Operators Manual
172 Pages
Preview
Page 1
Operator's Manual
Root®
with noninvasive blood pressure and temperature
For Sale in the USA These operating instructions provide the necessary information for proper operation of all models of the Root. 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 Root are prerequisites for its proper use. Do not operate Root 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. 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. 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. Wireless Radio FCC ID:VKF-RDS7A IC:7362A-RDS7A IC Model: RDS7A Masimo Corporation 52 Discovery Irvine, CA 92618, USA Tel.: 949-297-7000 Fax.: 949-297-7001 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 3149433
Conforms to ANSI/AAMI ES 60601-1, CAN/CSA C22.2 No. 60601-1, and applicable Particular (IEC 60601-2-49, IEC 80601-2-30, ISO 80601-2-56) 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 , Iris, Masimo, MOC-9, PVi, Radical-7, Radius-7, rainbow, Root, RRa, SedLine, SET, Signal Extraction Technology, SpCO, SpHb, and SpMet are federally registered trademarks of Masimo Corporation. ISA, MyView, and SpOC are trademarks of Masimo Corporation. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium. All other trademarks and registered trademarks are property of their respective owners. © 2018 Masimo Corporation
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Contents About This Manual-------------------------------------------------------------------------------------------7 Product Description and Features, Intended Use and Indications for Use ----------------------- 9 Product Description and Features -------------------------------------------------------------------- 9 Intended Use -------------------------------------------------------------------------------------------- 9 Indications for Use-------------------------------------------------------------------------------------- 9 Contraindication --------------------------------------------------------------------------------------- 11 Safety Information, Warnings, and Cautions ---------------------------------------------------------- 13 Safety Warnings and Cautions ----------------------------------------------------------------------- 13 Performance Warnings and Cautions --------------------------------------------------------------- 16 Cleaning and Service Warnings and Cautions ---------------------------------------------------- 18 Compliance Warnings and Cautions ---------------------------------------------------------------- 19 Chapter 1: Description ------------------------------------------------------------------------------------ 21 Features -------------------------------------------------------------------------------------------------- 21 Chapter 2: Setting Up ------------------------------------------------------------------------------------- 25 Unpacking and Inspection --------------------------------------------------------------------------- 25 Guidelines for Setting Up ----------------------------------------------------------------------------- 25 Power On ------------------------------------------------------------------------------------------------ 26 Initial Battery Charging ------------------------------------------------------------------------------- 27 Radical-7 Connection ----------------------------------------------------------------------------------28 Radius-7 Connection-----------------------------------------------------------------------------------28 MOC-9 Connection ------------------------------------------------------------------------------------- 29 Nurse Call Connection ------------------------------------------------------------------------------- 30 Attach the Probe Well -------------------------------------------------------------------------------- 30 Attach the Temperature Probe ---------------------------------------------------------------------- 31 Attach NIBP Cuff --------------------------------------------------------------------------------------- 31 Masimo Kite --------------------------------------------------------------------------------------------- 31 Bluetooth Devices -------------------------------------------------------------------------------------- 31 Chapter 3: Operation ------------------------------------------------------------------------------------- 33 About the Main Screen ------------------------------------------------------------------------------- 33 About the Status Bar ---------------------------------------------------------------------------------- 34 About the Action Bar --------------------------------------------------------------------------------- 36 www.masimo.com
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Root NIBPT
Contents
Using the Touchscreen Interface-------------------------------------------------------------------- 37 Menu Navigation -------------------------------------------------------------------------------------- 40 Understanding Windows ----------------------------------------------------------------------------- 41 Accessing Main Menu Options ---------------------------------------------------------------------- 49 Alarm Interface----------------------------------------------------------------------------------------- 77 Trend Download ---------------------------------------------------------------------------------------- 81 Session Management --------------------------------------------------------------------------------- 82 Screen Capture ----------------------------------------------------------------------------------------- 83 Lights ---------------------------------------------------------------------------------------------------- 86 Chapter 4: Temperature Measurement ---------------------------------------------------------------- 89 Operation - Temperature ----------------------------------------------------------------------------- 89 Temperature Probes ----------------------------------------------------------------------------------- 91 Chapter 5: NIBP Measurement -------------------------------------------------------------------------- 93 Patient Measurement Mode ------------------------------------------------------------------------- 93 Cuff Selection and Placement ----------------------------------------------------------------------- 93 Patient Conditions ------------------------------------------------------------------------------------- 94 Operation - NIBP --------------------------------------------------------------------------------------- 95 Chapter 6: Admit and Discharge to Patient SafetyNet ------------------------------------------- 103 Not Admitted ----------------------------------------------------------------------------------------- 