Alignment Guide

Dénomination commerciale

Alignment Guide

05032982033528

5032982/INSGUIDE22/MU

Numéro de référence/catalogue

860-16-00

GS1

Classe I

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

—

URL des informations complémentaires

https://www.jri-ltd.co.uk/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• L0922ORTHOPAEDIC SURGERY GUIDES, REUSABLE

5 avertissements enregistrés — faire défiler le panneau pour tout voir.

• Warnings Non-sterile, reusable instruments MUST be cleaned and sterilised before use in accordance with the validated methods explained in JRI’s Instrument Reprocessing IFU (F403O). DO NOT use devices which are suspected to be unclean or non-sterile at the point of use. Reuse of single use devices which have come into contact with blood, bone, tissue, or other body fluids may lead to injury. Potential risks associated with the reuse of single use devices include but are not limited to breakage, incorrect function, or failure of the device and transmission of infectious agents. These risks may result in patient injury or death. All instruments should be inspected for wear and damage prior to each use. In the event of visible wear or damage such as deformation, corrosion, or blunting of sharp/cutting instruments, the instrument SHOULD NOT be used as it may not perform as intended and risks injury of the patient and user. DO NOT subject instruments to excessive force or high loads as this may result in breakage. Where there is the requirement for the application of reasonable force, this will be explained in the operative technique. DO NOT modify or alter instruments unless explicitly instructed to do so in the operative technique or reprocessing IFU. DO NOT permanently implant any instrument. Ensure that instruments and parts of instruments ARE NOT left in the surgical site prior to closure, as this may result in injury to the patient. Instruments may not be detectible using commonly used imaging techniques such as radiography, fluoroscopy, and CT scanning. DO NOT use JRI Instruments in an MR environment. The instruments have not been tested for safety or compatibility in an MR environment. Use in such environment may result in heating or migration. Patients and Users with a hypersensitivity to the materials used in JRI Instruments, such as Cobalt or Nickel, may experience an allergic reaction.

  AUTRE

• Contra-Indications For information on contra-indications, please refer to the IFU for the associated implant. All IFUs are available to download from the JRI Ltd website. At a minimum, JRI instrumentation MUST NOT be used: Where there is active infection. By untrained, or inexperienced persons, or persons who are not clinically qualified to carry out the procedure for which the instruments are intended. For clinical procedures for which they are not intended. If they are visibly broken, or damaged intra-operatively, or fail to function as intended due to incorrect assembly.