inofab Spirohome User Manual

Ultrasonic spirometer

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Prepared by

Quality Assurance

Reviewed by

Ahmet GÖKDERE

Approved by

Merthan ÖZTÜRK

REVISION

DATE

NUMBER

05.03.2018

22.07..2018

04.09.2018

14.10.2018

31.12.2018

11.01.2019

14/02/2019

29.03.2019

02.05.2019

SPIROHOME TECHNICAL FILE

USER MANUAL - PERSONAL

SPIROHOME

ULTRASONIC SPIROMETER

The document will be signed after revision.

FUNCTION

Regulatory Affairs

Deniz SARP

CEO

REVISION RECORD

COMMENTS

Initial Issue

Changes after Online Review

(27.03.2018)

Changes after NB review 2, contents

have been combined with IFU TD-

007-01

Amendments to the cleaning and

disinfection section and signs and

symbols section

Updated the cleaning and

disinfection protocol (1.3.1)

Added Device Indicators (1.2.3) and

minor additions to the disinfection

protocol (1.3.1)

Small additions and spelling

corrections

Updating parameters section and

added test quality

Small additions and spelling

corrections

Document No

Publication Date

Revision Number

Revision Date

Page

DATED

SIGNED

SUS-TD-028

05.03.2018

02.05.2019

1 / 68

SIGNED

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Summary of Contents for inofab Spirohome

