Equipment for neonatal and premature infants/LED Examination Light

Atom InfaLite
ORIGINAL

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.
● This Manual contains description of all the functions available. Please skip
any section unrelated to your unit.

EU OFFICE
Via Libia, 54 - 20081 Abbiategrasso (MI) - Italy
Tel: +39 02 9466329 Fax: +39 02 9081428

INTRODUCTION
This Operation Manual deals with the specifications, operation and maintenance of the InfaLite. Atom is by nomeans responsible for any malfunction arising from a user ignoring the instructions for operation and maintenancedescribed in this Manual as well as any accident attributable to repair by someone other than technical personnel
belonging to your local Atom representative.
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 products and parts past their expected life span should be disinfected and/or sterilized toprevent infection from them and then disposed of in accordance with applicable waste disposal
laws and regulations.
Federal (US and Canada) Law restricts this device to sale by or on the order of a physician.

INTENDED USE
The unit utilizes quality medical white light emitting diodes (white LED) during operation.

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. This unit should only be used at authorized medical institutions or facilities.
4. This unit should only be operated by people who have received appropriate training and guidance.
5. 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.
6.	If a serious accident involving equipment occurs, report it to the manufacturer and the regulatory authorityof the country where the equipment is being used.

1

7. 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.

Definition of Warning Indication
Three levels of warning indication are used throughout this Manual and on the unit. They are defined asfollows.
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 useof 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
SymbolTitle and indication
General attention
Indicates unspecified general danger, warning or caution.

2. Symbols to prohibit action
SymbolTitle 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 otherhazards.
Prohibition of use of fire
Indicates prohibition of use of fire where an external use of fire may cause the unit to ignite undercertain conditions.
3. Symbols to give instructions for action
SymbolTitle and indication

General instruction
Indicates unspecified general action on the part of the user.
Remove the AC adapter plug from the power outlet
Instructs the user to remove the AC adapter plug from the power outlet in the case of malfunction
or when there is a threat of lightning.

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

stand-by or preparatory state for a part of equipment
This symbol indicates that the unit is in standby, or a part of the unit is in a preparatory state.
Manufacturer
This symbol indicates the name and the address shown adjacent to the symbol is of the manufacturer.
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 amanner 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 againstelectric shock.
5. Other symbols
SymbolTitle and indication

Operation
This symbol is used to indicate that the user has increased the light intensity.
Operation
This symbol is used to indicate that the user has reduced the light intensity.

3Precautions on Jamming

WARNINGThe unit is intended for use in hospitals.
Portable and mobile communication equipment and other devices which generate high frequency
should be used at least 30cm away from the unit, including cables specified by the manufacturer.
Failure to do so may cause malfunction.
Note: The emission characteristics of this unit make it suitable for use in industrial areas or hospitals (CISPR11 Class A). Take care when using the unit in residential environments (normally
CISPR11 Class B), as it may not provide adequate protection from wireless frequency communication services. The user may also need to relocate or realign the unit to alleviate the problem.

Responsibility for Care of Equipment

CAUTION
It is the user (a hospital, a doctor’s office, a clinic) that is responsible for the operation, maintenanceand 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
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 oforder and contact your local Atom representative or service engineer immediately. See the end of
this Operation Manual for whom to contact.
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.

4

INTRODUCTION..................................................... 1
PLEASE READ WITHOUT FAIL
[1]

1-1.

DANGER................................................... 6

1-2.

WARNING................................................. 6

1-3.

CAUTION.................................................. 7

Parts Identification....................................... 8
2-1. Main Unit........................................................... 8
2-2. Irradiation Head............................................... 9
2-3. Operation Panel............................................... 9

PREPARATION[3]

Preparation before Use............................. 10

OPERATION
How to Operate the Unit............................ 15
4-1. Operating the Irradiation Head.................... 15
4-2. Lighting and Light Control............................ 17
4-3. Turning Off and Storing the Light................ 17

OPERATION

3-1. Assembling the Mounting Section............... 10
3-2. Power Outlet................................................... 10
3-3. Unit Installation............................................... 13
3-4. Daily Inspection.............................................. 14[4]

