Potential Complications - Medovations SafeGuide Dirección

MEDOVATIONS SAFEGUIDE™ OVER THE GUIDEWIRE DILATATION SYSTEM
Directions for Use and Cleaning.
Read carefully prior to use
DESCRIPTION
The SAFEGUIDE™ OVER THE GUIDEWIRE ESOPHAGEAL DILATATION SYSTEM includes:
1. A set of flexible, tapered, polyvinylchloride (PVC) dilators that have a central, longitudinal
lumen for over-the-guidewire placement.
2. A marked, stainless steel Spring Tip Guidewire, 210cm long with a removable end cap.
3. Cleaning accessories such as a brush and disposable cleaning adaptors.
4. A storage case.
ALL OF THE ABOVE COMPONENTS MAY BE PURCHASED SEPARATELY.
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
Medovations SafeGuide™ Guidewire, product number 1214-02.
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;
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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 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.
Medovations, Inc.
102 E. Keefe Ave.
Milwaukee, WI 53212 USA
800.558.6408
414.265.7620
Fax 414.265.7628
medo@medovations.com
www.medovations.com
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