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Summary of Contents for Durr Dental VC 65
- Page 1 VC 65 Operating Instructions 0297 0672100006L02 *0672100006L02*...
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Page 3: Table Of Contents
About this document ....VC 65 Cart ....Warnings and symbols .. - Page 4 Contents 12.1 Lubricating the o-rings ..Troubleshooting 13 Tips for operators and service techni- cians ......Appendix 14 Handover record .
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Page 5: Important Information
These installation and operating instructions apply to: Refer to Operating Instructions. VC 65 Order number: 0672500000; 0672500900 CE labelling with the number of the noti- fied body Warnings and symbols... -
Page 6: Copyright Information
Important information Safety Use a mask. Dürr Dental has designed and constructed this unit so that when used properly and for the inten- ded purpose it does not pose any danger to Use protective clothing. people or property. Despite this, the following residual risks can remain: Wear protective gloves. -
Page 7: Information About Infection Pro
Keep a minimum distance of 30 cm between ❯ observed during work with the VC 65 and during the unit and mobile radio devices. disposal. Note that cable lengths and cable extensions ❯... -
Page 8: Essential Performance Charac
If you have any questions about the correct ❯ disposal of parts, please contact your dental The VC 65 unit does not have any essential per- trade supplier. formance characteristics as set out in IEC 60601-1 (EN 60601-1) section 4.3. -
Page 9: Product Description
Product description Product description Overview VC 65 cart Foot switch Hose manifold Mains cable surgical suction unit 0672100006L02 2205V008... -
Page 10: Scope Of Delivery
VC 65 ..... . . 0672500000 VC 65 China ....0672500900 –... -
Page 11: Technical Data
Product description Technical data Electrical data Rated voltage 220-240 Nominal current Type of protection IP 22 Protection class Mains frequency 50 / 60 Fuse T 2.5 AH/250 V IEC 60127-2/V Classification Medical Device Class (MDR) General technical data Dimensions (W x H x D) 325 x 349 x 372 Dimensions with cart (W x H x D) 454 x 1050 x 571... - Page 12 Product description Electromagnetic compatibility (EMC) Interference emission measurements Interference voltage at the power supply connection Compliant CISPR 11:2009+A1:2010 Electromagnetic interference radiation Compliant CISPR 11:2009+A1:2010 Electromagnetic compatibility (EMC) Interference immunity measurements on the cover Immunity to electrostatic discharge IEC 61000-4-2:2008 Compliant ±...
- Page 13 Product description Immunity to interference levels, near fields of wireless HF communication devices Radio service Frequency band Test level TETRA 400 380 - 390 GMRS 460 430 - 470 FRS 460 LTE band 13, 17 704 - 787 GSM 800/900 TETRA 800 iDEN 820 800 - 960...
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Page 14: Type Plate
To adjust the pressure, close the suction hand- piece and adjust the pressure on the control knob. After insertion of a surgical suction cannula into the suction handpiece the VC 65 is ready for operation. The aspirated material passes directly to the collecting container. Inside the collecting container, the air is separated from the aspirated fluids and other particles. -
Page 15: Foot Switch
Product description Foot switch To switch on the unit, briefly press the foot switch once. Pressing the foot switch again will switch off the unit. The foot switch operates pneumati- cally. Suction handpiece A suction cannula and a disposable hose can be plugged onto the curved suction handpiece. -
Page 16: Assembly
Assembly Installation Assembly Remove the transport locks Remove the transport protection on the under- ❯ Requirements side of the device. Installation/setup room The room chosen for installation must satisfy the following requirements: – Closed, dry room. – Should not be a room made for another pur- pose (e.g. -
Page 17: Vc 65 Cart
Assembly VC 65 Cart Connecting the unit to the mains supply Place the unit on the VC cart and secure it. ❯ Requirements: ü Properly installed power outlet close to the unit (max. mains cable length 5 m) ü Easily accessible power outlet ü... -
Page 18: Preparation Of The Device
Assembly Preparation of the device WARNING Attach the hose manifold Risk of cross contamination when Attach the hose manifold to the housing until it reusing the disposable bag ❯ snaps into place. Do not use the disposable bag more ❯ than once (disposable item). - Page 19 Assembly Close the connecting sleeve on the disposable Connecting the foot switch ❯ bag and press the cover slightly down in the Connect the hose coming from the foot switch ❯ middle until the disposable bag has completely to the connecting sleeve on the unit. unfolded.
