InfaLite Service Manual & Parts List Jan 2013

PARKER H e a l t h c a r e w w w . p a r k e r h e a l t h . c o m . a u

Parker Healthcare Pty Ltd Head Office & International Department:

16 Redland Drive, Mitcham VIC 3132 Australia Ph: +61 3 9872 0222 Fax: +61 3 9873 5911 Email: [email protected]

EU OFFICE Via Libia, 54 - 20081 Abbiategrasso (MI) - Italy Tel: +39 02 99763101 Fax: +39 02 99763110

INTRODUCTION This Service Manual & Parts List describes procedures for inspecting and repairing the InfaLite. It also describes troubleshooting in faulty conditions. The procedures described in this Service Manual should be carried out only by personnel trained in electricity and the operation of the unit. Neither Atom Medical Corporation nor its representative will be responsible for the quality and performance of the unit if the unit should not be handled as instructed or if unauthorized parts should be used in repairs. It should be noted that any responsibility arising from inspecting or repairing the settings of the unit lies with the person who carried it out. Read this Service Manual & Parts List carefully and familiarize yourself thoroughly with its contents before inspecting or repairing the unit. Keep this Manual where it is readily accessible for reference when needed. For more detailed information on inspecting and repairing the unit, contact your local Atom representative. Read the Operation Manual thoroughly before using the Service Manual.

SAFETY INFORMATION Please read the Service Manual carefully before operating the unit. Please follow the instructions when operating the unit.

Basic Instructions 1. Medical institutions are responsible for the maintenance, inspection and care of the unit. 2. When you choose to have the unit maintained and inspected or when the unit is found to be in need of repairs from the results of inspection, consult your local Atom representative and take one of the following measures. (1) Ask someone who has completed a training course specified by Atom and who has sufficient technical knowledge and skills to do the work. (2) Ask Atom to send its service engineer if a person who has completed a training course specified by Atom and who has sufficient technical knowledge and skills is not available. (3) Ask Atom for its approval of returning the unit for repair service. 3. Follow the instructions for safety. Follow the operating precautions described in this Service Manual and the Operation Manual for the safe use of the unit. 4. Inspect the unit on a periodical basis. Periodical inspection is needed to use the unit under optimum conditions. 5. Take proper measures to ensure that a defective unit will not be used by mistake before it is properly inspected and repaired for normal operation. Such measures include indicating on the unit that it is under inspection or repair and keeping it away from other devices that function correctly.

1

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.

2

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.

Precautions on Jamming

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

3

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.

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 Service 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]

Wiring Diagram... 29

[10] Parts List ... 31

1-1.

DANGER ... 6

APPENDIX

1-2.

WARNING ... 6

[11] Technical Information ... 34

1-3.

CAUTION ... 7

11-1. InfaLite Principle of Operation... 34 11-2. Technical Data ... 35 11-3. EMC Level and Classification ... 36

Parts Identification ... 8

MAINTENANCE

[12] Disposal ... 40

Maintenance Inspection... 10 Measuring the Light Intensity ... 10 Inspection before Use ... 11 Monthly Inspection... 12 Semiannually Inspection... 12 Inspection Checklist ... 13 Periodical Replacement Parts ... 14

[4]

Cleaning and Disinfection ... 15

[5]

Troubleshooting ... 16 5-1. Troubleshooting ... 17

DISASSEMBLY AND REPLACEMENT

6-1. Replacing the Operation Panel Sheet ... 19 6-2. Replacing the Main Unit Cover/ Lens Cover... 19 6-3. Replacing the Non-Contact Sensor ... 20 6-4. Replacing the LED Light Source Board ... 21 6-5. Replacing the Control Board ... 22 6-6. Replacing the Flexing Arm ... 22 6-7. Replacing the AC Adapter/Relay Cable ... 23

INFORMATION

Disassembly and Replacement Procedures ... 19

DISASSEMBLY AND REPLACEMENT

3-1. 3-2. 3-3. 3-4. 3-5. 3-6.

