ACS
AMERICAN CONTRACT SYSTEMS, INC. · Model WHBC80C
BEACH CHAIR SHOULDER ARTHROSCOPY - 34346
Intended use: A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.
Key tips
- ·A failed leak test means the scope does not get reprocessed or used - send it for repair, full stop.
- ·A shortened reprocessing cycle is a real infection-control failure, not a minor deviation - follow AAMI ST91 exactly.
- ·Track light-source lamp-hours against the manufacturer's limit rather than running to failure.
PM Checklist
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
- ·Leak testing before each reprocessing cycle
- ·Scope reprocessing per AAMI ST91
- ·Light source lamp-hour tracking
- ·Annual full PM
Technical Specs
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- Yes
- Single use
- Yes
- FDA distribution status
- In Commercial Distribution
- Device type (GMDN)
- General surgical procedure kit, non-medicated, single-use
- FDA product classification
- General surgery tray
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- Endoscopy suite / GI lab
- Operating Room
- Bronchoscopy suite
Documents & Manuals
No documents available for this device yet.
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