INSTRUCTIONS FOR USE
Thank you for your purchase. Our Laryngoscopes are
ISO:7376:2009 compatible and manufactured with great care
in a US-FDA Audited, ISO:9001:2015 and 13485:2016 certified
facility and are designed for a prolonged, trouble free life.
INTENDED USE
Laryngoscopes are medical devices and should only be used by authorized personnel, who have
received adequate training in tracheal intubation.
Use only MR conditional Laryngoscopes in MRI environment.
It is the users responsibility to read and understand these instructions prior to use of this product and
comply with the medical waste disposal guidelines and federal laws which are applicable.
Note:
Great care must be taken when holding these devices. Do not drop or allow to come into direct
contact with sharp objects that would otherwise damage the product. After autoclaving, the product
should be allowed to slowly cool. Rapid cooling may result in damage to the product or reduced product
life. United States “Centre for Disease Control & Prevention” classified Laryngoscopes as ‘Semi-
Critical” items ( items that directly or indirectly contact patient mucous membrance of the respiratory
tract ) they should be sterilized or subject to high level of disinfection before reuse.
On October 24, 2011 Joint Commission issued a new standard related FAQ addressing
the processing & storage of Laryngoscope Blades. As per ‘AORN” the Joint
Commission surveyors / auditors will evaluate processes related to Laryngoscope
blades cleaning to ensure they are safe for use on next patient – this include checking
that Laryngoscope are processed properly either by sterilization or high level of
disinfection, and packed and stored in such a way that would prevent decontamination.
PRE-USE CHECKS:
Check all blades and handles for flaws or sharp edges. Attach blade to handle and
switch ON to check light intensity. If low light intensity or flickering is observed, replace
handle batteries. Ensure light is bright and steady. In the event of pre-use check failure,
return defective device to supplier for further inspection.
HANDLE:
Our fiber optic handles are Greenspec compliant and have a lamp located in
head harness which is further fitted with an automatic ON – OFF mechanism.
Conventional light laryngoscope handles have a metal contact pin in the center of head
harness to perform as an automatic ON – OFF.
BLADE:
Conventional light laryngoscope blade has a metal casing LED lamp near its
distal end. Modular F/O blade has a detachable metal F/O light tube on blades, which is
secured into green plastic block with grub screw onto blade heel. Integrated F/O blade
has its fibre optic channel completely sealed into the blade itself. This has no
removable part and is very ideal from cleaning point of view.
LAMP:
Great care should be taken to ensure direct contact with the lamp glass is
avoided with the exception of an appropriate laryngoscope blade. Only use genuine
lamps with these laryngoscopes. Allow lamps to cool before replacing.
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3
2
BLADE HANDLE ENGAGEMENT
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2
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FLEXION BLADE HANDLE ENGAGEMENT
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WARRANTY STATEMENT
Our Laryngoscope products and parts are made from medical grade material/alloys and warranted to be of good
quality and free from manufacturing defects in material and workmanship for specified period from week of
manufacture, as it appears marked on the product. (i.e. LOT 0708) – means manufactured in 07 week of year
2008.
Replacement product will be provided without charge for any of our
product not meeting this warranty, subject to
the following terms and exceptions :
Integrated / Modular fibre optic blades & light guides, Flexion
Blades, Conventional Blades, all Fibre
Optic Handles and Conventional Handles
covering all sizes, are warranted to perform for a period of 24
months from week of manufactured as it appears etched in the form of LOT number
.
MR Conditional
battery packs are warranted by the manufacturer as mentioned on battery packs.
All Disposable
Laryngoscope Blades and Handles
are warranted for a period of 18 months from week of
manufacture as it appears on the package.
All of the above warrantees are conditional to the product being used, cared for, handled, cleaned, disinfected
and / or sterilized according to the manufacturer's instructions as they appear in the
INSTRUCTIONS FOR USE
that accompany each of our product.
The above warranty does not cover products that have been deemed defective due to misuse, improper
cleaning and handling, neglect, accident, improper storage or application, unauthorized repair or unreasonable
damage.
We will have no obligation under this warranty for:
Consumables such as Bulbs, LED's or Batteries,
Products labelled “ / Disposable / Single Patient Use / Do not Autoclave” where any attempt has
been made to reprocess them.
Reusable products that have been reprocessed without following the appropriate use, care, repair and
reprocessing guidelines and instructions provided by manufacturer in the Instructions or User Manual.
We 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. Our obligation shall be the 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 the products.
Only use genuine accessories and lamps with our products. Alternatives may shorten product life and may
invalidate product guarantee. Our sole obligation under this warranty is to repair or replace, at our discretion, any
component (e.g. laryngoscope blade handle, battery, lamp), which is found upon our inspection to be, defective in
material or workmanship during the period prescribed above. Such product will be repaired or replaced without
charge to the user provided that, (1) prior written approval is acquired before returning any product, (2) freight to
the manufactory is pre-paid and (3) any product returned must be decontaminated and sterilized and be
accompanied with relevant documented evidence. This warranty does not apply to battery or bulb depletion, wear
or failure occurring as a result of any of the following:
Abuse, misuse, any alteration or modification made to the product without our express written consent, attempted
disassembly, neglect, improper installation, or any other use inconsistent with the specification or warnings or
recommended operating practices specific to the blade / handle, battery or bulb.
THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES (EXCEPT OF TITLE) EXPRESSED, IMPLIED, OR
STATUTORY INCLUDING ANY WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR
PURPOSE.
