infinitas DB10-0020 Instruments and Aluminium Tray User Manual

infinitas DB10-0020 Instruments and Aluminium Tray

Product Information

The Instruments & Aluminium Tray – Non-Sterile are reusable hand-held devices supplied by DB Orthodontics Limited for use in a healthcare setting. These instruments are intended to be processed before use and are designed to be used by appropriately trained healthcare professionals. The product includes various instruments and an aluminium tray. The instruments are available in different types and have specific product codes for easy identification. The aluminium tray is used for storing and transporting the instruments. These non-sterile instruments and trays are made from high-quality materials and are sterilized using moist heat (ISO 17665) before initial use.

Product Usage Instructions
Initial Treatment at Point of Use

• After each use, do not allow blood and/or bodily fluids to dry on the instruments or aluminium tray. Remove them immediately using a disposable cloth or paper wipe.
• It is recommended to process the instruments and tray through a validated washer disinfector as soon as possible after patient use.
• Handle contaminated devices with protective gloves to prevent any potential exposure.

Containment & Transportation:

• Transport the used instruments and aluminium tray to the Decontamination area in closed or covered containers to prevent unnecessary contamination risk.
• If transport outside of the healthcare facility is required, use containers that meet the requirements of UN3291.

Preparation Before Cleaning

• Select a pH-neutral detergent and prepare all cleaning solutions according to the concentration and temperature recommended by the detergent manufacturer.
• Use potable water to prepare cleaning solutions.
• Disconnect the Standard Handle (DB10-0020) from the inserts (DB10-0021, DB10-0022, DB10-0023) before processing.

Cleaning Instructions

• Place the instruments and aluminium tray in the cleaning\ solution and ensure they are fully submerged.
• Follow the cleaning cycle recommended by the detergent manufacturer, including agitation and rinsing.
• Inspect the instruments and tray after cleaning for\ cleanliness, damage, or corrosion. Repeat the cleaning cycle if any soil remains.

Maintenance & Inspection

• Before preparing the instruments and aluminium tray for reprocessing, visually inspect all parts under good lighting.
• Check for visible soiling, damage, corrosion, and wear.

Note: These usage instructions are in accordance with the requirements contained in BS EN ISO 17664. It is essential to follow these instructions for the safe and effective use of the non-sterile Infinitas Instruments and Aluminium Tray. General Instructions for Care, Handling and Reprocessing of DB Orthodontics non-sterile Infinitas Instruments and the aluminium tray. Method: Sterilized using moist heat (ISO 17665)

DESCRIPTION

These reprocessing instructions are in accordance with the requirements contained in BS EN ISO 17664 and apply to the nonsterile Infinitas, reusable hand-held Instruments and the reusable aluminium tray supplied by DB Orthodontics which are intended for reprocessing in a healthcare setting. The instruments and the aluminium tray are reusable devices and as such should be reprocessed according to the instructions provided below. These reprocessing instructions have been validated as being capable of preparing the Infinitas instruments and the aluminium tray for use. It is the responsibility of the user/hospital/healthcare provider to ensure that reprocessing is performed using the appropriate equipment and materials and that personnel have been adequately trained in order to achieve the desired result; This normally requires that equipment and processes are routinely monitored. Any deviation from these instructions should be evaluated for effectiveness to avoid potential adverse consequences.

WARNINGS

• Use a washer disinfector that meets the requirement of ISO 15883 parts 1 & 2.

• Use detergents and other processing chemicals in accordance with the manufacturer’s instructions, including residual testing (as applicable).

• Saline and cleaning/disinfection agents containing aldehyde, chloride, active chlorine, bromine, bromide, iodine or iodide are corrosive and should not be used.

• Metal brushes and scouring pads must not be used during manual cleaning. Only use soft bristle brushes to aid with manual cleaning.

• The use of hard water should be avoided. Purified water should be used for final rinsing to prevent mineral deposits.

• Some sensitive materials can be damaged by higher alkaline solutions (pH > 10). If the devices are used in conjunction with other devices, such as powered handpieces, ensure the companion devices are
  reprocessed according to the relevant manufacturer’s instructions. These instructions only apply to the DB Orthodontics devices outlined above.

• The Standard Handle (DB10-0020); should be disconnected from the inserts (DB10-0021, DB10-0022, DB10-0023) prior t processing.

• Wear suitable personal protective equipment such as gloves, clothing and face covering (e.g., visor) as necessary when handling used devices or conducting manual cleaning and disinfection.

