Page 1: ...Operator s Manual O3 Regional Oximeter...
Page 2: ......
Page 3: ...o sale by or on the order of a physician See instructions for use for full prescribing information including indications contraindications warnings precautions and adverse events This Operator s Manua...
Page 4: ......
Page 5: ...onal Oximetry 13 Components of the Regional Oximetry System 14 Chapter 2 System Description 15 Root 15 O3 Module and O3 Sensor 16 Chapter 3 Setting Up the O3 System 17 Unpacking and Inspecting the Sys...
Page 6: ...Symbols 39 Guidance and Manufacturer s Declarations 41 Chapter 8 Service and Maintenance 43 Cleaning Procedure 43 General Maintenance for O3 Module 43 Service Instructions 43 Repair Policy 44 Return P...
Page 7: ...given when actions may result in a serious outcome for example injury serious adverse effect death to the patient and user The following is an example of a warning WARNING This is an example of a war...
Page 8: ......
Page 9: ...s might improve patient outcomes The O3 Regional Oximeter System O3 System should not be used as the sole basis for diagnosis or therapy Indications for Use The noninvasive Masimo O3 Regional Oximeter...
Page 10: ......
Page 11: ...Do not use the O3 Module and O3 Sensor in the presence of flammable anesthetics or other flammable substance in combination with air oxygen enriched environments or nitrous oxide WARNING To protect ag...
Page 12: ...cent placement of optical sensors that are not connected to the same O3 Module Abnormal venous pulsations e g tricuspid value regurgitation Trendelenburg position WARNING Inaccurate rSO2 readings or n...
Page 13: ...ntended for patient monitoring Note The O3 Sensor duration of use is dependent on the condition of the sensor site and patient s skin integrity and sensor adhesion quality The O3 Sensor has been bioco...
Page 14: ...O3 Regional Oximeter Safety Information Warnings and Cautions www masimo com 12 Masimo Note Use the O3 Module in accordance with the Environmental Specifications section in the Operator s Manual...
Page 15: ...In the above equation Io is light intensity at the source and I is light intensity after having traveled a distance of in a medium with an absorption coefficient of a The human body is opaque to most...
Page 16: ...through relatively superficial shallow section of tissue Deep detector This detector is farther from the emitter and receives optical signal traveled deeper into the tissue in addition to passing thr...
Page 17: ...of three 3 components Root O3 Module O3 Sensor s Up to two 2 O3 Sensors can be connected to a single O3 Module Up to two 2 O3 Modules can be connected to Root Root Root displays parameters and trends...
Page 18: ...lect physiological signals The O3 Module includes Masimo technology for processing the signals which result in rSO2 measurements In turn these measurements are displayed on the Host Backboard device T...
Page 19: ...s a claim with the carrier 3 If anything is missing or damaged contact the Masimo Technical Service Department Preparation for Use Prior to using the O3 System for monitoring 1 Confirm that you have a...
Page 20: ...d when the O3 Module window displays on Root with all parameters and measurements dashed out because no O3 Sensor has been connected to the module For more information on the O3 Module window see The...
Page 21: ...sor to an activated O3 Module 1 Apply sensor on the patient For more instructions on applying the sensor on the patient see the Directions for Use for the O3 Sensor series 2 Once the sensor s has been...
Page 22: ...ion Note that 1 is defaulted to the left forehead and 2 is defaulted to the right forehead The sensor site selection can be modified by accessing the Site Selection menu For information on how to acce...
Page 23: ...below the selected LAL Baseline This feature is displayed when Set Baseline has been enabled To enable this option see Baseline View on page 26 Baseline rSO2 displays the user defined baseline value f...
Page 24: ...d in the name of the window When multiple technologies are connected to Root each technology s parameters are displayed in an individual window The relative size of each window can be configured using...
Page 25: ...O3 Sensor Display Options There are two 2 display options available 1 Trend View 2 Baseline View Trend View Trend View is the default viewing option for an O3 window The trend view displays rSO2 tren...
Page 26: ...SpO2 sensor site over time1 3 SpO2 Region Displays the difference between levels of SpO2 peripheral SpO2 sensor site and rSO2 of the O3 Sensor site over time 4 rSO2 Trend Line Displays rSO2 level of t...
Page 27: ...the current difference between levels of rSO2 and selected baseline rSO2 Also displays the unit of measurement Press the value to access the Delta Baseline menu 14 Y axis Shows the current view range...
Page 28: ...d area The Baseline View is displayed only when Set Baseline has been enabled The Baseline can be enabled in two 2 ways 1 Tap the action menu on the top right corner of the O3 Module window Press the...
