PROFESSIONAL MEDICAL PRODUCTS
ENGLISH
SURGICAL SCISSORS
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 office is
located.
Devices
Surgical Scissors (Non Sterile, Stainless steel) supplied by company comprising fixed assemblies and
simple hinged assemblies made of stainless steel.
Product Specification
The product is made by hand or partly mechanically from high-grade stainless steel for the production
of medical instruments according to ISO and ASTM standards.
Recommended Decontamination & Sterilization Procedure
As with the decontamination procedure, personnel should follow accepted guidelines for hand wash-
ing, the sue of protective attire, etc. as recommended by A.A.M.I. Standards and Recommended
Practice., “Safe Handling and Biological Decontamination of Medical Devices in Health Care Facilities
and in Non-Clinical Settings”, ANSI/AAMI ST35:2003.
A. Manual Decontamination. Is a process consisting of two steps:-
I. Thorough Cleaning.
II. Sterilization / disinfection.
Pre-cleaning
To remove gross debris from the surgical instruments using a lap sponge and sterile water during the
procedure to prevent drying out of the blood and bodily fluids over the instruments.
Manual cleaning
To minimize the risk to personnel undertaking manual cleaning, splashing and the creation of spray
must be avoided at all times. Staff carrying out manual cleaning should wear PPE at all times.
Devices should be:
1) Cleaned using a non-linting cloth, impregnated with the appropriate detergent solution, followed by
a clean, damp, non-linting cloth; and then
2) Dried using another clean, non-linting cloth. Alcohol-impregnated wipes may be used following a
manual cleaning process.
Detergents: Detergents used must be specifically designed to clean surgical instruments: washing-up
liquid should not be used.
Use of an enzymatic detergent to facilitate the cleaning of surgical instruments.
Disinfection
Long stone’s powder / paper coated instruments are not autoclavable but they can be cleaned/disin-
fected with disinfectants like Endo Star (high level instruments disinfectant) or with any other better
disinfectant/sterilizing solution. 20ml Endo Star in 1 liter tap water (2% dilution)
require 30 minutes immersion and 30ml Endo Star in 1 liter tap water (3% dilution) require 15 minutes
immersion.
Instruments with powder coating color can also be sterilized in simple mineral water up to temperature
110°C for about 5 - 10 minutes.
Point of use handling
All reusable surgical instruments supplied by LONG STONE INTERNATIONAL CO. may only be used
for the purpose of which they are designed, by adequately qualified personal only. The proper surgical
technique for the use of the instrument is the responsibility of the surgeon. Moreover, the surgeon is
responsible for an appropriate training and sufficient information for the operating theatre staff as well
as for an adequate expertise with the handling of the instruments.
Limitations
Frequent reprocessing has little impact on the lifetime, which is generally determined by wear and
damage incurred during the intended surgical use, or by misuse. After the instrument’s utilization on
patients with Creutzfeldt- Jacob disease (CJD) or its variations we refuse all responsibility for reutili-
zation! We recommend destroying the instruments. If you reprocess and reutilize the instrument nev-
ertheless, even according to the RKI2- guidelines, you bear all responsibility. Instruments containing
aluminum get damaged by alkaline cleaner > pH7!
Storage & maintenance
The storage area should be appropriately designed to prevent damage to packs and to allow for the
strict rotation of stocks. Shelving should be easily cleaned and allow the free movement of air around
the stored product.
Products must be stored above floor level away from direct sunlight and water in a secure, dry and
cool environment.
Containment & transportation
To minimise this risk, the instruments must be placed in closed, secure containers and transported to
the decontamination area as soon as possible following use.
Transport containers must protect both the product during transit and the handler from inadvertent
contamination and therefore must be:
• leak-proof
• easy to clean
• rigid, to contain instruments, preventing them becoming a sharps hazard to anyone handling the
goods and to protect them against accidental damage
• capable of being closed securely
• lockable, where appropriate, to prevent tampering
• clearly labelled to identify the user and the contents
• robust enough to prevent instruments being damaged in transit.
