Nonin 7500FO User Manual
Contents
1. Li nenin Parts and Accessories The following NONIN accessories function with the Model 7500FO Detailed information regarding specified sensor use patient population body tissue and application can be found in the respective sensor instructions Model Number Description AvantB Battery Pack 7500FO Manual Operator s Manual for the Model 7500FO 300PS UNIV Battery Charger Universal Desktop with IEC320 Connector Cord Set Charger must not exceed 2 meters Pulse Oximeter Reusable Sensors 8000FC Adult Fiber Optic Pulse Oximeter Sensor 8000F1 Infant Pediatric Fiber Optic Pulse Oximeter Sensor External Cables 7500 SC 7500 serial output cable 7500A 7500 analog output cable unterminated Sensor Accessories 8000FW Adult Sensor Wrap 8000TW Infant Pediatric Sensor Wrap Other Accessories nVISION nVISION software for Microsoft Windows 95 98 2000 NT 4 0 XP operating systems Avant PC Pole Mount Clamp Contact your distributor or NONIN for options 30 Wiwonin For more information about NONIN parts and accessories contact your distributor or contact NONIN at 800 356 8874 USA and Canada or 763 553 9968 This information is also available on the NONIN website www nonin com WARNING The use of accessories sensors and cables other than those listed in this manual may result in increased electromagnetic emission and or decreased immunity of this device WARNING Use only NONIN br2. A dash appears in the SpO2 display An inadequate signal from the finger is being detected Reposition finger or insert a different finger keeping sensor motionless for at least 10 seconds Position sensor 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 If the error persists disconnect all power and then reconnect the power and turn the unit back on If the error still persists note the error code and contact NONIN Technical Service 36 Wiwonin Problem Possible Cause Possible Solution The unit is in Alarm mode but no audible alarms can be heard The 2 minute Alarm Silence button is activated Press the Alarm Silence button to re engage alarm volume or wait for two minutes After two minutes alarm tones will automatically re engage Audible volume set to o F F in alarm limits Adjust volume through setup mode The Model 7500FO does not record data The battery is low Recharge the battery The battery is missing Contact your distribu
3. gt 14 Setup Mode Viewing Limits and Setting Time 14 Factory Defaults reseter trnstrtenneeerren nne 14 User Defined Defaults 15 Patient Security Mode ne 15 Operator Functions ri 17 Care and Maintenance iii 21 Cleaning the Model 7500FO AA 21 Alarms and Limits aacciiai ia 22 High Priority Alarms iaia ae 22 Medium Priority Alarms 22 Watchdog Alarms i 22 Informational TOES iii aaan 22 Alarm Summary cioe glia e 23 Reviewing and Setting Volume and Alarm Limits 24 Reviewing Setting or Changing Volumes and Alarm Limits 24 Silencing TEEN 24 Recalling Previous Settings 25 ETTOr COGS Li iano 25 Memory and Data Output Features 26 Serial Patient Data Output i 26 Ee e BA LEE 27 Memory Features nnne 28 Parts and Accessories rr 30 Service Support and Warranty 32 VIE LE VAR E E ede kee 33 Troubleshooting riiiiii 34 Wimonin Technical Information iii 38 Manufacturer s Declaration rn rererrren re 38 Equipment Response Time 42 Testing SUMMAN usi alal 43 SPECINCALONS eenaa ono aaa Ainaa 44 Wiwonin Guide to Symbols
4. Possible Cause Possible Solution Unable to obtain a green pulse display on the bargraph cont d The sensor is applied incorrectly Apply the sensor correctly There is possible interference from one of the following sources e arterial catheter blood pressure cuff electrosurgical procedure infusion line Reduce or eliminate any interference Make sure that the sensor is not placed on the same arm being used for other patient therapies or diagnostics e g blood pressure cuff The red LED is not lit in the sensor s finger insertion area Ensure the sensor is securely attached to the Model 7500FO Check the sensor for any visible signs of deterioration Contact NONIN Technical Service Frequent or steady pulse quality indication There is excessive ambient light Shield the sensor from the light source The Model 7500FO is applied to a polished or artificial fingernail Apply the sensor to a finger without artificial or polished nails Position the sensor at a different site The red LED is not lit in the sensor s finger insertion area Ensure the sensor is securely attached to the Model 7500FO Check the sensor for any visible signs of deterioration Contact NONIN Technical Service Excessive patient motion Reduce patient motion Li nenin Problem Possible Cause Possible Solution
5. Low 52dBA Informational Tone Volume High 30dBA Low 26dBA Red Infrared Measurement Wavelengths and Output Power b 660 nm 0 8 mW maximum average 910 nm 1 2 mW maximum average Memory 70 hours assuming continuous operation Temperature Operating Temperature Storage Transportation 0 to 40 C 32 F to 104 F 30 to 50 C 22 F to 122 F Humidity Operating Humidity Storage Transportation 10 to 90 noncondensing 10 to 95 noncondensing Altitude Operating Hyperbaric Pressure Up to 12 000 meters 40 000 feet Up to 4 atmospheres Power Requirements Mains 100 240 VAC 50 60 Hz DC Input 12 VDC 1 5A AC adapter in MR use battery operation only Internal Power Battery Operating Life fully charged battery Storage Life Recharge Rate 7 2 volt NiMH battery pack 30 hours minimum when 5V 250 mA accessory power supply is not used 10 hours when 5V 250 mA accessory power supply is used 27 days minimum 4 hours maximum 44 a 1 Arms represents approximately 68 of measurements b This information is especially useful for clinicians performing photodynamic therapy Wiwonin Dimensions Approximately 219 mm 8 6 W x 92 mm 3 6 H x 142 mm 5 6 D Weight Approximately 900 grams 2 Ibs with battery Warranty 3 years Classification per IEC 60601 1 CSA601 1 UL60601 1 30EM Type of Protectio
