GE Corometrics 250cx Series, Operator'S Manual

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Revision C 250cx Series Maternal/Fetal Monitor 17-9
2036946-001
Technical Specifications: Operating Modes
Maternal Pulse Oximetry Mode (Ohmeda)
Technique:
Sensor Type
1
:
Pulse Rate Accuracy:
Saturation Range:
Pulse Rate Range:
Saturation Accuracy:
2
Wavelengths:
Red
Infrared
Maximum Optical Output Power:
Alarms: (audio and visual)
Audio
Visual
Limits
Technical
Spectrophotometry and plethysmography
OXY-AP and OXY-F
30-250 bpm; ± 2 digits or ± 2%, whichever is greater (no motion)
30-250 bpm; ± 5 digits or ± 5%, whichever is greater (with motion)
30-250 bpm; ± 3 digits or ± 3%, whichever is greater (during low
perfusion)
0-100%
30-250 bpm
Accuracy, A
rms
(root mean square of paired values; previously
represented by ± 1 standard deviation)
70-100% ± 2 digits (without motion)
70-100% ± 3 digits (during clinical motion)
1
70-100% ± 2 digits (during clinical low perfusion)
Below 70% unspecified
650-670 nm
930-950 nm
10.5 mW
Alternating 1.5-second chimes
Flashing SpO
2
numeric or message
User-selectable high and low SpO
2
, and high and low pulse rate
Sensor errors, connection errors, insufficient signal, excessive motion,
communication problem, internal calibration error, or self-test failure.
1
Applicability: Adult/Pediatric. Accuracy of Oxy-F sensors has not been validated under clinical motion conditions. Ohmeda sensor accuracy tests were done with
13 healthy adult subjects. The volunteer population was composed of 3 females and 10 males. The ages ranged from 19 to 35 years old. The weights ranged from 120 to
185 lb with a mean weight of 158 lb. The skin tones were as follows: 2 African-American and Jamaican subjects with dark pigmentation, 1 Asian subject with light yellow
pigmentation, 1 Hispanic subject and 1 Mexican subject with medium pigmentation, and 8 Caucasian subjects with light to medium pigmentation. OXY- AP sensor
has been validated under motion condition. Three types of motion artifacts were evaluated: mechanically induced tapping at 3 Hz, random frequency clinical rubbing motion
with hand in prone position, and random frequency clinical rubbing motion with hand in supine position.
2
sensors are validated during low perfusion conditions. Low perfusion was achieved by having the room chilled to 60-68º F, keeping the left side of the subject
warm and the right side cooled to a perfusion index level <= 0.1. Saturation readings were compared against a reference system that was compared to arterial blood draws.
NOTE:
Because pulse oximeter equipment measurements are statistically distributed, only about two-thirds of pulse oximeter equipment measurements can be
expected to fall within ±
A
rms
of the value measured by a CO-Oximeter.
NOTE:
Use of a functional SpO
2
simulator to assess the accuracy of the Corometrics 250cx SpO
2
parameter has not been demonstrated.
This device is covered under one or more of the following US Patents: 5,503,148, 5,766,127, 5,934,277, 6,381,479, 6,385,471, 6,397,092, 6,408,198, 6,415,166,
6,434,408, 6,505,060, 6,505,133, 6,510,329, 6,650,918, 6,707,257, 6,714,803.
Operating Mode Specifications (Continued)