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1)
Concentration levels specified by the manufacturer of the detergent must be strictly
adhered to. Contact times specified in these instructions for use must be strictly adhered
to. Use only freshly prepared solutions.
2)
Do not soak the handpiece in Isopropyl Alcohol or other corrosive liquids that may not be
compatible with the instrument.
3)
Always use fresh volumes of water for rinsing. Do not reuse rinsing water for rinsing or
any other purpose.
10.1.
CLEANING INSTRUCTIONS
Proper cleaning must be performed prior to sterilization. An effective cleaning process is essential to ensure
effective sterilization.
Clean the handpiece as soon as possible after use.
If it is not possible to clean/rinse the handpiece immediately following a procedure, the instrument should be
placed in a basin with clean lukewarm tap water until proper cleaning can be commenced per the instructions
below.
Cleaning Agent:
Use ENZOL® or an equivalent neutral pH enzymatic detergent. Enzymatic detergents aid in the removal of
organic soil such as blood.
Cleaning the Handpiece:
1)
Disassemble the handpiece from the other system components.
a.
Remove the shaver blade/RF probe from the handpiece.
b.
Dispose of all used shaver blades/RF probes according to hospital regulations.
c.
Disconnect the handpiece from the RELIGN Controller.
2)
Attach the soaking cap to the cable connector.
Caution
Always install the soaking cap prior to cleaning or sterilization. If moisture reaches the
connection pins of the cable connector, it could damage the connector.
3)
Gently and thoroughly rinse the handpiece under running lukewarm tap water 72° - 109°F (22° - 43°C)
for a minimum of 2 minutes, flushing water through all passages.
4)
Lay the handpiece horizontally in a clean pan.
DCO-1394
Effective Date: 12-JAN-2022
5)
Prepare the cleaning solution, enzymatic neutral pH cleaner (ENZOL® or equivalent), in accordance with
the concentration defined by the manufacturer of the detergent.
6)
Add a sufficient amount of the prepared cleaning solution to the pan to completely cover the handpiece.
Caution
Do not immerse the handpiece when it is hot. This may damage the handpiece.
7)
Soak the handpiece for a minimum of 10 minutes. Move the handpiece back and forth 5 times to ensure
that all surfaces are exposed to cleaning solution. This will reduce blood, protein, and mucus from the
instrument.
8)
Flush the cavity and lumens of the instrument 5 times with minimum 25mL volume of cleaning solution
using a disposable syringe.
9)
Scrub the Shaver Blade/RF Probe Cavity using the Shaver Blade Cavity cleaning brush for a minimum of
1 minute.
10)
Scrub the Motor Shaft using the Motor Shaft cleaning brush for a minimum of 1 minute.
11)
Scrub the Fluid Channel using the Fluid Channel cleaning brush for a minimum of 1 minute.
12)
Ensure that all interior surfaces, crevices, lumens, cavities, and holes of the handpiece are scrubbed
thoroughly to remove any visible debris.
13)
Scrub the exterior surface of the handpiece with a gauze pad soaked in the cleaning solution for a
minimum of 1 minute.
LBL-6059 Rev D
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