6. This table describes the symbols that are found on the Model 7500FO Detailed information about functional symbols can be found in Operating the Model 7500FO Symbol Description Caution Consult Instructions for Use Type BF Applied Part Patient isolation from electrical shock Magnetic Resonance MR Conditional P eHe Magnetic Resonance MR Unsafe SIE 6 ae UL Mark for Canada and the United States with respect to electric shock fire and mechanical hazards only in accordance with UL 60601 1 and CAN CSA C22 2 No 601 1 0123 CH Ia CE Marking indicating conformance to EC directive No 93 42 EEC concerning medical devices Serial Number Indicates separate collection for electrical and electronic equipment WEEE Authorized Representative in the European Community Mm zag Protected against vertically falling water drops when enclosure is tilted up to 15 degrees per IEC 60529 SpO gt SpO display 9 Pulse Rate Display HHH Numeric LEDs Li nonin Description 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 0006006 LI SRC mm Wl gt e Non ionizing electromagn
7. Uy gt 95 dip in Uz should be that of a typical interruptions and for 9 5 cycle for 0 5 cycle commercial or hospital voltage 40 Ur 40 Ur environment Ifthe user of variations on FARE MO the device requires power supply 60 dip in Ur 60 dip in Ur continued operation input lines for 5 cycles for 5 cycles during power mains IEC 61000 4 11 70 Ur 70 UT interruptions it is 30 dip in Uy for 25 cycles 30 dip in Uy for 25 cycles recommended that the device be powered from an uninterruptible power lt 5 Uy lt 5 Ur o S supply or battery pack gt 95 dip in Ut gt 95 dip in Ur for 5 sec for 5 sec Power 3 A m 3 A m Power frequency Frequency magnetic fields should be 50 60 Hz at levels characteristic of Magnetic Field a typical location in a IEC 61000 4 8 typical commercial or hospital environment Note U7 is the AC mains voltage before application of the test level 39 Li nenin Table 4 Guidance and Manufacturer s Declaration Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance This device is intended for use in the electromagnetic environment specified below The user of this device should ensure that it is used in such an environment equation applicab Portable and mobile RF communications equipment should be used no closer to any part of the de
8. or repair the electronics Opening the case may damage the device and void the warranty When operating in an MR environment securely fasten this device to a non movable pole mount or other large object and keep it as far from the magnetic field as possible For magnetic equipment with a magnetic strength of 1 5T or less the device must be a minimum of 2 meters away from the magnet The fiber cable for this device is extremely sensitive and must be handled with caution at all times Do not use a damaged sensor To avoid injury or potential equipment damage always keep the oximeter battery charger 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 must be located outside the 200 Gauss line of the MR room and must be firmly attached to a fixed object When audible alarms cannot be heard due to ambient noise visible alarms must be used A Cautions This equipment complies with IEC 60601 1 2 2001 for electromagnetic compatibility for medical electrical equipment and or systems This standard is designed to provide reasonable protection against harmful interference in a typical medical installation However because of the proliferation of radio frequency transmitting equipment and other sources of electrical noise in healthcare and other environments it is possible that high levels of such interference due to close
9. per minute in the interval from 201 to 300 pulses per minute 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 confirm your selection using the Limits button 28 Wiwonin Playing Back Memory Data The Model 7500FO has a Memory Playback feature allowing stored data to be output through an external serial connection Playing back the data does not clear the data from memory 1 With the unitoff connect the serial connector port of the Model 7500FO to the back of your computer using the 7500 SC cable which is available from NONIN 2 Press and hold the Plus button while briefly pressing the ON STANDBY button 3 Release the Plus button Playback mode will be shown on the SpO and Pulse Rate displays until memory playback is completed 4 When Memory Playback is complete the device will return to normal operation NOTES e Patient memory cannot be cleared when the Model 7500FO is in Patient Security mode If using nVISION software select the Model 2500 option for model type the Model 2500 option also applies to the Model 7500FO 29
10. the device e Ifinterference is suspected to the MR image or to the 7500FO contact NONIN Technical Service at 800 356 8874 or 763 553 9968 for assistance When operating the 7500FO inside the MR environment operate the Gei 7500FO on battery power only Remove the 7500FO from the MR environment to recharge the batteries when the pulse oximeter is not in use 13 Li NONIN Operating Modes and Defaults The Model 7500FO features Setup mode Factory Defaults User Defined Defaults and Patient Security modes NOTE Patient Security mode overrides any default settings Setup Mode Viewing Limits and Setting Time In Setup mode users can adjust alarm limits and volumes set clock and calendar information and clear the device s memory Pressing the Limits button activates Setup mode and all adjustments can be made using the Plus or Minus buttons Setup mode is available when the device is operating or during the startup initialization process Time is set by adjusting each of the last five options in setup mode year month day hour and minute Setup mode is not available in Patient Security mode In Patient Security mode pressing the Limits button scrolls through the limits on the displays 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 param
11. ANTIES OF ANY KIND WHETHER STATUTORY WRITTEN ORAL OR IMPLIED INCLUDING WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE OR MERCHANTABILITY SHALL APPLY 33 Li neonin Troubleshooting Problem Possible Cause Possible Solution Model 7500FO will not activate The unit has no power Plug in the AC adapter Model 7500FO will not operate on batteries The battery pack is not charged Plug in the Model 7500FO AC Adapter to charge the battery pack The battery pack is inoperable Contact NONIN Technical Service for repair or replacement Unable to obtain a green pulse display on the bargraph NOTE In some instances patient perfusion may be inadequate for pulse detection The patient pulse strength is indiscernable or perfused poorly Reposition the finger or insert a different finger and keep the sensor motionless for at least 10 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 with a blanket Position the sensor at a different site 34 Wiwonin Problem
