Sdi Radii xpert User manual

radii xpert

Professional LED Curing Light

Instructions For Use

Please read these instructions before operating this unit

Product description

Thank you for purchasing the Radii Xpert LED curing light. The Radii Xpert is a high performance light source for the intraoral polymerization of

light-cured materials with photoiniator(s) in the wavelength range of 440 nm - 480 nm (standard curing tip). It has been designed to consistently

produce optimum polymerization for all light-cured materials in order to produce high-quality restorations.

Target assist technology, a special low power light, has been incorporated into the Radii Xpert to assist users to accurately position the curing tip

before polymerization begins.

The Radii Xpert is a high quality medical device which has been designed in accordance to the latest science and technology for curing lights.

Each unit comes with an international power supply and is suitable for power outlets from 100 - 240 Volts.

Your Smile. Our Vision.

www.sdi.com.au

Smarter design.

Optimal cure every time.

SAFETY, WARNINGS & CAUTIONS

Use of the Radii Xpert is restricted to qualiﬁed medical professionals in accordance with the safety instructions below:

1. Do not open or alter the Radii Xpert in anyway. Only dealers authorised by SDI Ltd may open the housing and repair

the device.

2. Do not introduce any objects into the unit with the exception of replacement parts handled in accordance with this manual.

3. Only charge the Radii Xpert handpiece in the Radii Xpert charger.

4. Connect the power plug into a suitable grounded and approved outlet.

5. Always unplug the power to the charger during cleaning of the unit.

6. Do not use damaged power cord.

7. Should you have any reason to suspect the safety of the Radii Xpert to be compromised, the unit must be taken out of

operation and appropriately labelled to prevent third parties from inadvertently using a potential defective unit.

1. The Radii Xpert emits a high intensity light and must only be used as indicated in this manual.

2. Do not look directly into the light source.

3. Operator, assistants and patient must always wear appropriate blue light blocking eye protection or use a blue light

blocking light shield.

4. Restrict exposure to the oral cavity in which clinical treatment is intended.

5. Avoid direct contact of curing tip with soft tissues and mucosa.

1. Radii Xpert can only be operated with the supplied LED tip and is not compatible with previous Radii model

of LED attachments.

2. Condensation resulting from unit being transferred from a cold to a warm environment may be a potential risk.

The unit should only be turned on after it is completely equilibrated to ambient temperature.

3. Use only genuine SDI Ltd parts when replacing defective components as directed in this manual.

4. Do not operate the unit in the proximity of ﬂammable mixtures.

5. Keep solvents, ﬂammable liquids and sources of intense heat away from the unit as they may damage the

plastic housing.

6. Do not allow cleaning agents to enter the Radii Xpert as this may short circuit the unit.

7. Do not use the Radii Xpert in patients or by users:

a. with heart pacemaker implants who have been advised to be cautious with regard to their exposure to small

electrical devices.

b. with a history of photo biological reactions (including individuals with urticaria solaris or erythropoietic

protoporphyria) or who are currently on photo-sensitising medication (including 8-methoxypsoralen or

dimethylchlorotetracycline).

c. who have history of retinal disease.

d. who have had surgery for eye cataracts.

Seek advice from their prescribing medical practitioner prior to operating the Radii Xpert on these patients.

8. Prior to each use of the Radii Xpert, ensure that the emitted intensity is sufﬁcient to safely guarantee polymerization.

9. The Radii Xpert was developed and tested in accordance to relevant EMC regulations and standards to conform with legal

requirements. Due to variables that may exist within the work environment, such as power supply, wiring and the ambient

conditions that can affect the EMC properties of the Radii Xpert, EMC disruption may occur. If this happens, move the unit

to a different location.

10. SDI Ltd accepts no liability for any damage resulting from the use of the Radii Xpert for any other purpose than the

polymerization of light-cured dental materials.

