Eighteeth CuringPen-E Скачать руководство пользователя страница 30

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12 EMC Tables

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Nowadays, many RF wireless equipment have being used in various

healthcare locations where medical equipment and/or systems are used.

When they are used in close proximity to medical equipment and/or

systems, the medical equipment and/or systems’ basic safety and

essential performance may be affected. The

CuringPen-E

has been

tested with the immunity test level in the below table and meet the related

requirements of IEC 60601-1-2:2014+A1:2020. The customer and/or user

should help keep a minimum distance between RF wireless

communications equipment and the

CuringPen-E

as recommended

below.

Test

freque

ncy

(MHz)

Band

(MHz)

Service

Modulation

Maxim

power

(W)

Dist

anc

(m)

Immun

ity test

level

(V/m)

385

380-390

TETRA

400

Pulse

modulation

18Hz

1.8

0.3

450

430-470

GMRS

460

FRS 460

kHz

deviation

1 kHz sine

0.3

710

704-787

LTE Band

13, 17

Pulse

modulation

217Hz

0.2

0.3

745

780

810

800-960

GSM

800/900,

TETRA

800,

iDEN

820,

CDMA

850,

LTE Band

Pulse

modulation

18Hz

0.3

870

930

1720

1700-

1990

GSM

1800;

CDMA

1900;

GSM

1900;

DECT;

Pulse

modulation

217Hz

0.3

1845

1970

Содержание CuringPen-E

Страница 1: ...CuringPen E Dental Curing Light USER MANUAL Changzhou Sifary Medical Technology Co Ltd ...

Страница 2: ...Version S03 IFU 6535021 Issued 2022 03 30 Size 180mm 87mm ...

Страница 3: ...he light source head 9 4 2 Install the disposable sleeve 9 4 3 Install the protective light shield 9 4 4 Plug the adapter 10 5 Use Interface 11 5 1 Panel key 11 6 Setting 12 6 1 Selecting memory mode 12 7 Operation 13 7 1 Handpiece operation 13 7 2 Operation mode 15 7 3 Charge 17 8 Maintenance 19 8 1 Foreword 19 8 2 General recommendations 19 8 3 Disinfection components 19 9 Error Warning 22 10 Tr...

Страница 4: ...1 Scope of CuringPen E Page 4 33 1 Scope of CuringPen E 1 1 Parts Identification 1 2 3 4 5 6 1 Disposable sleeve 2 Light source head 3 Protective light shield 4 Adapter 5 Handpiece 6 Base ...

Страница 5: ...1pcs 6535021 For different regions there are several different adapter options to be selected as follows Standard Adapter Power plug European standard Adapter 1pcs 6516007 American standard Adapter 1pcs 6516008 American standard power plug 1pcs 6316008 Multi standard Adapter 1pcs 6516008 British standard power plug 1pcs 6316006 Australian standard power plug 1pcs 6316007 Argentina standard power p...

Страница 6: ...erformance SN Serial number REF Catalogue number Manufacturer Date of manufacture Class II equipment Type B applied part Direct current Dispose of in accordance with the WEEE directive Keep dry 2 Do not reuse Consult instructions for use EC REP Authorized Representative in the European Community Temperature limitation Humidity limitation Atmospheric pressure limitation Manufacturer s LOGO Lot numb...

Страница 7: ...blished in pregnant women and children Warning Read the following warnings before use 1 The device must not be placed in humid surroundings or anywhere where it can come into contact with any type of liquids 2 Do not expose the device to direct or indirect heat sources The device must be operated and stored in a safe environment 3 The device requires special precautions with regard to electromagne...

Страница 8: ...nventional method If soft tissue exposure to the curing light cannot be avoided the Turbo Mode must not be used as exposure may result in damage of the soft tissues 6 If irregularities occur in the device during treatment switch it off Contact the agency 7 No modification of this equipment is allowed Never open or repair the device yourself otherwise void the warranty ...

Страница 9: ...treatment Warning Only the original light source head can be used Check the light source head and handpiece before installation Do not use damaged light source head and handpiece After installing the light source head pull it gently to make sure the connection is good otherwise it may cause unexpected fault even hurt the patients 4 2 Install the disposable sleeve Apply a disposable sleeve over the...

