Masimo Radical User manual
Signal Extraction Pulse Oximeter
OPERATOR’S MANUAL
The Radical Operating Instructions are intended to provide the necessary information for proper
operation of all models of the Radical pulse 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 Pulse Oximeter are a prerequisite for proper use.
Do not operate the Radical Pulse Oximeter without completely reading and understanding these
instructions.
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
2852 Kelvin Avenue
Irvine, CA 92614
USA
Tel.: 949-250-9688
Fax.: 949-250-9686
www.masimo.com
Authorized Representative:
MDSS GmbH
Burckhardstrasse 1
D-30163 Hanover
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 2601-1/CAN/CSA C22.2 No. 601.1
USA Patents 5337744, 5452717, 5482036, 5490505, 5638818, 5645440, 5758644 and 5782757 and international
equivalents. Other patents pending.
Manufactured in USA
© 2001 Masimo Corporation. Masimo, SET and LNOP are federally registered trademarks of Masimo Corporation.
Radical, SatShare, Signal IQ, FastSat and RadicalScreen are trademarks of Masimo Corporation.
i Radical Signal Extraction Pulse Oximeter Operator’s Manual
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES
The Radical Signal Extraction Pulse 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.
■
Explosion hazard. Do not use the pulse oximeter in the presence of flammable anesthetics or other
flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide.
■
The pulse oximeter is NOT intended for use as an apnea monitor.
■
A pulse 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.
■
The pulse 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.
■
Electric shock hazard. Do not open the pulse 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.
■
As with all medical equipment, carefully route patient cabling to reduce the possibility of patient
entanglement or strangulation.
■
Do not place the pulse oximeter or accessories in any position that might cause it to fall on the
patient. Do not lift the pulse oximeter by the power cord or any other cable.
■
Interfering Substances: Carboxyhemoglobin may erroneously increase readings.The level of
increase is approximately equal to the amount of carboxyhemoglobin present. Dyes, or any
substance containing dyes, that change usual blood pigmentation may cause erroneous readings.
■
Severe anemia may cause erroneous SpO2readings.
■
Do not use the pulse oximeter or oximetry sensors during magnetic resonance imaging (MRI)
scanning. Induced current could potentially cause burns. The pulse oximeter may affect the MRI
image, and the MRI unit may affect the accuracy of the oximetry measurements.
■
For home use, ensure that the pulse 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 being used.
■
Always remove the sensor from the patient and completely disconnect the patient from the
pulse oximeter before bathing the patient.
■
Do not place the pulse oximeter where the controls can be changed by the patient.
■
Do not place the pulse oximeter face against a surface. This will cause the alarm to be muffled.
■
Do not place the pulse oximeter on electrical equipment that may affect the pulse oximeter,
preventing it from working properly.
■
Do not expose the pulse oximeter to excessive moisture such as direct exposure to rain.
Excessive moisture can cause the pulse oximeter to perform inaccurately or fail.
■
Do not place containers containing liquids on or near the pulse oximeter. Liquids spilled on the
pulse oximeter may cause it to perform inaccurately or fail.
■
Failure of Operation - If the pulse oximeter fails any part of the setup procedures or leakage tests,
remove the pulse oximeter from operation until qualified service personnel have corrected the situation.
■
Patient Safety - If a sensor is damaged in any way, discontinue use immediately.
Radical Signal Extraction Pulse Oximeter Operator’s Manual ii
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES (CONTINUED)
■
The pulse oximeter can be used during defibrillation, but the readings may be inaccurate for a
short time.
■
This equipment has been tested and found to comply with the limits for medical devices to the
IEC 601-1-2:1994, 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:
❚
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.
