Equipment for neonatal and premature infants: Phototherapy unit

Atom Phototherapy Unit 106

ORIGINAL

0123

Operation Manual

TO THE OPERATOR AND THE PERSON IN CHARGE

OF MAINTENANCE AND CARE OF THE UNIT:

●●Read this Manual carefully before operating the unit.

●●Keep this Manual where it is readily accessible for reference when
needed.
 EU OFFICE
Via Libia, 54 - 20081 Abbiategrasso (MI) - Italy
Tel: +39 02 99763101 Fax: +39 02 99763110
 INTRODUCTION

This Operation Manual deals with the specifications, operation and maintenance of the BILI-THERAPY Spot Type.
Atom is by no means responsible for any malfunction arising from a user ignoring the instructions for operation
and maintenance described in this Manual as well as any accident attributable to repair by someone other than
technical personnel belonging to or authorized by Atom.
Read this Manual carefully and familiarize yourself with its contents before operating the unit. Keep this Manual
where it is readily accessible for reference when needed. If any technical problem should arise, please contact
your local Atom representative.

CAUTION
This product is shipped without being disinfected. Be sure to clean and disinfect the unit before
using it for the first time after purchase.

Used parts and products past their expected life span should be disinfected and/or sterilized to
prevent infection from them and then disposed of in accordance with applicable waste disposal
laws and regulations.

INTENDED USE

The BILI-THERAPY Spot Type is a phototherapy unit intended for the treatment of neonatal hyperbilirubine-
mia.

SAFETY INFORMATION

Instructions to ensure the safe operation of the unit are found throughout this Manual. Please read the Manual
carefully before operating the unit. Please follow the instructions when operating the unit.

Basic Instructions
1. Follow the instructions for the safe use of the unit.
Follow the operating instructions described in this Manual for the safe use of the unit.

2. Inspect the unit on a periodical basis.

Periodical inspection is needed to use the unit in the optimum condition.

3. Never use the unit if it is found to be defective.

If any damage or malfunction of the unit should be noticed, stop using it immediately and contact your local
Atom representative.

4. Follow the EMC information described in this Manual.

Medical electrical equipment needs special precautions regarding EMC. It needs to be installed and put into
service according to the EMC information described in this Manual.

1
 Definitions of Warning Indication
Three levels of warning indication are used throughout this Manual and on the unit. They are defined as
follows.
A DANGER notice indicates an immediately hazardous situation which, if not avoided,
DANGER: will result in death or serious injury, serious damage to property such as total loss of use
of equipment or fire.
A WARNING notice indicates an indirectly (potentially) hazardous situation which,
WARNING: if not avoided, will result in death or serious injury, serious damage to property such as
total loss of use of equipment or fire.
A CAUTION notice indicates a hazardous situation which, if not avoided, can result in
CAUTION: minor or moderate injury, partial damage to equipment, and loss of data stored
in computers.

Definition of Symbols
1. Symbols to indicate danger, warning or caution
Symbol Title and indication

General attention
Indicates unspecified general danger, warning or caution.

2. Symbols to prohibit action

Symbol Title and indication

General prohibition
Indicates unspecified general prohibition.

Prohibition of disassembly
Indicates prohibition of disassembly of the unit where it may cause an electric shock or other
hazards.

3. Symbols to give instructions for action

Symbol Title and indication

General instruction
Indicates unspecified general action on the part of the user.

Remove the power plug from the power outlet

Instructs the user to remove the power plug from the power outlet in the case of malfunction or
when there is a threat of lightning.
Shield the infant’s eyes with an eye protector
Indicates that the infant’s eyes must be shielded with an eye protector when they are exposed
to phototherapy light.

2
4. Symbols of international standards (IEC)
Symbol Title and indication

Lamp
Pressing the switch located next to this symbol turns ON the lamp for observation.

Alternating current
This symbol indicates alternating current.

Manufacturer
This symbol indicates the name and the address shown adjacent to the symbol is of the manu-
facturer.

Date of manufacture
Indicates the date when the unit was manufactured in the factory.

Authorised representative in the European community

This symbol indicates the name and the address shown adjacent to the symbol is of the authorised
representative in the European Community.
WEEE symbol
In the EC area, an electrical and electronic product falling in one of the categories specified by
“DIRECTIVE 2002/96/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27
January 2003 on Waste Electrical and Electronic Equipment (WEEE)” should be disposed of in
a manner consistent with relevant laws and regulations.
This symbol indicates that the above-mentioned requirement applies to this product.
Class II device
This symbol shows that the device is categorized into class II device in terms of protection against
electric shock.

Direct current
This symbol indicates direct current.

Stepless
This symbol indicates stepless adjustment.

Caution
Indicates that the user needs to see a relevant accompanying document before operating
the unit.

3
 5. Other symbols
Symbol Title and indication

Switch
Pressing the switch located next to this symbol starts phototherapy.

Installation on F-Rail
This symbol shows that the device is intended for use with F-Rail and that tightening the fixing
knob secures the device to the mounting part.
Lamp / lighting (bright) Button
With the power switch depressed to the “ ” side, press this button to make the light brighter.
With the power switch depressed to the “ ” side or in the neutral position, press this button to
display the operation time of the light source.
Patient / lighting (dark) Button
With the power switch depressed to the “ ” side, press this button to make the light darker.
With the power switch depressed to the “ ” side or in the neutral position, press this button
to display or reset patient irradiation time.
Plug polarity
This symbol indicates that the internal terminal of the plug is positive (+), and the external ter-
minal negative (-).
Mounting the irradiation head
This symbol indicates to depress the lever of the suction pad, and fix the irradiation head to the
top of the incubator hood.

Attaching to the Holder Part

This symbol shows that the Mount Type irradiation head should be secured where it does not
catch the relay cable between itself and the power source part holder.

4
Precautions on Jamming
WARNING
Electric surgical knives, portable and mobile communication equipment, and other devices which
generate high-frequency noise can cause jamming to various kinds of electric equipment for medi-
cal use and thus result in malfunction.
Since portable and mobile communication equipment, etc. are often used in medical facilities, some
measures should be taken to prevent jamming due to such devices.
Portable and mobile communication equipment and other devices which generate high frequency
should not be used near the unit during its operation to prevent malfunction of the unit due to jam-
ming.

Responsibility for Care of Equipment

CAUTION
It is the user (a hospital, a doctor’s office, a clinic) that is responsible for the operation, maintenance
and care of the electric equipment for medical use. The equipment should be used only by medical
personnel.

Prohibition of Modification
WARNING
Do not disassemble or modify the unit.
Otherwise, a fire, an electric shock or injury may result.

Periodical Inspection
CAUTION

Proper periodical inspection is needed to use the unit in the optimum condition.

In Case of Trouble
CAUTION
If any abnormal condition or trouble should occur to the unit, indicate on the unit that it is out of
order and contact your local Atom representative or service engineer immediately.

If any abnormal condition or trouble should occur, do not use the unit until it has been repaired
completely by a service engineer so as to prevent possible danger.

5
 CONTENTS

PLEASE READ WITHOUT FAIL

INTRODUCTION........................................................... 1 APPENDIX

[8] Technical Information. .................................. 39

PLEASE READ WITHOUT FAIL
8-1. Technical Data................................................ 39
[1] Operating Precautions.................................... 8 8-2. EMC Level and Classification...................... 41
1-1. DANGER................................................... 8 [9] Treatment Considerations. ......................... 45
1-2. WARNING................................................. 8
1-3. CAUTION................................................ 11

[2] Parts Identification......................................... 13

PREPARATION
PREPARATION

[3] Preparation before Use................................. 16

3-1. Power Outlet................................................... 16
3-1-1. Arm Type, Stand Type.......................... 16
3-1-2. Mount Type............................................. 17
3-2. Installation....................................................... 18
3-2-1. Arm Type................................................ 18
3-2-2. Stand Type............................................. 19
3-2-3. Mount Type............................................. 20
3-3. Daily Inspection.............................................. 23

OPERATION
3-4. Attaching the Eye Mask to the Infant.......... 23

OPERATION

[4] How to Operate the Unit............................... 25

4-1. Checking the LED Lights.............................. 26
4-2. Adjusting the Irradiation Position................. 26
4-3. Phototherapy Treatment................................ 26
4-4. Observing the Infant (with the Lamp)......... 27
4-5. Storage after Use........................................... 27

MAINTENANCE
4-6. Safety Function.............................................. 28

MAINTENANCE

[5] Cleaning and Disinfection. ......................... 29

[6] Maintenance Inspection............................... 30
6-1. Measuring the Irradiance Level................... 31
6-1-1. Arm Type, Stand Type.......................... 31
6-1-2. Mount Type............................................. 32
6-2. Inspection before Use................................... 33
6-3. Monthly Inspection......................................... 34
6-4. Periodical Replacement Parts..................... 35
APPENDIX

6-5. Inspection Checklist...................................... 36

6-6. Disposal.......................................................... 37
[7] Troubleshooting. ............................................. 38
 Operating Precautions

[1] Operating Precautions

Please follow the operating instructions described in this Manual for the safe use of the unit. The unit should
be operated only by those who have been trained and instructed properly in its operation. The unit should be
operated only for its intended use.