PREPARATION[2]

Operating Precautions................................ 6

PLEASE READ WITHOUT FAIL

CONTENTS

MAINTENANCE
Cleaning and Disinfection........................ 18[6]

Maintenance Inspection............................ 19
6-1. Measuring the Light Intensity....................... 19
6-2. Inspection before Use................................... 20
6-3. Monthly Inspection......................................... 21
6-4. Semiannually Inspection............................... 21
6-5. Periodical Replacement Parts..................... 22
6-6. Inspection Checklist...................................... 23

MAINTENANCE[5]

6-7. Disposal.......................................................... 24[7]

Troubleshooting.......................................... 25[8]Technical Information................................ 26
8-1. Technical Data................................................ 26
8-2. EMC Level and Classification...................... 27

APPENDIXAPPENDIXOperating Precautions[1] Operating Precautions
Please follow the operating instructions described in this Manual for the safe use of the unit. The unit shouldbe 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 due to a fire or an electric shock will result if the instructions given below are not followed.
Never place a body warmer or any other possible ignition source in or near the unit.
Use of oxygen will increase the risk of explosion or fire. Body warmers or other devices in which fireis used or which will generate a spark may cause an explosion or a fire if used near the unit.
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.

1-2.

WARNING

Death or serious injury due to a fire or an electric shock will result if the instructions given below are not followed.
Take care of the usage environment.
Using the unit in a strong electromagnetic environment may affect the light intensity.
Do not use the unit next to other devices.
Using the unit next to or stacked with other devices may cause malfunction.
When it is unavoidable to do so, it is necessary to check that the unit and the other devices are operating correctly.
Do not use a power cord other than the one 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 isused, the unit may become susceptible to high frequency noise generated by other electric devices
and thus result in malfunction.
Do not stare into the light source or continuously shine it into someone’s eyes.
It may cause damage to the retina of the eye.
If the infant’s pupils seem abnormal, shield their eyes from the light source.
It may cause damage to the retina of the eye.
Do not let the light source directly touch the infant.
Keep it at least 30cm away from the infant at all times.

6

Operating Precautions

CAUTION

Injury or damage to surrounding objects may result if the instructions given below are not followed.
Remove the AC adapter plug from the power outlet before moving the unit to another placeor when the unit is not going to be used for a long time.
Moving the unit to another place with the AC adapter plug connected to the power outlet will damage
the AC adapter cable and may cause a fire or an electric shock.

PLEASE READ WITHOUT FAIL

1-3.

Do not expose the unit to extraordinarily high temperature or excessive humidity.
Do not let the unit hit anything, fall or drop inadvertently.
Do not forcefully bend the flexing arm.
When adjusting the position of the irradiation head, do not forcefully bend the flexing arm.
Doing so may cause a breakdown.
The unit is not water resistant.
If the unit has water or another liquid spilled on it, turn off the stand-by switch, remove the AC adapter
plug from the power outlet and then clean the liquid with a dry cloth. If water has condensed on the insideof the lens cover, wait until the water has completely evaporated and then inspect the unit before use.

7

Parts Identification[2] Parts Identification
2-1.

Main Unit

③

④

⑤

⑦

①

⑫

⑧

⑥
②

⑬
⑨

⑩

⑪

No.
①
②
③
④
⑤
⑥
⑦
⑧
⑨
⑩
⑪
⑫
⑬

8

Name
Irradiation head
Operation panel
Flexing arm
Arm joint
Linking arm
Arm cover
Mounting section
Relay cable
Cable cover
AC adapter
AC adapter plug
F-Rail Attachment (sold separately)
Pole Mounting Attachment (sold separately)

Parts Identification

Irradiation Head

①
②
④

③

No.
①
②
③
④

2-3.

PLEASE READ WITHOUT FAIL

2-2.

Name
Non-contact sensor
White LED (with lens)Lens cover
Irradiation head coverOperation Panel

①

No.
①
②
③
④
⑤

②

③

④

⑤

Name
Operation indicator
Light control button “−”Light control button “+”Stand-by indicatorStand-by switch

9

Preparation before Use[3] Preparation before Use
3-1.