iii Radical Signal Extraction Pulse Oximeter Operator’s Manual
table of contents
SECTION 1 / OVERVIEW
About this Manual ........................................................................................................................1
Warnings, Cautions and Notes ....................................................................................................2
Product Description ......................................................................................................................3
Features and Benefits................................................................................................3
Indications for Use ....................................................................................................3
Pulse Oximetry..............................................................................................................................4
General Description ..................................................................................................4
Principle of Operation ................................................................................................4
Functional Vs. Fractional Saturation ..........................................................................5
Measured Vs. Calculated Saturation ........................................................................5
Masimo SET Signal Extraction Technology ..............................................................5
SECTION 2 / SYSTEM DESCRIPTION
Introduction ..................................................................................................................................6
Radical Handheld..........................................................................................................................7
Handheld Front Panel................................................................................................7
Pleth + Signal IQ View ....................................................................................7
Numbers View..................................................................................................7
Handheld Back Panel..............................................................................................10
Radical Standalone ....................................................................................................................11
Standalone Front Panel ..........................................................................................12
Standalone Back Panel ..........................................................................................13
Symbols ..................................................................................................................14
Radical Monitor Interface............................................................................................................14
SECTION 3 / SETUP
Introduction ................................................................................................................................15
Unpacking and Inspection ..........................................................................................................15
Preparation for Monitoring ..........................................................................................................15
Radical Power Requirements ..................................................................................15
Initial Battery Charging ............................................................................................16
Initial Installation ......................................................................................................16
Monitor Setup..............................................................................................................................17
SatShare Setup ..........................................................................................................................18
HP VueLink Setup ......................................................................................................................20
Spacelabs Universal Flexport Setup ..........................................................................................20
Radical Signal Extraction Pulse Oximeter Operator’s Manual iv
SECTION 4 / OPERATION
Introduction ................................................................................................................................21
Basic Operation ..........................................................................................................................21
General Setup and Use ..........................................................................................21
Successful SpO
2
Monitoring ......................................................................................................23
Numeric Display-SpO
2
............................................................................................23
Numeric Display-Pulse Rate ..................................................................................23
Signal IQ ..................................................................................................................24
Low Perfusion ..........................................................................................................25
Actions to be Taken..................................................................................................25
Touch Key Control Buttons and Icons ....................................................................26
First Page ................................................................................................................26
Second Page ..........................................................................................................26
Navigating the Main Menu..........................................................................................................27
Main Menu Selection ..............................................................................................27
Menu Categories ....................................................................................................27
Editing a Parameter ................................................................................................28
Menu Tree ................................................................................................................28
Alarms ........................................................................................................................................30
SpO
2
High Limits ....................................................................................................30
SpO
2
Low Limits......................................................................................................30
Pulse Rate High Limits (BPM) ................................................................................30
Pulse Rate Low Limits (BPM) ................................................................................30
Type of Limits ..........................................................................................................30
Silence ....................................................................................................................31
Level ........................................................................................................................31
Display ........................................................................................................................................32
View ........................................................................................................................32
Pleth + Signal IQ View ..................................................................................32
Pleth Only ......................................................................................................32
Numbers ........................................................................................................32
Contrast....................................................................................................................32
Language ................................................................................................................32
General........................................................................................................................................33
Averaging Time ........................................................................................................33
FastSat ....................................................................................................................33
table of contents
v Radical Signal Extraction Pulse Oximeter Operator’s Manual
Home Use................................................................................................................33
Interface Alarms ......................................................................................................33
SatShare Numbers ..................................................................................................33
Power Save..............................................................................................................33
Clock............................................................................................................................................33
Time ........................................................................................................................33
Time Format ............................................................................................................33
Date ........................................................................................................................33
Date Format ............................................................................................................33
About ..........................................................................................................................................33
Output..........................................................................................................................................34
Serial Mode..............................................................................................................34
