mtts 4meter User manual

4-meter. User Manual
User Manual
Effective date: January 2022
Issue Number: 03 Version: 00 EN
Issue Date: January 2022 www.mtts-asia.com
Model: LM-800
meter

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4-meter. User Manual
Contents
Company Information
Introduction
Device Description
Warnings
Operation
Alarm System
Optional Accessories
Cleaning
Maintenance and Service
Explanation of Symbols
Warranty Policy
04
05
06
09
10
24
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27
28
31
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4-meter. User Manual
The 4-meter major function is a spectroradiometer for measuring the
irradiance (radiant power) of neonatal phototherapy lights and bili-
beds.
In additon the device can be connected to the other optional sensors
for:
- Oxygen measurement
- Flow measurement
- Pressure measurment
IntroductionCompany Information
MEDICAL TECHNOLOGY TRANSFER AND SERVICES Co., LTD
House No. 26, Alley 41, An Duong Vuong Street,
Tay Ho District, Hanoi City, Vietnam
Ph.: +84 24 3766 6521
Fax: +84 24 3718 8050
Email: [email protected]
www.mtts-asia.com
Logic s.r.l.
Via Antonio Pigafetta 1
34147 Trieste, Italy
This user manual is intended for health care professionals.
-
tions should be read before use.
WARNING - a warning statement refers to the conditions when
the possibility of injury to the patient or user exists if a proce-
dure is not followed correctly.
NOTE - a note statement provides additional information in-
tended to clarify points, procedures or instructions.
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4-meter. User Manual
Sensor
Device Description
Overview
4-meter is single measurement unit suitable for overhead and bed
type phototherapy. It has 2 sensors located on both sides of the unit.
Device Description
Display
Sensor
Batteries
compartment
panel, do not press hard
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06
Display
1 Battery status Battery usage information
2 Top sensor bar Top sensor measurement information including light
source, value and estimated bandwidth
3 Bottom sensor bar Bottom sensor measurement information including
light source, value and estimated bandwidth
4 Total measurement bar
Total measurement value (top + bottom) with the
measurement unit
Touch this area to hold the measurement values
5Menu Touch this button to enter Menu screen
6Multi-point mode Touch this button to enter Multi-point mode screen
7 Status Touch this button to enter Status screen
1
Measurement
Indicator
ON/OFF button
2
3
4
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Device Description
Explosion hazard. Do not use this device in the presence of
Read and be familiar with this instruction manual before
using this device.
Inspect this device before each use to ensure proper
functioning.
!
!
!
The hospital/facility is responsible for ensuring that all per-
sonnel who operate or maintain this device are trained in its
operation and safe use, and for maintaining training records
of attendance and evidence of understanding.
Warnings
09
08
Measuring Irradiance
4-meter is a spectroradiometer that measures the therapeutic irradi-
ance (radiant power) of neonatal phototherapy lights. It measures the
irradiance of the wavelengths from 400 to 520 nanometers (nm), the
blue-green portion of the spectrum, which includes the principal ac-
tion spectrum of bilirubin. The device accounts for cosine correction
allowing more light from different angles.
Units of Measurement
4-meter measures relative irradiance (µW/cm2/nm) and absolute ir-
radiance (µW/cm2).
When referring to the relative irradiance, a nanometer is a measure
of wavelength equal to one-billionth of a centimetre. The term “per
nanometer” indicates the average irradiance per nanometer across
the spectral band being measured, which is 120 nm wide. This makes
it possible to compare average irradiance across spectral bands of
different widths.
Instrument Response Characteristics
4-meter, which matches the action spectrum of bilirubin as closely
as possible.
390
25
50
75
100
400 410 420 430 440
Wavelength
%
440 450 460 470 480 490 500 510 520 530

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3. Read irradiance measurement from the display. Adjust the aim of
4-meter sensor to obtain the maximum reading.
4. The values can be ‘frozen’ on the display. Touch the total measure-
ment area to stop the measurement and hold the values.