12. DC 1 second 0 4 VDC 1 second 0 5 VDC 1 second 0 6 VDC 1 second 0 7 VDC 1 second 0 8 VDC 1 second 0 9 VDC 1 second 1 0 VDC 1 second 1 27 VDC Repeat 27 Li nenin Memory Features The Model 7500FO can collect and store 70 hours of continuous SpO and pulse rate information Data may be played back with data retrieval software NONIN s nVISION software is recommended If you wish to create your own software contact NONIN for the data format The memory in the Model 7500FO functions much like an endless loop tape When the memory is full the unit begins overwriting the oldest data with new data CAUTION Data is written in four minute intervals so if the entire memory is filled portions of the oldest record will be overwritten when a new record begins Each time the Model 7500FO is turned on the current time date information if the clock is set properly is stored in memory starting a new recording session Only recording sessions greater than one minute in length are stored in memory Patient SpO and pulse rate are sampled every second Every 4 seconds the extreme value of the 4 second sample period is stored Oxygen saturation values are stored in 1 increments in the range of 0 to 100 The stored pulse rate ranges from 18 to 300 pulses per minute The stored values are in increments of one pulse per minute in the interval from 18 to 200 pulses per minute and in increments of 2 pulses
13. EC on is displayed in the display area and three informational tones sound The upper alarm limits are then displayed followed by the lower alarm limits NOTE Patient memory cannot be cleared when this device is in Patient Security mode In addition Patient Security mode is not disabled when the unit is turned off Viewing and Changing Patient Security Mode To enter Patient Security mode press and hold the Alarm Silence button while turning on the device To exit Patient Security mode press and hold the Alarm Silence and Limits buttons while turning on the device 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 e GEC of F is displayed when Patient Security mode is disabled 16 Wiwonin Operator Functions The Model 7500FO has several easy to use basic functions Most involve pressing only a single button Function Button Instruction Turn the Model 7500FO on and off Press the ON STANDBY button to turn on the Model 7500FO Press and hold the button for at least one second to turn off the Model 7500FO In Patient Security mode hold the ON STANDBY button for three seconds to turn off the Model 7500FO Initiate an event marker Momentarily press the ON STANDBY button while the unit is on Mute the audible alarms 2 minutes Momentarily press
14. WI NONIN Operator s Manual Model 7500FO Digital Pulse Oximeter C Go English CAUTION Federal law USA restricts this device to sale by or on the order of a licensed practitioner BR Consult Instructions for Use NONIN reserves the right to make changes and improvements to this manual and the products it describes at any time without notice or obligation Nonin Medical Inc 13700 1st Avenue North Plymouth Minnesota 55441 5443 USA 1 763 553 9968 800 356 8874 USA and Canada Fax 1 763 553 7807 mail nonin com www nonin com Authorized EC Representative MPS Medical Product Service GmbH Borngasse 20 D 35619 Braunfels Germany References to NONIN in this manual shall imply Nonin Medical Inc NONIN Flexi Form FlexiWrap PureLight and nVISION are registered trademarks or trademarks of Nonin Medical Inc Microsoft and Windows are registered trademarks of Microsoft Corporation 2007 NONIN Medical Inc 5934 001 03 LC NONIN Contents Guide to Symbols i 1 Indications for Use 3 Contraindicatlons cicia re 3 UCI EE 3 CAUTIONS saath sailing 4 Displays Indicators and Controls 7 Operating the Model 7500FO 11 Operating Instructions rrriiinn 12 Operating in the MR Environment sses 12 Operating Modes and Defaults
15. anded PureLight pulse oximeter sensors These sensors are manufactured to meet the accuracy specifications for NONIN pulse oximeters Using other manufacturers sensors can result in improper pulse oximeter performance CAUTION Use the Model 7500FO only with power adapters supplied by NONIN Medical When using the 300PS UNIV battery charger ensure that the AC cord is plugged into a grounded outlet 31 Limwonin Service Support and Warranty A return authorization number is required before returning any product to NONIN To obtain this return authorization number contact NONIN Technical Service Nonin Medical Inc 13700 1st Avenue North Plymouth Minnesota 55441 5443 USA 800 356 8874 USA and Canada 1 763 553 9968 outside USA amp Canada Fax 1 763 553 7807 E mail mail nonin com www nonin com WARNING This device is a precision electronic instrument and must be repaired by qualified technical professionals Field repair of the device is not possible Do not attempt to open the case or repair the electronics Opening the case may damage the device and void the warranty 32 Wiwonin Warranty NONIN MEDICAL INCORPORATED NONIN warrants to the purchaser for a period of one year from the date of purchase each Model 7500FO battery pack NONIN warrants the pulse oximetry module of the Model 7500FO for a period of three years from the date of purchase Extended warranties are availabl
16. arms 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 with the alarm bar The Alarm Silence LED will be lit solidly when the alarm volume is set to less than 45 dB Audible indicators can be turned off in the Limits menu by selecting QF F in the corresponding Alarm Volume menu option 24 Linonin Recalling Previous Settings The digital pulse oximeter includes a feature that allows recall of the operator adjusted settings in use when the device was last turned off The following settings are recalled when this feature is activated e SpOz high and low alarm limits e Pulse rate high and low alarm limits e Alarm volume settings Previous operator adjusted settings can be recalled by pressing the Limits button while the unit is on e C L appears indicating that previous alarm limit settings may be recalled To recall the settings press the Plus button and select 4 Press the Limits button again to accept the recall and return to normal operation A CAUTION Review all limits to ensure they are appropriate for the patient NOTE The recalled value for the SpO low alarm will not be less than the current default Error Codes This device includes error codes that indicate problems wit
