DCO-0599
Effective Date: 14-DEC-2018
LBL-6025 Rev B
Page 3 of 8
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.
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.