Table of Contents
Advertisement
System Accuracy:
Rate Accuracy is ±5%, achieved under nominal conditions
Rate Accuracy is ±10%, achieved under low flow conditions
Occlusion Alarm Limits
Achieved under nominal conditions
Level
L2 - Low L5 - Medium
Pressure
230
(mmHg)
approx .
Maximum Occlusion Alarm Pressure:
Post Occlusion Bolus:
Bolus volume generated at 25 ml/h when the minimum occlusion
alarm threshold is reached <0.45 ml
Bolus volume generated at 25 ml/h when the maximum occlusion
alarm threshold is reached <0.95 ml
Bolus Volume Accuracy:
Typical: -4.1%, Max: -3.2%, Min: -5.5% 1ml @ 10ml/h
Typical: -1.3%, Max: -0.9%, Min: -1.6% 100ml @ 1200ml/h
Administering a Bolus
Parameter
Bolus Rate
10 - 1200ml/h in steps of 10ml/h
Bolus Volume
0 .0ml - 100 .0ml in steps of 0 .1ml
Displayed
Starting the Infusion / Set-up
Infusion Parameter
Infusion Rate
0 .1 - 99 .9ml/h in steps of 0 .1ml/h &
100 - 999ml/h in steps of 1ml/h
1000 - 1200ml/h in steps of 10ml/h
VTBI Primary
(0 - OFF), 1 - 9999ml
VI (Total)
0 .1 - 9999ml
Maximum time for activation of occlusion alarm:
At Maximum Pressure, time to alarm at 0.1ml/h is nominally 735 [±50]
minutes (Maximum <883 min)
At Minimum Pressure, time to alarm at 0.1ml/h is nominally 234 [±25]
minutes (Maximum <309 min)
At Maximum Pressure, time to alarm at 1.0ml/h is nominally 65 [±4]
minutes (Maximum <95 min)
At Minimum Pressure, time to alarm at 1.0ml/h is nominally 16 [±2]
minutes (Maximum <28 min)
At Maximum Pressure, time to alarm at 25ml/h is nominally 119 [±7]
seconds (Maximum <3 min)
At Minimum Pressure, time to alarm at 25ml/h is nominally 29 [±3]
seconds (Maximum <50 sec)
Infusion Specifications
1a,2
1a,4
L8 - High
L8 - High
<= 200 ml/h
> 200 ml/h
460
725
1250 mmHg
Range
Range
1000DF00498 Issue 3
Air Sensor:
Integral Ultrasonic Sensor.
Air in line detection:
1b,2
Single Bubble (configurable): 50µl, 100µl, 250µl & 500µl.
Bubble accumulation: 1ml over a 15 minute window.
Critical Volume
The maximum volume infused following a single fault condition
is for rates < 10ml/h: +/- 0.25 ml, rates < 100ml/h: +/- 0.5ml, rates
950
≥100ml/h: +/- 2 ml
Set based, pump activated Safety Clamp Device to prevent free
flow
Notes:
1a.
Nominal conditions are defined as:
Set Rate: 1 to 1200 ml/h;
Recommended disposable: 60593;
Needle: 18 gauge x 40 mm;
Solution Type: De-ionized & Degassed Water;
Temperature: 23°C ± 2°C
Fluid Head Height: +300 ± 30 mm;
Back Pressure: 0 ± 10 mmHg.
1b.
Low flow conditions are defined as:
Set Rate: less than 1.0ml/h
Recommended disposable: 60593;
Needle: 18 gauge x 40 mm;
Solution Type: De-ionized & Degassed Water;
Temperature: 23°C ± 2°C
Fluid Head Height: +300 ± 30 mm;
Back Pressure: 0 ± 10 mmHg.
2.
The system accuracy will change by the following percentages:
Temperature: nominally -5.7 (±1.5)% at 5 °C and nominally +0.3
(±1.7)% at 40 °C
Fluid Head Height: nominally -3.4 (±1.3)% at -0.5 m and 0.0 (±1.1)%
at +0.5 m
Duration: nominally -1.1 [±0.2] % over 24 hours of continuous use
Back Pressure: nominally +2.0 (±1.3)% at -100 mmHg, -13.4 (±1.8)%
at +800 mmHg respectively
Atmospheric pressure: ± 5% at 25ml/h at 700hPa
3.
Tested using Distilled water, 20% lipid, 50% glucose, 0.9% Normal
Saline and 5% Alcohol solutions.
4.
The occlusion pressure accuracy will change by the following:
Temperature: Low setting nominally 7 (±12) mmHg at 5 °C and
-24 (±17) mmHg at 40 °C respectively
Normal setting nominally 4 (±16) mmHg at 5 °C and -41 (±18)
mmHg at 40 °C respectively
High Pressure nominally 4 (±14) mmHg at 5 °C and -38 (±21)
mmHg at 40 °C respectively
A
The specified accuracy may not be maintained if the above
conditions are not met, see notes 1 to 4.
38/42
3
Advertisement
Table of Contents
