Documentation
Resources
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Case Study: Using SenSmart Regional Oximetry to Aid in Transfusion Decisions View
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Case Study: Partial Anomalous Pulmonary Venous Return (PAPVR) and Bicuspid Aortic Valve, Nonin Medical’s SenSmartTM Universal Oximetry View
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Understanding Accuracy, Bias, and Variability in SpO2 Readings View
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Accuracy and Superior Performance of PureSAT and PureLight Oximetry Technologies View
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Accurate Oximetry Monitoring – See the Technology Difference View
3500SP Specifications
Displayed Carboxyhemoglobin Range (COHb): 0 to 40%
Displayed Met Hemoglobin Range (MetHb): 0 to 40%
Displayed Oxygen Saturation Range (SpO2): 0 to 100%
Displayed Pulse Rate Range: 18 to 321 beats per minute (BPM)
Displayed Regional Saturation Range (rSO2): 50% to 100%
SpO2 Measurement Wavelengths and Output Power*: Two wavelengths between 660 and 910 nanometers with output power range between 0.8 – 3.0 mW nominal.
CO-Met Measurement Wavelengths and Output Power*: Eight wavelengths between 600 and 920 nanometers with output power range between 1.5 and 18 mW
rSO2 Measurement Wavelengths and Output Power*: Three or four wavelengths between 730 and 880 nanometers with output power range between 3.0 and 4.5 mW max. avg.
SpO2 Accuracy (Arms**): 70 to 100%
No Motion | Adults/Pediatrics*** | Neonates |
---|---|---|
REUSABLE: | ||
8100AX Series: | ± 2 digits | N/A |
8100SX Series: | ± 2 digits | N/A |
8100Q2: | ± 2 digits | N/A |
DISPOSABLE: | ||
6100CX Series: | ± 2 digits | ± 3 digits |
Motion | ||
REUSABLE: | ||
8100AA: | ± 2 digits | N/A |
8100AP: | ± 3 digits | N/A |
8100SX Series: | ± 3 digits | N/A |
DISPOSABLE: | ||
6100CA/6100CP/6100CI | ± 2 digits | N/A |
Low Perfusion**** | ||
8100AX, 8100Q2, 6100C(X) | 70 – 97% ± 2 digits | N/A |
8100S(X) | 70 – 100% ± 2 digits | N/A |
Pulse Rate Accuracy | Adults/Pediatrics*** | Neonates |
---|---|---|
No Motion | ||
REUSABLE: | ||
8100AX Series: | 40 – 240 BPM ± 3 digits | N/A |
8100SX Series: | 18 – 300 BPM ± 3 digits | N/A |
8100Q2: | 40 – 240 BPM ± 3 digits | N/A |
DISPOSABLE: | ||
6100CX Series: | 20 – 250 BPM ± 3 digits | 20 – 250 BPM ± 3 digits |
Motion (40 – 240 BPM) | ||
REUSABLE: | ||
8100AX Series: | ± 5 digits | N/A |
8100SX Series: | ± 5 digits | N/A |
Low Perfusion (40 – 240 BPM) **** | ± 3 digits | ± 3 digits |
* This information is especially useful for clinicians performing photodynamic therapy.
