GERATHERM Ambistik CPET, Instructions For Use Manual

Page 1: ...PFT Ambistik CPET Serial numbers 2024xxxxx 2025xxxxx Instructions for Use Version 1 Release date 31 January 2022 Please read carefully and store in a place which is always accessible for future consu...

Page 2: ...numbers 2024xxxxx 2025xxxxx 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 respirat...

Page 3: ...nd Personnel Qualification 21 3 2 Storage Conditions stipulated by the Manufacturer 22 3 3 The Technical State of Ambistik PFT Ambistik CPET and System Construction 22 3 4 Operation Servicing and Main...

Page 4: ...11 2 2 Ambistik PFT Ambistik CPET 53 12 Technical Specifications 54 12 1 Technical Data 54 12 2 Installation and Operating Conditions 56 12 3 Electrical Safety Concept 57 12 3 1 Ambistik PFT Ambistik...

Page 5: ...sion 1 Release date 31 January 2022 Page 5 14 Product Labeling Type Label 65 15 Warranty and Service 67 15 1 General Conditions 67 15 2 Warranty Exemption 67 15 3 Packaging and Shipping 68 16 Authoris...

Page 6: ...regulatory requirements for medical devices class I 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 Ambistik PFT Ambi...

Page 7: ...partner on site You can obtain the contact details via a form provided by the manufacturer at www geratherm respiratory com login 1 1 Abbreviations The following simplified style of writing and abbre...

Page 8: ...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 hazardou...

Page 9: ...er IPx0 No protection of enclosure against harmful ingress of water Do not dispose of the device along with general household waste It must be disposed of in a proper and correct manner via the specia...

Page 10: ...Area EEA Caution non ionising electromagnetic radiation Precautions must be taken to avoid an unexpected effect of non ionising radiation Fragile handle with care The package contains a product that...

Page 11: ...CPET Serial no 2024xxxxx 2025xxxxx Version 1 Release date 31 January 2022 Page 11 Symbol Explanation Atmospheric pressure limitation The product can be safely transported stored or operated within the...

Page 12: ...t 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 in...

Page 13: ...ole system 2 1 Intended Purpose The medical device Ambistik PFT Ambistik CPET is a PC based measuring device used to determine environmental conditions temperature air humidity and pressure From these...

Page 14: ...lung function examinations who uses Ambistik PFT Ambistik CPET after verifiable instruction by the responsible organisation and or is responsible for rectifying faults to the Ambistik PFT Ambistik CPE...

Page 15: ...Operating Conditions The responsible organisation must ensuring that only medically trained specialist personnel see chap 2 1 1 Definition of the Groups of People operates Ambistik PFT Ambistik CPET...

Page 16: ...der certain circumstances negatively change constructive prescribed properties of Ambistik PFT Ambistik CPET and in the worst case impair the safety of the patient user operator and or third parties T...

Page 17: ...ials from unauthorised access Observe the storage conditions stipulated by the manufacturer 2 2 1 1 Original Spare Parts Accessories The following components can be purchased via specialist retail par...

Page 18: ...mponent Description name Supply scope in units Ambistik PFT Supply scope in units Ambistik CPET Ambistik PFT 01 654063 Ambistik CPET 01 493425 USB cable type A to type C 01 01 104080 BLUE CHERRY Media...

Page 19: ...ou 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 respiratory com login Component Descripti...

Page 20: ...ersonnel Maintained or serviced improperly In order for Ambistik PFT Ambistik CPET or the total system to be operated in accordance with its intended use the safety information and procedures in this...

Page 21: ...ning information on Ambistik PFT Ambistik CPET may not be altered or removed Have missing or not readable information replaced immediately When working with auxiliary materials always observe the safe...

Page 22: ...ossible danger to life Reason Electric shock Cross contamination Misdiagnosis caused by measurement error Therefore Do not overstress Ambistik PFT Ambistik CPET Use with care Do not modify or use prod...

Page 23: ...the mains with an isolation voltage of 4 kV Ensure that the users or third party persons do not touch the patient and any conductive connections or parts of the device that are located outside the pat...

Page 24: ...pecifications Do not operate Ambistik PFT Ambistik CPET if there are flammable or explosive gases in the room Do not operate Ambistik PFT Ambistik CPET near the magnetic field of an MRI system Possibl...

