NELLCOR DIGITAL ™

AT THE HEART
OF OUR MISSION

Nellcor Digital™ Technology

Pulse Qualification
Cardiac Gated Averaging (CGA)
Digital Calibration

Evolving With You

PULSE At the Heart of our Mission | Nellcor Digital™ Technology

QUALIFICATION
We believe the cardiac signal is key to mitigating interference and achieving an accurate reading because arterial
pulses are essential to pulse oximetry. Our cardiac-base algorithm use Pulse Qualification to reject, for example,
pulses with abnormal shapes or periods that would be indicative of signal interference, while accepting those that
are of physiological origin, including regular pulses with or without dicrotic notches and arrhythmias. Because we
qualify individual pulses, you can be confident that the values posted are accurate.

The Pulse Oximeter Looks For Consistency

Shape of the pulse* Signal pulse amplitude * Frequency of the pulse*

*Qualifies a pulse on a beat-by-beat basis

Figure 1. Nellcor™ pulse oximeter examine each individual pulse – its shape, amplitude and frequency – to determine whether it is true
physiological pulse and to ensure that it is not caused by noise or interference.

Our Technology
Determines real-time cardiac activity
Processes sensor signals to compute SpO₂ and pulse rate
Qualifies when conditions are appropriate for posting the computed SpO₂ and pulse rate

“Because we qualify
individual pulses, you can
be confident that the values
posted are accurate.“

DIGITAL
CALIBRATION SpO₂ Reading

Sensor Calibration 100%

Every Nellcor™ OxiMax™ sensor incorporates Programmed
a small digital memory chip. Now, instead of calibration choices
relying on a limited number of preprogrammed
90%
curves within the monitor, the OxiMax™ system
relocates the sensor’s individual calibration
curve into the sensor itself. In this new design, Previously
every OxiMax™ sensor is digitally programmed incompatible
80%
sensor design
with the specific coefficients that define its
proper calibration curve.
The OxiMax™ platform has enabled Nellcor™ to 70% SpO₂ determined
expand the accuracy specifications of certain from light signals
OxiMax™ sensors to an industry-leading +/–3% and sensor’s
in the 60% - 80% SpO₂ range. This LoSat calibration curve
expanded accuracy feature helps clinicians 60%
better manage patients in the challenging
lower saturation ranges.
Relative red-to-IR pulse signal (R)
CARDIAC GATE AVERAGING At the Heart of our Mission | Nellcor Digital™ Technology

(CGA)
CGA averages multiple waveforms synchronous with the heart rate to enhance “good”
cardiac pulse signals and reduce the effects of random interference.
To manage signal interference, we measure the cardiac rhythm’s characteristic frequency and follow its
progression over time. CGA processing attenuates signal that does not occur synchronously with the average
rhythm of the heartbeat. Figure 2 and 3 illustrate the principle of CGA.

Pulse Without Interference

Oldest Average PR
Data Interval

Most Recent Intervals Figure 2. Cardiac Gated

Averaging breaks the
incoming signal into segments
corresponding to the average
Prior New heart rate. These segments are
Composite Composite numerically combined to create
Signal Signal a composite “pulse” signal.

Pulse With Interference

Oldest Averagaging is increased when incoming signal quality is poor. Average PR

Data Interval
...

Most Recent PR Intervals

Prior (1 - ω) New
Composite Composite
Signal Signal

Weighing (ω) ranges between approximately 0 and 1

Figure 3. Weighting is adjusted when signal interference is present. When characteristics of the incoming signal indicate that the pulses may
be distorted by interference, more weight is given to the prior composite signal in the averaging process, further reducing the influence of
the interference. The parts of the waveform that are synchronous with the average heart rate pass through the CGA process unaffected.

