Truflex - Truphatek

TM
Maximizes your intubation success
Instructions For Use
Truflex™ stylet
Read carefully, follow instructions and save for future reference.
www.truphatek.com
www.truphatek.com
TM
Maximizes your intubation success
©2012 Truphatek
All rights reserved
Manufactured by
Truphatek International LTD
P.O. Box 8051
Netanya, Israel, 42504
Phone: 972- 9-885-1155
Fax: 972-9-885-1212
helpdsk@truphatek.com
How supplied
Warranty Statement
The Truflex™ flexible stylet has been tested to
withstand over 100 repeated cycles of Sterrad
plasma systems and is guaranteed to be of good
quality and free from manufacturing defects in
material and workmanship for a period of 12
months from date of manufacture, as it appears
marked on the product.
This warranty is conditional on the product being
used, cared for, handled, cleaned, disinfected
and sterilized according to the manufacturer’s
instructions.
The above warranty does not cover units that
have been deemed defective due to misuse,
improper cleaning and handling, neglect,
accident, unauthorized repair, unreasonable
damage, improper storage or application
or that have worn out after a reasonable
lifetime of use.
Authorized Representative Europe
Medes Ltd.
5 Beaumont Gate
Shenley Hill, Radlett
Herts, WD7 7AR
England
Tel: +423-663-169205
Truphatek reserves the right to inspect prior
to repair or replacement any product that
is deemed by the customer to be subject to
manufacturing or materials defect.
Truphatek’s obligation shall be that warranty
specifically defined in this statement and shall
not be liable for any consequential, incidental,
direct or indirect damages or loss arising out of
the design, manufacture, sale, use or repair of
this product.
Part Number 410005 (single unit)
Each Truflex is supplied factory clean in a
unit blister pack containing an Instruction
For Use card.
Normal hospital practice would require the
unit to be sterilized before patient use.
Clinical experiences referring to this product
are listed on: www.truphatek.com
Truflex™ is a trademark of Truphatek
International Ltd. and should not
be used without prior written permission.
TM
41000505-1-5/12
Patent Pending
Approvals: ISO 9001:2008, ISO 13485:2003
FDA registered manufacturer
Description
The Truflex flexible stylet is a reusable device
manufactured from medical grade 304/316L
stainless steel. The dynamic tip can be flexed
in a vertical direction, up to an angle of
30°- 60° (depending on endotrachial tube
diameter) by using light handle pressure.
In this way, it allows the anesthetist to
more easily control the direction of the
endotracheal tube tip and to circumvent
the cricopharyngeal muscle.
An essential piece of equipment
for all difficult airway carts
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➌
➍
➋
➊
Benefits
Cleaning
Physicians who perform difficult intubation
procedures using a laryngoscope often
experience considerable difficulties navigating
the endotracheal tube in the limited space
available to them. The use of video-laryngoscopes
improves the view but appears to have increased
the navigation skills required to successfully
advance the endotracheal tube through the
epiglottis.
Immediately after use, the Truflex stylet should be
rinsed in running water under the tap and cleaned
using a soft brush to prevent any risk of encrusted
deposits.
The Truflex’s tongue-bending angle and unique
dynamic tip flexibility allows the clinician to
maneuver the endotrachial tube, containing
the stylet, and to direct it more easily towards
the required location.
Truflex has been designed to lock the endotrachial
tube into position during the actual intubation, yet
allow the physician to easily pull the stylet out of
the endotrachial tube using one finger at the end
of the intubation.
The Truflex can be inserted into
endotrachial tubes of sizes 6.5 to 8.5 mm
diameter since it has a stopper that can
be moved into various positions locking
the different lengths of endotrachial
tubes into position.
TM
➊ Flexible Element
➋ Stopper locking endotrachial tube
➌ Handle, controls the tongue angle
➍ Main Truflex rod
➎ Locking Slots
E-T Tube Sizes 6.5 to 8.5 mm
Warning
Truflex is compatible with treatment using
thermal disinfectors.
A suitable hospital disinfectant should be used
and manufacturer’s guidelines for recommended
exposure times and solution strengths must always
be followed. Chemical sterilants, containing
caustic ingredients, such as povidone-iodine
solutions, bleach, peroxide solution, sodium
hypochloride etc. should not be used since
they could lead to irreparable damage to the
instrument.
After exposure to any disinfectant solution, it is
essential to rinse the Truflex in warm water and
then to thoroughly dry all parts using warm air.
1. The Truflex tip should never extend beyond
the endotracheal tube eye.
2. Do not use the Truflex for tube insertion
beyond the vocal cords.
3. Thoroughly clean and sterilize the
product after every usage.
Sterilization
Instructions for use
Truflex may be autoclaved up to a maximum
temperature of 138˚C or as per manufacturer’s
recommended temperatures and time instructions.
Truflex is suitable for sterilization by ethylene oxide
(ETO) and STERRAD 100NX Standard Cycle plasma
systems.
1. Choose the appropriate endotrachial tube
according to the size of the patient. Tube must
be between sizes 6.5 to 8.5 mm.
2. Slide the Truflex stylet into the endotrachial
tube until the stylet tip reaches the endotracheal
tube eye - a position of 10 mm from the end
of the tube.
Warning
Take care that the Truflex stylet does not extend,
in any way, beyond this position since this is the
position for maximum flexibility.
3. Move the stopper by pressing its security screw
to fit the desired endotrachial tube size.
4. Insert the endotrachial tube fully into the
stopper, testing that it is locked into place
and that it cannot move independently.
5. Introduce the endotrachial tube into the mouth
at a 90 degree angle to the laryngoscope viewing
blade and progress towards the vocal cords.
6. Rotate the endotrachial tube ,in a 90 degree
anti-clockwise direction, until the tip of the
endotrachial tube can be clearly seen in the
laryngoscope view.
7. Use the Truflex handle to gently adjust the
tip up or down according to need.
Warning
Do not advance the endotrachial tube into the
vocal chords while it contains the Truflex stylet
within it.
8. Once the endotrachial tube is correctly placed,
disengage the Truflex stylet from the tube by
using slight pressure to disengage the stopper
from the endotrachial tube and withdraw it
from the patient.
9. Continue to complete intubation.
TM
Part # Description of parts