103 Admitting a Patient --------------------------------------------------------------------------------- 104 Discharging a Patient ------------------------------------------------------------------------------- 105 Not Monitoring Message --------------------------------------------------------------------------- 106 Monitoring Resumed Message----------------------------------------------------------------------107 Chapter 7: Electronic Medical Record (EMR) Push ------------------------------------------------- 109 Determining EMR Push is Active ------------------------------------------------------------------ 109 Manually Entering Patient Data ------------------------------------------------------------------- 109 Sending Patient Data to the EMR ----------------------------------------------------------------- 110 Chapter 8: Radical-7 ------------------------------------------------------------------------------------- 111 Chapter 9: Radius-7 -------------------------------------------------------------------------------------- 113 Chapter 10: MOC-9 --------------------------------------------------------------------------------------- 115 Using MOC-9 Ports ----------------------------------------------------------------------------------- 115 Chapter 11: Iris -------------------------------------------------------------------------------------------- 117 Using Iris Connectivity Ports ----------------------------------------------------------------------- 118 www.masimo.com
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Root NIBPT
Contents
Iris Icon ------------------------------------------------------------------------------------------------ 119 Iris Screen --------------------------------------------------------------------------------------------- 120 Chapter 12: Bluetooth Devices ------------------------------------------------------------------------ 123 Connect Device to Root ----------------------------------------------------------------------------- 123 Chapter 13: Messages ----------------------------------------------------------------------------------- 125 Chapter 14: Troubleshooting -------------------------------------------------------------------------- 129 Troubleshooting Radical-7, Radius-7, and MOC-9 Modules ----------------------------------- 129 Troubleshooting Root ------------------------------------------------------------------------------- 129 Chapter 15: Specifications ----------------------------------------------------------------------------- 133 Measurement Accuracy ----------------------------------------------------------------------------- 133 Alarms-------------------------------------------------------------------------------------------------- 134 Nurse Call Specifications --------------------------------------------------------------------------- 134 Connectors -------------------------------------------------------------------------------------------- 134 Display Ranges --------------------------------------------------------------------------------------- 135 NIBP Pressurization Ranges ----------------------------------------------------------------------- 136 Electrical ----------------------------------------------------------------------------------------------- 136 Environmental ---------------------------------------------------------------------------------------- 136 Touchscreen Display --------------------------------------------------------------------------------- 137 Wireless Specifications------------------------------------------------------------------------------ 137 Compliance-------------------------------------------------------------------------------------------- 139 Guidance and Manufacturer's Declaration-Electromagnetic Emissions ---------------------141 Guidance and Manufacturer's Declaration-Electromagnetic Immunity -------------------- 142 Recommended Separation Distances ------------------------------------------------------------ 144 Symbols ------------------------------------------------------------------------------------------------ 145 Chapter 16: Service and Maintenance --------------------------------------------------------------- 149 Cleaning ----------------------------------------------------------------------------------------------- 149 Replacing the Fuses --------------------------------------------------------------------------------- 149 Power-On Self Test ----------------------------------------------------------------------------------- 150 NIBP Module Calibration Test --------------------------------------------------------------------- 150 Zero Point Calibration------------------------------------------------------------------------------- 152 Span Point Calibration ------------------------------------------------------------------------------ 153 NIBP Air Leak Test ----------------------------------------------------------------------------------- 154 Overpressure Test ------------------------------------------------------------------------------------ 156 www.masimo.com
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Root NIBPT
Contents
Nurse Call Setting Connections ------------------------------------------------------------------- 159 Battery Test ------------------------------------------------------------------------------------------- 160 Repair Policy ------------------------------------------------------------------------------------------ 160 Return Procedure ------------------------------------------------------------------------------------ 160 Masimo Technical Services ------------------------------------------------------------------------ 160 Contacting Masimo ----------------------------------------------------------------------------------- 161 Appendix: Concepts of Alarm Response Delay ----------------------------------------------------- 163 Concepts of Alarm Response Delay --------------------------------------------------------------- 163 Index ------------------------------------------------------------------------------------------------------- 165
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About This Manual This manual explains how to set up and use Root® with noninvasive blood pressure and temperature. Important safety information relating to general use of Root 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 and Features, Intended Use and Indications for Use Product Description and Features ®
Root with noninvasive blood pressure and temperature is a patient monitoring and connectivity platform. It offers multiple high-impact innovations for broad applications across the continuum of care. •
Instantly interpretable, high-visibility display of Masimo’s breakthrough SET® and rainbow® SET measurements.
