Masimo Radical-7 User manual

Radical-7
Operator's Manual
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The Radical-7 operating instructions provide the necessary information for proper operation
of all models of the Radical-7 Pulse CO-Oximeter system. 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 the Radical-7 are prerequisites for its
proper use. Do not operate the Radical-7 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.
Wireless Radio
FCC ID: VKF-RADICAL7 IC: 7362B-RADICAL7
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
© 2012 Masimo Corporation
®, Adaptive Probe Off Detection®, APOD®, Discrete Saturation Transform®, DST®,
FastSat®, FST®, Masimo®, Pulse Oximeter®, PVI®, rainbow®, SatShare®, SET®, Signal
Extraction Technology®, Signal IQ®, SpCO®, SpHb®, SpMet® are federally registered
trademarks of Masimo Corporation.
Pleth Variability Index™, Radical-7™, Rainbow Acoustic Monitoring™, rainbow Resposable™,
RDS™, RRa™,SafetyNet™, SpOC™ are trademarks of Masimo Corporation. All other trademarks
and registered trademarks are property of their respective owners. The use of the trademarks
PATIENT SAFETYNET and PSN is under license from University HealthSystem Consortium.
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Contents
About this Manual -------------------------------------------------------------------------------------------7
Product Description, Indications for Use, Contraindications, and Features ---------------------- 9
Product Description------------------------------------------------------------------------------------- 9
Indications for Use-------------------------------------------------------------------------------------10
Contraindications --------------------------------------------------------------------------------------10
Safety Information, Warnings, and Cautions---------------------------------------------------------- 11
Parameter Related Safety Information, Warnings, and Cautions------------------------------ 11
Device Related Safety Information, Warnings, and Cautions----------------------------------- 14
Electrical Safety Information, Warnings, and Cautions ----------------------------------------- 17
Alarm Related Safety Information, Warnings, and Cautions -----------------------------------19
Sensor Related Safety Information, Warnings, and Cautions --------------------------------- 20
Chapter 1: Technology Overview ------------------------------------------------------------------------23
Signal Extraction Technology (SET) ----------------------------------------------------------------23
rainbow Pulse CO-Oximetry Technology -----------------------------------------------------------25
rainbow Acoustic Monitoring (RAM) Technology-------------------------------------------------29
Chapter 2: Radical-7 Descriptions --------------------------------------------------------------------- 33
General System Description------------------------------------------------------------------------- 33
Functionality of the Radical-7------------------------------------------------------------------------34
Handheld ----------------------------------------------------------------------------------------------- 35
Standalone ---------------------------------------------------------------------------------------------- 37
Monitor Interface With SatShare------------------------------------------------------------------- 40
Chapter 3: Setup ------------------------------------------------------------------------------------------- 41
Unpacking and Inspection --------------------------------------------------------------------------- 41
Docking Station Power Requirements -------------------------------------------------------------- 41
Setting Up the Docking Station ---------------------------------------------------------------------42
Initial Battery Charging-------------------------------------------------------------------------------42
Setting Up for Philips, Agilent, or HP VueLink----------------------------------------------------42
Setting Up for SpaceLabs Flexport------------------------------------------------------------------43
Setting Up and Using SatShare ---------------------------------------------------------------------44
Chapter 4: Operation--------------------------------------------------------------------------------------45
Using the Touchscreen and Buttons----------------------------------------------------------------45
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Radical-7 Contents
Using Screen Lock -------------------------------------------------------------------------------------46
Using the Home Button ------------------------------------------------------------------------------46
Navigating the Radical-7 ----------------------------------------------------------------------------- 47
About the Display View -------------------------------------------------------------------------------48
Sensitivity Modes Overview--------------------------------------------------------------------------55
Changing Sensitivity Modes -------------------------------------------------------------------------56
Accessing the Main Menu ---------------------------------------------------------------------------- 57
Navigating the Main Menu--------------------------------------------------------------------------- 57
Parameter Settings------------------------------------------------------------------------------------59
Sounds --------------------------------------------------------------------------------------------------- 70
Device Settings----------------------------------------------------------------------------------------- 71
Trends---------------------------------------------------------------------------------------------------- 77
About----------------------------------------------------------------------------------------------------- 87
Chapter 5: Profiles-----------------------------------------------------------------------------------------89
Profiles Overview---------------------------------------------------------------------------------------89
Changing Profiles ------------------------------------------------------------------------------------- 90
