MediLED Mini User and Technical Service Manual

LED Phototherapy VOLTAGE FREQUENCY POWER

100-240 V~ 50-60 Hz 50 VA

CLASSIFICATION AS PER IEC-60601-1 / IEC 60601-2-50 STANDARDS APPLICABLE PART

NOT APPLICABLE

ELECTRICAL PROTECTION

CLASS I

PROTECTION AGAINST INGRESS OF IPX0 LIQUIDS THIS EQUIPMENT IS NOT SUITABLE FOR USE IN PRESENCE OF FLAMMABLE ANAESTHETIC MIXTURES WITH AIR, OXYGEN OR NITROUS OXIDE

THIS EQUIPMENT IS NOT SUITABLE FOR STERILIZATION

Figure 1:

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TABLE OF CONTENTS USER WARNING ...5 LIMITED WARRANTY ...5 TECHNICAL ASSISTANCE ...5 SPARE PARTS SUPPLY – USEFUL LIFE ...5 WARNING, CAUTION, AND NOTE DEFINITIONS...6 CUSTOMER SERVICE...6 CE AUTHORIZED REPRESENTATIVE ...6 SUMMARY OF WARNINGS, CAUTION AND NOTES ...7 USED SYMBOLS ...10 WARNINGS ON THE EQUIPMENT ...12 EQUIPMENT IDENTIFICATION...12 1. INTRODUCTION ...13 1.1 1.2

INTENDED USE ...13 DESCRIPTION ...13

2. UNPACKING AND ASSEMBLY ...17 2.1

ASSEMBLY INSTRUCTIONS ...17

3. OPERATION DESCRIPTION...19 3.1 BASIC OPERATION ...19 3.2 EFFECTIVE SURFACE AREA ...19 3.3 IRRADIANCE ...20 3.4 SAFETY – VERY IMPORTANT WARNINGS ...20 3.5 COMMENTS ON ELECTROMAGNETIC COMPATIBILITY ...21 3.5.1 Emissions...21 3.5.2 Immunity ...22 3.5.3 Bibliography ...22 3.5.4 Recommended Electromagnetic Environment ...22 4. COMMAND MODULE DESCRIPTION...27 4.1

INDICATORS AND CONTROLS ...27

5. OPERATING INSTRUCTIONS...29 5.1 5.2 5.3 5.4

OPERATION ...29 LIGHT COVER ...30 LIGHT INTENSITY MEASUREMENT ...31 FUNCTIONAL CHECKING PROCEDURE ...31

6. TROUBLESHOOTING ...33 6.1

FAILURE INDICATOR ...33

7. HYGIENE, DISINFECTION AND MAINTENANCE ...35 7.1 7.2 7.3

HYGIENE AND DISINFECTION ...35 ROUTINE MAINTENANCE PLAN ...36 WASTE DISPOSAL ...36

8. TECHNICAL SERVICE ...37 8.1 8.2 8.3 8.4

BLOCK DIAGRAM ...37 TECHNICAL SERVICE FUNCTIONAL CHECKING PROCEDURE ...38 LEDS MODULE CALIBRATION ...39 REPLACING A DEFECTIVE LED ...40

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8.5

REPLACING THE LEDS BOARD ...41

9. PARTS ...43

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User Warning The information contained in this document has the purpose of offering adequate and detailed information to the user, for an easy installation, use, maintenance and request of spare parts of this equipment. The information contained in this manual is intended to be updated and accurate as at the date of its publishing or revision. Nevertheless, there is no guarantee that this document is free of mistakes.

Limited Warranty Medix I.C.S.A. warrants that every new device is free from manufacturing and material defects for regular use and functioning for a period of 1 (one) year as from the shipping date. This warranty does not cover disposables or consumables (i.e. filters, sensors, draft excluders, etc.), nor damage or break-downs due to misuse. This warranty only covers the repair or replacement of defective products during the warranty period, at manufacturer’s option. This warranty does not apply to any product modified without the express, written consent of Medix I.C.S.A., and under no circumstances will seller be responsible for direct or indirect damage. This warranty is non-transferable.

Technical Assistance The equipment of Medix I.C.S.A. subject to warranty must be repaired in authorized repairing centers. If the equipment needs repairing, contact your local dealer or the Medix I.C.S.A. Technical Assistance Department. Before calling, please have the model and serial number at hand. Should shipping be necessary, please pack the equipment and all accessories carefully, in order to avoid damage during transportation. Include all relevant accessories with the equipment.