Page 1 Document No SUS-TD-028 SPIROHOME TECHNICAL FILE Publication Date 05.03.2018 Revision Number USER MANUAL - PERSONAL Revision Date 02.05.2019 SPIROHOME Page 1 / 68 SPIROHOME ULTRASONIC SPIROMETER The document will be signed after revision. FUNCTION DATED SIGNED Regulatory Affairs Prepared by...
Page 2 Document No SUS-TD-028 SPIROHOME TECHNICAL FILE Publication Date 05.03.2018 Revision Number USER MANUAL - PERSONAL Revision Date 02.05.2019 SPIROHOME Page 2 / 68 Cover page: Spirohome Ultrasonic Spirometer User Manual...
Page 3 Revision Number USER MANUAL - PERSONAL Revision Date 02.05.2019 SPIROHOME Page 3 / 68 Welcome to Spirohome Before using your Spirohome device and mobile application, please ensure that you have read this user manual and labels and information on the product...
Page 4 Document No SUS-TD-028 SPIROHOME TECHNICAL FILE Publication Date 05.03.2018 Revision Number USER MANUAL - PERSONAL Revision Date 02.05.2019 SPIROHOME Page 4 / 68 CONTENTS CONTENTS INTRODUCTION 2.1. PRODUCT DESCRIPTION WHAT’S IN THE BOX 2.2. 2.3. INTENDED USE 2.4. RESTRICTIONS ON USE AND CONTRAINDICATIONS 2.5.
Page 5 Carrying pouch (d) CAUTION: Please check to ensure that there is no visible damage on any of the components of the Spirohome Personal. If damage is present, do not use or attempt to repair the device, please contact the manufacturer directly.
Page 6 Spirohome Personal is to be used by only single user. The device can log the information and tests results that belong to one specific user. If another user intends to use the device, ensure that the personal data of the previous user is erased from device memory and the personal data of the new user is entered into the system.
Page 7 If you have or suspect having any of the conditions above, consult to your healthcare professional before using the Spirohome Personal. 2.5. PARAMETERS The Spirohome Personal records and displays the following spirometry data: Parameters Definition Unit Forced Vital Capacity — The volume of air that can forcibly be blown out after full inspiration Forced Expiratory Volume after 0.75 seconds: The volume of...
Page 8 3.1. OPERATING ENVIRONMENT The Spirohome Personal is designed for use at home, by a single user. It is not intended for use in clinical settings such as an operating room or private clinics. The operating conditions for the Spirohome Personal is specified as:...
Page 9 3.2. SETTING UP YOUR DEVICE 1. Download the Spirohome Personal app from the App Store or Google Play Store into your smart device. 2. Follow the steps given in the app to create an account as a new user or log in to your...
Page 10 4. Enable Bluetooth® on your smart device and pair the Spirohome Personal with your smart device, following the instructions on the app.
Page 11 1. Remove the Spiroway Reusable mouthpiece from its plastic packaging and insert it all the way into the Spirohome Personal in the correct orientation (as shown). You will hear the click when you correctly insert the Spiroway Resusable mouthpiece into the Spirohome...
Page 12 Page 12 / 68 2. Open the Spirohome App on your smart device and make sure you are signed in. Tap the plus button to start the test procedure. 3. Follow the instructions that appear on the screen. The first step will be to record a...
Page 13 Document No SUS-TD-028 SPIROHOME TECHNICAL FILE Publication Date 05.03.2018 Revision Number USER MANUAL - PERSONAL Revision Date 02.05.2019 SPIROHOME Page 13 / 68 4. Place the mouthpiece in your mouth, past your teeth (necessary for measurement accuracy) and form a tight seal around the mouthpiece with your lips.
