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Nonin Sensmart H500, Operator'S Manual

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Nonin Sensmart H500 Operator'S Manual Download Page 13

7

System Symbols

Date of Manufacture

Manufacturer

Storage/Shipping Temperature Range

Handle With Care.

Keep Dry

Storage/Shipping Humidity Range

Not an Alarm System

Li-ion Battery

Lithium-ion Polymer Battery

BDA

Bluetooth Device Address

Table 1.  Labeling and Packaging Symbols (Continued)

Symbol

Description

Summary of Contents for Sensmart H500

Page 1: ...Operator s Manual Sensmart Model H500 Multi Sensing Portable Oximetry System English ...

Page 2: ...l infointl nonin com nonin com MPS Medical Product Service GmbH Borngasse 20 D 35619 Braunfels Germany References to Nonin in this manual shall imply Nonin Medical Inc Nonin and CO Met are trademarks or registered trademarks of Nonin Medical Inc The Bluetooth word mark and logos are owned by the Bluetooth SIG Inc and any use of such marks by Nonin Medical Inc is under license Other trademarks and ...

Page 3: ...em Components and Set Up 14 Unpacking 14 System Configuration 16 System Display 16 Signal Processor SP BLE 18 Sensors 20 System Operation 21 Initial System Set Up 21 Start up Sequence 21 Taking a Measurement 22 Determining Pulse Signal Quality 22 Event Marking 23 Charging the System 23 Battery 24 Checking Signal Processor Battery Status 24 Placing Device in Long Term Storage Mode 25 Data Download ...

Page 4: ...37 Technical Information 39 Manufacturer s Declaration 39 Equipment Response Time 44 Testing Summary 45 COHb MetHb Principles of Operation 45 COHb Accuracy Testing 45 MetHb Accuracy Testing 45 SpO2 Principles of Operation 46 SpO2 Accuracy Testing 46 SpO2 Accuracy Testing in Presence of COHb and MetHb 46 Pulse Rate Accuracy Testing 46 rSO2 Accuracy Testing 47 Specifications 48 Transmitter 50 ...

Page 5: ...igure 9 Signal Processor Lock Replacement 20 Figure 10 Pulse Signal Quality 22 Figure 11 Event Marking 23 Figure 12 Start Up Screen Select Transfer Icon 25 Figure 13 Data Download Screen 1 Select Menu Icon 26 Figure 14 Data Download Screen 2 Memory Stick Location 26 Figure 15 Data Download Screen 3 Select Files to Transfer 27 Figure 16 Data Transfer Successful 27 Figure 17 Download Data Files 28 F...

Page 6: ...8 Table 3 H500 Monitoring Screen Symbols and Indicators 12 Table 4 H500 Features 17 Table 5 SP BLE Features 18 Table 6 Electromagnetic Emissions 39 Table 7 Electromagnetic Immunity 40 Table 8 Guidance and Manufacturer s Declaration Electromagnetic Immunity 41 Table 9 Recommended Separation Distances 43 ...

Page 7: ...pot checking multiple spot checks to observe change and or continuous monitoring of adult and pediatric patients in professional healthcare facilities mobile and EMS settings Warnings Display and signal processor cannot be used outside of carrying case This device is intended only as an adjunct device in patient assessment It should not be used as the sole basis for diagnosis or therapy decisions ...

Page 8: ... data at the remote monitoring location This device turns off after approximately 30 minutes when the low battery indicator appears If this device is used adjacent to or stacked with other equipment the device should be observed carefully to verify normal operation The use of signal processors sensors accessories and cables other than those listed in the Parts and Accessories List may result in in...

Page 9: ...ironment general population exposure limits specified in ANSI IEEE Std C95 Factors that may degrade oximeter performance include the following Batteries are a fire hazard if damaged Do not damage mishandle disassemble service or replace with non specified components Do not charge Li Ion batteries at a temperature of 0 C 32 F or less as this may result in significantly reduced battery life Do not a...

Page 10: ...pal waste This device contains WEEE materials please contact your distributor regarding take back or recycling of the device If you are unsure how to reach your distributor please call Nonin for your distributor s contact information A functional tester can only be used to assess the performance of the SpO2 only sensors If this device fails to respond as described discontinue use until the situati...

Page 11: ...he outlet where the receiver is connected or 4 Consult the dealer or an experienced radio TV technician for assistance The Model H500 is designed and manufactured to not exceed the emission limits for exposure to radio frequency RF energy set by the Federal Communications Commission of the U S Government These limits are part of comprehensive guidelines and establish permitted levels of RF energy ...

