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Nonin 7500FO Скачать руководство пользователя страница 37

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Technical Information

Technical Information

NOTE:

This product complies with ISO 10993-1, Biological Evaluation of Medical Devices Part 1:

Evaluation and Testing.

Manufacturer’s Declaration

Essential Performance

Essential Performance of the 7500FO Oximetry System includes SpO2 Accuracy, Pulse Rate
Accuracy, and Limit Alarm Conditions or generation of a Technical Alarm Condition. Accuracies or
alarms may be affected as a result of exposure to electromagnetic disturbances that are outside
of the environments listed in the Indications For Use

.

If issues are experienced, move Nonin

system away from the source of electromagnetic disturbances.

Refer to the following table 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 a pulse

oximeter monitor or sensor.

CAUTION:

All parts and accessories connected to the serial port of this device must

be certified according to at least IEC Standard EN 60950, IEC 62368-1, or UL 1950
for data-processing equipment.

WARNING: Portable RF communications equipment such as cell phones or radios
(including peripherals such as antenna cables and external antennas) should be used
no closer than 30 cm (12 inches) to any part of the ME system, including cables
specified by the manufacturer. Otherwise, degradation of the performance of this
equipment could result.

Table 6. Electromagnetic Emissions

Emissions Test

Compliance

This device is intended for use in the electromagnetic environment specified in the Indications For Use.

The user of this device should ensure that it is used in such an environment.

RF Emissions

CISPR 11

Group 1, Class B

Harmonic Emissions

IEC 61000-3-2

Class A

Voltage Fluctuations/Flicker Emissions

IEC 61000-3-3

Complies with IEC 61000-3-3

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Содержание 7500FO

Страница 1: ...Operator s Manual Model 7500FO Pulse Oximeter English ...

Страница 2: ...cal B V Prins Hendriklaan 26 1075 BD Amsterdam Netherlands 31 0 13 79 99 040 Europe Fax 31 0 13 79 99 042 E mail 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 PureLight and nVISION are registered trademarks or trademarks of Nonin Medical Inc Microsoft and Windows are regist...

Страница 3: ...ults 12 User Defined Defaults 13 Patient Security Mode 13 Viewing and Changing Patient Security Mode 14 Operator Functions 15 Care and Maintenance 18 Cleaning the Model 7500FO 18 Alarms and Limits 19 High Priority Alarms 19 Medium Priority Alarms 19 Watchdog Alarms 19 Informational Tones 19 Alarm Summary 20 Patient Alarms 20 Equipment Alarms 20 Reviewing and Setting Volume and Alarm Limits 21 Revi...

Страница 4: ... Device into a Medical System 26 Parts and Accessories 27 Service Support and Warranty 28 Warranty 28 Troubleshooting 29 Technical Information 31 Manufacturer s Declaration 31 Essential Performance 31 Equipment Response Time 33 Testing Summary 34 SpO2 Accuracy Testing 34 Low Perfusion Testing 34 Principles of Operation 35 Specifications 35 ...

Страница 5: ...iii Figures Figure 1 Model 7500FO Front View 6 ...

Страница 6: ...le 1 Symbols 4 Table 2 Factory Default Settings 12 Table 3 Basic Functions 15 Table 4 Limits Display Sequence 15 Table 5 Advanced Functions 16 Table 6 Electromagnetic Emissions 31 Table 7 Electromagnetic Immunity 32 ...

Страница 7: ...factured to meet the accuracy specifications for Nonin pulse oximeters Using other manufacturers sensors can result in improper pulse oximeter performance To prevent improper performance and or patient injury verify compatibility of the monitor sensor s and accessories before use No modifications to this device are allowed as it may affect device performance Do not use a damaged sensor If the sens...

Страница 8: ...rength of a source might disrupt the performance of this device Medical electrical equipment needs special precautions regarding EMC and all equipment must be installed and put into service according to the EMC information specified in this manual When mounting the monitor to a mobile pole mounting the monitor higher than 1 5 meters 5 feet or mounting more than 2 kilograms 4 5 pounds of equipment ...

Страница 9: ...fect the accuracy of the measurement include the following A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor All parts and accessories connected to the serial port of this device must be certified according to at least IEC Standard EN 60950 IEC 62368 1 or UL 1950 for data processing equipment Operation of this device below the minimum amplitude of 0 3 ...

