Radical-7 Signal Extraction Pulse CO-Oximeter Service Manual
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The Radical-7 Pulse CO-Oximeter Service Manual is intended to provide
the necessary information for proper servicing of all models of the
Radical-7 Pulse Oximetry and CO-Oximetry systems. This manual is
structured to support troubleshooting to the assembly or module level.
This manual does not provide instructions for troubleshooting to the
printed circuit board component level. There may be information
provided in this manual that is not relevant for your system. Do not
service the Radical-7 pulse oximeter without completely reading and
understanding these instructions. Service training provided by Masimo is
required prior to utilization of this manual.
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, 7,221,971, 7,215,986, 7,215,984,
7,186,966, 6,979,812, 6,861,639, 6,850,787, 6,826,419, 6,816,741, 6,745,060, 6,699,194, 6,684,090,
6,654,624, 6,650,917, 6,643,530, 6,606,511, 6,515,273, 6,501,975, 6,463,311, 6,430,525, 6,388,240,
6,360,114, 6,263,222, 6,236,872, 6,229,856, 6,157,850, 6,067,462, 6,011,986, 6,002,952, 5,919,134,
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.htm Products containing Satshare® feature are also
covered by U.S. Patent 6,770,028. Other patents pending.
14 Docking Station Wiring Interconnect........................................14-1
15 Radical-7 Color Parts List ..........................................................15-1
16 Radical-7 Monochrome Parts List.............................................16-1
17 Docking Station Parts List (RDS-1, RDS-1B and RDS-3)........17-1
18 RDS2 Parts List...........................................................................18-1
iv
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1 Overview
1.1 About this Manual
This manual explains how to service the Radical-7 Pulse CO-Oximeter.
Important safety information relating to general use of the Radical-7
Pulse CO-Oximeter appears in the Radical-7 CO-Oximeter Operator’s
Manual. Other important safety information is located throughout this
manual where appropriate.
1.2 Warnings, Cautions and Notes
Please read and follow any warnings, cautions and notes presented
throughout this manual. An explanation of these labels is 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:
WARNING: THIS IS A SAMPLE OF A WARNING STATEMENT.
A caution is given when any special care is to be exercised by the
patient or user to avoid injury to the patient, damage to this 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 statement.
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2 Maintenance
2.1 Introduction
2.1.1 This chapter covers how to test the operation of the Radical7 and SatShare interface (if applicable), how to properly
clean the Radical-7 pulse oximeter, how to recharge and
replace the batteries, how to replace the fuses, and how to
obtain service under normal operation. No internal
adjustment or recalibration is required. Service 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
THE UNIT OFF AND DISCONNECT THE POWER
CORD FROM THE BACK OF THE UNIT.
2.2 Cleaning
2.2.1 To clean the display panel use a cotton swab moistened with
70% isopropyl alcohol and gently wipe the panel.
2.2.2 To clean the outer surface of the oximeter, use a soft cloth
moistened with a 70% isopropyl alcohol. Do not allow liquids
to enter the interior of the instrument.
2.2.3 To decontaminate unit, refer to Section 7.2.2.
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. Allow unit to air dry. 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.
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3 Battery Operation and Maintenance
3.1 Overview
3.1.1 The Radical-7 Handheld includes a 2.0 Amp-hr Nickel Metal
Hydride (NiMH) battery. The Radical-7 Docking Station may
include the optional 6.5 Amp/hr NiMH battery.
3.1.2 Before using the Radical-7 as a handheld or transport
monitor, the Handheld battery and the optional Docking
Station battery need to be fully charged.
3.2 Battery Charging
3.2.1 To charge the battery(s), attach the Handheld unit to the
Docking Station.
3.2.2
Note: Some older units are configured with an AC power switch. Turn the AC
power switch to the ‘I’ position.
Ensure that AC power is attached to the Docking Station.
3.2.3 The battery charging LED indicator(s) on the Docking Station
will initially flash, then remain illuminated while the battery(s)
is (are) charging. A prolonged 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.
3.2.4 The Handheld battery requires approximately 2 to 3 hours
for charging. The optional Docking Station battery requires
approximately 6 hours for charging.
3.2.5 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.
3.2.6 It is advisable to completely discharge and fully recharge the
batteries periodically to maintain optimum battery health.
Refer to the Battery Deep Discharge function as described in
the Radical-7 Operators Manual, Section 4, Service.
CAUTIONS: on next page.