Page 14 Document No SUS-TD-028 SPIROHOME TECHNICAL FILE Publication Date 05.03.2018 Revision Number USER MANUAL - PERSONAL Revision Date 02.05.2019 SPIROHOME Page 14 / 68 fast as you can into the mouthpiece, keep blowing for at least 6 seconds without breaking the seal of your lips. When performing the forced exhalation, be sure to keep blowing until you feel like you have completely emptied your lungs.
Page 15 Document No SUS-TD-028 SPIROHOME TECHNICAL FILE Publication Date 05.03.2018 Revision Number USER MANUAL - PERSONAL Revision Date 02.05.2019 SPIROHOME Page 15 / 68 7. Repeat these steps for each successive spirometry test, ensuring a 15-30 second resting period between each test.
Page 16 Document No SUS-TD-028 SPIROHOME TECHNICAL FILE Publication Date 05.03.2018 Revision Number USER MANUAL - PERSONAL Revision Date 02.05.2019 SPIROHOME Page 16 / 68 Grade Criteria ≥ 3 acceptable tests with repeatability within 0,150 L For ages 2-6, 0,100 L, or 10% of the highest value, whichever is greater.
Page 17 Document No SUS-TD-028 SPIROHOME TECHNICAL FILE Publication Date 05.03.2018 Revision Number USER MANUAL - PERSONAL Revision Date 02.05.2019 SPIROHOME Page 17 / 68 Humidity Limit Atmospheric pressure limitation Do not use if package is damaged Keep away from sunlight Keep dry...
Page 18 WARNING to elderly, pediatric or differently-able users prior to use of the device. Regardless of the data presented on the Spirohome Ultrasonic Spirometer, if you feel unwell or have respiratory illness symptoms please contact your healthcare provider immediately. Only your doctor can decide on an appropriate treatment plan for you based on respiratory data obtained with the Spirohome Spirometer.
Page 19 To prevent damage to the Spirometry Module due to battery leakage or oxidation, remove all batteries if the Spirohome device is not to be used or is to be stored for a long period of time. Dispose of device and/or device batteries responsibly as required by local legislation.
Page 20 Please follow all data security warnings and recommendations for your personal smart device as per its manufacturer’s instructions as your personal data, which will include that recorded and stored on the Spirohome App, may otherwise be at risk. The user is encouraged to not share their Spirohome app account information with unauthorized parties.
Page 21 1. Before beginning the procedure wash hands thoroughly with soap and water. 2. Perform cleaning Remove the Spiroway Reusable from the Spirohome Personal body if it is inserted. Use a high- level disinfectant (Sodium Hypochlorite) wipe for 30 seconds to remove all visible contaminants from all accessible surfaces of the device as shown below.
Page 22 Document No SUS-TD-028 SPIROHOME TECHNICAL FILE Publication Date 05.03.2018 Revision Number USER MANUAL - PERSONAL Revision Date 02.05.2019 SPIROHOME Page 22 / 68 After cleaning all accessible surfaces of the device and cap with a high-level disinfectant (Sodium Hypochlorite) wipe, use a second fresh wipe to wipe over all surfaces again using moderate pressure and for the contact time recommended by the wipe manufacturer to achieve disinfection.
Page 23 4.3. BATTERIES The Spirohome device is suitable to work with any 1.5V AAA battery, including off-the-shelf AAA rechargeable batteries. The battery life of the Spirohome is approximately 6-9 months, assuming daily use of the device. The battery charge level is continuously monitored by the device. When battery charge level is low, the device will not turn on and the device will make a beeping sound to notify the user.
Page 24 Document No SUS-TD-028 SPIROHOME TECHNICAL FILE Publication Date 05.03.2018 Revision Number USER MANUAL - PERSONAL Revision Date 02.05.2019 SPIROHOME Page 24 / 68 2. Remove the battery cover by sliding it as shown. 3. Remove the dead batteries. 4. Place the new batteries in the correct orientation.
