GERATHERM Ergostik Blueflow Instructions For Use Manual Download

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Instructions for Use

Ergostik Blueflow

Serial no.: xx|8|201|yyy and 2203xxxxx

Page 16

Version: 6 | Release date: 02 August 2022

2.1.1

Indication

The Ergostik Blueflow can be used for cardio-pulmonary

(exercise) tests for diagnosis, follow-up, screening and severity
assessment of pulmonary diseases. These include in particular:

Evaluation of exercise intolerance

Unexplained dyspnea

Evaluation of patients with cardiovascular diseases

Evaluation of patients with respiratory diseases

•

Chronic obstructive pulmonary disease

•

Interstitial lung disease

•

Chronic pulmonary vascular disease

•

Cystic fibrosis

•

Exercise-induced bronchospasm

Preoperative assessment

•

Preoperative assessment for lung cancer resection

surgery

•

Surgery to reduce lung volume

•

Evaluation for lung or heart-lung transplantation

•

Preoperative evaluation of other procedures

•

Prescription of pulmonary rehabilitation exercises

Assessment of the impairment / disability

Summary of Contents for Ergostik Blueflow

Page 1: ...tik Blueflow Serial numbers xx 8 201 yyy and 2203xxxxx Instruction for Use Version 6 Release date 02 August 2022 Please read carefully and store in a place which is always accessible for future consultation ...

Page 2: ...ers xx 8 201 yyy and 2203xxxxx Software version valid from 1 1 0 Geratherm Respiratory GmbH Kasernenstraße 4 97688 Bad Kissingen GERMANY Tel 49 971 7857043 0 Fax 49 971 7857043 30 info geratherm respiratory com www geratherm respiratory com EUDAMED SRN DE MF 000006818 Geratherm Respiratory GmbH 0494 ...

Page 3: ...26 2 2 1 2 Optional Expansions 30 2 2 2 Consumable Items Auxilary Materials 35 3 Safety in Handling 37 3 1 General Safety at Work and Personnel Qualification 38 3 2 The Technical State of Ergostik Blueflow and System Construction39 3 3 Operation Servicing and Maintenance 41 3 4 Electromagnetic Compatibility EMC 42 3 5 Cleaning and Disinfection 43 4 Structure and General Function of Ergostik Bluefl...

Page 4: ...w Sensor 61 7 4 1 Assembly Face Mask 62 7 4 2 Assembly Blueflow Mouthpiece 63 7 5 Calibrating Ergostik Blueflow 64 7 6 Using Ergostik Blueflow Performing Measurements 64 7 7 Exchange of Disposable Products Disinfection 67 7 7 1 Noseclip Blueflow Disposable Exercise Mask Adapter Blueflow67 7 7 2 Mask 68 8 Servicing Maintenance 69 8 1 Duties of the Responsible Organisation 69 8 2 Servicing Maintenan...

Page 5: ...nd without Isolation Transformer 87 12 4 Electromagnetic Compatibility EMC Guidelines 88 12 4 1 Emitted Interference Guideline and Manufacturer Declaration 88 12 4 2 Interference Resistance for all ME Systems Guideline and Manufacturer Declaration 89 12 4 3 Interference Resistance for None Life Supporting ME Systems Guideline and Manufacturer Declaration 90 12 4 4 Recommended Safety Distances for ...

Page 6: ...tandards This means that Ergostik Blueflow 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 it easier to familiarise yourself with Ergostik Blueflow as well as give you instructions about its intended use and safe operation This IFU has been written for healthcare professionals who are qua...

Page 7: ... simplified 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 Personnel instructed in cleaning maintenance work Operator s 1 2 Explanations For the safety of your patients for your personal safety and to avoid damage to property observe the meaning of the follo...

Page 8: ...ation 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 Blueflow Attention Not observing this war...

Page 9: ...t with 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 touching Protection by double or reinforced insulation For the prevention of electric shock Only use indoors IP20 Protection type safe environmental conditions IP2x Protection of enclosure against i...

