SenSmart Multi-Sensing 8330AA

SenSmart Multi-Sensing 8330AA Specifications

Print Specs

Overall Accuracy:

Accuracy (Arms) is expected to encompass approximately 68% of measured values and 95% Limits of Agreement are expected to encompass approximately 95% of measured values.

DescriptionSaO2 RangeMetHb or COHb RangeClinical AccuracyExpected Accuracy/95% Limits of Agreement
%SpO2 accuracy with COHb70 - 100%0 - 3% COHb± 2(-2.6, 3.2)
%SpO2 accuracy with COHb80 - 100%0 - 15% COHb± 2(-2.3, 2.9)
%SpO2 accuracy with MetHb70 - 100%0 - 2% MetHb± 2(-2.3, 3.7)
%SpO2 accuracy with MetHb80 - 100%0 - 15% MetHb± 2(-3.0, 3.8)
%COHb accuracy with elevated HHb95 - 100%0 - 15% COHb± 3(-5.2, 4.3)
%COHb accuracy with elevated HHb80 - 100%0 - 15% COHb± 3(-5.5, 4.5)
%MetHb accuracy97 - 100%0 - 15% MetHb± 1(-1.5, 1.7)
%MetHb accuracy with elevated HHb80 - 100%0 - 15% MetHb± 1(-1.7, 2.1)

Observed Clinical Study Accuracy

The tables below show Arms values measured using the Model 8330AA in a clinical study of healthy volunteer subjects.

%SpO2 Clinical Accuracy (Arms)1,2:

SaO2 RangeCOHb RangeOxygen Saturation (Figure A)
70 - 100%0 - 3%± 2
70 - 80%0 - 3%± 2
80 - 90%0 - 3%± 3
90 - 100%0 - 3%± 2
SaO2 RangeCOHb RangeOxygen Saturation with COHb (Figure B)
80 - 100%0 - 15%± 2
80 - 90%0 - 15%± 3
90 - 100%0 - 15%± 2
SaO2 RangeMetHb RangeOxygen Saturation (Figure C)
70 - 100%0 - 2%± 2
70 - 80%0 - 2%± 2
80 - 90%0 - 2%± 2
90 - 100%0 - 2%± 2
SaO2 RangeMetHb RangeOxygen Saturation with MetHb (Figure D)
80 - 100%0 - 15%± 2
80 - 90%0 - 15%± 3
90 - 100%0 - 15%± 2

%COHb Accuracy (Arms):

SaO2 RangeCOHb Range%COHb Accuracy (Figure E)
95 - 100%0 - 15%± 3
95 - 100%0 - 5%± 2
95 - 100%5 - 10%± 3
95 - 100%10 - 15%± 3
SaO2 RangeCOHb Range%COHb Accuracy with Elevated HHb (Figure F)
80 - 100%0 - 15%± 3
80 - 100%0 - 5%± 3
80 - 100%5 - 10%± 3
80 - 100%10 - 15%± 3

%MetHb Accuracy (Arms):

SaO2 RangeMetHb Range%MetHb Accuracy (Figure G)
97 - 100%0 - 15%± 1
97 - 100%0 - 5%± 1
97 - 100%5 - 10%± 1
97 - 100%10 - 15%± 1
SaO2 RangeMetHb Range%MetHb Accuracy with Elevated HHb (Figure H)
80 - 100%0 - 15%± 1
80 - 100%0 - 5%± 1
80 - 100%5 - 10%± 1
80 - 100%10 - 15%± 1

Pulse Rate Accuracy: 40 – 250 BPM ±3 digits (Arms):

Temperature:
Operating: -10 °C to 40 °C (14 to 104 °F)
Transient Operating: -20 °C to 50 °C (-4 to 122 °F)
Storage/Transportation: -40 °C to 70 °C (-40 to 158 °F)

Humidity:
Operating: 15% to 93% non-condensing
Transient Operating: 15% to 90% non-condensing
Storage/Transportation: Up to 93% non-condensing

Operating Altitude: 0 to 4,000 meters (0 to 13,123 feet)

Measurement Wavelengths and Output Power
Wavelength range: 600 to 910 nanometers
Output range: 1.5 to 18 mW

Compliance
This product complies with ISO 10993-1.
Not made with natural rubber latex.

Warranty
For warranty information refer to: https://www.nonin.com/warranty/

Nonin
Locations

Nonin Medical Inc
(Global Headquarters)

Address
13700 1st Ave N,
Plymouth, MN 55441

Email
info@nonin.com

Toll Free (USA and Canada)
1.800.356.8874

Phone
+1.763.553.9968

Nonin Medical B.V.
(Europe)

Address
Doctor Paul Janssenweg 150
5026 RH Tilburg
The Netherlands

Email
infointl@nonin.com

Phone
+31 (0)13-79 99 040

Fax
+31 (0)13-79 99 042

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