EMS FB-358 Dental Reprocessing Instruction Manual

: June 13, 2024
: EMS

Table of Contents

EMS FB-358 Dental Reprocessing
RELATED ACCESSORIES
BEFORE USE
CLEANING AND DISINFECTION FOR DEVICES AND HANDPIECE CORDS
INTRODUCTION
PREPARE
AUTOMATIC CLEAN AND DRY WITH WASHER
MANUAL CLEAN WITHOUT ULTRASOUND BATH + 03 DRY
INSPECT
STERILIZE
ONLY USE ORIGINAL EMS PRODUCTS
ONLY USE EMS POWDERS
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

EMS FB-358 Dental Reprocessing

EMS-FB-358-Dental-Reprocessing-product

BEFORE USE

Please read these Operating Instructions carefully as they explain all the most important details and procedures. Please pay special attention to the safety precautions. Always keep these Instructions close at hand.

These Instructions are only applicable to the equipment they were delivered with.
To prevent injury to persons or damage to property, please observe the corresponding directives and symbols.
Translations in this manual are based on the English version. Thus the English text will be referred to in case of discrepancy.

CLEANING AND DISINFECTION FOR DEVICES AND HANDPIECE CORDS

The following instructions have been validated for all reusable products1 of EMS dental devices. It remains the responsibility of the processor to ensure that the processing, as actually performed using the equipment, materials and personnel in the processing facility, achieves the desired result. This requires validation and/or 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 effects.

CLEAN AND DISINFECT
Use a cleaning and disinfecting wipe (less than 35% alcohol) compatible EPA-registered intermediate-level surface disinfectant or that complies with the standards applicable in the country (e.g. MICRO-KLEEN or Opti-Cide³ wipes).

Follow carefully the instructions provided by the disinfection solution manufacturer.
DO NOT use CaviWipes™ or Advantaclear wipes. It damages EMS products.

INTRODUCTION

EMS recommends compliance with cleaning, packaging for sterilization, and sterilization procedures according to ISO 17664.
Always report adverse events related to device reprocessing directly to EMS.
Products must be cleaned and, if applicable, sterilized prior to first use. Do not reprocess the products over the authorized number of sterilization cycles. To replace, refer to the “Service life” section of these Instructions.
Concentrations and contact times specified by the manufacturer of the cleaning agent must be observed.
Remember that sterilization mustn’t be achieved unless assembly components are cleaned first.
If parts of these instructions are not clear or seem to be inadequate, do not hesitate to contact/inform EMS.
Users shall also observe any legal requirements applicable in their country as well as the hygiene regulations in effect at the hospital or clinic.
This applies especially with regard to additional requirements for the inactivation of prions.

SERVICE LIFE

The products have been designed for a large number of sterilization cycles. The materials used in their manufacture were selected accordingly. However, with every renewed preparation for use, thermal and chemical stresses will result in aging of the products.
Always replace products that present signs of wear or early degradation regardless of the number of sterilization cycles left unused.
DO NOT expose the products to temperatures exceeding 280°F (138°C).
EMS handpieces must not be lubricated or otherwise exposed to oil whether directly or indirectly.
Lifetime: see product’s Instructions for Use.

SYMBOLS

Caution/Danger – Risk of property damage or injury
Please note – Useful additional information and hints
Prohibited
Refer to instruction manual
Sterilizable at up to 135°C in the autoclave
Suitable for thermal disinfection
Required time – Abbreviations used: min (minute); s (second)

PREPARE

At the point of use: Immediately after patient treatment, rinse the lumen(s) line of the handpiece/instrument with water2. Coarse soiling must be removed by wiping the products. Special attention need to be paid to cracks, crevices and hard to reach areas. Place the products on an appropriate rack to transport them to the reprocessing area to avoid any product damage and contamination to the environment and people involved in the reprocessing process.

Always carry out AIRFLOW® and PERIOFLOW® Handpiece powder unclogging and check for both lumens (water and powder) clearance before proceeding. Use Easy Clean3.

Products have to be disassembled as shown below:

PIEZON® Endochuck:
- Remove any installed file.
- Remove the screw and separate the small O-ring.
PIEZON® Handpieces:
- Remove any installed instrument.
- Remove the nose cap and separate the light guide and O-ring.
PIEZON® Instruments with CombiTorque®:
Separate the PIEZON® Instrument and the CombiTorque® but keep each original instrument and CombiTorque® together throughout their life.
Cleaning is to be performed within 1 hour from use.
Wear personal protective equipment according to the type of preparation.
Any product must be cleaned manually or automatically by the washer. Follow the dedicated cleaning section according to your dental equipment.
EMS handpieces must not be lubricated or otherwise exposed to oil whether directly or indirectly.

AUTOMATIC CLEAN AND DRY WITH WASHER

Correctly place the product into a suitable rack, connect all lumens to the rinsing connectors, and start the automated cleaning. Instructions of the manufacturer of the washer must also be observed. Carefully follow the instructions provided by the solution manufacturer.

