EMS DENTAL Reprocessing Instructions

RELATED ACCESSORIES EASY CLEAN FV-083

AIRFLOW® HANDPIECES EL-185# - EL-308# - EL-540# - EL-545#

PERIOFLOW® HANDPIECES EL-354# - EL-542#

CLIP+CLEAN EL-655

PIEZON® HANDPIECES EN-041# - EN-046# - EN-060# - EN-061#

FLAT WRENCH

HOLDER

DT-018

DS-010A

Including nose cap and light guide

ALL EMS INSTRUMENTS

PI MAX Instrument Tool FV-117

COMBITORQUE® FV-060 - FV-097

SUMMARY EN

ENGLISH ------------------------------------ p.4

LT

LIETUVIŠKAI ----------------------------- p.64

BG

БЪЛГАРСКИ ----------------------------- p.8

LV LATVIEŠU ---------------------------------- p.68

CS

ČESKÝ --------------------------------------- p.12

MS BAHASA MELAYU --------------------- p.72

DA

DANSK --------------------------------------- p.16

NL NEDERLANDS --------------------------- p.76

DE

DEUTSCH ---------------------------------- p.20

NO NORSK --------------------------------------- p.80

EL

ΕΛΛΗΝΙΚΆ --------------------------------- p.24

PL POLSKI -------------------------------------- p.84

ES

ESPAÑOL ----------------------------------- p.28

PT PORTUGUÊS ------------------------------ p.88

ET

EESTI KEEL -------------------------------- p.32

RO ROMÂNĂ ----------------------------------- p.92

FI

SUOMI --------------------------------------- p.36

RU РУССКИЙ ---------------------------------- p.96

FR

FRANÇAIS --------------------------------- p.40

SK SLOVENSKY ------------------------------ p.100

HR

HRVATSKI ---------------------------------- p.44

SL SLOVENŠČINA -------------------------- p.104

HU

MAGYAR ------------------------------------ p.48

SV SVENSKA ---------------------------------- p.108

ID

INDONESIA -------------------------------- p.52

TH ไทย ----------------------------------------------------------------- p.112

IT

ITALIANO ----------------------------------- p.56

TR TÜRKÇE ------------------------------------- p.116

KO

한국어 ----------------------------------------- p.60

VI

TIẾNG VIỆT -------------------------------- p.120

BEFORE USE Please read these Operating Instructions carefully as they To prevent injury to persons or damage to property, please explain all the most important details and procedures. Please observe the corresponding directives and symbols. pay special attention to the safety precautions. This instruction follows the recommendations of RKI Robert Always keep these Instructions close at hand. Koch Institut, Germany. These Instructions are only applicable to the equipment Translations in this manual are based on the English version. they were delivered with. 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) that complies with the standards applicable in the country. EMS recommends the use of either - CleanWipes, IC-100 or PlastiSept Eco Wipes from ALPRO MEDICAL GmbH AIRFLOW® and PIEZON® devices

Handy

PIEZON Kit on your unit ®

- Micro-Kleen3™ Surface Disinfectant Wipes from MicroScientific Follow carefully the instructions provided by the wipes manufacturer. DO NOT use CaviWipes™ or Advantaclear wipes. They damage EMS products.

INTRODUCTION EMS recommends compliance with cleaning, disinfection, Concentrations and contact times specified by the packaging for sterilization and sterilization procedures manufacturer of the cleaning and disinfection agent must be according to ISO 17664. observed. Always report adverse events related to device Remember that sterilization mustn't be achieved unless reprocessing directly to EMS. assembly components are cleaned and disinfected first. Products must be cleaned, disinfected and, if applicable, sterilized prior to first use. Do not reprocess the products over If parts of these instructions are not clear or seem to be the authorized number of sterilization cycles. To replace, refer inadequate, do not hesitate to contact/inform EMS. to the “Service life” section of these Instructions. 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 DO NOT expose the products to temperature exceeding sterilization cycles. The materials used in their manufacture 138°C. were selected accordingly. However, with every renewed EMS handpieces must not be lubricated or otherwise preparation for use, thermal and chemical stresses will result exposed to oil whether directly or indirectly. in ageing of the products. Always replace products that present signs of wear or early degradation, regardless of the number of sterilization Lifetime : see product's Instructions for Use. cycles left unused.

