GERATHERM 356246 Скачать руководство пользователя страница 2

Страница: 2 / 94

Version:

Release date:

02. August 2021

Filename:

TDOSPB0050R7

Language:

English

Affected serial numbers:

2111xxxxx

Software version:

valid from 1.3.1

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 356246

Страница 1: ...Spirostik Blue Serial numbers 2111xxxxx Instructions for Use Version 7 Release date 02 August 2021 Please read carefully and store in a place which is always accessible for future consultation...

Страница 2: ...al numbers 2111xxxxx Software version valid from 1 3 1 Geratherm Respiratory GmbH Kasernenstra e 4 97688 Bad Kissingen GERMANY Tel 49 971 7857043 0 Fax 49 971 7857043 30 info geratherm respiratory com...

Страница 3: ...are Parts Accessories 20 2 2 1 2 Optional Expansions 24 2 2 2 Consumable Items Auxiliary Materials 25 3 Safety in Handling 28 3 1 General Safety at Work and Personnel Qualification 29 3 2 The Technica...

Страница 4: ...Switching Spirostik Blue On Off 54 7 4 Inserting the Flow Sensor 56 7 5 Calibrating Spirostik Blue 58 7 5 1 Spirostik Blue with Single use Flow Sensor 58 7 5 2 Spirostik Blue with Reusable Flow Sensor...

Страница 5: ...rostik Blue without Medical Device Cart and without Isolation Transformer 83 12 4 Electromagnetic Compatibility EMC Guidelines 84 12 4 1 Emitted Interference Guideline and Manufacturer Declaration 84...

Страница 6: ...ulatory 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 Spirostik Blue as...

Страница 7: ...ter 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...

Страница 8: ...on 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...

Страница 9: ...Only use indoors IP42 Protection type safe environmental conditions IP4x Protection against penetration of foreign bodies with a diameter of 1 0 mm IPx2 Protection against falling drops of water when...

Страница 10: ...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 whic...

Страница 11: ...ay 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 within the...

Страница 12: ...ubject 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 inaccurac...

Страница 13: ...tended Purpose Spirostik Blue is an electric medical device It is a PC connected spirometer intended to identify the static and dynamic lung volume in pulmonary function testing in a clinical setting...

Страница 14: ...ue pulmonary function examinations can be carried out for diagnosing monitoring of process screening and assessing the severity of pulmonary diseases In particular this includes Obstructive diseases C...

Страница 15: ...g 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 Angina X Severe hypertens...

Страница 16: ...n 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 in a si...

Страница 17: ...organisation and or is responsible for rectifying faults to the Spirostik Blue as well as its calibration User must be aware of the clinical meaning and for example be a physician physician s assista...

Страница 18: ...see chap 2 1 3 Definition of the Groups of People operates Spirostik Blue Personnel must demonstrably have been given training in the function of Spirostik Blue This also includes a complete study of...

Страница 19: ...ty for such consequences All warranty claims shall expire See also chap 15 2 Warranty Exemption Possible danger to life Reason Cross contamination Therefore Ensure that the used components are undamag...

Страница 20: ...list retail partners 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 respiratory com log...

Страница 21: ...fe Comes together with intuitive Windows based diagnostic software platform for pulmonary function BLUE CHERRY 01 356246 old 40 070 BLUE CHERRY Media Pack Modular and intuitive Windows based diagnosti...

Страница 22: ...ensure stable measurement quality For approximately 10 000 spirometry tests Dispos able Reusa ble 860490 old 40 060 03 Softclip Disposable noseclip for lung function tests Made of soft skin friendly...

Страница 23: ...7002 Spirostik Blue Head Replacement head for Spirostik Blue 01 164930 Drying Bellows For removal of residual moisture in flow sensor Dispos able Reusa ble 01 409245 Quick Start Guide Spirostik Blue D...

Страница 24: ...nstructions on safe system construction in Chap 4 1 5 of this IFU The separate Ambistik IFU Component Description name Calibration Syringe Precision calibration instrument for calibration of flow or v...

