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GERATHERM 979119, Инструкция по эксплуатации

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Instructions for Use 

Ergostik 

Serial no.: xx|8|201|yyy and 2201xxxxx 

 

 

 

 

Page 8 

Version: 7 | Release date: 02. August 2021 

 

 

Indicates 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 hazardous situation. 

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 injuries. 

 

 

 

Indicates places in the IFU which are relevant to the current 

topic but do not present any danger, or which simplify your 
handling of the Ergostik. 

 

 

 

 

Attention 

Not observing this warning information may lead to faults or 
malfunctions of the Ergostik or may indicate that something in 
its environment may be damaged. 

Содержание 979119

Страница 1: ...rgostik Serial numbers xx 8 201 yyy and 2201xxxxx Instruction 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: ...rs xx 8 201 yyy and 2201xxxxx Software version valid from 1 1 0 Geratherm Respiratory GmbH Kasernenstra e 4 97688 Bad Kissingen GERMANY Tel 49 971 7857043 0 Fax 49 971 7857043 30 info geratherm respir...

Страница 3: ...ssories 24 2 2 1 2 Optional Expansions 27 2 2 2 Consumable Items Auxilary Materials 32 3 Safety in Handling 33 3 1 General Safety at Work and Personnel Qualification 34 3 2 The Technical State of Ergo...

Страница 4: ...6 7 4 Inserting the Flow Sensor 57 7 4 1 Assembly Face Mask 58 7 4 2 Assembly Silicone Mouthpiece 59 7 5 Calibrating Ergostik 60 7 6 Using Ergostik Performing Measurements 60 7 7 Exchange of Disposabl...

Страница 5: ...n Transformer 83 12 4 Electromagnetic Compatibility EMC Guidelines 84 12 4 1 Emitted Interference Guideline and Manufacturer Declaration 84 12 4 2 Interference Resistance for all ME Systems Guideline...

Страница 6: ...uality standards This means that Ergostik 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 make...

Страница 7: ...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 8: ...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 9: ...h the patient BF Body Floating In order to comply with the limit value for the patient leakage current the applied part is insulated from earth Device of protection class II safety measure against tou...

Страница 10: ...t 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 Ergostik itself but to the consumable items used in connection...

Страница 11: ...tromagnetic 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 appropriate ca...

Страница 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 ina...

Страница 13: ...and metabolism whilst their body is being put under a defined load The test subject is put under load whilst on an ergometer Their heart rate breathing rate respiratory minute volume oxygen intake an...

Страница 14: ...t 2021 Examination Required option Bronchoprovokation Provokation 403680 Resting Energy Expenditure Resting Metabolic Rate REE 526143 You can find more information in IFU Spirometry for carrying out t...

Страница 15: ...ts with cardiovascular diseases Evaluation of patients with respiratory diseases Chronic obstructive pulmonary disease Interstitial lung disease Chronic pulmonary vascular disease Cystic fibrosis Exer...

Страница 16: ...severe aortic stenosis X Uncontrolled heart failure X Acute pulmonary embolus or pulmonary infarction X Thrombosis of lower extremities X Suspected dissecting aneurysm X Uncontrolled asthma X Pulmonar...

Страница 17: ...licated pregnancy X Electrolyte abnormalities X Orthopedic impairment that compromises exercise performance X As the transitions between absolute and relative contraindication can be fluid in the asse...

Страница 18: ...resence of emergency equipment defibrillator emergency medication Availability of emergency medically trained personnel for assistance The following side effects may also occur Side effect Frequency R...

Страница 19: ...re dyspnoea X Clinical signs of low perfusion cyanosis X Persistent duration 30 sec ventricular tachycardia X Exhaustion of the patient X Technical problems defective ECG registration X Hypertensive d...

Страница 20: ...any natural or legal person who is responsible for the operation of the health institution where Ergostik is used by their employees users User is a medically trained specialist who is familiar with c...

Страница 21: ...trolled 19 C 25 C rooms in a clinical area In the respective room there must be neither flammable or explosive gases nor magnetic fields e g MRI The following applies in general The installation of Er...

