parkell DURA30-PS Magnetostrictive Ultrasonic Insert Instruction Manual

: June 16, 2024
: parkell

Table of Contents

parkell DURA30-PS Magnetostrictive Ultrasonic Insert
Product Information
FAQ
Device Description
Precautions
Operating Instructions
Mechanical Cleaning
Maintenance, Inspection and Testing
Performance Guide Maintenance and Reprocessing
Explanation of Symbols Used
CONTACT
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

parkell DURA30-PS Magnetostrictive Ultrasonic Insert

parkell-DURA30-PS-Magnetostrictive-Ultrasonic-Insert-
PRODUCT

Product Information

Specifications

Product Name: Magnetostrictive Ultrasonic Insert
Model: hDURA30-PS, DURA30-US
Manufacturer: Topdental (Products) Ltd
Address: 12 Ryefield Way, Silsden, West Yorkshire BD20, 0EF England UK
Sterility: Non-sterile (needs to be sterilized before use)
Intended Users: Licensed dental professionals

Indications for Use

The Magnetostrictive Ultrasonic Insert is used for ultrasonic procedures in dental treatments.

Contraindications

No specific contraindications are mentioned in the user manual.

Warnings

It is important to sterilize the insert before use. Once opened, the product is non-returnable.

Precautions

The Dental Healthcare Professional should take the following precautions:

Select the proper insert for the teeth/root surfaces being treated.
Follow the scaler manufacturer’s instructions to fill the handpiece with water.
Lubricate the O-ring with water before inserting the insert into the handpiece.
Always start with the lowest power setting based on the patient’s clinical condition.
Adjust the water control for a rapid drip flow or light spray at the tip.
Use a suitable intraoral or extraoral finger fulcrum for stabilization and better control while scaling.
Adapt the insert tip so that the point is not directed into the tooth or root surface.
Maintain a light, smooth, gentle pressure against the tooth surface.
Keep the tip of the insert in motion, using overlapping horizontal and vertical strokes.
The inactivated insert tip can be used to explore and evaluate the tooth surfaces.

Infection Control Procedures

The following procedures should be followed for infection control:

Limitations on Processing: Follow the recommended processing limitations.
Point of Use (Post-Treatment): Clean and disinfect the insert after each use.
Mechanical Cleaning (Ultrasonic Cleaners): Use ultrasonic cleaners for mechanical cleaning.
Manual Cleaning: Perform manual cleaning as per standard cleaning procedures.
Maintenance, Inspection and Testing: Regularly inspect and test the insert for proper functioning.

Sterilization

The insert can be sterilized using the following methods:

Steam Sterilization: Use steam sterilization cycles for bagged and unbagged inserts.

Using The Performance Guide to Check For Tip Wear

Follow these steps to check for tip wear using the Performance Guide:

Position the base of the insert into the cutout of the Performance Guide and align the curvature of the tip over the outline of the tip on the guide. (Figure 2).
Ensure that the tip is flat against the guide.
Evaluate the tip for wear. If the end of the insert tip extends beyond the border of the 3mm measurement groove (Figure 3), it has not yet reached 3 mm of wear and will continue to operate at peak efficiency.
If the end of the tip does not extend fully across the 3 mm indicator groove (Figure 4) is flush with the left side of the groove, or is short of the groove, the tip has reached 3 mm of wear and should be removed from service and replaced.

Disposal

Dispose of inserts under state and local laws.

FAQ

Is the Magnetostrictive Ultrasonic Insert sterile?
No, the insert is non-sterile and needs to be sterilized before use.
Can the insert be returned once opened?
No, the insert is non-returnable once opened.
What is the recommended power setting for using DuraTip Perio Slim and Universal Slim inserts?
DuraTip Perio Slim and Universal Slim inserts may be used up to the maximum power setting.
How should I adapt the insert tip during usage?
The insert tip should be adapted so that the point is not directed into the tooth or root surface.
How should I clean and disinfect the insert after each use?
You can use mechanical cleaning with ultrasonic cleaners or manual cleaning following standard cleaning procedures.

Device Description

Parkell DuraTip® magnetostrictive ultrasonic inserts are designed for use with all major manufacturers’ 30KHz magnetostrictive ultrasonic scalers. DuraTip inserts, unlike any other inserts currently available, are uniquely designed to maintain a consistently high level of efficiency for a full 3 mm of tip wear.

Includes

1 DuraTip Insert
1 Color-coded Performance Guide

Indications for Use

Used for ultrasonic procedures including;
All general supra and subgingival scaling procedures
Periodontal debridement

Contraindications

Do not use amalgams, composites, gold, or porcelain.
Do not use on white spot lesions.
Do not use for restorative or endodontic procedures.

