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XHZ-90L Operator's Manual

This manual provides instructions for the safe and effective use of the Neonatal Bilirubin Phototherapy Equipment XHZ-90L. It includes statements about the electromagnetic emissions and immunity of the equipment, as well as guidelines to ensure an adequate electromagnetic environment.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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0% found this document useful (0 votes)
31 views23 pages

XHZ-90L Operator's Manual

This manual provides instructions for the safe and effective use of the Neonatal Bilirubin Phototherapy Equipment XHZ-90L. It includes statements about the electromagnetic emissions and immunity of the equipment, as well as guidelines to ensure an adequate electromagnetic environment.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

MANUAL OF OPERATION FOR NEONATAL BILIRUBIN PHOTOTHERAPY EQUIPMENT EDIT/REVIEW/1

XHZ-90L
Phototherapy Equipment of
Bilirubin for Neonates

OPERATOR'S MANUAL

Thank you for purchasing the XHZ-90L bilirubin phototherapy equipment for neonates. For its application
Correct, please read this manual carefully and keep it for future reference.

NINGBO DAVID MEDICAL DEVICE CO., LTD.


NEONATAL BILIRUBIN PHOTOTHERAPY EQUIPMENT OPERATION MANUAL EDIT/REVIEW 1

Manufacturer's Declaration and Guide - Electromagnetic Emissions -


For all TEAMS and SYSTEMS

Manufacturer's Declaration and Guide – Electromagnetic Emissions


The neonatal bilirubin phototherapy team XHZ-90 is designed for use in the environment
electromagnetic specified below. The customer or user of phototherapy equipment
Neonatal bilirubin XHZ-90 must ensure that it is used in such an environment.
Emission test Conformity Guide - Electromagnetic Environment
RF Emission The bilirubin phototherapy team of
CISPR 11 NeonatoXHZ-90L uses RF energy only for its
internal functioning. Therefore, your
Group 1 RF emissions are very low and it is little
likely to interfere with any equipment
nearby electronic.
RF Emission The bilirubin phototherapy equipment of
Class B
CISPR 11 NeonatoXHZ-90Les adaptable to all
Harmonic Emissions establishments, including establishments
Class A
IEC 61000-3-2 domestics and those in direct contact with
emissions of the low voltage power supply network
fluctuations y what feeds buildings used for purposes
Complies domestic
voltage flicker
IEC 61000-3-3

Page 1 of 4
OPERATION MANUAL FOR NEONATAL BILIRUBIN PHOTOTHERAPY EQUIPMENT EDIT/REVIEW/1

Manufacturer's Declaration and Guide - Electromagnetic Immunity -


For all TEAMS and SYSTEMS

Manufacturer's Declaration and Guide - Electromagnetic Immunity


The neonatal bilirubin phototherapy team XHZ-90L is designed for use in the
electromagnetic environment specified below. The customer or user of phototherapy equipment
The neonatal bilirubin meter XHZ-90L must ensure that it is used in that environment.
Test of Test Level Level of Guide–environment
immunity IEC 60601 Compliance electromagnetic
Download 6 kV contact 6 kV contact The floors must be made of wood.
electrostatics (ESD) 8 kV air 8 kV air concrete or ceramic tiles. Yes
IEC 61000-4-2 the floors are covered with
synthetic material, humidity
relative must be at least 30%.
burst / transients 2 kV for networks of 2kV for networks of The quality of the power
fast IEC supply supply the principal should be that of a typical
61000-4-4 environment hospitality o
commercial.
Overvoltage 1 kV differential mode 1 kV mode The quality of power
IEC 61000-4-5 2 kV common mode differential the principal should be that of a typical
2 kV common mode environment hospitality o
commercial.
Voltage drops, <5% UT <5% UT The quality of power
short interruptions (>95% dip in U)T) >95% drop in UT) the principal should be that of a typical
y variations of For 0.5 cycles For 0.5 cycles environment hospital o
voltage in the lines commercial. If the user of
electric 40% UT 40% UT phototherapy equipment of
supply of (60% dip in UT) (60% dip in UT) neonatal bilirubin XHZ-90L
power For 5 cycles For 5 cycles requires continuous operation
IEC 61000-4-11 during the interruptions of
70% UT 70% UT power principal it
(30% dip in U)T) 30% dip in UT) recommends that the team of
For 25 cycles For 25 cycles bilirubin phototherapy of
Newborn XHZ-90L sea
<5% UT <5% UT powered by a supply of
>95% dip in UT) >95% dip in UT) power uninterrupted o
For 5 seconds For 5 seconds battery.
NOTE UTIt is the main AC voltage before the application of the test level.

