+44 (0)1932 320064 | +44 (0)7990 113723€¦ · X Prismatic Telescopes 3.5 X Prismatic Telescopes 5.0 X Prismatic Telescopes 7.5 X The most advanced dental Loupes ever designed; built

A BRYANT DENTAL PRODUCT

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Bryant Dental is empowering dentists with technology that is beautifully designed and expertly engineered.

Innovation in prototyping with rapid 3D modelling and precision printing, combined with the latest AI technology in customer service, allows us to deliver to you products previously thought impossible.

Making smart dentistry simpler.

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Ultra bespoke dental Loupes

Contents08 Loupes

Instructions10 Cleaning Loupes12 Loupes Storage14 The Collection15 Loupes Warranty16 Ignis® Wireless

Light System

>> Ignis® LED with Integrated Headstrap

>> X1 Dichroic Wavelength Filter

>> X2 Ignis® Batteries>> X1 Battery

Charging Plate>> X1 Ignis® USB Wall

Plug (country specific)>> X1 Ignis® Screw Driver>> X1 Ignis® Bracket

>> LumaDent Headlight>> X1 Headlight>> X1 Orange

Composite Filter>> X1 LumaDent Battery>> X1 Smart Charger>> X1 1.5M Power Cable

LumaDent kit(Optional) (Optional)


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PRECISE LENSESPOWERED BY

X E N O S YS


ADVANCED FRAME RIGIDITY

High-rigidity alloy prevents distortion and lens misalignment over time. Having no flexibility at the bridge arm eliminates alignment errors, preventing double vision and eye strain.

ULTIMATE LENS CLARITY

Designed and constructed using next-generation techniques, our Loupes give you unrivalled clarity, with minimal chromatic and spherical aberration. You really need to see it to believe it.

REFINED LENS COATINGS

>> Anti-scratch >> Anti-fog>> Anti-glare

Loupes Instructions

Try out your new set of Loupes. Check your vision is clear and unobstructed. If you experience any problems please contact us on +44 (0)1932 320064.

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Intended use: A medical device to view the magnified image of the affected part or a part of a surgical operation.


Adjusting nose pads will help your posture. If your neck is tilting too much, we suggest you widen the nose pads to help the Loupes sit lower on the nose. Please call us if further angulation is required.

Adjustments only if vision is obstructed

Opening nose pads widerwill help Loupes sit lower.

Squeezing nose pads together will help Loupes sit higher.

Start with patient high in chair and lower patient until they come into focus. Move patient, not yourself.

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Always wipe and dry with deep piled microfibre towel with Formula 42®.

Use BD iShields® Visor system for additional protection.

Use 3 in 1 to help remove debris without scratching the lens.

Maintaining your new Loupes is very important. To help prolong the life of your new investment, we recommend cleaning them regularly. We have provided some suggestions shown right.

We only recommend Formula 42® Loupes cleaning system, as we can finely control the chemical makeup and ensure no damage to the lenses, scratch and glare coating.

Cleaning Loupes

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Loupes Storage

Keep your equipment safe with our TSA-approved lock. Your matte black case has been engineered for the highest level of impact resistance, to help protect your Loupes from the elements and from intruders. Please see instructions shown right.


Located on the reverse of the lock face.

Setting the code

Closing / opening

Select a 3-digit code

Opening: Select your chosen code and push the side buttons

OFF SET

Move switch to ‘OFF’Move switch to ‘SET’

Closing: Shut the lock buckle down and change code

OFF SET

Forgotten your code?

The master key is not included with your order, it is held with Bryant Dental in the event you forget your code. Please contact +44 (0)1932 320064.

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The Collection

Galilean Telescopes 2.5X

Galilean Telescopes 2.8X Prismatic Telescopes 3.5X

Prismatic Telescopes 5.0X Prismatic Telescopes 7.5X

The most advanced dental Loupes ever designed; built completely bespoke to you.


Loupes Warranty

C O N D I T I O N S

>> Ensure Loupes are wiped with Formula42® to ensure telescope longevity.

>> Store at room temperature.

>> Do not change or modify any of the existing components without authorisation from Bryant Dental.

L I M I T E D L I A B I L I T Y P O L I C Y

Bryant Dental will repair any issue arising from a manufacturing defect for a period of 5 years, without charge. The liability will not exceed the amount you originally paid for the product.