Страница 10: ... Canada and the United States with respect to electric shock fire and mechanical hazards only in accordance with ANSI AAMI ES60601 1 2005 R 2012 and CAN CSA C22 2 No 60601 1 14 ISO 80601 2 61 2011 IEC 60601 1 8 2006 A1 2012 CE Marking indicating conformance to EC Directive No 93 42 EEC concerning medical devices SN Serial Number Indicates separate collection for electrical and electronic equipment...

Страница 11: ...SpO2 display Pulse Rate Display Numeric LEDs Alarm Bar LED Pulse Quality LED Sensor Alarm LED Pulse Strength Bargraph LED Alarm Silence LED AC Power Adapter LED Low Battery LED ON STANDBY button Alarm Silence button Limits button Plus button Minus button Non ionizing electromagnetic radiation Equipment includes RF transmitters interference may occur in the vicinity of equipment marked with this sy...

Страница 12: ...or accuracy information Pulse Rate Display The pulse rate display is located on the right hand side of the Model 7500FO front panel and is identified by the symbol This display shows the pulse rate in beats per minute from 18 to 321 The numeric displays blink during pulse rate alarm conditions See Specifications for sensor accuracy information NOTE LED means light emitting diode Numeric LEDs Green...

Страница 13: ...nd alarm silence button must be toggled to clear LED WARNING Do not use a damaged sensor If the sensor is damaged in any way discontinue use immediately and replace the sensor Pulse Strength Bargraph LED This 8 segment tricolor bargraph indicates pulse strength as determined by the oximeter The height of the Pulse Strength Bargraph LED is proportional to the pulse signal and the color is determine...

Страница 14: ...tting it into Standby mode In Standby mode all device functions are shut off with the following exceptions The AC Power Adapter LED is lit whenever the device is plugged in Batteries are charged whenever the device is plugged in Momentarily pressing this button while the unit is on initiates an event marker Alarm Silence Button This button toggles alarms between silenced and audible Pressing the A...

Страница 15: ...and Controls Plus and Minus Buttons These buttons adjust values for many Model 7500FO functions The Plus and Minus buttons are used to adjust time date volume and upper and lower alarm limits except in Patient Security mode ...

Страница 16: ...ortant to monitor SpO2 and pulse rate readings Use the following procedure to verify that the sensor is working properly 1 Ensure that the Model 7500FO is on with the sensor connected 2 Apply the pulse oximeter sensor see sensor instructions for use 3 Verify that a good SpO2 reading is displayed that a pulse rate value appears and that the pulse strength bargraph LED is active CAUTION If the devic...

Страница 17: ...contain conductive wires The 7500FO and the connectors for the fiber optic contain ferrous material and must be kept as far away from the magnet as possible at all times WARNING To avoid injury or potential equipment damage always keep the oximeter and metal end of fiber optic cable beyond the distance of magnetic attraction To ensure safe operation of the 7500FO in the MR environment the monitor ...

Страница 18: ...ys allowing the operator to view the current limits Pressing and holding the Plus button also reviews the limits regardless of operating mode Factory Defaults In Factory Defaults all adjustable parameters are set as indicated in the table below This is the Model 7500FO s default operating setting The Model 7500FO is shipped with factory defaults active To revert to factory default alarm limits fro...

Страница 19: ...annot be recalled Clock and calendar data cannot be changed SpO2 and pulse rate alarm limits and volumes cannot be changed Pressing the Limits button allows the operator to review the limits Patient memory cannot be cleared To put the device into Standby mode the ON STANDBY button must be held for at least 3 seconds Memory playback not available Patient Security mode remains active when the device...

Страница 20: ...rning the device on Exit Patient Security Mode With the device off press and hold the Alarm Silence and Limits buttons while turning the device on When the device is restarted the Patient Security mode status is displayed on the Numeric LEDs for 1 second SEC on is displayed when Patient Security mode is enabled SEC 0FF is displayed when Patient Security mode is disabled ...

Страница 21: ...unit is in operating mode Press again to sequence through volume options for pulse tones Set alarm limits or alarm volumes clear memory or set clock Momentarily press the Limits button to step through the Limits menu Use the Plus or Minus buttons to adjust alarm limits or selected volumes as desired When pressing Limits button settings will appear in the order shown in Table 4 CAUTION Review all l...

