Masimo Radical Signal Extraction Operator`s manual

with color display
signal extraction pulse co-oximeter
with Rainbow Technology
OPERATOR’S MANUAL
with color display
Signal Extraction Pulse CO-Oximeter
OPERATOR’S MANUAL
The Radical-7 Pulse CO-Oximeter Operating Instructions provide the necessary information for
proper operation of all models of the Radical-7 Pulse CO-Oximetry system. There may be information provided in this manual that is not relevant for your system.
General knowledge of pulse oximetry and an understanding of the features and functions of the
Radical-7 Pulse CO-Oximeter are a prerequisite for its proper use.
Do not operate the Radical-7 Pulse CO-Oximeter without completely reading and understanding the
instructions in this manual.
If a Radical-7 unit has been upgraded to include the latest available parameters by utilizing the
upgrade tool (sold separately), please discontinue using the previous Radical-7 manual and use the
new manual provided.
NOTICE:
Purchase or possession of this device does not carry any express or implied license to use this
device with replacement parts which would, alone or in combination with this device, fall within the
scope of one of the patents relating to this device.
CAUTION:
Federal law (U.S.) restricts this device to sale by or on the order of a physician.
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
30175 Hannover, Germany
Tel.: +49-511-62 62 86 30
Fax.: +49-511-62 62 86 33
MEDICAL ELECTRICAL EQUIPMENT WITH RESPECT TO ELECTRIC SHOCK,
FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 606011/CAN/CSA C22.2 No. 601.1
Covered by one or more of the following U.S. Patents: RE38,492, RE38,476, 6,850,787, 6,826,419,
6,816,741, 6,699,194, 6,684,090, 6,658,276, 6,654,624, 6,650,917, 6,643,530, 6,606,511, 6,584,336,
6,580,086, 6,501,975, 6,463,311, 6,430,525, 6,397,091, 6,360,114, 6,263,222, 6,236,872, 6,229,856,
6,206,830, 6,157,850, 6,067,462, 6,011,986, 6,002,952, 5,919,134, 5,823,950, 5,769,785, 5,758,644,
5,685,299, 5,632,272, 5,490,505, 5,482,036, international equivalents, or one or more of the patents
referenced at www.masimo.com/patents. Products containing Satshare® feature are also covered by
U.S. Patent 6,770,028. Other patents pending.
© 2007 Masimo Corporation. Masimo, Discrete Saturation Transform, DST, DCI, FastSat, Satshare,
SET, Radical logo, Signal IQ, LNOP and LNCS are federally registered trademarks of Masimo
Corporation. Rainbow and SpCO are federally registered trademarks of Masimo Laboratories.
Radical-7, RadNet, RadicalScreen, LNOPv and APOD are trademarks of Masimo Corporation.
SpMet and Signal Extraction Pulse CO-Oximeter are trademarks of Masimo Laboratories.
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
i
table of contents
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES
The Radical-7 Signal Extraction Pulse CO-Oximeter is designed to minimize the possibility of hazards from errors in the software program by following sound engineering
design processes, Risk Analysis and Software Validation.
■
For home use, ensure that the Pulse CO-Oximeter’s alarm can be heard from
other rooms in the house especially when noisy appliances such as vacuum
cleaners, dishwashers, clothes dryers, televisions, or radios are operating.
■
Always remove the sensor from the patient and completely disconnect the patient
from the Pulse CO-Oximeter before bathing the patient.
■
Do not place the Pulse CO-Oximeter where the controls can be changed by the
patient.
■
Explosion hazard. Do not use the Pulse CO-Oximeter in the presence of flammable anesthetics or other flammable substance in combination with air, oxygenenriched environments, or nitrous oxide.
■
High intensity extreme lights (such as pulsating strobe lights) directed on the sensor,
may not allow the Pulse CO-Oximeter to obtain vital sign readings.
■
The Pulse CO-Oximeter is NOT intended for use as an apnea monitor.
■
■
The Pulse CO-Oximeter should be considered an early warning device. As a
trend towards patient hypoxemia is indicated, blood samples should be analyzed
by laboratory instruments to completely understand the patient’s condition.
Do not place the Pulse CO-Oximeter face against a surface. This will cause the
alarm to be muffled.
■
Do not place the Pulse CO-Oximeter on electrical equipment that may affect the
Pulse CO-Oximeter, preventing it from working properly.
■
The Pulse CO-Oximeter is to be operated by qualified personnel only. This manual, accessory directions for use, all precautionary information, and specifications
should be read before use.
■
Do not expose the Pulse CO-Oximeter to excessive moisture such as direct
exposure to rain. Excessive moisture can cause the Pulse CO-Oximeter to perform inaccurately or fail.
■
Electric shock hazard. Do not open the Pulse CO-Oximeter cover except to
replace the battery of the Handheld unit. Only a qualified operator may perform
maintenance procedures specifically described in this manual. Refer servicing to
Masimo for repair of this equipment.
■
Do not place containers with liquids on or near the Pulse CO-Oximeter. Liquids
spilled on the Pulse CO-Oximeter may cause it to perform inaccurately or fail.
■
Failure of Operation - If the Pulse CO-Oximeter fails any part of the setup procedures or leakage tests, remove the Pulse CO-Oximeter from operation until qualified service personnel have corrected the situation.
■
Patient Safety - If a sensor is damaged in any way, discontinue use immediately.
■
Disposal of product - Comply with local laws in the disposal of the unit and/or its
accessories.
■
The Pulse CO-Oximeter can be used during defibrillation, but the readings may
be inaccurate for up to 20 seconds.
■
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. These
limits are designed to provide reasonable protection against harmful interference in a typical medical 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 other devices in the vicinity.
However, there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to other devices,
which can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the following
measures:
■
As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.
■
Do not place the Pulse CO-Oximeter or accessories in any position that might
cause it to fall on the patient. Do not lift the Pulse CO-Oximeter by the power
cord or any other cable.
■
Interfering Substances: SpO2 is a functional calculation of arterial oxygen saturation. Carboxyhemoglobin and Methemoglobin may erroneously increase SpO2
readings. The level of increase is approximately equal to the amount of carboxyhemoglobin and/or methemoglobin that is present. Dyes, or any substance
containing dyes, that change usual blood pigmentation may cause erroneous
readings.
■
Elevated levels of Methemoglobin (MetHb) will lead to inaccurate SpO2 measurements.
■
Elevated levels of Carboxyhemoglobin (COHb) will lead to inaccurate SpO2 measurements.
■
Severe anemia may cause erroneous SpO2 readings.
■
Do not use the Pulse CO-Oximeter or oximetry sensors during magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns.
The Pulse CO-Oximeter may affect the MRI image, and the MRI unit may affect
the accuracy of the oximetry measurements.
■
ii
table of contents
If using Pulse CO-Oximetry during full body irradiation, keep the sensor out of
the irradiation field. If the sensor is exposed to the irradiation, the reading might
be inaccurate or the unit might read zero for the duration of the active irradiation
period.
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
■
■
Reorient or relocate the receiving device.
■
Increase the separation between the equipment.
■
Connect the equipment into an outlet on a circuit different from that to which
the other device(s) are connected.
■
Consult the manufacturer for help.
A functional tester cannot be utilized to assess the accuracy of the Pulse COOximeter or any sensors.
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
iii
table of contents
SECTION 1 - OVERVIEW
About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Warnings, Cautions and Notes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Features and Benefits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Indications for use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Pulse CO-Oximetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SpO2 General Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SpCO General Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SpMet General Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Principle of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Functional vs. Fractional Saturation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Measured vs. Calculated Saturation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Masimo SET Signal Extraction Technology for SpO2 Measurements . . . . . . . . . . .
SpCO and SpMet Measurements During Patient Motion . . . . . . . . . . . . . . . . . . . . .
Masimo SET Parallel Engines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Masimo SET DST ® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1-1
1-2
1-3
1-3
1-3
1-4
1-4
1-4
1-4
1-5
1-6
1-6
1-6
1-6
1-7
1-7
SECTION 2 - SYSTEM DESCRIPTION
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Radical-7 Pulse CO-Oximeter Handheld . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Handheld Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Main Screen Trend Graph Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Handheld Back Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Radical-7 Pulse CO-Oximeter Standalone. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Standalone Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Standalone Back Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Radical-7 Monitor Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
SECTION 3 - SETUP
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Unpacking and Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Preparation for Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Radical-7 Docking Station Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . .
Initial Battery Charging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Initial Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Monitor Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Factory Default Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Custom (User) Defined Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Adult/Neo (Hospital Defined) Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Satshare Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SatShare Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Philips VueLink Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Spacelabs Universal Flexport Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
RadNet Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
iv
3-1
3-1
3-1
3-1
3-2
3-2
3-3
3-3
3-3
3-4
3-4
3-5
3-6
3-7
3-7
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
table of contents
SECTION 4 - OPERATION
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Basic Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
General Setup and Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Successful Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Numeric Display - SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Masimo Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Numeric Display - Pulse Rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Numeric Display - SpCO. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Numeric Display - SpMet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Numeric Display - PI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Signal IQ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Low Perfusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Actions To Be Taken . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Touch Key Control Button and Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Traditional User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
First Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Second Page. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Simplified User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
First Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Second Page. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Navigating the Main Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Main Menu Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Menu Categories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Editing a Parameter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Menu Tree . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
Rotate Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18
Clock. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18
About . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19
Config . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19
3D Alarm System (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19
Output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20
Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22
Trend Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23
Navigating the Trend Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25
First Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25
Second Page. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25
Third Page. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25
Trend Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26
Histogram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-27
BacklightOperation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-28
Satshare Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-28
Home Mode Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30
Password Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
v
table of contents
SECTION 5 - ALARMS AND MESSAGES
System Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3D Alarm System Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3D Alarm System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Desat Index Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Perfusion Index (PI) Delta Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Desat Index Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
User Interaction to Implement Desat Index Alarm . . . . . . . . . . . . . . . . . . . . . . . . . .
Perfusion Index (PI) Delta Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
User Interaction to Implement PI Delta Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3D Alarm menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5-1
5-3
5-3
5-3
5-3
5-3
5-4
5-5
5-6
5-6
5-7
SECTION 6 - TROUBLESHOOTING
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
SECTION 7 - SPECIFICATIONS
Radical-7 specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Electrical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Environmental . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Serial interface specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Serial Interface Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Serial Printer Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analog Output / Nurse Call Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analog Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Nurse Call . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
table of contents
SECTION 9 - SERVICE AND MAINTENANCE
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Battery Operation and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Performance verification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Service and repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9
Repair Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9
Return Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10
Exclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10
End-user license agreement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10
SECTION 10 - ACCESSORIES
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
7-1
7-1
7-1
7-1
7-2
7-4
7-4
7-5
7-6
7-7
7-7
7-7
SECTION 8 - SENSORS & PATIENT CABLES
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Selecting a Masimo SET Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Sensor Application instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Masimo Rainbow Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Rainbow Reusable Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Rainbow Adhesive Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Masimo SpO2 Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Red Reusable Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
LNOP® Reusable Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
®
LNOP Adhesive Sensors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
TM
LNCS Reusable Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
TM
LNCS Adhesive Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
TM
LNOPv Adhesive Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Sensor Accuracy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
Cleaning And Reuse Of Masimo Reusable Sensors and Cables . . . . . . . . . . . . . . 8-6
Reattachment of Single Use Adhesive Sensors. . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
vi
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
vii
overview
1
About This Manual
This manual explains how to set up and use the Radical-7™ Pulse CO-Oximeter
containing Masimo Rainbow® SET® technology. Important safety information relating to
general use of the Pulse CO-Oximeter 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 monitor.
In addition to the safety section, this manual includes the following sections:
SECTION 1
OVERVIEW gives a general description of Radical-7 Pulse COOximeter.
SECTION 2
SYSTEM DESCRIPTION describes the Radical-7 Pulse COOximeter system and its functions and features.
SECTION 3
SETUP describes how to setup the Radical-7 Pulse CO-Oximeter
for use.
SECTION 4
OPERATION describes the operation of the Radical-7 Pulse COOximetry system.
SECTION 5
ALARMS AND MESSAGES describes the alarm system messages.
SECTION 6
TROUBLESHOOTING describes troubleshooting information.
SECTION 7
SPECIFICATIONS gives the detailed specifications of the
Radical-7 Pulse CO-Oximeter.
SECTION 8
SENSORS AND PATIENT CABLES outlines how to use and care
for Masimo Rainbow SET technology sensors, Masimo Rainbow
SET technology patient cables, Masimo Red sensors and
Masimo Red PC cables.
SECTION 9
SERVICE AND MAINTENANCE describes how to maintain, service and obtain repair for the Radical-7 Pulse CO-Oximeter.
SECTION 10
ACCESSORIES lists the available Radical-7 Pulse CO-Oximeter
accessories.
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
1-1
1
overview
overview
Warnings, Cautions and Notes
Product Description
Please read and follow any warnings, cautions and notes presented throughout this
manual. An explanation of these labels are as follows:
The Radical-7 Pulse CO-Oximeter is a noninvasive, arterial oxygen saturation and pulse
rate monitor. The Radical-7 Pulse CO-Oximeter can be used as either a Handheld or a
Standalone monitor. The Radical-7 Pulse CO-Oximeter features a backlit Liquid Crystal
Display (LCD) that continuously displays numeric values for SpO2, SpMet™*, SpCO®*,
pulse rate, Perfusion Index (PI). It also provides graphical displays for plethysmographic
waveform and Signal Identification and Quality Indicator (Signal IQ®). The Radical-7
Pulse CO-Oximeter can be used to interface with a multiparameter patient monitor to
provide only Masimo SET SpO2 information to that monitor for display.
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 gray shaded box.
Sample of Warning:
WARNING: THIS IS A SAMPLE OF A WARNING STATEMENT.
FEATURES AND BENEFITS
These features are common to the Radical-7 family:
■
■
A CAUTION is given when any special care is to be exercised by the patient or user to
avoid injury to the patient, damage to this device or damage to other property.
Sample of Caution:
CAUTION: THIS IS A SAMPLE OF A CAUTION STATEMENT.
A NOTE is provided when extra general information is applicable.
Sample of Note:
NOTE: This is a sample of a Note.
1
■
■
■
■
■
■
■
■
■
■
■
■
■
■
Clinically proven Masimo SET technology performance.
New Masimo rainbow SET technology uses multi-wavelengths of light to obtain
more physiological data.
Color display allows immediate differentiation of critical measurements.
Rainbow technology allows the most reliable Adaptive Probe Off Detection
(APOD™).
Quick Trend feature uses one-touch button access to parameter trending information.
Applicable for use on neonate, infant, pediatric and adult patients.
Proven for accurate monitoring in motion and low perfusion environments.
Universal application: Handheld, Standalone and Patient Monitor Interface.
Automatic upright display with RadicalScreenTM.
Signal IQ® for signal identification and quality indication.
Analog output and nurse call.
SpO2, SpMet*, SpCO*, pulse rate, perfusion index, 3D Alarm System*, alarm,
trend and pleth waveform (non-normalized) displays.
Lightweight design.
Internal batteries for transport:
Standalone -10 hours (optional)
Handheld - 4 hours
Serial output to printers and PCs
RadNetTM capability (only when used with a RadNetTM Ready Docking Station)
INDICATIONS FOR USE
The Radical-7 Pulse CO-Oximeter and accessories are indicated for the continuous,
noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2),
pulse rate (measured by an SpO2 sensor), carboxyhemoglobin percentage and
methemoglobin percentage (measured by a SpCO/SpMet sensor). The Radical-7 Pulse
CO-Oximeter and accessories are indicated for use with adult, pediatric and neonatal
patients during both motion and no motion conditions, and for patients who are well or
poorly perfused in hospitals, hospital-type facilities, mobile and home environments.
* Optional parameters
1-2
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
1-3
1
overview
Pulse CO-Oximetry
PRINCIPLE OF OPERATION
SpO2 GENERAL DESCRIPTION
Pulse CO-Oximetry is a continuous and non-invasive method of measuring the level of
arterial oxygen saturation in blood. The measurement is taken by placing a sensor on a
patient, usually on the fingertip for adults and the hand or foot for neonates. The sensor is
connected to the Pulse CO-Oximetry instrument with a patient cable. The sensor collects
signal data from the patient and sends it to the instrument. The instrument displays the
calculated data in three ways:
Pulse CO-Oximetry is governed by the following principles:
1. Oxyhemoglobin (oxygenated blood), deoxyhemoglobin (non-oxygenated blood) carboxyhemoglobin (blood with carbon monoxide content) and methemaglobin (blood
with oxidized hemoglobin) species differ in their absorption of visible and infrared
light (using spectrophotometry, see figure below).
Absorption Spectra
8
2.
As a pulse rate (PR)
3.
As a plethysmographic waveform
The following figure shows the general monitoring setup.
SET
99
85
Sp0 2
140
50
BPM
3.0
0.3
6
50
5
SpCO
SpMet
Deoxyhemoglobin
4
2
0
600
1
Masimo rainbow
Carboxyhemoglobin
Oxyhemoglobin
Methemoglobin
As a percent value for arterial oxygen saturation (SpO2)
Absorption (mm-1)
1.
650
700
750
800
850
900
950
1000
PI
10/11/06
Signal Extraction
12:23:11am
Pulse CO-Oximeter
Wavelength (nm)
1. Instrument
2. Patient Cable
2
3. Sensor
3
SpCO GENERAL DESCRIPTION
Pulse CO-Oximetry is a continuous and non-invasive method of measuring the levels of
carbon monoxide concentration (SpCO) in arterial blood. It relies on the same principles
of pulse oximetry to make its SpCO measurement. The measurement is taken by placing
a sensor on a patient, usually on the fingertip for adults and the hand or foot for infants.
The sensor connects directly to the Pulse CO-Oximetry instrument 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 percentage value for the SpCO. The Radical-7
can be configured to be a combined SpO2 monitor with other available parameters.
SpMet GENERAL DESCRIPTION
Pulse CO-Oximetry is a continuous and non-invasive method of measuring the levels of
methemoglobin concentration (SpMet) in arterial blood. It relies on the same principles of
pulse oximetry to make its SpMet measurement. The measurement is taken by placing a
sensor on a patient, usually on the fingertip for adults and the hand or foot for infants. The
sensor connects directly to the Pulse CO-Oximetry instrument 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 percentage value for the SpMet. The Radical-7
can be configured to be a combined SpO2 monitor with other available parameters.
1-4
1
overview
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
2. The amount of arterial blood in tissue changes with your pulse (photoplethysography). Therefore, the amount of light absorbed by the varying quantities of arterial
blood changes as well.
The Radical-7 Pulse CO-Oximeter uses a multi-wavelength sensor to distinguish
between oxygenated blood, deoxygenated blood, blood with carbon monoxide content
and blood with oxidized hemoglobin. Signal data is obtained by passing various visible
and infrared lights (LED’s, 500 to 1000nm) through a capillary bed (for example, a
fingertip, a hand, a foot) 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 22mW. See figure below. The Radical-7 utilizes a sensor
with various light-emitting diodes (LEDs) that pass light through the site to a photodiode
(photodetector). The photodetector receives the light, converts it into an electronic
signal and sends it to the Radical-7 for calculation.
1
1. Light Emitting Diodes (LEDs)
2. Recessed Photo Detector
2
Once the Radical-7 receives the signal from the sensor, it utilizes Masimo Rainbow
SET signal extraction technology to calculate the patient’s functional oxygen saturation, fractional concentration of carboxyhemoglobin, methemoglobin and pulse rate.
The SpCO and SpMet measurements rely on a multiwavelength calibration equation to
estimate the percentage of carbon monoxide and oxidized hemoglobin in arterial blood.
The maximum of the skin surface temperature is measured at an ambient temperature
of less than 106º F (41º C). This is verified by Masimo sensor skin temperature test
procedures
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
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1
overview
FUNCTIONAL VS. FRACTIONAL SATURATION
The Radical-7 is calibrated to measure and display functional saturation (SpO2): the
amount of oxyhemoglobin expressed as a percentage of the hemoglobin that can
transport oxygen. The Radical-7 does not measure fractional saturation: oxygenated
hemoglobin expressed as a percentage of the four main hemoglobin species, i.e.,
oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin. To convert
fractional saturation to functional saturation, the fractional saturation measurements
must be converted according to:
Fractional saturation
x 100
Functional saturation =
100 - (% carboxyhemoglobin + % methemoglobin)
MEASURED VS. CALCULATED SATURATION
SpO2, SpCO and SpMet measurements that can be obtained from the Radical-7 are
commonly compared to invasive measurements obtained from blood gas samples.
When comparing invasive and noninvasive measurements and interpreting values, caution should be used, as the calculated values obtained from the blood gas sample may
differ from the SpO2, SpCO and SpMet measurements of the Pulse CO-Oximeter. In the
case of SpO2, different results are usually obtained from the arterial blood gas sample
if the calculated measurement is not appropriately corrected for the effects of variables
that shift the relationship between the partial pressure of oxygen (PO2) and saturation,
such as: pH, temperature, the partial pressure of carbon dioxide (PCO2), 2,3-DPG,
and fetal hemoglobin. In the case of SpCO and SpMet, in addition to the effects of
temperature and pH, different results are also expected if the oxygen saturation and/or
concentration of methemoglobin in the blood gas sample are abnormal (less than 90%
for arterial oxygen saturation, and greater than 1% for methemoglobin concentration).
As blood gas 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 core oxygen saturation and carboxyhemoglobin concentration of the patient are stable and not changing
over the period of time that the blood gas sample is taken.
1
overview
MASIMO SET PARALLEL ENGINES
R/IR
(Conventional
Pulse Oximetry)
R/IR
Digitized,
Filtered &
Normalized
Adaptive
Filter with
DST®
MEAS
CONF
Post
Processor
MEAS
CONF
MEAS
SSTTM
CONF
Confidence
Based
Arbitrator
Saturation
MEAS
Proprietary
Algorithm 4
CONF
MEAS
Proprietary
Algorithm 5
CONF
MASIMO SET DST ®
MASIMO SET SIGNAL EXTRACTION TECHNOLOGY FOR SpO2 MEASUREMENTS
Masimo Signal Extraction Technology’s signal processing differs from conventional
pulse oximeters. Conventional pulse oximeters assume that arterial blood is the only
blood moving (pulsating) in the measurement site. During patient motion, however, the
non-arterial blood also moves, causing conventional pulse oximeters to read low values,
because they cannot distinguish between the arterial and venous blood movement
(sometimes referred to as noise). Masimo SET pulse oximetry utilizes parallel engines
and adaptive digital filtering. Adaptive filters are powerful because they are able to
adapt to the varying physiologic signals and/or noise and separate them by looking at
the whole signal and breaking it down to its fundamental components. The Masimo SET
signal processing algorithm, Discrete Saturation Transform® (DST)®, reliably identifies
the noise, isolates it and, using adaptive filters, cancels it. It then reports the true arterial
oxygen saturation for display on the monitor.