Page 10: ...st 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 Blueflow itself but to the consumable items used in connection with it This is applied to the respective packaging and must be observed Batch number This symbol identifies the batch or lot code given by the manufacturer The code is placed adjacent to th...

Page 11: ...mbH as Notified Body Caution non ionizing electromagnetic radiation Precautions must be taken to avoid an unexpected effect of non ionizing radiation General warning symbol Warning of a hazardous area Fragile handle with care The package contains a product that must be handled with appropriate care to prevent damage during transport and storage Keep away from rain The package contains a product th...

Page 12: ...ow Serial no xx 8 201 yyy and 2203xxxxx Page 12 Version 6 Release date 02 August 2022 Symbol Explanation Atmospheric pressure limitation The product can be safely transported stored or operated within the permissible atmospheric pressure ...

Page 13: ...ument 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 inaccuracies in this document version cannot be completely ruled out The liability of the manufacturer for direct or indirect damages arising in connection with the present documentation is excluded...

Page 14: ...irements of the medical device and assumes complete product liability for the whole system 2 1 Intended Purpose The medical device Ergostik Blueflow is a PC based measuring device used to determine physical exercise tolerance by measuring gas exchange The interaction of heart circulation respiration and metabolism is analyzed during defined physical stress The test person is subjected to a load on...

Page 15: ...2022 Page 15 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 the examination IFU BLUE CHERRY for the general operation of the software and carrying out the examination ...

Page 16: ... of patients with cardiovascular diseases Evaluation of patients with respiratory diseases Chronic obstructive pulmonary disease Interstitial lung disease Chronic pulmonary vascular disease Cystic fibrosis Exercise induced bronchospasm Preoperative assessment Preoperative assessment for lung cancer resection surgery Surgery to reduce lung volume Evaluation for lung or heart lung transplantation Pr...

Page 17: ...matic 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 Pulmonary edema X Respiratory failure X Room air desaturation at rest 85 X Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise X Mental impairment leading...

Page 18: ...ns ATS ACCP Statement on cardiopulmonary exercise testing 2003 Am J Respir Crit Care Med 167 211 277 The following contraindications apply to spirometry examinations Contraindications Due to increases in myocardial demand or changes in blood pressure Acute myocardial infarction within 1 week Systemic hypotension or severe hypertension Significant atrial ventricular arrhythmia Noncompensated heart ...

Page 19: ...tions predisposing to transmission of infections such as hemoptysis significant secretions or oral lesions or oral bleeding Spirometry should be discontinued if the patient experiences pain during the maneuver Relative contraindications do not preclude spirometry but should be considered when ordering spirometry The decision to conduct spirometry is determined by the ordering healthcare profession...

Page 20: ...low Presence of emergency equipment defibrillator emergency medication Availability of emergency medically trained personnel for assistance The following side effects may also occur Side effect Frequency Rules of conduct Exhaustion Frequent Stopping the exercise after medical assessment Shortness of breath Frequent Stopping the exercise after medical assessment Chest pain Frequent Stopping the exe...

Page 21: ... Severe 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 dysregulation Rrsyst 230 260 mmHg Rrdiast 115 mmHg X Blood pressure decrease 10 mmHg compared to the initial blood pressure without signs of myocardial ischemia no angina pectoris no ST depression...

Page 22: ...gal person who is responsible for the operation of the health institution where Ergostik Blueflow is used by their employees users User is a medically trained specialist who is familiar with cardio pulmonary exercise tests who uses Ergostik Blueflow on the patient after verifiable instruction by the responsible organisation and or is responsible for rectifying faults to the Ergostik Blueflow as we...

Page 23: ...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 Ergostik Blueflow is only deemed safe and in line with intended use when this is carried out in accordance with the details in chap 12 2 Installation and Operating Conditions The responsible organisation must e...

