Perenio IONIC SHIELD Manuel utilisateur

Installation and Operation Manual

for the PERENIO IONIC SHIELD™

Ion Diffuser

(Model: PEWOW01)

July, 2021

Installation and Operation Manual for the

PERENIO IONIC SHIELD™ Ion Diffuser

Page 3 of 34

Table of Contents

Table of Contents ............................................................................................ 3

Introduction.................................................................................................... 5

Copyrights...................................................................................................... 5

Disclaimer ...................................................................................................... 6

Responsibility and Technical Support................................................................. 8

Conformance to Standards ............................................................................... 9

Warnings and Restrictions .............................................................................. 10

1 General Description and Specifications.......................................................... 15

1.1 Device Purpose..................................................................................... 15

1.2 Technical Specification........................................................................... 19

1.3 Device package .................................................................................... 21

1.4 Packaging and Labelling......................................................................... 21

2. Installation and Setup................................................................................ 22

2.1 Preparation for Work ............................................................................. 23

2.2 Operation Process ................................................................................. 24

2.3 Removing and Replacing the CoV Capsule ............................................... 25

3 Maintenance and Repair .............................................................................. 28

4 Warranty ................................................................................................... 29

5 Storage, Transportation and Disposal of Devices............................................ 31

6 Other information....................................................................................... 32

7 Troubleshooting ......................................................................................... 33

8 Glossary .................................................................................................... 34

Figures and Tables

Figure 1 –Exterior (Side view) ....................................................................... 16

Figure 2 –Exterior (Top view) ........................................................................ 16

Figure 3 –Buttons, connectors and indicators .................................................. 17

Figure 4 –Scope of Supply............................................................................. 21

Figure 5 –Examples of installation.................................................................. 22

Figure 6 –View of the sticker atop the capsule................................................. 23

Installation and Operation Manual for the

PERENIO IONIC SHIELD™ Ion Diffuser

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Figure 7 –Tightening the capsule.................................................................... 23

Figure 8 –Capsule replacement process .......................................................... 26

Table 1 –LED Indicator statuses ..................................................................... 18

Table 2 –Basic technical specifications ............................................................ 19

Table 3 –CoV Capsule ................................................................................... 26

Table 4 –Typical Errors and Troubleshooting Methods....................................... 33

Installation and Operation Manual for the

PERENIO IONIC SHIELD™ Ion Diffuser

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Introduction

PERENIO IONIC SHIELD™ is an Ion Diffuser with CoV capsule (model PEWOW01)

(hereinafter also referred to as the “Device” or “Ion Diffuser”). The Device intends

to significantly reduce and suppress the level of viral concentration in the enclosed

area of application (air and surfaces), as tested and confirmed by accredited

laboratories. The viral concentration refers to the family of viruses called

coronaviruses. This includes the Severe acute respiratory syndrome coronavirus 2

(SARS-CoV-2).

The Device emits complex groups of negative and positive ions of Mg, K, Pt, Au, Zn,

H and is developed to be used by human beings for prevention purposes against

infections caused by known coronaviruses. It has also undergone a clinical evaluation

demonstrating its conformity with the relevant general safety and performance

requirements. Such clinical evaluation will be ongoing throughout the life cycle of the

Device.

Classification of the Device: non-invasive, active medical device class I.

Ozone concentration and radiations are tested below background levels. Ozon is

below limits as specified in Clause 32 of EN/IEC 60335-2-65.

The present Installation and Operation Manual (hereinafter also referred to as the

“Manual”) contains a detailed description of the Device, as well as instructions for its

installation and operation.

Copyrights

Perenio®and PERENIO IONIC SHIELD™ trademarks are licensed to Perenio IoT

spol s r.o. (hereinafter referred to as the Perenio IoT). All other similar trademarks

and names, as well as logos and other symbols are the property of their respective

owners.

All materials under trademarks contained herein are protected in accordance with

international and local laws including Acts on Copyrights and related rights.

Any reproduction, copying, publication, as well as further distribution or public display

of material contained in the present document (whether in full or in part) shall not

be allowed until an appropriate permission of the copyright owner is obtained.

