Bistos BT-410 User Manual

BT-410

BT-410

Head-worn light

Operator Manual

P/N : OPM(BT-410)EN, Rev.05

BT-410 Operator Manual 1

P/N : OPM(BT-410)EN

Bistos Co.,Ltd

Rev. 05(2013.04.12)

Information and descriptions contained in this manual are the property of
Bistos Corporation 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 Corporation.

Revision 05
April 2013

Copyright © Bistos Corporation 2011 All rights reserved.

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7

Fl., A Bldg., Woolim Lions Valley 5-cha, 144-3,
Sangdaewon-dong, Jungwon-gu, Seongnam-si,
Gyeonggi-do, Korea

Telephone: ++82 31 750 0340
Fax: ++82 31 750 0344

Printed in Korea

Proprietary Material

BT-410 Operator Manual 2

P/N : OPM(BT-410)EN

Bistos Co.,Ltd

Rev. 05(2013.04.12)

Table of Contents

1. Safety ………………………………………………… 3

1.1 Instructions for the Safe Operation and Use of the BT-410 .…… 3

1.2 Warnings …………………………………………………… 3

1.3 Cautions .…………………………………………………… 3

1.4 Definitions of Symbols ……………………………………… 5

2. Introduction .………………………………………… 6

2.1 General ……………………………………………………… 6

2.2 Brief Device Description …………………………………… 6

2.3 Intended Use .……………………………………………… 6

2.4 Product Features .………………………………………… 7

2.5 Product Configuration …………………………………… 7

3. Assembly and Operation ..………………………… 8

3.1 The overall panel .…………………………………………… 8

3.2 Loupe (Optional) Assembly …………………………………… 9

3.3 Astral Lamp (Optional) Assembly .……………………………… 10

4. Use Method .………………………………………… 11

4.1 Adjustable headband ...……………………………………… 11

4.2 Turn on the power Method …………………………………… 11

4.3 Adjust distance of focusing light(only for standard)…………………… 11

4.4 Turn off the power Method ..………………………………… 11

4.5 Adjust intensity of light(only for “Optional Main body”)……………… 11

4.6 Charging Method ...………………………………………… 12

4.7 Charger operation ....………………………………………… 13

4.8 Optional Features …………………………………………… 13

5. Maintenance and Cleanliness .……………………… 14

5.1 Checking the Light Intensity ..……………………………… 14

5.2 Cleaning …………………………………………………… 14

5.3 Battery Disposal and Handling ..……………………………… 14

6. Specifications ………………………………………… 15

BT-410 Operator Manual 3

P/N : OPM(BT-410)EN

Bistos Co.,Ltd

Rev. 05(2013.04.12)

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

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.

NOTE: Background information provided to clarify a particular step or procedure.

WARNING: Incorrect use of the light, or the use of parts and accessories that are

not manufactured of supplied by Bistos Corporation can damage the light, and may

WARNING: 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.

Section 1

Safety

1.1 Instructions for the Safe Operation and Use of the BT-410 .

 Before administering BT-410, read all section of this manual carefully.
 Observe all precautions to ensure the safety of the patient and those

near the instrument.

 Do not attempt to service the BT-410. Only qualified service personnel

should attempt any needed internal servicing.

1.2 Warnings

1.3 Cautions

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P/N : OPM(BT-410)EN

Bistos Co.,Ltd

Rev. 05(2013.04.12)

Avoid placing in an area
exposed to moisture. Do not
touch the equipment with wet hand.

Avoid exposure to direct
sunlight

Avoid placing in an area
where there is a high variation
of temperature.
Operating temperature
ranges from 10C to 40C.
Operating humidity ranges
from 20% to 90%.

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 into the
equipment.

Do not disjoint or disassemble
the equipment.
BISTOS Co., Ltd. does not take
responsibility of it.

The equipment

shouldn’t be

connect to the
power while used.
May cause it may
cause damage to
equipment

CAUTION: 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

CAUTION:

-The equipment conforms to Class A according to IEC/EN 60601-1(Safety of
Electric Medical Equipment)

- This equipment conforms to Level B according to IEC/EN 60601-1-2
(Electromagnetic Compatibility Requirements)

General Precaution on Environment

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

BT-410 Operator Manual 5

P/N : OPM(BT-410)EN

Bistos Co.,Ltd

Rev. 05(2013.04.12)

Symbol

Description

Requirements

Stand-by

IEC TR 60878

This symbol identifies a safety note. Ensure you
understand the functions of these controls before
using it. Function controls are described in the
operator’s manual.