Страница 25: ...d dosage administration Automatic calculation of threshold parameters 403680 old 10 507 2 2 2 Consumable Items Auxiliary Materials The following items were tested by the manufacturer for Spirostik Blu...

Страница 26: ...disposable flow sensor includes disposable noseclip for use with bacteria virus filter Including sensor codes determined during production to ensure measurement quality and avoid frequent calibration...

Страница 27: ...w sensor with low chloride concentration InstruPlus Dr Deppe GmbH Bomix Plus BODE Chemie GmbH Desinfektion N ANTISEPTICA Dr Hans Joachim Molitor GmbH Gigasept Pearls Sch lke Mayr GmbH For disinfection...

Страница 28: ...el Maintained or serviced improperly In order for Spirostik Blue or the complete system to be operated in accordance with its intended use the safety information and procedures in this IFU must be und...

Страница 29: ...ed 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 p...

Страница 30: ...roducts that are not part of the complete system This also includes only components approved by the manufacturer such as Bluetooth dongle rechargeable batteries battery chargers connection cables and...

Страница 31: ...ionality must be checked properly before putting into operation Regularly check the specified maintenance schedule If a maintenance schedule is exceeded do not continue to use the complete system Requ...

Страница 32: ...ses in the room Do not operate Spirostik Blue near the magnetic field of an MRT system Possible danger to life Reason Electric shock Cross contamination Misdiagnosis caused by measurement error Device...

Страница 33: ...fore each test When carrying out tests observe the content of the applicable guidelines and recommendations e g ATS ERS Guidelines Do not use single use products more than once Possible physical injur...

Страница 34: ...n the EMC guidelines Ask your authorised specialist retail partner about this 3 5 Cleaning and Disinfection Possible danger to life Reason Cross contamination For this Observe the general medical prin...

Страница 35: ...1 Mouthpiece 2 Handle with integrated measurement electronics 3 LED status display see also chap 4 1 3 4 Blueflow flow sensor see also chap 4 1 4 5 Replaceable Spirostik Blue head see also chap 4 1 2...

Страница 36: ...11xxxxx Page 36 Version 7 Release date 02 August 2021 4 1 2 Replaceable Head Spirostik Blue head Latch for positioning flow sensor for rolling down movement Sealing Adapter holes for pressure measurem...

Страница 37: ...Off No empty rechargeable batteries Insert replace the rechargeable atteries see chap 6 1 2 Inserting the rechargeable Batteries and preparing the Device for Operation RED 10 seconds then off Charging...

Страница 38: ...are preserved Therefore Exactly follow instructions for cleaning disinfection and calibration The heart of the Spirostik Blue is the Blueflow flow sensor The Blueflow is available in two versions As...

Страница 39: ...be constructed by a specialist retail partner but may also be carried out by the responsible organisation of Spirostik Blue themselves It is essential to note Anyone who combines additional devices or...

Страница 40: ...complete system This also includes only components approved by the manufacturer such as Bluetooth dongle rechargeable batteries battery chargers connection cables and computers that are not permitted...

Страница 41: ...mmended maintenance schedule Therefore Regularly check the specified maintenance schedules If a maintenance schedule is exceeded do not continue to use the complete system Request maintenance work fro...

Страница 42: ...ccessories Optional Expansions For further information see Chap 6 1 1 Driver Installation information on setting up the data connection The integrated encryption of the Bluetooth interface is used for...

Страница 43: ...Operation removing or replacing the rechargeable batteries Attention Spirostik Blue could be damaged Reason Leaking battery fluid Therefore Remove the rechargeable batteries when Spirostik Blue is no...

Страница 44: ...em 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 c...

Страница 45: ...he specialist retail partner authorised by the manufacturer is responsible for supplying Spirostik Blue to the responsible organisation Unpacking and transport to the actual place of use are the respo...

Страница 46: ...ilicone adapter small 6 Accompanying documentation with BLUE CHERRY Media Pack Spirostik Blue Reusable 1 Spirostik Blue 2a Drying bellows 2b Flow sensors 3x 2c Noseclips 3x Mouthpieces 3x 3 Bluetooth...