See
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CAUTIONS:
•If the Radical-7 has not been charged for 1 month or more, then
recharge the battery prior to use.
•At low battery warning, connect the Radical-7 to AC power to prevent
interruption of power.
•Additional information on the Radical-7 batteries may be found in the
Radical-7 Operators Manual.
3.3 Replacing the Handheld Battery
3.3.1 Turn the Radical-7 Handheld off and remove the patient
cable connection. Detach the Radical-7 Handheld from the
Docking Station (if docked).
3.3.2 Place the Handheld face down on a soft surface such that no
cosmetic damage occurs to the unit.
3.3.3 Loosen the closure screw on the battery, or on color models,
the battery compartment door, and remove the battery.
3.3.4 Position the replacement battery into the Handheld, bottom
first. On color models, the battery needs to be plugged in /
unplugged.
3.3.5 Replace the enclosure (if applicable) and tighten the battery
screw until it is secure. If there is a grasp loop, make sure it
is pointing towards the top of the Handheld and lays flat into
the plastic housing.
3.3.6 Place Handheld into Docking Station. Turn on power and if
necessary, charge battery according to Section 9 of the
Radical-7 Operator’s Manual: Battery Operation and
Maintenance.
3.4 Replacing the Docking Station Battery
CAUTION: Do not over-tighten screws. Tighten the screws throughout
the Radical-7 Handheld and Docking Station to 80 in.- oz.
Note: Docking Station Battery can only be installed in RDS-1B or RDS3B type replacement units.
Note: It will be necessary to perform safety testing after replacement.
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3.4.1 With the AC power cord disconnected, remove the Handheld
from the Docking Station.
3.4.2 Lay the Docking Station on its side on a soft surface, with
the screw holes facing up
3.4.3 Remove the five (5) screws from the unit using a #1 Phillips
screw driver.
3.4.4 Carefully turn the Docking Station over to allow the screws to
fall out of the unit in a manner that allows the technician to
catch the screws.
3.4.5 Lay the Docking Station on its feet and remove the top
plastic cover.
3.4.6 For units with a battery installed, disconnect the battery
connector (J21) from the Docking Station system board.
Remove the screw that holds the Docking Station System
board in place. Lift this board to allow access to the Battery.
Remove the battery.
3.4.7 Carefully install the replacement battery into its
compartment.
3.4.8 Reinstall the screw to secure the Docking Station system
board. Attach the battery connector.
3.4.9 Carefully install the top plastic cover. Make sure no internal
cables are pinched between top and bottom case.
3.4.10 Turn the unit over, and re-install the screws.
3.4.11 Attach the Handheld onto the Docking Station.
3.4.12 If necessary, charge the battery before using the Docking
Station according to Section 3.2 of this manual.
CAUTION: Follow local governing guidelines for proper disposal of
internal batteries. Do not incinerate.
3.5 Replacing the Fuses
3.5.1 Disconnect unit from AC power.
3.5.2 Use a small flat-blade screwdriver and gently pry loose the
fuse holder from the power entry module.
3.5.3 Note how the fuses are placed in the fuse holder for
installation of the new fuses.
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3.5.4 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.
3.5.5 Place fuses as needed (1 Amp, Metric, fast acting, 5x20mm,
250V) in the fuse holder, observing the proper orientation.
3.5.6 Slide the fuse holder back into the power entry module and
press firmly to make sure it is firmly inserted.
3.5.7 The unit is ready to be reconnected to AC power.
Note: If the fuses blow after replacement, troubleshoot the unit.
WARNING: FIRE HAZARD: TO PROTECT AGAINST FIRE HAZARD,
REPLACE ONLY WITH FUSES OF THE SAME TYPE,
CURRENT RATING, AND VOLTAGE RATING.
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4 Software
4.1 Overview
4.1.1 The Radical-7 product is configured to allow software
downloads directly from a PC. The Radical-7 product has
three different boards that utilize software that may require
upgrade. The Pulse Oximeter Board, Handheld System
Board and Docking Station System Board all operate with
software that is independent of each other. The software
must be compatible between the boards for the Radical-7
product to operate properly. The boards communicate with
each other through on board connections - in the case of the
Oximeter Board to Handheld System Board. For the
Handheld to Docking Station communication, this is
accomplished through a Contact Pin/Interface Cable.
4.1.2 When software upgrades are affected, it is imperative that
FRM-1312 is completed and returned to Masimo to ensure
each unit is tracked with the software version of each unit.
