Instruction Manual

Please read this manual before operating
RF-SWA-M001-1.1

20210506

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Safety Precautions

1. This product is intended for use in hospitals and dental clinics only. The use of the product mustcomply with the requirements of the relevant operating specifications and relevant regulations of the
medical department. Users must be professionally trained and qualified as dentists or technicians.
Do not look directly into the light output. Patient, clinician and assistants are always suggested
wearing protectors (safety goggle, face shield…) to avoid crossing infection.
2. The products are reusable:
Prior to each use, place a new barrier sleeve over the curing light Swan. The hygienic barrier sleeve
is customs fitted to the curing light and keeps the surface of the curing light clean. The barrier sleevehelps prevent cross contamination, helps keep dental composite material from adhering to thesurface of the lens and curing light, and prevent discoloration and corrosion from cleaning solutions.
The curing lights must be cleaned and sanitized with appropriate cleaning and/or sanitizing agentsafter each patient. The sleeve is not equipped with the curing light. Please note that the sleeve mustmeet the requirements of relevant medical device regulation and it’s disposable.
3. During the operation, the light should be aimed straightly at the composite resin to ensure theeffect of solidification.
4. Please use the original light hood and follow the right installation ways to avoid the damage ofblue light to the eyes.
5. Please do not use other than the specified voltage to recharge the battery. Only the originalpedestal charger, adapter and Lithium battery could be used, because other brand pedestal charger,
adapter and Lithium battery are likely to damage the circuit.
6. Please recharge the battery at least 4 hours before first time usage. It’s forbidden to connect the
charger to the base for long time while not charging and it’s not allowed to use the curing light whilecharging.
7. It is forbidden to touch the charging connector with metal or other conductor, to avoiding damage
the circuit of charge or the battery.
8. Please recharge the battery in cool and ventilated room. Please press the main unit to the buckleof charging base, in order to avoid the poor connection.
9. It is forbidden to self-taking-apart the battery, in order not to result in short-circuit or leakage.
10. It is forbidden to extrude, shake or rock the battery. The Lithium battery is forbidden to be inshort-circuiting situation and it is forbidden to put the battery with metal or other conductors.
11. The instrument has electromagnetic interference. Do not use it around electronic surgery, anduse the instrument with caution in an environment with strong electromagnetic interference.
12. This product does not contain toxic or hazardous substances and it is discarded in accordancewith the relevant laws and regulations on waste medical devices. Please deal with the replacedbattery according to national regulations
13. As a professional manufacturer of medical instruments, we are only responsible for the safety
on the following conditions:• The maintenance, repair and modification are made by the manufacturer or the authorized dealer.
• The changed components are original of our company and operated correctly according to
instruction manual.
Product contraindications:
The heart disease patient, pregnant woman, children and the person who are allergic to blue lightshould be cautious to use this equipment.

Symbol instruction
SymbolInstruction

SymbolInstruction

Warning, Caution and Important!
Check the Instruction Manual

Consult the accompanying
documents

Date of manufacture

Manufacturer

According to the type of protection
against electric shock: CLASS II
EQUIPMENT

According to the degree ofprotection against electric
shock:Type B applied partScrew inside/ outside

Used indoor only

Recovery

Keep dry

Handle with care

Atmospheric pressure for storage

Temperature limitation for storage

Humidity limitation for storage

Appliance compliance WEEE directive,
Dispose as required by the law.

CE Mark2

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Turn on/off

M

Mode

Authorised Representative in the
EUROPEAN COMMUNITY

T

Time setting

1 Product introduction

The curing light manufactured by Guilin Refine Medical Instrument Co., Ltd. uses the principle of light radiation
to irradiate photosensitive resin in order to quickly cure it. This product is intended for use in hospitals and dental
clinics and it’s used for prevention and treatment of dental complications of adults or children.
Scope of application: suitable for dentistry, used to cure light-curing materials.
Product composition: main unit, LED light, light hood, charging base, battery and power adapter, etc.
The features of this product are:
1.1 A variety of different working modes and working hours can be set.
1.2 Constant light power output, the decrease of battery power will not affect the curing effect.
1. 3 Large-capacity battery. While full charged, under 10 seconds of light per time, it can be used continuously formore than 500 times.
1. 4 Product schematicLight guidelight hoodon/offScreenTime/mode

Screen of base
Light meter
Power connector

2 Replacement instructions for accessories
Accessories

Period of replacement

Method of replacement

Power adapter

DamagedReplace directly according to the requirements of the manual.