SpCO AND SpMet MEASUREMENTS DURING PATIENT MOTION
The Radical-7 displays measurements of SpCO and SpMet during patient motion.
However, because of the changes in the physiological parameters such as blood volume,
arterial-venous coupling, etc. that occur during patient motion, the accuracy of such measurements are not reliable.
1-6
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
1-7
system description
2
Introduction
The Radical-7 provides the functionality of three instruments in one:
■ The Radical-7 is a fully featured Handheld Pulse CO-Oximeter.
■ The Radical-7 is a fully featured Standalone Pulse CO-Oximeter.
■ The Radical-7 interfaces to the SpO2 input module of multiparameter patient
monitors* to upgrade conventional pulse oximetry technology to Masimo SET
technology.
Masimo
rainbow
The Handheld portion of the Radical-7 contains the
majority of the Pulse CO-Oximeter features. All pulse
oximetry measurement information, as well as device status data is displayed on the Handheld LCD
screen. All user input is performed through the control buttons on the front panel. The sensor cable connector is located on the Radical-7 Handheld Pulse
CO-Oximeter.
The Handheld Pulse CO-Oximeter oximeter snaps
into the Radical Docking Station to provide a fully
featured standalone Pulse CO-Oximeter. The Docking Station connects to AC power for standalone
operation or charging of the Handheld. An optional
Docking Station battery is available. The standalone
Radical-7 features nurse call, analog output and interfaces to serial printers.
SET
97
--95
%SpO 2
76
140
50
BPM
3.00
1.65
20
PI
Signal Extraction
3.0
0.3
%SpMet
Pulse CO-Oximeter
50
5
%SpCO
APOD
FastSat
MAX
TREND
APOD
GRAPH
Masimo rainbow
SET
99
85
Sp0 2
140
50
BPM
3.0
0.3
50
5
SpCO
SpMet
PI
10/11/06
Signal Extraction
12:23:11am
r
Pulse CO-Oximete
Masimo rainbow
SET
99
85
Sp0 2
140
50
BPM
3.0
0.3
SpMet
50
5
SpCO
PI
10/11/06
Signal Extraction
Pulse CO-Oximeter
12:23:11am
Utilizing a SatShare® cable, the standalone
Radical-7 also interfaces with the SpO2 input of a validated multiparameter patient
monitor*, instantly upgrading the conventional pulse oximetry to Masimo SET pulse
oximetry. The SatShare cable attaches to
the back of the Radical Docking Station, and
SatShare cables are available to interface
with most multiparameter patient monitors*.
CAUTION:
■ THE WAVEFORM DISPLAYED ON THE MULTIPARAMETER PATIENT MONITOR
IS A SIMULATED SIGNAL (NON-NORMALIZED). REFER TO THE RADICAL-7
PULSE CO-OXIMETER DISPLAY FOR PATIENT WAVEFORM.
■ IF DISPLAYING THE SIMULATED WAVEFORM IS NOT DESIRABLE, IT IS
RECOMMENDED TO TURN OFF THE PLETH WAVEFORM DISPLAY ON THE
MULTIPARAMETER MONITOR.
■ ONLY USE A SATSHARE CABLE THAT HAS A FERRITE BEAD INSTALLED.
■ SpCO AND SpMet CANNOT BE DISPLAYED ON THE MULTIPARAMETER
MONITOR WITH SATSHARE.
Refer to Section 3, SatShare Setup and Section 4, SatShare Operation for additional
details.
*Contact Masimo for the latest list of SatShare validated multiparameter monitors.
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
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2
system description
Radical-7 Pulse CO-Oximeter
Handheld
system description
HANDHELD
RELEASE
BUTTON
1
The Handheld Radical-7 Pulse CO-Oximeter provides most of the functionality of the Pulse
CO-Oximeter. All user input and displays are controlled by this part of the Radical-7 Pulse
CO-Oximeter system. The sensor cable connects into the connector on the Handheld unit.
The Handheld is battery powered and can be used either as a transport monitor or as a
Handheld Pulse CO-Oximeter for spot checks.
2
97
HANDHELD FRONT PANEL
The following figure and corresponding text outline all the features of the Handheld Radical7 Pulse CO-Oximeter:
Pleth + Signal IQ View
3
1
3
2
4
6
5
9
8
12
11
13
14
15
16
17
Masimo
rainbow
SET
99
Masimo rainbow SET
4
Sensor Off
Philips VueLink
99
85
Sp0 2
FastSat
50
5
3.0
0.3
SpMet
140
50
BPM
85
SpCO
PI
APOD
10/11/06
5
12:23:11am
Signal Extraction Pulse CO-Oximeter
27
26
25
24
APOD
22
23
21
20
19
18
Numbers View
6
4
2
27
28
1.65
25
3.0
Masimo rainbow SET
Sensor Off
7
Philips VueLink
140
50
BPM
99
85
Sp0 2
0.3
50
5
3.0
0.3
SpMet
SpCO
FastSat
APOD
8
PI
10/11/06
Sensor Off
9
2-2
7
10
MASIMO
RAINBOW SET
SATURATION
ALARM LIMITS
DISPLAY
9
21
23
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
20
Press down the Handheld Release Button and pull the
Handheld device off the Docking Station.
The functional arterial hemoglobin oxygen saturation is
displayed in units of percentage SpO2. The upper and lower
SpO2 alarm limits are also displayed next to the SpO2 measurement. When a sensor is not connected to a patient and
during pulse search, the display will show dashed lines and
the message Sensor Off will appear at the top of the display
screen. When the measured value is outside of the alarm
limits, the SpO2 Measurement Display flashes and an alarm
will sound. The oxygen saturation is calculated and the display is updated at a frequency of once per second.
The Masimo Rainbow SET label is shown on the Radical-7
display when SET processing is active.
NOTE: Patient information, not Masimo SET will be displayed when using a RadNet compatible unit connected to a
RadNet central station.
The Saturation Alarm Limits Display shows the upper and
lower saturation alarm limits. When an alarm limit is exceeded, the SpO2 value and the violated limit flashes.
The alarm status indicator (a bell) can be shown with or
without a slash. It flashes when an alarm condition is present.
When the alarm is silenced using the Alarm Silence Button,
ALARM STATUS an alarm status indicator with a slash and a timer is shown
to indicate that the alarm is temporarily silenced. When the
INDICATOR
alarm is silenced through the All Mute menu selection (which is
permanent until power is cycled or deselected using the menu)
an alarm status indicator with a slash is shown to indicate that
alarm has been silenced.
The measurement of methemoglobin concentration levels
is displayed in units of percentage SpMet. The upper and
lower SpMet alarm limits are also displayed next to the
SpMet measurement. When a sensor is not connected to
SpMet*
MEASUREMENT a patient and during pulse search, the display will show
DISPLAY
dashed lines and the message Sensor Off will appear at
the top of the display screen. The methemoglobin is calculated and the display is updated at a frequency of once per
second.
The SpMet Alarm Limits Display shows the upper and lower
SpMet ALARM
alarm limits. When the measured value is outside of the
LIMITS DISPLAY alarm limits, the SpMet measurement display flashes and
an alarm will sound.
The system messages generated by the instrument are disSYSTEM
played in the System Message Area. See Section 5, System
MESSAGE AREA messages.
12:23:11am
Signal Extraction Pulse CO-Oximeter
6
SpO2
MEASUREMENT
DISPLAY
2
SpCO*
MEASUREMENT
DISPLAY
The measurement of carbon monoxide concentration levels
is displayed in units of percentage SpCO. When a sensor
is not connected to a patient and during pulse search, the
display will show dashed lines and the message Sensor Off
will appear at the top of the display screen. The carboxyhemoglobin is calculated and the display is updated at a
frequency of once per second.
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
2-3
2
system description
The SpCO Alarm Limits Display shows the upper and lower
alarm limits. When the measured value is outside of the
alarm limits, the SpCO measurement display flashes and an
alarm will sound
The Pulse Waveform Display shows the acquired plethysmoPULSE
graph waveform. The pleth waveform is scaled with signal
WAVEFORM
strength. Signal strength is defined as the relation of arterial
DISPLAY
pulsatile signal to the non-pulsatile signal component.
The Battery Status Indicators show the capacity of the
Radical-7 Handheld and optional Docking Station batterBATTERY
ies. The indicator flashes when less than 15 minutes of batSTATUS
tery life is left and the battery needs to be recharged. The
INDICATORS
Docking Station Battery Status indicator is not shown when
the optional Docking Station battery is not present.
TOUCH KEY
Press a Touch Key Control Button to select the correspondCONTROL
ing touch key icon. See Section 4, Touch Key Control
BUTTONS
Buttons and Icons for more details.
Press the Backlight Button to change the illumination level
of the backlight. With the AC line power connected, four
levels of illumination are available (in addition to the no
BACKLIGHT
illumination level). In the Handheld mode, three levels of
BUTTON
illumination are available (again in addition to the no illumination level). Use the lowest illumination for most efficient
battery usage.
Press the Alarm Silence Button to temporarily silence
patient and low battery alarms. Press the Alarm Silence
Button when the SENSOR OFF message is flashing (i.e.
the sensor is removed from the patient) to acknowledge
the end of monitoring. In this state, all further alarms are
ALARM SILENCE suspended until the Pulse CO-Oximeter starts measuring
BUTTON
SpO2, SpMet, SpCO and pulse rate again.
50
10
SpCO ALARM
LIMITS DISPLAY
5
11
12
13
14
15
16
SPEAKER
17
PATIENT CABLE
CONNECTOR
18
POWER/ON/OFF
BUTTON
19
20
2-4
MAX
TREND
APOD
GRAPH
10/11/06 12:23:11am
TOUCH KEY
ICONS
TIME AND DATE
INDICATOR
Note: System failure alarms can be silenced by pressing
the Power/Standby or Alarm Silence Button. If the Power/
Standby Button does not silence the system fault alarm,
press the Alarm Silence Button
The speaker indicates audio alarms. Care should be taken
not to cover the speaker and muffle the audible alarm
volume.
Connect a patient cable or a direct cable sensor into the
Handheld Radical-7 by plugging the cable into the Patient
Cable Connector. Use only Masimo compatible sensors
and cables with this oximeter. See Section 8, Sensors and
Patient Cables for more details.
Press the Power/On/Off Button to turn the instrument on.
Press, hold the button for more than 2 seconds and then
release the button to turn the instrument off.
The Touch Key Icons indicate the software menu items that
can be selected through the Touch Key Control Buttons.
Pressing a Touch Key Control Button next to an icon selects
the option.
The Time and Date Indicator displays the current time and
date. The time is displayed in 12 or 24 hour format. The date
is displayed in dd/mm/yy or mm/dd/yy format. Select the
date and time display formats in the Clock menu.
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
system description
21
SIGNAL IQ
The Signal IQ shows the acquired signal quality and the
timing of the pulse. A tall vertical line indicates a high quality signal, while a small vertical line indicates a low quality
signal. The Signal IQ may will be displayed as a single,
pulsating bar in the Numbers mode.
22
BRIGHTNESS
LEVEL
The Brightness level icon displays when utilizing the
Backlight/Contrast button.
The Perfusion Index indicates numerically the percentage of
pulsatile signal to non-pulsatile signal (pulse strength).
23
3.00
PI
PERFUSION
INDEX
24
APOD
SENSITIVITY
25
26
140
50
FastSat
27
76
28
Philips VueLink
PULSE RATE
ALARM LIMITS
DISPLAY
FASTSAT
2
The MAX or APOD™ sensitivity icon is shown on the
Radical-7 display to indicate if the Radical-7 is set to operate in Normal sensitivity, Maximum sensitivity or Adaptive
Probe Off Detection mode
The Pulse Rate Alarm Limits Display shows the upper
and lower pulse rate alarm limits. When an alarm limit is
reached or exceeded, the pulse rate value and the violated
limit flashes.
The FastSat® label is shown on the Radical-7 display whenever the Radical-7 is set to operate in the FastSat mode.
PULSE RATE
The Pulse Rate Measurement Display shows the patient’s
pulse rate in beats per minute. The upper and lower pulse
rate alarm limits are also displayed next to the pulse rate
measurement. The pulse rate is calculated and the display
is updated at a frequency of once per second.
SERIAL
OUTPUT MODE
The Serial Output Mode displays the selected output interface
when interfaced with the Docking Station. and connected to the
serial port with the selected Satshare cable.
* For instruments that include SpMet and SpCO parameters: the SpMet and SpCO
parameters will be grayed out in the display screen if a patient cable is not attached or a
non-Rainbow sensor is being used.
NOTE: The Pulse CO-Oximeter display view will be different without the optional SpCO
and SpMet options.
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
2-5
2
Masimo rainbow SET
99
85
Sp0 2
140
50
BPM
1 Hr
50
5
3.0
0.3
SpMet
1251 0000 536
1
HANDHELD BACK PANEL
The Handheld back panel features the interconnection to the Docking Station, an accessory
mount for the pole clamp accessory and access to the Handheld battery pack.
11328/2269M-0805
MAIN SCREEN TREND GRAPH DISPLAY
The Radical-7 Pulse CO-Oximeter provides a Trend Graph display function which allows the
user to quickly check the trend of each parameter by allowing to step through and selecting
the desired parameter. This is done by repeatedly pressing down on the Trend Graph control
button. Once the parameter is selected, the numeric value is highlighted and the selected
parameter is displayed above the trend graph.
2
system description
Covered by one or more of the following U.S. Patents: RE38,492,
RE38,476, 6,850,787, 6,826,419,
6,816,741, 6,699,194,
6,684,090, 6,658,276, 6,654,624, 6,650,917, 6,643,530,
6,606,511, 6,584,336, 6,501,975, 6,463,311, 6,430,525,
6,360,114, 6,263,222, 6,236,872, 6,229,856, 6,206,830,
6,157,850, 6,067,462, 6,011,986, 6,002,952, 5,919,134,
5,823,950, 5,769,785, 5,758,644, 5,685,299, 5,632,272,
5,490,505, 5,482,036, international equivalents, or one or more
of the patents referenced at www.masimo.com/patents.
Products containing Satshare® feature are also covered by
U.S. Patent 6,770,028. Other patents pending.
system description
MEDICAL ELECTRICAL EQUIPMENT
UL 2601-1/CAN/CSA C22.2 No. 601.1
80FK
2
SpCO
PI
Trend
88
95
1
97
2
3
100
50
10/11/06
12:23:11am
1
DOCKING
STATION
CONNECTOR
The Radical-7 Handheld interfaces with the Docking Station
through this connector.
2
POLE CLAMP
ACCESSORY
HOLDER
The optional Pole Clamp accessory attaches to this holder.
See the Directions for Use of the Pole Clamp accessories
for attachment instructions.
3
BATTERY PACK
The Radical-7 Handheld is powered by a NiMH battery
located in this compartment. For battery care and replacement please see Section 9, Replacing the Batteries.
Signal Extraction Pulse CO-Oximeter
5
2-6
4
3
1
The first top line of the trend graph display shows the time scale of the trend graph
followed by the selected parameter. The parameter’s numeric value is highlighted.
2
The second top line of trend graph display shows the minimum, average and maximum measurement of the selected parameter contained in the displayed data set
(excluding zero measurements).
3
The Trend Graph control button initates the trend graph display. Repeatedly pressing down on the button will step through each parameter, highlighting the numeric
value and displaying the parameter above the trend graph.
4
The lines on the trend graph indicate the minimum and maximum values of the
parameter.
5
The trend graph shows the desired parameter measurements displayed versus
time and the accuracy range
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
2-7
2
system description
Radical-7 Pulse CO-Oximeter
Standalone
When the Radical-7 Pulse CO-Oximeter Handheld is placed into the Docking Station, the
Radical-7 Pulse CO-Oximeter becomes a full-featured standalone device. The Radical-7
Pulse CO-Oximeter Standalone acts as a battery charger for the Handheld device and has
AC power connection capabilities. If the mains supply is temporarily interrupted, then the
battery in the Handheld device will allow continuous operation. The Standalone can also
interface to serial devices, nurse call or analog output devices, and multiparameter patient
monitors through a SatShare cable.
system description
STANDALONE FRONT PANEL
The following figure and corresponding text review the features of the Radical-7 Standalone
device.
Masimo rainbow SET
1
99
85
Sp0 2
2
140
50
BPM
3
50
5
3.0
0.3
SpMet
SpCO
PI
4
10/11/06
There are several models of Docking Stations available. The following table outlines which
features are available for each model of Docking Station.
DOCKING STATION FEATURES
RDS-1
RDS-1B
RDS-2
SatShare Interface
Serial RS-232 Interface
Nurse Call/Analog Output Interface
Automatic Display Rotation Support (Gravity Detector)
Docking Station Battery Charging Indicator
Handheld Battery Charging Indicator
Visual Alarm Indicator
1
DOCKING
STATION
BATTERY
CHARGING
INDICATOR
The Docking Station Battery Charging Indicator is illuminated when the Docking Station battery is charging.
The indicator blinks just prior to charging. The charging
indicator does not illuminate when the battery is fully
charged or when the battery is not present.
2
HANDHELD
BATTERY
CHARGING
INDICATOR
The Handheld Battery Charging Indicator is illuminated
when the Handheld battery is charging. The indicator
blinks just prior to charging. The Charging Indicator does
not illuminate when the battery is fully charged or when
the battery is not present.
3
VISUAL
ALARM
INDICATOR
The Visual Alarm Indicator is illuminated when an alarm
condition is active and the Alarm Status Indicator is
shown.
AC Power Indicator
Docking Indicator
Handheld Battery Deep Discharge Support
4
AC POWER
INDICATOR
The AC Power Indicator is illuminated when the Radical7 Docking Station is plugged into AC line power.
Docking Station Battery Deep Discharge Support
5
DOCKING
INDICATOR
The Docking Indicator is illuminated when the Handheld
unit is turned on and is properly interfaced to a Docking
Station.
The RDS-1 and RDS-3 are optionally available with RadNet capability. (Refer to Section 3
RadNet Setup for details)
2-8
Signal Extraction Pulse CO-Oximeter
12:23:11am
5
RDS-3
AC Power Input
10-hour Extended Battery
2
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
NOTE: When the Radical-7 Pulse CO-Oximeter Standalone is turned on, all indicator
LEDs initially turn on and off at start up.
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
2-9
2
system description
STANDALONE BACK PANEL
1
2
SYMBOLS
The following symbols are found on the back of the Radical-7 Pulse CO-Oximeter Docking
Station or packaging and are defined below:
3
2
system description
NOTE: Some of the interfaces and symbols are not available in all versions of the
Docking Station.
P1
P2
P3
SYMBOLS
MEDICAL ELECTRICAL EQUIPMENT
UL 60601-1/CAN/CSA C22.2 No. 601.1
80FK
Rx Only
DEFINITION
RS-232
Manufactured by:
Masimo Corporation
Irvine, CA 92618 USA
Made in USA
SatShare Interface
Covered by one or more of the following U.S. Patents: RE38,492, RE38,476,
6,850,787, 6,826,419, 6,816,741, 6,699,194, 6,684,090, 6,658,276, 6,654,624,
6,650,917, 6,643,530, 6,606,511, 6,584,336, 6,501,975, 6,463,311, 6,430,525,
6,360,114, 6,263,222, 6,236,872, 6,229,856, 6,206,830, 6,157,850, 6,067,462,
6,011,986, 6,002,952, 5,919,134, 5,823,950, 5,769,785, 5,758,644, 5,685,299,
5,632,272, 5,490,505, 5,482,036, international equivalents, or one or more of the
patents referenced at www.masimo.com/patents. Products containing Satshare®
Equipotential Ground Terminal
5
See Instructions for Use
4
Fuse Replacement
1
2
3
4
SERIAL OUTPUT
CONNECTOR
ANALOG OUTPUT
/ NURSE CALL
CONNECTOR
Use the Analog Output Connector with a ferrite bead installed
to interface with an analog output device, such as a chart
recorder or nurse call system. All external device connections
to the Analog Output / Nurse Call Connector must be IEC60950 compliant.
SATSHARE CABLE
CONNECTOR
Use the SatShare Cable Connector to connect a SatShare cable
to the SpO2 input connector of a multiparameter patient monitor.
All external device connections to the SatShare Cable Connector
must be IEC-60601-1-1 compliant. SatShare cables are available to
interface with most major multiparameter patient monitors. Check the
label on the SatShare cable and the SatShare Directions for Use to
ensure that the correct cable is used for each type of patient monitor.
Refer to Section 10 - Accessories of this manual or the Masimo web
site at www.masimo.com for the latest SatShare cables and validated
instruments.
POWER ENTRY
MODULE
Analog Out Interface
Use the Serial Output Connector with a ferrite bead installed
to connect a serial device, including a serial printer, RadNet
Interface Module or PC, to the Radical-7 Pulse CO-Oximeter.
The data is provided in standard RS-232C format. See
Section 7, Serial Interface Specifications. All external
device connections to the Serial Output Connector must be
IEC-60950 compliant.
Nurse Call Interface
WEEE Compliant
Rx ONLY
Mark of Conformity to European Medical Device Directive
93/42/EEC
Federal law restricts this device to sale by or on the order of a
physician (USA audiences only)
Underwriter's Laboratories Inc. approved
5%-95% RH
+70 C
-40 C
+1060 hPa - +500 hPa
795 mmHg - 375 mmHg
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
The power entry module contains the input connector for AC
power and two fuses. The AC input provides power to the system from the AC line. Always connect the Pulse CO-Oximeter
to the mains power for continuous operation and/or battery
recharging.
NOTE: Use the power cord as the means to disconnect the
device from the mains power supply.
5
2-10
EQUIPOTENTIAL
GROUND
CONNECTOR
Use the Equipotential Ground Connector for grounding.
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
2-11
2
system description
setup
Radical-7 Monitor Interface
Introduction
In addition to being a full-featured Handheld and Standalone Pulse CO-Oximeter, the
Radical-7 Pulse CO-Oximeter’s unique SatShare interface links the Radical-7 Pulse COOximeter to most existing multiparameter patient monitors through the pulse oximetry
patient cable or SpO2 input connector.
Before the Radical-7 Pulse CO-Oximeter can be used in a clinical setting, it needs to be
inspected, properly setup and the batteries need to be fully charged.
3
Unpacking and Inspection
Remove the instrument from the shipping carton and examine it for signs of shipping damage. Check all materials against the packing list. Save all packing materials, invoice and bill
of lading. These may be required to process a claim with the carrier.
Masimo rainbow
SET
99
85
Sp0 2
140
50
BPM
3.0
0.3
SpMet
50
5
SpCO
PI
10/11/06
Signal Extraction
12:23:11am
Pulse CO-Oximeter
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.
