Pentax EB-1970TK Instructions For Use Manual page 3

Sterility Statement
The endoscopes identified in this IFU are reusable semicritical devices. Since they are packaged non-sterile, they must be high-
level disinfected or sterilized BEFORE inital use. Prior to each subsequent procedure, they must be subjected to appropriate
cleaning and either high-level disinfection or sterilization processes.
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
Throughout 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.
: 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
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
Symbols on Marking
Symboles distinctifs
Symboles distinctifs
Symbol for "MANUFACTURER"
Symbol for "DATE OF MANUFACTURE"
Symbol for "Authorised Representative in the European Union"
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 certi e 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.
this equipment.
Attention, consult instructions for use
Attention, consulter le manuel d'utilisation
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)