ASCII 1 ..........................................................................................................34
ASCII 2 ..........................................................................................................34
HP Vuelink ......................................................................................................34
Spacelabs Flexport ........................................................................................34
Analog Output Mode ..............................................................................................34
0%-100%........................................................................................................34
50%-100%......................................................................................................34
0V Output ......................................................................................................34
1V Output ......................................................................................................34
Service ........................................................................................................................................35
Trend Display ..............................................................................................................................36
Navigating Trend Display ........................................................................................38
First Page ......................................................................................................38
Second Page..................................................................................................38
Third Page......................................................................................................38
Trend Setup..............................................................................................................39
%SpO
2
High Scale ........................................................................................39
%SpO
2
Low Scale ........................................................................................39
PR High Scale (BPM) ....................................................................................39
PR Low Scale (BPM) ....................................................................................39
Default View ..................................................................................................39
Trend Action ..................................................................................................39
Trend Period ............................................................................................................40
Radical Signal Extraction Pulse Oximeter Operator’s Manual vi
table of contents
Backlight / Contrast Operation....................................................................................................40
SatShare Operation ....................................................................................................................40
Home Mode Operation ..............................................................................................................42
Password Operation....................................................................................................................42
SECTION 5 / ALARMS AND MESSAGES
Introduction ................................................................................................................................43
Alarm Identification ....................................................................................................................44
Alarm Operation..........................................................................................................................45
Alarm Messages ........................................................................................................................45
System Messages ......................................................................................................................45
SECTION 6 / TROUBLESHOOTING
Troubleshooting ..........................................................................................................................47
SECTION 7 / SPECIFICATIONS
Radical Specifications ................................................................................................................48
Performance ............................................................................................................48
Electrical ..................................................................................................................48
Environmental..........................................................................................................49
Physical Characteristics ..........................................................................................49
Serial Interface Specifications ....................................................................................................50
Serial Interface Setup ..............................................................................................51
Serial Printer Setup ................................................................................................51
Analog Output/Nurse Call Specifications ..................................................................................52
Analog Output..........................................................................................................53
SpO
2
........................................................................................................................53
Pulse Rate ..............................................................................................................53
Calibration................................................................................................................53
Nurse Call ................................................................................................................53
SECTION 8 / SENSORS AND PATIENT CABLES
Introduction ................................................................................................................................54
Masimo LNOP Sensors ..............................................................................................................54
Selecting a Masimo LNOP Sensor ........................................................................54
Cleaning and Reuse of Masimo LNOP Sensors ....................................................55
Reattachment of Single Use Adhesive Sensors ....................................................55
Masimo SET Patient Cables ......................................................................................................56
Cleaning and Reuse of Masimo SET Patient Cables ............................................56
vii
Radical Signal Extraction Pulse Oximeter Operator’s Manual
table of contents
Radical Signal Extraction Pulse Oximeter Operator’s Manual viii
table of contents
SECTION 9 / SERVICE AND MAINTENANCE
Introduction ................................................................................................................................57
Cleaning ................................................................................................................................57
Battery Operation and Maintenance ..........................................................................................58
Replacing the Batteries ..........................................................................................60
Replacing the Fuses................................................................................................61
Performance Verification ............................................................................................................61
Service and Repair ....................................................................................................................65
Repair Policy............................................................................................................65
Return Procedure ....................................................................................................65
Warranty......................................................................................................................................66
Exclusions ..................................................................................................................................66
SECTION 10 / ACCESSORIES
Accessories ............................................................................................................67
ix Radical Signal Extraction Pulse Oximeter Operator’s Manual
about this manual
This manual explains how to set up and use the Radical Pulse Oximeter. Important safety
information relating to general use of the Radical Pulse 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 pulse oximetry.
SECTION 2 SYSTEM DESCRIPTION describes the Radical Pulse Oximeter
system and its functions and features.
SECTION 3 SETUP describes how to setup the Radical Pulse Oximeter for use.
SECTION 4 OPERATION describes the operation of the Radical Pulse
Oximetry system.
SECTION 5 ALARMS AND MESSAGES describes the alarm system messages.
SECTION 6 TROUBLESHOOTING gives troubleshooting information.
SECTION 7 SPECIFICATIONS gives the detailed specifications of the
Radical Pulse Oximeter.
SECTION 8 SENSORS AND PATIENT CABLES outlines how to use and
care for the Masimo SET LNOP sensors and Masimo SET
patient cables.
SECTION 9 SERVICE AND MAINTENANCE describes how to maintain,
service and obtain repair for the Radical Pulse Oximeter.
SECTION 10 ACCESSORIES gives you a list of available Radical accessories.
Radical Signal Extraction Pulse Oximeter Operator’s Manual 1
1
overview
overview
2 Radical Signal Extraction Pulse Oximeter Operator’s Manual
1
warnings, cautions and notes
Please read and follow any warnings, cautions and notes presented throughout this
manual. An explanation of these labels are as follows:
A WARNING is provided when actions may result in a serious outcome (i.e., injury,
serious adverse affect, death) to the patient or user. Look for text in a gray shaded box.
