Bistos BT-410F Manuale utente

BT-410F and BT-410A

Head-worn light

Operation Manual

Keep this manual for future reference

P/N : 410-ENG-OPM-EUR-R12

BT-410F and BT-410A Operation manual

P/N:410-ENG-OPM-EUR-R12 Bistos Co.,Ltd. 2021,05

Proprietary Material

Information and descriptions contained in this manual are the property of Bistos Co. Ltd. and may not be

copied, reproduced, disseminated or distributed without express written permission from Bistos

Corporation.

Information furnished by Bistos Corporation is believed to be accurate and reliable. However, no

responsibility is assumed by Bistos Corporation. For its use or any infringements of patents or other rights

of third parties, that may result from its use. No license is granted by implication or otherwise under any

patent or patent rights of Bistos Co. Ltd.

The information contained herein is subjects to change without notice.

Prepared by:

Bistos Co., Ltd.

7th FL., A Bldg., Woolim Lions Valley 5-cha,

302, Galmachi-ro, Jungwon-gu, Seongnam-si,

Gyeonggi-do, Korea

Telephone: +82 31 750 0340

Fax: +82 31 750 0344

Revision 12

May, 2021

Printed in Korea

BT-410F and BT-410A Operation manual

P/N:410-ENG-OPM-EUR-R12 Bistos Co.,Ltd. 2021,05

Table of Contents

0. Safety information ---------------------------------------------------------------------------------------------------------------3

0.1 Symbols used ---------------------------------------------------------------------------------------------------------------3

0.2 Warnings and cautions --------------------------------------------------------------------------------------------------4

0.3 Battery warnings ---------------------------------------------------------------------------------------------------------4

0.4 General precautions on environment --------------------------------------------------------------------------------5

1. Introduction ------------------------------------------------------------------------------------------------------------------------5

1.1 General ----------------------------------------------------------------------------------------------------------------------5

1.2 Brief device description -------------------------------------------------------------------------------------------------6

1.3 Intended use --------------------------------------------------------------------------------------------------------------6

1.4 Contraindication ----------------------------------------------------------------------------------------------------------6

1.5 Product features ----------------------------------------------------------------------------------------------------------6

1.6 Product configuration ---------------------------------------------------------------------------------------------------6

2. Assembly and operation -------------------------------------------------------------------------------------------------------7

2.1 Product outlook and description -------------------------------------------------------------------------------------7

2.2 Loupe (optional) assembly ----------------------------------------------------------------------------------------------8

2.3 Astral lamp (optional) assemble --------------------------------------------------------------------------------------9

3. Operation ---------------------------------------------------------------------------------------------------------------------------9

3.1 Adjust the headband ----------------------------------------------------------------------------------------------------9

3.2 Turn on the power --------------------------------------------------------------------------------------------------------9

3.3 Focusing the light --------------------------------------------------------------------------------------------------9

3.4 Turn off the power --------------------------------------------------------------------------------------------------------9

3.5 Adjust the intensity of light --------------------------------------------------------------------------------------10

3.6 Charging the battery pack ---------------------------------------------------------------------------------------------10

3.7 Charger ---------------------------------------------------------------------------------------------------------------------11

3.8 Optional operation ------------------------------------------------------------------------------------------------------11

4. Maintenance and cleaning ----------------------------------------------------------------------------------------------------11

4.1 Checking the light intensity -------------------------------------------------------------------------------------------11

4.2 Cleaning -------------------------------------------------------------------------------------------------------------------12

4.3 Battery disposal and handling ----------------------------------------------------------------------------------------12

5. Troubleshooting -----------------------------------------------------------------------------------------------------------------12

6. Specifications --------------------------------------------------------------------------------------------------------------------12

7. Manufacturer’s declaration on EMC ---------------------------------------------------------------------------------------13

7.1 Electromagnetic emissions --------------------------------------------------------------------------------------------13

7.2 Electromagnetic immunity --------------------------------------------------------------------------------------------14

Product warranty ------------------------------------------------------------------------------------------------------------------16

BT-410F and BT-410A Operation manual

P/N:410-ENG-OPM-EUR-R12 Bistos Co.,Ltd. 2021,05

0 Safety information

Before using BT-410F and BT-410A, read this entire manual and be fully understood the following safety

information to prevent injury of patient and user.

Observe all precautions to ensure the safety of the patient and those near the instrument.

0.1 Symbols used

The following symbols identify all instructions that are important to safety. Failure to follow these

instructions can lead to injury or damage to the device. When used in conjunction with the following words,

the symbols indicate:

WARNING

Identifies conditions or practices that might present danger or possible injury to the

patient and/or user.

CAUTION

An instruction that, if not followed, can result in a condition that could damage the light.

NOTE

Background information provided to clarify a particular step or procedure.

The following symbols are placed on product, label, packaging and this manual in order to stand for the

information about:

Stand-by

Those symbols identify safety information.

