Masimo Rad-5 User manual

Operator's Manual
Rad-5®/5v®Pulse Oximeter

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These operating instructions provide the necessary information for proper operation of all
models of the Rad®-5/5v. 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-5/5v are prerequisites for its proper use. Do not operate Rad-
5/5v without completely reading and understanding these instructions. If you encounter any
serious incident with product, please notify the competent authority in your country and the
manufacturer.
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. If you encounter any serious incident with
product, please notify the competent authority in your country and the manufacturer.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
See instructions for use for full prescribing information, including indications,
contraindications, warnings and precautions.
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
Tel.: [phone]
Fax.: [phone]
Authorized Brazil Company Representative:
MEDSTAR IMPORT AND EXPORT EIRELI
R VALENCIO SOARES RODRIGUES, 89- ROOM 1
CEP: 06.730-000
NEIGHBORHOOD: CENTER
MUNICIPALITY:VARGEM GRANDE PAULISTA
UF: SP
3149433
MEDICAL ELECTRICAL EQUIPMENT
WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH
ANSI/AAMI ES 60601-1:2005+A1:2012, CAN/CSA C22.2 No. 60601-1:2014,
and applicable Particular (EN/ISO 80601-2-61:2011) and related Collateral
(IEC 60601-1-8:2006+A1:2012) Standards for which the product has been
found to comply by Intertek.
Patents: www.masimo.com/patents.html
Masimo, SET, , Rad, Rad-5, Rad-5v, Signal IQ, Discrete Saturation Transform (DST), APOD,
and FastSat are federally registered trademarks of Masimo Corporation. Rad-5 is part of the
Rad line of products.
TrendCom, RED, and SIQ are trademarks of Masimo Corporation.

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© 2020 Masimo Corporation.

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Contents
About This Manual------------------------------------------------------------------------------------------ 5
Product Description, Features and Indications for Use------------------------------------------------7
Product Description--------------------------------------------------------------------------------------7
Features----------------------------------------------------------------------------------------------------7
Indications for Use-------------------------------------------------------------------------------------- 8
Contraindications --------------------------------------------------------------------------------------- 8
Safety Information, Warnings and Cautions ----------------------------------------------------------- 9
Safety Warnings and Cautions------------------------------------------------------------------------ 9
Performance Warnings and Cautions---------------------------------------------------------------10
Cleaning and Service Warnings and Cautions ----------------------------------------------------12
Compliance Warnings and Cautions----------------------------------------------------------------13
Chapter 1: Technology Overview ------------------------------------------------------------------------15
Signal Extraction Technology®(SET®) -------------------------------------------------------------15
Chapter 2: Description ------------------------------------------------------------------------------------19
General System Description--------------------------------------------------------------------------19
Front View -----------------------------------------------------------------------------------------------19
Back View------------------------------------------------------------------------------------------------22
Chapter 3: Basic Setup and Use-------------------------------------------------------------------------23
Unpacking and Inspection ---------------------------------------------------------------------------23
Initial Setup---------------------------------------------------------------------------------------------23
Basic Use ------------------------------------------------------------------------------------------------23
Chapter 4: Operation--------------------------------------------------------------------------------------25
Basic Operation ----------------------------------------------------------------------------------------25
Advanced Operation-----------------------------------------------------------------------------------28
Chapter 5: Alarms and Messages ---------------------------------------------------------------------- 39
Alarm Indication -------------------------------------------------------------------------------------- 39
Alarm Silence ------------------------------------------------------------------------------------------ 40
Messages ------------------------------------------------------------------------------------------------ 41
Chapter 6: Troubleshooting------------------------------------------------------------------------------45
Troubleshooting Chart --------------------------------------------------------------------------------45
Chapter 7: Specifications --------------------------------------------------------------------------------- 47