Page 2 of 4
MANUAL OF OPERATION FOR NEONATAL BILIRUBIN PHOTOTHERAPY EQUIPMENT EDIT/REVIEW/1
Manufacturer's Declaration and Guide – Electromagnetic Immunity
For LIFE SUPPORT EQUIPMENT and SYSTEMS

Manufacturer's Declaration and Guide - Electromagnetic Immunity


The XHZ-90L Neonatal Bilirubin Phototherapy Unit is designed for use in the
electromagnetic environment specified below. The client or user of phototherapy equipment
The neonatal bilirubin meter XHZ-90L must ensure that it is used in that environment.
Test of Test Level Level of
Guide–electromagnetic environment
immunity IEC 60601 Conformity
Portable and mobile RF communication equipment
they should not be used near the phototherapy equipment of
Neonate bilirubin XHZ-90L, including cables,
that the recommended separation distance calculated
from the equation applicable to the transmitter frequency.
Recommended Separation Distance
3.5
Conducted RF 3Vrms 3 Vrms d P
IEC 61000-4-6 150 kHz to 80 MHz V1

RF Irradiated 10 V/m
IEC 61000-4-3 80 MHz to 2.5 GHz 3 V/m

80 MHz to 800 MHz

800 MHz to 2.5 GHz


Where is the maximum power output measured for
the transmitter in watts (W) according to the manufacturer of the
transmitter and the separation distance
recommended in meters (m).b
The force fields of fixed RF transmitters are
determined by a survey,c
They must be lower than the compliance level
required in each frequency range.d
Interference may occur in the surroundings of the
equipment marked with the following symbol:

NOTE1 At 80 MHz and 800 MHz, apply the higher frequency range.
NOTE2 These guidelines do not apply in all situations.
Electromagnetic propagation is affected by the absorption and reflection of structures, objects, and people.
a
The force fields of fixed transmitters, such as base stations for radio (cellular/wireless) phones and radios
from the ground, amateur radio, AM and FM radio stations, and TV stations cannot be predicted theoretically with accuracy.
To study the electromagnetic environment due to fixed RF transmitters, an electromagnetic survey must be considered.
of the site. If the magnetic field measured at the location of the neonatal bilirubin phototherapy device XHZ-90L
applicable RF compliance level, the neonatal bilirubin phototherapy equipment must be monitored to ensure the
normal operation. If abnormal performance is observed, additional measures should be taken if necessary, such as
reorient or change the location of the neonatal bilirubin phototherapy equipment XHZ-90L.
b
For the frequency range of 150 kHz to 80 MHz, fields must be less than 3 V/m.

Page 3 of 4
NEONATAL BILIRUBIN PHOTOTHERAPY EQUIPMENT OPERATION MANUAL EDITING/REVIEW/1

Recommended separation between RF communication equipment


laptops and mobiles and the TEAM or SYSTEM
for VITAL SUPPORT EQUIPMENT or SYSTEMS

Recommended separation between RF communication equipment


laptops and mobile phones and the neonatal phototherapy equipment for bilirubin XHZ-90L
The neonatal bilirubin phototherapy equipment XHZ-90L is designed for use in an environment where RF emissions
be controlled. The client or user of the neonatal bilirubin phototherapy equipment XHZ-90L can help prevent the
electromagnetic interference maintaining a minimum distance between portable and mobile communication equipment and the equipment
of the neonatal bilirubin phototherapy XHZ-90L as recommended below, according to the maximum output power of
communication team.
Separation distance according to the transmitter frequency (m)
Power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
maximum output
measure of 3.5 3.5 7
d P d P d P
Transmitter (W) V E E
1 1 1
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
100 12 12 23
For transmitters measured at a maximum output power that is not on the list, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the transmitter frequency where P is the measure of Power of
Maximum output of the transmitter in (W) according to the manufacturer of the transmitter.

NOTE1 At 80 MHz and 800 MHz, apply the separation distance for the higher frequency range.
NOTE2 These guidelines do not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection of structures, objects and people.

Page 4 of 4
OPERATION MANUAL FOR NEONATAL BILIRUBIN PHOTOTHERAPY EQUIPMENT EDIT/REVIEW/1

WARRANTY
The product described in this manual is guaranteed against defects in materials or workmanship.
for one year from the date of shipment, with the following exceptions.
All consumer and disposable products are guaranteed to be free from defects.
only until the shipment.

