mtts Impala - V1 User manual
Impala User manual
User Manual
Effective date: July 2020
Issue Number: 00 Version: 02 EN
Issue Date: June 2020 www.mtts-asia.com
Impala
ventilator
Model: Impala - V1
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Impala User manual
Contents
Company Information
Introduction
Device Description
Warnings
Setup
Operation
Alarm System
Cleaning
Maintenance
Explanation of Symbols
Warranty Policy
04
05
06
09
11
16
22
24
26
28
30
32
03
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Impala User manual
Impala ventilator is an invasive mechanical ventilator with 8 ventilation modes AC-
VCV, AC-PCV, SIMV-VC, SIMV-PV, VCV/ PS, PCV/PS, CPAP, and BiPAP intended to use
in intensive care units or transportation of emergency patients. The device contains a
delivered to the patient
Introduction
05
Company Information
04
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: assistanc[email protected]
www.mtts-asia.com
PROMETEO SRL
Via Mantova 9
38122 Trento
Italy
This user manual is intended for health care professionals.
manual is a reference only that you should read, and understand before using
the Impala ventilator on a patient to ensure particularly the safety considera-
tions listed.
However, it is not intended to supersede your institution’s protocol regarding
the safe use of assisted ventilation.
WARNING - a warning statement refers to the conditions when the possibility
of injury to the patient or user exists if a procedure is not followed correctly.
NOTE - a note statement provides additional information intended to clarify
points, procedures or instructions.
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06
Device Description Device Description
07
Overview Control Panel
1 Pressure Graph Shows measured airway pressure as a function of time
2 Flow Graph
3 Ventilation Timer Shows how long the patient has been ventilated
4 Status Bar Shows infomation about locking, battery remaining capacity and
charging conditions
5 Ventilation Mode Button Shows the current ventilation mode. Touch this button to change mode.
6 Standby Button Enable/Disable Standby mode.
7 Alarm Silence Button Touch this button to mute auditory alarm for 2 minutes.
8 Setting Button Touch this button to open/close Setting screen
9 Ventilator Parameters Each button shows name, unit, measured value and/or setpoint of a
ventilator’s parameter. Details are depicted on the next page.
Impala Ventilator functions are controlled by touch screen.
1
2
34
6
9
7
8
5
Front view
Side view
Inspiratory port
Control panel
Power button
Oxygen inlet
12VDC inlet
Hatch
Exhalation valve
control port
Flow and pressure
measurement ports
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08
Device Description Warnings
09
trigger sensitivity can be found in the Setting screen.
To adjust a parameter setpoint, touch its button.
The ventilation machine must be used only under the responsibility and on the
prescription of a doctor/clinician.
them for a ventilator-dependent patient. Make sure that they can already take
experiences a problem This manual, accessory Directions for Use, all precau-
enriched environments, or nitrous oxide.
Do not modify this equipment without authorization of the manufacturer.
performance.
Do not operate the device if any of the components appear to be damaged or
broken. Damaged or broken components should be discarded and replaced.
Do not position the device in a location that reduces its ventilation.
Do not block any of the air vents on the back of the device.
The presence of electro-surgical devices, shortwave or microwave equipment
near this device could lead to electrical interference that would negatively
affect the function of the device.
Ensure that the Locking key is activated so that some critical information of
Using tubing or other breathing circuit components without cleaning or disin-
fection between patients can result in infections.
them.
Parameter name Parameter setpoint
Measured value
Parameter unit
Ventilator parameter
Details of each ventilator parameter are showed in a button as below.
Following table describes frequently used parameters that are available on the main
screen of each ventilation mode.
Ventilation mode ISO 19223 code Parameters on the main screen
AC-PCV A/C PC Ventilation rate, Peak/control pressure, PEEP, FiO2, Tidal volume, I:E ratio
AC-VCV A/C VC Ventilation rate, Peak pressure, PEEP, FiO2, Tidal volume, Peak inspiratory
SIMV-PC SIMV-PC Ventilation rate, Peak/control pressure, PEEP, FiO2, Tidal volume, I:E ratio
SIMV-VC SIMV-VC Ventilation rate, Peak pressure, PEEP, FiO2, Tidal volume, Peak inspiratory
PCV/PS S/T-vtPS/vtPC Ventilation rate, Peak/control pressure, PEEP, FiO2, Tidal volume, I:E ratio,
Support pressure
VCV/PS S/T-PS/VC Ventilation rate, Peak pressure, PEEP, FiO2, Tidal volume, Peak inspiratory
CPAP CPAP Ventilation rate, Peak pressure, PEEP, FiO2, Tidal volume, Apnea time
BiPAP BPAP Ventilation rate, Peak pressure, PEEP, FiO2, Tidal volume, Apnea time,
IPAP
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Warnings
10
To comply with the biosafety standards to reduce the risk of infection such as
washing your hands thoroughly before and after handling the ventilator or its
accessories. To clean the ventilator and its accessories regularly and system-
atically before and after each use and following any maintenance procedure to
reduce the risks of infection.