Preparation for Monitoring
■
Upgrades any approved and validated monitor to Masimo SET performance by
using the calculated SpO2 and pulse rate determined by Radical-7 to simulate an
ideal waveform, which is sent to the validated multiparameter patient monitor.
■
Connects into the SpO2 patient cable or SpO2 input connector of the multiparameter
patient monitor.
Refer to Section 3, SatShare Setup and Section 4, SatShare Operation for additional details.
CAUTIONS:
■
2-12
THE WAVEFORM DISPLAYED ON THE MULTIPARAMETER PATIENT MONITOR
IS A SIMULATED SIGNAL (NON-NORMALIZED). REFER TO THE RADICAL-7
PULSE CO-OXIMETER DISPLAY FOR PATIENT WAVEFORM.
■
IF DISPLAYING THE SIMULATED WAVEFORM IS NOT DESIRABLE, IT IS
RECOMMENDED TO TURN OFF THE PLETH WAVEFORM DISPLAY ON THE
MULTIPARAMETER MONITOR
■
ONLY USE A SATSHARE CABLE THAT HAS A FERRITE BEAD INSTALLED.
■
SPCO AND SPMET CANNOT BE DISPLAYED ON THE MULTIPARAMETER
MONITOR WITH SATSHARE.
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
The following sections of the manual describe the preparation, set-up and initial installation of the Radical-7 Pulse CO-Oximeter.
RADICAL-7 DOCKING STATION POWER REQUIREMENTS
Always use a hospital grade, AC power cable to connect the Radical-7 Pulse COOximeter to an AC power source. Do not connect the Radical-7 Docking Station to an AC
outlet controlled by a switch because the power to the instrument may be inadvertently
be switched off.
Verify the AC power voltage and line frequency before use. Verify that the power source
can provide adequate power rating as indicated on the rear panel of the Radical-7 Docking
Station.
The Radical-7 Pulse CO-Oximeter is designed to operate on 100 to 240VAC, 47-63 Hz.
The device is rated at 55 VA max.
Connect a hospital grade power cable to the power entry module of the Radical-7 unit
(IEC-320 connector type at the unit). Connect the power cable to an AC power source.
Ensure that the unit is adequately powered by verifying that the AC power indicator on
the Docking Station is illuminated.
CAUTION:
■ DO NOT UNDER ANY CIRCUMSTANCES REMOVE THE GROUNDING CONDUCTOR FROM THE POWER PLUG.
■ DO NOT USE EXTENSION CORDS OR ADAPTERS OF ANY TYPE. THE POWER
CORD AND PLUG MUST BE INTACT AND UNDAMAGED.
■ USE THE POWER CORD AS THE MEANS TO DISCONNECT THE DEVICE FROM
THE MAINS POWER SUPPLY
■ IF THERE IS ANY DOUBT ABOUT THE INTEGRITY OF THE PROTECTIVE EARTH
CONDUCTOR ARRANGEMENT, OPERATE THE OXIMETER ON INTERNAL BATTERY POWER UNTIL THE AC POWER SUPPLY PROTECTIVE CONDUCTOR IS
FULLY FUNCTIONAL.
■ TO ENSURE PATIENT ELECTRICAL ISOLATION, CONNECT ONLY TO OTHER
EQUIPMENT WITH ELECTRICALLY ISOLATED CIRCUITS.
■ DO NOT CONNECT TO AN ELECTRICAL OUTLET CONTROLLED BY A WALL
SWITCH OR DIMMER.
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
3-1
3
setup
INITIAL BATTERY CHARGING
Before use, the Radical-7 Pulse CO-Oximeter Handheld battery and the optional
Docking Station battery needs to be fully charged.
Monitor Setup
To charge the batteries:
■
Factory – these options are restored to factory values
1.
Attach the Handheld unit to the Docking Station.
■
2.
Plug in the AC power cord to power entry module. Make sure it is securely plugged
in.
Custom – these settings can be changed by the user and retained through the
power cycle.
■
3.
Plug the AC power cord into an AC power source.
Adult / Neo – these settings can be selected to revert to factory or hospital-defined
values (for Adult or Neonatal) after a power cycle.
4.
Verify that the batteries are charging.
The battery charging LED indicators on the Docking Station flash prior to charging and
remain illuminated while the batteries are charging.
Refer to Section 9, Battery Operation and Maintenance, for proper battery charging.
INITIAL INSTALLATION
Place the Docking Station on a stable hard flat surface near the patient. Always place the
Radical-7 Pulse CO-Oximeter unit on a dry surface. Maintain a minimum of 3 cm (1 inch)
free space around the Radical-7 Pulse CO-Oximeter Standalone unit. Make sure that the
Radical-7 loudspeaker is not covered to avoid a muffled alarm sound.
The Radical-7 Pulse CO-Oximeter Handheld, Docking Station or Standalone should not
be operated outside the following environmental conditions:
OPERATING ENVIRONMENTAL CONDITIONS
The Radical-7 Pulse CO-Oximeter maintains three types of default values which will
automatically revert to after a power cycle:
The following outlines the default values the Radical-7 Pulse CO-Oximeter reverts to
after a power cycle.
FACTORY DEFAULT SETTINGS
OPTION
DEFAULT SETTING
LCD SCREEN ILLUMINATION
AC Power
Battery Power
Set to maximum, level 4
SENSITIVITY
Set to normal mode
Set to minimum, level 1
CUSTOM (USER) DEFINED SETTINGS
This mode is indicated by “Mode Custom” on the Alarms menu.
The following table outlines the settings that may be changed by the user and the Radical-7
Pulse CO-Oximeter will remember after a power cycle.
OPTION
DEFAULT SETTING
DISPLAY VIEW
Set to Pleth + SigIQ
AVERAGING TIME
Set to 8
FASTSAT
Set to No
HOME USE
Set to No
Configure the unit for your regional power line frequency (50 or 60 hz) if needed. Default is
60 hz (standard for the United States). See Section 4, Operation, Config.
INTERFACE ALARMS
Set to Yes
SATSHARE NUMBERS
Set to Yes
CAUTION: THE UNIT MUST BE CONFIGURED TO MATCH YOUR LOCAL POWER
LINE FREQUENCY TO ALLOW FOR THE CANCELLATION OF NOISE
INTRODUCED BY FLUORESCENT LIGHTS AND OTHER SOURCES.
POWER SAVE
Set to No
DATE FORMAT
Set to mm/dd/yy
TIME FORMAT
Set to 12 hr.
LANGUAGE
Set to English
ANALOG OUTPUT
Set to Analog 1: SpO2 0-100%
Set to Analog 2: Pulse Rate
SERIAL OUTPUT PORT MODE
Set to Binary
PULSE BEEP VOLUME
Set to Level 4
TREND DISPLAY PARAMETERS
Set to %SpO2
TEMPERATURE
3-2
3
setup
+5°C to +40°C, +41°F to +104°F
HUMIDITY
5% to 95%, non-condensing
OPERATING ALTITUDE
1060 mbar to 500 mbar pressure
-1000 ft to 18,000 ft (-304 m to 5,486 m)
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
3-3
3
setup
OPTION
DEFAULT SETTING
SATSHARE SETUP
TREND PERIOD
Set to 1 Hr.
1.
LOW SpO2 ALARM LIMIT
Set to 0
SpMet HIGH/LOW ALARM LIMIT
Set to High: 3.0/Low: ---
SpCO HIGH/LOW ALARM LIMIT
Set to High: 45/Low: ---
SMART TONE
Set to Yes
ADULT/NEO (HOSPITAL DEFINED) SETTINGS
The following table outlines settings that may be defined by the hospital. If enabled (via a
password protected screen, see Section 4 Password Operation), these settings will return
to pre defined values after a power cycle. This mode is indicated by “Mode Adult” or “Mode
Neo” on the Alarms menu. See Section 4, Operation for details on enabling and setting
these parameters.
OPTION
CUSTOM SETTING
(DEFAULT)
SPO2 HIGH/LOW ALARM
LIMIT
Set to High: ---/Low: 90
PULSE RATE HIGH/LOW
ALARM LIMIT
Set to High: 140/Low: 50 BPM
SpMet HIGH/LOW ALARM
LIMIT
Set to High: 3.0/Low: ---
SpCO HIGH/LOW ALARM
LIMIT
Set to High: 45/Low: ---
ALARM SILENCE
Set to 120 seconds
ALARM VOLUME
Set to 3
ALARM DELAY
Set to 5
Select the SatShare cable that is appropriate for the multiparameter monitor that
is being connected. Check the Masimo web site at www.masimo.com for the latest list of available SatShare cables and validated instruments.
Masimo rainbow
SET
99
85
Sp0 2
140
50
BPM
3.0
0.3
SpMet
50
5
SpCO
PI
10/11/06
Signal Extraction
12:23:11am
Pulse CO-Oximeter
ADULT / NEO SETTING
(PRE DEFINED)
2.
Connect the labeled end of the cable to the SatShare Cable Connector port on
the back of the Docking Station. Tighten the connector screws for a secure connection.
3.
Connect the other end of the SatShare cable either to the sensor connector of
the multiparameter monitor’s SpO2 cable or directly to the SpO2 connector on the
monitor.
4.
Verify that the Radical-7 Pulse CO-Oximeter recognizes the correct cable. The
name of the SatShare cable will be displayed on the LCD screen when the
SatShare mode is functional.
5.
Set the multiparameter monitor’s high and low saturation and pulse rate alarm
limits as appropriate.
6.
Set the multiparameter monitor’s averaging time to the lowest setting (i.e. fastest
response). The Radical-7 Pulse CO-Oximeter’s ideal waveform necessitates the
need for additional averaging by the monitor. If the multiparameter monitor’s averaging time is not changed, the time to display physiological changes in saturation
on the monitor will be increased with SatShare. However, the delay can be minimized by reducing the multiparameter monitor’s averaging time.
7.
While in the SatShare mode, if there are any significant discrepancies between
the readings from the Radical-7 Pulse CO-Oximeter and those on the monitor displaying the values obtained from SatShare, the values reported by the Radical-7
Pulse CO-Oximeter are to be considered the correct values.
8.
To use the Radical-7 Pulse CO-Oximeter with SatShare while it is not connected
to AC power, set the Power Save parameter in the General menu to “No” and
refer to Section 4-Operation. Please note that if the Radical-7 Pulse CO-Oximeter
is used in this mode, the length of time the Radical-7 Pulse CO-Oximeter can
operate on battery power will be significantly diminished.
Same settings
Satshare Setup
The Radical-7 Pulse CO-Oximeter has been proven to be accurate during patient motion
and low perfusion conditions. Saturation and pulse rate values from the Radical-7 Pulse
CO-Oximeter may be displayed on a multiparameter monitor through the SatShare feature.
The SatShare feature provides an ideal, simulated waveform corresponding to the measured saturation and pulse rate values determined by the Masimo SET technology. This
waveform may be used to display these values on multiparameter monitors through the
multiparameter monitor’s oximetry sensor or input connector.
It is recommended that the Radical-7 Pulse CO-Oximeter is positioned close to the multiparameter monitor with the Radical-7 Pulse CO-Oximeter screen visibly displaying the
plethysmographic waveform and the saturation and pulse rate measurements.
CAUTION: SIMULTANEOUS USE OF SATHSARE AND SERIAL PORT IS NOT
SUPPORTED.
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setup
9.
setup
Set the SatShare Numbers and the Interface Alarms parameters in the General
menu according to Customer preference.
1.
Select the Philips VueLink selection from the Output menu on the Radical-7 Pulse
CO-Oximeter. Refer to Section 4, Output.
10. If displaying the simulated waveform is not desirable, it is recommended to turn
off the pleth waveform display of the multiparameter patient monitor.
2.
Connect one end of the VueLink cable to the Serial Output connector on the back
of the Docking Station.
3.
Connect the other end of the VueLink cable to the VueLink module and insert the
module into the Philips monitor rack.
4.
The SpO2 and pulse rate values will automatically appear on the Philips monitor.
5.
In order for the pleth waveform to be displayed on the Philips monitor and for
the Philips monitor to indicate the alarm conditions measured by the Pulse
CO-Oximeter, the user must configure the Philips monitor. Refer to the Philips
Operator’s Manual for complete instructions.
6.
The Radical-7 can be set up to audibly indicate all patient alarms while communicating with the Philips VueLink module. Use the Interface Alarms setting in the
General menu to enable and disable audible alarms on the Radical-7.
SATSHARE SIGNALS ARE IDEAL SIMULATED WAVEFORMS CORRESPONDING TO THE CALCULATED SATURATION AND PULSE RATE VALUES AND DO
NOT CONTAIN ALL OF THE INFORMATION CONTAINED IN PHYSIOLOGICAL
WAVEFORMS. THE MULTIPARAMETER PATIENT MONITOR DECODES THESE
SIGNALS INTO SATURATION AND PULSE RATE VALUES.
DURING SATSHARE OPERATION, THE AUDIBLE ALARMS MAY BE MUTED
ON THE RADICAL-7 PULSE CO-OXIMETER. WHEN THE AUDIBLE ALARM IS
MUTED (INDICATED BY THE BELL WITH A SLASH THROUGH IT) ON THE
RADICAL-7 PULSE CO-OXIMETER, USE THE MULTIPARAMETER MONITOR
FOR AUDIBLE ALARM INDICATION.
DURING SATSHARE OPERATION DO NOT USE THE PLETH WAVEFORM DISPLAY ON THE MULTIPARAMETER MONITOR FOR DIAGNOSTIC PURPOSES.
INSTEAD, USE THE PLETH WAVEFORM DISPLAYED ON THE RADICAL-7
PULSE CO-OXIMETER SCREEN.
Spacelabs Universal Flexport Setup
CAUTIONS:
TO AVOID EXCESSIVE BATTERY DISCHARGING, DO NOT CONNECT ANY
EQUIPMENT TO THE SATSHARE CONNECTOR UNLESS THE RADICAL-7
PULSE CO-OXIMETER IS CONNECTED TO THE AC MAINS POWER SUPPLY.
1.
Select the Spacelabs Flexport selection from the Output menu on the Radical-7.
TO ENSURE THAT THE SAFETY LEVEL DURING DEFIBRILLATION IS MAINTAINED, MAKE SURE THAT THE SATSHARE CABLE CONNECTOR IS PROPERLY SECURED AT THE DOCKING STATION.
2.
Connect one end of the Spacelabs Flexport cable to the Serial Output connector
on the back of the Docking Station.
3.
ONLY USE A SATSHARE CABLE THAT HAS A FERRITE BEAD INSTALLED.
Connect the other end of the Spacelabs Flexport cable to the Spacelabs
Universal Flexport connector.
SPCO AND SPMET CANNOT BE DISPLAYED ON THE MULTIPARAMETER
MONITOR WITH SATSHARE.
4.
The SpO2 and pulse rate values will automatically appear on the Spacelabs
screen.
5.
In order for the pleth waveform to be displayed on the Spacelabs screen and
for the Spacelabs monitor to indicate the alarm conditions measured by the
Pulse CO-Oximeter, the user must configure the Spacelabs monitor. Refer to the
Spacelabs monitor Operator’s Manual for complete instructions.
6.
The Radical-7 Pulse CO-Oximeter can be set up to audibly indicate all patient
alarms while communicating with the Spacelabs Flexport module. Use the
Interface Alarms setting in the General menu to enable and disable audible
alarms on the Radical-7 Pulse CO-Oximeter.
WARNING: EXTERNAL DEVICE CONNECTIONS TO THE SATSHARE PORT
MUST BE IEC-60601-1-1 COMPLIANT.
CAUTIONS:
3-6
SIMULTANEOUS USE OF SATSHARE AND SERIAL PORT IS NOT
SUPPORTED.
SpMet AND SpCO CANNOT BE DISPLAYED ON THE MULTIPARAMETER MONITOR WITH FLEXPORT.
Philips VueLink Setup
SIMULTANEOUS USE OF SATSHARE AND SERIAL PORT IS NOT SUPPORTED.
IF THE RADICAL DOCKING STATION IS COMPATIBLE WITH RADNETTM, VUELINK
IS NOT SUPPORTED.
RadNet Setup
SPCO AND SPMET CANNOT BE DISPLAYED ON THE MULTIPARAMETER MONITOR WITH VUELINK.
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
3
CAUTIONS:
SIMULTANEOUS USE OF SATSHARE AND SERIAL PORT IS NOT SUPPORTED.
SpMet AND SpCO CANNOT BE DISPLAYED ON THE MULTIPARAMETER MONITOR WITH RADNET.
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setup
operation
NOTE: Confirm that the Radical Docking Station is RadNet Ready before proceeding.
Introduction
1.
Select the ASCII 2 selection from the Output menu on the Radical-7 Pulse
CO-Oximeter.
To operate the Radical-7 Pulse CO-Oximeter effectively, the device must be set up properly and the operator must:
2.
Connect one end of the serial cable to the Serial Output connector on the back of
the Docking Station.
Know how the Pulse CO-Oximeter derives its readings (see Section 1, Pulse COOximetry).
3.
Connect the other end of the serial cable to the RadNet Interface Module connector.
Be familiar with its controls, components and operation.
Understand its status and alarm messages (see Section 5, Alarm Identification,
System Messages and Section 6, Troubleshooting).
4.
Turn the RadNet Interface Module on.
5.
The SpO2 and pulse rate values will automatically appear on the RadNet Central
Station Monitor screen.
6.
In order for the pleth waveform to be displayed on the RadNet Central Station
Monitor screen and for the RadNet Central Station Monitor to indicate the alarm
conditions measured by the Pulse CO-Oximeter, the user must configure the
RadNet Central Station monitor. Refer to the RadNet General Floor Monitoring
System Operator’s Manual for Hardwired and Wireless Systems for complete
instructions.
GENERAL SETUP AND USE
The Radical-7 Pulse CO-Oximeter can be set up to audibly indicate all patient
alarms while communicating with the RadNet Interface module. Use the Interface
Alarms setting in the General menu to enable and disable audible alarms on the
Radical-7 Pulse CO-Oximeter.
7.
CAUTION: ENSURE THAT THE RADICAL-7 PULSE CO-OXIMETER HANDHELD
REMAINS IN THE RADNET READY DOCKING STATION WHEN CONNECTED TO THE RADNET CENTRAL MONITORING SYSTEM. REMOVING
THE RADICAL-7 PULSE CO-OXIMETER HANDHELD FROM THE RADNET
READY DOCKING STATION WILL CAUSE LOSS OF COMMUNICATION TO
THE RADNET CENTRAL MONITORING STATION.
4
Basic Operation
1.
Inspect the Pulse CO-Oximeter case for damage.
2.
Connect a patient cable or a direct cable sensor to the Patient Cable Connector of
the Radical-7 Pulse CO-Oximeter. Make sure it is a firm connection and the cable is
not twisted, sliced or frayed.
3.
If utilizing the Standalone setup, ensure that the power cord is plugged into the Power
Cable Connector of the Docking Station and into the AC power.
4.
Select a sensor that is compatible with the Pulse CO-Oximeter before connecting
it to the patient cable or unit. See section 8, Sensors and Patient Cables. If using a
single patient adhesive or disposable sensor, check that the emitter (red light) and the
photodetector are properly aligned. Remove any substances that may interfere with
the transmission of light between the sensor’s light source and photodetector.
5.
Attach the sensor to the patient. Refer to the Directions for Use of the sensor.
6.
Connect the sensor to the unit (or patient cable) with the logos lining up; make sure
it is a firm connection.
7.
Press the Power/Standby button to turn the Pulse CO-Oximeter on.
8.
Make sure the display window is free of alarm and system failure messages (see
Section 5, Alarm Identification).
9.
On the display, verify:
• The high and low alarm limits for SpO2, SpMet, SpCO and pulse rate.
• The readings for SpO2, SpMet, SpCO, pulse rate and perfusion index.
NOTE: “- - - “ will remain lit on the numeric display until the SpO2, SpMet, SpCO, pulse
rate and perfusion index readings have stabilized (less than 15 seconds for SpO2 and up
to 25 seconds for SpCO and SpMet).
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4
Successful Monitoring
10. Verify that the patient alarms are functional by setting the high and low SpO2, SpMet,
SpCO and pulse rate alarm limits beyond the patient readings.
An alarm tone sounds.
The violated alarm limit and reading flash on the display.
The red alarm indicator flashes on the Docking Station (standalone operation).
11. Verify the sensor alarms are functional by removing the sensor from the sensor site.
Sensor Off appears in the message area of the graphic display.
The alarm tone sounds.
The alarm indicator flashes.
Disconnect the sensor from the patient cable or oximeter.
Confirm that Sensor Off appears in the message area of the graphic display.
12. Verify alarm silence operation.
Create an alarm condition by lowering the SpO2 or pulse rate high alarm
limits beyond the patient readings.
Press the Alarm Silence button.
The alarm tone ceases for the displayed amount of time.
Perform the above steps for the SpCO and SpMet alarm limits.
13. To begin patient monitoring:
Adjust the alarm limits.
Adjust the alarm volumes.
Adjust the pulse beep volume.
14. Verify the sensor is on correctly and that the measured data is appropriate, see
Section 4, Successful Monitoring.
15. Monitor the patient .
16. After monitoring is complete, remove the sensor from the patient and store or
dispose of the sensor according to governing rules. See the Directions for Use of
the sensor.
17. Press and hold the Power/Standby Button for 2 seconds to turn the oximeter off.
The following general points will aid in ensuring Pulse CO-Oximetry monitoring success.
■ Place the sensor on a site that has sufficient perfusion and provides proper alignment of the LED’s and photodetector.
■ Place the sensor on a site that has unrestricted blood flow.
■ Do not secure a sensor with tape.
■ Do not select a site near potential electrical interference (electrosurgical unit, for
example).
■ Read the sensor Directions for Use for proper sensor application.
NUMERIC DISPLAY - SpO2
Stability of the SpO2 readings may be a good indicator of signal validity. Although stability
is a relative term, experience will provide a good feeling for changes that are artifactual or
physiological and the speed, timing, and behavior of each. The stability of the readings over
time is affected by the averaging mode being used. The longer the averaging time, the more
stable the readings tend to become. This is due to a dampened response as the signal is
averaged over a longer period of time than during shorter averaging times. However, longer
averaging times delay the response of the oximeter and reduce the measured variations
of SpO2 and pulse rate.
MASIMO SENSORS
Before use, carefully read the Masimo sensor Directions for Use.
Use only Masimo sensors for oximetry measurements.
Tissue damage can be caused by incorrect application or use of a sensor, for example by
wrapping the sensor too tightly. Inspect the sensor site as directed in the sensor Directions
for Use to ensure skin integrity and correct positioning and adhesion of the sensor.
