GL LUV 01 User Manual

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0123

User's Manual

Laser Lancet [LUV (GL-01)]

GL Inc.
(Toechon-dong), 82-326, BI CENTER 20,
Changwondaehak-ro, Uichang-gu, Chang-won-si,
Gyeongsangnam-do, 51140, REPUBLIC OF KOREA
Tel : [phone], Fax : [phone]
Homepage : www.glinc.co.kr

OBELIS S.A
Bd. General Wahis, 53, 1030 Brussels, Belgium
Tel: [phone], Fax [phone],
Email: [e-mail] Homepage : http://www.obelis.net

Documentation : GL-UM-001
Revision History : Rev. 3 Date: October 27, 2016

Table of Contents

Chapter 1. Introduction

1.1 Introduction ·························································································································· 1

1.2 Intended Use ······················································································································· 1

1.3 Before Use ··························································································································· 1

1.4 Warning, Contraindication and Side effect ·······························································1

1.5 Intended Operators & Patients Profile ········································································ 1

1.6 Caution ·································································································································· 2

Chapter 2. Danger, Warning, Caution

2.1 DANGER ································································································································ 3

2.2 WARNING ······························································································································ 3

2.3 CAUTION ·······························································································································3

Chapter 3. Device symbols & Labels

Chapter 4. Laser Lancing Device

Chapter 5. Performances

Chapter 6. Characteristics

6.1 Principle of operation ······································································································· 9

6.2 Electrical rate ······················································································································9

6.3 Protection type and level regarding electric shock ·············································· 9

6.4 Safety ····································································································································· 9

Chapter 7. Operation

7.1 Check points before use ······························································································10

7.2 Operation method ············································································································ 11

7.3 Functional operation method ·······················································································13

7.4 Keeping the device after use ······················································································ 13

7.5 Precautions before use ·································································································· 13

7.6 Range of use ···················································································································· 13

7.7 Emergency Stop ··············································································································· 13

Table of Contents

Chapter 8. Routine Maintanance ········································································13

Chapter 9. Trouble Shooting ················································································ 13

Chapter 10. Supplies, Warranty and Customer support ····························· 14

Chapter 11. Electromagnetic Compatibility(EMC) Declaration ···················15

Chapter 12. Discard ································································································ 16

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Chapter 1. Introduction

1.1 Introduction
This portable laser lancing device is used to get blood from finger using single
pulsed laser. Diabetes or anyone who want to get blood can use this device.
Rechargeable battery is embedded and getting blood up to 50 to 60 times after one
time full charge,

1.2 Intended Use
This device can get blood from capillary using Er:YAG laser with 2,940 nano meter
wave length.

1.3 Before Use

(1) Read user manual before use.
(2) Use only for the right purpose.
(3) Check the state-of-charge before use.

1.4 Warning, Contraindication and Side effect

(1) Warning

Do not operate the Laser Lancet near the inflammable gas mixture or metallic

materials.

(2) Contraindication

Its usage is restricted or prohibited on people with hemorrhagic diseases,

immunization diseases or acute diseases and others (those who are decided not
to be subject to use by a doctor) through considering conditions.

(3) Side effect

After or during using, temporary side effects such as edema, blistering, treatment

pain can be caused.

1.5 Intended Operators & Patients Profile

(1) Diabetes having Doctor's prescription
(2) People need getting blood with Doctor's prescription.
(3) intended patient population.

: People of all ages who need the blood collection available.

(4) intended part of the body or type of tissue.

: Use Finger Tips.

(5) Intended user profile.

: People of all ages who need the blood collection or those who know how to use
this lancet that can collect in person available.

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Chapter 1. Introduction

(6) intended condition of use environment

: This lancet is home appliance

1.6 Caution

(1) Keep or use condition see 5.10 this manual.
(2) Do not have to sterilize and disinfect this lancet.
(3) Please do not use the outside.
(4) Can use whenever you need.

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Chapter 2. Danger, Warning, Caution

2.1 DANGER

(1) Indicates an imminent situation in which the possibility of exposure to hazardous
laser radiation may occur that could result in serious injury to the operator, user, or
staff
(2) Do not use this product near flammable anesthetic gases. This product may cause
ignition of explosive or flammable anesthetic gases.

