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GERATHERM 356246 Instructions For Use Manual Download Page 78

 

Instructions for Use 

Spirostik Blue 

Serial no.:

 

2111xxxxx 

 

 

 

 

Page 78 

Version: 7 | Release date: 02. August 2021 

 

11.3.5

 

Infectious / Contaminated Single Use Items 

 

 

All contaminated items such as single use flow sensors, filters, 

mouthpieces and 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 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 personal 
protective equipment (PPE)! 

 

 

 

Summary of Contents for 356246

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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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