This form can be found in this manual, in the contents of the
software disk and can also be acquired from Masimo if
necessary by contacting Masimo using the information in
Section 7.2.4.
Note: The Pulse Oximeter Board (MX-1) is not upgradeable using the
PC_FlashApp Program. Only the Docking Station and Portable System Board
are upgradeable in this fashion. The upgrade of the MX board requires the use
of a special field upgrade tool.
4.2 Software Download Procedure
Note: No software is installed in the RDS-2 and the unit does not require
programming.
4.2.1 On the PC, open PC_FlashApp.exe from your hard drive.
Masimo software can be obtained by Authorized Service
providers by calling Masimo Technical Support Within the
United States at (800) 326-4890, option #2, or From Outside
the United States at country code (+1) 949-297-7498 option
#2.
4.2.2 Set the default “Target”, “Port” and “Baud” parameters as
shown in the table below.
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Programming
Software
PC_FlashApp Portable COM1 57600
PC_FlashApp Docking Station COM1 57600
Target Port Baud1
4.2.3 For programming the Radical-7 Handheld System Board,
perform the following steps:
4.2.4 Connect a Docking Station to AC outlet and turn the AC
Switch to ON (if applicable).
4.2.5 Connect a straight through serial cable between the PC and
the Docking Station.
4.2.6 Install the Radical-7 Handheld to the Docking Station.
4.2.7 Turn off the Handheld, if it is on.
4.2.8
Start the FlashApp program. Click Browse and select the proper
Image file to be loaded. It will be listed under the monitor’s PSA
subdirectory.
•If loading on a Radical-7C “Color” the proper file will be
named PPSA.ROM.
•If loading on a Radical-7 “Monochrome” the proper file will
be named PPSAMX.ROM.
4.2.9 Select the proper Port (usually COM1), and Select Portable
(Blue) as the Target.
4.2.10 Press the “Green” Program button. A ‘status message’ of
“waiting for docking station” will be displayed.
4.2.11 Turn on the Radical-7 Handheld.
4.2.12 The green Program button will turn off, and the red Stop
button will illuminate. Wait until the green button turns on
again indicating a successful transfer.
4.2.13 If the message on the Status window is “Complete –
Success”, continue with the next step. If programming is not
successful, go back to 4.2.7 and repeat. If this cycle is
repeated 3 times without success, troubleshooting is
required.
4.2.14 Turn off the Handheld.
1
If a unit does not program with 57,600, set baud rate to 9,600.
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4.2.15 To program Radical-7 Docking Station, perform the following
steps:
4.2.16 Connect a Docking Station to AC outlet and turn the switch
to ON position (if applicable).
4.2.17 Connect a serial cable between computer and the Docking
Station.
4.2.18 Install a known good Radical-7 Handheld to the Docking
Station.
4.2.19 Turn off the Handheld, if it is on.
4.2.20 Start the FlashApp program. Click Browse and select the
proper Image file to be loaded. It will usually be listed under
a SDSSA subdirectory.
4.2.21 Select the proper Port (usually COM1), and Select Docking
Station as the Target.
4.2.22 Press the “Green” Program button. A ‘status message’ of
“waiting for docking station” will be displayed.
4.2.23 Turn on the Handheld.
4.2.24 The green Program button will turn off, and the red Stop
button will illuminate. Wait until the green button turns on
again indicating a successful transfer. .
4.2.25 If the message on the Status window is “Complete –
Success”, continue with next step. If the message is
“Complete – Fail”, go back to 4.2.19 and repeat. If this cycle
is repeated 3 times without success, troubleshooting is
required.
4.2.26 To check software version numbers, perform the following
steps:
4.2.27 Turn off the Handheld.
4.2.28 Turn on the Handheld.
4.2.29 Press the Menu key.
4.2.30 Press the Down key and select “About”.
4.2.31 Verify that the Handheld (Handheld, Masimo SET) and
Docking Station (D-Station) software version(s) are the
intended version. The Handheld must be docked to the
Docking Station in order to see the version of the Docking
Station.
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4.2.32 Record software version in FRM-1312 and notify Masimo as
per Section 4.1.2.
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5 Performance Verification
Note: Under normal operation, no internal adjustment or recalibration is
required.
5.1 Overview
5.1.1 To test the performance of the Radical-7 pulse oximeter
following repairs or during routine maintenance, follow the
procedure outlined in this section. If the Radical-7 fails any of
the described tests, discontinue its use and correct the
problem before returning the unit back to the user.
