Intended Use; Warnings And Precautions - Steris BioShield 00711903 Instrucciones De Uso

This product is not made with natural rubber latex.

Intended Use:

®
The single use BioShield biopsy valve is used to cover the opening to the biopsy/suction channel of flexible gastrointestinal endoscopes. It
provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the
biopsy port throughout the endoscopic procedure and provides access for irrigation.
Device Descriptions:
Product Name
biopsy valve EUS – linear
®
BioShield
(sterile)
Device description:
biopsy valve EUS – linear covers the Olympus
®
- The BioShield
biopsy valve EUS – linear has a pierceable membrane for passage of instruments.
®
- This BioShield
biopsy valve EUS – linear has a tether that prevents it from getting misplaced. When the cap is removed, the tether
®
- The BioShield
keeps the device attached to the echoendoscope. (See Figure 2).

Warnings and Precautions:

biopsy valve EUS – linear is only compatible with Olympus linear echoendoscopes.
®
1. This BioShield
2. Exposure to bodily fluids may occur during connection or disconnection of this device: Follow universal precautions, use appropriate
infection control principles and wear appropriate PPE.
3. Do not leave a device hanging from the valve. Doing so can create a larger valve slit or hole that may cause leakage.
4. If the lid of the valve is opened while attached to the endoscope during a procedure, scope suction will be compromised, and leakage
may occur.
5. Consult the medical literature relative to techniques, technical principles, clinical applications, complications, risks, and hazards prior to
the performance of any endoscopic ultrasound procedure.
6. Endoscopic ultrasound procedures should only be performed by persons having adequate training and familiarity with endoscopic
ultrasound techniques.
7. 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, but are not limited to, those specific to any endoscopic procedure
•
Use on incorrect endoscope (See chart above for endoscope compatibility).
732963 Rev. C
Product
number
00711903
Figure 1
Endoscope Compatibility
®
Olympus linear echoendoscopes
®
linear echoendoscope instrument channel port (See Figure 1).
Figure 2
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