The following automated process4 can be used: 2 min

Pre-clean with cold tap water 5.
Drain 5 min
Clean at 55°C with tap water and 0.5% of neither MediClean Dental (Dr Weigert) solution.
Drain 3 min
Rinse and neutralize with cold demineralized water6.
Drain 2 min
Rinse with cold demineralized water 7.
Drain

MANUAL CLEAN WITHOUT ULTRASOUND BATH + 03 DRY

The 2 following validated processes can be used:

Validated products	EMS products to clean	Process

Enzymax

|

EMS

Handpieces

| • For a minimum of 3 minutes, fully immerse EMS Handpieces and allow them to soak in the Enzymax cleaning solution7. While immersed, ensure that all lumens are filled with the cleaning solution. Use a syringe, if needed. All surfaces must be moistened.

• Clean EMS Handpiece using a soft bristled brush until all visible soiling is removed.

• Rinse the whole part under running RO/DI8 water for 10 seconds.

• Repeat the cleaning process if the last rinse does not run clear, or if stains are still visible on the products.

• Fully dry all products at room temperature using a clean lint free cloth.

Enzol® 2%

| • For a minimum of 5 minutes, fully immerse EMS Handpieces and allow them to soak in the Enzol® cleaning solution7. While immersed, ensure that all lumens are filled with the cleaning solution. Use a syringe, if needed. All surfaces must be moistened.

• Clean EMS Handpieces using a soft bristled brush until all visible soiling is removed.

• Flush through all lumina with the cleaning solution at least 5 times in the flow direction (do not back rinse) using a minimum of 50 mL applied to the nozzles of EMS Handpieces.

• Fully submerge EMS Handpieces after cleaning in RO/DI8 water.

• Flush through all lumina with the RO/DI8 water at least 3 times in the flow direction (do not back rinse) using a minimum of 50 mL applied to the nozzles of the products.

• Repeat the cleaning process if the last rinse does not run clear, or if stains are still visible on the products.

• Fully dry all products at room temperature using a clean lint free cloth.

MANUAL CLEAN WITH ULTRASOUND BATH + 03 DRY
DO NOT use any ultrasound bath cleaning procedure with the handpieces: it may destroy the products.

The 2 following validated processes can be used:

Validated products	EMS products to clean	Process

Enzymax

|

EMS PIEZON®

Instruments and file holders

| • For a minimum of 3 minutes, fully immerse EMS products and allow them to soak in the Enzymax cleaning solution7. While immersed, ensure that all lumens are filled with the cleaning solution. Use a syringe, if needed. All surfaces must be moistened.

• Clean EMS products using a soft bristled brush until all visible soiling is removed.

• Prepare a new bath of Enzymax cleaning solution following the manufacturer’s recommendation7 in a ultrasonic unit.

• Sonicate for a minimum of 5 minutes.

• If visible soil remains, brush the products with a soft-bristled brush using the cleaning solution.

• Rinse the whole product under running RO/DI8 water for at least 10 seconds.

• Repeat the cleaning process if the last rinse does not run clear, or if stains are still visible on the products.

• Fully dry all products at room temperature using a clean lint-free cloth.

Enzol® 2%

| • For a minimum of 5 minutes, fully immerse all products and allow to soak in the Enzol® cleaning solution7. While immersed, ensure that all lumens are filled with the cleaning solution. Use a syringe, if needed. All surfaces must be moistened.

• Clean the products using a soft-bristled brush until all visible soiling is removed.

• Prepare an Enzol® fresh solution following the manufacturer’s recommendation in an ultrasonic unit.

• Sonicate for a minimum of 3 minutes.

• If visible soil remains, brush the products with a soft-bristled brush using the cleaning solution.

• Fully submerge the products after cleaning in RO/DI8 water.

• Flush all product lumens using a sterile syringe.

• Repeat the cleaning process if the last rinse does not run clear, or if stains are still visible on the products.

• Fully dry all products at room temperature using a clean lint-free cloth.

For example Miele Professional G 7836 CD with Miele Rack E429
cold tap water = 16°C +/- 2°C
cold demineralized water = 20°C +/- 2°C
Follow the manufacturer’s recommendation (Enzymax: 1 oz/gallon of lukewarm tap water; Enzol® 2%)
RO: Reverse Osmosis/DI: De-ionized water

INSPECT

If stains are still visible on the product after cleaning, the entire cleaning procedure must be repeated. Products with visible damage, chip/flake loss, corrosion or deformation must be disposed of (no further use is allowed). Check also the integrity of O-rings and gaskets and replace them if damaged or deformed.
Verify the product to be fully dry. In case of detection of residues of water, remove these using an air pistol (clean compressed air). Fully dry the lumen and the whole product until no more residues of water are present (visible or detectable).

PACK

Only previously cleaned products must be sterilized.
Effective sterilization must take place only on fully dry products. Ensure each part (internal lumens and any surface) is perfectly dry before reassembling and packing.
Prior to sterilization, the products need to be reassembled for ready use and placed in suitable sterilization packaging. The pouch must be sealed according to the manufacturer’s instructions.
PIEZON® Handpieces:
- This product must be sterilized disassembled or reassembled.
- If you prefer to reassemble it: reinstall the O-ring first, then put the light guide into the nose cap and screw it on the handpiece.
PIEZON® Endochuck:
Reinstall the small O-ring (gasket) first, and then gently screw the retention bolt without tightening.
PIEZON® Instruments with CombiTorque®:
Reinstall the original instrument with its CombiTorque®.