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 USE DAMAGED PATIENT CABLES. DO NOT IMMERSE THE PATIENT
CABLES IN WATER, SOLVENTS, OR CLEANING SOLUTIONS (THE PATIENT
CABLE CONNECTORS ARE NOT WATERPROOF). DO NOT STERILIZE BY
IRRADIATION, STEAM, AUTOCLAVE OR ETHYLENE OXIDE.
NUMERIC DISPLAY - PULSE RATE
The Pulse Rate displayed on the Radical-7 Pulse CO-Oximeter 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 instruments or application of the sensor or patient
cable. The pulsations from intra-aortic balloon support can cause the pulse rate displayed
on the Pulse CO-Oximeter to be significantly different than the ECG heart rate.
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NUMERIC DISPLAY - SpCO
A stable SpCO reading is associated with correct sensor placement, small physiological
changes during the measurement and acceptable levels of arterial perfusion in the patient’s
fingertip (measurement site). Physiological changes at the measurement site are mainly
caused by fluctuations in the oxygen saturation, blood concentration and perfusion.
Inaccurate measurements may be caused by:
■
Significant levels of methemoglobin.
■
Intravascular dyes such as indocyanine green or methylene blue.
■
Abnormal hemoglobin levels.
■
Abnormally low arterial perfusion.
NUMERIC DISPLAY - SpMet
A stable SpMet reading is associated with correct sensor placement, small physiological
changes during the measurement and acceptable levels of arterial perfusion in the patient’s
fingertip (measurement site). Physiological changes at the measurement 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.
■
Abnormal arterial perfusion
NUMERIC DISPLAY - PI
The Perfusion Index (PI) display provides a relative numeric indication of the pulse strength
at the monitoring site. It is a calculated percentage between the pulsatile signal and nonpulsatile signal of arterial blood moving through the site. PI may be used to find the best
perfused site and to monitor physiological changes in the patient. It displays an operating
range of 0.02 percent to 20.00 percent. A percentage greater than 1.00 percent is desired.
Extreme changes in the display number are due to changes in physiology and blood flow.
SIGNAL IQ
The Radical-7 Pulse CO-Oximeter display provides a visual indicator of the plethysmogram
signal quality and an alert when the displayed SpO2 values are not based on adequate
signal quality. The signal quality indicator displayed on the Radical-7 Pulse CO-Oximeter
is called the Signal IQ. The Signal IQ can be used to identify the occurrence of a patient’s
pulse and the associated signal quality of the measurement.
With motion, the plethysmographic waveform is often distorted and may be obscured by
artifact. The Signal IQ, shown as a vertical line, coincides with the peak of an arterial pulsation. Even with a plethysmographic waveform obscured by artifact, the Radical-7 Pulse
CO-Oximeter locates the arterial pulsation. The pulse tone (when enabled) coincides with
the vertical line of the Signal IQ.
The height of the vertical line of the Signal IQ indicates the quality of the measured signal.
A high vertical bar indicates that the SpO2 measurement is based on a good quality signal.
A small vertical bar indicates that the SpO2 measurement is based on data with low signal
quality. When the signal quality is very low the accuracy of the SpO2 measurement may
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4
be compromised, and a Low Signal IQ message is displayed in the message area on the
Radical-7 Pulse CO-Oximeter display. When the Low Signal IQ message appears proceed
with caution and do the following:
■ Assess the patient.
■
Check the sensor and ensure proper sensor application. The sensor must be well
secured to the site for the Radical-7 Pulse CO-Oximeter to maintain accurate readings. Also, misalignment of the sensor’s emitter and detector can result in smaller
signals.
■
Determine if an extreme change in the patient’s physiology and blood flow at the
monitoring site occurred, (e.g. an inflated blood pressure cuff, a squeezing motion,
sampling of an arterial blood specimen from the hand containing the pulse oximetry
sensor, severe hypotension, peripheral vasoconstriction in response to hypothermia,
medications, or a spell of Raynaud’s syndrome.)
■
With neonates or infants, check that the peripheral blood flow to the sensor site is not
interrupted. Interruption, for example, may occur while lifting or crossing their legs,
during a diaper change.
After performing the above, if the Low Signal IQ message is displayed frequently or continuously obtaining an arterial blood specimen for CO-Oximetry analysis may be considered
to verify the oxygen saturation value.
LOW PERFUSION
The Radical-7 Pulse CO-Oximeter displays a “Low Perfusion” message when there are
very low amplitude arterial pulsations.
It has been suggested that at extremely low perfusion levels, pulse oximeters can measure
peripheral saturation, which may differ from central arterial saturation1. This “localized
hypoxemia” may result from the metabolic demands of other tissues extracting oxygen
proximal to the monitoring site under conditions of sustained peripheral hypoperfusion.
(This may occur even with a pulse rate that correlates with the ECG heart rate.)
CAUTION: IF THE LOW PERFUSION MESSAGE IS FREQUENTLY DISPLAYED, FIND
A BETTER-PERFUSED MONITORING SITE. IN THE INTERIM, ASSESS
THE PATIENT AND, IF INDICATED, VERIFY OXYGENATION STATUS
THROUGH OTHER MEANS.
1
Severinghaus JW, Spellman MJ. Pulse Oximeter Failure Thresholds in Hypotension
and Vasoconstriction. Anesthesiology 1990; 73:532-537
ACTIONS TO BE TAKEN
If the SpO2 readings show significant differences, do the following:
■ Make sure the emitter and photodetector are aligned directly opposite each other.
■ Select a site where the distance between the emitter and photodetector is minimized.
■ Wipe the sensor site with a 70% isopropyl alcohol pad or rubefacient cream (1030% methyl salicylate and 2-10% menthol) for 20-30 seconds to increase perfusion.
However, strong vasodilator creams, such as nitroglycerin paste, are not recommended.
■
If possible, remove electrical noise sources such as electrosurgical units or other
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
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operation
electrical/electronic equipment. If these solutions are not possible, operate the Pulse
CO-Oximeter on battery power, or try plugging the Pulse CO-Oximeter into a different
electrical outlet.
■
■
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 Radical-7 with integrated Masimo Rainbow SET technology has significant immunity to ambient light, excessive ambient light may cause readings to be
incorrect.
Touch Key Control Button and Icons
The touch key control buttons are the four dark grey control buttons to the right of the
Handheld display. To select a touch key icon, press and release the dark gray control button
to the right of the icon.
On the Radical-7 Pulse CO-Oximeter display, four icons are shown on the right side or
bottom of the LCD display.
Traditional User Interface
FIRST PAGE
Press the Next Menu Page button to access the second page of
selections.
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.
SENSITIVITY
Three sensitivity levels enables a clinician to tailor the response of the Radical-7 to the
needs of the particular patient situation. They are as follows:
■
Normal Sensitivity – This is the recommended mode for typical monitoring purposes.
It is advisable for care areas where patients are observed frequently, such as ICU’s.
■
Adaptive Probe Off Detection (APOD) – This is the recommended monitoring mode
where there is a high probability of the sensor becoming detached. It is also the suggested mode for care areas where patients are not visually monitored continuously.
This mode delivers enhanced protection against erroneous pulse rate and arterial
oxygen saturation readings when a sensor becomes inadvertently detached from a
patient due to excessive movement.
■
Maximum Sensitivity (MAX) - This mode is recommended for patients with low perfusion or when the low perfusion message is displayed on the screen in APOD or normal sensitivity mode. This mode is not recommended for care areas where patients
are not monitored visually, such as general wards. It is designed to interpret and
display data at the measuring site when the signal may be weak due to decreased
perfusion. When a sensor becomes detached from a patient, it will have compromised protection against erroneous pulse rate and arterial saturation readings.
CAUTION: WHEN USING THE MAXIMUM SENSITIVITY SETTING, THE PERFORMANCE OF THE SENSOR OFF DETECTION MAY BE COMPROMISED.
IF THE UNIT IS IN THIS SETTING AND THE SENSOR BECOMES DISLODGED FROM THE PATIENT, THE POTENTIAL FOR FALSE READINGS
MAY OCCUR DUE TO ENVIRONMENTAL ‘NOISE’ SUCH AS LIGHT, VIBRATION AND EXCESSIVE AIR MOVEMENT.
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NEXT MENU
PAGE
Press and hold the button for 8 seconds to toggle between
Traditional User Interface and the Simplified User Interface. Enter
password when prompted (refer to Section 4 Password Operation).
The Radical-7 will retain this setting after a power cycle.
MENU ACCESS
Press the Menu Access button to enter the main menu.
Press the Sensitivity button to toggle between the Normal, APOD
and Maximum Sensitivity modes. Use the Normal Sensitivity setting for typical monitoring purposes. Use the APOD setting where
there is a high probability of the sensor becoming detached. Use
the Maximum Sensitivity setting for patients with low perfusion or
when the low perfusion message is displayed on the screen in
APOD or normal sensitivity mode. The default is APOD.
MAX
SENSITIVITY
APOD
CAUTION: When using the Maximum Sensitivity setting, the performance of the SENSOR OFF detection may be compromised.
Note: In “Custom” mode the unit will remain in Normal or APOD
setting after a power cycle. Maximum Sensitivity will automatically
reset to Normal Sensitivity after a power cycle.
In “Neo” or “Adult” mode the unit will reset the sensitivity to the
hospital specified setting (Normal or APOD) after a power cycle.
TREND
GRAPH
TREND GRAPH
Press the Trend Toggle button to alternate between SpO2, BPM, PI,
SpMet and SpCO Quick Trend displays.
SECOND PAGE
Press the Next Menu Page button to access the first page of
selections.
NEXT MENU
PAGE
Press and hold the button for 8 seconds to toggle between
Traditional User Interface and the Simplified User Interface. Enter
password when prompted (refer to Section 4 Password Operation).
The Radical-7 will retain this setting after a power cycle.
Press the Trend Display button to show the trend data on the disTREND DISPLAY play.
Press the Increase Loudness button to increase the volume of the
INCREASE
pulse beep.
LOUDNESS
Seven levels of volume exist
DECREASE
Press the Decrease Loudness button to decrease the volume of
LOUDNESS
the pulse beep.
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operation
Simplified User Interface
Navigating the Main Menu
By enabling the Simplified User Interface, users are exposed to only the most common
oximeter features, while the all the remaining settings remain available behind password
protection.
When the main menu is accessed, the plethysmograph and Signal IQ waveform displays
are replaced with the main menu items. The touch key icons, displayed along the right edge
of the LCD display, are also replaced by the menu access icons. When the main menu is
accessed the monitor remains functional and the saturation and pulse rate numbers will
continue to be displayed.
FIRST PAGE
Press the Next Menu Page button to access the second page of
selections.
NEXT MENU
PAGE
ALARM MENU
Press and hold the button for 8 seconds to toggle between
Traditional User Interface and the Simplified User Interface. Enter
password when prompted (refer to Section 4 Password Operation).
The Radical-7 will retain this setting after a power cycle.
Press the Alarm Menu Access button to enter the alarm settings
menu.
Press the Sensitivity button to toggle between the Normal, APOD
and Maximum Sensitivity modes. Use the Normal Sensitivity setting for typical monitoring purposes. Use the APOD setting where
there is a high probability of the sensor becoming detached. Use
the Maximum Sensitivity setting for patients with low perfusion or
when the low perfusion message is displayed on the screen in
APOD or normal sensitivity mode. The default is APOD.
MAX
SENSITIVITY
APOD
CAUTION: WHEN USING THE MAXIMUM SENSITIVITY SETTING, THE PERFORMANCE OF THE SENSOR OFF DETECTION MAY BE COMPROMISED.
Note: In “Custom” mode the unit will remain in Normal or APOD
setting after a power cycle. Maximum Sensitivity will automatically
reset to Normal Sensitivity after a power cycle.
In “Neo” or “Adult” mode the unit will reset the sensitivity to the
hospital specified setting (Normal or APOD) after a power cycle.
TREND
GRAPH
TREND GRAPH
Press the Trend Toggle button to alternate between SpO2, BPM, PI,
SpMet and SpCO Quick Trend displays
MAIN MENU SELECTION
The top menu category uses the following four menu selections and touch key control
buttons and icons.
EXIT
Select the Exit icon to exit the main menu.
SELECT
CATEGORY
Select the Select Category icon to select the highlighted menu
item and enter the next level menu.
PREVIOUS
NEXT
Press the Next Menu Page button to access the first page of
selections.
NEXT MENU
PAGE
ALARM MENU
INCREASE
LOUDNESS
DECREASE
LOUDNESS
Select the Previous icon to scroll through the menu items without
selecting them. Once a menu item is highlighted, enter the menu
by pressing the Select Category icon.
Select the Next icon to scroll through the parameters. Once a
parameter is highlighted, edit the parameter by pressing the Edit
Parameter icon.
MENU CATEGORIES
Once a menu category has been selected, a new set of menu selections and icons are
displayed.
EXIT
Select the Exit icon to exit the menu category and return to the
previous menu.
EDIT
PARAMETER
Select the Edit Parameter icon to select the highlighted parameter
for editing.
PREVIOUS
SECOND PAGE
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operation
NEXT
Select the Previous icon to scroll through the parameters. Once a
parameter is highlighted, edit the parameter by pressing the Edit
Parameter icon.
Select the Next icon to scroll through the parameters. Once a
parameter is highlighted, edit the parameter by pressing the Edit
Parameter icon.
Press and hold the button for 8 seconds to toggle between
Traditional User Interface and the Simplified User Interface. Enter
password when prompted. The Radical-7 will retain this setting
after a power cycle.
Press the Trend Display button to show the trend data on the display.
Press the Increase Loudness button to increase the volume of the
pulse beep.
Seven levels of volume exist
Press the Decrease Loudness button to decrease the volume of
the pulse beep.
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operation
operation
EDITING A PARAMETER
Once a parameter has been selected for editing, a new set of menu selections and icons
are displayed.
EXIT
Select the Exit icon to exit the parameter without making the new
selections permanent.
ACCEPT
Select the Accept icon to save the changes
PREVIOUS
Select the Previous icon to increase or toggle the parameter settings.
NEXT
Select the Next icon to decrease or toggle the parameter settings.
4
Averaging Time
GENERAL
FastSat
Home Use
Interface Alarms
SatShare Numbers
Power Save
Smart Tone
Time (hour/minute/seconds)
Time display format
Day
MENU TREE
CLOCK
SpO2 High/Low limit
Year
Pulse rate High/Low limit (bpm)
Format (mm/dd/yy)
SpMet High/Low limit
ALARMS
Month
Display Clock
SpCO High/Low limit
Silence
ABOUT
Software Version
CONFIG
Enter password to change line frequency
(refer to Section 4 Password Operation).
Volume
Delay (volume delay)
Mode
Serial
Landscape 1
ROTATE
SCREEN
Analog 1
Vertical 1
Landscape 2
OUTPUT
Analog 2
Nurse Call
Vertical 2
Polarity
View
SERVICE
Trend
DISPLAY
Handheld Battery Deep Discharge
DS Battery Deep Discharge
Contrast
Language
Default
3D ALARM
SYSTEM
(OPTIONAL)
Desat Index
PI Delta
Vertical Layout
4-10
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operation
Alarms
MENU ITEMS
Check alarm limits each time the Pulse CO-Oximeter is used to ensure that they are
appropriate for the patient being monitored. An audible alarm and a flashing alarm icon
(and indicator light) will occur when an alarm limit is exceeded. It is best that the operator
be within a minimum of 10 feet from the unit.
MENU ITEMS
SpO2 HIGH LIMIT
SpO2 LOW LIMIT
PULSE RATE HIGH
LIMIT (BPM)
PULSE RATE LOW
LIMIT (BPM)
SpMet HIGH LIMIT
SpMet LOW LIMIT
SpCO HIGH LIMIT
30, 60, 90,120 SECONDS
The alarm silence can be set for these durations. As an indicator that
the alarm system is silenced, the Alarm Status Indicator is shown as a
bell with a slash through it. A timer is shown next to the bell indicating
the remaining alarm silence duration.
The SpO2 high alarm limit can be set anywhere between 2% and 99%,
with a 1% step size. In the “----” (off) setting, the alarm can be turned
off completely.
NOTE: The low alarm limit always has to be set below the high alarm
setting. When the high alarm limit is set below the low alarm limit, the
low alarm limit will automatically adjust to the next setting below the
newly entered high alarm limit setting.
NOTE: The SpO2 low limit can not be set below the password
protected minimum low SpO2 alarm limit. See Section 4, Operation,
Display for details.
The pulse rate high alarm limit can be set anywhere between
30 BPM and 240 BPM, with a 5 BPM step size.
The pulse rate low alarm limit can be set anywhere between 25 BPM
and 235 BPM, with a 5 BPM step size.
NOTE: The low alarm limit always has to be set below the high alarm
setting. When the high alarm limit is set below the low alarm limit, the
low alarm limit will automatically adjust to the next setting below the
newly entered high alarm limit setting.
DESCRIPTION
This menu allows the user to set the alarm silence period. An alarm is
silenced by pressing the Alarm Silence button on the front panel.
DESCRIPTION
The SpO2 low alarm limit can be set anywhere between 1% and 99%,
with a 1% step size.
4
operation
Note: The alarm silence period is reset to 120 seconds (or 90 seconds
in neonatal mode) upon power cycle, except for when the Radical-7 is
set to operate in the Home mode.
SILENCE
ALL MUTE
All patient alarm conditions are silenced. Only system alarms will be
indicated by an audible alarm. As an indicator that the system is set
to All Mute, the Alarm Status Indicator is shown as a bell with a slash
through it.
ALL MUTE WITH AUDIBLE REMINDER
All patient alarm conditions are silenced. Only system alarms will be
indicated by an audible alarm. As a reminder, a single audible alarm
will occur every three minutes. As an indicator that the system is set
to All Mute the Alarm Status Indicator is shown as a bell with a slash
through it.
The SpMet high alarm limit can be set anywhere between 1% to 100%.
Between 1% and 2%, the step increment is 0.1%. Between 2% and
100%, the step increment is 0.5%.
WARNING: IF AN ALARM CONDITION OCCURS WHILE THE ALARM SILENCE
PERIOD IS SET TO ALL MUTE, THE ONLY ALARM INDICATIONS
WILL BE VISUAL DISPLAYS AND SYMBOLS RELATED TO THE
ALARM CONDITION. NO ALARM TONE WILL SOUND.
The SpMet low alarm limit can be set anywhere between 0.1% to
99.5%. Between 0.1% and 2%, the step increment is 0.1%. Between
2% and 99.5%, the step increment is 0.5%. In the “----” (off) setting, the
alarm can be turned off completely.
NOTE: If there is a loss of power for any length of time, the Alarm settings will be set back
to the User set defaults. If the user has not utilized this option, then they will be set back
to the factory defaults.
NOTE: The low alarm limit must always be below the high alarm
limit. If the high alarm limit is set below the low alarm limit, the low
alarm limit will automatically adjust to the next setting below the newly
entered high alarm limit.
The SpCO high alarm limit can be set anywhere between 2% and
100%, with a 1% step size.
The SpCO low alarm limit can be set anywhere between 1% and 99%,
with a 1% step size. In the “----” (off) setting, the alarm can be turned
off completely.
SpCO LOW LIMIT
4-12
NOTE: The low alarm limit must always be below the high alarm
limit. If the high alarm limit is set below the low alarm limit, the low
alarm limit will automatically adjust to the next setting below the newly
entered high alarm limit.
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operation
MENU ITEMS
VOLUME
DELAY
4
operation
Rotate Screen
DESCRIPTION
This menu allows the user to set the alarm volume. Four levels are
available: level 1 being the softest and level 4 being the loudest. The
device retains the Alarm Volume setting upon a power cycle.
MENU ITEMS
DESCRIPTION
NOTE: For home use, set the alarm level to level 4.
LANDSCAPE 1
The viewing screen will be in a horizontal fashion when the Radical-7 is
in the upright, horizontal position.
This menu allows the users to set an audible saturation delay. The
delay can be set to either 0, 5 or 10 seconds. The delay setting only
affects saturation alarms indications.
VERTICAL 1
The viewing screen will be in a vertical fashion when the Radical-7 is in
the upright, vertical position.
LANDSCAPE 2
The viewing screen will be in an inverted horizontal fashion (rotated
180o) when the Radical-7 is in the upright, horizontal position.
VERTICAL 2
The viewing screen will be in an inverted vertical fashion (rotated 180o)
when the Radical-7 is in the upright, vertical position.
NOTE: In “Custom” mode (see Section 4-Operation) the unit will retain
the Alarm Delay setting after a power cycle. In “Neo” or “Adult” mode
(see Section 4-Operation) the unit will reset the Alarm Delay to the
hospital specified setting after a power cycle.
The Radical-7 stores three types of modes: Adult, Neonatal or Custom
limits. Adult and Neonatal must be initially set and enabled (via
password protected screen, see Section 4 Password Operation) before
they can be selected.
CUSTOM
Any changes to settings on the Alarm menu will be retained after a
power cycle.*
ADULT
Any changes to settings on the Alarm menu will be reset to pre-defined Adult defaults after a power cycle.†
MODE
NEO
Any changes to settings on the Alarm menu will be reset to pre-defined Neonatal defaults after a power cycle.†
TYPES
ADULT
LIMITS†
NEONATAL
LIMITS†
CUSTOM
LIMITS*
SpO2
(HIGH)
SpO2
(LOW)
PULSE RATE PULSE RATE
(HIGH)
(LOW)
Off
90%
140 BPM
50 BPM
100%
90%
180 BPM
100 BPM
Off*
90%*
140 BPM*
50 BPM*
NOTE: Limits are set at the factory to the values listed in this table.
*Once Custom values are changed by the user, they will be retained
after a power cycle.
†Adult and Neo settings can be changed (via a password protected
screen, see Section 4 under Password Operation) to specific hospital/unit requirements. If the settings are changed, then any values
changed by the user will be returned to the unit's default values after it
is powered down.
4-14
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operation
Display continued
Display
MENU ITEMS
VIEW
TREND
4
operation
DESCRIPTION
Three views are available: Pleth and Signal IQ, Numbers and Pleth
Only.
PLETH + SIGNAL IQ
Shows the SpO2 and pulse rate numbers on the left or top of the
screen. The plethysmograph and Signal IQ waveform on the right,
two-thirds or bottom of the screen. The screen also indicates the signal
strength of the measured signal as a perfusion index (PI). The PI is
calculated as the relation of arterial pulsatile signal to the non-pulsatile
signal component.The percentage measurements of methemoglobin
(SpMet) and carboxyhemoglobin (SpCO) are displayed in the middle
upper third of the screen above the PI measurement.
PLETH ONLY
Shows the SpO2 and pulse rate numbers on the left or top of the
screen. The plethysmograph waveform on the right, two-thirds or
bottom of the screen. The screen also indicates the signal strength of
the measured signal as a perfusion index (PI). The PI is calculated as
the relation of arterial pulsatile signal to the non-pulsatile signal component.The percentage measurements of methemoglobin (SpMet) and
carboxyhemoglobin (SpCO) are displayed in the middle upper third of
the screen above the PI measurement.