2. Calibrations are considered normal maintenance and are not included in the 1-year warranty.
year.
During the warranty period, any defective part apart from those mentioned above
will be replaced at no cost to the customer.
This guarantee will be voided and the company will not be responsible for the results of it if:
Damage to the unit is incurred as a result of mismanagement.
The client does not provide maintenance in the proper way.
The customer uses parts or accessories not specified or sold by our company.
4. The sale or service is carried out by a distribution or service agency or not
certified.
This warranty replaces any other warranty, expressed or implied, and our company will not be
in no case shall be liable for incidental or consequential damages, including loss of use,
material damages or personal injuries caused by breach of warranty.
The Hospital Accreditation Manual requires that all equipment be tested before use.
initially and at least once a year thereafter. To comply with this standard, it is recommended
that users participate in our compliance testing accreditation program
during the warranty period. This service can be carried out through our company and
authorized distributors.

SERVICE
For optimal performance, the product service must be carried out only by personnel from
qualified service.
MANUAL OF OPERATION OF NEONATAL BILIRUBIN PHOTOTHERAPY EQUIPMENT EDITING/REVIEW/A/1

OPERATIONAL PRECAUTIONS
The misuse of the BILIRUBIN PHOTOTHERAPY EQUIPMENT FOR NEONATES
BILIRUBIN PHOTOTHERAPY EQUIPMENT) can result in harm to the baby. THE EQUIPMENT OF
BILIRUBIN PHOTOTHERAPY FOR NEONATES should only be used by trained personnel.
properly trained according to the instructions of a duly qualified doctor aware
of the detected risks and benefits.
2. Products that are easily interfered with by magnetic fields should not be used nearby.
of phototherapy, as they can interfere with it.
3. Phototherapy could not be used within a high electromagnetic field.
4. Phototherapy equipment should not be used in the presence of gases that may lead to
combustion (for example, oxygen, nitrous oxide, anesthetic agents).
5. It is not allowed to treat phototherapy equipment with flammable solutions (antiseptics,
cleaning products, etc.)
6. Do not store medications or infusion liquids in the radiation area of the EQUIPMENT
BILIRUBIN PHOTOTHERAPY FOR NEONATES.
7. For the safety of the infant, the BILIRUBIN PHOTOTHERAPY EQUIPMENT FOR NEONATES
It must be used by infants in a protective barrier, such as a basket, a crib.
open, an incubator or a radiant heater, etc.
8. The various environmental conditions (for example, temperature, radiation source)
Around the PATIENT, they can affect the patient's temperature and the bilirubin value. For
ensure to keep the baby's body temperature stable when the child receives the
phototherapy treatment, try to maintain an adequate and stable environmental setting where the
BILIRUBIN PHOTOTHERAPY EQUIPMENT FOR NEONATES is located.
on the contrary, the baby will be affected. If the ambient temperature is much lower, it will reduce the
baby's body temperature causing the baby to feel cold, while if the temperature
the environment is much greater, it will raise the baby's body temperature causing a
heating in the baby's temperature. On the other hand, the ambient air flow rate
it decreases the baby's body temperature and makes him feel cold.
9. Although the intensity of the infrared radiation from the BILIRUBIN PHOTOTHERAPY EQUIPMENT
FOR NEONATES it is much lower, with radiation for a long time, it will cause the temperature
the baby's body increases. Additionally, when the BILIRUBIN PHOTOTHERAPY TEAM
FOR NEONATES is used simultaneously with thermotherapy devices, such as a
incubator, a radiant heater or a heating mattress will affect the uniformity of the
temperature of these thermotherapy devices to raise the baby’s body temperature.
Therefore, the operator should measure the baby's body temperature regularly.
less than once every hour
10. Make the previously mentioned thermotherapy devices work in Baby Mode,
the opposite, the air temperature of thermotherapy devices must be reduced from
according to measurements of body temperature.
11. Please do not place your hand over the space between the lamp and its mounting bracket as
OPERATION MANUAL FOR NEONATAL BILIRUBIN PHOTOTHERAPY EQUIPMENT EDIT/REVIEW/1

indicates the figure to avoid injuring your fingers.


12. For optimal stability of the BILIRUBIN PHOTOTHERAPY EQUIPMENT FOR
NEONATES, and to prevent the child from falling off the EFFECTIVE SURFACE AREA, it is necessary to

block the mobile support wheels during use.


13. For the safety and effectiveness of the BILIRUBIN PHOTOTHERAPY EQUIPMENT FOR
NEONATES, customers can only use the spare parts sold by our company, such
like fluorescent tubes.
14. For the effectiveness of the BILIRUBIN PHOTOTHERAPY TEAM FOR NEONATES,
make sure that all fluorescent tubes must be changed when their lifespan has been reached
overcome.
15. Before replacing the fuse, you must cut off the power supply, then change the fuses.
as indicated.
16. The device, accessories, and packaging must be disposed of correctly.
At the end of use. Please follow the local ordinances or regulations for disposal.

