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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-RDS7A IC Model: RDS7A FCC ID: VFK-RDS7A Model - RDS7A www.masimo.com Masimo...
Chapter 3- Operation ------------------------------------------------------------------------ 29 About the Status Bar --------------------------------------------------------------------- 29 About the Main Screen ------------------------------------------------------------------ 31 Using the Touchscreen Interface ------------------------------------------------------- 33 Menu Navigation ------------------------------------------------------------------------- 37 Understanding Windows ---------------------------------------------------------------- 38 Accessing Main Menu Options --------------------------------------------------------- 45 Alarm Interface --------------------------------------------------------------------------- 60 www.masimo.com Masimo...
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. www.masimo.com Masimo...
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.
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.
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Root Product Description, Features and Intended Use 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. www.masimo.com Masimo...
WARNING: To reduce the risk of explosion, only replace battery with Masimo supplied parts. WARNING: Fire Hazard: To protect against fire hazard, replace only with fuses of same type, current rating, and voltage rating.
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.
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Primary access point signal strength at least -67 dBm. 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 www.masimo.com Masimo...
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. www.masimo.com Masimo...
Note: Excessive cleaning solution can flow into the device and cause damage to internal components. Compliance Warnings and Cautions WARNING: Changes or modifications not expressly approved by Masimo shall void the warranty for this equipment. WARNING: Do not incinerate the battery.
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93/42/EEC. These limits are designed to provide reasonable protection against harmful interference in all establishments, including domestic establishments. 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 Masimo...
Provides a docking station for the Radical-7 and Radius-7 (Note: Battery Charging Adapter required for Radius-7). Docking Station While docked, the Radical-7 can communicate monitored parameters and measurements.* Root Display Provides an interface for user interactions. Touchscreen Home Button Provides access to the Main Screen. www.masimo.com Masimo...
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*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. www.masimo.com Masimo...
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Provides optional functional earthing for Root to eliminate Equipotential potential differences. The use of the Equipotential Ground Ground Connector Connector should be in accordance with IEC 60601-1. Iris Connectivity Provide connection for standalone devices. Ports (4) www.masimo.com Masimo...
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Description System Status Provides an indication of alarms and system messages. See Lights System Status Lights. 2 Power Button Places Root in Power On, Standby and Power Off modes. 3 MOC-9 Ports (3) Provide connectivity for MOC-9 modules. www.masimo.com Masimo...
Root AC Power Cord If anything is missing or damaged, contact Masimo's Technical Service Department. See Return Procedure. Guidelines for Setting Up Root has a built-in bracket interface that allows it to be mounted on a pole or roll stand.
On, press the Power Button for two (2) seconds until a single audible tone sounds. Once Root turns on, if no Radical-7, Radius-7 or MOC-9 module is connected, the Root display shows the following message: Please Connect a Device. The user is now able to connect Radical-7, Radius-7 and MOC-9 module. www.masimo.com Masimo...
Status Bar. 4. The Root Charging Indicator remains orange while the battery is charging and will illuminate green when Root is fully charged. See Root Battery and About the Status Bar. See Safety Informations, Warnings and Cautions. www.masimo.com Masimo...
An illuminated Radical-7 Battery icon will also appear in the Status Bar. Root display will show active measurements and parameters. For Radical-7 charging conditions, see Radical-7 Charging Indicator. Nurse Call Connection Use a Nurse Call connection cable to connect to a Nurse Call System. www.masimo.com Masimo...
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Depending on the connection type of the Nurse Call System, it may be necessary to orient the other end of the Nurse Call connection cable to fit correctly into the system connection. For more information, see Device Output. www.masimo.com Masimo...
Provides access to the Profiles screen. The example shown illustrates that Profiles is currently set to Adult for an adult Profiles patient. See Profiles. Provides access to the Bluetooth screen. If this icon is visible, then Bluetooth connectivity has been enabled. Bluetooth See Bluetooth. www.masimo.com Masimo...
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This icon does not indicate the actual volume level Sounds of the alarm and pulse tone. See Sounds. Displays the current time and provides access to the Localization screen which contains settings related to local time, language Current and geography. Time See Localization. www.masimo.com Masimo...
Description Displays system status as well as icons that provide shortcuts to Status Bar menu items or actions. See About the Status Bar. Provides a dynamic, user-configurable display area for all the Windows data from connected medical devices. www.masimo.com Masimo...
