Masimo Root RDS-7 User manual

Root™
Operator's Manual

www.masimo.com 1 Masimo
Root operating instructions provide the necessary information for proper
operation of Root. There may be information provided in this manual that is
not relevant for your system. Do not operate Root without completely reading
and understanding the instructions in this manual.
NOTICE:
Purchase or possession of this instrument does not carry any express or
implied license to use this instrument with replacement parts which would,
alone or in combination with this instrument, fall within the scope of one of the
patents relating to this instrument.
Caution: Federal law restricts this device to sale by or on the order of a
physician. .
For professional use. See instructions for use for full prescribing information,
including indications, contraindications, warnings, precautions and adverse
events.
Wireless Radio
IC:7362A-RDS7
IC Model: RDS-7
FCC ID: VKF-RDS7
Model - RDS-7
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
D-30175 Hannover, Germany
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
Patents: www.masimo.com/patents.htm
© 2013 Masimo Corporation
Masimo and , are federally registered trademarks of Masimo Corporation.
Root is a trademark of Masimo Corporation.

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The use of the trademarks PATIENT SAFETYNET and PSN is under license
from University HealthSystem Consortium.
All other trademarks and registered trademarks are property of their
respective owners.

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Contents
About this Manual----------------------------------------------------------------------------7
Product Description and Intended Use-------------------------------------------------9
Product Description----------------------------------------------------------------------9
Intended Use ------------------------------------------------------------------------------9
Safety Information, Warnings, and Cautions---------------------------------------- 11
Safety Information, Warnings, and Cautions ------------------------------------ 11
General Information, Warnings and Cautions----------------------------------- 12
Compliance Information, Warnings and Cautions------------------------------ 13
Electrical Information, Warnings and Cautions --------------------------------- 15
Chapter 1: Description-------------------------------------------------------------------- 17
Features ---------------------------------------------------------------------------------- 17
Chapter 2: Setting Up--------------------------------------------------------------------- 21
Unpacking and Inspection------------------------------------------------------------ 21
Guidelines for Setting Up------------------------------------------------------------- 21
Power On--------------------------------------------------------------------------------- 22
Initial Battery Charging---------------------------------------------------------------- 23
Radical-7 Connection------------------------------------------------------------------ 24
Nurse Call Connection Port---------------------------------------------------------- 24
Chapter 3: Operation---------------------------------------------------------------------- 27
About the Main Screen---------------------------------------------------------------- 28
About the Status Bar------------------------------------------------------------------- 29
Using the Touchscreen Interface--------------------------------------------------- 31
Menu Navigation------------------------------------------------------------------------ 34
Understanding Windows-------------------------------------------------------------- 35
Accessing Main Menu Options------------------------------------------------------ 43
Device Settings ------------------------------------------------------------------------- 44
About -------------------------------------------------------------------------------------- 53

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Trend Settings--------------------------------------------------------------------------- 53
Profiles ------------------------------------------------------------------------------------ 54
Iris ------------------------------------------------------------------------------------------ 54
Layout ------------------------------------------------------------------------------------- 55
Sounds------------------------------------------------------------------------------------ 57
Alarm Interface-------------------------------------------------------------------------- 58
Trend Download ------------------------------------------------------------------------ 62
Lights -------------------------------------------------------------------------------------- 63
Chapter 4: MOC-9------------------------------------------------------------------------- 67
MOC-9 Ports----------------------------------------------------------------------------- 67
Chapter 5: Iris------------------------------------------------------------------------------- 69
Iris Connection Ports ------------------------------------------------------------------ 70
Iris Status Screen----------------------------------------------------------------------- 71
Chapter 6: Messages--------------------------------------------------------------------- 73
Chapter 7: Troubleshooting ------------------------------------------------------------- 75
Troubleshooting Radical-7 and MOC-9 Modules------------------------------- 75
Troubleshooting Root------------------------------------------------------------------ 75
Chapter 8: Specifications ---------------------------------------------------------------- 79
Electrical---------------------------------------------------------------------------------- 79
Environmental--------------------------------------------------------------------------- 79
Display ------------------------------------------------------------------------------------ 80
Alarms------------------------------------------------------------------------------------- 80
Nurse Call Specifications------------------------------------------------------------- 81
Connectors------------------------------------------------------------------------------- 81
Communication Specifications------------------------------------------------------ 81
Applicable Standards and Regulations ------------------------------------------- 82
Symbols----------------------------------------------------------------------------------- 84
Chapter 9: Service and Maintenance------------------------------------------------- 87
Cleaning ---------------------------------------------------------------------------------- 87

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Replacing the Fuses------------------------------------------------------------------- 88
Power-On Self Test-------------------------------------------------------------------- 88
Nurse Call Setting Connections----------------------------------------------------- 88
Battery Test------------------------------------------------------------------------------ 90
Repair Policy----------------------------------------------------------------------------- 90
Return Procedure----------------------------------------------------------------------- 91
Contacting Masimo--------------------------------------------------------------------- 91
Sales & End-User License Agreement-------------------------------------------- 92
Warranty---------------------------------------------------------------------------------- 92
Exclusions-------------------------------------------------------------------------------- 93
Restrictions------------------------------------------------------------------------------- 93
Index ------------------------------------------------------------------------------------------ 95

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About this Manual
This manual explains how to set up and use Root. Important safety
information relating to general use of the product 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 and, death) to the patient or user. The
following is an example of a warning:
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 Root or damage to other
property. The following is an example of a caution:
CAUTION: This is an example of caution statement.
A note is given when additional general information is applicable. The
following is an example of a note:
Note: This is an example of a note.

