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In addition, when you use any of the other equipment We accept no liability in the event that these 7.2 Installation
that you have in your practice, make sure you instructions are disregarded or processes that
follow the directions for use for this equipment. have not been validated are used to prepare the Y-MK1-431 7.2.1 Charger
en As part of your responsibility for ensuring that the accessories for reuse. en
accessories are sterile, always make sure that only • Select the charger plug adapter which matches
validated cleaning, disinfection and sterilization Make sure undamaged sterile packaging is used. your power outlet (Fig. 2).
methods are used, that the equipment (sterilizer)
is regularly maintained and inspected, and that the
validated parameters are adhered to each time.
In addition, ensure that you always comply with 8.2.1 Pre-treatment
the applicable statutory rules and regulations 3 Europe USA Australia UK
with regard to hygiene in your practice or clinic. In • Pulp and dentine remnants must be removed
particular, this applies to the guidelines regarding immediately from the accessories; if necessary,
effective prion inactivation. use a brush to carefully clean the products (no later
For your own safety, when handling contaminated than 2 hours after use). Do not allow remnants to Fig. 3 Battery symbol is flashing red
dry on. After using the accessories on the patient,
accessories, always wear gloves, protective place them directly into a dish filled with a suitable
eyewear and a surgical mask. cleaning and disinfection solution (e.g. CIDEZYME ,
®
ENZOL ® Enzymatic Detergent Solutions, NOTE
Johnson & Johnson Medical, 0.8% for between Fig. 2 Plug adapters for charger The device with flashing red battery
WARNINGS 1 minute and 2 hours) for cleaning, pre- symbol is still functional and may be
• The measuring cable cannot be disinfection and interim storage. Make sure that • Slide the plug adapter downwards into the slots used for several treatments before the
autoclaved. the products are fully immersed. Then wash the until it locks in place with a click. device shuts down.
• The use of substances and materials accessories under running sterile, deionized water
other than those referred to above may or in a disinfection solution at least three times
damage the equipment and accessories. for one minute each time, in order to remove all WARNINGS Charging Screen
• Do not employ sterilization methods that visible traces of contamination and remnants. The • Prior to first use, the battery must be Battery status during battery charging is shown on
disinfectant should be aldehyde-free (aldehyde
use heat, radiation, formaldehyde, ethylene causes blood to stain permanently), tested for charged for 6 hours! the charging screen:
oxide or plasma. efficacy (e.g. VAH/DGHM or FDA certification or • Use the original charger only.
CE mark), suitable for disinfecting the accessories, Red: charging, low battery level
and compatible with the accessories (see section
8.2 Cleaning, Disinfection and 8.2.7, "Material resistance"). Yellow: charging, medium battery level
Sterilisation
(in accordance with DIN EN ISO 17664) 7.2.2 Rechargeable Battery Green: charging completed, battery
• Only use clean, soft brushes to manually remove fully charged
contamination and remnants, or a clean, soft cloth
®
The cleaning, disinfection and sterilization process or wipe that is only used for this purpose. Do not RAYPEX 6 is powered by a Nickel-Metal Hydride
applies only to the lip clip, file clip and touch probe. use metal brushes or wire wool. Check that no (NiMH) rechargeable battery. Battery status during
As long as they are treated with due care and are visible contamination or remnants remain, and the operation is shown on the main screen: To charge the battery, follow the next steps:
not damaged or contaminated, these accessories repeat the pre-cleaning process if necessary. • Make sure that the measurement cable is not
can be reused multiple times. Battery Symbol connected to the patient.
White: indicates battery level from fully charged to • Remove the measurement cable from RAYPEX 6.
®
approximately 20% of capacity.
Flashing red: When battery level drops under 20%, • Connect the external charger to the device jack
and plug it into the power outlet.
the indicator will turn red and start flashing. The
battery needs to be recharged (Fig. 3). • If the battery is fully discharged, e.g. when it has
not been used for a long period of time, it must be
recharged for 6 hours.
• If the battery is low, 4 hours recharging is
sufficient.
Endo Easy Efficient ®
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Y-MK1-431
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