1-1. DANGER
Death or serious injury will result if the instructions given below are not followed.

Do not use the unit in the presence of a flammable anesthetic gas.

The unit may cause an explosion or a fire if used in the presence of such a gas.

Do not use the unit with an infant to whom phototherapy has not been prescribed.

1-2. WARNING
Death or serious injury due to a fire, an electric shock, tipping over of the unit, etc. will result if the instructions
given below are not followed.

Be sure to inspect the unit at the start of each day.

Operating the unit without inspecting it at the start of each day may let a defect pass unnoticed and cause a po-
tentially unfavorable outcome.

Do not look directly at the LED light.

Cover the infant’s eyes with an eye protector during phototherapy treatment.
Otherwise, damage may occur to the infant’s eyes.

Before using the unit, be sure to check that there is no risk of the infant falling off the incuba-
tor, the infant warmer, etc.
Make sure that the infant will not fall off even if he or she moves.

The electrical rating of this unit is as follows:

Rating: AC100-240V; Power consumption: 30VA; Frequency: 50/60Hz; Operating voltage range:
AC100-240V±10%.
Do not connect the unit to any other power source.

Before using the unit, be sure to check that the arm mount is attached securely to the incu-
bator or the infant wamer.
If the arm mount is not attached securely, the unit may fall..

Be sure to fix the upper support column of the Stand Type securely with the fixing knob to
prevent it from sliding down.

Avoid damaging the power cord.

A damaged power cord may cause a fire or an electric shock.
••Do not get the power cord caught between the unit and the wall, a shelf or the floor.
••Do not place the power cord near a heating apparatus or heat it.

8
 Operating Precautions

••Do not put anything heavy on the power cord.

PLEASE READ WITHOUT FAIL

••Always grasp the power plug with your hand to remove the power cord from the power outlet. A damaged power
cord should be replaced immediately with a new one.

Use only the power cord and the AC adapter supplied with the unit.
Otherwise, a fire or an electric shock may result. A power cord or an AC adapter other than the one supplied with
the unit can generate high frequency noise, cause jamming to other electric devices for medical use and thus result
in malfunction. In addition, when such a power cord or an AC adapter is used, the unit may become susceptible
to high frequency noise generated by other electric devices and thus result in malfunction.

Do not touch the power plug with a wet hand.

Touching the power plug with a wet hand may cause an electric shock.

The power outlet should be located near the unit to prevent accidental contact with a trailing
power cord. Use a separate power outlet for each unit.

Do not put many loads on one power outlet.

Do not use a device generating high frequency near the unit.

To prevent malfunction of the unit due to jamming, do not use electric surgical knives, portable and mobile com-
munication equipment and other devices which generate high frequency near the unit during its operation.

Do not disassemble or modify the unit.

Disassembling or modifying the unit may cause a fire, an electric shock or injury.

Use only the parts and accessories specified for the unit
Otherwise, the unit may malfunction or break down.

Place the unit in such a way that an infant near it will not be exposed to phototherapy light.
If phototherapy light should get in the eyes of an infant who is not receiving phototherapy treatment, problems may
occur to his or her eyes. Cover the eyes of an infant ajacent to the unit with a phototherapy mask if necessary.

Nursing staff should be cautious about symptoms of visual discomfort.

Staying in an irradiated area for a long time may cause a headache, nausea or mild vertigo. To reduce such symp-
toms, use the unit in a well-lighted area or wear glasses with yellow lenses. Turn off the unit while the infant is
being taken care of under the unit.

The unit does not use a cold light.

Pay attention to the rise of the infant’s skin temperature when using the unit.

Do not use the unit in a high oxygen environment.

The unit is not designed to be used in a high oxygen environment. Operate the unit surrounded by room air.

Do not pour any liquid directly on the unit.

Otherwise, a fire, an electric shock or damage to the unit will result. If a copious amount of liquid should be poured
on the unit accidentally, wipe it off immediately and check the electronic circuits inside the unit.

Do not operate the unit where it is exposed to excessive humidity, dust or steam.
Operating the unit in such a place may cause a fire or an electric shock.

9
 Operating Precautions

Do not place photosensitive medicines near the unit.

Photosensitive medicines may deteriorate when exposed to phototherapy light. Never place or store such medi-
cines near or within the irradiated area.

Stop using the unit immediately if any trouble is detected.

If the unit does not function normally, stop using it immediately, indicate on the unit clearly that it is out of order
and contact your local Atom representative.

The unit should be serviced only by qualified personnel according to an appropriate service
manual.

Be sure to lock the caster stopper on the stand type except when the unit is being moved.

As Mount Types are only designed for incubators, they must not be applied to other prod-
ucts.

Be sure to attach the F-Rail Attachment and the Pole Mounting Attachment of the Mount Type
to the power source part.

Be sure to connect the relay cable of the unit to the connector area of the irradiation head of
the Mount Type. Do not also connect the relay cable to any other product than the unit.
It may cause damage to the equipment.

Be sure to attach the irradiation head of Mount Type to the top surface of the incubator hood.
Do not attach it to the sloping section of the hood whenever possible. Do not also attach it
to the curved surface of the hood.
It may cause the irradiation head to fall off the hood.

Before attaching the irradiation head of the Mount Type, be sure to check the surface of the
hood and suction pad, and do not attach the irradiation head if either of them is damaged.
If so, the adhesiveness of the suction pad is reduced, so that it may cause the irradiation head to fall off the
hood.

The Mount Type must not be used for treatment while the canopy of Dual Incu i is being
raised.
Be sure to perform the treatment with the canopy being lowered. As the irradiation distance from an infant under
treatment to the unit is too long when the canopy is raised, the efficacy of treatment will be reduced.

Before attaching the irradiation head of the Mount Type, clean the incubator hood surface
and Mount Type suction pad.
If dust or dirt adhere to the surface and suction pad, the absorption power of the suction pad is reduced, so that
it may cause the irradiation head to fall off the hood.

Check that the relay cable of the Mount Type is positioned so that it does not interfere with
the operation of the incubator, etc. or the treatment of an infant.

Do not get the relay cable of the Mount Type pinched.

It may cause the cable to be broken.

10
 Operating Precautions

PLEASE READ WITHOUT FAIL

Be sure to check that the relay cable is not pinched before inserting the irradiation head into
the holder.
When trying to insert the irradiation head into the holder part with the relay cable of the Mount Type being
pinched between the irradiation head and power source part, the irradiation head cannot be securely fixed to the
power source part and may fall off.

1-3. CAUTION
Injury or damage to surrounding objects may result if the instructions given below are not followed.

Be sure to clean and disinfect the unit before using it for the first time after purchase.
The unit is shipped without being disinfected.

Before using the unit, it is recommended that you measure the irradiance level of the unit
according to “6-1. Measuring the Irradiance Level”, and follow the doctor’s treatment policy.

The unit should be operated within the ambient temperature of 10-30ºC. Do not operate the
unit outside of the temperature range mentioned above.
When the LEDs are used properly, deterioration of their light output can be minimized throughout their service
life. The LEDs operate for approximately 10,000 hours. However, if they are used in an environment outside the
operating conditions, their service life may be reduced.

Be sure to clean the irradiation head cover.

If the irradiation head cover is dirty, radiant energy will be reduced and the infant may not be treated properly.

Bear in mind the following points when operating the unit.

