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Nonin CO-Pilot H500, Operator'S Manual

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Nonin CO-Pilot H500 Operator'S Manual Download Page 66

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Technical Information

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Summary of Contents for CO-Pilot H500

Page 1: ...Operator s Manual CO Pilot Model H500 Wireless Handheld Multi Parameter System English...

Page 2: ...ww 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 trad...

Page 3: ...Tissue Oximetry 14 System Components and Set Up 18 Unpacking 18 System Configuration 19 System Display 19 Signal Processor SP BLE 21 Sensors 23 System Operation 24 Initial System Set Up 24 Start up Se...

Page 4: ...Time 52 Testing Summary 53 COHb MetHb Principles of Operation 53 COHb Accuracy Testing 53 MetHb Accuracy Testing 53 SpO2 Principles of Operation 54 SpO2 Accuracy Testing 54 SpO2 Accuracy Testing in Pr...

Page 5: ...essor Lock Replacement 23 Figure 11 Pulse Signal Quality 25 Figure 12 Event Marking 26 Figure 13 Start Up Screen Select Transfer Icon 29 Figure 14 Data Download Screen 1 Select Menu Icon 29 Figure 15...

Page 6: ...able 3 CO Pilot Measurement Screen Symbols and Indicators 15 Table 4 D HH Features 20 Table 5 SP BLE Features 21 Table 6 Electromagnetic Emissions 47 Table 7 Electromagnetic Immunity 48 Table 8 Guidan...

Page 7: ...d for spot checking multiple spot checks to observe change and or measuring during clinician assessment of adult and pediatric patients in professional healthcare facilities mobile and EMS settings Re...

Page 8: ...See Specifications section from display to signal processor Moving outside this range may cause missing or lost data This device turns off after approximately 30 minutes when the low battery indicato...

Page 9: ...Pilot is designed and manufactured not to exceed the emission limits for exposure to radio frequency RF energy set by the United States FCC These limits are part of comprehensive guidelines and estab...

Page 10: ...ce 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...

Page 11: ...armful interference in a residential installation This equipment generates uses and can radiate radio frequency energy If not installed and used in accordance with the instructions it may cause harmfu...

Page 12: ...ny changes or modifications to this device that are not expressly approved by Nonin Medical Inc may void the user s authority to operate the equipment NOTE No modifications to this device are allowed...

Page 13: ...for Canada and the United States with respect to electric shock fire and mechanical hazards only in accordance with IEC 60601 1 UL 60601 1 and CAN CSA C22 2 No 601 1 IP33 Enclosure Degree of Ingress P...

Page 14: ...etooth Device Address Table 2 Power Supply Labeling and Packaging Symbols Symbol Description BSMI Mark Taiwan Federal Communications Commission PSE Mark Japan RCM Tick Mark Australia and New Zealand M...

Page 15: ...9 System Symbols Indoor Use Only Class II Double Insulated Table 2 Power Supply Labeling and Packaging Symbols Continued Symbol Description...

Page 16: ...10 Display Screens and Symbols Display Screens and Symbols Refer to the following Table for definitions to the numbered items associated with Figures 1 3 Start Up 1 17 14 15 16 18...

Page 17: ...11 Display Screens and Symbols CO Met Figure 1 CO Met Measurement Screen CO Met Enabled 1 3 4 7 6 2 9 10 13 12 11...

Page 18: ...12 Display Screens and Symbols Figure 2 CO Met Measurement Screen CO Met Disabled 1 3 7 2 9 10 13 12 11 19...

Page 19: ...13 Display Screens and Symbols Pulse Oximetry Figure 3 SpO2 Measurement Screen 2 3 7 10 11 13 12 1 9...

Page 20: ...14 Display Screens and Symbols Cerebral and Tissue Oximetry Figure 4 rSO2 Measurement Screen 1 5 8 11 12...

Page 21: ...alid Pulse Rate data displays from 18 to 321 BPM when a signal processor receives an adequate signal from an attached sensor The symbol will change color based on the pulse signal quality see Determin...

Page 22: ...te and Time The date and time display in 24 hour clock format yyyy mm dd hh mm To set the date and or time see Setting Date and Time section on page 35 11 Signal Processor Battery Indicator The indica...

Page 23: ...vision for the D HH 18 SP BLE Device and Software Provides the serial number and software revision for the SP BLE 19 Enable Disable CO Met When shown COHb and MetHb measurements will not be displayed...

Page 24: ...all components for damage Compare the packing list with the accessories received to make sure the shipment is complete The standard system configuration includes these non sterile components D HH Non...

Page 25: ...stem 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 sect...

Page 26: ...is 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 off Off Long Te...

Page 27: ...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...

Page 28: ...ck over the sensor connector and click it into place Figure 9 C Figure 9 Connect Sensor to Signal Processor 2 To disconnect a Flip the clear lock on the signal processor back to disengage the lock fro...

Page 29: ...re 10 B Figure 10 Signal Processor Lock Replacement Sensors Detailed information regarding specific sensor use e g patient population body tissue application connecting the sensor to the system can be...