** ±1 Arms represents approximately 68% of measurements at zero bias.
*** Includes infant patients.
**** Does not apply to those sensors listed as N/A under the neonate column and 8100Q2.
Notes:
SpO2 Reusable Group:
8100AX Finger Clip Sensors: 8100AA-1, 8100AP-1
8100SX Soft Sensors: 8100SS, 8100SM, 8100SL,
8100Q2 Ear Clip Sensor
SpO2 Disposable Group:
6100C Series Sensors: 6100CA, 6100CP, 6100CI, 6100CN
CO-Met Reusable Group: 8300AA
rSO2 Reusable Group: 8003CA, 8004CA, 8004CB, 8004CB-NA
rSO2 Disposable Group: 8204CA
8300AA CO-Met™ Accuracy:
Description (No Motion) | SaO2 Range | MetHb or COHb Range | Accuracy |
---|---|---|---|
%SpO2 accuracy with COHb | 70 – 100% | 0 – 3% COHb | ± 2 |
%SpO2 accuracy with COHb | 80 – 100% | 0 – 15% COHb | ± 2 |
%SpO2 accuracy with MetHb | 70 – 100% | 0 – 2% MetHb | ± 2 |
%SpO2 accuracy with MetHb | 80 – 100% | 0 – 15% MetHb | ± 2 |
%COHb accuracy | 95 – 100% | 0 – 15% COHb | ± 2 |
%COHb accuracy with elevated HHb | 80 – 100% | 0 – 15% COHb | ± 3 |
%MetHb accuracy | 97 – 100% | 0 – 15% MetHb | ± 0.8 |
%MetHb accuracy with elevated HHb | 80 – 100% | 0 – 15% MetHb | ± 1.0 |
rSO2 Accuracy
8004CA, 8204CA: 50 – 100%
Accuracy | Right | Left | Both | Hypercapnia | Hypocapnia |
---|---|---|---|---|---|
Absolute | 4.1 | 3.8 | 3.9 | 5.1 | 3.3 |
Trend | 1.9 | 3.0 | 2.5 | 3.4 | 3.8 |
8004CB, 8004CB-NA: 45 – 95% ±5.9
8003CA: 45 – 100%
Accuracy | Right | Left | Both | Hypercapnia | Hypocapnia |
---|---|---|---|---|---|
Trend | 2.3 | 4.6 | 3.6 | 6.6 | 3.7 |
Temperature (Operating):
Signal Processor: -5 to +50 °C
8100AX Series, 8100Q2, 8300AA: -10 to +40 °C
8100SX Series, 6100C(X) Series: 0 to +40 °C
rSO2 sensors: -5 to +40 °C
Storage/Transportation:
Signal Processor, 8100SX Series, 6100C(X) Series, rSO2 sensors: -30 to +70 °C
8100AX Series, 8100Q2, 8300AA: -40 to +70 °C
Humidity (Operating):
SpO2 and CO-Met sensors: 15% to 93% non-condensing
rSO2 sensors: 10% to 90% non-condensing
Storage/Transportation:
SpO2 and CO-Met sensors: Up to 93% non-condensing
rSO2 sensors: 10% to 95% non-condensing
Altitude (Operating): 0 to 4,000 meters (13,123 feet)
Patient Isolation: Meets IEC 60601-1 Dielectric withstand
Degree of protection: Type BF-Applied Part
Leakage Current: Not Applicable
Dimensions (approximate):
Cable Length: .75 meter ±10%
Housing: 76.2 mm (3 in.) x 21.6 mm (.85 in.) x 25.4 mm (1 in.)
Weight (approximate): 50 grams
Power Draw (typical):
No Sensor Attached: 210 mW
SpO2 Sensor Attached: 310 mW
rSO2 Sensor Attached: 315 mW
CO-Met Sensor Attached: 360 mW
Maximum Power Draw:
No Sensor Attached: 280 mW
SpO2 Sensor Attached: 370 mW
rSO2 Sensor Attached: 385 mW
CO-Met Sensor Attached: 490 mW
Inrush Power1: An average of 810 mW within a sliding 5 mS window for any voltage input from 3.82 to 5.40 VDC.
Voltage Input: t5 ± 0.25 VDC, w/100 mV max. Ripple
Minimum input voltage at signal processor connector: 3.82 VDC
Maximum input voltage at signal processor connector: 5.4 VDC
Minimum slope: 10 V/s (i.e. Maximum rise time 0.5 seconds)
Data I/O Signals: RS-485 type UBUS: S- line must be at least 200 mV lower than the S+ line when driven
Fluid Spill Resistance: IP32
Ruggedness: IEC 60068-2-27
Shock: Sinusoidal – IEC 60068-2-6
Ruggedness (Vibration): Random – IEC 60068-2-64
Sensors: Designed to use Nonin branded CO-Met™ sensors and Nonin-branded PureLight® SenSmart™ sensors (see Accessories)
Shielding: An RF shield is included (placed over the analog components)
Regulatory Status/Information: Contact Nonin regulatory@nonin.com
ROHS: 2011/65/EU
Biocompatability: ISO 10993-01
This product complies with all applicable clauses of the following standards:
IEC 60601-1, 3rd Ed
IEC 60601-1-11:2010
ISO 9919:2005
ISO 80601-2-61
1 Dependent upon type of sensor connected.
t Nonin recommendation for input voltage. Voltage drops across extension cables will reduce the amount of voltage delivered to the device and must be taken into account.
110665-000-02
Nonin
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