ELECTRICAL PRECAUTIONS
To ensure reliable grounding, connect the A.C. power cable only to a
hospital-grade three-wire ground connection or a hospital-grade outlet. Do not use
extension cords. If there is any doubt regarding the grounding connection, do not use the equipment.
There is a risk of electric shock in the Lamp when the cover is removed. The
maintenance must be carried out exclusively by qualified personnel with the documentation of
appropriate service.
Make sure the building power source is compatible with the electrical specifications shown on the
rear of the Lamp.
3. The safety of auxiliary devices must meet the general requirements of
safety according to IEC60601-1.
The switch only disconnects one of the poles of the electrical network, it is not a switch for
security disconnection, the device's input is used as a disconnection device. Use the
device entry as the intended isolation medium.

SEASONAL SECURITY CONTROL


1. Please clean the power cable connector at least once a year. Excess dust on the
connector can spark a fire.
2. The following security controls must be performed at least every 12 months by a
qualified person who has proper training, knowledge, and practical experience to
carry out these tests. The data must be recorded in a equipment log. If the
device does not function correctly or fails in any of the previous tests, the device
It needs to be repaired.
Inspect the equipment and accessories for mechanical and functional damage.
MANUAL OF OPERATION FOR NEONATAL BILIRUBIN PHOTOTHERAPY EQUIPMENT EDIT/REVIEW/1

Inspect
2 the relevant safety labels for readability.
Inspect
3 the fuse to verify compliance with current characteristics and
last hour.
○.
4 Verify that the device operates correctly as described in the instructions for

use.
Test
5 the earth protection resistance according to IEC 60601-1:1988 + A1:1991 + [Link]
Limit 0.1Ω.
○.
6 Test the earth leakage current according to IEC 60601-1:1988 + A1:1991 + [Link] Limit:

NC 500μA, SFC: 1000μA.


○.7 Test of leakage from the current enclosure according to IEC 60601-1:1988 + A1:1991 + [Link] Limit:

NC 100μA, SFC: 500μA.

TABLE OF DEFINITIONS AND SYMBOLS


TECHNICAL DEFINITIONS
EFFECTIVE SURFACE AREA: Surface where the PATIENT rests according to the
expected position and that is radiated by the PHOTOTHERAPY EQUIPMENT.
TOTAL IRRADIATED FOR BILIRUBINAEwithIrradiated equal to irradiation evaluated in the range
between 400 nm and 550 nm.

UNIFORMITY G2of the total irradiated for bilirubin: Radius of the smallest
TOTAL IRRADIATION FOR BILIRUBINAEwith me to the highest TOTAL IRRADIATION FOR
BILIRUBINbi maxin the AREA OF EFFECTIVE SURFACE.
LIFETIME OF THE NEONATAL BILIRUBIN PHOTOTHERAPY EQUIPMENT: The period
understood between the expiration date and the discard date as useless.
LIFETIME OF THE LIGHT SOURCE: The time after the average total irradiation of
Bilirubin Ebi decreases by 25%.

NOTE, IMPORTANT, CAUTION AND WARNING


NOTE: A note is inserted in the text to indicate the procedures or conditions that differ from another.
can be misunderstood or overlooked. A note can also serve
o
t calyfriapparenyltconra
tdcio
tryorconu
fsnigsu
tiaoitns.
IMPORTANT: Similar to a note but used when greater emphasis is required.
CAUTIONS: A caution is inserted in the text to draw attention to a
procedure that if not followed exactly can lead to damage or destruction of the
team.
WARNINGS: A warning is inserted in the text to draw attention to the
hazardous or risky conditions inherent to operation, cleaning, and maintenance
of the equipment that can result in personal injury or death of the operator or patient.
NEONATAL BILIRUBIN PHOTOTHERAPY EQUIPMENT OPERATION MANUAL EDITING/REVIEW/1

SYMBOLS
Attention, Please Check Attached Documents.
e

CLASS I Class I Equipment Caution: DO NOT pinch fingers

110-120V~ Input power


T 3.15AL/250V Type F fuse 3.15AL/250V
50/60Hz
On Off

Manufacture Date SN Serial Number

Eye Mask Brand CE Mark

Non-ionizing radiation
MANUAL OF OPERATION FOR NEONATAL BILIRUBIN PHOTOTHERAPY EQUIPMENT EDITING/REVISION/1

