Spot Check Pulse CO-Oximeter
OPERATOR’S
MANUAL
These operating instructions intend to provide the necessary information for proper operation of the Masimo
Rainbow® SET® Pronto-7™ Pulse CO-Oximeter.
General knowledge of Pulse CO-Oximetry and an understanding of the features and functions of the Pronto-7
are prerequisites for proper use.
Do not operate the Pronto-7 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 LAW (U.S.) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.
For further information contact:
Masimo Corporation
40 Parker
Irvine, CA 92618
USA
Tel.: 949-297-7000
Fax.: 949-297-7001
www.masimo.com
EU Authorized Representative for Masimo Corporation:
EC REP
MDSS GmbH
Schiffgraben 41
D-30175 Hannover, Germany
Tel.: +49-511-62 62 86 30
Fax.: +49-511-62 62 86 33
Covered by one or more of the following U.S. Patents: 5919134; 6002952; 6067462; 6229856;
6388240; 6463311; 6606511; 6643530; 6684090; 6699194; 6816741; 6961598; 6979812;
7003339; 7044918; 7186966; 7215984; 7215986; 7221971; 7254433; 7489958; 7496393;
7596398; international equivalents, or one or more of the patents referenced at www.masimo.com/
patents.htm. Other patents pending.
Masimo, SET,
, PVI, Signal Extraction Pulse CO-Oximeter, Rainbow and Signal IQ are registered
trademarks of Masimo Corporation.
Pronto-7, SIQ and SpHb are trademarks of Masimo Corporation.
All other trademarks and registered trademarks are property of their respective owners.
Printed in USA
© 2010 Masimo Corporation.
Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter
i
NON-INVASIVE TOTAL HEMOGLOBIN (SpHb) ACCURACY COMPARED TO INVASIVE
LABORATORY METHODS*
In 3519 comparisons of non-invasive total hemoglobin (SpHb) and invasive hemoglobin (tHb)
measurements from a laboratory CO-Oximeter, SpHb accuracy was as follows
0.91 correlation ■
0.8 g/dL standard deviation ■
Below 12 g/dL, 99% of SpHb readings were within 2 g/dL of the laboratory tHb value ■
At or above 12 g/dL, 99% of SpHb readings were within 2 g/dL of the laboratory value ■
* Masimo FDA Submission Data
CONTRAINDICATIONS: The Pronto-7 is contraindicated for use as an apnea monitor. The
Pronto-7 is also contraindicated for use as a continuous monitor.
:
Safety Information, Warnings and
Cautions
The Pronto-7 is designed to minimize the possibility of hazards from errors in the sofware program by
following sound engineering design processes, Risk Analysis and Software Validation.
The Pronto-7 is to be operated by qualified personnel only. This manual, accessories, directions ■
for use, all precautionary information, and specifications should be read before use.
Variation in hemoglobin measurements may be profound and may be affected by sample ■
type, body positioning, as well as other physiological conditions. As with most hemoglobin
tests, Pronto-7 test results should be scrutinized in light of a specific patient’s condition. Any
results exhibiting inconsistency with the patient’s clinical status should be repeated and/or
supplemented with additional test data.
Explosion hazard. Do not use the Pronto-7 in the presence of flammable anesthetics or other ■
flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide.
Electric shock hazard. Do not open the Pronto-7 instrument. Only a qualified operator may ■
perform maintenance procedures specifically described in this manual. Refer servicing to
Masimo for repair of this equipment.
High intensity extreme lights (including pulsating strobe lights) directed on the sensor, may not ■
allow the Pronto-7 to obtain readings.
Check for possible EMI radiation interference such as, computer displays and/or LCD/plasma ■
TVs.
The Pronto-7 should be considered an early warning device. For measurements of high or low ■
SpO2 and/or SpHb readings, blood samples should be analyzed by laboratory instruments to
completely understand the patient’s condition.
If patient hypoxemia is indicated, blood samples should be analyzed by laboratory devices to ■
completely understand the patient’s condition.
Pulse rate measurement is based on the optical detection of a peripheral flow pulse ■
and therefore may not detect certain arrhythmias. The Pronto-7 should not be used as a
replacement or substitute for ECG based arrhythmia analysis.
ii
Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter
Safety Information, Warnings and Cautions, continued
As with all medical equipment, carefully route patient cabling to reduce the possibility of patient ■
entanglement or strangulation.
Do not place the Pronto-7 or accessories in any position that might cause it to fall on the ■
patient. Do not lift the Pronto-7 by the cable or sensor.
Patient Safety - If a sensor is damaged in any way, discontinue use immediately. ■
Always remove the sensor from the patient and completely disconnect the patient from the ■
Pronto-7 before bathing the patient.
Interfering Substances: Dyes, or any substance containing dyes, that change usual blood ■
pigmentation may cause erroneous readings.
Do not use the Pronto-7 or sensor during magnetic resonance imaging (MRI) scanning. ■
Induced current could potentially cause burns. The Pronto-7 may affect the MRI image and the
MRI device may affect the accuracy of the Pulse CO-Oximetry parameters and measurements.
Do not use the Pronto-7 during electrocautery. ■
Do not use the Pronto-7 or sensors during defibrillation. ■
If using the Pronto-7 during full body irradiation, keep the sensor out of the radiation field. If the ■
sensor is exposed to the radiation, the reading might be inaccurate or the instrument might
read zero for the duration of the active irradiation period.
Do not place the Pronto-7 where the controls can be changed by the patient. ■
Do not place the Pronto-7 on electrical equipment that may affect the instrument, preventing it ■
from working properly.
Do not expose the Pronto-7 to excessive moisture such as direct exposure to rain. Excessive ■
moisture can cause the instrument to perform inaccurately or fail.
Do not place containers with liquids on or near the Pronto-7. Liquids spilled on the instrument ■
may cause it to perform inaccurately or fail.
Changes or modifications not expressly approved by the party responsible for compliance could ■
void the user's authority to operate the equipment.
SpO ■
is empirically calibrated to functional arterial oxygen saturation in healthy adult
2
volunteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb). The
Pulse CO-Oximeter cannot measure elevated levels of COHb or MetHb. Increases in either
COHb or MetHb will affect the accuracy of the SpO2 measurement.
Inaccurate SpO2 readings can be caused by: ■
Elevated levels of ❚ COHb and MetHb
For increased COHb: COHb levels above normal tend to increase the level of SpO ❚
. The
2
level of increase is approximately equal to the amount of COHb that is present.
NOTE ❚ : High levels of COHb may occur with a seemingly normal SpO2. When elevated
levels of COHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample
should be performed.
For increased MetHb: the SpO2 may be decreased by levels of MetHb of up to ❚
approximately 10% to 15%. At higher levels of MetHb, the SpO2 may tend to read
in the low to mid 80s. When elevated levels of MetHb are suspected, laboratory
analysis (CO-Oximetry) of a blood sample should be performed.
Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter
iii
Safety Information, Warnings and Cautions, continued
Externally applied coloring (such as nail polish) ❚
Elevated levels of Total Bilirubin ❚
Severe anemia ❚
Motion artifact ❚
Inaccurate SpHb readings can be caused by: ■
Elevated levels of Total Bilirubin ❚
Low perfusion ❚
Hemoglobin synthesis disorders ❚
Hemoglobinopathy ❚
Peripheral vascular disease ❚
Externally applied coloring (such as nail polish) ❚
EMI radiation interference ❚
Motion artifact ❚
Do not place the Pronto-7 against a surface. This can cause the a system or battery (non- ■
clinical) alarm to be muffled.
Additional information specific to the Masimo Rainbow PDC-SC reusable sensor including ■
information about parameter/measurement performance during motion and low perfusion, may
be found in the sensor's Directions For Use (DFU).
