Bistos BT-410F User manual

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
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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: [phone]
Fax: [phone]
Revision 12
May, 2021
Printed in Korea
Copyright © Bistos Corporation 2020. All rights reserved.

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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
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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.

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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.

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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.

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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
X
O
Control of Light Focus
O
X
Light Spot Size (at 300mm)
70mm
30~70mm
Astral Lamp (option)
X
O
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)

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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)

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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)

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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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3.6 Charging the battery pack
There are two ways of battery charging. One is charging the battery pack as separated and the other is
unseparated. When charging unseparated, be sure the device turned off. To separate or assemble the
battery pack, refer below.
Fig. 3.1 Battery pack assembly method
Fig. 3.2 Battery pack separation method
Fig. 3.3 Two way of charging the battery pack
3.7 Charger
1) Normal state
When connect the charger to the power socket, the red light has comes on. While charging, the red light
Dial for adjusting
intensity of light

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changed to orange light. When the charging has been finished, the light changes to green.
2) Fault state
In below case, the charger may be defected.
There is no light or a flickering light.
A red light still doesn’t change to orange.
If a green light does not come on after sufficient time has been passed or if the light color changes from
green to red or orange.
CAUTION
The battery pack may be discharged when the device remains turned on for a long time. Please
turn off the device when do not use it.
Note
It is not necessary to charge the lithium-ion battery pack every day. Charging every day may
decrease the life time of battery pack. Thus, please charge the battery pack when the LED
indicator turns to orange.
3.8 Optional operation
1) Loupe
This function can be used to enlarge the examination area. When not using the loupe, loupe can be
separated or turn the loupe 90 degrees to secure the view.
Fig. 3.4 Loupe turned 90 degrees
2) Astral Lamp (BT-410A only)
This function can be used to reduce shadows during surgery or other cases.
4 Maintenance and cleaning
4.1 Checking the light intensity
It is recommended that the intensity of the light be checked before each use, and at least every six months.
When required, please contact to your regional service agent or Bistos Co., Ltd.
CAUTION
Only qualified service personnel should perform service, repair or intensity adjustment.
4.2 Cleaning
WARNING
Before cleaning, remove the battery pack.
Remove dust from the exterior of the device with a soft brush or soft cloth wetted with tepid water.
Remove the dust and dirt on the cable, wipe the unit with a cloth soaked in lukewarm water (40˚C / 104℉).
Also kindly wipe it with a clinical alcohol about once a week.
CAUTION
•Do not use caustic or abrasive cleaners.
•Do not clean with alcohol, acetone, or other solvents.
•Never immerse the device or its parts.
4.3 Battery disposal and handling
Be cautious when disposing of the battery pack. Adhere to all applicable laws regarding recycling
Where you try to keep the battery, avoid storing battery above 60°C (140°F). If clothing or skin comes in
contact with material leaked from inside the battery, immediately wash with plenty of clean water.
When you need to replace battery pack, please contact to your local distributor or Bistos Co., Ltd for
technical support.

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5 Troubleshooting
Problems
Possible cause
Corrective action
Headlight does not turn on.
Battery is discharged or is
defective.
Recharge the battery pack.
If the device does not turned
on after charging, contact to
the service center
Brightness decreases during
use.
Temperature of LED may have
increased due to blockage of
airflow.
Turn off the headlight, check
and remove any obstructions
from the headlight module and
vent hole.
Brightness is diminished
and/or the spot appears fuzzy.
Headlight lens may be
contaminated.
Clean the lens according to this
manual.
Fully charged battery operates
for less than 2 hours.
Battery may be losing its
capacity.
Contact to the service center
to replace battery pack.
※ If you have not resolved the problem with device or you have further questions, please contact Bistos
customer center.
6 Specifications
The BT-410F and BT-410A head-worn light is classified as follows in accordance with EN/IEC 60601-1
Category Name
Specification
Type of electric shock protection
Internally powered equipment
Operating mode
Continuous mode
Main body
Dimensions
303(L) X 165(H) X 195(D) mm
Illumination
(at 25 cm working distance)
15,000 ~ 30,000 lx
Maximum illumination with Astral lamp: 50,000 lx (Applicable
model: BT-410A)
LED lift time
50,000 hours
Headband size
534 ~ 638 mm
Weight
119 g
Battery pack
Type
Lithium-ion rechargeable battery
Capacity
3.7V, 2,600mAh
Continuous operating time
4 hours
Life span
800 charge-discharge cycles
Weight
69 g
Battery charger
Input
AC 100 ~ 240 Vac, 50/60 Hz
Output
DC 4.2V, 1000 mA
Charging time
4 hours (100%)
Environment
Operating
Temperature
10°C to 40°C (50°F to 104°F)
Humidity
5 ~ 85% non-condensing
Atmospheric pressure
70 -106kPa
Transport and storage
Temperature
- 20°C to 60°C (–4°F to 140°F)
Humidity
0% to 95% non-condensing

