PSV-1L and PSV-2L •
Prima Series
®
Vaginal LEEP Specula
Directions for Use • English
(continued)
C
Cleaning Method (after each use)
1.
Rinse and/or pre-soak.
2.
Manually clean with brushes using a mild soap
and warm water.
3.
Using a round bristle brush, clean inside the tip channel
using warm water, then cleaning agent,
then warm water again.
4.
Rinse.
5.
Enzymatic cleaner.
6.
Rinse.
7.
Dry with cloth or gauze and compressed air.
8.
Inspect.
9.
Prepare for storage and/or sterilization.
NOTE:
Dry instruments completely with filtered compressed air
(including inside channels) and/or a dry oven [maximum
temperature 280 °F (138 °C)].
SPECIAL LEEP SPECULA CLEANING
1.
Although stain resistant,
Prima Series
®
specula may
be stained by Lugol’s and therefore should be cleaned
immediately after use with StainEnder™
or a similar solution.
2.
Wash the specula after use with hot soapy water. Rinse
with hot water. To minimize the potential of
contaminating the StainEnder solution, disinfectant
should be used prior to inserting them into the cleaning
solution.
3.
Completely immerse the disinfected specula in
undiluted StainEnder. Allow the instrument to
soak until all stains are removed. Any permanent Lugol
stains will appear as a whitish discoloration after
autoclaving.
D
Sterilization with an Approved Liquid Chemical Sterilant
Specula must be cleaned thoroughly following
A
,
B
and
C
,
prior to cold sterilization. Cold soak solutions with 2%
glutaraldehyde solution can be used for sterilizing the
instruments. Specula are to be
fully
immersed. Follow the
manufacturer’s instructions for sterilization times. Soak and
rinse thoroughly in two separate sterile, deionized water
baths. Dry specula.
E
Reassembly
Reassemble the yoke to the remainder of the speculum
assembly using the knurled nut removed earlier.
STORAGE
Thoroughly dried specula should be stored individually in a
moisture-free area in a protective tray with partitions. Protect
with cloth or gauze if stored in drawers.
RECOMMENDED STEAM AUTOCLAVE STERILIZATION
PARAMETERS
•
The specula should be thoroughly cleaned of all foreign
matter prior to sterilization following
A
through
C
.
•
Follow the manufacturer’s instructions for operating and
loading the steam autoclave.
•
There must be direct steam exposure to all surfaces of
the specula being sterilized.
•
Autoclave temperatures should not exceed 280 °F
(138 °C); pressure should not exceed 32 PSI
(2.2 atmospheres).
•
Standard cycle of 270 °F (132° C) for 10 minutes will vary
depending on autoclave model, autoclave size, load size, and
load configuration.
Allow longer times for lower temperatures. Allow instruments to
cool down from autoclave to room temperature. Do not immerse
in any fluid until the instrument has been allowed to cool.
RECOMMENDED HOSPITAL ETHYLENE OXIDE STERILIZATION
PARAMETERS
•
Specula should be thoroughly cleaned of all foreign matter
prior to sterilization following
A
through
C
.
•
Follow the manufacturer’s instructions for operating and loading
the sterilizer and utilize a valid EO cycle.
•
There must be direct exposure to all surfaces of the instruments
being sterilized.
•
Instruments should be sterilized in their “open” position.
•
Contact of plastic to bare metal should be avoided.
Ethylene Oxide Cycle
Temperature
125 °F–130 °F (52 °C–54 °C)
50% RH (pre-humidity) 60 minutes -0/+10 minutes
Pre-vacuum
24” Hg ± 2” Hg (61 cm Hg ± 5 cm Hg)
Gas Pressure
6–8 PSIG (550–660 mg/L EO)
Exposure Time
4 hours minimum -0/+0.25 hours
Post Vacuum
24” Hg 2X ± 2” Hg
(61 cm Hg 2X ± 5 cm Hg)
Aeration
12 -0/+1 hours at 120 °F (49 °C)
NOTE:
The particular EO cycle must be validated per the
equipment manufacturer’s requirements. It is recommended that
each institution employ procedures, which include the use of
biological indicators in order to determine the effectiveness of
the ethylene oxide process.
EXPLANATION OF SYMBOLS
35634-DFU • Rev. A • 7/14
95 Corporate Drive
Trumbull, CT 06611 USA
Phone: (800) 243-2974
Fax: (800) 262-0105
www.coopersurgical.com
EMERGO EUROPE
Molenstraat 15
2513 BH, The Hague
The Netherlands
International
Phone: (203) 601-9818
Fax: (203) 601-4747
EC REP
REF
Reorder Number
Authorized Representative in the European Community.
EC REP
Product conforms to the Medical Device Directive 93/42/EEC
Prima
®
&
Prima Series
®
are registered trademarks of CooperSurgical, Inc.
CooperSurgical is a registered trademark of CooperSurgical, Inc.
StainEnder™ is a trademark of CooperSurgical, Inc.
© 2014 CooperSurgical, Inc.
Made in the USA
Consult instructions for use.
Not made with natural rubber latex.
U.S. Federal law restricts this device to sale by or on
the order of a licensed physician.
Manufacturer
CooperSurgical, Inc.
95 Corporate Drive
Trumbull, CT 06611 USA
LATEX
R
x
Only
N
O
N
S
TER
I
LE
Non Sterile