Do not expose the PDC-SC reusable sensor to moisture, liquids or a humid environment, as ■
this may make the sensor perform inaccurately or fail.
If the ■ Pronto-7 fails any part of the setup procedures or leakage spot check, remove the
instrument from operation until qualifi ed service personnel have corrected the situation.
Do not incinerate battery. ■
To protect against injury from electric shock, follow the directions below: ■
Avoid placing the device on surfaces with visible liquid spills. ❚
Do not soak or immerse the device in liquids. ❚
Use cleaning solutions sparingly. ❚
This device complies with part 15 of the FCC Rules. Operation is subject to the following two ■
conditions: (1) This device may not cause harmful interference, and (2) this device must accept
any interference received, including interference that may cause undesired operation.
This equipment has been tested and found to comply with the limits for a Class B digital ■
device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable
protection against harmful interference in a residential installation. This equipment generates,
uses and can radiate radio frequency energy and, if not installed and used in accordance with
the instructions, may cause harmful interference to radio communications. However, there is
no guarantee that interference will not occur in a particular installation. If this equipment does
cause harmful interference to radio or television reception, which can be determined by turning
Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter
Safety Information, Warnings and Cautions, continued
the equipment off and on, the user is encouraged to try to correct the interference by one or
more of the following measures:
Reorient or relocate the receiving antenna. ❚
Increase the separation between the equipment and receiver. ❚
Connect the equipment into an outlet on a circuit different from that to which the receiver ❚
is connected.
Consult the dealer or an experienced radio/TV technician for help. ❚
This equipment has been tested and found to comply with the limits for medical devices to ■
the EN 60601-1-2: 2002, Medical Device Directive 93/42/EEC and Class B. These limits are
designed to provide reasonable protection against harmful interference in a typical medical
installation.
A functional tester cannot be utilized to assess the accuracy of the Pronto-7 or its PDC-SC ■
reusable sensor.
Cleared Use Only: The device and related accessories are cleared by the Food and Drug ■
Administration (FDA) 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 FDA, or in any manner inconsistent with the instructions for use or labeling.
The device and related accessories are not intended for use in combination with other medical
devices or in high-risk applications.
Disposal of product - Comply with local laws in the disposal of the instrument and/or its ■
accessories.
Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter
vi
Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter
table of contents
Safety Information, Warnings and Cautions ............................................................................ii
SECTION 1 - OVERVIEW
About this Manual ................................................................................................................ 1-1
Warnings, Cautions and Notes ............................................................................................1-2
Product Description ............................................................................................................. 1-3
Features and Benefits .............................................................................................. 1-3
Indications for Use .................................................................................................. 1-3
Pulse CO-Oximeter ............................................................................................................. 1-4
General Description........................................................................................ 1-4
SpO
2
SpHb General Description .......................................................................................1-4
Principles of Operation ............................................................................................. 1-5
Functional Saturation ............................................................................................... 1-5
Pronto-7 vs. Drawn Whole Blood Measurements ..................................................... 1-5
SpHb Measurements During Patient Motion ............................................................ 1-6
SECTION 2 - SYSTEM DESCRIPTION
Introduction ......................................................................................................................... 2-1
Front Panel and Touchscreen .............................................................................................. 2-1
Front Panel and Touchscreen Details ....................................................................... 2-2
Back Panel........................................................................................................................... 2-2
Back Panel Details ................................................................................................... 2-2
Bottom Panel ...................................................................................................................... 2-3
Bottom Panel Details ................................................................................................ 2-3
Symbols ............................................................................................................................... 2-4
SECTION 3 - SETUP
Introduction .......................................................................................................................... 3-1
Unpacking and Inspection ................................................................................................... 3-1
Commonly Used Buttons .........................................................................................3-1
Preparation for Use ............................................................................................................. 3-2
Introduction ............................................................................................................... 3-2
Initial Setup............................................................................................................... 3-2
Spot Check System ............................................................................................................. 3-2
SECTION 4 - OPERATION
Pronto-7 Operation .............................................................................................................. 4-1
Connecting and Testing .......................................................................................... 4-1
Test Results .............................................................................................................. 4-3
Ensuring a Successful Spot Check ..................................................................................... 4-4
Masimo Sensors....................................................................................................... 4-4
Numeric Display - SpO
........................................................................................... 4-4
2
Numeric Display - Pulse Rate .................................................................................. 4-5
Numeric Display - PI ................................................................................................ 4-5
Troubleshooting Sensor Placement .......................................................................... 4-5
Main Menu Screen ................................................................................................... 4-6
Menu Options Table .................................................................................................. 4-6
SECTION 5 - ALARMS / MESSAGES
Messages ............................................................................................................................ 5-1
Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter
vii
table of contents
SECTION 6 - TROUBLESHOOTING
Troubleshooting ................................................................................................................... 6-1
SECTION 7 - SPECIFICATIONS
Specifications ...................................................................................................................... 7-1
SECTION 8 - SENSOR
Introduction .......................................................................................................................... 8-1
Masimo Rainbow PDC-SC (Pronto-7 Direct Connect-Spot Check) Reusable Sensor ....... 8-2
Sensor Accuracy ...................................................................................................... 8-2
Cleaning And Reuse of a Masimo Reusable Sensor ............................................... 8-2
SECTION 9- SERVICE / MAINTENANCE
Introduction .......................................................................................................................... 9-1
Cleaning .............................................................................................................................. 9-1
Ordering Spot Check Credits .............................................................................................. 9-2
Installing Credits ....................................................................................................... 9-2
Service and Repair .............................................................................................................. 9-3
Repair Policy ............................................................................................................ 9-3
Return Procedure ..................................................................................................... 9-3
Sales & End-User License Agreement ................................................................................ 9-5
Warranty ..............................................................................................................................9-5
Exclusions ........................................................................................................................... 9-5
End-User License ................................................................................................................ 9-6
Restrictions .......................................................................................................................... 9-6
No Implied License ............................................................................................................ 9-7
Sensors Licensed for Monitoring Use Only ....................................................................... 9-7
viii
Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter
overview
About this Manual
This manual explains how to set up and use the Pronto-7. Important safety information relating to
general use of the instrument appears before this introduction. Other important safety information
is located throughout the manual where appropriate.
Read the entire safety information section before you operate the instrument.
In addition to the safety section, this manual includes the following sections:
SECTION 1 ■ OVERVIEW
SECTION 2 ■ SYSTEM DESCRIPTION
SECTION 3 ■ SETUP
SECTION 4 ■ OPERATION
SECTION 5 ■ MESSAGES
SECTION 6 ■ TROUBLESHOOTING
SECTION 7 ■ SPECIFICATIONS
SECTION 8 ■ SENSORS
1
SECTION 9 ■ SERVICE AND MAINTENANCE
Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter 1-1
1
overview
Warnings, Cautions and Notes
Please read and follow any warnings, cautions and notes presented throughout this
manual. An explanation of these labels are as follows:
A WARNING is provided when actions may result in a serious outcome (i.e., injury,
serious adverse affect, death) to the patient or user. Look for text in a box.
WARNING: THIS IS A SAMPLE 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 instrument or damage to other property.
CAUTION: THIS IS A SAMPLE OF A CAUTION STATEMENT.
A Note is provided when extra general information is applicable.
Note: This is a sample of a Note.
1-2 Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter
overview
Product Description
The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter (instrument) with Masimo Rainbow
SET Technology is developed to simultaneously and non-invasively measure functional arterial
oxygen saturation (SpO2), pulse rate (PR), total hemoglobin (SpHb) and perfusion index (PI). The
instrument has a single on/off button and an interactive touchscreen for administering tests along
with user selectable options.