TABLE OF CONTENTS
SECTION PAGE
1. GENERAL INTRODUCTION………………………………………………………………………………1
2. FORESEEN USE………………………………………………………………………………...…………1
3. PRODUCT COMPOSITION..........................1

4. DESCRIPTION………………………………………………………………………………………………1
5. SPECIFICATIONS…………………………………………………………………………...……3
6. INSTALLATION………………………………………………………………………………………………5
7. GENERAL OPERATING PROCEDURES.......................................................7

8. CLEANING......................................................10

9. STERILIZATION………………………………………………………………………………….…10
10. MAINTENANCE……………………………………………………………………………………….10
11. PROBLEM SOLVING………………………………………………………………………….10
NEONATAL BILIRUBIN PHOTOTHERAPY EQUIPMENT OPERATION MANUAL EDITION/REVIEW/1
1. GENERAL INTRODUCTION
This manual provides instructions for installation, debugging, use, cleaning and
maintenance of the BILIRUBIN PHOTOTHERAPY EQUIPMENT FOR NEONATES. No
we can take responsibility for the performance of the PHOTOTHERAPY TEAM
BILIRUBIN FOR NEONATES if the user does not operate the unit in accordance with the
instructions in the manual or perform repairs with unauthorized components. The
repairs must be carried out only by qualified personnel. The technical information is
available through your local distributor.
Before using the device, all personnel who will be working with the unit must
read and thoroughly understand this manual.
This manual should be kept with the BILIRUBIN PHOTOTHERAPY EQUIPMENT
FOR NEONATES to consult when needed.
2. EXPECTED USE
It emits a high-intensity visible light in the range of 400 nm - 550 nm through tubes.
blue fluorescent lights expected for the treatment of neonatal hyperbilirubinemia.
3. PRODUCT COMPOSITION
The BILIRUBIN PHOTOTHERAPY DEVICE FOR NEONATES consists of the lamp, and the
mobile support. It can be used with the mobile support (MOBILE PHOTOTHERAPY UNIT), or only
the lamp without the mobile support for use on the incubator cover (UNIT OF
PHOTOTHERAPY set up in incubator.
4. DESCRIPTION
Mobile
1 Phototherapy Unit
Lamp Module Timer
Lock button
Power switch

Mounting bracket for the lamp Protection panel


(With light radiation source inside)

Height adjustment rod

Utility clip
Support
Mobile
Lamp Column

Support

Dustproof cover

FIGURE 1
MANUAL OF OPERATION FOR NEONATAL BILIRUBIN PHOTOTHERAPY EQUIPMENT EDIT/REVIEW/1

DESCRIPTION OF
EXPLANATION
PARTS
This main part is composed of the light radiation source,
the reflection panel, a timer function and so on,
Lamp module
and it is the core of the BILIRUBIN PHOTOTHERAPY TEAM FOR
NEONATES.
Mounting support for the
lamp To adjust the radiation angle of the lamp module.

lock button
Height adjustment rod,
For adjusting the height of NEONATE BILIRUBIN PHOTOTHERAPY
clamp nut,
EQUIPMENT.
lamp column
To move the BILIRUBIN PHOTOTHERAPY EQUIPMENT FOR
Support
NEONATES. With 4pcs wheels with brake.

○.
2 PHOTOTHERAPY UNIT mounted in incubator

Lamp Module Timer Switch

Protection panel (with radiation source of light inside)

Lamp Column

Incubator of
Infant

FIGURE 2
MANUAL OF OPERATION FOR NEONATAL BILIRUBIN PHOTOTHERAPY EQUIPMENT EDITION/REVISION/1

DESCRIPTION OF THE
EXPLANATION
PART
This main part is made up of the radiation source of the
light, the reflection panel, a timer function and so on
Lamp Module
successively, and it is the core of the PHOTOTHERAPY TEAM OF
BILIRUBIN FOR NEONATES.
To install the phototherapy unit at the top of the
Lamp Column
baby incubator.