17. d battery power are lost Patient Security Mode Alarm limits cannot be changed when the Model 7500FO is in Patient Security mode Patient Security mode prevents accidental changes to critical parameters The Model 7500FO allows users to lock and unlock alarm limits volume settings and time settings through the use of Patient Security mode Operators will notice several operating differences with Patient Security mode Default and other previous device settings cannot be recalled e Clock and calendar data cannot be changed e SpO and pulse rate alarm limits and volumes cannot be changed Pressing the Limits button allows the operator to review the limits e Patient memory cannot be cleared e To put the device into Standby mode the ON STANDBY button must be held for at least 3 seconds e Memory playback not available Patient Security mode remains active when the device is turned off and then turned back on Patient Security mode is retained even when both external and battery power are lost NOTE Turn on the device and verify Patient Security mode and settings after initiating Patient Security mode 15 Li nonin When the Patient Security mode is enabled operators cannot change SpOz or Pulse Rate limits or Alarm Volume though it is still possible to view those settings In Patient Security mode operators cannot view or set the time and date When the Model 7500FO is turned on in Patient Security mode G
18. damage the Model 7500FO and void the warranty If the Model 7500FO is not functioning properly see Troubleshooting CAUTION Follow local state and national governing ordinances and recycling instructions regarding disposal or recycling of the device and device components including batteries Use only NONIN approved bat tery packs Batteries might leak or explode if used or disposed of improp erly Cleaning the Model 7500FO Clean the Model 7500FO with a soft cloth dampened with isopropyl alcohol mild detergent or a 10 bleach 5 25 sodium hypochlorite with 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 Allow the unit to dry thoroughly before reusing it WARNING Do not use this device in or around water or any other liquid with or without AC power CAUTION Do not immerse this device in liquid and do not use caustic or abrasive cleaning agents on the device Do not gas sterilize or autoclave this device Do not place liquids on top of this device 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 21 Li nonin Alarms and Limits The Model 7500FO is equipped with audio and visual alarm indicators to alert the operator to provide immediate patient attention or to abn
19. e is suitable for use in all CISPR 11 establishments including domestic and those directly connected to the Harmonic Emissions N A e IEC 61000 3 2 public low voltage power supply network that supplies buildings used Voltage Fluctuations N A for domestic purposes Flicker Emissions IEC 61000 3 3 38 Wiwonin Table 3 Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance This device is intended for use in the The user of this device should ensure that it is used electromagnetic environment specified below in such an environment Electrostatic Discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical Fast 2 kV for power 2 kV for power Mains power quality Transient Burst supply lines supply lines should be that of a typical IEC 61000 4 4 1 kV for input 1 kV for input commercial or hospital output lines output lines environment Surge 1 kV differential 1 kV differential Mains power quality IEC 61000 4 5 mode mode should be that of a typical 2 kV common 2 kV common commercial or hospital mode mode environment Voltage dips 5 UT 5 UT Mains power quality short gt 95 dip in
20. e on most NONIN pulse oximeter models Please consult your local NONIN distributor for additional information NONIN shall repair or replace any Model 7500FO 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 notification occurs within the applicable warranty period This warranty shall be the sole and exclusive remedy by the purchaser hereunder for any Model 7500FO delivered to the purchaser which is found to be defective in any manner whether such remedies be in contract tort or by law This warranty excludes cost of delivery to and from NONIN All repaired units shall be received by the purchaser at NONIN 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 7500F0O is a precision electronic instrument and must be repaired by qualified technical professionals Accordingly any sign or evidence of opening the Model 7500FO field service by non authorized personnel tampering or any kind of misuse or abuse of the Model 7500FO 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 SET FORTH IN THIS MANUAL ARE EXCLUSIVE AND NO OTHER WARR
21. eters 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 from the user defined default alarm limits simultaneously press the alarm silence and minus buttons NOTE User Defined Default values are lost when Factory Defaults are set active Factory Adjustment Alarm Limit Default Options Increment SpO2 High Alarm Limit Off Off 80 100 1 SpO gt 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 Alarm Volume High Off Low High N A Default alarm and volume settings are automatically selected for every operating session in which the parameters were not recalled or changed within the setup menu 14 Wiwonin User Defined Defaults In User Defined Defaults alarm limit and volume settings must be adjusted To set the User Defined Defaults set the alarm limits hold the Alarm Silence button and then press the Limits button This sets the User Defined Defaults to be the same as the current alarm limits The Model 7500FO recalls User Defined Default settings at startup whenever this option is selected Once activated User Defined Defaults have priority over Factory Defaults NOTE All user defined default settings are retained even when both external an
