Illuminated Dental Isolation System

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Device Description Isolite® Illuminated Dental Isolation System

h EIL0201 (USA) h EIL0204 (EU) h EIL0205 (AUS) This system is intended for use with the Mouthpieces developed by Zyris, Inc. These Mouthpieces are available in a wide range of sizes for effective isolation. Each Isolite Illuminated Dental Isolation System is comprised of four main components: 1) Titanium Control Base, 2) Vacuum Light Pipe, 3) Power Hose, 4) LED Smart Stick. Titanium Control Base h PIL0201 The Titanium Control Base includes two Vacuum Levers (P/N: PIL0205) to adjust suction in the upper and lower areas of the Mouthpiece.

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Power Hose h PIL0203 (USA) (1.82 m / 72 in) h PIL0208 (USA) (0.91 m / 36 in) h PIL0209 (USA) (1.22 m / 48 in) h PIL0210 (USA) (1.52 m / 60 in) h PIL0211 (EU/AUS) (1.32 m / 52 in) The Power Hose delivers both power and vacuum suction from the LED Smart Stick vacuum canister to the Control Head. h PIL0202 The Power Hose connects to the The LED Smart Stick controls the vacuum canister. At the end of the LED light source. The one-button Power Hose, an indicator light will light control adjusts: on/off, alert the user if an incorrect power 5 levels of brightness, and a adapter has been plugged into the cure-safe mode. Power Hose. Vacuum Light Pipe Power Adapter h PIL0204 h PIL0207 The Vacuum Light Pipe transmits The Power Adapter delivers electrical ultra-bright light while channeling power to the Power Hose and the suction. The Mouthpiece attaches LED Smart Stick. It connects to the onto the Vacuum Light Pipe. Power Hose at the Power Jack and plugs into a standard power outlet (110v or 220v).

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Plug Adapter kit h AIL0219 (EU) h AIL0220 (NZ/AUS) International power plug adapters.

Mouthpieces h CILXX0X (non-sterile) Sold Separately

Suction Line Plug h PIL0206

Mouthpieces are single use only and available in various sizes. The Mouthpieces are constructed of a soft, flexible polymer and are not made with natural rubber latex. They do not contain phthalates or BPAs. For more information on sizes, go to Zyris.com.

O-ring Maintenance Kit h AIL0206 (USA/AUS) h AIL0223 (EU) 3/8" Y-Adapter Kit h AIL0207 (USA/AUS) 9.5 mm Y-Adapter Kit h AIL0222 (EU) Double End Tube Brush h AIL0204 Mouthpiece Lubricant h AIL0202 Barrier Sleeves h AIL0203 (non-sterile) Sold Separately Non-sterile Control Head Barrier Sleeves are available for additional protection from cross-contamination. Use of Barrier Sleeves does not eliminate the need to follow disinfecting and sterilization recommendations for the Control Head and Vacuum Light Pipe.

Intended Use Isolite is a dental isolation system for clinical use by dental professionals. The system is designed to isolate two quadrants at once, simultaneously providing intra-oral illumination, tongue and cheek retraction, and continuous suction. The retraction and continuous suction are the important functions that control the oral environment, reducing contamination and improving bond strength while protecting the airway and soft tissue. Contraindications No known contraindications. Do not use without reviewing how to select the correct Mouthpiece size for each patient. Do not use if unable to position the Mouthpiece correctly. 5

Side Effects Use of the Mouthpiece may trigger a pharyngeal reflex (laryngeal spasm) in hypersensitive patients, or if it is not placed correctly within the oral cavity. How Supplied Isolite

The Isolite Illuminated Dental Isolation System contains: Titanium Control Base, LED Smart Stick, 6 Vacuum Light Pipes, Power Hose, Power Supply, Plug Adapter Kit (for specific countries), Instructions for Use. Accessories: Suction Line Plug, Mouthpiece Lubricant, Y-adapter Kit, Double End Tube Brush, and O-ring Maintenance Kit. Mouthpieces

Mouthpieces (sold separately) are supplied in convenient operatory boxes. Each Mouthpiece is individually packaged.

Installation Isolite is designed to install easily in most dental operatories (Figure 1). Installation and usage instructions, including a video demonstration, are also available at zyris.com. Step 1 Connect the Power Hose to the vacuum canister by fitting the end of the vacuum hose onto an auxillary HVE port on the vacuum canister. If an auxillary HVE port is not available, use the provided Y-adapter, so that the standard HVE hose may remain connected. Vac Canister Control Head

HVE Port 2

Power Jack Standard HVE Hose

Power Hose

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Figure 1. Installation

HVE Port 1 Vac Canister Hose Power Adapter

NOTE: For countries outside the USA, installation may need to be completed by a qualified service technician. Please consult your in-country representative for additional information.