NUMBERS
Shows the SpO2 and pulse rate numbers and the signal IQ in the form
of a pulse bar on the screen. The Screen also indicates the signal
strength of the measured signal as a perfusion index (PI). The PI is
calculated as the relation of arterial pulsatile signal to the non-pulsatile
signal component. The percentage measurements of methemoglobin
(SpMet) and carboxyhemoglobin (SpCO) are displayed in the middle
of the screen in line with the PI measurement.
This allows the user to select and view the Trend data between:
■ SpO2 and pulse rate (%SpO2 + BPM)
■ SpO2 and perfusion index (%SpO2 + PI)
■ SpO2 and methemoglobin (%SpO2 + MET)
■ SpO2 and carboxyhemoglobin (%SpO2 + CO)
■ Pulse rate and perfusion index (BPM + PI)
■ Pulse rate and methemoglobin (BPM + MET)
■ Pulse rate and carboxyhemoglobin (BPM + CO)
■ Perfusion index and methemoglobin (PI + MET)
■ Perfusion index and carboxyhemoglobin (PI + CO)
■ Methemoglobin and carboxyhemoglobin (MET + CO)
■ %SpO2
■ Pulse Rate (BPM)
■ Perfusion Index (PI)
■ Methemoglobin (MET)
■ Carboxyhemoglobin (CO)
MENU ITEMS
LANGUAGE
DESCRIPTION
Allows the user to select the language displayed on the screen.
Allows the user to select user mode or reset the settings to factory
defaults.
NOTE: A password is required to access these menu options. Refer to
Section 4 Password Operation
LOW % SpO2 LIMIT
Allows the user to set a custom default minimum low SpO2 limit (1%99%).
The unit will return to this setting after a power cycle.
DEFAULT
SAVE LAST
This allows the user to either use Custom setting or Adult/Neonatal
settings. Select “Yes” to use custom settings.
SAVE AS ADULT
Store current settings as Adult default setting.
SAVE AS NEO
Store current settings as Neonatal default setting.
VERTICAL LAYOUT
RESTORE FACTORY
Recall factory setting for Custom, Adult and Neonatal.
DEFAULT
Displays the alarm parameters in vertical sequence of SpO2, SpMet,
SpCO, BPM and PI.
TRADITIONAL
Displays the alarm parameters in vertical sequence of SpO2, BPM, PI,
SpMet and SpCO.
Note: These parameters are viewed when utilizing the Trend Display
function and not the Trend Graph function.
4-16
Radical-7 Color Display
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operation
General
About
MENU ITEMS
DESCRIPTION
The signal averaging time of this device can be set to: 2, 4, 8, 10, 12,
14 and 16 seconds*.
AVERAGING TIME
*With FastSat the averaging time is dependent on the input signal. For
the 2 and 4 second settings, the averaging times may range from 2-4
and 4-6 seconds, respectively.
Select Yes to activate the FastSat algorithm. In the 2 and 4 seconds
averaging mode, the FastSat algorithm is automatically enabled.
FASTSAT
Set the Radical-7 to the Home Mode. The Radical-7 will remain in the
Home Mode until the No setting is selected. A password is required to
activate or deactive this mode. See Section 4, Home Mode Operation,
for a detailed description.
During SatShare, Philips Vuelink, Spacelabs Flexport and RadNet
operation, the audible alarms can be enabled or disabled by selecting
Yes or No.
HOME USE
INTERFACE
ALARMS
During SatShare operation the saturation and pulse rate measurements can be displayed on the Radical-7 by selecting a SatShare
Numbers setting of Yes.
SATSHARE
NUMBERS
4
operation
This displays the copyright and software versions of the Handheld and
Docking Station.
MENU ITEMS
MORE
DESCRIPTION
Allows the user to view the current Line Frequency setting without a
password.
Config
MENU ITEMS
DESCRIPTION
Enter password. See Section 4, Password Operation.
ENTER PASSWORD
Set to match regional power line frequency (50 or 60 Hz) to allow
for cancellation of noise introduced by fluorescent lights and other
sources. Default is 60 Hz (standard for the United States).
3D Alarm System (optional)
Refer to Section 5, 3D Alarm System option.
Select Yes to maximize battery-operating time of the Radical-7 while
powered by the Handheld battery or optional Docking Station battery.
Selecting Yes will disable Docking Station functions such as SatShare,
Serial and Analog output. Selecting No will activate these Docking Station functions while operating on battery power. (While operating in the
Power Save mode, a power cycle of the Radical-7 may be required to
activate the Docking Station again after it has been disabled.)
Select Yes to activate the SmartTone function. This will allow the
audible pulse to continue to beep when the pleth graph shows signs of
motion. Select NO to turn off SmartTone.
POWER SAVE
SMART TONE
Clock
MENU ITEMS
4-18
DESCRIPTION
TIME
Set the time - hour, minutes and seconds - in 24 hour format.
TIME FORMAT
Set the format of the time display as it will be shown on the front panel.
Available options are 12 hour (default) and 24 hour display.
DAY
Set the numerical day.
MONTH
Set the numerical month.
YEAR
Set the numerical year.
DAY FORMAT
Set the format of the date display as it will be shown on the front panel.
Available options are mm/dd/yy (default) and dd/mm/yy.
DISPLAY CLOCK
Set to display the date and time on the front panel by selecting YES
or NO.
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4
operation
Output
4
operation
Output continued
NOTE: The output menu selections are only available when the Radical-7 Handheld is
interfaced to the Docking Station.
MENU ITEMS
DESCRIPTION
0V OUTPUT
MENU ITEMS
DESCRIPTION
The following serial output modes are supported. All serial output is
RS-232 based. See the interface specifications in Section 7-Specifications.
ANALOG1 OR
ANALOG 2
(CONTINUED)
ASCII text data is sent to the serial interface at one-second intervals.
The ASCII text includes: date and time stamp, SpO2 pulse rate, PI,
SpMet, SpCO and alarm and exception values. All text is single line
followed by a line feed character and a carriage return.
ALARMS
The nurse call output will be activated based on alarm events.
ASCII 2
SERIAL
LOW SIGNAL IQ
NURSE CALL
The nurse call output will be activated based on alarm and Low Signal
IQ events.
Compressed binary data is sent to the serial interface following a query
from the connecting computer.
NORMAL
PHILIPS VUELINK
SPACELABS FLEXPORT
SpO2, pulse rate and plethysmographic waveform data are sent in
Spacelabs Flexport format to the serial port.
SpO2 0 - 100%
Scales the saturation measurement with 0% being equal to 0 Volt and
100% equal to 1 Volt.
The nurse call output will be activated based on Low Signal IQ events.
ALARM & SIGNAL IQ
BINARY
SpO2, pulse rate and plethysmographic waveform data are sent in
Philips VueLink format to the serial port.
1V OUTPUT
A 1 Volt calibration signal is mapped to the analog output. Use this signal for calibration of recording devices. (1 Volt represents a saturation
of 100% and a pulse rate of 250 bpm).
ASCII 1
ASCII text data is sent to the serial interface following a query from the
connecting computer. This mode will need to be active for RadNet data
output.
A 0 Volt calibration signal is mapped to the analog output. Use this signal for calibration of recording devices. (0 Volts represents a saturation
of 0% and a pulse rate of 0 bpm).
POLARITY
Standard polarity. See section 7, Analog output / nurse call specifications.
INVERT
This setting reverses the Normally Open and Normally closed contacts.
See section 7, Analog output / nurse call specifications.
CAUTION: TO AVOID EXCESSIVE BATTERY DISCHARGING, DO NOT CONNECT ANY
EQUIPMENT TO THE SERIAL PORT ON THE BACK PANEL UNLESS THE
RADICAL-7 IS CONNECTED TO THE AC MAINS POWER SUPPLY.
SpO2 50 - 100%
Scales the saturation measurement with 50% being equal to 0 Volt and
100% equal to 1 Volt.
PULSE RATE
ANALOG1 OR
ANALOG 2
Scales the pulse rate measurement with 0 BPM being equal to 0 Volt,
and 250 BPM equal to 1 Volt.
PLETH
Traces the plethysmographic waveform as shown on the Radical-7
display.
SIGNAL IQ
Traces the Signal IQ waveform as shown on the Radical-7 display. A
full scale Signal IQ signal (100%) is represented as 1 Volt, while a zero
Signal IQ signal (0%) is represented as 0 Volt.
4-20
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4-21
4
operation
4
operation
Service
Trend Display
NOTE: The Service menu selections are only available when the Radical-7 Pulse COOximeter Handheld is interfaced to the Docking Station.
Once the Trend Display touch key icon is selected, the trend data is displayed on the main
screen. The Radical-7 Pulse CO-Oximeter stores one data set of SpO2, pulse rate, SpMet,
SpCO, PI and system messages in a dedicated memory area. Depending on the Trend
Period, a setting for how often the data is stored in the trend memory, the Radical-7 Pulse
CO-Oximeter can store between 72 hours and 18 days of trend data. The Radical-7 Pulse
CO-Oximeter also employs a sophisticated data compression scheme. The actual amount
of trend data that is stored is dependent on the type of data that is collected.
Only qualified Biomedical or Clinical Engineering department personnel should access the
service menu. See Section 4, Password Operation, on how to enter the password.
MENU ITEMS
DESCRIPTION
HANDHELD
BATTERY
DISCHARGE
To deep discharge the Handheld battery, select this menu item. See
Section 9, Battery Operation and Maintenance, for more information.
DS BATTERY
DISCHARGE
To deep discharge the optional Docking Station battery, select this
menu item. See Section 9, Battery Operation and Maintenance, for
more information.
The Radical-7 Pulse CO-Oximeter only stores data in the trend memory while the device
is turned on, and the trend data remains in memory until the memory fills up, or is cleared
by the user.
CAUTION: CHANGING THE DATE AND TIME OF THE SYSTEM CLOCK, OR CHANGING THE TREND PERIOD, WILL ALSO CLEAR THE DATA IN THE TREND
MEMORY.
The following table outlines the trend capacity for sample Trend Period settings:
The discharge cycle will take approximately 16 hours to complete for the Handheld battery.
The Docking Station battery will take approximately 30 hours to complete. A message will
appear in the service screen when the discharge cycle is complete. The batteries will be
fully charged after completion of the cycle.
When deep discharge is started, the backlight will automatically turn down to the default
handheld battery powered level. Wait until the message changes from (In Progress) to
(Done).
NOTE: In order for the discharge cycle to be properly completed, AC power must be supplied to the instrument throughout the cycle.
WARNING: WHEN DEEP-DISCHARGING THE HANDHELD OR DOCKING STATION BATTERY, MAKE SURE THAT THE DEVICE HAS BEEN
REMOVED FROM SERVICE UNTIL FULL BATTERY CAPABILITY
CAN BE RESTORED.
4-22
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
TREND PERIOD
TREND MEMORY CAPACITY
2 SECONDS
MINIMUM OF 72 HOURS (3 DAYS)
10 SECONDS
TYPICALLY 435 HOURS (18 DAYS)
The Trend Display can be configured to display one or two of any of the five available trend
parameters (SpO2, SpMet, SpCO, pulse rate or PI) that are selected by the user. The unit
is storing all 5 parameters in trend memory, but can only display one or two user selected
parameters at any one time. The Trend Display can be adjusted to the desired parameter
by Selecting Trend from the Main, Display Menu.
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operation
Masimo rainbow SET
1 Hr
99
85
Sp0 2
100
140
50
BPM
50
PI
FIRST PAGE
10/11/06
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12:23:11pm
Trend
SpMet
NAVIGATING THE TREND DISPLAY
In the Trend Display view there are a total of 10 touch key icon selections on 3 pages of
menu selections. These menu screens are not accessable when using the Simplified User
Interface.
2
1
98
1.7
4
operation
96 97
NEXT MENU
PAGE
Press the Next Menu Page button to access the next page of menu
selections.
EXIT
Press the Exit button to return to the normal display screen.
7.3 4.7
20
0
SCROLL RIGHT
Signal Extraction Pulse CO-Oximeter
7
6
5
4
3
SCROLL LEFT
1
The top line on the trend display shows the time scale of the trend graph,
followed by the starting date, starting time and end time of the data set that is
displayed on the screen.
2
The second line of the display shows the minimum, average, and maximum
SpO2, SpMet, SpCO, PI or pulse rate measurements contained in the displayed data set (excluding zero measurements).
3
The scale range of SpO2, BPM, PI, SpMet and SpCO, PI graphs can be set
in the Trend Setup menu. For other settings, see Trend Setup in the following
pages.
4
A vertical line on the trend graph indicates the averaged data, while the
horizontal show beginning and ending periods of the trend or when the sensor
was removed from the patient.
5
A grayed-out box or line located on the bottom axis of the saturation graph
indicates a period of time for which the Low Signal IQ indicator was active,
indicating the signal quality was very low and the accuracy of the measurement may have been compromised.
6
7
SECOND PAGE
NEXT MENU
PAGE
ZOOM
ZOOM FROM
LEFT
ZOOM FROM
RIGHT
Press the Next Menu Page button to access the next page of menu
selections.
Press the Zoom button to change the time scale of the trend view.
The available time scales are 24 hrs, 12 hrs, 8 hrs, 4 hrs, 2 hrs, 1
hr, 30 minutes, 10 minutes, 1 minute and 20 seconds. The Zoom
button uses the last recorded data point as the zoom reference
point. In other words, the last recorded data point is always shown
as the right-most data point on the display.
Press the Scroll Right button to scroll through the data set. The
display scrolls by ½ the selected time scale. For example if a 2 hr
display view is selected, then pressing the Scroll Right button will
scroll the displayed data by 1 hr to the right.
Press the Scroll Left button to scroll through the data set. The
display scrolls by ½ the selected time scale. For example if a 2 hr
display view is selected, then pressing the Scroll Left button will
scroll the displayed data by 1 hr to the left.
THIRD PAGE
The available trend graphs show two of the desired trend parameter measurements displayed versus time.
By default, the trend display automatically refreshes, at a rate of once every 10 seconds, to
show the latest measured SpO2, SpMet, SpCO, PI or pulse rate data. This feature is only
available while the trend view is 2 hours or less, and the latest measured data is shown.
If the user scrolls through the data set to display previously recorded trend data, or if the
trend scale is greater than 2 hours, the trend display will time out after 1 minute of inactivity
(i.e. the user does not press any of the touch key control buttons) and the normal Radical-7
Pulse CO-Oximeter display will be shown.
4-24
Press the Scroll Right button to scroll through the data set. The
display scrolls by ½ the selected time scale. For example if a 2 hr
display view is selected, then pressing the Scroll Right button will
scroll the displayed data by 1 hr to the right.
Press the Scroll Left button to scroll through the data set. The
display scrolls by ½ the selected time scale. For example if a 2 hr
display view is selected, then pressing the Scroll Left button will
scroll the displayed data by 1 hr to the left.
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
NEXT MENU
PAGE
Press the Next Menu Page button to return to the first page of
menu selections.
TREND SETUP
Press the Trend Setup button to enter the Trend Setup Menu.
HISTOGRAM
Press the Histogram button to display the selected data set (the
data set shown in the trend view) in histogram format.
CLEAR TREND
DATA
Press the Clear Trend Data button to clear the data stored in the
trend memory.
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
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4
operation
TREND SETUP
4
operation
MENU ITEMS
DESCRIPTION
SERIAL DUMP
Masimo rainbow SET
1 Hr
SpO2
SpMet
SpCO
100
15.0
40
Min
50
1.0
1.0
140
50
BPM
BPM
PI
Max
200
20
Min
25
1
Default View
1 min
Trend Action
None
Trend Period
2
To send all the data that is stored in trend memory to the serial port select the Serial Dump option. Use this option to communicate the stored
data set to trend graphing software applications.
10/11/06
11:23:11pm
12:23:11pm
Trend
99
85
Max
Sp0 2
ANALOG DUMP
TREND ACTION
PRINT
Signal Extraction Pulse CO-Oximeter
To print the trend data that is shown in the Trend View select the Print
option. The trend data is first printed in histogram format, followed by a
table of data that shows the time and date stamp of a trend record, and
the SpO2, pulse rate, SpMet, SpCO and PI measurement. Each trend
record is printed on a single line followed by a carriage return and line
feed character.
This menu allows the user to set the default trend settings or download the trend data t. The
default settings are used to scale the trend graphs when the trend data button, located on
the main display, is accessed.
MENU ITEMS
DESCRIPTION
%SpO2 MAX SCALE Sets the maximum scale of the SpO2 trend graph.
%SpO2 MIN SCALE
Sets the minimum scale of the SpO2 trend graph.
PR MAX SCALE
(BPM)
Sets the maximum scale of the pulse rate trend graph.
PR MIN SCALE
(BPM)
Sets the minimum scale of the pulse rate trend graph.
PI MAX SCALE
Sets the maximum scale of the PI trend graph.
PI MIN SCALE
Sets the minimum scale of the PI trend graph.
%SpMET MAX
SCALE
%SpMET MIN
SCALE
%SpCO MAX
SCALE
To send all the data that is stored in the trend memory to the analog
output select the Analog Dump option. Use this option to print the trend
information on an analog chart recorder.
Sets the maximum scale of the SpMet trend graph.
Sets the minimum scale of the SpMet trend graph.
TREND PERIOD
The Trend period setting determines how often a set of SpO2, pulse rate,
SpMet, SpCO and PI data points is stored in trend memory. A setting
of 2, for example, sets the Radical-7 Pulse CO-Oximeter to store one
set of SpO2, pulse rate, SpMet, SpCO and PI measurements every 2
seconds, resulting in a minimum trend capacity of 72 hours. A setting
of 10, for example sets the Radical-7 Pulse CO-Oximeter to store one
set of data points every 10 seconds, resulting in a typical trend storage
capacity of 18 days.
NOTE: Since the Radical-7 Pulse CO-Oximeter employs a sophisticated data compression
scheme, the actual trend capacity is dependent on the type of data that is collected.
HISTOGRAM
The figure below is an example of the display output of the Histogram function. The
Histogram displays the trend data of selected parameters as numerical percentages shown
in specific ranges.
Sets the maximum scale of the SpCO trend graph.
Masimo rainbow SET
%SpCO MIN SCALE
DEFAULT VIEW
Sets the minimum scale of the SpCO trend graph.
Selects the default time scale of the trend view. This setting only selects
the time scale of the trend view when the trend data is initially displayed,
(i.e. when the trend data is initially accessed). The selections are 24 hrs,
12 hrs, 8 hrs, 4 hrs, 2 hrs, 1 hr, 30 minutes, 10 minutes, 1 minute and
20 seconds.
99
85
Sp0 2
140
50
BPM
1 Hr
%SpO 2
Histogram
96-100
100
91-95
0
0
86-90
0
81-85
0
0
1-80
16.1-20.0
0
0
PI
12.1-16.0
0
0
8.1-12.0
0
0
4.1-8.0
83
0
0.1-4.0
17
0
Signal Extraction Pulse CO-Oximeter
4-26
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4
operation
operation
BacklightOperation
■
The backlit LCD screen of the Radical-7 Pulse CO-Oximeter Handheld can be set to four
levels of illumination, in addition to no illumination, when the Radical-7 Pulse CO-Oximeter
operates as a standalone Pulse CO-Oximeter. The Radical-7 Pulse CO-Oximeter temporarily indicates the illumination level on the display following a change in illumination level. To
select the level of illumination, simply press the Backlight button located on the front panel
of the Handheld.
In the SatShare mode, the pulse beep tone of the Radical-7 Pulse CO-Oximeter is
initially set to the lowest volume (mute). The pulse beep volume can be manually
increased. Refer to Section 4 Traditional User Interface.
■
The Radical-7 Pulse CO-Oximeter may automatically set the averaging time during
SatShare operation. For averaging times of 10 seconds and higher, the Radical-7
Pulse CO-Oximeter will automatically set the averaging time to 8 seconds during
SatShare operation. Averaging times of 2, 4 or 8 seconds remain unchanged during
SatShare operation. When the Radical-7 Pulse CO-Oximeter returns to non-SatShare
operation, the Radical-7 Pulse CO-Oximeter will maintain the averaging time setting
used in the SatShare mode.
■
When the Radical-7 Pulse CO-Oximeter starts to operate in the SatShare mode the
sensitivity mode is set to Normal sensitivity. The sensitivity mode can manually be set
to Maximum or APOD sensitivity. Refer to Section 2 Handheld Front Panel.
■
While operating in the SatShare mode, the Radical-7 Pulse CO-Oximeter may automatically disable the SatShare interface if the perfusion index drops below 0.1% while
the sensitivity is set to Max sensitivity. To enable the SatShare interface again, set the
Radical-7 Pulse CO-Oximeter to the Normal or APOD sensitivity mode, increase the
perfusion at the measurement site (by warming the patient or sensor site), or move
the sensor to a site with better perfusion.
When the Radical-7 Pulse CO-Oximeter Handheld unit is released from the Docking
Station, the illumination of the LCD screen automatically reverts to the lowest level to
conserve battery power. To select a different level of illumination, press the Backlight button
again. In the Handheld mode, three levels of illumination are available.
When the Handheld unit is re-attached to the Docking Station, as well as when the Radical7 Pulse CO-Oximeter is powered on in the Standalone configuration, the backlight is automatically set to the maximum illumination when the unit is AC line powered.
Satshare Operation
When the SatShare cable is connected to the Radical-7 Pulse CO-Oximeter and to a
multiparameter patient monitor, the Radical-7 Pulse CO-Oximeter automatically starts to
operate in the SatShare mode.
In the SatShare mode, Radical-7 Pulse CO-Oximeter operates as follows:
CAUTIONS:
■
All visual alarms remain active.
■
■
All audible alarms may be disabled by software configuration of the Radical-7 Pulse
CO-Oximeter. Refer to Section 4 Alarms.
■
The SpO2 and pulse rate numbers may or may not be displayed on the Radical-7
Pulse CO-Oximeter display depending on the SatShare Numbers setting of the
General menu. Refer to Section 3 SatShare Setup.
SATSHARE SIGNALS ARE IDEAL SIMULATED WAVEFORMS CORRESPONDING TO THE CALCULATED SATURATION AND PULSE RATE VALUES AND DO
NOT CONTAIN ALL OF THE INFORMATION CONTAINED IN PHYSIOLOGICAL
WAVEFORMS. THE MULTIPARAMETER PATIENT MONITOR DECODES THESE
SIGNALS INTO SATURATION AND PULSE RATE VALUES.
