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.

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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.

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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)