• When processing medical devices always follow local Health & Safety procedures.

• It remains the responsibility of the end user/ hospital/healthcare provider to ensure that the reprocessing has achieved the desired result. This normally requires validation and routine monitoring of the process.

• The Infinitas instruments and aluminium tray are intended to be used in a healthcare environment by appropriate healthcare professionals, who are familiar with, and have experience of the devices and techniques used.

INTENDED USE
Infinitas instruments and aluminium tray are supplied non-sterile. They are intended to be processed before use.

INTENDED USERS
The Infinitas instruments and aluminium tray are intended to be used in a healthcare environment by appropriate healthcare professionals, who are familiar with and have experience of the devices and techniques used.

LIMITATIONS ON PROCESSING
Infinitas Instruments and aluminium tray are however suitable for reprocessing with no limits on the number of reprocessing cycles. Repeated processing according to these instructions has minimal effect upon these reusable devices. When the maintenance instructions below are followed, the end of life for instruments is determined by wear and tear/damage and loss of functionality  It is important that users inspect the devices as instructed below before each patient use to verify that they are fit for purpose.

INITIAL TREATMENT AT POINT OF USE
Do not allow blood and/or bodily fluids to dry on the instruments or aluminium tray; remove with a disposable cloth/paper wipe. It is recommended that the instruments and aluminium tray are processed through a validated washer disinfector immediately after patient use. Handle contaminated devices with protective gloves.

CONTAINMENT & TRANSPORTATION
The used instruments and aluminium tray must be transported to the decontamination area for reprocessing in closed or covered containers to prevent unnecessary contamination risk. Where transport outside of the healthcare facility is required, containers meeting the requirements of UN3291 should be used.

PREPARATION BEFORE CLEANING
Select a pH-neutral detergent (prepare all cleaning solutions at the concentration and temperature recommended by the detergent manufacturer). At least potable water should be used to prepare cleaning solutions. The Standard Handle (DB10-0020); should be\ disconnected from the inserts (DB10-0021, DB10-0022, DB10-0023) prior to processing. Remove any gross soil with a steady stream of lukewarm water (below 45°C), using a soft brush if necessary. Special attention should be taken when washing part numbers DB10-0022, DB10-0023, DB10-0027 and DB10-0028; as these parts come into contact with bone and tissue. The devices are suitable for use in an ultrasonic cleaner; in the case of devices with heavy or difficult to remove soiling such as bone debris. Water temperature should not exceed 45°C and a pH-neutral detergent may be used at the concentration recommended by the manufacturer, including any necessary rinsing stages. A maximum frequency of 50kHz is recommended. Rinse each instrument thoroughly, do not use saline or chlorinated solutions. Give special attention to any joints, slots, holes and grooves.

AUTOMATED CLEANING & DISINFECTION

• Equipment: Validated Washer Disinfector meeting the requirements of EN ISO 15883 parts 1 & 2; with a pH neutral detergent.
• Lay the instruments flat in a suitable basket with sufficient space from each other so that all surfaces can easily be contacted by the detergent and rinse water and drain sufficiently.
• Wash the aluminium tray separately in another suitable basket and do not stack them – ensure there is sufficient space for contact with the detergent and water and to drain sufficiently.
• The baskets must be placed in the washer-disinfector in such a way as to prevent mechanical damage e.g., washer disinfector Spray arms should be free so as to avoid touching the instruments and aluminium tray.
• Select an appropriate cleaning cycle according to the following parameters:
• An initial cleaning cycle below 45°C is recommended for optimal protein removal.
• A main wash cycle using a pH-neutral detergent at the manufacturer-recommended concentration and temperature, followed by a rinse cycle.
• The final rinse cycle should be sufficient for thermal disinfection to AO ≥ 600, e.g. 90°C for 1 minute or 80°C for 10 minutes. Final rinse water should be performed using purified water or to the requirements of national regulations.
• A drying cycle sufficient to remove all visible signs of water, ≤ 100°C.
• Instruments and aluminium tray should be completely dry prior to removing them from the washer disinfector.
• When removing the instruments and aluminium tray from the washer-disinfector, carefully inspect the devices for visual check for cleanliness, damage or corrosion. Repeat the cycle if any soil remains.