Page 29: ...menu There are two 2 ways to access this menu 1 To access this menu tap the action menu on the top right corner of the O3 Module window Then press on the Site Selection button Or 2 Press the Gear ico...
Page 30: ...e selected sensor location can be changed Note that 1 is defaulted to Forehead Left and 2 is defaulted to Forehead Right 2 Touch the new desired sensor site location in the image The sensor site can b...
Page 31: ...Choose either the Sensor 1 or Sensor 2 button to select the sensor and change sensor site location Only the selected sensor can be changed 3 Touch the new desired sensor site location in the image Th...
Page 32: ...ich to configure specific parameter display and alarm settings Below are the various setting options for each parameter Note All setting options will hold through power cycle unless otherwise stated r...
Page 33: ...ollowing are the various setting options for AUC About An informational read only screen appears with the following definition for AUC Settings Area Under the Curve AUC minutes displayed as an index q...
Page 34: ...rent rSO2 level Alarms Option Description Factory Default Configuration Options Resolution Delta Limit Threshold of base that triggers an alarm Off Off 1 to 99 1 Silence Duration Duration of the tempo...
Page 35: ...nce to the O3 Module has been detected Low Perfusion Index The signal detected is too weak No Sensor Connected The O3 Sensor is not connected not fully inserted into the O3 Module Pulse Search The O3...
Page 36: ...elow lists the types of alarms that can appear on Root when using O3 Module Alarm Message Indication Low rSO2 rSO2 level is below low limit High rSO2 rSO2 level is above high limit Low base rSO2 level...
Page 37: ...or more information about connecting O3 Sensor to O3 Module see Chapter 3 Setting Up the O3 System on page 17 of the Operator s Manual O3 Sensor may be defective Replace O3 Sensor O3 Module may be def...
Page 38: ...ble Cause Action Sensor Off Patient O3 Sensor is not properly applied on the patient Confirm that O3 Sensor is properly applied on the patient For more information see Directions for Use for the O3 Se...
Page 39: ...ARMS of the reference measurements in a controlled study Note ARMS is indicative of use with the large adhesive O3 Sensor 40kg only for adults and the pediatric O3 Sensor 5 kg to 40 kg only for pedia...
Page 40: ...Humidity 10 to 95 non condensing O3 Module Storage Item Description Storage Temperature 40 F to 158 F 40 C to 70 C Storage Humidity 10 to 95 non condensing Altitude Up to 12 000 feet 3700 meters Physi...
Page 41: ...rt Non Sterile Separate collection for electrical and electronic equipment WEEE Recyclable Caution Federal USA law restricts this device to sale by or on the order of a physician Authorized representa...
Page 42: ...rage temperature range Serial number Keep dry Fragile handle with care Storage humidity limitation Do not use if package is damaged Atmospheric pressure limitation Equipotential Ground Terminal AC cur...
Page 43: ...conditions 2 Degree of Protection against Electric Shock of the O3 Module with O3 Sensor An F type applied part is isolated from all other parts of the equipment to such a degree that the patient lea...
Page 44: ...imeter Chapter 7 Specifications www masimo com 42 Masimo Safety Compliance Safety Compliance ANSI AAMI ES 60601 1 EN IEC 60601 1 3rd Ed EN ISO 80601 2 61 EMC Compliance EMC Compliance See Operator s M...
Page 45: ...ion General Maintenance for O3 Module Safety tests and internal adjustments should be done by qualified personnel only Safety checks should be performed at regular intervals or in accordance with hosp...
Page 46: ...ble and enclose or include the following information and items A letter describing in detail any difficulties experienced with the O3 Module Include the RMA number in the letter Warranty information a...
Page 47: ...ch they are not labeled and f neglect misuse improper operation accident fire water vandalism weather war or any act of God This warranty does not extend to any product that has been used in violation...
Page 48: ...the written materials 3 Transfer Restrictions In no event may Purchaser transfer assign rent lease sell or otherwise dispose of the Product or the Software on a temporary basis Purchaser shall not as...
Page 49: ...aning Procedure 43 44 Compliance Warnings and Cautions 11 Components of the Regional Oximetry System 14 Connecting the O3 Module to Root 17 Connecting the O3 Sensor s to the O3 Module 19 Contacting Ma...
Page 50: ...2 21 Regional Oxygenation Information 21 Repair Policy 44 Restrictions 46 Return Procedure 44 Root 15 rSO2 Settings 30 S Safety Classifications 41 Safety Compliance 42 Safety Information Warnings and...
Page 51: ......
Page 52: ...www masimo com 38987 LAB 9358C 0718...
