db orthodontics DB04-0160 Intraoral Photographic Mirrors Instruction Manual

db orthodontics DB04-0160 Intraoral Photographic Mirrors Instruction

Manual

Product Information

• Product Name: Photography Focus – Intraoral Photographic Mirrors
• Manufacturer: DB Orthodontics Ltd
• Model Numbers: DB04-0160, DB04-0161, DB04-0161C, DB04-0162, DB04-0163, DB04-0164

Product Description

The Intraoral Photographic Mirrors are medical devices with a chrome-plated surface that provides a sharp and clear image reflection. These mirrors minimize artifacts and double reflections, ensuring high-quality image capture.

Intended Use and Indications

The mirrors are intended for intraoral photography to capture detailed images of the oral cavity for diagnostic and documentation purposes.

Operating Conditions

Proper maintenance, care, and regular functional checks are essential for safe operation. The manufacturer disclaims liability for damages resulting from improper use or handling.

Reprocessing and Sterilization

The mirrors are shipped non-sterile and must be processed and sterilized before each use. Follow the recommended manual disinfection or automated cleaning processes for proper sterilization.

Product Usage Instructions

Sterilization Process

Follow the fractionated pre-vacuum sterilization process according to EN ISO 17665-1. Use suitable sterilization packaging and store in a clean area post- sterilization.

Preparation Before Use

Prior to use, prevent fogging by running the mirror under hot water briefly. Wipe off any droplets with a soft towel or sterile gauze.

Usage

Manually insert the mirror into the patient’s mouth as needed for capturing images. Position the mirror accordingly for maxillary or mandibular pictures.

Disposal

After use, dispose of the mirror in appropriate containers. Do not dispose of it in the environment.

Specifications

• Chrome-plated surface for clear image reflection
• No artifacts or double reflections
• Models: DB04-0160, DB04-0161, DB04-0161C, DB04-0162, DB04-0163, DB04-0164

Important Instructions

Read these instructions for use carefully before each use and keep them easily accessible for the users or the relevant specialists. Please refer to the specific information on intended purpose, indication and contraindication.Carefully read these instructions for use. Improper use of the products may result in serious injury to the patient, the user or third parties *Notice to user that 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.

Product Description

The medical device Intraoral Photographic Mirrors are mirrors with chrome- plated surface. This feature allows a very sharp and clear image mirroring. No artifacts, double reflections are visible into both the mirrored image and the camera picture.

Intended Use and Indications

Intraoral Photographic Mirrors are intended to be used for dental diagnosis and diseases prevention. Should be used only by properly trained and qualified medical staff. The product is intended exclusively for the medical field described above and must therefore be used in a suitable medical environment. It is mandatory that the user and the relevant specialist staff become familiar with the product and this instruction for use before use it. Intraoral Photographic Mirrors are indicated to grab pictures of mouth anatomical site when is not possible or not easy to reach the target of the picture. It can be used on both adult patients and child patients according the chosen size or part number. The device is supplied not sterile and in a not sterile plastic bag. The device must be cleaned and sterilized before use according this instruction for use. Sterilization and Reprocessing of the device is validated according EN ISO 17644 International Standard.

Operating Conditions

To ensure safe operation of the aforementioned product, proper maintenance and care of the products are essential. In addition, a functional or visual check should be carried out before each application. The manufacturer assumes no liability for any consequential damage caused by improper use or handling of the product.

Instruction for use for Reprocessing and Sterilization

The medical device is shipped in non-sterile condition and must be processed and sterilized by the user in accordance with the instructions below before the first as well as before any further application.

Inspection and Preparation

Before use check the surface and edges for non uniformities and sharpness. Do not use the device if either the surface or the edges are damaged or sharp, they can injure the patient and/or operator. If your inspection of the new instrument confirms it is in perfect condition proceed with the cleaning and sterilization as provided in this document. Follow instructions and warnings as issued by manufacturers of any decontaminants, disinfectants and cleaning agents used. Wherever possible avoid the use of abrasive agents. Follow hospital/facility approved Health & Safety procedures at all times. Wear protective clothes, gloves and eye wear as specified in your Health and Safety procedures.