Rad-5/5v Contents
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Display Range ------------------------------------------------------------------------------------------ 47
Accuracy (ARMS*) ------------------------------------------------------------------------------------- 47
Resolution-----------------------------------------------------------------------------------------------48
Electrical-------------------------------------------------------------------------------------------------48
Environmental------------------------------------------------------------------------------------------48
Physical Characteristics ------------------------------------------------------------------------------49
Modes ----------------------------------------------------------------------------------------------------49
Alarms ---------------------------------------------------------------------------------------------------49
Display/Indicators -------------------------------------------------------------------------------------50
Compliance ---------------------------------------------------------------------------------------------50
Guidance and Manufacturer's Declaration - Electromagnetic Emissions -------------------- 51
Guidance and Manufacturer's Declaration - Electromagnetic Immunity --------------------52
Recommended Separation Distances --------------------------------------------------------------54
Symbols--------------------------------------------------------------------------------------------------55
Citations-------------------------------------------------------------------------------------------------56
Chapter 8: Service and Maintenance ------------------------------------------------------------------ 57
Cleaning ------------------------------------------------------------------------------------------------- 57
Battery Installation and Replacement ------------------------------------------------------------- 57
Performance Verification -----------------------------------------------------------------------------58
Repair Policy------------------------------------------------------------------------------------------- 60
Return Procedure ------------------------------------------------------------------------------------- 60
Restrictions -------------------------------------------------------------------------------------------- 60
Contacting Masimo------------------------------------------------------------------------------------ 61
Index ---------------------------------------------------------------------------------------------------------63

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About This Manual
This manual explains how to set up and use Rad-5®/5v®Pulse Oximeter. Important safety
information relating to general use of Rad-5/5v 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.

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Product Description, Features and
Indications for Use
Product Description
The Rad-5 family of Handheld Pulse Oximeters are noninvasive, arterial oxygen saturation
and pulse rate monitors. The Rad-5 family features a multicolored LED display that
continuously displays numeric values for SpO2and pulse rate, as well as LED indicator bars
for Perfusion Index (PI) and Signal Identification and Quality Indicator (Signal IQ®).
The Rad-5 family consists of two models: the full-featured Rad-5 and the Rad-5v entry-level
spot checker. Both devices are built on the same motion tolerant pulse oximetry technology,
with the Rad-5 adding parameter alarming, three sensitivity settings and adjustable
averaging times.
Features that apply to the Rad-5 only will be indicated with "(Rad-5)".
Features
These features are common to the Rad-5 family:
Clinically proven Masimo SET®technology performance
Applicable for use on neonate, pediatric and adult patients
Proven for accurate monitoring in motion and low perfusion environments
SpO2, pulse rate, alarm, and perfusion index displays
Signal I.Q. for signal identification and quality indication
Lightweight, convenient handheld design
Long battery life: over 30 hours on 4 “AA” alkaline batteries
Audible Alarm for no sensor, sensor-off, interference detected and low battery
The Rad-5 adds these features:
Alarms for High/Low saturation and High/Low pulse rate
FastSat®
SmartTone
User definable alarm limit settings
Sleep study mode
Three sensitivity levels - Max, Normal and APOD®
Stores up to 72 hours of trending memory
Adjustable alarm volume
Adjustable averaging 2 to 16 seconds

Rad-5/5v Product Description, Features and Indications for Use
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Indications for Use
Rad-5
The Masimo SET®Rad-5 Pulse Oximeter is indicated for the continuous noninvasive
monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate
(measured by an SpO2 sensor). The Masimo SET®Rad-5 Pulse Oximeter is indicated for use
with adult, pediatric, and neonatal patients during both no motion and motion conditions,
and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile,
and home environments.
Rad-5v
The Masimo SET®Rad-5v Pulse Oximeter is indicated for the non-continuous noninvasive
monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate
(measured by an SpO2sensor). The Masimo SET®Rad-5v Pulse Oximeter is indicated for use
with adult, pediatric, and neonatal patients during both no motion and motion conditions,
and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile,
and home environments.
Contraindications
None