Page 24: ... organisation of Ergostik Blueflow 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 without exception Attention Electromagnetic compatibility EMC in accordance with DIN EN 60601 1 2 2016 05 VDE 0750 1 2 2016 05 IEC 60601 1 2 2014 See chap 12 4 Electromagnetic Compatibility E...

Page 25: ... properties of Ergostik Blueflow 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 Possible danger to life Reason Cross contamination Therefore Ensure that the used components are undamaged and that you are working in a careful way Do not use consumable articles with a li...

Page 26: ...e book as well as the most updated version at www geratherm 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 units Ergostik Blueflow Cardiopulmonary exercise system for accurate measurement of flow O2 and CO2 USB 2 0 based desktop device 01 979119 old 4...

Page 27: ...ted during production ensure measurement quality and avoid frequent calibrations 100 523557 Exercise Mask Adapter Blueflow Adapter for attaching the Blueflow sensor to the face mask 100 311107 Blueflow Disposable Mouthpiece Disposable mouthpiece for use with Blueflow type flow sensor 03 404506 Softclip Disposable noseclip for lung function tests Made of soft skin friendly foam for best wearing com...

Page 28: ...c minifilter and Blueclip adapter for Blueflow 02 240903 Calibration Tube Tube 1 5 m with black Luer connector for gas calibration of Ergostik Outer diameter 4 mm 01 862229 old 40 421 Power Supply 12 V Medical grade 12 V power supply 01 628020 old 10 841 Power Cord CEE 7 16 C7 IEC 60320 EU Power cord with European plug for use with power supply 12 V 01 142297 old 10 838 USB Connection Cable 1 8 m ...

Page 29: ...ze small used for Ergoflow and Blueflow to connect to calibration syringe 01 919774 old 10 831 Mini filter Hydrophobic filter for use with the Permapure tube set at the exhaust connection 582573 old 10 817 Ambistik USB 2 0 Ambient conditions module for accurate online BTPS conditions Continuous measurement of ambient temperature pressure and humidity Runs on Windows based diagnostic software platf...

Page 30: ...piratory 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 drawer block 1 storage shelf 2 monitor holder 2 Liter gas bottle holder and 1 Universal bottom storage shelf incl safety transformer and multiple sockets 445929 old 10 900 Calibration Syringe Precis...

Page 31: ...1 Pressure Regulator Calibration Gas CHE FRA 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 Accessory Pack for Ergostik Blueflow with 2 x Exercise mask S and XS 2 x Headgear M and S 650202 Exercise Mask Blue silicone rubber exercise mask with anat...

Page 32: ...eadgear Pediatric for Exercise Mask Soft headgear to fix exercise mask pediatric sizes S and L 594009 old 10 826 Pulstik USB 2 0 receiver for heart rate from Polar Transmitter Runs on Windows based diagnostic software platform BLUE CHERRY 493419 old 40 449 Polar Soft Strap Polar Soft Strap belt including electrodes 860695 old 10 809 01 Polar H3 Heart Rate Sensor Polar H3 Heart Rate Sensor to measu...

Page 33: ... 291945 old 10 878 Forehead Sensor Forehead sensor for WristOx2 Model 3150 including 16 to 9 adapter cable and mounting kit 10 units 269627 old 10 879 CO2stik USB 2 0 module for continuous correction of ambient CO2 Measurement range 0 2000 ppm CO2 Runs on Windows based diagnostic software platform BLUE CHERRY 197357 old 40 448 Software option BGA Interface Imports results from blood gas analyzers ...

Page 34: ...ld 40 451 Software option Lactate Software Software option for BLUE CHERRY to interface with existing Ergonizer lactate software to synchronise lactate results 119616 old 40 455 Software option WINLactat Software Software option for BLUE CHERRY to interface with existing Winlactat software to synchronise lactate results 508249 old 10 531 Software option LIPOXmax Software Software option for BLUE C...

