Masimo Pronto Pulse CO-Oximeter Operator'S Manual Download Page 5

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Contents

About This Manual------------------------------------------------------------------------------------------ 5

Product Description, Features, and Indications for Use -----------------------------------------------7

Product Description and Features ---------------------------------------------------------------------7

Indications for Use ---------------------------------------------------------------------------------------7

Contraindications ----------------------------------------------------------------------------------------7

Safety Information, Warnings, and Cautions ----------------------------------------------------------- 9

Safety Warnings and Cautions ------------------------------------------------------------------------ 9

Performance Warnings and Cautions --------------------------------------------------------------- 10

Cleaning and Service Warnings and Cautions ---------------------------------------------------- 13

Compliance Warnings and Cautions ---------------------------------------------------------------- 14

Chapter 1: Technology Overview ------------------------------------------------------------------------ 15

Masimo Signal Extraction Technology (Masimo SET®) ----------------------------------------- 15

rainbow Pulse CO-Oximetry Technology ----------------------------------------------------------- 17

Chapter 2: System Description -------------------------------------------------------------------------- 21

Front Panel ---------------------------------------------------------------------------------------------- 21

Rear Panel ----------------------------------------------------------------------------------------------- 23

Chapter 3: Setup ------------------------------------------------------------------------------------------- 25

Unpacking and Inspection --------------------------------------------------------------------------- 25

Power Requirements ----------------------------------------------------------------------------------- 25

Initial Setup --------------------------------------------------------------------------------------------- 25

Chapter 4: Operation -------------------------------------------------------------------------------------- 27

Basic Operation ---------------------------------------------------------------------------------------- 27

Default Settings ---------------------------------------------------------------------------------------- 29

Audible Alerts ------------------------------------------------------------------------------------------ 30

Battery Level Indicator ------------------------------------------------------------------------------- 30

Navigating the Menu ---------------------------------------------------------------------------------- 31

Trend Setup and Use --------------------------------------------------------------------------------- 33

Chapter 5: Messages ------------------------------------------------------------------------------------- 35

Messages ----------------------------------------------------------------------------------------------- 35

Chapter 6: Troubleshooting ----------------------------------------------------------------------------- 39

Troubleshooting --------------------------------------------------------------------------------------- 39

Summary of Contents for Pronto Pulse CO-Oximeter

Page 1: ...Operator s Manual Pronto Pulse CO Oximeter...

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Page 3: ...ient 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...

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Page 5: ...Compliance Warnings and Cautions 14 Chapter 1 Technology Overview 15 Masimo Signal Extraction Technology Masimo SET 15 rainbow Pulse CO Oximetry Technology 17 Chapter 2 System Description 21 Front Pa...

Page 6: ...ts 45 Display Indicators 46 Compliance 46 Citations 48 Symbols 49 Guidance and Manufacturer s Declaration Electromagnetic Emissions 51 Guidance and Manufacturer s Declaration Electromagnetic Immunity...

Page 7: ...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 state...

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Page 9: ...mputer Indications for Use The Masimo Rainbow SET Pronto Pulse CO Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial oxygen hemoglobin SpO2 pulse...

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Page 11: ...ents or nitrous oxide WARNING Do not place the Pronto or accessories in any position that might cause it to fall on the patient WARNING To ensure safety avoid stacking multiple devices or placing anyt...

Page 12: ...G Do not use Pronto during electrocautery WARNING Do not place containers with liquids on or near Pronto Liquids spilled on Pronto may cause it to perform inaccurately or fail WARNING Interfering Subs...

Page 13: ...such as Raynaud s and peripheral vascular disease Hemoglobinopathies and synthesis disorders such as thalassemias Hb s Hb c sickle cell etc Hypocapnic or hypercapnic conditions Peripheral vascular di...

Page 14: ...ed only under careful clinical supervision for short time periods to minimize interference with photodynamic therapy CAUTION If SpO2 values indicate hypoxemia a laboratory blood sample should be taken...

Page 15: ...personnel trained in the repair of this equipment CAUTION Do not submerge Pronto in any cleaning solution or attempt to sterilize by autoclave irradiation steam gas ethylene oxide or any other method...

Page 16: ...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 b...

Page 17: ...read low values because they cannot distinguish between the arterial and venous blood movement sometimes referred to as noise Masimo SET pulse oximetry utilizes parallel engines and adaptive filtering...