Charging baseDamagedReplace directly according to the requirements of the manual.

Battery

DamagedTake out the damaged battery and replace it with a new one.

Light hood

DamagedReplace directly according to the requirements of the manual.

3 Technical parameters
3.1 Technical Parameters of each model (table 1)
Dimensions

Φ86mm*223mm

Net weight

265g

Classified by power supply

Powered by rechargeable lithium battery

Input

Charging: DC5V 1A

Working: 3.6V lithium battery(ICR 18650)

Battery model: ICR 18650
Rechargeable lithium battery

Battery voltage and capacity: 3.6V/2600mAh
The battery has overvoltage, overcurrent and short circuit protection.

Power supply (Adapter)

Input : 100-240V AC 50Hz/60Hz 0.4A Max Output: DC 5V/1A
Built-in fuse: T1A 250Va) 10W high power blue and purple LED lamp.

Performance of led lampb) Wave length: 385nm-515nm

Light Intensity

1000mW/cm²-2500mW/cm²

Inspection method of LED
lampc) Category: class I.d)Shoot limit(AEL): 3.9*10―³J
When operating correctly, the LED lamp lights up, indicating that the lamp is ingood condition. Dental resin materials commonly used in clinic can match thewavelength of this curing light, such as 3M, Dentsply and other resins.

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TURBO mode: Blue and purple light, 2500mW/cm2 for 1s, 3s
NORMAL mode: Blue and purple light, 1200mW/cm2 for 5s, 10s, 15s, 20s
Modes and time setting

ORTHO mode: Blue and purple light, 2500mW/cm2 for 3s to work 10 times
every cycle, or 5s to work 10 times every cycle, interval 1s
CHECK mode: purple light, 900mW/cm2 for 30s, 60s

Effective area of irradiation
light

66.4mm²

3.2 Environmental factors
3.2.1 Operation: +5°C - +40°C
3.2.2 Relative humidity: 10% - 93%
3.2.3 Atmospheric pressure: 70kPa-106kPa

3.3 Equipment safety classification

3.3.1 Classified by type of protection against electric shock: Class Ⅱ

3.3.2 Classified by degree of protection against electric shock: Type B application part3.3.3 Classified according to the degree of protection against incoming liquid: Ordinary equipment (IPXO), nonwaterproof
3.3.4 Classified by operation mode: Short-term operation equipment
3.3.5 Classification of safety degree when using flammable anesthetic gas mixed with air or oxygen or nitrous
oxide: Equipment that cannot be used with flammable anesthetic gas mixed with air or oxygen or nitrous oxide.

4 Installation and demounting

Insert the large end of the light guide (front connector) into the mounting hole at the upper end of the curing light(please insert it into the bottom in a rotating way, do not be obliquely).
Clamp and install the light hood at the root of the light guide (front joint).
When removing or replacing the light guide, proceed in the opposite direction above.

5 Operation

5.1 When the machine is under stand-by mode, press the time/mode key to light up the screen.
5.2 Mode setting: press the time/mode key for more than 2 seconds to select the mode; during mode switching,
the display screen has a transition picture (the picture shows the full English name of the mode to be switched to),and every time the key is pressed, there’s a beep. Without operating within 1 minute, the screen will turn off andthe main unit enters the sleep state.
5.3 Time setting: press the time/mode key to select time, see table 1 for settable curing time.
5.4 Point the light guide rod (front connector) light source at the right position, press the switch button and there’s
a beep. The curing light will start to work as the mode setting. The display screen starts counting down from theselected time, and after the timing ends, the display screen displays the setting time.
5.5 Before the end of setting time, at any time pressing the on/off key can finish the work.
5.6 After the end of an irradiation cycle, you can immediately press the switch to start the next irradiation cycle. If
the handle starts to become hot, please stop working until the handle is completely cooled down. It is recommended that the number of consecutive irradiations should not exceed 10 times.
5.7 If the transparent cover is stained with resin after use, please wipe it with a cotton cloth to avoid affecting thelight intensity.
5.8 The effective light intensity of this machine is many times higher than that of the halogen lamp curing light, andthe curing depth of the light-curing composite resin is not less than 4mm for 10 seconds.
5.9 The front connector at the front end can be removed, but high temperature and high-pressure sterilization is
not allowed, otherwise it will cause damage.

