Instructions for Use - Reusable Surgical Instruments
This instruction for use (IFU) is valid for 3 Contraindication intolerant to their composition. Surgical
all reusable surgical instruments instruments are made of stainless steel,
supplied by Boss Instruments Ltd. The improper use of a surgical titanium, titanium alloy, aluminum alloy
unless otherwise stated with the instrument during handling, surgical use and other biocompatible, autoclavable,
packaging of the product. or reprocessing, for which they are non-metallic materials on an individual
indicated, may result in damaged or basis.
Important Information broken instruments. Furthermore, the
instruments must be used according to Functional Impairment
Read this instruction carefully their intended use in the medical fields Surgical instruments corrode and their
before every application and and by respectively trained and qualified functionality can become impaired if they
keep it easily accessible for all medical personal only. The instruments come into contact with corrosive
users. should not be used in direct contact with substances. Therefore, it is essential to
Carefully read the warnings the central circulatory system and/or follow all applicable cleaning and
marked with this symbol. direct contact with central nervous sterilization guidelines as stated in this
Improper use of the products system. IFU.
may result in serious injuries
to the patient, the 4 Warnings Operating Conditions
users or third parties. Surgical instruments require correct
Creutzfeldt Jakob Disease/TSE maintenance and care in order to
1 Intended Use If this instrument is/was used in a guarantee that the devices operate safely.
patient with, or suspected of having Due to this, functionality testing and a
Surgical Instruments are intended for
Creutzfeldt-Jakob Disease (CJD), the visual inspection should be performed
use in the surgical setting for clamping,
instrument cannot be reused and must prior to each use.
cutting, dissecting, grasping, probing,
be destroyed due to the inability to
retracting and/or suturing. The
reprocess or sterilize to eliminate the 6 Reprocessing
instruments must be used according to
risk of cross-contamination. Consult
their intended use in the medical fields
WHO and local regulations for further
and by adequately trained and qualified Precautions
information. Dry heat, ethanol,
staff only. When reprocessing surgical instruments,
formaldehyde and glutaraldehyde have
The treating physician and/or user is a fixing but no inactivating effect on always handle with care, wearing
responsible for choosing the correct TSE pathogens (prions). Of the protective clothing, gloves and eyewear in
surgical instrument(s) for specific sterilization methods available, only accordance with local health & safety
applications and/or operative use, for steam sterilization (especially 134°C, requirements.
having the adequate training and 18 minutes) has been shown to have a Instruments manufactured from different
knowledge, and for having sufficient limited effect. metals should be processed separately to
experience regarding the handling of avoid electrolytic action between the
surgical instruments. Non-Sterile! metals resulting in pitting and rusting of
The instruments are intended for Surgical instruments are delivered in a stainless-steel instruments.
transient use and should be replaced non- sterile condition and must be
inspected, cleaned, and sterilized Delicate surgical instruments require
after such time period has passed. special handling to prevent damage.
before each use.
2 Description of Symbols Used Do not use excessive force or place strain
on joints; mishandling can result in
5 Cautions
misalignment or cracks to box locks or
Caution Caution: jaws.
Federal law (U.S.A.) restricts this device Aluminum and titanium instruments that
Consult instructions for use to sale by or on the order of a physician. are color anodized may lose their color
All surgical instruments covered by this over time through normal use and
IFU are considered to be medical devices reprocessing.
Prescriptive device for use in human medicine with regards Keep ebonized instruments separate from
to national and international laws. other stainless steel instruments to avoid
Catalogue number scratches or damage to the coating.
Attention!
