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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 ofce is
located.
Devices
Surgical Scissors (Non Sterile, Stainless steel) supplied by company comprising xed assemblies and
simple hinged assemblies made of stainless steel.
Product Specication
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 washing, 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 uids 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 specically 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/disinfected 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 qualied 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 sufcient 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 reutilization! We recommend destroying the instruments. If you reprocess and reutilize the instrument nevertheless, 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 oor 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 conrms the pack has been subjected to an appropriate sterilization process; 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 classied as class-I as per Medical Device Regulation (MDR) 2017/745. It is obvious that the risk to both the patient and the user are minimal if the instrument is used for its intended
purpose by the qualied 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.
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M20520-M-Rev.4-12.21
IT Codice prodotto GB Product code
PT Código produto FR Code produit
DE Erzeugniscode ES Código producto
IT Leggere le istruzioni per lʼuso
GB Consult instructions for use
PT Consulte as instruções de uso
FR Consulter les instructions d’utilisation
DE Gebrauchsanweisung beachten
ES Consultar las instrucciones de uso
IT Dispositivo medico conforme al regolamento (UE) 2017/745
GB Medical Device compliant with Regulation (EU) 2017/745
PT Dispositivo médico em conformidade com a regulamento (UE) 2017/745
FR Dispositif médical conforme au règlement (UE) 2017/745
DE Medizinprodukt im Sinne der Verordnung (EU) 2017/745
ES Producto sanitario conforme con el reglamento (UE) 2017/745
IT Fabbricante GB Manufacturer
PT Fabricante FR Fabricant
DE Hersteller ES Fabricante
IT Conservare al riparo dalla luce solare
GB Keep away from sunlight
PT Guardar ao abrigo da luz solar
FR Á conserver à l’abri de la lumière du soleil
DE Vor Sonneneinstrahlung geschützt lagern
ES Conservar al amparo de la luz solar
20520 - 20521 - 20522 - 20529
20531 - 20532 - 20533 - 20534
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
Made in Pakistan
IT Non sterile GB Non-sterile PT Não estéril
FR Pas stérile DE Nicht steril ES No estéril
IT Conservare in luogo fresco ed asciutto
GB Keep in a cool, dry place
PT Armazenar em local fresco e seco
FR Á conserver dans un endroit frais et sec
DE An einem kühlen und trockenen Ort lagern
ES Conservar en un lugar fresco y seco
IT Numero di lotto
GB Lot number
PT Número de lote
FR Numéro de lot
DE Chargennummer
ES Número de lote
IT Dispositivo medico GB Medical Device
PT Dispositivo médico FR Dispositif médical
DE Medizinprodukt ES Producto sanitario
IT Attenzione: Leggere e seguire attentamente le istruzioni (avvertenze) per l’uso
GB Caution: read instructions (warnings) carefully
PT Cuidado: leia as instruções (avisos) cuidadosamente
FR Attention: lisez attentivement les instructions
(avertissements)
DE Achtung: Anweisungen (Warnungen) sorgfältig lesen
ES Precaución: lea las instrucciones (advertencias) cuidadosamente
IT Data di fabbricazione
GB Date of manufacture
PT Data de fabrico
FR Date de fabrication
DE Herstellungsdatum
ES Fecha de fabricación
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