2.2 WARNING

(1) Indicates a potentially hazardous situation in which the possibility of exposure to
electrical shock may occur that could result in serious injury to the operator, patient,
or staff.
(2) Use of controls or adjustments or performance of procedures other than those
specified herein may result in hazardous laser radiation exposure.
(3) Placement of foreign objects into the beam path may reflect laser radiation
outward and cause injury.
(4) Never attempt to look into the laser aperture. Never attempt to use mirrors or other
devices to observe the laser beam or lens.
(5) This device is intended for use in collection human blood samples. Follow the
infection control precautions as directed by your institutional policy.
(6) Take caution when handing any blood infected waste.
(7) This product contains high voltage circuitry. Do not attempt to remove or open
any part of the device casing.
(8) Use of damaged or improperly adjusted equipment, or improper use of
equipment, could result in personal injury to the patient or the operator. Any abuse of
the equipment, including opening of the casing, will void the warranty.
(9) Service should only be performed by qualified manufacture's representatives.
(10) This device is intended for use in collecting human blood samples. Follow the
infection control precautions as directed by your institutional policy. Take caution when
handling and blood infected waste.
(11) The operation of LUV can cause electromagnetic interferences due to its inherent
high voltage circuits. Thus, when using the device must be careful not to affect and
cause malfunction of other machines.

2.3 CAUTION

(1) Indicates a potentially hazardous situation that, if not avoided, could result in
damage to the equipment.

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Chapter 3. Device symbols & Labels

: MANUFACTURER

: SERIAL NUMBER

: REFER MANUAL

: EXAMINATION AGENCY

: DIRECT CURRENT

: WARNING SIGN

: DATE OF MANUFACTURE

: KEEP DRY

: BF TYPE APPLIED PARTS

: A SECOND TYPE OF EQUIPMENT

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Chapter 3. Device symbols & Labels

Product Name

Laser Lancet

Brand Name

LUV

Model Name

GL-01

Rated Input

Battery : Lithium Polymer 3.7 V / 460 mAh
5V , 1.0A (Micro USB type)

GL Inc.

(Toechon-dong), 82-326, BI CENTER 20, Changwondaehak-ro,
Uichang-gu, Chang-won-si, Gyeongsangnam-do, 51140, REPUBLIC
OF KOREA

OBELIS S.A
Bd. General Wahis, 53, 1030 Brussels, Belgium
Tel : [phone] Fax : [phone]

www.glinc.co.kr

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Chapter 4. Laser Lancing Device

① Laser Shooting Aperture

: Must put finger tip on the aperture hole to collect blood sample by shooting laser.

② Indication LED

: Indicate operating status

③ Level Indicator

: Indicate Battery charging, Laser power level, and Battery status check

④,⑤ Level setting up/down button
⑥ Laser Shoot button

: Push this button when shot is ready.

⑦ 5-pin micro USB port only for charging the inner mounted lithium-ion battery
⑧ Reset switch hole for reset the device when floated.
⑨,⑩,⑪ Contact plates(points)

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Chapter 5. Performance

5.1 Electrical rating

(1) Micro USB Charger

: MICRO USB Type-B standard charger
(Input : AC100~240V 50/60Hz, Output : DC 5.0V, 1A)

(2) Embedded Battery : Lithium-Polymer (DC 3.7V, 460mAh)

5.2 Protection type and level regarding electric shock

: Class Ⅱ and Internally Powered Equipment, Type BF applied Parts

5.3. Power Consumption : Max. 3W

5.4. Laser medium : Er:YAG Laser

5.5 Laser Wavelength : 2,940nm

5.6 Output Intensity : Max. 34 mJ, standard of maximum output 34mJ ± 10%

5.7 Range of Output : standard of maximum output 34mJ ± 10%

(GL measuring instrument(GL-T-01) standard : 41,000~47,000)

Mode
Output

Level 1

Level 2

Level 3

Level 4

Level 5

ENERGY

84%

of Level 5

88%

of Level 5

92%

of Level 5

96%

of Level 5

34mJ ±

10%

(41,000

~47,000)

※ Since output values are allocated sequentially from Level 1 ~ Level 5 at maximum
output, only the maximum output checked measure and verify. (The device is
programmed to change voltage proportionally compared to the maximum output value
and output energy is proportional to voltage.)