Spare Parts Supply – Useful Life Medix I.C.S.A. guarantees the supply of original parts and spare parts for a 10 (ten) yearperiod after the manufacturing date of this equipment.

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Warning, Caution, and Note Definitions The terms “Warning,” “Caution,” and “Note” have special meanings as used in the operation instructions. The definitions of these terms are set out below:

! WARNING Possibility of injury to yourself or others.

CAUTION Possibility of damage to the equipment or to other property.

NOTE

Interesting items for a more efficient or convenient use.

Customer Service In case of doubt or enquiry concerning the safety and operation of this equipment, please contact: Medix I.C.S.A., José Arias 293, (1672) Villa Lynch, Buenos Aires, Argentina, Phone: +54-11-4754-5555, Fax: +54-11-4754-1713 E-mail: [email protected]

CE Authorized Representative The authorized representative of Medix I.C.S.A. before the Economic European Community (Medical Devices Directive 93/42 EEC) is: Hispamerica S.L., c/Puerto Canencia 21, 28.935 Mostoles, Madrid, Spain, CIF B-82101643.

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Summary of warnings, caution and notes Before starting to use the LED Phototherapy, it is recommended to thoroughly read the following WARNINGS, CAUTION and NOTES, which are contained in this manual.

! WARNING Manufacturer is liable for the safety, reliability and functioning of the equipment as long as: a) Installation, modification or repairing are carried out by the Company’s authorized technical staff, or by qualified and dully trained technical staff, using only elements, spare parts or replacement parts provided by manufacturer. b) Electrical installation and its authorization conform to local safety standards. c) The equipment is operated following the operation instructions described in this manual. Check that the power supply is compatible with electrical specifications shown on the unit. To assure a good ground connection, connect the AC cable only to a grounded plug. Do not remove ground wire. Do not use extension cables. If there is any doubt regarding ground connection, do not operate or turn the phototherapy light on. There is risk of electric shock during cleaning and maintenance procedures. Make sure that the power cable is disconnected from the wall socket. Technical service must be performed by qualified personnel only. The unit must be checked by specialized technical staff before it is switched on. Medical devices require special precautions regarding electromagnetic compatibility (EMC) and must be installed and put into service following the EMC information provided in the user and technical service manual. Special care must be taken to effectively cover the infant’s eyes before turning the lamp on. It is recommended not to use the lamp at distances shorter than 30 cm. Conventional phototherapy devices affect air sensor’s measurements in incubators, and the heater power of infant warmers or heated mattresses. Although is a cold lamp, it is recommended to use thermotherapy equipment in baby controlled mode. Patients near the phototherapy equipment may need to be protected with shields or protective glasses, etc. While the patient is under phototherapy treatment, bilirubin levels should be measured regularly. Bilirubin photoisomers may cause toxic effects. Water balance may be disturbed in some patients undergoing phototherapy. The safety of protective devices intended to prevent the patient from falling off the effective surface area should be checked regularly. The phototherapy equipment auxiliary devices shall comply with the general safety requirements set forth in IEC60601-1 Standard. Drugs and infusion liquids must not be stored in the phototherapy equipment irradiated area. 7

Do not place the LED phototherapy equipment under a radiant heat source. LED phototherapy does not affect the patient’s body temperature or the heat provided by thermotherapy equipment (incubators, infant warmers, or heating mattresses). Changes in environmental conditions, such as room temperature and different radiation sources, may adversely affect the patient. Since the equipment does not emit significant radiation, it cannot cause dangerous temperatures due to the use of reflective sheets. LED phototherapy must be used only by properly trained personnel and led by qualified physicians aware of the currently known risks and benefits of this equipment. The power supply cable must be connected to a proper socket with ground connection. Do not use adapters or extension cables. This equipment is not suitable to be used in presence of anesthetic gases. While the equipment is in use, verify that vents are not blocked by blankets or covers. Before placing the equipment on an incubator, it is recommendable to clean the canopy’s surface and the equipment’s pads in order to enhance its adherence. Be careful not to accidentally pull from the power supply cable or to abruptly move the incubator, because the equipment could fall. If the LED phototherapy operator remains too long in the radiated zone, he may experience headaches, nausea, or mild vertigo. If one LED stops working, a whole branch of six LEDs will go out of operation, and there will be illuminated and dark regions within the lighting area. In this case, turn the device off and contact the authorized technical service for the replacement of the damaged LED. The IEC Standard recommends replacing the LED board once its irradiance falls 25% below the value stated by manufacturer. Despite this reduction, the equipment continues delivering an efficient irradiance. Check that the acrylic panel is dust-free and that the inner filter placed over the acrylic vents is dust-free and not obstructed. Do not sterilize the unit with steam or gas. Do not clean the equipment with flammable solutions. When using the equipment on an incubator, place it in the correct position, as shown in the figures on the label on the front of the equipment.