Replacing Factory Default Settings for Adult and Neo Profiles --------------------------------93
Powering Off the Radical-7 ---------------------------------------------------------------------------94
Chapter 6: Alarms and Messages-----------------------------------------------------------------------95
About Alarms -------------------------------------------------------------------------------------------95
Silencing the Alarms ----------------------------------------------------------------------------------95
3D Alarms ----------------------------------------------------------------------------------------------- 97
Messages ------------------------------------------------------------------------------------------------99
Chapter 7: Troubleshooting---------------------------------------------------------------------------- 105
Troubleshooting Measurements------------------------------------------------------------------- 105
Troubleshooting the Radical-7 ---------------------------------------------------------------------107
Chapter 8: Specifications ------------------------------------------------------------------------------ 109
Performance ------------------------------------------------------------------------------------------ 109
Accuracy ----------------------------------------------------------------------------------------------- 109
Resolution---------------------------------------------------------------------------------------------- 111
Electrical------------------------------------------------------------------------------------------------ 111
Environmental----------------------------------------------------------------------------------------- 111
Physical Characteristics -----------------------------------------------------------------------------112
Trending------------------------------------------------------------------------------------------------ 112
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Radical-7 Contents
Alarms---------------------------------------------------------------------------------------------------112
Display Indicators------------------------------------------------------------------------------------ 113
Compliance---------------------------------------------------------------------------------------------114
Output Interface-------------------------------------------------------------------------------------- 115
Wireless Radio (If Installed) ----------------------------------------------------------------------- 115
Serial Interface Specifications--------------------------------------------------------------------- 116
Serial Interface Setup ------------------------------------------------------------------------------- 116
Analog Output and Nurse Call Specifications----------------------------------------------------117
Symbols------------------------------------------------------------------------------------------------ 119
ISO Country Codes (FCC and EU)------------------------------------------------------------------ 120
Citations ----------------------------------------------------------------------------------------------- 122
Chapter 9: Service and Maintenance----------------------------------------------------------------- 125
Cleaning ----------------------------------------------------------------------------------------------- 125
Battery Operation and Maintenance ------------------------------------------------------------- 125
Performance Verification --------------------------------------------------------------------------- 128
Repair Policy ------------------------------------------------------------------------------------------ 130
Return Procedure------------------------------------------------------------------------------------- 130
Contacting Masimo ---------------------------------------------------------------------------------- 131
Appendix: Best Practices for Comparisons to Reference Measurements----------------------- 133
Best Practices Checklist for Continuous SpHb Comparisons --------------------------------- 133
Best Practices Checklist for SpCO Comparisons ------------------------------------------------ 136
Best Practices Checklist for Acoustic Respiration Rate Comparisons----------------------- 138
Index ------------------------------------------------------------------------------------------------------- 143
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About this Manual
This manual explains how to set up and use the Radical-7 Pulse CO-Oximeter. Important
safety information relating to general use of the Radical-7 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 affect, death) to the patient or user. The following is an example of a 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 instrument or damage to other property. The following
is an example of a caution:
Caution
This is a sample of caution statement.
A note is given when additional general information is applicable. The following is an
example of a note:
Note: This is a sample of a note.
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Product Description, Indications for Use,
Contraindications, and Features
The following chapter contains the Radical-7 product description, key features and benefits,
indications for use, contraindications, and safety information, including cautions, warnings,
and notes.
Product Description
The Radical-7 is a noninvasive monitor that measures arterial oxygen saturation (SpO2),
pulse rate, and perfusion index (PI), along with optional measurements of hemoglobin
(SpHb), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total oxygen content (SpOC),
Pleth Variability Index (PVI), and Acoustic Respiration Rate (RRa).
The Radical-7 can be used as either a Handheld or a Standalone monitor. The Radical-7
features a touchscreen Liquid Crystal Display (LCD) that continuously displays numeric
values for all parameters.
The Radical-7 provides graphical displays for plethysmographic waveform, respiratory
waveform, Signal Identification and Quality Indicator (Signal IQ).
The Radical-7 can also be used to interface with a multi-parameter patient monitor to send
Masimo SET pulse oximetry information to that monitor for display.
The Radical-7 has an embedded 802.11 wireless radio that can be used for connectivity.