SHOCK HAZARD

HIGH INTENSITY

LIGHT

CAUTION

TRANSPORT AND STORAGE CONDITIONS

Ambient

temperature:

85%

max

10%

+40°

+104° F

32°F

0° C1060 hPa

500 hPa

0.5 atm

1.0 atm

Relative

humidity:

Atmospheric

pressure:

CAUTION

Do not autoclave the

LED light attachment or

any part of the Radii Xpert.

PRODUCT OVERVIEW

AC power pack

with international

plug adaptor heads

Intensity indicator

light check with

blue LED’s status indicator

Charging

charging (low battery) - solid red

charging - pulsing green

fully charged - solid green

Charging dock

User interface

- control buttons

- function display

- adjustable timer with countdown

power on

favourites mode timer units

- s = seconds

- mins =minutes

activate curing

sound icon

countdown timer

battery status

Handpiece

Rotatable

LED attachment

Status indicator

charging (low battery) - solid red

charging - pulsing green

fully charged - solid green

curing in progress - solid blue

radii

xpert

CHARGING DOCK

Operating voltage 100 – 240 V – 50 / 60 Hz

Power input 12 V DC

Dimensions Length: 142 mm, Width: 70 mm,

Height: 70 mm

Weight 155 g

Classiﬁcation Class II - double insulated

Safety IEC 60601-1

EMC

(Electro-Magnetic Compliance)

IEC 60601-1-2

Protection from

electrical shock

Type BF

Protection from ingress

of liquids

Handpiece: IPX4

Charging dock: IPX3

INDICATIONS FOR USE

1. Standard curing attachment:

• To polymerize all light-cured products in the wavelength range of 440 nm - 480 nm (standard curing tip)

TECHNICAL DATA

HANDPIECE

Wavelength emission range Standard curing attachment:

440 nm - 480 nm

Wavelength peak Standard curing attachment:

460 nm

Dimensions Length: 255 mm

Diameter: 30 mm

Weight 185 g

CHARGER AND HANDPIECE

Time to charge low battery For everyday case approximately

3 hours

Time to charge ﬂat battery Allow 5 - 6 hours.

(Best left on overnight)

Operating temperature 10°C - 40°C (50°F - 104°F)

Relative humidity 10 % - 85 %

Atmospheric pressure 0.5 atm - 1.0 atm

(500 hPa to 1060 hPa)

Total height with handpiece 290 mm

POWER PLUG WITH INTERNATIONAL AC ADAPTERS

Input voltage 100 – 264 V – 50 / 60 Hz

Output voltage 12 V DC

Output current 1.0 A

Dimension 38 mm H x 45 mm W x 70 mm L

Weight 104 g / 3.66 ounces

Rating Medical grade (UL, CE, RoHS,

WEEE)

Charging dock (Figure 1)

1. Slide the correct AC adapter head into the power plug and plug into power supply. Tilt it slightly and apply slight pressure until you hear it

snap into place.

2. Plug the other end of the AC power plug into the back of the charging dock.

3. Place charging dock on a suitable ﬂat table top and turn the power ON.

4. The LED lights on the charging dock will ﬂash once from all red to all green to all blue. This indicates the unit is ready to use.

Handpiece (Figure 2)

1. Remove the Radii Xpert handpiece from its packaging and place into the charging dock.

2. Allow the Radii Xpert to fully charge until status ring and all ﬁve lights on the charging base illuminate solid green.

Note:

1. During charging, the status ring and lights on the charging base illuminate pulsing green.

2. The Radii Xpert contains a lithium ion rechargeable battery that does not have any memory and can be recharged at any time.

Operating

1. Remove the Radii Xpert handpiece from the charging dock and place a hygienic barrier sleeve.

Note: Ensure the Radii Xpert barrier sleeve ﬁts ﬂush over the lens without wrinkling/folds. Seam of the sleeve should be

positioned down the sides of the attachment and handpiece. (Figure 3)

2. Rotate the curing tip to desired position.

3. Press (top button) and hold. A very low intensity light will illuminate to assist you to position the curing tip in the oral cavity. When the

tip is in the correct position, release your ﬁnger tip and curing will commence. Status ring illuminates solid blue with the standard curing tip

attached. The LCD displays 20, counting down to 0.