1. Endeavor to identify the cause of neonatal jaundice (hemorrhage, infection, bleeding, etc.) and provide ap-
propriate causal therapy concurrently.
2. The infant’s skin color becomes less correlated with his or her serum bilirubin level during phototherapy
treatment. Therefore, readings obtained by the icterometer are not reliable at all. Measure the infant’s serum
bilirubin level at least once a day. It has been reported that in very rare cases, separated serum may assume a
brownish tinge (methemalbuminemia).

Remove the power plug from the power outlet before moving the unit to another place or
when the unit is not going to be used for a long time.
Moving the unit to another place with the power plug connected to the power outlet will damage the power cord
and may cause a fire or an electric shock.

Remove the power plug from the power outlet before cleaning and disinfecting the unit.
Cleaning and disinfecting the unit with the power plug connected to the power outlet may cause an electric
shock.

Install the unit on a stable surface.

Installing the unit on an unstable platform or a tilted surface will cause it to fall or drop and may injure someone.
Therefore, before installing the unit, make sure that the place where the unit is to be installed is stable and strong
enough to support the weight of the unit.

Install the unit out of reach of small children.

11
 Operating Precautions

Do not operate the unit covered with a cloth, etc.

Operating the unit covered with a cloth or pressed tightly against a wall may cause a fire or an electric shock due
to overheating.

Do not install the unit in direct sunlight or near a heating apparatus.

Do not place anything heavy on the unit.

Do not let the unit hit anything or let it tip over. Do not drop it.

After operating the Arm Type, be sure to fold the arm and then move the unit to a storage area
by holding the arm base.

After operating the Stand Type, be sure to fold the arm, slide down the upper support column
to the lowest position and tighten the fixing knob and the auxiliary fixing knob. Then unlock
the caster stopper, move the unit to a storage area by holding the stand column and lock
the stopper.

Phototherapy can disturb the water balance of the infant. Make sure that the water balance
of the infant is maintained during phototherapy treatment.

Be sure to push the lever of the suction pad of the Mount Type until it reaches the end.

Do not forcibly try to remove the irradiation head from the holder while the suction pad of
the Mount Type is fixed to the power source part.
Be sure to remove the suction pad before removing it from the incubator. It may cause damage to the equip-
ment.

As the adhesiveness decreases, which may cause the irradiation head to fall off, when the
suction pad of the Mount Type is dirty, be sure to clean the pad with a soft cloth dampened
with a disinfectant solution and wipe it again with a soft dry cloth after use.

Remove the irradiation head of the Mount Type when raising or lowering the canopy of the
Dual Incu i.
If you raise or lower the canopy when the irradiation head is attached, strain is placed on the canopy, which may
cause the emergency stop alarm to sound.

Since phototherapy treatment may increase the temperature of the child, use the servo control
to set the temperature according to the body temperature of the child on the incubator and
the infant warmer. In case the body temperature of the child goes up, lower the incubator air
temperature setting.

Please be careful that the bilirubin photoisomer may cause a toxic effect.

Please be careful when using reflective foil the child’s body temperature may reach a critical
level.

Do not place anything that interrupts or deteriorates the light irradiating the child.
This equipment treats high bilirubin polycythemia by irradiating the child. If light does not reach or deteriorates,
curative effect will decrease.

12
 Parts Identification

[2] Parts Identification

PLEASE READ WITHOUT FAIL

■■Arm Type

No. Name No. Name

① Irradiation head ⑦ Arm base
② Irradiation head cover ⑧ Arm mount
③ Power switch ⑨ Fixing knob
④ Pilot lamp ⑩ AC adapter
⑤ Operation panel ⑪ Power cord (120V)
⑥ Arm ⑫ Power cord (230V)

■■Operation panel

No. Name
⑬ Lamp operation time indicator
⑭ Patient irradiation time indicator
⑮ Time display (1-hour unit)
⑯ Lamp / lighting (bright) button
⑰ Patient / lighting (dark) button

13
 Parts Identification

■■Stand Type

No. Name No. Name

① Irradiation head ⑩ Upper support column
② Irradiation head cover ⑪ Fixing knob
③ Power switch ⑫ Stand column
④ Pilot lamp ⑬ Stand base
⑤ Operation panel ⑭ Caster (with stopper)
⑥ Arm ⑮ Power cord (120V)
⑦ Arm base ⑯ Power cord (230V)
⑧ AC adapter ⑰ Auxiliary fixing knob
⑨ Cord cleat

14
 Parts Identification

■■Mount Type

PLEASE READ WITHOUT FAIL

No. Name No. Name
① Irradiation head ⑩ Power source part
② Irradiation head cover ⑪ AC adapter
③ Power switch Pole Mounting Attachment
⑫
④ Pilot lamp (Optional accessory)
⑤ Operation panel F-Rail Attachment
⑬
⑥ Suction pad (Optional accessory)
⑦ Holder part ⑭ Power cord (120V)
⑧ Cover guard ⑮ Power cord (230V)
⑨ Relay cable

15
 Preparation before Use

[3] Preparation before Use

3-1. Power Outlet

3-1-1. Arm Type, Stand Type

WARNING
The electrical rating of this unit is as follows:
Rating: AC100-240V; Power consumption: 30VA; Frequency: 50/60Hz; Operating voltage range:
AC100-240V±10%.
Do not connect the unit to any other power source.

The power outlet should be located near the unit to prevent accidental contact with a trailing power
cord. Use a separate power outlet for each unit.

Do not put many loads on one power outlet.

The unit should be serviced only by qualified personnel according to an appropriate service manual.
Be sure to use the replacement parts specified by Atom.

(1) Connect the power cord to the AC adapter.

Power cord

AC adapter

(2) Plug the power cord connected to the AC adapter Power outlet
into the power outlet. 20cm
The pilot lamp of the irradiation head comes on.
*K
 eep an area of over 20cm around the power
outlet clear so that the power cord can be quickly
removed.

Power cord

16
 Preparation before Use

3-1-2. Mount Type

(1) Connect the power cord to the AC adapter.

AC adapter

Power cord

(2) Connect the relay cable to the connector area of the Connector of

PREPARATION
irradiation head. the relay cable
Relay cable
WARNING
●● Be sure to connect the relay cable of the unit to the
connector area of the irradiation head. Do not also
connect the relay cable to any other product than
Connector area of the irradiation head
the unit. It may cause damage to the equipment.

(3) Plug the power cord connected to the AC adapter Power outlet
to the power outlet. 20cm
* K eep an area of over 20cm around the power
outlet clear so that the power cord can be quickly
removed.

Power cord

17
 Preparation before Use

3-2. Installation

3-2-1. Arm Type

(1) Fix the arm mount to the F-Rail of the incubator or
the infant warmer.
①H  old the Arm Type with your hands and insert the
clawed end of the arm mount into the groove of
the F-Rail of the incubator or the infant warmer.
②T  ighten the fixing knob.
• Products to which the Arm Type is attachable:
Dual Incu i, Incu i, Infa Warmer i, Infa Warmer V-505
Atom Infant Incubator V-2200, Atom Infant Incubator
V-2100G, Rabee Incu i
(Only applicable when the F-Rail Pole is attached.)
*F or information on other products to which the
Arm Type is attachable, contact your local Atom
representative.

(2) Check that the unit is positioned where it does not

interfere with the operation of the incubator or the
infant warmer, or the treatment of the infant.

(3) As shown in the diagram, with the arm down, adjust

the vertical position of the arm mount so that the
distance between the irradiation head cover and
15cm
the infant is at least 30cm. See the figures on the (Unit placement dimensions)
diagrams for proper attachment. However, when
the infant is to be irradiated from above the hood
of the incubator, adjust the vertical position of the
arm mount to the height just above the top surface
Example of attachment (Dual Incu i )
of the hood.

(4) Make sure that the arm mount is fixed correctly

to the F-Rail of the incubator or the infant warmer
to prevent the unit from dropping or sliding out of
position during use. 41cm
(Unit placement dimensions)

Example of attachment (Infa Warmer i )

(5) Press the “Patient / lighting (dark) button” twice to

reset the irradiation time displayed on the operation
panel to “0.”
* “ 0” is also displayed when the duration of previous
operation was less than one hour. Be sure to press
the “Patient / lighting (dark) button” twice before
operating the unit.
Indicator “0” is Patient / lighting
on displayed (dark) button

18
 Preparation before Use

3-2-2. Stand Type

(1) Move the unit to where the incubator, the infant
warmer or a cot is.

(2) Lock the caster stopper to prevent the unit from

moving around.

