EMS AIRFLOW Prophylaxis Master Instructions For Use Manual
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Table of Contents
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PROPHYLAXIS MASTER
INSTRUCTIONS
FOR USE
(FOR AUSTRALIA & NEW
ZEALAND ONLY)
Table of contents
1.
BEFORE USE .........................................................2
1.1.
.................................................... 3
1.2.
1.3.
................................................. 4
1.4.
1.5.
1.6.
................................................... 5
1.7.
2.
INSTALLATION ......................................................7
2.1.
2.2.
-
-
2.3.
2.4.
2.5.
®
2.6.
PIEZON
®
H
ANDPIECE AND
3.
DEVICE USE ........................................................ 17
3.1.
...................................................... 17
3.2.
4.
OPTIONAL EQUIPMENT ...................................... 22
4.1.
®
4.2.
5.
CLEANING & REPROCESSING............................... 23
5.1.
5.2.
S
I
AFETY
NFORMATION ON
5.3.
R
EPROCESSING OF
ENGLISH
............................................. 3
.......................................... 4
........................................... 5
........................................ 6
.......................... 7
.................................. 9
.......................................... 13
®
.................. 14
®
H
........ 15
I
.............. 16
....................................... 21
..................................... 22
........................... 22
....................................... 23
NIGHT CLEANER ......... 25
EMS
............................. 26
PARTS
FB-618/AU - rev.E - ed.2019/08
®
6.
MAINTENANCE & TROUBLESHOOTING ............... 34
6.1.
AIRFLOW
®
H
6.2.
®
6.3.
PIEZON
®
LIGHT GUIDE CHECK
6.4.
6.5.
6.6.
6.7.
6.8.
6.9.
6.10.
7.
SUSTAINABILITY ................................................ 41
7.1.
7.2.
8.
WARRANTY ....................................................... 41
9.
TECHNICAL DESCRIPTION ................................... 42
9.1.
.......................................................... 43
9.2.
10. ALPHABETICAL INDEX ........................................ 47
ANDPIECE POWDER UNCLOGGING
.......................... 34
&
............... 34
........................... 35
............................................... 35
&
........................... 36
......................................... 36
............................................ 37
..................... 40
............................ 40
.................................. 41
.......................................... 41
....................... 45
1/48
....... 34
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Table of Contents
Troubleshooting
Related Manuals for EMS AIRFLOW Prophylaxis Master
Summary of Contents for EMS AIRFLOW Prophylaxis Master
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Page 1: Table Of Contents
........6 ENERAL RECAUTIONS 6.7.......... 36 AIRING A NEW PEDAL INSTALLATION ............7 6.8..........37 ROUBLESHOOTING 6.9. EMS S ..... 40 O CONTACT ERVICE SUPPORT 2.1......7 QUIPMENT INCLUDED IN THE BOX 6.10......40 O REPORT AN DVERSE VENT 2.2. -
Page 2: Before Use
We recommend that you visit our website regularly to consult and/or download the latest version of the documentation for your device at www.ems-instruction.com • Please contact EMS technical support or your local EMS representative for further information and support. ENGLISH FB-618/AU –... -
Page 3: Intended Use
1.1. Intended Use The device is a fixed table top unit combining: - PIEZON ® : ultrasound scaler - AIRFLOW : air polishing technology ® Intended for use in PREVENTION, MAINTENANCE AND TREATMENT during dental prophylaxis to remove biofilm and calculus from natural teeth, restorations and implants 1.2. -
Page 4: Intended Users
Do you know the Guided Biofilm therapy? If not: GET TRAINED NOW Please contact your local EMS representative for further information. Professional product installation and product introduction by EMS certified person is highly recommended for optimal setup and reliability. 1.4. Patient Population PIEZON ®... -
Page 5: Contraindications
1.5. Contraindications Suggestion for alternatives: Treatments contraindications: Patients with severe or unstable upper are contraindicated respiratory tract infections, chronic PIEZON ® ® ® with bronchitis/asthma Pregnant and breastfeeding AIRFLOW ® ® is contraindicated with patients and PIEZON ® Patients with severe inflammation and/or AIRFLOW PLUS ®... -
Page 6: General Precautions
RF communications equipment and mobile devices placed nearby as far away as possible to rule out interference. • Stop using the device if the electromagnetic disturbances persist and contact EMS technical support for assistance. ENGLISH FB-618/AU –... -
Page 7: Installation
2. INSTALLATION 2.1. Equipment included in the box Check contents for any damage that may have occurred during transportation. AIRFLOW Prophylaxis Quick Guide Power cord Master Unit ® providing links to Plug type depends on with Master Screw, eIFU download and country water &... - Page 8 FS-447 FS-462 FS-443 EL-308: AIRFLOW ® Handpiece EN-060 : PIEZON ® Handpiece EL-354: PERIOFLOW ® Handpiece AB-470A/A: Easy Clean 3x DS-016A : Instrument PS AB-358/B Nozzle extractor (under) 10x AB-327A/A: PERIOFLOW ® EL-651: Cord gaskets 4x AB-340: Light guide nozzle El-600: Water filter 6x DT-064: Instrument PI EL-599: Air filter...