To prevent possible patient injury, do not enter the diagnostic mode while a
patient is connected to the ventilator. Verify that the patient is disconnected
before proceeding.
Ensure that always verify all settings are set in accordance with the required
prescription before starting ventilation. Avoid the patient to remain connected
to the ventilator when ventilation is stopped, because a substantial quantity of
exhalation gas, primary carbon dioxide, may be inhaled by the patient.
To prevent possible patient injury due to no annunciating alarms, verify the
operation of any alarm device before use.
They must be discarded after single use. Reusing, disassembling, cleaning,
disinfecting, or sterilizing a single-use part may compromise its functional-
ity and system performance, leading to a possible operator or patient hazard.
Performance is not guaranteed if an item labeled as single-use is reused.
An alternative means of ventilation shall be available whenever the ventilator
is in use. If a fault is detected in the ventilator or its life-support functions are
in doubt, disconnect the Impala Ventilator from the patient and immediately
start ventilation with such a device.
Do not add any attachments or accessories to the ventilator that contravene
the instructions for use of the ventilator or accessory, as the ventilator might
not function correctly, leading to the risk of patient death or serious deteriora-
tion of health.
-
gen-enriched environments. Do not use antistatic or electrically conductive
tubing.
Setup
11
1. Attach gas hose, breathing circuit
A. Attach the compressed oxygen source to the CGA 1240 oxygen inlet.
B. Attach the breathing circuit to the device.
1. Prepare breathing circuit as follow
disposable circuit
-
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Impala User manual
2. Attach inspiratory tube to the inspiratory port in front of the device
3. Insert exhalation valve into the breathing circuit at the end of the expiratory
tube
4. Attach exhalation valve control tube to the control port in front of the device
5. -
tion.
6. Attach the blue and clear tubes to the measurement ports on the ventilator.
7.
12
13
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Impala User manual
2. Plug in and power up
A. The connector plugs into the side of the device and then directly into the power
outlet in the wall.
Only use power supply unit provided by MTTS.
The gas sources must provide pressure within the range of 10 to 60 psi
Attaching the compressed oxygen will not waste any oxygen. The machine will
not use any compressed oxygen until you increase the FiO2 setpoint.
Always at-
tach the blue tube to the port marked with blue color.
Setup Setup
The device will start with the default STANDBY mode.
14
15
B. Press and hold the Power Button to turn the device ON.
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Operation
Calibrate oxygen sensor
Oxygen sensor is automatically calibrated. The process takes 90 seconds to com-
plete. The display shows the calibration progress.
Calibrate ow sensor
-
bration process.
16
17
Operation
Set patient information
After turning on, a window automatically appears and shows information about the
last patient. Touch OK to continue with the patient or change information to setup a
new patient.
tidal volume with a factor of 6 ml/kg.
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19
Operation
Adjust parameters
Touch the parameter to open its window for adjustment. On this window, touch
‘+’ or ‘-’ to increase or decrease the parameter setpoint. Some preset values are also
given on the window for quick selection. Touch OK to return to the main screen.
18
Set ventilation mode
Touch ventilation Mode button to open Mode selection window. On this window,
select desired ventilation mode and touch OK.
-
-
tween the different modes are compatible. This reduces the risk of discom-
fort and harm to the patient
Ensure another source of ventilatory support is available during the calibra-
tion and testing. The patient must be disconnected from ventilator during the
calibration and testing processes.
To cancel the calibration or testing process while in progress, touch Skip but-
ton on the screen.
If calibration is skipped, the device starts ventilating but measurements can
be inaccurate.
process.
Operation
Perform tightness test
is gradually pressurized to 50 cmH2O. Any leak in the breating circuit will result in
the test failure.
connection during testing.
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Impala User manual
Operation
20
Operation
21
Set alarm limits
To set alarm limits, touch the ‘Alarm’ button on the Setting screen. Select desired
alarm limit and adjust its value. Touch OK to return to the Setting screen.
Setting screen
Setting screen, touch Setting button on the main screen. To return the main screen,
touch the Setting screen again.
Following features are available on the Setting screen:
• Go to the Device information screen
•
• Set alarm limits
• Check system tightness
• Adjust less frequenly used parameters
• Adjust alarm sound loudness
The Setting screen and available features may vary depending on the soft-
ware version.
Turn the device off
Press and hold the Power button to turn the device off.
