Pulse Oximeter
9650-0806-01 Rev. D
Propaq MD Operator’s Guide
A-21
Energies (Radiant Power) of light for
Rainbow Sensors at 100 mA pulsed:
25 mW
Bio-Compatibility:
Patient contacting material meets requirements of ISO 10993-1, Biological
Evaluation of Medical Device - Part I, for external devices, intact surfaces and
short-term exposure
Environmental:
Operating Temperature: 0
º
to 50
º
C (32
º
to 122
º
F)
Storage Temperature: -40
º
to 70
º
C (-40
º
to 158
º
F)
Electromagnetic Immunity (SpO
2
Option Only):
AAMI DF-80; EN61000-4-3:2002 to 10 V/m
Note:
The Propaq MD Pulse Oximetry Option is calibrated for functional saturation.
1 The Masimo SET Technology with LNOP sensors has been validated for no motion accuracy in human blood
studies on healthy adult volunteers in induced hypoxia studies in the range of 70 - 100% SpO
2
against a
laboratory CO-oximeter and ECG monitor.
2 The Masimo SET Technology with LNOP sensors has been validated for no motion accuracy in human blood
studies on healthy adult volunteers in induced hypoxia studies in the range of 70 - 100% SpO
2
against a
laboratory CO-oximeter and ECG monitor. 1% has been added to the saturation accuracy to account for the
effects of fetal hemoglobin. This variation equals plus or minus one standard deviation, which encompasses
68% of the population.
3 The Masimo SET Technology with LNOP sensors has been validated for motion accuracy in human blood
studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions,
at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to
3 cm in induced hypoxia studies in the range of 70 - 100% SpO
2
against a laboratory CO-oximeter and ECG
monitor. 1% has been added to the saturation accuracy to account for the effects of fetal hemoglobin. This
variation equals plus or minus one standard deviation, which encompasses 68% of the population.
4 The Masimo SET Technology has been validated for low perfusion accuracy in bench top testing against a
Biotek Index 2 simulator and a Masimo simulator with signal strengths of greater than 0.02% and a %
transmission of greater than 5% for saturations ranging from 70 to 100%. This variation equals plus or minus
one standard deviation, which encompasses 68% of the population.
5 The Masimo SET Rainbow Technology with Rainbow DC-dc sensors have been validated in human blood on
healthy adult volunteers against a laboratory CO-oximeter from 1 - 40% for carboxyhemoglobin and 1 - 15%
for methemoglobin. This variation equals plus or minus one standard deviation, which encompasses 68% of the
population.
Summary of Contents for Propaq MD
Page 1: ...Propaq MD Operator s Guide 9650 0806 01 Rev D...
Page 40: ...CHAPTER 1 GENERAL INFORMATION 1 28 www zoll com 9650 0806 01 Rev D...
Page 60: ...CHAPTER 2 PRODUCT OVERVIEW 2 20 www zoll com 9650 0806 01 Rev D...
Page 74: ...CHAPTER 4 TRENDS 4 4 www zoll com 9650 0806 01 Rev D...
Page 84: ...CHAPTER 5 ALARMS 5 10 www zoll com 9650 0806 01 Rev D...
Page 94: ...CHAPTER 6 MONITORING ECG 6 10 www zoll com 9650 0806 01 Rev D...
Page 104: ...Chapter 7 Monitoring Respiration Resp and Heart Rate HR 7 10 www zoll com 9650 0806 01 Rev D...
Page 120: ...CHAPTER 8 MONITORING NON INVASIVE BLOOD PRESSURE NIBP 8 16 www zoll com 9650 0806 01 Rev D...
Page 154: ...CHAPTER 11 MONITORING INVASIVE PRESSURES IBP 11 10 www zoll com 9650 0806 01 Rev D...
Page 160: ...CHAPTER 12 MONITORING TEMPERATURE 12 6 www zoll com 9650 0806 01 Rev D...
Page 186: ...CHAPTER 14 12 LEAD ECG INTERPRETIVE ANALYSIS 14 16 www zoll com 9650 0806 01 Rev D...
Page 212: ...CHAPTER 17 ADVISORY CPR PROTOCOL DEFIBRILLATION 17 6 www zoll com 9650 0806 01 Rev D...
Page 222: ...CHAPTER 18 EXTERNAL PACING 18 10 www zoll com 9650 0806 01 Rev D...
Page 240: ...CHAPTER 21 PATIENT DATA 21 6 www zoll com 9650 0806 01 Rev D...
Page 268: ...CHAPTER 22 COMMUNICATIONS 22 28 www zoll com 9650 0806 01 Rev D...
Page 284: ...CHAPTER 24 MAINTENANCE 24 12 www zoll com 9650 0806 01 Rev D...
Page 326: ...ACCESSORIES B 6 www zoll com 9650 0806 01 Rev D...