Assembling the Mounting Section
WARNING
Make sure that the F-Rail Attachment/Pole Mounting Attachment is securely attached to the mainunit.

Attach the appropriate part to the unit (F-Rail Attachment or Pole Mounting Attachment, sold separately) according to the “Installation Manual” included with this unit.

3-2.

Power Outlet
WARNINGThe electrical rating of this unit is as follows:
AC120–240V; power consumption 13VA; frequency 50/60Hz; operating voltage range; AC120–
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.

10

Preparation before Use(1)

How to attach and remove a plug to and from the power adapter
You can attach a plug appropriate for use in your region to the power adapter supplied with the unit.

EU

UK

US

AU

Plug

PREPARATION• Attaching a plug to the power adapter
Align the plug with the groove of the power adaptor.
Slide the plug in the direction of the arrow until thelock button clicks.

GrooveLock button

Plug• Removing a plug from the power adapter
Slide the plug in the direction of the arrow whilepressing the lock button, and then remove the
plug.

Plug

Lock button

11Preparation before Use(2)

Insert the AC adapter into the power outlet. The
stand-by indicator on the irradiation head will turngreen.

The stand-by indicatorturns on "green".

Irradiation head

CAUTION● Keep an area of over 15cm around the power
outlet clear so that the AC adapter can be quickly
removed.

Power outlet
15cm

AC adapter

12Preparation before Use

3-3.

Unit Installation
WARNINGBe sure to attach the unit securely to the incubator/infant warmer.

(1)

When attaching the F-Rail Pole to the incubator or infant warmer, refer to the unit placement dimensions
in the diagram to secure the F-Rail Attachment.

Fixing knob①

Dual Incu i, Incu i
Atom Infant Incubator V-2200, Atom Infant Incubator
V-2100G, Rabee Incu i (Only applicable when theF-Rail Pole is attached.)
Infa Warmer i, Infa Warmer V-505✽ For other products, contact your local Atomrepresentative.
① Support the unit with your hand, and insert the
tip of the F-Rail Attachment into the F-Rail groovein the products mentioned above.
② Tighten the fixing knob.
③ Make sure that the placement of the mounting
section does not interfere with the operation of
the incubator or the treatment of the infant.
④ Make sure that the F-Rail Attachment is secured
correctly to the F-Rail of the incubator etc. toprevent the unit from falling off while in use.
(2)②

PREPARATION• Attachable Products

25cm

Example of attachment (F-Rail Pole)

When attaching the I.V Pole, refer to the diagram tosecure the Pole Mounting Attachment.
① Support the unit with your hand, and loosen the
Pole Mounting Attachment knob while inserting
the I.V Pole.
② Tighten the knob.
③ Make sure that the placement of the mounting
section does not interfere with the operation of
the incubator or the treatment of the infant.
④ Make sure that the I.V Pole is secured correctly
to the Pole Mounting Attachment to prevent theunit from falling off while in use.

Example of attachment (I.V Pole)

13

Preparation before Use

3-4.

Daily Inspection

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

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

14

How to Operate the Unit

[4] How to Operate the UnitWARNING
Do not stare into the light source or continuously shine it into someone’s eyes.
It may cause damage to the retina of the eye.
If the infant’s pupils seem abnormal, shield their eyes from the light source.
It may cause damage to the retina of the eye.
Do not let the light source directly touch the infant.
Keep it at least 30cm away from the infant at all times.
Do not let the irradiation head close to the heater unit in the canopy of the Infa Warmer i or Infa
Warmer V-505.
Be sure to place the irradiation head away from the heater unit. Otherwise, the irradiation unit will
overheat and cause the unit to break down.
Do not operate the unit covered with a cloth.
Otherwise, the irradiation unit will overheat and cause the unit to break down.

4-1.

OPERATION

Make sure that the Dual Incu i canopy does not hit anything when raising and lowering it.
Before moving the canopy of the Dual Incu i upward, be sure to move the InfaLite away so thatit does not interfere with the canopy. Also make sure that the InfaLite does not interfere with the
canopy when moving it downward.

