Quality and Manufacturer Warranty
Quality and Manufacturer Warranty
FRANCIS CORPORATION is totally committed to today’s quality requirements. We
comply to and is registered with ISO 9001:2008, ISO 13485:2016, CE Directive
(93/42/EEC) and FDA QSR (cGMP). We operate a quality management Policy that
addresses the compliance with international & local applicable standards of
quality and assurance of complete customer satisfaction through continuous
improvement. The procedures within this quality management system are mandatory
and all staff is responsible for maintaining and reviewing the objectives
within QMS. Only the highest quality raw materials are used in our
manufacturing processes that comply with international standards and
grades. FRANCIS CORPORATION is an equal opportunities company, with a
well-established training and development program following the principles
of Investing in People. In-house & outside training programs are conducted
for employees that include technical and professional skills as per the job and
career requirements. So that the workforce can be prepared for upcoming
standards, innovation and technology challenges. By following these standards
and codes of practice, FRANCIS
CORPORATION is proud to have developed
a reputation for reliability, confidence and quality of service and
The manufacturer hereby guaranties
that the quality of manufactured materials is in compliance with the
requirements listed in the Technical specifications chapter of the Operating
that the conditions of proper storage, transportation, and usage are met by the
Five years warranty:
One year warranty for
Francis Corporation's instruments is stated in Operating Manuals that are
enclosed with each good.
Within the warranty
period, we will replace any damaged device for free.
Warranty obligations are
not applicable in the following cases:
- Upon warranty period expiration;
- When consumers fail to meet the conditions of proper storage, transportation, and usage listed in Operating Manuals for the devices.
Warranty is not
valid in the following cases:
- Device exposure to third-party interference or
reparation in an unauthorized service center is detected;
- Unauthorized device construction or scheme changes are
- Device has been mechanically damaged;
- Device has been damaged by means of foreign objects,
substances or liquids placed inside;
- Device has been damaged due to power network parameters
following are guidelines of Cleaning, Sterilizing & Maintaining surgical
Use of distilled or deionized
water and a neutral pH cleaning solution is recommended for all these
Immediately after surgery,
rinse instruments under warm (not hot) water. It may be helpful to use a nylon
toothbrush to rinse the lock boxes and joints of the instrument. Be sure to
remove all blood, body fluids, and tissue.
If you do not clean your
instruments immediately after rinsing, instruments should be submerged for a in
a solution of water and neutral pH (7) detergent. They should never be placed
in saline solution, as it may cause corrosion and eventually irreversible
damage to the instrument.
A. Ultrasonic Cleaning-
We recommend you manually clean
micro & delicate instruments.
Instruments should be processed
in a cleaner for the full recommended cycle time- usually 5-10 minutes.
Place instruments in open
position into the ultrasonic cleaner. Make sure that sharp blades such as
scissors, knives, osteotomes, etc. do not touch other instruments.
All instruments have to be
Do not place dissimilar metals
(stainless, copper, chrome plated etc.) in the same cleaning cycle.
Change solution frequently, at
least as often as recommended by the manufacturer.
Rinse instruments after
ultrasonic cleaning with distilled or de-ionized water to remove ultrasonic
B. Automatic Washer Sterilizers-
recommendations. Make sure instruments are lubricated after last rinse cycle
and before sterilization cycle.
C. Manual Cleaning-
Most instrument manufacturers
recommend ultrasonic cleaning as the best and most effective way to clean
surgical instruments, particularly those with hinges, locks, and other moving
parts. If ultra sonic cleaning is not available observe the following steps.
I. Use stiff plastic cleaning
brushes (nylon etc.).
Do not use steel wool or wire
brushes except specially recommended stainless steel wire brushes for
instruments such as bone files, or on stained areas in knurled handles.
only neutral pH (7) detergents such as the Roboz Instrument Cleaner (IC-1000)
or the Roboz Enzymatic Cleaner (EC-1000.) If not rinsed off properly after
cleaning, low pH detergents will breakdown the stainless protective surface and
cause black staining.
High pH detergent will cause
surface deposit of brown stain (this deposit may look like rust) which will
also interfere with smooth operation of the instrument.
III. Brush delicate
instruments carefully and, if possible, handle them totally separate from
IV. Make sure all instrument
surfaces are visibly clean and free from stains and tissue.
This is a good time to inspect
each instrument for proper function and condition.
Check the following:
Scissor blades glide smoothly
from open to closed (they must not be loose when in closed position). Test
scissors by cutting into thin gauze. Three quarters of the length of the blade
should cut all the way to the scissor tips, and not hang up.
Forceps should have properly
Hemostats and needle holders
should not show any light between the jaws. They should lock and unlock easily
and the joints should not be too loose. Check needle holders for wear at the
Suction tubes should be clean
Retractors should open, close
and lock properly.
Blades of all cutting edges should
be sharp and undamaged.
V. After manually scrubbing
instruments, rinse them thoroughly under running water (distilled water is
best). While rinsing, open and close scissors, hemostats, needle holders and
other hinged instruments to make sure the hinge areas are rinsed out, as well
as the outside of the instruments.
3. After Cleaning-
If the instruments are to be
stored, let them air dry and store them in a clean and dry environment.
If instruments are to be reused
A. Lubricate all instruments
which have any metal to metal action such as scissors, hemostats, needle
holders, and retractors. B. Use disposable paper or plastic pouches
to sterilize individual instruments. Make sure you use a wide enough pouch (4”
or wider) for instruments with ratchet locks such as needle holders and
hemostats so the instrument can be sterilized in the open and unlocked
If you are autoclaving
instrument sets unlock all instruments and sterilize them in an open position.
Place heavy instruments at the bottom of the set (when two layers are
Never lock an instrument during
autoclaving. It will not be sterile as the steam cannot reach the metal to
metal surfaces. The instrument might develop cracks in hinged areas caused by
the heat expansion during the autoclave cycle.
Do not overload the autoclave
chamber. Pockets may form that do not permit steam penetration. Place a towel
on bottom of pan to absorb excess moisture during autoclaving. This will reduce
the chance of getting “wet packs”. Make sure the towels used in sterilization
of the instruments have no detergent residue and are neutral pH(7) if immersed
in water. The residue of the inexpensive, high-pH (9-13) detergents used by
some laundries to clean the towels could cause stains on some instruments.
CAUTION: At the end of the autoclave cycle- before the drying cycle- unlock
the autoclave door and open it more than a crack about ¾”. Then run the dry
cycle for the period recommended by the autoclave manufacturer. If the
autoclave door is opened fully before the drying cycle, cold room air will rush
into the chamber, causing condensation on the instruments. This will result in
water stains on the instruments and cause “wet packs”.
If you have unusual staining on
your instruments during sterilization contact your local instrument
representative or look in our web site under staining.
5. Cold Sterilization-
Most cold sterilization
solutions render instruments sterile only after a 10 hour immersion. This
prolonged chemical action can be more detrimental to the surgical instruments
than the usual 20 minute autoclave cycle. If the instruments need to be
disinfected only, cold sterilization is recommended since disinfection will
take place in only 10 minutes.
Keep in mind the difference
between STERILE and DISINFECTED: Sterile- an absolute term (no living organism
survives); Disinfected- basically clean.
Always use the proper
sterilization/cleaning technique to render the instrument in required condition
Important: For instruments with
tungsten carbide inserts such as needle holders, scissors, and tissue forceps
we do not recommend use of solutions containing Benzyl Ammonia Chloride. This
will destroy the tungsten carbide inserts.