Warnings

Handle all inserts with care. Improper handling may result in injury and/or cross-contamination.
Insert is NOT sterile when shipped and must be autoclaved before first use.
Failure to follow properly validated sterilization processes may result in cross-contamination.
Inserts with tips that have been bent or reshaped should be discarded to avoid possible in-use breakage.

Precautions

It is the responsibility of the Dental Healthcare Professional to:
Operate the inserts only at the recommended power settings.
Avoid contact of the vibrating tip with intraoral tissues.
Do not bend or reshape insert tips. Ultrasonic insert tips that have been bent, reshaped, or otherwise damaged, are susceptible to in-use breakage and should be immediately discarded and replaced.
Verify that the green O-ring is in place before use. Lubricate the O-ring with water before inserting the insert into the handpiece.
When inserting the insert into the handpiece, always use a twisting motion.
Replace any worn or missing O-rings with a Parkell-approved replacement part ( DORING-GR).

Adverse Reactions

None known.

Residual Risks

Manually bending tips may result in in-use breakage and possible injury.
Failure to follow proper handling procedures or not properly drying the insert may cause the insert to stain, corrode, or clog.
Improper handling of the insert, especially the tip, may result in:
- Injury to the patient and/or the clinician.
- Insert damage.
Failure to follow proper sterilization procedures may result in cross-contamination.
Not properly handling O-rings according to these instructions could potentially cause leaking, and/or inability to properly seat the insert into the handpiece.

Unit Power Setting
DuraTip Perio Slim and Universal Slim inserts may be used up to maximum power.

Operating Instructions

Select the proper insert for the teeth/root surfaces being treated.
Fill the handpiece with water according to the scaler manufacturer’s instructions.
Lubricate the O-ring with water.
Gently twist the insert while inserting it into the handpiece until it is fully seated.
Begin by always using the lowest power setting based on the patient’s clinical condition.
Adjust the water (lavage) control for a rapid drip flow or light spray at the tip.
Take hold of the insert using a pen or modified pen grip.
For stabilization and better control while scaling, always use a suitable intraoral or extraoral finger fulcrum.
The insert tip should be adapted so that the point is not directed into the tooth or root surface.
Always maintain a light, smooth, gentle pressure (touch) against the tooth surface.
Always keep the tip of the insert in motion, using overlapping horizontal and vertical strokes.
The inactivated insert tip can also be used to explore and evaluate the tooth surfaces.

Infection Control Procedures

All devices (including the Performance Guide) should be cleaned and sterilized before each use.
When a three-step process is required, where disinfection is necessary before sterilization, all devices must be cleaned, disinfected, and sterilized before use.
Disinfection alone is not an acceptable method for reprocessing between patients.

Limitations on Processing

Repeated processing should have minimal effect on the inserts when done correctly.
Always use neutral pH instrument cleaning or disinfecting detergent solutions. The inserts can be damaged by the use of alkaline and acidic detergents.
Failure to follow the cleaning solution’s recommended concentration rates and contact times may result in rapid deterioration of the insert grip as well as other insert components.
Cold liquid disinfection/sterilization, chemical vapor sterilization, and dry heat sterilization have not been tested or validated and should not be used.

Point of Use (Post-Treatment)

The ultrasonic insert must be removed from the handpiece before processing.
Residue or any other form of contamination must not be allowed to dry on the insert. All excess soil/gross debris must be removed by rinsing under running water.
The insert should be removed from the treatment area and reprocessed, as soon as practical, following use.

Mechanical Cleaning

(Ultrasonic Cleaners)

Follow the manufacturer’s instructions for instrument cleaning solution, observing concentration rates and contact times.
May be cleaned using an ultrasonic water bath for up to 15 minutes. May use a non-ammoniated detergent or mild soap.
When using cassettes, to avoid insert damage, make sure the cassette does not put excessive pressure on the insert stack or tips.
Remove the instruments from the ultrasonic cleaning bath and rinse under warm running water for 30 seconds to remove any cleaning agents.
Inspect instruments for visible debris. Manually remove any debris using a nylon brush with a cleaning solution.
Rinse the instrument under warm running water for 30 seconds to remove any cleaning agents.
Dry the insert using a dry, disposable cloth or a dental instrument dryer. An insert left wet may stain, corrode, or clog.

Manual Cleaning

Prepare an enzymatic pH-neutral instrument cleaning solution per the manufacturer’s instructions, paying attention to concentration rates.
Fully immerse the inserts in the instrument cleaning solution for the recommended contact time.
Rinse the instrument under warm running water for 30 seconds.
Inspect instruments for visible debris. Manually remove any debris using a nylon brush with a cleaning solution.
Rinse the instrument under warm running water for 30 seconds to remove any cleaning agents.
Dry the insert using a dry, disposable cloth or a dental instrument dryer. An insert left wet may stain, corrode, or clog.

