Biolight BCD 650 Animal Manual de usuario

User manual

BiolightTM

BCD 650

Animal

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Important

Read all instructions and

warnings prior to use.

BiolightAB only accepts responsibility

for the equipments safety,usability and

performance if:

» the equipment is used in accordance with

its intended use,and

» maintenance and repairs are performed by

individuals authorised by BiolightAB,and

» the equipment is used in accordance with

this document.

Article number: BL2543

Document number: M17001 ver0

Valid from: December 01, 2017

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Contents

1 Introduction ...................................................6

1.1 Definitions ...................................................... 6

1.2 Intended use ................................................... 6

1.3 Operating principles ........................................ 6

1.4 Intended users................................................. 6

1.5 General conditions of use.................................. 6

1.6 The manual .................................................... 6

1.7 Manufacturer .................................................. 9

1.8 Compliance with regulatory requirements.............. 9

1.9 Disposal ........................................................ 9

1.10 Warranty ....................................................... 9

2 Device description........................................10

2.1 Included parts ............................................... 10

2.2 User interface................................................ 15

3 Power supply ...............................................16

3.1 General information ....................................... 16

3.2 Power supply unit........................................... 16

3.3 Battery powered............................................ 16

3.4 Charging battery unit...................................... 16

3.5 Disconnecting power supply ............................ 17

4 Menus.........................................................18

4.1 Navigation buttons......................................... 18

4.2 Navigating menus ......................................... 19

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5 Operating instructions...................................22

5.1 Device Mode indications................................. 22

5.2 Start-up procedure.......................................... 23

5.3 Start treatment ............................................... 23

5.3.1Treatment time............................................... 23

5.4 Pause or cancel on-going treatment.................... 23

5.5 Treatment finnished......................................... 23

5.6 Power save mode .......................................... 23

6 Safety instructions ........................................24

6.1 Precautions................................................... 24

6.2 Operating environment ................................... 24

6.3 Environmental effect ....................................... 24

6.4 Handling ..................................................... 25

6.5 Cleaning ..................................................... 25

6.6 Service & Maintenance................................... 25

6.7 Transport and storage ..................................... 25

6.8 Other misuse................................................. 26

6.9 Battery, other warnings and notices.................... 26

7 Troubleshooting ...........................................27

8 Technicalspecications .................................29

8.1 Primary battery.............................................. 29

8.2 Means of isolation ......................................... 29

8.3 Battery unit ................................................... 30

8.4 Battery charger.............................................. 30

8.5 Power supply unit with cable ............................ 30

9 Appendix A.................................................31

9.1 Guidance and manufacturer’s declaration ........... 31

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1 Introduction

1.1 Denitions

» BCD......Biolight Care Device

» LED......Light Emitting Diode

» IR.........Infra-Red

1.2 Intended use

Biolight Care Device (BCD) is a life science

product intended for wound healing,

reduction of inammations,lowering pain

and for increasing blood circulation.This is

made by emitting monochromatic light.

1.3 Operating principles

The device is emitting monochromatic light

from the LEDs to the object through a

bottom transparent window.The diodes

deliver the light therapy in accordance with

pre-programmed treatment programs.

Every treatment is controlled by a number of

parameters:time,the wavelength of the light,

which also affects the choice of diode (IR/

Red) for the treatment,the intensity of the

light and the light patterns on the diode

array.

1.4 Intended users

The device operator is limited to adults.No

specic training is required but the operator is

expected to read the user manual before

using the device.

1.5 General conditions

of use

» The BCD labelling is positioned

underneath the handle and the operator

must tilt the BCD for acceptable legibility.

» The BCD is reusable and can be used for

multiple use.

» The BCD is emitting both red and infrared

light.Infrared light is not visible to the

human eye.To check if the treatment is

running,check the indicator light on top

of the BCD or look for a small number of

red diodes circulating at the treatment

surface.

» See Power supply instruction in section 4

and Safety instruction in section 7.

1.6 The manual

This manual contains both the instructions

for use for the operator and technical

information including installation and

maintenance instructions.

This manual describes the handling of

BCD 650.

