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orangedental spot-on nxt Instructions For Use Manual

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Instructions for Use

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  • Page 1 Instructions for Use...

  • Page 3: Dear Customer

    GmbH & Co. KG [hereafter referred to as orangedental] only considers itself responsible for the effects on safety, reliability and performance of the device, if:...

  • Page 4: Responsibility Of The Operator

    spot – Instructions for Use | 1.1.2. Responsibility of the Operator Among other things, the operator is responsible for: adherence to the accident prevention regulations as well as the regulation concerning the installation, operation and use of active medical products (German regulation MPBetreibV). the operation.

  • Page 5: Table Of Contents

    spot – Instructions for Use | 1.2. Content Dear Customer ....................1 1.1. Prologue ......................1 1.1.1. Responsibility of the Manufacturer ............1 1.1.2. Responsibility of the Operator ..............2 1.2. Content ......................3 1.3. Conventions, Symbols Used ................4 About the Product ..................

  • Page 6: Conventions, Symbols Used

    spot – Instructions for Use | 1.3. Conventions, Symbols Used In these instructions, the conventions set out below indicate important information: This symbol is used if deviating from the procedure described ARNING can lead to physical injury or death. This symbol is used if deviating from the procedure described AUTION can lead to damage to the product or to loss of data.
  • Page 7 spot – Instructions for Use | EDICAL EVICE This symbol is used to indicate that the product is a medical device. CE M ARKING This symbol, attached by the manufacturer, indicates that the medical product is in conformity with and fulfills all requirements of the medical device regulation (EU) 2017/745.

  • Page 8: About The Product

    spot – Instructions for Use | ABOUT THE PRODUCT 2.1. Intended Use spot – is used for illumination of the oral cavity of a patient using spot – a binocular loupe system of the practitioner. The is designed for use by dentists or qualified dental personnel within a dental workspace. There are no known contraindications for the use of the lamp.

  • Page 9: Spare Parts And Accessories

    – Instructions for Use | 2.3. Spare Parts and Accessories The following parts below can be reordered from orangedental GmbH & Co KG via your depot under the article number indicated. snap-on arm strap Art.Nr. zublup0499380 (long) Art.Nr. zublup0499390 (short) Battery unit ArtNr.

  • Page 10: Installation

    If the lamp is not already attached to the magnifying glasses, please contact Note: orangedental if necessary. Now allow the magnetic plug on the lamp, as shown in the illustration bellow, to snap into the battery casing coupling. Illustration: Plug for connecting the charging or lamp cable If you want to use the battery unit in the traditional way, attach the battery now to the clip on the rear side of your belt, your pocket or waistband.
  • Page 11 spot – Instructions for Use | Illustration: Installing the arm strap In order to attach the device to the arm, you should first of all put the suitable arm strap (shorter arm strap for delicate arms and longer one for larger arms) to the rear side of the casing underneath both spring arms.

  • Page 12: Usage

    spot – Instructions for Use | USAGE spot – is operated by means of a sensor surface situated in the middle of the battery casing and has some display elements which are not visible in normal operation. Switching on: When you touch the sensor surface with your finger (for less than a second), the lamp switches on.
  • Page 13 spot – Instructions for Use | Look at an even surface through the magnifying glasses. By pressing the lamp on the glasses up or down, you can adjust the way your field of vision is illuminated. Switching off: By briefly pressing the sensor surface with your finger again, you can switch the lamp off.

  • Page 14: Assembly Of Spare Parts And Accessories

    spot – Instructions for Use | Note: To avoid a deep discharge of the battery, please charge the battery every three months - even when not in use. ASSEMBLY OF SPARE PARTS AND ACCESSORIES 5.1. Mounting the spot-on blue 1. Disconnect the cable connection from the spot –...

  • Page 15: Mounting The Orange Filter

    spot – Instructions for Use | 5.2. Mounting the orange filter 1. Make sure that the pre-assembled grub screw does not protrude into the inside of the orange filter. 2. Place the orange filter on the spot – and screw in the grub screw using the Allen key.

  • Page 16: Safety, Handling And Maintenance

    spot – Instructions for Use | SAFETY, HANDLING AND MAINTENANCE 6.1. General spot – Remember that the illuminates very brightly when in operation. When using it, make sure that you do not shine the device into the eyes of patients or staff. Although the light capacity is low enough for the blinking reflex of the eye to prevent damage to the retina, the dazzling effect of the lamp is very strong as soon as the light shines towards eyes.

  • Page 17: Cleaning

    spot – Instructions for Use | spot – should be cleaned immediately after use in order to prevent any residual blood or protein from solidifying. 6.2.1. Cleaning Take the lamp off the battery unit and pull the arm strap out of the holder. First of all, remove any residue by wiping with a mild cleaning agent.

  • Page 18: Disinfection Agents For The Spot-On Nxt

    Take the device out of operation if there are visible ARNING signs of damage or any malfunctioning. Contact your orangedental service point in such cases. 6.4. Disposal spot – and the accessories contain a lithium polymer accumulator as well as components which are not suitable for disposal with normal household refuse.

  • Page 19: Specifications, Conformity

    – Instructions for Use | SPECIFICATIONS, CONFORMITY orangedental GmbH & Co. KG Aspachstrasse 11 | 88400 Biberach / Riss 7.1. Requirements for the Environment of Use spot – should only be operated by skilled and MPORTANT trained persons. Place the device so that is not exposed to direct sunlight.

  • Page 20: Electrical Characteristics

    spot – Instructions for Use | 7.3.2. Electrical Characteristics data unit supply voltage battery unit V DC max. power input 1500 battery LiPo 7.3.3. Optical Characteristics data unit Light intensity spot – 20 / 30 / 45 x1000 Lux normal/amplified/maximum approx. measured at a working distance of 25 cm Irradiance spot –...

  • Page 21: Ambient Conditions

    spot – Instructions for Use | 7.3.6. Ambient Conditions Operation conditions Use only in a normal climate temperature: +10°C to +40°C rel. humidity: 25 to 75% air pressure: 800 hPa to 1060 hPa Transport conditions temperature: -20°C to +60°C rel. humidity: 10 to 90% air pressure: 500 hPa to 1060 hPa...

  • Page 22: Electromagnetic Compatibility

    spot – Instructions for Use | 7.3.8. Electromagnetic Compatibility Guidance and manufacturer’s declaration – electromagnetic emissions spot – is intended for use in an environment as described below. spot – The customer or the user of the should assure that it is used in such an environment.
  • Page 23 spot – Instructions for Use | Guidance and manufacturer’s declaration – electromagnetic immunity spot – is intended for use in the electromagnetic environment specified spot – below. The customer or the user of should assure that it is used in such an environment.
  • Page 24 spot – Instructions for Use | Guidance and manufacturer’s declaration – electromagnetic immunity spot – is intended for use in an environment as described below. The customer or the user of the spot – should assure that it is used in such an environment.
  • Page 25 spot – Instructions for Use | NOTE 1 at 80 MHz and 800 MHz the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
  • Page 26 spot – Instructions for Use | Recommended separation distances between portable and mobile RF spot – communications equipment and the spot – is intended for use in an electromagnetic environment in which spot – radiated RF disturbances are controlled. The customer or the user of the can help prevent the electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment spot –...

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