Diversatek Healthcare SAFEGUIDE Instrucciones De Uso Y Limpieza página 5

1. Completely immerse dilator in a disinfectant. Note: Refer to disinfectant solution instructions for duration of
immersion required for high level disinfection or sterilization. If difficulty is encountered with solution penetration
into the guidewire lumen, attach suction to the tapered end of dilator or utilize a SafeGuide® Cleaning Adaptor.
2. Rinse dilator thoroughly with clean, running water. Rinse the guidewire lumen by attaching suction to tapered end of
dilator or using a SafeGuide® Cleaning Adaptor to suction water through this inner guidewire lumen. Note: Proper
rinsing with clean water and complete drying of dilator and guidewire lumen is necessary following use of these
solutions.
3. Dry external portions for dilator completely with a lint-free cloth. Use medical grade (oil-free) forced air to dry
guidewire lumen.
The Reusable SafeGuide® Guidewire (without the protective end cap, part number 1214-02 only) and Reusable SafeGuide®
Cleaning Brush (part number 1214-03R only) may be exposed to steam autoclave, using a standard steam sterilization cycle of
132°C for 15 minutes. The guidewires and reusable cleaning brushes should be individually wrapped for the steam sterilization
cycle. After steam sterilization, allow the guidewires/cleaning brushes to completely cool to room temperature (25°C). Do not
immerse in cold liquids. Dry thoroughly.
The Disposable SafeGuide® Cleaning brush (part number 1214-03D) and Disposable SafeGuide® Guidewire (part number 1214-
02D) are single-use only. Do not reuse, reprocess, or resterilize single-use products. The materials used in the manufacture of
the device may not withstand repeated reprocessing. The device may not perform as intended by the manufacturer if it is
reused.
SafeGuide® Dilators are made with flexible, medical-grade polyvinylchloride (PVC). The products are compatible with ethylene
oxide (EO) gas sterilization.
Device to be sterilized should first be placed in appropriate packaging materials capable of maintaining sterility, such as Tyvek®
peel pouches. Typical conditions for ethylene oxide sterilization are 500 mg/L ethylene oxide, 50-70% relative humidity (RH)
and 120-130°F with exposure time dependent on hospital regulations and/or sterilizer instructions. EO cycle temperatures
should not exceed 135°F or 80% relative humidity (RH). EO cycle should have adequate aeration time to meet the
requirements of ISO 10993-7.
The user must validate cycle efficacy along with the corresponding packaging/sterile barrier materials.
STORAGE
The SafeGuide® Dilators should be out of direct light, and at room temperature. SafeGuide® Dilators may be stored flat or hung
vertically. The SafeGuide® Storage Case provides a protected environment.
DESCRIPTION OF SYMBOLS USED ON LABELS
Manufacturer
Date of manufacture (YYYY-MM-DD)
Use-by date (YYYY-MM-DD)
Lot number
Part number
Non-sterile
SafeGuide® Over the Guidewire Esophageal Dilatation System
Instructions for Use
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