Страница 47: ...ion Spirostik Blue should only be assembled and installed by officially trained personnel authorised by the manufacturer For further information see Chap 4 1 5 System Construction and Electrical Safet...

Страница 48: ...Reason Electric shock Therefore After assembly or modification of a system a test of the electrical safety of the complete system as well as all tests required by the respective manufacturer of the in...

Страница 49: ...en the battery compartment 1 For this Press the snap lock 1a at the battery compartment cover 1b lower side of device and open 2 Insert the rechargeable batteries For this observe the polarity 2 see a...

Страница 50: ...completing the installation are The successful driver installation See chap 6 1 1 Driver Installation and Inserted full batteries sufficiently charged accumulators See chap 6 1 2 Inserting the recharg...

Страница 51: ...communication confirm this If a Windows message appears Pairing Device confirm this If Windows asks for a password to pair with the device enter 97688 ZIP Code of the manufacturer 3 Complete installat...

Страница 52: ...ther assembled properly the USB Bluetooth dongle connected to the computer and Spirostik Blue fitted with sufficiently charged batteries and calibrated With calibration the regulatory requirement on f...

Страница 53: ...bjects on Spirostik Blue Do not lay any objects on it Never push foreign objects into the housing 7 1 Checking for Worn Parts The Spirostik Blue should be checked for defective wearing parts each day...

Страница 54: ...n and is initially in standby mode When the movement is stopped Spirostik Blue returns to standby mode after a latency time standard setting 45 seconds When you take the Spirostik Blue in your hand it...

Страница 55: ...ve the rechargeable batteries please read Chap 6 1 2 Inserting the rechargeable Batteries and preparing the Device for Operation Attention Spirostik Blue could be damaged Reason Leaking battery fluid...

Страница 56: ...thpiece 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 mouthpiece 1 onto the flow sensor 2 as far as possible b Attach the bac...

Страница 57: ...date 02 August 2021 Page 57 Orient the mouthpiece 1 to the LED status display 6 direction place the flow sensor 2b onto the latch 4 of the head of the handle 3 Fold the flow sensor in a rolling movem...

Страница 58: ...he end opposite the mouthpiece Depending on the type of flow sensor used the required frequency can be read in the table below For details on individual calibrations please read The separate Calibrati...

Страница 59: ...fore Inform yourself and observe the respective contraindications before each test When carrying out tests observe the content of the applicable guidelines and recommendations e g ATS ERS Guidelines R...

Страница 60: ...e correct function of the Spirostik Blue Reason Electric shock Therefore Ensure that the users or third party persons do not touch the patient and any conductive connections or parts of the device tha...

Страница 61: ...ter each use For this observe the applicable regulatory requirements for biologically hazardous materials Observe regulations on wearing personal protective equipment PPE Clean and disinfect Spirostik...

Страница 62: ...sensor in a rolling movement upwards 2 Grasp the opposite side of the mouthpiece to lower the risk of cross contamination 3 Dispose the flow sensor disposable single use flow sensor or disinfect reus...

Страница 63: ...ears 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 t...

Страница 64: ...arging the Rechargeable Batteries Once per day Visual checks of the device and its components for damage and replacing them if necessary see chap 8 2 2 Checking for Damage Once per day Checking the se...

Страница 65: ...ed by the manufacturer 8 2 1 Charging the Rechargeable Batteries You find information for safe handling of rechargeable batteries while charging In the separate IFU of the battery charger The safety i...

Страница 66: ...nding component must be replaced For replacing components see Chap 4 1 5 System Construction and Electrical Safety Chap 6 2 Returning to Operation after Servicing Cleaning Work 8 2 2 2 Checking Replac...

Страница 67: ...object for example a paper clip 2a Remove the head 1 from the handle with an upwards movement along the guide rail 1a 2 Install the new head 1 For this Proceed with the sequence described in step 1 in...

Страница 68: ...n The following intervals apply Component Interval Method Single use flow sensor and mouthpiece After each patient Dispose of Noseclip After each patient Dispose of Bacteria Virus Filter After each pa...