Operation
If more than one phototherapy light is being used on the
infant, take separate measurements for each light and chart
each reading.
operations. When the ‘hold the values’ function is active, the
indicator stays red.
Operation
11
10
Taking Measurements - Overhead Phototherapy
1. Turning the unit ON and OFF
To turn on: press the ON/OFF button
To turn off: press and hold ON/OFF button
2. Hold the unit against the infant’s body as near to the umbilical as
below).
- For reproducible measurements, always hold the sensor on the
same place on the infant’s body.
- Changes in the distance or angle of the light to the patient will
change the irradiance the patient receives, requiring new measure-
ments to be taken.
Sensor aimed for
maximum reading Photothrapy
lights

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4-meter. User Manual
Taking Measurements - Bili-Bed Phototherapy
1. Turning the unit ON and OFF
To turn on: press the ON/OFF button
To turn off: press and hold ON/OFF button
2. Place 4-meter in the middle of the lighted side of the pad or mat-
or mattress.
3. Read irradiance measurement from the display. Adjust the aim of
4-meter to obtain the maximum reading.
4. Take two additional readings at different places on the pad, then
average all three readings.
5. The values can be ‘frozen’ on the display. Touch the total measure-
ment area to stop the measurement and hold the values.
Phototherapy bed
lighted side up
4-meter
If a Bili-Bed is being used at the same time as an overhead
phototherapy light 4-meter displays combined value of both
devices.
operations. When the ‘hold the values’ function is active, the
indicator stays red.
Operation Operation
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Operation Operation
Additional options
4-meter offers a selection of choices for different types of measure-
ments.
Bandwidth estimator and units of measurement
4-meter measures the bandwidth of 400-520 nm. As opposed to the
narrow-banded. The aim of 4-meter is to estimate light source band-
width to get meaningful average values.
Given the complexity of the light measurement 4-meter offers the
user the choice of 2 measurement units:
- µW/cm2/nm for relative irradiance measurement and
- µW/cm2for absolute irradiance measurement
In the example below:
- the estimated bandwidth of the light source is 60 nm
- the top relative irradiance measured is 20 µW/cm2/nm
- the bottom relative irradiance measured is 40 µW/cm2/nm
- the total relative irradiance measured is 60 µW/cm2/nm
- the total absolute irradiance measured is 3,600 µW/cm2
Change unit
Changes units between
relative irradiance (µW/cm2/nm) and
absolute irradiance (µW/cm2)
Top sensor Activates / deactivates the top sensor. When the Top sensor is
deactivated, the top sensor bar is gray.
Bottom sensor Activates / deactivates the bottom sensor. When the bottom sensor is
deactivated, the Bottom sensor bar is gray.
Set relative Sets the current measurement as reference values
Show relative Shows / hides the relative ratio of current measurement to the
previously set reference value
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Operation Operation
Activating/deactivating sensors
4-meter measures the irradiance using 2 sensors:
- top for overhead phototherapy units
- bottom for bed-type phototherapy units
- top and bottom - for double sided phototherapy units
Both sensors (top and bottom) are active when the device
is turned on.
To disable the top sensor and use only the bottom sensor touch the
menu icon and select ‘Top sensor’ from the list.
To disable the bottom sensor and use only the top sensor touch the
menu icon and select ‘Bottom sensor’ from the list.
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Operation Operation
Relative measurement
Relative measurement can be used to determine/verify treatment size
of a phototherapy device.
The example below explains the process for a single sided photo ther-
apy device.
1. Select: Menu - ‘Bottom sensor’ to disable the bottom sensor (see
above)
2. Place 4-meter unit under a phototherapy device in centre position.
3. Select: Menu - ‘Set relative’ to set the current measurement as ref-
erence value
4. Select: Menu - ‘Show relative’ to show the ratio between current
measurement and reference value.
The ratio is shown on the left side of the top sensor bar (‘1.00’).
5. Move 4-meter unit away from centre position, the irradiance should
decrease. This will also be indicated by a decreasing ratio.
In this example 4-meter unit was moved away from centre to a posi-
tion where irradiance is 60% of the centre (reference) irradiance point.
