Atom InfaLite User manual

Equipment for neonatal and premature infants/LED Examination Light
Atom InfaLite
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.
ORIGINAL

Via Libia, 54 - 20081 Abbiategrasso (MI) - Italy
Tel: [phone] Fax: [phone]
EU OFFICE

1
INTRODUCTION
This Operation Manual deals with the specifications, operation and maintenance of the InfaLite. 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 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.
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.
Used products and parts 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.
Federal (US and Canada) Law restricts this device to sale by or on the order of a physician.
CAUTION
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. 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.

2
Definition 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,
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,
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
minor or moderate injury, partial damage to equipment, and loss of data stored
in computers.
DANGER:
WARNING :
CAUTION:
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.
Prohibition of use of fire
Indicates prohibition of use of fire where an external use of fire may cause the unit to ignite under
certain conditions.
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 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.

3
4. Symbols of international standards (IEC)
Symbol Title 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 manufac-
turer.
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.
5. Other symbols
Symbol Title 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.

4
Precautions on Jamming
WARNING
The 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 hos-
pitals (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 communi-
cation services. The user may also need to relocate or realign the unit to alleviate the problem.
Responsibility for Care of Equipment
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.
CAUTION
Prohibition of Modification
WARNING
Do not disassemble or modify the unit.
Otherwise, a fire, an electric shock or injury may result.
Periodical Inspection
Periodical inspection is needed to use the unit in the optimum condition.
CAUTION
In Case of Trouble
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. 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.
CAUTION

PREPARATION OPERATION MAINTENANCE APPENDIX
PLEASE READ WITHOUT FAIL
CONTENTS
INTRODUCTION .................................................... 1
PLEASE READ WITHOUT FAIL
[1] Operating Precautions ............................... 6
1-1. DANGER .................................................. 6
1-2. WARNING ................................................ 6
1-3. CAUTION ................................................. 7
[2] Parts Identification ...................................... 8
2-1. Main Unit.......................................................... 8
2-2. Irradiation Head .............................................. 9
2-3. Operation Panel .............................................. 9
PREPARATION
[3] Preparation before Use ............................ 10
3-1. Assembling the Mounting Section.............. 10
3-2. Power Outlet .................................................. 10
3-3. Unit Installation.............................................. 13
3-4. Daily Inspection............................................. 14
OPERATION
[4] 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
MAINTENANCE
[5] 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
6-7. Disposal.......................................................... 24
[7] Troubleshooting......................................... 25
APPENDIX
[8] Technical Information............................... 26
8-1. Technical Data............................................... 26
8-2. EMC Level and Classification ..................... 27

6
Operating Precautions
Operating Precautions[1]
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 due to a fire or an electric shock will result if the instructions given below are not fol-
lowed.
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 fire
is 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 fol-
lowed.
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 operat-
ing 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 is
used, 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.

7
PLEASE READ WITHOUT FAIL
Operating Precautions
1-3. 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 place
or 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.
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 inside
of the lens cover, wait until the water has completely evaporated and then inspect the unit before use.

8
Parts Identification
Parts Identification[2]
Main Unit2-1.
⑨
①
③④⑤
⑥
⑦
⑧
⑩
⑪
⑫
⑬
②
No. Name
①Irradiation head
②Operation panel
③Flexing arm
④Arm joint
⑤Linking arm
⑥Arm cover
⑦Mounting section
⑧Relay cable
⑨Cable cover
⑩AC adapter
⑪AC adapter plug
⑫F-Rail Attachment (sold separately)
⑬Pole Mounting Attachment (sold separately)

9
PLEASE READ WITHOUT FAIL
Parts Identification
Irradiation Head2-2.
①
②
③④
No. Name
①Non-contact sensor
②White LED (with lens)
③Lens cover
④Irradiation head cover
Operation Panel2-3.
⑤④③②①
No. Name
①Operation indicator
②Light control button “−”
③Light control button “+”
④Stand-by indicator
⑤Stand-by switch

10
Preparation before Use
Preparation before Use[3]
Assembling the Mounting Section3-1.
WARNING
Make sure that the F-Rail Attachment/Pole Mounting Attachment is securely attached to the main
unit.
Attach the appropriate part to the unit (F-Rail Attachment or Pole Mounting Attachment, sold separately) ac-
cording to the “Installation Manual” included with this unit.
Power Outlet3-2.
The 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.
WARNING

11
PREPARATION
Preparation before Use
How to attach and remove a plug to and from the power adapter(1)
You can attach a plug appropriate for use in your region to the power adapter supplied with the unit.
AU
USUKEU
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 the
lock button clicks.
Removing a plug from the power adapter•
Slide the plug in the direction of the arrow while
pressing the lock button, and then remove the
plug.
Plug
Groove
Plug
Lock button
Plug
Lock button

