Masimo Pronto Pulse CO-Oximeter User manual

Operator's Manual
Pronto®Pulse CO-Oximeter®

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These operating instructions provide the necessary information for proper operation of all
models of the Pronto. There may be information provided in this manual that is not relevant
for your system. General knowledge of pulse oximetry and an understanding of the features
and functions of Pronto are prerequisites for its proper use. Do not operate Pronto without
completely reading and understanding these instructions.
Notice: Purchase or possession of this device does not carry any express or implied license to
use with replacement parts which would, alone or in combination with this device, fall within
the scope of one of the relating patents.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
Note: Cleared Use Only: The device and related accessories are cleared by the Food and Drug
Administration (FDA) and are CE Marked for noninvasive patient monitoring and may not be
used for any processes, procedures, experiments, or any other use for which the device is not
intended or cleared by the applicable regulatory authorities, or in any manner inconsistent
with the directions for use or labeling.
For professional use. See instructions for use for full prescribing information, including
indications, contraindications, warnings, and precautions.
Masimo Corporation
40 Parker
Irvine, CA 92618, USA
Tel.: [phone]
Fax.: [phone]
www.masimo.com
EU authorized representative for Masimo Corporation:
MDSS GmbH
Schiffgraben 41
D-30175 Hannover, Germany
80fk
Medical electrical equipment with respect to electric shock, fire, and mechanical
hazards only in accordance with UL 60601-1/CAN/CSA C22.2 No. 601.1
Patents: www.masimo.com/patents.htm
© 2016 Masimo Corporation
, Discrete Saturation Transform, DST, FST, Masimo, Pronto, Pulse CO-Oximeter, rainbow,
rainbow ReSposable, SET, Signal Extraction Technology, Signal I.Q., and SpHb are federally
registered trademarks of Masimo Corporation.
All other trademarks and registered trademarks are property of their respective owners.

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Contents
About This Manual------------------------------------------------------------------------------------------ 5
Product Description, Features, and Indications for Use -----------------------------------------------7
Product Description and Features---------------------------------------------------------------------7
Indications for Use---------------------------------------------------------------------------------------7
Contraindications ----------------------------------------------------------------------------------------7
Safety Information, Warnings, and Cautions----------------------------------------------------------- 9
Safety Warnings and Cautions------------------------------------------------------------------------ 9
Performance Warnings and Cautions---------------------------------------------------------------10
Cleaning and Service Warnings and Cautions ----------------------------------------------------13
Compliance Warnings and Cautions---------------------------------------------------------------- 14
Chapter 1: Technology Overview ------------------------------------------------------------------------15
Masimo Signal Extraction Technology (Masimo SET®) -----------------------------------------15
rainbow Pulse CO-Oximetry Technology ----------------------------------------------------------- 17
Chapter 2: System Description -------------------------------------------------------------------------- 21
Front Panel---------------------------------------------------------------------------------------------- 21
Rear Panel-----------------------------------------------------------------------------------------------23
Chapter 3: Setup-------------------------------------------------------------------------------------------25
Unpacking and Inspection ---------------------------------------------------------------------------25
Power Requirements-----------------------------------------------------------------------------------25
Initial Setup---------------------------------------------------------------------------------------------25
Chapter 4: Operation-------------------------------------------------------------------------------------- 27
Basic Operation ---------------------------------------------------------------------------------------- 27
Default Settings ----------------------------------------------------------------------------------------29
Audible Alerts------------------------------------------------------------------------------------------ 30
Battery Level Indicator------------------------------------------------------------------------------- 30
Navigating the Menu----------------------------------------------------------------------------------31
Trend Setup and Use --------------------------------------------------------------------------------- 33
Chapter 5: Messages ------------------------------------------------------------------------------------- 35
Messages ----------------------------------------------------------------------------------------------- 35
Chapter 6: Troubleshooting----------------------------------------------------------------------------- 39
Troubleshooting--------------------------------------------------------------------------------------- 39