5.1.2 Before performing the following tests place the Radical-7
Handheld into the Docking Station, connect the Radical-7 to
AC power and fully charge the Radical-7 Handheld battery
(the AC mains switch must be on). Disconnect any patient
cables or pulse oximetry sensors, as well as SatShare, serial
or Analog Output/Nurse Call cables from the instrument.
5.2 Power-On Self-Test
5.2.1 Connect the unit to AC power and verify that the AC Power
Indicator LED is illuminated. If it is not, verify that the AC
mains switch is on.
5.2.2 Turn the unit on by depressing the Power/Standby Button.
Within 5 seconds all available LEDs are momentarily
illuminated, a 1-second beep tone sounds, and the Masimo
SET logo is displayed.
5.2.3 The Docking Indicator LED, AC Power Indicator LED,
Handheld Battery Charge LED and Docking Station Charge
LED (if Docking Station is equipped with optional battery) are
illuminated and the Radical-7 begins normal operation.
5.3 Key Press Button Test
5.3.1 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 an
associated change on the display.
5.4 Alarm Limit Test
5.4.1 With the monitor turned on, select the Menu Access key and
enter the Alarm menu. Change the desired parameter,
below, to a value two points below the currently selected
value, and accept the change.
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5.4.2 Verify that the newly set parameter is shown on the
Saturation Alarm Limit Display, next to the SpO2 or pulse
rate measurement display.
5.4.3 Return the Alarm parameter to its original setting.
5.4.4 Perform steps 5.4.1 through 5.4.3 with the High Saturation
Alarm parameter.
5.4.5 Perform steps 5.4.1 through 5.4.3 with the Low Saturation
Alarm parameter.
5.4.6 Perform steps 5.4.1 through 5.4.3 with the High Pulse Rate
Alarm parameter.
5.4.7 Perform steps 5.4.1 through 5.4.3 with the Low Pulse Rate
Alarm parameter.
5.4.8 Reset the alarm limits again to the original settings.
5.5 Display Contrast Test on Monochrome only
5.5.1 With the monitor turned on, select the Menu key and enter
the Display menu. Change the Contrast parameter by
scrolling through the contrast settings.
5.5.2 Return the Contrast setting to the original value, or a value
that allows maximum viewing contrast.
5.5.3 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.
5.5.4 Release the Backlight/Contrast button again when the
display shows maximum viewing contrast.
5.6 Testing with Masimo SET Tester
5.6.1 Turn the Radical-7 off and then on again.
5.6.2 Set the alarm limits to:
% SpO2 Pulse Rate
High 100 140
Low 90 50
5.6.3 Connect the Masimo tester to the Radical-7. A patient cable
LNOP to Red PC cable adapter (4', 8' or 12')
required to connect a modular tester to the Radical-7.
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5.6.4 Verify that within 20 seconds a plethysmographic and a
Signal IQ waveform displays.
5.6.5 Verify that the SpO2 measurement is between 78% and
84%. (with tester values of 81% +/- 3%)
5.6.6 Verify that the pulse rate measurement is between 59 bpm
and 63 bpm (with tester values of 61 +/- 1 bpm).
5.6.7 Verify that an audible alarm occurs and that the SpO2
measurement and the low SpO2 alarm are flashing
5.6.8 Press the Alarm Silence button once and verify that the
alarm is silenced.
5.6.9 Wait 120 seconds and verify that the alarm silence times out
and the audible alarm is activated again. Disable the Alarm
before continuing.
5.6.10 Press the Increase Loudness button several times and verify
that the loudness of the pulse beep tone increases.
5.6.11 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.
Note: This is performed as a functional test only.
5.7.1 Connect a Masimo SET Rainbow sensor to the Radical-7
Handheld.
5.7.2 Insert the non-dominate hand’s ring finger into the finger
sensor.
5.7.3 Under %SpCO, a healthy, non-smoking individual would
have a typical reading between 0 – 5 on the display. (These
numbers are for reference only and should not be used for
diagnostic purposes)
Note: This is performed as a functional test only.
5.8.1 Connect a Masimo SET Rainbow sensor to the Radical-7
Handheld.
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5.8.2 Insert the non-dominant hand’s ring finger into the finger
sensor.
5.8.3 Under %SpMET, a healthy, non-smoking individual would
have a typical reading between 0-2% on the display. (These
numbers are for reference only and should not be used for
diagnostic purposes)
Note: This is performed as a functional test only.