■
DURING SATSHARE OPERATION, THE AUDIBLE ALARMS MAY BE MUTED ON
THE RADICAL-7 PULSE CO-OXIMETER. WHEN THE AUDIBLE ALARM IS MUTED
(INDICATED BY A BELL WITH A SLASH THROUGH IT) ON THE RADICAL-7
PULSE CO-OXIMETER, USE THE MULTIPARAMETER MONITOR FOR AUDIBLE
ALARM INDICATION.
■
DURING SATSHARE OPERATION DO NOT USE THE PLETH WAVEFORM DISPLAY ON THE MULTIPARAMETER MONITOR FOR DIAGNOSTIC PURPOSES.
INSTEAD, USE THE PLETH WAVEFORM DISPLAYED ON THE RADICAL-7
SCREEN.
■
TO AVOID EXCESSIVE BATTERY DISCHARGING, DO NOT CONNECT ANY
EQUIPMENT TO THE SATSHARE CONNECTOR UNLESS THE RADICAL-7 IS
CONNECTED TO THE AC MAINS POWER SUPPLY.
■
TO ENSURE THAT THE SAFETY LEVEL DURING DEFIBRILLATION IS MAINTAINED, MAKE SURE THAT THE SATSHARE CABLE CONNECTOR IS PROPERLY
SECURED AT THE DOCKING STATION.
■
All other items are displayed, including the alarm limits, the plethysmogram and Signal
IQ waveform.
■
The user can access the menu system.
■
If the SatShare cable is connected to the Radical-7 Pulse CO-Oximeter only, and not
to a patient monitor, the SatShare cable type is flashing on the LCD screen.
■
Once the Radical-7 Pulse CO-Oximeter detects the presence of a patient monitor, the
SatShare cable type remains constantly displayed on the LCD screen.
■
Patient Alarms of the multiparameter patient monitor will be triggered by the alarm setting of the patient monitor and not the Radical-7 Pulse CO-Oximeter. To synchronize
the alarm events set the alarm limits of the Radical-7 Pulse CO-Oximeter to those of
the patient monitor, or vice versa.
■
4-28
Once the Radical-7 Pulse CO-Oximeter detects that the SatShare cable is disconnected from the patient monitor, or if the patient monitor is turned off, the Radical-7
automatically returns to normal, standalone operation.
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Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
4
4-29
4
operation
alarms and messages
■
ONLY USE A SATSHARE CABLE THAT HAS A FERRITE BEAD INSTALLED.
System Messages
■
SPMET, SPCO AND PI CANNOT BE DISPLAYED ON THE MULTIPARAMETER
MONITOR WITH SATSHARE.
The following chart alphabetically lists all system messages displayed on the LCD screen.
The cause of the message, and the action(s) to be taken are also shown.
To return from SatShare operation to normal standalone operation, simply disconnect
the SatShare cable from the patient monitor or disconnect the SatShare cable from the
SatShare connector on the back of the Radical-7 Pulse CO-Oximeter.
The operator should become thoroughly familiar with this information before using the
oximeter for patient monitoring.
MESSAGE
Home Mode Operation
The Radical-7 Pulse CO-Oximeter can be placed into the Home Mode to protect unqualified users from changing the Radical-7 Pulse CO-Oximeter alarm settings and operation.
Entering a password does not automatically reset the Radical-7 Pulse CO-Oximeter to the
Normal operating mode. In the Home Mode, a password is required to access the menu
system and the touch key control buttons and icons.
NOTE: When the Radical-7 Pulse CO-Oximeter is set to operate in the Home mode the
default values that the Radical-7 reverts to after a power cycle are set according to
Section 3, Monitor Setup, with the exception of the Alarm Silence setting, which is
set to the pre-power down setting.
X
3
First press 2
1
4-30
Then press X
X
3
3
2
2
1
Finally press AMBIENT LIGHT
Remove or reduce lighting. Cover sensor
from light. Reposition sensor..
CABLE LIFE EXP
Cable is no longer useable.
Replace with new or operable cable.
Oximeter cannot identify
Inoperative or faulty cable; Replace cable.
DEFECTIVE CABLE the connected cable or the Refer to the Directions for Use of the cable
cable has failed.
being used.
DEFECTIVE
SENSOR
Oximeter cannot identify
the connected sensor or
the sensor has failed.
Broken sensor cable wire or inoperative
LEDs or faulty detector; Replace sensor.
Refer to the instructions for the sensor being
used.
EMITTER RANGE
The temperature of the
emitter is outside of the
designed range.
Disconnect and reconnect the sensor. If the
message continues to display, replace the
sensor.
INCOMPATIBLE
SENSOR
Not a proper Masimo
sensor.
Replace with a proper Masimo sensor. Refer
to Section 8.
INTERFERENCE
Outside signal or energy
preventing reading.
Remove outside interference.
INVALID SENSOR
Oximeter cannot identify
the connected sensor.
Broken sensor cable wire or inoperative
LEDs or faulty detector; the sensor has
failed. Replace sensor. Refer to the instructions for the sensor being used.
LOW BATTERY
Battery charge is low.
Charge battery by placing the Radical-7
Handheld into the Docking Station and powering the unit with AC line power. Replace
battery if necessary.
LOW PERFUSION
Signal too small.
Move sensor to better perfused site. Refer to
Section 4, Low Perfusion.
LOW SIGNAL IQ
Low signal quality.
Ensure proper sensor application. Move
sensor to a better perfused site. Refer to
Section 4, Signal IQ.
LOW SpCO CONF
SpCo measurement
reading is obscured.
Ensure proper sensor application. Check
sensor to see if it is working properly. If not,
replace the sensor
LOW SpMet CONF
SpMet measurement
reading is obscured.
Ensure proper sensor application. Check
sensor to see if it is working properly. If not,
replace the sensor
1
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
RECOMMENDATION
Too much light on patient
(sensor). Inadequate
tissue covering sensor
detector.
Password Operation
The Radical-7 Pulse CO-Oximeter password is 2-3-1. To enter the password use the touchkey control buttons to the right or bottom of the LCD display and press the buttons in the
sequence shown in the following figure:
POSSIBLE CAUSE(S)
5
Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual
5-1
5
alarms and messages
MESSAGE
POSSIBLE CAUSE(S)
RECOMMENDATION
alarms and messages
3D Alarm System Option
Contact Masimo Tech Support. Refer to Section 9 Service and repair.
This section applies only if you have purchased the optional 3D Alarm System. Contact
Masimo if you are interested in purchasing this option.
Cable not attached or
not fully inserted into the
connector.
Disconnect and reconnect cable into connector.
Purpose
Sensor not fully inserted
into the connector.
Maybe an incorrect sensor, or a defective
sensor or cable. Insert sensor into connector. Disconnect and reconnect sensor. Refer
to the instructions for the sensor being used.
Unit is searching for
patient’s pulse.
Disconnect and reconnect the sensor into
the Patient Cable Connector.
PULSE SEARCH
Unit is searching for
patient’s pulse.
If values are not displayed within 30 seconds, disconnect and reconnect sensor. If
pulse search continues, remove sensor and
replace on a better perfused site.
SENSOR
CALIBRATING
Unit is checking the sensor for proper functioning
and performance.
If values are not displayed within 30
seconds, disconnect and reconnect sensor.
If values are still not displayed, replace with
a new sensor.
SPEAKER FAILURE Unit requires service
NO CABLE
NO SENSOR
The sensor has expeSENSOR CURRENT rienced a current limit
outside of its designed
LIMIT
range.
Replace the sensor. Refer to the instructions
for the sensor being used.
SENSOR LIFE
EXPIRED
The sensor is no longer
usable.
Replace the sensor. Refer to the instructions
for the sensor being used.
SENSOR OFF
Sensor off patient.
Disconnect and reconnect sensor.
Reattach sensor.
SERVICE REQUIRED*
Internal Failure.
Unit requires service.
UNRECOGNIZED
CABLE
Not a proper cable.
Replace with a proper cable. Refer to
Section 8.
5
The purpose of this section is to familiarize clinicians with the optional 3D Alarm System of
the Radical-7 Pulse CO-Oximeter .
3D Alarm System Overview
The Radical-7 Pulse CO-Oximeter includes user-selectable High and Low alarm limits for
SpO2 and pulse rate to provide audible and visual indication of specific levels of these vital
signs that the clinician has determined merits their attention as described in Section 4 of
this manual. The 3D Alarm System enables clinicians to be alerted to changes in multiple
interacting factors to provide an additional level of vigilance and flexibility to manage their
patients.
The following is a summary of each of the 3D Alarm System features:
DESAT INDEX ALARM
The Desat Index Alarm is a user-selectable feature which allows a clinician to request an
audible and visual alarm if a patient experiences a specified number of desaturations over
a specific period of time.
PERFUSION INDEX (PI) DELTA ALARM
The PI Delta Alarm is a user-selectable feature which allows a clinician to request an
audible and visual alarm if perfusion at the monitored site decreases by a specified level
(delta) over a specific period of time.
NOTE: The alarms in this option are considered to be Medium priority.
*The SERVICE REQUIRED message fills the entire display. This is a numeric error
code. Contact Masimo for service.
5-2
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5-3
5
alarms and messages
alarms and messages
Desat Index Alarm
USER INTERACTION TO IMPLEMENT DESAT INDEX ALARM
Traditional high and low SpO2 alarm limits alert clinicians to saturation levels that exceed
user-selected thresholds, and these thresholds are typically established at a considerable
change from the patients’ baseline saturation level. However, in select patient populations,
substantial desaturation events that exceed a typical low alarm limit threshold may be preceded by a cycle of transient desaturations over a limited timeframe, and the ability to alert
clinicians to a cycle of these smaller desaturations may provide an earlier indication of a
potential significant decline in the patient’s status and the need for more focused monitoring
and/or a change in treatment.
The Desat Index Alarm function is enabled in the Radical-7 by the following method:
To address patient populations at risk for cyclic, moderate desaturations, the 3D Alarm
System option includes a user-selectable Desat Index Alarm which allows the clinician to
request an audible and visual alarm in the event the patient experiences a specified number
of desaturations beyond a defined level from the patient’s baseline saturation over a specific window of time, with each of these variables selectable by the user within established
ranges as noted below:
Desat Index Threshold:
Range of 2% to 10% in 1% increments, default of 4%
Desat Index Timeframe:
Range of 1 to 4 Hrs in 1-Hr increments, default of 1 Hr
Desat Index Alarm/Quantity:
Range of 1 to 25 desaturations, default is OFF
To translate the above Desat Index variables and ranges into perspective, consider a patient
at risk of respiratory compromise with the definition for respiratory compromise of 5 or more
transient moderate desaturations (associated with a 4% drop in SpO2) per hour. To request
a Desat Index alarm for this situation, the clinician would set the Desat Index variables as
follows:
Desat Index Threshold:
4%
Desat Index Timeframe:
1 hour
Desat Index Alarm
5 (desaturations)
5
1. Select the 3D ALARMS menu from the main menu page.
2. Select Desat Index.
3. The Desat Index Aarm menu will be displayed and the user can select from the following entries:
Desat Index Threshold:
Range of 2% to 10% in 1% increments, default of 4%
Desat Index Time:
Range of 1 Hr to 4 Hrs in 1-HR increments, default
of 1 hr
Desat Index Alarm:
Range of 1 to 25 desaturations, default is OFF
If the measured Desat Index parameter is greater than the configured Desat Index
Alarm level selected, the Radical-7 will make a MEDIUM priority alarm tone and post an
alarm message as follows:
DESAT INDEX = ##
where ## is equal to the current Desat Index and updates real time.
If the Alarm Suspend key is pressed during the Desat Index alarm, the tone is silenced
and will not return when the Alarm Suspend time expires unless the condition is
removed and then returns. The message will remain on the screen until the Alarm
condition is removed.
Post-operative patients receiving pain medication may be predisposed to respiratory
depression. If the patient has an underlying respiratory condition, pain medication may
cause the patient to spiral into a cascade of cyclic desaturations, which initially are mild
but may worsen quickly. The Desat Index Alarm may give an early warning of this type of
respiratory disturbance that can lead to respiratory depression and even arrest.
CAUTION: THE DESAT INDEX ALARM IS INTENDED AS AN ADJUNCT RATHER THAN
IN PLACE OF THE LOW SATURATION ALARM
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5
alarms and messages
Perfusion Index (PI) Delta Alarm
Perfusion Index gives an indication of the level of perfusion at the monitored site. The
Radical-7 measures perfusion at the SpO2 site by comparing the pulsatile signal to the nonpulsatile signal, and expressing that ratio as a percentage. PI has been clinically proven to
be useful as a predictor of the level of illness in neonates and adults and that PI may change
dramatically in response to sympathetic changes caused by inhalational agents and pain
stimulation. If PI decreases over time, there may be underlying physiological reasons that
may need to be addressed.
The 3D Alarm System provides an audible and visual alert to important changes in perfusion compared to the patient’s baseline PI rate. The baseline is set by the Radical-7 once
the user has enabled the alarm. The baseline is 30 seconds of currently averaged PI. The
3D Alarm System option includes a user-selectable PI Delta Alarm. This allows the clinician
to request an audible and visual alarm if perfusion at the monitored site decreases by a
specified level (delta) over a specified window of time. Three of the variables are selectable
by the user within established ranges as noted below:
Set Baseline:
Select OFF or SET. Default is OFF.
PI Delta %
Change:
Range of 10% to 100%. Default is 50%
PI Delta Timeout
Range of 1 min, 5 min, 30 min, 1 hr. 4 hr, 8 hr, 12 hr, 24 hr, 36 hr, 48
hr and NONE. Default is NONE.
PI Delta Baseline
2. Select PI Delta.
3. The PI Delta Alarm menu will be displayed and the user can select from the following
entries:
5-6
PI DELTA = ##%
where ## is equal to the current PI Delta percentage and updates real time.
The PI trend graph will also display.
If the Alarm Suspend key is pressed during this alarm, the tone shall be silenced and not
returned when the Alarm Suspend time expires unless the condition is removed and then
returns. The message will remain on the screen until the Alarm condition is removed.
3D Alarm menu
PARAMETER
DESAT INDEX
ALARM
Set Baseline:
Select OFF or SET. Default is OFF.
PI Delta %
Change:
Range of 10% to 100%. Default is 50%
PI Delta Timeout
Range of 1 min, 5 min, 30 min, 1 hr. 4 hr, 8 hr, 12 hr, 24 hr, 36 hr, 48
hr and NONE. Default is NONE.
MENU ITEM
DESCRIPTION
DESAT
THRESHOLD
The Desat Threshold can be set in the range of 2%
to 10% in 1% increments. Default is 4%
DESAT INDEX The Desat Index Time can be set in the range of 1
TIME
Hr to 4 Hrs in 1-Hr increments. Default is 1 hr.
DESAT INDEX
ALARM
The Desat Index Alarm can be set in the range of
1 to 25 desaturations. Default is OFF.
The Set Baseline can be turned on by selecting
SET BASELINE SET. Selecting OFF disables the alarm. Default
is OFF.
NOTE: This is a Read Only display and not user interactive.
1. Select the 3D ALARMS menu from the main menu page.
5
If the PI Delta parameter is greater (more negative) than the configured PI Delta Alarm,
then the Radical-7 will make a MEDIUM priority alarm tone, and post an alarm message
as follows:
Displays OFF, the current PI baseline or TIMEOUT.
USER INTERACTION TO IMPLEMENT PI DELTA ALARM
The PI Delta Alarm function is enabled in the Radical-7 by the following method:
PI Delta Baseline
alarms and messages
PI DELTA
ALARM
PI DELTA %
CHANGE
The PI Delta % Change can be set in the range of
10% to 100%. Default is 50%.
PI DELTA
TIMEOUT
The PI Delta Timeout can be set in the range of
the following increments: 1 min, 5 min, 30 min, 1
hr. 4 hr, 8 hr, 12 hr, 24 hr, 36 hr, 48 hr and NONE.
Default is NONE.
PI DELTA
BASELINE
The PI Delta Baseline displays OFF, the current PI
baseline or TIMEOUT.
NOTE: This is a Read Only display and not user
interactive.
Displays OFF, the current PI baseline or TIMEOUT.
NOTE: This is a Read Only display and not user interactive.
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6
troubleshooting
Troubleshooting
The following chart describes what to do if the Radical-7 Pulse CO-Oximeter system
does not operate properly or fails.
PROBLEM
POSSIBLE CAUSE(S)
Low battery/ not plugged
into AC power supply
DIFFICULTY OR NO
SpCO/SpMet READING
Inappropriate sensor
RECOMMENDATION
Interference from line-frequency
induced noise.
Verify/set 50/60hz menu setting.
Refer to Section 3, Initial Setup for
details.
Verify use of an SpCO/SpMet
capable sensor.
Excessive motion
Minimize or eliminate motion at the
monitoring site.
Excessive ambient or
strobing light
Shield the sensor from excessive
light.
Also, see Section 4, Successful Monitoring for additional
information.
UNIT DOES NOT POWER One or both of the fuses
Replace the fuses.
ON.
have blown.
Use the Backlight/Contrast button
UNIT POWERS ON BUT
The viewing contrast is
to adjust the viewing angle. If the
THE GRAPHIC DISPLAY
not correct.
condition persists, the unit requires
IS BLANK.
service.
Unit requires service. Press the
Alarm Silence button to silence
CONTINUOUS SPEAKER
Internal failure.
the alarm. If alarm continues to
TONE.
sound, power down unit and remove
Handheld battery if necessary.
BUTTONS DON’T WORK
Internal failure.
Unit requires service.
WHEN PRESSED
The following chart describes what to do when encountering common problems:
PROBLEM
5-8
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
POSSIBLE CAUSE(S)
RECOMMENDATION
HANDHELD BATTERY
DOES NOT CHARGE
AC power cable may be
disconnected.
Restore power to the device.
PRINT FUNCTION DOES
NOT WORK
Wrong serial cable is
used.
LED LIGHTS ON LEFT
SIDE OF DOCKING STATION CONTINUOUSLY
FLASH
Incompatable version of
software on Radical-7
handheld and docking
station.
BATTERY RUN-TIME
IS SIGNIFICANTLY
REDUCED
Memory effects
Make sure a null modem cable is
used.
Upgrade to current software versions.
Match handheld to docking station
with compatable software versions.
Use Battery Discharge function as
described in Section 4, Service.
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
6-1
7
specifications
Radical-7 specifications
PERFORMANCE
Measurement Range
Oxygen Saturation (%SpO2):
Carboxyhemoglobin Saturation (%SpCO):
0-100%
Methemoglobin Saturation (%SpMet):
0-99.9%
Pulse Rate:
Perfusion Index:
Response Time:
0-99%
25-240 beats per minute (bpm)
0.02% - 20%
<1 second delay
ACCURACY
Saturation
70% to 100%
No Motion1
Adults, Pediatrics
Neonate2
±2 digits
±3 digits
Motion3
Adults, Pediatrics
Neonate
Low Perfusion4
Adults, Pediatrics
Neonate
Carboxyhemoglobin Saturation Accuracy (%SpCO)5
Methemoglobin Saturation Accuracy (%SpMet)5
Pulse Rate Accuracy10
Pulse rate:
No Motion1
Adults, Pediatrics, Neonate
Motion3
Adults, Pediatrics, Neonate
±3 digits
±3 digits
±2 digits
±3 digits
1% - 40% ±3 digits
1% - 15% ±1 digit
25-240 bpm
±3 digits
±5 digits
Low Perfusion4
Adults, Pediatrics, Neonate
Resolution
Saturation (%SpO2)
±3 digits
1%
Carboxyhemoglobin saturation (%SpCO), digital display
1%
Methemoglobin saturation (%SpMet), digital display
.1%
Pulse Rate (bpm)
1 bpm
ELECTRICAL
Standalone
AC Power requirements:
Power consumption:
Fuses:
100-240 VAC, 47-63 Hz
55 VA
1 Amp, Fast Acting, Metric, (5x20mm), 250V
Batteries
Handheld:
Type:
Capacity:
Charging time:
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
NiMH
4 hours6
3 hours
7-1
7
specifications
Docking Station (RDS-1B):
Type:
Capacity:
Charging time:
Display/Indicators
NiMH
10 hours6
6 hours
ENVIRONMENTAL
Operating Temperature:
Storage Temperature:
Operating Humidity:
Operating Altitude:
41°F to 104°F (5°C to 40°C)
-40°F to 158°F (-40°C to +70°C)7
5% to 95%, non-condensing
500 mbar to 1060 mbar pressure
-1000 ft to 18,000 ft (-304 m to 5,486 m)
Data display:
%SpO2, %SpCO, %SpMet, pulse rate, pleth waveform, alarm status, trends, status messages, Signal IQ, perfusion index, APOD and FastSat
Display update rate:
1 second
Display Color:
Multi-color
Type:
Backlit LCD
Pixels:
480 x 272 dots
Dot Pitch:
0.25 mm
Output Interface
SatShare (RDS-1, RDS-1B)
PHYSICAL CHARACTERISTICS
Serial RS-232 (RDS-1, RDS-1B, RDS-3)
Dimensions:
Handheld:
Standalone:
8.9” x 3.3” x 2.1” (22.6 cm x 8.4cm x 5.3 cm)
3.5” x 10.5” x 7.7” (8.9 cm x 26.7cm x 19.6cm)
Weight
Nurse Call/Analog Output (RDS-1, RDS-1B, RDS-3)
Philips Vuelink, Spacelabs Universal Flexport, RadNet, RadLink (RDS-1, RDS-1B, RDS-3)
Compliance
Handheld:
1.3 lbs. (0.59 kg)
EMC Compliance:
Docking Station (RDS-1, RDS-2, RDS-3):
2.5 lbs. (1.14 kg)
Equipment Classification:
Docking Station (RDS-1B):
4.11 lbs (1.86 kg)
Type of Protection
EN60601-1-2, Class B
IEC 60601-1 / UL 60601-1
Class 1 (on AC power), Internally powered (on battery power)
Standalone (RDS-1, RDS-2, RDS-3):
3.8 lbs. (1.73 kg)
Degree of Protection-Patient Cable:
Type BF-Applied Part
Standalone (RDS-1B):
5.4 lbs. (2.45 kg)
Degree of Protection-SatShare Cable:
Type CF-Applied Part
Trending
Mode of Operation:
72 hours of trending at 2 second resolution, up to 18 days of trending at 10 second resolution, output to
serial printer or other serial devices
1 The Radical-7 with LNOP Adt sensors has been validated for no motion accuracy 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
Pulse 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.
2 The Radical-7 with LNOP Neo sensors has been validated for no motion accuracy 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
Pulse 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. 1% has been added to the saturation accuracy to account for the effects of fetal
hemoglobin. This variation equals plus or minus one standard deviation, which encompasses 68% of the population.