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Page 9: Step-By-Step Installation
EMS Service for on-site support by qualified personnel. Be aware The use of cables and accessories other than those supplied by EMS may negatively affect EMC performance. Use only parts supplied by EMS. The device uses a low power radio, 8 dBm EIRP max, Bluetooth ®... - Page 10 Connect air and water hoses Turn the device over and place it upside down. Pressure: 4.5 to 7 bar Connect the air hose EH-142 to the cabinet/dental unit. Dry air. Max. humidity: 1.032 g/m Push the hose connector into the air jack firmly (it may be hard). Filtration: max.
- Page 11 Check the cord connections PUSH HARD PUSH The handpiece cord is not fully connected. to lock in. PUSH HARD The system is well connected & locked. To disconnect the handpiece cord system, unlock the connection and pull at the same time. Fix the device You will find a “Master Screw”...
- Page 12 Power your device You can now connect the power cord to the mains grid. Voltage: 100-240 Vac Frequency: 50 to 60 Hz. Protective earth is required! Operating current: 4 A max. Be sure your power grid has an efficient protective earth. Installation of the wireless pedal Insert two (2) AA 1.5V lithium batteries into the wireless pedal.
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Page 13: Powder Chambers
Pressure is automatically reduced for compatibility with subgingival treatments, including Perioflow treatments (Supra applications also possible). Compatible EMS Powders: PLUS and PERIO (refer to paragraph “Compatibility” for details). CLASSIC The CLASSIC Powder chamber is designed for the CLASSIC Powder and can only be used for supragingival treatments. -
Page 14: Water Supply And Piezon
2.4. Water supply and PIEZON ® bottle Without Bottle: With Bottle connected: PIEZON & AIRFLO W use external water supply. AIRFLOW uses external water supply. ® ® ® PIEZON ® uses bottle liquid supply. Connect the PIEZON bottle ® The CLIP+CLEAN shall be Place the CLIP+CLEAN into the previously cleaned and disinfected Only use the PIEZON... -
Page 15: Airflow And Perioflow
AIRFLOW or PERIOFLOW Handpiece. ® ® Follow the “Reprocessing of EMS parts” instructions and the present-day regulations on reprocessing enforced in your country. In case the AIRFLOW Handpiece gets clogged, refer to the “Maintenance & Troubleshooting” ® section for instruction. -
Page 16: Nstruments
Not reprocessed handpieces and accessories may cause bacterial or viral infections. Follow the “Reprocessing of EMS parts” instructions and the present-day regulations on reprocessing enforced in your country. Check tip length and tip thread through the cover right folder of your Quick Guide. -
Page 17: Device Use
3. DEVICE USE 3.1. Interfaces BOOST Press hard NORMAL Press gently ON: the device goes into operating mode. ON/OFF-mode OFF: the device reverts back to standby. Standby (After 1 hour of inactivity, the unit switches to off-mode standby) Powder chamber is pressurized or depressurized. A white light illuminating the powder chamber will turn on when pressurized. - Page 18 PIEZON power setting ® The unit is equipped with NO PAIN ® technology which provides an adaptive response in function according to the load applied to the instrument. The following table shows the maximum output power as per user power setting: PIEZON ®...
- Page 19 PIEZON and AIRFLOW BOOST ® ® BOOST effect Pressing hard on the center of the wireless pedal activates the BOOST mode and results in an increase of power, as the following table shows: AIRFLOW ® Power Setting Boost Corresponding Boost Level PIEZON ®...
- Page 20 Water temperature and acoustic feedback settings AIRFLOW and PIEZON liquids’ temperature is 40°C by default. ® ® To adjust the water temperature or the acoustic feedback, follow the procedure below: 1. Turn the device ON. 2. Securely place both handpieces (AIRFLOW and PIEZON ) back into their holders.
