XHZ-90L Operator's Manual
XHZ-90L Operator's Manual
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.
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OPERATION MANUAL FOR NEONATAL BILIRUBIN PHOTOTHERAPY EQUIPMENT EDIT/REVIEW/1
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MANUAL OF OPERATION FOR NEONATAL BILIRUBIN PHOTOTHERAPY EQUIPMENT EDIT/REVIEW/1
Manufacturer's Declaration and Guide – Electromagnetic Immunity
For LIFE SUPPORT EQUIPMENT and SYSTEMS
RF Irradiated 10 V/m
IEC 61000-4-3 80 MHz to 2.5 GHz 3 V/m
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.
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NEONATAL BILIRUBIN PHOTOTHERAPY EQUIPMENT OPERATION MANUAL EDITING/REVIEW/1
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.
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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
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.
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:
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%.
SYMBOLS
Attention, Please Check Attached Documents.
e
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
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 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
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
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
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
lamp module.
FIGURE 5
d. Insert the power cable
Insert the power cable into the outlet in figure 5.
Insert the power cable into the auxiliary power socket of the infant incubator.
1 10
2
11
3
12
4
6
13
7
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
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
200mm
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.
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
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