Nellcor Oxygen Saturation Accuracy Spec Grid March 2002

Oxygen Saturation Accuracy Specification Grid for N-595 Pulse Oximeter Sensor Models

SpO2 Range 70%–100%

OXIMAX Sensor Models Single Patient Use MAX-A,* MAX-AL*

±2

MAX-N†* (Adult)

±2

MAX-N†* (Neonate)

±3

MAX-P*

±2

MAX-I*

±2

MAX-FAST

±2

MAX-R‡

± 3.5

OxiCliq Sensor Models Single Patient Use OxiCliq A

± 2.5

OxiCliq P

± 2.5

OxiCliq N† (Adult)

± 2.5

OxiCliq N† (Neonate)

± 3.5

OxiCliq I

± 2.5

Accuracy Specifications: Accuracy specifications are based on controlled hypoxia studies with healthy, non-smoking adult volunteers over the specified saturation SpO2 range. Pulse oximeter SpO2 readings were compared to SaO2 values of drawn blood samples measured by hemoximetry. All accuracies are expressed as ± “X” digits. This variation equals ± one standard deviation (± 1 SD), which encompasses 68% of the population. Neonatal Accuracy: When sensors are used on neonatal subjects as recommended, the specified accuracy range is increased by ± 1 digit as compared to adult usage, to account for the theoretical effect on oximeter measurements of fetal hemoglobin in neonatal blood. For example, MAX-N accuracy on neonates is ± 3 digits, rather than ± 2. Oxygen saturation accuracy can be affected by certain environmental and patient physiological conditions, as discussed in the operator’s manual for the monitor. Use Nellcor sensors only with Nellcor patient monitors and monitors containing Nellcor oximetry, or with instruments licensed to use Nellcor sensors (Nellcor-compatible instruments). Consult individual manufacturers for accuracy specifications and compatibility information of particular instruments and Nellcor sensor models.

Reusable Sensor Models D-YS (Infant to Adult)

±3

D-YS (Neonate)

±4

D-YS & D-YSE

± 3.5

D-YS & D-YSPD

± 3.5

DS-100A

±3

OXI-A/N (Adult)

±3

OXI-A/N (Neonate)

±4

OXI-P/I

±3

* The accuracy specification under motion conditions is ± 3. For a definition of motion, contact Nellcor Technical Services or your local Nellcor representative. † The MAX-N and the OxiCliq N were tested on patients > 40 kg. ‡ The accuracy specification has been determined between saturations of 80%–100%.

Copyright 2002 Nellcor Puritan Bennett Inc. All rights reserved.

Tyco Healthcare Group LP Nellcor Puritan Bennett Division Pleasanton, CA USA Authorized Representative Tyco Healthcare UK LTD Gosport PO13 0AS, U.K. 065232A-0302