Performance Considerations; Monitoring System Constraints; Nellcor™ Sensor Performance Considerations; Patient Conditions - Covidien Nellcor GR101704-RR Operator's Manual

Nellcor™ Respiration Rate

Performance Considerations

1.6

Monitoring System Constraints

1.6.1
In addition to the pulse rate and saturation constraints listed in the Operator's
Manual, the following constraint applies:
Respiration Rate — The monitoring system displays respiration rate levels from
•
4 to 40 breaths per minute (breaths/min). Detected breaths/min above 40 appear
as 40. Detected breaths/min below 4 appear as 4. It calculates with an average
accuracy of ±1 breaths per minute, relative to a capnography-based reference.

Note:
Claims on motion and low perfusion conditions represented in the pulse oximetry
indications for use are not applicable to Nellcor Respiration Rate.
Nellcor™ Sensor Performance Considerations
1.6.2
All sensor performance considerations described in the Operator's Manual
apply to use of the Nellcor™ Adult Respiratory Sensor. Apply the sensor as
directed in the accompanying Instructions for Use, and follow all warnings,
cautions, and guidelines in the Operator's Manual to mitigate situations that
may lead to inaccurate measurements or signal loss.

Patient Conditions

1.6.3
All patient conditions described in the Operator's Manual that can affect mea-
surements made by the monitoring system also apply to respiration rate. In
addition, the following patient conditions can cause inaccurate respiration rate
measurements:
Respiration rate outside the range of 4 to 40 breaths per minute
•
Documented history of atrial fibrillation
•
Implanted pacemaker
•
ADD-22 Operator's Manual Addendum