Rad-57 Signal Extraction Pulse CO-Oximeter with Rainbow Technology

A medical first --- noninvasive measurement of carbon monoxide and methemoglobin in the blood

• Masimo SET^® pulse oximetry: proven accurate during motion and low perfusion in more than 100 independent clinical studies
• Masimo Rainbow SET^® technology analyzes 7+ wavelengths of light to accurately measurecarboxyhemoglobin (SpCO^®) and methemoglobin (SpMet^TM) percent levels in the bloodnoninvasively and continuously
• Eliminates the risk of misdiagnosing unsuspected CO poisoning as flu or fatigue
• Detects potentially life-threatening acquired methemoglobinemia
• Quick and easy to use - requires no user calibration and does not require patient cooperation or consciousness
• Complete replacement for existing pulse oximeters with continuous monitoring of SpCO^®, SpMetTM, SpO2, Pulse Rate, Perfusion Index, and SIQ^®
• Rugged and lightweight - ideal for any field or hospital setting

Rad-57 Features

• Revolutionary hardware and software analyzes 7+ wavelengths of light simultaneously to accurately measure Carboxyhemoglobin (SpCO) and Methemoglobin (SpMet) percent levels in the blood within seconds, noninvasively
• Designed for continuous or spot check applications
• User configurable power up default settings
• Four AA alkaline batteries deliver over 8 hours of continuous monitoring of SpCO, SpMet, SpO2, Pulse Rate and Perfusion Index
• Perfusion Index (PI) indicates arterial pulse signal strength and may be used as a diagnostic tool during low perfusion
• Low Signal IQ^® (SIQ) indicator highlights conditions of low signal quality
• FastSat^® tracks rapid changes in arterial O2 with unmatched fidelity
• SmartToneTM beeps in sync with pulse, even under patient motion conditions
• Up to 72 hours of trending memory of SpCO, SpMet, SpO2, Pulse Rate and Perfusion Index
• Sensitivity options: APOD, Normal, and MAX
• Protective boot covers and carrying cases available in multiple colors

Performance

Measurement Range

• SpO2: 0 – 100%
• SpMet: 0 – 99.9%
• SpCO: 0 – 99%
• SpHb: 0 – 25 g/dL
• Pulse Rate: 25 – 240 bpm
• Perfusion Index: 0.02 – 20%

SpO2 Saturation Accuracy

• Saturation: 70 – 100%
• No Motion
  - Adults/Pediatrics: ± 2 digits
  - Neonate: ± 3digits
• Motion
  - Adults/Pediatrics: ± 3 digits
  - Neonate: ± 3 digits
• Low Perfusion
  - Adults/Pediatrics: - ± 2 digits
  - Neonate: ± 3 digits

SpCO Accuracy

• SpCO: 1% - 40% ± 3 digits

SpMet Accuracy

• SpMet: 1% - 15% ± 1 digits

Pulse Rate Accuracy

• Pulse Rate: 25 – 240 bpm
• No Motion
  - Adults/Pediatrics/Neonates: ± 3 digits
• Motion
  - Adults/Pediatrics/Neonates: ± 5 digits
• Low Perfusion
  - Adults/Pediatrics/Neonates: ± 3 digits

Resolution

• (%SpO2): 1%
• Pulse Rate (bpm): 1 bpm
• Carboxyhemoglobin (%SpCO)
  - Numeric Display: 1%
  - Bar Display: variable
• Methemoglobin Saturation (%SpMet)
  - Numeric Display: 1%
  - Bar Display: variable

Electrical

Batteries

• Type: 4AA Alkaline
• Capacity (battery life): over 8 hours

Environmental

• Operating temperature: 0°F to 129°F (-18°C to 54°C)
• Storage temperature: -40°F to 158°F (-40°C to + 70°C)
• Operating humidity: 5% to 95%, noncondensing
• Operating altitude: -1000 ft to 18,000 ft (-304 m to 5,486 m)

Physical Characteristics

• Handheld: 6.2” x 3.0” x 1.4” (15.8 cm x 7.6 cm x 3.6 cm)

Weight

• Handheld: 13 oz (.37 kg)

Trending
Provides 72 hours of trending at 2 second resolution of SpO2, SpCO, SpMet, pulse rate, and perfusion index.Output to PC running Masimo TrendComTM Utility.

SpO2 Modes

• Averaging mode: 2, 4, 8, 10, 12, 14, or 16 seconds
• Sensitivity.: Normal, APOD, and Maximum
• FastSat: On / Off

Alarms
Audible and visual alarms for high and low saturation (SpO2 1% to 100%, SpCO 5% - 50%,
SpMet 1%-70%, and pulse rate 25 - 240 bpm)

Display/Indicators

• Data display: %SpO2,%SpCO, %SpMet, SpCO bar, SpMet bar, pulse rate, perfusion index, low Signal IQ alarm status, alarm silence and battery life
• Type: LED

Compliance

• EMC Compliance:  EN60601-1-2, Class B
• Equipment Classification:  IEC 60601-1-1
• Degree of Protection:  Type BF-Applied part