The resulting CGA composite signal retains the contributions from the underlying cardiac-induced pulsations while
reducing the relative influence of random interference. SpO2 and PR values determined from the composite signal
thus are more reliable.
SENSOR SELECTION At the Heart of our Mission | Nellcor Digital™ Technology

INFORMATION
Adult And Paediatric
Forehead SpO2 sensor
For patients with low perfusion Can be used with
Our latest technology responds mechanically ventilated
up to 90 secondsfaster than a finger patients
sensor — and responds 0.6 seconds Single-patient use
faster than an arterial line1 Sterile sensor
Suitable for long-term monitoring

Part Units Accuracy Accuracy

Weight Range
Number Per Case 70 - 100% 60 - 80%
Maxfast
Forehead Sensor
And Headband MAXFASTI >10 Kg 24 ±2 ±3

Adult, Paediatric, Infant, Neonatal

Adhesive SpO2 sensors
Suitable for continuous monitoring Single-patient use
Comfortable, form-fitting sensors Sterile sensor

Part Weight Units Accuracy Accuracy

Number Range Per Case 70 - 100% 60 - 80%

MAXAI/MAX-AL-I MAX-P-I MAXAI/

Adult >30 kg 24 ±2 ±3
MAX-AL-I
Neonatal/adult
MAX-N-I 24 ±2 ±3
<3 kg or >40 kg

MAX-I-I Infant 3-20 kg 24 ±2 ±3

MAX-I-I MAX-N-I MAX-P-I Pediatric 10-50 kg 24 ±2 ±3

Adult And Neonatal

Non-adhesive SpO2 sensors
For patients with fragile skin Suitable for long-term
Nellcor™ non-adhesive SpO2 sensor monitoring
specifications show the same Single-patient use
accuracy in neonates as the Nellcor™ Sterile sensor
MAX-N-I and MAX-I-I sensors.2

Part Weight Units Accuracy

Number Range Per Case 70 - 100%
SC-A-I

SC-A-I Adult > 40 KG 24 ±2

SC-NEO-I Neonatal 1.5-5 kg 24 ±2

SC-PR-I SC-NEO-I SC-PR-I Preterm Infant <1.5 kg 24 ±2

SENSOR SELECTION At the Heart of our Mission | Nellcor Digital™ Technology

INFORMATION

Adult
Respiration rate sensor
Measures SpO2, pulse rate and Single-patient use
respiration rate
Sterile sensor
For patients with low perfusion
Suitable for long-term monitoring
Use with Nellcor™ Respiration
Rate enabled monitor

Accuracy
Part Weight Units Accuracy Accuracy 4 - 40 Breaths
Number Range Per Case 70 - 100% 60% - 80% Per Minute

±1 breath
10068119 10068119 >30 KG 24 ±2 ±3
per minute

Nellcor™ SpO2 A04 Module

Compatible with the full line of Single-patient -use and
Nellcor™ sensors with Digital™ specialty sensor Accurac y3,4,5
technology, including the Nellcor™ (Adult - Neonate)
SpO2 forehead sensor Saturation (% SpO2 ± 1 SD):
70% to 100% ± 2 digits
Produces the numerics for the arterial 60% to 80% ± 3 digits
oxygen saturation value and the pulse
Low perfusion:
rate and a real-time wave for the 70% to 100% ± 2 digits
plethysmogram for display on Philips
Pulse rate:
IntelliVue®* patient monitors 25 to 250 bpm ± 3 digits
Designed to be used in a range of Low perfusion:
critical care environments 25 to 250 bpm ± 3 digitss

Rugged design to withstand the

10076644 (includes M1943NL Cable)
stresses of the clinical environment

Compatible With
Philips Intellivue® Systems† Part Number Dimensions Weight Contents

MP40 MP90
MP50 MX400/450 Nellcor™ SpO₂ Module,
99.6 x 36 x 102.5mm 210g
MP60 MX500/550 10076644 instructions for use
(3.9 x 1.4 x 4.0 in.) (8.2oz)
MP70 MX700 and M1943NL Cable
MP80 MX800
†
Revision C.0 or higher software
References:
1. MaxFast video – internal protocol on file.
2. Nellcor™ Oxygen Saturation Accuracy Specification
Grid. Part No. 10091796 Rev B 01/2013.
3. FDA 510(k).
4. MAX-N-I: Clinical functionality has been demonstrated
on a population or hospitalized neonate patient. The
observed SpO₂ accuracy was 2.5% in a study of 42
patients with ages of 1 to 23 days, weighing from 750 to
4100 grams, and 63 observations made spanning a
range of 85 to 99% SaO₂ while monitored with Nellcor™
OxiMax™ N-595 pulse oximeters. The accuracy
specification has been determined between saturations
of 80%–100%.
5. MAX-R-I ± 3.5 digits determined between saturations of
80%–100%.

AT THE HEART
OF OUR MISSION
Nellcor Digital™ Technology

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