6 Low battery prompt and charging

6.1 Low voltage indication: The battery symbol on the display starts to flicker, accompanied by a sound prompt;
6.2 When charging, insert the charging cable into the TYPE-C socket at the back of the base, the blue light at thebottom of the base will light up, and the brightness will be changing;
6.3 Correctly put the main unit into the charging base, the base display will automatically light up and display thepower;
6.4 The charging base has a light meter function. When the base is in standby mode, the display is off. Only whenthe main unit is charged or when testing light intensity that the display will automatically light up.If it is not charged
or measured, the base display will automatically turn off.

7 Transportation, storage and maintenance

7.1 Transportation
7.1.1 During transportation, avoid shocking and vibration, handle with care and avoid inversion.
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7.1.2 Do not mix with dangerous goods during transportation.
7.1.3 Avoid sunlight, rain or snow during transportation

7.2 Storage
7.2.1 Do not mix with toxic, corrosive, flammable and explosive materials during storage.
7.2.2 The product should be stored in an environment where the relative humidity does not exceed 10% - 93%,
the atmospheric pressure is 70kPa - 106kPa, and the temperature is -20°C - +40°C.

7.3 Maintenance7.3.1 This equipment should be handled with care, far away from the source of the earthquake, and should beinstalled or stored in a cool, dry and ventilated place.
7.3.2 When the device is not in use, turn off the power switch and unplug the power plug; when not in use for along time, charge the main unit every 3 months.
7.3.3 To clean or disinfect, wipe the surface with clean water or disinfectant, do not soak.
7.3.4 After use, check if there is any resin remaining on the surface of lamp, so as not to affect the life of thefront joint or affect the curing effect.

8. Troubleshooting
FaultyNo reaction

Possible cause

solutions
1．Charge/Change a new battery
2．Change a new battery
3．Activate it by putting it on thebase

1．Out of battery
2．Faulty of battery
3．Battery protection

There is resin remaining on the
1．Remove the resin
Insufficient Light intensity surface of the transparent cover
2．Change the transparent coverof light guide.
1．The adapter is not connected
well
Not charging when con2．Faulty of adapter or incompatnecting with the adapter
ible
3．The charging point is impurity.

1．Reconnect.
2．Change the adapter
3．Clean the inner connector of
charging base by the alcoholLess working life after
Capacity of battery decreased
fully charge

Change a new battery

The mode indicator twinLow voltage
kles when charging

Back to normal after 15-minutecharging.

If the fault still cannot be resolved, please contact your local dealer or our company.

9. Electromagnetic compatibility
Attention:●This Curing Light meets the relevant requirements of YY 0505 standard electromagnetic compatibility. The basic
performance of the light curing machine is: the front LED light can emit blue (UV) when working.
●The user should install and use it according to the electromagnetic compatibility information provided by theaccompanying documents.
●Portable and mobile radio frequency communication equipment may affect the performance of the curing light,
avoid strong electromagnetic interference when using it, such as close to mobile phones, microwave ovens, etc.;●The guidelines and manufacturer’s declaration are detailed in the attachment.
●Without the express consent of Guilin Refine Medical Instrument Co., Ltd., unauthorized changes ormodifications to the equipment may cause damage to the equipment or other
The electromagnetic compatibility of the equipment.
Alert:●This light curing machine should not be used close to or stacked with other equipment. If it must be used closeor stacked, it should be observed and verified that it can be used in the configuration used.
Normal operation.
● Except for the cables sold by the manufacturer of the curing light as spare parts of internal components, the useof accessories and cables other than those specified may cause the curing light
Increase in emission or decrease in immunity.
● The following cables must be used to comply with electromagnetic emission and anti-interference requirements:

Cable Name

Cable Type

Cable Length

Power Line (Output end)

Unshielded Parallel Lines

1.2 m● Key components of electromagnetic compatibility
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The key components of electromagnetic compatibility of this product are IC chip, main PCB, lithium battery, power
adapter and LED lamp. Use or replace the accessories and cables that are not designed to match, will cause
the electromagnetic compatibility emission and anti-interference performance to be significantly reduced. Do notchange machine parts without authorization.