[6]

[9]

Operating Precautions ... 6

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

[3]

Block Diagram ... 28

MAINTENANCE

[2]

[8]

PLEASE READ WITHOUT FAIL

CONTENTS

INFORMATION Settings ... 25 7-1. Confirming the Product Version ... 25 7-2. Checking the Operation of the Non-Contact Sensor ... 26 7-3. Setting the Non-Contact Sensor... 26

APPENDIX

[7]

Operating Precautions

[1] Operating Precautions Please follow the operating instructions described in this Service 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. Do not use the unit in the presence of a flammable 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. Do not attach anything other than the included plug to the AC adaptor. It may cause a fire, electric shock, or a breakdown in the unit. 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 patient’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 patient. Keep it at least 30cm away from the patient 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 power cord 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 becomes wet, turn off the function switch and remove the AC adaptor plug from the power outlet. Then wipe the machine off with a dry cloth.

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Parts Identification

[2] Parts Identification 2-1.

Main Unit

③

④

⑤

⑦

⑫

① 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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Maintenance Inspection

[3] 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 and its accessories before maintenance inspections, repairs, or disposal.

r
Inspection before use Check the basic functional operation of each part of the unit every time you are going to use the unit. r
Monthly inspection Check the operation of each function of the unit every month. r
Semiannually inspection Check the operation of each function of the unit every six months. r
Periodical inspection Contact your local Atom representative annually for periodical inspection. r
Parts requiring periodical replacement Some parts need to be replaced periodically depending on their period of use.

3-1.

Measuring the Light Intensity

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

Attach the mattress cover to the mattress, then place the light intensity measurement device on the mattress cover. Set the irradiation head lens cover and the light detector so that they are parallel, then align the lens cover and the light detecting section of the light detector so their centers are aligned and they are 60cm apart.

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

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Lens cover Mattress Cover

Irradiation head Parallel-60cm Mattress

Measurement section Light intensity measurement device

Maintenance Inspection

(2)

Turn on the unit’s light, then press “+” on the light control button to set it to its highest intensity. Wait at least ten minutes, and then confirm that the light intensity has reached the default value.

CAUTION ● Allow at least 10 minutes for the irradiance of the LED light source to stabilize. ● The maximum light intensity is 1,400Lx or higher (factory default: 2,000Lx or higher).

Inspection before Use

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

MAINTENANCE

3-2.

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

Item to check Appearance

AC adapter

Cable cover Stand-by switch Non-contact sensor Light control button “−”/“+” Lens cover

Flexing arm

Linking arm

Description The main unit should be free of damage. (Otherwise, the parient and/or user may get injured due to breakage, etc..) The AC adapter plug should be neither damaged or deformed. The relay cable should be free of damage or dirt. (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 should cause the non-contact sensor to respond when the palm of your hand is moved within 15cm of the irradiation head. 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. Check that the irradiation head is held in place. ✽It may not be secure while in a horizontal position and may drop downward. This is not a defect. The F-Rail Attachment/Pole Mounting Attachment should not be broken. Check that the movable parts can be rotated.

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

The F-Rail Attachment/Pole Mounting Attachment should not be broken. Check that it is securely attached to the incubator, etc.

Operation Manual

The operation manual should be kept where it is readily accessible. (Otherwise, the unit may be operated incorrectly due to lack of accessible information.) 11

Maintenance Inspection

3-3.

Monthly Inspection

Check the following points every month. Item to check F-Rail Attachment/ Pole Mounting Attachment (Sold separately)

All parts White LED (with lens)

Flexing arm

Linking arm AC adapter

3-4.

Procedure

Description Shake the unit to check that the F-Rail AtShake the main unit. tachment/Pole Mounting Attachment is not loose. Remove the main unit from the peripheral Loosen the fixing knob. devices. They should not be deteriorated (cracked, Visually check each part. bent, damaged, etc.) Visually check the LED. The white LED should emit light. The irradiation head should hold in place. ✽It may not be secure while in a horizontal Move the main unit. position and may drop downward. This is not a defect. Each movable part should rotate without Move the main unit. becoming loose. Insert the AC adapter into the The stand-by indicator on the irradiation power outlet. head should turn “green”.