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Root Chapter 3- Operation Ref. Feature Description Main Menu Provides access to the configuration options for Root and icon connected medical devices. See Accessing Main Menu Options www.masimo.com Masimo...
Drop releasing. Below is a list of all the different types of controls available on Root and the various ways to interact with each type of control. Control Applicable Actions Description Toggle Slide knob Switches between toggle states www.masimo.com Masimo...
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Quickly moves knob to Tap position along slider path Press center When closed, expands the spinner (focused) tile When open, collapses the spinner Swipe up/down When open, scrolls through spinner tiles Press unfocused tile When open, scrolls tile into center (focused) www.masimo.com Masimo...
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When no parameter or measurement alarm is measurement present, opens parameter or measurement menu When parameter or measurement alarm is present, silences parameter or measurement alarm Press and hold Enables parameter and measurement drag and drop Live Swipe down Separates pleth and acoustic waveforms www.masimo.com Masimo...
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Press time label Resets time range to default Alarm Silence Press Silences all alarms icon Audio Pause Press Enables Audio Pause icon Other Status Press Opens relevant menu Bar icons Back Arrow Press Exits menu, abandons any changes www.masimo.com Masimo...
To navigate to the previous screen, press the arrow at the top left corner of the touchscreen. To return to the Main Screen, at any time, press the Home Button at any time. The Home Button is always illuminated when Root is powered on. www.masimo.com Masimo...
Description The area where all data from a docked Radical-7, Radius-7 or Window connected MOC-9 module are displayed. Drop Down Settings Menu Shows a parameter or measurement over time (only for Radical- Waveform 7, Radius-7 and MOC-9 modules). www.masimo.com Masimo...
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The following diagram and table describe key features of a parameter's Trend Display in Trend View. Feature Description Indicates current viewing of the parameter or measurement. 1 Value Range Press to access the Trend menu where the minimum and maximum of the range can be modified. www.masimo.com Masimo...
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3 Numeric Value Indicates current reading of the parameter or measurement. Indicate high and low alarm limits for the parameter or 4 Alarm Limits measurement, if supported. Parameter or Indicates the name of the parameter or measurement. Measurement Label www.masimo.com Masimo...
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General features of the Analog View are: Ref. Feature Description Indicates current status of a parameter or Needle measurement. Indicate high and low alarm limits for the Alarm Limits parameter or measurement. Indicates current reading of the parameter or Numeric Value measurement www.masimo.com Masimo...
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Root Chapter 3- Operation Ref. Feature Description Parameter or Indicates the name of the parameter or Measurement Label measurement. www.masimo.com Masimo...
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88% will trigger an alarm, and the PR gauge is shown as a half circle, where values below 50 bpm and above 140 bpm will trigger an alarm. Quarter Circle Half Circle www.masimo.com Masimo...
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Label. When a parameter is expanded, it will be shown as either a Trend Display or Gauge. To expand a parameter or measurement Order Instruction Step 1 Press and hold the Numeric Value until it dims. Step 2 Drag the Numeric Value over any Trend Display. Step 3 Release the Numeric Value. www.masimo.com Masimo...
Step 2 Drag the Numeric Value to the Well. Step 3 Release the Numeric Value. Accessing Main Menu Options To access the Main Menu options At the bottom right corner of the touchscreen, press the Main Menu icon. www.masimo.com Masimo...
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Root Chapter 3- Operation The Main Menu options are: Device Settings See Device Settings. About See About. Trend Settings See Trend Settings. Profiles See Profiles. Iris See Iris. Layout See Layout. Sounds See Sounds. Device Settings www.masimo.com Masimo...
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The Device Settings options are: Localization See Localization. Wi-Fi See Wi-Fi Ethernet See Ethernet. Bluetooth See Bluetooth. Root Battery See Root Battery Radical-7 Battery See Radical-7 Battery. Brightness See Brightness. Access Control See Access Control. Device Output See Device Output www.masimo.com Masimo...
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Sets the current time. Wi-Fi The Wi-Fi radio allows for networked communication of data and alarm signals between Root and a secondary patient monitoring station, Masimo’s Patient SafetyNet over an IEEE 802.11 a/b/g wireless network. The wireless data www.masimo.com Masimo...
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Additional fields in the Wi-Fi screen display read-only settings about the Wi-Fi connection that cannot be configured by the user. Your Masimo sales representative can provide necessary information regarding an initial Wi-Fi connection. For more information on Patient SafetyNet, see Operator's Manuals of Patient SafetyNet.