MAINTENANCE & INSPECTION

Before preparing instruments and the aluminium tray for reprocessing all instruments and the aluminium tray should be inspected. Visual inspection under good lighting of all parts of the instruments and aluminium tray should be performed to check for visible soiling, damage, corrosion and wear.
Particular attention should be paid to:

• Recessed features such as joints, slots, holes and grooves where soiling could accumulate.
• Cutting surfaces that can sustain damage or bluntness.
• Discard any instruments that are damaged or worn. The aluminium tray should be inspected to ensure all components fit in the box. Instruments and aluminium tray must be completely dry prior to pouching or wrapping to avoid surface discolouration/ corrosion damage and to avoid compromising the sterilization process.
• Cutting instruments that are frequently used should be reconditioned every six (6) to nine (9) months. If articulated joints do not move smoothly, lubricate prior to sterilization with a medical-grade lubricant. The lubricant must be biocompatible and suitable for steam sterilization.

PACKAGING
Instruments and the aluminium tray are to be packed following local protocol in accordance with relevant standards or the decontamination manual process. Packaging should ensure the sterility of instruments and aluminium trays until opened for use at the sterile field and permit removal of contents without contamination. Place instruments and the aluminium tray into suitable, validated packaging which has been validated for steam sterilization (temperature resistant up to 141°C/286° F). i.e., AISI AAMI, ISO 11607 compliant, medical grade single-use wraps or pouches before loading into a perforated general instrument autoclave tray. The aluminium tray is intended to hold all the required instruments together during the sterilization process.
Note: If the aluminium tray is not used; the instruments should be packaged individually or into a suitable all-purpose sterilization basket. Do not exceed the sterilizer’s maximum load when sterilising multiple instruments in the autoclave. Only validated loading patterns.

STERILIZATION

• Use only the sterilization procedure below. Other sterilization procedures have not been validated for their ability to achieve sterility or to prevent damage to the instruments or aluminium tray and are solely the responsibility of the user.
• Use a suitably approved autoclave (e.g., CE marked for medical device sterilization).
• The autoclave must be validated in accordance with ISO 17665-1, CFPP 01-01, Health & Technical Memoranda or other equivalent National / local regulations and guidelines.
• Do not use the flash sterilization procedure.
• Infinitas instruments and the aluminium tray must be placed in suitable, validated packaging (refer to the ‘Packaging’ section above).
• Use one of the following sterilization exposure times at the sterilization temperature:

Fractioned Vacuum Autoclave
Temperature: 121°C, Exposure time: 15 minutes, 132°C, Exposure time: 4 minutes, OR Temperature: 134°C, Minimum exposure
Time: 3 minutes. Cool down time/dry time: 20 minutes.
Note: Take care not to exceed the maximum temperatures specified by the packaging manufacturer.
Note : The final responsibility for the validation of sterilization techniques and equipment lies directly with the healthcare facility. To ensure optimal processing, all cycles and methods should be validated for different sterilization chambers, wrapping methods and/or various load configurations.

STORAGE
The shelf life is dependent on the storage, environmental and handling conditions. A maximum shelf life for sterilized medical devices should be defined by the healthcare facility. Store Infinitas instruments or aluminium trays after sterilization in a dry and dust-free place. Sterility can only be maintained if the devices remain sealed or wrapped in their undamaged packaging.

LIMITATION OF LIABILITY

Except where prohibited by law, DB Orthodontics will not be liable for any loss or damages arising from this product, whether direct, indirect, special, incidental or consequential, regardless of the theory asserted, including warranty, contract, negligence or strict liability. This limitation does not apply to third-party personal injury claims.

RETURNING INSTRUMENTS TO US
Products returned to us after use must have a decontamination certificate that testifies that each instrument and/or aluminium tray has been thoroughly cleaned and disinfected. Failure to supply evidence of cleaning and disinfection will result in a delay in your enquiry being processed.

REFERENCES
BS EN ISO 17664 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices HTM 01-01 Management & decontamination of surgical instruments (medical devices) used in acute care BS EN ISO 15883 Parts 1 & 2: Washer disinfectors EN ISO 17665 part 1 Sterilization of health care products – moist heat

SERIOUS INCIDENTS
Any serious incident that has occurred in relation to the device should be reported to the Manufacturer and the Competent Authority of the Member State in which the user and/or patient is established.
The instructions provided above have been validated by DB Orthodontics for the reusable Infinitas Instruments and reusable aluminium trays for their use and reprocessing. It remains the responsibility of the processor to ensure that processing, as actually performed using equipment, materials and personnel in the processing facility, achieves the desired result. This requires verification and/or validation and routine monitoring of the processes as well as suitable maintenance and validation of the equipment used.

References

• DB Orthodontics - Orthodontic Supplies – DB Orthodontics Limited

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