Start/Stop ventilation
After selecting ventilation mode and all neccessary parameters are set, ventila-
tion can be started by touching Standby button. Touching Standby during ventilation
will put the device in Standby mode and stop ventilation. A timer in the standby but-
ton starts counting up to show how long the patient has not been ventilated.
Red color of the standby button indicates that the device is in Standby mode.
Refer to Ventilator Parameter section for available parameters in each venti-
lation mode.
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22
23
Alarm systemAlarm system
Alarm Cause/Ventilator Response Corrective Action
High rate Adjustment of Max the total of
breath per minute too low
Re-adjust Max the total of breath per minute
Adjustment of the inspiratory sensi-
tivity level too low
Adjust trigger sensitivity according to the pa-
tient
Patient hyperventilating Silence the alarm and call for a medical team if
the symptoms persist
Check for auto-cycling and adjust inspiratory
sensitivity, manage leaks or drain condensation
from patient circuit
representative
Low rate Adjustment of Max the total of
breath per minute too high
Re-adjust Max the total of breath per minute
Adjustment of the inspiratory sensi-
tivity level too high
Adjust trigger sensitivity according to the pa-
tient
representative
High Vti Adjustment of the Max Vti level too
Note: Always consult the clinical before chang-
ing PEEP, FiO2, pressure, volume or rate set-
tings.
Modify the Max Vti level
Flow sensor not calibrated properly
Low Vti Adjustment of Min Vti too high or f
pressure level not enough to reach
Modify the Min Vti level or the pressure level ac-
cording to the physician’s prescription
Patient circuit obstructed or discon-
nected
Clean, unblock, and/or re-connect the patient
circuit
Flow sensor not calibrated properly
Low FiO2 Not enough oxygen delivered by the
ventilator
Check oxygen source.
Replace oxygen tank if it’s empty.
High FiO2 Oxygen sensor not calibrated prop-
erly
Calibrate the oxygen sensor
The Impala Ventilator will generate visual and audible alarm signals to notify you of
alarm conditions detected.
An alarm condition is indicated by:
• Audible alarm tone
•
In order to verify the operation of auditory and visual alarms, perform the following
procedure:
2. Check pressure audible alarm sounds
Alarm system test
Alarm silence
Audible alarms may be suspended, while visual alarms may not. The alarm silence
button is used to temporarily silence audible alarms for 2 minutes. When this but-
ton is pressed, its color turns red indicating audible alarms are silenced. The alarm
sounds are can be restored by press the button again.
List of alarms
Alarm Cause/Ventilator Response Corrective Action
Low battery
cut-off
and internal battery capacity is
Reconnect the device to an AC power outlet
High pressure Adjustment of Max PIP too
Note: Always consult the clinical before
changing PEEP, FiO2, pressure, volume or
rate settings. Increase the Max PIP threshold
Airway obstruction Check patient’s trachea and clear the ob-
exhalation efforts
Treat patient’s cough. Silence the alarm, if
necessary
Patient inspiratory resistance or
compliance changes
Have physician determine if ventilator set-
tings are appropriate for the patient.
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Impala User manual
24
25
Cleaning
Comply with hospital, local and national guidelines for product cleaning fre-
quencies.
Ensure oxygen supply is turned off and disconnected from Impala Ventilator
before performing cleaning procedures.
Before cleaning, remove and discard all used disposable products using rec-
ommended method of disposal.
Dust all surfaces with clean damp soft cloth.
-
Dry all the surfaces after cleaning with a clean soft cloth or paper towel.
Ensure that no part of Impala Ventilator is immersed in any cleaning liquid or
cleaning solution.
Do not use abrasive cleaning solutions.
Ensure all Impala Ventilator parts and accessories are checked before re-
turning the device to service.
The reusable breathing circuit includes parts that must be completely disassembled
sensor, exhalation valve, straight and wye connectors. These parts are not manufac-
tured by MTTS, please comply with the original manufacturers’ guidlines.
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Impala User manual
Maintenance
-
dures.
After the maintenance is completed, ensure the equipment is functioning cor-
Ensure only approved replacement parts are used during service and mainte-
nance procedures.
Please contact an authorised MTTS representative for further assistance with
any servicing or maintenance requirement.
26
The Impala Ventilator includes a number of parts that must be replaced or serviced
during the lifetime of the device. These parts include:
Component Approx. Duration of Use Maintenance Information
6 months Clean or replace.
Oxygen sensor 18 months Replace if it is fauty or FiO2 control
is not accurate after calibration.
Maintenance
27
Device information screen
To better understand the device performance, device information should be checked
before opening the device. From Setting screen, touch the Info button to see this in-
formation.