Page 35: ...is IFU or in your medical device book as well as the most updated version at www geratherm respiratory com login Komponente Description name Blueflow Disposable Single use flow sensor Sensor codes validated during production ensure measurement quality and avoid frequent calibrations 523557 Exercise Mask Adapter Blueflow Adapter for attaching the Blueflow sensor to the face mask 311107 Blueflow Dis...

Page 36: ...ith fast response time Measurement range 0 100 O2 318415 old 40 404 Disinfectant 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 InstruPlus Dr Deppe GmbH Bomix Plus BODE Chemie GmbH Desinfektion N ANTISEPTICA Dr Hans Joachim Molitor GmbH Gigasept Pearls Schülke Mayr Gmb...

Page 37: ...ructed personnel Maintained or serviced improperly In order for Ergostik Blueflow or the total system to be operated in accordance with its intended use the safety information and procedures in this IFU must be understood Ensure that these are followed Otherwise in the worst case death or severe injuries are the consequence resulting from the risks described in more detail in the respective chapte...

Page 38: ...ot 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 suitable protective clothing Reason Electric shock False diagnosis Ignoring contraindications Triggering malfunctions of Ergostik Blueflow Unqualified user operator can detect sources of failures too...

Page 39: ...onnect any devices systems equipment and other products 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 accessories and consumables which are authorised by the manufacturer as well as authorised replacement components add ons and auxiliary materials Check th...

Page 40: ...and or misdiagnosis due to loss of electrical 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 total system Request maintenance work from your authorised specialist retail partner Only use accessories and consumables which are authorised by the manufacturer ...

Page 41: ...flow near 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 working in a careful way Therefore Ensure that the used components are undamaged and that you are working in a careful way Do not use consumable articles with a limited life span after their us...

Page 42: ...rythmia triggered by exercise Therefore Perform exercise tests only in presence of a physician Ensure availability of resuscitation equipment defibrillator medications and trained emergency personnel Monitor cardiac function with appropriate methods e g ECG during exercise test 3 4 Electromagnetic Compatibility EMC Possible danger to life Reason Misdiagnosis due to measurement error caused by a sy...

Page 43: ...nd disinfect Ergostik Blueflow 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 Therefore Dispose single use items disposable flow sensors mouthpieces and noseclips after each use For this observe the applicable regulatory requirements for biologicall...

Page 44: ... into electronic components Therefore Disconnect the Ergostik Blueflow from the power supply before cleaning and disinfecting When switching off via the On Off switch of the equipment cart shut down the PC completely before doing so Wipe off remaining moisture with a dry cloth Reason Damaged connections Therefore To disconnect electrical connections always pull the plug and never the cable ...

Page 45: ...Function of Ergostik Blueflow 4 1 Hardware 4 1 1 Overview 1 Ergostik Blueflow 2 Medical power supply unit see also chap 4 1 3 3 Ergostik Blueflow tube set 4 Blueflow Disposable flow sensor see also chap 7 4 5 Ambistik 6 Type label on the bottom of the case see also chap 14 7 Type label on the bottom of the Ambistik see also chap 14 6 5 3 2 1 4 7 ...

Page 46: ... Interfaces of the Ergostik Blueflow 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 switch Calibration gas connection 12 V DC Power supply unit connection Flow Connection Device front view Power LED Device rear view ...

Page 47: ...low sensor is used for precise flow measurement it is essential to comply with the cleaning and calibration instructions Attention Ergostik Blueflow could be damaged Reason Sensors are precise and high resolution components For this Ensure the respective functions are preserved Therefore Exactly follow instructions for cleaning disinfection and calibration You will find a detailed description in C...

Page 48: ...ions 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 Blueflow The system may be set up only by an authorised specialist retail partner It is essential to note Anyone who combines additional devices or medical devices or unauthorised or non original compon...

Page 49: ...ystem contrary 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 Regularly check the specified maintenance schedules If a maintenance schedule is exceeded do not continue to use the total system Request maintenance work from your authorised specialist retail ...