4. One long beep will sound when curing ﬁnishes and the status ring goes OFF.

5. Press to start another 20 second cure.

6. To change pre-set curing time (temporary setting), press (bottom button) and hold for 1-2 seconds. Numbers on LCD start ﬂashing.

7. Press to scroll up through the options from last setting used. Press once to select. Numbers on LCD stop ﬂashing.

8. Discard barrier sleeve after each patient.

9. Clean and sanitise the handpiece. See MAINTENANCE AND CLEANING section in this manual.

Note:

1. Single patient use hygienic Radii Xpert barrier sleeve (100 pieces is included in each kit) is strongly recommended to prevent cross

contamination and protect the lens cap from dental material adhering to its surface and body. These sleeves have been especially designed

to produce optimal emission.

2. Light output may be signiﬁcantly reduced if the wrong barrier sleeve is used or not correctly placed.

Curing time

1. Follow the recommended curing times published by the manufacturer of your restorative materials.

2. The indicated curing times usually assume the light tip is held at the correct position over the material being polymerized.

QUICK START-UP

ALL FIGURES CAN BE FOUND ON PAGE 9

Check the content of the box for completeness and any possible transportation damage. If parts are damaged or missing, contact your local

SDI Ltd representative immediately.

Factory settings

The factory setting of the Radii Xpert’s standard curing attachment is 20 seconds per exposure cycle.

QUICK LIGHT INTENSITY STATUS CHECK USING THE BUILT-IN INTENSITY INDICATOR (Figure 4)

1. Gently place the LED attachment tip on the test area

of the charging dock. Ensure the tip is level and central

within the test area. If not centered, it may give you lower

readings.

2. Activate the light.

All 5 blue LEDs 100%

4 blue LEDs 90%

3 blue LEDs 80%

2 blue LEDs 70%

1 blue LED 60%

SLEEP MODE

The Radii Xpert will go into a sleep mode (LCD turns OFF) when it is:

1. Sitting on the charging dock or

2. Not in use for more than 3 minutes

The unit will automatically wake up when removed from the charging dock. Press to start curing.

If the unit turns OFF / goes into sleep mode outside the charging dock, press once to wake unit up. Press to start curing.

OPERATION

1. Handpiece

LED ATTACHMENT PROGRAM

Standard curing

attachment

(440 nm - 480 nm)

• Default curing time: 20 seconds

• LCD counting down

20, 19, 18….3,2,1

• User option curing time:

2, 10, 20 seconds

Note: Observe Instructions for Use of the

material applied when selecting

curing time.

STATUS - WHILE CHARGING STATUS RING INDICATOR

Charging (low battery) Solid red

Charging in progress Pulsing green

Charge completed Solid green

STATUS - WHILE CHARGING CHARGING DOCK

INDICATOR

Charging (low battery) Solid red

Charging in progress Pulsing green

Charge completed Solid green

2. Charging dock lights display (while handpiece is charging)

STATUS - WHILE OPERATION STATUS RING INDICATOR

Positioning light (target assist) Solid yellow

Curing in progress Solid blue

LED attachment too warm

(allow to cool)

1 red ﬂash, then shuts off

Charge level low Solid blue for 1 second and

2 short beeps

HOW TO CHANGE THE LED (Figure 5)

To change the LED attachment, carefully pull off the LED attachment from the handpiece and click in a new LED attachment.

HOW TO CHANGE THE LENS CAP (Figure 6)

1. Turn the lens cap anti-clockwise to remove.

2. Replace with a new lens cap by screwing it on clockwise.

HOW TO SET FAVOURITE CURING TIME (Figure 7)

1. Press and hold for 1-2 seconds. Numbers on LCD start ﬂashing.

2. Press to scroll up through the options from last setting used.

3. Press and hold for 1-2 seconds to save. Numbers on LCD stop ﬂashing. Status ring illuminates solid green for 2 seconds with one short

beep, to conﬁrm selection is saved.