22. etic radiation Equipment includes RF transmitters interference may occur in the vicinity of equipment marked with this symbol AS De da YK Wiwonin Indications for Use The NONIN Model 7500FO Digital Pulse Oximeter is a portable tabletop device indicated for use in simultaneously measuring displaying and recording functional oxygen saturation of arterial hemoglobin SpO and pulse rate of adult pediatric and infant patients in an Magnetic Resonance MR environment while operating on battery power alone Testing was performed in MR conditional environments at 1 5T and 3T It is intended for spot checking and or continuous monitoring of patients who are well or poorly perfused Contraindications Explosion Hazard Do not use in an explosive atmosphere or in the presence of flammable anesthetics or gasses e This device is not defibrillation proof per IEC 60601 1 1990 clause 17h The battery charger cannot be used in the MR environment Warnings This device is intended only as an adjunct device in patient assessment It must be used in conjunction with other methods of assessing clinical signs and symptoms Oximeter readings of this device may be affected by the use of an electrosurgical unit ESU Use only NONIN branded PureLight pulse oximeter sensors These sensors are manufactured to meet the accuracy specifications for NONIN pulse oximeters Using other manufactu
23. h the unit Error codes are indicated by E in the SpO display and a captial E followed by a 2 digit code in the pulse rate display To correct error conditions perform the following steps 1 Turn the unit off and then back on again to remove the error code 2 Ifthe error persists disconnect all power and then reconnect the power and turn the unit back on If the error still persists note the error code and contact NONIN Technical Service at 800 356 8874 USA and Canada or 1 763 553 9968 25 Li nonin Memory and Data Output Features The Model 7500FO provides real time serial patient data output as well as analog output signals for SpO pulse rate and event markers Serial Patient Data Output This device features real time data output capabilities The serial format includes an ASCII header containing model number time and date information The device provides real time data output capability via the serial connector port The 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 SPO XXX HR YYY NOTE Pressing the ON STANDBY button will insert a at the end of the corresponding printed line to ser
24. ical parameters The Model 7500FO allows users to lock and unlock alarm limits volume settings and time settings Enter Patient Security Mode De To enter Patient Security mode press and hold the Alarm Silence button while turning on the device Exit Patient Security Mode CY 6 To exit Patient Security mode press and hold the Alarm Silence and Limits buttons while turning on the device 19 Li nenin Function Button Instruction Make Current Alarm Values User defined To set the User Defined Defaults to the current alarm settings hold the Alarm Silence button and then press the Limits ooe 6 Defaults button Revert to To revert to the factory defaults from the Factory User Defined Defaults alarm limits hold Defaults the alarm Silence button and then press the Minus button NOTE User defined default values will be lost when factory defaults are made active La CAUTION Review all limits to ensure they are appropriate for the patient 20 Linonin Care and Maintenance The advanced digital circuitry within the pulse oximeter of the Model 7500FO requires no calibration or periodic maintenance other than battery replacement by qualified technical professionals Field repair of the Model 7500FO circuitry is not possible Do not attempt to open the Model 7500FO case or repair the electronics Opening the case may
25. ically single beeps or a series of three beeps Informational tones include the startup initialization tone and the pulse rate tone which changes in pitch with SpO values higher tones for higher SpO gt and lower tones for lower SpOp 22 Wiwonin Alarm Summary The Model 7500FO detects both patient and equipment alarms In general patient alarms are identified as high priority while equipment alarms are identified as medium priority High priority alarms always take priority over medium priority alarms Alarm indicators remain active for as long as the alarm condition is present Patient Alarms If patient SpO or pulse readings are equal to or above the upper alarm limit or if they are equal to or below the lower alarm limit the device will signal a high priority alarm indicated by numeric LEDs flashing in sync with the red Alarm Bar LED Factory Adjustment Alarm Description Default Options Increment SpO gt High Alarm Limit Off Off 80 100 1 SpO 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 Equipment Alarms Visual Indicator Battery LED blinks in sync with Alarm Bar LED This alarm signifies that the battery has less than 30 minutes of normal operation When Critical Low Battery is reached the de
26. l hemoglobin saturation value SpO of the sensors is compared to arterial hemoglobin oxygen SaOz 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 SpOo range of 70 100 Accuracy data is calculated using the root mean squared Arms Value for all subjects per ISO 9919 2005 Medical Electrical Equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use Low Perfusion Testing This test uses an SpO Simulator to provide a simulated pulse rate with adjustable amplitude settings at various SpO levels for the oximeter to read The oximeter must maintain accuracy in accordance with ISO 9919 2005 for heart rate and SpO at the lowest obtainable pulse amplitude 0 3 modulation 43 Li nenin Specifications Oxygen Saturation Display Range 0 to 100 SpO2 Pulse Rate Display Range 18 to 321 pulses per minute BPM Displays Pulse Quality LED amber Sensor Alarm LED amber Pulse Strength Bargraph 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 SpO Accuracy Ayms FO Sensor 70 100 2 digits Pulse Rate Accuracy A ms No Motion 3 digits 18 300 BPM Low Perfusion 3 digits 40 240 BPM Alarm Volume High 63dBA
27. lowing safety considerations Use only NONIN branded 8000FC or 8000FI Fiber Optic Sensors Do Gei not use cables or sensors that 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 must be located outside the 200 Gauss line of the MR room and must be firmly attached to a fixed object MR Conditions MR OPERATIONS USE ONLY NONIN Fiber Optic Sensors Sensors containing electrical conductors will cause patient burns The Model 7500FO must be kept outside the 200 Gauss line of the MR field and affixed to an immovable object Do not place on MR bed 5682 000 04 MR environment Gei CONTRAINDICATION The battery charger cannot be used in the When operating the 7500FO in the MR environment observe the following installation recommendations 12 Wiwonin e Install the 7500FO in the MR environment near the observation window or outside the MR environment so the displayed values on the pulse oximeter may be clearly viewed The 7500FO monitor must also be firmly attached to a fixed object using the mounting hole 1 4 20 thread on the bottom of
