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13.3 Operating environment
Temperature:
Humidity:
Atmospheric pressure:
14 Flow rate of Affinity CP centrifugal blood pump
Note: The actual obtainable flow is dependent on afterload of the pump which results from the extracorporeal circuit components and
the patient's arterial resistance.
Note: Pressure drop is the difference between the outlet of the pump and the inlet of the pump.
Figure 7. Hydraulic performance of the Affinity CP centrifugal blood pump
1 Pressure drop (mmHg)
2 Flow rate (L/min)
15 Limited warranty
The following LIMITED WARRANTY applies to United States customers only:
A. This LIMITED WARRANTY is available solely to the original purchaser of the Affinity CP centrifugal blood pump with Cortiva
bioactive surface, Model CBAP40 (hereinafter, referred to as "Product").
(1) In the event that the Product fails to function within normal tolerances due to a defect in materials or workmanship within a
period of one (1) year, commencing with the delivery of the Product to the purchaser, Medtronic will at its sole option: (a)
repair or replace any defective part or parts of the Product; (b) issue a credit to the purchaser equal to the Purchase Price
(as defined in Subsection A(2) below) against the purchase price of the replacement Product; or (c) provide a functionally
comparable replacement Product at no charge.
(2) As used herein, Purchase Price shall mean the lesser of (i) the net invoiced price of the original Product, (ii) the price of
currently functional comparable equipment, or (iii) the price of replacement equipment.
B. To qualify for the repair, replacement or credit set forth in Section A above, the following conditions must be met:
(1) The Product must be returned to Medtronic within sixty (60) days after discovery of the defect;
(2) The Product must not have been used other than in strict accordance with the Instructions for Use, must not have been used
on more than a single patient, and must not have been altered or repaired in any way which, in the judgment of Medtronic,
affects the stability and reliability of the Product. The Product must not have been subjected to misuse, abuse or accident;
and
(3) The Use-by date for the Product must not have passed.
10°C to 40°C (50°F to 104°F)
20% to 75% noncondensing
70 kPa to 106.3 kPa
800
700
600
500
400
300
200
100
1500
a
1000
0
0
2
4
3000
a
2500
a
2000
a
6
8
3
a
= RPM
19
a
4000
a
3500
a
10
12
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