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Operation Operation
Multi-point mode
Multi-point mode supports irradiance measurement of up to 9 loca-
tion points.
Select: ‘Multi-point mode’ on the main display
4
5
12 3
1 Start Activates the multi-point measurement process
2 Relative/Absolute Changes between absolute and relative view of multi-
point measurement data.
3 Exit Exits multi-point measurement
4 Relative/Absolute indicator Indicates absolute {ABS} and relative {REL} view
5Measurement matrix
1. Select relative or absolute measurement units.
2. Touch ‘Start’ button to begin the multi-point measurement
3. Touch the highlighted area to assign its measurement value.
4. Assign the values to the remaining measurement points.
A B
The process can be completed at any time. It’s not neces-
sary to assign values to all 9 measurement points.
A Stop button Stops the process and exits to the main menu
B Clear button Clears the data and starts the process over
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Operation Operation
5. Touch ‘Stop button’ to complete the process
6. The multi-point matrix displays absolute values of collected data
7. Touch ‘Relative/Absolute’ button to switch between relative and ab-
solute values of the collected multi-point data points.
4-meter calculates relative values in the reference to the
highest value measured. The remaining values are calcu-
lated as the ratio of the highest value.
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4-meter. User Manual
Alarm System
1. Low battery - Battery power is low
replace the battery (see page 28)
2. System failure - contact the authorized representative
3. Out of measurement - the light irradiance is outside the
measurement range of the device
24
Optional sensors
4-meter unit can be connected to the other optional sensors for:
- Oxygen measurement
- Flow measurement
- Pressure measurment
Name Order code Specication Calibration
recommendation
Oxygen analyzer LM-800-020
Range: 0 .. 100% O2
Accuracy: ±3% O2
Resolution: 0.1% O2
Not required
Lifetime:
18-24 months
Flow meter LM-800-030
Range: -180 .. 180 l/min
Accuracy: ±2.5%
Resolution: 0.1 l/min
Every 2 years
Manometer LM-800-040
Range: 0 .. 100cm H2O
Accuracy: ±1%
Resolution: 0.1cm H2O
Not required
List of supported accessories:
ONLY use accessories and cable supplied by MTTS. Using
non-compliant cable or accessory may cause damage to the
device.
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Cleaning
Required items:
To clean the 4-meter:
2. Dampen the cloth with either the mild soap-and-water solution or
detergent, then wipe down all exterior surfaces of the 4-meter.
Mild
Detergent
Clean
Cloth
27
Optional sensors
Accessory port
Manometer can be connected directly to the device.
accompanied cable.
The device will automatically recognize the plugged accessory and
change the display to appropriate mode to show measurement.
Accessory port
Multiple sensors can be connected at the same time using a
port extender supplied by MTTS.
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4-meter. User Manual
Maintenance and Service
Replacing the Batteries
device.
Read and be familiar with this instruction manual before us-
ing this device.
The printed circuit boards (PCBs) contain static sensitive
parts. Always use appropriate electrostatic discharge pro-
tection, such as an electrical-grounding wrist strap, when
working with internal components.
!
!
!
Required items:
2 x AAA/LR6/1.5V alkaline, non-rechargeable batteries
To replace the battery:
1. Remove the back cover
2. Insert the new 1.5-volt batteries into the battery holder
Batteries cover
Batteries holder
Calibrating 4-meter
Maintenance and Service
Each 4-meter unit is factory calibrated to a radiometric standard in
accordance to the National Institute of Standards and Technology
To assure continued accurate measurement of irradiance, the 4-me-
ter should be recalibrated every 24 months to a radiometric (irradi-
ance) standard. Because certain calibration factors are stored in the
device memory, the unit must be recalibrated at MTTS. The date of the
The 4-meters under warranty are recalibrated at no cost. Others are
recalibrated at nominal cost. For information on returning the device,
see below.
Service and Repair
4-meter has no customer serviceable parts, and must be returned
to MTTS for all repairs and parts replacement. After any service, the
device must be recalibrated radiometrically to assure accurate meas-
urement of irradiance.