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Intuitive, touchscreen navigation for easy and adaptable use in any hospital environment.
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Flexible measurement expansion through Masimo Open Connect (MOC-9®).
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Designed for third-party measurement expansion to allow other companies to add to the platform measurements.
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Built-in network connectivity gateway through Iris® for standalone devices such as IV pumps, ventilators, beds, and other patient monitors.
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Docking and charging station for Radical-7® and Radius-7® Battery Module.
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Integrated noninvasive blood pressure (NIBP) technology.
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Optional integrated temperature technology.
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Ability to display data on a secondary display.
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Ability to display data from external devices using Bluetooth.
For all prescribing information and instructions for use of the compatible medical devices that are connected to Root, see Operator’s Manual or Instructions for Use for the specific medical device.
Intended Use The Masimo Root Monitoring System is indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments. The Masimo Root Monitoring System can transmit data for supplemental remote viewing and alarming (e.g., at a central station). The Masimo Root Monitoring System can be used with the optional Radical-7, ISA product family, Radius-7, and/or the SedLine module. The Masimo Root Monitoring System is intended to be used with connected measurement modules compatible with Root interfaces.
Indications for Use The Masimo Root Monitoring System is indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments. The Root www.masimo.com
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Root NIBPT
Product Description and Features, Intended Use and Indications for Use
Monitoring System, when used with the optional ISA module, is not intended to be used in road ambulances. The Masimo Root Monitoring System can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station). The optional Masimo Radical-7 Pulse CO-Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radical-7 Pulse CO-Oximeter and accessories 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 Pulse CO-Oximeter and accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Radical-7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate to multi-parameter devices for the display of those devices. The optional Masimo Radius-7 Wearable Pulse Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and/or respiratory rate (RRa). The Masimo Radius-7 Wearable Pulse Oximeter and accessories are indicated for use with adult, and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, and hospital-type facilities. The optional ISA product family consists of three types of side stream gas analyzers (ISA CO2, ISA AX+ and ISA OR+), intended to be connected to other medical backboard devices for monitoring of breath rate and the following breathing gases: ISA CO2: CO2 ISA AX+: CO2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane ISA OR+: CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane ISA CO2, ISA AX+ and ISA OR+ are intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. The intended environment is the operating suite, intensive care unit and patient room. ISA CO2 is also intended to be used in road ambulances. The intended patient population is adult, pediatric and infant patients. The optional SedLine Sedation Monitor is indicated for use in the operating room (OR), intensive care unit (ICU), and clinical research laboratory. It is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSi), a proprietary computed EEG variable that is related to the effect of anesthetic agents. The optional temperature module is indicated to measure temperature (oral, adult axillary, pediatric axillary, and rectal) of adult and pediatric patients. The device is intended to be used by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider.
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Masimo
Root NIBPT
Product Description and Features, Intended Use and Indications for Use
The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive measurement of arterial blood pressure in healthcare environments. The NIBP module is designed to measure blood pressure for patient population described in the following table: Patient Population Approximate Age Range Newborn (neonate) Birth to 1 month of age Infant
1 month to 2 years of age
Child
2 to 12 years of age
Adolescent
12-21 years of age
Adult
21 years of age and older
Contraindication There are no contraindications.
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Safety Information, Warnings, and Cautions CAUTION: Root is to be operated by, or under the supervision of, qualified personnel only. The manual, accessories, directions for use, all precautionary information, and specifications should be read before use. Refer to Operator's Manuals for ISA, Kite, Patient SafetyNet, Radical-7, Radius-7, TIR-1 and SedLine for additional safety information, warnings, and cautions.
