mtts Colibri User manual

Colibri. User manual
User Manual
Effective date: May 2016
Issue Number: 01 Version: 01 EN
Issue Date: March 2016 www.mtts-asia.com
2265
Colibri
phototherapy

V.01.EN
Colibri. User manual
Contents
Company Information
Introduction
Device Description
Warnings
Setting up Phototherapy
Using Phototherapy
Safety information
Irradiance measurement
Specications
Explanation of Symbols
Warranty Policy
04
05
06
08
09
12
15
17
18
20
21
03

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Colibri. User manual
Phototherapy is one of the simplest and safest methods to treat jaundice in
neonatal intensive care. Untreated jaundice leads to an excessive level of bilirubin
in the blood which may potentially result in brain damage or death.
What does phototherapy do?
Reduces the bilirubin level in the blood through:
Photo-oxidation
Congurational isomerisation
Structural isomerisation
Phototherapy starts medical treatment immediately after it’s turned on.
It emits very little heat because of the LED light source, so does not cause
dehydration.
Phototherapy with Colibri
Colibri Phototherapy equips you to deliver high-intensity phototherapy to
treat this potentially hazardous condition.
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: [phone]
Fax: [phone]
Email: assistanc[email protected]om
www.mtts-asia.com
PROMETEO SRL
Via Mantova 9
38122 Trento
Italy
EC
REP

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Colibri. User manual
06
Device Description Device Description
07
Overview
Back Canopy
Control Panel
Height Adjustment
Front Canopy
Lockable Castors
Control Panel
12 3
1 On/Off Button Press this button to turn Colibri Photothrapy
display and functions on and off.
2 Therapy Mode Button Press this button to switch between standard
and intensive therapy mode.
3 Display Shows therapy mode and treatment time.

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Colibri. User manual
08
Warnings Setting up Phototherapy
Using the device outside of the specied ambient temperature range
(19-37°C) or humidity range (0-90%RH) can compromise 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 impairs its ventilation.
Do not cover the the device with blankets during operation.
The presence of electro-surgical devices, shortwave or microwave
equipment near this device could lead to electrical interference that
negatively affects the function of the device.
Do not modify this equipment without authorization of the manufacturer.
Step 1 - Remove components from the box
Box content:
1. Stand
2. Base
3. Canopy set
LED lifetime warning: The blue LEDs in Colibri Phototherapy are rated to
provide effective treatment for 44 000 hours.
After turning ON Colibri Phototherapy the display will show the “total device
hours” for 3 seconds and ‘Error 4’ message after that. Error message will
continue to appear every second during treatment time.
Note: The estimated 44000 hour life span is equal to a full 5 years of non-
stop use. After this period of time the LED phototherapy lights will continue
to function, however treatment will be signicantly less effective and Colibri
Phototherapy should be replaced.
09
Step 2 - Stand assembly preparation
1. Remove protection label
2-3. Unscrew slowely height asdjustment knob.
4. Remove height adjustment knob.
1 2 3
1 2 3 4
While unscrewing the knob secure inner pole with hand in order to prevent uncontrolled releasing.

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Setting up Phototherapy Setting up Phototherapy
11
Step 3 - Base assembly
Step 4 - Sand assembly
Step 5 - Canopy set assembly
Step 6 - Plug in and power up
The connector plugs into the back of Colibri Photothrapy base and then directly into the power outlet in the
wall.
Only use the cable and connector that is provided by MTTS.
Colibri Photothrapy should only be used with the power outlets that have a
protective earth (ground) pin.
100 - 240 V (AC)
1. Insert the stand into the base
2. Screw in 3 bolts into the thread hole.
3-4. Connect and secure DC connector
5. Tighten the bolts using wrench (size 13)
1. Pull out plastic bracket with DC connector from inside of the stand
2. Connect it with Canopy set wire
3-4. Insert connected wire back to the stand and cover it with plastic bracket
5. Attach canopy set tp the stand and secure it with screws
1. Insert stand support ring
2. Screw back height adjustment knob
1 2 3
45
12
Operations 2-4 might
require 2 poeple to
perform them
1 2 3 4 5