Sample of Warning:
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.
WARNING: THIS IS A SAMPLE OF A WARNING STATEMENT.
product description
The Radical Pulse Oximeter is a noninvasive, arterial oxygen saturation and pulse rate
monitor. Radical can be used as either a Handheld or a Standalone monitor. Radical
features a backlit Liquid Crystal Display (LCD) that continuously displays numeric values
for SpO
2
, pulse rate, plethysmographic waveform and Signal Identification and Quality
Indicator (Signal IQ
TM
). Radical can be used to interface with a multiparameter patient
monitor to provide Masimo SET pulse oximetry information to that monitor for display.
FEATURES AND BENEFITS
■
Clinically proven Masimo SET technology performance
■
Applicable for use on neonate, 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 RadicalScreen
TM
■
Signal IQTMfor signal identification and quality indication
■
Analog output and nurse call
■
SpO2, pulse rate, alarm, perfusion index, trend, and pleth waveform displays
■
Lightweight design
■
Internal batteries for transport:
Standalone -12 hours (optional)
Handheld - 4 hours
■
Serial output to printers and PCs
INDICATIONS FOR USE
The Radical Pulse Oximeter and accessories are indicated for the continuous, noninvasive
monitoring of functional oxygen saturation of arterial hemoglobin (SpO
2
) and pulse rate
(measured by an SpO
2
sensor).The Radical Pulse 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. In addition, the Radical Pulse Oximeter is
indicated to provide continuous noninvasive monitoring data, obtained from the Radical
Pulse Oximeter, to validated multiparameter patient monitors* for display on those monitors.
*Contact Masimo for the latest list of SatShare validated multiparameter monitors.
Radical Signal Extraction Pulse Oximeter Operator’s Manual 3
1
overview
pulse oximetry
GENERAL DESCRIPTION
Pulse 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 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:1) as a percent value for arterial oxygen saturation (SpO
2
), 2) as a pulse
rate (PR) and 3) as a plethysmographic waveform. The following figure shows the general
monitoring setup.
PRINCIPLE OF OPERATION
Pulse oximetry is governed by the following principles:
1. Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood)
differ in their absorption of red and infrared light (spectrophotometry).
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 Pulse Oximeter uses a two-wavelength pulsatile system to distinguish
between oxygenated and deoxygenated blood. Signal data is obtained by passing red (rd)
(660 nm wavelength) and infrared (ir)(905 nm wavelength) light through a capillary bed
(for example a fingertip, a hand, a foot) and measuring changes in light absorption during
the pulsatile cycle. See figure below. The Radical utilizes a sensor with red and infrared
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, via
a patient cable, to the Radical for calculation.
Once Radical receives the signal from the patient sensor, it utilizes Masimo SET signal
extraction technology for calculation of the patient’s functional oxygen saturation and pulse rate.
overview
4 Radical Signal Extraction Pulse Oximeter Operator’s Manual
1
Recessed
Photo Detector
LED's
Instrument
Patient Cable
Sensor
FUNCTIONAL VS. FRACTIONAL SATURATION
The Radical measures and displays functional saturation: the amount of oxygenated
hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen.The
Radical does not measure fractional saturation: oxygenated hemoglobin expressed as a
percentage of all measured hemoglobin, including measured dysfunctional hemoglobin
such as carboxyhemoglobin or methemoglobin. To convert fractional saturation to
functional saturation, the fractional saturation measurements must be converted
according to:
Functional saturation =
Fractional saturation
x 100
100 - (% carboxyhemoglobin + % methemoglobin)
MEASURED VS. CALCULATED SATURATION
Oxygen saturation measurements obtained from a pulse oximeter are commonly
compared to saturations calculated from the partial pressure of oxygen (PO
2
) obtained
from an arterial blood gas sample. When comparing the two measurements, caution
should be used when interpreting the values, as the calculated value obtained from the
blood gas sample may differ from the SpO
2
measurement of the pulse oximeter. Different
results are usually obtained from the blood gas sample if the calculated saturation is not
appropriately corrected for the effects of variables that shift the relationship between PO
2
and saturation, such as: pH, temperature, the partial pressure of carbon dioxide (PCO2),
2,3-DPG, and fetal hemoglobin. Also, as blood gas samples are usually taken over a period
of 20 seconds (the time it takes to draw blood) a meaningful comparison can only be
achieved if the core oxygen saturation of the patient is stable and not changing over the
period of time that the blood gas sample is taken.