Warning and caution necessarily well-know when operating the device or control

in order to avoid undesirable consequences.

Indicates the manufacturer.

Indicates the production date.

Serial number

Authorized representative in the European Community

Refer to Operation Manual

Indicates the temperature limitation for transport and storage.

Humidity limitation for transport and storage.

Keep dry. Transport package shall be kept away from rain.

Fragile, handle with care

Indicate correct upright position on the transport package.

Indicate that the product contains the recyclable parts depending on whether

there is a collection mechanism within the local community for those particular

materials.

The product conforms to European Medical Directive 93/42/EEC as amended by

2007/47/EC and meets applicable health, safety and environmental requirements.

0.1.1 Symbols on the power adapter

Polarity of DC power connector / DC Adaptor

This symbol indicates that the power adaptor is a class II device.

BT-410F and BT-410A Operation manual

P/N:410-ENG-OPM-EUR-R12 Bistos Co.,Ltd. 2021,05

This symbol indicates that the power adaptor is for indoor use only.

This symbol indicates direct current.

This symbol indicates alternating current.

UL Listing means that UL has tested representative samples of a product and

determined that the product meets specific, defined requirements.

This symbol indicates to not dispose the device together with unsorted

municipal waste (for EU only). The solid bar symbol indicates that mains

adapter is put on the market after 13 August 2005.

0.2 Warnings and cautions

WARNING

•Do not attempt to connect or disconnect a power cord with wet hands. Make certain that

your hands are clean and dry before touching a power cord.

•Incorrect use of the light or the use of parts and accessories, especially LED and Battery that

were not supplied by Bistos Co., Ltd. can damage the light, and may cause injury to the user.

•Do not use in the out of range for humidity, temperature and atmospheric pressure

environment than indicated in this manual.

•Do not use the light in the presence of gases that support combustion (for example, oxygen,

nitrous oxide, or other anesthetic agents).

CAUTION

•The relevant law restricts this device to sale by or on the order of a physician.

•Do not operate the unit if it is damp or wet because of condensation or spills. Avoid using

the equipment immediately after moving it from a cold environment to a warm humid

location.

•Do not attempt to service the BT-410F and BT-410A. Only qualified service personnel should

attempt any needed internal servicing.

0.3 Battery warnings

WARNING

•Do not use the device during recharging the battery. Using the device during recharging the

battery may cause injury to the user.

•Improper operation may cause the internal lithium ion battery to be hot, ignited or

exploded, and it may lead to the decrease of the battery capacity. It is necessary to read the

operation manual carefully and pay more attention to warning message.

•Do not open the housing of battery pack. Only the qualified service personnel authorized by

the manufacturer can open the battery pack and replace the battery, and batteries of same

model and specification should be replaced.

•Be careful when connecting the battery with polarity.

•Do not use the battery near fire or environmental temperature exceeds 60 ℃. Do not heat

or splash the battery or throw it into fire or water.

•Do not destroy the battery. Do not pierce battery with a sharp object such as a needle. Do

not hit with a hammer, step on or throw or drop the battery. Do not disassemble or modify

the battery. The battery can heat, smoke, deformation or burning.

•When leakage or foul smell is found, stop using the battery immediately. If your skin or

cloth comes into contact with leaked liquid, cleanse it with clean water at once. If the leaked

liquid splashes into your eyes, do not wipe them. Irrigate them with clean water first and go

to see a doctor immediately.

•Properly dispose of or recycle the depleted battery according to local regulations.

BT-410F and BT-410A Operation manual

P/N:410-ENG-OPM-EUR-R12 Bistos Co.,Ltd. 2021,05

0.4 General precautions on environment

Do not keep or operate the equipment under the environment listed below.

Avoid placing in an area

exposed to moisture. Do not

touch the Head worn light

with wet hand.

Avoid exposure to direct

sunlight

Avoid placing in an area

where high variation of

temperature exists.

Operating temperature

ranges from 10 ~ 40℃.

Operating humidity ranges

from 5 ~ 85 %.

Avoid in the vicinity of

electric heater.

Avoid placing in an area

where there is an excessive

humidity rise or ventilation

problem.

Avoid placing in an area

where there is an excessive

shock or vibration.

Avoid placing in an area

where chemicals are stored

or where there is in danger

of gas leakage.

Avoid dust and especially

metal material enters into

the Head worn light.

Do not disjoint or

disassemble the Head worn

light. Bistos Co., Ltd. does not

have liability of it.

Power off when the Head

worn light is not fully ready

to operate. Otherwise, the

Head worn light could be

damaged.