Operating the Irradiation Head
CAUTION
If you are using an incubator with this unit, make sure that the irradiation head of this unit and hoodof the incubator do not become perpendicular. Otherwise, the non-contact sensor may becomeunresponsive.
Do not forcefully bend the flexing arm.
When adjusting the position of the irradiation head, do not forcefully bend the flexing arm. Doingso may cause a breakdown.
Keep the irradiation head at least 30cm away from the infant at all times.
This is so that the irradiation and head of the infant do not make contact.

15

How to Operate the Unit

(1)

Move the linking arm or flexing arm so that the
infant is exposed to, but at least 30cm away fromthe irradiation head.

Flexing arm✽The flexing arm may not be secure while in a horizontal position and may drop downward.

RotateRotateLinking arm

Example (Dual Incu i)(2)

If operating the irradiation head with an incubator, make sure that the hood of the incubator andirradiation head of this unit are slightly angled sothat they do not become perpendicular. If they are
perpendicular, the non-contact sensor may becomeunresponsive.

Irradiation
head

Hood

Vertical position

Estimated Illumination Intensity at the Center of the Light Field

Central illumination
intensity (Lx)Maximum
level

Light
distance (cm)Minimum
level

8,000

2,000

ø30

30

4,500

1,100

ø40

40

2,900

700

ø50

50

2,000

500

ø60

60

Light field (cm)✽The standard light intensity is set to be the central light intensity at a distance of 60cm.
16How to Operate the Unit

4-2.

Lighting and Light Control
CAUTIONThe non-contact sensor may not respond to black objects. Make sure to use the palm of your handto activate it.
If the front of the lens cover is dirty, wipe the dirt away. If the lens cover is used while dirty, the lightintensity may drop and the response of the non-contact sensor may become poor.

(1)

Press the stand-by switch of the operation panel.

(2)

Confirm that the color of the operation light is “blue”,
then hold the palm of your hand in front of the irradiation head to turn it on.

Operation
panel
Irradiation
head

Within approx.
15cm

 he non-contact sensor responds when an object✽Tis within 15cm of the irradiation head.

When adjusting the light, press the light control
button “+” or “−” to adjust the light to the desired
level.
 he light is set to its highest intensity as a factory✽T
default.
I f you are not using the non-contact sensor, contact
your local Atom representative.

4-3.

Light control
button "+"Light control
button "–"OPERATION(3)

Operation
indicatoris blue.

Turning Off and Storing the Light(1)

Hold the palm of your hand against the front of the irradiation head to turn it off.

(2)

Press the stand-by switch of the operation panel.

(3)

Remove the AC adapter plug from the power outlet.

(4)

Move the linking arm or flexing arm so that it does not interfere with the operation of the incubator/
infant warmer or the operator.

17

Cleaning and Disinfection[5] Cleaning and Disinfection
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.
See the accompanying document of the disinfectant you are going to use for appropriate concentration, contact time and handling. Follow the directions for use and dosage and precautions givenin the document.
Be sure to dilute 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 stand-by switch and remove the AC adapter from the power outlet before
cleaning 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 contamination. If contamination 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 theunit for disinfection.
Dirt on the lens cover may cause a lowered light intensity or a loss in non-contact sensor responsiveness. Use a soft, clean cloth and disinfectant to clean the lens cover, and then wipe the lenscover with a soft, dry cloth.

(1)

Obtain a soft clean cloth and a disinfectant solution for cleaning and disinfection.
✽R ecommended disinfectant solutions include the following. Never use these solutions undiluted.
• Benzalkonium chloride aqueous solution• Benzethonium chloride aqueous solution• Chlorhexidine aqueous solution• Amphoteric surfactant aqueous solution

(2)

18

After cleaning the unit and its parts with a soft cloth dampened with a disinfectant solution, wipe themagain with a soft, dry cloth.

Maintenance Inspection[6] Maintenance Inspection
In order to use the unit safely for a longer period, perform the maintenance inspections described below.

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 before maintenance inspections, repairs, or disposal.

• 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.
• Semiannually inspection
Check the operation of each function of the unit every six months.
• 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.

6-1.