Stopper

(3) With the arm down, adjust the vertical position of

PREPARATION
the arm mount so that the distance between the ir-
radiation head cover and the patient is at least 30cm. Hold the upper
Hold the upper support column or the arm base with support column
your hand, loosen the auxiliary fixing knob, and then or arm base
with your hand.
loosen the fixing knob to adjust the vertical position
of the arm base. Check that the unit does not hinder Loosen the
Loosen the auxiliary
the operation of the incubator or the infant warmer,
fixing knob. fixing knob.
and then tighten the fixing knob, and tighten the
auxiliary fixing knob to secure the arm base.
However, when the infant is to be irradiated from
above the hood of the incubator, adjust the vertical
position of the arm mount to the height just above
the top surface of the hood.

(4) Check that the unit is positioned where it does not

interfere with the operation of the incubator or the
infant warmer, or the treatment of the infant.

(5) Press the “Patient / lighting (dark) button” twice to

reset the irradiation time displayed on the operation
panel to “0.”
* “ 0” is also displayed when the duration of previous
operation was less than one hour. Be sure to press
the “Patient / lighting (dark) button” twice before
operating the unit.
Indicator “0” is Patient / lighting
on displayed (dark) button

■■Guide for the irradiation distance and the irradiance level

Irradiance level
Irradiation distance
(cm) 400-550 nm
(μW/cm2/nm)
(mW/cm2)
30 35 2.1
35 32 1.9
40 29 1.7
*M
 easurements obtained by the BiliBlanket® Meter II
(For details on the measurement procedure, see “6.1 Measuring the Irradiance Level.” However, the ef-
fective irradiated area and the measurement points are not changed even when the irradiation distance
is changed.)

19
 Preparation before Use

3-2-3. Mount Type

WARNING
As Mount Types are only designed for incubators, they must not be applied to other products.

Be sure to attach the F-Rail Attachment and the Pole Mounting Attachment of the Mount Type to
the power source part.

CAUTION
When attaching the Mount Type to the following incubator, refer to the unit placement dimensions
in the diagram to secure the F-Rail Attachment.

(1) When attaching the Mount Type to the following

incubator, refer to the unit placement dimensions in Groove of the
the diagram to secure the F-Rail Attachment. mounting section

• Products to which the Mount Type is attachable:

Dual Incu i, Incu i Within 12cm
Atom Infant Incubator V-2200, Atom Infant Incuba- (Unit placement
Fixing dimensions)
tor V-2100G, Rabee Incu i knob
(Only applicable when the F-Rail Pole is attached.)
Power F-Rail
① Support the power source part with your hand,
source Attachment
and insert the tip of the F-Rail Attachment into
part
the groove of the incubator’s mounting section
as shown in the diagram to the right. < Example of attachment (F-Rail Pole)>
② T ighten the fixing knob.
③ Check that the power source part is positioned
where it does not interfere with the operation of
the incubator or the infant warmer, or the treat-
ment of the infant.
④ Make sure that the groove of the mounting sec-
tion is secured correctly to the F-Rail Attachment
to prevent the unit from falling off while in use.

20
 Preparation before Use

(2) When attaching the I.V pole, refer to the diagram to I.V pole
secure the Pole Mounting Attachment. knob
①S  upport the power source part with your hand,
and loosen the Pole Mounting Attachment knob
while inserting the I.V pole. Tighten the knob
② T ighten the knob.
③ Check that the power source part is positioned Pole Mounting
Attachment
where it does not interfere with the operation of
the incubator or the infant warmer, or the treat-
ment of the infant.
④ Make sure that the I.V pole is secured correctly
to the Pole Mounting Attachment to prevent the

PREPARATION
unit from falling off while in use.

< Example of attachment (I.V Pole)>

(3) As shown in the figure to the right, hold the irradia-
Power
tion head with both hands around the marked areas
source
and pull it off of the power source part. part

Marked
Irradiation areas
head

(4) Place the irradiation head on the top surface of the

Relay cable Suction pad
incubator’s hood, and align the center of the former
Center of the hood
with that of the latter. Check that the relay cable
is positioned where it does not interfere with the
operation of the incubator or the infant warmer, or
the treatment of the infant.

* When attaching to Atom Infant Incubator Model

Hood top surface cap
V-2200, Atom Infant Incubator V-2100G, or Rabee
Incu i, remove the cap used on the incubator and
attach the supplied hood top surface cap, and then
attach the irradiation head.

21
 Preparation before Use

WARNING
●● Be sure to attach the irradiation head to the top
surface of the incubator hood. Do not attach it
to the sloping section or curved surface of the
hood. It may cause the irradiation head to fall off
the hood.
●● Before attaching the irradiation head, make sure to
check the incubator hood surface and the Mount
Type suction pad. Do not attach the irradiation
head if the incubator hood surface or Mount Type
suction pad is damaged. If so, the adhesiveness
of the suction pad is reduced, so that it may cause
the irradiation head to fall off the hood.
●● Before attaching the irradiation head, make sure
to clean the incubator hood surface and Mount
Type suction pad. If smear and dirt adhere to the
surface and suction pad, the adhesiveness of the
suction pad is reduced, so that it may cause the
irradiation head to fall off the hood.
●● Do not use alcohol or other solvent for cleaning
the suction pad. It may cause the suction pad to
fall off the hood.
●● Check that the relay cable is positioned where
it does not interfere with the operation of the
incubator or the infant warmer, or the treatment
of the infant.
●● Do not get the relay cable pinched. It may cause
the cable to be broken.

(5) After raising the lever of the suction pad, while push-
ing the suction pad onto the hood of the incubator, Lever
push the lever of the suction pad until it reaches
the end.

CAUTION
●● Be sure to push the lever of the suction pad until
it reaches the end.
●● Do not forcibly try to remove the irradiation head
from the holder while the suction pad is fixed to the
power source part. Be sure to remove the suction
pad before removing it from the incubator. It may
cause damage to the equipment.
●● Be sure to clean the place where the suction pad
connects.

22
 Preparation before Use

●● If the irradiation head is attached to the Dual Incu i,

remove it from the hood and return it to the power
source part when raising or lowering the canopy. If
you raise or lower the canopy when the irradiation
head is attached, strain is placed on the canopy,
and the emergency stop alarm may sound.

(6) Make sure that the suction pad is fixed correctly to

the incubator hood to prevent the unit from falling
off or sliding out of the position while in use.

(7) Check once or twice a day to make sure that the

PREPARATION
suction pad has not been removed from the power
source part.

3-3. Daily Inspection

Before using the unit, follow “6-2. Inspection before Use” to check the unit carefully for any faults, contamina-
tion, missing parts or defective parts to make sure that it can be operated safely.

WARNING
Be sure to inspect the unit at the start of each day. Operating the unit without inspecting it at the
start of each day may let a defect pass unnoticed and cause a potentially unfavorable outcome.

3-4. Attaching the Eye Mask to the Infant

WARNING
The Eye Mask is intended to cover the infant’s eyes during phototherapy treatment or whenever it is
necessary to protect the infant’s eyes from light. Do not use the Eye Mask for any other purpose.

Before using the Eye Mask, carefully read the usage instructions in the respective manufacturer’s
manual, and fit the Eye Mask correctly to the infant.

The Eye Mask is for single infant use only. Do not reuse it.

When attaching the Eye Mask, be careful not to put pressure on the infant’s ears.

During phototherapy treatment, check the Eye Mask on the infant periodically to ensure that it is
attached properly to the infant. If the Eye Mask should get out of position, the infant’s eyes cannot
be protected. In addition, a dislodged mask may cover the infant’s nose or mouth and cause suf-
focation.

23
 Preparation before Use

Atom Medical recommends eye masks from the following manufacturers.

Sales manufacturer Part name Sales manufacturer Code No.

Children’s Medical Ventures WeeSpecs® Phototherapy Mask (Preemie) 99071-01
Children’s Medical Ventures WeeSpecs Phototherapy Mask (Small)
®
99071-02
Children’s Medical Ventures WeeSpecs® Phototherapy Mask (Medium) 99071-03
natus biliband (Micro) 900644
natus biliband (Premature) 900643
natus biliband (Regular) 900642

24
 How to Operate the Unit

[4] How to Operate the Unit

WARNING
Before turning on the unit, make sure that the infant’s eyes are protected with the Eye Mask, etc. If
they are not protected, be sure to cover them with the Eye Mask, etc. Put a diaper on the infant to
protect its gonads from phototherapy light.