5.8 Safety level : ⅠM under IEC60825-1

5.9 Optical transmission method

(1) Focus operation method : Single focus (7mm)
(2) Focus diameter : 0.15㎜

5.10 Environment and condition for use

(1) Storage & Shipping condition

1) Temperature : -25℃ ~ 70℃

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2) Humidity : 15 % to 93 % R.H.

3) Atmospheric Pressure : 700hPa to 1060hPa

(2) Operation condition

1) Temperature : 5℃ ~ 40℃

2) Humidity : 15 % to 93 % R.H.

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Chapter 5. Performance

3) Atmospheric Pressure : 700hPa to 1060hPa

5.11 Software Release Version

L1F01 : Software program of GL-01

5.12 Degree of protection against the ingress of water : Ordinary

5.13 Mode of operation : Continuous operation

※ Equipment not suitable for use in the presence of a flammable anesthetic mixture
with air or with oxygen or nitrous oxide.

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Chapter 6. Characteristics

6.1 Principle of operation

(1) This laser produce 2,940nm wave laser using Er:YAG(Erbium YAG) and Xenon tube
is using as light source.
(2) Produced laser energy is concentrated through focusing lens and perforate on the
finger and collecting blood.
(3) Laser power level is adjustable and rechargeable lithium polymer battery embed in
the product.
(4) Connector for charging power supply is used Micro-USB Type-B (Input:
AC100~240V 50/60Hz, Output: DC 5.0V 1A). Internal battery is embedded lithium
polymer(DC 3.7V, 460mAh).
(5) Laser level is selected by +, - button

6.2 Electrical rate

(1) Micro USB Charger

: MICRO USB Type-B standard type
(Input : AC100~240V 50/60Hz, Output : DC 5.0V 1A)

(2) Embedded battery: Lithium battery(DC 3.7V, 460mAh)

6.3 Protection type and level regarding electric shock
Class Ⅱ and Internally Powered Equipment, Type BF applied Parts

6.4 Safety
Safety contacts: three contacts should be connected concurrently for closed loop
circuit through human body to discharge laser. This is a safety system for preventing
accidental shooting.

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Chapter 7. Operation

7.1 Check points before use

(1) Check appearance of the device

(2) Open the cap and rub the surface of the focusing lens to remove dust or foreign
materials with cotton swab before use.

(3) Touch once the shot button to check the status of internal battery.
(Battery level from 1 to 5, level 5 is the full charged)

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Chapter 7. Operation

7.2 Operation method

※ Recommendation: Wash your hand before use

(1) For power ON, push the shot button for 2 to 3 second.

(2) Select suitable level using level adjustment button(+/-).
(3) The default level is set level 3 for ordinary person.

Shoot Level

Level 1

Level 2

Level 3

Level 4

Level 5

Range

Infant or

children

Female,

Soft finer

skin

Ordinary

person

Ordinary

person with

relatively

thicker

person

Ordinary

person

thick

finger

skin

※ Please set the suitable level if the blood is too much or too small
blood.

(4) The LED is blinking while the device is ready to shoot.

(5) Put the target finger on the aperture and apply a pressure strongly. The beep and
blinking LED are indicating the device is ready to shoot.

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Chapter 7. Operation

(6) Just push shot button slightly for emit the laser and squeeze the finger for getting
blood.

(7) Push the shot button slightly once again if you want to operate once again. Take
the (5) and (6) step for getting blood.
(8) Press the shot button for 2 to 3 seconds to power off. The power is automatically
off if the device is not used for 2 minutes.

(9) Open the aperture and rub the surface of the focusing lens and put the device in
the case and keep it under dry condition.

(10) Connect with the micro USB 5 pin connector to computer or charging adapter for
recharging.
(11) The device is not operated when the device is recharging. Please stop charging
immediately and contact the nearest customer center.

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Chapter 7. Operation

7.3 Functional operation method

(1) Battery check

Push the shot button slightly once, the battery status is indicated.

(2) Press level adjustment button and press the shot button to check the number of
shot times of the device. The blinking times indicate the number of shot times.