MASIMO SET SIGNAL EXTRACTION TECHNOLOGY
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, which causes 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 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. Masimo SET signal processing algorithm, Discrete Saturation Transform
TM
(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.
Radical Signal Extraction Pulse Oximeter Operator’s Manual 5
1
overview
Masimo SET DST
introduction
Radical provides the functionality of three pulse oximeters in one:
■
Radical is a fully featured Handheld pulse oximeter
■
Radical is a fully featured standalone pulse oximeter
■
Radical interfaces to the SpO2input module of multiparameter patient monitors* to
upgrade conventional pulse oximetry technology to Masimo SET technology.
The Handheld portion of Radical contains the majority
of the pulse oximeter features. All pulse oximetry
measurement information, as well as device status data
is displayed on the Handheld LCD screen. All user input
is handled through the control buttons on the front panel.
The sensor cable connector is located on the Radical
Handheld oximeter.
The Handheld oximeter snaps into the Radical Docking
Station to provide a fully featured standalone pulse
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 features nurse call, analog output and
interfaces to serial printers.
Utilizing a SatShare
TM
cable, the standalone
Radical also interfaces with the SpO
2
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*.
CAUTIONS:
■
THE WAVEFORM DISPLAYED ON THE MULTIPARAMETER PATIENT MONITOR
IS A SIMULATED SIGNAL. REFER TO THE RADICAL 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
*Contact Masimo for the latest list of SatShare validated multiparameter monitors.
system description
6 Radical Signal Extraction Pulse Oximeter Operator’s Manual
2
90
4
radical handheld
The Handheld Radical provides most of the functionality of the pulse oximeter. All user
input and displays are controlled by this part of the Radical system. The sensor cable
connects into the swivel connector on the Handheld unit.The Handheld is battery powered
and can be used either as a transport monitor or as a Handheld Pulse Oximeter for spot
checks.
HANDHELD FRONT PANEL
The following figure and corresponding text outline all the features of the Handheld Radical:
Radical Signal Extraction Pulse Oximeter Operator’s Manual 7
2
system description
06:10:23pm 03/27/01
140
50
BPM
100
85
%SpO
2
No Sensor
1110932
6
20 18 17 1219
1
22
4
23 15 13
16 14
HPO1
Masimo SET FastSat
5 7
8
21
4
90
Pleth + Signal IQ View
Numbers View
23
Masimo SET
100
85
5
%SpO
2
11:42:46 03/27/01
160
BPM
40
22
system description
8 Radical Signal Extraction Pulse Oximeter Operator’s Manual
2
FastSa
t
Masim
o SET
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 SpO
2
. The upper and lower SpO2alarm limits are also displayed
next to the SpO
2
measurement. When a sensor is not connected to a patient
and during pulse search, the display will show dashed lines. When the
measured value is outside of the alarm limits, the SpO
2
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 SET symbol is shown on the Radical display when SET
processing is active.
The FastSat symbol is shown on the Radical display whenever the Radical is
set to operate in the FastSat mode.
The Saturation Alarm Limits Display shows the upper and lower saturation
alarm limits. When an alarm limit is reached or exceeded, the SpO
2
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, an alarm status indicator with a slash and a timer is
shown to indicate that the alarm is temporarily silenced. When the alarm is
silenced through All Mute menu selection, which is permanent until power is
cycled or deselected using menu, an alarm status indicator with a slash is
shown to indicate that alarm has been silenced.
The system messages generated by the instrument are displayed in the
System Message Area. See Section 5, System Messages.
The Maximum Sensitivity icon is shown on the Radical display whenever the
Radical is set to operate in the Maximum sensitivity mode.
The Battery Status Indicators show the capacity of the Radical Handheld and
optional Docking Station batteries. The indicator flashes when less than 15
minutes of battery life is left and the battery needs to be recharged. The
Docking Station Battery Status indicator is not shown when the optional
Docking Station battery is not present.
Press a Touch Key Control Button to select the corresponding touch key icon.