Page 50: ... Windows can 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 will find more detailed information in Chap 2 2 1 Original Spare Parts Accessories Optional Extensions Respectively consult with your authorised specialist retail partner The hardware connecti...

Page 51: ...rry out depict 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 standardised software interfaces e g HL7 GDT Paid software options are necessary for this if applicable A modular and flexible hardware and software concept makes it possible to combine t...

Page 52: ...ostik Blueflow Serial no xx 8 201 yyy and 2203xxxxx Page 52 Version 6 Release date 02 August 2022 For further information see the separate IFU of BLUE CHERRY information on the configuration and use of the software BLUE CHERRY ...

Page 53: ...formation see Chap 11 Decommissioning Disposal Chap 15 Warranty and Service The specialist retail partner authorised by the manufacturer are responsible for delivering the Ergostik Blueflow to the operator and for unpacking and transporting it to the actual installation location 5 2 Storage Requirements regarding space requirements media connections and operating conditions can be found in chap 12...

Page 54: ...ialist retail partners Possible danger to life Reason Electric shock Misdiagnosis caused by measurement error Therefore Prevent improper assembly installation Ergostik Blueflow should only be assembled and installed by officially trained personnel authorised by the manufacturer For further information see Chap 4 1 3 System Construction and Electrical Safety Information on assembly work in connecti...

Page 55: ... 6 2 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 Servicing work here also includes the necessary checks which are necessary if Ergostik Blueflow should fall down Attention Ergostik Blueflow could be damaged Reason careless operation Therefore A...

Page 56: ...ly and calibrated 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 Tube Possible physical injury Reason Measurement error due to leakage caused by incorrect assembly of components Therefore Carefully observe the assembly instructions Attention Function...

Page 57: ...the calibration 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 calibration gas connection For this Turn calibration tube 4 clockwise 3 Connect the minifilter to the gas exhaust For this Turn the minifilter 5 clockwise 5 4 3 1 2 ...

Page 58: ...s 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 Accessories Connect the Ergostik Blueflow in order to make it ready for operation 1 USB connection cable 1 to the USB socket of the Ergostik Blueflow 2 Power supply unit 2 with power cord 2a and the power supply con...

Page 59: ...ement error 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 Cleaning and Disinfection 7 1 1 Minifilter Permapure Check The permapure drying tube and minifilter must be checked regularly for discoloration Please note that the permapure tube and minifi...

Page 60: ...sconnecting 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 Blueflow must be activated To extend the life of the gas sensors the Ergostik Blueflow should be switched off if there are long intervals between measurements After switching on the Ergostik Blueflow needs a warm up time of 15 minutes Only after this...

Page 61: ...Ergostik Blueflow 2 For this Screw the flow 1a and gas tubes 1b clockwise to the color coded connections on the front of the Ergostik Blueflow 2 Insert the Blueflow flow flow sensor into the Blueclip 3 For this Place the flow sensor guide 3 on the head guide 4 on the Blueclip 3 Insert the flow sensor into the head of the Blueclip with a rolling movement 5 Lock unlock 6 engages 5 6 3 4 1 2 1b 1a ...

Page 62: ...rough the round opening of the silicone mask so that the lower ring of the adapter is inserted into the incision 6a b Position the mask adapter Blueflow For this Position the oval opening 5a of the mask adapter Blueflow vertically to the face mask 2 Mount the Blueflow flow sensor in the Blueclip adapter on the face mask For this Press the Blueflow flow sensor with the patient close side into the r...

Page 63: ...embly Blueflow Mouthpiece 1 Attach the Blueflow mouthpiece 1 to the flow sensor 2 For this Orient the Blueflow mouthpiece 1 in such a way that the arrow symbols on the mouthpiece 1a and on the flow sensor 2a sit on top of one another Push the Blueflow mouthpiece 1 onto the Blueflow flow sensor 2 as far as possible 1 2 1a 2 1 2a 2b ...