28. mory clear command dE L will be displayed only if Y amp 5 was selected as the setting for the C L parameter 2 These parameters are restored when Recall Alarm Settings is set to yE 5 These are also the settings displayed by Review Alarm Settings 3 The low SpO 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 18 Wiwonin The Model 7500FO features a number of advanced options which are intentionally more difficult to activate These functions are recommended only for trained operators and require multiple button presses to prevent accidental activation Function Button Instruction Recall Previous Press the Limits button while the unit is on Alarm Limit CL appears indicating that previous Settings alarm limit settings may be recalled To recall the settings press the Plus button and select YES Press the Limits button again to confirm Memory Press and hold the Plus button while Playback turning on the Model 7500FO This 006 functions with the NONIN nVISION software Select the Model 2500 option in nVISION software the Model 2500 option also applies to the Model 7500FO NOTE Alarm limits cannot be changed when the Model 7500FO is in Patient Security mode Patient Security mode prevents accidental changes to crit
29. n Internally powered on battery power Class with AC adapter Degree of Protection Type BF Applied Part Mode of Operation Continuous Enclosure Degree of Ingress Protection IPX2 Analog Outputs SpO Output Range 0 1 VDC 0 100 SpO _ 1 27 VDC no data Pulse Rate Output Range 0 1 VDC 0 300 BPM 1 27 VDC no data Event Maker 0 V no event 1 V event occurred Accuracy 2 SpO2 5 Pulse Rate Load Current 2 mA maximum 45
30. n the location in which the device is used exceeds the applicable RF compliance level above the device should be observed to verify normal opera tion If abnormal performance is observed additional measures may be neces sary such as reorienting or relocating the device b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 40 Wiwonin Table 5 Recommended Separation Distances This table details the recommended separation distances between portable and mobile RF communications equipment and this device This device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled Users of this device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment transmitters and the device as recommended below according to maximum output power of the communications equipment Separation Distance According to Frequency of Transmitter ni sii 150 kHz to 80 MHz to 800 MHz to 2 5 GHz utput Power o 80 MHz 800 MHz S Transmitter W d mb Gee d 2 33 P 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 TA 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 the transmitter where P i
31. nsors Follow local state and national governing ordinances and recycling instructions regarding disposal or recycling of the device and device components including batteries Use only NONIN approved battery packs When using the 300PS UNIV battery charger ensure that the AC cord is plugged into a grounded outlet In compliance with the European Directive on Waste Electrical and Electronic Equipment WEEE 2002 96 EC do not dispose of this product as unsorted municipal 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 To prevent potential loss of monitoring or inaccurate data remove any objects that might hinder pulse detection and measurement e g blood pressure cuffs Data is written in four minute intervals so if the entire memory is filled portions of the oldest record will be overwritten when a new record begins Li nonin A Cautions Continued e This device is designed to determine the percentage of arterial oxygen saturation of functional hemoglobin Factors that may degrade pulse oximeter performance or affect the accuracy of the measurement include the following excessive ambient light excessive motion electrosurgical interference blood flow restrictors arterial catheters blood press
32. onditions See Specifications for sensor accuracy information Li nonin 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 Wi 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 numeric LEDs display SpO and pulse rate values When setting the device these LEDs also display values for alarm limits volume and date and time settings co m man 10 KM LI LI m Cam Indicators and Icons Alarm Bar LED This LED indicates all alarm conditions For high priority patient alarms the indicator is displayed in red blinking fast For medium priority alarms the indicator is displayed in amber blinking slowly Pulse Quality LED A This amber LED blinks to indicate an inadequate pulse signal If there is a sustained period of poor quality signals this LED will display a steady constant light 2 Sensor Alarm LED This amber LED indicates when a sensor has become disconnected has failed or is not compatible with this monitor NOTE In the 7500FO the Sensor Alarm LED latches Sensor must be properly attached to patient and alarm silence button must be toggled to clear LED WARNING Do no
33. ormal device conditions High Priority Alarms High priority alarms require immediate attention to the patient They include SpOz pulse rate and low perfusion alarms On the Model 7500FO high priority alarms are indicated by a rapidly blinking red Alarm Bar LED when the value is equal to or greater than the alarm limit In addition the pulse strength bargraph LED illuminates a red segment to indicate low perfusion High priority alarms are sounded as follows three beeps pause two beeps and a 10 second pause Medium Priority Alarms Medium priority alarms signal potential 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 AlarmBar 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 are sounded as three beeps and a 25 second pause Watchdog Alarms Watchdog alarms are loud two tone steadily beeping signals that indicate a hardware or software malfunction When a watchdog alarm is activated it can be cleared by shutting down the Model 7500FO If the watchdog alarm cannot be cleared remove power and contact your distributor or NONIN Technical Service Informational Tones Informational tones communicate important information They are typ