Страница 10: ...apter Plug the round connector of the adapter into the charging hole at the rear of handpiece and then the buzzer makes beeps twice and then the display symbol of charging cycle will show on the screen and then place the handpiece on the Base NOTE Only the original adapter can be used Otherwise the device may be damaged The round connector of the adapter must be pluged into the charging hole at th...

Страница 11: ...s up with green letters and numbers indicating it is on Mode Selection Press setting key in standby state to select the operating mode Time Selection Press setting key in standby state to select the seconds Start Stop Light Intensity Output In standby state press to start the output of light intensity and press to stop the output The icon shows P2 working mode The icon shows 03 seconds ...

Страница 12: ...ey gently again to change the memory Curing Time setting In the curing time setting menu press T to select different times The time selection is different under different light intensity light intensity mode time selection sec P1 Normal Mode 05 10 15 20 25 30 35 40 P2 High Power Mode 01 03 05 10 P3 Turbo Mode 01 03 05 P4 Pulse Mode 05 10 15 20 P5 Ramp Mode 05 10 15 20 NOTE The light intensity of P...

Страница 13: ...ishing treatment or every 5 seconds while working and the output is automatically turned off after the countdown ends In the on state press T then press to shut down Warning When the device is working do not directly illuminate the eyes otherwise it will cause injury Do not directly illuminate the skin otherwise high temperature burns may occur Before using please try it outside the oral cavity to...

Страница 14: ...ensity output within 60 seconds When using the light should be directly irradiated onto the curing dental resins and composites to avoid improper exposure The disposable sleeve and protective light shield are highly recommended If there is any abnormal functioning stop using the device and report to the distributor Gloves are compulsory during treatment Always disinfect the handpiece and light sou...

Страница 15: ...light intensity Time P2 High Power Mode Light intensity 2000mW cm Wavelength 380nm 515nm When is pressed the set light intensity is output immediately There is a beep prompt after finishing treatment or every 5 seconds while working 100 light intensity Time P3 Turbo Mode Light intensity 3000mW cm Wavelength 380nm 515nm When is pressed the set light intensity is output immediately There is a beep p...

Страница 16: ... a beep prompt after finishing treatment or every 5 seconds while working 100 light intensity Time P5 Ramp Mode Light intensity 1200mW cm Wavelength 380nm 515nm When is pressed the light intensity gradually increases from 0mW cm2 to 1200mW cm2 and then continues to output 1200mW cm2 There is a beep prompt after finishing treatment or every 5 seconds while working 100 light intensity Time ...

Страница 17: ... 300 500 times depending on the operating conditions of the device If there is a significant decline in battery power please report to the distributor so as not to affect the curing effect NOTE When the E0 low battery warning shows on the screen the device must be recharged within 15 days otherwise the battery may cause irreparable damage due to long periods of low power If the device flickers on ...

Страница 18: ...ice is not used for a long time please change the device at least once a month The device automatically enters the shutdown state after 120 seconds without operation Please press to restart the device Warning Do not change the battery only trained technician or distributor can change the battery the electronic parts will be damaged if use a wrong battery or install with a wrong way ...

Страница 19: ...f signs of material degradation In case of damage the device should be reprocessed before sending back to the manufacturer for repair 8 2 General recommendations The user is responsible for the sterility of the product for the first cycle and each further usage as well as for the usage of damaged or dirty instruments where applicable after sterility For your own safety please wear personal protect...

Страница 20: ...rface with a cloth moistened in Ethanol 70 to 80vol until the components are free of visible soils Repeat this step with a new gauze soaked in Ethanol 70 to 80vol if necessary Dry the components with compressed air Disinfection Wipe he handpiece light source head and protective light shield surface with a cloth lightly moistened with Ethanol for Disinfection Ethanol 70 to 80vol at least 2min repea...

Страница 21: ...fect the handpiece and light source head in an autoclave or other sterilization container 2 Do not soak or immerse any part of the handpiece and light source head in liquid Storage Store the components in a clean and dry place for the next treatment ...