7.4 Keeping the device after use

(1) Open the aperture and rub the surface of the focusing lens and put the device in
the case and keep it under dry condition.
(2) Keep the safe place from vibration and electromagnetic or physical shock.
(3) Please do not open or operate the device and contact the customer center when
the device appears trouble. Please

7.5 Precautions before use

(1) Do not open the case or handle the device without skilled engineer. It causes
trouble of the device.
(2) Please read the use manual or use instruction before use.
(3) Light sensitive person should consult the doctor.
(4) Do not draw into the water. If the device is dropped into the water with POWER
OFF status, dry with the fan without power ON and use but the best way to repair the
device is contact the customer center.
(5) Please contact the nearest customer center immediately, if the device is dropped
into the water with POWER ON status.
(6) Please keep the device away from children even if no possibility of danger from
malfunction.
(7) Do not use this laser lancet the public place or outside.
(8) Do not use other than means operation.
(9) If the patient use other purpose of this lancet, the lancet will do not work
properly.
(10) If the temperature of surface lancet excess 40℃ do not use this lancet, as until
less than 39℃.

7.6 Range of use
Do not use other purpose without getting blood from finger.

7.7 Emergency Stop
Please contact the customer center immediately, If the device is dropped into the
water.

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Chapter 8. Routine Maintenance

8.1 Routine check

This device is not required a routine basically. Please check only the battery status
before use. (5 LED shows full charged status)

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Chapter 9. Trouble Shooting

9.1 Trouble shooting
(1) There is no specific error message in this device. Please push the reset button
and restart when this device is not operated(floating).
(2) Please contact the customer center, even if the device is not restarted when
reset button is pushed.( in this case, the device is surely out of order)
(3) Please change the laser level up to level 5 when the blood is not drawn even if
the laser is properly operated. Please contact the customer center if the blood is
not drawn with level 5.

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Chapter 10. Supplies, Warranty and Customer support

10.1 Supplies
There is no specific supplies but cotton swab for cleaning the lens is needed.
Please buy cotton swab at near mark.

10.2 Warranty
The warranty period is two(2) years. New device will be provided immediately in
advance, if the device is troubled within warranty period.

10.3. Customer support
If you need any support for the device, please contact the nearest customer center
or the following contacts.

[Contact Point]
GL Inc.
82-326 BI Center, National Changwon University, 20 Changwondaehak-ro,
Uichang-gu, Changwon-city, Gyengsangnam-do, Republic of Korea.

10.4. Etc.

(1) Expected Service Life: Approximately 5 years
(2) Do not open and break this lancet.
(3) The full charge of this battery can be used 50 times.
(4) The battery life is typically 5 years.
(5) Period to replace the batteries is 5 years.
(6) The number of uses, more than 500 times or the lancet is older than 5 years,
should change battery.
(7) If you want to use multiple patients, the lancet should be controlled under no risk
of transmission and infection condition.
(8) Do not use for purposes other than medical grounds.(pets, kids, pests.),

(9) Charging time of the LUV is 30 minutes.

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Chapter 11. Electromagnetic Compatibility(EMC) Declaration

This equipment has been tested and found to comply with the limits for medical
devices in EN60601-1-2. These limits are designed to provide reasonable protection
against harmful interference in a typical medical installation.
This equipment generates, uses and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause harmful interference
to other devices in the vicinity. However, there is no guarantee that interference will
not occur in a particular installation.
If this equipment does cause harmful interference to other devices, which can be
determined by turning the equipment off and on, the user is encouraged to try to
correct the interference by one or more of the following measures:

-. Reorient or relocate the receiving device.

-. Increase the separation between the equipment.

-. Connect the equipment into an outlet on a circuit different from that to which the
other device(s) are connected.

-. Consult the manufacturer or field service technician for help.

The unit meets the Collateral Standards of Electromagnetic compatibility ­Requirements and tests EN 60601-1:2007(IEC 60601-1-2) the limits and methods of
measurement of electromagnetic disturbance characteristics of industrial, scientific and
medical radio frequency equipment EN 55011 Group 1, Class A, Medical Electrical
Equipment is subject in regard to the electromagnetic compatibility(EMC) and its
special precautionary measure

Guidelines for the operator to use the GL-01 in electromagnetic environments.

