digit power™ Instructions

digit power™ Instructions
digit power
™
Dispenser
OPERATION MANUAL – ENGLISH
Dispenser
Caution: For dental use only.
U.S.A.: Rx only.
1. PRODUCT DESCRIPTION
Cap
Regulator
™
The digit power Dispenser consists of a dispensing handpiece, with an air supply tube connected to
an adjustable pressure regulator. The regulator can be connected to an existing standard ISO 4-hole,
5-hole or 6-pin air supply line, or if equipped, to a MIDWEST® Stylus™/XGT, StarDental HiFlo® or KaVo
MULTIflex® coupler. The adapter allows airline activation using the standard foot pedal for control of
the Dispenser. The adapter is adjustable, providing fit to most commonly used delivery systems and
tool pockets.
1.1 Delivery forms*
The digit power™ Regulator is available with the following airline connections:
• ISO Threaded Connector
(compatible with ISO 4-hole, 5-hole fiber optic, and 6-pin dental hoses)
Speed Control Knob
Alignment
Notch
Speed Indicator
Speed Settings
Grip
Push
Fitting
Adapter
Adjustable
Arm Screw
4-hole
5-hole
6-pin
• MIDWEST® Insert female quick-connect/disconnect
(compatible with MIDWEST® Stylus™ and XGT couplers)
• StarDental HiFlo® Insert female quick-connect/disconnect
(compatible with StarDental HiFlo® Swivel Connectors)
• KaVo MULTIflex® Insert female quick-connect/disconnect
(compatible with KaVo MULTIflex® coupler)
1.2 Indications
The digit power™ Dispenser is indicated for intraoral delivery of materials provided in the
digit power™ cartridges.
Adapter
Adjustable
Arm
Adapter
Threaded
Ring
Push
Fitting
1.3 Contraindications
None known.
Adapter
Post
Air Supply Hose
2. GENERAL SAFETY NOTES
Be aware of the following general safety notes.
2.1 Warnings
None known.
2.2 Precautions
• Wear suitable protective eyewear, mask, clothing and gloves. Protective eyewear is recommended for patients.
• digit power™ Dispenser regulator is designed for input pressures of 60 to 80 psi. Lower input pressures may affect output pressure and material dispensing rate.
• Improper alignment of the notches on the cap and grip after loading a cartridge can result in a device malfunction.
• Always put the digit power™ Dispenser in the adapter with the dispensing end up to prevent clogging.
• Do not autoclave the digit power™ Dispenser body, tubing or regulator.
• Do not immerse the digit power™ Dispenser in water or disinfectant. Do not spray liquids directly into the Dispenser. Spray a towel, then wipe the Dispenser.
Prevent liquids from entering openings on the Dispenser.
• If plungers do not retract after releasing foot pedal, allow cartridge to empty away from patient field, disconnect unit and return for service.
Do not attempt to disassemble or use further.
• Do not use the digit power™ Dispenser with Aquasil Ultra Material XLV, LV and Regisil Rigid in digit® Targeted Delivery System cartridges.
Device and cartridge malfunction may occur.
2.3 Adverse reactions
None known.
2.4 Storage conditions
Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Store at temperatures between 10ºC/50ºF - 24°C/75°F.
• Use the product at room temperature.
• Do not store used cartridges with new (unused) mixing tips attached.
• Do not freeze.
• Protect from moisture.
• Do not use after expiration date.
Connector
(regulator
type varies)
3. STEP-BY-STEP INSTRUCTIONS
3.1 digit power™ Dispenser Installation: Traditional Style Delivery Unit
• Step 1: Test fit the Adapter post in the tool holder. If necessary, adjust the Adapter arm length by removing the screw and selecting the proper alignment for a customized fit.
• Step 2: Attach the Regulator to the dental hose via an ISO Threaded Connector or quick connect coupler depending on your configuration.
• Step 3: Place the Regulator in the tool holder to deactivate the air line.
• Step 4: Place the Adapter post in the tool holder to activate the air line.
Step 3
Step 1
Step 4
Step 2
3.2 digit power™ Dispenser Installation: Continental Style Delivery Unit
• Step 1: Remove Adapter arm by removing the screw. Loosen the threaded nut on the regulator, flip the regulator upside down and reattach
it with the threaded nut. The Regulator knob should face down.
• Step 2: Attach the Regulator to the dental hose via an ISO threaded connector or quick connect coupler depending on your configuration.
• Step 3: Place the digit power™ Dispenser on the tool rest to deactivate the air line.
• Step 4: To activate, pull hose forward and lay the digit power™ Dispenser on the procedure tray.
Step 1
Step 2
Step 3
Step 4
3.3 Replacing digit power™ Dispenser air supply hose
If a longer reach if desired, an extended Dispenser air supply hose is available separately. Shortening or replacement of a damaged air supply hose
may be accomplished by following the Operations Manual directions below.