Customer attempts to service 4-meter will invalidate the
warranty and may result in irreparable damage
!
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Returning for Service
Maintenance and Service
When sending equipment for service:
- Contact MTTS Technical Service for more information on returning
address and shipping details
- Clean the device, securely package it, and include the RMA number
on the outside of the box.
- In the Asia, ship the equipment to:
Medical Technology Transfer and Services (MTTS) Ltd
No 26 Lane 41 An Duong Vuong
Tay Ho, Hanoi
Specications
Control Settings
LIGHT SENSOR
Spectral response
Measuring range
Resolution
Cosine characteristics
Accuracy
OXYGEN SENSOR - FIO2
PRESSURE SENSOR
FLOW SENSOR
Displays
Characteristics
Features
Indicators
400–520 nm
0.0 – 150.0 µW/cm²/nm
0.0 – 300.0 µW/cm²/nm
0.1 µW/cm²/nm
±2% @ 30 degree angle
±7% @ 60 degree angle
±25% @ 80 degree angle
+/- 3%
21-100%
0-100cm H2O
0-120 lpm, bi-directional
Touch LCD
auto-zeroing, self-check, auto-off after 1 min,
results ‘freeze’
low battery, system failure, out of measurement
Dimensions (HxWxD)
Total unit mass
148 x 73 x 17 mm
200 g
Battery
Operational Duration
2 x AAA 1.5V alkaline batt, non-recharg.
Up to 120h
Operating
Transport and storage
Exclusions
Ambient temperature 10°C to 40°C
Humidity: 30% to 90% RH non condensing
Atmospheric Pressure: 70-106kPa
Ambient temperature 0°C to 50°C
Humidity: 5% to 90% RH non condensing
Atmospheric Pressure: 70-106kPa
None
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double side

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Standards for Reference
ISO 13485:2016
IEC 61010-1:2010
IEC 61326-1:2012
ROHS III
Specications Explanation of Symbols
Explanation of Symbols
Do not disassemble 4-meter unless you are an MTTS
trained technician or have been instructed to by quali-
Device manufacturer.
Date of manufacture.
Keep out of direct sunlight.
This device should be disposed of separately from
normal household waste so that components can be
recycled.
Refer to User Manual before operating this device.
Serial Number
CE Marking
Name and address of European Authorized Representative
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Warranty Policy
General Terms
This MTTS Limited Warranty gives you, the customer,
express limited warranty rights from MTTS, the manu-
Please refer to the MTTS Website for an extensive de-
scription of your limited warranty entitlements. In addi-
tion, you may also have other legal rights under applica-
ble law or special written agreement with MTTS.
MTTS MAKES NO OTHER EXPRESS WARRANTY OR
CONDITION WHETHER WRITTEN OR ORAL AND MTTS
EXPRESSLY DISCLAIMS ALL WARRANTIES AND CON
DITIONS NOT STATED IN THIS LIMITED WARRANTY.
TO THE EXTENT ALLOWED BY LOCAL LAW OF JURIS
DICTIONS OUTSIDE VIETNAM, MTTS DISCLAIMS ALL
IMPLIED WARRANTIES OR CONDITIONS, INCLUDING
ANY IMPLIED WARRANTIES OF MERCHANTABILITY
AND FITNESS FOR A PARTICULAR PURPOSE. FOR ALL
TRANSACTIONS OCCURRING IN VIETNAM ANY IMPLIED
WARRANTY OR CONDITION OF MERCHANTABILITY,
SATISFACTORY QUALITY, OR FITNESS FOR A PARTICU
LAR PURPOSE IS LIMITED TO THE DURATION OF THE
EXPRESS WARRANTY SET FORTH ABOVE. SOME COUN
TRIES DO NOT ALLOW A LIMITATION ON HOW LONG
AN IMPLIED WARRANTY LASTS OR THE EXCLUSION
OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL
DAMAGES FOR CONSUMER PRODUCTS. IN SUCH
COUNTRIES, SOME EXCLUSIONS OR LIMITATIONS OF
THIS LIMITED WARRANTY MAY NOT APPLY TO YOU. FOR
CONSUMER TRANSACTION, THE LIMITED WARRANTY
TERMS CONTAINED IN THIS STATEMENT, EXCEPT TO
THE EXTENT LAWFULLY PERMITTED, DO NOT EXCLUDE,
RESTRICT, OR MODIFY BUT ARE IN ADDITION TO THE
MANDATORY STATUTORY RIGHTS APPLICABLE TO THE
SALE OF THIS PRODUCT TO YOU.