Page 25 Document No SUS-TD-028 SPIROHOME TECHNICAL FILE Publication Date 05.03.2018 Revision Number USER MANUAL - PERSONAL Revision Date 02.05.2019 SPIROHOME Page 25 / 68 5. Slide the battery cover back to the closed position. 6. Insert the Spiroway in the right orientation. Your device is now ready to use.
Page 26 Document No SUS-TD-028 SPIROHOME TECHNICAL FILE Publication Date 05.03.2018 Revision Number USER MANUAL - PERSONAL Revision Date 02.05.2019 SPIROHOME Page 26 / 68 7. If the device is not to be used, keep close to your devices cap in order to contamination risk of the mouthpiece.
Page 27 Spiroway mouthpiece is proper installation of installed incorrectly Spiroway Close the cap of the Spirohome to avoid effects of environmental flow Test does not start - Cannot Direct air current in Place device on a flat surface set up baseline...
Page 28 Document No SUS-TD-028 SPIROHOME TECHNICAL FILE Publication Date 05.03.2018 Revision Number USER MANUAL - PERSONAL Revision Date 02.05.2019 SPIROHOME Page 28 / 68 Quit test and start new test Test does not start - Quit application and start a animated balloon is not...
Page 29 TERMS OF WARRANTY Spirohome Personal, together with any accessories provided, is guaranteed for a period of 24 months, effective from the date of purchase, upon the provision of an invoice or sales receipt. The service life of the product is 5 years, effective from the date of purchase.
Page 30 ELECTROMAGNETIC COMPATIBILITY Meeting the requirements for EMC (electromagnetic compatibility) and preventing the unsafe use of the device, medical devices including Spirohome manufactured by Inofab Health Technologies conform to the EN60601-1-2 standard which defines the levels of immunity to electromagnetic interference as well as maximum levels of electromagnetic emissions for medical devices. For...
Page 31 Table 1: Emission table for IEC 60601-1-2 Guidance and manufacturer’s declaration – electromagnetic emissions Spirohome battery-operated spirometer devices are intended for use in the electromagnetic environment specified below. Users of these devices should assure that it is used in such environment.
Page 32 Table 2: Immunity (Stimulation mode) table according to IEC 60601-1-2 Guidance and manufacturer’s declaration – electromagnetic immunity SPIROHOME battery-operated spirometer devices are intended for use in the electromagnetic environment specified below. Users of these devices should assure that it is used in such environment.
Page 33 Page 33 / 68 Guidance and manufacturer’s declaration – electromagnetic immunity Spirohome battery-operated spirometer devices are intended for use in the electromagnetic environment specified below. Users of these devices should assure that it is used in such environment. Immunity test...
Page 34 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Spirohome devices are used exceeds the applicable RF compliance level above, the Spirohome device should be observed to verify normal operation.
Page 35 MANUFACTURER INFORMATION İnofab Sağlik Teknolojileri A.Ş. Name: Üniversiteler Mah. İhsan Doğramaci Blv. No: 19 Çankaya / Ankara / Turkey Address: Phone: +90 312 988 03 08 Web: www.spirohome.io The Spirohome Ultrasonic Spirometer and Accessories are CE certified (NB1984) products.
Page 36 Document No SUS-TD-028 SPIROHOME TECHNICAL FILE Publication Date 05.03.2018 Revision Number USER MANUAL - PERSONAL Revision Date 02.05.2019 SPIROHOME Page 36 / 68 Kapak Sayfası: Spirohome Ultrasonik Spirometer Kullanim Kilavuzu...