FEATURES AND BENEFITS
Accurate and Non-invasive Measurement and Display of Functional Arterial Oxygen
Saturation (SpO2) and Pulse Rate (PR)
The instrument uses multiple wavelengths of light and proprietary algorithms to obtain functional
arterial oxygen saturation (SpO2) and pulse rate (PR) readings.
Total Hemoglobin (SpHb)
The instrument measures total hemoglobin (SpHb) using similar principles as pulse oximetry with
more wavelengths of light and proprietary algorithms to obtain the measurements.
Perfusion Index (PI)
The instrument measures the Perfusion Index (PI). This indicates arterial pulse signal strength.
Clinically Useful Features Include:
Lightweight, ergonomic handheld design ■
1
Interactive color touchscreen interface ■
Audible voice guided feedback (English) ■
Spot check test results in approximately 45 seconds ■
Test countdown timer ■
Plethysmograph display ■
Real time feedback of sensor motion ■
Review and sort previous test results ■
Optional input for patient identification number, name and other details ■
Interference Scanner mode for detecting interference in testing environments ■
Print and email options ■
INDICATIONS FOR USE
The Masimo Rainbow SET Pronto-7 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 Pronto-7 Pulse
CO-Oximeter and Accessories are indicated for use, by trained personnel, with adult and pediatric
individuals, for individuals who are well or poorly perfused and in clinical and non-clinical settings
(e.g., hospitals, hospital-type facilities, home, clinics, physician offices, blood donation facilities,
and ambulatory surgery centers).
Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter 1-3
1
overview
Pulse CO-Oximeter
GENERAL DESCRIPTION
SpO
2
Pulse oximetry is a noninvasive method of measuring the level of functional arterial oxygen saturation in blood. The measurement is taken by placing a sensor on a patient, usually on the fingertip
for adults and pediatric patients. The sensor connects to the pulse oximetry instrument directly or
with a patient cable. The sensor collects signal data from the patient and sends it to the instrument. The instrument displays the calculated data as a percent value for functional arterial oxygen
saturation (SpO
).
2
Instrument
1
2
Sensor
SpHb GENERAL DESCRIPTION
Instruments containing Masimo Rainbow SET Technology offer a non-invasive method of
measuring the levels of total hemoglobin in blood (SpHb). It relies on the same principles of pulse
oximetry to make SpHb measurements. The measurements are taken by placing a sensor on
a patient, usually on the fingertip for adults as shown in the figure above. The sensor connects
directly to the instrument. The sensor collects signal data from the patient and sends it to the
instrument. The instrument displays the calculated data as grams/deciliter (g/dL) for SpHb (with
different units of measure available in the display menu).
1-4 Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter
overview
PRINCIPLES OF OPERATION
Pulse CO-Oximetry is governed by the following principles:
Oxyhemoglobin (oxygenated blood), deoxyhemoglobin (non-oxygenated blood) 1.
carboxyhemoglobin (blood with carbon monoxide content), methemoglobin (blood with
oxidized hemoglobin) and blood plasma constituents differ in their absorption of visible and
infrared light (using spectrophotometry):
The amount of blood in tissue changes with a person’s pulse (photoplethysmography). 2.
Therefore, the amount of light absorbed by the varying quantities of blood changes as well.
The Pronto-7 uses a multi-wavelength sensor to distinguish between oxygenated blood,
deoxygenated blood and blood plasma. The Pronto-7 utilizes a sensor with various light-emitting
diodes (LEDs) that pass light through the site to multiple photodiodes (detectors). See the figure
below.
Signal data is obtained by passing various infrared lights (ranging from 500 up to 1300nm) through
a capillary bed (for example, a fingertip) and measuring changes in light absorption during the
blood pulsatile cycle. This information may be useful to clinicians. The maximum radiant power of
the strongest light is rated at ≤ 25mW. The detectors receive the light, convert it into an electronic
signal and send it to the instrument for calculation.
1
Once the Pronto-7 receives the signal from the sensor, it utilizes Masimo Rainbow SET technology
to calculate the patient's functional oxygen saturation (SpO
%), pulse rate and total hemoglobin
2
(SpHb [g/dl]). The SpHb measurement relies on a multiwavelength calibration equation to quantify the
percentage of total hemoglobin in blood. In an ambient temperature of 95º F (35º C) the maximum skin
surface temperature has been measured at less than 106º F (41º C), verified by Masimo sensor skin
temperature test procedure.
FUNCTIONAL SATURATION
The Pronto-7 is calibrated to measure and display functional saturation (SpO
): the amount of
2
oxyhemoglobin expressed as a percentage of the hemoglobin that is available to transport oxygen.
See the Safety information, Warnings and Cautions section in front of this manual for details.
PRONTO-7 VS. DRAWN WHOLE BLOOD MEASUREMENTS
When SpHb measurements obtained from the instrument (noninvasive) are compared to drawn whole
blood (invasive) measurements by blood gas and/or laboratory CO-Oximetry methods, caution should
be taken when evaluating and interpreting the results. The blood gas and/or laboratory CO-Oximetry
measurements may differ from the SpHb measurements of the Pronto-7. High levels of bilirubin may
cause erroneous SpHb readings. As blood samples are usually taken over a period of 20 seconds (the
time it takes to draw the blood) a meaningful comparison can only be achieved if the carboxyhemoglobin
or mehemoglobin concentration of the patient are stable and not changing over the period of time that
the blood gas sample is taken. Subsequently, blood gas and laboratory CO-Oximetry measurements
Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter 1-5
1
overview
of SpHb may vary with the rapid administration of fluids and in procedures such as dialysis. Additionally,
drawn, whole-blood testing can be affected by sample handling methods and time elapsed between
blood draw and sample testing.
MEASUREMENTS DURING PATIENT MOTION
SpO2 and SpHb measurement accuracy may not be reliable during excessive motion because of the
changes in the physiological parameters such as blood volume, arterial-venous coupling, etc. that
occur during patient motion. When motion or low signal quality are detected during a test, the screen
will display a poor signal quality indication progress bar. If this bar fills completely the test will not be
able to complete. (See example below)
motion bar
A Test Incomplete message will display with information describing the problem encountered and if any
corrective course of action is needed.
1-6 Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter
system description
Introduction
The Pronto-7 is a Spot Check Pulse CO-Oximeter which provides functional arterial oxygen
saturation (SpO2) and non-invasive total hemoglobin (SpHb) measurements. The instrument is
designed for accuracy and ease of operation. All pulse CO-Oximetry measurement information,
as well as instrument status data, is displayed on the front panel's touchscreen.
A Masimo Rainbow Pronto-7 Direct Connect-Spot Check (PDC-SC) reusable sensor attaches to
the top of the Pronto-7. The Pronto-7 is powered by a rechargeable lithium polymer battery.
Front Panel and Touchscreen
PDC-SC Connector Port
2
2
Spot checks
remaining
LCD
Touchscreen
Perform a test
20
14.2
Test
Power On/Off
12:23 P.M .
99
71
.2 %
5
SpHb
g/dL
SpO2
%
PR
BPM
PI
Battery status
Current time
Parameters and
Measurements
Menu
Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter 2-1
2
system description
FRONT PANEL AND TOUCHSCREEN DETAILS
Power On/Off
Press Power to turn the instrument on or off.
LCD Touchscreen
The touchscreen is interactive. Move through screens, select options, enter information, view
instrument specific messages.
PDC-SC Connector Port
Connect a PDC-SC (Pronto-7 Direct Connect-Spot Check) reusable sensor to enable spot checks
and instrument capability.
Spot Checks Remaining
Displays the number of spot checks remaining. Press the number to see details and how to order
more spot checks.
Date and Time
Displays the current time. Press the time to see detailed information.
Battery Status
Displays the battery power remaining. Press the battery icon to see details about the current
battery. Use only the included power cable to recharge.
Parameters and Measurements Display
Default parameters and meaurements are displayed.