Page 64: ...s 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 as well as after opening a new carton of flow sensors Volume calibration Once per week Flow linearity test After Maintenance Cleaning Volume calibration 7 6 Using Ergostik Blueflow Performing Measurements Descriptions of t...

Page 65: ...ent error caused by a system failure due to uncontrollable electromagnetic fields of inadmissible transmitting devices Therefore While using Ergostik Blueflow do not use any transmitting devices e g mobile phones portable phones power lines that exceed the immunity levels as specified in the EMC guidelines Ask your authorised specialist retail partner Reason Electrical shock Therefore Ensure that ...

Page 66: ...nel Monitor cardiac function with appropriate methods e g ECG during exercise test Attention Ergostik Blueflow could be damaged Reason Penetrating liquid Uncleanliness External exposure Therefore Do not use any liquids near Ergostik Blueflow Do not expose Ergostik Blueflow or the entire system to dust or other contamination Do not drop any objects on Ergostik Blueflow Do not lay any objects on it ...

Page 67: ...ce exercise mask adapter Blueflow and noseclip after each use Observe the applicable regulatory requirements for biohazardous materials Observe regulations on wearing personal protective equipment PPE The combination of disposable flow sensor incl exercise mask adapter Blueflow or mouthpiece and noseclip offers the highest degree of patient safety against cross contamination This is achieved by re...

Page 68: ...022 7 7 2 Mask All parts which have come into contact with the patient or patient breathing during the examination must be disinfection For further weekly cleaning and disinfection tasks please see Chap 9 Cleaning and Disinfection Information about disposal of the disposable products can be found in Chap 11 3 Disposal ...

Page 69: ...lueflow 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 operation of the device However to maintain a high quality of measurement results and the safe operation the manufacturer recommends having the device safety and measurement precision checked by an au...

Page 70: ...rgostik Blueflow over its whole service life regular servicing and repairs if applicable are required Intervall Servicing work Before each examination Checking the cable and tube connections 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 After about 50 to 100 examinations Replacing the perm...

Page 71: ...ust be replaced or repaired properly Reason Electric shock Triggering malfunctions of Ergostik Blueflow Unqualified user operator can detect sources of failures too late or even cause them Therefore All maintenance and servicing work may only be performed by specialised personnel who have been authorised by the manufacturer 8 2 1 Checking Exchanging of Tubes and Cables All parts of Ergostik Bluefl...

Page 72: ...s apply Component Interval Method Noseclip After each patient Dispose of Blueflow Disposable After each patient Dispose of Exercise Mask Adapter Blueflow After each patient Dispose of Blueflow Disposable mouthpiece After each patient Dispose of Face mask After each patient Cleaning and disinfection bath Mask net After each patient Cleaning and disinfection bath Ergostik Blueflow Weekly Wipe surfac...

Page 73: ...re with a dry cloth Ergostik Blueflow 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 handling with the disposable items please read Chap 7 7 Exchange of Disposable Products Disinfection 9 2 Disinfection All parts of the Ergostik Blueflow can be cleaned of dirt with a soft cloth using a...

Page 74: ...disinfectants 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 First test the disinfectant for material compatibility in an inconspicuous place During the regular visual inspection for damage also pay attention to material changes discoloration cracks embrit...

Page 75: ...ubstances that are approved by the manufacturer See chap 2 2 2 Consumable Items Auxiliary Materials Follow the instructions on the concentration and dwell time stated by the cleanser and disinfectant manufacturer Do not place Ergostik Blueflow in the cleaning and disinfection solutions The device contains electrical components that will be damaged by doing so For the selection of suitable disinfec...

Page 76: ...ueflow All parts of the Ergostik Blueflow which come or could come into contact with the patient must be treated with surface disinfection 9 2 2 Blueflow Flow Sensor Blueclip Removal 1 Remove Blueflow flow sensor For this Proceed in reverse order as described in chap 7 4 Inserting the Flow Sensor Dispose of Blueflow afterwards see chap 7 7 ...