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CAUTION Any maintenance and cleaning procedure not specified in this section must be performed only by authorized technical staff.

NOTE

The presence of impurities in the filter significantly reduces the lighting power of the equipment. Its regular cleaning is recommended. Due to the manufacturer’s permanent interest in upgrading its products, it reserves the right to make changes without prior notice.

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Used Symbols The following table shows the symbols found on the equipment or contained in this manual, and their meaning: International electrical symbols:

Symbol

Description ATTENTION, SEE USER MANUAL DANGER – HIGH VOLTAGE

~

ALTERNATING CURRENT PROTECTIVE EARTH FUNCTIONAL EARTH

Symbols for storage and packing:

Symbol

Description FRAGILE, HANDLE WITH CARE

VERTICAL POSITION

KEEP DRY

TEMPERATURE LIMITATION 4ºC (40ºF) – 43ºC(110ºF)

DO NOT HANG

DO NOT TILT

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Other symbols:

Symbol

Description POWER SUPPLY CONECTION INDICATOR SELECTED INTENSITY VALUE INDICATORS

PATIENT’S OCULAR PROTECTION REQUIRED

AUTHORIZED REPRESENTATIVE BEFORE CE MANUFACTURER

REFER TO INSTRUCTIONS MANUAL

LEDS ON/OFF KEY

INTENSITY SELECTION KEY

TREATMENT TIMER RESET KEY ELECTRICAL EQUIPMENT SELECTIVE COLLECTION SERIAL NUMBER

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Warnings on the equipment

Equipment Identification

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1. Introduction This manual provides instructions for installation, use, preventive maintenance of, and troubleshooting guide for the LED Phototherapy . It should be read and thoroughly understood before putting the Phototherapy Unit into operation. Place this manual in a place of easy access to all personnel who will be using the LED Phototherapy . This equipment has been designed to function within an alternating current between 50 and 60 Hz and voltage values ranged between 100 and 240 V~. Its functioning and technical specifications are guaranteed within these conditions, with no need for any modification.

1.1

Intended Use

Phototherapy administration for neonatal jaundice. The fundamental value of phototherapy is to avoid serum bilirubin levels from reaching those at which exchange transfusion is indicated. The wavelength of the blue light matches the light absorption spectrum of bilirubin, therefore, it is the most effective light to degrade bilirubin. It meets the American Academy of Pediatrics (AAP) guidelines for intensive phototherapy (PEDIATRICS, Vol.114, Nº1, July 2004, Appendix 2: Phototherapy).

1.2

Description

is a portable phototherapy device with blue LEDs, which enables the selection between three possible intensity values (high, medium, and low). It has a container body where the product’s electronic and lighting components are located, an operation and transport handle at its side, and rubber pads at the bottom, providing the necessary adherence to flat surfaces. It is a multivoltage 100 to 240V~ device, and it has a 1.8 m. long power supply cable, affixed to the device with a safety lock, in order to prevent it from accidentally getting disconnected. The equipment’s design makes it perfect for incubators of all brands, since it can be easily and safely placed on their acrylic canopy, therefore saving space around the incubator. The device’s commands are placed on its front. It has an on/off key, an intensity selection key and a treatment timer reset key. When the equipment is turned on, both the lighting LEDs and the device and treatment timers are activated. The latter indicate the total time of use of the device and of phototherapy treatment. The operating panel also counts with a green indicator LED which signals that the device is connected to the power supply and three green LEDs which turn on one at a time to show the selected light intensity (high, medium, and low). Characterized by silent operation, the LED phototherapy offers a comfortable treatment, allowing patient and family to rest peacefully. does not emit significant ultraviolet (UV) or infrared (IR) radiation, preventing the overheating of the newborn, the risk of fluid loss and potential skin damage. Its cold light makes it possible to place the equipment at a minimum distance from the patient without transferring any heat. Like this, the effectiveness of the treatment is enhanced by using peak intensity.