Страница 69: ...infectants 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 meta...

Страница 70: ...by the cleanser and disinfectant manufacturer Do not place Spirostik Blue in the cleaning and disinfection solutions The device contains electrical components that will be damaged by doing so Remove t...

Страница 71: ...ual of the respective manufacturer The safety instructions contained must be observed 9 2 1 Spirostik Blue All parts of the Spirostik Blue can be cleaned of dirt with a soft cloth using a cleaning sol...

Страница 72: ...isinfection solution with an ultrasonic bath 4 Rinse the flow sensor and mouthpiece thoroughly in distilled water to clear any remaining contamination and disinfectant 5 Air dry flow sensor and mouthp...

Страница 73: ...ater The following disinfection options are permitted Disinfection bath aqueous solution with for example ammonium chloride do not use alcohol based disinfectants oils fats solvents or acids Brief boi...

Страница 74: ...scribed 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 Danger...

Страница 75: ...ostik Blue is set up in BLUE CHERRY see chap 6 1 3 Complete Installation with BLUE CHERRY Check that the Bluetooth dongle is connected correctly see chap 6 1 1 Driver Installation 6 1 3 Complete Insta...

Страница 76: ...formation such as is described in this IFU as well as other technical standard regulations are adhered to 11 2 Removing from Operation When removing the device from operation the accumulators of Spiro...

Страница 77: ...may be disposed of via household or practice waste In order to ensure environmentally friendly disposal please contact the authorised specialist retail partner where you purchased Spirostik Blue and...

Страница 78: ...nd noseclips must be disposed of via hospital or practice waste Possible severe physical injuries Reason Contamination with transferable germs during improper disposal Therefore Dispose single use ite...

Страница 79: ...y supplied with power Protection type IP42 Applied part BF according to DIN EN 60601 1 PC interface Bluetooth 4 0 2 400 2 4835 GHz GFSK PI 4 DQPSK 8DPSK Transmitter with Output Power 8 dBm Power suppl...

Страница 80: ...C First error 60 C Storage Transport min max Temperature 10 C 50 C Relative air humidity 0 95 non condensing Minimum PC system requirements Standard at least EN 62368 1 EN 60950 recommended EN 60601...

Страница 81: ...ge Transport min max Temperature 10 C 50 C Relative air humidity 20 95 non condensing Atmospheric pressure 700 hPa 1100 hPa Operation min max Environmental temperature 15 C 35 C Avoid extreme fluctuat...

Страница 82: ...tructions for Use Spirostik Blue Serial no 2111xxxxx Page 82 Version 7 Release date 02 August 2021 12 3 Electrical Safety Concept 12 3 1 Spirostik Blue with Medical Device Cart and Isolation Transform...

Страница 83: ...Instructions for Use Spirostik Blue Serial no 2111xxxxx Version 7 Release date 02 August 2021 Page 83 12 3 2 Spirostik Blue without Medical Device Cart and without Isolation Transformer...

Страница 84: ...ronment as specified below The user operator of the Spirostik Blue should ensure that it is operated in this environment Measurement of electromagnetic emissions Compliance Electromagnetic environment...

Страница 85: ...that it is operated in this environment Measurement of interference immunity IEC 60601 test level Compliance level Electromagnetic environment Guideline Electrostatic discharge ESD according to IEC 61...

Страница 86: ...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 Spirostik Blue as t...

Страница 87: ...s The propagation 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 an...

Страница 88: ...er 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 3 5 1 80 MHz to 800 MHz 3 5 1 800 MHz to...

Страница 89: ...lly 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 eva...

Страница 90: ...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 accord...

Страница 91: ...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 cl...

Страница 92: ...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...

Страница 93: ...o 2111xxxxx 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 www ge...

Страница 94: ...Use Spirostik Blue Serial no 2111xxxxx Page 94 Version 7 Release date 02 August 2021 Attachment Declaration of Conformity The Spirostik Blue declaration of conformity is enclosed with each device by...

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