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Bluetooth The Bluetooth radio allows for the detection of the close proximity of Masimo’s MyView Presence Tag. Root’s detection of Masimo’s MyView Presence Tag is an optional feature that allows for the display of predetermined customized settings by a clinician.
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The user can also access the Battery screen by pressing the Radical-7's Battery icon on the Status Bar. See About the Status Bar. Option Description State of Charge Provides a read-only display of battery level remaining. Battery Allows trained personnel to access battery diagnostic Diagnostics information www.masimo.com Masimo...
Adjust the brightness level of the Brightness Root display by sliding the button 1, 2, 3, 4 (4 is brightest). Access Control Access Control contains configurable options and settings that require a password. To enter Access Control www.masimo.com Masimo...
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Saves current profile parameter Press Save to Pediatric as the Pediatric Profile. load. Saves current profile parameter Press Save to Save as Neo as the Neonatal Profile. load. Factory Options are restored to factory Press Restore. Defaults values. Device Output www.masimo.com Masimo...
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Module A, Sedline, SpecTable Radical and Sedline Numerics Only Note: The Nurse Call feature is disabled when Audio Pause is enabled and Nurse Call Trigger is set to Alarms. For more information about Audio Pause, see Audio Pause. www.masimo.com Masimo...
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Custom profiles can also be created to accommodate usage in any hospital care area. See the Masimo Instrument Configuration Tool Directions for Use for information on adding Profiles. For more information regarding Profiles, see the Instructions for Use or Operator’s Manuals for Radical-7,Radius-7 and appropriate MOC-9 module(s).
Note: This feature only applies to Trend View. See Using Trend View. Option Description Factory Default Configurable Setting Settings Layout Controls the sizing of Trend Fixed Fixed or Dynamic Style Displays. The following diagram and tables explain the differences between Fixed and Dynamic modes for a Trend View. www.masimo.com Masimo...
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Available Layout When only Radical-7,Radius-7 or a single MOC-9 module is connected to Root, the Available Layout will be 100%. When Radical-7 and/or multiple devices are connected, the user will have the option to select from several pre-configured layouts. www.masimo.com Masimo...
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If Permanent with Reminder Audio Pause. is selected, a tone will sound every three (3) minutes as a reminder that Permanent is active. *Requires user to have All Mute Enabled (Permanent Silence Duration) in the Access Control menu. See Access Control. www.masimo.com Masimo...
(140). Note that the borders of both the PR Trend Display as well as the Window are illuminated red, and the explanation of the alarm is shown at the top of the Window (High PR > 140). www.masimo.com Masimo...
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Status Bar (Low Battery). For more details about specific alarms on Radical-7,Radius-7 and MOC-9 modules, see Instructions for Use or Operator’s Manuals for Radical-7,Radius-7 and MOC-9 modules. www.masimo.com Masimo...
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There are currently no active alarms, but at least one alarm has been and is still silenced. There is currently at least one active alarm that has not been silenced. There is currently at least one active alarm, but all active alarms are silenced. www.masimo.com Masimo...
USB for evaluation. Trend data is stored in non-volatile memory, so it is not erased when Root is shut off. Trend data download is initiated using the Masimo Instrument Configuration Tool, which converts the data to a .TXT or .CSV file.
Root. The following are system level alarm messages that accompany System Status Lights when Radical-7,Radius-7 and MOC-9 modules are not connected: Status Light Message Alarm Priority Low battery Service required High AC Power Indicator www.masimo.com Masimo...
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Whenever Root is connected to an AC power source, if not fully charged, its battery will charge. Light Battery Indication Status Green Battery is fully charged. Orange Battery is charging. Battery charging error. Battery is not being charged. Root is not connected to AC power source. www.masimo.com Masimo...
Window that displays all the data from Radius-7. Root also acts as a charging station for Radius-7. Radius-7 is docked onto Root via a Battery Charging Adapter. See Radius-7 Operator's Manual for more information. www.masimo.com Masimo...
(rSO2), including cerebral tissue. It can be used in any hospital and hospital- type facility where rSO2 measurements might improve patient outcomes. The Masimo O3 Regional Oximeter and Sensors are indicated for the continuous noninvasive monitoring of regional hemoglobin oxygen saturation of blood (rSO2) in the tissue below the sensor in hospital and hospital-type facilities.
Use a MOC-9 cable to connect other MOC-9 modules to Root. To use an MOC-9 Port Identify the MOC-9 end of the cable. Orient the cable to fit correctly into an MOC-9 Port. Insert the MOC-9 cable securely into any of the three (3) compatible ports on Root. www.masimo.com Masimo...