Air lter and oxygen sensor replacement
Oxygen sensor
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Specications
28
Tyoe of mechanical ventilation device
Intended use
Ventilation modes
Required accessories
I:E ratio
Trigger
Invasive
All patients that need help ventilation
AC-VCV, AC-PCV, SIMV-PC, SIMV-VC, VCV/
PS, PCV/PS, CPAP, BiPAP
-
1:9 - 4:1
:
:
:
:
:
:
Total unit mass
Alarms
Internal pump
Ingress Protection
20 cm x 22cm x 20 cm
3 kg
5 pulse burst, followed by 0.5 second delay,
followed by 5 pulse burst, followed by 3
second delay
3 pulse burst, followed by 2.5 second delay
Blower, 12VDC
75 cmH2O
overall
High Priority Audible
Medium Priority Audible
Medium Priority Visual
Alarm Volume
Type
Maximum limited pressure
IP21
Specications
29
Support pressure
0-25 cmH2O
5-60 cmH2O
2-60 bpm
5-60 cmH2O
25-2000 ml
:
:
:
:
:
:
±1 bpm
:
:
:
:
:
Operating
Transport and storage
Exclusions
Standards for Reference
EN ISO 13485:2016
EN ISO 14971:2012
EN 60601-1:2006/A1:2013
EN 60601-1-2:2015
EN 60601-1-6:2010
EN 60601-1-8:2007/A11:2017
ISO 80601-2-12:2020
MEDDEV 2.12-1 Rev. 8
MEDDEV. 2.7.1 Rev. 4
MEDDEV. 2.12-2 Rev. 2
Atmospheric Pressure: 70-106kPa
Atmospheric Pressure: 70-106kPa
None
Power characteristics
Off-the-shelf external power supply
Battery
60W, 100-240VAC, 47/63Hz
International medical safety approvals
100k hours MTBF
RoHS 2 compliant
Over voltage / over current protection
11.1V Li-ion
6 cells, 6000mAh
Type
Capacity
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30
31
Explanation of Symbols
Do not disassemble Beluga Resuscitator unless you are
an MTTS trained technician or have been instructed to by
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
Power supply polarity
12V DC 5A 12 Volt, Direct Current, 5 Ampere
2265
Name and address of European Authorized Representative
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Impala User manual
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, INCLUD
ING ANY IMPLIED WARRANTIES OF MERCHANTABIL
ITY AND FITNESS FOR A PARTICULAR PURPOSE. FOR
ALL TRANSACTIONS OCCURRING IN VIETNAM ANY
IMPLIED WARRANTY OR CONDITION OF MERCHANT
ABILITY, SATISFACTORY QUALITY, OR FITNESS FOR A
PARTICULAR PURPOSE IS LIMITED TO THE DURATION
OF THE EXPRESS WARRANTY SET FORTH ABOVE. SOME
COUNTRIES DO NOT ALLOW A LIMITATION ON HOW
LONG AN IMPLIED WARRANTY LASTS OR THE EXCLU
SION OR LIMITATION OF INCIDENTAL OR CONSEQUEN
TIAL 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
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 ma-
terials or workmanship under normal use during Lim-
ited 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 entitled
to hardware warranty service according to the terms and
conditions of this document if a repair to your MTTS prod-
uct 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
or parts equivalent to new in performance and reliability,
has been discontinued. Replacement parts are warrant-
ed to be free from defects in material or workmanship for
Period of the MTTS product they are replacing or in which
they are installed, whichever is longer.
32
Warranty Policy
MTTS will, at its sole discretion, repair or replace any
components or product that manifests a defect in materi-
als or workmanship during the Limited Warranty Period.
All component parts removed under this Limited War-
ranty become the property of MTTS. In the unlikely event
that your MTTS product has recurring failures, MTTS at
replacement unit selected by MTTS that is the same or
to give you a refund of your purchase price or lease pay-
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
of accident, misuse, abuse, contamination, improper or
parameters stated in the user documentation shipped
-
-
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 PROD
UCT OR THE FAILURE OF THE PRODUCT TO PERFORM,
INCLUDING ANY LOST PROFITS OR SAVINGS OR SPE
CIAL, 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.
33
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Impala User manual
Warranty Policy
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-
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 documentation
do not solve the problem, you can receive support by do-
ing one of the following:
-
stall software patches, run MTTS diagnostics and
Implement temporary procedures or workarounds
provided by MTTS while MTTS works on permanent
Cooperate with MTTS in attempting to resolve the
problem using online chat, email, or telephone. This
may involve performing routine diagnostic procedures,
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.
34
-
-
-
-
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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: assistanc[email protected]
www.mtts-asia.com
PROMETEO SRL
Via Mantova 9
38122 Trento
Italy
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