4. A star appears on the bottom left of the LCD screen. Unit is ready to use.

HOW TO ADJUST THE AUDIO VOLUME (Figure 8)

1. Press to turn the unit on.

2. Remove the LED attachment from the Radii Xpert handpiece.

3. Press and hold for 1-2 seconds to activate change mode.

4. Speaker symbol lights up.

5. Bar graph displays volume settings

6. Press to scroll through options. Buzzer will sound to demonstrate the volume level (mute, low, medium, high).

7. Press and hold for 1-2 seconds to save. Status ring illuminates solid green for 2 seconds with one short beep, to conﬁrm

selection is saved.

8. A star appears on the bottom left of the LCD screen. Re-insert the LED attachment. Unit is ready to use.

HOW TO CHANGE THE BATTERY

1. Hold the handpiece in the palm of your left hand.

2. Use your right hand to turn the bottom of the handpiece approximately 10 degrees anti-clockwise (twist then pull, Figure 9).

3. Carefully remove the battery from the handpiece.

4. Insert a new battery and lock in position twisting it 10 degrees clockwise (push then twist, Figure 10).

5. Turn ON the Radii Xpert handpiece and place it into the charging dock until status ring shows solid green.

Note: The LED attachment does not have to be attached to the handpiece to charge the battery.

6. Dispose of used battery in accordance to local regulations. Do not dispose with unsorted household waste.

Battery Life Expectancy: Battery life is dependent on the amount of use and LED efﬁciency. SDI Ltd guarantees the battery to have a minimum

of 300 total discharges. To extend the life of your Radii Xpert battery, keep it on the charging dock at the end of each day if possible.

PROBLEM POSSIBLE CAUSE SOLUTION

Handpiece status ring ﬂashes red. Handpiece over heated. Allow handpiece to cool down before reuse.

Handpiece status ring shows solid red. Battery low. Handpiece can still be used for curing. Return to

charging dock as soon as possible.

Handpiece status ring ﬂashes blue once

and goes OFF.

Battery empty. Return to charging dock for charging.

No light appears on the charging dock

when handpiece is docked.

No power. 1. Check all connections are clean and properly

connected.

2. Ensure power outlet is switched ON.

3. If the above does not work, move the whole

unit to a different powerpoint.

4. Call your local SDI Ltd representative for repair.

Unit works ﬁne yesterday but will not turn

on this morning.

Moisture from condensation. 1. Check for sign of moisture inside the barrier

sleeve.

2. Remove barrier sleeve and allow unit to dry for

a few hours.

No audio beep heard when connecting

with the handpiece.

Battery empty. Return to charging dock for charging.

The light intensity is too low. 1. Dirty or scratched lens cap.

2. Barrier sleeve.

Check and clean lens cap. Replace if required.

Ensure barrier sleeve ﬁts tightly over the emission

tip.

The LCD on the handpiece ﬂashes. Unit is in the setting mode. Press once to come out of the setting mode.

Battery shows corrosion or emits a

scorched odour.

Do not use unit. Call your local SDI Ltd representative.

The dental material does not

cure completely.

Wrong attachment? Ensure the correct LED attachment is used. Check

material speciﬁcations for curing requirement

from the manufacturer.

I want to delete my favourite setting and

go back to the factory setting.

Place the handpiece on the charging dock.

Press (top & bottom button)

simultaneously for 1-2 seconds, then status ring

illuminates solid yellow for 4 seconds and returns

to factory setting.

The handpiece has been on the charger

overnight. Status ring still showing red and

handpiece felt very hot.

Charging problem. Battery maybe at the

end of its useful life.

Replace battery.

The light emission does not start when the

button is pressed.

Battery is ﬂat. Return to charging dock for charging.

The LED attachment does not ﬁt

the handpiece.

Wrong Radii LED attachment. LED attachments from previous model of

Radii are not compatible with the Radii Xpert.

TROUBLE SHOOTING

Do not autoclave the LED light attachment

or any part of the Radii Xpert.