The warranty does not cover defects arising from negligence, product modification, unauthorised repairs, accidental damage, theft, loss or acts of God.

Description: Magnifying Glasses.

Warranty Period: 5 Years with Bryant Dental.

Manufacturer: Xenosys Co Ltd.

Telephone: 82-32-875-9811.

See device arm

See device arm

See device

Xenosys Co Ltd. 2, Venture-ro 100beon-gil, Yeonsu-gu, Incheon, 406-840, Republic of Korea.

Do not use if package is damaged

Meets requirements of the Medical Device Directive

Follow instructions for use

Keep dry

Fragile, handle with care

This device is not sterile

Bryant Dental® are registered trademarks in the United Kingdom and Australia.Bryant Dental, Old Cow Barn, Hilltop Farm, Lyne Lane, Lyne, KT16 0AN

Registered in England & Wales No. 10396020. Registered in Australia No. 634 752 980

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Wireless Light System

Contents20 Ignis® Instructions24 Charging25 Technical26 Safety Instructions30 Servicing and

Troubleshooting31 Disposal Notice31 Warranty

Head strap is a specialised silicone rubber, which is disinfectable and non-sticky.

SPECIALISED SILICONE RUBBER

HINGELESSRotating lens filter design.

UNIFORM BEAM PATTERNEdge-edge conformityfor maximum clarity.

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PLEASE DO NOT USE if you have a silicone rubber allergy.

Neodymium magnets hold the battery securely in place and allow a super quick swap-over time of less than three seconds.

NO FIDDLING WITH SCREWS OR WIRES

Cool Blue Indicator light for battery management.

INDICATION


Ignis® Headlight / Dichroic Lens Filter

Ignis® Instructions

The Ignis® Kit comes pre-asssembled, hassle free and ready to use. Please follow the instructions presented for usage. A screw driver is provided if you require further adjustments.

If you experience any problems please contact us on +44 (0)1932 320064.

Intended use: Ignis® Wireless Headlight is an illumination device attached to spectacles that is intended to illuminate oral structures and operating areas.

This device is designed to be used by qualified dental professionals, including, but not limited to, dentists and dental hygienists, as well as medical doctors and/or professionals. Ignis® must be used with the bracket provided, which is specific to your frames.

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Silicone head strap

Attach the battery switch to the base plate attached on the head strap, aligning the grooves to the ‘OFF’ position.


What’s included

Attaching the battery switch

>> Ignis® LED with Integrated Headstrap

>> X1 Dichroic Wavelength Filter

>> X2 Ignis® Batteries>> X1 Battery Charging Plate>> X1 Ignis® USB Wall Plug

(country specific)>> X1 Ignis® Screw Driver>> X1 Ignis® Bracket

Neodymium magnet-powered battery switch

Base plate

Off Regular High

Twist one click for regular power (shown above).

Keep switch vertical to power off device (shown above).

Twist two clicks for high power (shown above).

IMPORTANT: For safety reasons, to operate in high power mode, the battery must first be switched to regular and then to high.

Blue indicator lights are activated when device is ON.

When indicator light does not show any bars, the battery is near depletion and requires charging. (See page 24 for charging.)

Battery takes 1.5s to power up when switched ON to calculate optimum output.

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Select power modes


Dichroic Lens Filter – this smart filter is held in place with six neodymium magnets, allowing a really smooth transition between regular light and filtered light. This design prevents the filter accidentally rotating into place.

This filter cuts out the curing wavelengths of light, to prevent composite setting with a bright yellow tint rather than dark orange. This allows fine aesthetic work with the light on.

Selecting the lens filter

TO AVOID DAMAGE. Please do not lift the lens filter upwards. Rotate only.

Dos and Don’ts

ROTATE LIFT

Charging

It’s important to take care of the batteries. Intelligent adaptive charging means the batteries cannot be overcharged. Each battery comes with a two-year warranty.

Detach the battery from the head strap plate.

Do not expose batteries to naked flame.

Combine your USB mains adaptor and battery charging plate together (shown below).

Attach battery to battery charging plate. Aligning the grooves on the top to activate the charging sequence (shown above).

Once a FULL bar appears and stops flashing, the battery is fully charged.

CHARGED IN 1 HOUR 45 MINS

Neodymium magnet-powered battery switch.USB mains adaptor attached to battery charging plate.