Back Panel
Certification label
Serial Number
BACK PANEL DETAILS
Certification Label
The instrument’s certification marks are displayed.
Serial Number
This number can be used to uniquely identify the instrument and will be needed if Masimo Service
is called.
2-2 Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter
system description
Bottom Panel
2
MicroSD card slot
Earphone jack
Mini USB port
Power port
BOTTOM PANEL DETAILS
Earphone Jack
To listen to the parameter or measurement results of a successful spot check, plug a standard
earphone into the 3.5mm earphone jack.
MicroSD Card Slot
A MicroSD flash memory card is optional. To use, insert the card into the MicroSD card slot until
you feel a click. This ensures the card is securely connected. The MicroSD card can currently be
used to upload new software or additional spot check credits.
Mini USB Port
A mini USB to USB cable is included with the instrument. To connect the instrument to a computer,
plug the mini USB cable into the port on the instrument and plug the USB cable to the USB port
on a computer. Use the mini USB to USB cable to download data to the instrument or upload
information to the computer. To protect the instrument, connect only to a medical grade computer
to ensure grounding is sufficient. Use only the included mini USB to USB cable.
Do not connect the mini USB to USB cable during a test. ■
To prevent possible data loss or interruption, plug the ■ instrument into an AC power supply
while uploading or downloading files.
Do not disconnect the USB cable from the ■ instrument or the computer while a file transfer is
in place.
Eject the ■ instrument as you would any other external drive, per the recommended
requirements of your computer manufacturer.
Power Port
To charge the instrument, plug the included medical grade +5V/3A power cable into the power port
of the instrument and plug the other end into an AC power outlet. Use only the included power
cable. Spot check tests can be run while the power cable is plugged into an outlet.
Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter 2-3
2
7
system description
Symbols
The following symbols may be found on the Pronto-7 or packaging and are defined below:
SYMBOL DESCRIPTION
Caution, consult accompanying documents
Type BF applied part complying with IEC 60601-1
WEEE Compliant
Mark of Conformity to European Medical Device Directive 93/42/EEC
Rx Only
5%-95% RH
+70 C
-40 C
+1060 hPa - +500 hPa
95 mmHg - 375 mmHg
REP
EC
Federal law restricts this device to sale by or on the order of a physician (USA
audiences only)
Year of manufacture
Storage humidity range: 5% to 95%
Storage temperature range: +70˚C to -40˚C
Storage altitude range: +1600hPa to +500hPa
Keep dry
Fragile/breakable, handle with care
EU authorized representative
Manufacturer
ETL
Federal Communications Commission (FCC) licensing.
Non-ionizing electromagnetic radiation
IPX1
SpHb
2-4 Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter
Protection against vertically falling water drops
Not for continuous monitoring
setup
Introduction
Before the Pronto-7 can be used, it needs to be inspected, properly setup and have the battery
fully charged.
Unpacking and Inspection
Remove the instrument from the shipping carton and examine for signs of shipping damage. Check
all materials against the packing list. Save the invoice, bill of lading and all packing materials. These
may be required if it is necessary to process a claim with the carrier.
If anything is missing or damaged, contact the Technical Service Department. The contact address
and phone numbers are listed in Section 9, Service and Repair.
Included in the package:
1 Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter (instrument)
1 Masimo Rainbow PDC-SC reusable sensor
1 AC power cable
1 mini USB to USB cable
1 LCD cleaning cloth
1 Pronto-7 Operator's Manual
1 PDC-SC Sensor Directions for Use (DFU)
3
COMMONLY USED BUTTONS
BUTTON DESCRIPTION
Turn the instrument on or off.
Start a test.
Go to the Main menu screen.
To move back one screen, press and release.
Press and hold to return to "Ready" screen.
To exit a screen.
Scroll down a list or page.
Scroll up a list or page.
Displays an interactive dialogue for user options: printing, e-mailing, or deleting test
results.
Add patient specific information such as name or ID number (#).
Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter 3-1
3
setup
Preparation for Use
INTRODUCTION
To operate the Pronto-7 effectively, the operator must:
Know how the Pronto-7 derives its readings (see Section 1, ■ Pulse CO-Oximeter)
Be familiar with its controls and operation. ■
Understand its status and messages (see Section 5, ■ Messages and Section 6, Troubleshooting)
INITIAL SETUP
Inspect the Pronto-7 case for damage.1.
Power the instrument on. The touchscreen will illuminate and an audible tone will sound. The 2.
time and date need to be set. Enter your region's correct date and time and press
confirm.
Fully charge the instrument using the included AC power cable.3.
Note: The intial battery charge can take up to 6 hours. The battery should be recharged as needed.
It will operate for approximately 2 hours at a time when fully charged. See Section 4, Battery
Level Indicator section for more information about the battery.
to
No other setup is required.
Spot Check System
To administer a non–invasive test using the Pronto-7, use a Masimo Rainbow PDC-SC reusable
(PDC-SC) reusable sensor with spot check credits.
To see if the PDC-SC reusable sensor contains spot check credits, connect it to a Pronto-7. A
numeric value will appear in the top left corner of the screen, next to the Masimo icon, with the
number of available spot check credits it contains (e.g. 200).
If there is 1 or more credits the instrument's main screen will display the title “Ready” across the
screen.
If no spot checks are available, the instrument's main screen will show 0 credits in the upper left
corner in red and the main screen message will show No Spot Check Credits.
3-2 Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter
operation
Pronto-7 Operation
CONNECTING AND TESTING
Connect the included patient PDC-SC reusable sensor to the instrument’s patient sensor 1.
connector port.
4
Press 2.
to power on the instrument. There will be an audible tone and the following
screen will display:
If a sensor is not attached or not connected completely, this screen displays: 3.
Attach a sensor and continue with step 4.
When a sensor is attached, the following screen displays and testing can begin4.
Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter 4-1
:
4
Patient Testing
Note: It is recommended to perform patient testing with the patient in a seated position.
operation
Press 5.
When the test is running, a timer will count down the seconds until the test is complete: 6.
If motion is detected, the motion bar at the bottom of the screen will begin to fill. (If the entire bar is
full, the test will fail as a result of too much motion). If the test needs to be interrupted, press
.
After a successful test there will be an audible tone and the results screen will display:7.
on the instrument’s display screen.
4-2 Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter
operation
TEST RESULTS
Completed Test
After a successful Spot Check test, detailed information about the patient can be entered by
pressing the
will appear at the bottom of the screen. The results can be sent to a designated printer or email
address by following the on-screen instructions.
Press the parameter name or value for more information and references for understanding the
measurement.
button. If the printer or email options were set up, a printer and/or email button
4
Press
minutes of inactivity to indicate to the user that the numbers they are viewing are not current.
Incomplete Test
An incomplete test can occur due to excessive motion, interference to the instrument or if
was pressed. The examples below show incomplete test message screens.
to exit and return to the "Ready" screen. The test results will dim and turn grey after 5
Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter 4-3
4
operation
Ensuring a Successful Spot Check
The following general points will aid in ensuring successful measurement.
Place the sensor on a site that has sufficient perfusion (preferably the middle or ring finger of ■
the non-dominant hand) and provides proper alignment of the LEDs and detector.
Place the sensor on a site that has unrestricted blood flow. ■
Do not secure the sensor with tape. ■
Do not select a site near potential electrical interference (electrosurgical device, for example). ■
Read the sensor's ■ Directions for Use for proper sensor application.
(
MASIMO SENSORS
Before use, carefully read the Masimo Rainbow PDC-SC reusable sensor's Directions for Use.
Use only a PDC-SC reusable sensor for spot checking measurements.