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1.3 Technical Specifications All specifications are related to IEC60601-2-50 (2000) standard: “Particular requirements for the safety of infant phototherapy equipment”. Nominal and weight dimensions Height 9 cm (min) - 10 cm (max) Depth 18 cm Width 36 cm Weight 2.2 kg Power 50 VA Voltage / Frequency 100-240 V~, 50-60 Hz Light source • Royal blue intensity LEDs. •

Wavelength: typical value 455 nm, range 440-460 nm.

•

Peak intensity measured at a 40 cm height: >50µW/cm /nm (in peak intensity value).

•

Intensity variation until stable regimen: <10% (on lighting area).

•

Lighting effective surface area at 40 cm height: 22 x 29 cm.

•

Intensity index: >0.4 (Intensity min / Intensity max).

•

Approximate LEDs useful life: 10,000 hs (useful life is considered to lapse when the initial peak

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value falls 25%). (*) Irradiance measurements were done with a BiliMeter 22 Olympic radionanometer.

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DEVICE timer Low consumption and quartz precision electronic hour meter (up to 99999.9 hs). It tracks the total operation time of the phototherapy or the LEDs’ useful life. This counter cannot be reset by the user. Once the LEDs useful life lapses and all LEDs are replaced, the Authorized Technical Service will reset the timer. TREATMENT timer Low consumption and quartz precision electronic hour meter (up to 99999.9 hs). It tracks the operation time of the phototherapy, indicating the patient’s treatment time. Users may reset this timer to zero with the reset key located in the commands panel. *Note: The timer’s decimal digit equals 6 minutes of exposure (0.1hs = 6 minutes). Environmental conditions for normal operation Environmental temperature 18ºC to 30ºC (64.4°F to 8 6°F) Humidity 10-95% non condensing. Altitude Sea level to 3.5 km (2.17 miles). Noise Under no circumstances does the noise level caused by the LED phototherapy exceed 60dBA. Packing and storage Medical equipment – Fragile – Do not pile up. Storage ambient conditions: keep dry. Temperature: 4ºC to 43ºC (39.2°F to 109.4°). Relative humidity: 10-90%. Atmospheric pressure: 86-106 kPa (648-795 mmHg).

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2. Unpacking and Assembly 2.1

Assembly Instructions

! WARNING Manufacturer is liable for the safety, reliability and functioning of the equipment as long as: a) Installation, modification or repairing are carried out by the Company’s authorized technical staff, or by qualified and dully trained technical staff, using only elements, spare parts or replacement parts provided by manufacturer. b) Electrical installation and its authorization conform to local safety standards. c) The equipment is operated following the operation instructions described in this manual. • • • • •

The phototherapy unit is packed in a single box. Before opening it, verify that there were no damages during its transport. Immediately report any damage occurred during transport to your insurance agent. Carefully open the box and take out the device and all its accessories from their original box. Keep all packing material in order to use them in case you need to reship or store the lamp. Compare the packing list with the received supplies, to check that you have all necessary items. Connect the power supply cable to the device and then plug it to an alternating current socket (100-240 V~). Check that the Power supply connection indicator (green light) lights up on the front of the device. If this does not happen, please contact the authorized technical service.

! WARNING

Check that the power supply is compatible with electrical specifications shown on the unit. To assure a good ground connection, connect the AC cable only to a grounded plug. Do not remove ground wire. Do not use extension cables. If there is any doubt regarding ground connection, do not operate or turn the phototherapy light on. There is risk of electric shock during cleaning and maintenance procedures. Make sure that the power cable is disconnected from the wall socket. Technical service must be performed by qualified personnel only. •

Perform the general hygiene procedure as described in section 7 of this manual.

! WARNING

The unit must be checked by specialized technical staff before it is switched on. • •

Make sure to keep this manual in a place of easy access to all phototherapy lamp users. Complete the warranty card and send it back.

! WARNING

Medical devices require special precautions regarding electromagnetic compatibility (EMC) and must be installed and put into service following the EMC information provided in the user and technical service manual.

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3. Operation Description 3.1

Basic Operation

The basic operation of a LED phototherapy lamp is to treat neonatal jaundice (hyperbilirubinemia). The wavelength of the blue light matches the light absorption spectrum of bilirubin, therefore, it is the most effective light to degrade bilirubin.