Страница 22: ...nisation of Ergostik alone is liable for any damage resulting from not adhering to these conditions Intended use also includes complying with all further information and instructions in this IFU witho...

Страница 23: ...erties of Ergostik and in the worst case impair the safety of the patient operator and or third parties The manufacturer assumes no liability for such consequences All warranty claims shall expire Pos...

Страница 24: ...m respiratory com login Instructions on safe system construction in chap 4 1 3 of this IFU Further information about Ambistik in the separate IFU Ambistik Component Description name Supply scope in un...

Страница 25: ...ung function tests Made of soft skin friendly foam for best wearing comfort One size 03 787158 old 10 200 Exercise Tube Set incl Ergoclip 2 m Flow and gas connection Tube set with permapure tube for m...

Страница 26: ...8 m USB connection cable male A and male B to connect USB based devices to PC 01 362803 old 10 820 Silicon Adapter Small 28 mm x 2 mm x 50 mm Silicon adapter size small used for Ergoflow PFTstik Bodys...

Страница 27: ...ry com login Instructions on safe system construction in chap 4 1 3 of this IFU Further information about Ambistik in the separate IFU Ambistik Component Description name Exercise Cart Base frame draw...

Страница 28: ...Pressure regulator for exercise gas calibration providing a fixed flow of 2 liter min For bottles with connector DIN 477 1 1990 No 6 External thread right hand thread W 21 80 x 1 14 623668 old 10 823...

Страница 29: ...M 144381 old 10 812 L 477893 old 10 834 Headgear Pediatric for Exercise Mask Soft headgear to fix exercise mask pediatric sizes S and L 594009 old 10 826 Exercise Mask Adapter Adapter to fit Ergoflow...

Страница 30: ...tteries 816016 old 10 882 WristOx2 Model 3150 Activation Key Activation Key for the use of the WristOx2 Model 3150 with Bluetooth 220553 old 10 532 Soft Finger Sensor Soft finger sensor for WristOx2 M...

Страница 31: ...raining Planer Software Software option for BLUE CHERRY to create individual exercise training plans based on the results of a CPET test 551941 old 40 451 Software option Lactate Software Software opt...

Страница 32: ...spiratory com login Komponente Description name Softclip Disposable noseclip for lung function tests Made of soft skin friendly foam for best wearing comfort One size 787158 old 10 200 CPET Oxygen Sen...

Страница 33: ...personnel Maintained or serviced improperly In order for Ergostik or the total system to be operated in accordance with its intended use the safety information and procedures in this IFU must be unde...

Страница 34: ...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 35: ...cts that are not part of the total system Never obstruct the access to the mains plug or On Off switch of the equipment cart Disconnection of the power supply must be easily accessible Only use access...

Страница 36: ...ctrical safety caused by exceeding the recommended maintenance schedule Therefore Regularly check the specified maintenance schedules If a maintenance schedule is exceeded do not continue to use the t...

Страница 37: ...the magnetic field of an MRT system Possible danger to life Reason Electrical shock Cross contamination or measurement error For this Ensure that the used components are undamaged and that you are wor...

Страница 38: ...e use products 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 electromagneti...

Страница 39: ...ervals as specified Possible severe physical injury Reason Contamination with transferable germs during improper disposal Therefore Dispose single use items disposable flow sensors mouthpieces and nos...

Страница 40: ...electronic components Therefore Disconnect the Ergostik from the power supply before cleaning and disinfecting When switching off via the On Off switch of the equipment cart shut down the PC complete...

Страница 41: ...e and General Function of Ergostik 4 1 Hardware 4 1 1 Overview 1 Ergostik 2 Medical power supply unit see also chap 4 1 3 3 Exercise tube set 4 Ergoflow flow sensor see also chap 7 4 5 Ambistik 6 Type...

Страница 42: ...Interfaces of the Ergostik 4 1 2 1 Ergostik Device and Connections LED to show the power supply Gas Connection Flow Connection USB Connection Gas outlet Multisocket for connecting accessories On Off s...

Страница 43: ...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 Attention Ergostik could be dama...

Страница 44: ...4 1 3 System Construction and Electrical Safety The following instructions are intended for safe handling of the entire system taking into account the electrical safety concept of the Ergostik The sys...