See Section 4, Touch Key Control Buttons and Icons for more details.
The loudspeaker indicates audio alarms. Care should be taken not to cover
the loudspeaker and muffle the audible alarm volume.
Connect the patient cable to the Handheld Radical 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.
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 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 waveform display is updated with
a frequency of 31.25 times per second. The Signal IQ may also be shown as
a single, pulsating bar.
Handheld
Release
Button
SpO
2
Measurement
Display
Masimo SET
FastSat
Saturation
Alarm Limits
Display
Alarm Status
Indicator
System
Message Area
Maximum
Sensitivity
Battery Status
Indicators
Touch Key
Control Buttons
Loudspeaker
Patient Cable
Connector
Touch Key
Icons
Signal IQ
1
2
3
4
6
7
8
9
10
11
12
13
5
14
Max
19
Radical Signal Extraction Pulse Oximeter Operator’s Manual 9
2
system description
Pulse
Waveform
Display
Time and Date
Indicator
Backlight/
Contrast
Button
Alarm Silence
Button
Output Mode
Indicator
Power/Standby
Button
Perfusion Index
Pulse Rate
Alarm Limits
Display
Pulse Rate
Measurement
Display
The Pulse Waveform Display shows the acquired plethysmograph waveform.
The pleth waveform is scaled with signal strength. Signal strength is defined as
the relation of arterial pulsatile signal to the non-pulsatile signal component.
The Pulse Waveform Display is updated with a frequency of 31.25 times per
second.
The Time and Date Indicator displays the current time and date. The date and
time is displayed in dd/mm/yyyy or mm/dd/yyyy format. Select the date and
time display format in the Clock menu.
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 illumination level). In the Handheld mode, three levels of
illumination are available (again in addition to the no illumination level). Use
the lowest illumination for most efficient battery usage. The backlight Button is
also used to change the contrast of the LCD display. Press and hold the
Backlight Button for longer than two seconds to change the contrast. Release
the Backlight Button at the desired contrast setting.
Press the Alarm Silence Button to temporarily silence patient alarms. Press the
Alarm Silence Button when the SENSOR OFF or NO SENSOR messages are
flashing (i.e. the sensor is removed from the patient) to acknowledge the end of
monitoring. In these states, all further alarms are suspended until the pulse
oximeter starts measuring SpO
2
and pulse rate again.
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 Output Mode Indicator displays the output mode selected by the user.
The Output Mode Indicator also displays the type of SatShare
TM
cable. The
Output Mode indicator is only displayed when the Radical device actively
outputs data other than ASCII text, or interfaces with a monitor through the
SatShare cable.
Press the Power/Standby 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 Perfusion Index indicates numerically the percentage of pulsatile signal to
non-pulsatile signal.
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 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.
15
16
17
18
21
PI
22
20
23
system description
10 Radical Signal Extraction Pulse Oximeter Operator’s Manual
2
3
MEDICAL ELECTRICAL EQUIPMENT
UL 2601-1/CAN/CSA C22.2 No. 601.1
80FK
11328J-1000
1
2
3
The Radical Handheld interfaces with the Docking Station through this
connector.
The optional Pole Clamp accessory attaches to this holder. See the Directions
for Use of the Pole Clamp accessories for attachment instructions.
The Radical Handheld is powered by a NiMH battery located in this
compartment. For battery care and replacement please see Section 9,
Replacing the Batteries.
Docking
Station
Connector
Pole Clamp
Accessory
Holder
Battery Cover
1
2
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.
1251 0000 536
Radical Signal Extraction Pulse Oximeter Operator’s Manual 11
radical standalone
When the Radical Handheld is placed into the Docking Station, the Radical becomes a
full-featured standalone device. The Radical Standalone acts as a battery charger for
the Handheld device and has AC power connection capabilities. The Standalone can also
interface to serial devices, nurse call or analog output devices, and multiparameter patient
monitors through a SatShare cable.