Measuring the Light Intensity

Check that the light intensity is operating at its specified level every six months.
Use a calibrated commercial light intensity measurement device to measure the light intensity.
(1)

Lens cover
Mattress
Cover
Light intensity
measurement
deviceIrradiation head
Measurement
section60cm Parallel
Mattress

MAINTENANCE

Attach the mattress cover to the mattress, thenplace the light intensity measurement device on
the mattress cover. Make sure that the lens coverof the irradiation head and the light intensity measurement device are parallel, and that the distance
between them is 60cm. Next, align the center of theirradiation head with the center of the light intensity
measurement device.

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

19

Maintenance Inspection(2)

Turn on the unit’s light, then press “+” on the lightcontrol button to set it to its highest intensity. Wait
at least ten minutes, and then confirm that the lightintensity has reached the value specified for the
maximum intensity.
Next, press “–” on the light control button to set it to
the lowest intensity. Confirm that the light intensity
dims to the value specified for the lowest intensity.

CAUTION● Allow at least 10 minutes for the irradiance of the
LED light source to stabilize.
● The specified value is a minimum light intensityof 500Lx or lower and a maximum of 2,000Lx orhigher.

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 partsor defective function in the inspection, stop using the unit immediately and contact your local Atomrepresentative.
Item to checkAppearance
AC adapter
Cable coverStand-by switch
Non-contact sensor
Light control button“−”/“+”
Lens cover
Flexing arm
Linking arm

20

Description
The main unit should be free of damage.
(Otherwise, the infant and/or the user may get injured due to breakage, etc.)
The AC adapter plug should be neither deformed or broken. The AC adapter cableshould be neither damaged or dirty.
(Otherwise, the unit may not receive power.)
The F-Rail Attachment/Pole Mounting Attachment should not be broken.
(Otherwise, the unit may not receive power.)Pressing the stand-by switch and activating the non-contact sensor should cause its
light to turn on.
Pressing the stand-by switch and activating the non-contact sensor should cause thelight to turn on or off.
After turning on the power, turning on the light with the non-contact sensor, and pressing “−” or “+” on the light control button should cause the light intensity to change.
The lens cover should not have any cracks, dirt, fog, or damage.
(Otherwise, the light intensity may drop and the response of the non-contact sensor may become poor.)
The F-Rail Attachment/Pole Mounting Attachment should not be broken, and theirradiation head should be held securely in place.
✽It may not be secure while in a horizontal position and may drop downward, but this is not a defect.
The F-Rail Attachment/Pole Mounting Attachment should not be broken, and themovable parts should be able to rotate.

F-Rail Attachment/PoleThe F-Rail Attachment/Pole Mounting Attachment should not be broken, and should
Mounting Attachment
be securely fixed to the incubator, etc.
(Sold separately)
The operation manual should be kept where it is readily accessible.
Operation Manual(Otherwise, the unit may be operated incorrectly due to lack of accessible information.)

Maintenance Inspection

6-3.

Monthly Inspection

Check the following points every month.
Item to check

Procedure

F-Rail Attachment/
Pole Mounting Attachment(Sold separately)

Shake the main unit.

All parts

Visually check each part.

White LED (with lens)

Visually check the LED.

Flexing arm

Move the main unit.

Linking arm
AC adapter

6-4.

Loosen the fixing knob.

Description
Shake the unit to check that the F-Rail Attachment/Pole Mounting Attachment is
not loose.
Remove the main unit from the peripheraldevices.
They should not be deteriorated (cracked,
bent, damaged, etc.)
The white LED should emit light.
The irradiation head should hold in place.
✽It may not be secure while in a horizontal

position and may drop downward, but thisis not a defect.
Each movable part should rotate without
Move the main unit.
becoming loose.
Insert the AC adapter plug into The stand-by indicator on the irradiation
the power outlet.
head should turn “green”.

Semiannually Inspection

Check the following points every six months.
Item to check
White LED (with lens)Procedure
Description
Measure the light intensity with The light intensity of the white LED shoulda light intensity measurement reach the specified value (see “6-1. Measurdevice.
ing the Light Intensity”).

MAINTENANCE
21

Maintenance Inspection

6-5.

