Nom de l'organisation

Keeler Ltd

SRN

GB-MF-000009031

Statut du fabricant

Actif

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

• Avertissement

  • Care should be taken not to trap fingers in pinch points during gas bottle change.

• Voir mode d’emploi/manuel d’utilisation

  • Keep this operator manual safe for future reference.

• P232 - Protéger de l’humidité.

  • To prevent condensation from forming, allow instrument to come to room temperature before use. • For indoor use only (protect from moisture). • This product should not be immersed in fluids. • Keep the console away from sources of liquids and do not spray with water.

• • US Federal law restricts this device to sale by or order of a physician or practitioner. • Keep out of the reach of children • The product has been designed to function safely when at an ambient temperature between +10°C and +35°C. • Do not use in the presence of flammable gases / liquids, or in an oxygen rich environment. • Do not use if the product is visibly damaged, and periodically inspect for signs of damage. • Inspect the Cryo probe hose and silicone ‘O’ rings for damage before every use. If there is any sign of damage return to the manufacturer for servicing prior to use. • Do not try to straighten a bent Cryo tip. • Do not try to re-shape a Cryo tip. • Do not obstruct the vent holes on the disposable probe (located on the tube) and reusable probe, located as indicated below. • Route power cords safely to eliminate risk of tripping or damage to equipment. • Follow guidance on cleaning / routine maintenance to prevent personal injury / damage to equipment. • Do not use hypercarbonate or phenolic based cleaning solutions or disinfectants containing cationic surfactants (e.g. Dettox) to clean the console. • Ensure that the system is clean and dry prior to storage. • Ensure that the system is inspected by properly trained personnel once per annum for performance and safety checks. • Failure to carry out recommended routine maintenance as per these Instructions for Use may reduce the operational lifetime of the product. • No modification of this equipment is allowed. • There are no user serviceable parts inside. Contact authorised service representative for further information. • Use only genuine Keeler approved parts and accessories or device safety and performance may be compromised. • At product end of life dispose of in accordance with local environmental guidelines (WEEE).

  AUTRE

• H281 - Contient un gaz réfrigéré; peut causer des brûlures ou blessures cryogéniques.

  • This product is suitable for use with only Nitrous Oxide or Carbon Dioxide medical gases. • Only non-syphonic gas cylinders should be used with this device. • Ensure that sufficient gas is available in the cylinder prior to operation. TEST BEFORE USE. If in doubt ensure that a replacement cylinder is immediately available at the point of use. • In the unlikely event that the probe fails to defrost, immediately switch off the console and apply saline solution to the probe.

• GHS04 - Avertissement - Gaz comprimé

  • Observe the usual safety precautions associated with the use of medical gases, at all times. Copies of these guidelines will be available from the gas supplier. • High pressure gases are present inside the unit. Maximum operating pressure 45 Bar / 650 PSI, maximum cylinder pressure 83 Bar / 1200 PSI. • Ensure the correct disposition of gas exhausted from the system so as to minimise the exposure to Nitrous Oxide or Carbon Dioxide. This is the responsibility of the user.

• Ne pas utiliser si l’emballage est endommagé

  • Check your Cryomatic MKII for signs of transport / storage damage prior to use.

• Consulter la notice d’utilisation

  • Carefully read this Instruction Section before using your Keeler product. For your own safety and that of your customers observe all cautionary information provided in this section. The following information is intended to highlight potential safety hazards that can be associated with misuse, or damage. • Before you connect system to the mains socket, carefully read and understand all the installation instructions in Section 6. • Relevant accessories are listed in the Spare Parts and Accessories section.

• Dangers liés aux champs magnétiques

  • Although compliant with applicable EMC standards, this equipment may still be susceptible to excessive emissions and/or may interfere with other more sensitive material. This system should be installed and used following the EMC environment guidelines contained in section 13 of this manual. • This system should only be used in conjunction with the relevant accessories and mains leads as supplied by the manufacturer or distributor. Failure to do this may affect the EMC performance of the system i.e. increased emissions or reduced immunity.

• Prudence, risque de choc électrique

  • To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. • Do not fit mains power adapter into a damaged mains outlet socket • The mains plug is the means of isolating the device from the mains supply. Ensure the equipment is positioned in such a way that it can be disconnected from the mains easily. • Switch off the electrical supply and disconnect from the mains electrical supply before cleaning and inspection

Marché principal en France ; disponible dans 25 pays au total.

Dénomination commerciale

CRYOMATIC MKII CONSOLE

Code d'IUD-ID

ID primaire

L'ID primaire est l'IUD-ID principal qu'un fabricant désigne comme identifiant de référence d'un dispositif dans EUDAMED.

05055272711753

IUD-ID de base

IUD-ID de base

L'IUD-ID de base est l'identifiant principal qui regroupe toutes les variantes d'un même modèle de dispositif — la clé de la « famille » réglementaire.

B-05055272711753

Numéro de référence/catalogue

2509-P-1010

Entité d'attribution

Entités d'attribution IUD

Les entités d'attribution sont les organismes que la Commission européenne a désignés pour attribuer les identifiants uniques des dispositifs au titre du système IUD de l'UE.

GS1

Catégorie de risque

Classes de risque RDM

Les classes de risque du RDM classent les dispositifs médicaux du risque le plus faible (classe I) au plus élevé (classe III), ce qui détermine le niveau de contrôle réglementaire.

Classe IIb

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

UNITÉ DE COMMANDE CRYOCHIRURGIQUE

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel

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

• Z120102CRYOSURGERY EQUIPMENT

• Dispositifs médicaux de Classe IIb dans EUDAMED

Aucun certificat ne référence l'IUD-ID de base de ce dispositif.