Do not look directly at the LED light.

Before using the unit, be sure to check that there is no risk of the infant falling off the incubator, the
infant warmer, etc.

Observe the infant’s condition periodically during phototherapy treatment. Be sure to turn off the
unit, or switch to normal lighting before checking the infant’s skin color, etc.

When using the unit together with the infant warmer, place the unit away from the infant warmer to
prevent thermal influence from its heater, and then proceed to phototherapy.

Staying in an irradiated area for a long time may cause a headache, nausea or mild vertigo. To
reduce such symptoms, use the unit in a well-lighted area or wear glasses with yellow lenses. Turn
off the unit while the infant is being taken care of under the unit.

Do not operate the unit covered with a cloth or pressed tightly against a wall. It may cause a fire or

OPERATION
an electric shock due to overheating.

If you are using the Arm Type or the Stand Type, check that the moving parts of the arm and the
arm mount are securely fixed. The arm can stay in a given position. If it is found to be less effective
in staying in a given position, stop using the unit immediately and contact your local Atom repre-
sentative.

Be sure to attach the irradiation head of Mount Type to the top surface of the incubator hood. Do not
attach it to the sloping section of the hood whenever possible. Do not also attach it to the curved
surface of the hood. It may cause the irradiation head to fall off the hood.

Before attaching the irradiation head of the Mount Type, make sure to check the incubator hood
surface and the Mount Type suction pad. Do not attach the irradiation head if the incubator hood
surface or suction pad is damaged. If so, the absorption power of the suction pad is reduced, so
that it may cause the irradiation head to fall off the hood.

The Mount Type must not be used for treatment while the canopy of Dual Incu i is being raised. Be
sure to perform the treatment with the canopy being lowered. As the irradiation distance from an
infant under treatment to the unit is too far when the canopy is raised, the efficacy of treatment will
be reduced.

25
 How to Operate the Unit

4-1. Checking the LED Lights

(1) Alternately depress the power switch of the irradia-
tion head to the “ ” side and the “ ” side, and
make sure that all LEDs come on.

(2) If the irradiation head is dirty, the irradiance level

may be reduced. Before operating the unit, be sure
to check that the irradiation head cover is clean.

The irradiation head

cover should be clean.

4-2. Adjusting the Irradiation Position

(1) Place the unit so that the infant on the incubator,
infant warmer, or cot is within the effective irradi-
ated area. Make sure that the distance between the
infant and the irradiation head cover of the unit is
at least 30cm.

(2) Attach the Eye Mask to the infant to protect the

infant’s eyes from phototherapy light.

(3) Put a diaper on the infant to protect its gonads from

phototherapy light.

4-3. Phototherapy Treatment

(1) Follow the doctor’s instructions and determine a
treatment policy for the infant.

(2) Depress the power switch on the “ ” side to start

the treatment.

Depress the
power switch.

(3) Check how long the infant has been exposed to

Patient irradiation time
phototherapy light if necessary.
The patient irradiation time is displayed in units of
one hour on the operation panel.
By pressing the “Patient / lighting (dark) button”
twice, the irradiation time is reset to “0.”

Patient / lighting (dark) button

26
 How to Operate the Unit

(4) Observe the infant constantly during phototherapy

treatment.

4-4. Observing the Infant (with the Lamp)

(1) If using the unit as a lamp to observe or treat the
infant, depress the power switch to the “ ” side.

Depress the
power switch.

(2) To adjust the brightness of the lamp, with the power

Lamp / lighting (bright) button
switch depressed to the “ ” side, press the “Lamp
/ lighting (bright) button” or “Patient / lighting
(dark) button.”

OPERATION
Patient / lighting (dark) button

4-5. Storage after Use

(1) Set the power switch in the neutral position to turn
off the unit.

(2) Disconnect the power plug from the power outlet.

■■Storing the Arm Type
Fold the Arm Type arm and then move the unit to
a storage area.
■■Storing the Stand Type
Unlock the caster stopper and move the unit away
from the incubator, etc. Then, store it in an appropri-
ate area with the arm folded and the upper support
column slid down.
■■Storing the Mount Type
Raise the lever of the suction pad in the irradiation
head, then hold up the tab in the suction pad and Raise the le ver
remove the irradiation head.

Hold up the ta b

27
 How to Operate the Unit

Be sure to insert the irradiation head into the holder Holder

part in the power source part until it reaches the end part
without getting the relay cable pinched.
Power
source
part
Irradiation
head

WARNING
●● When trying to insert the irradiation head into the
holder part with the relay cable being pinched
between the irradiation head and power source
part, the irradiation head cannot be securely fixed
to the power source part and may fall off. Make
sure that the relay cable is not pinched between
the irradiation head and the power source part
before attaching the irradiation head.
Relay cable

4-6. Safety Function

■■Automatic stop of temperature rise in the irradiation head

The unit stops operating when temperature inside the irradiation head becomes high during operation.
Action to take: T
 urn off the unit, wait until the temperature returns to normal, and then turn on the unit
again.
Inspection: C
 heck the position of the irradiation head to make sure that heat from the infant warmer etc. is
not affecting it.
If the temperature inside the irradiation head continues to become high after checking the above
and the operation of the unit stops, stop using the unit and contact your local Atom representative.

28
 Cleaning and Disinfection

[5] Cleaning and Disinfection

CAUTION
This product is shipped without being disinfected. Be sure to clean and disinfect the unit before us-
ing it for the first time after purchase.

See the accompanying document of the disinfectant you are going to use for appropriate concen-
tration, contact time and handling. Follow the directions for use and dosage and precautions given
in the document.

Be sure to dilute the disinfectant agents with water for cleaning and disinfection. Never use the
agents undiluted.

Do not use any abrasive cloth, cleaner, thinner or other solvent, alcohol, acetone or other solution
for cleaning and disinfection.

Be sure to turn off the power switch and remove the power plug from the power outlet before clean-
ing and disinfecting the unit.

If any part of the unit is dirty, clean it before disinfecting the unit.

Disinfect the unit periodically in order to prevent infection. If infection is suspected while the unit is
in operation, stop using it immediately and disinfect it.

The timing and method of disinfection varies with the frequency and conditions of use. The medical
institution should determine the timing and method appropriate for the institution.

Do not autoclave (sterilize with high pressure steam) or sterilize the unit with EOG. Do not boil the
unit for disinfection.

If the irradiation head cover is dirty, the irradiance level will be reduced. After operating the unit, be
sure to clean the irradiation head cover with a soft cloth dampened with a disinfectant solution and
then wipe it again with a soft dry cloth.

MAINTENANCE
As the absorption power is lowered, which may cause the irradiation head to fall off, when the
suction pad of the Mount Type is dirty, be sure to clean the pad with a soft cloth dampened with a
disinfectant solution and wipe it again with a soft dry cloth after use.

(1) Obtain a soft clean cloth and a disinfectant solution for cleaning and disinfection.
* Recommended disinfectant solutions include:
• Benzalkonium chloride aqueous solution
• Benzethonium chloride aqueous solution
• Chlorhexidine aqueous solution
• Amphoteric surfactant aqueous solution
Never use the above agents undiluted.

(2) A
 fter cleaning the unit and its parts with a soft cloth dampened with a disinfectant solution, wipe them again
with a soft dry cloth.
*T  o prevent hepatitis B antigen contamination, it is recommended to use a glutaraldehyde aqueous solution,
etc.
• Cleaning the unit
Clean the unit with a soft cloth dampened with a disinfectant solution and then wipe it again with a soft dry
cloth.

29
 Maintenance Inspection

[6] Maintenance Inspection

In order to use the unit safely for a longer period, perform the maintenance inspections described below.

WARNING
Check every month that the irradiance level reaches the specified value (see “6-1. Measuring the
Irradiance Level”).

CAUTION
Medical institutions are responsible for performing the maintenance inspections. They are allowed
to entrust the maintenance inspections of the unit to an appropriate external contractor.

Clean and disinfect the unit and its accessories before maintenance inspections, repairs, or dis-
posal.

• Inspection before use

Check the basic functional operation of each part of the unit every time you are going to use the unit.

• Monthly inspection
Check the operation of each function of the unit every month.

• Periodical inspection
Contact your local Atom representative annually for periodical inspection.

