Track the truth

Do no harm

Give no false assurance

Nellcor™ SpO2 module for use with Philips Intellivue®* Patient monitors

Nellcor™ SpO2 module

Features• Designed to be used in a range of critical care environments

• Compatible with the full line of Nellcor sensors with OxiMax technology, including the Nellcor SpO2 forehead sensor

• Produces the numerics for the arterial oxygen saturation value and the pulse rate and a real-time wave for the plethysmogram for display on Philips IntelliVue®* patient monitors

• Rugged design to withstand the stresses of the clinical environment

• Light indicator for identifying affected parameter module during a monitor task

• Color-coded patient cable connectors for quick and easy identification

• Compatible with the following monitor families:

– IntelliVue MP40/50/60/70/80/90/MX800 with software revision C.0 or higher

Track the TruthBecause arterial pulses are essential to pulse oximetry, we believe the cardiac signal is key to mitigating interference and achieving an accurate reading. During patient activity, each of the light-absorbing components can be disruptive and degrade the detected light signals. See Figure 1 below.

Our cardiac-based algorithm assumes that random signal interference will occur, but that it won’t occur consistently or in synchrony with the heartbeat. Our system focuses on the true cardiac signal to obtain the true arterial saturation.

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

Quiet Conditions Patient Activity

Arterial blood

Venous blood

Bone, tendon, vesselsCoupling loss

to/from tissue

Figure 1. Depicts the absorption of light by the tissue bed

Source: Paul Mannheimer clinical research and data.

Heartrate

Heartrate

Track the truth

Do no harm

Give no false assurance

give No False AssuranceTo manage signal interference, we measure the cardiac rhythm’s characteristic frequency and follow its progression over time. We can then track the underlying heart rate and arterial saturation within the signal interference. See Figure 2 below.

Using this methodology:• Signals from successive pulse intervals are averaged

based on the quality of incoming signals

• The true cardiac signal passes through, while random interference is attenuated by the averaging process

do No harm At Covidien, we design our technology knowing that the best possible outcomes happen when all parts of the system work together. We address specific needs, but do it seamlessly, without creating upheaval for your patients or your organization.

From the sensors to the front-end electronics and the signal processing, our products are engineered to provide:

• Accurate and reliable, real-time SpO2 readings, even in challenging patient conditions1

• Earlywarningtoalertyoutopotentiallyharmfulevents1

If it doesn’t meet our high standards, it doesn’t go to market.

We are dedicated to innovation, but will not sacrifice due diligence, rigorous testing or a full understanding of the impact of the product or technology.

Our technology tracks the truth, despite a patient’s age, size or condition. Our pulse oximetry technology meets the needs of your organization no matter your facility’s size, areas of care, or safety and standardization initiatives. Which is why for more than 25 years, clinicians have trusted Covidien Nellcor technology to deliver quality, accuracy and reliability across the continuum of care.

To learn more about how Covidien Nellcor technology can help you provide superior, continuous monitoring throughout your organization, please call us at 800-NELLCOR.

Figure 2. Representation of how Covidien Nellcor™ cardiac-gated averaging methodology works

Averaging is increased only when incoming signal quality is poor

Oldestdata

Average pulse rateinterval

Source: Mannheimer PD, Baker CR, Nellcor Technical Staff. Digital signal processing technology in Nellcor™ OxiMax™ pulse oximeters. Internal study. Data on file at Covidien.

Averaged pulse gives better measure of the true cardiac signal

Canceling out interference by overprocessing a signal can often compromise signal fidelity. This can prevent a clinician from noticing an event.

The Covidien Nellcor technology advantage: Unlike approaches using a fixed averaging interval, our algorithm uses the incoming signals to automatically determine how much averaging is required to track the true value with high fidelity.