5. SPECIFICATIONS
The specifications for the BILIRUBIN PHOTOTHERAPY EQUIPMENT FOR NEONATES are
provided in table 1.1.
TABLE 1.1 SPECIFICATIONS
This equipment belongs to Class I equipment, applied part Type BF, normal device (IP20)
operated continuously.
Power Requirements……………………………………………AC 110-120V, 50/60Hz, 75VA
Light source ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... LED

Maximum spectrum……………………………………………………………………………………465 nm
Lifespan of the light source .....................................................5000 hours
Remote treatment ………………………………………………………………………………40 cm
46 cm (above the cover)
The highest total irradiation for bilirubinEbi max in effective surface area…3.5mW/cm 2
(for MOBILE PHOTOTHERAPY UNIT)
1.7mW/cm2
(for PHOTOTHERAPY UNIT mounted in incubator)
The maximum total spectral irradiance in the effective surface area……………….≥3.7mW/cm2
(for MOBILE PHOTOTHERAPY UNIT)
≥1.7mW/cm2
(for PHOTOTHERAPY UNIT mounted in incubator)
Total irradiation for bilirubin among all pointsmy mineyEbi max measured in the area of
effective surface……………………………≥2.5mW/cm (for mobile 2 PHOTOTHERAPY UNIT)
≥1.3mW/cm2(for PHOTOTHERAPY UNIT mounted in incubator)
Uniformity G2of the total irradiated for bilirubin……………………………………………… 0.4
Infrared radiation in the effective surface area……………………………………≤1mW/cm2
Ultraviolet radiation in the effective surface area... ≤1.0×10-5mW/cm2(180nm < λ ≤ 400nm)
Work noise…………………………………ambient noise ≤40dB(A), work noise ≤50dB(A)
Adjusting radiation range for the lamp module angle…0 - 60ofrom horizontal
(only for mobile PHOTOTHERAPY UNIT)
Adjusting the height range of the lamp module............................1350mm 1650mm

(for MOBILE PHOTOTHERAPY UNIT only)


Built-in Timer Range………………………………………0 to 9999 hours 59 minutes

AMBIENT TEMPERATURE (Do not use in environments that exceed the specified values to
continuation)
Operating range…………………………………………………………………..…..….…..28º 34º
NEONATAL BILIRUBIN PHOTOTHERAPY EQUIPMENT OPERATION MANUAL EDIT/REVIEW/1

-40º to +55º
AMBIENT HUMIDITY
Range of Operations …………………………………………………………………………30%~75%
Storage Range …………………………………………………………………………………≤93%

ATMOSPHERIC PRESSURE
Storageandshippingrange:500hPa~1060hPa
OperatingRange………………………………………………700hPa~1060hPa

AIR FLOW RATE


Ambient air movement rate …………………………………………………………<0.3m/s

ANOTHER SPECIFICATION
M e d i d a d e the a UNIT D E PHOTOTHERAPY Move
Width 620×Height 1350×Length 705mm (height adjustment rod in the lowest position)
Width 620 × Height 1650 × Length 705 mm (Height adjustment rod in the lowest position)
Measurements of the PHOTOTHERAPY UNIT mounted in the incubator
Width 420 × Height 810 × Length 1000 mm
Weight of the MOBILE PHOTOTHERAPY UNIT………………………………………………18kg
Weight of the PHOTOTHERAPY UNIT mounted in incubator………………………………10kg

Useful Life

The total spectral irradiance Ebi over a wavelength interval of 5 nm for the
wavelength range between 320nm and 550nm.

Spectral distribution

1.2
1
0.8

The Calibration Curve of sλ 0.6


0.4
Measuring Device
0.2
0
390 430 470 510 550
λnm
NEONATAL BILIRUBIN PHOTOTHERAPY EQUIPMENT OPERATION MANUAL EDIT/REVIEW A/1

6. INSTALLATION
In general, the mobile phototherapy unit is usually packed in a cardboard box, and the unit of
fixed phototherapy is generally packaged with the infant incubator. When removing the equipment from the
cardboard boxes, be careful not to damage the spare parts.
At least two professionals install the PHOTOTHERAPY EQUIPMENT of
BILIRUBIN FOR NEONATES with a screwdriver and keys.
A. Installation of the Mobile Phototherapy Unit
a. Install the lamp column in the support.
See figure 3, first loosen the 4 flat head screws M6 X16 to secure the bracket.
pressure washer Φ6, and the flat washer Φ6 with a screwdriver, then place the column
from the lamp on the stand, move the dust cover up, secure the lamp pole to the
support with the previously loose screws and the washers. Finally, lower the dust cover.
gently.

Flat screws of
stripes M6×16 Lamp column
Pressure Washer Φ6
Flat washer Dust cover

Support

FIGURE 3
b. Install the height adjustment bar.
Turn the nut in Figure 4 counterclockwise and remove the nut.
the adjustment ring, the adjustment claw, and the clamp seat.
Pass the clamp seat, the adjusting claw, the adjusting ring, and the nut through
the height adjustment bar, and then insert the bar inside the lamp column, then adjust
the nut in the direction of the clock hands.
A. Height adjustment bar

B. Nut
[Link] ring
OPERATION MANUAL FOR NEONATAL BILIRUBIN PHOTOTHERAPY EQUIPMENT EDITING/REVIEW/1

[Link] claw

E. Clamp Seat
[Link] of the lamp

c. Install the lamp module FIGURE 4


See figure 5, insert the lamp module into the height adjustment bar.
② Unscrew the cover cap in the opposite direction of the clock hands and tighten the screw.
hexagonal M8×120 with a key to adjust the lamp module on the height adjustment bar
and install the cover lid in its own position.