Guidance and manufacturer's declaration - Electromagnetic Emissions

The GL-01 is intended for use in the electromagnetic environment specified below. The customer or the
user of the GL-01 should assure that it is used in such an environment.

Emissions test

Compliance

Electromagnetic environment

RF emissions
CISPR 11

Group 1

The GL-01 uses RF energy only for its internal function.
Therefore, its RF missions are very low and are not likely to
cause any interference in nearby electronic equipment.

RF emissions
CISPR 11

Class B

The GL-01 is suitable for use in all establishments other
than 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
purposes, provided the following warning is heeded:
Warning: This GL-01 is intended for use by healthcare
professionals only. This GL-01 may cause radio interference
or may disrupt the operation of nearby equipment. It may be
necessary to take mitigation measures, such as re-orienting
or relocating the GL-01 or shielding the location.

Harmonic emissions
IEC 61000-3-2

Class A

Voltage fluctuations/
flicker emissions
IEC 61000-3-3

Complies

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Guidance and manufacturer's declaration - Electromagnetic Immunity

The GL-01 is intended for use in the electromagnetic environment specified below.
The customer or the user of the GL-01 should assure that it is used in such an environment.

IMMUNITY test

IEC 60601 test level

Compliance level

Electromagnetic environment

Electrostatic
discharge (ESD)
IEC 61000-4-2

± 6 kV contact
± 8 kV air

± 6 kV contact
± 8 kV air

Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.

Electrical fast
transient/burst
IEC 61000-4-4

± 2 kV for power
supply lines
± 1 kV for
input/output lines

± 2 kV for power
supply lines
± 1 kV for
input/output lines

Mains power quality should be that of
a typical commercial or hospital
environment.

Surge
IEC 61000-4-5

± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth

± 1 kV differential
mode
± 2 kV common
mode

Mains power quality should be that of
a typical commercial or hospital
environment.

Voltage dips,
short interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11

<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 s

<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 s

Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the GL-01
requires continued operation during
power mains interruptions, it is
recommended that the GL-01 be
powered from an uninterruptible power
supply or a battery.

Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8

3 A/m

3 A/m

Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical
commercial or hospital environment.

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 kHz to 80 MHz

3 V/m

80 MHz to 2,5 GHz

3 Vrms

3 V/m

Portable and mobile RF
communications equipment should be
used no closer to any part of the
GL-01, including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance

80 MHz to 800 MHz

800 MHz to 2,5 GHz
where P is the maximum output
power rating of the transmitter in
watts (W) according to the transmitter
manufacturer and d is the
recommended separation distance in
metres (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 vicinity
of equipment marked with the
following symbol:

NOTE 1 UT is the a.c. mains voltage prior to application of the test level.
NOTE 2 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 3 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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a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the GL-01 is used exceeds the applicable RF compliance level above, the GL-01
should be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as re-orienting or relocating the GL-01.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and the
GL-01

The GL-01 is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the GL-01 can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the GL-01 as recommended below, according to the maximum output power of the
communications equipment.

Rated maximum output

power of transmitter W

Separation distance according to frequency of transmitter m

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2,5 GHz

0,01

0,12

0,12

0,23

0,1

0,38

0,38

0,73

1

1,2

1,2

2,3

10

3,8

3,8

7,3

1001212

23

For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for 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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Chapter 12. Discard

-. If this equipment has completed its expected service life, it can be returned to
manufacturer or can be disposed by the user in compliance with the local
environmental regulations.

-. In case of the return to the manufacturer, the whole parts of the equipment or
some parts of the equipment can be returned.

-. In case that the equipment is decided to be disposed by the user, it will be ideal
to dispose the equipment after disassembly of the equipment to the proper level.

-. Disposal of old Electrical & Electronic Equipment

(Application in the European Union and other European countries with

separate collection system.)
This symbol indicates that this product shall not be treated as household waste.
Instead, it shall be handed over to the applicable collection point for the recycling of
electrical and electronic equipment. By ensuring this product is disposed of correctly,
you will help prevent potential negative consequences for the environment and human
health, which could otherwise be caused by inappropriate waste handling of this
product. For more detailed information about recycling this product, please refer to
local governing ordinances and recycling plans