General Instruments Cleaning &

Fading of anodized aluminium
alumin
instruments may be
accelerated if cleaning and sterilization instructions are not
followed.
General Instruments Cleaning & Sterilization Guide
Reusable Instruments Instructions for Use
These instructions for use (IFU) are intended for reusable
surgical instruments labelled with the FusionKraft™ name.
This cleaning and sterilization guide does not replace
instrument-specific instructions for use already included
with the instrument.
How Supplied
Instruments are packaged as non-sterile.
sterile. Cleaning and
sterilization of instruments must occur prior to use.
Limitations on Reprocessing
Repeated processing
sing has minimal effect
FusionKraft™ instruments.. End of life is
determined by wear and damage due to use.
on the
normally
Warnings
FusionKraft™ instruments shall be used in accordance with
these Instructions for Use. Read all sections of this IFU
prior to use. Improper use of these instruments may cause
serious injury.
In addition, improper care and maintenance of the
instruments may render the instruments unfit prior to patient
use and may cause serious injury to the health care
provider or the patient.
Cautions
If there are any variations between these Instructions for
Use and either the facility’s policies and / or the cleaning /
sterilizing equipment manufacturer’s instructions, those
variations should be brought to the attention of the
appropriate responsible hospital personnel for resolution
before proceeding with cleaning and sterilization of the
FusionKraft™ instruments.
Use of an instrument for a task other than what it is
intended for will usually result
sult in a damaged or broken
instrument.
Prior to use, inspect the instruments to ensure proper
function and condition. Do not use the instruments if they do
not satisfactorily perform their intended function or if they
have physical damage.
ical shock or overstressing the instruments.
Avoid mechanical
Close distal ends prior to insertion or removal through
cannulas.
Always use caution when inserting or removing the
instruments through the cannula. Lateral pressure on the
instrument during removal can damage the working tip, and
/ or shaft of the instrument.
©2016 Myra & Co. All Rights Reserved.
Myra & Co.
#293, Ground Floor, Niti Khand – 2,
Indirapuram. Ghaziabad. U.P.-201010
201010. INDIA.
Be sure the tips are closed and the instrument is pulled
straight out until completely clear of the cannula to avoid
catching the valve assemblies in cannulas or dislodging the
cannula.
Only the cleaning and sterilization processes which are
defined within these Instructions for Use have been
validated. Use only neutral pH (6-8)
(6
detergent solutions.
Pre-processing
processing Instructions
Initiate cleaning of the instruments within 2 hours of use.
Transport the instruments via the institutions established
transport procedure.
Remove excess gross soil / debris as soon as possible after
use by rinsing or wiping the instrument.
All the instruments must be processed in the completely
open position (i.e. jaws, catch etc.) to allow solution contact
of all surfaces..
Note: that applicable instrument disassembly should not
require any mechanical tooling (i.e. screwdriver, pliers etc.)
unless otherwise indicated.
Manual Cleaning Process
Enzymatic / Neutral
eutral pH Detergent
1. Ensure all pre-processing
processing instructions are followed prior
to cleaning.
2. Prepare the enzymatic/neutral pH detergent solution,
utilizing drinking water with a temperature range of 27°C to
44°C (81°F to 111°F), as per manufacturer’s
m
instructions.
3. Place the instrument in the open / relaxed position with
jaws / catch open. Completely immerse the instrument in
the detergent solution and allow it to soak for a minimum of
3-5 minutes.
Actuate all movable parts during the initiation of the soak
time.
4. Using a soft bristled brush, remove all visible soil / debris
from the instrument.
Actuate the instrument while brushing, paying particular
attention to the hinges, crevices and other difficult to clean
areas.
Note: It is recommended that the detergent solution be
changed when it becomes grossly contaminated (bloody
and/or turbid).
5. Rinse the instrument by completely immersing it in
treated water with a temperature range of 27°C to 44°C
(81°F to 111°F), for a minimum
mini
of 30 seconds to remove
any residual detergent and / or debris.
lint
towel.
6. Dry the instrument with a clean, lint-free
7. Visually examine each instrument for cleanliness.
FusionKraft™
FusionKraft™t
8. If visible soil / debris remains, repeat cleaning procedure
until the instrument is thoroughly clean.