Maintenance, Inspection and Testing

Visually inspect the insert to ensure all contamination has been removed.
Visually inspect O-rings for wear. Replace worn O-rings with Parkell-approved parts.
Lubricate O-rings before use.
Check for damaged inserts.
Check for tip wear using the appropriate “Performance Guide” for the selected insert style and shape.

Sterilization of Insert

Steam Sterilization Cycles| Sterilizing Temperature| Sterilizing Cycle Time
---|---|---
Dynamic Air Removal| 270°F/132°C| 4 Minutes
Gravity Displacement| 270°F/132°C| 15 Minutes

Bagged Inserts

Place an insert in a paper or paper/plastic steam sterilizer pouch. Place the paper side up when using a paper/plastic steam sterilizer pouch. Place the bagged insert(s) into the steam sterilizer and run the cycles listed above based on the type of sterilizer being used. The sterilization cycle is followed by a 20–30-minute drying time.
To maintain sterility, the insert(s) should remain in the sealed pouch(es) until ready for use.

Unbagged Inserts

Place the insert(s) on a tray or in a cassette into the steam sterilizer and run the cycles listed above based on the type of sterilizer being used. The sterilization cycle is followed by a 20–30-minute drying time.
When using cassettes, make sure the cassette does not put excessive pressure on the insert stack or tips that might cause damage.
Use the insert immediately.

*Using The Performance Guide To Check For Tip Wear**

DuraTip insert “Performance Guides” (included with every insert) are colour-coded to correspond to the color of the grip of the insert.
While DuraTip inserts maintain a consistently high level of efficiency, and provide optimal scaling performance throughout their life, it is always important to regularly check for wear so the insert can be removed from service at the appropriate time. The recommended interval for wear measurements is once per week.
How to Use Performance Guide:
Select the appropriate color-coded Performance Guide for the tip being measured (Figure 1).
Position the base of the insert into the cutout of the Performance Guide and align the curvature of the tip over the outline of the tip on the guide. (Figure 2).
Be sure the tip is flat against the guide.
Evaluate the tip for wear. If the end of the insert tip extends beyond the border of the 3mm measurement groove (Figure 3), it has not yet reached 3 mm of wear and will continue to operate at peak efficiency.
If the end of the tip does not extend fully across the 3 mm indicator groove (Figure 4) or is flush with the left side of the groove, or is short of the groove, the tip has reached 3 mm of wear and should be removed from service and replaced.

parkell-DURA30-PS-Magnetostrictive-Ultrasonic-Insert-
FIG-1

Performance Guide Precautions

To avoid unintended injury from pointed/sharp insert tips, use appropriate precautions while measuring wear.
Always keep fingers away from the end of the tip when measuring.
Do not take measurements post-treatment when the insert tip is contaminated. Measurements should only be taken pre-treatment, when the insert and Performance Guide are removed from their corresponding sterilization pouches.

Performance Guide Maintenance and Reprocessing

Performance Guides are NOT sterile when shipped and must be autoclaved before first use.
After each use the Performance Guide can be cleaned of debris with an EPA-registered low-level to intermediate-level hospital disinfectant then placed in a paper or paper/ plastic steam sterilizer pouch. Place the paper side up when using a paper/plastic steam sterilizer pouch into the steam sterilizer and run the cycles listed below based on the type of sterilizer being used. The sterilization cycle is followed by a 20–30-minute drying time.
To maintain sterility, the Performance Guide should remain in the sealed pouch until needed.

Sterilization of Performance Guide

Steam Sterilization Cycles| Sterilizing Temperature| Sterilizing Cycle Time
---|---|---
Dynamic Air Removal| 270°F/132°C| 4 Minutes
Gravity Displacement| 270°F/132°C| 15 Minutes

Disposal
Dispose of inserts in accordance with state and local laws.

Explanation of Symbols Used

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• Professional use only

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|

• Follow instructions for use

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• Temperature limit

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• Store product tightly sealed away from direct sunlight.

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• Sterilizable in a steam sterilizer (autoclave)

at the temperature specified

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• Keep dry

| • Do not dispose this product into the ordinary municipal waste or garbage system
| ****

• Non-Sterile

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• Package contents

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• Serial number

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• Batch code

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• Catalogue / stock number

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• Unique Device Identifier

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• Medical Device

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• Importer

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• Single use only

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• Manufacturer

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• Do not use if package is damaged

This Performance Guide is intended for general reference purposes only. It is the responsibility of the user to decide when an insert should be replaced based on their own professional judgement. Measurements obtained with the guide may vary due to variations
in manufacturing and user handling of both the insert and the guide. The guide is not suitable for inserts that have been used improperly or have damaged or altered tips.