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39 

K01/03/23.12.2021 

 

11.

 

Contraindications and Indications 

•

 

Contraindication: 

means that the treatment is unsuitable

.

 

This device is unsuitable for Pentomidin medications. 

It is not suitable for pulmonary edema patients. 

İt is not suitable for 

acute lung embolism. 

•

 

Indications: t

hese are the situations in which treatment is appropriate.

 

It is used in the treatment of respiratory tract diseases such as asthma, COPD, 

chronic laryngitis, laryngitis, upper respiratory tract infections, allergies, by 

converting liquid drugs into aerosol mist and inhaling into the body. 

•

 

Side effects: 

No side effects have been identified as a device. The side effects of the drugs used 

with the device are specifically described in the instructions for use of the products 

used. 

•

 

Patient population: 

The product can be used in adults, pediatrics and infants. 

The device is designed for patients from every age but babies, small children and 

adults who need special care should use it under the control of an adult. 

•

 

Intended User: 

This device may be used by the patient, the caregiver, or by qualified medical 

professionals for home treatment, under the instructions of a legally licensed 

medical professional such as a doctor, nurse, or therapist. 

The user should also be able to understand the general operating principles of the 

device and the instructions in the device user manual. 

•

 

Warnings: 

Before use the device take-out all the protective equipments. 

Содержание HNK-MESH-01

Страница 1: ...HNK MESH 01 Ta nabilir Mesh Nebulizat r Portable Mesh Nebulizer Kullan m K lavuzu User Manual H nkar Ecza ve Medikal San Tic Ltd ti...

Страница 2: ...zellikleri 5 5 Cihaz Kurulum Talimatlar 6 6 Cihaz G Se enekleri 7 7 Cihaz Kullan m Talimatlar 9 8 Temizleme ve Dezenfekte Etme 11 9 Bak m ve pu lar 13 10 Cihaz Teknik Verileri 14 11 Kontrendikasyonlar...

Страница 3: ...la v cut i eresine al nmas n sa lamaktad r Cihaz her ya tan hastan n kullan m i in uygundur Aktif titre imli mesh teknolojisi ile Nimo Ta nabilir Mesh Neb lizat r hastay rahats z etmeden sessiz ve h z...

Страница 4: ...rya 2 4 V 1000 mAh Nebulizasyon H z 0 5 0 15 ml dk MMAD 2 5 30 m Titre im Frekans 120 kHz 10 kHz la Kab Kapasitesi 10 ml al ma Ortam Ko ullar S cakl k 5 C 40 C Nem oran 80 R H Atmosfer Bas nc 86 106 k...

Страница 5: ...zellikleri Tu Fonksiyonu Cihaz a ma ve kapama PRESS la Kab karma Tu u Par a Numaras Par a smi Par a Numaras Par a smi 1 la Kab Kapa 6 Cihaz A ma Kapama Tu u Led I k G stergesi 2 la Kab 3 Mesh Disk 7...

Страница 6: ...m Paketi A n Ard ndan Cihaz Ve Aksesuarlar kar n 2 la Kab n Cihaz Ana nitesine Yerle tirme Mavi I k Cihaz al yor Ye il I k Cihaz arj Oluyor I k Yok Cihaz al m yor la kab n resimde g sterildi i gibi ci...

Страница 7: ...uygun standartta adapt r kullan n z G adapt r n n teknik parametreleri DC 5 0V 1 0A k ile uyumlu olmal d r Cihaz n g sistemi arj edilebilir lityum titanat pil ile donat lm t r Maskeyi resimde g steril...

Страница 8: ...li yanacakt r Cihaz tam arjl durum da s rekli al ma s resi yakla k 60 dakikad r Cihaz pil mr y lda 3000 kez arj de arj imk n ile 5 y ld r Cihaz kullanmasan z bile ayda 1 kez arj de arj etmeniz tavsiye...

Страница 9: ...tesini ge meyiniz Maksimum kapasite ila kab l e inde 10 ml olarak belirtilmi tir lac ila kab na koyduktan sonra d k lmemesi i in ila kab kapa n tedavi s resi boyunca kapal tutunuz 2 Tedavi a Cihaz a k...

Страница 10: ...ek istiyorsan z a kapa tu una yeniden bas n z L tfen ila kab nda ila oldu undan emin olunuz e lem bittikten sonra cihaz kapatmak i in a kapa tu una bas n z ve al may durdurunuz la kab nda arta kalan t...

