Product Description; Indications For Use - Medtronic Affinity Fusion BB811 Instrucciones De Uso

Affinity Fusion ®
Oxygenator with Integrated Arterial Filter and Balance
1. Model
BB811
Accessories Sold Separately
ATP210
AUH2093
AMH2014
RCL841

2. Product Description

The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is a single-use,
microporous, hollow-fiber, gas-exchange device with plasma-resistant fiber and integrated heat
exchanger and arterial filter. The oxygenator is bonded on its primary blood contacting surfaces with
a nonleaching biocompatible surface to reduce platelet activation and adhesion and preserve platelet
function.
The device is single-use, nontoxic, nonpyrogenic, supplied STERILE in individual packaging. Sterilized
by ethylene oxide.
3. Specifications
Oxygenator Membrane Type
Maximum Gas:Blood ratio
Heat Exchanger
Oxygenator Membrane Surface Area 2.5 m
Static Priming Volume
Recommended Blood Flow Range
Maximum Water Pressure
Maximum Rated Blood Pressure
Filtration
Storage Temperature
Storage Humidity

4. Indications for Use

The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is intended to be
used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood
and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in
duration.
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is designed to
filter from the circuit microemboli larger than the specified micron size for periods up to six hours during
cardiopulmonary bypass surgery. The Affinity Fusion Oxygenator with Integrated Arterial Filter and
Balance Biosurface is suitable for transfer of the volatile anesthetics isoflurane and sevoflurane by
administration through the oxygenator gas inlet by means of a suitable gas vaporizer.
5. Contraindications
This device used for any purpose other than the indicated use is the responsibility of the user.
6. Warnings
■
Read all warnings, precautions, and Instructions for Use carefully prior to use. Failure to read and
follow all instructions, or failure to observe all stated warnings, could cause serious injury
or death to the patient.
■
Only persons thoroughly trained in cardiopulmonary bypass procedures should use this device.
Operation of each device requires constant supervision by qualified personnel for patient safety.
■
The fluid pathway is sterile and nonpyrogenic. Inspect each package and device prior to use. Do
not use if the package is opened or damaged, the device is damaged, or the protective caps are
not in place as the sterility of the device may have been compromised and/or performance may be
affected.
1 Technology licensed under agreement from BioInteractions, Limited, United Kingdom.
22 Instructions for Use
Oxygenator with Integrated Arterial Filter and Balance
Affinity ® Temperature Probe
Affinity Orbit ® Holder System
Affinity ® Manifold Holder
Recirculation line
Microporous polypropylene hollow fiber
2:1
Polyethylene terephthalate (PET)
260 mL
1.0–7.0 L/min
206 kPa (1550 mm Hg)
100 kPa (750 mm Hg)
25 µm
−30°C–50°C (−22°F–122°F)
30–75% noncondensing
English
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® Biosurface
® Biosurface
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