WARNING: Please ensure that the M8×120 hex screw is secure.


adjusted, or the whole device would roll due to the horizontal inclination of the

lamp module.
FIGURE 5
d. Insert the power cable
Insert the power cable into the outlet in figure 5.

B. Installation of the fixed phototherapy unit


a. Install the rectangular rule frame
See figure 6, place the rectangular rulers on the left and right sides of the cover
respectively, and adjust it with the washers and the hexagonal screw.
b. Install the lamp column
See figure 6, adjust the lamp column and the rectangular rule with the washers and the
hexagonal nut. The installation of the left and right lamp column is the same.
c. Install the lamp module
See figure 6, adjust the lamp module between the columns of the left lamps and
right with the washers, the lamp column, and the screws.
d. Insert the power cable
MANUAL OF OPERATION FOR NEONATAL BILIRUBIN PHOTOTHERAPY EQUIPMENT EDIT/REVIEW/1

Insert the power cable into the auxiliary power socket of the infant incubator.

1 10

2
11
3
12
4

6
13
7

1 Lamp column....2 2 Lamp module........1 3 Hexagonal screw M10×90...4

4 Hexagonal screw M8×16.4 5 Hexagonal screw M8×3...4 6 Flat washer 8.........12


7 Marco of the rectangular rule....2 8 Bush 9 Flat washer..............4
10 Pressure washer 10 ...4 Hexagonal Nut M8........4
13 Pressure washer 8......8

FIGURE 6
7. GENERAL OPERATING PROCEDURES

WARNING
1. Use the eye mask on the patient during phototherapy treatment to prevent
keratitis or damage to the patient's retina due to heat.
2. Please cover the genitals with a diaper during phototherapy treatment for
avoid damage to the genitals.
The water balance in the patient can be disturbed during the treatment of
phototherapy, nurses must provide water to the patient on time.
4. The photoisomers of bilirubin can cause toxic effects. For example, the
patient may have diarrhea, lack of Kernicterus, hemolysis, anemia, and so on
successively, so the nurse must provide a lot of care.
OPERATION MANUAL FOR NEONATAL BILIRUBIN PHOTOTHERAPY EQUIPMENT EDIT/REVIEW/1

5. Measure the patient's bilirubin concentration regularly.


6. To avoid the phenomenon of feeling dizzy or feeling partially blind, the nurse
One should not remain in the radiation area for long.

7.1 Preparation before the operation


7.1.1 Make sure to clean and sterilize the PHOTOTHERAPY UNIT according to the instructions
in Section 8 of this user manual.
7.1.2 Ensure that the PHOTOTHERAPY UNIT is operational. For example, all the
light sources can work and the timer can work too.
7.1.3 If you have purchased the mobile PHOTOTHERAPY UNIT, please follow the next procedure.
before giving the phototherapy treatment patient:
Loosen the locking button in figure 1, and adjust the angle of the lamp module to the position
parallel above the effective surface in figure 7, and then adjust the height of the
MOBILE PHOTOTHERAPY UNIT loosening the nut clip counterclockwise
clock hands in the counterclockwise direction in figure 1 until the distance between the module of the
lamp and the effective surface is 40 cm.
.

Mobile PHOTOTHERAPY UNIT

About effective surface 300mm×200mm

FIGURE 7
IMPORTANT: 1. For the safety of the patient and the efficacy of phototherapy treatment,

maintain the distance between the lamp module and the effective surface at
40 cm.
2. To achieve the best phototherapy treatment, you must ensure that
that the central point of the lamp module and that of the effective surface are
they are found on the same line.

WARNING
Please do not loosen your hand while rotating the nut to prevent the lamp module.
and the height adjustment rod comes out of the lamp column. (See figure 1)

7.1.4 If you purchased the PHOTOTHERAPY UNIT mounted in an incubator, it is not necessary to process the
OPERATION MANUAL FOR NEONATAL BILIRUBIN PHOTOTHERAPY EQUIPMENT EDITING/REVIEW/1

preparation in point 7.1.3.