Page 37 SPIROHOME TECHNICAL FILE Publication Date 05.03.2018 Revision Number USER MANUAL - PERSONAL Revision Date 02.05.2019 SPIROHOME Page 37 / 68 Spirohome'a hoş geldiniz Spirohome cihazinizi ve mobil uygulamasini kullanmadan önce, lütfen bu kullanim kilavuzunu, ürün üzerindeki etiket ve bilgileri okuduğunuzdan emin olun.
Page 38 Document No SUS-TD-028 SPIROHOME TECHNICAL FILE Publication Date 05.03.2018 Revision Number USER MANUAL - PERSONAL Revision Date 02.05.2019 SPIROHOME Page 38 / 68 İÇİNDEKİLER İÇİNDEKİLER GİRİŞ 2.1. ÜRÜN AÇIKLAMASI KUTU İÇERİĞİ 2.2. 2.3. KULLANIM AMACI KULLANIM VE TERS ETKİ OLUŞTURACAK DURUMLARA İLİŞKİN 2.4.
Page 39 Kisacasi, kullanici ağizlik yoluyla cihaza soluk verince, dahili ultrasonik sensörler, içinden geçen havanin hacmini ve hizini algilar, cihaz bu bilgiyi spirometrik verilere dönüştürür ve bağli bir akilli cihazdaki Spirohome uygulamasi araciliğiyla gösterir. Spirohome uygulamasi, doğru veri toplama ve kayit için kullaniciyi test boyunca önayak olur ve yönlendirir.
Page 40 KULLANIM AMACI Spirohome Personal akciğer fonksiyon testlerinde kullanilan portatif spirometredir. Kullanicinin zorlu ekspirasyon manevrasi ile Spirohome PEF (Peak Expiratory Flow, Zirve Akim Hizi), FEV (Forced Expiratory Volume in first second of expiration, ilk bir saniyede elde edilen Zorlu Ekspirasyon Hacmi), FEV...
Page 41 (örn. nedeni bilinmeyen hemoptizi), mide bulantisi, kusma, şiddetli solunum sikintisi, fiziksel veya zihinsel engeller ya da bunama. Yukaridaki bahsedilen durumlarin herhangi birinin sizde olduğundan şüpheleniyorsaniz, Spirohome Personal cihazinizi kullanmadan önce sağlik uzmaniniza danişiniz. 2.5.
Page 42 Document No SUS-TD-028 SPIROHOME TECHNICAL FILE Publication Date 05.03.2018 Revision Number USER MANUAL - PERSONAL Revision Date 02.05.2019 SPIROHOME Page 42 / 68 Toplam verilen nefesin hacminin %25 ile %75’i arasindaki süredeki MMEF ortalama hacimsel akiş hizi — FEF ile aynidir 25-75 FVC’nin ilk çeyreği verildiği andaki (%25) nefesin hacimsel akiş...
Page 43 Relatif Nem: %0 ve %85 arasi Basinç: 500 hPa ve 1060 hPa arasi Spirohome Personal yanici sivi veya deterjanlar yakininda ya da yanici anestezi gazlarinin (oksijen veya nitrojen) yakininda kullanilmamalidir. Cihaz direkt hava akimi olan ortamda (örn. Rüzgarli ortam), sicaklik veya soğukluk kaynaklari, doğrudan güneş...
Page 44 3. Aşağida gösterildiği gibi pil kapağini açip doğru yönlendirmede pilleri ekleyiniz, kapaği kapatiniz ve cihazi çalişir hale getirmek için güç düğmesine 1 saniye boyunca basiniz. basiniz. 4. Akilli cihazinizda Bluetooth® fonksiyonunu aktive ettikten sonra, akilli cihazini uygulamada verilen talimatlara göre Spirohome Personal ile eşleştirin.
Page 45 AKCİĞER FONKSİYON TESTİNİN GERÇEKLEŞTİRİLMESİ 3.4. 1. Spiroway Yeniden Kullanilabilir Ağizlik parçasini plastik kiliftan çikariniz ve Spirohome Personal cihazina aşağida gösterildiği gibi doğru oryantasyonda boşluğu tamamiyla dolduracak şekilde takiniz. Spirohome Personal cihazina Spiroway Yeniden Kullanilabilir Ağizliği doğru bir şekilde taktiğinizda click sesini (ağizliğin cihaza tam yerleşme sesi)
Page 46 Page 46 / 68 duyacaksiniz. 2. Akilli cihazinda Spirohome uygulamasini açiniz ve kullanici hesabiniza giriş yapiniz. Test prosedürünü başlatmak için ekrandaki arti düğmesine basiniz. 3. Ekranda çikan talimatlari gerçekleştiriniz. İlk adimda, cihazin ortamdaki hava akimina göre referans değeri hazirlama işlemini (baseline ayarlanmasi) tamamlamaniz...
Page 47 Document No SUS-TD-028 SPIROHOME TECHNICAL FILE Publication Date 05.03.2018 Revision Number USER MANUAL - PERSONAL Revision Date 02.05.2019 SPIROHOME Page 47 / 68 4. Ağizliği ağziniza, dişleriniz arkasina geçecek şekilde (doğru ölçüm için önemlidir) aliniz ve dudaklarinizla ağizliğin etrafinda havanin sizmasini engelleyecek bir şekilde temas oluşturunuz.