Page 30: ...indicated 7 System is now ready to take a measurement or to be turned off for future use Start up Sequence Each time the display is turned on it performs a brief start up sequence 1 Press On Off Slee...

Page 31: ...te briefly press the On Off Sleep button on display to end session and turn off the device Signal processor will turn off automatically During patient measurements the system may reach temperatures of...

Page 32: ...gins a new patient record After turning on the system and applying the sensor to the patient 1 Press the event mark button to place an event mark in the recorded data 2 Verify the event mark on screen...

Page 33: ...act with the patient during charging CAUTION Charging signal processor at temperatures below 0 degrees C 32 degrees F will decrease battery life Do not charge signal processor at temperatures below 0...

Page 34: ...Term Storage Mode 3 Press and hold the On Off button on the signal processor until all signal processor lights flash simultaneously Signal processor is now in Long Term Storage Mode To take system ou...

Page 35: ...Select Transfer Icon NOTE If using the same USB memory stick the display may automatically return to the file location used for the last data download 3 Display will show Data Download Screen 1 Tap m...

Page 36: ...T Data download will begin automatically once files are selected Figure 16 Data Download Screen 3 Select Files to Transfer 6 Data transfer is successful if the File Transfer icon has been replaced wit...

Page 37: ...31 System Operation Figure 17 Data Transfer Successful...

Page 38: ...tem 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 18 Download Data...

Page 39: ...ay start up screen tap the File Delete icon to start the data delete process as shown below Figure 19 Start Up Screen Select File Delete Icon 2 Tapping the File Delete icon once will cause the Delete...

Page 40: ...t File Delete Confirm icon 3 Pressing the Check Mark icon will delete all files on the D HH device and pressing the X will return to the previous screen Start Up Screen Select File Delete Icon NOTE On...

Page 41: ...to show Start Up screen 2 Tap the date and time button Figure 21 Start Up Screen Setting Date and Time 3 Date and Time screen will appear Figure 22 Select Set date and enter the appropriate date 4 Sel...

Page 42: ...ime Screen Settings 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 mobile device there is no wa...

Page 43: ...cloth dampened with a cleaning solution taking care to avoid liquid entering open connectors leave reusable sensors connected to the signal processor ensure display charging port cover is fully inser...

Page 44: ...shing liquid detergents dissolve dirt and grease WARNING Protect from exposure to water or any other liquid with or without AC power CAUTION Do not place the device in liquid or clean it with any clea...

Page 45: ...rger supplied by Nonin Medical Model Description Charger H500 PS Power Supply 25W and cable Instructions for Use CO Pilot Manual Operator s Manual for the CO Pilot system Display D HH CO Pilot System...

Page 46: ...ness of 12 5 25 5 mm 0 5 1 0 in 8100SM Measures SpO2 and pulse rate of adult and pediatric patients who are well or poorly perfused during both motion and non motion conditions with digit height thick...

Page 47: ...ensing Reusable Finger Clip Sensor Measures SpO2 COHb MetHb and pulse rate of adult and pediatric patients 66 lbs 30 kg WARNING The use of signal processors sensors accessories and cables other than t...

Page 48: ...ocessor are within the specified operating range and free of obstructions or interference sources Contact Nonin if signal processor is charged and turned on and an error persists Sensor Fault Connect...

Page 49: ...he signal processor is charging Disconnect the signal processor from the charger Signal processor has no lights on inactive Signal processor is long term storage off mode or battery is depleted Try tu...

Page 50: ...OXI 01 SP BLE is not sending critical data Attempt connection 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...

Page 51: ...de USA and Canada Fax 1 763 553 7807 E mail technicalservice nonin com Nonin Medical B V Doctor Paul Janssenweg 150 5026 RH Tilburg The Netherlands E mail technicalserviceintl nonin com www nonin com...

Page 52: ...System includes providing accurate measurements within claimed tolerances or giving indication of abnormal operation Manufacturer s Declaration Refer to the following tables for specific information r...

Page 53: ...onment 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 RF Emissions CISPR 11 Class B Th...

Page 54: ...utput 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...

Page 55: ...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 reco...

Page 56: ...tic 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 co...

Page 57: ...ccording 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...

Page 58: ...rference 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 Re...

Page 59: ...ion 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 a...

Page 60: ...s per 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 Dur...

Page 61: ...rs use a proprietary patented arrangement of light emitters LEDs and light detectors photodiodes This arrangement effectively provides a deep tissue absorption measurement focused on the cerebrum The...

Page 62: ...ange 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 Min...

Page 63: ...operation From a fully charged new battery measuring SpO2 PR COHb and MetHb D HH Charging Time SP BLE Charging Time Approximately 3 hours Approximately 9 hours From critical battery level a This info...

Page 64: ...f QoS ensure that both the display and signal processor are within operating distance of each other and are separated from potentially interfering devices or objects Communication Disruption If the wi...

Page 65: ...sion power of a typical Wi Fi router is about 0 1 Watts and the transmission power of a typical cellular phone is about 0 5 Watts Security The display and signal processor are paired during manufactur...

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