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Product Description and Intended Use
Product Description
Root is a patient monitoring and connectivity platform to transform care. It
offers multiple high-impact innovations for broad applications across the
continuum of care.
Instantly interpretable, high-visibility display of Masimo’s
breakthrough rainbow® and SET® measurements from Masimo's
Radical-7® handheld monitor
Intuitive, touchscreen navigation for easy and adaptable use in any
hospital environment
Flexible measurement expansion through Masimo Open Connect
(MOC-9™)
Designed for third-party measurement expansion to allow other
companies to add to the platform measurements
Built-in connectivity gateway through Iris™ for standalone devices
such as IV pumps, ventilators, beds, and other patient monitors
Intended Use
Root is a docking station for the Radical-7 handheld monitor. It is also a
platform device intended for use with MOC-9 modules. Root is intended to be
used in hospitals and hospital-type facilities. It is not intended for home use.
For all prescribing information and instructions for use of the compatible
medical technologies, refer to the operator’s manual or instructions for use for
the specific medical technology.

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Safety Information, Warnings, and
Cautions
The following section lists warnings, cautions, notes, and safety information
for Root.
Root is to be operated by qualified personnel only. The manual, accessories,
directions for use, all precautionary information, and specifications should be
read before use.
Safety Information, Warnings, and Cautions
WARNING: Do not use Root if it appears to be damaged. Contact your
biomedical engineering department for guidance before using Root.
WARNING: To ensure safety, avoid stacking multiple devices or placing
anything on the instrument during operation.
WARNING: Do not place Root or accessories in any position that might
cause it to fall on the patient.
WARNING: Do not use Root during magnetic resonance imaging (MRI).
WARNING: Explosion hazard: Do not use the Root in the presence of
flammable anesthetics or other flammable substance in combination with air,
oxygen-enriched environments or nitrous oxide.
WARNING: Replace only with fuses of same type, current rating, and voltage
rating.
WARNING: Do not adjust, repair, open, disassemble or modify Root.
CAUTION: An operator may only perform maintenance procedures
specifically described in the manual. Refer servicing to qualified service
personnel trained in the repair of this device.
CAUTION: Do not place Root where the controls can be changed by the
patient.
Note: Do not monitor more than a single patient at a time on Root.

Root Safety Information, Warnings, and Cautions
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General Information, Warnings and Cautions
WARNING: When placed on a flat surface, the device should be secured
with a mounting system recommended by Masimo.
WARNING: Do not touch, press or rub the touchscreen with abrasive
cleaning compounds, instruments, brushes or rough-surface materials, or
bring them into contact with anything that could scratch the touchscreen.
WARNING: Do not use petroleum-based solutions, acetone solutions or
other harsh solvents to clean Root. These substances affect the device’s
materials, and device failure can result.
CAUTION: Ensure that the speaker is not covered.
CAUTION: Do not place Root against a surface that may cause the alarm to
be muffled.
CAUTION: Should the Radical-7 and Root become unable to communicate,
parameters and measurements will not show on the Root display. This will
not affect Radical-7's ability to monitor the patient.
Note: Root is not intended for use during patient transport outside the
healthcare facility.
Note: Excessive cleaning solution can flow into the device and cause
damage to internal components.

Root Safety Information, Warnings, and Cautions
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Compliance Information, Warnings and Cautions
WARNING: In accordance with international telecommunication
requirements, the frequency band of 2.4 GHz and 5.15 to 5.25 GHz is only for
indoor usage to reduce potential for harmful interference to co-channel
mobile satellite systems.
CAUTION: Disposal of product: Comply with local laws in the disposal of the
instrument and/or its accessories.
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 FDA or other applicable regulatory authorities, or in any manner
inconsistent with the instructions for use or labeling.
Note: This equipment has been tested and found to comply with the limits for
a Class A digital device, pursuant to part 15 of the FCC Rules. These limits
are designed to provide reasonable protection against harmful interference
when the equipment is operated in a commercial environment. This
equipment generates, uses, and can radiate radio frequency energy and, if
not installed and used in accordance with the instruction manual, may cause
harmful interference to radio communications. Operation of this equipment in
a residential area is likely to cause harmful interference in which case the
user will be required to correct the interference at his own expense.
In order to maintain compliance with FCC regulations, shielded cables must
be used with this equipment. Operation with non-approved equipment or
unshielded cables is likely to result in interference to radio and TV reception.
The user is cautioned that changes and modifications made to the equipment
without the approval of manufacturer could void the user's authority to
operate this equipment.
Note: 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 and Class A. These limits are designed to provide reasonable
protection against harmful interference in a typical medical installation.
Note: To satisfy RF exposure requirements, this device and its antenna must
operate with a separation distance of at least 20 cm from all persons and
must not be co-located or operating in conjunction with any other antenna or
transmitter.
Note: This device complies with Part 15 of the FCC Rules. Operation is
subject to the following two conditions: (1) This device may not cause harmful
interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation.