Liquids must not enter any part of the

handpiece or charger.

Do not spray liquids directly onto, or apply

copious amounts of liquids to the Radii Xpert.

Instead, spray solutions on a cloth to wipe.

Handpiece

1. After each use, remove and dispose of barrier sleeve.

2. Wipe the Radii Xpert handpiece with a disinfectant wipe

(benzalkonium base) or soft cloth moistened with isopropyl

alcohol/ethyl alcohol based cleaners.

3. Do not wipe electrical contacts at the base of the handpiece.

Use a dry cloth to clean if required.

4. Allow handpiece to air dry before placing a new barrier sleeve.

Note: If using anti-bacterial wipes, ensure they are not soaked in excess liquid.

Liquid residue must not enter any part of the handpiece or charger.

Charging dock

1. Disconnect power from charging dock.

2. Wipe surface with a disinfectant wipe (benzalkonium base) or soft cloth moistened with isopropyl alcohol/ethyl alcohol based cleaners.

3. Use an air gun to blow off any debris collected inside the handpiece holder and carefully wipe clean without wetting the electrical contacts.

MAINTENANCE AND CLEANING

STORAGE DURING EXTENDED PERIODS OF NON-USE

If the Radii Xpert is not to be used for an extended period of time, ie during holiday periods, fully charge the handpiece or keep it on the

charging dock with the power ON.

The Radii Xpert has a built in safety feature to prevent the battery from discharging totally.

DISPOSAL INSTRUCTION

Do not dispose unserviceable battery and curing lights as unsorted municipal waste. Hazardous substances are present in electronic

equipment and present potential risks to human health and the environment if disposed of in municipal landﬁlls which are not

designed to prevent migration of substances into the soil and groundwater.

Please dispose of in accordance to your speciﬁc country regulations.

CAUTION

CLEANING AGENT APPROVED FOR USE CLEANING AGENT NOT APPROVED FOR USE

70% Isopropanol alcohol Oxidising agents such as hydrogen peroxide

Neutral-enzymic cleaner High alkaline detergents

Ethyl alcohol based Hand soaps and dish soaps

Antiseptic benzalkonium chloride wipes Abrasive cleaners

Chlorhexidine gluconate Acetone based cleaners

Glutaldehyde Bleach based cleaners

Any cleaners with phosphoric acid

Ammonia or iodine complex solution

WARRANTY

SDI Ltd provides a three (3) year warranty against defects in materials or workmanship from the date of purchase to the original purchaser of this

product with the exception of the battery which has a two (2) year warranty. User is responsible for determining the suitability of the product

for user’s application. If this unit is defective within the warranty period, SDI Ltd or your local approved service centre will repair the unit at no

cost. This warranty is only valid providing an inspection indicates that any such defect developed during normal and proper use subject to the

conditions below.

SDI Ltd shall under no circumstances be liable for incidental or consequential damages. The warranty does not apply to any damage or defect

caused by the user’s failure to follow the instructions for use or the other user error in operating or maintaining the unit. Although SDI Ltd offers

services to repair the Radii Xpert after the expiration of the warranty, SDI Ltd only guarantees the availability of such services and replacement

parts for two (2) years after the model has been discontinued.

Only the above warranty shall be applicable, all other warranties, expressed or implied are hereby excluded.

Claim

In case of a claim under warranty, the complete unit (handpiece, charging dock, AC power plug and LED attachment) is returned, carriage paid

to the dealer or directly to SDI Ltd together with a copy of the purchase document together with a clear description of the defect. Ensure you

have your Radii Xpert’s serial number ready when communicating with the Customer Service team.

Registering your Radii Xpert warranty

To speed up your warranty claim, it is advisable to register your Radii Xpert with SDI Ltd as soon as possible using the following two options:

1. Fill out the warranty card included in kit and return with a copy of your receipt to:

SDI Ltd PO Box 314 Bayswater, VIC 3153 AUSTRALIA

2. Alternatively goto http://www.sdi.com.au/warranty to register your warranty.

Guidance and manufacturer’s declaration - electromagnetic emissions

The Radii Xpert is intended for use in the electromagnetic environment speciﬁed below. The customer or the user of the Radii Xpert should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions

CISPR 11

Group 1 The Radii Xpert uses 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.