Page 12: ...king indicating conformance to all applicable directives including EC Directive No 93 42 EEC concerning medical devices IP33 Enclosure Degree of Ingress Protection in Carrying Case H500 SP BLE IP33 Class II Double Insulated Serial Number Direct Current Type BF Applied Part Indicates separate collection for waste electrical and electronic equipment WEEE Non ionizing electromagnetic radiation Equipm...

Page 13: ...Storage Shipping Temperature Range Handle With Care Keep Dry Storage Shipping Humidity Range Not an Alarm System Li ion Battery Lithium ion Polymer Battery BDA Bluetooth Device Address Table 1 Labeling and Packaging Symbols Continued Symbol Description ...

Page 14: ...MI Mark Taiwan Federal Communications Commission PSE Mark Japan RCM Tick Mark Australia and New Zealand Medical Power Supply Certification UL Safety Mark for united States and Canada CE Marking indicating conformance to all applicable directives Indoor Use Only Class II Double Insulated PS E ...

Page 15: ...reens and Symbols Display Screens and Symbols Refer to the following Table for definitions to the numbered items associated with Figures 1 3 COMet Figure 1 COMet Screen and Symbols SN05555554 1 3 4 7 6 2 9 10 13 12 ...

Page 16: ...10 Display Screens and Symbols Pulse Oximetry Figure 2 SpO2 Monitoring Screen SN05555554 2 1 3 7 9 10 11 13 12 ...

Page 17: ...11 Display Screens and Symbols Cerebral and Tissue Oximetry Figure 3 rSO2 Monitoring Screen SN05555554 1 5 8 ...

Page 18: ...eading is valid COHb data displays from 0 to 99 when a signal processor receives an adequate signal from an attached sensor 5 rSO2 Cerebral and Tissue Hemoglobin Oxygen Saturation NOTE rSO2 displays when an absolute cerebral and tissue sensor is attached to a signal processor rSO2 displays from 0 to 100 when a signal processor receives an adequate signal from an attached cerebral and tissue sensor...

Page 19: ... on page 29 11 Signal Processor Battery Indicator The indicator shows the approximate percentage of battery life remaining on the signal processor 12 Event Marker Button Can be tapped to add an event mark in the data Displays current event mark number 13 EXAMPLE Signal Processor Serial Number Unique identification number for signal processor Table 3 H500 Monitoring Screen Symbols and Indicators No...

Page 20: ...m configuration includes these non sterile components D HH Nonin SenSmart handheld display SP BLE Nonin SenSmart Signal Processor Bluetooth Low Energy H500 CC Nonin SenSmart H500 System Carrying Case H500 PS Nonin SenSmart H500 Power Supply When the SP BLE is stored in the H500 CC carrying case the surface temperatures of the SP BLE may exceed 41 degrees Celsius reaching a maximum temperature of 4...

Page 21: ...15 System Components and Set Up Figure 4 Unpacking the H500 System ...

Page 22: ... System Display The system display allows the user to view COHb MetHb SpO2 and pulse rate data See below for display features and descriptions For cleaning instructions refer to Care and Maintenance section on page 31 H500 System in Carry Case with Finger clip sensor attached ...

Page 23: ...utton On Pressing this button once turns on the display Each time the display is turned on it activates the signal processor Sleep Quickly press the On Off button to turn both display and signal processor is off Off Long Term Storage Mode For information on putting display into long term storage mode see Placing Device in Long Term Storage Mode section on page 25 3 Display Charging Port See Chargi...

Page 24: ...No Symbol Description 1 On Off Button On Press and hold power button Off Long Term Storage Mode For information on putting signal processor into long term storage mode see Placing Device in Long Term Storage Mode section on page 25 2 NA Signal Processor Charging Port 3 Bluetooth Indicator Bluetooth indicator LED flashes blue when signal processor is ready for a connection to display and solid blue...

Page 25: ...r the sensor connector and click it into place Figure 8 B Figure 8 Connect Sensor to Signal Processor 2 To disconnect a Flip the clear lock on the signal processor back to disengage the lock from the connector b Grasp the connector and remove it from the signal processor Replacing the Lock on the Signal Processor NOTE Replacement locks may be ordered if the lock is lost or damaged 1 Align the lock...

Page 26: ...Replacement Sensors Detailed information regarding specific sensor use e g patient population body tissue application connecting the sensor to the system can be found in the respective sensor instructions for use For a list of compatible sensors refer to the Parts and Accessories section on page 33 A B ...

Page 27: ...ed parameters are indicated 7 System is now ready to take a measurement or to be turned off for future use Start up Sequence Each time the monitor is turned on it performs a brief start up sequence 1 Press On Off Sleep button on display 2 The display lights up and displays the welcome screen 3 Sensor and signal processor turn on CAUTION Between patients turn the H500 system to Sleep Mode When the ...