Enclosure:
Guidance and manufacturer’s declaration - electromagnetic emissions
The models Curing Light are intended for use in the electromagnetic environment specified below. The
customer or the user of the models Curing Light should assure that it is used in such an environment.
Emissions test

Compliance

RF emissionsGB
4824

Group 1

RF emissionsGB
4824

Class B

Harmonic
emissions
17625.1

Electromagnetic environment - guidance
The models Curing Light use RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.

The models Curing Light are suitable for used in domestic establishUnapplicable ment and in establishment directly connected to a low voltage power
supply network which supplies buildings used for domestic purposes.

Voltage fluctuations / flicker
Complies
emissions 17625.1

Guidance & Declaration — electromagnetic immunity
The models Curing Light are intended for use in the electromagnetic environment specified below. The customer
or the user of the models Curing Light should assure that It is used in such an environment.
Immunity test

IEC 60601 test level

Electrostatic discharge±8 kV contact(ESD)±15 kV air
GB/T 17626.2

Compliance level Electromagnetic environment - guidance±8 kV contact±15 kV air±2kV for power supply
Electrical fast transient/lines±2kV for powerburst±1 kV for Input/output supply lines
GB/T 17626.4
lines
Surge
±1 kV line to line
±1 kV line to line
GB/T 17626.5±2 kV line to earth<5 % UT<5 % UT

Voltage dips, shortinterruptions andvoltage variations on
power supply input
lines
GB/T 17626.11

Power frequency(50/60 Hz) magnetic
field(>95% dip in UT.) for
0.5 cycle(>95% dip in UT.)

40 % UT

40 % UT(60% dip in UT) for 5
cycles(60% dip in UT)
for 5 cycles

70% UT

70% UT

Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be atleast 30 %.
Mains power quality should be that of a typicalcommercial or hospital environment.
Mains power quality should be that of a typicalcommercial or hospital environment.

for 0.5 cycle(30% dip in UT) for 25 (30% dip in UT)
cyclesfor 25 cycles<5% UT<5% UT(>95 % dip in UT) for
5 sec(>95 % dip in UT)

3A/m

3A/m

Mains power quality should be that of a typicalcommercial or hospital environment. If the userof the models Curing Light requires continued
operation during power mains interruptions, it
is recommended that the models Curing Light
be powered from an uninterruptible power
supply or a battery.

for 5 sec
Power frequency magnetic fields should be atlevels characteristic of a typical location in a
typical commercial or hospital environment.

GB/T 17626.8

NOTE: UT is the a.c. mains voltage prior to application of the test level.

Guidance & Declaration - Electromagnetic immunity
The models Curing Light are intended for use in the electromagnetic environment specified below. The customer
or the user of the models Curing Light should assure that it is used in such an environment.
Immunity test

IEC 60601 testlevel

ComplianceElectromagnetic environment - guidance
level

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Conducted RF 3 Vrms
GB/T
150 kHz to 80
17626.6
MHz
Radiated RF
GB/T17626.3

3 V/m
80 MHz to 2.5
GHz

3 Vrms
3 V/mPortable and mobile RF communications equipment should
be used no closer to any part of the models Curing Light,
including cables, than the recommended separation distancecalculated from the equation applicable to the frequency of thetransmitter.
Recommended separation distanced=[3,5/V1]×P1/2
d=[1.2/E1]×P1/2 80 MHz to 800 MHz
d=[2.3/E1]×P1/2 800 MHz to 2.5 GHz
Where P is the maximum output power rating of the transmitterin watts (W) according to the transmitter manufacturer and d Is
the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined byan electromagnetic site survey, a should be less than the compliance level in each frequency range
Interference may occur In the vicinity of equipment marked
with the following symbol:

NOTE: 1 At 80 MHz end 800 MHz the higher frequency range applies.
NOTE: 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoreticallywith accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which the models Curing Light areused exceeds the applicable RF compliance level above, the model Curing Light should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the models Curing Light.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
The Rated maximum
output power of
the transmitterW

