Instructions for use PROPHYflex 4 Table of contents Table of contents 1 User instructions ........................ 5 2 Safety..........................7 2.1 Infection hazard ......................7 2.2 Air embolism and skin emphysema.................. 7 2.3 Technical condition......................8 2.4 Accessories and combination with other equipment ............8 2.5 Qualification of personnel....................
Page 4
Instructions for use PROPHYflex 4 Table of contents 7.4.5 Automated drying ....................27 7.5 Care products and systems - Servicing................27 7.6 Packaging ........................27 7.7 Sterilisation........................28 7.8 Storage ........................28 8 Auxiliary equipment ......................29 9 Terms and conditions of warranty ..................31...
Page 6
Instructions for use PROPHYflex 4 1 User instructions Please note the electronic instructions for use Note: observe accompanying documents EAC conformity mark (Eurasian Conformity) GOST R certification Transportation and storage conditions (Temperature range) Transportation and storage conditions (Air pressure) Transportation and storage conditions...
Instructions for use PROPHYflex 4 2 Safety | 2.1 Infection hazard 2 Safety The instructions for use are a component of the product and must be read care- fully prior to use and be accessible at all times. The device may only be used in accordance with the intended use, any other type of use is not permitted.
Instructions for use PROPHYflex 4 2 Safety | 2.3 Technical condition 2.3 Technical condition A damaged device or components could injure patients, users and third parties. ▶ Only operate devices or components if they are undamaged on the outside. ▶ Check that the device is working properly and is in satisfactory condition before each use.
▶ Both patient and user have to wear protective goggles during the treat- ment. ▶ KaVo recommends the use of dust extraction equipment and mouth protec- tion during the treatment with PROPHYflex. 9 / 34...
Instructions for use PROPHYflex 4 3 Product description | 3.2 Technical data ▪ adhere to the specified intended use ▪ to protect him or herself, the patient and third parties from hazards, and ▪ to prevent contamination from the product 3.2 Technical data...
Instructions for use PROPHYflex 4 3 Product description | 3.3 Scope of delivery 3.3 Scope of delivery The set consists of: No./ Description Mat.No. Item no. 1 x ① PROPHYflex 4 with: Long gripping sleeve 3.003.0520 Cannula 3.003.1138 Powder container 3.002.8136...
Instructions for use PROPHYflex 4 3 Product description | 3.4 Transportation and storage conditions 3.4 Transportation and storage conditions NOTICE Startup after refrigerated storage. Malfunction. ▶ Prior to startup, very cold products must be heated up to a temperature of 20 °C to 25 °C (68 °F to 77 °F).
Instructions for use PROPHYflex 4 4 Start up and shut down | 4.1 Installing the MULTIflex coupling 4 Start up and shut down WARNING Hazard from non-sterile products. Infection hazard for dentist and patient. ▶ Before first use and after each use, prepare and sterilise the medical device and accessories appropriately.
▶ Only use original KaVo powder. ▶ Reprocess and refill the powder container before each patient. ▶ Comply with the safety data sheets for KaVo powders. ▶ Safety data sheets are available for inspection at www.kavo.com, "Safety data sheets". 15 / 34...
Page 16
Instructions for use PROPHYflex 4 5 Operation | 5.3 Filling the powder container ▶ Unscrew the powder container anticlockwise. ▶ Before filling the powder container, shake the powder in the refilling bag well. ▶ Fill the powder container up to the marking.
Instructions for use PROPHYflex 4 5 Operation | 5.4 Mounting the gripping sleeve 5.4 Mounting the gripping sleeve The gripping sleeve is available in two different lengths. ▪ Long gripping sleeve: 3.003.0520 ▪ Short gripping sleeve: 3.003.2607 ▶ Mount the ergonomically fitting gripping sleeve on the instrument without tilting it.
Instructions for use PROPHYflex 4 6 Troubleshooting | 6.1 Cleaning a blocked cannula 6 Troubleshooting Preventive measures ▶ After each treatment and before each sterilisation, unscrew the powder container in an anticlockwise direction and replace it with a clean powder container.
Instructions for use PROPHYflex 4 6 Troubleshooting | 6.2 Cleaning a clogged main body 6.2 Cleaning a clogged main body ▶ Pulling off the grip sleeve with cannula. ▶ Unscrew the powder container anticlockwise. ▶ Push the nozzle needle through the aperture of the nozzle.
Page 21
Instructions for use PROPHYflex 4 6 Troubleshooting | 6.2 Cleaning a clogged main body ▶ Use the cleaning drill to clean or remove obstructions from the media tube from the front and the back. ▶ Tighten the nozzle with the wrench again.
Instructions for use PROPHYflex 4 7 Reprocessing steps in accordance with ISO 17664 | 7.1 Preparation at the site of use 7 Reprocessing steps in accordance with ISO 17664 7.1 Preparation at the site of use WARNING Hazard from contaminated products.
7 Reprocessing steps in accordance with ISO 17664 | 7.3 Manual Reprocessing 7.3.2 Manual internal cleaning Manual internal cleaning of the PROPHYflex 4 is not applicable. For effective re- processing, the inside of the device must be subjected to automated cleaning in a cleaning and disinfection unit in accordance with ISO 15883-1.
Instructions for use PROPHYflex 4 7 Reprocessing steps in accordance with ISO 17664 | 7.4 Automated reprocessing 7.4 Automated reprocessing WARNING Incomplete disinfection. Infection hazard. ▶ Only use disinfection procedures that are verified to be bactericidal, fungi- cidal and virucidal.
Instructions for use PROPHYflex 4 7 Reprocessing steps in accordance with ISO 17664 | 7.4 Automated reprocessing 7.4.1 Overview of the reprocessing options Pre-clean- Automated Automated Automated Sterilisa- external internal internal tion cleaning cleaning and ex- ternal dis- infection Main body...
Instructions for use PROPHYflex 4 7 Reprocessing steps in accordance with ISO 17664 | 7.4 Automated reprocessing 7.4.2 Pre-cleaning Accessories required: ▪ Tap water 30 C ± 2 C (86 F ± 4 ▪ Brush, e.g. medium-hard toothbrush ▶ Disassemble the instrument completely.
Note Please observe the instructions for use of the thermodisinfector. ▶ In order to prevent impairment of the KaVo medical device, make sure that the inside and outside of the device is dry after the end of the cycle. 7.5 Care products and systems - Servicing NOTICE Improper care.
Screw together the powder container and handpiece only in the cold state. The KaVo medical device has a maximum temperature resistance up to 138 ℃ (280.4 °F). Select a suitable procedure (depending on the available autoclave) from the fol- lowing sterilisation processes: ▪...
12 months from the date of the invoice, subject to the following conditions: In case of justified complaints, KaVo will honour its warranty with a free re- placement or repair. Other claims of any nature whatsoever, in particular with respect to compensation, are excluded.
Need help?
Do you have a question about the PROPHYflex 4 and is the answer not in the manual?
Questions and answers