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PROFESSIONAL MEDICAL PRODUCTS
MANICO / PINZA BIOPSIA
HANDLE / BIOPSY FORCEPS
Manuale d’uso - User manual
È necessario segnalare qualsiasi incidente grave vericatosi in relazione al dispositivo medico da noi fornito al fabbricante e all’autorità competente dello Stato membro
in cui si ha sede.
All serious accidents concerning the medical device supplied by us must be reported
to the manufacturer and competent authority of the member state where your registered ofce is located.
M29420-M-Rev.1-02.20
29420 - 29421 - 29422
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
Made in Pakistan
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29420 - HANDLE FOR BIOPSY FORCEPS
29421 - BIOPSY FORCEPS 3,5x8 mm CUP JAWS 420 mm
29422 - BIOPSY FORCEPS 4 mm CUTTING JAWS 420 mm
ATTENTION
The operator/user must carefully read and understand this manual thoroughly to keep the
product performance durable and reliable for a long period. Failure to understand and observe any warning statement in this manual could lead to patient sever injuries. Check that
the product is in perfect conditions.
OPERATING INSTRUCTIONS
Biopsy forceps are brought exactly to the target site in the gastric mucosa. The jaws are then
used to cut the sample from the tissue. It is necessary to accurately position the jaws on the
lesion to ensure the best sample. This may be done by rotating the jaws, or it may be necessary to approach the lesion tangentially. Biopsy forceps with jaws that operate independently
will assist the tangential approach.
It is important that the sample is cut cleanly from the patient and not torn out, as this minimizes bleeding and ensures a sample of maximum quality. After the sample is obtained, it is
retained within the biopsy forceps cup to ensure safe passage up the endoscope channel.
Care should be taken when retracting the biopsy forceps from the channel not to
damage the endoscope. This is particularly the case when retracting through the bending
section of the endoscope.
The instrument has got the following major features:
• Stainless steel construction making it durable, easier to clean and disinfect with conventional solutions.
• Precisely nished smooth cutting edges.
• Ergonomically formed handle which is comfortable to hold.
• Single handle for all types of forceps.
• Shaft rotatable through 360 degrees.
Precautions
- Repairs shall only be carried out by qualied persons.
- Check the correct operation of the device before use.
- Use only original parts and accessories.
ENGLISH
Cleaning procedure
Immediately after use, the biopsy forceps should be rinsed under cool running tap water
until all visible soil is removed. Ensure that all hard-to-reach areas are ushed with the running tap water. Immerse biopsy forceps in a presoak enzymatic cleaner solution, prepared in
accordance to manufacturer’s recommendations for a minimum of two minutes.
Remove device from enzymatic cleaner solution and rinse with lukewarm running tap water
for a minimum of one minute to remove all residues and visible soils. Then, immerse device
in enzymatic detergent. Brush thoroughly using a soft bristle brush, while ensuring that in
all hard-to-reach areas visible soils / residues are removed. Dry with lint-free, clean cloth or
ltered pressurized air. Follow with HIGH LEVEL DISINFECTION or STEAM STERILIZATION
PROCEDURE.
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ENGLISH
Disinfection
Soaking in solutions or in a sterilized thermochemical washer up to 93°C may perform disinfection. Manufacturer’s instructions regarding duration and concentration of solutions
should be strictly adhered. After disinfection, rinse thoroughly in sterile water and dry with
a clean lint-free cloth.
Cold Soak Solution
To achieve a high-level disinfection, Cidex®OPA or 2.4% Glutaraldehyde solution may be
used according to manufacturer’s instructions. Dry with lint-free, clean cloth or ltered pressurized air. Reassemble all parts and test the product for proper functioning.
Do not immerse biopsy forceps in Bleach, Betadine or Potassium Hydroxide solutions. Doing so will severely damage instruments. Also avoid metal to metal contact
after soaking. The biopsy forceps should be rinsed under sterile water to remove
chemical residues and dried with lint-free clean cloth or ltered pressurized air.
Sterilization
Before performing any of the procedures described below, the biopsy forceps should be
cleaned as described in the cleaning Procedure.
Gas Sterilization
Gas sterilization by Ethylene oxide up to a maximum temperature of 65°C and 8 psi may be
performed, which is preferred especially if sterilization is to be performed regularly.
Steam Sterilization
Steam Sterilization can also be performed. Insert device in appropriate autoclave pouch.
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(A) GRAVITY
DISPLACEMENT STEAM
Temperature 121°C (250°F) 134°C (270°F)
Cycle time 30 Minute 5 Minutes
Dry time 15 Minutes 20 Minutes
Note
Do not exceed temperature of 135°C and pressure of 28 psi.
Flash autoclaving and hot air sterilization should be avoided as these processes will
damage the instrument.
Recommended operating environment
Operation
Temperature 10°C to 40°C
Humidity 30% to 75%
Air Pressure 700hPa to 1060hPa
Altitude 0 - 13123 feet (0 - 4000 meters)
(B) PRE-VACUUM STEAM
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Storage and Transport
Temperature -20°C to 60°C
Humidity 10% to 90% (Without Condensation)
Air Pressure 500hPa to 1060hPa
Precautions
To avoid any unwanted event follow the instructions/precautions as written
a) Read the label before loosening packing.
b) Store in clean environment and preserve at comfortable temperature.
c) Only qualied medical personnel should use it.
d) Use protective gloves and wash hands with anti germs and anti bacterial soap before
operating any medical operation.
e) Use properly to increase the shelf life of the instrument. Avoid placing the instrument for
a long time in salty or humid atmosphere.
Warning
a) Don’t use the equipment in case it is damaged, apply to you retailer.
b) If the Handle has rusted then don’t use it.
Shelf life: 5 years
ENGLISH
Product code
Lot number
Keep in a cool, dry place
Keep away from sunlight
Consult instructions for use Medical Device
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
Manufacturer
Medical Device compliant
with Regulation (EU) 2017/745
(only for code 29420)
Medical Device complies
with Directive 93/42/EEC
(only for codes 29421 - 29422)
Caution: read instructions
(warnings) carefully
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