34. proximity or strength 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 Portable and mobile RF communications equipment can affect medical electrical equipment If this device fails to respond as described discontinue use until the situation is corrected by qualified technical professionals The sensor might not work on cold extremities due to reduced circulation Warm or rub the finger to increase circulation or reposition the sensor Wiwonin A Cautions Continued Do not gas sterilize or autoclave this device Batteries might leak or explode if used or disposed of improperly This device has motion tolerant software that minimizes the likelihood of motion artifact being misinterpreted as good pulse quality In some circumstances however the device may still interpret motion as good pulse quality Inspect the sensor application site at least every 6 to 8 hours to ensure correct sensor alignment and skin integrity Patient sensitivity to sensors and or double backed adhesive strips may vary due to medical status or skin condition Do not place liquids on top of this device Do not immerse this device or sensors in any liquids Do not use caustic or abrasive cleaning agents on the unit or se
35. rers sensors can result in improper pulse oximeter performance Do not use a damaged sensor Do not use this device in or around water or any other liquid with or without AC power As with all medical equipment carefully route patient cables and connections to reduce the possibility of entanglement or strangulation e Use this device only with power adapters supplied by NONIN Medical This device turns off after approximately 30 minutes when in low battery mode This device should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the device should be observed carefully to verify normal operation The battery pack must be installed at all times while the device is operating even when operating on AC power Do NOT use the device without batteries Li nenin Warnings Continued The use of accessories sensors and cables other than those listed in this manual may result in increased electromagnetic emission and or decreased immunity of this device To comply with relevant product safety standards ensure that all alarm volumes are set appropriately and are audible in all situations Do not cover or otherwise obstruct any speaker openings This device is a precision electronic instrument and must be repaired by qualified technical professionals Field repair of the device is not possible Do not attempt to open the case
36. s the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTES At 80 MHz and 800MHz the separation distance for the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 41 LT NONN Equipment Response Time SpO 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 Example AC Exponential Averaging SpO decreases 0 75 per second 7 5 over 10 seconds Pulse Rate 75 BPM 100 95 90 85 80 Spo2 75 70 65 60 Sa02 Reference 4 Beat Average zs 00 08 0 94 vi Time in seconds 079 OL 0 08 Specific to this example e The response of the 4 beat average is 1 5 seconds 42 Li Nenin Testing Summary SpO gt accuracy and low perfusion testing were conducted by NONIN Medical Inc as described below SpO Accuracy Testing SpO accuracy testing is conducted during induced hypoxia studies on healthy non smoking light to dark skinned subjects during motion and no motion conditions in an independent research laboratory The measured arteria
37. 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 Alarm Silence button silences the alarm for two minutes Pressing it again while alarms are silenced returns the alarms to their audible mode Li nonin CAUTION The two minute alarm silence is automatically engaged at startup 10 00 OP Limits Button This button displays the upper and lower limits for alarm indications for SpO and heart rate measurements Pressing the Limits button allows users to access advanced menu options including adjusting alarm settings alarm volume and date and time settings All adjustments can be made using the Plus and Minus buttons 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 LT NONIN Operating the Model 7500FO NOTES Before using the Model 7500FO please review all contraindications warnings and cautions Before using the Model 7500FO the battery must be charged for four 4 hours When the Model 7500FO reaches critical bat
38. t use a damaged sensor CG U Wiwonin 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 determined by pulse strength Green a good pulse strength Amber a marginal pulse strength Red alow pulse strength high priority alarm Alarm Silence LED This amber LED indicates that the audible alarm is silenced for two minutes when it blinks When alarms are active this LED blinks in time with the alarm bar If no alarms are active this LED flashes at the medium priority alarm rate When lit solid the Alarm Silence LED indicates that audible alarm volumes are set to less than 45 dB AC Power Adapter LED This green LED is displayed when an external power supply is providing power to the Model 7500FO Low Battery LED This amber LED indicates a low battery charge when blinking and a critical battery charge when lit solidly This LED does not indicate that the Model 7500FO is running on battery power WARNING This device turns off after approximately 30 minutes when in low battery mode Model 7500FO Front Panel Buttons ON STANDBY Button Pressing this button once turns on the Model 7500FO Holding this button for at least 1 second shuts down the unit putting it into Standby mode In Standby mode all device functions are
39. tery a medium priority alarm will sound To clear the alarm charge the battery and turn the device off and back on Press the ON STANDBY button When the unit is first turned on the Model 7500FO performs a brief initialization sequence Verify that all LEDs illuminate and the unit beeps three times during the first phase of the initialization sequence If any LED is not lit except the AC Power Adapter LED do not use the Model 7500FO Contact NONIN Technical Service for assistance To verify that the Model 7500FO is functioning properly it is important to monitor SpO 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 SpO reading is displayed that a pulse rate value appears and that the pulse strength bargraph LED is active WARNING This device is intended only as an adjunct device in patient assessment It must be used in conjunction with other methods of assessing clinical signs and symptoms WARNING As with all medical equipment carefully route patient cables and connections to reduce the possibility of entanglement or strangulation 11 I NONIN Operating Instructions Operating in the MR Environment When operating the 7500FO in the MR magnetic resonance environment observe the fol