5.9.1 Connect a Red Masimo SET Rainbow sensor to the Radical7 Handheld.
5.9.2 Insert the non-dominant hand’s ring finger into the finger
sensor.
5.9.3 PVI will fluctuate depending on motion, perfusion, physiology
and other factors, so there is no ‘normal’ value. If a number
is displayed, then the PVI feature is functioning properly.
5.10 Nurse Call Test
Note: Refer to Section 8 in this manual for connector pin outs noted in
Sections 5.10
5.10.1 Disconnect the 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.
5.10.2 Connect the common lead of a digital multimeter to pin 12
(Nurse Call - Common) of the Analog Output/Nurse Call
Connector (see Service Manual, Troubleshooting, Section 8,
Analog Output/Nurse Call Test) on the Radical-7. Connect
the positive lead of the multimeter to pin 6 (Nurse Call Normally Open) of the Analog Output/Nurse Call Connector
and measure that the resistance is greater than 1 MΩ (open
circuit).
5.10.3 Trigger an alarm on the monitor (e.g. by disconnecting a
sensor after it was measuring data) and verify the resistance
is < 20Ω.
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5.11 Analog Output Test
5.11.1 Disconnect all patient cables and sensors from the Radical-
7. Turn the Radical-7 off and then on again.
5.11.2 Connect the common lead of a multimeter to the pin 2
(Ground) of the Analog Output/Nurse Call Connector.
Connect the positive lead of the multimeter to pin 9 (Analog
1) of Analog Output/Nurse Call Connector.
5.11.3 Enter the menu system and set the "Output", "Analog 1" to
"0v Output". Verify that the voltmeter measures a voltage of
approximately between –10mV and 100mV.
5.11.4 Set “Analog 1” to 1v Output”. Verify that the voltmeter
measures a voltage between 0.90V to 1.10V.
5.11.5 Reset “Analog1” to “Spo2 0 – 100%”.
5.11.6 Repeat steps 5.8.3 and 5.8.4 with the positive lead of the
multimeter connected to pin 15 (Analog2) and set “Analog2”
to “0V Output” and “1V Output”.
5.11.7 Reset “Analog2” to “Pulse Rate”.
5.12 Serial Port
5.12.1 The serial port outputs ASCII data using standard RS-
232 protocol via a straight through serial cable. The
Handheld must be docked with AC power applied.
5.12.2 Validation of the port can be done by connecting a serial
printer or using a PC with Hyper Terminal and the following
setup:
5.12.3 Communication Parameters
baud rate 9600 bps
data bits 8
stop bit 1
parity none
hand shaking none
5.12.4
With the Radical-7 connected as per the above setup, attach a
patient cable and sensor to the Radical-7. From the Output menu,
select ASCII 1 and the printer (or PC monitor) will print in the
following format every second.
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5.13 Battery Test
5.13.1 Fully charge the Radical-7 Handheld Battery by placing the
Handheld into the Docking Station and connecting the AC
power (the AC mains switch must be on).
5.13.2 Verify that the green Handheld Battery Indicator LED is
illuminated.
5.13.3 When the Radical-7 is fully charged the green Handheld
Battery Indicator turns off.
5.13.4 Turn the Radical-7 on and verify that the Handheld Battery
indicator shows a full charge.
5.13.5 Fully charge the Radical-7 Docking Station Battery by
placing the Handheld into the Docking Station and
connecting the AC power (the AC mains switch must be on).
5.13.6 Verify that the green Handheld Battery and blue Connection
Indicator LEDs, on the Docking Station, are illuminated.
5.13.7 When the Radical-7 is fully charged the green Docking
Station Battery Indicator turns off.
5.13.8 Turn the Radical-7 on and verify that the Docking Station
Battery indicator shows a full charge.
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6 Repair
6.1 Safety Precautions:
WARNING: DO NOT DISASSEMBLE OR ASSEMBLE THE UNIT WITH
THE AC POWER CORD ATTACHED.
WARNING: ENSURE THE UNIT HAS BEEN CLEANED PER THE
CLEANING INSTRUCTIONS.
6.2 General Procedures
6.2.1 Examine the unit prior to disassembly or troubleshooting and
inspect for cosmetic damage. External damage may be
helpful in determining the root cause of the failure.
6.2.2 Note any markings or labeling the end user may have placed
on the unit that may need to be duplicated or transferred in
the event the housing or ancillary components are to be
replaced.