This Limited Warranty is applicable in all countries and
may be enforced in any country or region where MTTS or
its authorized service providers offer warranty service for
the same product model number (subject to the terms
and conditions set forth in this Limited Warranty)
Under this Limited Warranty, products purchased in one
country or region may be transferred to another country
or region where MTTS or its authorized service provid-
ers offer warranty service for the same product model
number. Warranty terms, service availability, and service
response times may vary from country or region to coun-
try or region. Standard warranty service response time is
subject to change due to local parts availability. If so, your
MTTS authorized service provider can provide you with
MTTS product to make it operate in a country for which
it was never intended to function for legal or regulatory
reasons. MTTS is not responsible for any tariffs or duties
that may be incurred in transferring the products.
MTTS guarantees that the product that you have pur-
chased or leased from MTTS is free from defects in
materials or workmanship under normal use during
Limited Warranty Period. The Limited Warranty Period
starts on the date of purchase or lease from MTTS, or
from the date MTTS completes installation. Your dated
sales or delivery receipt, showing the date of purchase of
the product, is your proof of the purchase or lease date.
You may be required to provide proof or purchase or lease
as a condition of receiving warranty service. You are enti-
tled to hardware warranty service according to the terms
and conditions of this document if a repair to your MTTS
product is required within the Limited Warranty Period.
Unless otherwise stated, and to the extent permitted by
local law, new MTTS product may be manufactured using
new materials and used materials equivalent to new in
performance and reliability. MTTS may repair or replace
MTTS products (a) with new or previously used products
or parts equivalent to new in performance and reliability,
or (b) with equivalent products to an original product that
has been discontinued. Replacement parts are warrant-
ed to be free from defects in material or workmanship for
ninety (90) days or, for the reminder of Limited Warranty
Period of the MTTS product they are replacing or in which
they are installed, whichever is longer.
MTTS will, at its sole discretion, repair or replace any
components or product that manifests a defect in ma-
terials or workmanship during the Limited Warranty
Period. All component parts removed under this Limited
Warranty become the property of MTTS. In the unlikely
event that your MTTS product has recurring failures,
MTTS at its sole discretion, may elect to provide you with
(a) a replacement unit selected by MTTS that is the same
or equivalent to your MTTS product in performance or (b)
to give you a refund of your purchase price or lease pay-
ments (less interests) instead of a replacement. This is
your exclusive remedy for defective products.
Exclusions
MTTS DOES NOT WARRANT THAT THE OPERATION OF
FREE. MTTS IS NOT RESPONSIBLE FOR DAMAGE THAT
OCCURS AS RESULT OF YOUR FAILURE TO FOLLOW THE
INSTRUCTIONS INTENDED FOR THE PRODUCT.
This Limited Warranty does not apply to expendable or
consumable parts and does not extend to any product
from which the serial number has been removed or that
gas been damaged or rendered defective (a) as a result
of accident, misuse, abuse, contamination, improper or
inadequate maintenance or calibration (if required) or
other external causes; (b) by operation outside the usage
parameters stated in the user documentation shipped
with the product; (c) by software, interfacing, parts or
supplies not supplier by MTTS; (d) improper site prepara-
tion or maintenance; (e) virus infection; (f) loss or dam-
other than (i) MTTS personnel, (ii) an MTTS authorized
service provider, or (iii) your own installation of end-user
replaceable MTTS or MTTS approved parts if available
for your MTTS product in the servicing country or region.