Manual Cleaning

Manual cleaning is not recommended when an automated washer-disinfector is available. For a proper cleaning, it is suggested to dip the medical device in neutral enzymatic cleaning 0.5% solution for 5 minutes (GIOPLURIZIM 0.5%), then remove from the bath and carefully brushed with a soft sponge to remove all the visible dirt or residuals. Rinse under a volume of cold running tap water (10-15°C) corresponding to about 20 liters for 2 minutes, moving them slightly to allow water to reach the entire surface, to remove any detergent residues.

Manual Disinfection

Manual Disinfection is not recommended when an automated washer-disinfector is available. For a proper disinfection, it is suggested to brush with an absorbent cloth soaked with alcohol-based solution for 1 minutes (GIOALCOL), then dry with an absorbent cloth that leaves no residues.

Automated cleaning and disinfection

We recommend using a washer-disinfector meeting the requirements of ISO 15883 series. Automated cleaning and disinfection instructions: washing in cold water with the enzymatic detergent (GIODETER MATIC E)
thermal disinfection at 93°C +/-2 °C for 10 minutes; neutralization in cold water with the use of an acid liquid neutralizer (ACIDGLASS P2) for 2 minutes; rinse with demineralized water for 2 minutes;
rinse with hot demineralized water (75°C) for 1 minute;

At the end of the cycle, dry with an absorbent cloth that leaves no residues. The specific instructions by the manufacturer of the automatic cleaning/disinfection machine must be observed. After the cycle is finished, the instruments need to be inspected as per Inspection/Function Testing as follows: check the surface and edges for nonuniformities and sharpness. Do not use the device if either the surface or the edges are damaged or sharp, they can injure the patient and/or operator.

Instructions for Use for Photography Focus – Intraoral Photographic

Mirrors – Issue 2 – 21/07/2023

Sterilization

Sterilization of the products using the fractionated pre-vacuum process (according to EN ISO 17665-1), taking into account the respective national requirements. The products must be sterilized in suitable sterilization packaging. The sterilization is to be carried out using a fractionated pre- vacuum method with the following parameters:  temperature: 134°C ± 3°C time: 10 minutes pressure: 2 bar ± 1 bar

Storage

Following sterilization processing, packaged instruments may be stored in a clean area free of temperature and humidity extremes by your facility’s policies.

Additional Information

Other forms of cleaning and sterilization are available, but always follow the instructions for use as issued by the processing equipment manufacturer and always consult with them if in any doubt over the suitability of any process used. Any deviation by the processor from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences. All cleaning and sterilization processes require validation at the point of use. The instructions provided above have been validated as being capable of preparing a medical device for re-use. It remains the responsibility of the processor to ensure that the processing as actually performed, using equipment, materials and personnel in the processing facility, achieve the desired result. This requires validation and routine monitoring of the process. Likewise, any deviation by the processor from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences.

Product life

If stored in the original packaging, the medical device is valid for 5 years from the date of manufacture. The service life of the products essentially depends on the careful handling during application and processing of the products by the user. However, the product is validated for 25 cycles of sterilization but can be used until the user does not recognize any evidence of damages or any other alteration of the product (ex. Removal of the chrome layer). In this case reject the product and change it with a new one.

How to use it

Just before use, in order to prevent fogging, run the mirror under hot water for a few seconds. Use a soft towel or sterile gauze to remove droplets. The device is inserted manually into the patient’s mouth, in positions that may vary depending on the investigation area or depending on the area you want to photograph. Carefully introduce the device into the patient’s mouth as shown below.

Disposal methods

After use, throw the device in the appropriate containers if it is no longer used. Do not disperse in the environment.

FAQ

Q: Can the mirrors be reused after sterilization?

A: Yes, the mirrors can be reused after proper sterilization following the recommended procedures.

Q: How should I store the mirrors post-sterilization?

A: Store the mirrors in a clean area free of extreme temperature and humidity as per your facility’s policies.

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