Gima SPLINTER User guide

PROFESSIONAL MEDICAL PRODUCTS

ENGLISH

SPLINTER TWEEZERS

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 ofce is located.

Devices

Magnifying Glass Splinter Tweezers (Non Sterile, Stainless steel) supplied by company comprising xed assem­blies and simple hinged assemblies made of stainless steel.

Description

The product is made by hand or partly mechanically from high grade stainless steel. Product should be used only
for its intended purpose mentioned in Technical le.

Warnings

Never:

• Misuse instruments or overstrain joints or racks.

• Use of abrasives on instruments, will spoil the surface nish. This may later cause discoloration, rusting or pit­ting.

• Handle instruments by their tips. These should be cleaned by trained personnel only who will ensure the delicate
working ends are adequately protected during storage or sterilization.

• Pack instruments with other, heavier instruments. Remember always - heavy instruments on the bottom and
light instruments on the top.

• Use general-purpose oils for instruments; only water-soluble lubricants should be used.

• Leave instruments soaking longer than necessary in chemical sterilizing solutions. After they have been steri­lized they should be washed thoroughly in warm water to remove all traces of the chemicals to prevent discolor­ation or pitting.

• Store damp instruments. They must be thoroughly dried rst.

Instructions

Always:

• Check all instructions for use and sterilization of new instruments. Unless otherwise directed they should be
inspected, cleaned, rinsed and lubricated before being put into service.

• Lubricate after cleaning with a proprietary water-soluble instrument lubricant.

• Follow approved cleaning procedure of hospital.

• Do not use corrosive cleaning agents. We recommend cleaning solutions and rinses with ph 7.0.

• Do not use abrasive cleaners & brushes with hard bristles.

• Use distilled water for rinsing only. Water with chloride contents may damage or even destroy the instruments.

• Do not leave instruments in cleaning or disinfecting solutions for long terms (over night or weekend), the instru­ments can be destroyed.

• Ensure all instruments are only used for the purpose for which they were designed.

• Handle all instruments gently. Never overstrain, drop or misuse them.

• Check all instruments for damage after use.

• Give special attention to microsurgical instruments. Their ne tips can easily be damaged by contact with other
instruments or the sides of the case in which they should be kept. Hand cleaning is preferable.

• Ensure all instruments are thoroughly dried before being stored.

• Pack instruments carefully with the heavier ones lying on a piece of cloth or towel at the bottom.

• Store and sterilize bow-handled instruments on a special holder. Always leave racks and ratchets open.

• Check the hardness of the water used in the autoclave. Too hard water will leave a deposit on the instruments.

• If a water softener is used ensure it is at the manufacturers recommended level. Too much may cause discolor­ation or pitting.

Cleaning and disinfection

Before preliminary cleaning, remove any dirt (remaining biological material like bone, tissue or dust, etc.) Using
disposable hygienic wipes, paper towels or brushes with unnatural plastic bers (e.g. nickel).
The product should be cleaned in a washer-disinfector using liquids only for this purpose, in accordance with the
manufacturer’s instructions for the product and the device itself. Disinfection is carried out at temperature 93°C /
about 199.4°F of a de-ionized water bath without detergents in about 10 minutes and then dried.

Sterilization

Instruments should be sterilized by moist heat sterilization method with 270°F (132°C) for 15 minutes (Vali­dated in accordance with EN ISO 17665-1-2006 prior to use in surgery. It is recommended that sterilization
temperatures should not exceed 280°F (137°C).

Disposal

No special decomposition or disposal required for Surgical Instruments as they don’t contain any toxic or haz­ardous material; the material stainless steel is recyclable in ordinary steel manufacturing units.

GIMA WARRANTY TERMS

The Gima 12-month standard B2B warranty applies.

M24391-M-Rev.3-12.21

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

24391

Gima S.p.A.

Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]

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