Key Features
The following features are available for the Radical-7. Some features are optional:
•Masimo SET is clinically proven to satisfy all sensitivity and specificity
requirements for pulse oximeter technology.
•Rainbow technology uses 7+ wavelengths of light to continuously and
noninvasively measure carboxyhemoglobin (SpCO), methemoglobin (SpMet), and
total hemoglobin (SpHb), as well as providing a more reliable probe-off
detection.
•Total oxygen content (SpOC) provides a calculated measurement of the amount
of oxygen in arterial blood, which may provide useful information about oxygen
both dissolved in plasma and combined with hemoglobin.
•Perfusion Index (PI) with trending capability indicates arterial pulse signal
strength and may be used as a diagnostic tool during low perfusion.
•Pleth Variability Index (PVI) may show changes that reflect physiologic factors
such as vascular tone, circulating blood volume, and intrathoracic pressure
excursions.
•Respiration rate can be determined by the acoustic (RRa) waveform.
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Radical-7 Product Description, Indications for Use, Contraindications, and Features
•Signal IQ waveform for signal identification and quality indication during
excessive motion and low signal to noise situations.
•FastSat tracks rapid changes in arterial O2.
•Variable pitch provides tonal variance for every 1% change in saturation.
•SatShare interface allows transfer of SpO2 and pulse rate to an existing
multi-parameter monitor and allows for the reading of SpCO, SpMet, SpHb, and
SpOC on the monitor.
•Automatic screen rotation provides upright display for vertical or horizontal
monitor positioning.
•Multi-gesture touchscreen interface.
•Detachable portable Handheld for patient transport.
•Desat Index Alarm may help clinicians to detect an increasing quantity of smaller
desaturations that may precede declining respiratory status.
•Perfusion Index (PI) Delta Alarm alerts clinicians to possible changes in
perfusion, often a reliable indicator of illness severity.
•Remote alarm interface.
Indications for Use
The Masimo Radical-7 and accessories are indicated for the continuous noninvasive
monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR),
carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total
hemoglobin concentration (SpHb), and/or respiratory rate (RRa).
The Masimo Radical-7 and accessories have been validated and are 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.
In addition, the Masimo Radical-7 and accessories are indicated to provide the continuous
noninvasive monitoring data obtained from the Masimo rainbow SET Radical 7 Pulse
CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2)
and pulse rate (PR) to multi-parameter devices for the display of those devices.
Contraindications
The Radical-7 is not intended for use as an apnea monitor.
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Safety Information, Warnings, and
Cautions
The following section lists warnings, caution, notes, and safety information.
The Radical-7 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.
The Radical-7 is to be operated by qualified personnel only. The manual, accessories,
directions for use, all precautionary information, and specifications should be read before
use.
Always use the Radical-7 precisely in accordance with the directions in this manual,
including finger selection, finger alignment in the sensor, and subject behavior during
testing. Failure to follow all of the directions in this manual could lead to inaccurate
measurements.
Caution
For SpHb, the Radical-7 should be considered an early warning device. Blood
samples should be analyzed by laboratory instruments prior to clinical
decision making to completely understand the patient’s condition.
Caution
Variation in hemoglobin measurements may be profound and may be
affected by sample type, body positioning, as well as other physiological
conditions. As with most hemoglobin tests, Radical-7 test results should be
scrutinized in light of a specific patient’s condition. Any results exhibiting
inconsistency with the patient’s clinical status should be repeated and/or
supplemented with additional test data.
Parameter Related Safety Information, Warnings, and
Cautions
This section contains parameter related safety information.
Caution
If patient hypoxemia is indicated, blood samples should be analyzed by
laboratory devices to completely understand the patient’s condition.
Caution
If the Low Perfusion message is frequently displayed, find a better perfused
monitoring site. In the interim, assess the patient and, if indicated, verify
oxygenation status through other means.
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Radical-7 Safety Information, Warnings, and Cautions
Caution
Changing the SpHb Cal, the date and time of the system clock, or the trend
period clears the data in the trend memory.
Caution
Excessive ambient noise may affect the accuracy of the respiration rate reading
from the Acoustic Respiration Sensor.
Note: Interfering Substances: Dyes, or any substance containing dyes, that change usual
blood pigmentation may cause erroneous readings.