Page 77: ...low In reserve order as described in chap 7 4 1 Assembly Face Mask 2 Dispose of the Exercise Mask Adapter Blueflow see chap 7 7 3 Wipe off visible contamination with a soft cloth 4 Insert the silicone mask into a disinfectant solution 5 Wash the silicone mask thoroughly in distilled water so that no residues of contamination and disinfectants remain 6 Air dry silicone mask until no moisture is vis...

Page 78: ...ct 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 carry out work which is described and permitted by the manufacturer In case of not complying with this restriction the responsible organisation alone is liable for any resulting injuries to persons an...

Page 79: ...form volume calibration No gas signal Check that the Blueflow is correctly positioned in the Blueclip Check the tube connection between Blueclip and Ergostik Blueflow Check for moisture in the tube connection piece of the Blueflow Perform gas calibration Drift on gas signal Note the warm up time of the Ergostik Blueflow 15 minutes Check for moisture in the tube connection piece of the Blueflow Per...

Page 80: ...erform gas calibration Check the set type of the O2 Sensor Software error message CO2 out of measuring range Check tube connection between Blueclip and Ergostik Blueflow Check for moisture in the tube connection piece of the Blueflow Check gas outlet for blockage Perform gas calibration obvious measuring error Check that the Blueflow is correctly positioned in the Blueclip Check tube connection be...

Page 81: ...posal 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 reused or sent for material recycling Before doing so you should check whether it is possible to reuse the packaging 11 3 2 Ergostik Blueflow Ergostik Blueflow is an active medical device and is thus subjec...

Page 82: ...s and noseclips must be disposed of via hospital or practice waste Possible severe physical injury Reason Contamination with transferable germs during improper disposal Therefore Dispose single use items disposable flow sensors mouthpieces and noseclips after each use For this observe the applicable regulatory requirements for biologically hazardous materials Observe regulations on wearing persona...

Page 83: ...20 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 EMC Group 1 Class B Noise emission 80 dB A Surface temperature Normal operation 41 C Flow measurement Flow sensor Blueflow Measuring principle Differential pressure Measuring range 16 l s Ventilation measur...

Page 84: ...0 1 vol 13 21 1 FS 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 recommended EN 60601 Processor X86 amd64 compatible 1 GHz or higher RAM storage 1 GB or higher Hard drive storage 5 GB or higher Monitor XGA 1024 x 768 or higher PC interface USB 2 0...

Page 85: ...humidity 10 95 non condensing Atmospheric pressure 700 hPa 1100 hPa 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 synthetic flooring Atmospheric pressure 700 hPa 1100 hPa Setup mobile Space requirement complete with medical cart L 900 mm x W 900 mm x H 1900 mm Required floor load capacity 1...

Page 86: ...ines Mains Power 100 240 VAC N L PE Pink Lines Mains Power 100 240 VAC N L Purple Lines 12 VDC Power Supply Medical Device Red Lines Non Electrical Connections Green Lines USB Connectivity Yellow Lines Unknown ExternalData Connections Double Framework Galvanic Isolation fromElectrical Connections Arrows Plug Connections Patient Environment 1 5 m 1 5 m Ambistik REF 634247 Dual Pressure Tube Gas Sam...

Page 87: ... Power 100 240 VAC N L PE Pink Lines Mains Power 100 240 VAC N L Purple Lines 12 VDC Power Supply Medical Device Red Lines Non Electrical Connections Green Lines USB Connectivity Yellow Lines Unknown ExternalData Connections Double Framework Galvanic Isolation fromElectrical Connections Arrows Plug Connections ErgostikBlueflow REF 929463 Patient Environment 1 5 m 1 5 m Ambistik REF 634247 Dual Pre...