Limitation of Liability
IF YOUR MTTS PRODUCT FAILS TO WORK AS WARRANT
ED ABOVE, THE MAXIMUM LIABILITY OF MTTS UNDER
THIS LIMITED WARRANTY IS EXPRESSLY LIMITED TO
THE LESSER OF THE PRICE YOU HAVE PAID FOR THE
PRODUCT OR THE COSTS OF REPAIR OR REPLACE
MENT OF ANY HARDWARE COMPONENTS THAT MAL
FUNCTION IN CONDITIONS OF NORMAL USE.
EXCEPT AS INDICATED ABOVE, IN NO EVENT WILL
MTTS BE LIABLE FOR ANY DAMAGES CAUSED BY THE
PRODUCT OR THE FAILURE OF THE PRODUCT TO PER
FORM, INCLUDING ANY LOST PROFITS OR SAVINGS OR
SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES.
MTTS IS NOT LIABLE FOR ANY CLAIM MADE BY A THIRD
PARTY OR MADE BY YOU FOR A THIRD PARTY.
THIS LIMITATION OF LIABILITY APPLIES WHETHER
DAMAGES ARE SOUGHT, OR CLAIM MADE, UNDER THIS
CONTRACT CLAIM, OR ANY OTHER CLAIM. THIS LIMITA
TION LIABILITY CANNOT BE WAIVED OR AMENDED BY
ANY PERSON. THIS LIMITATION OF LIABILITY WILL BE
EFFECTIVE EVEN IF YOU HAVE ADVISED MTTS OF THE
POSSIBILITY OF ANY SUCH DAMAGES. THIS LIMITATION
OF LIABILITY, HOWEVER, WILL NOT APPLY TO CLAIMS
FOR PERSONAL INJURY.
THIS LIMITED WARRANTY GIVES YOU SPECIFIC LEGAL
RIGHTS. YOU MAY ALSO HAVE OTHER RIGHTS THAT MAY
VARY FROM COUNTRY TO COUNTRY. YOU ARE ADVISED
TO CONSULT APPLICABLE COUNTRY LAWS FOR A FULL
DETERMINATION OF YOUR RIGHTS.
Warranty Policy
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Limited Warranty Period
The Limited Warranty Period for this MTTS product is a
-
your sales receipt is the date of purchase unless MTTS or
your reseller informs you otherwise in writing.
Customer Responsibilities
In order to avoid the risk of charges for issues not cov-
ered by your limited warranty (issues that are not due to
defects in materials and workmanship on MTTS product),
you will be asked to assist MTTS as follows:
Contacting MTTS
If your MTTS product fails during the Limited Warranty
Period and the suggestions in the product documenta-
tion do not solve the problem, you can receive support by
doing one of the following:
install software patches, run MTTS diagnostics and
utilities;
Implement temporary procedures or workarounds
provided by MTTS while MTTS works on permanent
solution;
Cooperate with MTTS in attempting to resolve the
problem using online chat, email, or telephone.
This may involve performing routine diagnostic pro-
cedures, installing additional software updates or
patches;
of warranty service provided by MTTS and any other
actions that MTTS may reasonably request in order to
best perform the warranty support
Locate and contact your nearest MTTS service pro-
vider via MTTS website:
http://www.mtts-asia.com/support/
Call the Technical Support Centre:
+84 24 3766 6521
-
-
Before calling MTTS or an MTTS authorized service pro-
vider please have the following information available:
Product serial number and model name
Applicable error messages
Detailed questions
-
-
-
CUSTOMER IS RESPONSIBLE FOR DELIVERING THE
CATION TO THE MTTS AUTHORIZED SERVICE POINT.
-
-
-
-
Warranty Policy
36

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MEDICAL TECHNOLOGY TRANSFER AND SERVICES Co., LTD
House No. 26, Alley 41, An Duong Vuong Street,
Tay Ho District, Hanoi City, Vietnam
Tel: +84 24 3766 6521
Fax: +84 24 3718 8050
Email: [email protected]
www.mtts-asia.com
Logic s.r.l.
Via Antonio Pigafetta 1
34147 Trieste, Italy
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