Surgical instruments are only designed Limitations on Reprocessing
Batch code
for surgical use and must not be used Repeated reprocessing has minimal effect
for any other purpose. Improper on the instruments. Boss Instruments does
Non-sterile product handling and maintenance as well as not define the maximum number of usage
misuse may result in the premature or preparation cycles for reusable surgical
wear and tear of the instruments. instruments. The life cycle of an instrument
Manufacturer can be dependent upon many factors
Material intolerance including the type and length of usage,
Medical device Under no circumstances should the handling, storage and transport of the
instruments be used if the user instruments. The end of useful life for
becomes aware of the patient being metal surgical instruments is normally
Page 1 of 3 L-CH003 REV I 7/30/2024
Instructions for Use - Reusable Surgical Instruments
determined by wear during their use or Do not soak instruments in hot water, sized autoclavable soft nylon brush, apply
damage to the instrument. Thorough alcohol, disinfectants or antiseptics to validated cleaning solution to all surfaces
examination and functional testing avoid coagulation of mucus, blood or until all soil has been removed. Pay
before the next use is the best possible other body fluids. Do not exceed 2 particular attention to serrations, teeth,
way to detect non-functioning hours soaking in any solution. ratchets, box locks and hinges, always
instruments. Do not use steel wool, wire brushes, brushing away from the body and avoiding
pipe cleaners or abrasive detergents. splashing.
Reprocessing Instructions
Follow all manufacturer’s instructions for
From Point of Use Cleaning/Disinfection: Automated required concentration, temperature and
Use only validated washer-disinfector contact time of the validated cleaning
Wherever possible, do not allow blood,
machines with proven effectiveness solution.
debris or body fluids to dry on
instruments. For best results and to (e.g. U.S. FDA approval or CE mark Ensure rongeurs and hinged instruments
prolong the life of the surgical according to EN ISO 15883) and low- are thoroughly cleaned in both open and
instruments reprocess immediately after foaming, non-ionizing cleaning agents closed positions.
use. If they cannot be reprocessed and detergents.
Use a large syringe or water jet to
immediately, use an enzymatic foam Load instruments carefully, leaving box thoroughly flush all channels and lumens
spray cleaner to help prevent soil from locks and hinges open so that any with cleaning solution to remove debris.
drying. openings in instruments can drain.
In the second sink, rinse instruments
All instruments opened in the operating Place instruments with curved surfaces thoroughly with soft, highly purified water
or procedure room should be facing down to prevent pooling of water. which is controlled for bacterial
considered contaminated whether or Place heavy instruments on the bottom endotoxins, so that the water reaches all
not they have been used. of containers, taking care not to place parts of the instrument, then carefully
on delicate instruments or overload hand dry or use a drying cabinet
Transport
wash baskets.
Soiled instruments should be clearly Cleaning Inspection
Ensure that soft, highly purified water
identified and transported in rigid,
that is controlled for bacterial endotoxins After cleaning, visually inspect all
puncture-resistant, closed containers or
is used in the final rinse stage. surfaces, ratchets, box locks, holes,
other methods that prevent
Proof of suitability of the instruments for channels and lumens for complete
unnecessary contamination risk.
an effective mechanical cleaning and removal of soil and fluids. If ANY soil or
Preparation for Decontamination thermal disinfection (93°C for a fluid is still visible, return the instrument for
minimum of 5 minutes) has been repeat decontamination.
Reprocess all instruments as soon as it
is reasonably practical following use. conducted by an independently Drying
accredited test laboratory using the
Follow instructions and warnings as Instruments must be thoroughly dried and
"Miele Disinfector G7836 CD" (Miele &
issued by manufacturers of any all residual moisture must be removed
Cie. GmbH & Co., Gütersloh, Germany)
decontaminants, disinfectants and before they are sterilized. Use a soft
and the detergent "neodisher
cleaning agents used. Wherever absorbent towel or cloth to dry external
MediClean forte" (Dr. Weigert GmbH &
possible avoid use of mineral acids and surfaces.
Co. KG, Hamburg).
harsh, abrasive agents.
