Track the truth. Give no false assurance. Do no harm. Nellcor SpO 2. Module for use with Philips IntelliVue * Patient Monitors

Transcription

1 Track the truth Give no false assurance Do no harm Nellcor Module for use with Philips IntelliVue * Patient Monitors

2 Nellcor 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 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 Track the truth Give no false assurance 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 Do no harm Track the Truth Because 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 and pulse rate Qualifies when conditions are appropriate for posting the computed and pulse rate Arterial blood Venous blood Bone, tendon, vessels Coupling loss to/from tissue Quiet Conditions Heart rate Patient Activity Heart rate Source: Paul Mannheimer clinical research and data. Figure 1. Depicts the absorption of light by the tissue bed

3 Give No False Assurance To 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 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. The true cardiac signal passes through, while random interference is attenuated by the averaging process Averaging is increased only when incoming signal quality is poor Average pulse rate interval Oldest data Averaged pulse gives better measure of the true cardiac signal Source: Mannheimer PD, Baker CR, Nellcor Technical Staff. Digital signal processing technology in Nellcor OxiMax pulse oximeters. Internal study. Data on file at Covidien. Figure 2. Representation of how Covidien Nellcor cardiac-gated averaging methodology works 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 readings, even in challenging patient conditions 1 Early warning to alert you to potentially harmful events 1 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.

4 Nellcor Sensors with OxiMax Technology Selection Guide Specialty sensors Specialty sensors Forehead Sensor For patients with low perfusion; suitable for long-term monitoring Forehead Sensor and Headband Adult/Neonatal Sensor, Nonadhesive For patients with fragile skin; suitable for long-term monitoring Adult Neonatal Preemie Adult/Pediatric >10 kg Adult >40 kg Neonatal kg Preterm Infant <1.5 kg CATALOG NO. CASE/24 MAXFAST CATALOG NO. SC-A SC-NEO SC-PR CASE/24 Single-Patient-Use Sensors Adhesive Sensors Comfortable, 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 kg Adult Nasal >50 kg CATALOG NO. MAXA/MAXAL MAXN MAXI MAXP MAXR CASE/24 Two-Piece Sensors Sensors Single 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 kg Sensor Cable 3 CATALOG NO. A N I P OC-3 CASE/24 SENSORS, 1/PKG CABLE Sensors with low saturation expanded accuracy range

5 Nellcor Module SPECIFICATIONS Physical Dimensions: 99.6 x 36 x mm (3.9 x 1.4 x 4.0 in.) Weight: 210 g (8.2 oz) Safety Complies with IEC , IEC , CSA C22.2#601.1-M90AMD2, ISO 9919, IEC Type CF applied part, defibrillator proof US Federal law restricts this device to sale by or on the order of a physician. Single-patient-use and specialty sensor Accuracy 1,2,3 (Adult - Neonate) Saturation (% ± 1 SD) 70% to 100% ± 2 digits 60% to 80% ± 3 digits Low perfusion: 70% to 100% ± 2 digits Pulse rate: Low perfusion: 25 to 250 bpm ± 3 digits 25 to 250 bpm ± 3 digits Sensors Wavelength range: Emitted light energy: Environmental Module Operating temperature: Storage temperature: Operating humidity: Storage humidity: Operating altitude: Storage altitude: 500 to 1,000 nm 15m W 0 to 45 C (32 to 113 F) 40 to 70 C ( 40 to 158 F) 95% RH max. at 40 C (104 F) 95% RH max. at 65 C (150 F) Up to 4,600 m (15,000 ft) Up to 15,300 m (50,000 ft) Compatible with Philips IntelliVue * systems MP40 MP50 MP60 MP70 MP80 MP90 MX800 Revision C.0 or higher software A Philips M1943NL is required to use the Nellcor Module. part number Part # : Includes Nellcor Module, M1943NL Cable, and Instructions for Use. Part # : Includes Nellcor Module and Instructions for Use.

6 1. FDA 510(k). 2. MAX-N: Clinical functionality has been demonstrated on a population or hospitalized neonate patient. The observed 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% SaO 2 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%. 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 Covidien. All rights reserved. 11-PM-0331a SN Gunbarrel Avenue Boulder, CO