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Atmospheric pressure
70 -106kPa
7 Manufacturer’s declaration on EMC
BT-410F and BT-410A needs special precautions regarding EMC (Electromagnetic compatibility) and needs
to be used according to the EMC information provided in this manual. Wireless communications equipment
such as wireless home network devices, mobile phones, cordless telephones and their base stations,
walkie-talkies can affect the head-worn light BT-410F and BT-410A and should be kept at least 1 m away
from the equipment.
7.1 Electromagnetic emissions
The head-worn light BT-410F and BT-410A is intended for use in the electromagnetic environment
specified below. The customer or the user of BT-410F and BT-410A should assure that it is used in such
an environment.
Emissions test
Compliance
Electromagnetic environment-guidance
RF emissions
CISPR 11
Group 1
BT-410F and BT-410A is no intentional or controlled RF
emission for it’s intended performance. Therefore, its RF
emissions are very low and are not likely cause any
interference with nearby electronic equipment.
RF emissions
CISPR 11
Class A
The BT-410F and BT-410A is suitable for use in all
establishments including domestic, and may be used in
domestic establishments and those directly connected to the
public low-voltage power supply network that supplies
buildings used for domestic purpose.
Harmonic emission
IEC61000-3-2
Class A
Voltage fulctuations
/flicker emissions
IEC61000-3-3
Complies
WARNING
•The BT-410F and BT-410A should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the device should be observed to verify
normal operation in the configuration in which it will be used.
•Portable RF communications equipment (including peripherals such as antenna cables
and external antennas) should be used no closer than 30 cm (12 inches) to any part of the
BT-410F and BT-410A, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
•Use of adapter other than those specified or provided by the manufacturer of this
equipment could results in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation.
7.2 Electromagnetic immunity
BT-410F and BT-410A is intended for use in the electromagnetic environment specified below. The
customer or the user of BT-410F and BT-410A should assure that it is used in such an environment.
Immunity test
Test level
Compliance level
Electromagnetic
environment -guidance
Electrostatic
Discharge (ESD)
IEC61000-4-2
±8 kV
Contact
±2 kV, ±4 kV,
±8 kV, ±15 kV
Air
±8 kV
Contact
±2 kV, ±4 kV,
±8 kV, ±15 kV
Air
Floors should be wood,
concrete or ceramic tile. If
floors are covered by
synthetic material, the
relative humidity should be
at least 30 %.
Electrical Fast
Transient/Burst
IEC61000-4-4
±2 kV AC,
100 kHz PRR
±2 kV AC,
100 kHz PRR
Mains power quality should
be that of a typical
commercial or hospital
environment.
Surge
IEC61000-4-5
±0.5 kV, ±1 kV
L1 to L2 (DM)
±0.5kV, ±1kV
L1 to L2 (DM)
Mains power quality should
be that of a typical

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commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
0 % UT for 0.5 cycle
At 0˚, 45˚, 90˚, 135˚,
180˚, 225˚, 270˚, 315˚
0% UT for 1 cycle
At 0˚, 180˚
50 Hz :
70 % UT for 25 cycles
At 0˚, 180˚
50 Hz :
0 % UT for 250 cycles
At 0˚, 180˚
0 % UT for 0.5 cycle
At 0˚, 45˚, 90˚, 135˚,
180˚, 225˚, 270˚, 315˚
0% UT for 1 cycle
At 0˚, 180˚
50 Hz :
70 % UT for 25 cycles
At 0˚, 180˚
50 Hz :
0 % UT for 250 cycles
At 0˚, 180˚
Mains power quality should
be that of a typical
commercial or hospital
environment. If the user
requires continued
operation during power
mains interruptions, it is
recommended that the BT-
410F and BT-410A be
powered from
uninterruptable power
source, battery.
Power frequency
(50Hz)
magnetic field
IEC61000-4-8
30 A/m, 50Hz
30 A/m, 50Hz
Power frequency magnetic
fields should be at levels
characteristic of a typical
commercial or hospital
environment.
Conducted RF
IEC61000-4-6
3 Vrms
150 kHz to 80 MHz
6 Vrms in ISM bands
between 0.15 MHz
and 80 MHz
3 Vrms
150 kHz to 80 MHz
6 Vrms in ISM bands
between 0.15 MHz
and 80 MHz
Portable and mobile RF
communications equipment
should be used no closer to
any part of the electric breast
pump, including cables, than
the recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
Recommended separation
distance:
d = 1.2
P
d = 1.2
P
80 MHz ~ 800
MHz
d = 2.3
P
800 MHz ~ 2.7
MHz
where P is the maximum
output power rating of the
transmitter (W) according to
the transmitter manufacturer
and d is the recommended
separation distance in
meters(m).
Field strengths from fixed RF
transmitters, as determined
by an electromagnetic site
survey a, should be less than
the compliance level in each
frequency range b.
Interference may occur in the
Radiated RF
IEC61000-4-3
3 V/m
80 MHz to 2.7 GHz
80% AM
3 V/m
80 MHz to 2.7 GHz
80% AM

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vicinity of equipment marked
with the following symbol:
(IEC 60417, Ref. no. 5140:
“Non-ionizing
electromagnetic radiation”)
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people

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Product Warranty
Product Name
Head-worn light
Model Name
BT-410F and BT-410A
Serial No.
Warranty Period
1 Years
Date of Purchase
Customer
Hospital name:
Address:
Contact Name:
Telephone:
Sales Agency
Manufactured by
Bistos Co., Ltd.
※Thank you for purchasing BT-410F and BT-410A
※This product is manufactured and passed through strict quality control and inspection.
※Compensation standard concerning repair, replacement, refund of the product complies with
“Framework Act on Consumers”noticed by Fair Trade Commission of Republic of Korea.
Service Telephone and Fax. Numbers
Telephone: [phone]
Fax: [phone]
Bistos Co., Ltd.
7th FL., A Bldg., Woolim Lions Valley 5-cha, 302,
Galmachi-ro, Jungwon-gu, Seongnam-si,
Gyeonggi-do, Korea
www.bistos.co.kr
[e-mail]
Obelis s.a
Bd. Général Wahis 53
1030 Brussels, BELGIUM
Telephone: + (32) 2. 732.59.54
Fax.: + (32) 2.732.60.03