Gyrus ACMI
Gyrus ACMI, LLC · Model OL10-0A
OPER LAP 10mm 0 AUTOCLAVE
Intended use: An endoscope with a rigid inserted portionangulus iridocornealis for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. It is inserted through an incision made in the abdominal wall (routinely just below the umbilicus) during laparoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. The abdominal wall is distended, typically using a gas, providing the space to allow the surgeon to view and/or operate on the exposed organs. This reusable device is commonly used to evaluate/treat abdominal or pelvic pain, ectopic pregnancy, ovarian cysts, appendicitis, and perform female sterilization.
Key tips
- ·A failed biological indicator means the entire load is not sterile - no exceptions, regardless of how the cycle printout looks.
- ·Door gasket wear is the most common real cause of a failed vacuum/pressure test - check it before deeper diagnostics.
- ·Water quality directly affects steam-cycle validity - don't ignore scale or mineral buildup.
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.
- ·Daily biological and chemical indicator test loads
- ·Door gasket / seal inspection
- ·Steam trap and drain strainer cleaning
- ·Annual full PM and pressure-vessel certification
Technical Specs
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- Yes
- Single use
- Yes
- Prescription use
- Rx only
- FDA distribution status
- Not in Commercial Distribution
- Device type (GMDN)
- Rigid optical laparoscope
- FDA product classification
- Laparoscope, general & plastic surgery
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- Central Sterile Supply Department (CSSD)
- OR sterile core
- Satellite reprocessing areas
Documents & Manuals
No documents available for this device yet.
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