orangedental spot-on nxt Instructions For Use Manual Download Page 8

Instructions for Use |

 

spot–

on

nxt

 

Page 6 of 24 

Date: 18.05.2021 

 

00.005.444-08 | EN 

2.

 

ABOUT THE PRODUCT 

2.1.

 

Intended Use 

The 

spot–

on

nxt

 

is used for illumination of the oral cavity of a patient using 

a binocular loupe system of the practitioner. The 

spot–

on

nxt

 

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. There are no 
restrictions regarding the intended patient group. 

As an accessory to the spot-on cordfree, the 

spot–

on

blue

nxt

 improves the 

visibility of composites and composite residues as well as plastic residues 
from  orthodontic  brackets  by  using  a  special  spectral  range.  The 

spot–

on

blue

nxt

  is  intended  for  use  by  orthodontists,  dentists  or  dental 

professionals in dental workplaces. There are no known contraindications 
for the use of the 

spot–

on

blue

nxt

. There are no restrictions regarding the 

intended patient group. 

2.2.

 

Delivery scope 

 

 

 

 

 

 

 

 

    
Allen key 

 

 

 
 
spot–

on

nxt 

 

lamp 

This is normally 
already mounted  
on the glasses 

 
 
Battery unit for 
attachment to  
arm or belt 

Power supply 
unit for charging 
the battery unit 

Charging cable for 
connecting power 
supply unit and  
battery unit 

Summary of Contents for spot-on nxt

Page 1: ...Instructions for Use...

Page 2: ......

Page 3: ...ase keep them to hand If you pass this product on to a third party please give them this document too as it contains important information on commissioning and handling the product Please use these in...

Page 4: ...revention regulations as well as the regulation concerning the installation operation and use of active medical products German regulation MPBetreibV the operation the maintenance the proper and safe...

Page 5: ...on bluenxt 12 5 2 Mounting the orange filter 13 6 Safety Handling and Maintenance 14 6 1 General 14 6 2 Hygiene 14 6 2 1 Cleaning 15 6 2 2 Disinfection 15 6 2 3 Disinfection Agents for the spot onnxt...

Page 6: ...points The meaning of the symbols which are used on this product its packaging or in these instructions is listed below CHECK INSTRUCTIONS This symbol indicates that this user manual contains importa...

Page 7: ...that the product is a medical device CE MARKING This symbol attached by the manufacturer indicates that the medical product is in conformity with and fulfills all requirements of the medical device re...

Page 8: ...the spot on cordfree the spot onbluenxt improves the visibility of composites and composite residues as well as plastic residues from orthodontic brackets by using a special spectral range The spot o...

Page 9: ...rts 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 zubl...

Page 10: ...p below the magnetic socket while the battery unit is charging The lamp has two lighting levels bright during the main charging time and darker in the precharge time and recharging time Note If the la...

Page 11: ...horter arm strap for delicate arms and longer one for larger arms to the rear side of the casing underneath both spring arms Now press the casing with the magnetic coupling upwards on your upper arm T...

Page 12: ...current battery charge level and the set light intensity are displayed Battery charge level green 3 lamps 66 100 2 lamps 33 66 1 lamp 1 33 of a fully charged battery Light intensity yellow 3 lamps max...

Page 13: ...rom becoming unpleasantly warm the highest illumination level is switched down to the middle level after 5 minutes It is likewise switched down to the middle illumination level after the device is swi...

Page 14: ...AND ACCESSORIES 5 1 Mounting the spot on bluenxt 1 Disconnect the cable connection from the spot onnxt battery 2 Remove the spot onnxt from your magnifying glasses 3 Attach the spot on bluenxt to you...

Page 15: ...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 onnxt and screw in the grub screw...

Page 16: ...t be directed towards the eyes Do not use the spot on cordfree for eye examinations examination of pupils Increased risk of glare Note that the reaction of the eyes decreases under the influence of dr...

Page 17: ...positively with regard to their compatibility with the plastics used We cannot guarantee that other agents will not affect the surfaces of the battery unit Wipe the battery casing the arm strap the ca...

Page 18: ...u 6 3 Servicing and Maintenance The device may only be repaired by a service point authorized by orangedental WARNING Take the device out of operation if there are visible signs of damage or any malfu...

Page 19: ...1 Requirements for the Environment of Use IMPORTANT The spot onnxt should only be operated by skilled and trained persons Place the device so that is not exposed to direct sunlight 7 2 Product labelin...

Page 20: ...plified maximum approx measured at a working distance of 25 cm 20 30 45 x1000 Lux Irradiance spot on bluenxt normal amplified maximum approx measured at a working distance of 20 cm 39 58 87 W m 7 3 4...

Page 21: ...C rel humidity 10 to 90 air pressure 500 hPa to 1060 hPa Storage conditions temperature 5 C to 50 C rel humidity 10 to 75 air pressure 700 hPa to 1060 hPa 7 3 7 EMC Classification data EN 60601 1 2 g...

Page 22: ...agnetic environment guidance RF emissions as per CISPR 11 Group 1 The spot onnxt uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any i...

Page 23: ...supply lines 1 kV for input output lines Not appli cable Mains power quality should be that of a typical commercial or hospital environment Surges IEC 61000 4 5 1 kV line s to line s 2 kV line s to li...

Page 24: ...le RF communications equipment should be used no closer to any part of the spot onnxt including cables then the recommended separation distance calculated from the equation applicable to the frequency...

Page 25: ...mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To access the electromagnetic environment due to fixed RF transmitters an electro...

Page 26: ...power of transmitter in Watt Separation distance according to frequency of transmitter m 150 kHz to 80 MHz in the ISM bands d 1 17 P 80 MHz to 800 MHz d 1 17 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0...

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