7.2 Operation
7.2.1 Place the naked patient on the effective surface in figure 7. If it is the UNIT OF
PHOTOTHERAPY set up in incubator, please place the patient on the mattress. (Note: All the
the surface of the infant incubator mattress is the effective surface.
Central Point of the Mattress

200mm

In the surface area 200mmx200mm


IMPORTANT: To achieve the best phototherapy treatment, have the patient do

request about the effective surface.


7.2.2 Use the eye mask for the patient, and cover the genitals with a diaper.
7.2.3 Connect the power supply and turn on the equipment to start the phototherapy treatment.
patient.
NOTE: Regarding the timing of phototherapy treatment, please follow the instructions.
from the doctor.

WARNING
You must use the power cable along with this model, otherwise, it will decrease the
unit security.
7.2.4 The operator must leave the radiation area after completing the previous procedure.
to avoid light radiation for a long time. Please do not look at the light source when it
use the unit again.
7.2.5 Operating timer
The timer can count the elapsed time or reset and start again.
turn off the power switch, the counter will display the elapsed time and will stop working
until the power switch is turned on again, then it will remain in the
count. If you want to reset the timer, please press the reset key.
OPERATION MANUAL FOR NEONATAL BILIRUBIN PHOTOTHERAPY EQUIPMENT EDITING/REVIEW/1

RESET KEY

FIGURE 8
NOTE: 1. To ensure the accuracy of the elapsed time or the current working time, for
Please do not turn on the device before connecting the power source.
To accurately record the elapsed time of the lamp, please do not press
RESET (Reset Button) to clear the current time at the moment of lifting the
the lamp has not expired.

8. CLEANING
Please clean and sterilize the entire unit for initial use or use it for one week.
Please cut the power supply and turn off the switch before cleaning.
Use a disinfectant-detergent registered by the nation to thoroughly clean all the
surface including all corners and the hollow part, and then dry with a clean cloth or towel
of paper.
NOTE: To avoid cracks in the acrylic cover, please do not clean it with alcohol, acetone, or
Another organic solution is not to expose it to ultraviolet radiation.
WARNING: Avoid liquid flowing inside the device through the hole.
radiator during cleaning.
9. STERILIZATION
NOTE: Please do not use steam autoclave.
Please use cold sterilization.
10. MAINTENANCE
In order to ensure the good effect of phototherapy treatment, when the useful life of the
lamp, must be replaced, even if it may still function normally. The reasons are
the following:
That the capacity of light radiation will be reduced with the prolongation of work time and will make
that the average radiation of total bilirubin is reduced to 25% of its original value so that the team
it loses its preventive effect during phototherapy treatment.
To replace the lamp, it must be done by qualified personnel.
11. PROBLEM SOLVING
The problem-solving of the PHOTOTHERAPY UNIT is presented in the following table.
If the fault cannot be located in the panel, the phototherapy unit must be taken out of service and
must be sent to our company or the authorized qualified service personnel.

SYMPTOM POSSIBLE CAUSE SOLUTION


The power switch is Turn off the switch.
Not all light sources short power supplement
they work
No power cable connection Connect the power cable
OPERATION MANUAL FOR NEONATAL BILIRUBIN PHOTOTHERAPY EQUIPMENT EDITING/REVIEW/1

Turn on the switch of


The switch is not on
power supplement
Damaged fuse Replace the fuse
The timer does not Turn on the switch of
The switch is not on
works power supplement

SPECIAL STATEMENT: All the content of the manual has been reviewed.
carefully, if there is any error or misunderstanding in the content of the
printing, our company will maintain the final explanation of this document.
NOTE: The appearance of the product may differ from that of the manual, but this does not affect the

product capacity. Please understand if this causes you any problems.

NINGBO DAVID MEDICAL DEVICE CO., LTD.


NO.158DAQINGROAD,SHIPU,NINGBO,ZHEJIANGPROVINCE,CHINA
NEONATAL BILIRUBIN PHOTOTHERAPY EQUIPMENT OPERATION MANUAL EDIT/REVIEW/1

315731 0086-574-65962111
MARKETING CENTER: NO. 100, JINGHUA ROAD, HI-TECH INDUSTRIAL DEVELOPMENT
ZONE, NINGBO, CHINA
315000
0086-574-87800008, 87800009 0086-574-87801111
E-MAILL: sales@[Link] sales@[Link]
[Link]
EUROPEAN REPRESENTATIVE: SHANGHAI INTERNATIONAL HOLDING [Link] (EUROPE)
EIFFESTRASSE 80, 20537 HAMBURG, GERMANY
TEL:0049-40-2513175 0049-40-255726

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