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This product is not made with natural rubber latex.
Intended Use:
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® direct suction device are available:
Product #HZ-711511 is appropriate for use with Pentax gastrointestinal endoscopes.
Product #HZ-711512 and #HZ-711513 are appropriate for use with Olympus or Fujifilm G5 series or newer gastrointestinal
endoscopes.
Warnings and Precautions:
The product number version of the BioVac® direct suction device selected by the clinician must accommodate the
type/manufacturer of gastrointestinal endoscope utilized. Selection is determined based on whether the clinician intends to
use: (1) a Pentax gastrointestinal endoscope (Product #HZ-711511) or (2) an Olympus or Fujifilm G5 series or newer
gastrointestinal endoscope (Product #HZ-711512 and #HZ-711513).
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® direct suction device require a vacuum powered suction source, such as hospital wall suction or a
suction pump 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® device’s suction valve (trumpet valve)
is being activated/de-activated. Doing so may redirect and/or clog the available vacuum power directed to the BioVac® device.
All versions of the BioVac® direct suction device require a syringe or water pump with auxiliary water pump extension tubing
(not included) for 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.
Do not attempt to reuse, reprocess, refurbish, remanufacture, or resterilize this device. STERIS Endoscopy did not design this
device nor is it intended to be reused, reprocessed, refurbished, remanufactured, or resterilized. Performing such activities on
this disposable medical device presents a safety risk to patients (i.e. compromised device integrity, cross-contamination,
infection).
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 BioVac® device (Pentax or Olympus-Fujifilm G5 series or newer) onto the biopsy channel inlet
of the endoscope.
2. For product #HZ-711511 and #HZ-711512 (See Fig. 1-3):
Set Up Option 1 Using Endoscope’s Suction Canister
a. 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). Do not attach the BioVac®
device to the endoscope’s umbilical suction barb.
Set Up Option 2 Using Independent Suction Canister (with existing tubing)
b. Attach the BioVac® device’s suction tubing with coupler and yellow tag (See Fig. 2A) to an existing length of
suction tubing extending from an independent suction source/canister (See Fig. 2B).
Set Up Option 3 Using Independent Suction Canister (without existing tubing)
c. Remove the coupler from the BioVac® device’s suction tubing with yellow tag (See Fig. 3A) and attach the tubing
directly to the suction canister’s incoming/“patient” suction inlet (See Fig. 3B).
3. For product #HZ-711513 (See Fig. 1, 4):
A Y-port adaptor is attached for bifurcation of the endoscope’s existing suction source.
Set Up
a. 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).