Periodical Replacement Parts

Periodical replacement parts are those which gradually deteriorate and wear down with use. They need periodical 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

AC adapter plug2∼3 years

AC adapter✽2∼3 years

Flexing arm✽

2∼3 years

White LED (with lens)✽

Lens cover✽Reason for replacement
Damage or deformation of the plug may cause malfunctions during operation.
Damage or dirt on the cord may cause malfunctions
during operation.
Deterioration or damage of the flexing arm maycause it to be unable to hold in a position.

When the operation time of
the unit has exceeded 10,000
hours. Light intensity does A lowered light intensity may interfere with treatnot reach the specified value ment.
(see “6-1. Measuring theLight Intensity”).
A lowered light intensity or a loss in non-contact sen2∼3 years
sor responsiveness may interfere with treatment.

✽If a replacement is necessary, contact your local Atom representative.

22

Maintenance Inspection

6-6.

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
Serial No.

InfaLite

Date of inspection
Inspector

Item to check
Inspection before use (every time)

YES / NOYES / NOYES / NOYES / NOYES / NOYES / NOYES / NOYES / NOYES / NOYES / NOYES / NOYES / NOYES / NOYES / NOYES / NOYES / NO

MAINTENANCE

Is the main unit free of damage?
Is the AC adapter free of damage or deformation? Is the cable of AC adapter free of damage ordeformation?
Is the cable cover free of damage?
Does pressing the stand-by switch and activating the non-contact sensor cause its light to turn on?
Does pressing the stand-by switch and holding the palm of your hand within 15cm of the non-contact
sensor cause the sensor to respond and the light to turn on?
Does turning on the power, turning on the light with the non-contact sensor, then pressing “−” or“+” on the light control button cause the light intensity to change?
Is the lens cover free of any cracks, dirt, or damage?
Is the flexing arm free of damage? Is the irradiation head held in place?
Is the linking arm free of damage? Do the movable parts rotate?
Is the F-Rail Attachment/Pole Mounting Attachment (sold separately) securely attached to the
incubator, etc.?
Is the Operation Manual kept where it is readily accessible?
Monthly inspection
Is the F-Rail Attachment/Pole Mounting Attachment (sold separately) securely attached to the incubator, etc.? Can the F-Rail Attachment/Pole Mounting Attachment be detached from the incubator,etc. by loosening the fixing knob?
Are the parts of the unit deteriorated or damaged (cracked, bent, damaged, etc.)?
Does the white LED emit light?
Does the flexing arm hold the irradiation head in place?
Does each movable part of the linking arm rotate without becoming loose?
Does the stand-by indicator on the irradiation head turn “green” when the AC adapter plug is inserted into the power outlet?
Semiannually inspection
Does the light intensity of the white LED reach the specified value (see “6-1. Measuring the Light
Intensity”)?

Results

YES / NOYES / NO23

Maintenance Inspection

6-7.

Disposal

The medical institution concerned is responsible for proper disposal of the unit, old parts past their expected
life span and disposables in accordance with applicable waste disposal laws and regulations.

24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.

TroubleAction to take
The power does not turn on.
Is the AC adapter plug inserted into the power outlet?
Pressing the light control button does notcause the light to become brighter. Also, it Are you confusing “−”and “+” on the light control button?
also does not become dimmer.
Did you move your hands near the non-contact sensor?
Is the palm of your hand outside of the detection zone for the noncontact sensor (approx. 15cm)?
Is the lens cover dirty?
If you are using an incubator, are the main unit’s irradiation headand hood perpendicular?
The light does not turn on.
✽See “4-1. Operating the Irradiation Head”.
Is the non-contact sensor responding to something black?
Is the operation indicator “blue”?
✽If the operation indicator does not turn on or turns on in a color

MAINTENANCE

The main unit is loose during operation.

other than blue, the non-contact sensor has stopped working or
is broken. Contact your local Atom representative.
Is the fitting knob of the F-Rail Attachment/Pole Mounting Attachment (sold separately) loose?

25

Technical Information[8] Technical Information
8-1.

