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Contents

Glossary ------------------------------------------------------------------------------------------------------- 5

Device Description -------------------------------------------------------------------------------------------7

Product Description --------------------------------------------------------------------------------------7

Purpose of the Device (Indications for Use) ---------------------------------------------------------7

General Warnings and Precautions ---------------------------------------------------------------------- 9

Safety Warnings ----------------------------------------------------------------------------------------- 9

Performance Warnings -------------------------------------------------------------------------------- 10

Cleaning and Service Warnings --------------------------------------------------------------------- 11

Compliance Warnings --------------------------------------------------------------------------------- 11

Risks and Benefits ----------------------------------------------------------------------------------------- 13

Risks of MightySat Rx --------------------------------------------------------------------------------- 13

Benefits of MightySat Rx ------------------------------------------------------------------------------ 13

Description -------------------------------------------------------------------------------------------------- 15

Parts List ------------------------------------------------------------------------------------------------- 15

MightySat Rx Features -------------------------------------------------------------------------------- 16

Basic Setup and Use--------------------------------------------------------------------------------------- 17

Notes: ---------------------------------------------------------------------------------------------------- 19

Advanced Setup and Use --------------------------------------------------------------------------------- 21

Using the Touchpad ----------------------------------------------------------------------------------- 21

Main Menu Options ------------------------------------------------------------------------------------ 22

Connecting to a Smart Device via Bluetooth (Optional) ---------------------------------------- 22

Notes: ---------------------------------------------------------------------------------------------------- 24

Appendix ---------------------------------------------------------------------------------------------------- 25

Troubleshooting ---------------------------------------------------------------------------------------- 25

Specifications ------------------------------------------------------------------------------------------- 26

Cleaning, Disinfecting, and Service ----------------------------------------------------------------- 43

Notes: ---------------------------------------------------------------------------------------------------- 46

Index --------------------------------------------------------------------------------------------------------- 47

Содержание MightySat Rx

Страница 1: ...Home Care Manual MightySat Rx Fingertip Pulse Oximeter ...

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Страница 3: ... which would alone or in combination with this device fall within the scope of one of the relating patents 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 For professional use See directions for use for full prescribing information inclu...

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Страница 5: ...arnings 11 Compliance Warnings 11 Risks and Benefits 13 Risks of MightySat Rx 13 Benefits of MightySat Rx 13 Description 15 Parts List 15 MightySat Rx Features 16 Basic Setup and Use 17 Notes 19 Advanced Setup and Use 21 Using the Touchpad 21 Main Menu Options 22 Connecting to a Smart Device via Bluetooth Optional 22 Notes 24 Appendix 25 Troubleshooting 25 Specifications 26 Cleaning Disinfecting a...

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Страница 7: ...blood supply Oxygen Saturation The percentage of hemoglobin in blood that is bound to oxygen Parameter A parameter is an element of a system that is critical in evaluating the system s condition Perfusion The bodily process of delivering blood to the capillary beds Pulse Oximeter A medical device that uses a sensor to indirectly measure oxygen saturation of blood and pulse rate Quality of Service ...

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Страница 9: ...l oxygen saturation SpO2 Pulse Rate PR and Perfusion Index Pi Bluetooth LE radio is intended to transfer of parameter data to a compatible smart device MightySat Rx Bluetooth LE PVi and RRp Intended to measure and display arterial oxygen saturation SpO2 Pulse Rate PR Perfusion Index Pi and Pleth Variability Index PVi and Pleth Respiration Rate RRp Bluetooth LE radio is intended for transfer of par...

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Страница 11: ...ch pressure to a finger can cause skin damage WARNING Check the sensor site every hour to ensure proper blood flow skin quality and sensor placement Skin damage pressure necrosis or inaccurate readings may result WARNING Only use Masimo approved accessories and devices with MightySat Rx to prevent damage to the device and inaccurate readings WARNING Keep MightySat Rx away from small children Small...