Battery position

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Technical


Only use supplied charging plug

Spot Size 8.4cm diameter @ 40cm Working Distance

Beam Colour Temperature 5700K

Beam Intensity 45-84 Lumens

Overall Unit Weight 32g

LED Weight 9g

IPX IPX0 (0 Rated)

The charge circuit is protected by a MCP73831 charge control chip. This has current limiting protection and over temperature protection, along with reverse discharge protection.

Adverse Reactions None Known

Storage Temperature 0-35ºC

Charging Temperature 10-35ºC

Operating Temperatures 10-40ºC

Operating Power • DC3.7V 700mA

Charger Input AC100-240V, 50-60Hz

Charger Output • 12W 5V 2A

Storage Temperature 0-35ºC

Relative Humidity 30-75%

Storage & Shipping Conditions

Environmental Operating Conditions

Operating Temperature 10-40ºC

Relative Humidity 30-75%

Atmospheric Pressure 70.0 kPa to 106.0 kPa

>> POWER MODE HIGH (constant use: 1 hour 10 mins, clinical use: 2 hours)

>> POWER MODE REGULAR (constant use: 2 hours 45 mins, clinical use: 3-4 hours)

>> BATTERY CYCLE COUNT >300

>> LED CYCLE COUNT >10,000

Headlight unit weight 9g, full unit weight 32g.

Fully CNC machined housing, using 6061 Grade aluminium.

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Safety Instructions

C O N D I T I O N S

>> Only use supplied wall charger, using another charger will damage the batteries and invalidate the warranty.

>> Do not immerse any of the Ignis® light parts in water.

>> If any problems occur with the unit return to Bryant Dental for repair, attempting to repair yourself will void the warranty.

>> Do not change or modify any of the existing components without authorisation from Bryant Dental.

>> Do not leave the light on inside a pocket – it will cause the unit to overheat.

>> Do not leave the batteries on exposed skin.>> Do not charge unattended or leave in

environments exceeding 40°C.>> Do not attach multiple batteries together.>> Batteries should be stored in a cool, dry place.>> If batteries behave abnormally immediately

contact Bryant Dental.

>> Take care when attaching battery to base plate to avoid trapping your hair.

>> Take care not to touch the LED during use as this can reach 60-65ºC and cause a burn injury.

>> Avoid eye contact with the light switch on as this will dazzle other persons.

>> Do not bring LED within 200mm of the patient.

>> Do not bring neodymium magnets on batteries closer than 25cm to patients or operators with pacemakers.

200mm minimum safe distance from patient.

C L E A N I N G & M A I N T E N A N C E I N S T R U C T I O N S


You may disinfect using a low-alcohol disinfectant such as Formula42® or soap and water. Please follow the instructions on the disinfectant product to ensure satisfactory sanitisation.

>> Take care to ensure the ventilation gap around the LED is thoroughly cleaned along with all other surfaces that may be contaminated.

Ventilation gap

DO NOT RUN UNDER WATER.

DO NOT SPRAY THE DEVICE.

DO NOT SUBMERGE IN ANY LIQUID OR ULTRASONIC CLEANER.

DO NOT PULL ON EXPOSED CABLES DURING CLEANING.

DO NOT USE AUTOCLAVE OR CHEMICLAVE.

DO NOT USE GLUTARALDEHYDE OR IDOPHOR.

DO NOT USE A CLEANER WITH ALCOHOL CONCENTRATION GREATER THAN 70%.

Close the left Loupe arm (shown above).With an

Ignis® Kit

Followed by the right Loupe arm. Silicone straps should cross over (shown above).

5 easy steps to

store your Loupes

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Face your Loupes towards you. Hold the battery base plate and fold up (shown above).

Place folded Loupes in the center of the flight case (shown left).

Attach the battery charging plate to the roof of the box and place the neodymium magnet-powered battery switches on the bottom side wall (shown above).


S E R V I C I N G R E Q U I R E M E N T S

>> Lithium Ion batteries are considered expendable and will last 300 charge/discharge cycles before gradually losing capacity. New batteries can be ordered directly from Bryant Dental.

Battery is not charging If the battery is fully charged, and it senses it is going to ‘overcharge’, it will go into sleep mode and stop charging. The battery can appear dead. By putting the battery on a light to discharge it, it will then re-charge when put back on a charging plate. If this does not solve the issue – immediately cease use of the battery and contact Bryant Dental.