6.2.3 Make note of the unit serial number.
6.2.4 Make note of the software versions in the event the Oximeter
board or system boards are replaced, as these boards
require software updates to make them compatible with the
end users version of software.
6.2.5 Contact Masimo Corporation using the information in Section
7.2.4 to research the warranty history of the unit to
determine if the unit will be covered under warranty.
WARNING: A HI-POT SAFETY TEST IS REQUIRED IN THE EVENT
THE DOCKING STATION HAS BEEN DISASSEMBLED.
6.3 Troubleshooting
6.3.1 The troubleshooting procedures in this manual instruct the
technician to isolate the failure down to the sub-assembly
level. The intention is to have the Unit Under Test (UUT)
repaired with minimal steps. A safety analyzer or Hipot/Current Leakage test unit will be needed in the event the
Docking Station is disassembled. The Masimo SET Tester
will be needed to perform the Performance Verification in
Section 5 upon completion of repairs.
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Tools required are as follows:
Phillips head screwdriver
Multimeter
10mm wrench or small pliers
6.3.2 The troubleshooting steps below are presented in order of
the most probable cause first. Proceed to the next step only
if unit continues to fail.
6.3.3 Always note the software versions of all three boards prior to
repair.
6.3.4 All units must have Performance Verification in Section 5
performed after repairs have been affected.
6.3.5 All Docking Stations that have been opened must be safety
tested after reassembly.
6.3.6
Service Messages
6.3.6.1 R2.0.x.x – When a fault is detected, the unit either
watchdogs or displays “Service Required XXX” (where
“XXX” indicates one of the symptoms below), and
generates high priority alarm sound. In either case the
fault is latched until power is cycled or the alarm silence
key is pressed.
6.3.6.2 R2.1.x.x – When a fault is detected, the unit either
watchdogs or displays “XXX” and generates high priority
alarm sound. When the fault triggers watchdog alarm, it
is latched until the power is cycled or the alarm silence
key is pressed. But when the unit displays “XXX”, it also
resets itself to clear the fault. If the fault is one-time
event, software clears the fault and continues to operate
normally. If the fault is permanent, the Radical-7 will
display “XXX”, reset, display “XXX”, reset…
Symptom Cause and Corrective Action
Steps
• 001
• 002
• 003
• 004
• SRAM Memory Failure
1. Replace Portable System Board
• Flash Memory Failure
1. Replace Portable System Board
• Low Speed Bus Timeout
1. Replace Portable System Board
• Display or Low Speed Bus
Failure
1. Replace Portable System Board
6-2
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Symptom Cause and Corrective Action
Steps
2. Replace Display
• 005
• 006
• 007
• Dual UART Failed at Power Up
1. Replace Portable System Board
• Oximeter Board Failure
1. Replace Oximeter Board
• Oximeter MX Board
Communication Error
1. Verify Oximeter Board (SET)
Software is correct
a. If version is incorrect or not
displayed, return unit to an
authorized service center or use
a field upgrade tool to reload
the oximeter board software.
b. If version is correct, replace
Oximeter Board.
c. Replace Portable System Board
• 008
• 009
• Real Time Clock Failure
1. Replace Portable System Board
• Watchdog Failure
1. Replace Portable System Board
• 010 • Docking Station Watchdog
Failure
1. Replace Docking Station System
Board.
2. Replace Portable System Board
•200 • Invalid SatShare coefficients
1. Replace Docking Station System
Board.
Symptom Cause and Corrective Action
Steps
• All Flashing LED's
1. Flashing alternates between
all LED's and AC Power
LED.
2. Refer to Radical-7
Operators
Manual for LED status
Parameters.
• Communication error between
Portable and Docking Station
1. Verify software versions of
Portable and Docking Station
System Boards using the Portable
menu
a. If versions are incorrect or not
displayed, reload System
Application Software for that
device utilizing procedures
outlined in the Software
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Symptom Cause and Corrective Action
Alarm Condition But No
Steps
Download Procedure.
2. Replace The Interface Cable
3. Replace the Portable System
Board
4. Replace the Docking Station
System Board
•No LED'S Illuminated
1. Both Portable and Docking
Station are turned on.
2. Refer to Radical-7
Operators
Manual for LED status
Parameters.