Page 18: ...SpO2 The Pronto is calibrated to measure and display functional oxygen saturation SpO2 the amount of oxyhemoglobin expressed as a percentage of the hemoglobin that is available to transport oxygen No...

Page 19: ...Signal data is obtained by passing various visible and infrared lights LEDs 500 to 1400nm through a capillary bed for example a fingertip a hand a foot and measuring changes in light absorption during...

Page 20: ...period of 20 seconds the time it takes to draw the blood a meaningful comparison can only be achieved if the oxygen saturation carboxyhemoglobin and methemoglobin concentration of the patient are stab...

Page 21: ...ameters such as blood volume arterial venous coupling etc that occur during patient motion the accuracy of such measurements may not be reliable during excessive motion In this case the Low SIQ indica...

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Page 23: ...by control buttons on the front panel and the sensor cable connection is located at the top edge of the device Pronto is powered by four 4 AA alkaline batteries to provide up to eight 8 hours of conti...

Page 24: ...onnector The Patient Cable Sensor connector is where a compatible sensor is connected to the device 8 Low SIQ Indicator This illuminates to indicate low confidence in the measurement displayed For mor...

Page 25: ...Pronto Chapter 2 System Description www masimo com 23 Masimo Rear Panel Ref Feature 1 Serial Number Label 2 Certification Label 3 Battery Cover 4 Battery Cover Release...

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Page 27: ...of non alkaline batteries may affect the accuracy of the battery level indicator on the device Use of batteries with cell voltage of more than 1 5V could damage the device See Battery Level Indicator...

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Page 29: ...n on Pronto All front panel indicators will illuminate momentarily and an audible tone will sound If applicable the device will display the number of sensor uses remaining The device displays RDY indi...

Page 30: ...ndicator is illuminated the value may be checked again 10 After the spot check is complete remove the sensor from the patient and store or dispose of the sensor according to the governing rules For mo...

Page 31: ...rend CLR TND No No Yes Oxygen Saturation SpO2 02 On On Off Pulse Rate PR PR On On Off Perfusion Index PI PI On On Off Line Frequency LF LF 60 Hz 50 60 Hz Software Version UER HH HH MX read only SpHb C...

Page 32: ...y Level Indicator Four LED indicators provide information on the remaining battery capacity The operator should monitor these indicators periodically to determine remaining spot check uses and if the...

Page 33: ...below press the SpHb button repeatedly 3 To change a setting see table below for a menu option selected in the previous step press Up and Down arrow buttons 4 Press the SpHb button to confirm the chan...

Page 34: ...ult PR Off PI PI On Default PI Off LF LF 60 Default LF 50 UER Software Version HH Software Default Software Version MX Software HB SpHbv Calibration Venous Default SpHb Calibration Arterial TON Pulse...

Page 35: ...erred to a PC Trend data is stored in non volatile memory so it is not erased when the device is shut off A trend data download is initiated using the TrendCom utility not included which downloads the...

Page 36: ...11 00 09 36 SpO2 100 PR 070 PI 01 32 SpCO 00 00 Met 00 00 SpHb 15 1 PVI 000 EXC 00000000 12 01 11 00 12 45 SpO2 096 PR 068 PI 03 52 SpCO 00 00 Met 00 00 SpHb 13 8 PVI 000 EXC 00000000 12 01 11 00 13 1...

Page 37: ...r whenever a spot check is performed If necessary shield the sensor from excessive ambient or strobing light Low SIQ Indicator illuminates Low Signal IQ 1 Rule out occlusion of blood flow 2 Verify pla...

Page 38: ...d Replace cable Temporarily blinking message RPL CBL Cable life expired Replace cable as soon as possible Temporarily blinking message RPL SEN Sensor life expired Replace sensor as soon as possible Te...

Page 39: ...ect the reusable part of the ReSposable sensor system Assemble the ReSposable sensor system and then connect to the device INC ADH The adhesive part of the Masimo ReSposable sensor system is incompati...

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Page 41: ...nd Cautions on page 9 and the sensor Directions for Use DFU Unit does not power on Low battery Check replace batteries See Battery Replacement on page 57 Continuous speaker tone Internal failure Unit...

Page 42: ...sessment of the confidence of the measurement displayed When the Low SIQ Indicator illuminates confidence in the measurement displayed is low Proceed with caution and do the following Assess the patie...

Page 43: ...may result in the device shutting down and leaving the patient in an unmonitored condition WARNING Use only alkaline batteries Use of non alkaline batteries may affect the accuracy of the Battery Lev...

