appropriate cleaning and either high-level disinfection or sterilization processes.
Refer to the companion PENTAX Instruction for Use (reprocessing) describing in detail the recommended instructions on the
care, cleaning, disinfection, and sterilization of these endoscopes.
Contraindication
Please consult regional and national health authority recommendations and requirements regarding protocols to follow in order
to reprocess and/or destroy endoscopes that will be used or have been determined to have been used (post procedure) on
patients afflicted with Creutzfeldt-Jacob Disease (CJD or vCJD).
Conventions
Throuhghout this IFU, the following conventions will be used to indicate a potentially hazardous situation which, if not avoided;
WARNING
: could result in death or serious injury.
CAUTION
: may result in minor or moderate injury or property-damage.
NOTE
: may result in property-damage. Also, advises owner/operator about important information on the use of this
equipment.
Prescription Statement
Federal (U.S.A) law restricts this device to sale by or on the order of a physician or other appropriately licensed medical
professional
Symbols on Marking
Symboles distinctifs
この
CE
マーキングは
EC
指令への適合宣言マークです。
The CE marking assures that this product complies with the requirements of the EC directive for safety.
Das CE Zeichen garantiert, daß dieses Produkt die in der EU erforderlichen Sicherheitsbestimmungen erfüllt.
Le logo CE certifie que ce produit est conforme aux normes de sécurité prévues par la Communauté Européenne.
II marchio CE assicura che questo prodotto è conforme alle direttive CE relative alla sicurezza.
La marca CE asegura que este producto cumple todas las directivas de seguridad de la CE.
Attention, consult instructions for use
Attention, consulter le manuel d’utilisation
Symbol for “Authorised Representative in the European Union”
Symbol for “DATE OF MANUFACTURE”
Symbol for “MANUFACTURER”
Type BF applied part (Safety degree specified by IEC 60601-1)
Partie appliquée de type BF (niveau de sécurité spécifié par la norme CEI 60601-1)