Pronto Contents
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Low Perfusion-------------------------------------------------------------------------------------------40
Low Signal I.Q. (Low SIQ) ----------------------------------------------------------------------------40
Low Battery Audible Alert ---------------------------------------------------------------------------- 41
Chapter 7: Specifications---------------------------------------------------------------------------------43
Performance Specifications --------------------------------------------------------------------------43
Display Ranges ----------------------------------------------------------------------------------------- 44
Resolution----------------------------------------------------------------------------------------------- 44
Electrical------------------------------------------------------------------------------------------------- 44
Environmental------------------------------------------------------------------------------------------45
Physical Characteristics ------------------------------------------------------------------------------45
Trend Memory ------------------------------------------------------------------------------------------45
Alerts----------------------------------------------------------------------------------------------------- 45
Display Indicators--------------------------------------------------------------------------------------46
Compliance ---------------------------------------------------------------------------------------------46
Citations-------------------------------------------------------------------------------------------------48
Symbols--------------------------------------------------------------------------------------------------49
Guidance and Manufacturer's Declaration - Electromagnetic Emissions -------------------- 51
Guidance and Manufacturer's Declaration - Electromagnetic Immunity --------------------52
Recommended Separation Distances --------------------------------------------------------------55
Chapter 8: Service and Maintenance ------------------------------------------------------------------ 57
Cleaning ------------------------------------------------------------------------------------------------- 57
Battery Replacement---------------------------------------------------------------------------------- 57
Performance Verification -----------------------------------------------------------------------------58
Service and Repair-------------------------------------------------------------------------------------58
Limited Warranty ------------------------------------------------------------------------------------- 60
Exclusions ---------------------------------------------------------------------------------------------- 60
Limitation of Warranty------------------------------------------------------------------------------- 60
Sales & End-User License Agreement-------------------------------------------------------------- 61
Restrictions --------------------------------------------------------------------------------------------- 61
Index ---------------------------------------------------------------------------------------------------------63

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About This Manual
This manual explains how to set up and use Pronto® Pulse CO-Oximeter®. Important safety
information relating to general use of Pronto appears in this manual. Read and follow any
warnings, cautions, and notes presented throughout this manual. The following are
explanations of warnings, cautions, and notes.
A warning is given when actions may result in a serious outcome (for example, injury, serious
adverse effect, death) to the patient or user.
WARNING: This is an example of a warning statement.
A caution is given when any special care is to be exercised by the patient or user to avoid
injury to the patient, damage to this device, or damage to other property.
CAUTION: This is an example of a caution statement.
A note is given when additional general information is applicable.
Note: This is an example of a note.

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Product Description, Features, and
Indications for Use
Product Description and Features
Pronto® Pulse CO-Oximeter® is a noninvasive device intended to monitor functional oxygen
saturation of arterial hemoglobin (SpO2), pulse rate (PR), perfusion index (PI), and total
hemoglobin (SpHb®).
The following key features are available for Pronto:
•Masimo SET® and rainbow® SET technology performance.
•SpO2 and pulse rate monitoring in motion and low perfusion environments.
•Noninvasive spot-checking of total arterial hemoglobin concentration (SpHb).
•Download capabilities to transfer data from the device to a computer.
Indications for Use
The Masimo Rainbow SET® Pronto Pulse CO-Oximeter and Accessories are indicated for
noninvasive spot checking of functional saturation of arterial oxygen hemoglobin (SpO2),
pulse rate, and total hemoglobin concentration (SpHb). The Masimo Rainbow SET® Pronto
Pulse CO-Oximeter and Accessories are indicated for use, by trained personnel, with adult and
pediatric individuals during both no motion and motion conditions, and for individuals who
are well or poorly perfused in clinical and nonclinical settings (e.g., hospitals, hospital-type
facilities, mobile environments, homes, clinics, physician offices, blood donation facilities,
and ambulatory surgery centers).
Contraindications
Pronto is contraindicated for use as an apnea monitor. Pronto is also contraindicated for use
as a continuous monitor.