GIMA F-35W Disposable Skin Stapler Instruction Manual

: October 30, 2023
: GIMA

Table of Contents

Main Structure
Working Principle
Capability Index
Application
How-to-use
Limit of use
Precautions of use
Contraindications
Storage conditions
Period of Validity
Service after Sold
Documents / Resources

PROFESSIONAL MEDICAL PRODUCTS
DISPOSABLE SKIN STAPLER

GIMA F 35W Disposable Skin Stapler -

Our special designed and manufactured disposable skin stapler is the speci昀椀c instrument for surgical skin suture. With novel structure and application security, our skin stapler has the advantages of quick speed of sewing up during the operation, little histological reaction, good wound matching and healing, small surgical scar, and no pain for removing, etc. Our disposable skin stapler enables you not to only work with higher ef昀椀ciency, but also avoid cross-infection effectively.

Main Structure

a. The product is composed of skin stapler and staple. Each skin stapler has some quantities of staples inside.(Please check the detail refer to the product label). The skin stapler is composed of the component of body, handle, cartridge, staple push device and staple turn back device.
b. The raw material of the staple is the stainless steel for medical usage.

Working Principle

For the aim of skin suture, after the handle was pushed by outside force, the staples will be shaped after extrusion under the mechanical transmission of the each part.

Capability Index

a. The suture force of the skin stapler should be no more than 55N
b. The metal components of the skin stapler have the good function of anti- eroded.
c. he skin stapler is sterilized with ethylene oxide. The leftover of the ethylene oxide should be less than 10 mg/kg before the products are released from factory.

Application

Disposable skin stapler is used to do the wound suture of skin during the surgical operation.

How-to-use

a. Remove the Tyvek paper and take out the skin stapler from blister package.
b. With a pair of tweezers lift the skin of both sides of the wound, bring them together and hold it.
c. Make sure that the front end of the stapler is well over the wound and the staple is vertical to the longitudinal axis of the incision. Gently put the stapler onto the incision till the fore-arrow levels with the middle line of the incision. Do not press hard on the wound using the stapler as it would make the removalof the staples diffcult and painful.
d. Caution : Clasp the handle and do not loosen it until the staple is out, remove the stapler and get ready for the next step. See Images 1-2-3.

Limit of use

The use of this medical devices is exclusively for quali昀椀ed medical personnel.

Precautions of use

a. The skin stapler is sterilized with ethylene oxide.
b. Sterile medical device, do not use in case of damaged single blister packaging or if the expiry date is over.
c. Make sure the product can not be polluted when it was taken out of blister package.
d. The product is limited to disposable use. Please destroy/dispose the 昀椀nished product according to the related regulation.
e. The skin stapler is only to be used for wound suture of at least 5 mm depth. If the depth of the wound suture is less than 5mm, the skin stapler is forbidden to be used for suture.
f. If the hypodermic part under the incision is too thick, it is advised to 昀椀rst do an hypodermic suture and then a skin suture.
g. The advised distance between each staple is of 5 to 10 mm. Please use the speci昀椀c staple remover to remove the staples after 7~10 days. Or please refer to the doctor’s prescribing.
h. Please use the skin stapler within the period of validity.

Contraindications

If the wound depth is less than 5mm, the use of stapler for skin closure is contraindicated.
The use of skin stapler is contraindicated in patients with known sensitivities or allergies to the metals contained in 317L stainless steel, i.e. chromium, nickel, iron, molybdenum, copper.
Do not be used for internal tissue closure.
This product is not designed, sold, or intended for use except as indicated.

Storage conditions

The skin stapler must be stored in a cool dry place, with a humidity level ≤ 80% with no erosive gases. To
be manipulated with care. Do not store other products on top of skin staplers’ cartons.

Period of Validity

5 Years since sterile date. Please see expiry date of each product on the packaging.

Service after Sold

If you have any quality complains, please contact with suppliers or manufacturer.
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.

| Product code| | Humidity limit
---|---|---|---
| Lot number| | Manufacturer
| Date of Manufacturing| | Date of manufacture
| Keep in a cool, dry place| | Keep away from sunlight
| Authorized representative in the European community| | Medical Device complies with Directive 93/42/EEC
| Sterilised using ethylene oxide| | Disposable device, do not re-use
| Consult instructions for use| ****| Caution: read instructions (warnings) carefully
| This side up| | Fragile, handle with care
U.S. FOOD & DRUG ADMINISTRATION| |

F-35W (25891)

Ningbo Advan EIectricaI Co. ,Ltd.
IndustriaI DeveIopment Zone Fuhai Town
315332 Cixi City, Ningbo, Zhejiang Province
PEOPLE’S REPUBLIC OF CHINA
Made in China
Shanghai International
Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537
Hamburg, Germany
Imported by

Gima S.p.A. Via Marconi, 1
20060 Gessate (MI) Italy
gima@gimaitaly.com
export@gimaitaly.com
www.gimaitaly.com

GIMA F 35W Disposable Skin Stapler - icon17 M25891-M-Rev.2-11.21