CAUTIONS
DO NOT USE DAMAGED SENSORS. DO NOT USE A ■
SENSOR WITH EXPOSED
OPTICAL OR ELECTRICAL COMPONENTS. DO NOT IMMERSE THE SENSOR IN WATER,
SOLVENTS, OR CLEANING SOLUTIONS (THE SENSORS AND CONNECTORS ARE
NOT WATERPROOF). DO NOT STERILIZE BY IRRADIATION, STEAM, AUTOCLAVE OR
ETHYLENE OXIDE UNLESS OTHERWISE INDICATED IN THE SENSOR DIRECTIONS
FOR USE. SEE THE CLEANING INSTRUCTIONS IN THE DIRECTIONS FOR USE FOR
ALL MASIMO REUSABLE SENSORS.
DO NOT ATTEMPT TO REPROCESS, RECONDITION OR RECYCLE MASIMO SENSORS ■
AS THESE PROCESSES MAY DAMAGE THE ELECTRICAL COMPONENTS, POTENTIALLY
LEADING TO PATIENT HARM.
NUMERIC DISPLAY - SpO
2
An SpO2 reading is associated with correct sensor placement, small physiological changes during
the measurement and acceptable levels of arterial perfusion at the measurement site. Inaccurate
measurements may be caused by:
Intravascular dyes such as indocyanine green or methylene blue. ■
Elevated levels of carboxyhemoglobin. ■
Elevated levels of methemoglobin. ■
Severe anemia. ■
Elevated Total Bilirubin levels. ■
Low arterial perfusion. ■
Motion artifact. ■
NUMERIC DISPLAY - SpHb
An SpHb reading is associated with correct sensor placement, small physiological changes during
the measurement and acceptable levels of arterial perfusion at the measurement site.
synthesis disorders may cause erroneous SpHb readings.
Physiological changes at the measurement
Hemoglobin
site are mainly caused by fluctuations in the oxygen saturation, blood concentration and perfusion.
Inaccurate measurements may be caused by:
Intravascular dyes such as indocyanine green or methylene blue. ■
4-4 Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter
operation
Low arterial perfusion. ■
Low arterial oxygen saturation levels. ■
Elevated Total Bilirubin levels. ■
Hemoglobin synthesis disorder. ■
NUMERIC DISPLAY - PULSE RATE
The Pulse Rate displayed on the Pronto-7 may differ slightly from the heart rate displayed on ECG
monitors due to differences in averaging times. There may also be a discrepancy between cardiac
electrical activity and peripheral arterial pulsation. Significant differences may indicate a problem
with the signal quality due to physiological changes in the patient or one of the devices or application
of the sensor or patient cable. The pulsations from intra-aortic balloon support can cause the pulse
rate displayed on the Pronto-7 to be significantly different than the ECG heart rate.
NUMERIC DISPLAY - PI
The Perfusion Index (PI) display provides a numeric indication of the pulse strength at the measurement
site. It is a calculated percentage between the pulsatile signal and non-pulsatile signal of arterial blood
moving through the site. It displays an operating range of < .02 percent to 20 percent.
4
TROUBLESHOOTING SENSOR PLACEMENT
1
2
Example of Correct Sensor Placement
■ Make sure the emitters and detectors are aligned directly opposite each other.
■ Select a site where the distance between the emitter and detector is minimized.
■ Wipe the sensor site with a 70% isopropyl alcohol pad or rubefacient cream (10-30% methyl
salicylate and 2-10% menthol) for 20-30 seconds to increase perfusion. However, strong vasodilator
creams, such as nitroglycerin paste, are not recommended.
Do not expose the sensor to moisture, humid environments or liquids. ■
■ If possible, remove electrical noise sources such as electrosurgical devices or other electrical/
electronic equipment.
■ If artificial nails or excessive fingernail polish are present, select another site or remove the
polish/artificial nails.
■ If possible, ensure that the sensor is placed in a location with low ambient light. Although the
Pronto-7 with integrated Masimo Rainbow technology has significant immunity to ambient light,
excessive ambient light may cause readings to be incorrect.
■ Check for possible EMI radiation interference such as, computer displays and/or LCD/plasma TVs.
CAUTION: IF ANY MEASUREMENT SEEMS QUESTIONABLE, FIRST CHECK THE PATIENT’S VITAL SIGNS
BY ALTERNATE MEANS AND THEN CHECK THE PULSE CO-OXIMETER FOR PROPER FUNCTIONING.
Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter 4-5
4
MAIN MENU SCREEN
operation
To access the Main menu, press
from any screen where it is shown.
MENU OPTIONS TABLE
MENU FACTORY
OPTIONS
DEFAULT
Test Results
Sortable by column. From the test results screen a user can press the options button to delete tests, edit
patient information, print or e-mail the test results (if those options are setup).
Time
ID # or Name
SpHb
Descending Ascending or descending
ID #, one Name, All Names
Most recent tests Most recent tests, Single test
ID #, Name (either can be descending or
ascending)
Display - The display and voice languages will be the same
Brightness
SpHb Units of Measure
Display Parameters
Language
Sound
Volume
Sound Effects
Voice
Settings
Date & Time
Clock Display
Time Format
Time
Date Format
Date
10 1-10
g/dL g/dL, g/L, mmols
All All, PR Off, PI Off
English English
7 Off-10
On
On
On On, Off
12 hour 12 hour, 24 hour
hh/mm/pm user editable
yy/mm/dd yy/mm/dd, mm/dd/yy, dd/mm/yy
n/a user editable
On, Off
On, Off
4-6 Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter
operation
4
MENU FACTORY
OPTIONS
DEFAULT
Interference Test/Line Freq
Check Environment for
Interference
Line Frequency Hz
Pin # Protection
Restrict Access
Create/Change Pin#
If the PIN # is forgotten, press the "Forgot Pin" button along the upper right edge of the Enter PIN
keypad.
About Pronto
Masimo Contact
Information
About Owner
Registered to
information
Restore Default Settings
n/a Scan
60 50, 60
Off On, Off
Both Testing, Menu, Both
n/a Up to 15 digit numeric PIN, user editable
Tech Support Contact Info n/a
n/a
n/a No, Yes
user editable
Connections
Connections should be created or modified by an Administrator familiar with wireless networking and it is
recommended that the instrument be connected to a secure wireless network.
Completed test result screens can be emailed or printed.
Printing can be done over an internet connection or through a Bluetooth printer and Bluetooth barcodes
can be included.
Wireless Network
Wireless Connection
LAN Configuration
Networks Available
New Network
Outgoing Email
Reply to address
User Name n/a enter Masimo server name
Password n/a enter Masimo server password
Attach Image (test
screen shot)
Off On, Off
DHCP View, DHCP, Static
available networks list user selectable from list
n/a user selectable (SSID, Security On, Off,
encryption key WEP64, WEP-128, WPATKIP, WPA2-AES, Network password key)
n/a
Yes Yes, No
user editable (About Owner screen)
Attach .CSV (.csv
data file)
Bluetooth Pairing
Bluetooth (2.0)
Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter 4-7
Ye s
Off On, Off
Ye s , N o
4
operation
MENU FACTORY
OPTIONS
DEFAULT
Available Devices
Printer Configuration
Printer Address
Por t
Print Style
Paper Size
Include Picture
Include Barcodes
Bluetooth Printouts
Help
Quick Start A short slide show of basic testing operation
Common Questions
Contact Tech Support
Equipment Report which
includes:
Scan Scan (user editable On, Off for available
devices)
n/a User editable
n/a User editable
Color Color, B & W (Black & White)
Letter
Yes Yes, No
No Yes, No
A list of questions and answers to features about the instrument
Masimo Tech Support contact information
Device Serial #, Software Version, Total Device Run Time, Last Service/
Location, Sensor Serial #, Total Sensor Run Time, Spot Checks Obtained,
Event History
Letter
4-8 Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter
operation
BATTERY LEVEL INDICATOR
The Pronto-7 is powered by a rechargeable lithium polymer battery. It can also be powered by AC
power, when used with the included AC power cable. Battery charge level is indicated by the battery
icon in the upper right hand corner of the touchscreen. Battery conditions are:
When the battery is fully charged, the icon will be solid green: ■
When the battery is fully charged and plugged into AC power, an electrical plug symbol displays ■
on the battery icon:
As the battery discharges, the capacity will be equivalent to the fraction of green filling the icon: ■
When the battery is charging, a charging symbol will display on the battery icon: ■
4
LOW BATTERY ALARM
It the battery power level is too low, the instrument will not allow a test to be taken. There will be ■
a visual display, indicating the AC power cable must be used to continue.