1 Introduction

1.1 General

This chapter provides a general description of the BT-410F and BT-410A Head-worn light including:

•Brief Device Description

•Product Features

•Model Configurations

1.2 Brief device description

This Head-worn light is used for medical examination by fixing it on the head and illuminating with

condensed light to the injured part. This unit doesn't intend to contact directly to the patient's body and

can be used for all medical field except ophthalmology. All material is made of the light plastic, and is

consist of main-body and headband. The main body is composed of a light source (LED), main frame, and

battery pack. Optional accessories are consisting of an astral lamp for shadow less effect, and loupe

(magnifying glass). The battery is a lithium-ion rechargeable one, and operating time is about 4 hours. Full

recharge takes about 4 hours. LED's optical power will be a little decreased even though you use the unit

normally according to recommended operating time. The expectedly possible operating time is for

approximately 50,000 hours.

1.3 Intended use

The Head-worn light utilizes to provide supplemental light to improve visibility by illuminating during minor

medical procedures such as examination.

The device designed to use by a medical professionals by wearing it onto the head.

1.4 Contraindication

The head-worn light is not intended to the any procedure for ophthalmology. Do not glare the light directly

to the patient’s eyes. It may cause temporary vision impairment.

BT-410F and BT-410A Operation manual

P/N:410-ENG-OPM-EUR-R12 Bistos Co.,Ltd. 2021,05

1.5 Product features

•Battery pack can be separated. Please separate it from the main body during recharging.

•Check the battery capacity by LED indicator. When the battery is low, please recharging it immediately.

•Irradiating to up & down and left & right side is possible by pivot joint.

•Operation is very simple, so the unit is easy to use.

1.6 Product configuration

BT-410 series is supplied in two derivatives –BT-410A and BT-410F. BT-410A has Fixed Focus lens but BT-

410F has Variable focus lens. BT-410F and BT-410A system consists of the following function and elements.

Model

BT-410F

BT-410A

Control of Light Intensity

Control of Light Focus

Light Spot Size (at 300mm)

70mm

30~70mm

Astral Lamp (option)

Open the packaging contains the following accessories, please check. Also check for any damage to the

console and accessories, please check.

1)BT-410A (Fixed Focus Lens)

Standard

Option

Name

Main body

Charger

Astral Lamp

Additional battery pack

Loupe

Shape

(output: 4.2V 1000mA)

2)BT-410F (Variable Focus Lens) : This model cannot attach the Astral lamp

Standard

Option

Name

Main body

Charger

Additional battery pack

Loupe

Shape

(output: 4.2V 1000mA)

BT-410F and BT-410A Operation manual

P/N:410-ENG-OPM-EUR-R12 Bistos Co.,Ltd. 2021,05

2 Assembly and operation

2.1 Product outlook and description

Fig. 2.1 BT-410A outlook and description

①

Headband height adjustable part

②

Headband part

③

Headband size adjustable part

④

Protect band

⑤

Power On/Off button

⑥

LED indicator

⑦

Main Frame Part

⑧

Battery Pack

⑨

Pivot joint

⑩

Source of Light Part

⑪

Loupe (Optional)

⑫

Astral Lamp (Optional)

BT-410F and BT-410A Operation manual

P/N:410-ENG-OPM-EUR-R12 Bistos Co.,Ltd. 2021,05

Fig. 2.2 BT-410F outlook and description

2.2 Loupe (optional) assembly

The loupe can be assembled to the joint of BT-410F and BT-410A. Assemble the loupe in the sequence

shown below.

Fig. 2.3 Loupe Assembly

2.3 Astral lamp (optional / BT-410A only) assembly

The astral lamp can be assembled at the bottom of light source. Remove the lens cap from the light source

and connect the astral lamp to the connector as shown below.

①

Headband height adjustable part

②

Headband part

③

Headband size adjustable part

④

Protect band

⑤

Power On/Off button

⑥

LED indicator

⑦

Main Frame Part

⑧

Battery Pack

⑨

Pivot joint

⑩

Source of Light Part

⑪

Loupe (Optional)

BT-410F and BT-410A Operation manual

P/N:410-ENG-OPM-EUR-R12 Bistos Co.,Ltd. 2021,05

Fig. 2.4 Astral Lamp Assembly

3 Operations

3.1 Adjust the headband

Adjust the height and size of headband to fit the user’s head.

3.2 Turn on the power

Press the power button to turn on the light. The power button is push lock type. It remains lock in when

pushed. Press the button smoothly until it locked.

Battery charging status will be displayed by LED light. If the LED turns to orange light, please charging

immediately for further use.

WARNING

•Do not charge the light while turned on. The high charging voltage may cause the device

malfunction.

3.3 Focusing the light (BT-410F only)

You can adjust the focal length between 25~30 cm. Adjust the focus for the best light quality before

treatment and examination.

CAUTION

•Do not glare the light directly to the patient’s eyes. It may cause temporary vision

impairment.

3.4 Turn off the power

Press the power button again to turn off the device.

CAUTION

•You must turn off the device to avoid running out of the battery and to save the lifetime of a

light source (LED).

3.5 Adjust the intensity of light (BT-410A only)

User can adjust intensity of light using the dial at the bottom side of the “Source of Light Part” by rotating

the dial CW or CCW. The range of intensity is from 15,000lx to 30,000lx at 25cm working distance.

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