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Warnings,cautions and notes are used in the manual in the following way:

Terminology Meaning

WARNING The safety of the object or user may be involved.

Disregarding this information could result in injury

CAUTION These instructions point out special service procedures or precautions

that you must follow to avoid damaging the device

NOTE This provides information you might find espacially useful or infor-

mation that facilitates maintenance or clarifies important instructions

The BCD 650 Hand Unit has been labelled with the following symbols:

Symbol Meaning

Serial Number

Consult instructions for use

The parts applied to the object are insulated from mains according to

Type B applied part described in IEC 60601-1

Keep dry

Electronic waste bin. This unit should be disposed in accordance with

the regulations specified in the instructions for use

0413 Complies with Medical Device Directive 93/42/EEC

Complies with RoHS 2 Directive 2011/65/EU

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The BCD 650 Packaging has been labelled with the following symbols:

Symbol Meaning

REF

Catalogue number

Serial Number

Keep dry

Store within given Temperature range

Store within given Humidity range

Store within given Atmospheric Pressure range

0413 Complies with Medical Device Directive 93/42/EEC

Complies with RoHS 2 Directive 2011/65/EU

The BCD 650 Battery Unit is labelled with the following symbols:

Symbol Meaning

Double insulation, class II equipment

Electronic waste bin. This unit should be disposed in accordance with

the regulations specified in the instructions for use

Federal Communications Comission (USA)

Universal recycling symbol. This unit should be disposed in accor-

dance with the regulations specified in the instructions for use

Complies with RoHS 2 Directive 2011/65/EU

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1.7 Manufacturer

BiolightAB

Nybrogatan 28B

SE-114 39 Stockholm

SWEDEN

Phone:+46 725 223 650

www.biolight.se

BCD 650 is designed,developed and

manufactured by BiolightAB.Unless

otherwise noted,TM indicates registered or

unregistered trademark or service mark

owned by,or licensed to,BiolightAB or one of

its subsidiaries.

1.8 Compliance with

regulatory require-

ments

The BCD 650 is manufactured in accordance

to EU’s directives regarding current Medical

Device equipment 93/42/EEC and

RoHS 2 Directive 2011/65/EU.

1.9 Disposal

NOTE: To avoid environmental damage

and/or personal injury, handling and

disposal of batteries and electronic

equipment shall be done in accordance

with applicable local, state and federal

laws and regulations.

WARNING: The Device contains a Lithium-

Manganese primary button cell for the

system real-time clock. Danger of explosion.

1.10Warranty disclaimer

Although BCD 650,hereafter referred to as

BCD,has been manufactured under carefully

controlled conditions,BiolightAB,has no

control over the conditions under which the

product is used.BiolightAB,therefore

disclaims all warranties,both expressed and

implied,with respect to the product,

including,but not limited to,any implied

warranty of merchantability or tness for a

particular purpose.BiolightAB shall not be

liable to any person or entity for any medical

expenses or any direct,incidental or

consequential damages caused by any use,

defect,failure or malfunction of the product,

whether a claim for such damages is based

upon warranty,contract,tort or otherwise.

No person has any authority to bind

BiolightAB to any representation or

warranty with respect to the product.

The exclusions and limitations set out above

are not intended to,and should not be

construed so as to contravene mandatory

provisions of applicable law.If any part or

term of this Disclaimer ofWarranty is held to

be illegal,unenforceable or in conict with

applicable law by court of competent

jurisdiction,the validity of the remaining

portions of this Disclaimer of Warranty shall

not be affected,and all rights and obligations

shall be construed and enforced as if this

Disclaimer ofWarranty did not contain the

particular part or term held to be invalid.

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2 Device

description

BCD 650 is a hand-held Device.The Device has a user interface with a display,buttons and

LEDs indicating Device status.

2.1 Included parts

Table below list included parts of the equipment,also see picture 1 to 5.

Component Comment

1. Hand unit Standard kit

14. Power supply unit Optional order

15. Power cord Optional order

17. Battery unit Standard kit

20. Battery charger Standard kit

22. Biolight battery cable Standard kit

Biolight carrying case (not in picture) Standard kit

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