Do not use high acid (pH 4.0 or lower) Note: Automated cleaning may not Lubrication
or high alkaline (pH 10.8 or higher) be suitable for all lumens and channels, Apply surgical grade (non-silicone, water
products for disinfection. Neutral pH in which case clean manually with a soluble) lubricants to hinges, box locks
detergents 7.0 – 9.0 are preferred. water jet, if available, and an and moving parts as per the lubricant
If appropriate, disassemble instruments
appropriate brush (and stylet if manufacturer’s instructions.
provided) that reaches the depth of the
prior to cleaning and sterilization, Inspection and Function Testing
feature. After manually cleaning, pass
without the use of tools unless
all instruments through an automatic Visually inspect and check: all instruments
specifically provided by the
cleaning cycle to achieve disinfection. for damage and wear; cutting edges are
manufacturer to do so.
free of nicks and present a continuous
Open jaws of hinged instruments for Cleaning/Disinfection: Manual edge; jaws and teeth align correctly; all
cleaning. Give special attention to joints Manual cleaning is not advised if an articulated instruments have a smooth
and serrations when cleaning. automatic washer-disinfector is movement without excess play; locking
Remove gross contaminants with a available. If this equipment is not mechanisms (such as ratchets) fasten
steady stream of lukewarm/cool water, available, use the following process for securely and close easily; long, slender
not to exceed 35° C (95° F). Rinse each manual cleaning: instruments are not distorted; any
instrument thoroughly. Movable parts Use a double sink system (wash/rinse) component parts fit and assemble
must be moved. dedicated for instrument cleaning (not correctly with mating components.
Where available, use appropriate used for hand washing). Ensure that the Consider removing for repair or
cleaning accessories to flush water temperature does not exceed 35º replacement any blunt, worn out, flaking,
instruments with channels or lumens. C (95º F). fractured, corroded, stained, discolored or
Do not use saline or chlorinated In the first sink, keeping the instrument damaged instruments.
solutions. totally immersed, with an appropriately-
Packaging
Page 2 of 3 L-CH003 REV I 7/30/2024
Instructions for Use - Reusable Surgical Instruments
All instruments should be wrapped or instructions provided must be properly
packaged following local procedures; evaluated for effectiveness and
specific requirements can be found in potential adverse consequences.
ANSI/AAMI ST79 and/or ISO 11607-1
and EN 868. Service and Repair
Ratcheted instruments should be Do not carry out any repairs or changes
unlatched. Racks, pins, stringers, or to the products yourself. Boss
other specifically designed devices can Instruments Ltd. can supply authorized
be used to hold the instruments in the repair services.
unlatched position.
Note: If an instrument is returned to
Rigid container systems may be used the manufacturer / supplier, the
for the sterilization of surgical instrument must be decontaminated and
instruments. When such a system is sterilized and be accompanied with the
used, all items should be contained relevant documented evidence,
within a basket or tray with the otherwise a cleaning charge may apply
container system. Instruments should and delay processing of the repair.
also be positioned in such a way as to
Please contact Boss
allow sterilant to come into contact with
Instruments Ltd. for
all surfaces. Always follow all container
additional information.
manufacturer’s instruction for use.
_______________________
Stacking of containers is allowed if so
_______
indicated in the container
manufacturer’s instruction for use.
Sterilization Boss Instruments Ltd.
Sterilization of products with a 104 Sommerfield Drive
fractionated pre-vacuum method has Gordonsville, VA 22942 USA
been validated (according to ISO Toll Free (USA): 800-210-2677
17665). Phone: 540-832-5000
Fax: 540-832-5515
Do not exceed 140° C (284° F) during
www.bossinstruments.com
sterilization cycle.
Use only a validated, properly
maintained steam sterilizer to conduct
all sterilization processes and always
follow the sterilizer manufacturer’s
instructions for use.
Validated exposer time and temperature
to achieve 10-6 sterility assurance are
as follows:
Minimum Minimum
Cycle Exposure Time /
Type Temperature
Dry Time *
4 minutes / 20
minutes dry time
Pre- for metal or
vacuum 132° C (270° metal/plastic
F)
Method trays and 45
minutes for all
plastic trays
* AAMI/AORN steam sterilization cycles
with longer times than those listed are
also acceptable
Attention! It is the responsibility of
the reprocessor to ensure that the
reprocessing, as actually performed
using equipment, materials and
personnel in the reprocessing facility.
Achieve the desired result. This
requires validation and routine
monitoring of the process Likewise, any
deviation by the reprocessor from the
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