Page 88: ...tion in an electromagnetic environment as specified below The user operator of the Ergostik Blueflow should ensure that it is operated in this environment Measurement of electromagnetic emissions Compliance Electromagnetic environment Guideline RF emissions CISPR 11 Group 1 The Ergostik Blueflow uses RF energy exclusively for its internal function Therefore its RF emission is very low and is impro...

Page 89: ...tput 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 4 5 1 kV Voltage outer conductor outer conductor 2 kV Voltage outer conductor end 1 kV Voltage outer conductor outer conductor 2 kV Voltage outer conductor end The quality of the supply voltage should b...

Page 90: ...ent 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 Ergostik Blueflow as the recommended safety distance calculated according to the equation applicable to the transmission frequency Recommended safety distance Conducted HF distrubance variable IEC 61000 4 6 ...

Page 91: ... to IEC 61000 4 3 3 V m 80 MHz to 2 7 GHz 𝐸𝐸1 3 V m 𝑑𝑑 3 5 𝐸𝐸1 𝑃𝑃 from 80 MHz up to 800 MHz 𝑑𝑑 7 𝐸𝐸1 𝑃𝑃 from 800 MHz up to 2 7 GHz 27 V m PM 18 Hz 385 MHz 𝐸𝐸2 27 V m PM 18 Hz 𝑑𝑑 6 𝐸𝐸2 𝑃𝑃 28 V m FM 5 kHz Hub 1 kHz Sinus 450 MHz 𝐸𝐸3 28 V m FM 5 kHz Hub 1 kHz Sinus 𝑑𝑑 6 𝐸𝐸3 𝑃𝑃 9 V m PM 217 Hz 710 MHz 745 MHz 780 MHz 𝐸𝐸4 9 V m PM 217 Hz 𝑑𝑑 6 𝐸𝐸4 𝑃𝑃 28 V m PM 18 Hz 810 MHz 870 MHz 930 MHz 𝐸𝐸3 28 V m PM...

Page 92: ...omagnetic 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 radios amateur radio stations AM and FM radio and television transmitters can theoretically not be predicted exactly In order to determine the electromagnetic environment with regard to the stationary transm...

Page 93: ...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 𝑑𝑑 1 17 𝑃𝑃 80 MHz to 800 MHz 𝑑𝑑 1 17 𝑃𝑃 800 MHz to 2 7 GHz 𝑑𝑑 2 33 𝑃𝑃 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 2 1 2 2 3 10 3 7 3 7 7 4 100 12 12 23 For transmitters whose maximum power rating is not given in the table above...

Page 94: ...are 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 were evaluated and tested according to DIN EN ISO 10993 1 2017 04 Biological evaluation of medical devices biocompatibility Ergostik Blueflow is a class IIa active medical device Conformity with the...

Page 95: ...umber 5 Catalog number 6 Manufacturer details 7 For symbol descriptions see chap 1 3 Symbols 8 Input power 9 Medical Device 10 Type label revision indication 11 Follow the IFU 12 Conformity mark in accordance with the Medical Device Directive 93 42 EEC with identification of the involved notified body 13 Date of manufacture Safety symbols have been applied to the Ergostik Blueflow type label It ma...

Page 96: ...ion 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 warranty claims expire if the repairs were unauthorised 15 2 Warranty Exemption The warranty does not cover damage which was caused by the following Not complying with the storage or transportation co...

Page 97: ...void 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 packing is the responsibility of the customer In addition insurance during transport is recommended Claims due to loss or damage must be made by the shipper ...

Page 98: ... 201 yyy and 2203xxxxx Page 98 Version 6 Release date 02 August 2022 16 Authorised Specialist Retail Partner You can reach your responsible specialist retail partner via a contact form of the manufacturer www geratherm respiratory com login see depositors ...

Page 99: ...ik Blueflow Serial no xx 8 201 yyy and 2203xxxxx Version 6 Release date 02 August 2022 Page 99 Attachment Declaration of Conformity The Ergostik Blueflow declaration of conformity is enclosed with each device by the manufacturer ...

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