SPECIAlTy SENSOrS

Forehead SpO2 SensorFor patients with low perfu-sion; suitable for long-term monitoring

Forehead Sensor and headband

Adult/Pediatric >10 kg

CATALOG NO. MAXFAST

CASE/24

SPECIAlTy SENSOrS

Adult/Neonatal SpO2 Sensor, NonadhesiveFor patients with fragile skin; suitable for long-term monitoring

Adult Neonatal Preemie

Adult >40 kg Neonatal 1.5-5 kg Preterm Infant <1.5 kg

CATALOG NO. SC-A SC-NEO SC-PR

CASE/24

SINglE-PATIENT-uSE SENSOrS

Adhesive SpO2 SensorsComfortable, form-fitting sensors; suitable for long-term monitoring

Adult Neonatal/Adult Infant Pediatric Adult

Adult >30 kg Neonatal/Adult<3 kg or >40 kg

Infant 3-20 kg Pediatric 10-50 kg Adult Nasal >50 kg

CATALOG NO. MAXA/MAXAL MAXN MAXI MAXP MAXR

CASE/24

TwO-PIECE SENSOrS

SpO2 SensorsSingle patient use adhesive bandage, reusable cable

Adult Neonatal/Adult Infant Pediatric Sensor Cable

Adult >30 kg Neonatal/Adult<3 kg or >40 kg

Infant 3-20 kg Pediatric 10-50 kg Sensor Cable 3’

CATALOG NO. A N I P OC-3

CASE/24 SENSORS, 1/PKG CABLE

Nellcor™ Sensors with Oximax™ Technology Selection guide

Sensors with low saturation expanded accuracy range

SPECIFICATIONSPhySICAlDimensions: 99.6 x 36 x 102.5 mm (3.9 x 1.4 x 4.0 in.)Weight: 210 g (8.2 oz)

SAFETyComplies with IEC 60601-1, IEC 60601-1-2, CSA C22.2#601.1-M90AMD2, ISO 9919, IEC 80601-2-61

Type CF applied part, defibrillator proof

US Federal law restricts this device to sale by or on the order of a physician.

SPO2 SENSOrSWavelength range: 500 to 1,000 nmEmitted light energy: ≤ 15m W

ENvIrONmENTAlmoduleOperating temperature: 0 to 45°C (32 to 113°F)Storage temperature: – 40 to 70°C (– 40 to 158°F)Operating humidity: 95% RH max. at 40°C (104°F)Storage humidity: 95% RH max. at 65°C (150°F)Operating altitude: Up to 4,600 m (15,000 ft)Storage altitude: Up to 15,300 m (50,000 ft)

A Philips M1943NL is required to use the Nellcor SpO2 Module.

PArT NumbErPart #10076644: Includes Nellcor SpO2 Module, M1943NL Cable, and Instructions for Use.

Part #10083058: Includes Nellcor SpO2 Module and Instructions for Use.

Nellcor™ SpO2 module

SINglE-PATIENT-uSE ANd SPECIAlTy SENSOr ACCurACy1,2,3

(Adult - Neonate)Saturation (% SpO2 ± 1 SD) 70% to 100% ± 2 digits 60% to 80% ± 3 digitsLow perfusion: 70% to 100% ± 2 digits

Pulse rate: 25 to 250 bpm ± 3 digitsLow perfusion: 25 to 250 bpm ± 3 digits

COmPATIblE wITh PhIlIPS INTEllIvuE®* SySTEmS†

MP40MP50MP60MP70MP80MP90MX800†Revision C.0 or higher software

COVIDIEN, COVIDIEN with logo, Covidien logo and positive results for life are U.S. and internationally registered trademarks of Covidien AG. Other brands are trademarks of a Covidien company. ™* and ®* are trademarks of their respective owners. ©2012 Covidien. All rights reserved.

11-PM-0331a SN12112

1. FDA 510(k).2. MAX-N: 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%.3. MAX-R ± 3.5 digits determined between saturations of 80%–100%.

6135 Gunbarrel AvenueBoulder, CO 80301

800-635-5267 www.covidien.com