Instructions For Use VATEA. Endodontic Irrigation Device

Transcription

1 Instructions For Use VATEA Endodontic Irrigation Device

2 VATEA Irrigation System Instructions for use 1. Indications for use The VATEA system is intended to be attached to dental handpieces to deliver irrigation during endodontic procedures. 2. Device description The VATEA system is a self-contained, fluid delivery unit consisting of a pump console, irrigation reservoir and disposable tubing intended to be used in endodontics to provide irrigation while attached to dental handpieces. The VATEA is an electronically operated device, powered by a rechargeable battery. Flow rate and timer is adjusted via control panel display, and the irrigation is toggled using a foot pedal. The unit has a positive displacement peristaltic pump to prevent fluid retraction thus avoiding patient cross-contamination. RD VATEA IFU English - rev 4 Aug 1 st

3 2.1 Description of the front panel LCD Display Battery Indication LED Flow Rate / timer Control Buttons Fluid Connection Socket (luer-lock) Foot Pedal Connection Socket Figure 1: Front panel of the VATEA RD VATEA IFU English - rev 4 Aug 1 st

4 2.2 Description of the rear panel Cap Liquid Reservoir Master On/ Off Power Switch Electrical Charger Socket Figure 2: Rear panel of the VATEA RD VATEA IFU English - rev 4 Aug 1 st

5 3. Precautions This device is to be used by dental professionals only. Batteries should be charged until indicating LED light changes to green. See instructions regarding batteries in paragraph 13. Electrical charger (medical AC/DC power supply adapter complies to UL ) Make sure that the silicone tube and foot pedal cable are properly connected. Use only sodium hypochlorite in the reservoir. 4. Contraindications Do not use without a rubber dam. RD VATEA IFU English - rev 4 Aug 1 st

6 5. Getting started 5.1 Unpack the system carefully and place it on a flat, stable surface. 5.2 Connect the electrical charger power cable to the electrical charger socket on the rear panel. Charge the batteries until indicating LED light changes to green. 5.3 Connect the foot pedal plug and the fluids connector to the socket on the front panel: Position the foot pedal plug in a way that the marking arrow will be placed in front of the marking dot, as shown in figure 3(a). Push the plug until you hear a click sound. Tighten the luer-lock connector. To release the foot pedal plug turn it to the left as marked and pull it out. To release the fluid connector, screw it anti clockwise. (a) (b) Figure 3: Connecting (a) and disconnecting (b) the foot pedal plug and the fluids connector RD VATEA IFU English - rev 4 Aug 1 st

7 6. How to operate the VATEA system 6.1 Fill the reservoir with sodium hypochlorite, up to the 400ml indication line. It is required to use a funnel. Secure the cap. RD VATEA IFU English - rev 4 Aug 1 st

8 6.2 Assemble the silicone ring on the handpiece, as shown in figure 4: Figure 4: Assembly of the silicone ring on the handpiece 6.3 Turn on the system using the master power switch, located on the rear panel. Master On/ Off Power Switch RD VATEA IFU English - rev 4 Aug 1 st

9 6.4 Flow rate is displayed when the system starts up and/or when adjusting the flow rate. 6.5 Timer will start running when irrigation is switched on with the foot pedal. 6.6 The timer will count 10 minutes and then reset to "00" 6.7 During the first minute, the time is displayed in seconds (1-59 sec). 1 sec 59 sec 6.8 The following 9 minutes are presented in minutes (left digit), together with an indication of active irrigation by cyclic moving segments (right digit). RD VATEA IFU English - rev 4 Aug 1 st

10 1:00 min 1:01 min 1:02 min 1:03min 2 min 3 min 2 min 3 min RD VATEA IFU English - rev 4 Aug 1 st

11 6.9 A beeping sound will be heard after 2 minutes of operation When reaching 4 minutes, the buzzer indicates end of treatment, and the display starts blinking. The timer will keep running until stopped by the foot pedal Stopping the irrigation during the first 4 minutes stops the timer but does not reset it to "00" Stopping the irrigation after 4 minutes with the foot pedal resets the timer A manual reset is possible by pressing the "+/-" control buttons on the front panel simultaneously An integrated buzzer is used for notifications and alarms (see section 9). (if it is desired to mute the buzzer the flow rate should be adjusted to zero and then the "+/-" control buttons pressed simultaneously. To turn on the buzzer again repeat this action) When working with the electrical charger connected there will be a steady LED notification for the battery status. See LED indication table in paragraph When working with batteries, there will be a flashing LED notification according to the table in paragraph When the batteries discharge there will be a sound notification and a low battery icon notification on the screen before the system shuts down When connecting and disconnecting the electrical charger while the system is on, there will be a beeping sound. RD VATEA IFU English - rev 4 Aug 1 st