40. the Alarm Silence button Change Pulse tone volume De Momentarily press the Plus button while the 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 _ Os 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 1 17 WZimonin Table 1 Limits Display Sequence Parameter Initial SpO Setting Parameter Display n Adjustment Range play Recall Alarm Settings CL no YES or no Low SpO Alarm Limit go 28 Bs OFF 50 to 95 by 1 Pulse High Alarm Limit yy 2 200 OFF 75 to 275 by 5 Pulse Low Alarm Limit VII SQ OFF 30 to 110 by 5 High SpO Alarm Limit gau OFF OFF 80 to 100 by 1 Alarm Volume Adb H DEET or Lo or H Clear Memory Che no YES or no Confirm Memory Clear JEL no YES or no Year y 00 0 to 99 by 1 Month nn 00 0 to 12 by 1 Day d 00 1t031by1 Hour Ae 00 0 to 23 by 1 Minutes nn 00 0 to 59 by 1 Notes 1 Both of these menu options are part of the me
41. tor or NONIN Technical Service for repair or replacement If these solutions do not correct the problem please contact NONIN Technical Service at 800 356 8874 USA and Canada or 1 763 553 9968 37 Li nenin Technical Information NOTE This product complies with ISO 10993 1 Biological Evaluation of Medical Devices Part 1 Evaluation and Testing CAUTION A functional tester cannot be used to assess the accuracy of VAN 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 or UL 1950 for data processing equipment CAUTION Portable and mobile RF communications equipment can A affect medical electrical equipment Manufacturer s Declaration Refer to the following table for specific information regarding this device s compliance to IEC 60601 1 2 Table 2 Electromagnetic Emissions Electromagnetic Emissions Test Compliance Environment Guidance This device is intended for use in the electromagnetic environment specified below The user of this device should ensure that it is used in such an environment RF Emissions Group 1 This device uses RF energy only for its CISPR 11 internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions Class B This devic
42. ure cuffs infusion lines etc moisture in the sensor improperly applied sensor incorrect sensor type poor pulse quality venous pulsations anemia or low hemoglobin concentrations cardiogreen and other intravascular dyes carboxyhemoglobin methemoglobin dysfunctional hemoglobin artificial nails or fingernail polish a sensor not at heart level e 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 or UL 1950 for data processing equipment Operation of this device below the minimum amplitude of 0 3 modulation may cause inaccurate results Review all limits to ensure they are appropriate for the patient The two minute alarm silence is automatically engaged at startup 6 Linonin Displays Indicators and Controls This section describes the displays indicators and controls for the Model 7500FO Alarm Alarm Silence SpO2 Pulse Rate Bar On Standby Display Display Speaker Sensor Plus Limits Connector SpO gt Display The SpObz display is located on the left hand side of the Model 7500FO front panel and is identified by the Sp02 symbol This display shows blood oxygen saturation from 0 to 100 percent The numeric displays blink during SpO alarm c
43. ve as an event marker Pin Number Pin Assignment Analog Output SpO No Connect Serial Data Output Analog Output Pulse Rate Ground No Connect Event Marker No Connect o CO N OO A oi N 5V 250 mA Accessory Power Supply 26 LC NONIN Analog Output The Model 7500FO provides analog output signals for SpO pulse rate and event markers Each output level conforms to the specifications shown below Output Specification SpO 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 SpO less than low alarm limit Analog Output Load Current 2 mA maximum SpO Analog Output Accuracy 2 Pulse Rate Analog Output Accuracy 5 Analog Output Calibration Analog calibration signals that allow external device calibration are provided after initial power up and continue until the Model 7500FO begins tracking SpO and pulse rate readings The calibration routine ends when the system begins tracking signals The calibration signal sequence is as follows Time Interval Analog Signal 30 seconds 1 0 VDC 30 seconds 0 0 VDC 1 second 0 1 VDC 1 second 0 2 VDC 1 second 0 3 V
44. vice s oximetry functions are disabled Alarm Description Low Battery Alarm Sensor Alarm Sensor Alarm LED blinks in sync with Alarm Bar LED This alarm signifies a sensor fault or disconnect Other Equipment Alarms Error code appears in main display area 23 Li nenin Reviewing and Setting Volume and Alarm Limits NOTE Alarm limits reset themselves to default values each time the unit is powered up unless the unit is in Patient Security mode In Patient Security mode alarm limits and volumes cannot be adjusted they can only be viewed WARNING To comply with relevant product safety standards ensure that all alarm volumes are set appropriately and are audible in all situations Do not cover or otherwise obstruct any speaker openings Reviewing Setting or Changing Volumes and Alarm Limits 1 Ensure that the device is on 2 Press the Limits button until the limit you want to view or change is displayed e The current limit appears in the SpO display e The current setting appears in the pulse rate display e Continue to press the Limits button until the limit you want to change is displayed 3 To change the displayed value press the Plus or Minus buttons as desired 4 Continue to press the Limits button until the unit returns to normal operation d CAUTION Review all limits to ensure they are appropriate for the patient Silencing Al
45. vice including cables than the recommended separation distance calculated from the e to the frequency of the transmitter Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz 3V 3 V m Recommended Separation Distance 1 17 JP d d 1 17 P 80 MHz to 800MHz d 2 33 P_ 800MHz 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 survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol di aw NOTES At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength i
Download Pdf Manuals
Related Search