US endoscopy BioVac 00711511 Instrucciones De Uso página 2

Intended Use:
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The disposable BioVac direct suction device is indicated for transendoscopic evacuation, debulking, and/or lysing of blood, retained blood clots, or
fluid, such as residual stool, within the gastrointestinal tract through the biopsy/suction channel of flexible gastrointestinal endoscopes. It also provides
access for endoscopic device passage and exchange, and allows for supplemental intraprocedural irrigation when desired.
Three (3) different versions of the BioVac
Product #00711511 is appropriate for use with Pentax gastrointestinal endoscopes.
Product #00711512 and #00711513 are appropriate for use with Olympus or Fujinon G5 series or newer gastrointestinal endoscopes
Warnings and Precautions:
•
The product number version of the BioVac
gastrointestinal endoscope utilized. Selection is determined based on whether the clinician intends to use: (1) a Pentax gastrointestinal
endoscope (Product #00711511) or (2) an Olympus or Fujinon G5 series or newer gastrointestinal endoscope (Product #00711512 and
#00711513)
.
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Endoscopic procedures should only be performed by persons having adequate training and familiarity with endoscopic techniques.
•
Consult the medical literature relative to complications, hazards and techniques prior to the performance of any endoscopic procedure.
•
All versions of the BioVac
machine providing a suction force range of 10 to 30 inches Hg, or 127 to 762mm Hg, or 17 to 100KPA Hg.
•
Extended application of suction against the mucosa should be avoided in order to prevent potential mucosal trauma.
•
The endoscope's suction valve should not be activated/de-activated when the BioVac
activated/de-activated. Doing so may redirect and/or clog the available vacuum power directed to the BioVac
•
All versions of the BioVac
the purpose of intraprocedural lavage.
•
Liberal lavage of the GI lumen during endoscopic evacuation, debulking, and/or lysing procedures is recommended.
•
Exposure to bodily fluids may occur during connection or disconnection of this device; adherence to Body Substance Isolation protocols is the
responsibility of the user.
•
US Endoscopy did not design this device to be reprocessed or reused, and therefore cannot verify that reprocessing can clean and/or sterilize
or maintain the structural integrity of the device to ensure patient and/or user safety.
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The BioVac family of devices is not intended for reuse.
remanufactures, resterilizes, and/or reuses these disposable medical device's must bear full responsibility for their safety and effectiveness.
Contraindications:
Contraindications include those specific to any endoscopic procedure.
Instructions for Use:
1. Prior to clinical use, you should familiarize yourself with the device. Read the Instructions for Use and review the diagrams.
•
If endoscopic observation identifies the need for evacuating, debulking, and/or lysing blood, retained blood clots, or removing
fluid/residual stool, carefully remove the existing biopsy valve from the biopsy channel inlet of the endoscope and attach the appropriate
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BioVac device (Pentax or Olympus-Fujinon G5 series or newer) onto the biopsy channel inlet of the endoscope.
2. For product #00711511 and #00711512 (See Fig. 1-3):
Set Up Option 1 Using Endoscope's Suction Canister

Remove the existing length of suction tubing from the endoscope's umbilical suction barb (See Fig. 1) and attach the BioVac
device's suction tubing with coupler and yellow tag (See Fig. 2A) to the existing length of suction tubing extending from the
endoscope's dedicated suction source/canister (See Fig. 2B).
umbilical suction barb.
Set Up Option 2 Using Independent Suction Canister (with existing tubing)

Attach the BioVac
extending from an independent suction source/canister (See Fig. 2B).
Set Up Option 3 Using Independent Suction Canister (without existing tubing)

Remove the coupler from the BioVac
suction canister's incoming/"patient" suction inlet (See Fig. 3B).
3. For product #00711513 (See Fig. 1, 4):
A Y-port adaptor is attached for bifurcation of the endoscope's existing suction source.
Set Up

Remove the existing length of suction tubing from the endoscope's umbilical suction barb (See Fig. 1) and connect it to
Y-port tubing extension with coupler and yellow tag (See Fig. 4A).

Attach Y-port tubing extension with pinch clamp and orange tag (See Fig. 4B) to the endoscope's umbilical suction barb.

Bifurcation of a single suction vacuum is accomplished by opening or closing the pinch clamp; the suction (vacuum) power to the
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BioVac device is initiated by closing (engaging) the pinch clamp; the suction (vacuum) power back to the endoscope is initiated
by opening (disengaging) the pinch clamp.
4. If the clinician chooses to attach the BioVac
device's suction valve (trumpet valve) to the endoscope's control head, just above the biopsy channel inlet of the endoscope (See Fig. 5).
5. An irrigation line is attached to the BioVac
the blue pinch clamp prevents "whistling" when the irrigation line is not in use. When lavage is desired, attach a syringe (up to 60cc) or the auxiliary
water pump extension tubing from a water pump to the irrigation line.
6. Once the clinician observes and targets the desired evacuation site and material, the BioVac
activated/de-activated.
7. The endoscope's suction valve should not be activated/de-activated when the BioVac
activated/deactivated; doing so may redirect and/or clog the available vacuum power directed to the BioVac
00731348 Rev. F
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direct suction device are available:
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direct suction device selected by the clinician must accommodate the type/manufacturer of
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direct suction device require a vacuum powered suction source, such as hospital wall suction or a suction pump
®
direct suction device require a syringe or water pump with auxiliary water pump extension tubing (not included) for
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device's suction tubing with coupler and yellow tag (See Fig. 2A) to an existing length of suction tubing
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device's suction tubing with yellow tag (See Fig. 3A) and attach the tubing directly to the
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device's suction valve (trumpet valve) to the endoscope, utilize the Velcro strap and tether the
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device's biopsy valve. Close the blue pinch clamp on the irrigation line until lavage is desired. Closing
Rx Only
(U.S.A.)
Any institution, practitioner, or third party who reprocesses, refurbishes,
Do not attach the BioVac
®
®
device's suction valve (trumpet valve) is being
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device's suction valve (trumpet valve) is being
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device.
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device to the endoscope's
device's suction valve (trumpet valve) should be
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device.
.
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