flexicare 040-021U Instruction Manual

INSTRUCTIONS AND GUIDELINES
FOR REPROCESSING FLEXICARE
REUSABLE LARYNGOSCOPE
HANDLES & BLADES:

Reprocessing should be undertaken by
specialists with the necessary training
and understanding of the process and
equipment. These instructions are
intended for use by these specialists and
should be read in conjunction with all
other relevant manufacturer’s instructions,
hospital policies, local guidelines/
regulations.
Immediately after use and before
cleaning, remove the batteries and light
source from the laryngoscope.
To remove from a conventional blade,
unscrew the bulb from the tting.
To remove the light source from a bre
optic handle, unscrew the knurled
housing from the underside of the blade
block.
Remove the blade from the handle and
immerse both soiled components in a
holding solution of disinfectant/enzyme
solution.
Precautions
- Use pre-approved packaging
designed for use with your
sterilisation equipment.
- Follow all manufacturer’s instructions.
- Prior to sterilisation, ensure the
handle and blade is completely dry
and visually clean. If contaminants are
visible, repeat the decontamination/
cleaning procedure.
- Always wear appropriate PPE and
handle devices and materials with
care.
- If the device will be unused for
prolonged periods, remove the
batteries prior to storing.
- Always check the condition of the
batteries by switching on the light
source before commencing clinical
procedure.
Warnings and Cautions
- Avoid using mineral acids and
abrasive agents.
- DO NOT use sterilants with caustic
ingredients, such as surgical scrub
solutions, peroxide solutions, bleaches,
or povidone-iodine solutions.
- DO NOT sterilise along with sub-
standard stainless steel instruments
as this may cause severe damage.
- No part of the process should
exceed 138°C.
- Ultrasonic cleaning and ash
autoclaving is not recommended.
Decontamination/Cleaning
Clean the removed light source using
a cloth dampened with 70% isopropyl
alcohol.
Disassembled handles and blades should
be decontaminated as soon as possible
after use by either:

A. Automated washer/disinfector:
Use only validated washer/disinfectors
and cleaning agents. Follow the washer/
disinfector manufacturer’s instructions for
use, warning and recommended cycles.
B. Manual processing:
Use dedicated equipment and Personal
Protective Equipment (PPE).
Fully submerge the laryngoscope handle/
blade in a compatible dilute detergent
solution. Brush/scrub/wipe all surfaces to
remove all visual contamination.
Remove from the solution and allow to
drain.
Rinse thoroughly with clean water and
allow to drain before drying.
Sterilisation
Flexicare recommends reprocessing
laryngoscopes blades and handles
through sterilisation. Follow instructions
and warnings as issued by manufacturers
of any decontaminates, disinfectants and
cleaning agents used.
Please adhere to the following
laryngoscope autoclave parameters:
Temp: 134 -138°C, Pressure: 2.25bar,
Cycle time: 3 minutes
Other forms of sterilisation may be
available such as an Orthophthalaldehyde
(OPA) soak and Ethylene Oxide (≤65°C).
These are suitable only if used in
accordance with the manufacturer’s
instructions. If in doubt, consult the
manufacturer.
REUSABLE LARYNGOSCOPE
HANDLES AND BLADES
120mm
160mm

Catalogue
Number
Batch Code Product
conforms with
Directive
93/42/EEC
Consult
Instructions
for Use
Caution Non-sterile
Product not
made with
Phthalate
DEHP
Product not
made with
natural rubber
latex
Manufactured
by
SYMBOLS GLOSSARY Before Next Use
After reprocessing, ret the light source
and reassemble the bre optic handle/
ret the bulb into a conventional blade.
To test function, t the batteries and
connect blade to the handle. Pull blade
to open position. If unit fails to illuminate
or light ickers, check the security of the
bulb and batteries.
Batteries
Refer to the battery manufacturer’s
guidelines on use and disposal of
batteries.
The following batteries are recommended:
WARRANTY STATEMENT
Flexicare Medical Limited warrants
that the product purchased meets the
labelled specications of the product
and will be free from defects in
materials and workmanship that occur
within ve (5) years from the date of
purchase. Consumables, such as bulbs
and batteries, are excluded from the
warranty.
This warranty does not cover damage
caused by:
1. Handling during shipping.
2. Use or maintenance contrary to
labelling and instructions, including
but not limited to incorrect
disassembly, reprocessing and
reassembly.
3. Alteration or repair by anyone not
authorised by Flexicare Medical
PART NUMBER BATTERY TYPE
040-021U/011U 2x C
040-022U/012U 2x AA
040-023U/013U 2x AA
040-813U 2x C
040-814U 2x AA
040-815U 1x CR 123 (Li-on)
040-811U/821U 2x C
040-812U/822U 2x AA
040-823U/824U 2x AA
Flexicare Medical Ltd.
Cynon Valley Buisness Park,
Mountain Ash,
CF45 4ER, UK. United Kingdom
[phone]
[phone]
enquiries@exicare.com
www.exicare.com
FC2149 | VP5500-80A | 082017
Abuse, misuse or accidental damage
If a product covered by this warranty
is determined to be defective because
of defective materials, components, or
workmanship, and the warranty claim
is made within the warranty period
described above, Flexicare Medical
Limited will, at its discretion, repair or
replace the defective product free of
charge.
Written authorisation must be obtained
from Flexicare Medical Limited to
return the product prior to sending it
with carriage paid to Flexicare Medical
Limited’s designated agent.
This warranty is in lieu of all other
warranties, express or implied, including
but not limited to, the implied warranties
of merchantability and tness for a
particular purpose. Flexicare Medical
Limited’s obligation under this warranty
is limited to repair or replacement of
products containing a defect. Flexicare
Medical Limited is not responsible for
any indirect or consequential damages
resulting from a product defect covered
by the warranty.
This warranty shall be governed by and
construed in accordance with Flexicare
Medical Limited’s Terms and Conditions.
Limited.