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Page 45: ...Pulse Rate PR 5 Condition Range Arms No Motion 25 240 bpm 3 bpm Motion 3 25 240 bpm 5 bpm Low Perfusion 4 25 240 bpm 3 bpm Total Hemoglobin SpHb 6 Condition Range Arms No Motion 8 g dL 17 g dL 1 g dL...

Page 46: ...g dL to 25 g dL PR Pulse Rate 25 bpm to 240 bpm PI Perfusion Index 0 02 to 20 Resolution Parameter Resolution SpO2 1 SpHb 0 1 g dL Pulse Rate 1 bpm Electrical Battery Type Four 4 AA alkaline Capacity...

Page 47: ...ensing Operating Altitude 500 mbar to 1060 mbar 1000 ft to 18 000 ft 304 m to 5 486 m Physical Characteristics Dimensions 6 2 x 3 0 x 1 4 15 8 cm x 7 6cm x 3 6 cm Weight 13oz 0 37 kg Trend Memory Tren...

Page 48: ...l Pulse Rate bpm PI Indicators Low Signal IQ Indicator Battery Level Indicator Spot Check Progress Indicator Pulse Indicator and Sensor Use Indicator Type LED Compliance Safety Compliance UL 60601 1 C...

Page 49: ...01 1 2 Class B Equipment Classification per IEC 60601 1 Type of Protection Internally powered battery powered Degree of Protection Against Electric Shock Type BF Applied Part Environment Not for use i...

Page 50: ...2 to 3 cm in induced hypoxia studies in the range of 70 100 SpO2 against a laboratory CO Oximeter and ECG monitor 4 The Pronto has been validated for low perfusion accuracy in bench top testing again...

Page 51: ...onsult Instructions for Use Type BF Applied Part Not for Continuous Monitoring Separate Collection for Electronic Waste WEEE Mark of Conformity to European Medical Device Directive 93 42 EEC Federal l...

Page 52: ...emperature Range Storage Transport Relative Humidity Range Keep Dry Fragile Breakable Handle with Care Authorized representative in the European community UL LLC Certification Instructions Directions...

Page 53: ...ent should assure that it is used in such an environment Emission Test Compliance Electromagnetic Environment Guidance RF Emissions CISPR 11 Group 1 ME Equipment uses RF energy only for its internal f...

Page 54: ...east 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines N A Mains power quality should be that of a typical commercial or hospital environment Sur...

Page 55: ...to the frequency of the transmitter Recommended separation distance Conducted RF IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz 3 Vrms 150 kHz to 80 MHz Radiated RF IEC 61000 4 3 3 V m 150 kHz to 80MHz 3 V m...

Page 56: ...land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an el...

Page 57: ...ication equipment Rated maximum output power of transmitter W Separation Distance According to Frequency of Transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5GHz 0 01 0 12 0 018 0 035 0...

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Page 59: ...Note The performance of a device with a touchscreen will not be affected when using the recommended cleaning solutions Battery Replacement Pronto is powered by four 4 AA alkaline batteries Do not use...

Page 60: ...erial cables or sensors from the device Power On Self Test 1 Turn on the device by pressing the Power button For about 5 seconds all available LEDs are illuminated and a brief beep tone sounds 2 Verif...

Page 61: ...fficulties experienced with the Pronto Include the RMA number in the letter Warranty information a copy of the invoice or other applicable documentation must be included Purchase order number to cover...

Page 62: ...sed with other products like new sensors reprocessed sensors or other accessories not intended by Masimo to be used with the Product f not used or maintained as provided in the operator s manual or as...

Page 63: ...fer the Software from the Product to any other device Purchaser may not disclose publish translate release distribute copies of modify adapt translate reverse engineer decompile disassemble or create...

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Page 65: ...ngs and Cautions 14 36 57 Contacting Masimo 59 Contraindications 7 D Default Settings 25 29 34 40 Display Indicators 46 Display Ranges 44 E Electrical 44 Environmental 45 Erasing Trend Memory 33 Exclu...

Page 66: ...nd Indications for Use 7 Pulse CO Oximetry vs Drawn Whole Blood Measurements 18 R rainbow Pulse CO Oximetry Technology 17 Rear Panel 23 Recommended Separation Distances 55 Repair Policy 58 Resolution...

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Page 68: ...www masimo com 32900 5052J 0616...

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