SafetyNet. Root receives and may display information from Radical-7, MOC-9 modules, as well as standalone devices. Ref. Description 1 - 4 Standalone devices connected via Iris (e.g., monitor, pump, ventilator) Root Radical-7 MOC-9 modules Patient SafetyNet or Masimo Connectivity Gateway Electronic Health Records system www.masimo.com Masimo...
Root via one of the Ports, the corresponding part of the icon will be lit green or yellow. In the example below, a standalone device is connected to Iris Connectivity Port 1. Port 1 (connected) Port 2 www.masimo.com Masimo...
Status and connection type are read-only and not configurable by the user. For more information on Iris connectivity, see Instructions for Use or Operator’s Manual for the appropriate version of Masimo Patient SafetyNet. Using Iris Connectivity Ports Use Iris Adapters and RJ-45 cables to connect standalone devices to Root.
Alarm Silence icon. Reconnect Radius-7 or Radius-7 Radius-7 is disconnected from acknowledge message by Disconnected Root pressing the Alarm Silence icon. For additional messages, see Instructions for Use or Operator's Manuals for Radical- 7, Radius-7 and MOC-9 modules. www.masimo.com Masimo...
If the condition persists, Root requires or blank. correct. service. Contact Masimo Technical Support. See Return Procedure. Root requires service. Contact Masimo Touch functionality Internal Failure Technical Support. See Return is not responsive Procedure. Ensure that the connections are securely...
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Root requires service. See Return not work when Internal failure. Procedure. pressed. AC power cable Battery does not may be Unplug and replug AC power cable. charge. disconnected. Root Charging Root requires service. See Return Indicator illuminates Internal failure. Procedure. red. www.masimo.com Masimo...
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Root Chapter 9- Troubleshooting Symptom Possible Cause Correction Unplug and replug Nurse Call connector. Nurse Call does not Connection error communicate. See Nurse Call Setting Connections www.masimo.com Masimo...
*This represents approximate run time at the lowest brightness, using a fully charged battery. Environmental Root Operating Temperature 32°F to 122°F (0°C to 50°C) Transport/Storage Temperature -40°F to 158°F (-40°C to 70°C) Operating Humidity 10% to 95%, non-condensing www.masimo.com Masimo...
-1000 ft to 18,000 ft (-304 m to 5,486 m) Display Characteristic Description Type Backlit Active Matrix TFT LCD Resolution 1280 x 800 pixels Size 10.1 in (25.65 cm) Diagonal Color 24 bit RGB Touchscreen Characteristic Description Type Multi-Touch P-Cap www.masimo.com Masimo...
The Nurse Call relays have the following electrical specifications per switch: Parameter Specification Max Voltage 36 VDC or 24 VAC peak Connectors Connector Type Number of Ports Ethernet 10/100 MBps Nurse Call 1/4 inch round female MOC-9 Masimo Connector USB 2.0 Iris RS-232/RJ-45 www.masimo.com Masimo...
802.11g - 6, 9, 12, 18, 24, 36, 48, 54 Mbps. Communication (Bluetooth) Type Bluetooth Frequency 2402-2480 MHz Max Peak Output Power Bluetooth 1.3 dBm Classification of Output Conducted Power Rating Output Power Type Fixed at the Factory Modulation Types www.masimo.com Masimo...
802.1X: LEAP, PEAP< TTLS, TLS, EAP-FAST Radio Compliance FCC ID: VKF-RDS7A Model - RDS7A Canada IC:7362A-RDS7 IC Model: RDS7A RSS-210 Europe EN 300 328 EN 301 489-17 R & TTE Directive EMC Compliance EMC Compliance EN 60601-1-2, Class A device www.masimo.com Masimo...
CAN/CSA 22.2 No. 601.1:2005 IEC 60601-1 / UL 60601-1: 1988 + A1: 1991 + A2:1995 EN 60601-1: 1990 + AI: 1993 + A2:1995 ISO 9919:2005 IEC-60601-2 - 49:2001 Type of Protection Class I (on AC power) Internally powered (on battery power) www.masimo.com Masimo...
CISPR 11 interference in nearby electronic equipment. RF Emissions Class A CISPR 11 Harmonic For hospital environment only. Emissions Class A Not intended for use in a domestic environment. IEC 61000-3-2 Voltage Fluctuations / Complies Flicker Emissions IEC 61000-3-3 www.masimo.com Masimo...