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Page 20: Commissioning
Assembly Commissioning NOTICE Short circuit due to the build up of condensation Do not switch on the unit until it has ❯ warmed up to room temperature and it is dry. If reusable items are used, comply with the reprocessing instructions of the man- ufacturers. -
Page 21: Usage Operation
Usage Replace the fuse Usage Prior to working on the unit or in case of danger, disconnect it from the mains. Operation Pull out the fuse shaft. ❯ Requirements: – Suction hoses and collecting container are free of damage (no leaks) –... -
Page 22: Cleaning And Disinfection
Usage 10 Cleaning and disinfection Disinfect the surfaces using a disinfection wipe. ❯ Alternatively, use disinfectant on a soft, lint-free cloth. Prior to working on the unit or in case of danger, disconnect it from the mains. The hose manifold can be disinfected by heat and sterilised (at up to 134°);... -
Page 23: 11 Reprocessing
Usage 11 Reprocessing Important information! The reprocessing notes in accordance 11.1 Risk analysis and categorisa- with ISO 17664 have been independently tion tested by Dürr Dental for the preparation of the device and its components for their A risk analysis and categorisation of medical reuse. -
Page 24: Preparation At The Operating
Usage The reprocessing procedure was validated as fol- Only use cleaning agents that are non-fixing ❯ lows: and aldehyde-free and display material com- – Pre-cleaning patibility with the product. – FD 350 Disinfection wipes (Dürr Dental) Only use disinfectants that are aldehyde-free ❯... -
Page 25: Manual Cleaning, Intermediate Rinsing, Disinfection, Final Rinse, Drying
Usage Disassemble the suction handpieces and Intermediate rinsing ❯ remove the O-rings. After the action time prescribed by the manufac- turer: Rinse off all components under water for at ❯ least 1 minute (temperature < 35°C). Disinfection Place individual components in a cleaning and ❯... -
Page 26: Check For Function
Usage Place components in the basket for small ❯ NOTICE parts. Damage to equipment due to incor- Attach cannula to suitable holders in the ❯ rect sterilisation washer-disinfector. If the sterilisation process is not per- 11.6 Check for function formed correctly, this can cause dam- After the end of the cleaning and disinfection age to the product. -
Page 27: Storing Parts For Sterilisation
Usage 11.9 Storing parts for sterilisation Comply with the stated storage conditions: ❯ – Store the parts protected against contami- nation – Dust-protected, e.g. in a locked cabinet – Protected against moisture – Protected against excessive temperature fluctuations – Protected against damage Packaging for a sterile medical device can suf- fer damage as a result of a particular incident and the passage of time. -
Page 28: Maintenance
Usage 12 Maintenance WARNING Infection due to contaminated unit Clean and disinfect the suction before working on the unit. ❯ Wear protective equipment when working (e. g. impermeable gloves, protective goggles and ❯ mouth and nose protection). Only trained specialists or personnel trained by Dürr Dental may service the device. Prior to working on the unit or in case of danger, disconnect it from the mains. -
Page 29: Lubricating The O-Rings
Usage 12.1 Lubricating the o-rings Suction handpieces are easier to handle when the O-rings have been lubricated with Vaseline. Disassemble the suction handpieces regularly ❯ and lubricate the O-rings. 0672100006L02 2205V008... -
Page 30: Troubleshooting
Troubleshooting Troubleshooting 13 Tips for operators and service technicians Any repairs exceeding routine maintenance may only be carried out by qualified personnel or our service. WARNING Infection due to contaminated unit Clean and disinfect the suction before working on the unit. ❯... -
Page 31: Appendix
Appendix Appendix 14 Handover record This document confirms that a qualified handover of the medical device has taken place and that appropriate instructions have been provided for it. This must be carried out by a qualified adviser for the medical device, who will instruct you in the proper handling and operation of the medical device. Product name Order number (REF) Serial number (SN) - Page 32 Appendix 0672100006L02 2205V008...
- Page 34 Hersteller / Manufacturer: DÜRR DENTAL SE Höpfigheimer Str. 17 74321 Bietigheim-Bissingen Germany Fon: +49 7142 705-0 www.duerrdental.com info@duerrdental.com...
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