• Parts requiring periodical replacement

Some parts need to be replaced periodically depending on their period of use.

You can check how long the light source (blue LEDs) has
Lamp / lighting (bright) button
been operated by pressing the “Lamp / lighting (bright)
button” on the operation panel. The operation time of
the light source is displayed only as long as this button
is pressed down. The operation time displayed on the
operation panel cannot be reset.

Operation time of the light source

30
 Maintenance Inspection

6-1. Measuring the Irradiance Level

6-1-1. Arm Type, Stand Type

Check every month that the irradiance level reaches the specified value. Use a photometer* to measure the
irradiance level.
(1) Cover the mattress with a mattress cover and place Effective
the photometer on the mattress cover. Make sure irradiated Light
that the irradiation head cover of the unit is paral- area detector
Parallel
lel to the photometer. The distance between the Mattress Mattress
30cm
irradiation head cover and the light detector of the cover
photometer should be 30 cm.

CAUTION
●● Use a clean mattress and a new mattress cover so
that correct measurements can be obtained.

(2) Depress the power switch of the irradiation head to

the “ ” side.

CAUTION
●● Allow at least ten minutes for the irradiance of the Depress the
LED light source to stabilize. power switch.

(3) Place the light detector of the photometer at the six

MAINTENANCE
Effective irradiated area
measurement points (A-F) determined by locating
5cm 5cm
the center of the effective irradiated area as shown
in the figure on the right and measure the irradiance
level at each point. A B
10cm

Center of the effective

(4) Check that the average of the irradiance levels ob- irradiated area

tained at the six measurement points (A-F) reaches C D

the specified value.
10cm

CAUTION
E F
●● The specified maximum irradiance level is at
least 22.5 μW/cm2/nm (1.35 mW/cm2)(when the
BiliBlanket® Meter II is used).
10cm

* The irradiance level is measured before shipment with the BiliBlanket® Meter II (the specified value: at least
30 μW/cm2/nm).

31
 Maintenance Inspection

6-1-2. Mount Type

(1) Attach the irradiation head to the top surface of the
incubator hood.
Cover the mattress with a mattress cover and place
the photometer on the mattress covers.
30cm
Raise the bed, position the device radiation head
cover so that it is parallel with the photometer, and
ensure that the radiation head cover and the light
detector of the photometer are 30cm apart.
In incubators that cannot be raised, and it is not
possible to ensure that the measurement distance
is 30cm, place an object under the mattress to adjust
its height so that this distance is 30cm.

CAUTION
●● Use a clean mattress and a new mattress cover so
that the correct measurements can be obtained.

(2) Depress the power switch of the unit to the

“ ”side.

CAUTION
●● Allow at least ten minutes for the irradiance of the Depress the
LED light source to stabilize. power switch.

(3) Place the light detector of the photometer at the six

Effective irradiated area
measurement points (A-F) determined by locating
5cm 5cm
the center of the effective irradiated area as shown
in the figure on the right and measure the irradiance
level at each point. A B
10cm

Center of the effective

(4) Check that the average of the irradiance levels ob- irradiated area

tained at the six measurement points (A-F) reaches C D

the specified value.
10cm

CAUTION
E F
●● The specified maximum irradiance level is at
least 22.5 μW/cm2/nm (1.35 mW/cm2)(when the
BiliBlanket® Meter II is used).
10cm

32
 Maintenance Inspection

6-2. Inspection before Use

Check the following points every time you are going to use the unit.

CAUTION
If you should notice any strange smell, strange noise, overheating, strange vibration, missing parts
or defective function in the inspection, stop using the unit immediately and contact your local Atom
representative.

Item to check Description

The unit should not be broken. (Otherwise, the infant or the user may get
Appearance
injured due to breakage, etc.)
The plug should be neither deformed nor broken. The cord should be
Power cord neither damaged nor dirty. (Otherwise, the infant and/or the user may get
injured due to breakage, etc.)
It should function correctly when depressing it. (Phototherapy treatment
Power switch
↔ off ↔ Lamp) (Power may not be applied for some defect.)
Each moving part of the arm should stay in a given position when you move
Arm (Arm Type, Stand Type)
the arm with your hand.
It should not have any cracks, dirt, breakage, etc.
Irradiation head cover
(Otherwise, the irradiance level may be reduced.)
Irradiation head (LEDs) All the LEDs should come on.
Arm base Each moving part of the arm base should stay in a given position when you
(Arm Type, Stand Type) move the arm base with your hand.
It should not be broken.
Arm mount (Arm Type)
Check that the arm mount is fixed securely.
F-Rail Attachment/
The F-Rail Attachment/Pole Mounting Attachment should not be broken.
Pole Mounting Attachment
Check that it is securely attached.
(Optional accessory)
The upper support column should slide up and down when the fixing knob
Height adjustment unit of the stand and the auxiliary fixing knob are loosened. The upper support column

MAINTENANCE
(Stand Type) should be fixed securely after the fixing knob and the auxiliary fixing knob
are tightened.
The suction pad should be neither deformed nor damaged.
Suction pad (Mount Type)
(Otherwise, the irradiation head may not be fixed.)
The connector area should be neither deformed nor damaged, and the cable
Relay cable (Mount Type)
should not be damaged. (Otherwise, power may not be turned on.)
Each Eye Mask for a neonatal or premature infant, including spares, should
Eye Mask/ Biliband be free of tears, holes and other defects.
(Otherwise, problems may occur to the infant’s eyes.)
It should be kept where it is readily accessible. (Otherwise, the unit may be
Operation Manual
operated incorrectly due to lack of accessible information.)

33
 Maintenance Inspection

6-3. Monthly Inspection

Check the following points every month.

Item to check Procedure Description

The arm mount should be detachable and
Arm mount Shake the unit.
securely attachable.
(Arm Type)
Loosen the fixing knob. It should be detachable from the F-Rail.
The F-Rail Attachment/ Pole Mounting
F-Rail Attachment/
Shake the unit. Attachment should be securely fixed and
Pole Mounting At-
not rattle.
tachment
It should be detachable from the F-Rail
(Optional accessory) Loosen the fixing knob.
or pole.
No part should be deteriorated or damaged
Each part Check each part by visual inspection.
(cracks, bends, breakage, etc.).
The LEDs should glow properly.
The brightness of the lighting should
Check the irradiation head by visual in- change when pressing the “Lamp / light-
spection. ing (bright) button” or “Patient / lighting
(dark) button” on the operation panel when
the power switch is depressed to the “ ”
side.
The irradiance level provided by the LED
Irradiation head Measure the irradiance level with a pho- light source should reach the specified
(LEDs) tometer. value (see “6-1. Measuring the Irradiance
Level”).
When the operation time of the light source
exceeds 10,000 hours, check that the irradi-
ance level reaches the specified value (see
Check its operation time. “6-1. Measuring the Irradiance Level”). (If
the operating time of the irradiation head
exceeds 10,000 hours, the pilot lamp will
turn orange.)
Each moving par t of the arm and the
Arm, Arm base (Arm Move the movable parts of the arm and
arm base should stay in a given position
Type, Stand Type) the arm base.
properly.
Irradiation head Check the irradiation head cover by visual
It should be fixed securely.
cover inspection.
Loosen the fixing knob and the auxiliary
The upper support column should slide
Height adjustment fixing knob and slide up and down the up-
up and down.
unit of the stand per support column.
(Stand Type) Tighten the fixing knob and the auxiliary The upper support column should be se-
fixing knob. curely fixed.
Move the unit. The casters should move smoothly.
Caster (Stand Type)
Lock the caster stopper. The caster stopper should lock securely.
The irradiation head should be securely
Holder part (Mount Attach the irradiation head to the power attachable and detachable and should not
Type) source part. rattle. Also, the irradiation head should
click into place.
Relay cable Connect the relay cable to the irradiation The pilot lamp of the irradiation head
(Mount Type) head. should turn on.

34
 Maintenance Inspection

6-4. Periodical Replacement Parts

Periodical replacement parts are those which gradually deteriorate and wear down with use. They need peri-
odical replacement to keep the accuracy and performance of the unit at a proper level. Timing of replacement
varies with the frequency and conditions of use. Consult your local Atom representative for replacement.