• Power fault
1. Replace external Power Cable
2. Check fuses at AC Input Filter
3. Check 12VDC power (Sections 7
& 8)
4. Replace Docking Station System
Board
•No Battery Icon Displayed • NiMH Battery Fault
1. Replace NiMH battery
2. Replace Portable System Board
• Battery LED Not
Illuminated
1. No fault, battery is fully charged
2. Check 12VDC power (Sections 7
& 8)
3. Replace Docking Station System
Board
•Battery LED Flashing
1. Ensure Service Mode – Deep
Discharge is not enabled
2. Allow NiMH Battery to cool down
3. Verify Fan operation
4. Replace NiMH Battery
5. Replace Docking Station System
Board.
• Alarm LED does not
Illuminate
1. Unit must be in alarm state
1. Replace Docking Station System
Board
2. Replace LED Cable.
2. Audible alarm can be heard
•
Audible Indication.
1. Unit must be in alarm
• Alarm Fault
1. Replace Speaker
2. Replace Portable System Board
condition.
2. Should hear sound upon
button depression.
•Display Missing Segments
1. Replace LCD
2. Replace Portable System Board
• Display Backlight Will Not
Illuminate
•Button Function Error
1. Replace Portable System Board
2. Replace Display
1. Replace Keypad
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Symptom Cause and Corrective Action
Steps
1. Any front panel button
2. Replace Portable System Board
affected
2. Buttons do not activate
feature
3. Buttons hard to press
• Rightmost Touch Key
Difficult to Depress
1. Open unit. If Swivel Connector flex
cable is interfering with button,
replace Swivel Connector
2. Replace Keypad.
• "No Sensor", “Defective
Sensor” or “Sensor Off”
Displayed
• Display Does Not Rotate
Automatically
1. Replace sensor.
2. Replace patient cable.
3. Replace oximeter board.
1. Ensure Docking Station is
powered up
2. Ensure Power Save feature is not
enabled
3. Replace Docking Station System
Board
• Display Does Not Rotate
Manually
1. Flex interference? Replace Swivel
Connector.
2. Replace Keypad
3. Replace Portable System Board
• Docking Station Fails
When Portable is Docked
1. Ensure software of Handheld and
Docking Station is compatible
2. Replace Portable System Board
3. Replace Docking Station System
Board
4. Replace Interface Cable
• Fan Does Not Function
1. Ensure AC power is on
1. Replace Fan
2. Replace Docking Station System
Board
• Portable Will Not Power
Up When Undocked
1. If Clicking is heard when
On/Off button is depressed,
1. Check NiMH Battery charge
2. Replace Battery if charging is not
successful
3. Replace Portable System Board.
perform Step 3.
• Portable will not Power Up
When Docked
1. Docking Station is
1. Replace Interface Cable
2. Replace Docking Station System
Board
functioning
2. Portable powers up
undocked
•Portable Will Not Turn Off
1. Replace Portable System Board
2. Adjust or replace Keypad
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Symptom Cause and Corrective Action
Steps
• Portable Will Not Undock
• From Docking Station
1. Ensure Portable Lock is not in
2. Latch failure, gently pry latch
down; once removed, replace
latch and/or striker
•Watchdog Alarm
1. Replace Portable System Board
1. Other than "Service"
failures
WARNING: IF SYMPTOMS ARE PRESENT AND ARE NOT
CORRECTABLE, DO NOT USE MALFUNTIONING
COMPONENT.
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6.4 SatShare Diagnostics
CAUTION: As SatShare Diagnostics simulates physiological information
(SpO2 and Pulse Rate values), it should be performed with caution,
especially in areas with central monitoring. The attending nurse
and supervisor should always be made aware that SatShare
Diagnostic testing is being performed.
6.4.1
If the SpO2 and pulse rate values displayed on a multi-
parameter monitor is in question, perform the following steps.
6.4.1.1 Press Menu – General – SatShare Numbers – Yes.
6.4.2 With the Handheld docked and AC power applied,
disconnect the patient cable from Radical-7. Press the
following key sequence: Menu – About – More – 2 – 1 – 1
(see Service menu for number key assignments). Five (5)
different SatShare values can be selected by pressing
the Select key. The selected value will be displayed on the
multi-parameter monitor if the unit is working properly. The
SatShare Diagnostics feature times out if a key is not
pressed within 1 minute.
Note: During transient situations, the SpO2 and pulse rate values on the
Radical-7 and multi-parameter monitor may differ by more than the
specified tolerance. The averaging time set on the multi-parameter
monitor may also affect the delay during transient situations.
