Arbutus Medical DCB127 Manuel d'utilisation - Page 5
Parcourez en ligne ou téléchargez le pdf Manuel d'utilisation pour {nom_de_la_catégorie} Arbutus Medical DCB127. Arbutus Medical DCB127 18 pages.
Imprimer la page2. INTENDED USE AND TECHNICAL DESCRIPTION
This instructions for use gives users essential information to prepare the device for use and
to reprocess for re-use. The DrillCover Hex System is a battery powered drilling system
equipped with a standard hex quick-change drive and reusable aseptic enclosure. The
device is meant for use by orthopaedic surgeons. Surgical staff require training in sterile
technique and surgical fire prevention. The intended patient population is patients
indicated for trauma or reconstructive procedures involving orthopaedic bone drilling.
Contraindications for use: oxygen rich environments or patients not indicated for
orthopaedic procedures.
Specifications
Drill Specification
Charger Specification
Battery Specification
Storage/Transport
Use Environment
Sterilization Specification
In this instructions for use,
conveys a general warning message which describes a foreseen risk.
conveys mandatory action.
tells the user to refer to these instructions for use.
signifies a type B applied part.
This equipment has been evaluated for compliance with IEC60601-1. Any modification will
require evaluation to the requirements of this standard.
Classification of device when assembled for use: Internally powered ME equipment.
DrillCover Linen and Chuck adapter components are Type B applied parts. We do not claim
IPXX ingress protection (IPX0). Sterilization of patient contacting components by moist
heat. Not suitable for use in oxygen rich environment. Suitable for continuous operation.
DCF610
DCB113 or DCB115
DCB120 or DCB127
See charger and battery manual for associated charger and
battery specification.
10 -40 º C and 700-1060 hPA, 30-70% humidity.
10 -32 º C and 700-1060 hPA, 30-70% humidity.
Prevacuum or gravity displacement autoclave.
DrillCover Hex System: Instructions For Use
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