IEC 61000-4-4 +1 kV for input/output lines. Surge +1 kV - Mains power quality should be differential that of a typical hospital IEC 61000-4-5 mode environment. +2 kV - common mode www.masimo.com Masimo...
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Power frequency magnetic fields (50 / 60 Hz) should be at levels characteristic magnetic field. of typical location in a typical hospital environment. IEC 61000-4-8 Conducted RF 3 Vrms 3 Vrms IEC 61000-4-6 150 kHz to 80 MHz www.masimo.com Masimo...
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(m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol: www.masimo.com Masimo...
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ME Equipment should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the ME Equipment. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m. www.masimo.com Masimo...
(W) according to the transmitter manufacturer. Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. www.masimo.com Masimo...
Federal (USA) Law Restricts Fuse Replacement. See this Device to Sale by Or on Replacing the Fuses section the Order of a Physician of the Operator's Manual. Equipotential Ground UL, LLC, Certification Terminal Federal Communications Iris Connection Commission (FCC) licensing www.masimo.com Masimo...
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Mark of Conformity to European Medical Device AC Current Directive 93/42/EEC Authorized representative in Nurse Call Interface the European community Wireless Features Can be Used in Member States with Defibrillation Proof Type the restriction of indoor use in France www.masimo.com Masimo...
Cidex Plus (3.4% glutaraldehyde) 10% bleach solution 70% isopropyl alcohol solution Do not allow liquids to enter the interior of Root. Using the recommended cleaning solutions on the touchscreen will not affect the performance of Root. www.masimo.com Masimo...
Power On Root. Within five (5) seconds, all available indicators will illuminate, the device will emit a tone, and the Masimo logo will display. Nurse Call Setting Connections For maximum flexibility, either normally open or normally closed signals are available.
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2 and 3 contacts normally closed Polarity Normal 1 and 2 contacts normally closed Nurse Call 2 and 3 contacts normally opened Polarity Inverse 1 and 2 contacts normally closed Nurse Call 2 and 3 contacts normally opened Polarity Inverse www.masimo.com Masimo...
Power On Root and verify that the Root Battery Indicator icon on the Status Bar shows a full charge. Repair Policy Masimo or an authorized Service Department must perform warranty repair and service. Do not use malfunctioning equipment. Have the device repaired. Clean contaminated and/or dirty equipment before returning, following the cleaning procedure described in Cleaning.
Return Procedure Clean contaminated/dirty equipment before returning, following instructions in Cleaning. Make sure the equipment is fully dry before packing. Call Masimo at 800- 326-4890 and ask for Technical Support. Ask for an RMA number. Package the equipment securely, in the original shipping container if possible, and enclose or include the following information and items: ...
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Chapter 11- Service and Maintenance Warranty with Battery Masimo warrants to the initial Purchaser for a period of one (1) year from the date of purchase that: each new Product and the Software media as delivered are free from defects in workmanship or materials.
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Sales & End-User License Agreement This document is a legal agreement between you (“purchaser”) and Masimo Corporation (“Masimo”) for the purchase of this Product (“Product”) and a license in the included or embedded Software (“Software”) except as otherwise expressly agreed in a separate contract for the acquisition of this Product, the following terms are the entire agreement between the parties regarding your purchase of this Product.
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Product or the Software on a temporary basis. Purchaser shall not assign or transfer this License, in whole or in part, by operation of law or otherwise without Masimo's prior written consent; except that the Software and all of Purchaser’s rights hereunder shall transfer automatically to any party that legally acquires title to the Product with which this Software is included.
Chapter 8- Messages • 65 Chapter 9- Troubleshooting • 67 Cleaning • 83 Connectors • 71 About • 47 Contacting Masimo • 86 About the Main Screen • 27 Customizing Windows • 37 About the Status Bar • 25 About this Manual • 7 AC Power Indicator •...
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Power-On Self Test • 84 Trend Download • 55 Product Description and Features • 9 Trend Settings • 47 Product Description, Features and Troubleshooting Radical-7, Radius-7 Intended Use • 9 and MOC-9 Modules • 67 Profiles • 48 Troubleshooting Root • 67 www.masimo.com Masimo...
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Using Analog View • 34 Using Iris Connectivity Ports • 63 Using MOC-9 Ports • 59 Using the Touchscreen Interface • 28 Using Trend View • 33 Warranty with Battery • 87 Wi-Fi • 41 Wireless Specifications • 71 www.masimo.com Masimo...