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Nonin CO-Pilot H500, Руководство оператора

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46

Technical Information

Technical Information

NOTE: 

This product complies with ISO 10993, Biological Evaluation of 

Medical Devices Part 1: Evaluation and Testing.

Essential Performance

Essential performance of the CO-Pilot™ Wireless Handheld Multi-Parameter 
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 regarding this device’s 
compliance to IEC 60601-1-2.

CAUTION: 

A functional tester cannot be used to assess the accuracy of 

the display, signal processor or sensor.

CAUTION: 

Portable and mobile RF communications equipment can 

affect medical electrical equipment.

!

!

Содержание CO-Pilot H500

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

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

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 66: ...60 Technical Information THIS PAGE INTENTIONALLY LEFT BLANK...

Страница 67: ...61 Technical Information THIS PAGE INTENTIONALLY LEFT BLANK...

Страница 68: ......

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