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Page 21: Treatment Sequence
3.2. Treatment sequence Consult the Treatment Recommendations (document series FB-648) before starting any treatment to the patient. AIRFLOW ® Position the powder chamber. Pressurize the chamber. Set the AIRFLOW power. ® Set the water flow. Take the AIRFLOW ® Handpiece. Press the pedal to start treatment. -
Page 22: Optional Equipment
4. OPTIONAL EQUIPMENT 4.1. PERIOFLOW ® Nozzles Cannot be reprocessed. Single-use nozzle. DO NOT use the nozzle if the package is damaged or open. Fully connect the Make sure the nozzle is correctly attached = fully nozzle by pushing inserted. on a hard surface. -
Page 23: Cleaning & Reprocessing
Otherwise, repeat the rinsing procedure. Always empty out and wash the water bottle used for rinsing before any new use. EMS recommends a weekly use of a bottle cleaning agent (e.g. BC-San 100 from Alpro Medical GMBH). - Page 24 Never use scouring powder or an abrasive sponge. It will damage its surface. End of day: Overnight cleaning Use only EMS NIGHT CLEANER as a cleaning agent. Other products may damage or not clean the unit, and cause patient intoxication. Place the NIGHT...
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Page 25: Night Cleaner
Do not sterilize the NIGHT CLEANER bottle and its nozzle cap by steaming or dry thermal reprocessing. Use only ambient temperature active disinfectant and cleaning agents. Do not use Hydrogen Peroxide like EMS Ultra Clean. It deactivates after some time in the device’s bottle. -
Page 26: R Eprocessing Of Ems
If there is anything in the following instructions that is not clear or seem to be inadequate, do not hesitate to contact/inform EMS. The following instructions have been validated as being capable of preparing for re-use the EMS medical devices and parts listed in the “Intended Use and Compatibility” chapter. It remains the responsibility of the user to ensure that the processing as actually performed using equipment, materials and personnel in the processing facility achieve the desired result. - Page 27 Preparation Manual pre-cleaning is required: Immediately after use, rinse the lumen(s) line of the handpiece/instrument with water for 20 seconds. Coarse soiling must be removed immediately after application. For AIRFLOW and PERIOFLOW : always carry out handpiece powder unclogging and check ®...
- Page 28 Cleaning Any part can be cleaned manually or automatically by washer or disinfector. EMS recommends the use of an ISO 15883 compliant automatic washer-disinfector (WD) for an optimal effectiveness and part service life. DO NOT use any Ultrasound Bath cleaning procedure with the PIEZON , AIRFLOW ®...
- Page 29 Manual Cleaning with Ultrasound Bath DO NOT USE WITH HANDPIECE BODY The following validated process is intended ONLY for the EMS PIEZON Instruments and file holders: • Remove away any surface soiling (gross contamination) on the product with a wetted cloth and tap water.
- Page 30 Any part can be disinfected manually or automatically by a disinfector. HIGHLY RECOMMENDED! ALTERNATIVE Automated Disinfection Manual Disinfection DO NOT use any Ultra Sound Bath disinfecting EMS highly recommends the use of an ISO procedure with the PIEZON , AIRFLOW ® ® 15883 compliant automatic washer-disinfector...
- Page 31 Final rinse water requirements: Free from optional pathogenic micro-organisms. Deionized water is recommended to avoid deposits or crystallization on the medical device. Potential bacterial contamination must be taken into account depending on the water treatment process used. Sterilization shall be performed immediately after cleaning-disinfection. Inspection and final dry before sterilization If stains are still visible on the part after cleaning/disinfection, the entire cleaning/ disinfection procedure must be repeated.
- Page 32 Moist heat sterilization of parts shall be performed according to ISO 17665 and under consideration of the respective country requirements. The following validated Pre-vacuum Moist Heat (steam) process can be used with any EMS part packaged in appropriate single or double pouches: Parameters for the Pre-vacuum Moist Heat cycle: •...
- Page 33 It is the duty of the user to ensure that the reprocessing processes, including resources, materials and personnel, are capable to reach the required results and maintained over the time: keeping actual the validation of the reprocessing processes is under the responsibility of the user. Storage Store the sterilized instruments in a dry, clean and dust free environment at a temperature of 5°C to 40°C.
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Page 34: Maintenance & Troubleshooting
6. MAINTENANCE & TROUBLESHOOTING 6.1. AIRFLOW ® Handpiece powder unclogging In case of a clogged handpiece and before the reprocessing of AIRFLOW ® and PERIOFLOW ® Handpieces. Easy Clean Provided in your Application box ® Blow air to dry. Rinse through central lumina in the normal direction of flow (no back rinsing) using Easy Clean with a disposable syringe filled with more... -
Page 35: Handpiece Cord Replacement
6.4. Handpiece cord replacement Disconnect the mains plug for purposes of maintenance and in case of malfunction. Depressurize the powder chamber before disconnecting the AIRFLOW cord. ® In case of persistent malfunction or damage to the PIEZON ® or AIRFLOW ®... -
Page 36: Yearly Maintenance & Repair
Provide the contact details of your EMS dealer for a quicker service process (see § 6.9). 6.7. Pairing a new pedal 1. -
Page 37: Troubleshooting
1° Unplug the device power cord, wait for 30 seconds, then plug it back again and restart the device (to check for effective permanent fault condition). 2° If the error is still present, contact EMS aftersales service for repair. ... - Page 38 1° Your device is too hot. Unplug it, wait for 1 hour and start the device again. 2° If error is still present, contact EMS aftersales service. Note: This error also shows up when the device is operating below the minimum temperature.