12
Preparation before Use
(2) Insert the AC adapter into the power outlet. The
stand-by indicator on the irradiation head will turn
green.
CAUTION
●Keep an area of over 15cm around the power
outlet clear so that the AC adapter can be quickly
removed.
The stand-by indicator
turns on "green".
Irradiation head
AC adapter
15cm
Power outlet

13
PREPARATION
Preparation before Use
Unit Installation3-3.
Be sure to attach the unit securely to the incubator/infant warmer.
WARNING
(1) When attaching the F-Rail Pole to the incubator or in-
fant warmer, refer to the unit placement dimensions
in the diagram to secure the F-Rail Attachment.
Attachable Products•
Dual Incu i, Incu i
Atom Infant Incubator V-2200, Atom Infant Incubator
V-2100G, Rabee Incu i(Only applicable when the
F-Rail Pole is attached.)
Infa Warmer i, Infa Warmer V-505
✽ For other products, contact your local Atom
representative.
①Support the unit with your hand, and insert the
tip of the F-Rail Attachment into the F-Rail groove
in 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.
④Make sure that the F-Rail Attachment is secured
correctly to the F-Rail of the incubator etc. to
prevent the unit from falling off while in use.
(2) When attaching the I.V Pole, refer to the diagram to
secure the Pole Mounting Attachment.
①Support the unit with your hand, and loosen the
Pole Mounting Attachment knob while inserting
the I.V Pole.
②Tighten the knob.
③Make sure that the placement of the mounting
section does not interfere with the operation of
the incubator or the treatment of the infant.
④Make sure that the I.V Pole is secured correctly
to the Pole Mounting Attachment to prevent the
unit from falling off while in use.
Fixing knob
①
②
25cm
Example of attachment (F-Rail Pole)
Example of attachment (I.V Pole)

14
Preparation before Use
Daily Inspection3-4.
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.
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.
WARNING

15
OPERATION
How to Operate the Unit
How to Operate the Unit[4]
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.
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 that
it does not interfere with the canopy. Also make sure that the InfaLite does not interfere with the
canopy when moving it downward.
WARNING
Operating the Irradiation Head4-1.
If you are using an incubator with this unit, make sure that the irradiation head of this unit and hood
of the incubator do not become perpendicular. Otherwise, the non-contact sensor may become
unresponsive.
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.
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.
CAUTION

16
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 from
the irradiation head.
✽The flexing arm may not be secure while in a hori-
zontal position and may drop downward.
Flexing arm
Linking arm
Rotate
Rotate
Example (Dual Incu i)
(2) If operating the irradiation head with an incuba-
tor, make sure that the hood of the incubator and
irradiation head of this unit are slightly angled so
that they do not become perpendicular. If they are
perpendicular, the non-contact sensor may become
unresponsive.
Vertical position
Irradiation
head
Hood
Estimated Illumination Intensity at the Center of the Light Field
500
2,000
1,100
700
2,000
8,000
4,500
2,900
ø60
ø30
ø40
ø50
60
30
40
50
Light
distance (cm)
Central illumination
intensity (Lx)
Maximum
level
Minimum
level
Light field (cm)
✽The standard light intensity is set to be the central light intensity at a distance of 60cm.

17
OPERATION
How to Operate the Unit
Lighting and Light Control4-2.
The non-contact sensor may not respond to black objects. Make sure to use the palm of your hand
to activate it.
If the front of the lens cover is dirty, wipe the dirt away. If the lens cover is used while dirty, the light
intensity may drop and the response of the non-contact sensor may become poor.
CAUTION
(1) Press the stand-by switch of the operation panel.
Confirm that the color of the operation light is “blue”,(2)
then hold the palm of your hand in front of the ir-
radiation head to turn it on.
✽ The non-contact sensor responds when an object
is within 15cm of the irradiation head.
Operation
indicator
is blue.
Irradiation
head
Within approx.
15cm
Operation
panel
(3) When adjusting the light, press the light control
button “+” or “−” to adjust the light to the desired
level.
✽ The light is set to its highest intensity as a factory
default.
If you are not using the non-contact sensor, contact
your local Atom representative.
Light control
button "+"
Light control
button "–"
Turning Off and Storing the Light4-3.
Hold the palm of your hand against the front of the irradiation head to turn it off.(1)
Press the stand-by switch of the operation panel.(2)
Remove the AC adapter plug from the power outlet.(3)
Move the linking arm or flexing arm so that it does not interfere with the operation of the incubator/(4)
infant warmer or the operator.

18
Cleaning and Disinfection
Cleaning and Disinfection[5]
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 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 the
unit for disinfection.
Dirt on the lens cover may cause a lowered light intensity or a loss in non-contact sensor respon-
siveness. Use a soft, clean cloth and disinfectant to clean the lens cover, and then wipe the lens
cover with a soft, dry cloth.
CAUTION
Obtain a soft clean cloth and a disinfectant solution for cleaning and disinfection.(1)
✽ Recommended 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
After cleaning the unit and its parts with a soft cloth dampened with a disinfectant solution, wipe them(2)
again with a soft, dry cloth.