Note: Inaccurate SpCO and SpMet readings can be caused by:
•Levels of methemoglobin approximately 1.5% or above
•Intravascular dyes such as indocyanine green or methylene blue
•Abnormal hemoglobin levels
•Low arterial perfusion
•Low arterial oxygen saturation levels including altitude induced hypoxemia
•Elevated total bilirubin levels
•Motion artifact
•SpCO readings may not be provided if SpO2 readings are less than 90%
•SpCO readings may not be provided if SpMet readings are greater than 2%
Note: SpO2, SpCO, SpMet, and SpHb are empirically calibrated in healthy adult volunteers
with normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb).
Note: The Radical-7 cannot measure elevated levels of COHb or MetHb.
Note: Inaccurate SpO2 readings may be caused by:
•Elevated levels of COHb and MetHb
•For increased COHb: COHb levels above normal tend to increase the level of
SpO2. The level of increase is approximately equal to the amount of COHb
that is present.
•Note: High levels of COHb may occur with a seemingly normal SpO2. When
elevated levels of COHb are suspected, laboratory analysis (CO-Oximetry) of
a blood sample should be performed.
•For increased MetHb: the SpO2 may be decreased by levels of MetHb of up to
approximately 10% to 15%. At higher levels of MetHb, the SpO2 may tend to read
in the low to mid 80s. When elevated levels of MetHb are suspected, laboratory
analysis (CO-Oximetry) of a blood sample should be performed.
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Radical-7 Safety Information, Warnings, and Cautions
Note: Inaccurate SpO2 readings may be caused by:
•Intravascular dyes such as indocyanine green or methylene blue
•Externally applied coloring and texture such as nail polish, acrylic nails, glitter,
etc.
•Elevated levels of bilirubin
•Severe anemia
•Low arterial perfusion
•Motion artifact
Note: Inaccurate SpHb and SpOC readings may be caused by:
•Intravascular dyes such as indocyanine green or methylene blue
•Externally applied coloring and texture such as nail polish, acrylic nails, glitter,
etc.
•Elevated levels of bilirubin
•Low arterial perfusion
•Motion artifact
•Low arterial oxygen saturation levels
•Elevated carboxyhemoglobin levels
•Elevated methemoglobin levels
•Difference between patient's finger skin and finger core temperature
•Hemoglobin synthesis disorders
•Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb c,
sickle cell, etc.
•Vasospastic disease such as Raynaud's
•Elevated altitude
•Peripheral vascular disease
•Liver disease
•EMI radiation interference
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Radical-7 Safety Information, Warnings, and Cautions
Note: Inaccurate SpHb readings may be caused by:
•Intravascular dyes such as indocyanine green or methylene blue
•Externally applied coloring and texture such as nail polish, acrylic nails, glitter,
etc.
•Elevated levels of bilirubin
•Low arterial perfusion
•Motion artifact
•Low arterial oxygen saturation levels
•Elevated carboxyhemoglobin levels
•Elevated methemoglobin levels
•Difference between patient's finger skin and finger core temperature
•Hemoglobin synthesis disorders
•Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb c,
sickle cell, etc.
•Vasospastic disease such as Raynaud's
•Elevated altitude
•Peripheral vascular disease
•Liver disease
•EMI radiation interference
Note: SpO2 monitoring is required when monitoring RRa (acoustic respiration).
Note: Inaccurate respiration rate measurements may be caused by:
•Low arterial perfusion
•Motion artifact
•Low arterial oxygen saturation
•Excessive ambient or environmental noise
•Improper sensor placement
Device Related Safety Information, Warnings, and Cautions
This section contains device related safety information.
Warning
Explosion hazard: Do not use the Radical-7 in the presence of flammable
anesthetics or other flammable substance in combination with air,
oxygen-enriched environments, or nitrous oxide.
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Radical-7 Safety Information, Warnings, and Cautions
Warning
Do not use the Radical-7 or sensor during magnetic resonance imaging (MRI)
scanning.
Warning
Do not place the Radical-7 or accessories in any position that might cause it to
fall on the patient.
Caution
Do not place the Radical-7 where the controls can be changed by the patient.
Caution
Disposal of product - Comply with local laws in the disposal of the instrument
and/or its accessories.
Caution
During SatShare operation, do not use the plethysmographic waveform display
on the multi-parameter monitor for diagnostic purposes. Instead, use the
plethysmographic waveform displayed on the Radical-7 screen.