Using The Led Smart Stick Adjust lighting functions by using the one-button light control.

Step 2 Plug the Power Adapter into an

Operation

Action

Turn light on / off

Tap button once

Set brightness

Press and hold button to cycle through brightness levels; release to set

Engage / disengage cure-safe mode

With light on, double-tap button

electrical outlet. Plug the DC connector into the Power Jack at the end of the Power Hose. Connect the Control Head to the head of the Power Hose. When properly installed, a green LED indicator light will appear on the LED Smart Stick. Once connected, test the dual Vacuum Levers to confirm suction functionality. NOTE: For countries outside the USA, attach the appropriate plug adapter to the power adapter. See the illustration included with the Plug Adapter Kit. Direct wire installations require completion by a qualified service technician. Please consult your in-country representative for additional information. Step 3 Place the Isolite in an open slot on

the toolbar when not in use.

How to Operate Using the Dual Vacuum Levers Dual Vacuum Levers adjust suction intensity in both the upper and lower quadrants. To adjust, rotate the left and right Vacuum Levers to the desired suction intensity for each quadrant. To shut off suction, rotate the levers to the most downward position.

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Table 1. LED Operation

The LED Smart Stick features an LED indicator which provides the status of the system. LED Indicator

Status

Steady green, pulsing every 10 sec

System is ready; power is connected and the light is off

Steady green

Light is on

Blinking blue

With button pressed and held, marks each of the 5 brightness levels

Steady amber

Cure-safe mode

Steady blue

Self-regulating temperature control has automatically lowered the brightness to reduce heat level

Table 2. LED Status 7

Selecting the Mouthpiece To select the correct Mouthpiece size, measure the patient’s interincisal opening. If between sizes, you may select the smaller size. Mouthpiece Size

Approx. Interincisal Opening

Pediatric (PED)

< 30 mm

Extra Small (XSM)

< 30 mm

Small (SML)

30 mm

Medium (MED)

30-45 mm

Medium Deep Vestibule (MDV)

30-45 mm

Large (LRG)

> 45 mm

Cheek Shield

Flexible Isthmus

Vacuum Channels

Tongue Retractor

Integrated Bite Block

Locking Barb Openings Mouthpiece Sleeve

Table 3. Mouthpiece Sizes Figure 3. Mouthpiece

The Finger Method

The finger method may also be used to select the appropriate Mouthpiece size (Figure 2). For additional assistance, watch a video demonstration online at Zyris.com.

INTERINCISAL OPENING IN MM

Pediatric / Extra Small One Finger (< 30 mm) Small Two Fingers (30 mm) Medium / Medium DV Three Fingers (30-45 mm) Large Four Fingers (> 45 mm)

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Figure 2. The Finger Method

Attaching the Mouthpiece Slide the Mouthpiece onto the Vacuum Light Pipe until the two locking barbs engage. Water or mouthpiece lubricant may be used to lubricate the inside surface of the Mouthpiece sleeve to ease attachment.

Placing the Mouthpiece Prior to placing the Mouthpiece within the patient’s oral cavity, moisten the Mouthpiece and the patient’s lips.

Step 1

Step 1

Hold the sides of the Control Head with your index finger and thumb. With your other hand, fold the Cheek Shield onto the Tongue Retractor. Gently slide the folded mouthpiece into the buccal vestibule on the side to receive treatment. Angle the mouthpiece to allow the lower edge of the Tongue Retractor to move along the buccal edge of the teeth.

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Step 2

Step 2

Move the bite block onto the occlusal surface of the teeth, just distal to the mandibular cuspid. Instruct the patient to “rest gently” on the bite block to secure. Step 3

Place the Cheek Shield into the buccal vestibule. Move the Isthmus onto the retromolar pad behind the maxillary tuberosity. Adjust the Tongue Retractor in the lingual vestibule as needed. Move the bite block distally to provide more vertical working room. Step 3

Figure 4, 5, & 6. Mouthpiece Placement

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Disassembly of the Control Head Step 1

Press the release button (Figure 7) on the underside of the Titanium Control Base to release and disconnect the Vacuum Light Pipe. Step 2

