Font: http://www.meyco.chMeyco diamond
scalpels (applicable to ME100-ME799)
Description
Diamond scalpels are reusable instruments, consisting of a
handle and a diamond blade. The blades are made from natural
diamond and measure between 100mm
and 200mm
thick; the handles are made from titanium.
Applications
Diamond scalpels are designed for various eye operations.
Precautions
-
Read instructions before use
-
Diamond scalpels are not sterile and must be sterilised.
-
Diamond scalpels must be handed to surgeons with the
blade retracted and handed back by them with the blade in the
same position. They must not be placed opened on
the instrument tray.
Instructions for use
-
Diamond scalpels must be thoroughly cleaned and sterilised
before use. Diamond scalpels must also be cleaned and then
sterilised after every subsequent use. For instructions on how
to clean and sterilise diamond scalpels please refer to the
section entitled Cleaning and Sterilisation.
-
The diamond blades must never come into contact with other
instruments. Special care must therefore be taken during
surgical operations, to ensure that the blades do not come into
contact with instruments such as forceps/tweezers or sharp
surgical instruments.
-
Ensure that diamond blades are not damaged before use. Damaged
diamond scalpels should not be used. The blades can be
re-sharpened.
-
After every use of a diamond scalpel, care must be taken to
ensure that the blade is pulled back into the handle, using the
pressure or bayonet mechanism.
Cleaning
Immediately after using a diamond scalpel, the blade must be
rinsed with water using a 20ml spray, preventing cell particles
or visco-elastic materials from sticking to the blade.
Dirt on the titanium handle can be removed using a small soft
brush. Care must be taken to ensure that the blade has been
retracted into the handle.
Manual cleaning
The following cleaning process has been approved in accordance
with the ASTM standard test method E 2314-03 (with a germ
reduction rate of up to 410). The manufacturer
recommends manual cleaning.
-
Immediately after use, the blade must be rinsed with water using
a 20ml syringe
-
The diamond scalpel must be placed in an alkaline cleaning
solution (pH ≥ 10) for at least 12 minutes at 55°C
-
The diamond scalpel must then be neutralised for 2 minutes in
citric acid and then washed for at least 2 minutes in running
water (3l/min).
Machine cleaning
In accordance with the recommendations of RKI, diamond scalpels
must be cleaned in a washing machine designed for micro-surgical
instruments. The manufacturer’s instructions should be followed.
This is not a procedure validated by the diamond scalpel
manufacturer.
Note:
After cleaning, the condition of the instrument must be checked.
Following this, the diamond scalpel must be immediately placed
in the sterilisation box or in another suitable container.
Diamond scalpels can also be cleaned using ultra-sound cleaning
systems.
Sterilisation
·
Diamond scalpels must be sterilised before each use.
·
Diamond scalpels must be sterilised with the diamond blades
retracted. Please therefore ensure that the blade has been
pushed back into the titanium handle.
·
Sterilisation filters must be fitted with protective materials
(cushioned mats).
The above specifications meet the industry standards for steam
sterilisation cycles.
Since there are variations in different steam sterilisation
systems and the levels of germs on instruments in clinical use
vary greatly, ANTON MEYER & CO. AG cannot provide any specific
data to guarantee an appropriate level of sterilisation. Every
hospital must check the correct procedures for guaranteeing a
proper level of sterilisation. Please refer to the current
ANSI/AAMI standards on hospital procedures for steam
sterilisation and sterilisation guarantees or the hospital’s own
procedures for the most suitable specifications.
For steam sterilisation, please refer to ANSI/AAMI standards
and recommended practice volume 1: Sterilisation, ST46-1993,
Section 5.8.
For flash processes, please refer to ANSI/AAMI standards for
“Good Hospital Practice”: Flash Sterilization – Steam
sterilisation for “Patient care items for immediate use”.
ST37-1996, Section 5.4
We recommend that packaged diamond scalpels should be steam
sterilised at 270°F (134°) either in a centrifugal cycle for 18
minutes or in a flash cycle for 18 minutes.
Note:
-
Diamond blades are made from an extremely hard but
sensitive material. Handle these ultra-sharp blades carefully to
avoid damage.
-
Mechanical contact must be prevented.
-
Diamond scalpels must be cleaned and sterilised before
each use.
-
After use the blade must be immediately retracted into
the titanium handle.
-
When used correctly, diamond scalpels can withstand
several hundred cleaning and sterilisation cycles.
-
Diamond scalpels must never be stored un-cleaned.
Diamond
scalpels (RK-Blades) with a micrometer (ME400 – ME499)
Setting the micrometer dial;
We recommend that the cutting depth should be checked. The
cutting depth can be measured using an ME409 (for DK-Blades
[double edged]) or ME459 (for M-Blades [single edged]) device.
Guarantee
ANTON MEYER & CO. AG provides a 3-year guarantee for all
mechanical components, on condition that the scalpels are
used correctly with the titanium handle.
Manufacturer:
ANTON MEYER & CO. AG
Helmstrasse 1
CH-2560 Nidau
Tel.:
Fax: +41 32 331 52 57 |