Bayer HealthCare Certegra, Operation Manual

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internal temperature less than the continuous load operating temperatures, but greater than the no
load operating temperatures. Under normal operating conditions with a minimum of 10 minutes
between injections, the internal temperature of the head will not raise enough to degrade safety, sys-
tem performance or reliability
17.5.7 Fluid Delivery Performance
17.6 Over and Under Infusion Protection
The following means are provided to protect against over and under infusions:
• Warnings displayed on the Safety screen remind the operator to check the programmed
injection parameters prior to the injector being armed.
• An on-screen indication of insufficient volume is provided whenever the total volume pro-
grammed to be delivered is greater than the amount of fluid in the syringe.
Table 17 - 1: Fluid Delivery Performance
Description Specification
Volume Range 1 mL to maximum syringe capacity in 1mL increments
Flow Rate Range 0.1 to 10 mL/sec in 0.1 mL/sec increments
Programmable Pressure limit
(PSI / kPa)
200 mL syringe pressure limit selections (PSI / kPa): Choice of
50/345, 100/689, 150/1034, 200/1379, 225/1551, 250/1724,
300/2068, 325/2241
Pause 1 second to 900 seconds in 1 second increments
Hold Maximum Hold time is 20 minutes
Syringes (Volume Capacity) Maximum two (200 mL)
Injection Capabilities Maximum 6 phases per protocol
Elapsed Injection Time Minimum of 0 - 999 seconds
Flow Rate Accuracy
NOTE:
The injection system performs within the defined
accuracy specifications over steady state. Steady state
is averaged over:
- a 2 second interval for flow rates > 5 mL/s, or
- a 10mL volume for flow rates > 5 mL/s
Single syringe injection:
• +/- (5% + 0.1) mL/s
Simultaneous (DualFlow) injection:
• +/- 25% for flow rates < 1 mL/s
• +/- 15% for flow rates >= 1 mL/s and < 2 mL/s
• +/- 10% for flow rates >= 2 mL/s
Volume Delivered Accuracy
NOTE:
Accuracy performance may vary depending on
disposable configurations.
Single syringe injection:
• +/- (2% + 1 mL)
Simultaneous (DualFlow) injection:
• +/- (4% + 2 mL)