Disclaimer Of Warranties - Biostable HAART 201 Instrucciones De Uso

Automated Cleaning Parameters
Process Time
Step (mm:ss)
Enzymatic 04:00
Wash
Wash 02:00
Rinse 02:00
Dry 15:00
Visually inspect each instrument for remaining soil and
moisture. If soil remains, repeat the cleaning process. If
instruments are wet, use filtered compressed air or a lint
free wipe to dry.
Warning: Ultrasonic cleaning should not be used on the
Sizers since it may cause crazing of the polymer material
and markings.
The user is responsible for the qualification of any deviation
from the recommended cleaning method.
9.2 Sterilization Instructions
The Handles should be removed from the Sizer or Gage
Sphere prior to cleaning and sterilization.
The four Sizers, the single Gage Sphere, and Handles should
be placed in the instrument tray for steam sterilization. The
following sterilization cycle is recommended:
Temperature: 132°C (270°F)
Dwell time: 4 minutes
Cycle: Pre-vacuum
Dry time: 20 minutes minimum
The user is responsible for qualification of any deviations
from the recommended sterilization method.
BioStable acknowledges that the sterilization cycle
described below is routinely used by European hospitals
and has been validated for many similar heart valve sizer
systems and surgical instruments.
Pre-vacuum: cycle
Temperature: 134°C (274°F)
Dwell time: 3 minutes
Dry time: 20 minutes
6
Temp Cleaner
(C)
Hot tap Steris
water Prolystica
2X Concentrate
Enzymatic
Presoak and Cleaner
3 mL/liter
60 Steris
Prolystica
Ultra-Concentrate
Neutral Detergent
0.7 mL/liter
70 N/A
Low N/A
DWG-01-034 Rev. A - ©2021
The components of the HAART 201 Instrument Set do not
pose any significant challenge to sterilization using this
widely validated process. The instrument materials can
withstand temperatures up to 137°C.
9.3 Re-use
BioStable has performed a minimum of 50 sterilization
and use cycles on the HAART 201 Instrument Set without
any signs of wear being noted.
Caution: The Sizers, Gage Sphere, and Handle are
intended for multiple uses as long as they are inspected
before each use for signs of damage. The Sizers and
Gage Sphere should be visually inspected for crazing
of polymer materials, cracks and signs of structural
weakness or unreadable markings before each use. The
Handle should be inspected for visible cracks or signs of
structural weakness before each use and after bending.
Replace any instrument that exhibits these faults, as it
may not function properly and could cause patient injury.

Disclaimer of Warranties

Although the HAART 200 Aortic Annuloplasty Device
and HAART 201 Instrument Set, hereafter referred to
as "product," have been manufactured under carefully
controlled conditions, BioStable Science & Engineering
has no control over the conditions under which this
product is used. BioStable Science & Engineering and its
affiliates (collectively, "BioStable"), therefore, disclaims
all warranties, both express and implied, with respect
to the product, including, but not limited to, any implied
warranty of merchantability or fitness for a particular
purpose. BioStable shall not be liable to any person or
entity for any medical expenses or any direct, incidental,
or consequential damages caused by any use, defect,
failure, or malfunction of the product, whether a claim
for such damages is based upon warranty, contract,
tort, or otherwise. No person has any authority to bind
BioStable to any representation or warranty with respect
to the product.
The exclusions and limitations set out above are not
intended to, and should not be construed so as to,
contravene mandatory provisions of applicable law.
If any part or term of this Disclaimer of Warranty and
Limitation of Liability is held by any court of competent
jurisdiction to be illegal, unenforceable, or in conflict
with applicable law, the validity of the remaining portion
of the Disclaimer of Warranty and Limitation of Liability
shall not be affected, and all rights and obligations
shall be construed and enforced as if this Disclaimer of
DWG-01-034 Rev. A - ©2021 7