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Avita NS1, Инструкция по эксплуатации

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18 /25page 

 

10. Explanation of Symbols 

 

 

The CE marking with the Registration Number of the Notified 
Body. This denotes the compliance of European Medical 
Device Directive 93/42/EEC 

 

Medical Device 

 

Manufacturer 

 

Authorized representative in the European Community 

Содержание NS1

Страница 1: ...pirator Model NS1 EN RoHS REACH MDSS GmbH Schiffgraben 41 30175 Hannover Germany AViTA Corporation 9F No 78 Sec 1 Kwang Fu Rd San Chung Dist New Taipei City 24158 Taiwan China AViTA WUJIANG Importer Distributor ...

Страница 2: ...RATING THIS UNIT Contents 1 Introduction 1 2 Important Information Before Use 3 3 Product Features 5 4 Battery Installation 6 5 Instructions For Use 8 6 Cleaning and Disinfecting 10 7 Technical Specifications 12 8 Troubleshooting 13 9 EMC Tables 14 10 Explanation of Symbols 18 ...

Страница 3: ...ration tip has a comfortable design to prevent the possibility for injury during operation Replaceable Tip Long Short Tip Available Compact Design This device is compact easy to hold and operate It is also safe and comfortable for baby use Battery Operated strong stable Washable Head Module Design Tips collection cup head part can be taken off from the device and washed Collection cup can also be ...

Страница 4: ...pact Hygiene Light Weight Low Noise Easy to use while the baby is sleeping NOTE Under any circumstances the device is ONLY for removing nasal secretion Any further medical action should follow the device of doctors ...

Страница 5: ...y this equipment without authorization of the manufacturer Do not expose the device to extreme temperature very high humidity level or direct sunlight Avoid extreme stress shock or accidental drop down Please replace all batteries when the power or and the sound of the pump is getting weak while using the device It is recommended to remove the batteries if the device will not be used for a period ...

Страница 6: ...asal Aspirator is for cleaning removing the nasal secretion only Do not use this device other than the intended purposes During the use of the device the baby should not hold his breath close his mouth or swallow his saliva to avoid vacuum pressure cause eardrum unbalanced If the baby does not feel well when using the device stop and consult a doctor immediately NOTE This Nasal Aspirator must only...

Страница 7: ...5 25page 3 Product Features Valve Filter optional ...

Страница 8: ...ted polarity symbols Always use new batteries Replace the battery cover Battery operated Always use NEW batteries never mix old and new batteries Do not use rechargeable batteries rechargeable batteries can vary greatly in quality and strength Use of rechargeable batteries may affect the performance of this device Please properly dispose of the batteries away from small children ...

Страница 9: ...mmended to remove the batteries if the unit will not be used for an extended period of time Batteries must be disposed of in accordance with local environmental and institutional policies Remove the battery during extended storage ...

Страница 10: ...ion pressure and ensure the unit is operating correctly before placing in the nostril Hold the baby or child upright the aspirator should not be used while the patient is reclined Be careful not to place the tip too far into the nostril or press against the inside wall of the nostril Press the POWER button to turn on the aspirator on Allow the suction to clear the mucus Repeat in the other nostril...

Страница 11: ...n NOTE This mucus may not immediately be visible in the collection reservoir It is recommended that the silicone tip and aspirator head be removed and rinsed between each use to keep any mucus from drying and clogging the device ...

Страница 12: ...rubber seal inside the module head be removed for cleaning and to help ensure the unit is fully dry before use and to prevent the growth of bacteria It is recommended at the that the silicone tip and collection cup be at minimum rinsed well with hot water between uses to prevent mucus from drying and clogging the unit To Clean at the end of the day as needed Wash the collection cup and tip with mi...

Страница 13: ...us be sucked into the device The head module with filter can only be washed by water it may be rinsed with hot water but should not be cleaned with any soap or chemical cleaners Allow all pieces to dry completely before reassembly NOTE 1 Protect the nasal aspirator from mechanical shock or heavy impact 2 Store the unit in an area away from sunlight dust and humidity 3 The filter optional under val...

Страница 14: ...ion Tip Soft Silicone Operating environment 16 35 60 8 95 with relative humidity up to 85 non condensing Storage Transportation environment 25 55 13 131 with relative humidity up to 85 non condensing Power supply 2 x 1 5V AA alkaline batteries Weight approx 132g without battery Dimensions approx 93 5mm x 39 9mm x 148mm L x W x H ...

Страница 15: ...eck or replace batteries The gray rubber ring located where the collection cup screws in is missing Make sure there is a gray rubber ring where the collection cup screws in The collection cup is not properly screwed in Make sure the three guides on each side of the collection cup line up with the guides on the suction portion of the aspirator ...

Страница 16: ...s declaration Electromagnetic emissions Phenomenon Professional healthcare facility environment a HOME HEALTHCARE ENVIRONMENT a Conducted and radiated RF EMISSIONS a CISPR 11 Group 1 Class B Harmonic distortion Not applicable Voltage fluctuations and flickering Not applicable a The equipment is suitable for use in Home Health Environments and Professional Health Care Environments limited to patien...

Страница 17: ...is not applicable in this environment unless the ME EQUIPMENT and ME SYSTEM used will be connected to the PUBLIC MAINS NETWORK and the power input is otherwise within the scope of the Basic EMC standard Guidance and manufacturer s declaration Electromagnetic immunity Enclosure port Phenomenon Basic EMC standard or test method Immunity test levels Professional healthcare facility environment HOME H...

Страница 18: ...tween portable and mobile RF communications equipment transmitters and the NS1 can be requested from supplier using the contact information provided in this manual However it is advisable to keep the electromechanical aerosol equipment at an adequate distance of at least 0 5 m from mobile phones or other RF communications transmitters to minimise possible interference RATED power frequency IEC 610...

Страница 19: ...ed to patient rooms and respiratory treatment facilities in hospital or clinics The more restrictive IMMUNITY acceptance limits have been considered and applied b Before modulation is applied c This test level assumes a minimum distance of at least 15 cm between the ME EQUIPMENT or ME SYSTEM and sources of power frequency magnetic fields ...

Страница 20: ... Symbols The CE marking with the Registration Number of the Notified Body This denotes the compliance of European Medical Device Directive 93 42 EEC Medical Device Manufacturer Authorized representative in the European Community ...

Страница 21: ...19 25page Date of manufacture YYYY MM DD or YYYY MM Batch code YYMMWWWW Serial number YYMWWWXXXXX Keep dry Temperature limit ...

Страница 22: ...20 25page Humidity limitation Atmospheric pressure limitation Caution Consult the instruction for use ...

Страница 23: ...Directives RoHS This product fulfilling the requirements of the RoHS Directive 2011 65 EU REACH This product fulfilling the requirements of the REACH Directive EC 1907 2006 and its amendments do not contain Substances of Very High Concern in concentration above the limit of 0 1 No substance s is are present in the parts of the product above the concentration of 0 1 weight by weight ...

Страница 24: ... BF This product meets the basic safety and essential performance requirements indicated in the IP22 conditioning test protection against solid foreign objects of 12 5mm and greater and against vertically falling water drops when enclosure tiled up to 15 ...

Страница 25: ... completely flat batteries must be disposed of through specially designated collection boxes recycling points or electronics retailers You are legally required to dispose of the batteries Importer Distributor Model Number ...

Страница 26: ...24 25page Country of Manufacturer Unique Device Identifier NS1P 22237AV 2022 04 22 ...

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