Страница 11: ...eme ve Dezenfekte Etme E er ila kab do ru ekilde ve s k s k temizlenmez ise enfeksiyon riski olu abilir Her kullan mdan sonra ila kab n ila kab kapa n a zl k ve maskeleri dezenfekte ediniz Cihaz temiz...

Страница 12: ...min olun 10 T m par alar n temizledikten sonra tamamen kuruland klar ndan emin olun Cihaz ana g vdesi tamamen elektronik bir r n olmas sebebiyle herhangi bir s v ile do rudan temas ettirmeyiniz Par al...

Страница 13: ...izat r ve aksesuarlar a nd r c s v lara ve gazlara maruz b rakmay n z Kesici delici nesneler ve el ile cihaz n mesh k sm na dokunmay n z Aksi halde bu durum mesh k sm nda kal c hasara neden olarak cih...

Страница 14: ...sen aeorosol partik l boyut de eridir Sol dikey eksen e rinin y kselen e ilimine kar l k gelen hacmin k m latif oran d r 50 k m latif partik l k tlesi i in partik l boyutu ap m MMAD n k k olmas isteni...

Страница 15: ...ar n yan etkileri ise kullan lan r nlerin kullan m talimatlar nda ayr ca tan mlanmaktad r Hasta pop lasyonu r n yeti kin pediatrik bebeklerde kullan labilir Cihaz her ya tan hastan n kullan m na uygun...

Страница 16: ...lmas halinde cihaz arj adapt r n prize slak el ile takmay n ve karmay n Cihaz kullan m k lavuzu ve r n kutusu zerinde tan mlanm olan depolama ve ta ma ortam artlar nda muhafaza edin al ma ortam ko ull...

Страница 17: ...ge erlilik s resi vard r Paketi ta ma esnas nda slanmaktan darbelerden ve ezilmelerden koruyunuz Cihaz ocuklar n uzanamayaca yerlerde saklay n z Cihaz g ne ndan ve a nd r c gazlardan muhafaza ediniz...

Страница 18: ...n p s nerek cihaz kendini kapat yor Cihaz n arj bitmek zere cihaz arj etme talimatlar n izleyin Mavi k 3 kez yan p s n yor ve cihaz kendini kapat yor la kab n n cihaza do ru tak l p tak lmad n kontrol...

Страница 19: ...EMC hakk nda daha fazla bilgi edinmek i in a a daki tablolara bak n z K lavuz ve imalat n n bildirimi elektromanyetik emisyonlar Bu cihaz a a da belirtilen elektromanyetik ortamda kullan lmak amac yl...

Страница 20: ...ans 100 kHz ebeke g c kalitesi tipik ticari veya hastane ortam kalitesinde olmal d r Hat Hat Aras Bo alma IEC 61000 4 5 0 5 kV 1 kV 0 5 kV 1 kV ebeke g c kalitesi tipik ticari veya hastane ortam kalit...

Страница 21: ...i donan m n yak n nda parazit olu abilir Not 1 80 MHz ve 800 MHz de daha y ksek olan frekans aral ge erlidir Not 2 Bu y nergeler her ko ulda ge erli olmayabilir Elektromanyetik yay lma binalar nesnele...

Страница 22: ...12 6 12 23 Yukar daki listede yer almayan maksimum k g c l len vericiler i in vericinin frekans na uygun denklem kullan larak nerilen ay rma mesafesi metre m cinsinden hesaplanabilir burada verici re...

Страница 23: ...11 b g n RFID 2450 LTE Bant 7 Darbe Mod lasyonu b 217 Hz 2 0 3 28 5240 5100 5800 WLAN 802 11 a n Darbe Mod lasyonu b 217 Hz 0 2 0 3 9 5240 5785 Not BA I IKLIK TEST SEV YES N elde etmek gerekli ise ve...

Страница 24: ...Tipi Uygulanabilir Par alar Kullan m K lavuzunu Okuyunuz LOT Numaras IP22 IP kodlu cihaz Cihaz 12 5 mm den b y k kat cisimlere ve 15 kadar damlayan s v ya kar korumal r n model numaras r n Seri Numar...

Страница 25: ...az Cihaz erisinde S n rlar A lm ve Yasaklanm Zararl Kimyasal Bulundurmaz Cihaz Barkod Numaras 18 CE Uygunluk areti Onaylanm Kurulu KIWA Belgelendirme Hizmetleri A 1984 r n T bbi Cihazlar Y netmeli ine...