Part name Period of use Reason for replacement

The unit may operate improperly due to a deformed
Power Cord 2-3 years
or broken plug or a damaged or dirty cord.
Arm* The arm may become less effective in staying in a
2-3 years
(Arm Type, Stand Type) given position due to deterioration or wear.
The irradiance level may be reduced because of a
Irradiation head cover* 1-2 years reduced optical transparency due to deterioration
or wear.
Packing of the height The upper support column may become less effec-
adjustment unit of the 2-3 years tive in staying in a given position due to deterioration
stand (Stand Type) or wear.
When the operation time of
the unit has exceeded 10,000
hours.
Effective phototherapy cannot be expected due to
LED board* When the irradiance level has
a reduced irradiance level.
fallen below the specified value
(see “6-1. Measuring the Irradi-
ance Level”).
Relay cable* The unit may operate improperly due to a deformed
2-3 years
(Mount Type) or damaged connector area or a damaged cable.
Suction pad* As the absorption power is reduced due to deteriora-
1-2 years
(Mount Type) tion or wear, the irradiation head may fall off.
Holder part* As the fixed power is reduced due to deterioration
1-2 years
(Mount Type) or wear, the irradiation head may fall off.
* When replacement is required, contact your local Atom representative.

MAINTENANCE

35
 Maintenance Inspection

6-5. Inspection Checklist

WARNING
If any trouble is detected in any inspection, indicate on the unit that it is out of order and seek repair
without fail.

Contact your local Atom representative for further information on repairs.

Unit name BILI-THERAPY Spot Type Date of inspection

Serial No. Inspector

No. Item to check Results

Inspection before use (every time)
1 Is the unit free of breakage? YES / NO
Is the power plug free of deformation and breakage?
2 YES / NO
Is the power cord free of damage and dirt?
3 Does the power switch function correctly for treatment, lighting and switching off? YES / NO
4 Is the irradiation head cover free of cracks, dirt, breakage, etc.? YES / NO
5 Do all the LEDs come on? YES / NO
Can the moving parts of the arm and the arm base stay in a give position? (Arm Type, Stand
6 YES / NO
Type)
7 Is the arm mount fixed securely? (Arm Type) YES / NO
8 Is the F-Rail Attachment/Pole Mounting Attachment securely attached? (Mount Type) YES / NO
9 Is the suction pad neither deformed nor damaged? (Mount Type) YES / NO
Is the connector area of the relay cable neither deformed nor damaged, or is the cable not
10 YES / NO
damaged? (Mount Type)
Is each Eye Mask for a neonatal or premature infant, including spares, free of defects such
11 YES / NO
as tears and holes?
12 Is the Operation Manual readily accessible? YES / NO
Monthly inspection
13 Can the arm mount be detached? Can it be securely fixed? (Arm Type) YES / NO
Can the F-Rail Attachment/Pole Mounting Attachment be detached? Can it be securely
14 YES / NO
fixed? (Mount Type)
15 Is each part free of deterioration (cracks, bends, breakage, etc.)? YES / NO
16 Do the LEDs glow properly? YES / NO
17 Can illumination be dimmed? YES / NO
Does the irradiance level provided by the LED light source reach the specified value (see
18 YES / NO
“6-1. Measuring the Irradiance Level”)?
19 Can the arm and the arm base stay in a give position properly? (Arm Type, Stand Type) YES / NO
20 Is the irradiation head cover fixed securely? YES / NO
21 Does each caster move smoothly? Does the caster stopper lock securely? (Stand Type) YES / NO
22 Is the irradiation head reliably attached to the power source? (Mount Type) YES / NO
23 Is the irradiation head attached securely to the hood? (Mount Type) YES / NO
Does the pilot lamp turn on when the relay cable is connected to the irradiation head? (Mount
24 YES / NO
Type)
36
 Maintenance Inspection

6-6. Disposal
The medical institution concerned is responsible for proper disposal of the unit, old parts past their expected
life span and disposables (including accessories) in accordance with applicable waste disposal laws and regula-
tions.

MAINTENANCE

37
 Troubleshooting

[7] Troubleshooting

WARNING
If the unit seems to be defective, indicate on the unit that it is out of order, stop using it immediately,
and contact your local Atom representative.

CAUTION
Check the following points before requesting repair service.

Trouble Action to take

The temperature inside the irradiation head • Check that the irradiation head is installed in an appropriate
rises. location.
• Check whether the casters are locked.
The stand cannot be moved. (Stand Type)
• Check the rotation axes of the casters for any dust or dirt.
The height of the stand cannot be adjusted. • Check whether either the fixing knob or the auxiliary fixing
(Stand Type) knob or both are tightened.
• Check whether the relay cable is connected to the irradia-
The unit cannot be powered on.
tion head.
• Check whether the lever of the suction pad is raised. Check
The irradiation head cannot be fixed to the incu-
also whether the suction pad and the mounting surface of
bator. (Mount Type)
the hood are dirty.
The irradiation head cannot be removed from • Check whether the lever of the suction pad is depressed. If
the incubator. (Mount Type) the lever is raised, raise the tab in the suction pad.

38
 Technical Information

[8] Technical Information

8-1. Technical Data

Power requirements Rating: AC100-240V;
Power consumption: 30VA;
Frequency: 50/60Hz;
Operating voltage range: AC100-240V±10%
Classification Type of protection: ClassII equipment
Degree of protection: no applied part
Not for use in an air and flammable anesthetic gas mixture or an oxygen/nitrous
oxide and flammable anesthetic gas mixture.
Operation mode: Continuous operation
Light source Blue LEDs
Wavelength: peak wavelength 450 - 475nm
Irradiance level At least 30 - 40 μW/cm2/nm (1.8 - 2.4 mW/cm2)
* (obtained by the BiliBlanket® Meter II at the irradiation distance of 30cm)
Changes in irradiance over 6 hours: ±10% (in the effective irradiated area)
Effective irradiated area: 20×30cm
Maximum irradiance level 43.8 μW/cm2/nm (2.6 mW/cm2)
Relative irradiance level
100
BILI-THERAPY
Relative irradiance level [%]

Output
80
BiliBlanket® Meter II
Sensitivity
60

40

20

0
380 420 460 500 540
Wavelength [nm]

Intensity of illumination 500 - 2,000 lx (Values measured with illumination distance of 30cm) * Dimmable
Noise This product is not equipped with parts which generate noise (e,g. cooling fan).
Dimensions Arm Type: 100 (W) × 13 (D) × 45 (H) cm
Stand Type: 45 (W) × 71 (D) × 190 (H) cm
Mount type (irradiation head): 12.5 (W) × 33 (D) × 8 (H) cm
APPENDIX

Mount type (power source part): 18 (W) × 34 (D) × 11 (H) cm

Weight Arm Type: Approx. 2.2kg
Stand Type: Approx. 12kg
Mount type (irradiation head): Approx. 0.8kg
Mount type (power source part): Approx. 0.9kg

39
 Technical Information

Life of the light source When the operation time of the light source has exceeded 10,000 hours, check that
the irradiance level reaches the specified value (see “6-1. Measuring the Irradiance
Level”).
*The life of the LED used is 60,000 hours (70% lumen maintenance)
Time display Patient irradiation time: 0-99,999 (one hour increments)
Lamp operation time: 0-99,999 (one hour increments)
Operating conditions Ambient temperature: 10-30°C (50-86°F)
Relative humidity: 30-85% (non-condensing)
Atmospheric pressure: 70-106kPa (525-795mmHg)
Storage conditions Ambient temperature: 0-50°C (32-122°F)
Relative humidity: 30-75% (non-condensing)
Atmospheric pressure: 70-106kPa (525-795mmHg)
Transport conditions Ambient temperature: 0-50°C (32-122°F)
Relative humidity: 30-75% (non-condensing)
Atmospheric pressure: 70-106kPa (525-795mmHg)
Accessories Power cord (120V).............................................................1
Power cord (230V).............................................................1
Hood top surface cap.........................................................1 (Mount Type)
Optional accessories F-Rail Attachment Order No. : 60217
Pole Mounting Attachment Order No. : 60218

* The unit meets the EMC (electromagnetic­compatibility) requirements of IEC 60601-1-2.