Страница 12: ...ources and direct sunlight to minimize interference that may result in no or inaccurate readings CAUTION Keep the MightySat Rx away from electrical equipment that emits radio frequencies to minimize radio interference Radio interference may result in no or inaccurate readings CAUTION Keep the MightySat Rx away from electrical equipment that emits radio frequencies to minimize radio interference Ra...

Страница 13: ...mpounds instruments brushes or rough surface materials These can damage the device CAUTION Do not submerge MightySat Rx in liquid or attempt to sterilize the MightySat Rx by any method to prevent damage to the device Compliance Warnings WARNING Changes or modifications not expressly approved can void the user s authority to operate the equipment WARNING The frequency bands of this device 2 4 GHz a...

Страница 14: ...allation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Consult the dealer or an experienced radio TV t...

Страница 15: ...all parts away from small children to prevent such hazards As with all items applied directly to the skin there is always a risk of skin irritation pressure injury and general discomfort while a sensor or cuff is applied to a patient Periodically check the areas where the patient s skin makes contact with the sensor or blood pressure cuff to prevent potential issues Benefits of MightySat Rx Mighty...

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Страница 17: ...www masimo com 15 Masimo Description Parts List MightySat Rx consists of the following items Item Description 1 MightySat Rx 2 Batteries 3 Lanyard 4 Carrying Case ...

Страница 18: ...surements and indicators Note Numbers are dim when confidence in the measurement is low 5 Waveform and SIQ or Pulse Bar When the waveform option is turned on the Waveform and SIQ line display The height of the SIQ line shows the confidence in the measurement displayed When the waveform option is turned off the Pulse Bar displays the pulse rate The height of the Pulse Bar shows the confidence in th...

Страница 19: ...rk if the batteries are inserted backwards 1 Place the MightySat Rx with the display screen facing down 2 Push lightly on the battery button identified by the arrow to release and remove the battery cover 3 Insert two new AAA alkaline batteries to match the labels and inside of the battery case 4 Snap the battery door back onto the device CAUTION Ensure that the battery door is installed before us...

Страница 20: ...ice is correctly placed on the finger release the device to close The display should be facing up 3 4 The tip of the finger should touch the finger stop as shown in the image below Note Ensure the finger is correctly positioned After the MightySat Rx is correctly placed on the finger readings display Note If readings are not displayed see Troubleshooting on page 25 CAUTION Do not press the top of ...

Страница 21: ...MightySat Rx Basic Setup and Use www masimo com 19 Masimo The MightySat Rx turns off after removing it from the finger Notes ...

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Страница 23: ...Enter the Menu Screen Press and hold the Touchpad The menu allows changes to MightySat Rx settings See Main Menu Options on page 22 Navigate the Menu Screen Swipe left or right on the Touchpad Switches between menu items on the Menu Screen Select a menu item Touch and release the Touchpad Select an item on the Menu Screen to switch between options or enable disable that option See Main Menu Option...

Страница 24: ...he icon is white when Off the icon is gray dimmed Connecting to a Smart Device via Bluetooth Optional Note Bluetooth LE is an optional feature available on specific versions of MightySat Rx for use with compatible smart devices For a full list of compatible smart devices see www masimoprofessionalhealth com Bluetooth Connection The MightySat Rx provides a Bluetooth LE wireless option to allow conn...

Страница 25: ... Health app are the same without a delay greater than 10 seconds Note If the delay is greater than 10 seconds move the MightySat Rx closer to the smart device and repeat the connection process Note To prevent unauthorized connection to the MightySat Rx turn off the optional Bluetooth LE feature on the MightySat Rx when a connection is not required CAUTION When using MightySat Rx optional Bluetooth...

Страница 26: ... 1 On the smart device access the Masimo Professional Health app Options 2 Press select the Paired Device information 3 Select Forget this Device MightySat Rx will be disconnected from the smart device MightySat Rx will need to be paired if it is to be used with this smart device again Notes ...

