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Spot Vital Signs LXi Directions for Use - Frank's Hospital Workshop

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58 Specifications Welch Allyn <strong>Spot</strong> <strong>Vital</strong> <strong>Signs</strong> <strong>LXi</strong><br />

Nellcor ® Sensor Accuracy Guide<br />

Nellcor Patents<br />

Accuracy specifications are based on controlled hypoxia studies with healthy,<br />

non-smoking adult volunteers over the specified saturation SpO 2 range. Pulse oximeter<br />

SpO 2 readings were compared to SaO 2 values of drawn blood samples measured by<br />

hemoximetry. All accuracies are expressed as + “X” digits. This variation equals + one<br />

standard deviation (+ 1 SD), which encompasses 68% of the population.<br />

Table 25. OxiMax Sensor Models, Single Patient <strong>Use</strong><br />

Sensor Models SpO 2 Range<br />

70% to 100%<br />

MAX-AI ± 2<br />

MAX-PI* ± 2<br />

MAX-II ± 2<br />

MAX-RI 1<br />

1<br />

The accuracy specification has been determined between saturations of 80% to 100%.<br />

± 3.5<br />

Table 26. OxiCliq Sensor Models, Single Patient <strong>Use</strong><br />

Sensor Models SpO 2 Range<br />

70% to 100%<br />

OXICLIQ-PI ± 2.5<br />

Table 27. Reusable Sensor Models<br />

Sensor Models SpO 2 Range<br />

70% to 100%<br />

D-YS (Infant to Adult) ± 3<br />

D-YS and D-YSE ± 3.5<br />

D-YS and D-YSPD ± 3.5<br />

DS-100A ± 3<br />

OXI-A/N (Adult/neonate) Adult: ± 3<br />

Neonate: ± 4<br />

OXI-P/I (Pediatric/infant) ± 3<br />

Covered by one or more of the following US Patents: 4,802,486; 4,869,254; 4,928,692;<br />

4,934,372; 5,078,136; 5,351,685; 5,485,847; 5,533,507; 5,577,500; 5,803,910; 5,853,364;<br />

5,865,736; 6,083,172; 6,708,049; Re. 35,122 and <strong>for</strong>eign equivalents.

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