Battery isn’t lasting a full morning or afternoon session

After about 2 years, the battery capacity will begin to decrease as in most Lithium Ion batteries. If the battery is under 1 year old and not lasting a full session please ensure it is being used in ‘regular’ mode not ‘high’ power mode. If still an issue – please contact Bryant Dental and cease further use of the battery.

Battery keeps twisting on my back

Lay your frames and Ignis® out on a flat table. Unslide the earpieces from the silicone tubes and relieve any tension in the straps. With the base of the Ignis® Plate flat on the table, re-attach the tubes and this should solve any twisting issues. Please contact Bryant Dental if not.

Light comes on intermittently Ensure batteries are fully charged.

Light is flickering Ensure batteries are fully charged.

There is no light output The light must be turned on regular first, then high. If you go straight to high the light won’t turn on. This is to prevent accidental discharge at high power.

Battery is behaving abnormally

If the battery exhibits abnormal function please cease use immediately and contact Bryant Dental. Abnormal function could include, though is not limited to, overheating, expanding or changing shape.

T R O U B L E S H O O T I N G

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Servicing and Troubleshooting

>> Ensure the Ignis® Wireless headlight is regularly cleaned and disinfected.

>> Enquire with Bryant Dental about a service plan for the highest level of support.


Disposal Notice

L I M I T E D L I A B I L I T Y P O L I C Y

Bryant Dental will repair any LED or wiring issue arising from a manufacturing defect for a period of 5 years, without charge. Batteries and filters are covered for a period of 2 years. The liability will not exceed the amount you originally paid for the product. The warranty does not cover defects arising from negligence, product modification, unauthorised repairs, accidental damage, theft, loss or acts of God.

Warranty

When you plan to dispose of the device, please return to Bryant Dental for recycling.

The European Union Waste Electrical and Electronic Equipment (WEEE) Directive forbids the disposal of waste electrical and electronic equipment as unsorted municipal waste, requiring that it be collected and recycled or disposed of separately. Hazardous substances are present in electrical and electronic equipment and present potential risk

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.

The Ignis® battery packs contain Lithium Ion cells. Recycle or dispose of the batteries according to national, state, and local regulations.

Compliant with RoHS Directive 2011/65/EU.

www.bryant.dental+44 (0)1932 320064 | +44 (0)7990 113723

EN1.0/IG/IFU Rev1.5 Oct 2019

Ignis® and Bryant Dental® are registered trademarks in the United Kingdom and Australia.Bryant Dental, Old Cow Barn, Hilltop Farm, Lyne Lane, Lyne, KT16 0AN

Bryant Dental, Old Cow Barn, Hilltop Farm, Lyne Lane, Lyne, KT16 0AN United Kingdom.

Do not use if package is damaged

Possible hazardous optical radiation emitted from this product. Do not stare at the operating lamp. May be harmful to your eyes - Risk Group 2.

Meets requirements of the Medical Device Directive

Follow instructions for use

Keep dry

Fragile, handle with care

EN 60601-1:2006

EN 60601-1-2:2015

IEC 60601-1-6:2010/AMD1:2013

IEC 60601-1-2:2014

ICES-003 (Issue 6)

IEC 62471:2006 (Risk Group 2)

Medical Devices Directive 93/42/EEC (MDD)

Part Name Part Code Supplier

Ignis® LED with Integrated Headstrap BD2 Bryant Dental

Dichroic Wavelength Filter 1.X Bryant Dental

Ignis® Battery BDBATT15 Bryant Dental

Battery Charging Plate BDCP1 Bryant Dental

Ignis® Screw Driver IGNIS Bryant Dental

Ignis® USB UK Wall Plug BDUKP1 Bryant Dental

Ignis® Bracket BDXAMP1 Bryant Dental

Parts List: Applicable Standards:

See LED device

See LED device

5060678490003

Registered in England & Wales No. 10396020. Registered in Australia No. 634 752 980

Temperature limit40ºC

10ºC

This device is not sterile Do not dispose

Known Contraindications: Silicone Rubber Allergy or Sensitivity

Documents

+44 (0)1932 320064 | +44 (0)7990 113723€¦ · X Prismatic Telescopes 3.5 X Prismatic Telescopes 5.0 X Prismatic Telescopes 7.5 X The most advanced dental Loupes ever designed; built