40
 Technical Information

8-2. EMC Level and Classification

Guidance and manufacturer’s declaration − electromagnetic emissions

The BILI-THERAPY Spot Type is intended for use in the electromagnetic environment specified below.
The customer or the user of the BILI-THERAPY Spot Type should assure that it is used in such an environ-
ment.
Emissions test Compliance Electromagnetic environment − guidance
The BILI-THERAPY Spot Type uses RF energy only
for its internal function.
RF emissions
Group 1 Therefore, its RF emissions are very low and are not
CISPR 11
likely to cause any interference in nearby electronic
equipment.
RF emissions
Class A
CISPR 11 The BILI-THERAPY Spot Type is suitable for use in
Harmonic emissions✽ all establishments including domestic establishments
Class A
IEC 61000-3-2 and those directly connected to the public low voltage
Voltage fluctuations/ power supply network that supplies buildings used
flicker emissions✽ Complies for domestic purposes.
IEC 61000-3-3

✽There are no required test conditions in areas that use 100V power supplies.

APPENDIX

41
 Technical Information

Guidance and manufacturer’s declaration − electromagnetic immunity

The BILI-THERAPY Spot Type is intended for use in the electromagnetic environment specified below.
The customer or the user of the BILI-THERAPY Spot Type should assure that it is used in such an
environment.
IEC60601 Compliance Electromagnetic environment
Immunity test
test level level − guidance
Floors should be wood, concrete or
Electrostatic
±6kV contact ±6kV contact ceramic tile. If floors are covered
discharge (ESD)
±8kV air ±8kV air with synthetic material, the relative
IEC 61000-4-2
humidity should be at least 30 %.
±2kV for power ±2kV for power
Electrical fast Mains power quality should be that
supply lines supply lines
transient/burst of a typical commercial or hospital
±1kV for input/ ±1kV for input/
IEC 61000-4-4 environment.
output lines output lines
Mains power quality should be that
Surge ±1kV differential mode ±1kV differential mode
of a typical commercial or hospital
IEC 61000-4-5 ±2kV common mode ±2kV common mode
environment.
Equipment which emits high levels
power frequency of power line magnetic fields (in
magnetic field 50/60 Hz 3A/m 3A/m excess of 3A/m) should be kept at
(IEC 61000-4-8) a distance to reduce the likelihood
of interference.
Mains power should be that of a
typical commercial or hospital en-
vironment. If user requires contin-
voltage dips and short dip >95%, 0.5 periods >95%, 0.5 per. ued operation during power mains
interruptions on AC dip 60%, 5 periods 60%, 5 per. interruptions insure that batteries
mains input lines dip 30%, 25 periods 30%, 25 per. are installed and charged. Insure
(IEC 61000-4-11) dip >95%, 5 seconds >95%, 5 sec. that battery life exceeds longest
anticipated power outages or pro-
vide and additional uninterruptible
power source.

42
 Technical Information

Guidance and manufacturer’s declaration − electromagnetic immunity

The BILI-THERAPY Spot Type is intended for use in the electromagnetic environment specified below.
The customer or the user of the BILI-THERAPY Spot Type should assure that it is used in such an
environment.
IEC 60601 test Compliance Electromagnetic environment –
Immunity test
level level guidance
Portable and mobile RF communications
equipment should be used no closer to
any part of the, including cables, than
the recommended separation distance
calculated from the equation applicable
to the frequency of the transmitter as
below.
Recommended separation distance

Conducted RF 150 kHz to 80 MHz 3 Vrms

rf coupled into lines outside ISM
(IEC 61000-4-6) bandsa

radiated rf
(IEC 61000-4-3)
80 MHz – 2.5 GHz 3 Vrms , 80MHz to 800MHz
, 800MHz to 2.5GHz

where P is the maximum output power

rating of the transmitter in watts (W) ac-
cording to the transmitter manufacturer
and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmit-
ters, as determined by an electromag-
netic site surveya, should be less than
the compliance level in each frequency
rangeb.

Interference may occur in the vicinity

of equipment marked with the follow-
ing symbol:
APPENDIX

a T
 he ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795
MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
b Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the equipment is used exceeds the applicable RF compliance level above, the equipment should be observed
to verify normal operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the equipment.
43
 Technical Information

Recommended separation distances between portable and mobile RF communications

equipment and the BILI-THERAPY Spot Type
The BILI-THERAPY Spot Type is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the BILI-THERAPY Spot Type can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF commu-
nications equipment (transmitters) and the BILI-THERAPY Spot Type as recommended below, according
to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
Rated maximum output power (m)
of transmitter
150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz
(W)

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 rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80MHz and 800MHz, the higher frequency range applies.
Note 2: The guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.

44
 Treatment Considerations

[9] Treatment Considerations

CAUTION
Endeavor to identify the cause of neonatal jaundice (hemorrhage, infection, bleeding, etc.) and
provide appropriate causal therapy concurrently. The infant’s skin color becomes less correlated
with his or her serum bilirubin level during phototherapy treatment. Therefore, readings obtained
by the icterometer are not reliable at all. Measure the infant’s serum bilirubin level at least once a
day. It has been reported that in very rare cases, separated serum may assume a brownish tinge
(methemalbuminemia).

Refer to the following when using the phototherapy unit.

Phototherapy is characterized by the benefits that it is very easy to use and operate and that it is also useful
prophylactically. However, it is said that phototherapy should not be given indiscriminately for treating neonatal
jaundice. It is advised that this treatment should be used with a correct knowledge of neonatal hyperbilirubinemia
and that exchange transfusion should not be delayed just because phototherapy is being given. The following is
the instructions for use of the Atom Phototherapy Unit extracted from the research material of the Department
of Pediatrics, Nagoya City University Medical School.

Preface
Although the clinical effects of phototherapy have been proven, it should be given with caution. Read the instruc-
tions for use carefully. In particular, determine whether to indicate or discontinue phototherapy on the basis of the
infant’s serum bilirubin level and be sure to shield the infant’s eyes completely from phototherapy light. Use the
phototherapy unit in an environment where sufficient equipment and nursing care are available.

Indications

1) It is not advisable to administer phototherapy to neonates indiscriminately. The reference serum bilirubin
level for starting phototherapy treatment should be 15mg/100ml for a mature infant and 12mg/100ml for
a premature infant when the intant’s serum bilirubin level is measured in the White method.
2) If there is possibility that the infant’s serum bilirubin level may rise rapidly within three days of birth,
start phototherapy even if the serum bilirubin level is 10mg/100ml or so.
3) When a premature infant has a breathing problem and bilirubin in the blood stream is likely to diffuse into
the surrounding tissues, or when hyperbilirubinemia is likely to develop, start phototherapy prophylacti-
cally even when the infant has not shown any symptoms of hyperbilirubinemia.
4) For infants with severe blood group incompatibility, perform exchange transfusion in principle. For infants
APPENDIX

with mild blood group incompatibility, phototherapy can be administered. However, monitor fluctuations
in the infant’s serum bilirubin level during phototherapy in order not to miss the timing for exchange
transfusion. Doing phototherapy after exchange transfusion can reduce the necessity of further exchane
transfusion.

45
 Treatment Considerations

●●References 

1. Cremer,R.J et al.:
INFLUENCE OF LIGHT ON THE HYPERBILIRUBINEMIA OF INFANTS.
Lancet1:1094-1097, 1958
2. Lucey.J. et al.
PREVENTION OF HYPERBILIRUBINEMIA OF PREMATURITY BY PHOTO THERAPY.
Pediatrics41:1047-1054,1968
3. Behrman,R.E.&Hsia,D.Y.Y.:
SUMMARY OF A SYMPOSIUM ON PHOTOTHERAPY FOR HYPERBILIRUBINEMIA.
J.Pediat.75:718-726,1969
Shoju Onishi, et. al.:
Features of kernicterus in premature infants and phototherapy as a preventive method against it.
Japanese Journal of Pediatrics 22:138-150, 1969
Shoju Onishi, et. al.:
Bilirubin metabolism in phototherapy for neonatal jaundice.
Journal of the Japan Pediatric Society, 74-159-171, 1970
Shoju Onishi, et. al.:
Consideration on the light sources in phototherapy for neonatal jaundice.
Journal of the Japan Pediatric Society, 75:318-322, 1971
Shoju Onishi, et. al.:
Phototherapy for neonatal jaundice.
Pediatrics, 12:729-740, 1971

46
••Reproduction of all or part of this Manual without permission from Atom Medical Corporation is strictly
prohibited.
••The contents of this Manual are subject to change without notice due to technical improvement.
••All possible measures have been taken to ensure the accuracy of the contents of this Manual. However, if any
errors should be noticed, Atom would greatly appreciate being informed of them.
 D63MC112

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