InfaLite Examination Light Operation Manual Sept 2021

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.

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 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.

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 authority of the country where the equipment is being used.

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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 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. 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.

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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 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 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 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, 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 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. 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.

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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

APPENDIX

APPENDIX

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 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 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 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 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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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 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.

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 inside of the lens cover, wait until the water has completely evaporated and then inspect the unit before use.

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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

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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 cover

Operation Panel

①

No. ① ② ③ ④ ⑤

②

③

④

⑤

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

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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 main unit.

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 WARNING 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.

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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 the lock button clicks.

Groove

Lock button

Plug • 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

Lock button

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Preparation before Use

(2)

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

The stand-by indicator turns 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

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Preparation before Use

3-3.

Unit Installation WARNING Be 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 knob ①

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. ④ Make 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)

②

PREPARATION

• Attachable Products

25cm

Example of attachment (F-Rail Pole)

When attaching the I.V Pole, refer to the diagram to secure 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 the unit from falling off while in use.

Example of attachment (I.V Pole)

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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.

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.

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How to Operate the Unit

[4] How to Operate the Unit WARNING 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 that it 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 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.

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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.

Flexing arm

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

Rotate Rotate Linking arm

Example (Dual Incu i) (2)

If operating the irradiation head with an incubator, 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.

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 CAUTION 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.

(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 ✽T is 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 indicator is 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.

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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 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 responsiveness. Use a soft, clean cloth and disinfectant to clean the lens cover, and then wipe the lens cover 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)

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After cleaning the unit and its parts with a soft cloth dampened with a disinfectant solution, wipe them again 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 device

Irradiation head Measurement section 60cm Parallel Mattress

MAINTENANCE

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

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

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