Masimo Rad-67 Pulse CO-Oximeter User manual

Operator's Manual
Rad-67™ Pulse CO-Oximeter®
Spot-Check

www.masimo.com 1 Masimo
For Sale in the USA
These operating instructions provide the necessary information for proper operation of all
models of the Rad-67. 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 Rad-67 are prerequisites for its proper use. Do not operate Rad-67
without completely reading and understanding these instructions.
Note: Cleared Use Only: The device and related accessories are cleared by the Food and
Drug Administration (FDA) and are CE Marked for noninvasive patient monitoring and may
not be used for any processes, procedures, experiments, or any other use for which the device
is not intended or cleared by the applicable regulatory authorities, or in any manner
inconsistent with the directions for use or labeling.
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 (USA) law restricts this device to sale by or on the order of a physician.
Wireless Radio
FCC ID: VKF-MWM1 Model Rad-67 IC: 7362A-MWM1 IC Model: MWM1
Masimo Corporation
52 Discovery
Irvine, CA 92618, USA
Tel.: [phone]
Fax.: [phone]
www.masimo.com
EU authorized representative for Masimo Corporation:
MDSS GmbH
Schiffgraben 41
D-30175 Hannover, Germany
3149433
MEDICAL ELECTRICAL EQUIPMENT
WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL
HAZARDS ONLY IN ACCORDANCE WITH
ANSI/AAMI ES 60601-1:2005, CAN/CSA C22.2 No. 60601-1:2008, and
applicable Particular (EN/ISO 80601-2-61:2011) and related Collateral (IEC
60601-1-8:2006) Standards for which the product has been found to comply
by Intertek.
Patents: www.masimo.com/patents.htm
®, Adaptive Probe Off Detection®, APOD®, Masimo®, Pulse CO-Oximeter®, rainbow®,
SET®, Signal Extraction Technology®, Signal IQ®, SpHb®, and X-Cal™ are federally
registered trademarks of Masimo Corporation.
Rad-67™ is a trademark of Masimo Corporation. All other trademarks and registered
trademarks are property of their respective owners.
© 2019 Masimo Corporation

www.masimo.com 3 Masimo
Contents
About This Manual-------------------------------------------------------------------------------------------7
Product Description, Features and Indications for Use----------------------------------------------- 9
Product Description------------------------------------------------------------------------------------- 9
Indications for Use-------------------------------------------------------------------------------------- 9
Contraindications --------------------------------------------------------------------------------------- 9
Safety Information, Warnings and Cautions ---------------------------------------------------------- 11
Safety Warnings and Cautions----------------------------------------------------------------------- 11
Performance Warnings and Cautions--------------------------------------------------------------- 12
Cleaning and Service Warnings and Cautions ----------------------------------------------------15
Compliance Warnings and Cautions----------------------------------------------------------------15
Chapter 1: Technology Overview ------------------------------------------------------------------------19
Signal Extraction Technology® (SET®)------------------------------------------------------------19
rainbow Pulse CO-Oximetry Technology® ---------------------------------------------------------21
Chapter 2: Description ------------------------------------------------------------------------------------25
General System Description--------------------------------------------------------------------------25
Features--------------------------------------------------------------------------------------------------26
Chapter 3: Setting Up------------------------------------------------------------------------------------- 27
Unpacking and Inspection --------------------------------------------------------------------------- 27
Preparation for Use ------------------------------------------------------------------------------------ 27
Guidelines for Setting Up----------------------------------------------------------------------------- 27
Initial Battery Charging------------------------------------------------------------------------------- 27
Powering the Rad-67 ON and OFF-------------------------------------------------------------------28
Chapter 4: Operation--------------------------------------------------------------------------------------29
Using the Touchscreen and Home Button---------------------------------------------------------29
About the Main Screen------------------------------------------------------------------------------- 33
Accessing Main Menu Options---------------------------------------------------------------------- 38
Parameter Settings ----------------------------------------------------------------------------------- 40
Additional Settings ------------------------------------------------------------------------------------43
Spot-Check Settings -----------------------------------------------------------------------------------44
Spot-Check Sessions-----------------------------------------------------------------------------------44
Sounds --------------------------------------------------------------------------------------------------- 47

Rad-67 Contents
www.masimo.com 4 Masimo
Device Settings----------------------------------------------------------------------------------------- 47
About-----------------------------------------------------------------------------------------------------54
Screenshot Capture------------------------------------------------------------------------------------54
Chapter 5: Spot-Check------------------------------------------------------------------------------------ 57
Performing a Spot-Check -----------------------------------------------------------------------------58
Spot-Check Results ------------------------------------------------------------------------------------ 61
Chapter 6: Alerts and Messages ------------------------------------------------------------------------63
About Alerts---------------------------------------------------------------------------------------------63
Messages ------------------------------------------------------------------------------------------------64
Chapter 7: Troubleshooting------------------------------------------------------------------------------ 67
Troubleshooting Measurements--------------------------------------------------------------------- 67
Troubleshooting Rad-67 ------------------------------------------------------------------------------ 71
Chapter 8: Specifications -------------------------------------------------------------------------------- 75
Display Range ------------------------------------------------------------------------------------------ 75
Accuracy (ARMS*) ------------------------------------------------------------------------------------- 75
SpO2 Performance Specifications------------------------------------------------------------------- 76
SpHb Accuracy Data----------------------------------------------------------------------------------- 77
Resolution----------------------------------------------------------------------------------------------- 78
Electrical------------------------------------------------------------------------------------------------- 79
Environmental------------------------------------------------------------------------------------------ 79
Physical Characteristics ------------------------------------------------------------------------------ 79
Display Indicators------------------------------------------------------------------------------------- 80
Compliance -------------------------------------------------------------------------------------------- 80
Output Interface --------------------------------------------------------------------------------------- 81
Wireless Specifications ------------------------------------------------------------------------------- 81
Guidance and Manufacturer's Declaration-Electromagnetic Emissions----------------------83
Guidance and Manufacturer's Declaration-Electromagnetic Immunity----------------------84
Recommended Separation Distances -------------------------------------------------------------- 87
Symbols--------------------------------------------------------------------------------------------------88
Citations------------------------------------------------------------------------------------------------ 90
Chapter 9: Service and Maintenance ------------------------------------------------------------------93
Cleaning -------------------------------------------------------------------------------------------------93
Performance Verification -----------------------------------------------------------------------------93

Rad-67 Contents
www.masimo.com 5 Masimo
Maintenance --------------------------------------------------------------------------------------------94
Repair Policy ------------------------------------------------------------------------------------------- 95
Return Procedure-------------------------------------------------------------------------------------- 95
Contacting Masimo ----------------------------------------------------------------------------------- 95
Index -------------------------------------------------------------------------------------------------------- 99

www.masimo.com 7 Masimo
About This Manual
This manual explains how to set up and use Rad-67™ Pulse CO-Oximeter®. Important safety
information relating to general use of Rad-67 appears in this manual. Read and follow any
warnings, cautions, and notes presented throughout this manual. The following are
explanations of warnings, cautions, and notes.
A warning is given when actions may result in a serious outcome (for example, injury, serious
adverse effect, death) to the patient or user.
WARNING: This is an example 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.
CAUTION: This is an example of a caution statement.
A note is given when additional general information is applicable.
Note: This is an example of a note.