Page 28: ...gnal processor is activated the Bluetooth LED will be solid blue or flashing blue once every three seconds 4 Place the sensor on the patient according to sensor instructions 5 Take measurement 6 When operation is complete quickly press the On Off Sleep button on display to end session and turn off the device Signal processor will turn off automatically Determining Pulse Signal Quality The pulse si...

Page 29: ...the event mark on screen increased by 1 The event marker icon number will increment with each mark event Pressing the event marker icon below will place an event number in the data file Figure 11 Event Marking Charging the System Display and signal processor must both be charged to use system 1 Charge the display and signal processor using the provided Nonin chargers 2 Insert charger into respecti...

Page 30: ...ng ordinances and recycling instructions regarding disposal or recycling of the device and device components including batteries Batteries are a fire hazard if damaged Do not damage mishandle disassemble service or replace with non specified components Do not charge Li Ion batteries at a temperature of 0 C 32 F or less as this may result in significantly reduced battery life Battery Indication Bat...

Page 31: ...eously Signal processor is now in Long Term Storage Mode To take system out of Long Term Storage mode for use follow steps 2 5 in Initial System Set Up section on page 21 Data Download Session data can be downloaded from the display onto a memory stick NOTE Data can only be downloaded via download dongle and memory stick Data cannot be downloaded directly from device by use of included charging ca...

Page 32: ...ownload screen 1 Tap menu icon in upper left of screen Figure 13 Data Download Screen 1 Select Menu Icon 4 Select memory stick location by tapping the USB symbol in menu Figure 14 Data Download Screen 2 Memory Stick Location Press upper left icon to select the memory stick Locate and select the USB symbol icon to store data on memory stick ...

Page 33: ...matically once files are selected Figure 15 Data Download Screen 3 Select Files to Transfer 6 Data transfer is successful if the File Transfer icon has been replaced with a checkmark symbol as shown below Figure 16 Data Transfer Successful Press the SELECT button to store all available records to the memory stick ...

Page 34: ...stem Operation To view downloaded files 1 Disconnect memory stick from data download cable 2 Connect memory stick to computer USB port 3 Open desired file using Microsoft Excel Figure 17 Download Data Files ...

Page 35: ...e screen will appear Select Set date and enter the appropriate date 4 Select Set time and enter the appropriate time Figure 19 Date and Time Screen Settings From the Welcome screen press the Date and time three times to enter set date and time Select Manually set the date Manually set the time Make sure the following are set Automatic OFF Automatic time zone disabled NOTE The display is not a mobi...

Page 36: ...itor uses an automatically switchable class I class II Bluetooth radio with a maximum range of about 60 meters 196 feet spherical radius The Model H500 features point to point communications allowing one master device the remote monitor to be paired to one slave device the H500 monitor Once connected the H500 monitor will not connect with any other Bluetooth enabled device Bluetooth Security The B...

Page 37: ... cleaning solution Do not use undiluted bleach or any cleaning solution other than those listed below as permanent damage could result 2 Allow to air dry Approved cleaning chemicals Isopropyl Alcohol The following cleaning instructions apply to the carrying case Clean with a mild detergent see note in warm water Allow to air dry Do not machine wash or dry NOTE To clean washable surfaces use in a s...

Page 38: ...e the device in liquid or clean it with agents containing ammonium chloride isopropyl alcohol or products that are not listed in this operator s manual CAUTION Use a detergent that is safe for skin and washable surfaces Most detergents can be high sudsing so use sparingly Wipe with a damp detergent free cloth to remove residue ...

Page 39: ...ion Charger H500 PS Power Supply 25W and cable Instructions for Use H500 Manual Operator s Manual for the H500 system Display D HH H500 system display Signal Processors and Accessories SP BLE Signal processor for use with the H500 system X 100SL Signal processor sensor lock 2 pack Cables and Other Accessories H500CC Carrying case Model Description 8330AA Multi Sensing Reusable Finger Clip Sensor 8...

Page 40: ... Intermediate Cable NOTE For use with 8204CA only INT 200 Intermediate Cable NOTE For use with SenSmart SpO2 only sensors only WARNING Use the Model H500 only with charger supplied by Nonin Medical WARNING The use of signal processors sensors accessories and cables other than those in the Parts and Accessories List may or will result in increased electromagnetic emission and or decreased immunity ...

Page 41: ...ocessor and engage sensor lock Display cannot connect to signal processor Check that the signal processor is charged and turned on Charge signal processor is necessary Contact Nonin if signal processor is charged and turned on and an error persists Sensor Fault Connect new sensor to signal processor Signal Quality Error Unable to get high quality signal from sensor Check sensor placement on patien...