3 The Radical-7 with LNOP Adt sensors has been validated for motion accuracy in human blood studies on healthy adult male and
female volunteers with light to dark skin pigmentation in induced hypoxia studies while performing rubbing and tapping motions, at 2
to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia
studies in the range of 70-100% SpO2 against a laboratory Pulse 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.
Mode
2, 4, 8,10, 12, 14 or 16 seconds8
Normal and Maximum9 and APOD
Averaging mode:
Sensitivity:
Alarms
Audible and visual alarms for high low saturation and pulse rate (SpO2 range 1-100%, pulse rate range
25-240 bpm, SpCO 1%-99%, SpMet 1%-99.9%)
Sensor condition, system failure and low battery alarms
High Priority:
571 Hz tone, 5 pulse burst, pulse spacing: 0.250s,
0.250s, 0.500s, 0.250s, repeat time:10s
Medium Priority:
550 Hz tone, 3 pulse burst, pulse spacing: 0.375s,
0.375s, repeat time: 7s
Low Priority:
500 Hz tone, 1 pulse burst, repeat time: 5s
Alarm Muted reminder:
Alarm Volume:
7-2
7
specifications
500Hz tone, 2 pulse burst, pulse spacing 0.375s,
repeat time: 3min.
High Priority: 70 dB (min),
Medium Priority: 70 dB (min),
Low Priority: 45 dB (min)
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
Continuous
4 The Radical-7 with SatShare has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and
Masimo’s simulator with signal strengths of greater than 0.02% and a % transmission of greater than 5% for saturations ranging from
70 to 100%. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of
the population.
5 SpCO and SpMet accuracy has been validated on healthy adult male and female volunteers with light to dark skin pigmentation in
the range of 0% - 40% SpCO and 0% - 15% SpMet against a laboratory Pulse CO-Oximeter. This variation equals plus or minus one
standard deviation, which encompasses 68% of the population. The SpCO accuracy and SpMet accuracy have not been validated
under motion conditions.
6 This represents approximate run time with the backlight at minimum and Power Save mode on, using a new, fully charged battery.
7 If the batteries are to be stored for extended periods of time, it is recommended that they be stored between -20°C to +30°C, and at a
relative humidity less than 85%. If stored for a prolonged period at environmental conditions beyond these limits, overall battery capacity
may be diminished, and lifetime of the batteries may be shortened.
8 With FastSat the averaging time is dependent on the input signal. For the 2 and 4 second settings the averaging time may range from
2-4 and 4-6 seconds, respectively.
9 Maximum sensitivity mode fixes perfusion limit to 0.02%.
10 Masimo Rainbow SET technology with LNOP, LNOPv and LNCS sensors has been validated for pulse rate accuracy for the range of
25-240 bpm in bench top testing against a Biotek Index 2 simulator. This variation equals plus or minus one standard deviation which
encompasses 68% of the population.
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
7-3
7
specifications
Serial interface specifications
The digital interface for serial communication is based on the standard RS-232 protocol.
The Radical-7 Pulse CO-Oximeter by default always outputs ASCII 1 text data through
the serial port, unless the user selects a different output mode in the Output menu. To
interface with the Radical-7 Pulse CO-Oximeter and receive serial text data, simply connect a serial interface cable with a ferrite bead installed to the serial output connector
located on the back of the Radical-7 Docking Station.
NOTE: The Radical-7 Pulse CO-Oximeter serial interface is only available when the
Radical-7 Pulse CO-Oximeter Handheld is properly attached to the Radical-7 Pulse COOximeter Docking Station.
NOTE: The serial interface is not available in all versions of the docking station.
Once serial communication is established, packets of data are communicated at 1 second intervals. The data packets contain: the date, time, SpO2, pulse rate, perfusion index
and alarm and exception values. (in ASCII format).
WARNING: ALL EXTERNAL DEVICE CONNECTIONS TO THE ANALOG OUTPUT/ NURSE CALL CONNECTOR MUST BE IEC-60950
COMPLIANT.
SERIAL INTERFACE SETUP
To interface with the Radical-7 Pulse CO-Oximeter serial port, set the following communication parameters on the interfacing serial device:
PARAMETER
7-4
7
specifications
The pin-outs for the RS-232 connector are shown in the following table:
PIN
SIGNAL NAME
1
No Connection
2
Receive data – RS-232 ±9 V (±5 Vmin)
3
Transmit data – RS-232 ±9 V (±5 Vmin)
4
No Connection
5
Signal Ground Reference for COM signals
6
No Connection
7
No Connection
8
No Connection
9
No Connection
SERIAL PRINTER SETUP
To print the SpO2 and pulse rate data in ASCII 1 format on a serial printer, simply connect
the laser printer to the serial port. Once serial communication is established, the Radical7 Pulse CO-Oximeter will automatically start printing the ASCII 1 text data.
WARNING: ALL EXTERNAL DEVICE CONNECTIONS TO THE RS-232 SERIAL
PORT MUST BE IEC-60950 COMPLIANT.
SETTING
BAUD RATE
9600 Baud bi-directional
NUMBER OF BITS PER CHARACTER
8
PARITY
None
BITS
1 start, 1 stop
HANDSHAKING
None
CONNECTOR TYPE
Female DB-9
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
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7
specifications
Analog Output / Nurse Call Specifications
The Analog Out and Nurse Call are features accessible on the same female high density
DB-15 connector.
NOTE: The Radical-7 Pulse CO-Oximeter analog output / nurse call interface is only
available when the Radical-7 Pulse CO-Oximeter Handheld is properly attached to the
Radical-7 Pulse CO-Oximeterocking Station. Only use an analog / nurse call cable that
has a ferrite bead installed.
NOTE: The analog output / nurse call interface is not available in all versions of the
Docking Station.
The following table shows the pinout of the analog output and nurse call.
PIN
SIGNAL NAME
1
+5V (60mA max.)
2
Ground
3
Ground
4
Ground
5
Ground
6
Nurse Call (Normally Open)
7
Nurse Call (Normally Closed)
8
Ground
9
Analog 1
10
Ground
11
Ground
12
Nurse Call – Common
13
Ground
14
Ground
15
Analog 2
7
specifications
ANALOG OUTPUT
The Radical-7 Pulse CO-Oximeter can interface with various analog recording devices
and/or strip chart recorders through its Analog Output connector located on the back of the
Docking Station. Depending on the configuration of the Output menu, the following parameters are output continuously on the Analog 1 and Analog 2 channels:
■
SpO2
■
SpCO
■
SpMet
■
Pulse rate
■
Pleth waveform
■
Signal IQ
The output signals vary from approximately 0 to 1 volt in a linear fashion.
NOTE: The actual Analog 1 and Analog 2 output voltage that are generated may not
exactly range between 0.0V to 1.0V. A variance of ± 40 mV is acceptable.
CALIBRATION
For measurement device calibration purposes, the analog output signals can be set to
either 0 Volts or 1 Volt in the menu system under Output/Analog Output Mode. Calibrate
your analog recording system to those levels before use.
NURSE CALL
The nurse call feature is available when Radical-7 Pulse CO-Oximeter is operating in its
standalone configuration. The nurse call feature on the Radical-7 Pulse CO-Oximeter is
based on the relay closing or opening depending on alarm, Low Signal IQ events or both.
For maximum flexibility, either normally open (pin 6) or normally closed (pin 7) signals
are available. Only qualified personnel should connect one of these two signals and
common (pin 12) to a hospital’s nurse call system. During an alarm condition, or a Low
Signal IQ event, depending on the configuration of the output menu, the normally open
pin will be connected to the common pin and the normally closed will be disconnected.
In addition the nurse call polarity can be inverted to accommodate various nurse call
stations requirements.
The nurse call relays have the following electrical specifications per switch:
PARAMETER
SPECIFICATION
MAX VOLTAGE
100VDC or AC peak
MAX CURRENT
100mA
WARNING: THE NURSE CALL FEATURE IS DISABLED WHEN THE AUDIBLE
ALARMS ARE SILENCED WHILE THE NURSE CALL SETTING IN
THE OUTPUT MENU IS SET TO “ALARMS”.
7-6
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
7-7
sensors & patient cables
8
Introduction
This section covers the use and cleaning of Masimo sensors and patient cables.
Before use of any sensor, carefully read the sensor’s Directions for Use.
Use only Masimo oximetry sensors and cables for SpO2, SpCO and SpMet measurements. Other oxygen transducers or sensors may cause improper Radical-7 Pulse
CO-Oximeter performance.
Tissue damage can be caused by incorrect application or use of a sensor, for example
by wrapping the sensor too tightly. Inspect the sensor site as directed in the sensor
Directions for Use to ensure skin integrity, correct positioning and adhesion of the sensor.
CAUTIONS:
■
DO NOT USE DAMAGED SENSORS OR PATIENT CABLES. DO NOT USE A
SENSOR OR PATIENT CABLE WITH EXPOSED OPTICAL OR ELECTRICAL
COMPONENTS.
■
DO NOT IMMERSE THE SENSOR OR PATIENT CABLE IN WATER, SOLVENTS,
OR CLEANING SOLUTIONS (THE SENSORS AND CONNECTORS ARE NOT
WATERPROOF).
■
UNLESS OTHERWISE SPECIFIED, DO NOT STERILIZE SENSORS OR PATIENT
CABLES BY IRRADIATION, STEAM, AUTOCLAVE OR ETHYLENE OXIDE. SEE
THE CLEANING INSTRUCTIONS IN THE DIRECTIONS FOR USE FOR REUSABLE MASIMO SENSORS.
■
DO NOT REPROCESS ANY MASIMO SET PATIENT CABLES OR SINGLE USE
SENSORS.
■
ALL SENSORS AND CABLES ARE DESIGNED FOR USE WITH SPECIFIC
MONITORS. VERIFY THE COMPATIBILIY OF THE MONITOR, CABLE AND
SENSOR BEFORE USE, OTHERWISE PATIENT INJURY CAN RESULT.
SELECTING A MASIMO SET SENSOR
When selecting a sensor, consider, the patient’s weight, the adequacy of perfusion, the
available sensor sites, and the duration of monitoring. For more information refer to the
following table or contact your Sales Representative. Use only Masimo sensors and sensor cables. Select an appropriate sensor, apply it as directed, and observe all warnings
and cautions presented in the Directions for Use accompanying the sensor.
High intensity extreme lights (such as pulsating strobe lights) directed on the 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.
SENSOR APPLICATION INSTRUCTIONS
Unless indicated otherwise in the directions for use, reposition reusable sensors at least
every 4 hours and for adhesive sensors inspect the site at least every 8 hours or sooner. If
indicated by circulatory condition or skin integrity, reapply to a different monitoring site.
7-8
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8
sensors & patient cables
Masimo Rainbow Sensors
Masimo SpO2 Sensors
Masimo Rainbow sensors must be used with the Radical-7 Pulse CO-Oximeter to enable
measurement of Carboxyhemoglobin (SpCO) and Methemoglobin (SpMet). Rainbow sensors will only function with instruments containing Masimo Rainbow SET Technology or
licensed to use Rainbow compatible sensors.
The Radical-7 Pulse CO-Oximeter may use standard Masimo LNOP, LNOPv and LNCS
SpO2 sensors, when used with Red PC, Red LNC or Rainbow Patient Cables respectively.
Rainbow sensors connect to the device directly or with a patient cable.
RED REUSABLE SENSORS
(Red DC-I and DC-IP sensors must be used in conjunction with Red PC cables)
RAINBOW REUSABLE SENSORS
SpO2 and pulse rate accuracy for the Rainbow sensors is specified in the following table.
SENSOR
Weight
Range
DCI
> 30 kg
DCIP
10 - 50 kg
Saturation
Pulse Rate
Low Perfusion
SpCO
SpMet
Accuracy Accuracy
Accuracy
Accuracy
Accuracy
No
No
Pulse
No
No
Motion
Motion Saturation
Motion
Motion
Motion
Motion
Rate
± 2%
± 3% ± 3 bpm ± 5 bpm
± 2%
± 3 bpm
± 3%
± 1%
± 2%
± 3%
± 3 bpm ± 5 bpm
± 2%
± 3 bpm
± 3%
± 1%
RAINBOW ADHESIVE SENSORS
SpO2 and pulse rate accuracy for the Rainbow sensors is specified in the following table.
SENSOR
Weight
Range
Saturation
Accuracy
No Motion
R25-L
R20-L
8-2
8
sensors & patient cables
Motion
Pulse Rate
Accuracy
No
Motion
Motion Saturation
60 - 80% ± 3%
± 3% ± 3 bpm ± 5 bpm
70 - 100% ± 2%
60 - 80% ± 3%
± 3% ± 3 bpm ± 5 bpm
3 - 10 kg
70 - 100% ± 2%
60
80%
±
3%
10 - 30
± 3% ± 3 bpm ± 5 bpm
kg 70 - 100% ± 2%
> 30 kg
Low Perfusion
Accuracy
± 2%
± 2%
± 2%
SpCO
Accuracy
SpMet
Accuracy
Pulse
No Motion No Motion
Rate
± 3 bpm
± 3 bpm
± 3 bpm
± 3.5%
± 3.5%
± 3.5%
± 1%
± 1%
± 1%
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
Select the appropriate patient cable to attach the LNOP or LNCS sensor to the device.
Masimo Red sensors can be used with the Radical-7 Pulse CO-Oximeter to enable measurement of
SpO2 only. Red sensors will only function with oximeter devices equipped with Masimo Rainbow SET
technology.
SENSOR
Weight
Range
DCI
> 30 kg
DCIP
10 - 50 kg
Saturation Accuracy
No Motion
Motion
± 2%
± 3%
± 2%
± 3%
Pulse Rate Accuracy
No Motion Motion
± 3 bpm
± 5 bpm
± 3 bpm
± 5 bpm
Low Perfusion Accuracy
Saturation Pulse Rate
± 2%
± 3 bpm
± 2%
± 3 bpm
LNOP® REUSABLE SENSORS
(LNOP sensors must be used in conjunction with Red PC cables)
SENSOR
Weight
Range
Saturation Accuracy
No Motion
Motion
± 2%
± 3%
Pulse Rate Accuracy
No Motion Motion
± 3 bpm
± 5 bpm
Low Perfusion Accuracy
Saturation Pulse Rate
± 2%
± 3 bpm
LNOP DCI
> 30 kg
LNOP DCIP
10 - 50 kg
± 2%
± 3%
± 3 bpm
± 5 bpm
± 2%
LNOP YI
> 1 kg
± 2%
± 3%
± 3 bpm
± 5 bpm
N/A
N/A
LNOP TC-I
> 30 kg
± 3.5%
N/A
± 3 bpm
N/A
± 3.5%
± 3 bpm
± 3 bpm
LNOP DC-195
> 30 kg
± 2%
± 3%
± 3 bpm
± 5 bpm
± 2%
± 3 bpm
LNOP TF-I
> 30 kg
± 2%
N/A
± 3 bpm
N/A
± 2%
± 3 bpm
NOTE: The LNOP TF-I and TC-I sensors were not validated under motion conditions.
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
8-3
8
sensors & patient cables
®
TM
LNOP ADHESIVE SENSORS
(LNOP sensors must be used in conjunction with PC cables)
SENSOR
Weight
Range
Saturation Accuracy
No Motion
Motion
± 2%
± 3%
8
sensors & patient cables
LNCS ADHESIVE SENSORS
(LNCS sensors must be used in conjunction with LNC or Rainbow cables)
Pulse Rate Accuracy
No Motion Motion
± 3 bpm
± 5 bpm
Low Perfusion Accuracy
Saturation Pulse Rate
± 2%
± 3 bpm
SENSOR
Weight
Range
Saturation Accuracy
No Motion
Motion
± 2%
± 3%
Pulse Rate Accuracy
No Motion Motion
± 3 bpm
± 5 bpm
Low Perfusion Accuracy
Saturation Pulse Rate
± 2%
± 3 bpm
LNOP Adt
> 30 kg
LNCS Adtx
> 30 kg
LNOP Adtx
> 30 kg
± 2%
± 3%
± 3 bpm
± 5 bpm
± 2%
± 3 bpm
LNCS Pdtx
10 - 50 kg
± 2%
± 3%
± 3 bpm
± 5 bpm
± 2%
LNOP Pdt
10 - 50 kg
± 2%
± 3%
± 3 bpm
± 5 bpm
± 2%
± 3 bpm
LNCS Inf-L
3 - 20 kg
± 2%
± 3%
± 3 bpm
± 5 bpm
± 2%
± 3 bpm
LNOP Pdtx
10 - 50 kg
± 2%
± 3%
± 3 bpm
± 5 bpm
± 2%
± 3 bpm
± 3%
± 3%
± 3 bpm
± 5 bpm
± 3%
± 3 bpm
LNOP Neo
< 10 kg
± 3%
± 3%
± 3 bpm
± 5 bpm
± 3%
± 3 bpm
LNCS Neo-L
< 3 kg
> 40 kg
± 2%
± 3%
± 3 bpm
± 5 bpm
± 2%
± 3 bpm
LNOP NeoPt
< 1 kg
± 3%
± 3%
± 3 bpm
± 5 bpm
± 3%
± 3 bpm
LNCS NeoPt-L
< 1 kg
± 3%
± 3%
± 3 bpm
± 5 bpm
± 3%
± 3 bpm
< 3 kg
± 3%
± 3%
± 3 bpm
± 5 bpm
± 3%
± 3 bpm
> 40 kg
± 2%
± 3%
± 3 bpm
± 5 bpm
± 2%
± 3 bpm
LNOP Neo-L
LNOP NeoPt-L
LNOP Inf-L
< 1 kg
± 3%
± 3%
± 3 bpm
± 5 bpm
± 3%
± 3 bpm
3 - 20 kg
± 2%
± 3%
± 3 bpm
± 5 bpm
± 2%
± 3 bpm
TM
LNOPv ADHESIVE SENSORS
(LNOPv sensors must be used in conjunction with PC cables)
SENSOR
®
LNOP SPECIALTY SENSORS
(LNOP sensors must be used in conjunction with PC cables)
SENSOR
LNOP
Newborn
Infant
LNOP
Newborn
Neonatal
SENSOR
Weight
Range
3 - 10 kg
Saturation Accuracy
No Motion
Motion
± 2%
± 3%
Pulse Rate Accuracy
No Motion Motion
± 3 bpm
± 5 bpm
LNOPv In
Low Perfusion Accuracy
Saturation Pulse Rate
± 2%
± 3 bpm
10 - 30 kg
± 2%
± 3%
± 3 bpm
± 5 bpm
± 2%
± 3 bpm
< 3 kg
± 3%
± 3%
± 3 bpm
± 5 bpm
± 3%
± 3 bpm
> 30 kg
± 2%
± 3%
± 3 bpm
± 5 bpm
± 2%
± 3 bpm
Weight
Range
Saturation Accuracy
No Motion
Motion No Motion
60 - 80% ± 4%
LNOP Blue 2.5 - 30 kg 70 - 100% ± 3.3%
80 - 100% ± 3%
Pulse Rate
Accuracy
± 3 bpm
Weight
Range
3 - 20 kg
Saturation Accuracy
No Motion
Motion
± 2%
± 3%
Pulse Rate Accuracy
No Motion Motion
± 3 bpm
± 5 bpm
Low Perfusion Accuracy
Saturation Pulse Rate
± 2%
± 3 bpm
LNOPv Ne
< 3 kg
± 3%
± 3%
± 3 bpm
± 5 bpm
± 3%
LNOPv Ad
> 30 kg
± 2%
± 3%
± 3 bpm
± 5 bpm
± 2%
± 3 bpm
LNOPv Ne
> 30 kg
± 2%
± 3%
± 3 bpm
± 5 bpm
± 2%
± 3 bpm
10 - 50 kg
± 2%
± 3%
± 3 bpm
± 5 bpm
± 2%
± 3 bpm
LNOPv Pd-L
± 3 bpm
Low Perfusion Accuracy
Motion
Saturation
Pulse Rate
N/A
± 3 bpm
N/A
± 3%
± 3 bpm
N/A
± 3 bpm
N/A
± 3%
± 3 bpm
N/A
± 3 bpm
N/A
± 3%
± 3 bpm
TM
LNCS REUSABLE SENSORS
(LNCS sensors must be used in conjunction with LNC or Rainbow cables)
SENSOR
Weight
Range
Saturation Accuracy
No Motion
Motion
± 2%
± 3%
Pulse Rate Accuracy
No Motion Motion
± 3 bpm
± 5 bpm
Low Perfusion Accuracy
Saturation Pulse Rate
± 2%
± 3 bpm
LNCS DC-I
> 30 kg
LNCS DC-IP
10 - 50 kg
± 2%
± 3%
± 3 bpm
± 5 bpm
± 2%
± 3 bpm
LNCS TC-I
> 30 kg
± 3.5%
N/A
± 3 bpm
N/A
± 3.5%
± 3 bpm
LNCS TF-I
> 30 kg
± 2%
N/A
± 3 bpm
N/A
± 2%
± 3 bpm
Note: The LNCS TF-I and TC-I sensors were not validated under motion conditions.
8-4
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8-5
8
sensors & patient cables
SENSOR ACCURACY
Refer to Section 7, Specifications for SpO2, SpMet, SpCO and pulse rate accuracy, unless
otherwise specified in the tables above.
Accuracy specified when used with Masimo Rainbow SET technology Pulse CO-Oximetry
monitors or with licensed Masimo SET pulse oximetry modules during no motion. Numbers
represent ± 1 standard deviation. Plus or minus one standard deviation represents 68%
of the population. SpO2 accuracy from 70% to 100%. Pulse rate accuracy from 25 to 240
bpm, SpCO accuracy from 1% to 40% and SpMet accuracy from 1% to 15%.
CLEANING AND REUSE OF MASIMO REUSABLE SENSORS AND CABLES
Reusable sensors and patient cables can be cleaned per the following procedure:
1.
Remove the sensor from the patient.
2.
Disconnect the sensor from the patient cable.
3.
Disconnect the patient cable from the monitor.
4.
Wipe the entire sensor and/or patient cable clean with a 70% isopropyl alcohol pad.
5.
Allow to air dry thoroughly before returning it to operation.
service / maintenance
9
Introduction
This section covers:
■
How to test the operation of the Radical-7 Pulse CO-Oximeter and the SatShare
interface
■
How to properly clean the Radical-7 Pulse CO-Oximeter
■
How to recharge and replace the batteries
■
How to replace the fuses
■
How to obtain service
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: ELECTRICAL SHOCK AND FLAMMABILITY HAZARD - BEFORE
CLEANING THE OXIMETER, ALWAYS TURN IT OFF AND DISCONNECT THE POWER CORD FROM THE AC POWER SUPPLY.