Page 48 Document No SUS-TD-028 SPIROHOME TECHNICAL FILE Publication Date 05.03.2018 Revision Number USER MANUAL - PERSONAL Revision Date 02.05.2019 SPIROHOME Page 48 / 68 6. Dudaklarinizla ağizlik arasindaki temasi siki tutarak, bu aldiğiniz derin nefesi mümkün olduğu kadar sert ve hizli bir şekilde ağizliğin içine veriniz, dudak temasini bozmadan 6 saniye boyunca nefesinizi vermeye devam ediniz.
Page 49 Document No SUS-TD-028 SPIROHOME TECHNICAL FILE Publication Date 05.03.2018 Revision Number USER MANUAL - PERSONAL Revision Date 02.05.2019 SPIROHOME Page 49 / 68 8. Testlerinizi tamamlayip sonuçlariniza baktiktan sonra cihazini güç düğmesine basarak kapatiniz. Ağizliğin kontaminasyon riskini azaltmak için cihazi kapattiktan sonra cihaz kapağini da kapatiniz.
Page 50 2-6 yaş için: 0,200 L ya da en yüksek değerin 10%’u (hangi değer daha büyükse) Bir adet kabul edilebilir test. Kabul edilebilir test yok. İŞARETLER VE SEMBOLLER 3.6. Spirohome Personal cihazinizin güvenli kullanim ve saklanilmasi için lütfen aşağida verilen işaret ve sembolleri dikkate aliniz. İşaretler Tanımlar “Üretici Firma”...
Page 51 Document No SUS-TD-028 SPIROHOME TECHNICAL FILE Publication Date 05.03.2018 Revision Number USER MANUAL - PERSONAL Revision Date 02.05.2019 SPIROHOME Page 51 / 68 Hava Basinç Limitleri Paket bütünlüğü bozulmuş ise kullanmayiniz. Güneş işiğindan uzak tutunuz. Kuru tutunuz. Tek kullanimliktir. Tip BF Elektronik Tibbi Cihaz...
Page 52 Spirohome Ultrasonik Spirometre tarafindan verilen sonuçlara bakmaksizin, kendinizi iyi hissetmiyor veya solunum rahatsizliği geçiriyorsaniz lütfen hemen sağlik sağlayiciniza haber veriniz. Sadece doktorunuz size Spirohome Spirometre ile elde edilen solunum değerlerine göre tedavi plani önermelidir. Paketinden çikan cihaz veya cihaz komponentlerinde herhangi hasar görürseniz, cihazi lütfen kullanmayiniz ve tedarikçinize geri veriniz.
Page 53 önlemek için cihazdan pilleri çikariniz. Cihaz ve/veya pillerini sorumlu bir şekilde yerel kanunlara uygun olarak imha ediniz. Spirohome Personal ve Spirohome Yeniden Kullanilabilir Ağizlik tek bir kullanici tarafindan kullanilmalidir, cihazinizi, aile üyeleri dahil, başkalari ile paylaşmayiniz. Cihazi yeni bir kullanici kullanacak ise, cihazin temizleyip dezenfekte ediniz (daha fazla bilgi için bu Kullanim Kilavuzunun...
Page 54 önerilerini izleyin, aksi takdirde bu durum riskte teşkil edebilir. Spirohome uygulamasina kurduğunuz kullanici hesap bilgilerinizi yetkili olmayan kişilerle paylaşmamaniz önerilmektedir. Spirohome Personal EN 60601-1, EN 60601-1-11, EN 60601-1-2 ve EN 300 328 uymaktadir. Bu cihaz RF teknolojisi ile çalişir ve radyo komünikasyonlarindan etkilenmemesi için yalnizca üreticinin tanimladiği şekilde kullanilmalidir.
Page 55 30’ar saniye boyunca siliniz. Sensörlerde hasar oluşturmamak için sensörün bulunduğu cihaz boşluğunu temizlerken ekstra özen gösteriniz ve nazik davraniniz. Spirohome Personal cihazinizi ve kapağini haftada bir ya da görülebilir kirlilik oluştukça temizleyiniz.
Page 56 Document No SUS-TD-028 SPIROHOME TECHNICAL FILE Publication Date 05.03.2018 Revision Number USER MANUAL - PERSONAL Revision Date 02.05.2019 SPIROHOME Page 56 / 68 Medipal® Chlorine Disinfectant mendilleri (Pal International Ltd.) bu amaca uygun yüskek-düzey dezenfektan ürünüdür ve www.palinternational.com/healthcare-wipes/disinfectant/ internet adresinden temin edilebilir.
Page 57 PİLLER 4.3. Spirohome cihazi kullanima hazir AAA tipi şarj edilebilen piller dahil herhangi bir 1.5V AAA pil ile çalişmaya uygundur. Günlük kullanim ile cihaza takilan pil ömrü ortalama 6-9 aydir. Cihaz pil seviyesini sürekli olarak takip eder. Pil seviyesi düşük olduğunda cihaz açilmayip sesli uyari verir.