Remove the LED Smart Stick from the Titanium Control Base. Step 3

Holding the head of the Power Hose, pull to remove the Titanium Control Base. Do not twist. Led Smart Stick (Do Not Autoclave) LED Light Control Button

Vacuum Light Pipe Vacuum Tubes Release Button Vacuum Levers

Vacuum Tubes

Figure 7. Control Head

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Titanium Control Base

Disinfection, Cleaning, and Sterilization Surface Disinfection of the Titanium Control Base Zyris, Inc. recommends performing a surface disinfection of the Titanium Control Base between each patient. To disinfect the Titanium Control Base, first remove the Vacuum Light Pipe and the LED Smart Stick. If the Titanium Control Base is visibly soiled with biomatter or blood, use an intermediate level disinfectant wipe with a claim to inactivate Mycobacterium tuberculosis. Otherwise, use a hospital grade disinfectant and follow the manufacturer’s instructions for contact time. Surface Disinfection of the LED Smart Stick Zyris, Inc. recommends performing a surface disinfection of the LED Smart Stick between each patient. Spray a ready-to-use, fast-killing disinfectant onto entire surface of the LED Smart Stick and allow to remain wet per manufacturer’s instructions. Using a nylon bristle brush, clean around the light control button area. Do not press the button while cleaning. Gently work the bristles in a circular motion, following the groove between the housing and the button for approximately 60 seconds to remove all visual debris. Repeat if any contaminants are still visible.

Wipe the LED Smart Stick thoroughly with a ready-to-use, fast-killing disinfectant for the specified contact time per manufacturer’s instructions. Dry off the LED Smart Stick and gold connector pins before use. Surface Disinfection of the Power Hose Zyris, Inc. recommends performing a surface disinfection of the Power Hose between each patient. Use a hospital grade disinfectant per manufacturer’s instructions. If components are visibly soiled with biomatter or blood, use an intermediate level disinfectant wipe with a claim to inactivate Mycobacterium tuberculosis. Barrier Sleeves may also be used and changed between patients. Cleaning and Sterilization of the Vacuum Light Pipe Zyris, Inc. recommends sterilization of the Vacuum Light Pipe between each patient. Remove biomatter and other debris from the suction channels using the provided Double End Tube Brush with a neutral pH (6.5-7.5) enzymatic cleaning solution. Do not use solution to hold parts. After cleaning, rinse with tap water, dry, and place components in an autoclave pouch to be sterilized in a steam autoclave. Use validated sterilization cycles (Table 4).

Cleaning and Sterilization of the Titanium Control Base Zyris, Inc. recommends following normal infection control protocol for dental devices. Users may sterilize the Titanium Control Base at their discretion.

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Remove the Vacuum Levers from the Titanium Control Base. Remove biomatter and other debris from the suction channels using the provided Double End Tube Brush with a neutral pH (6.5-7.5) enzymatic cleaning solution. Do not hold parts in cleaning solution or use ultrasonic cleaners. After cleaning, rinse with tap water, dry, and place components in an autoclave pouch to be sterilized in a steam autoclave. Use validated sterilization cycles (Table 4). After sterilization, lubricate the Vacuum Lever O-rings with the Dow 111 O-ring lubricant provided in the O-ring Maintenance Kit. Validated Sterilization Cycles Min. Exposure Min. Drying Time Time

Cycle

Temperature

Standard

121 °C / 250 °F 30 min

30 min

Standard

132 °C / 270 °F 15 min

15 min

Prevacuum 132 °C / 270 °F 4 min

20 min

Prevacuum 134 °C / 273 °F 3 min

20 min

Table 4. Validated Sterilization Cycles

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Maintenance Titanium Control Base The Vacuum Lever O-rings require weekly lubrication to operate at peak efficiency. Remove the Titanium Control Base from the Power Hose. To remove the Vacuum Levers, push the levers to the “off” position and keep pushing gently until each lever pops out, or gently pry them out. Coat the O-ring by applying a small amount of the Dow 111 O-ring Lubricant provided in the O-ring Maintenance Kit. Apply an additional amount to the Titanium Control Base retainer rings as well. Reattach the Vacuum Levers to the Titanium Control Base (Figure 8 and 9).