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Colibri. User manual
Using Phototherapy
13
Using Phototherapy
12
1. Plug in Colibri Photothrapy to the power outlet. Turn on the device by pressing “On/Off Button”.
The display shows the “total device hours”. This will be displayed for 3 seconds.
2. The blue phototherapy lights will now start to shine in STANDARD MODE.
The display will start counting the “treatment time” in STANDARD MODE.
This example shows 1 minute of STANDARD therapy.
3. The phototherapy treatment will continue until the doctor decides therapy is no longer necessary and
the device can be switched off by pressing “On/Off Button”.
This example shows 72 hours 30 minutes of STANDARD therapy.
Starting and stoping the therapy Selecting therapy mode
Colibri Phototherapy can be operated in 2 modes:
- STANDARD: ~25 µW/cm2/nm
- INTENSIVE: ~40 µW/cm2/nm
1. To select the mode press “Therapy Mode Button”
Colibri Photothrapy starts with STANDARD MODE once it is turned on. Pressing “Therapy Mode
Button” will switch it to INTENSIVE MODE.
STANDARD MODE is indicated by letter “n” on the display (“n” for “normal”)
INTENSIVE MODE is indicated by letter “b” on the display (“b” for “boost”)
The display shows the “total device hours of INTENSIVE MODE”. This will be displayed for 3 seconds.
2. The blue phototherapy lights will now start to shine in INTENSIVE MODE.
The display will start counting the “treatment time” in INTENSIVE MODE.
This example shows 1 minute of INTENSIVE therapy.
3. The phototherapy treatment will continue until the doctor decides therapy is no longer necessary and
the device can be switched off by pressing “On/Off Button”.
Pressing “Therapy Mode Button” will switch back the device to STANDARD MODE and restart the
treatment counter.
This example shows 13 hours 20 minutes of INTENSIVE therapy.
This example shows OFF message.
If there is power interruption after the restart the device will return to the same
mode that was in when the interruption happened.

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Colibri. User manual
Using Phototherapy Safety Information
14
15
Height adjustment
DO NOT disassemble any part of the Colibri Phototherapy
DO NOT place Colibri Photothrapy in direct sunlight.
Always cover the patients eye’s with a shield or patch whenever the patients
eye’s can be exposed to Colibri Photothrapy light. Periodically, you may want
to ensure that the baby’s eyes are protected and infection free.
Patient’s bilirubin values should be measured regularly while undergoing
phototherapy treatment.
To accurately assess the baby’s skin colour turn off the light when checking
the baby’s condition.
Regularly monitor the patient’s temperature and uid status.
Note: In the event of a power outage, eye coverings should be left on the patient whenever they are under
Colibri Photothrapy to protect the patient’s eyes in case the power returns.
Recommended distance from the light source to the patient is 30-40 cm.
Colibri Phototherapy can be moved up and down in order to select preferred distance
from the light source to the patient. The height of the device beteen 115 and 140 cm.
115 -140 cm
0 -25 cm

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Colibri. User manual
Safety Information Irradiance measurement
The lights will decay gradually over time, reaching approximately 70% of their
original irradiance at 44,000 hours.
Note that the irradiance should be measured when the device has reached 44,000
hours. After 44 ,000 hours the device should be replaced with a new one.
Note: to ensure that the device is functioning properly, regularly monitor Colibri Pho-
tothrapy in the following way.
Measurement instructions:
To test the irradiance of Colibri Photothrapy measure using a lightmeter specically
designed to measure wavelengths for phototherapy.
A stabilization time of 2 hours of continuous operation is required for accurate
measuring of the irradiance.
When measuring the light prop up the lightmeter 30-40 cm from the top to achieve
the surface area seen in the adjacent picture. Measure the irradiance of Colibri Pho-
totherapy in each of the sections seen in the adjacent picture.
16
17
Colibri Phototherapy should be used only by appropriately trained
personnel and under the direction of qualied medical personnel familiar with
currently known risks and benets of infant phototherapy equipment use.
Patients adjacent to the infant phototherapy equipment may need to be
protected with protective shields or eye protection.
The operator may experience some effects during prolonged exposure to the
area irradiated by the infant phototherapy equipment.*
Blue light can hinder clinical observations by masking skin colour changes,
such as cyanosis.
An infant’s water balance may be inuenced by phototherapy. Regular feeding
times may need to occur more often in order to prevent dehydration.
Varying the ambient conditions (ambient temperature and/or different radiation
sources) may negatively affect the patient. Refer to your hospital phototherapy
policy and procedure regarding appropriate ambient conditions.
Bilirubin photoisomers may be toxic.
Do not use Colibri Photothrapy if it appears that any part of the device is not
functioning properly or if any parts appear damaged. Contact MTTS.
In case of any malfunction DO NOT attempt to service this machine,
Colibri Photothrapy should only be serviced by a qualied MTTS technician.
Due to photo effects, drugs and infusion liquids should not be stored in the
radiation area.
Do not use the in the presence of potentially combustible gases including
oxygen, nitrous oxide or other anaesthetics.
*Sensitive individuals may experience headache, nausea or mild vertigo if he/she stays too long in the
illuminated area. Using Colibri Photothrapy in a well-lighted area or wearing glasses with yellow lenses can
alleviate potential effects. Guard Dog Bones glass es (p/n 413BB) are recommended and are available online at
www.safetyglasses.com
STANDARD MODE
INTENSIVE MODE
IRRADIANCE
20.0 - 29.9
30.0 - 39.9
40.0 - 49.9
50.0 - 59.9
20.0 23.7 24.1 23.7 21.6
26.3 30.3 30.8 30.1 27.6
20.2 22.4 23.7 22.4 20.1
32.6 40.4 40.9 39.0 34.4
45.9 55.1 56.6 53.5 48.4
33.3 37.5 38.0 36.0 31.5