Safety Warnings and Cautions WARNING: Do not use Root if it appears or is suspected to be damaged. WARNING: Do not adjust, repair, open, disassemble or modify Root. Injury to personnel or equipment damage could occur. Return Root for servicing. WARNING: Do not use Root during or nearby magnetic resonance imaging (MRI) or in an MRI environment. WARNING: Do not place Root or accessories in any position that might cause it to fall on the patient. WARNING: To ensure safety, avoid stacking multiple devices or placing anything on the device during operation. WARNING: Do not use Root in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments or nitrous oxide to avoid risk of explosion. WARNING: To reduce the risk of explosion, only replace battery with Masimo supplied parts. WARNING: Do not start or operate the Root unless the setup was verified to be correct. WARNING: To ensure safety, only use Masimo authorized devices with Root. WARNING: To protect against fire hazard, replace only with recommended fuses of the same type, current rating, and voltage rating. WARNING: Do not remove the back panel of the device. This could cause injury to personnel or device damage. WARNING: Electrical Shock Hazard: To protect against injury, follow the directions below: •
Avoid placing the device on surfaces with visible liquid spills.
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Do not soak or immerse the device in liquids.
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Do not attempt to sterilize the device.
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Use cleaning solutions only as instructed in this Operator's Manual.
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Do not attempt to clean the Root while monitoring patient.
WARNING: Do not plug in or remove the power cord with wet hands to avoid risk of electric shock. Ensure that your hands are clean and dry before touching the power cord. WARNING: When positioned on a flat surface, the device should be secured with a mounting system recommended by Masimo. www.masimo.com
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Root NIBPT
Safety Information, Warnings, and Cautions
WARNING: As with all medical equipment, carefully route patient cables to reduce the possibility of patient entanglement or strangulation. CAUTION: Do not place the Root where the controls can be changed by the patient. CAUTION: To ensure patient isolation, connect only Masimo devices that have been designed for Root. CAUTION: Equipment intended to be connected to signal input/signal output ports should comply with applicable electrical safety standards to further minimize the risk of electric shock. Only devices that have been configured to operate with Root may function properly when connected. 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: To avoid risk of electrical shock, this equipment must only be connected to a supply mains with a protective earth connection. Do not under any circumstances remove the grounding conductor from the power plug. CAUTION: Use a grounded outlet for proper equipment grounding. A hospital-grade outlet is required. CAUTION: Do not place Root where the appliance inlet or the AC power plug cannot be readily disconnected. Note: Disconnect the device from AC mains by removing the AC power cord connector from the device inlet. 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. Note: Do not monitor more than a single patient at a time on Root. 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.
Noninvasive Blood Pressure WARNING: Frequently check the blood pressure monitoring site to ensure adequate circulation. WARNING: Only use Root in neonatal mode with a neonatal blood pressure cuff to measure blood pressure on neonates. WARNING: Neonatal blood pressure measurements must always use a three (3) meter hose in order to avoid overpressure error caused by lack of air volume within the overall pneumatic system. WARNING: Frequently check the blood pressure monitoring site to ensure adequate circulation. WARNING: Do not apply the cuff to a limb that is on the same side of a mastectomy. www.masimo.com
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Root NIBPT
Safety Information, Warnings, and Cautions
WARNING: Do not use or stop blood pressure measurements if the patient appears to be affected by the pressurization of the cuff due to a physical condition (i.e. pregnant, pre-eclamptic, etc.) WARNING: Too frequent blood pressure measurements can cause injury to the patient due to blood flow interference. WARNING: Do not attach the cuff to a limb being used for IV infusions or any other intravascular access, therapy or an arterio-venous (A-V) shunt. The cuff inflation can temporarily block blood flow, potentially causing harm to the patient. WARNING: Before applying the cuff on the patient, confirm the cuff size is appropriate. WARNING: When a blood pressure measurement error code occurs, any blood pressure values reported should be disregarded. CAUTION: Applying the blood pressure cuff over a wound can cause further injury. CAUTION: A compressed or kinked connection hose may cause continuous cuff pressure resulting in blood flow interference and potentially harmful injury to the patient. CAUTION: If the blood pressure cuff is on the same limb as monitoring equipment (i.e., pulse oximeter probe), the pressurization within the cuff can cause temporary loss of function of the monitoring equipment.