RF emissions

CISPR 11

Class B The Radii Xpert is suitable for use in all establishments,

including domestic establishments. The Radii Xpert is powered

by 1 x 3.7 V 2600 mAh DC Lithium ion battery thus Harmonic

emission and Voltage Harmonic emissions ﬂuctuation/ﬂicker

emissions are not applicable.

Harmonic emissions IEC 61000-3-2 Not applicable

Voltage ﬂuctuations / ﬂicker emissions IEC 61000-3-3 Not applicable

Table 201 - Guidance and MANUFACTURER’S declaration - ELECTROMAGNETIC EMISSIONS - for all equipment and systems

Table 202 - Guidance and MANUFACTURER’S declaration - Electromagnetic IMMUNITY - for all equipment and systems

Table 204 - Guidance and MANUFACTURER’S declaration - Electromagnetic IMMUNITY - for all equipment and systems that are not LIFE-SUPPORTING

Guidance and manufacturer’s declaration - electromagnetic immunity

The Radii Xpert is intended for use in the electromagnetic environment speciﬁed below. The customer or the user of the Radii Xpert should assure that it is used in such an environment.

IMMUNITY test IEC 60601 test level Compliance level Electromagnetic environment - guidance

Electrostatic discharge (ESD) IEC 61000-4-2 +/- 6 kV contact

+/- 8 kV air

+/- 6 kV contact

+/- 8 kV air

Floors should be wood, concrete or ceramic tile.

If ﬂoors are covered with synthetic material, the

relative humidity should be at least 30%.

Power frequency (50/60 Hz) magnetic ﬁeld

IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic ﬁelds should be at levels characteristic of a

typical location in a typical commercial or hospital environment.

Guidance and manufacturer’s declaration - electromagnetic immunity

The Radii Xpert is intended for use in the electromagnetic environment speciﬁed below. The customer or the user of the Radii Xpert should assure that it is used in such an environment.

IMMUNITY test IEC 60601 test level Compliance level Electromagnetic environment - guidance

Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2,5 GHz 3 V/m Portable and mobile RF communications equipment should be used

no closer to any part of the TENS PRO 900, including cables, than

the recommended separation distance calculated from the equation

applicable to the frequency of the transmitter.

Recommended separation distance

Where P is the maximum output power rating of the transmitter in

watts (W) according to the transmitter manufacturer and d is the

recommended separation distance in metres (m). Field strengths

from ﬁxed RF transmitters, as determined by an electromagnetic site

survey, ashould be less than the compliance level in each frequency

range.b Interference may occur in the vicinity of equipment marked

withthe following symbol:

NOTE 1 At 80 MHz and 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.

a Field 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 theoretically with 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 Radii Xpert is used exceeds the applicable RF compliance level above, the Radii Xpert should be observed to verify normal operation. If abnormal performance is

observed, additional measures may be necessary, such as re-orienting or re-locating the Radii Xpert. bOver the frequency range 150kHz to 80MHz, ﬁeld strengths should be less than 10/Vm.

Table 206 - Recommended separation distances between portable and mobile RF communications equipment and the equipment and systems - for equipment and

systems that are not LIFE-SUPPORTING

Recommended separation distances between portable and mobile RF communications equipment and the Radii Xpert

The Radii Xpert is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Radii Xpert can help prevent electro-

magnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Radii Xpert as recommended below, according to

the maximum output power of the communications equipment.

Rated maximum output power of

transmitter W

Separation distance according to frequency of transmitter m

80 MHz 10 800 MHz 800 MHz a 2,5 GHz

0,01 0.12 0.23

0.1 0.38 0.73

1 1.2 2.3

10 3.8 7.3

100 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance din metres (m) can be estimated using the equation applicable to the frequency of

the transmitter, where Pis the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for 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.