Any unauthorized usage of materials contained herein may lead to civil liability and

criminal prosecution in accordance with applicable laws.

Installation and Operation Manual for the

PERENIO IONIC SHIELD™ Ion Diffuser

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Any eventual mentioning of other company names and equipment in the present

document is made solely for the purpose of clarifying and describing the device

operation and shall not infringe on the third party’s intellectual property rights.

Disclaimer

ANY PERSON ACQUIRING THIS PERENIO IONIC SHIELD™ model PEWOW01 ACCEPTS

THIS DESCLAIMER IN FULL AND ASSUMES FULL RESPONSIBILITY FOR USING THE

DEVICE IN ACCORDANCE WITH THE DIRECTIONS OF USE, AS WELL AS FOR ANY

CONSEQUENCES RESULTING FROM ANY INAPPROPRIATE USE IN CONTRAST WITH

THE INSTRUCTIONS OUTLINED IN THIS MANUAL.

1. Although rigorous testing was performed in accordance with the adopted and

published virucidal standards, under no circumstances Perenio IoT and/or the

manufacturer of the Device claim total and absolute neutralization, and

subsequent impossibility of infection whilst using the Device. Perenio IoT

and/or the manufacturer of the Device shall not be liable to any person, who

while using the Device becomes ill or infected with any virus. Numerous factors

play role in virus transmission, which may occur in different ways and cannot

be completely eliminated, even if most of the viruses are neutralized in the

enclosed area of application as per the instructions herein.

2. The user understands and accepts that the possibility of getting a viral infection

heavily relies on each individual’s unique immune system response, thus the

reduction of the viral load in the enclosed area of application, does not

completely eliminate the possibility of transmission, even whilst using the

Device.

3. Any claims by the manufacturer and/or Perenio IoT for neutralization,

suppression and destruction of viruses, relate only to the acceptable decrease

of the viral load in the enclosed area of application, tested and confirmed in

line with the adopted international standards.

4. The cases of any adverse reactions to the ions emitted are regarded extremely

rare and are highly unlikely, as necessary measures have been taken to ensure

the acceptable degree of emission, regulated by international standards.

However, if an individual, whilst using the Device observes any adverse side

effects, he/she is strongly advised to stop immediately the use of the Device

and consult a healthcare professional.

5. While the Device is intended for prevention of infections caused by known

coronaviruses by significant reduction of level of the viral load in the enclosed

area of application, Perenio IoT and/or the manufacturer of the Device do not

claim any therapeutic properties of the Device and they shall not be held liable

in relation to any underperformance in relation to any kind of therapeutic use.

Installation and Operation Manual for the

PERENIO IONIC SHIELD™ Ion Diffuser

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6. Perenio IoT and/or the manufacturer of the Device cannot assume any

responsibility for any potential misinformation of the end-users by distributors

and/or resellers of the Device. Any claims in relation to the properties of the

Device which are not concurring with the officially published and regularly

updated specifications: intended use, performance, antiviral and anti-pathogen

properties, which can be found on the official website perenio.com, are void

and cannot serve as a legal ground for any claims against Perenio IoT and/or

the manufacturer.

7. Users understand and accept that the use of multiple Devices at once, as well

as any attempt to compromise the capsule’s enclosure, in a closed space, may

lead to release of high density of ions into the air, which may lead to side

effects. The use of multiple Devices must be in accordance with the restrictions

contained herein.

