Cleaning Instructions - Diversatek Healthcare SAFEGUIDE Instrucciones De Uso Y Limpieza

a group of two (2) bands 40 cm from the tip. Each band represents 20 cm of distance to the spring tip, ending in a
grouping of seven (7) bands 140 cm from the tip.
A simple formula to measure the distance from a specific group of bands to the spring tip is:
(number of bands) x 20 cm = distance in centimeters to the spring tip
Measurements are taken from the most distal band in each group
CAUTION: When placing the guidewire, discontinue advancement of the wire if resistance is met.
4. When the guidewire is in position well beyond strictured area, slowly begin to withdraw endoscope in 5-10cm
increments while simultaneously advancing guidewire in 5-10cm increments to ensure guidewire remains in position.
CAUTION: Continuous fluoroscopic monitoring of the guidewire is essential in order to ensure it remains in proper
position.
5. When endoscope is removed completely, fluoroscopically confirm that guidewire has not been displaced.
Note: The guidewire position can be externally monitored using the marking bands (as described in 2 above) in
reference to the dental arch, both before and during dilatation.
6. Generously lubricate dilator and advance it over pre-positioned guidewire to strictured area.
Note: SafeGuide® Dilators have two (2) series of numbers printed on each dilator on opposing sides. One series
measures the distance to the distal tip, identified as FROM TIP (American). The other series measures the distance to
the stricture, identified as FROM MAX O.D. (European). These printed distance markings can be used as a guide to
avoid over-extending into the gastric cavity.
7. Proceed with esophageal dilation. Determine the SafeGuide® dilator to be used by the size of the strictures, starting
with a smaller French sized dilator and gradually increasing the French size. Hold the dilator at the blunt, proximal
end and place the lumen at the distal tapered tip over the end of the guidewire. Slide the dilator along the guidewire
while continuing to monitor the guidewire location. Carefully remove dilator after completed dilation.
Note: Successive dilations can be accomplished by repeating steps 5-6.
8. Upon completion of esophageal dilation, remove dilator and guidewire from patient.
9. Clean and prepare dilator for future use following cleaning instructions below.

CLEANING INSTRUCTIONS

CAUTION:
1. During cleaning, inspect integrity and function of device to determine advisability of reuse. If kinks, excessive wear,
bends or breaks exist, do not use. Dispose of device per institutional guidelines for biohazardous medical waste.
2. DO NOT USE Betadine to clean the dilators as it may cause discoloration of the material.
3. SafeGuide® Dilators CANNOT be steam autoclaved. The high temperatures of steam autoclaving will destroy the
dilator.
4. DO NOT USE alcohol for cleaning or disinfection.
5. Appropriate gloves, gowns, and other protective wear should be worn when cleaning and sterilizing soiled or used
dilators.
6. It is the responsibility of the user to qualify any deviations from the recommended methods of cleaning.
SafeGuide® Dilators must be thoroughly cleaned prior to use.
PRE-CLEANING (SafeGuide® Dilators and Spring Tip Guidewires):
1. Immediately after use, soak dilator/ guidewire in a solution of warm water and enzymatic cleaning solution. Note:
Refer to the enzymatic cleaning solution instructions for recommended duration of cleaning.
2. Remove gross contaminates on the external surfaces of the dilator/guidewire by hand, using a soft bristle brush,
sponge, or wipe, with warm water and enzymatic solution.
SafeGuide® Over the Guidewire Esophageal Dilatation System
Instructions for Use
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