Masimo Radical 7 Service manual

Signal Extraction Pulse CO-Oximeter

Monochrome and Color Display

Service Manual

Radical-7 Signal Extraction Pulse CO-Oximeter Service Manual

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.: [phone]

Fax.: [phone]

www.masimo.com

EU Authorized Representative for Masimo Corporation:

EC REP

MDSS GmbH

Schiffgraben 41

30175 Hannover, Germany

Tel.: [phone]

Fax.: [phone]

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.

© 2007 Masimo Corporation. LNOP, Masimo, Radical, the Radical logo, Rainbow, Satshare, SET, Signal IQ,
and SpCO are federally registered trademarks of Masimo Corporation. FlashApp, PVI, Radical-7, RDS, SpMet
and Signal Extraction Pulse CO-Oximeter are trademarks of Masimo Corporation.

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Radical-7 Signal Extraction Pulse CO-Oximeter Service Manual

Table of Contents

Page

1 Overview........................................................................................1-1

1.1 About this Manual....................................................................1-1

1.2 Warnings, Cautions and Notes................................................1-1

2 Maintenance ..................................................................................2-1

2.1 Introduction..............................................................................2-1

2.2 Cleaning...................................................................................2-1

3 Battery Operation and Maintenance ...........................................3-1

3.1 Overview..................................................................................3-1

3.2 Battery Charging......................................................................3-1

3.3 Replacing the Handheld Battery..............................................3-2

3.4 Replacing the Docking Station Battery....................................3-2

3.5 Replacing the Fuses................................................................3-3

4 Software.........................................................................................4-1

4.1 Overview..................................................................................4-1

4.2 Software Download Procedure................................................4-1

5 Performance Verification .............................................................5-1

5.1 Overview..................................................................................5-1

5.2 Power-On Self-Test .................................................................5-1

5.3 Key Press Button Test.............................................................5-1

5.4 Alarm Limit Test.......................................................................5-1

5.5 Display Contrast Test on Monochrome only............................5-2

5.6 Testing with Masimo SET Tester.............................................5-2

5.7 %SpCO (Carboxyhemoglobin) Testing (If Applicable) ............5-3

5.8 %SpMET (Methemoglobin) Testing (If Applicable) .................5-3

5.9 PVI (Pleth Variability Index) Testing (If Applicable).................5-4

5.10

Nurse Call Test ....................................................................5-4

5.11

Analog Output Test ..............................................................5-5

5.12

Serial Port ............................................................................5-5

5.13

Battery Test..........................................................................5-6

6 Repair.............................................................................................6-1

6.1 Safety Precautions:..................................................................6-1

6.2 General Procedures.................................................................6-1

6.3 Troubleshooting.......................................................................6-1

6.4 SatShare Diagnostics ..............................................................6-7

7 Repair and Returns.......................................................................7-1

7.1 Repair Policy............................................................................7-1

7.2 Return Procedure ....................................................................7-1

8 Analog Output/Nurse Call Test....................................................8-1

9 Docking Station Power Supply Power Measurement ...............9-1

Radical-7 Signal Extraction Pulse CO-Oximeter Service Manual

iii

10 Portable Functional Block Diagram..........................................10-1

11 Docking Station Functional Block Diagram.............................11-1

12 Radical-7 Isolation Block Diagram............................................12-1

13 Portable Wiring Interconnect.....................................................13-1

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

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Radical-7 Signal Extraction Pulse CO-Oximeter Service Manual

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.

Radical-7 Signal Extraction Pulse CO-Oximeter Service Manual

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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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Radical-7 Signal Extraction Pulse CO-Oximeter Service Manual

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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Radical-7 Signal Extraction Pulse CO-Oximeter Service Manual

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.

Radical-7 Signal Extraction Pulse CO-Oximeter Service Manual

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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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Radical-7 Signal Extraction Pulse CO-Oximeter Service Manual

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 [phone], option #2, or From Outside
the United States at country code ([phone] option
#2.

4.2.2 Set the default “Target”, “Port” and “Baud” parameters as

shown in the table below.

Radical-7 Signal Extraction Pulse CO-Oximeter Service Manual

4-1

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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Radical-7 Signal Extraction Pulse CO-Oximeter Service Manual