Overview
C-Arm Equipment Drapes Help reduce the risk of contamination in the Operating Room.Includes two scope drapes and one C-Arm drape with clips.
The scope arm is easily covered by the clip-on cover and prevents contamination.
Locking clips are included.
Intended Use
C-Arm Cover is used for isolating the contamination source to prevent contamination risk coming from hospital devices to media, patients or personnel during surgical operations from contamination.
C-Arm Covers are sterile and disposable medical devices with transient use.
The devices are intended for single use.
The main performance indicators for C-Arm Covers are sterility, to cover the device without preventing device use and to provide sterile media by preventing contamination from the device to media.
Package Components
2 pieces of scope/fluoroscopy drapes
One C-arm drape with 6 clips
Product Features
C-Arm Drape with Clips Specially folded for easy application.
Easy to use directional sticker labels for correct application.
Two durable straps to properly secure the device to the machine.
3 different sizes are available. Customized sizes are available upon request.
Quality Control
CE marking according to 93/42/EEC Medical Device Directive and classified as Class I sterile medical device.
Manufactured under ISO 13485:2012 Quality Management System standard.
Notified Body: UDEM LTD A.Ş. (2292)
EC Certification No: M.2016.106.7000
GMDN Code: 43970
Sterilization
Sterilized with Ethylene Oxide. Validated for ISO 11135 standard.
Shelf Life
5 years.
Packaging
20 in each case