SYMBOLS Caution / Danger - Risk of property damage or injury

Refer to instruction manual

Please note - Useful additional information and hints

Sterilizable at up to 135°C in the autoclave

Prohibited

Suitable for thermal disinfection Required time - Abbreviations used: min (minute) ; s (second)

Wear personal protective equipment

4

1 Hereinafter referred to as "products".

EN BG

PROCESS FOR RELATED PRODUCTS MENTIONED ON PAGE 3 02 CLEAN 03 DISINFECT

04 DRY

05 INSPECT

06 PACK

07 STERILIZE

CS

01 PREPARE

08 STORE

DA DE EL ES

01 PREPARE

ET

At the point of use: Immediately after patient treatment, rinse the channel(s) of the handpiece/instrument with cold tap water. Coarse soiling must be removed by wiping the products. Special attention need to be paid to cracks, crevices and hard to reach areas.

FI FR

Place the products on an appropriate rack to transport them to the reprocessing area to avoid any product damage, contamination to the environment and people involved in the reprocessing process.

HR

Always carry out AIRFLOW® and PERIOFLOW® Handpiece powder unclogging and check for both channels (water and powder) clearance before proceeding. Use Easy Clean2.

HU ID

or

IT

Products have to be disassembled as shown below:

KO LT

Remove any installed instrument. Remove the nose cap and separate the light guide and O-ring.

MS

Remove any installed file. Remove the screw and separate the small O-ring.

PIEZON® Handpieces:

LV

PIEZON® Endochuck:

NL NO

PIEZON® Instruments with CombiTorque®:

PL

Separate the PIEZON® Instrument and the CombiTorque® but keep each original instrument and CombiTorque® together throughout their life.

PT RO

Cleaning is to be performed within 1 hour from use. Wear personal protective equipment according to the type of preparation.

RU SK

Any product must be cleaned manually or automatically by washer or disinfector. Follow the dedicated cleaning part according to your dental equipments.

SL

EMS recommends the use of an ISO 15883 compliant automatic washer-disinfector (WD) for optimal effectiveness and service life. EMS handpieces must not be lubricated or otherwise exposed to oil whether directly or indirectly.

SV TH TR VI

2 An air water syringe can be used with Easy Clean

5

EITHER

02 03 04 AUTOMATIC CLEAN, DISINFECT AND DRY WITH WASHER DISINFECTOR The washer-disinfector must comply with ISO 15883, must have suitable baskets to hold small products and must have rinsing connections with diameter of approximately 16mm for the attachment to product lumen. 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 disinfector must also be observed. Carefully follow the instructions provided by the disinfection solution manufacturer. The following automated process3 can be used to achieve an A0 Level of 3000: Pre-clean with cold tap water4. Drain Clean at 55°C with tap water and 0.5% neodisher MediClean Dental (Dr Weigert) solution. 5 min Drain Rinse and neutralize with cold demineralized water5. 3 min Drain Rinse with cold demineralized water5. 2 min Drain Perform thermal disinfection (final rinse) with deionized water at 93°C minimum. 3 min Drain 20 min (at least) Dry at 100°C. 2 min

OR

02 MANUAL CLEAN +

03 DISINFECTION +

04 DRY

The following validated EMS process can be used with and without ultrasound. DO NOT use any ultrasound bath cleaning procedure with the handpieces: it may destroy the products. It is ONLY intended to be used with EMS PIEZON® Instruments and file holders. In case of ultrasound bath cleaning, place products in a metal sieve and sonicate 10 minutes. Validated product

Process

EMS products to clean/ disinfect

Process Brush the devices in a cleaning solution of 0.5% neodisher in deionized water at 40°C with a suitable soft bristled brush until all visible residue has been removed.