IEC TR 60878

Polarity of d.c. power connector

IEC TR 60878

1.4 Definitions and Symbols

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P/N : OPM(BT-410)EN

Bistos Co.,Ltd

Rev. 05(2013.04.12)

Section 2

Introduction

2.1 General

This chapter provides a general description of the BT-410 monitor including:

 Brief Device Description
 Product Features
 Model Configurations

2.2 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
mainbody and headband. The main body is composed of a light source (LED),
main frame, and battery pack. Optional accessories are consist of an astral lamp
for shadowless effect, and loupe (magnifying glass). The battery uses a lithium­ion rechargeable one, and using 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 using time. The expectedly possible using
time is for approximately 50,000 hours.

2.3 Intended Use

The BT- 410 Head-worn light allows doctors to examine with a clear eye onto
the affected part by wearing it onto the head.

2.4 Product Features

● Battery pack can be separated, so separate recharging is possible.

● You can check necessary recharging time with LED indicator of recharging status.

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

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

2.5 Product Configuration

BT-410 system consists of the following elements. Open the packaging contains
the following accessories, please check. Also check for any damage to your

BT-410 Operator Manual 7

P/N : OPM(BT-410)EN

Bistos Co.,Ltd

Rev. 05(2013.04.12)

Part

Name

Part

Name

Main body

Loupe

(Optional)

Charger

Astral Lamp

(Optional)

User Manual

Battery Pack

(Optional)

Main body

(Optional)

console and accessories, please check.

If you wish to purchase, please contact our office.

Table 1.1. BT-410 Configuration

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P/N : OPM(BT-410)EN

Bistos Co.,Ltd

Rev. 05(2013.04.12)

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)

Assembly and Operation

3.1 The overall panel

Section 3

Fig. 1.1 The overall panel

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P/N : OPM(BT-410)EN

Bistos Co.,Ltd

Rev. 05(2013.04.12)

3.2 Loupe (Optional) Assembly

BT-410 turn in front of our parts are assembled in the loupe.
In order to assemble the picture below.

< Loupe assembled with optional Main body>

Fig. 1.2 Loupe (Optional) Assembly

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P/N : OPM(BT-410)EN

Bistos Co.,Ltd

Rev. 05(2013.04.12)

3.3 Astral Lamp (Optional) Assembly

BT-410 is located at the bottom of the astral lamp and pay off the lens cap from
the bottom up by assembly.
In order to assemble the picture below.

Fig. 1.3 Astral Lamp(Optional) Assembly

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P/N : OPM(BT-410)EN

Bistos Co.,Ltd

Rev. 05(2013.04.12)

WARNING: Power is turned on, please do not charge. LED light might be faulty
due to high power from charging.

CAUTION: The light of a head-worn light directly to the patient's eyes should
avoid. It might cause temporary vision impairment.

CAUTION: You must turn off the head-worn light for battery consumption and
lifetime of a light source (LED). That may not reduce the equipment's life

Dial for adjusting
intensity of light

Section 4

Use Method

4.1 Adjustable headband

The height and size adjustable headband part call the user's head to adjust the
Head-worn light is worn

4.2 Turn on the power Method

Once the power switch button pressed remains locked in. When he turned on the
light from the light source occurs..
LED charging status indicator into orange charging status indicator and then
illuminated with charger must recharge.

4.3 Adjust distance of focusing light(only for standard)

250 ~ 300 mm focal length for the light to examine the treatment and
examination.

4.4 Turn off the power Method

The power switch once more to keep from pressing the button will turn off the
lights.

4.5 Adjust intensity of light(only for “Optional Main body”)

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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P/N : OPM(BT-410)EN

Bistos Co.,Ltd

Rev. 05(2013.04.12)

4.6 Charging Method

There are two ways of battery operations such as separation of battery pack and
its un-separation (However, the equipment must be powered off to charge the
battery, un-separated.) Please refer to the below, as shown simply in order of
how to separate the battery.

Fig. 2.1 Battery Pack assembled method

Fig. 2.2 Battery Pack separation method

Fig. 2.3 Battery charging method

BT-410 Operator Manual 13

P/N : OPM(BT-410)EN

Bistos Co.,Ltd

Rev. 05(2013.04.12)

NOTIFICATION: Lithium-Ion rechargeable battery doesn’t need to be charged
every day. Charging everyday might decrease the product life. Thus, please charge
the unit when LED indicator shows orange color.

CAUTION: Lithium-Ion rechargeable battery might be discharged when the unit
remains turned on for a long time. Please turn off a light source (LED) when you
don’t use it.

4.7 Charger operation

Normal

100 ~ 240 Vac, 50 / 60 Hz outlet, connect the charger to the red light illuminates
when charging fire red orange suspension changed, when the fire turns green fire.

Fault
In case of the below situations, recharging function might be defective.

1) There is no light or a light is flickering.

2) A red light still doesn’t change to green while recharging

3) If a green light is not shown with a full recharge status or if light colors
changes from green color to red or orange.

4.8 Optional Features

Loupe(Optional): Surgery or medical details by expanding the area used to be
you. And when not in use loupe loupe, or a separation of 90 degrees by raising
the visibility can be secured.