Страница 22: ...1 blinks on the screen it indicates that the light source head has failed Please stop using and contact your local distributor E2 When the indication E2 blinks on the screen please stop using and contact your local distributor EH When the indication EH blinks on the screen it indicates that the number of continuously using High light intensity mode reaches the limit Please stop the device working ...

Страница 23: ...f power Charge the battery The power LED does not light up when charging There is no electricity in the outlet Check the connection Use a wrong adapter Use the original adapter The adapter is damaged Contact your local distributor Handpiece is broken Contact your local distributor No sound Handpiece is broken Contact your local distributor Insufficient light intensity There are resin or other cont...

Страница 24: ...t of the light source head is short Contact your local distributor Handpiece is broken Contact your local distributor EH error warning The number of using High light intensity mode reachs the limit Keep the device from working for 60 seconds before continuing ...

Страница 25: ...wer input 0 2A Light intensity P1 1200 15 mW cm P2 2000 15 mW cm P3 3000 15 mW cm P4 1200 15 mW cm P5 1200 15 mW cm Wavelength 380nm 515nm Electrical safety class Class II Applied part B Operation mode Intermittent operation 5mins ON 1min OFF Operation conditions Use in enclosed spaces Ambient temperature 5 C 40 C Relative humidity 80 Operating altitude 3000m above sea level Atmospheric pressure 7...

Страница 26: ...function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The CuringPen E is suitable for use in professional healthca re facility environment Harmonic emissions IEC61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Guidance and manufacturer s declaration electromagnetic im...

Страница 27: ...e to line 0 5kV 1kV Line to line 0 5kV 1kV Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply lines IEC 61000 4 11 0 UT 0 5 cycle at 0 45 90 135 180 225 270 and 315 0 UT 1 cycle and 70 UT 25 30 cycles sine phase at 0 0 UT 250 300 0 UT 0 5 cycle at 0 45 90 135 180 225 270 and 315 0 UT 1 cycle and...

Страница 28: ...ngPen E is intended for use in the electromagnetic environment specified below The customer or the user of the CuringPen E should assure that it is used in such an environment Proximity magnetic fields IEC 61000 4 39 test level Compliance level Electromagnetic environment guidance Proximity magnetic fields 65A m 134 2kHz Pulse modulation 2 1 kHz 65A m Power frequency magnetic field should be at le...

Страница 29: ... GHz 80 AM at 1 kHz Refer to table Recommend ed minimum separation distances 3 V 0 15 MHz 80 MHz 6 V in ISM bands be tween 0 15 MHz and 80 MHz 80 AM at 1 kHz Portable and mobile RF communications equipment should be usedno closer to any part of the CuringPen E including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recom...

Страница 30: ... 1 2 2014 A1 2020 The customer and or user should help keep a minimum distance between RF wireless communications equipment and the CuringPen E as recommended below Test freque ncy MHz Band MHz Service Modulation Maxim um power W Dist anc e m Immun ity test level V m 385 380 390 TETRA 400 Pulse modulation 18Hz 1 8 0 3 27 450 430 470 GMRS 460 FRS 460 FM 5 kHz deviation 1 kHz sine 2 0 3 28 710 704 7...

Страница 31: ...oper operation Cable information Cable Name Cable Length m Shielded or not Remark Adapter Cable 1 2 No 2 Use of CuringPen E adjacent to or stacked with other equipment should be avoided because it could result in improper operation If such use is necessary CuringPen E and the other equipment should be observed to verify that they are operating normally 3 Portable RF communications equipment includ...

Страница 32: ...lectrical components and printed circuit boards are disposed as electrical scrap The lithium batteries are disposed as special refuse Please deal with them according to the local environmental protection laws and regulation Rights All rights of modifying the product are reserved to the manufacturer without further notice The pictures are only for reference The final interpretation rights belong to...

Страница 33: ... Xuejia County Xinbei District Changzhou City 213000 Jiangsu P R China Tel 86 0519 85962691 Fax 86 0519 85962691 Email Info sifary com Web www sifary com EC REP Caretechion GmbH Tel 49 211 2398 900 Add Niederrheinstr 71 40474 Duesseldorf Germany Email info caretechion de All rights reserved ...

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