neoprobe
TM
GDS Operation Manual
AW-000639
Page
22 of 38
Reprocessing of Console according to EN ISO 17664:2004
Manufacturer:
Devicor Medical Products, Inc.
300 E-Business Way, Fifth Floor
Cincinnati, OH 45241 USA
Method: Cleaning & Disinfection
Symbol:
Model 2300
Devices(s):
Reusable control units comprising fixed assemblies (no moving parts); sold nonsterile.
WARNING:
WARNING
: disconnect control unit from power source before cleaning to avoid
electrical shock.
Limitations on
reprocessing:
Repeated processing has little effect on instrument. End of life is normally determined by
abrasion, wear and damage. DAMP WIPE ONLY.
INSTRUCTIONS:
Point of use
:
Remove excess soil and surface contamination with disposable cloth/paper wipe.
Containment &
Transportation
:
No particular requirements. Recommend reprocessing instrument soon after surgical use.
Preparation for
cleaning
:
WARNING
: disconnect control unit from power source before cleaning to avoid
electrical shock.
Cleaning - Automated
:
Do not use automated cleaning. Clean by hand; cleaning instructions below.
Cleaning: Manual
Equipment: mild detergent, clean gauze pad or lint free cloth, and clean soft brush.
Method:
1.
Dampen cloth with mild detergent and wipe excess soil from surface
2.
Clean air flow vents with dry brush
3.
Visually inspect for cleanliness
4.
Repeat steps 1 to 3 until visually clean.
5.
Allow to dry in room air
Disinfection:
No requirement
Drying:
Air dry at room temperature
Maintenance:
Do not use damaged instruments
Inspection & Function
Testing:
All instruments: Visually inspect for damage or wear. Where instruments form part of a
larger assembly, check assembly with mating components.
Packaging:
No requirement
Sterilization:
Console does not require sterilization
Storage:
No requirement
Additional Information:
Remove debris near power button and probe input connector. Do not allow moisture to
enter through display or other openings.
Manufacturer Contact:
See troubleshooting section for telephone and address of local representative or telephone
1-877-926-2666
.
NOTE
: Instructions provided above are validated by medical device manufacturer as being capable of preparing a
medical device for re-use. It remains responsibility of reprocessor to ensure that reprocessing is actually performed using
equipment, materials, and personnel in processing facility to achieve desired result. This requires validation and routine
monitoring of processes. Likewise any deviation by processor from instructions provided should be properly evaluated for
effectiveness and potential adverse consequences.
Artwork No: AW-000639 Revision: A Artwork Status: Released Lifecycle Name: Artwork
PCO No: N/A ECN No: ECN-000214 Release Date: 10/09/2012 Effective Date: 10/09/2012