Semiannually Inspection

Check the following points every six months. Item to check White LED (with lens)

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Procedure Description Measure the light intensity with The light intensity of the white LED should a light intensity measurement reach the default value (see “3-1. Measuring device. the Light Intensity”).

Maintenance Inspection

3-5.

Inspection Checklist WARNING If any trouble is detected in any inspection, indicate on the unit that it is out of order and seek repair without fail. Contact your local Atom representative for further information on repairs.

Unit name

Date of inspection Inspector

Item to check Inspection before use (every time) Is the main unit free of damage? Is the AC adapter plug free of damage or deformation? Is the relay cable free of damage or deformation? 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 default value (see “3-1. Measuring the Light Intensity”)?

Results YES / NO YES / NO

MAINTENANCE

Serial No.

InfaLite

YES / NO YES / NO YES / NO YES / NO YES / NO YES / NO YES / NO YES / NO YES / NO

YES / NO YES / NO YES / NO YES / NO YES / NO YES / NO

YES / NO

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Maintenance Inspection

3-6.

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 plug

2∼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 may cause it to be unable to hold in a position.

If use has exceeded 10,000 hours. Light intensity does not A lowered light intensity may interfere with treatreach the default value (see ment. “3-1. Measuring the Light 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.

14

Cleaning and Disinfection

[4] 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.

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 plug from the power outlet before cleaning and disinfecting the unit.

MAINTENANCE

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

If any part of the unit is dirty, clean it before disinfecting the unit. Disinfect the unit periodically in order to prevent infection. If infection is suspected while the unit is in operation, stop using it immediately and disinfect it. The timing and method of disinfection varies with the frequency and conditions of use. The medical institution should determine the timing and method appropriate for the institution. Do not autoclave (sterilize with high pressure steam) and 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. ✽ Recommended disinfectant solutions include: t Benzalkonium chloride aqueous solution t Benzethonium chloride aqueous solution t Chlorhexidine aqueous solution t Amphoteric surfactant aqueous solution

(2)

Wipe the unit with a soft cloth dampened with a disinfectant solution, and then with a soft, dry cloth.

15

Troubleshooting

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

CAUTION Check the following points before requesting repair service.

Trouble Action to take The power does not turn on. Is the AC adapter plug inserted into the power outlet? Pressing the light control button does not cause the light to become brighter. Are you confusing “−”and “+” on the light control button? Also, it 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 head and hood vertical? The light does not turn on. ✽See “4-1. Operating the Irradiation Head” of the Operation manual. Is the non-contact sensor responding to something black? Is the operation indicator “green”? ✽If the operation indicator does not turn on or turns on in a color other than green, the non-contact sensor has stopped working or is broken. Contact your local Atom representative. The main unit is loose during opera- Is the fitting knob of the F-Rail Attachment/Pole Mounting Attachtion. ment (sold separately) loose?

16

Troubleshooting

5-1. (1)

Troubleshooting The power indicator and the LED do not turn on.

The AC adapter plug is faulty.

YES

Replace the AC adapter plug.

NO The AC adapter is faulty.

YES

Replace the AC adapter.

NO YES

Replace the relay cable.

NO The internal flexing arm cable has a broken wire.

YES

Replace the flexing arm.

MAINTENANCE

The relay cable has a broken wire.

NO Replace the control board.

(2)

The power indicator turns on, but the LED does not. The control board is faulty.

YES

Replace the control board.

NO The operation indicator is not green.

YES

Replace the non-contact sensor.

NO Replace the LED light source board with a new one.

17

Troubleshooting

(3) The non-contact sensor does not respond. The operation indicator is green.

YES

Start the non-contact sensor. *Refer to “7-3. Setting the Non-Contact Sensor” for more information

NO The control board is faulty.

YES

Replace the control board.

NO The operation indicator is not green.

YES

Replace the non-contact sensor.

NO Replace the LED light source board with a new one.

(4) Pressing the light control button does not change the level of illumination. The main unit cover is faulty. NO The control board is faulty.

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YES

Replace the main unit cover.