Root Safety Information, Warnings, and Cautions
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Note: This Class A digital apparatus complies with Canadian ICES-003.
Note: Use Root in accordance with Environmental Specifications section in
this manual.

Root Safety Information, Warnings, and Cautions
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Electrical Information, Warnings and Cautions
WARNING: Root may be used during electrocautery, but this may affect the
accuracy or availability of the parameters and measurements.
WARNING: Root may be used during defibrillation, but this may affect the
accuracy or availability of the parameters and measurements.
WARNING: Electrical shock hazard: Do not remove the back panel of the
device. This could cause injury to personnel or device damage.
WARNING: Electrical shock hazard: The battery should be installed and/or
removed from Root by qualified personnel only.
WARNING: Risk of explosion if battery is replaced with an incorrect type.
Replace with Masimo supplied parts only.
WARNING: Do not incinerate the battery.
CAUTION: To ensure patient electrical isolation, connect only to medical
technologies with electrically isolated circuits.
CAUTION: To minimize radio interference, other electrical equipment that
emits radio frequency transmissions should not be in close proximity to Root.
CAUTION: Electrical shock hazard: Carry out periodic tests to verify that
leakage currents of patient-applied circuits and the system are within
acceptable limits as specified by the applicable safety standards. The
summation of leakage currents must be checked and in compliance with IEC
60601-1 and UL60601-1. The system leakage current must be checked when
connecting external equipment to the system. When an event such as a
component drop of approximately 1 meter or greater or a spillage of blood or
other liquids occurs, retest before further use. Injury to personnel could occur.
CAUTION: Electrical shock hazard: to protect against injury, follow the
directions below:
Avoid placing the device on surfaces with visible liquid spills.
Do not soak or immerse the device in liquids.
Use cleaning solutions only as instructed in this operator's manual.
See Cleaning on page 87.
CAUTION: Electrical shock hazard: Injury to personnel could occur. Do not
plug in or remove the power cord with wet hands. Ensure that your hands are
clean and dry before touching the power cord.
CAUTION: Electrical shock and flammability hazard: Before cleaning Root,
always turn it off and disconnect the power cord from the AC power supply.
CAUTION: If Root has not been used or charged within seven (7) days or
more, then recharge the battery prior to use.

Root Safety Information, Warnings, and Cautions
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CAUTION: Do not under any circumstances remove the grounding conductor
from the power plug.
CAUTION: Do not use extension cords or adapters of any type.
CAUTION: Only use the AC power cable provided by Masimo. Using a
different AC power cable could cause damage to Root. Check the power cord
and plug to ensure that it is intact and undamaged.
CAUTION: Use a grounded outlet for proper grounding. A hospital-grade
outlet is required.
CAUTION: Do not connect to an electrical outlet controlled by a wall switch or
dimmer.
CAUTION: Failure to plug in the AC power cable promptly after a low battery
message may result in the device shutting down.
Note: Disconnect the instrument using the AC power cord connector.
Note: It is recommended that Root is attached to an AC power source when
it is not in use to ensure that the battery remains fully charged.
Note: For medical technologies that require AC power, the battery should be
adequately charged to ensure backup power in case of AC power disruption.
Note: If there is any doubt about the integrity of the protective earth
conductor arrangement, operate Root on internal battery power until the AC
power supply protective conductor is fully functional.

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Chapter 1: Description
Root can be used in the following ways:
As a docking station and charger for Radical-7
As a bedside monitoring display for parameters on Radical-7 and
MOC-9 modules
As a connectivity gateway for standalone devices.
Features
Front View
Ref.
Feature
Description
1
Docking Station
Provides a docking station for the Radical-7. While
docked, the Radical-7 can communicate monitored
parameters and measurements.*
2
Root Display and
Touchscreen
Provides an interface for user interactions.
3
Home Button
Provides access to the Main Screen.
4
Root Charging
Indicator
Shows an indication of the battery charge for Root.

Root Chapter 1: Description
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Ref.
Feature
Description
5
AC Power
Indicator
Shows an indication of AC power connection Root.
6
Radical-7
Charging
Indicator
Shows an indication of battery charge for the
Radical-7 in the Docking Station.
*Only the touchscreen version of the Radical-7 is able to communicate
monitored parameters and measurements. All other versions can only charge
in the docking station but not communicate with Root.
Back View
Feature
Description
1
Handle
Allows the user to transport Root.
2
Speaker
Provides audible notification.
3
Nurse Call Connector
Provides a connection to a Nurse Call system.