0.5% without neodisher ultrasound MediClean bath (Dr. Weigert)

all EMS products

0.5% with neodisher ultrasound MediClean bath6 (Dr. Weigert)

EMS PIEZON® Instruments and file holders

15 s

For products with lumens, flush all lumens with a spray gun (water jet gun, with a static water pressure of 2 bar) with cold tap water.

Place the product in 0.5% solution of neodisher with deionized water at 15 min (10 min with 40°C. Make certain that all lumens are filled with cleaning solution (use ultrasound) a syringe if needed). Rinse all lumens by flushing with a spray gun (water jet gun, with a static 15 s water pressure of 2 bar) with cold deionized water5. Rinse the whole product under cold running deionized water. 10 s At room temperature (15-25°C), use an air pistol (compressed air, max. 3 bars) to fully dry the lumen and the whole product until no more residues of water are present (visible or detectable).

Then disinfect: ASP CIDEX® OPA solution must be used undiluted, within its useful and shelf life, and in compliance with the manufacturer’s warnings and instructions for use.

5 min

Immerse the product completely into CIDEX® OPA solution at minimum 20°C. Make certain that all lumens are filled with disinfectant solution (use a syringe if needed).

The ASP CIDEX® OPA disinfectant requires a total of three rinses : keep the product totally immersed, and use a large (each rinse) volume7 of fresh water. Do not reuse the water for rinsing or any other purpose. Residues of disinfectant may cause serious side effects.

1 min

And dry At room temperature (15-25°C), use an air pistol (compressed air, max. 3 bars) to fully dry the lumen and the whole product until no more residues of water are present (visible or detectable).

05 INSPECT If stains are still visible on the product after cleaning/disinfection, the entire cleaning/disinfection 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 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).

6

3 For example: Miele Professional G 7836 CD with Miele Rack E429 4 cold tap water = 16°C +/- 2°C 5 cold demineralized water = 20°C +/- 2°C 6 For example: Bandelin, Sonorex 1028K, 35kHz 7 e.g. 2 gallons

EN EN BG

06 PACK

CS

Only previously cleaned and disinfected products must be sterilized.

DA

Effective sterilization must take place only on fully dry products. Ensure each part (internal lumens and any surface) to be perfectly dry before reassembling and packing. Prior to sterilization, the products need to be placed in suitable sterilization packaging.

DE EL

PIEZON® Handpieces: This product must be sterilized either dissassembled or reassembled.

ES

If you prefer to reassembled it: reinstall the O-ring first, then put the light guide into the nose cap and screw it on the handpiece.

ET FI FR

PIEZON® Instruments with CombiTorque®: Reinstall the original CombiTorque®.

instrument

with

its

HU

Reinstall the small O-ring (gasket) first, and then gently screw the retention bolt without tightening.

HR

PIEZON® Endochuck:

ID IT

Package your products with a single or double pouch: • suitable for prevacuum moist heat sterilization, • compliant with ISO 11607-1 or EN 868, • resistant to 138°C • and with adequate steam permeability (e.g. Wipak STERIKING flat rolls Type R43 and R44).

KO LT

07 STERILIZE

LV

Sterilization must be performed immediately after The prevacuum moist heat (steam) process can be used with any EMS product packaged in appropriate single or double cleaning-disinfection. The loading pattern defined by the autoclave manufacturer pouches:

MS

Parameters for the prevacuum moist heat cycle: DO NOT exceed a sterilization temperature of 138°C and • 3 prevacuum phases • Pressure of 3 bar8 a holding time of 20 min. • Humidity of 100% DO NOT use hot-air sterilization and radio-sterilization • Minimum temperature of 132°C procedures: they destroy the products. •  3 min (minimum) Hold time (full cycle) EMS recommends not to use class N sterilizers to •  20 min (minimum) Dry reprocess PIEZON® handpieces unless they include at least 20 minutes of drying cycle. The PIEZON® Handpiece lifetime Users must ensure that the reprocessing processes, can be reduced. including resources, materials and personnel, are capable to Moist heat sterilization of products shall be performed reach the required results and maintained over time: it is the according to ISO 17665 and in compliance with respective user's responsibility to ensure that validation of the reprocessing procedures is kept up to date at all times. country requirements. must be follow.