There are several models of Docking Stations available. The following table outline which
features are available for each model of Docking Station.
system description
2
DOCKI NG STATION FEATURES
RDS-1 RDS-1B RDS-2 RDS-3 RDS-3B
AC Power Input
■■■■■
SatShare Interface
■■
Serial RS-232 Interface
■■ ■■
Nurse Call/Analog Output Interface
■■ ■■
12-hour Extended Battery
■■
Automatic Display Rotation Support (Gravity Detector)
■■ ■■
Docking Station Battery Charging Indicator
■■ ■■
Handheld Battery Charging Indicator
■■■■■
Red Alarm Inidcator
■■ ■■
AC Power Indicator
■■■■■
Docking Indicator
■■ ■■
system description
12 Radical Signal Extraction Pulse Oximeter Operator’s Manual
2
STANDALONE FRONT PANEL
The following figure and corresponding text review the features of the Radical
Standalone device.
Check Sensor
Masimo SET FastSat
11:42:46 03/27/01
100
85
%SpO
2
140
50
BPM
1
2
3
4
5
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.
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.
The Visual Alarm Indicator is illuminated when an alarm condition is active and
the Alarm Status Indicator is shown.
The AC Power Indicator is illuminated when the Radical Docking Station is
plugged into AC line power.
The Docking Indicator is illuminated when the Handheld unit is turned on and
is properly interfaced to a Docking Station.
Docking
Station Battery
Charging
Indicator
Handheld
Battery
Charging
Indicator
Visual Alarm
Indicator
AC Pow er
Indicator
Docking
Indicator
1
2
3
4
5
NOTE: When the Radical Standalone is turned on, all indicator LEDs initially turn on and off
at start up.
Radical Signal Extraction Pulse Oximeter Operator’s Manual 13
2
system description
STANDALONE BACK PANEL
P2 P3
Manufactured by:
Masimo Corporation
Irvine, CA 92614
USA
Made in USA
Rx Only
U.S.A. Patents 5,482,036; 5,490,505; 5,632,272; 5,685,299;
5,738,644; 5,769,785.
MEDICAL ELECTRICAL EQUIPMENT
UL 2601-1/CAN/CSA C22.2 No. 601.1
80FK
11329H-0900
1
2
3
5 4
Use the Serial Output Connector to connect a serial device, including a serial
printer or PC, to the Radical. 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.
Use the Analog Output Connector 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 IEC-60950 compliant.
Use the SatShare Cable Connector to connect a SatShare cable to the SpO
2
input connector of a multiparameter patient monitor. All external device
connections to the SatShare Cable Connector must be IEC-60101-1-1
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 the Masimo web site at www.masimo.com for the
latest SatShare cables and validated instruments.
The power entry module contains the input connector for AC power, an on/off
switch and two fuses. The AC input and the on/off switch provide power to the
system from the AC line. Always connect the pulse oximeter to the mains power
for continuous operation and/or battery recharging.
NOTE: Some power entry modules may not have the on/off switch.
Use the Equipotential Ground Connector for grounding.
P1 Serial Output
Connector
P2 Analog Output /
Nurse Call
Connector
P3 SatShare Cable
Connector
Power Entry
Module
Equipotential
Ground
Connector
1
2
3
4
5
14 Radical Signal Extraction Pulse Oximeter Operator’s Manual
2
SYMBOLS
The following symbols are found on the back of the Radical Docking Station, they are
defined below:
system description
SYMBOLS
RS-232
SatShare interface
Equipotential Ground Terminal
See Instructions for Use
Fuse Replacement
Analog Out Interface
Nurse Call Interface
NOTE: Some of the interfaces and symbols are not available in all versions of the
Docking Station.
radical monitor interface
In addition to being a full-featured Handheld and Standalone Pulse Oximeter, Radical’s
unique SatShare interface links the Radical to most existing multiparameter patient
monitors through the pulse oximetry patient cable or SpO
2
input connector.
■
Upgrades any approved and validated monitor to Masimo SET performance by
using the calculated SpO
2
and pulse rate determined by Radical to simulate an
ideal waveform, which is sent to the validated multiparameter patient monitor.
■
Connects into the SpO2patient cable or SpO2input connector of the
multiparameter patient monitor.
CAUTION: THE WAVEFORM DISPLAYED ON THE MULTIPARAMETER PATIENT
MONITOR IS A SIMULATED SIGNAL. REFER TO THE RADICAL DISPLAY FOR THE
PATIENT WAVEFORM.
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