Contraindications - Apollo OverTube Mode D'emploi

4. Packaged System
The OverTube is packaged inside a sealed protective pouch.
5. Recommended Accessories
•
Water soluble lubricant
•
10ml Syringe (Aspiration Source)
•
63FR bite-block or larger

6. Contraindications

Contraindications include those specific to use of an
overtube and any endoscopic procedure, which may include,
but not be limited to, the following:
Esophageal Procedures:
•
Esophageal bleeding, ulceration and/or laceration
•
Laryngeal perforation and/or stenosis
•
Trauma to teeth, gums and/or pharynx which could be
aggravated during the procedure
•
Bleeding disorders/anticoagulation (non reversible
bleeding disorders with coagulopathy)
•
The patient has any other condition or anatomical
limitation that would contraindicate them from an
upper GI endoscopic procedure
Colonic Procedures:
•
Varices
•
Bleeding disorders/anticoagulation (non-reversible
bleeding disorders with coagulopathy)
•
The patient has any other condition or anatomical
limitation that would contraindicate them from a lower
GI endoscopic procedure
7. Warnings
•
Do not use device where the integrity of the
packaging has been compromised or if the device
appears damaged
•
Lubrication required. Generously lubricate inner and
outer surfaces of the OverTube with water soluble
lubricant prior to use
•
During insertion or removal of the OverTube, do not
advance or retract against resistance
•
Do not advance, remove, or reposition the OverTube
unless under endoscopic visual guidance
•
Reuse or reprocessing of the OverTube could result
in device malfunction or patient consequences to
include:
– Infection or the transmission of disease
– Damage to the polymer extrusion,
compromising safe access
– Impaired sealing when using insufflation
– Accumulation of lubricant and debris
8. Precautions
•
The system may only be used if purchased from Apollo
Endosurgery Inc. or one of its authorized agents
•
Prior to use, performing a baseline EGD can lower the
likelihood of patient complications with the use of the
OverTube
•
Endoscopic procedures and foreign body retrieval
should only be performed by clinicians with adequate
training and familiarity with endoscopic techniques.
Use of an overtube should not be attempted unless
proficiency in technique has been developed
•
Once placed, the OverTube should not be advanced
beyond the endoscope as tissue entrapment and
mucosal injury could occur. For any repositioning
required, refer to Section 13. Endoscope Removal and
Reinsertion
9. Adverse Events
Possible complications that may result from using the
OverTube include, but may not be limited to:
•
Hemorrhage
•
Hematoma
•
Infection / Sepsis
•
Allergic reaction
•
Pharyngeal, esophageal or bowel perforation
•
Pharyngeal, esophageal or bowel laceration
10. Preparations for Use
10.1 Endoscope Selection
10.1.1. The Endoscope must have an outer diameter (OD)
between 10.0mm and 16.0mm.
10.2 Accessory Preparation
10.2.1. Select and prepare all required accessories (listed in
Section 5. Recommended Accessories).
10.3 Patient Preparation
10.3.1. Prepare the patient for endoscopy as per
institutional guidelines or physician preference.
10.3.2. The use of a 63FR bite block is recommended to
prevent collapse of the OverTube by patient gums
or dentition.
10.4 Device Preparation
10.4.1. Remove the device from its outer package. Verify
the device has not been compromised by assuring
package integrity has been maintained.
10.4.2. Inspect the device for any bends, kinks, or other
signs of damage. If damaged, do not use the device.
NOTE: Check that Inflation Line is secure and tighten
if required.
10.4.3. Generously lubricate the entire length of the
Endoscope's outer sheath with a water soluble
lubricant.
3
10.4.4. Load the Hub opening of the OverTube with a
generous volume of water soluble lubricant.
10.4.5. Insert the distal end of the Endoscope through the
Hub of the OverTube and slide the OverTube fully
onto the Endoscope.
10.4.6. Ensure that the tapered tip of the OverTube forms
a gap-free interface with the outer diameter of
the Endoscope, and that it slides freely over the
Endoscope.
10.4.7. Generously lubricate the outside of the OverTube
including the tapered Tip.
11. Insertion
11.1. Perform baseline EGD.
11.2. Gently advance the OverTube over the well
lubricated Endoscope until it reaches the desired
anatomical location.
WARNING: During insertion or removal of the
OverTube, do not advance or retract against
resistance.
WARNING: Never advance or reposition the
OverTube without endoscopic visual guidance.
NOTE: The OverTube Hub includes a 27cm Marker
intended to aid positioning.
12. Seal Inflation (if insufflating)
12.1. Fill the 10ml Syringe with air.
12.2. Using the Luer fittings, connect the Syringe to the
Aspiration Line.
12.3. Ensure the Seal Valve is open.
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