Страница 27: ...tial measurement Reposition finger see Basic Setup and Use on page 17 in this manual Re orient batteries Replace with new batteries Relocate device Contact Masimo Technical Services Device display does not turn on No battery Incorrect battery orientation Device damaged Replace with new batteries Re orient batteries Contact Masimo Technical Services Numbers appear dim Brightness set low Exposed to ...

Страница 28: ...vice damaged Smart device damaged Confirm Bluetooth LE is on for the MightySat Rx and the smart device Confirm a compatible app is installed on the smart device Close and re launch the compatible app on the smart device Check that MightySat Rx is connected to the correct smart device Contact Masimo Technical Services Specifications Display Ranges Parameter Display Ranges SpO2 Oxygen Saturation 0 t...

Страница 29: ...opulation ARMS No Motion 4 25 bpm to 240 bpm Adults Pediatrics 3 bpm Motion 4 25 bpm to 240 bpm Adults Pediatrics 5 bpm Low perfusion 4 25 bpm to 240 bpm Adults Pediatrics 3 bpm Respiration Rate RRp 5 Range Accuracy 4 rpm to 70 rpm 3 rpm ARMS 1 rpm mean error See RRp Performance Specifications for additional RRp accuracy information ARMS accuracy is a statistical calculation of the difference betw...

Страница 30: ...htySat Rx with Masimo SET Oximetry Technology in a clinical study under no motion conditions Measured ARMS Values Range ARMS 90 100 1 08 80 90 1 95 70 80 1 79 Overall Claimed Accuracy Value Range ARMS 70 100 2 The below Bland Altman plot represents the correlation of SpO2 SaO2 versus SpO2 SaO2 2 under no motion with an upper 95 and lower 95 limits of agreement ...

Страница 31: ...rformance Specifications The below Bland Altman plots represent the correlation of RRp and the reference respiration rate in three different studies each with upper 95 and lower 95 limits of agreement Figure 2 Bland Altman plot of the RRp measurement with respect to the respiration rate value on a simulator RRref ...

Страница 32: ...www masimo com 30 Masimo Figure 3 Subject by subject Bland Altman plot of the RRp measurement with respect to the respiration rate determined by clinician scored capnograms RRref_c from a clinical study of healthy volunteers ...

Страница 33: ...spect to the respiration rate determined by clinician scored capnograms RRref_c from a clinical study of hospitalized patients Medical Conditions Medical Conditions from clinical study of hospitalized patients N N Autoimmune Infections Psoriasis 1 Cellulitis 1 Cardiovascular Muscular Atrial Septal Defect 1 Ventral Hernia 2 ...

Страница 34: ... Lipoma 1 Hypothyroidism 2 Malignant Tumor 1 Morbid Obesity 6 Neurological Gastrointestinal Bilateral Hand Tremors 1 Acid Reflux 1 Neuropathy 1 Crohn s Disease 1 Restless Leg Syndrome 1 Emesis 1 Ophthalmology GERD 3 Glaucoma 2 Hiatal Hernia 1 Other Reflux Disease 1 Lethargy 1 Genitourinary Subdural Hematoma 1 Bladder Cancer 1 Renal Breast Cancer Breast Cancer History 2 Kidney Disease 2 Cervical Ca...

Страница 35: ...ep Apnea 3 Anemia 1 Sleep Apnea 13 Blood Clotting Disorder Unspecified 1 Vascular Leukocytosis 1 Raynaud Phenomenon 1 Sickle Cell Disease 1 Hepatobiliary Cholelithiasis 2 Chronic Cholecystitis 1 Gall Stones 2 Liver Cyst 1 Battery Life Item Description Operating 1 5 Volt AAA Battery 2 Battery Life 15 hours screen brightness at 50 ...