Page 25: ...e 25 If there are any damages do not operate the system The damaged parts must be replaced or repaired properly Reason Misdiagnosis caused by measurement error due to incorrect components or improper...

Page 26: ...t drop any objects on Ambistik PFT Ambistik CPET Do not lay any objects on it Never push foreign objects into the housing Do not expose the Ambistik PFT Ambistik CPET to excessive temperature fluctuat...

Page 27: ...cm that exceed the immunity levels as specified in the EMC guidelines Ask your authorised specialist retail partner about this Reason Misdiagnosis caused by uncontrollable electromagnetic fields Trig...

Page 28: ...oper treated components Therefore For cleaning and disinfection only use those active substances that are approved by the manufacturer see chap 9 Cleaning and Disinfection Follow the instructions on t...

Page 29: ...1 Release date 31 January 2022 Page 29 4 Structure and General Function of Ambistik PFT Ambistik CPET 4 1 Hardware 4 1 1 Overview 1 Ambistik PFT CPET 2 Type label see also chap 14 3 Touch button with...

Page 30: ...t retail partner immediately You will find a list of specialised retailers in this IFU or in the manual of the medical device as well as the current version at www geratherm respiratory com login 4 1...

Page 31: ...annel If one or more of the measuring channels are in or outside the critical range the channel is automatically displayed The selected measuring channel is displayed by a white pulsating indicator LE...

Page 32: ...ED ring colour changes to yellow one of the measured values is in a critical range and something should be done The change to the critical range is performed automatically If the LED colour changes to...

Page 33: ...rotating Ambistik PFT Ambistik CPET performs LED function test Connect the Ambistik PFT Ambistik CPET to the computer s USB 2 0 port BLUE rotating Ambistik PFT Ambistik CPET performs warm up phase bo...

Page 34: ...xxx Page 34 Version 1 Release date 31 January 2022 Status LED RED Ambistik PFT Ambistik CPET shows values beyond the critical range Do not perform a measurement RED flashing Ambistik PFT Ambistik CPET...

Page 35: ...used by third parties or this combination is placed on the market will legally become a producer of a system or a procedure pack In any case the assembler of a system is therefore responsible for comp...

Page 36: ...conductive connections or parts outside the patient environment at the same time When connecting Ambistik PFT Ambistik CPET to other devices make sure that all connections and cables are secured and...

Page 37: ...harges Therefore Preferably no floor made of synthetic material Otherwise a relative air humidity of at least 30 is required 4 1 3 1 Bluetooth Computer Printer Data Connection The Ambistik PFT Ambisti...

Page 38: ...manage patient and examination data as well as carry out depict process and record measurements with the devices of the manufacturer The communication between the BLUE CHERRY software and a practice...

Page 39: ...ervice The specialist retail partner authorised by the manufacturer is responsible for supplying Ambistik PFT Ambistik CPET to the responsible organisation Unpacking and transport to the actual place...

Page 40: ...ent error Therefore Prevent improper assembly installation Ambistik PFT Ambistik CPET should only be assembled and installed by officially trained personnel authorised by the manufacturer For further...

Page 41: ...nsible organisation see chap 8 Servicing Maintenance may be carried out by the responsible organisation s own authorised specialist personnel This can also be the operator user themselves Possible dan...

Page 42: ...tic platform The Ambistik CPET can be used as an additional device for all Geratherm Respiratory devices that can be used to perform CO2 measurements i e Ergostik 1 Connect the USB cable For this Conn...

Page 43: ...1 Release date 31 January 2022 Page 43 6 2 Recommissioning The operator is responsible for recommissioning after maintenance cleaning work for which the user is authorised For the steps for recommissi...

Page 44: ...to dust or other contamination Do not drop any objects on Ambistik PFT Ambistik CPET Do not lay any objects on it Never push foreign objects into the housing 7 1 Checking for Worn Parts The Ambistik P...

Page 45: ...ed by the diagnostic platform BLUE CHERRY 1 Start the software For this Start the PC and press the BLUE CHERRY symbol on the desktop 2 Access the environmental conditions For this Press the BTPS butto...