Technical Data

Power requirements

Rating: AC120–240V; power consumption 13VA; frequency 50/60Hz
Operating voltage range: AC120–240V±10%

Classification

Type of protection: Class II equipment
Degree of protection: no applied partNot for use in an air and flammable anesthetic gas mixture or an oxygen/nitrous
oxide and flammable anesthetic gas mixture
Mode of operation: Continuous operation

Light source:

white LED
Color temperature: 4,000∼4,800K (changes in the ambient temperature may
cause slight variations)Light intensity

Below 500 to above 2,000Lx ✽ when adjusting the light(if the distance from the irradiation head and the light intensity measurement
device is 60cm)

Light field

Approximately ϕ60cm (if the distance from the irradiation head and the lightintensity measurement device is 60cm)

Light field life

10,000 hours (lumen maintenance factor 70%)

Non-contact sensor

Responds to objects within approximately 15cm

Dimensions

ϕ5.5(W) x 25(D) x 87(H) cm✽ With the flexing arm extended✽ Not including the F-Rail Attachment/Pole Mounting Attachment (sold separately)

Weight1.6kg✽ Not including the F-Rail Attachment/Pole Mounting Attachment (sold separately)

Operating conditions

Ambient temperature: 10∼30˚C
Relative humidity: 30∼85% (with no condensation)
Pressure: 70∼106 kPa(525∼795mmHg)

Storage conditions

Ambient temperature: 0∼50˚C
Relative humidity: 30∼75% (with no condensation)
Pressure: 70∼106 kPa(525 - 795mmHg)

Transport conditions

Ambient temperature: 0∼50˚C
Relative humidity: 30∼75% (with no condensation)
Pressure: 70∼106 kPa(525∼795mmHg)

Products sold separately

F-Rail Attachment Order No. : 60217
Pole Mounting Attachment Order No. : 60218✽The unit meets the EMC (electromagnetic compatibility) requirements of IEC 60601-1-2.

26

Technical Information

8-2.

EMC Level and Classification■ Emission test level
The unit is intended for use in the electromagnetic environment specified below.
The customer or the user of the unit should assure that it is used in such an environment.
Emissions test

Compliance

Conducted and radiated RF emissions
CISPR11

Group 1

Conducted and radiated RF emissions
CISPR11Class A

APPENDIX
27

Technical Information■ Immunity test level
The unit is intended for use in the electromagnetic environment specified below.
The customer or the user of the unit should assure that it is used in such an environment.
Immunity test

Compliance level

Electrostatic discharge
IEC61000-4-2±8kV contact±2kV, ±4kV, ±8kV, ±15kV air

Electrical fast transients/bursts
IEC61000-4-4±2kV(power port, ground port)

Surges
IEC61000-4-5±0.5kV, ±1kV (Line-to-line)

Voltage dips, Voltage interruptions
IEC61000-4-11

0%Ut: 0.5cycle(0,45,90,135,180,225,270,315°)
0%Ut: 1cycle (single phase: 0°)
70%Ut: 25/30cycle (single phase: 0°)0%Ut: 250/300cycle

Rated power frequency magnetic fields (50/60Hz)
IEC61000-4-8

30A/m

Conducted disturbances induced by RF fields
IEC61000-4-6

3Vrms
0.15MHz — 80MHz
6Vrms in ISM bands between 0.15MHz — 80MHz
80%AM at 1kHz

Radiated RF EM fields
IEC61000-4-3

3V/m
80MHz~2.7GHz
80%AM at 1kHz
Refer to another table for the proximity fields from RF
wireless communications equipment

28

Technical Information■ Details of test level of proximity fields from RF wireless communications equipment
Test frequency[MHz]

Maximum power[W]

Distance[m]

Immunity test level
[V/m]

385

1.8

0.3

27

450

2

0.3

28

0.2

0.3

9

2

0.3

28

2

0.3

28

2

0.3

28

0.2

0.3

9

710
745
780
810
870
930
1720
1845
1970
2450
5240
5500
5785

APPENDIX
29

• 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.

C73MC015

2-2-1, Dojo, Sakura-ku, Saitama-shi, Saitama, Japan
https://atomed-global.com

202109