Страница 22: ...l Alarm Settings is set to yES These are also the settings displayed by Review Alarm Settings 3 The low SpO2 Alarm limit saved for recall cannot be lower than the current default for that alarm limit If it is the default value will be used when alarm limits are restored Table 5 Advanced Functions Function Button Instruction Recall Previous Alarm Limit Settings Press the Limits button while the uni...

Страница 23: ...rity mode press and hold the Alarm Silence and Limits buttons while turning on the device Make Current Alarm Values User defined Defaults To set the User Defined Defaults to the current alarm settings hold the Alarm Silence button and then press the Limits button Revert to Factory Defaults To revert to the factory defaults from the User Defined Defaults alarm limits hold the alarm Silence button a...

Страница 24: ...th water solution Do not pour or spray any liquids onto the Model 7500FO and do not allow any liquid to enter any openings in the device 2 Allow the unit to dry thoroughly before reusing it Clean the Model 7500FO separately from its associated sensors For instructions regarding cleaning pulse oximeter sensors refer to the appropriate pulse oximeter sensor package inserts CAUTION Follow local state...

Страница 25: ...problems with the equipment or other non life threatening situations On the Model 7500FO medium priority alarms are indicated with a slowly blinking amber Alarm Bar LED Medium priority alarms are illuminated amber on the Alarm Bar LED and on the appropriate indicator s or numeric displays sometimes displaying an error code to help the user identify the source of the error Medium priority alarms ar...

Страница 26: ...d Alarm Bar LED Equipment Alarms Alarm Description Factory Default Adjustment Options Increment SpO2 High Alarm Limit Off Off 80 100 1 SpO2 Low Alarm Limit 85 Off 50 95 1 Pulse Rate High Alarm Limit 200 BPM Off 75 275 5 BPM Pulse Rate Low Alarm Limit 50 BPM Off 30 110 5 BPM Low Perfusion Alarm Red segment on Pulse Strength Bargraph indicates low pulse amplitude Alarm Description Visual Indicator L...

Страница 27: ...ue press the Plus or Minus buttons as desired 4 Continue to press the Limits button until the unit returns to normal operation Silencing Alarms Press the Alarm Silence button to silence alarms for two minutes The Alarm Silence LED blinks at the medium priority alarm rate while alarms are temporarily silenced If alarms are silenced during active alarm conditions the Alarm Silence LED blinks in time...

Страница 28: ...imits button again to accept the recall and return to normal operation NOTE The recalled value for the SpO2 low alarm will not be less than the current default Error Codes This device includes error codes that indicate problems with the unit Error codes are indicated by Err in the SpO2 display and a capital E followed by a 2 digit code in the pulse rate display To correct error conditions perform ...

Страница 29: ...7500 SC cable available from Nonin may be used to connect the Model 7500FO to the receiving computer The information from the Model 7500FO is sent in an ASCII serial format at 9600 baud with 8 data bits 1 start bit and 2 stop bits Each line is terminated by CR LF Data from the device are sent once per second in the following format SPO2 XXX HR YYY NOTE Pressing the ON STANDBY button will insert a ...

Страница 30: ...signal sequence is as follows Output Specification SpO2 Output Analog Range 0 1 0 VDC representing 0 100 1 27 VDC out of track Pulse Rate Output Analog Range 0 1 0 VDC representing 0 300 BPM 1 27 VDC out of track Event Marker 0 VDC or 1 0 VDC nominal representing an event Event marker high for SpO2 less than low alarm limit Analog Output Load Current 2 mA maximum SpO2 Analog Output Accuracy 2 Puls...

Страница 31: ...Patient data is retained even when both external and battery power are lost Clearing Patient Memory Patient memory can be cleared using the Model 7500FO s Setup mode Press the Limits button to enter Setup mode and use the Limits button again to scroll through the device s options until Memory Clear is displayed Select Yes or No using the Plus or Minus buttons to clear patient memory and then confi...

Страница 32: ... the system configuration Adding devices to or disconnecting devices from the system Updating or upgrading equipment connected to the system Issues resulting from user initiated system changes may include corruption or loss of data NOTES Use of a multiple socket outlet with multiple devices results in a Medical Electrical System When using the serial port to connect the device to other equipment f...

