Masimo PRONTO-7 User manual

DRAFT 02 17 14
Pronto-7
Operator's Manual

www.masimo.com 1 Masimo
Masimo rainbow SET Pronto-7 Spot Check CO-Oximeter, also referred to as
Pronto-7, operating instructions provide the necessary information for proper
operation of Pronto-7. There may be information provided in this manual that
is not relevant for your system. Do not operate Pronto-7 without completely
reading and understanding the instructions in this manual.
Notice:
Purchase or possession of this instrument does not carry any express or
implied license to use this instrument with replacement parts which would,
alone or in combination with this instrument, fall within the scope of one of the
relating patents.
Caution: Federal law (U.S.) restricts this device to sale by or on the
order of a physician.
For professional use. See instructions for use for full prescribing
information, including indications, contraindications, warnings,
precautions and adverse events.
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
3148433
Patents: www.masimo.com/patents.htm.
Masimo, , Signal Extraction Pulse CO-Oximeter, rainbow, Pronto-7, SET,
SpHb and Signal I.Q. are registered trademarks of Masimo Corporation.
All other trademarks and registered trademarks are property of their
respective owners.
Printed in U.S.A.

www.masimo.com 2 Masimo
© 2014 Masimo Corporation.

www.masimo.com 3 Masimo
Contents
About this Manual-------------------------------------------------------------------------- 55
Product Description ----------------------------------------------------------------------- 77
Indications for Use --------------------------------------------------------------------- 77
Contraindications----------------------------------------------------------------------- 77
Safety Information, Warnings, and Cautions---------------------------------------- 99
Safety Information, Warnings, and Cautions ---------------------------------1010
Compliance Information, Warnings and Cautions---------------------------1213
Sensor Information, Warnings and Cautions---------------------------------1414
Chapter 1: Technology Overview---------------------------------------------------1515
Signal Extraction Technology (SET)--------------------------------------------1515
rainbow Pulse CO-Oximetry Technology--------------------------------------1515
Functional Oxygen Saturation----------------------------------------------------1616
Pronto-7 vs. Drawn Whole Blood Measurements---------------------------1616
Non-Invasive Total Hemoglobin (SpHb) Accuracy Compared to Invasive
Laboratory Methods* ---------------------------------------------------------------1717
Chapter 2: Product Description------------------------------------------------------1919
Pronto-7 Description----------------------------------------------------------------1919
Pronto-7 Front Panel and Touchscreen ---------------------------------------2020
Pronto-7 Back Panel----------------------------------------------------------------2222
Pronto-7 Bottom Panel-------------------------------------------------------------2323
Parameter and Measurement Descriptions-----------------------------------2323
Chapter 3: Setup------------------------------------------------------------------------2525
Unpacking and Inspection the System-----------------------------------------2525
Preparation for Use -----------------------------------------------------------------2525
Chapter 4: Operation-------------------------------------------------------------------2727
Common Screens -------------------------------------------------------------------2828
Commonly Used Icons-------------------------------------------------------------2828
Recommended Initial Testing Procedure--------------------------------------3030

Pronto-7Pronto-7 Contents
www.masimo.com 4 Masimo
Patient Testing -----------------------------------------------------------------------3332
Completed Test----------------------------------------------------------------------3534
Incomplete Test----------------------------------------------------------------------3634
Key Features -------------------------------------------------------------------------3635
Main Menu Options-----------------------------------------------------------------5147
Battery----------------------------------------------------------------------------------5854
Chapter 5: Alarms and Messages--------------------------------------------------6157
Messages------------------------------------------------------------------------------6157
Chapter 6: Troubleshooting ----------------------------------------------------------6359
Troubleshooting----------------------------------------------------------------------6359
Chapter 7: Specifications-------------------------------------------------------------6561
Specifications-------------------------------------------------------------------------6561
Calibration Verification -------------------------------------------------------------6864
Symbols--------------------------------------------------------------------------------6864
Chapter 8: Service and Repair ------------------------------------------------------7167
Service and Repair------------------------------------------------------------------7167
Index---------------------------------------------------------------------------------------7973

www.masimo.com 5 Masimo
About this Manual
This manual explains how to set up and use Pronto-7. Important safety
information relating to general use of the product 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.
Awarning is given when actions may result ina serious outcome (for example,
injury, serious adverse effect and, death) to the patient or user. The following
is an example of a warning:
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 Pronto-7 or damage to other
property. The following is an example of a caution:
CAUTION: This is an example of caution statement.
A note is given when additional general information is applicable. The
following is an example of a note:
Note: This is an example of a note.
Read the entire safety information section before you operate the
instrument.

www.masimo.com 7 Masimo
Product Description
Indications for Use
The Masimo rainbow SET Pronto-7 Spot Check CO-Oximeter and
Accessories are indicated for noninvasive spot check testing of functional
saturation of arterial oxygen hemoglobin (SpO
2
), pulse rate (PR), and total
hemoglobin concentration (SpHb). The Masimo rainbow SET Pronto-7 Spot
Check CO-Oximeter and Accessories are indicated for use by trained
personnel, with adult and pediatric individuals, in clinical and non-clinical
settings (e.g., hospitals, hospital-type facilities, home, clinics, physician
offices, and ambulatory surgery centers).
The Masimo rainbow SET Pronto-7 Spot Check CO-Oximeter is designed to
simultaneously and noninvasively measure functional arterial oxygen
saturation (SpO
2
), pulse rate (PR), total hemoglobin (SpHb), perfusion index
(PI), and hematocrit (SpHct).
Advanced features available on the Pronto-7 include SpHct access, multi test
mode, low signal I.Q., measurement through motion of SpHb and SpO
2
,
wireless download of spot check tests, SpO
2
only mode and EMR connectivity
for parameter and measurement download.
The instrument is voice automated, provides step by step instructions when
administering tests and is equipped with an interactive touchscreen for user
selectable options.
Contraindications
The Pronto-7 is contraindicated for use as an apnea monitor. The Pronto-7 is
also contraindicated for use as a continuous monitor.