Intended Use; Potential Complications - Diversatek Healthcare SAFEGUIDE Instrucciones De Uso Y Limpieza

DESCRIPTION
The SAFEGUIDE® OVER THE GUIDEWIRE ESOPHAGEAL DILATATION SYSTEM includes:

A set of flexible, tapered, polyvinylchloride (PVC) dilators that have a central, longitudinal lumen for over-the-
guidewire placement.

A marked, stainless steel Spring Tip Guidewire, 210cm long with a removable end cap.

Cleaning accessories such as a reusable brush and disposable cleaning adaptors.

A storage case.

INTENDED USE

For dilatation of upper esophageal webs, lower esophageal rings, caustic strictures, peptic esophageal strictures, and temporary
ease of esophageal carcinoma.
The SafeGuide® Over the Guidewire Dilators are designed to be used over a pre-positioned SafeGuide® Guidewire, product
numbers 1214-02 and 1214-02D.
INSPECTION – PRIOR TO USE
CAUTION: Remove protective end cap from new guidewire outside of procedure room and discard.
Inspect new dilators and accessories for damage from shipping and handling.
Inspect older dilators for wear. Worn dilators should NOT be used. Signs of wear can include: enlarged distal tip lumen due to
repeated abrasions over the guidewire, surface cracks and crazing, cuts, and extremely faded print.
There is not an expiration date for the dilators because fitness for use is not age dependent. Fitness for use is determined by
inspection for wear.
Visually inspect the guidewire for signs of wear or degradation such as kinks, bends, or breaks. Worn guidewires should NOT be
used as they may not perform as expected.
CONTRAINDICATIONS
Contraindications include those specific to upper GI endoscopy.
Contraindications to dilation include, but are not limited to: uncooperative patient; asymptomatic strictures; inability to
advance the dilator through the strictured area; coagulopathy; known or suspected perforation; severe inflammation or
scarring near the dilation site, recent myocardial infarction, active ulcer and severe cervical arthritis.

POTENTIAL COMPLICATIONS

Potential complications associated with upper gastrointestinal endoscopy and esophageal dilation include, but are not limited
to: perforation, hemorrhage, aspiration, fever, infection, allergic reaction to medication, hypotension, respiratory depression or
arrest, cardiac arrhythmia or arrest.
INSTRUCTIONS FOR USE
1. Inspect all dilators and accessories before use. See INSPECTION - PRIOR TO USE section.
2. Perform screening endoscopy to identify strictured area.
3. Introduce the guidewire, spring tip end first, through the accessory channel of endoscope. A lubricant will help the
guidewire glide through smoothly.
Advance the guidewire until the spring tip is endoscopically visualized well beyond tip of scope and beyond the
strictured area.
The guidewire can also be externally monitored using the marking bands. The guidewire is marked in 20cm
increments to help determine the location of the spring tip. The markings are groups of bands, beginning distally with
SAFEGUIDE® OVER THE GUIDEWIRE DILATATION SYSTEM
Instructions for Use and Cleaning
Read carefully prior to use
ALL OF THE ABOVE COMPONENTS MAY BE PURCHASED SEPARATELY.
SafeGuide® Over the Guidewire Esophageal Dilatation System
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Instructions for Use
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