<Standard> <Optional Main body>

Fig. 2.4 Loupe image

Astral Lamp(Optional): During surgery or imaging to reduce shadows caused
partial use when you want to be.

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P/N : OPM(BT-410)EN

Bistos Co.,Ltd

Rev. 05(2013.04.12)

CAUTION: Only qualified personnel should perform service and repair, than the
light should be readjusted.

WARNING: Before cleaning, remove the battery Pack.

CAUTION: Observe the following precautions;

- Do not use caustic or abrasive cleaners.

- Do not clean with alcohol, acetone, or other solvents.

- Never immerse the light or its components parts

Section 5

Maintenance and Cleanliness

5.1 Checking the Light Intensity

It is recommended that the intensity of the light be checked before each use, and
at least every six months.

Have a qualified technician test the intensity level and readjust the intensity
potentiometers to achieve the desired output, if required.

5.2 Cleaning

Remove dust from the exterior of the light with a soft brush or soft cloth with
tepid water. Please remove the dust and dirt on the cable, wipe the unit with a

cloth, soaked in lukewarm water (40˚C / 104℉). Kindly also wipe it with a
clinical alcohol about once a week.

5.3 Battery Disposal and Handling

Be cautious when disposing of Lithium-ion Battery pack.
Adhere to all applicable laws regarding recycling. Avoid storing battery above
60°C (140°F). If clothing or skin comes in contact with material from inside the
battery, immediately wash with plenty of clean water.
When you replace Battery pack, contact us for our technical support.

BT-410 Operator Manual 15

P/N : OPM(BT-410)EN

Bistos Co.,Ltd

Rev. 05(2013.04.12)

Section 6

Specifications

BT-410 Head-worn light Specifications:

Main body

Dimensions: (L) 303 mm × (H) 165.00 mm × (D) 195.00 mm
Illumination

Standard : 30,000 lx (at 25 cm working distance) / 50,000lx (with astral lamp)

Optional Main body : 15,000lx ~ 30,000 lx (at 25 cm working distance)
Color Temperature : 6,000 Kelvin
Lighting (LED) Life time : 50,000 hours
Headband Size : 534 ~ 638 mm
Weight : 119 g

Battery Pack

Using the time : 4 hours
Rechargeable times : 800 times
Capacity : 3.7 V, 2,200 mAh
Type : Lithium-ion rechargeable battery (included protection circuit)
Weight : 69 g

Options

Optional Main body
Loupe : 3.5 x
Astral Lamp
Battery Pack

Safety

EN60601-1, EN60601-1-2-compliant application
Protection against electric shock Type : Internally Powered Equipment
Operation mode by Category : Continuous operation

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P/N : OPM(BT-410)EN

Bistos Co.,Ltd

Rev. 05(2013.04.12)

Internal Power

Battery :

Lithium-ion rechargeable battery 3.7V,
2,200mAh

Charger

Input :
Output :
Charging time :

AC 100 ~ 240 Vac, 50 / 60 Hz, 0.8 A
DC 4.2 V, 750 mA
4 hours

Power Consumption :

3.15 VA

Operating Temperature:

10°C to 40°C (50°F to 104°F)

Storage Temperature:

–20°C to 60°C (–4°F to 140°F)

Relative Humidity:

20% to 90% non-condensing

Altitude:

0 -3048m (0 -10,000 ft)

Atmosphere pressure :

70 kPa to 106 kPa

Power

Environmental

BT-410 Operator Manual 17

P/N : OPM(BT-410)EN

Bistos Co.,Ltd

Rev. 05(2013.04.12)

Product Name

Head-worn light

Model Name

BT-410

Approval No.

Approval Date

Serial No.

Warranty Period

2 Years

Date of Purchase

Customer

Hospital:
Address:
Name:
Telephone:

Sales Agency

Manufacture

Bistos Co., Ltd

Product Guarantee

※ Thank you for purchasing BT-410.

※ This product is manufactured and passed through strict quality control and

inspection.

※ Compensation standard concerning repair, replacement, refund of the

product complies with “Consumer’s protection law” noticed by

Economic Planning Dept.

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P/N : OPM(BT-410)EN

Bistos Co.,Ltd

Rev. 05(2013.04.12)

Service Telephone and Fax. Numbers

Telephone: [phone]

Fax: [phone]

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7

Fl., A Bldg., Woolim Lions Valley 5-cha, 144-3,

Sangdaewon-dong, Jungwon-gu, Seongnam-si,

Gyeonggi-do, Korea

Model Name: BT-410

EC Representative: Medical Econet Gmbh

Im Erlengrund 20 / D-46149 Oberhausen / Germany

Telephone: [phone]

Fax: [phone]

Bistos Co., Ltd.

www.bistos.co.kr

[e-mail]