NL NO PL PT RO RU SK

08 STORE

SL

Store the sterilized products at a temperature up to 40°C in a: • dry, • clean • and dust-free environment.

SV TH TR VI

8 Absolute pressure

7

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

TO THE TOP MONT BLANC, 4807M

ONLY USE ORIGINAL EMS PRODUCTS EMS powders are much less abrasive than traditional mechanical debridement techniques such as rubber cups and handscaling. We recommend to use 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. Damaged handpiece

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.

HEADQUARTERS CH

NYON, SWITZERLAND E.M.S. ELECTRO MEDICAL SYSTEMS S.A.

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 DE

MUNICH, GERMANY EMS ELECTRO MEDICAL SYSTEMS GMBH

PL

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

FR

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]

ES

PT

CAMBRIDGESHIRE, UNITED KINGDOM EMS UK LTD SUITE 2

US

STOCKHOLM, SWEDEN EMS NORDIC AB

Hammarby Fabriksväg 61 SE - 120 30 Stockholm T. +46 8 899 102 E-mail: [email protected]

DALLAS, USA EMS CORPORATION

11886 Greenville Avenue , Ste 120 US - Dallas, Texas 75243 T. +001 972 690 8382 F. +001 972 690 8981 E-mail: [email protected]

AU

SYDNEY, AUSTRALIA EMS OCEANIA PTY LTD

The Woolstores - Suite 3, Shed 73 4E Huntley Street AU - Alexandria, NSW 2015 T. +61 (02) 9313 4392 E-mail: [email protected]

JP

TOKYO, JAPAN E.M.S. JAPAN KK

Eminent Ningyoucho Bld 6F., 9-18, Kobuna-cho, Nihombashi JP - Chuo-ku, Tokyo, 103-0024 T. +81 (0) 3-6810-9351 F. +81 (0) 3-6810-9352 E-mail: [email protected]

CN

SHANGHAÏ, CHINA

医迈斯电子医疗系统贸易（上海）有限公司

E.M.S. ELECTRO MEDICAL SYSTEMS TRADING (SHANGHAI) CO., LTD.

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

SE

AMMAN, JORDAN EMS ELECTRO MEDICAL SYSTEMS JORDAN

No.2 - second floor, 195 Arar (Wadi Saqra) str. JO - Amman

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Via Carlo Pisacane 7B IT - 20016 Pero (MI) T. +39 02 3453 8111 E-mail: [email protected]

UK

JO

LISBON, PORTUGAL EMSPOR - ELECTRO MEDICAL SYSTEMS PORTUGAL, UNIPESSOAL LDA

Avenida Miguel Bombarda, 36, 6A PT - 1050-165 Lisboa T. +351 912 338 777 E-mail: [email protected]

IT

Al. Roździeńskiego 188H PL - 40-203 Katowice T. +48 32 4937060 E-mail: [email protected]

MADRID, SPAIN EMS ELECTRO MEDICAL SYSTEMS ESPAÑA SLU

C/ Tomás Bretón, 50-52 2ª planta ES - 28045 Madrid T. +34 91 528 99 89 E-mail: [email protected]

KATOWICE, POLAND EMS POLAND SP. Z O.O.

24A, Jin Sui Mansion, N°379 Pudong Nan Rd. CN - Shanghai 200120 T. +86 21 3363 2323 E-mail: [email protected]

KR

SEOUL, SOUTH KOREA EMS ELECTRO MEDICAL SYSTEMS KOREA LTD.

13, Beobwon-ro 8-gil, Songpa-gu T. +82 70 7807 2875 E-mail: [email protected]

Edition 2022/11 rev.G © FB-358

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