1 from production 11 2018 By pressing the dovetail of the shutter block into...

Страница 64: ...head 4a b For this Push the flow unit with the fixed side slightly to the stop and simultaneously turn it back and forth Turning in both directions has no functional task but serves only to protect th...

Страница 65: ...table arm with shutter system including connection sockets detailed overview see chap 4 1 3 2 1 From prod 11 2018 Screw shutter drive 3 to shutter block 1a until stop 2 Until prod 11 2018 Screw shutte...

Страница 66: ...301xxxxx Page 66 Version 7 Release date 02 August 2021 4 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...

Страница 67: ...pen the closure cap 2 upwards 2 Insert the 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 int...

Страница 68: ...USB connection cable supplied by the manufacturer as spare parts which are always part of the medical device The device may only be operated in conjunction with the equipment cart ergoline ergocar PC...

Страница 69: ...cart with the On Off switch Display Power Supply of the equipment cart lights up If the corresponding power supply unit is connected The LED Display Power Supply on the connection panel lights up Body...

Страница 70: ...atments You can get a description in Chap 8 Servicing Maintenance And Possible danger to life Reason Misdiagnosis caused by measurement error due to incorrect components or improper use Therefore Repl...

Страница 71: ...ncy Stop Chap 6 2 1 Recommissioning after Termination by Patient Chap 6 2 2 Recommissioning after Maintenance Cleaning Work by the Operator 7 3 Calibrating Bodystik There are various processes to be c...

Страница 72: ...of the chair doesn t touch the back wall of the cabin Adjust the seat height so that the patient s feet are horizontal on the floor and the thighs rest completely on the chair surface The height of th...

Страница 73: ...n or stand up and leave the cabin if necessary Height adjustment Swivel To unlock the swivel mechanism step on the footrest 2 Re engages automatically in the end positions of the swivel mechanism Poss...

Страница 74: ...tory Drive MIP MEP P0 1 CO Diffusion And for general use of the software BLUE CHERRY Possible danger to life Reason Disregard of a contraindication Misdiagnosis due to measurement errors For this Obse...

Страница 75: ...portable phones power lines within close proximity 30 cm that exceed the immunity levels as specified in the EMC guidelines Ask your authorised specialist retail partner about this Reason Electrical s...

Страница 76: ...leanliness External exposure Therefore Do not use liquids near the Bodystik Do not expose the Bodystik to excessive temperature fluctuations during operation Do not drop any objects on the device Do n...

Страница 77: ...filters provided by the manufacturer are optimally adapted to the measuring systems and due to the very high filtration rate offer maximum patient safety while protecting against cross contamination...

Страница 78: ...ower supply unit must be removed from the socket The Bodystik is intended for continuous operation and therefore doesn t need be switched on and off daily But Attention Bodystik could be damaged Reaso...

Страница 79: ...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 o...

Страница 80: ...work Once per day Visual checks of the device and its components for damage and replacing them if necessary see chap 8 2 1 Checking Exchange of Tubes and Cables Once per day Checking the O Rings and S...

Страница 81: ...y only be performed by specialised personnel who have been authorised by the manufacturer 8 2 1 Checking Exchange of Tubes and Cables All parts of Bodystik should be checked for visible mechanical dam...

Страница 82: ...ust be replaced Once a year it must generally be replaced Proceed as described below O Rings Shutter Block 1a Insert with a slight rotation 1b Press firmly Identical steps 1a und 1b see below O Rings...

Страница 83: ...sealing rubbers please note Chap 4 1 4 System Construction and Electrical Safety Chap 6 2 2 Recommissioning after Maintenance Cleaning Work by the Operator 8 2 3 Care of Door Rubbers To care for the...

Страница 84: ...ir function The following intervals apply Component Interval Method Bacteria and virus filter After each patient Dispose of Noseclip After each patient Dispose of Flow unit chap 9 2 1 Weekly Wipe disi...

Страница 85: ...seclips read Chap 7 6 Exchange of Disposable Products Disinfection 9 2 Disinfection In spite of the high filtration rate and single use of the bacteria and virus filters it is necessary to clean and d...

Страница 86: ...ectants 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 metal F...

Страница 87: ...by the cleanser and disinfectant manufacturer Do not put the flow unit and the shutter drive in cleaning or disinfection fluid Both are containing electronic components Do not disassemble the demand v...

Страница 88: ...ensor Attention Bodystik could be damaged Reason destruction of the orifice Therefore Do not clean the interior of the sensor mechanical or with hard water jet Do not use any disinfectants which conta...

Страница 89: ...om 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 cage 4 fro...

Страница 90: ...ace with a wet disinfecting cloth 9 2 4 Bodystik Cabin Attention Bodystik could be damaged Reason Penetrating liquid into electrical components Therefore Disconnect the Bodystik from the power supply...

Страница 91: ...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 carry out work which is descr...

Страница 92: ...he power supply Cable OK and connected Error message Flow No flow electronics detected Checking the connection between flow unit and Height Adjustable Arm see chap 6 2 3 2 Error message Pm No mouth pr...

Страница 93: ...nd 2301xxxxx Version 7 Release date 02 August 2021 Page 93 Error Rectification Resistance and TGV measurements cannot be performed Closing the cabin door Obvious measuring error Checking the last cali...

Страница 94: ...1 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...

Страница 95: ...or water Therefore Do not dispose the gas spring in household waste Disposal only through raw material dealers or hazardous waste collection points 11 3 4 Infectious Contaminated Single Use Items All...

Страница 96: ...vely 125 kg with chair swivelled out Electrical data Protection type IP20 IEC 529 Protection class II Applied part BF according to DIN EN 60601 1 PC interface USB 2 0 Power supply Primary site 100 240...

Страница 97: ...range 0 25 kPa Accuracy 1 5 of measured value 1 5 FSS Flow resolution 16 Bit Mouth pressure Measuring principle Differential pressure Measuring range 25 kPa Accuracy 0 25 FSS Flow resolution 15 Bit Mi...

Страница 98: ...esing Operation min max Environmental temperature 10 C 35 C Avoid extreme temperature fluctuations Relative air humidity 20 95 non condensing at least 30 for synthetic flooring Atmospheric pressure 80...

Страница 99: ...uctions for Use Bodystik Serial no xx 8 301 yyy and 2301xxxxx Version 7 Release date 02 August 2021 Page 99 12 3 Electrical Safety Concept 12 3 1 Bodystik with Medical Device Cart and Isolation Transf...

Страница 100: ...peration in an electromagnetic environment as specified below The user operator of the Bodystik should ensure that it is operated in this environment Measurement of electromagnetic emissions Complianc...

Страница 101: ...es 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 4 5 1 kV V...

Страница 102: ...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 from the...

Страница 103: ...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 PM 18 Hz 6 2 28 V...

Страница 104: ...ectromagnetic 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 rad...

Страница 105: ...wer 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 2...

Страница 106: ...re 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...

Страница 107: ...og 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 in accordance wit...

Страница 108: ...f 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 warra...

Страница 109: ...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 packi...

Страница 110: ...yy and 2301xxxxx Page 110 Version 7 Release date 02 August 2021 16 Authorised Specialist Retail Partner You can reach your responsible specialist retail partner via a contact form of the manufacturer...

Страница 111: ...e Bodystik Serial no xx 8 301 yyy and 2301xxxxx Version 7 Release date 02 August 2021 Page 111 Attachment Declaration of Conformity The Bodystik declaration of conformity is enclosed with each device...

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