Automatic Cleaning Process
Enzymatic / Neutral pH Detergent
•
•
Before sterilizing, lubricate the instrument with instrument
milk or a steam permeable
eable / water soluble lubricant,
following the lubricant manufacturer’s instructions.
Ensure all pre-processing
processing instructions are followed prior
to cleaning.
Clean the instruments via the automatic cleaning
parameters below.
Phase
Minimum
Recirculation
Time
Water
Temperature
Detergent Type &
Concentration
(If Applicable)
Pre-Wash
15 Sec
Cold Drinking
Water 1°C - 16°C
(33°F - 60°F)
N/A
Enzyme
Wash
60 Sec
Hot Drinking
Water
43°C - 82°C
(110°F - 179°F)
Wash
120 Sec
Drinking Water
43°C - 82°C
(110°F - 179°F)
•
•
•
Rinse
15 Sec
Pure
Rinse
10 Sec
Drying
N/A
Drinking Water
43°C - 82°C
(110°F - 179°F)
Treated Water
43°C - 82°C
(110°F - 179°F)
N/A
- Detergent: pHpH
neutral/e
neutral/enzymatic
- Concentration: As
per the Detergent
Manufacturer’s
recommendations
- Detergent: pHpH
neutral cleanser
- Concentration: As
per the Detergent
Manufacturer’s
recommendations
N/A
N/A
N/A
If visible moisture is present dry the instrument with a
clean, lint-free towel.
Visually examine each instrument for cleanliness.
If visible soil / debris remains, repeat cleaning procedure
until the instrument is thoroughly clean.
Let instruments drip dry for three (3) minutes before
packaging for sterilization.
Packaging
Instruments can be loaded into dedicated packaging
systems. Sterilization wrap material must be cleared for the
applicable sterilization modality by the respective country’s
regulatory body. Use in accordance with packaging
manufacturer’s sterilization instructions being sure to
protect jaws and the cutting edges from damage.
Sterilization
All the instruments must be processed in the completely
open position (i.e. jaws, catch etc.) to allow sterilant contact
of all surfaces. Note that applicable
app
instrument disassembly
should not require any mechanical tooling (i.e. screwdriver,
pliers etc.) unless otherwise indicated.
All instruments with concave surfaces shall be configured
so that water pooling does not occur.
Storage
After sterilization, the instruments should remain in
sterilization packaging and be stored in a clean, dry
environment.
Warranty
FusionKraft™ offers a 6 month Standard Warranty on every
surgical instrument bearing the FusionKraft™ brand name
(unless otherwise
rwise noted). Surgical instruments are
guaranteed to be free of functional defects in workmanship
and materials when used normally for its intended surgical
purpose. Any FusionKraft™ instrument proving to be
defective within the warranty period will be replaced or
repaired at no cost to the customer.
Note: the final rinse step should be performed with treated
water:purified, de-ionized,
ionized, distilled or reverse osmosis.
Contact Information
If drinking water is used as part of the final rinse, ensure
corrosion does not occur.
Inspection/Maintenance
Proper care and handling is essential for satisfactory
performance of any FusionKraft™ surgical instruments.
ins
Myra & Co.
#293,
293, Ground Floor, Niti Khand - 2,
Indirapuram. Ghaziabad. Uttar
U
Pradesh.
INDIA. PIN – 201010
Phone +91 120 6530330 (8 Lines)
The previous cautions should be taken to ensure
ensur long and
trouble-free service from all FusionKraft™ surgical
instruments. Inspect the instruments before each use for
broken, cracked, tarnished surfaces, movement of hinges,
and chipped or worn parts. If any of these conditions
appear, do not use the instrument. Return instruments to an
authorized repair service centre for repair or replacement.
©2016 Myra & Co. All Rights Reserved.
Myra & Co.
#293, Ground Floor, Niti Khand – 2,
Indirapuram. Ghaziabad. U.P.-201010
201010. INDIA.
FusionKraft™
FusionKraft™t
Hotline +91 120 6401193
Mobile +91 99999 06920
+91 99711 16920
www.myraandcompany.in
For Domestic Enquiries:
customer.support@myraandcompany.in
For International Enquiries:
Enquiries
org@myraandcompany.in
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