3.2

Effective Surface Area

Since the device is placed on an incubator, it is not possible to adjust the size of the effective surface area, because there is a fixed distance between the device and the mattress.

Effective surface area at a 40 cm height

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3.3

Irradiance

Since the device is placed on an incubator and it is not possible to vary intensity by adjusting distance, there are three possible intensity values for the user to select with a key placed on the front panel. Irradiance Effective Area 2 [µW/cm /nm] Length x Width [cm] High 55 29 x 22 40 Medium 37.5 29 x 22 Low 20 29 x 22 Note: Irradiance measurements were done with a BiliMeter 22 Olympic radionanometer. Distance [cm]

Selected Value

offers the latest technology in LED phototherapy, characterized by its great intensity exceeding 2

50µW/cm /nm at a 40cm distance.

3.4

Safety – Very Important Warnings

! WARNING

Special care must be taken to effectively cover the infant’s eyes before turning the lamp on.

! WARNING

It is recommended not to use the lamp at distances shorter than 30 cm.

! WARNING

Conventional phototherapy equipment affects air sensor’s measurements in incubators or heater power of infant warmers or heated mattresses. Although is a cold lamp, it is recommended to use thermotherapy equipment in baby controlled mode.

! WARNING

Patients near the phototherapy equipment may need to be protected with shields or protective glasses, etc.

! WARNING

While the patient is under phototherapy treatment, bilirubin levels should be measured regularly.

! WARNING

Bilirubin photoisomers may cause toxic effects.

! WARNING

Water balance may be disturbed in some patients undergoing phototherapy. 20

! WARNING

The safety of protective devices intended to prevent the patient from falling off the effective surface area should be checked regularly.

! WARNING

The phototherapy equipment auxiliary devices shall comply with the general safety requirements set forth in IEC60601-1 Standard.

! WARNING

Drugs and infusion liquids must not be stored in the phototherapy equipment irradiated area.

! WARNING

Do not place the LED phototherapy equipment under a radiant heat source.

! WARNING

LED phototherapy does not affect the patient’s body temperature or the heat provided by thermotherapy equipment (incubators, infant warmers, or heating mattresses).

! WARNING

Changes in environmental conditions, such as room temperature and different radiation sources, may adversely affect the patient.

! WARNING

Since the equipment does not emit significant radiation, it cannot cause dangerous temperatures due to the use of reflective sheets.

3.5

Comments on Electromagnetic Compatibility

The phototherapy lamp has been tested and meets the requirements of IEC60601-1-2: “Electromagnetic Compatibility” Standard.

3.5.1 Emissions According to the performed tests, the equipment does not emit radio frequency radiation (RF), low frequency radiation or magnetic fields that could generate a safety risk due to interference with other equipment (as per CISPR11).

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3.5.2 Immunity On radio frequency electromagnetic fields, the equipment performance meets the IEC-60601-2-50 (clause 36.202) standard: • It continues performing the intended function, according to the description provided in chapter 3 of this manual, up to the level of 3 V/m, for the frequency interval of 26MHz to 1GHz. • It continues performing the intended function, according to the description provided in chapter 3 of this manual, or aborts without creating any safety risk at a level lower than or equal to 10V/m, for the frequency interval of 26MHz to 1GHz.

3.5.3 Bibliography “Guidance on Electromagnetic Compatibility of Medical Devices for Clinical/Biomedical Engineers-Part 1: Radiated Radio-Frequency Electromagnetic Energy”, AAMI TIR No.18-1997

3.5.4 Recommended Electromagnetic Environment Manufacturer’s statement and guidance – Electromagnetic emissions is intended for use in the electromagnetic environment specified below. The customer or user of Emissions test

RF emissions CISPR 11

should make sure that it is used in such an environment. Compliance

Electromagnetic environment guidance uses RF energy only for its internal operation. Therefore, its RF emissions are very low

Group 1

and are not likely to cause any interference in nearby electronic equipment.

RF emissions Class B CISPR 11 Harmonic emissions Class B IEC 61000-3-2 Voltage fluctuations / flicker emissions Complies IEC 61000-3-3

is suitable for use in all facilities, including domestic and those connected to the public low-voltage power supply network that serves buildings used for domestic purposes. Table 1 (IEC 60601-1-2:2007)

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