Страница 45: ...rary to the respective manufacturer s specification Reason Electrical shock and or misdiagnosis due to loss of electrical safety caused by exceeding the recommended maintenance schedule Therefore Regu...

Страница 46: ...an be used for this 4 1 3 2 Equipment Cart with Isolating Transformer The cart approved by the manufacturer meets the requirements of the IEC 60601 series of standards so its use is recommended You wi...

Страница 47: ...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 by s...

Страница 48: ...Ergostik Serial no xx 8 201 yyy and 2201xxxxx Page 48 Version 7 Release date 02 August 2021 For further information see the separate IFU of BLUE CHERRY information on the configuration and use of the...

Страница 49: ...ormation see Chap 11 Decommissioning Disposal Chap 15 Warranty and Service The specialist retail partner authorised by the manufacturer are responsible for delivering the Ergostik to the operator and...

Страница 50: ...retail partners Possible danger to life Reason Electric shock Misdiagnosis caused by measurement error Therefore Prevent improper assembly installation Ergostik should only be assembled and installed...

Страница 51: ...Recommissioning after Servicing Cleaning Work The responsible organisation is responsible for returning the device to operation after servicing cleaning work for which the operator user is authorised...

Страница 52: ...ed Calibration also fulfils the regulatory requirements of MPBetreibV 7 for functional testing after maintenance work Please proceed as described in the respective chapters 6 2 1 Assembly Calibration...

Страница 53: ...alibration gas connection 1 and gas exhaust 2 For this Unscrew the protective caps counterclockwise so that the white marked connections 3 are accessible 2 Connect the calibration tube to the calibrat...

Страница 54: ...omponents Therefore Only use the Power Supply USB Connection Cable supplied by the manufacturer as spare parts which are always part of the medical device See chap 2 2 1 1 Original Spare Parts Accesso...

Страница 55: ...r due to incorrect components or improper use Therefore Replace the flow sensor and the mouthpiece in case of a functional error Always follow instructions see chap 8 Servicing Maintenance and chap 9...

Страница 56: ...cting the power supply When using a cart this is done via the On Off switch on the cart Otherwise the On Off switch on the back of the Ergostik must be activated To extend the life of the gas sensors...

Страница 57: ...ckwise to the color coded connections on the front of the Ergostik 2 Insert the Ergoflow flow sensor 3 For this Press the side with the connection pins 3a vertically onto the Ergoclip adapter 4 which...

Страница 58: ...dapter through the round opening of the silicone mask so that the lower ring of the adapter is inserted into the incision 6a b Position the adapter For this Position the oval opening 5a of the adapter...

Страница 59: ...xx Version 7 Release date 02 August 2021 Page 59 7 4 2 Assembly Silicone Mouthpiece 1 Assemble the flow sensor in the Ergoclip adapter to the silicone mouthpiece For this Press the flow sensor with th...

Страница 60: ...can be found in the tables below For details on individual calibrations please read The separate IFU Calibration Interval Calibration Once per day Gas calibration Once per day and after changing the...

Страница 61: ...nt error caused by a system failure due to uncontrollable electromagnetic fields of inadmissible transmitting devices Therefore While using Ergostik do not use any transmitting devices e g mobile phon...

Страница 62: ...ot drop any objects on Ergostik Do not lay any objects on it Never push foreign objects into the housing Reason Condensation Therefore Do not expose the device to excessive temperature fluctuations du...

Страница 63: ...ion about disposal of the disposable products can be found in Chap 11 3 Disposal 7 7 2 Ergoflow Mask Mouthpiece All parts which have come into contact with the patient or patient breathing during the...

Страница 64: ...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...

Страница 65: ...r In order to ensure a flawless operation of Ergostik over its whole service life regular servicing and repairs if applicable are required Intervall Servicing work Before each examination Checking the...

Страница 66: ...s must be replaced or repaired properly Reason Electric shock Triggering malfunctions of Ergostik Unqualified user operator can detect sources of failures too late or even cause them Therefore All mai...