Caution
Pulse rate measurement is based on the optical detection of a peripheral flow
pulse and therefore may not detect certain arrhythmias. The Radical-7 should
not be used as a replacement or substitute for ECG-based arrhythmia analysis.
Note: The Radical-7 can be used during defibrillation, but the readings may be inaccurate
for up to 20 seconds.
Note: Do not place containers with liquids on or near the Radical-7. Liquids spilled on the
instrument may cause it to perform inaccurately or fail.
Note: EMI radiation interference such as computer displays and/or LCD/plasma TVs can
cause error or incorrect measurements on the Radical-7.
Note: If the Radical-7 fails any part of the setup procedures or leakage spot check, remove
the instrument from operation until qualified service personnel have corrected the
situation.
Note: A functional tester cannot be used to assess the accuracy of the Radical-7.
Note: Do not autoclave, pressure sterilize, or gas sterilize the Radical-7.
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Radical-7 Safety Information, Warnings, and Cautions
Note: 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.
Note: Do not use petroleum-based or acetone solutions, or other harsh solvents, to clean the
Radical-7. These substances affect the device’s materials and instrument failure can result.
Note: An operator may only perform maintenance procedures specifically described in the
manual. Refer servicing to qualified service personnel trained in the repair of this
equipment.
Note: SatShare signals are ideal simulated waveforms corresponding to the calculated
saturation and pulse rate values and do contain all of the information contained in
physiological waveforms. The multi-parameter patient monitor decodes these signals into
saturation and pulse rate values.
Note: Simultaneous use of SatShare and serial port is not supported.
Note: Only SpO2 and pulse rate can be displayed on the multi-parameter monitor with
Flexport.
Note: If the Radical Docking Station is compatible with SafetyNet, Vuelink is not supported.
Use the Radical-7 in accordance with Environmental Specifications section in of this manual.
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.
Cleared Use Only: The device and related accessories are cleared by the Food and Drug
Administration (FDA) 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 in any manner inconsistent with the instructions for use or labeling.
Changes or modifications not expressly approved by the party responsible for compliance
could void the user's authority to operate the equipment.
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.
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Radical-7 Safety Information, Warnings, and Cautions
This equipment has been tested and found to comply with the limits for a Class B digital
device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable
protection against harmful interference in a residential 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 radio communications.
However, there is no guarantee that interference will not occur in a particular installation. If
this equipment does cause harmful interference to radio or television reception, 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 antenna.
•Increase the separation between the equipment and receiver.
•Connect the equipment into an outlet on a circuit different from that to which
the receiver is connected.
•Consult the dealer or an experienced radio/TV technician for help.
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 B. These limits are
designed to provide reasonable protection against harmful interference in a typical medical
installation.
This Class B digital apparatus complies with Canadian ICES-003.
Electrical Safety Information, Warnings, and Cautions
This section contains electrical related safety information.
Warning
Fire Hazard: To protect against fire hazard, replace only with fuses of same
type, current rating, and voltage rating.
Caution
Do not place the Radical-7 on electrical equipment that may affect the
instrument, preventing it from working properly.
Caution
Dispose of used batteries according to required country or regional instructions.
Caution
Risk of explosion if battery is replaced with an incorrect type. Replace with
Masimo supplied parts only.
Caution
At Low Battery, connect the Radical-7 to AC power to prevent loss of power.
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Radical-7 Safety Information, Warnings, and Cautions
Caution
Do not incinerate battery.
Caution
Electric shock hazard: Do not open the Radical-7 cover except to replace the
battery or batteries.
Caution
To protect against injury from electric shock, 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 sparingly.
Caution
Electrical shock and flammability hazard: Before cleaning the Radical-7, always
turn it off and disconnect the power cord from the AC power supply.
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. The power cord and plug
must be intact and undamaged.
Caution
To ensure patient electrical isolation, connect only to other equipment with
electrically isolated circuits.
Caution
Do not connect to an electrical outlet controlled by a wall switch or dimmer.
Note: All external instrument connections to the Analog Output/Nurse Call connector must
be IEC-60950 compliant.
Note: It is recommended that the Radical-7 Handheld is docked to the Docking Station that
is attached to an AC power source when it is not in use to ensure that the battery remains
fully charged.
Note: External instrument connections to the SatShare port must be IEC-60601-1
compliant.
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