Страница 26: ...33 8 Cleaning and Disinfecting 35 9 Maintenance and Clues 37 10 Device s Technical Data s 38 11 Contraindications and Indications 39 12 Keeping and Transportation 41 13 Troubleshooting 42 14 Warranty...

Страница 27: ...to aerosol and provides it to take inside to body via respiration This device is suitable for patients from all different ages Active vibrating mesh technology Nimo Portable Mesh Nebulizer gives the...

Страница 28: ...ery 2 4 VDC 1000mAh Nebulization Rate 0 5 0 15 ml min MMAD 2 5 30 m Working Frequency 120 kHz 10 kHz Medication Cup Capacity 10 ml Working Environment Temperature 5 C 40 C Humidity 80 R H Atmospheric...

Страница 29: ...cations Key Function On Off PRESS Medication Cup Take Out Key Piece Number Piece Name Piece Number Piece Name 1 Medication Cup Lid 6 Device On Off Key Led Light Indicator 2 Medication Cup 3 Mesh Disc...

Страница 30: ...en the whole package then take out the device and accessories 2 How to set medication cup to the main unit Blue Light Device is Working Green Light Device is Charging No Light Device is not Working As...

Страница 31: ...1 2007 or IEC60601 1 standards Technical parameters of power adaptor should be suitable with DC 50V 1 0 A Device s power system is rechargeable titanate battery As it is shown in the Picture install...

Страница 32: ...een light will be stable With full charge the device can be used for 60 minutes The device s battery life is 5 year and in a year it can charge and discharge for 3 000 cycles Even you don t use the de...

Страница 33: ...ss the maximum capacity of medication cup which is 10 ml After putting the medication to the cup in order not to pour close the lid till end of the cure 2 Treatment a Push the on off button for a seco...

Страница 34: ...the on off button again Please be sure there is medication in the medication cup e After cure process finish to switch off the device push on off button Empty the remaining residue in medication cup...

Страница 35: ...s infection risk if medication cup doesn t clean rapidly and properly After every usage disinfect the medication cup lid mouthpiece and masks Before cleaning the device if it is charging stop it and u...

Страница 36: ...or wet cloth Be sure electrodes are totally dried 10 After cleaned all the parts be sure all the parts dried totally Don t contact the main unit with any liquid directly since this device is totally...

Страница 37: ...with alcohol stay away from fire 9 Maintenance and Clues Don t exposure the mesh nebulizer and its accessories to abrasive liquids and gases Don t touch the mesh with sharp or perforator devices or wi...

Страница 38: ...e the value is logarithmic distribution The left vertical axis is the cumulative percentage of the volume corresponding to the rising trend of the curve The small particle size MMAD for 50 cumulative...

Страница 39: ...as a device The side effects of the drugs used with the device are specifically described in the instructions for use of the products used Patient population The product can be used in adults pediatr...

Страница 40: ...nplug the device s adaptor with wet hand Keep the device in the storage and transportation environment conditions defined on the user manual and product box use it in environments with working ambient...

Страница 41: ...plained up this device can be kept for 5 years While carrying protect the package from get wet impact and being crushed Keep the device away from children Keep the device away from direct sunlight and...

Страница 42: ...evice s charge is nearly finishing Please follow the charging instructions The blue light flashes 3 times and the device shutdown itself Check the medication cup is in right place Check there is medic...

Страница 43: ...ing tables for more information about this device and EMC Guidance and manufacturer s declaration electromagnetic emissions The device is intended for use in the electromagnetic environment specified...

Страница 44: ...ion frequency Mains power quality should be that of a typical commercial or hospital environment Surges Line to line IEC 61000 4 5 0 5 kV 1 kV 0 5 kV 1 kV Mains power quality should be that of a typic...

Страница 45: ...ked with the following symbol Note 1 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption...

Страница 46: ...1 9 3 8 7 3 100 12 6 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance in metres m can be estimated using the equation applicable to the freq...

Страница 47: ...400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation b 217 Hz 2 0 3 28 5240 5100 5800 WLAN 802 11 a n Pulse modulation b 217 Hz 0 2 0 3 9 5240 5785 Note If necessary to achieve t...

Страница 48: ...II Equipment per IEC 60601 1 Type BF Applied Part per IEC 60601 1 Consult instructions for use LOT Number IP22 Protected against foreign objects equal to or greater than 12 5mm in diameter and agains...

Страница 49: ...Barcode Number 18 European Conformity Mark Notified Body KIWA Belgelendirme Hizmetleri A 1984 The product conforms to European Medical Device Directive 93 42 EEC and meets applicable health safety an...

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