Страница 67: ...ethod Noseclip After each patient Dispose of Silicone mouthpiece After each patient Cleaning and disinfection bath Face mask After each patient Cleaning and disinfection bath Mask adapter After each p...

Страница 68: ...ing moisture with a dry cloth Ergostik could fail Reason Damaged connections Therefore To disconnect electrical connections always pull the plug and never the cable 9 1 Single Use For instructions on...

Страница 69: ...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 70: ...ances that are approved by the manufacturer See chap 2 2 2 Consumable Items Auxilary Materials Follow the instructions on the concentration and dwell time stated by the cleanser and disinfectant manuf...

Страница 71: ...he Ergostik which come or could come into contact with the patient must be treated with surface disinfection 9 2 2 Flow Sensor Ergoclip Removal 1 Remove Ergoflow For this Proceed in reverse order as d...

Страница 72: ...e maximum permissible temperature of 75 C for cleaning and disinfection Do not dry with heat Possible impairment of the measuring function Reason Moisture in the connection port Therefore Ensure that...

Страница 73: ...In reserve order as described in chap 7 4 1 Assembly Face Mask 2 Wipe off visible contamination with a soft cloth 3 Insert the adapter and silicone mask into a disinfectant solution 4 Wash the adapter...

Страница 74: ...ia 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 Users m...

Страница 75: ...Check that the Ergoflow is correctly positioned in the Ergoclip Check the tube connection between Ergoclip and Ergostik Check for moisture in the tube connection piece of the Ergoflow Perform gas cali...

Страница 76: ...f the O2 Sensor Software error message CO2 out of measuring range Check tube connection between Ergoclip and Ergostik Check for moisture in the tube connection piece of the Ergoflow Check gas outlet f...

Страница 77: ...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 reu...

Страница 78: ...be disposed of trough the hospital or medical practice waste Possible severe physical injury Reason Contamination with transferable germs during improper disposal Therefore Dispose single use items d...

Страница 79: ...t 1120 g Electrical data Protection class II Protection type IP20 IEC 529 Applied part BF according VDE 0750 DIN EN 60601 1 PC interface USB 2 0 Power supply 12 V DC max 5 A Power consumption 60 VA EM...

Страница 80: ...S t10 90 90 ms after filtering CO2 Principle Infrared spectroscopy Range 0 13 Accuracy 0 1 vol 2 5 7 5 t10 90 90 ms after filtering Minimum PC system requirements Standard at least EN 62368 1 EN 60950...

Страница 81: ...ative air humidity 0 95 non condensing Operation min max Environmental temperature 10 C 35 C Avoid extreme fluctuations in temperature Relative air humidity 20 95 non condensing at least 30 for synthe...

Страница 82: ...uctions for Use Ergostik Serial no xx 8 201 yyy and 2201xxxxx Page 82 Version 7 Release date 02 August 2021 12 3 Electrical Safety Concept 12 3 1 Ergostik with Medical Device Cart and Isolation Transf...

Страница 83: ...Instructions for Use Ergostik Serial no xx 8 201 yyy and 2201xxxxx Version 7 Release date 02 August 2021 Page 83 12 3 2 Ergostik without Medical Device Cart and without Isolation Transformer...

Страница 84: ...eration in an electromagnetic environment as specified below The user operator of the Ergostik should ensure that it is operated in this environment Measurement of electromagnetic emissions Compliance...

Страница 85: ...iate 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 outer c...

Страница 86: ...re that it is operated in this environment Measurement of interference immunity IEC 60601 level Compliance level Electromagnetic enviroment Guidline Portable and mobile RF communication devices should...

Страница 87: ...enced by absorptions 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...

Страница 88: ...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 89: ...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 90: ...r 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 in accor...

Страница 91: ...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...

Страница 92: ...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...

Страница 93: ...yy and 2201xxxxx Version 7 Release date 02 August 2021 Page 93 16 Authorised Specialist Retail Partner You can reach your responsible specialist retail partner via a contact form of the manufacturer w...

Страница 94: ...e Ergostik Serial no xx 8 201 yyy and 2201xxxxx Page 94 Version 7 Release date 02 August 2021 Attachment Declaration of Conformity The Ergostik declaration of conformity is enclosed with each device b...

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