Page 42: ...ction again Power the device off and then on If problem persists contact Nonin OXI 02 SP BLE internal error Power the device off and then on If problem persists contact Nonin OXI 03 SP BLE gas gauge failure Power the device off and then on If problem persists contact Nonin MEM 01 Application configuration failure Contact Nonin MEM 02 Failure during file transfer OTG cable may have been bumped duri...

Page 43: ...d H500 signal processor for a period of 2 years from the date of purchase Please consult your local Nonin distributor for additional information Nonin shall repair or replace any H500 display or H500 signal processor found to be defective in accordance with this warranty free of charge for which Nonin has been notified by the purchaser by serial number that there is a defect provided said notifica...

Page 44: ...technical professionals Accordingly any sign or evidence of opening the device field service by non authorized personnel tampering or any kind of misuse or abuse of the device shall void the warranty in its entirety All non warranty work shall be done according to Nonin standard rates and charges in effect at the time of delivery to Nonin DISCLAIMER EXCLUSIVITY OF WARRANTY THE EXPRESS WARRANTIES S...

Page 45: ... Emissions Test Compliance Electromagnetic Environment Guidance This device is intended for use in the electromagnetic environment specified below The customer and or user of this device should ensure that it is used in such an environment RF Emissions CISPR 11 Group 2 This device must emit electromagnetic energy in order to perform its intended function Nearby electronic equipment may be affected...

Page 46: ...output lines N A Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 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 for...

Page 47: ...V Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 2 Hz 80 AM 3 V m 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 compliance level in each frequency range b ...

Page 48: ...etic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above the device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the device b O...

Page 49: ...According to Frequency of Transmitter Rated Maximum Output Power of Transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 2 1 2 2 3 10 3 7 3 7 7 4 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of...

Page 50: ...erference Example SpO2 Exponential Averaging SpO2 decreases 1 0 every 2 seconds 5 over 10 seconds Pulse Rate 75 BPM Specific to this example The response of the SpO2 average is 6 seconds SpO2 Values Response Latency Fast Averaged SpO2 3 second or faster exponential time constant 2 beats Pulse Rate Values Response Latency Fast Averaged Pulse Rate 3 second or faster exponential time constant 2 beats...

Page 51: ...tion values COHb Accuracy Testing COHb accuracy testing was conducted at an independent research laboratory on healthy male and female non smoking light to dark skinned subjects that were 18 years of age and older The measured carboxyhemoglobin value COHb of the sensors was compared to simultaneous arterial blood samples as assessed by co oximetry The accuracy of the sensors in comparison to the c...

Page 52: ...r ISO 80601 2 61 Medical Electrical Equipment Particular requirements for basic safety and essential performance of pulse oximeter equipment SpO2 Accuracy Testing in Presence of COHb and MetHb During no motion conditions at an independent research laboratory SpO2 accuracy testing in the presence of COHb and MetHb was conducted during induced hypoxia studies on healthy male and female non smoking l...

Page 53: ...n measurement focused on the cerebrum The absorption measurement is largely unaffected by surface or near surface features irregularities or substances rSO2 Accuracy Testing At an independent research laboratory rSO2 accuracy testing was conducted during induced hypoxia studies on healthy non smoking light to dark skinned subjects that were 18 years of age and older The measured cerebral and tissu...

Page 54: ...e 18 to 321 beats per minute BPM Sensor Accuracy Refer to the sensor Instructions for Use IFU for accuracy data Measurement Wavelengths and Output Power a Refer to sensor IFU for details Memory Minimum 280 hours Temperature Operating 0 ºC to 40 ºC 32 ºF to 104 ºF Transient Operatingb 20 ºC to 50 ºC 4 ºF to 122 ºF Storage Transportation 30 ºC to 70 ºC 22 ºF to 158 ºF Humidity Operating 15 to 93 non...

Page 55: ...to the extreme environmental operating conditions Dimensions H500 305 mm W x 180 mm H x 130 mm D 12 0 in W x 7 2 in H x 5 0 in D SP BLE 21 4 mm H x 21 7 mm W x 72 7 mm L including strain relief with 0 75 m cable 0 84 in H x 0 85 in W x 3 1 in L including strain relief with 2 5 ft cable Weight H500 Approximately 900 grams 2 pounds SP BLE 40 grams 1 4 ounces Warranty Display Signal Processor 2 years...

Page 56: ...nformation Transmitter Bluetooth Compliance Version 4 2 or greater Output Power 8 dBm Operating Range Maximum range 60 meter 196 feet radius indoors line of sight Operation Bluetooth Low Energy Antenna Type Internal ...

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