Страница 36: ...ting Humidity 10 to 95 non condensing Storage Humidity 10 to 95 non condensing Atmospheric pressure 540 mBar to 1060 mBar Physical Characteristics Item Description Dimensions 3 x 1 7 x 1 3 7 6 cm x 4 3 cm x 3 3 cm Weight without Battery 0 2 lbs 90g Compliance Safety Compliance ANSI AAMI ES60601 1 CSA C22 2 No 60601 1 IEC EN 60601 1 IEC 60601 1 6 IEC 60601 1 11 ISO 80601 2 61 ...

Страница 37: ...ress IP23 Protection from ingress of particulates than 12 5 mm and ingress from spraying water Environment Not for use in the presence of flammable anesthetics Bluetooth LE Wireless Technology Information Bluetooth LE Wireless Technology Information Modulation Type GFSK Max Output Power 1 dBm Frequency Range 2402 MHz 2480 MHz Antenna Peak Gain 7 dBi Recommended Range 10 feet 3 meters line of sight...

Страница 38: ...ustomer or the user of the ME Equipment 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 function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 Class B This devic...

Страница 39: ...output lines N A Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth N A Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT ...

Страница 40: ...1 Clause 202 3 V m 150 kHz to 80MHz 20 V m 80 MHz to 2 5 GHz 3 V m 20 V m 80 MHz to 800 MHz 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the c...

Страница 41: ...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 Recommended Separation Distances Recommended Separation Distance Between Portable and Mobile RF Communication Equipment and the ME Equipment The ME Equipment is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The custom...

Страница 42: ...e 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Symbols The following symbols may appear on the product or product labeling Symbol Description Symbol Description Follow instructions for use Mark of conformity to European medical device directive 93 42 EEC Protection from ingress of particul...

Страница 43: ...logy used in the MightySat Rx Fingertip Pulse Oximeter has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo s simulator with signal strengths of greater than 0 02 and transmission of greater than 5 for saturations ranging from 70 to 100 4 The Masimo SET Technology used in the MightySat Rx Fingertip Pulse Oximeter has been validated for pu...

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Страница 45: ...w the instructions below Note Follow cleaning instructions prior to disinfecting the device Visibly wet the sensor pads and outer surfaces using a soft cloth dampened with a 10 1 10 chlorine bleach to water solution Allow the solution to sit for 10 minutes on the sensor pads before wiping them with a dry soft cloth Allow the MightySat Rx to dry thoroughly before using again The surfaces of the Mig...

Страница 46: ... described warranty to the extent permitted under applicable laws and regulations of the region in which the product was sold Exclusions The warranty does not apply to any non Masimo branded product or any software even if packaged with the Product or any Product that was a not new or in its original packaging when supplied to purchaser b modified without Masimo s written permission c supplies dev...

Страница 47: ...ally responsible for any copyright infringement that is caused or incurred by Purchaser s failure to abide by the terms of this Agreement Nothing in this License provides any rights beyond those provided by 17 U S C 117 2 Use Restrictions Purchaser may physically transfer the Product from one location to another provided that the Software is not copied Purchaser may not electronically transfer the...

Страница 48: ...MightySat Rx Appendix www masimo com 46 Masimo prohibited except to the extent expressly permitted by the terms of this Agreement Notes ...

Страница 49: ...6 E Environment 34 Exclusions 44 G General Warnings and Precautions 9 Glossary 5 Guidance and Manufacturer s Declaration Electromagnetic Emissions 36 Guidance and Manufacturer s Declaration Electromagnetic Immunity 37 L Limitation of Warranty 44 Limited Warranty 44 M Main Menu Options 21 22 23 Medical Conditions 31 MightySat Rx Features 16 N Notes 19 24 46 P Parts List 15 Performance Specification...

Страница 50: ...t Rx Index www masimo com 48 Masimo Sales End User License Agreement 45 Service 43 Specifications 23 26 SpO2 Performance Specifications 27 28 Symbols 40 T Troubleshooting 18 25 43 U Using the Touchpad 16 21 22 ...

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Страница 52: ...www masimo com 300162 LAB 10168A 0119 ...

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