12 7. Equipment supplied VATEA irrigation system. 10 disposable Silicone tube 1.5m with silicone ring and luer-lock (cat no. RDN-MCH0027). Foot pedal (cat no. RDN-MCH0035). Electrical charger (cat no. RDN-MCH0023). Funnel. Instructions for use. Use only certified parts supplied by the manufacturer. Figure 5: Equipment supplied RD VATEA IFU English - rev 4 Aug 1 st

13 8. LED indication Color Green Orange Red Indication The batteries are fully charged The batteries are half-charged The batteries are NOT charged, soon to be empty RD VATEA IFU English - rev 4 Aug 1 st

14 9. Error messages Error message displayed on Control Panel screen Call service and E1 Call service and E2 Call service and E3 Call service and E4 Description Electronics overloaded The lifetime of the pump is soon to expire The lifetime of the pump has expired The foot pedal plug is disconnected from the front panel Solution Switch off the system, restart it and if this error reoccurs call technician Continue the treatment to its end, then use the + / - buttons to reset the display. Call a technician to replace the pump. There are still 50 hours of operation left after this message but the message will appear with every system turn on until the user presses the + / - buttons. The machine stops working after 450 hours of use. Switch off the system and call a technician. The error message will appear with every system turn on and system operation will not be permitted. The pump will stop immediately. Reconnect the foot pedal plug to the front panel and the pump will restart operation at the previous flow rate. RD VATEA IFU English - rev 4 Aug 1 st

15 10. Maintenance 10.1 Silicone tube and ring are disposable and should be discarded after use. Before initial use the tube should be sterilized in the dental clinic autoclave at 134 o C for 3 minutes VATEA outer surfaces Wipe with disinfection wipes after each treatment Charging - Connect the electrical charger until indicating LED light changes to green. 11. Technical data Power inlet: 220V AC@ Hz or 110v@ 60Hz Supply voltage: 10V Current: 1.5A max Dimensions in mm: (HxWxD) 137x126x174 mm Weight in kg: 0.7 Kg Liquid reservoir capacity: 400ml Storage temperature: -10 C 60 C Operational temperature 10 C 40 C 12. Electrical Classification Type of protection against electrical shock: Internally powered equipment. Degree of protection against electrical shock: Type BF applied part. Degree of protection against ingress of water: VATEA: IPX0; Foot pedal: IPX1. RD VATEA IFU English - rev 4 Aug 1 st

16 Equipment not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide. Mode of operation: Intermittent operation: Operation time: 20 minutes; Rest time: 20 minutes. 13. Precautions in Battery Handling 13.1 Be sure to connect the positive and negative battery terminals to the corresponding terminals of the application device, in order to prevent reverse charging Never incinerate the battery Avoid subjecting a battery to strong vibrations, pressure or impact Never carry a battery with other metallic belongings to avoid shortcircuiting Never disassemble a battery or a cell Never short together the positive and negative terminals of a battery with any metal Never alter the factory configuration or remove/modify a component of a battery Never use other charger than specified to avoid possible heating, burning or rupture If any abnormality or problem is found while using the battery, stop its use, and bring it to your local dealer Never use the battery for any applications other than specified, this may result in damage to the battery and the appliances. RD VATEA IFU English - rev 4 Aug 1 st

17 14. Symbols in use Symbol Description Read Instruction for use prior use XXXXXX Catalogue number XXXXXX Serial number Type BF applied part CAUTION, consult accompanying documents CE mark TUVus mark Class II RD VATEA IFU English - rev 4 Aug 1 st

18 15. Manufacturer ReDent-Nova Ltd. 15 Ha taasia Street, POB 4159 Ra anana 43000, Israel. Tel: / 70, Fax: office@redent.co.il 16. European Representative Obelis s.a Boulevard Général Wahis Brussels, BELGIUM Tel: + (32) Fax: + (32) mail@obelis.net RD VATEA IFU English - rev 4 Aug 1 st

19 P.O.B 4159, Ra anana 43000, Israel Tel: Fax: