Masimo RAD-57C User manual

OPERATOR’S
MANUAL
Covers:
Rad-57c:
with SpO2and SpCO
Rad-57m:
with SpO2and SpMet
Rad-57cm:
with SpO2, SpCO
and SpMet
Signal Extraction
Pulse CO-Oximeter™
Masimo Rainbow® SET®

Signal Extraction Pulse CO-Oximeter™
OPERATOR'S MANUAL

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual
The Rad-57 Signal Extraction Pulse CO-Oximeter Operating Instructions intend to provide the nec-
essary information for proper operation of all Rad-57 Pulse CO-Oximeter models.
General knowledge of Pulse CO-Oximetry and an understanding of the features and functions of
the Rad-57 Signal Extraction Pulse CO-Oximeter models are prerequisites for proper use.
Do not operate any of the Rad-57 Signal Extraction Pulse CO-Oximeter models without completely
reading and understanding these instructions.
NOTICE
Purchase or possession of this device does not carry any express or implied license to use with
replacement parts which would, alone or in combination with this device, fall within the scope of one
of the relating patents.
CAUTION:
FEDERAL LAW (U.S.) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A
PHYSICIAN.
For further information contact:
Masimo Corporation
40 Parker
Irvine, CA 92618
USA
Tel.: [phone]
Fax.: [phone]
www.masimo.com
EU Authorized Representative for Masimo Corporation:
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 60601-1/CAN/CSA C22.2 No. 601.1
80fk
Covered by one or more of the following U.S. Patents: RE38,492, RE38,476, 7,221,971, 7,215986,
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, 6,206,830, 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. Other patents pending.
© 2009 Masimo Corporation. Masimo, , SET, LNCS, LNOP, Signal IQ, Discrete Saturation
Transform, DST, FastSat and SpCO are registered trademarks of Masimo Corporation.
Rad-57, Rad-57c, Rad-57m, Rad-57cm, SIQ, LNOPv, SpMet, Pulse CO-Oximeter and APOD are
trademarks of Masimo Corporation.
EC REP

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES
The Rad-57™ Handheld Pulse CO-Oximeter™ is designed to minimize the possibility
of hazards from errors in the software program by following sound engineering design
processes, Risk Analysis and Software Validation.
■Explosion hazard. Do not use the Pulse CO-Oximeter in the presence of flammable
anesthetics or other flammable substance in combination with air, oxygen-enriched
environments, or nitrous oxide.
■High intensity extreme lights (such as pulsating strobe lights) directed on the sensor,
may not allow the Pulse CO-Oximeter to obtain vital sign readings.
■The Pulse CO-Oximeter is NOT intended for use as an apnea monitor.
■A Pulse CO-Oximeter should be considered an early warning device. As a trend
towards patient hypoxemia is indicated, blood samples should be analyzed by
laboratory instruments to completely understand the patient’s condition.
■Pulse rate measurement is based on the optical detection of a peripheral flow pulse
and therefore may not detect certain arrhythmias. The pulse oximeter should not be
used as a replacement or substitute for ECG based arrhythmia analysis.
■The Pulse CO-Oximeter is to be operated by qualified personnel only. This manual,
accessory directions for use, all precautionary information, and specifications should
be read before use.
■Electric shock hazard. Do not open the Pulse CO-Oximeter cover except to replace
the batteries. 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 CO-Oximeter or accessories in any position that might cause
it to fall on the patient. Do not lift the Pulse CO-Oximeter by the patient cable.
■Interfering Substances: SpO2 is a functional calculation of arterial oxygen saturation.
Carboxyhemoglobin and methemoglobin may erroneously increase SpO2readings.
The level of increase is approximately equal to the amount of carboxyhemoglobin and/
or methemoglobin present. Dyes, or any substance containing dyes, that change usual
blood pigmentation may cause erroneous readings.
■Severe anemia may cause erroneous SpO2readings.
■Elevated levels of Total Bilirubin may lead to inaccurate SpO2measurements.
■Hemoglobin synthesis disorders may cause erroneous SpHb readings.
■Do not use the Pulse CO-Oximeter or oximetry sensors during magnetic resonance
imaging (MRI) scanning. Induced current could potentially cause burns. The Pulse
CO-Oximeter may affect the MRI image, and the MRI unit may affect the accuracy of
the oximetry measurements.
■If using Pulse CO-Oximetry during full body irradiation, keep the sensor out of the
radiation field. If sensor is exposed to the radiation, the reading might be inaccurate
or the device might read zero for the duration of the active radiation period.
ii

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual iii
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES
■Always remove the sensor from the patient and completely disconnect the patient
from the Pulse CO-Oximeter before bathing the patient.
■Do not place the Pulse CO-Oximeter where the controls can be changed by the patient.
■Do not place the Pulse CO-Oximeter face against a surface. This will cause the alarm
to be muffled.
■Do not place the Pulse CO-Oximeter on electrical equipment that may affect the
Pulse CO-Oximeter, preventing it from working properly.
■Do not expose the Pulse CO-Oximeter to excessive moisture such as direct exposure
to rain. Excessive moisture can cause the Pulse CO-Oximeter to perform inaccurately
or fail.
■Do not place containers containing liquids on or near the Pulse CO-Oximeter. Liquids
spilled on the Pulse CO-Oximeter may cause it to perform inaccurately or fail.
■Failure of Operation - If the Pulse CO-Oximeter fails any part of the setup
procedures remove the Pulse CO-Oximeter from operation until qualified service
personnel have corrected the situation.
■Patient Safety - If a sensor is damaged in any way, discontinue use immediately.
■Disposal of product - Comply with local laws in the disposal of the device and/or its
accessories.
■ The Pulse CO-Oximeter can be used during defibrillation, but the readings may be
inaccurate for up to 20 seconds.
■ This equipment has been tested and found to comply with the limits for medical
devices to the EN 60601-1-2: 2002, Medical Device Directive 93/42/EEC. These limits
are designed to provide reasonable protection against harmful interference in a typical
medical installation. This equipment generates, uses and can radiate radio frequency
energy and, if not installed and used in accordance with the instructions, may cause
harmful interference to other devices in the vicinity. However, there is no guarantee
that interference will not occur in a particular installation. If this equipment does
cause harmful interference to other devices, which can be determined by turning the
equipment off and on, the user is encouraged to try to correct the interference by one
or more of the following measures:
■Reorient or relocate the receiving device.
■ Increase the separation between the equipment.
■ Consult the manufacturer for help.
■ A functional tester cannot be utilized to assess the accuracy of the Pulse CO-Oximeter
or any sensors.

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual
table of contents
iv
SECTION 1 - OVERVIEW
About this manual.......................................................................................................... 1-1
Warnings, Cautions and Notes ...................................................................................... 1-2
Product Description ....................................................................................................... 1-3
Model Summary ....................................................................................................... 1-3
Features and Benefits .............................................................................................. 1-3
Indications for use .................................................................................................... 1-4
Pulse CO-Oximetry........................................................................................................ 1-5
SpO2General Description........................................................................................ 1-5
SpCO General Description....................................................................................... 1-5
SpMet General Description ...................................................................................... 1-5
Principle of Operation............................................................................................... 1-6
Functional vs. Fractional Saturation ......................................................................... 1-6
Measured vs. Calculated Values .............................................................................. 1-7
Masimo SET Signal Extraction Technology for SpO2measurements...................... 1-7
SpCO and SpMet measurements during patient motion ......................................... 1-7
Masimo SET Parallel Engines.................................................................................. 1-8
Masimo SET DST®.................................................................................................. 1-8
SECTION 2 - SYSTEM DESCRIPTION
Introduction .................................................................................................................... 2-1
Rad-57c Front Panel Controls ....................................................................................... 2-2
Rad-57m Front Panel Controls ...................................................................................... 2-4
Rad-57cm Front Panel Controls .................................................................................... 2-6
Rad-57 Rear Panel (all models) .................................................................................... 2-8
Symbols.................................................................................................................... 2-9
SECTION 3 - SETUP
Introduction .................................................................................................................... 3-1
Unpacking and Inspection ............................................................................................. 3-1
Preparation for Monitoring ............................................................................................. 3-1
Power Requirements ................................................................................................ 3-1
Monitor Setup ................................................................................................................ 3-2
Initial Setup............................................................................................................... 3-2
SECTION 4 - OPERATION
Introduction .................................................................................................................... 4-1
Basic Operation ............................................................................................................. 4-1
General Setup and Use............................................................................................ 4-1
Default Settings ........................................................................................................ 4-3
Successful SpO2Monitoring.......................................................................................... 4-4
Masimo Sensors....................................................................................................... 4-4
Numeric Display - SpO2........................................................................................... 4-4
Numeric Display - Pulse Rate ................................................................................. 4-5
Numeric Display - SpCO.......................................................................................... 4-5
Numeric Display - SpMet ......................................................................................... 4-5
Numeric Display - PI ................................................................................................ 4-5
Low Signal IQ (Low SIQ).......................................................................................... 4-5
Low Perfusion........................................................................................................... 4-6
Actions To Be Taken ................................................................................................ 4-6
Sensitivity ................................................................................................................. 4-7

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual v
table of contents
Battery Level Indicator.............................................................................................. 4-7
Low Battery Audible Alarm....................................................................................... 4-8
Normal Patient Monitoring ............................................................................................. 4-9
Setup Menu.................................................................................................................. 4-10
Menu Navigation .................................................................................................... 4-10
Setup Menu Level 1 – Alarm Volume and Alarm Silence ...................................... 4-10
Setup Menu Level 2 – Alarm Limits ....................................................................... 4-10
Setup Menu Level 3 – Sensitivity, Averaging, FastSat and SmartTone.................. 4-11
Setup menu Level 4 - Trend Settings ..................................................................... 4-11
Setup Menu Level 5 - LED brightness and Factory Defaults................................. 4-12
Menu selection ....................................................................................................... 4-12
Power Off................................................................................................................ 4-12
Special Menu ............................................................................................................... 4-12
Special Menu – Line Frequency Configuration............................................................ 4-13
Trend Setup and Use................................................................................................... 4-14
Introduction............................................................................................................. 4-14
TrendCom Utility Installation................................................................................... 4-14
TrendCom Utility Operation .................................................................................... 4-14
Erasing Trend Memory ........................................................................................... 4-15
Trend Data Format ................................................................................................. 4-15
Sample Trend Output.............................................................................................. 4-16
SECTION 5 - ALARMS / MESSAGES
Alarm Indication............................................................................................................. 5-1
Alarm Limits...................................................................................................................5-1
Alarm Silence ........................................................................................................... 5-3
Alarm Silenced Indicator .......................................................................................... 5-3
Messages ................................................................................................................. 5-4
SECTION 6 - TROUBLESHOOTING
Troubleshooting.............................................................................................................. 6-1
SECTION 7 - SPECIFICATIONS
Rad-57 Family Specifications ........................................................................................ 7-1
Performance ............................................................................................................. 7-1
Accuracy................................................................................................................... 7-1
Electrical................................................................................................................... 7-2
Environmental........................................................................................................... 7-2
Physical characteristics ............................................................................................ 7-2
SECTION 8 - SENSOR AND PATIENT CABLES
Introduction .................................................................................................................... 8-1
Selecting a Sensor ................................................................................................... 8-1
Sensor Application Instructions................................................................................ 8-1
Masimo Rainbow®Sensors............................................................................................ 8-2
Rainbow Reusable Sensors ..................................................................................... 8-2
Rainbow Adhesive Sensors ..................................................................................... 8-2
Masimo SpO2Sensors .................................................................................................. 8-2
Red Reusable Sensors ........................................................................................... 8-2
LNOP®Reusable Sensors ........................................................................................................... 8-3
SECTION 4 - OPERATION (CONTINUED)

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual
table of contents
vi
LNOP®Adhesive Sensors ....................................................................................... 8-3
LNOP®Specialty Sensors ....................................................................................... 8-3
LNCS®Reusable Sensors ...................................................................................... 8-3
LNCS®Adhesive Sensors ...................................................................................... 8-4
LNOPv™Adhesive Sensors ............................................................................................ 8-4
Sensor Accuracy ..................................................................................................... 8-4
Cleaning And Reuse Of Masimo Reusable Sensors and Cables............................ 8-4
Reattachment of Single Use Adhesive Sensors ...................................................... 8-4
SECTION 9- SERVICE / MAINTENANCE
Introduction .................................................................................................................... 9-1
Cleaning......................................................................................................................... 9-1
Battery Replacement................................................................................................ 9-2
Performance Verification ................................................................................................ 9-3
Power-On Self-Test................................................................................................... 9-3
Key Press Button Test .............................................................................................. 9-3
Alarm Limit Test........................................................................................................ 9-3
LED Brightness ........................................................................................................ 9-3
Service and Repair ........................................................................................................ 9-4
Repair Policy ............................................................................................................ 9-4
Return Procedure..................................................................................................... 9-4
Sales & End-user License Agreement .................................................................... 9-5
Warranty......................................................................................................................... 9-5
Exclusions...................................................................................................................... 9-5
End-user License .......................................................................................................... 9-6
Restrictions ................................................................................................................... 9-7
SECTION 10- ACCESSORIES
Accessories.................................................................................................................. 10-1
SECTION 8 - SENSOR AND PATIENT CABLES (CONTINUED)

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 1-1
1
overview
About this Manual
This manual explains how to set up and use the Rad-57c, Rad-57m and Rad-57cm Signal
Extraction Pulse CO-Oximeter. These three products will be generally referred to as the Rad-
57. Features and specifications apply to all models unless otherwise noted. Important safety
information relating to general use of the Rad-57 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 CO-Oximetry.
SECTION 2 SYSTEM DESCRIPTION describes the Rad-57 system, functions and
features.
SECTION 3 SETUP describes how to setup the Rad-57 for use.
SECTION 4 OPERATION describes the operation of the Rad-57.
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 Rad-57.
SECTION 8 SENSORS AND PATIENT CABLES outlines how to use and care for
Masimo Rainbow SET, LNOP®, LNOPv™ and LNCS®sensors, Masimo
Rainbow SET patient cables and Masimo SET patient cables.
SECTION 9 SERVICE AND MAINTENANCE describes how to maintain, service and
obtain repair for the Rad-57.
SECTION 10 ACCESSORIES