Страница 33: ...South America 7600PCS AU Power cord Australia 7600PCS JP Power cord Japan Pulse Oximeter Reusable Sensors 8000FC Adult Fiber Optic Pulse Oximeter Sensor 8000FI Infant Pediatric Fiber Optic Pulse Oximeter Sensor External Cables 7500SC 7500 serial output cable Sensor Accessories 8000FW Adult Sensor Wrap 8000TW Infant Pediatric Sensor Wrap Other Accessories nVISION nVISION software for Microsoft Wind...

Страница 34: ...nin s place of business Nonin reserves the right to charge a fee for a warranty repair request on any Model 7500FO that is found to be within specifications The Model 7500FO is a precision electronic instrument and must be repaired by Nonin Technical Service Accordingly any sign or evidence of opening the Model 7500FO field service by non authorized personnel tampering or any kind of misuse or abu...

Страница 35: ...seconds Warm the patient s finger by rubbing or covering with a blanket Position the sensor at a different site Circulation is reduced because of excess pressure on the sensor between the sensor and a hard surface after inserting finger Allow the hand to rest comfortably without squeezing or pressing the sensor on a hard surface The finger is cold Warm the patient s finger by rubbing or covering w...

Страница 36: ...sor at different site The finger was removed from the sensor Reinsert the finger and keep the sensor motionless for at least 10 seconds The Model 7500FO is not functioning Turn the unit off check all connections and retry Contact Nonin Technical Service An error code appears in the display area The Model 7500FO encountered an error Turn the unit off and then back on again to remove the error code ...

Страница 37: ...to assess the accuracy of a pulse oximeter monitor or sensor CAUTION All parts and accessories connected to the serial port of this device must be certified according to at least IEC Standard EN 60950 IEC 62368 1 or UL 1950 for data processing equipment WARNING Portable RF communications equipment such as cell phones or radios including peripherals such as antenna cables and external antennas shou...

Страница 38: ...ns and voltage variations on power supply input lines IEC 61000 4 11 0 UT for 0 5 Cycles at 50 Hz at 0 45 90 135 180 225 and 315 Phase 0 UT for 1 Cycle at 50 at 0 Phase 70 UT for 25 Cycles at 50 Hz at 0 Phase 0 UT for 250 cycles at 50 Hz at 0 Phase Power Frequency 50 60 Hz Magnetic Field IEC 61000 4 8 30 A m Conducted RF IEC 61000 4 6 150 kHz to 80 MHz 3 Vrms ISM and Amateur radio bands between 15...

Страница 39: ...lues freeze for 10 seconds and are then replaced with dashes SpO2 Values Average Latency Standard Fast Averaged SpO2 4 beat exponential 2 beats Pulse Rate Values Response Latency Standard Fast Averaged Pulse Rate 4 beat exponential 2 beats Equipment Delays Delay Display Update Delay 1 5 seconds Alarm Signal Generation Delay 0 seconds ...

Страница 40: ...in oxygen SaO2 value determined from blood samples with a laboratory co oximeter The accuracy of the sensors in comparison to the co oximeter samples measured over the SpO2 range of 70 100 Accuracy data is calculated using the root mean squared Arms value for all subjects per ISO 80601 2 61 Medical Electrical Equipment Particular requirements for the basic safety and essential performance of pulse...

Страница 41: ...ph LED bargraph tri color segments Alarm Indicator LED bi color Alarm Silenced LED amber Numeric Displays 3 digit 7 segment LEDs green Low Battery LED amber SpO2 Accuracy Arms a FO Sensor 70 100 2 digits Pulse Rate Accuracy Arms a No Motion 3 digits 18 300 BPM Low Perfusion 3 digits 40 240 BPM Alarm Volume High Low 75 dBA 64 dBA Informational Tone Volume High Low 30 dBA 26 dBA Measurement Waveleng...

Страница 42: ...um Recharge Rate 4 hours maximum Dimensions Approximately 219 mm 8 6 W x 92 mm 3 6 H x 142 mm 5 6 D Weight Approximately 900 grams 2 lbs with battery Warranty 3 years Classification per ANSI AAMI ES60601 1 and CAN CSA 22 2 No 60101 1 Type of Protection Internally powered on battery power Degree of Protection Type BF Applied Part Mode of Operation Continuous Enclosure Degree of Ingress Protection I...

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