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18
Specications
Performance Specications
Illumination source
Peak wavelength
Lamp duration
Average spectral irradiance
Effective surface area
Irradiance Uniformity Ratio
Time Totalizer
Measured with
Key features
Dimensions (LxWxD)
Height Adjustment
Total unit mass
Power characteristics
Off-the-shelf external power supply
No moving parts
Enclosed designed toward NEMA Type 5
60 cm x 55 cm x 155 cm
140 cm
115 cm
16 kg
High-power blue LEDs, 1-1.25W standard operating
445 - 465 nm (peak 455 nm)
LEDs rated to last 44,000 hours at max temperature
24.7 µW/cm2/nm
41.5 µW/cm2/nm
50 cm x 30 cm
0.65 (IEC Compliant >0.4)
0.56 (IEC Compliant >0.4)
Treatment time, total device hours, total device hours in
Intensive Mode
Olympic Bili-Meter
Standard Mode
Intensive Mode
max height
maximum
minimum
Physical Specications
Electrical Specications
60W, 100-240VAC, 47/63Hz
International medical safety approvals
(ANSI/AAMI/EN 60601-1, UL/TUV)
Class I construction is standard (ground required)
100k hours MTBF
Energy Star Efciency Level V compliant
RoHS 2 compliant
Over voltage / over current protection
19
Operating
Transport and storage
Exclusions
Standards for Reference
EN 60601-1:2006/AC2010: (3rd edition) Medical electrical equipment – Part 1 General requirements for basic
safety and essential performance
EN 60601-1-2:2007/AC2010: Medical electrical equipment – Part 1-2: General requirements for basic safety
and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
EN 60601-2-50: 2009: Medical electrical equipment – Part 2-50: particular requirements for the basic safety
and essential performance of infant phototherapy equipment
EN 60601-1-6:2010: Medical electrical equipment – Part 1-6: General requirements for basic safety and
essential performance – Collateral standard: Usability
Ambient temperature +10°C to +35°C
Humidity: 0% to 90% RH non condensing
Atmospheric Pressure: 70-106kPa
Ambient temperature +10°C to +85°C
Humidity: 0% to 90% RH non condensing
Atmospheric Pressure: 70-106kPa
None
Environmental Specications
Specications
Standard Mode
Intensive Mode

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Colibri. User manual
Explanation of Symbols
Do not disassemble Colibri Photothrapy, unless you are
an MTTS trained technician or have been instructed to by
qualied personnel.
Device manufacturer.
Date of manufacture.
Power supply polarity.
12 Volts, Direct Current, 5 Ampere
CE Logo with Notied Body Number
Keep out of direct sunlight.
An eye patch should always be placed on the patient
before commencing treatment.
This device should be disposed of separately from normal
household waste so that components can be recycled.
Please refer to User Manual before operating this device.
12V DC 5A
Warranty Policy
2265
20
21

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Warranty Policy
23
Warranty Policy
Customer Responsibilities