Bioquell ProteQ, Руководство пользователя

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BIOQUELL PROTEQ USER MANUAL -EN
TD092-O&M-001
REVISION 5 DRAFT
Page 2 of 58
REV Description Date C.R.No Orig Chkd Apprd
3 Update to spec, US distance measurer & user
access
8 th May 2019 CR3852 ORC PM REP
4 Addition of Flexi adaptor and Active directory 20 Feb 2020 CR4063 ORC PM REP
5 Addition of FDA requirement and new DoC 29 Oct 20 XXXXX ORC XX XX
Bioquell designs, manufactures and supplies as a service a broad range of bio-
decontamination solutions for:
•
rooms
• systems and processes
• laboratory equipment
•
biomedical equipment
For further information and contact details refer to website www.bioquell.com
Hydrogen peroxide vapour is potentially dangerous if used incorrectly. It is essential that
the safety and operating instructions described in this manual are observed.
These are the Original Instructions
The Bioquell ProteQ is only to be used by personnel who have been trained by
Bioquell or their agents on its safe use. If the equipment is used in a manner not
specified by the manufacturer, the protection provided by the equipment may be
impaired.
United States of America only:
• The Bioquell T echnology system has been authorized by the United States Food
Drug and Administration (FDA) to decontaminate compatible N95 respirators
under an Emergency Use Authorization (EUA).
•
The Bioquell Technology System has neither been cleared or approved by FDA, but
has been authorized for emergency use by FDA under an EUA for the
decontamination of compatible N95 respirators for single-user reuse by HCP to
prevent exposure to SARS-CoV-2 and other pathogenic biological airborne
particulates ;
• The emergency use of the Bioquell Technology System is authorized only for the
duration of the declaration that circumstances exist justifying the authorization of
the emergency use of medical devices during the COVID-19 outbreak, under
Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §
360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked
sooner .
Report Adverse events, including problems with test performance or results, to MedWatch by submitting the
online FDA Form 3500 (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home ) or
by calling 1-800-FDA-1088
This equipment has been tested and found to comply with the limits for a Class A digital device,
pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection
against harmful interference when the equipment is operated in a commercial environment. This
equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in
accordance with the instruction manual, may cause harmful interference to radio communications.
Operation of this equipment in a residential area is likely to cause harmful interference in which case
the user will be required to correct the interference at his own expense.