Optional Integrated Temperature WARNING: Always use single-use disposable probe covers to limit patient cross-contamination and/or patient discomfort. WARNING: Before use, verify the color of the removable probe well to confirm the proper application site: Red (rectal), Blue (oral/axillary). WARNING: The use of any other probe cover may produce temperature measurement errors or may result in inaccurate readings. WARNING: Do not take axillary temperature through the patient's clothing, direct probe cover-to-skin contact is required. CAUTION: Long-term continuous temperature monitoring, greater than 5 minutes, is not recommended. CAUTION: Ensure probe well is properly in place. CAUTION: Biting the probe tip while taking a temperature may result in damage to the probe. CAUTION: Use of the incorrect probe at the measurement site will result in temperature errors. Note: If a reliable spot check measurement cannot be made, the temperature module will automatically switch to continuous mode to make the measurement. Note: Verify the compatibility of the temperature probe and probe cover before use with Root.
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Root NIBPT
Safety Information, Warnings, and Cautions
Performance Warnings and Cautions WARNING: Root should not be used as the sole basis for medical decisions. It must be used in conjunction with clinical signs and symptoms. WARNING: Root may be used during defibrillation. This may affect the accuracy or availability of the parameters and measurements. WARNING: Root may be used during electrocautery. This may affect the accuracy or availability of the parameters and measurements. WARNING: Wireless communication of alarms to a secondary monitoring station should not be relied upon as a primary alarm. WARNING: Do not place the Root against a surface that may cause the alarm to be muffled. WARNING: Radical-7 may not fully charge in a high ambient temperature environment. WARNING: Always ensure settings including alarms are appropriate for each patient prior to use. WARNING: When using multiple devices in the same or similar environment, use of the same patient profile (including the same alarm presets) to avoid confusion that can lead to patient harm. CAUTION: Ensure the speaker is not covered. CAUTION: Before using Root under high intensity surgical lights, confirm that the display settings allow for clear display of measurements. CAUTION: Do not connect to an electrical outlet controlled by a wall switch or dimmer. CAUTION: Do not place the Root on electrical equipment that may affect the device, preventing it from working properly. CAUTION: Failure to charge Root promptly after a Low Battery alarm may result in the device shutting down. CAUTION: To minimize radio interference, other electrical equipment that emits radio frequency transmissions should not be in close proximity to Root. CAUTION: If the Radical-7 or Radius-7 stops communicating with Root, parameters and measurements will not show on the Root; however, this will not affect Radical-7's or Radius-7's ability to monitor the patient. CAUTION: In order to establish and maintain Root’s minimum Quality of Service, the following network specifications should be met before and after installation: •
Wired Network Connection During Ping Test, passing result if: a. At least 98% of packets have latency ≤ 30 milliseconds, and b. No more than 2 % packets loss.
•
Wireless Network Connection During Ping Test, passing result if: a. At least 98% of packets have latency ≤ 100 milliseconds, b. No more than 2 % packets loss, and c. Primary access point signal strength at least -67 dBm.
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Masimo
Root NIBPT
Safety Information, Warnings, and Cautions
CAUTION: The wireless quality of services may be influenced by the presence of other devices that may create radio frequency interference (RFI). Some RFI devices to consider are as follows: electrocautery equipment, cellular telephones, wireless PC and tablets, pagers, RFID, MRI electrically powered wheelchair, etc. When used in the presence of potential RFI devices, consideration should be taken to maximize separation distances and to observe for any potential signs of interference such as loss of communication or reduced Wi-Fi signal strength. Note: Root is provided with a Wi-Fi signal indicator as an indication of Wi-Fi communication. Note: Root’s alarm capabilities have been designed to be independent of the Wi-Fi communication feature in order to preserve Root’s primary alarms. Note: When the Root monitor is in synchronized waveform view, the EEG Chart Speed of the SedLine Window cannot be changed.
Noninvasive Blood Pressure WARNING: Before applying the cuff on the patient, confirm the cuff size is appropriate. WARNING: When a blood pressure measurement error code occurs, any blood pressure values reported should be disregarded. CAUTION: If the blood pressure cuff is on the same limb as monitoring equipment (i.e., pulse oximeter probe), the pressurization within the cuff can cause temporary loss of function of the monitoring equipment.
