3500SP

3500SP Specifications

Print Specs

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: IP22
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

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