Page 58 Document No SUS-TD-028 SPIROHOME TECHNICAL FILE Publication Date 05.03.2018 Revision Number USER MANUAL - PERSONAL Revision Date 02.05.2019 SPIROHOME Page 58 / 68 2. Pil kapağini aşağida gösterildiği gibi açiniz. 3. Kullanilmiş pilleri çikariniz. 4. Yeni pilleri doğru yönde takiniz.
Page 59 Document No SUS-TD-028 SPIROHOME TECHNICAL FILE Publication Date 05.03.2018 Revision Number USER MANUAL - PERSONAL Revision Date 02.05.2019 SPIROHOME Page 59 / 68 5. Pil kapağini tekrar kapatiniz. 6. Spiroway parçasini doğru yönde takiniz. Cihaziniz şimdi tekrar kullanilabilir.
Page 60 Document No SUS-TD-028 SPIROHOME TECHNICAL FILE Publication Date 05.03.2018 Revision Number USER MANUAL - PERSONAL Revision Date 02.05.2019 SPIROHOME Page 60 / 68 7. Cihaz kullanilmayacaksa, ağizliğin kontaminasyon riskini azaltmak için cihazi kapağini kapatarak tutunuz. İMHA 4.4. Bu cihaz normal ev attiği olarak değil, yerel yasal gerekliliklere göre elektronik atik olarak imha edilmeli ve elektronik cihazlarin geri dönüşüm noktalarina teslim edilmelidir.
Page 61 Document No SUS-TD-028 SPIROHOME TECHNICAL FILE Publication Date 05.03.2018 Revision Number USER MANUAL - PERSONAL Revision Date 02.05.2019 SPIROHOME Page 61 / 68 SORUN GİDERME Sorun Neden Çözüm Pillerin doğru yönde takildiğindan emin olunuz AAA pilleri çikarin, 30 saniye Cihaz butonuna bekleyin ve pilleri tekrar takiniz basildiğinda cihaz...
Page 62 Document No SUS-TD-028 SPIROHOME TECHNICAL FILE Publication Date 05.03.2018 Revision Number USER MANUAL - PERSONAL Revision Date 02.05.2019 SPIROHOME Page 62 / 68 Testi iptal edip yeni test başlatin Test başlamiyor - Uygulamayi kapatip yeni test animasyondaki balon Birden fazla neden başlatin...
Page 63 Aksesuarlari bu linkten sipariş edebilirsiniz www.spirohome.io GARANTİ ŞARTLARI Spirohome Personal cihazina, aksesuarlari ile birlikte, satin alma tarihinden itibaren 24 aylik süre boyunca, fatura veya makbuz sunma şartina tabi olarak, garanti verilmektedir. Cihazin servis ömrü satin alma tarihinden itibaren 5 yildir.
Page 64 64 / 68 ● Cihazin üzerindeki seri numarasi değiştirilmiş, iptal edilmiş, sökülmüş veya okunamaz hale gelmesi ELEKTROMANYETİK UYUMLULUK İnofab Sağlik Teknolojileri’nin üretimi olan Spirohome dahil tüm tibbi cihazlar, tehlikeli kullanimi önlemek ve Elektromanyetik Uyumluluk (EMC) gereklerine uyarak, 60601-1-2 sayili Tamamlayici Standart’in belirlediği...
Page 65 özellikteki seviyelerde olmalidir Kılavuz ve üreticinin beyanı – elektromanyetik bağışıklık SPIROHOME, aşağida belirtilen elektromanyetik ortamda kullanim için amaçlanmiştir. SPIROHOME müşterisi veya kullanicisi, sistemin böyle bir ortamda kullanilmasini sağlamalidir. Uyumluluk Elektromanyetik Çevre - Bağışıklık testi Test seviyesi Rehberliği...
Page 66 Document No SUS-TD-028 SPIROHOME TECHNICAL FILE Publication Date 05.03.2018 Revision Number USER MANUAL - PERSONAL Revision Date 02.05.2019 SPIROHOME Page 66 / 68 mesafesinden daha yakinda kullanilmamalidir. Önerilen Ayirma Mesafesi d = 1.2 √P d = 1.2 √P 80 MHz - 800 d = 2.3 √P 800 MHz - 2.5...
Page 67 önlemlere ihtiyaç duyulabilir. b) 150 kHz ila 80 MHz frekans araliğinin üzerinde, alan güçleri 3V/m'den az olmalidir. Taşınabilir ve mobil RF iletişim ekipmanları ve hayat destekli olmayan SPIROHOME arasındaki önerilen ayırma mesafeleri SPIROHOME, işinan RF parazitlerinin kontrol edildiği bir elektromanyetik ortamda kullanilmak üzere tasarlanmiştir.
Page 68 ÜRETİCİ BİLGİLERİ İnofab Sağlik Teknolojileri A.Ş. Ünvan: Üniversiteler Mah. İhsan Doğramaci Blv. No: 19 Çankaya / Ankara / Türkiye Adres: Telefon: +90 312 988 03 08 Web Sitesi: www.spirohome.io Spirohome Ultrasonik Spirometre ve Aksesuarlari CE-işaretli ürünlerdir (NB1984).