O-ring

Figure 8. Vacuum Levers

Retainer Ring

Power Hose Clean the inside of the Power Hose regularly according to frequency of use to prevent the accumulation of biofilm. Start by vacuuming water through the Power Hose. Then vacuum a dental hose cleaner through the hose per manufacturer’s instructions. The vacuum hose cleaner should be non-foaming, deodorizing, anti-microbial, and able to dissolve organic debris. Most enzymatic cleaners with a pH between 6 and 8 are acceptable. Do not use disinfectants as a vacuum hose cleaner. If further disinfection is necessary, consult your vacuum manufacturer for recommendations. To lubricate the Power Hose O-ring, remove the Titanium Control Base from the Power Hose. The black O-ring is located approximately 13 mm (½ inch) down the inside of the blue fitting at the head of the Power Hose. (Figure 10) Swab the O-ring with the Dow 111 O-ring lubricant provided in the O-ring Maintenance Kit.

O-ring

Figure 9. Titanium Control Base Figure 10. Power Hose

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Warnings

Precautions

YDdiL

YCAUTION: When performing dental procedures requiring high levels of blood evacuation, it is recommended that the Mouthpiece be intermittently flushed with water to prevent coagulation in the Mouthpiece to avoid loss of suction and light transmission. YCAUTION: Do not block access to the Power Adapter. The Power Adapter should be easily accessible so that it can be unplugged from the wall outlet if necessary. YCAUTION: To avoid electrical shock, the use of an extension cord with the Power Adapter is not recommended. YCAUTION: Do not crimp or fold the Power Hose to shut off suction. Internal damage to the Power Hose wiring may occur. YCAUTION: The LED Smart Stick contains sensitive electronics and requires special care and handling. Do not submerse, autoclave, Chemclave, or place in ultrasonic cleaner. YCAUTION: The LED Smart Stick should only be removed and installed while the Titanium Control Base is attached to the power hose. Failure to do so may result in damage to the gold connector pins.

YWARNING: Shock hazard if incorrect power supply is used. Only use the power adapter supplied with your Isolite. Use of other power sources may damage electronics and voids your product warranty. The electrical system requirement is 5.0 VDC, 1.0 amp. YWARNING: Do not place a metal HVE valve onto the Power Hose. This may damage electrical components and may present a shock hazard. D WARNING: Mouthpieces are single use only. Reuse can result in the transmission of infectious pathogens. Mouthpieces must be discarded after use. Mouthpieces cannot be safely resterilized after use. LWARNING: Do not use if the individual Mouthpiece package has been previously damaged or opened. Mouthpieces are individually packaged in polyethylene bags. YWARNING: Be sure to use established protocols and patient monitoring when using the Mouthpiece in conjunction with sedation dentistry. Patient management by a certified anesthesiologist is strongly recommended.

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YCAUTION: Do not autoclave the Titanium Control Base at temperatures above 135 °C; higher temperatures could damage components and void your product warranty. YCAUTION: Do not press the LED Light Control Button while cleaning. YCAUTION: Do not hold Titianium Control Base or LED Smart Stick in cleaning solution or use ultrasonic cleaners. YCAUTION: Failure to maintain properly lubricated O-rings can result in damage to the Isolite that is not covered by product warranty. YCAUTION: With regular use, cleaning, and maintenance, the device is designed to last for years. Check the device for wear prior to use to make sure that it is adequate for use.

Guide to Symbols

Non-sterile

Catalog number

Caution

Do not re-use

Positive polarity

Consult Instructions for Use

Do not use if package is damaged

Type B applied part electrical hazard

Date of manufacture

15:

Manufacturer

14

r

30:

Storage Conditions

Limited 1-Year Warranty

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Zyris Inc. warrants this product to be free from defects in material and workmanship for a period of one year from the date of original purchase. If the product exhibits such a defect, Zyris, Inc. will, at its option, repair or replace it without costs for parts and labor. The product must be returned by the customer to Zyris, Inc. in accordance with current Return Material Authorization procedures. Proof of date of original purchase may be required. This warranty does not cover finishes or normal wear, nor does it cover damage resulting from accident, misuse, dirt, tampering, unreasonable use, failure to provide reasonable and necessary maintenance, service performed or attempted by unauthorized individuals or service agencies, or devices that have been otherwise modified. All implied warranties, including any implied warranty or merchantability or fitness for any particular purpose, are limited in duration to one year from the date of receipt of the product. In no event will Zyris, Inc. be responsible for consequential damages resulting from the use of this product. Instructions for Use may also be found at: Zyris.com

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Zyris, Inc. 6868 Cortona Drive Santa Barbara, CA 93117 USA Phone +1-(805) 560-9888 Fax +1- (805) 966-6416 For the USA, toll free: 1-800-560-6066 www.Zyris.com

© 2018 Zyris® Systems. All rights reserved. Patent Information www.Zyris.com/patents

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