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7 Repair and Returns
7.1 Repair Policy
7.1.1 Masimo or an authorized Service Department must perform
warranty repair and service. Do not use malfunctioning
equipment. The product must be repaired.
7.1.2 Please clean contaminated/dirty equipment before returning.
Make sure it is fully dry before packing the equipment.
7.1.3 To return the Radical-7 unit for service, please follow the
Return Procedure outlined in this section.
7.2 Return Procedure
7.2.1 Please clean contaminated/dirty equipment before returning
and make sure it is completely dry before packing the
equipment.
7.2.2 Recommended decontamination procedure for Radical-7
equipment that has the potential for being exposed to blood
or other potentially infectious materials:
7.2.2.1 Put on Lab coat or other protective garment.
7.2.2.2 Put on gloves.
7.2.2.3 Place equipment on the designated decontamination
table.
7.2.2.4 Apply cleaning agent to paper towel. Clean with
70% Isopropyl alcohol wipes, or 1:10 bleach to water
solution. Wipe down all aspects of the equipment.
7.2.2.5 Let the equipment air dry completely.
7.2.2.6 Remove gloves.
7.2.2.7 Move equipment to the area designated for
equipment that has been through the
decontamination process.
7.2.2.8 Dispose of all contaminated products properly.
7.2.3 Package the equipment securely – in the original shipping
container if possible – and enclose the following information
and items:
7.2.3.1 Call Masimo From within the United States at (800)
326-4890, option #2, or from outside the United
States at country code (+1) 949-297-7498, option #2
and ask for an RMA number.
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7.2.3.2 Place a copy of the supplied RMA inside the box,
and write the RMA number on the outside of the
shipping container
7.2.3.3 A letter or email describing in detail any symptoms
or difficulties experienced with the pulse oximeter.
7.2.3.4 Warranty information – a copy of the invoice or other
applicable documentation must be included
7.2.3.5 Purchase order number to cover repair if the
oximeter is not under warranty, or for tracking
purposes if the warranty is in effect
7.2.3.6 Ship-to and bill-to information
7.2.3.7 Person (name, telephone/Telex/fax number, email
and country) to contact for any questions about the
repairs
7.2.3.8 A document stating the oximeter has been
decontaminated for blood borne pathogens
7.2.4 Return the pulse oximeter and a copy of the RMA to the
following shipping address:
WARNING: Disassembly or repair by authorized Service Personnel only.
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16 Radical-7 Monochrome Parts List
1.
2.
4.
7.
3.
8.
9.
10.
12.
22.
13.
15.
18.
20
11.
5.
6.
14.
21.
16.
19.
17.
1. Latch
2. Top Shell
3. Swivel Connector
4. Leash Pins
5. Speaker Gasket
6. Speaker
7. Keypad Adhesive
8. Keypad
9. Display.
10.
Display Retainer
11.
MX-x Standoff Mounting Hardware (4 pcs)
12.
Handheld System Board
13.
Portable System Board Mounting Hardware (2 pcs)85
14.
Standoff (4 pcs)
15.
MX-xx mounting Hardware (4 pcs)
16.
MX-1, MX-3
17.
Back Shell
18.
Plastics Hardware (6 pcs)
19.
NiMH Battery Pack
20.
Radical-7 Logo Label
21.
Lithium Coin Cell
22.
Foam Pad
Portable Board – MX-x board compatibility Table (lower case x indicates compatibility):
Portable System Board MX-12
20755 20699
Radical 7 Portable System Board Re-order Part Number 20841
MX-1 Board Re-order Part Number 2143
WARNING: Disassembly or repair by authorized Service Personnel only.
2
The Oximeter Board re-order part number is different than the part number label on the board. The re-order part number indicates that the board has been tested and programmed. The
portable Systems Board and the MX-x Circuit Board must be compatible. Re-order the part number as indicated in the table above.
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17 Docking Station Parts List (RDS-1, RDS-1B and RDS-3)
4
2
6
5
1
24
3
27
7
8
9
25
20
10
11
12
14
15
16
13
18
26
17
19
21
23
22
28
Note: Only RDS-1B configured Docking Stations will contain the 20284 Optional Battery Pack.
1. Front Shell
2. LED Status Label 11. AC Power Entry Module
3. Radical Logo Label 12. AC Filter Module Bracket
4. LED Status Cable 13. Fan
5. Interface Cable 14. AC Power Entry Module Bracket Hardware (5 pcs [1x2x2 ] )