Any EMS product must be correctly packaged using an FDA-cleared sterilization pouch that has been validated for the specified sterilization cycle.

STERILIZE

Sterilization must be performed immediately after cleaning.
DO NOT exceed a sterilization temperature of 280°F (138°C) and a holding time of 20 min.
DO NOT use hot-air sterilization and radio sterilization procedures: they destroy the products.
EMS recommends not to use class N sterilizers to reprocess PIEZON® handpieces unless they include at least 20 minutes of drying cycle. The PIEZON® Handpiece lifetime can be reduced.
Moist heat sterilization of products shall be performed according to ISO 17665 and in compliance with respective country requirements.
EMS recommends the use of biological indicators and chemical indicators that have been validated for use in a 270°F (132°C) pre-vacuum steam sterilization cycle.

The vacuum moist heat (steam) process can be used with any EMS product packaged in appropriate pouches:

Parameters for the pre-vacuum moist heat cycle:

3 pre vacuum phases
The pressure of 3 bar9
Humidity of 100%
Minimum temperature of 270°F (132°C)
4 min (minimum) Hold time (full cycle)
20 min (minimum) Dry

Users must ensure that the reprocessing processes, including resources, materials and personnel, are capable to reach the required results and maintained over time: it is the user’s responsibility to ensure that validation of the reprocessing procedures is kept up to date at all times.

STORE
Store the sterilized products at a temperature up to 104°F (40°C) in a:

dry,
clean
and dust-free environment.

FROM THE VALLEY

For more than 35 years EMS has developed high-end technologies and protocols in conjunction with the world‘s most advanced clinicians, enabling the patients to enjoy natural teeth and implants for much longer.
„Primum non nocere“ and minimal invasiveness are not only a must, they are our way of life.

EMS RESEARCH AND MANUFACTURE CENTER NYON, SWITZERLAND.

ONLY USE ORIGINAL EMS PRODUCTS

EMS powders are much less abrasive than traditional mechanical debridement techniques such as rubber cups and handscaling.
We recommend using AIRFLOW® and PERIOFLOW® first, followed by PIEZON®. GBT: the minimally invasive way for Professional Mechanical Plaque Removal (PMPR).
As part of the GBT disclosing phase, coloration also minimizes AIRFLOW® abrasion. No more color signifies that all biofilm has been removed: the objective of AIRFLOW® is achieved, to preserve the integrity of dental tissues.
- EMS devices have been designed and tested for exclusive use with EMS prophylaxis powders.

ONLY USE EMS POWDERS

So-called “EMS-compatible” powders in the marketplace may cause damage to oral tissues and the device.
See below a damaged Airflow nozzle after use with a “compatible” powder. If EMS products are damaged by using “compatible” powders the product Warranty will be lost.

ONLY USE THE SWISS ORIGINAL EMS INSTRUMENTS!

The EMS Instrument, the Handpiece, and the NO PAIN electronic module have to vibrate in harmony like in a trilogy.
Using so-called “compatible” and copy tips from third parties can damage your patients’ teeth as well as EMS handpieces.
They were developed and made for each other by EMS.
One PS Instrument is designed for up to 500 treatments, thus reducing the cost of one treatment to only a few cents.
Therefore, there is absolutely no reason to “save” money by using so-called “compatible” tips. Moreover, if the Piezon Handpiece gets damaged (the thread) it will lose its warranty so at the end of the day, “compatible” tips will always cost you more.

Contact Information

HEADQUARTERS

NYON, SWITZERLAND ELECTRO MEDICAL SYSTEMS SA Chemin de la Vuarpillière 31 CH – 1260 Nyon
www.ems-dental.com/en/contact
www.ems-dental.com
T. +41 22 994 47 00
F. +41 22 994 47 01

WORLDWIDE EMS AFFILIATES

MUNICH, GERMANY

EMS ELECTRO MEDICAL SYSTEMS GMBH Stahlgruberring 12 DE – 81829 München
T. +49 89 42 71 61 0
F. +49 89 42 71 61 60
E-mail: [email protected].

FONCINE, FRANCE

EMS ELECTRO MEDICAL SYSTEMS FRANCE SARL 32, route de Pontarlier
FR – 39460 Foncine-le-Haut
T. +33 3 84 51 90 01
F. +33 3 84 51 94 00
E-mail: [email protected].

CAMBRIDGESHIRE, UNITED KINGDOM

EMS UK LTD SUITE 2 Xenus House – Sandpiper Court Phoenix Park – Eaton Socon UK – St Neots, Cambridgeshire PE19 8EP
T. +44 01480 587260
Email: [email protected].

SHANGHAÏ, CHINA

E.M.S. ELECTRO MEDICAL SYSTEMS TRADING (SHANGHAI) CO., LTD. 24A, Jin Sui Mansion, N°379 Pudong Nan Rd. CN – Shanghai 200120
T. +86 21 3363 2323
E-mail: [email protected].

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