3.4 Quick Connect Regulator Conversion
The digit power™ Dispenser Regulator is available with connections for standard ISO threaded screw connectors, MIDWEST® female quick connect/disconnect
for Stylus™/XGT (does not fit MIDWEST® ATC), StarDental HiFlo® female quick connect/disconnect or KaVo MULTIflex® female quick connect/disconnect.
Although not a routine maintenance procedure, the connections may be converted at the user’s discretion. See Operations Manual directions below.
3.5 Regulator use
• The Regulator speed control knob has four dispensing speed settings with 1 being the slowest and 4 being the fastest.
The dispensing speed can also be set between numbers depending on your preference.
• Start out using the slowest speed setting and adjust upward as desired after becoming familiar with the technique.
• Check the pressure before each use and never bypass the Regulator.
3.6 Loading and using the digit power™ Dispenser
To test functionality pre-operative, please follow directions below, extruding one cartridge, prior to use on patients.
• Prepare a digit power™ Dispenser cartridge for use by snapping the circular disk off the cartridge. Insert unit dose cartridge into mixing tip.
Ensure both cartridge spurs fully lock into the square holes on the side of the mixing tip. Use only the provided digit power™ mixing tips.
• Remove the Cap from the Dispenser and insert the digit power™ cartridge mixing tip assembly into the Cap. (Fig. 1)
• Lock the Cap onto the Dispenser with a ¼ clockwise turn until the alignment notches line up.
• To reduce Dispenser contamination, placing a digit power™ protective barrier sleeve over Dispenser is recommended.
• Activate the Dispenser as outlined above. Depress the foot pedal and, away from the patient, bleed a small amount through the tip to assure
proper flow and a good mix. (Fig. 2) See enclosed Directions for Use for complete material placement instructions.
• Start and stop the flow of material using the foot pedal.
• The dispensing rate can be adjusted by adjusting the Regulator speed control knob.
• To disassemble, relieve pressure on the Dispenser plunger by stepping off of the foot pedal and place Regulator back into the tool holder.
Unscrew Cap and remove. Remove used cartridge/mixing tip. Replace Cap prior to Dispenser disinfection.
• The blue plastic components – Cap, Grip and Adapter – can be autoclaved. Properly discard used cartridge/mixing tip and prepare
Dispenser for reuse. (See Hygiene)
Fig. 1
Fig. 2
4. HYGIENE & MAINTENANCE
4.1 Cleaning the digit power™ Dispenser
Remove protective barrier and discard. The digit power™ Dispenser may be cleaned by scrubbing with a towel soaked with hot water and soap or detergent. Do not allow
solution to penetrate the casing. To clean plungers, remove Cap, depress foot pedal to advance plungers, and clean excess material with alcohol-moistened gauze.
4.2 Disinfection of the digit power™ Dispenser
Disinfect Dispenser with a hospital-level tuberculocidal disinfectant according to national and local regulations.
• Sodium hypochlorite (0.525%), water based dual phenolics, alcohol based dual phenolics, and dual or synergized quaternary ammoniums are approved disinfectants.
• Use impregnated wipes not sprays. Do not immerse the Dispenser in disinfectant.
The disinfectant manufacturer’s directions should be followed properly for optimum results.
The blue plastic components – Cap, Grip and Adapter – can be steam autoclaved, at 132°C for a minimum of 5 minutes (unwrapped). Cap, Grip and Adapter may be
autoclaved at least 200 times. Use of other sterilization procedures/methods is at the discretion and sole responsibility of the practitioner.
4.3 Maintenance
No additional maintenance is required except for routine cleaning and disinfecting.
5. SERIAL NUMBER
The digit power™ Dispenser and Regulator have different serial numbers located on their respective bodies. These serial numbers should be included in all correspondance.
6. WARRANTY
• Except with respect to those components parts and uses which are hereinafter described, DENTSPLY warrants this digit power™ Dispenser to be free from defects in material and workmanship
for a period of two (2) years from the date of sale. DENTSPLY’s liability under this warranty is limited solely to repairing or, at DENTSPLY’s option, replacing those products included within the
warranty which are returned to DENTSPLY within the applicable warranty period (with shipping charges prepaid), and which are determined by DENTSPLY to be defective. This warranty shall not
apply to any product which has been subject to misuse; negligence; or accident; or misapplied; or modified; or repaired by unauthorized persons; or improperly installed.
• INSPECTION: Buyer shall inspect the product upon receipt. The buyer shall notify DENTSPLY in writing of any claims of defects in material and workmanship within thirty (30) days after the buyer
discovers or should have discovered the facts upon which such a claim is based. Failure of the buyer to give written notice of such a claim within this time period shall be deemed to be a waiver
of such claim.
• DISCLAIMER: The provisions here-in stated DENTSPLY sole obligation and exclude all other remedies or warranties, expressed or implied, including those related to MERCHANTABILITY and
FITNESS FOR A PARTICULAR PURPOSE.
