Steris Bioguard Instrucciones De Uso página 2

This product is not made with natural rubber latex.
Intended use: This device is intended as part of the precleaning process, to help clear the air/water channel of Olympus GI endoscopes
post procedure.
Device description: BioGuard
not contain a balloon channel). It is used post procedure, during the precleaning stage of the endoscope cleaning process. This device
flushes the air/water channel with water and air to keep the air/water channel from clogging with debris.
Warnings and Precautions:

These devices are intended to be used with Olympus
utilize a balloon channel**

Do Not Use the BioGuard

Endoscopic cleaning procedures should only be performed by persons having adequate training with endoscope cleaning
techniques.

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 using on GI endoscopes that are not Olympus or the Olympus echoendoscope that has a balloon
channel.

Use during patient procedures in place of standard air/water valve for insufflation and lens washing.
Prior to Use:
1. Prior to clinical use, inspect and familiarize yourself with the device. If there is evidence of damage (i.e. deformed,
cracked/broken, damaged packaging), do not use this product, save for return, and contact your local Product Specialist.
Directions for Use:
1. Remove the device from the package.
2. Turn off the airflow regulator on the light source after initial rinsing of scope (per facility guidelines).
3. Remove the air/water valve from the scope.
4. Insert the BioGuard
5. Place the distal end of the scope into a basin of water.
6. On the light source, turn on the airflow regulator and set it to a maximum output of "high".
7. Depress the BioGuard
instructions.
Note: This flushes the air/water channel with water.
8. Release the BioGuard
9. Keep the distal end of the scope in the basin of water.
10. Flush air for the recommended time per the scope manufacturer's reprocessing instructions.
Note: Air bubbles will be seen in the basin of water.
11. Turn off the air/flow regulator on the light source.
12. Remove distal end of scope from basin of water.
13. Remove the BioGuard
14. Discard the BioGuard
Product Disposal:
After use, this product may be a potential biohazard which presents a risk of cross-contamination. Handle and dispose of in
accordance with accepted medical practice and applicable local, state and federal laws and regulations.
Issued Date: October 2019
Warning: An issued or revision date for these instructions is included for the user's information. In the event that two years have elapsed
between this date and product use, the user should contact STERIS to determine if additional information is available.
Unless otherwise indicated, all marks denoted with ® or ™ are registered with the U.S. Patent and Trademark Office, or are trademarks
owned by STERIS Corporation.
Serious incidents that have occurred in relation to this medical device should be reported to the manufacturer and competent authority in
the country where the incident occurred.
US Endoscopy, a wholly owned subsidiary of STERIS Corporation.
00732444 Rev C
®
air/water cleaning adapter is a valve that fits onto the air/water cylinder of Olympus endoscopes (that do
® air/water cleaning adapter during patient procedures. Continuous air flow could cause patient injury.
®
air/water cleaning adapter into the air/water cylinder on scope handle.
®
air/water cleaning adapter for the recommended time per the scope manufacturer's reprocessing
®
air/water cleaning adapter.
® air/water cleaning adapter from scope after precleaning step is completed.
® air/water cleaning adapter in accordance with institutional guidelines.
®
GI Endoscopes **EXCLUDING Olympus
®
echoendoscopes that