8. Perenio IoT and/or the manufacturer are not responsible and will not accept

any liability for claims for damages due to performance related issues, if:

•The Device is used in a manner which is not as prescribed in the Quick

Start Guide and/or this Manual;

•The body of the Device or the capsule have been tampered with;

•The input voltage and amperage are in any way changed;

•The top of the capsule has been in any way obstructed or covered with

foreign objects;

•The working and/or storage temperature is not within the range specified

by the manufacturer;

•The working and/or storage humidity is not within the range specified by

the manufacturer;

•The Device is used in high humidity environment like bathrooms or saunas;

•The Device is used in less than four (4) hours after been taken from cold

or humid environment;

•The Device is immersed in water or water was splashed at it, or it is

positioned in a wet place or a wet surface, resulting in water contact with

electrical parts;

•The user attempts to remove or replace the in-built battery;

•A non-original power adapter is used to recharge the Device;

•The Device is given to children, or put at ease of reach, with any

subsequent malfunctions as a result of such treatment;

•The Device is used without the capsule;

•The Device is used with a compromised capsule, or the counterfeit, or self-

made capsule.

•The Device is used in any manner that a reasonable person would deem to

be inappropriate or dangerous.

Installation and Operation Manual for the

PERENIO IONIC SHIELD™ Ion Diffuser

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Responsibility and Technical Support

The present Manual is prepared in accordance with all necessary requirements and

contains detailed information on the Device installation, configuration and control,

valid as of the date of its last update.

Perenio IoT reserves the right to make corrections or changes to this Manual without

prior notice to the users of the Device and shall not be responsible for any

consequences which may arise from the use of an outdated version of the Manual,

as well as for any possible technical and/or typographical errors, either omitted or

accidental, or any related damage that may result from the use of the Device or the

present document.

The latest version of the Manual will always be available at perenio.com/documents.

In case of any discrepancies between the language versions of the Manual, the

English version shall prevail.

For any technical issues, please contact the Tech Support Department at perenio.com.

Manufacturer:

SIA Joule Production

Bauskas iela 58A-15, Riga, LV-1004, Latvia

www.joule.lv

Manufactured for:

Perenio IoT spol s r.o.

Na Dlouhem 79, Ricany –Jazlovice 251 01, Czech Republic

perenio.com

Installation and Operation Manual for the

PERENIO IONIC SHIELD™ Ion Diffuser

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Conformance to Standards

ISO

The manufacturer has adopted and is under certification

process for EN ISO 13485 (medical device manufacturing)

Perenio IoT has been certified in accordance with EN ISO

9001 and EN ISO 14001

The Device is CE certified and complies with the requirements of

the following European Union legislation:

2014/35/EU Low Voltage Directive;

2004/30/EU Electromagnetic Compatibility Directive;

2017/745/EU Medical Devices Regulation.

The Device complies with the UKCA marking requirements for

selling the Device in the UK

The Device has passed all procedures of assessments established

in technical regulations of the Eurasian Customs Union and

conforms with standards of the Eurasian Customs Union

The Device complies with the requirements of Restriction of the Use

of Certain Hazardous Substances (RoHS) in Electronic and Electrical

Equipment (2011/65/EU Directive)

The crossed-out trash can symbol is used to label electrical and

electronic equipment, and indicates its separate collection.

The symbol is given in accordance with the Directive 2012/19/EU

on Waste Electrical and Electronic Equipment (WEEE)* and

indicates that this equipment requires separate collection at the

end of its life and must be disposed of separately from unsorted

household waste.

To protect the environment and human health, please dispose of

used electrical and electronic equipment according to approved

safe disposal guidelines

Installation and Operation Manual for the

PERENIO IONIC SHIELD™ Ion Diffuser

Page 10 of 34

Information about certificates received

is indicated in Section 7 of this

document. Copies of certificated and

declarations can be found in the

appropriate section on the website

perenio.com.

Warnings and Restrictions

Prior to installation and operation of the Device, the user shall carefully read and

understand information contained herein.

ATTENTION! Warnings, precautions, and instructions specified in this document

may not contain every possible hazardous situation. Please use the common

sense when operating the Device.

ATTENTION! Electric shock hazard! Do not touch live parts!

Warning Symbols and Icons

Electric shock hazard. The Device contains live parts

Indication on the need for the user to consult the Installation and

Operation Manual for important information such as warnings and

cautions

The Device is for indoor installation only

Indication of the Device manufacturer

Indication of the manufacturer's catalogue number (product article) of

the Device. Same model is in products catalog of Perenio IoT so that it

can be easily identified

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