Page 46: ...e ambient air is displayed at the bottom of the BLUE CHERRY screen 1 Example data 0 096 Therefore the CO2 concentration does not have to be entered manually for the correct calibration of the CO2 meas...

Page 47: ...k CPET 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 o...

Page 48: ...approved by the manufacturer the following steps must be observed Preferably use agents that correspond in composition to the approved agents The composition is available on data sheets which we can...

Page 49: ...ap 2 2 2 Auxiliary Materials Follow the instructions on the concentration and dwell time stated by the cleanser and disinfectant manufacturer Do not place Ambistik PFT Ambistik CPET in the cleaning an...

Page 50: ...thod described please contact your specialist retail partner You will reach your authorised specialist retail partner via contact form on the manufacturer s website www geratherm respiratory com login...

Page 51: ...es for example air condition Send the device to an authorised specialist retail partner for repair replacement Measurement data are not plausible Check installation location install the device as clos...

Page 52: ...alues outside the measuring range Check the installation location install the device as close as possible to the patient Do not install the device a heat outlet of the computer for example fan or othe...

Page 53: ...ated by the local authority should be complied with for disposal 11 2 1 Transport packaging The transport packaging should be reused or sent for material recycling Before doing so you should check whe...

Page 54: ...rective of 14 6 1993 annex IX Dimensions L 76 5 mm x W 30 mm x H 18 5 mm Weight 20 g Electrical data Protection type IP20 IEC 529 PC interface USB 2 0 or USB 3 0 Power supply via USB port Power consum...

Page 55: ...50 ppm Pressure measurement Measurement range 300 1100 hPa Resolution 1 hPa Scan rate 2 Hz Accuracy 10 hPa Minimum PC system requirements Standard at least EN 62368 1 EN 60950 recommended EN 60601 Pr...

Page 56: ...guaranteed by the manufacturer and for the safety of the patient and operator Storage Transport min max Temperature 10 C 50 C Relative air humidity 10 95 non condensing Operation min max Environmental...

Page 57: ...ite Medical DeviceCart Power Strip Power Socket PC Printer Monitor Mouse Keyboard Green Blocks Geratherm Respiratory Medical Devices Blue Blocks 3rd Party Medical Devices Grey Blocks Non Medical Devic...

Page 58: ...lation Transformer Green Blocks Geratherm Respiratory Medical Devices Grey Blocks Non Medical Devices Hatched Blocks Optional DevicesrespectivelyMedical Devices Blue Lines Mains Power 100 240 VAC N L...

Page 59: ...an electromagnetic environment as specified below The user operator of the Ambistik PFT Ambistik CPET should ensure that it is operated in this environment Measurement of electromagnetic emissions Com...

Page 60: ...CPET should ensure that it is operated in this environment Measurement of interference immunity IEC 60601 test level Compliance level Electromagnetic environment Guideline Electrostatic discharge ESD...

Page 61: ...immunity IEC 60601 test level Compliance level Electromagnetic environment Guidelines Portable and mobile RF communication devices should not be used at a shorter distance from the Ambistik PFT Ambist...

Page 62: ...gation 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 la...

Page 63: ...stik CPET depending on the emitted power of the communication device as indicated below Power rating of the transmitter W Safety distance depending on the transmitter frequency m 150 kHz to 80 MHz 1 1...

Page 64: ...ich are used 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 wi...

Page 65: ...s 1 Manufacturer logo 2 Product name 3 Product application 4 Serial number 5 Catalog number 6 Manufacturer details 7 Do not dispose of the device along with general household waste 8 Input power 9 Med...

Page 66: ...8 Input power 9 Medical Device 10 Type label revision edition 11 Follow the IFU 12 Conformity mark in accordance with the Medical Device Directive 93 42 EEC with identification of the involved notifi...

Page 67: ...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 warr...

Page 68: ...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 pack...

Page 69: ...24xxxxx 2025xxxxx Version 1 Release date 31 January 2022 Page 69 16 Authorised Specialist Retail Partner You can reach your responsible specialist retail partner via a contact form of the manufacturer...

Page 70: ...PFT CPET Serial no 2024xxxxx 2025xxxxx Page 70 Version 1 Release date 31 January 2022 Attachment Declaration of Conformity The Ambistik PFT Ambistik CPET declaration of conformity is enclosed with ea...