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eng

15.2.2 European EC Declaration

All NanoVi

™ devices carry the mark represented in the declaration below.

www.eng3corp.com | 206.525.0227 | [email protected]

EC Declaration of Conformity

We, the undersigned,

Manufacturer

Eng3 Corporation

Address, City

2234 Eastlake Ave E, Seattle, WA 98102

Country

USA

Phone number

US-206-525 0227

Fax number / e-mail

Fax: US-425-650 7171, email: [email protected]

Authorized representative in
Europe

See label with name and contact information on the backside of the product or
visit: www.eng3corp.com/service

certify and declare under our sole responsibility that the following apparatus:

Description

Medical Device, Class I

Manufacturer

Eng3 Corporation, Seattle, USA

Brand

NanoVi

Identification

NanoVi, NanoVi Eco,
NanoVi Pro, NanoVi Exo

Restrictive use

Professional use and Home use

conforms with the essential requirements for CE-marking of

Medical Devices Directive 93/42/EEC

and

2007/47/EG

in the wording of later regulations, based on the following specifications applied:

IEC 60601-1:2005+AMD1:2012 General Requirements for Basic Safety and Essential Performance

IEC 60601-1-2:2014 Collateral Standard: Electromagnetic disturbances - Requirements and tests

IEC 60601-1-6:2013 Collateral standard: Usability

ISO 14971:2007(E) Medical Devices - Application of Risk Management to Medical Devices

IEC 62366-1:2015 Application of Usability Engineering to Medical Devices

and therefore, complies with the essential requirements and provisions of the

Medical Devices Directive

Name

Hans J. Eng

Position of person binding

President / CEO

the manufacturer

Eng3 Corporation

or his authorized

representative

---

Date

April 05, 2017

Signature

Содержание 4650-00

Страница 1: ...User Manual NanoVi Devices Eng3 Corporation...

Страница 2: ...eng3 1...

Страница 3: ...Part Number 4530 00 M004 rev10 Copyright 2017 Eng3 Corporation All rights reserved No part of this publication may be reproduced copied stored in a retrieval system or transmitted in any form or by an...

Страница 4: ...eng3 3...

Страница 5: ...ating in Standard Mode 13 8 Operating in SmartCard Mode 15 8 1 Owner Card 15 8 2 User Card 18 9 Use with Accessories 20 9 1 Transportation Case 20 10 Cleaning Instructions 22 11 Maintenance 23 12 Disp...

Страница 6: ...eng3 5...

Страница 7: ...cal damage When this damage accumulates it is called oxidative stress damage and is in optimal situations counterbalanced by the body s oxidative response This involves repair and rejuvenation at the...

Страница 8: ...ser serviceable parts or parts required for maintenance inside This port is for factory use only Do not open or remove the factory port The NanoVi device has a universal power supply and is plugged in...

Страница 9: ...ons if necessary Drowsiness Use a shorter session length for the first few sessions Choose the time of the first session to accommodate unexpected drowsiness which might occur after the initial applic...

Страница 10: ...ce from extreme temperatures and moisture during operation or storage These conditions can damage internal components The device should only be used on a stable surface The NanoVi device should not be...

Страница 11: ...other device s Connect the NanoVi into an outlet on a circuit different from that to which the other device s are connected If it is not resolved or if you have questions contact the service departme...

Страница 12: ...sidered the OPERATOR and SERVICE PERSONEL WARNING Do not connect or attach any item that is not specified as an attachment by the manufacturer WARNING This product is not meant to be used in temperatu...

Страница 13: ...slide down into the device as shown in Figure 5 3 There will be a small gap between the humidifier and the device when there is a proper connection Figure 5 3 Inserting humidifier into device WARNING...

Страница 14: ...cart with the humidifier installed but should never be carried with the humidifier installed because it could fall off and do damage The PATIENT can be sitting or lying down The Flex Arm bends follow...

Страница 15: ...y pull the Flex Arm towards your face The end of the paper tube should be in front of your nose one to three inches away as shown in Figure 6 4 The Flex Arm can be moved and repositioned for comfort b...

Страница 16: ...ssion Use of the cannula is shown in Figure 6 6 6 4 Power On Press the large button on the front of the device to turn the power on The power button will illuminate with a green circle and the touch s...

Страница 17: ...important to start slowly to stay within your comfort zone If you are highly sensitive and or in need of detoxification start with only a few minutes and keep adding time each day as long as there are...