CAUTION: CAREFULLY ROUTE PATIENT CABLES TO REDUCE THE POSSIBILITY
OF PATIENT ENTANGLEMENT OR STRANGULATION.
Cleaning
REATTACHMENT OF SINGLE USE ADHESIVE SENSORS
■
Single use sensors may be reapplied to the same patient if the emitter and detector
windows are clear and the adhesive still adheres to the skin.
NOTE: If the sensor fails to track the pulse consistently, the sensors may be incorrectly
positioned. Reposition the sensor or choose a different monitoring site.
CAUTION: DO NOT REPROCESS ANY MASIMO SINGLE USE SENSORS.
To clean the display panel, use a cotton swab moistened with 70% isopropyl alcohol and
gently wipe the panel.
To clean the outer surface of the oximeter, use a soft cloth dampened with a mild soap and
water. Do not allow liquids to enter the interior of the instrument.
CAUTIONS:
■
DO NOT AUTOCLAVE, PRESSURE STERILIZE, OR GAS STERILIZE THIS
OXIMETER..
■
DO NOT SOAK OR IMMERSE THE MONITOR IN ANY LIQUID.
■
USE THE CLEANING SOLUTION SPARINGLY. EXCESSIVE SOLUTION CAN FLOW
INTO THE MONITOR AND CAUSE DAMAGE TO INTERNAL COMPONENTS.
■
DO NOT TOUCH, PRESS, OR RUB THE DISPLAY PANELS WITH ABRASIVE
CLEANING COMPOUNDS, INSTRUMENTS, BRUSHES, ROUGH-SURFACE
MATERIALS, OR BRING THEM INTO CONTACT WITH ANYTHING THAT COULD
SCRATCH THE PANEL.
■
DO NOT USE PETROLEUM-BASED OR ACETONE SOLUTIONS, OR OTHER
HARSH SOLVENTS, TO CLEAN THE OXIMETER. THESE SUBSTANCES ATTACK
THE DEVICE’S MATERIALS AND DEVICE FAILURE CAN RESULT.
Refer to Section 8, Cleaning and Reuse of Masimo Sensors for cleaning instructions of
the sensor.
8-6
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9
service / maintenance
Battery Operation and Maintenance
The Radical-7 Pulse CO-Oximeter Handheld includes a 1.5 Amp-Hour Nickel Metal
Hydride battery. The Radical-7 Pulse CO-Oximeter Docking Station may include the
optional 6.5 Amp-Hour Nickel Metal Hydride battery.
Before using the Radical-7 Pulse CO-Oximeter as a Handheld or transport monitor, the
Handheld battery and the optional Docking Station battery need to be fully charged.
To charge the battery(s), attach the Handheld unit to the Docking Station. Ensure that AC
power is attached to the Docking Station. Verify that the battery(s) are charging; the battery charging LED indicators on the Docking Station flash prior to charging and remain
illuminated while the battery(s) are charging. A continuously flashing battery charging
LED indicates that the internal battery temperature exceeds recommended operating
conditions for proper battery charging. Proper battery charging will proceed when the
temperature returns to recommended operating conditions.
The Handheld battery requires approximately 2 to 3 hours for charging. The optional
Docking Station battery requires approximately 6 hours for charging.
When the battery charging LED indicators turn off, additional trickle charging may occur
to complete charging. Although battery charging can occur while the Handheld is docked
and powered on, most efficient charge times are achieved with the Handheld unit turned
off.
CAUTIONS:
■
ALL BATTERIES LOSE CAPACITY WITH AGE, THUS THE AMOUNT OF RUN
TIME LEFT AT LOW BATTERY WILL VARY DEPENDING UPON THE AGE OF
THE BATTERY.
■
AT LOW BATTERY CONNECT THE RADICAL-7 PULSE CO-OXIMETER TO AC
POWER TO PREVENT LOSS OF POWER.
CAUTION:
■
IF THE RADICAL-7 PULSE CO-OXIMETER HANDHELD HAS NOT BEEN USED
OR CHARGED WITHIN SEVEN (7) DAYS OR MORE, THEN RECHARGE THE
BATTERY PRIOR TO USE.
■
IT IS RECOMMENDED THAT THE RADICAL-7 PULSE CO-OXIMETER HANDHELD
IS DOCKED TO THE DOCKING STATION ATTACHED TO AN AC POWER SOURCE
WHEN IT IS NOT IN USE TO ENSURE THAT THE BATTERY REMAINS FULLY
CHARGED.
The following tables outline the estimated run times of the battery powered Radical-7 Pulse
CO-Oximeter. The time estimates are based on a Radical-7 Pulse CO-Oximeter with fully
charged batteries. The time estimates are also based on a Radical-7 with and without
backlight lit, and the power save feature enabled and disabled.
The Radical-7 Pulse CO-Oximeter is always configured to include the Handheld battery. It
may optionally be configured to include the Docking Station battery. Please determine the
configuration of your system before referencing the following tables.
Configuration #1:
Radical-7 Pulse CO-Oximeter configured to only include the Handheld battery (standard
configuration); the Docking Station battery is excluded.
NOTE: For this configuration, it is advisable to operate only the Radical-7 Handheld unit
when running on battery power. Although it is possible to operate the entire Standalone
unit (the Handheld attached to the Docking Station, with the Handheld battery powering
the Docking Station as well) on battery power, the capacity of the Handheld battery pack
is insufficient to support this mode for long periods of time. The Power Save setting in the
General menu determines whether the Docking Station is powered or not during battery
operation. See Section 4, General, for a detailed description on proper use of the Power
Save setting.
During battery operation of the Radical-7 Pulse CO-Oximeter, please note that the following operating conditions affect the estimated run-time of the included batteries:
RADICAL-7
CONFIGURATION
■
ILLUMINATION OF THE BACKLIT LCD SCREEN. TO CONSERVE BATTERY
POWER, KEEP THE BACKLIT LCD SCREEN AT MINIMUM ILLUMINATION.
HANDHELD ONLY
Power Save “yes”
Backlight turned “off”
4 hrs
■
VOLUME OF THE ALARM TONES. TO CONSERVE BATTERY POWER, KEEP
THE FREQUENCY OF THE AUDIBLE ALARMS TO A MINIMUM AND AT MINIMUM VOLUME.
STANDALONE
Power Save “no”
Backlight turned “on”
1 hr
■
THE SATSHARE FEATURE. TO CONSERVE BATTERY POWER, ALWAYS KEEP
THE UNIT ON AC LINE POWER.
Memory effects of the battery pack may shorten run-time. When battery run time is
significantly reduced, it is advisable to completely discharge and fully recharge the battery pack. To properly discharge the battery pack, use the Battery Discharge function as
described in Section 4, under Service.
9-2
9
service / maintenance
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
OPERATION MODE
MINIMUM RUN-TIME
CONFIGURATION #2:
Radical-7 configured to include the Handheld and the Docking Station battery:
RADICAL-7
CONFIGURATION
OPERATION MODE
MINIMUM RUN-TIME
STANDALONE
Power Save “yes”
Backlight turned “off”
4 hrs
STANDALONE
Power Save “no”
Backlight turned “on”
1 hr
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9
service / maintenance
service / maintenance
REPLACING THE BATTERIES
REPLACING THE FUSES
■
Should a power problem blow one or both of the fuses in the power entry module on the
rear panel, the fuse(s) will need to be replaced.
Before installing or removing the battery, make sure the AC power cord is removed
and power to the Pulse CO-Oximeter is turned off.
To replace the Handheld battery, follow these instructions:
To replace the fuse(s), you will need a flat-blade screwdriver (5mm; 3/16”).
1.
To replace the fuses:
2.
Turn the Radical-7 Pulse CO-Oximeter Handheld off and remove the patient cable
connection. Detach the Radical-7 Pulse CO-Oximeter Handheld from the Docking
Station (if docked).
Loosen the closure screw on the battery compartment door and lift out the battery.
3.
Take a new battery, and place it in the compartment.
4.
Tighten the closure screw.
5.
Place Handheld into Docking Station, turn on line power and charge battery according
to this Section, Battery Operation and Maintenance.
CAUTION: FOLLOW LOCAL GOVERNING GUIDELINES FOR PROPER DISPOSAL
OF INTERNAL BATTERIES. DO NOT INCINERATE.
WARNING: THE DOCKING STATION BATTERY SHOULD BE INSTALLED AND/
OR REMOVED FROM DOCKING STATION BY QUALIFIED
PERSONNEL ONLY.
1.
Disconnect unit from AC power.
2.
Remove AC power cord from the power entry module at the rear of the docking station.
3.
Use the small flat-blade screwdriver and gently pry loose the fuse cover in the left
portion of the power entry module, exposing the fuse holder.
4.
Using the small flat-blade screwdriver, gently pry out the fuse holder.
5.
Note how the fuse(s) are placed in the fuse holder for installation of the new fuse(s).
6.
To remove the fuses from the fuse holder, use the edge of the screwdriver blade to
pry against the bottom of the metal portion of the fuse where it is secured to the glass
portion of the fuse.
7.
Place the fuse(s) (1 Amp, Metric, fast acting, 5x20mm, 250V) in the fuse holder,
properly orienting the fuse(s).
8.
Slide the fuse holder back into the power entry module and press firmly to make sure
it is completely seated.
9.
Close the fuse cover and press gently until it seats completely, flush with the back of
the docking station.
9
10. The unit is ready to be reconnected to AC power.
NOTE: If the fuses blow shortly after replacement, the unit requires service.
WARNING: FIRE HAZARD: TO PROTECT AGAINST FIRE HAZARD, REPLACE
ONLY WITH FUSES OF THE SAME TYPE, CURRENT RATING, AND
VOLTAGE RATING.
Performance verification
To test the performance of the Radical-7 Pulse CO-Oximeter following repairs or during
routine maintenance, follow the procedure outlined in this section. If the Radical-7 Pulse
CO-Oximeter fails any of the described tests, discontinue its use and correct the problem
before returning the unit back to the user.
Before performing the following tests place the Radical-7 Pulse CO-Oximeter Handheld
into the Docking Station, connect the Radical-7 to AC power and fully charge the Radical-7
Pulse CO-Oximeter Handheld battery. Also disconnect any patient cables or pulse oximetry
probes, as well as SatShare, serial or analog output cables from the instrument. Set the
Radical-7 Pulse CO-Oximeter to normal operating mode by selecting the Home Use parameter in the General Menu to “No”.
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9
service / maintenance
Power-On Self-Test:
Testing with Masimo SET Tester (Optional):
1.
Connect the monitor to AC power and verify that the AC Power Indicator is lit.
1.
Turn the Radical-7 off and then on again.
2.
Turn the monitor on by depressing the Power/Standby Button. Within 5 seconds all
available LEDs are illuminated, a 1-second beep tone sounds, and the Masimo SET
logo is displayed.
2.
Set the alarm limits to:
3.
9
service / maintenance
The blue Docking Indicator LED is illuminated and the Radical-7 begins normal operation.
% SpO2
PULSE RATE
High
100
140
Low
90
50
3.Connect the Masimo SET Tester to the Red Patient Cable Connecter.
Key Press Button Test:
1.
With the exception of the Power/Standby Button, press each soft key button and verify
that the Radical-7 acknowledges each key-press with an audible beep tone or by
indicating a change on the display.
4.
5.
Verify that the SpO2 measurement is between 79% and 84%.
6.
Verify that the pulse rate measurement is between 55 bpm and 65 bpm.
7.
Verify that an audible alarm occurs and that the SpO2 measurement and the low
SpO2 alarm are flashing
With the monitor turned on, select the Menu Access key and enter the Alarm menu.
Change the High SpO2 Alarm parameter to a value two points below the currently
selected value, and accept the change.
8.
Press the Alarm Silence button once and verify that the alarm is silenced.
9.
Wait 120 seconds and verify that the alarm silence times out and the audible alarm
is activated again.
2.
Verify that the newly set parameter is shown on the Saturation Alarm Limit Display,
next to the SpO2 or pulse rate measurement display.
10. Press the Increase Loudness button several times and verify that the loudness of the
pulse beep tone increases.
3.
Return the High Saturation Alarm parameter to its original setting.
4.
Repeat steps 1 to 3 for the following alarm parameters:
■
Low SpO2
11. Press the Decrease Loudness button and verify that the loudness of the pulse beep
tone decreases. Press the Decrease Loudness button and verify that the loudness of
the pulse beep tone can be turned off.
■
High and Low BPM
■
High and Low SpMet
■
High and Low SpCO
5.
Reset the alarm limits again to the original settings.
Alarm Limit Test:
1.
Nurse Call Test:
1.
Disconnect the Red patient cable or the Masimo SET Tester from the Radical-7 and
turn the instrument on. Ensure that there are no audible alarms and that the audible
alarms are not silenced. Verify the nurse call polarity is set to normal (default).
2.
Connect the common lead of a digital multi-meter to the pin 12 (Nurse Call Common) of the analog output connector on the Radical. Connect the positive lead of
the multi-meter to pin 6 (Nurse Call - Normally Open) of the analog output connector
and measure that the resistance is greater than 1 MW (open circuit).
3.
Trigger an alarm on the monitor (e.g. by disconnecting a sensor after it was measuring data) and verify that the resistance is less than 35 ohms.
Display Contrast Test:
9-6
Verify that within 20 seconds a plethysmographic and a Signal IQ waveform displays.
(may require the Radical-7 to be set to the Pleth and Signal IQ display setting).
1.
With the monitor turned on, select the Menu Access key and enter the Display menu.
Change the Contrast parameter by scrolling through the contrast settings.
2.
Return the Contrast setting to the original value, or a value that allows maximum viewing contrast.
3.
Exit the Menu system and press and hold down the Backlight/Contrast button for
several seconds. The display will scroll again through all the contrast settings.
4.
Release the Backlight/Contrast button again when the display shows maximum viewing contrast.
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9
service / maintenance
service / maintenance
Analog Output Test
Service and repair
1.
Disconnect all patient cables and sensors from the Radical-7. Turn the Radical-7 off
and then on again.
2.
Connect the common lead of a digital voltmeter to the pin 2 (Ground) of the analog
output connector on the Radical-7. Connect the positive lead of the voltmeter to pin
9 (Analog 1) of the analog output connector.
REPAIR POLICY
Masimo or an authorized Service Department must perform warranty repair and service.
Do not use malfunctioning equipment. Have the unit repaired.
3.
Enter the menu system and set the “Output”, “Analog 1” to “0V Signal”. Verify that the
voltmeter measures a voltage of approximately 0V.
4.
Enter the menu system and set the “Output”, “Analog 1” to “1V Signal”. Verify that the
voltmeter measures a voltage of approximately 1.0V.
5.
Repeat Steps 3 and 4, with the positive lead of the voltmeter connected to pin 15
(Analog 2).
6.
Connect a patient cable and sensor and verify that the voltage on pins 9 and 15 are
between 0V and 1.0V while measuring a saturation and pulse rate..
9
WARNING: DO NOT REMOVE THE COVER OF THE MONITOR EXCEPT FOR
BATTERY REPLACEMENT. 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 Radical-7 unit for service, please follow the Return Procedure.
Battery Test
1.
Fully charge the Radical-7 by placing the Handheld into the Docking Station and
connecting the AC power.
2.
Verify that the green Handheld Battery Indicator LED is lit up.
3.
When the Radical-7 is fully charged the green Handheld Battery Indicator turns off.
4.
Turn the Radical-7 on and verify that the Battery indicator shows a full charge.
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. Ask for an RMA number. Package the equipment securely – in the original shipping container if possible – and enclose or include the following information and items:
■ A letter describing in detail any difficulties experienced with the Pulse CO-Oximeter.
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 oximeter 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 oximeter has been decontaminated for bloodborne pathogens.
Return Radical-7 pulse oximeter to the following shipping address:
9-8
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
For USA and Asia Pacific:
For Europe:
Masimo Corporation
40 Parker
Irvine, California 92618
949-297-7000
FAX 949-297-7001
Masimo Europe Limited
304 RN6, Le Bois des Cotes 2
69760 Limonest
France
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
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service / maintenance
Warranty
Masimo warrants to the initial purchaser that each new Pulse CO-Oximeter will be free
from defects in workmanship or materials for a period of one (1) year from the date of
purchase. Masimo’s sole obligation under this warranty is to repair or replace any product
that Masimo deems to be covered under warranty with a repaired or a replacement Pulse
CO-Oximeter.
service / maintenance
2.
Ownership of Software/Firmware: Title to, ownership of, and all rights and interests in,
any MASIMO software and/or firmware and the documentation, and all copies thereof,
remain at all times vested in MASIMO Corporation, licensor to MASIMO, and they do
not pass to Purchaser.
3.
Assignment: 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; any attempt
without such consent, to assign any rights, duties or obligations arising hereunder
shall be void.
4.
Copy Restrictions: The software/firmware and the accompanying written materials
are copyrighted. Unauthorized copying of the software, including software that has
been modified, merged, or included with other software, or other written materials is
expressly forbidden. You may be held legally responsible for any copyright infringement that is cause or incurred by your failure to abide by the terms of this license.
Nothing in this license provides any rights beyond those provided by 17 U.S.C.
§117.
5.
Use Restriction: As the Purchaser, you may physically transfer the products from one
location to another provided that the software/firmware is not copied. You may not
electronically transfer the software/firmware from the products to any other device.
You may not disclose, publish, translate, release or distribute copies of the software/
firmware or accompanying written materials to others. You may not modify, adapt,
translate, reverse engineer, decompile, disassemble, or create derivative works based
on the software/firmware. You may not modify, adapt, translate, or create derivative
works based on the written materials without the prior written consent of MASIMO.
6.
Transfer Restrictions: The software/firmware is licensed to the Purchaser, and may not
be transferred to anyone, except other end-users, without the prior written consent of
MASIMO. In no event may you transfer, assign, rent, lease, sell, or otherwise dispose
of the software/firmware or the products on a temporary basis.
7.
Beneficiary: Masimo Corporation is a Beneficiary of this Agreement and has the right
to enforce its provisions.
8.
U.S. Government Rights: If you are acquiring software (including the related documentation) on behalf of any part of the United State Government, the following provisions apply: the software is 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 Agreement and shall be prohibited except to the extent expressly permitted by the
terms of this agreement.
Batteries are warranted for six (6) months.
To request a replacement under warranty, 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 the purchaser.
Exclusions
This warranty does not extend to any product that has been subject to misuse, neglect or
accident; that has been damaged by causes external to the Product; that has been used
in violation of the operating instructions supplied with the Product. The warranty does not
extend to any product that has been connected to an unlicensed instrument system, modified accessories or any unit that has been disassembled or reassembled by anyone but an
authorized Masimo agent.
THIS WARRANTY, TOGETHER WITH ANY OTHER EXPRESS WRITTEN WARRANTY
THAT MAY BE ISSUED BY MASIMO IS THE SOLE AND EXCLUSIVE WARRANTY
AS TO MASIMO’S PRODUCTS. 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.
End-user license agreement
THIS DOCUMENT IS A LEGAL AGREEMENT BETWEEN YOU, THE “PURCHASER,”
AND Masimo Corporation (“MASIMO”). IF YOU DO NOT AGREE TO THE TERMS OF
THIS AGREEMENT, PROMPTLY RETURN THE ENTIRE PACKAGE, INCLUDING ALL
ACCESSORIES, IN THEIR ORIGINAL PACKAGE, WITH YOUR SALES RECEIPT TO
MASIMO FOR A FULL REFUND.
1.
9-10
Grant of License: In consideration of payment of the license fee, which is part of
the price paid for this product, MASIMO grants to PURCHASER a nonexclusive,
nontransferable license, without right to sublicense, to use the copy of the incorporated software/firmware and documentation in connection with PURCHASER’ S
use of the Masimo Products for their labeled purpose. MASIMO reserves all rights
not expressly granted to Purchaser.
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
9
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10
accessories
Accessories
The following accessories and re-order parts are available with the Radical-7 Signal
Extraction Pulse CO-Oximeter:
DESCRIPTION
1315
REPLACEMENT BATTERY, RADICAL-7 HANDHELD
1317
RADICAL-7 POLE CLAMP
1395
RADICAL-7 HANDHELD LOCK
1584
RADICAL-7 POWER CORD LOCK, 5/PACK
1595
SATSHARE CABLE, AT01
1324
SATSHARE CABLE, DO01
1326
SATSHARE CABLE, DO02
1528
SATSHARE CABLE, DO03
1533
SATSHARE CABLE, DO04
2023
SATSHARE CABLE, DO05
1325
SATSHARE CABLE, DS01
1539
SATSHARE CABLE, DS02
1528
SATSHARE CABLE, DS03
1357
SATSHARE CABLE, HP03
1321
SATSHARE CABLE, MQ01
1789
SATSHARE CABLE, MS01
1367
SATSHARE CABLE, NK01
1368
SATSHARE CABLE, NK02
1366
SATSHARE CABLE, OH01
1646
SATSHARE CABLE, OH02
1840
SATSHARE CABLE, PM01
1323
SATSHARE CABLE, SL01
1362
SATSHARE CABLE, SL02
1322
SATSHARE CABLE, SM01
1605
SATSHARE EXTENSION CABLE
13608
RADICAL-7 OPERATOR’S MANUAL - ENGLISH
31640
RADICAL-7 OPERATOR’S MANUAL - FRENCH
31641
RADICAL-7 OPERATOR’S MANUAL - GERMAN
31642
RADICAL-7 OPERATOR’S MANUAL - ITALIAN
31643
RADICAL-7 OPERATOR’S MANUAL - SPANISH
31644
RADICAL-7 OPERATOR’S MANUAL - SWEDISH
31645
RADICAL-7 OPERATOR’S MANUAL - DUTCH
31646
RADICAL-7 OPERATOR’S MANUAL - DANISH
31647
RADICAL-7 OPERATOR’S MANUAL - PORTUGUESE
31648
RADICAL-7 OPERATOR’S MANUAL - CHINESE
31649
RADICAL-7 OPERATOR’S MANUAL - JAPANESE
30475
RADICAL-7 HANDHELD CASE
9081
MX FIELD UPGRADE TOOL
Please visit our website, www.masimo.com, for updated information about accessories.
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Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual
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PART NUMBER
10-1
www.masimo.com
Instruments and sensors containing Masimo Rainbow SET technology are
identified with the Masimo Rainbow SET logo.
© 2007 Masimo Corporation. Masimo, Discrete Saturation Transform, DST, DCI, FastSat, Satshare, SET, Radical logo, Signal IQ, LNOP and LNCS are federally
registered trademarks of Masimo Corporation. Rainbow and SpCO are federally registered trademarks of Masimo Laboratories.
Radical-7, RadNet, RadicalScreen, LNOPv and APOD are trademarks of Masimo Corporation.
SpMet and Signal Extraction Pulse CO-Oximeter are trademarks of Masimo Laboratories.