WARNING: FAILURE TO PLUG IN THE AC POWER CABLE PROMPTLY AFTER A LOW
BATTERY ALARM MAY RESULT IN THE INSTRUMENT SHUTTING DOWN.
WARNING: ONLY USE THE INCLUDED AC POWER CABLE. USING A DIFFERENT AC
POWER CABLE COULD CAUSE DAMAGE TO THE PRONTO-7.
Checking Battery Status
Press the battery icon, at any time to see the current battery status.
Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter 4-9
This page is intentionally left blank
Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter
messages
Messages
The Pronto-7 will indicate other data or system errors. Message conditions follow:
MESSAGE TYPE SOLUTION
5
Ready Ready for spot check
Connect Sensor No sensor is connected
Excessive Motion
Test Incomplete
Low Battery
Warning
Test Stopped
Poor Signal Quality
Other
Battery level too low at start of
measurement
Occurs when the "Stop" button
is pressed during a test
Initiate spot check by pressing the green
"Test" button
Connect a Masimo Rainbow PDC-SC
sensor to the instrument
Follow on-screen recommendations
Plug in AC power cord
Initiate new spot check by pressing the
green "Test" button
Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter 5-1
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Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter
troubleshooting
Troubleshooting
The following chart describes what to do if the Pronto-7 system does not operate properly or fails.
6
PROBLEM POSSIBLE
Sensor Placement Ensure sensor is placed on a well
Excessive Motion Minimize or eliminate patient movement
Signal Quality Make sure measurement site is well
Incomplete or no reading
Reflective and/or metallic
nail polish
RECOMMENDATION
CAUSE(S)
perfused site. Make sure the patient's
finger is all the way in the sensor and
touching the finger stop. Route sensor
cable along the back of the patient's
hand to ensure that the sensor is on in
the correct orientation (see DFU figure).
at the sensor site
perfused, free of debris and there is no
nail polish on the patient's nail. Check
the testing environment for interference
using the interference scanner in the
Settings menu (see Section 4, Menu
Options Table). If interference is high,
shield the sensor from excessive light,
modulated light sources (such as
computer displays) or strobbing lights.
Remove all nail polish
Also, see Section 4, Successful Spot Check for additional information.
Device does not power on Low battery Plug in included AC power cable, then
power on the instrument
PDC-SC sensor does not
connect to instrument.
A computer connected with
the included USB cable does
not recognize the Pronto-7
Touchscreen buttons do not
respond when pressed
Sensor orientation is
incorrect
Connection issue 1. Make sure the instrument is powered
System Failure Turn off the instrument and then power it
The sensor can only connect one way.
Make sure the sensor plug is oriented
correctly, according to the DFU and
on-screen directions and diagrams
on and plugged into AC power
2. Check the available drives on your
computer. If the Pronto-7 still does not
appear, search your computer's User
Manual for proper external drive mapping
and troubleshooting
on. If the problem reoccurs or persists
return for service (see Section 9, Service
and Repair).
Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter 6-1
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Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter
specifications
Specifications
Measurement Range
7
PERFORMANCE
SpO
2
PR (pulse rate)
SpHb (total hemoglobin)
PI (perfusion index)
ACCURACY
Arterial Oxygen Saturation, 70% to 100%
Pulse Rate accuracy,
Total Hemoglobin concentration accuracy (SpHb g/dl)
2
1
3
RESOLUTION
Arterial Oxygen Saturation (SpO2)
Pulse Rate
Total Hemoglobin
Perfusion Index
INTERFERING SUBSTANCES
Refer to Safety Information, Warnings and Cautions (see pages ii - iii)
0-100%
30 - 250 bpm
0 - 25 g/dL
0.02% - 20%
± 2%
± 3 bpm
6-18 g/dL ±1 g/dL
1 bpm
0.1 g/dL
0.01%
ELECTRICAL
Battery Power
Capacity
Isolation
AC Power
ENVIROMENTAL
Operating temperature
Storage temperature
Operating humidity
Operating altitude
PHYSICAL CHARACTERISTICS
Dimensions
Weight
Rechargeable lithium polymer
Approximately 2 hours after full charge
Medical Grade AC/DC Adapter
100-240V, 50-60 Hz, 15VA max.
41°F to 104°F (5°C to +40°C)
40°F to 158°F (-40°C to +70°C)
5% to 95%, non-condensing
500 mbar to 1060 mbar pressure
-1000 ft to 18,000 ft (-304 m to 5,486
m)
5.1” x 2.8” x 1” (13cm x 7.2cm x 2.5 cm)
10.5 oz (296.4 g)
Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter 7-1
7
specifications
Visual alarm
low battery
system failure
DISPLAY/INDICATORS
Data display: SpO2%, pulse rate (PR) beats per minute, SpHb g/dL, PI%, battery level indicator, pulse
plethysmograph waveform
Type
3.7” Resistive Touchscreen
COMPLIANCE
EMC Compliance
Equipment Classification
Type of Protection (battery power)
Type of Protection (AC Power)
Degree of Protection-Sensor
Mode of Operation
1.The SpO2 accuracy has been validated in human blood studies on healthy adult male and female
volunteers with light to dark skin pigmentation in induced hypoxia studies in the range of 70-100%
SpO2 against a laboratory CO-Oximeter and ECG monitor. This variation equals plus or minus
one standard deviation. Plus or minus one standard deviation encompasses 68% of the population
weight.
EN60601-1-2, Class B
IEC 60601-1
Internally powered
Class 2
Type BF-Applied Part
Spot Check
2. Masimo sensors have been validated for pulse rate accuracy for the range of 30-250 bpm in
bench top testing against a Fluke Biotek Index 2 simulator. This variation equals plus or minus one
standard deviation which encompasses 68% of the population.
3 The SpHb accuracy has been validated with (arterial/ venous) blood from healthy adult male and
female volunteers and on patients with light to dark skin pigmentation in the range of 6 - 18 g/dl
SpHb against a laboratory CO-oximeter. This variation equals plus or minus one standard deviation
which encompasses 68% of the population. The SpHb accuracy has not been validated with motion
or low perfusion
7-2 Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter
sensor
Introduction
This section describes the use and cleaning of the Masimo Rainbow PDC-SC reusable sensor. It
should be used as a reference and not as a substitute for the sensor's Directions for Use (DFU).
Use only the PDC-SC reusable sensor with the Pronto-7.
CAUTIONS:
Tissue damage can be caused by incorrect application or use of a sensor. Inspect the ■
sensor site as directed in the sensor's Directions for Use to ensure skin integrity and correct
positioning of the sensor.
Carefully route sensor cable to reduce the possibility of patient entaglement or strangulation. ■
Do not use damaged sensors. Do not use a sensor with exposed optical or electrical ■
components.
Do not immerse the sensor in water, solvents, or cleaning solutions (the sensors may fail or ■
work inaccurately from exposure to moisture or humidity).
Do not sterilize sensors. ■
Do not attempt to reprocess, recondition or recycle any Masimo sensors as these processes ■
may damage the electrical components, potentially leading to patient harm.