Страница 18: ...sun or moon symbols To turn the lights off press the moon symbol until the illumination disappears The orange bar will be all the way to the left The rotating color option is selected by pressing the...

Страница 19: ...he screen Figure 7 1 Figure 7 1 Initial splash screen Upon completion of the self test an input screen appears allowing you to enter the amount of time for the session Figure 7 2 Enter the desired ses...

Страница 20: ...rogress The pause button allows you to interrupt a session Figure 7 4 Pressing the start button restarts a paused session If a session has not been restarted within 15 minutes the device will automati...

Страница 21: ...is unique and specific to the device it comes with The User Cards will only work with the device that was used to program them 8 1 Owner Card The owner card can be inserted any time when the device is...

Страница 22: ...ibed in Section 7 Operating in Standard Mode To select this mode touch the top white button so that a dot appears as shown to the right 2 Infinity mode does not require a User Card and the device rema...

Страница 23: ...should insert a User Card to be loaded with minutes Remove the owner card and insert the first User Card to be loaded To return to the Owner Card screen press the page up arrow on the right Figure 8...

Страница 24: ...be inserted to run the device 8 2 User Card The screen below is displayed when a User Card is required A valid User Card or an Owner Card must be inserted to operate the device Figure 8 6 SmartCard m...

Страница 25: ...es left on the card Session Mode The device can be set up with a predetermined session time In this case the session time shows and no keyboard is visible Figure 8 8 In the example below the session t...

Страница 26: ...imension may allow it to be taken as a carry on but this depends on the size restrictions for each airline 2 The NanoVi device and necessary accessories fit in custom designed openings The humidifier...

Страница 27: ...ation case during operation 3 The case has two wheels and a pullout retractable handle The case offers the possibility to be locked lock not included Dimensions Length 22 5 57cm Width 15 38 cm Height...

Страница 28: ...oved from the device by pulling it straight up The glass container is then unscrewed from the top of the humidifier WARNING Do not attempt to unscrew the glass container while the Humidifier is still...

Страница 29: ...equipment Refer to the Technical Specifications in section 15 for the materials of the main components for reference for sorting parts for disposal 13 Storage For long term storage prepare the NanoVi...

Страница 30: ...vice Reseating the connection may resolve this problem It is also possible that the glass container is not tightly screwed into the glass container holder Note Figure 5 4 to see how the connection sho...

Страница 31: ...ustomer support when you call Use the number of the error message screen to reach technical support for the NanoVi device Code Error Message 101P Pump error 102A Excitation unit error 103L Lamp error...

Страница 32: ...olid variable speed transition Solid variable speed transition Excitation units excitation elements 1 6 2 12 4 24 Spectral emission max power 1 100 1 300 nm 6 x 700 pW 1 100 1 300 nm 12 x 700 pW 1 100...

Страница 33: ...anoVi Exo devices are registered with the United States Food and Drug Administration FDA FDA Device Listing number D097353 FDA Facility Registration number 3004152208 877 571 9206 www eng3corp com inf...

Страница 34: ...le USA Brand NanoVi Identification NanoVi NanoVi Eco NanoVi Pro NanoVi Exo Restrictive use Professional use and Home use conforms with the essential requirements for CE marking of Medical Devices Dire...

Страница 35: ...es during shipment must be filed promptly with the transportation company All correspondence concerning the equipment must specify both the model name and number and the serial number as it appears on...

Страница 36: ...identification Eng3 reserves the right to repair or replace any product found to be defective during the warranty period Repair may be provided in the form of replacement or exchange of parts or acces...

Страница 37: ...ACTURER Eng3 Corporation 2234 Eastlake Avenue E Ste A Seattle WA 98102 Office phone 1 206 525 0227 Fax 1 425 650 7171 E Mail Info eng3corp com URL www eng3corp com IMPORTER REPRESENTATIVE Contact www...

Страница 38: ...3 2 eng3 20 Appendix A Accompanying Documents 20 1 User Manual for Nasal Cannulas Model 1600 1...

Страница 39: ...eng3 3 3...

Страница 40: ...3 4 eng3...

Страница 41: ...eng3 3 5...

Страница 42: ...ng to the following specification 2 The input and output shall not exceed the rating on the label 3 The power supply shall be operated in dry conditions Manufacturer DongGuan Cincon Electronics Limite...

Страница 43: ...eng3 3 7...

Страница 44: ...3 8 eng3...

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