The distance between different frequencies of the transmitter

150kHz to 80MHz
d=1.2×P1/2

80MHz to 800MHz
d=1.2×P1/2

800MHz to 2,5GHz
d=2.3×P1/2

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.22.3

2.3

10

3.8

3.8

7.3

100

12

12

23

For the maximum rated output power of the transmitter not listed in the above table, the recommended separation distance (d) which in meters (m) that can be determined by the formula in the frequency column of the corresponding transmitter. The P is the maximum rated output power of the transmitter provided by the transmitter
manufacturer which in watts (W).
Note 1: At 80MHz and 800MHz frequency points, the higher frequency band formula is used.
Note 2: These guidelines may not be suitable for all situations. Electromagnetic propagation is affected by theabsorption and reflection of buildings, objects and human bodies.

10. Environmental protection
hazardous substance or element(Pb) (Hg) (Cd) (Cr6+) (PBB) (PBDE)
Main units
○
○
○
○
○
○
Charging base
○
○
○
○
○
○
Adaptor○○○○○○Mechanical element (Including screws, nuts, joint rings, etc.)
○
○
○
○
○
○
○: Indicates that the content of this toxic and hazardous substance in all homogeneous materials of thiscomponent is below the limit requirement in SJ/T-11363-2006 “Limit Requirements for Toxic and Hazardous
Substances in Electronic Information Products”.

Components

×: It means that the content of this toxic and hazardous substance in at least one of the homogeneousmaterials of the part exceeds the limit requirement of SJ/T11363-2006. (This product complies with EU RoHS
environmental protection requirements; currently there is no mature technology in the world that can replace or
reduce the lead content in electronic ceramics, optical glass, steel and copper alloys)

According to the “Administrative Measures for Restricting the Use of Hazardous Substances in Electrical andElectronic Products”, “Regulations for Recycling and Disposal of Waste Electrical and Electronic Products” andrelevant standards, please comply with the safety and use precautions of the products, and recycle or dispose of
the products in appropriate ways according to local laws and regulations after the use of the products.

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11. After sales service

11.1 If this equipment cannot work normally due to quality problems from the date of sale, please show the
warranty card and our company will be responsible for the maintenance. Please refer to the product warranty cardfor the warranty period and warranty scope.
11.2 This product does not contain replaceable parts. All maintenance, adjustment, calibration and modification oftechnical parameters of the product can only be carried out by our company’s technicians or special repair shops.
If customers need to repair themselves, our company can provide them on request Circuit diagrams, component
lists, legends, calibration specifications, or other materials needed to help qualified technical personnel repair theequipment parts designated by our company, but we will not bear any consequences.
11.3 The user must use the original parts, purchase please contact with the local dealer or the manufaturer. Do
not use the related accessories of other brands, so as not to cause damage to the light curing machine or otherdangers.
11.4 After the power adapter, charging base and other accessories are damaged, users should not repair bythemselves. Please buy new parts and replace them by yourself. If you need relevant information, please contact
the manufacturer.

12. Special instructions

The company reserves the right to modify the machine design, product technology or accessories, operation
manual and machine packaging content at any time without prior notice. The product is subject to the real object,
and the picture is for reference only. The final interpretation right belongs to
Guilin Refine Medical Instrument CO., LTD.

After service and Warranty Instruction
1 Period validity: two year’s free repair for the main unit, charging base, power adapter from the date of purchase.
One year’s free repair for lithium battery. Warranty card is necessary while submitting the repairing request.
2 Range of warranty: Within the warranty period of validity, we are responsible for any troubles caused by quality
problems or products technique and structure.
3 The followings are beyond our warranty:
1) The damage caused by disobeying the operation instruction or lack of the needed condition.
2) The damage caused by unsuitable operation or disassembly without authorization.
3) The damage caused by unadvisable transportation or preservation.
4) There isn’t the seal of distributor or the warranty card isn’t filled in completed.
5) Light tip and protective light shield.

After service card
Name ofCustomer

Address

Post CodeTel

E-mailPurchase Date

Production Date

Distributor
Model

Product No.

MedNet EC-REP GmbH
Borkstrasse 10 · 48163 Muenster · Germany
Product life: 5 years
Production date: please refer to packaging label.

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