Cercacor Laboratories PRONTO7 User Manual
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
Loading...