Inspection and testing
Before being used, the sterile product should be checked to ensure that:
• the packaging is intact;
• the sterilization indicator confirms the pack has been subjected to an appropriate sterilization pro-
cess; and
• the product is still within the expiry date.
Warning
Don’t use the rusty instrument. Sterilize before use. Wash the hands with anti-bacterial soap or use
approved hand sanitizer before use. Must only be used by the Surgeon or person authorized by the
Surgeon.
Precautions
Instruments must be handled by the trained personnel only. Only Surgeons or personnel authorized
by the Surgeons must be allowed to use the instruments. Don’t sterilize the instruments having the
solution with Chloride ions. Sterilization solution must have the pH near to 6.0 - 7.0. For professional
use only - disinfect before use.
RISK ASSESSMENT: EN 14971:2001
Estimation of Risk: The Risk related to rusting and breakage is minimal, as devices are tested for
both the risks before shipping to the customer. A Boil tests are performed on 100% of lot to assess
the effectiveness of the Passivation Process and resistance against oxidation / rust. Functional and
hardness test are performed to test the strength and durability of the instruments.
Acceptability of risk
These Associated Risk are very low and therefore can be accepted without further Analysis or change
in manufacturing.
Conclusion
This Medical Devices classified as class-I as per Medical Device Regulation (MDR) 2017/745. It is ob-
vious that the risk to both the patient and the user are minimal if the instrument is used for its intended
purpose by the qualified personnel. However, the sterilization and decontamination of the instruments
must be performed before every use.
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
IT Codice prodotto GB Product code IT Fabbricante GB Manufacturer IT Dispositivo medico GB Medical Device
IT Non sterile GB Non-sterile PT Não estéril
PT Código produto FR Code produit PT Fabricante FR Fabricant PT Dispositivo médico FR Dispositif médical
FR Pas stérile DE Nicht steril ES No estéril
DE Erzeugniscode ES Código producto DE Hersteller ES Fabricante DE Medizinprodukt ES Producto sanitario
IT Attenzione: Leggere e seguire attentamente le istruzioni (avvertenze) per l’uso
IT Leggere le istruzioni per lʼuso IT Conservare al riparo dalla luce solare IT Conservare in luogo fresco ed asciutto
GB Caution: read instructions (warnings) carefully
GB Consult instructions for use GB Keep away from sunlight GB Keep in a cool, dry place
PT Cuidado: leia as instruções (avisos) cuidadosamente
PT Consulte as instruções de uso PT Guardar ao abrigo da luz solar PT Armazenar em local fresco e seco
FR Attention: lisez attentivement les instructions
FR Consulter les instructions d’utilisation FR Á conserver à l’abri de la lumière du soleil FR Á conserver dans un endroit frais et sec
(avertissements)
DE Gebrauchsanweisung beachten DE Vor Sonneneinstrahlung geschützt lagern DE An einem kühlen und trockenen Ort lagern
DE Achtung: Anweisungen (Warnungen) sorgfältig lesen
ES Consultar las instrucciones de uso ES Conservar al amparo de la luz solar ES Conservar en un lugar fresco y seco
ES Precaución: lea las instrucciones (advertencias) cuidadosamente
IT Dispositivo medico conforme al regolamento (UE) 2017/745 IT Numero di lotto IT Data di fabbricazione
GB Medical Device compliant with Regulation (EU) 2017/745 GB Lot number GB Date of manufacture
PT Dispositivo médico em conformidade com a regulamento (UE) 2017/745 PT Número de lote PT Data de fabrico
FR Dispositif médical conforme au règlement (UE) 2017/745 FR Numéro de lot FR Date de fabrication
DE Medizinprodukt im Sinne der Verordnung (EU) 2017/745 DE Chargennummer DE Herstellungsdatum
ES Producto sanitario conforme con el reglamento (UE) 2017/745 ES Número de lote ES Fecha de fabricación
20520 - 20521 - 20522 - 20529
20531 - 20532 - 20533 - 20534
M20520-M-Rev.4-12.21
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
Made in Pakistan
