GIMA 819-600-00 Pinza Biopsia Handle For Biopsy Forceps Instruction Manual

: June 1, 2024
: GIMA

Table of Contents

GIMA 819-600-00 Pinza Biopsia Handle For Biopsy Forceps
Specifications
FAQ
OPERATING INSTRUCTIONS
Recommended operating environment
Precautions
CONTACT
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GIMA 819-600-00 Pinza Biopsia Handle For Biopsy Forceps

Specifications

Product Name: Manico per Pinza Biopsia – Handle for Biopsy Forceps
Model Number: 29420
Manufacturer: Gima
Product Code: 819-600-00 (Gima 29420)
Duration of Product: Approximately 5 years

FAQ

Q: How should I store the product when not in use?

A: Store the product in a cool, dry place away from direct sunlight. Follow the manufacturer's instructions for proper storage.

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 condition.

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 the following major features:

Stainless steel construction makes it durable, and easier to clean and disinfect with conventional solutions.
Precisely finished 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 qualified persons.
Check the correct operation of the device before use.
Use only original parts and accessories.

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 flushed 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 a device from the 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 the 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 filtered pressurized air. Follow with HIGH LEVEL DISINFECTION or STEAM STERILIZATION PROCEDURE.

Disinfection
Soaking in solutions or in a sterilized thermochemical washer up to 93°C may perform dis-infection. 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 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 filtered 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 filtered 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 the device in the appropriate autoclave pouch.

	(A) GRAVITY DISPLACEMENT STEAM	(B) PRE-VACUUM 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)

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

Read the label before loosening the packing.
Store in a clean environment and preserve at a comfortable temperature.
Only qualified medical personnel should use it.
Use protective gloves and wash hands with anti germs and anti bacterial soap before operating any medical operation.
Use properly to increase the shelf life of the instrument. Avoid placing the instrument for a long time in the salty or humid atmosphere.

Warning