- Page 39 Wired pedal does not work 1° Disconnect and reconnect the pedal. Check the cable for damage. Restart the device. 2° If still not solved, contact EMS aftersales service. No pressurization of the powder chamber 1° Check that your device is ON: at least 1 LED light should be ON.
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Page 40: To Contact Ems Service Support
6.10. To report an Adverse Event If any serious incident occurs that is directly or indirectly related to the treatment, report it immediately to EMS and to the competent authority of your country and of where the patient is established (if different). -
Page 41: Sustainability
Warranty is void if the device has been opened. EMS and the distributor of this device accept no liability for direct or consequential injury or damage resulting from improper use, arising in particular through non-observance of the instructions for use, or improper preparation and maintenance. -
Page 42: Technical Description
9. TECHNICAL DESCRIPTION Manufacturer EMS ELECTRO MEDICAL SYSTEMS SA, CH-1260 Nyon, Switzerland Models AIRFLOW Prophylaxis Master, product code FT-229 Classification IEC 60601-1 Electrical Insulation Class-I Applied part Type B IP20 Control unit IP21 Foot pedal Classification EU MDD Medical Device Class IIa... -
Page 43: Symbols
9.1. Symbols General Warning Warning Electricity Non-ionizing radiation (radio communication) Read the operation instructions Device requiring protective earth Disconnect the mains plug for purposes of maintenance and in case of malfunction Electronic instructions for use Mandatory action Expiration date Single use. Do not re-use. Do not do. - Page 44 AGREE PAR L'ANRT MAROC Numéro d'agrément: Moroccan ANRT compliance marking for wireless equipment MR 17713 ANRT 2018 MR 17713 ANRT 2018: Wireless pedal approval number / MR 14883 ANRT MR 14883 ANRT 2017: Device approval number 2017 Date d'agrément: 16- 10-2018 / 09-10-2017 United Arab Emirates TRA compliance marking for wireless equipment ER64514/18: BLE113 Bluetooth module approval number...
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Page 45: Electromagnetic Compatibility
9.2. Electromagnetic Compatibility The use of parts other than those supplied or listed as accessory may negatively affect EMC performance. The device has embedded a low power, 8 dBm EIRP max, Bluetooth 2.4 GHz module, for communication with the wireless pedal. This radio module is disabled when a wired pedal is connected (device reboot required). The Bluetooth module complies with all the restrictions foreseen by the ERC recommendations 70-03 for the CEPT countries concerning the Annex 3 (Wideband Data Transmission System band A 2400-2483.5 MHz) without requiring any modifications of the products by the user. - Page 46 Proximity fields from RF wireless communications equipment IEC 61000-4-3 Test Band Service Modulation Maximum power Distance Immunity Frequency test level (MHz) (MHz) (V/m) Pulse Modulation 380-390 TETRA 400 18Hz GMRS 460, 430-470 ±5 kHz deviation FRS 460 1 kHz sine Pulse 704-787 LTE Band 13, 17...
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Page 47: Alphabetical Index
COMBITORQUE, 16 STERILIZATION, 26, 31, 32, 33 MASTER SCREW, 7, 11 COMPATIBILITY, 5 STERILIZATION, 33 MONTHLY MAINTENANCE, 35 CONTACT EMS SERVICE SUPPORT, SYMBOLS, 43 CONTAMINATION, 9, 10, 24 CONTRAINDICATIONS, 5 NEWBORN (NEONATE), 4 CORD REPLACEMENT, 35 TIP, 16, 18, 19... - Page 48 Fax +41 22 99 44 701 www.ems-dental.com/en/contact www.ems-dental.com WORLDWIDE EMS AFFILIATES MUNICH, GERMANY DALLAS, EMS ELECTRO MEDICAL SYSTEMS GMBH EMS ELECTRO MEDICAL SYSTEMS Schatzbogen, 86 Corporation DE-81829 Munich 11886 Greenville Avenue, #120 Tel. +49 89 42 71 61 0 US-Dallas, TX 75243 Fax +49 89 42 71 61 60 Tel.