8
The PDC-SC reusable sensor is designed for use with the Pronto-7. Verify the compatibility of ■
the instrument and sensor before use, otherwise patient injury can result.
High intensity extreme lights (such as pulsating strobe lights) directed on the PDC-SC ■
reusable sensor, may not allow the sensor to obtain vital sign readings. High ambient
light sources such as surgical lights (especially those with a xenon light source), bilirubin
lamps, fluorescent lights, infrared heating lamps, and direct sunlight can interfere with the
performance of the sensor. To prevent interference from ambient light, ensure that the sensor
is properly applied, and cover the sensor site with opaque material, if required. Failure to take
this precaution in high ambient light conditions may result in inaccurate measurements.
Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter 8-1
8
Masimo Rainbow PDC-SC (Pronto-7 Direct
Connect-Spot Check) Reusable Sensor
SpO2, pulse rate accuracy and SpHb for the PDC-SC reusable sensor is specified in the following
table.
A PDC-SC reusable sensor connects to the instrument directly.
SENSOR ACCURACY
Complete accuracy specifications are located in the sensor's DFU and are specific for the type of
Masimo sensor used.
CLEANING AND REUSE OF A MASIMO REUSABLE SENSOR
Reusable Rainbow sensors can be cleaned per the following procedure:
Remove the sensor from the patient.1.
Disconnect the sensor from the instrument.2.
Clean the sensor by wiping it with a 70% isopropyl alcohol pad. To prevent damage, do not 3.
soak or immerse the sensor in any liquid solution. Do not sterilize.
sensor
Allow to air dry thoroughly before returning it to operation.4.
NOTE: If the sensor fails to track the pulse consistently, the sensor may be incorrectly positioned.
Reposition the sensor or choose a different measurement site.
8-2 Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter
service / maintenance
Introduction
This chapter covers how to test the operation, properly clean and how to obtain service for the
Pronto-7.
Under normal operation, no internal adjustment or recalibration is required. Safety tests and
internal adjustments should be done by qualified personnel only. Safety checks should be
performed at regular intervals or in accordance with local and governmental regulations.
WARNING: BEFORE CLEANING THE INSTRUMENT, ALWAYS TURN IT OFF.
The Pronto-7 is a reusable instrument. The instrument is supplied and used non-sterile.
Cleaning
The outer surface of the Pronto-7 can be cleaned with a soft cloth dampened with a mild detergent
and warm water solution. Do not allow liquids to enter the interior of the instrument. The outer
surface of the instrument can also be wiped down using the following solvents: Cidex Plus (3.4%
Glutaraldehyde), 0.25% Ammonium Chloride, 10% Bleach, and 70% Isopropyl Alcohol.
9
CAUTIONS:
Do not sterilize the Pronto-7. ■
Do not soak or immerse the Pronto-7 in any liquid. ■
Use the cleaning solution sparingly. Excessive solution can flow into the Pronto-7 and cause ■
damage to internal components.
Do not touch, press, or rub the display panels with abrasive cleaning compounds, devices, ■
brushes, rough-surface materials, or bring them into contact with anything that could scratch
the panel.
Use the included LCD cleaning cloth to remove fingerprints from the touchscreen. ■
Do not use petroleum-based or acetone solutions, or other harsh solvents, to clean the ■
Pronto-7. These substances erode the instrument’s materials and instrument failure can result.
Refer to Section 8, Cleaning and Reuse of a Masimo Reusable Sensor for cleaning instructions
of the sensor.
Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter 9-1
9
service / maintenance
Ordering Spot Check Credits*
New Masimo Rainbow PDC-SC reusable sensors typically come with a certain number of credits
preinstalled. To verify the number of credits, follow the procedure described in Section 3, Setup.
Note: Each PDC-SC reusable sensor has a serial number that can be found by connecting the
sensor to the Pronto-7 and then selecting Menu > Help > Equipment Report. It is necessary
to have this number when you call to purchase credits. Credits can only be installed on the
sensor that has that specific serial number.
INSTALLING CREDITS
Once credits have been ordered, a digital file will be transmitted (downloaded to a computer,
sent via email or mailed on a MicroSD card). To install credits onto the PDC-SC reusable sensor,
credits must be loaded through the Pronto-7 instrument. There are currently two ways to load
credits through the Pronto-7 onto the PDC-SC reusable sensor.
Using a MicroSD card to load spot check credits*
Connect the PDC-SC reusable sensor to the Pronto-7 instrument. 1.
Take the MicroSD card with spot check credits on it and insert it into the Pronto-7 MicroSD 2.
card slot.
After a few seconds, look in the upper left hand corner of the instrument's display to verify 3.
the number of credits now available on your sensor.
Using a USB cable to load spot check credits*
Connect the PDC-SC reusable sensor to the Pronto-7 instrument. 1.
Connect the Masimo supplied USB cable to a computer2.
†
. The Pronto-7 should appear as a
mass storage device (like a USB jump drive on a computer).
When the Pronto-7 instrument is visible as a drive, drag the purchased spot check credits file 3.
into the Pronto-7 drive.
Once the file has completed downloading to the Pronto-7 drive, follow the computer's 4.
standard procedure to eject an external mass storage device.
After the file has downloaded to the instrument successfully and the Pronto-7 has been 5.
correctly ejected as a mass storage device the USB cable can be disconnected from the
instrument and the computer.
After a few seconds, look in the upper left hand corner of the instrument's display to verify 6.
the number of credits now available on the sensor.
* The spot check credits file is only for one time use on the specific sensor designated at the time of
purchase.
†
To protect the instrument, connect only to a medical grade computer to ensure grounding is
sufficient. Use only the included mini USB to USB cable.
9-2 Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter
service / maintenance
Service and Repair
REPAIR POLICY
Masimo or an authorized Service Department must perform warranty repair and service. Do not
use malfunctioning equipment. Have the instrument repaired.
WARNING: AN OPERATOR MAY ONLY PERFORM MAINTENANCE
PROCEDURES SPECIFICALLY DESCRIBED IN THIS MANUAL. REFER
SERVICING TO QUALIFIED SERVICE PERSONNEL TRAINED IN THE
REPAIR OF THIS EQUIPMENT.
Please clean contaminated and/or dirty equipment before returning, following the cleaning
procedure described in Section 9, Cleaning. Make sure it is fully dry before packing the equipment.
To return the Pronto-7 for service, please follow the Return Procedure.
RETURN PROCEDURE
Please clean contaminated/dirty equipment before returning and make sure it is fully dry before
packing the equipment. Call Masimo at 800-326-4890 and ask for Technical Support to request an
RMA number. Package the equipment securely – in the original shipping container if possible – and
enclose or include the following information and items:
9
A letter describing in detail any difficulties experienced with the ■ Pronto-7. Please include the
RMA number in the letter.
Warranty information – a copy of the invoice or other applicable documentation must be ■
included.
Purchase order number to cover repair if the ■ instrument is not under warranty, or for tracking
purposes if it is.
Ship-to and bill-to information. ■
Person (name, telephone/Telex/fax number, and country) to contact for any questions about the ■
repairs.
A certificate stating the ■ Pronto-7 has been decontaminated for bloodborne pathogens.