Optional Integrated Temperature WARNING: The use of any other probe cover may produce temperature measurement errors or may result in inaccurate readings. WARNING: Do not take axillary temperature through the patient's clothing, direct probe-cover-to-skin contact is required. CAUTION: Long-term continuous temperature monitoring, greater than 5 minutes, is not recommended. CAUTION: Ensure probe well is properly in place. CAUTION: Biting the probe tip while taking a temperature may result in damage to the probe. CAUTION: Use of the incorrect probe at the measurement site will result in temperature errors. Note: If a reliable spot check measurement cannot be made, the temperature module will automatically switch to continuous mode to make the measurement. Note: Verify the compatibility of the temperature probe and probe cover before use with Root.
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Masimo
Root NIBPT
Safety Information, Warnings, and Cautions
Kite WARNING: When using Root the Kite accessory does not generate or manage alarms. The Root alarms, used in conjunction with clinical signs and symptoms, are the primary sources for determining that an alarm condition exists. CAUTION: Kite is not a primary display. Medical decisions should be made using data from the primary display of a device in conjunction with clinical signs and symptoms.
Patient SafetyNet System Note: The wireless communication status between Root and Patient SafetyNet is displayed by Patient SafetyNet.
Cleaning and Service Warnings and Cautions WARNING: Electrical Shock Hazard: The Root battery should be installed and/or removed from Root only by qualified personnel. WARNING: Do not use petroleum-based or acetone solutions, or other harsh solvents, to clean the Root. These substances affect the device’s materials and device failure can result. CAUTION: 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 display. CAUTION: Do not submerge the Root in any cleaning solution or attempt to sterilize by autoclave, irradiation, steam, gas, ethylene oxide or any other method. This will seriously damage the device. CAUTION: To prevent damage to the temperature probe do not autoclave. CAUTION: Electrical shock and flammability hazard: Before cleaning, always turn off the device and disconnect from any AC power source. 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 equipment. 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. Note: Excessive cleaning solution can flow into the device and cause damage to internal components.
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Masimo
Root NIBPT
Safety Information, Warnings, and Cautions
Compliance Warnings and Cautions WARNING: Changes or modifications not expressly approved by Masimo shall void the warranty for this equipment and could void the user’s authority to operate the equipment. WARNING: Do not incinerate the battery. 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: Consideration to the compliance of the IEC 60601-1-1 standard should be made when configuring Root as part of a Medical System. CAUTION: Disposal of Product: Comply with local laws in the disposal of the device and/or its accessories. Note: Use Root in accordance with the Environmental Specifications section in the Operator's Manual. 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. 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. If this equipment does cause harmful interference to radio or television, 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.
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 equipment has been tested and found to comply with the Class A limits for medical devices according to the EN 60601-1-2: 2007, Medical Device Directive 93/42/EEC. These limits are designed to provide reasonable protection against harmful interference in a hospital environment. Note: This Class A digital apparatus complies with Canadian ICES-003. Note: Root is not intended for use during patient transport outside the healthcare facility. www.masimo.com 19 Masimo
Chapter 1: Description Root can be used in the following ways: •
As a docking station and charger for Radical-7 and Radius-7 Battery Module.
•
As a bedside monitoring display for parameters on Radical-7, Radius-7, and MOC-9 modules.
•
As a bedside monitor for continuous or non-continuous NIBP and temperature. Note: Continuous Mode will take a measurement every one (1) second.
•
As a connectivity gateway for standalone devices.
Features Front View
Ref. Feature
Description
1
Docking Station
Provides a docking station for the Radical-7 and Radius-7 (Note: Battery Charging Adapter required for Radius-7). While docked, the Radical-7 can communicate monitored parameters and measurements.*
2
Root Display and Provides a frontal display and interface for user interactions. Touchscreen
3
Home Button
Provides access to the Main Screen.
4
Root Charging Indicator
Shows an indication of the battery charge for Root.
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Masimo
Root NIBPT
Ref. Feature
Chapter 1: Description
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
Ref. 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.
4
Ethernet Port
Provides a network connection to Root using an RJ-45 cable.
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Masimo
Root NIBPT
Chapter 1: Description
Ref. Feature
Description
5
USB Ports (2)
Provide USB 2.0 connectivity.
6
Power Entry Module
Contains the input connector for a hospital grade AC power cord and the fuse holder.
7
Equipotential Ground Connector
Provides optional functional earthing for Root to eliminate potential differences. The use of the Equipotential Ground Connector should be in accordance with IEC 60601-1.
8
Iris Connectivity Ports (4)
Provide connection for standalone devices.
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