• LIMITATION OF LIABILITY: Under no circumstances shall DENTSPLY be liable to the buyer for any incidental, consequential or special damages, losses or expenses.
• LIMITATION OF ACTIONS: The buyer must initiate any action with respect to claims under the warranty described in the first paragraph within one (1) year after the cause of action has accrued.
AIR SUPPLY HOSE REPLACEMENT
• Step 1: Remove the old air supply hose from the digit power™ Dispenser by holding down the push fitting while simultaneously
pulling off the hose. Technique tip: Use your thumb and index finger to hold the push fitting down tightly while pulling the
hose in the other direction.
• Step 2: The new air hose can be cut to length with scissors if desired.
• Step 3: Insert the new air hose into the push fittings. Technique tip: When pushing the air hose into the push fitting, it will
push in easily and then encounter a small resistance – continue pushing in firmly past this initial resistance.
• Step 4: Confirm that the air hose is properly connected to the push fitting by pulling gently on the hose.
• Step 5: Test the unit for proper assembly without a digit power™ cartridge. If the air hose leaks or pops off, reattach it and
push in firmly.
Dispenser or
Regulator
Push Fitting
ADAPTER REPLACEMENT
Traditional Style Delivery Unit
• Step 1: Test fit the Adapter post in the tool holder. If necessary, adjust the arm length on the Adapter by removing the screw and selecting
the proper alignment hole for a customized fit.
• Step 2: Attach the Regulator to the Adapter using the threaded nut as shown. The Regulator knob should face up. Put the Dispenser in the
Adapter cradle with the dispensing end up.
• Step 3: Attach the Regulator to the dental hose via an ISO threaded connector or quick connect coupler depending on your configuration.
• Step 4: Place the Regulator in the tool holder to deactivate the air line.
• Step 5: Place the Adapter post in the tool holder to activate the air line. Dispense material using the foot control.
Step 1
Step 2
Step 3 & 4
Step 5
Continental Style Delivery Unit
• Step 1: Remove the sliding arm by removing the screw.
• Step 2: Attach the Regulator to the Adapter using the threaded nut as shown. The Regulator knob should face down. Put the Dispenser in the
Adapter cradle with the dispensing end up.
• Step 3: Attach the Regulator to the dental hose via an ISO threaded connector or quick connect coupler depending on your configuration and place on the tool rest.
• Step 4: To activate the air line, pull the assembly off of the tool rest and set it on the procedure tray. Dispense material using the foot control.
Step 4
Step 2
Step 1
Step 3
INSERT CONVERSION
For conversion of digit power™ Regulators from and to any of the following configurations: ISO Threaded Connector; MIDWEST® Insert (Stylus™ and XGT);
StarDental HiFlo® Insert; KaVo MULTIflex® Insert
• Step 1: If converting a coupler system to another coupler system skip to Step 3. NOTE: Coupler insert may vary from photos depending on configuration.
• Step 2: If converting an ISO threaded connector to a coupler system, remove the ISO connector from the bottom of the regulator using a wrench (not provided).
Turn counter clockwise to remove. Skip to Step 5.
• Step 3: If converting a coupler system to another coupler system, remove the old insert from the bottom of the regulator using the 5/32 hex key.
Turn counter clockwise to remove.
• Step 4: Important: Ensure that the o-ring on the coupler insert is also removed and not lodged inside the regulator body.
• Step 5: Thread the desired coupler insert into the bottom of the regulator using caution to avoid cross threading the parts. Turn clockwise to install.
• Step 6: Tighten the coupler insert using the 5/32 hex key. Turn clockwise to tighten.
Step 2
Step 3
Step 4
o-ring
Step 5
Step 6
ORDERING INFORMATION
digit power™ Dispenser Accessories
INSERT CONVERSION KIT: Includes 1 Insert, 1 Hex Key
678096 ISO Threaded Connector Insert Compatible with ISO 4-hole, 5-hole fiber optic, and 6-pin dental hoses
678097 MIDWEST® Insert Compatible with MIDWEST® Stylus™ and XGT couplers (not ATC)
678098 KaVo MULTIflex® Insert Compatible with KaVo MULTIflex® coupler
678099 StarDental HiFlo® Insert Compatible with StarDental HiFlo® Swivel Connectors
678079
678091
678092
678093
678094
Disposable Barrier Sleeves (50)
Cap Refill (1)
Grip Refill (1)
Adapter Refill (1)
Air Supply Hose Refill (1 Extra Long)
Manufactured by:
DENTSPLY Caulk
38 West Clarke Avenue
Milford, DE 19963 USA
Phone: 1-302-422-4511
www.dentsply.com
KaVo MULTIflex and StarDental HiFlo are not registered
trademarks of DENTSPLY International
©2013 DENTSPLY International. All rights reserved. Form #578054 (8/21/13)
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