Return the Pronto-7 to the following shipping address:
For USA, Canada & Asia Pacific
(except Japan):
Masimo Corporation
40 Parker
Irvine, California 92618
Tel: 949-297-7000
FAX: 949-297-7001
Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter 9-3
9
For Japan: Masimo Japan Corporation
For Europe: Masimo International Sàrl
All other locations: Contact your local Masimo Representative
service / maintenance
Kojimachi Office
World Time Bldg. 4F
10-7, Ichiban-cho, Chiyoda-ku,
Tokyo 102-0082 JAPAN
Tel: 03 3237 3057, FAX: 03 3238 1110
Puits-Godet 10
2000 Neuchatel - SWITZERLAND
Tel: +41 32 720 1111
Fax.: +41 32 724 1448
9-4 Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter
service / maintenance
Sales & End-User License Agreement
THIS DOCUMENT IS A LEGAL AGREEMENT BETWEEN YOU (“PURCHASER”) AND MASIMO
CORPORATION (“MASIMO”) FOR THE PURCHASE OF THIS PRODUCT (“PRODUCT”) AND
A LICENSE IN THE INCLUDED OR EMBEDDED SOFTWARE (“SOFTWARE”). EXCEPT AS
OTHERWISE EXPRESSLY AGREED IN A SEPARATE CONTRACT FOR THE ACQUISITION
OF THIS PRODUCT, THE FOLLOWING TERMS ARE THE ENTIRE AGREEMENT BETWEEN
THE PARTIES REGARDING YOUR PURCHASE OF THIS PRODUCT. IF YOU DO NOT AGREE
TO THE TERMS OF THIS AGREEMENT, PROMPTLY RETURN THE ENTIRE PRODUCT,
INCLUDING ALL ACCESSORIES, IN THEIR ORIGINAL PACKAGES, WITH YOUR SALES
RECEIPT TO MASIMO FOR A FULL REFUND.
Warranty
Masimo warrants to the initial Purchaser for a period of one (1) year from the date of purchase
that: (i) each new Product and the Software media as delivered are free from defects in
workmanship or materials, and (ii) the Product and Software will perform substantially as labeled
in the directions for use. Masimo’s sole obligation under this warranty is to repair or replace any
Product or Software that is covered under warranty.
To request a replacement under warranty, Purchaser must contact Masimo for a returned goods
authorization. If Masimo determines that a Product must be replaced under warranty, it will be
replaced and the cost of shipment covered. All other shipping costs shall be the responsibility
of Purchaser.
9
Exclusions
The warranty does not extend to, and Masimo is not responsible for, repair, replacement, or
maintenance needed because of: a) modification of the Product or Software without Masimo’s
written authorization; b) supplies, devices or electrical work external to the Product or not
manufactured by Masimo; c) disassembly or reassembly of the Product by anyone but an
authorized Masimo agent; d) use of the Product with sensors or other accessories other than
those manufactured and distributed by Masimo; e) use of the Product and Software in ways or in
environments for which they are not labeled; and f) neglect, misuse, improper operation, accident,
fire, water, vandalism, weather, war, or any act of God. This warranty does not extend to any
Product that has been reprocessed, reconditioned or recycled.
This warranty also does not apply to any Products provided to Purchaser for testing or
demonstration purposes, any temporary Products modules or any Products for which Seller does
not otherwise receive a usage or purchase fee; all such Products are provided AS-IS without
warranty.
THIS WARRANTY, TOGETHER WITH ANY OTHER EXPRESS WRITTEN WARRANTY THAT
MAY BE ISSUED BY MASIMO IS THE SOLE AND EXCLUSIVE WARRANTY AS TO THE
PRODUCT AND SOFTWARE. THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY ORAL OR
IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. MASIMO SHALL NOT
BE LIABLE FOR ANY INCIDENTAL, SPECIAL OR CONSEQUENTIAL LOSS, DAMAGE OR
EXPENSE DIRECTLY OR INDIRECTLY ARISING FROM THE USE OR LOSS OF USE OF
ANY PRODUCTS OR SOFTWARE. IN NO EVENT SHALL MASIMO’S LIABILITY ARISING
FROM ANY PRODUCT AND SOFTWARE (UNDER CONTRACT, WARRANTY, TORT, STRICT
LIABILITY OR OTHER CLAIM) EXCEED THE AMOUNT PAID BY PURCHASER FOR THE
Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter 9-5
9
service / maintenance
PRODUCTS GIVING RISE TO SUCH CLAIM. THE LIMITATIONS IN THIS SECTION SHALL NOT
BE DEEMED TO PRECLUDE ANY LIABILITY THAT CANNOT LEGALLY BE DISCLAIMED BY
CONTRACT.
End-User License
Grant of License: In consideration of payment of the Software license fee, which is part of 1.
the price paid for the Product, Masimo grants to Purchaser a nonexclusive, nontransferable
(except as set forth below) license (“License”), without right to sublicense, to use the copy
of the Software in connection with Purchaser’s use of the Product for its labeled purpose
as set forth in these directions for use. Masimo reserves all rights not expressly granted to
Purchaser.
Ownership of Software: The Software is licensed not sold; all rights and interests in the 2.
Software and all copies thereof remain at all times vested in Masimo, and do not pass to
Purchaser. Any references in this Agreement to the purchase or sale of the Software shall be
deemed the purchase or sale of a Software License as set forth herein.
This software is proprietary and owned by Masimo or its third party suppliers and can be 3.
used solely in connection with the monitor described herein.
Restrictions
Copyright Restrictions: The Software and the accompanying written materials are copyrighted. 1.
Unauthorized copying of the Software, including Software that has been modified, merged,
or included with other software, or the written materials is expressly forbidden. Purchaser
may be held legally responsible for any copyright infringement that is caused or incurred by
Purchaser’s failure to abide by the terms of this Agreement. Nothing in this License provides
any rights beyond those provided by 17 U.S.C. §117.
Use Restrictions: Purchaser may physically transfer the Product from one location to 2.
another provided that the Software is not copied. Purchaser may not electronically transfer
the Software from the Product to any other device. Purchaser may not disclose, publish,
translate, release, distribute copies of, modify, adapt, translate, reverse engineer, decompile,
disassemble, or create derivative works based on the Software or the written materials.
Transfer Restrictions: In no event may Purchaser transfer, assign, rent, lease, sell, or 3.
otherwise dispose of the Product or the Software on a temporary basis. Purchaser shall
not assign or transfer this License, in whole or in part, by operation of law or otherwise
without Masimo's prior written consent; except that the Software and all of Purchaser’s rights
hereunder shall transfer automatically to any party that legally acquires title to the Product
with which this Software is included. Any attempt to assign any rights, duties or obligations
arising hereunder other than as set forth in this paragraph shall be void.
U.S. Government Rights: If Purchaser is acquiring Software (including the related 4.
documentation) on behalf of any part of the United State Government, the following
provisions apply: the Software and documentation are deemed to be “commercial software”
and “commercial computer software documentation,” respectively pursuant to DFAR
Section 227.7202 FAR 12.212, as applicable. Any use, modification, reproduction, release,
performance, display or disclosure of the Software (including the related documentation) by
the U.S. Government or any of its agencies shall be governed solely by the terms of this
9-6 Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter
Agreement and shall be prohibited except to the extent expressly permitted by the terms of
this Agreement.
No Implied License
Possession or purchase of this device does not convey any express or implied license to use the
device with unauthorized sensors or cables that would, alone, or in combination with the device,
fall within the scope of one or more of the patents relating thereto. BY ACCEPTANCE OR USE OF
THIS DEVICE, YOU ACKNOWLEDGE YOUR ACCEPTANCE OF THESE TERMS.
Sensors Licensed for Monitoring Use Only
Sensors designated for monitoring only are licensed to you under patents owned by Masimo
to be used for patient monitoring, in an unmodified form as originally received from Masimo,
and no license is granted to have Masimo’s sensors reprocessed or otherwise modified, unless
specifically authorized by Masimo. There is no license, implied or otherwise, that would allow use
of licensed sensors beyond their intended duration. After use of sensors through their designated
duration, there is no further license granted by Masimo to use the sensors and the sensors must
be discarded or returned to Masimo for reprocessing.
9
Additional typefaces for this product can be obtained at www.fonts.com
Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter 9-7
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Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter
www.masimo.com
33492/5621C-0210
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