User Manual - jawon medical
Contents
1. FULLY AUTOMATED BLOOD PRESSURE MONITOR OWNER S MANUAL ONE TOUCH operation WIDE LED display QUICK measure HIGH accuracy THERMAL HIGH SPEED printer VOICE message CARD using JAWON MEDICAL cr device bears the label accordance with the provisions of Medical Device Directive 93 42 THE PERSONS RESPONSIBLE FOR PLACING DEVICES ON THE MARKET UNDER MDD 93 42 Jawon Medical Co Ltd 1208 12 SHINSANG RI JINRYANG EUP KYUNGSAN CITY KYUNGSANG BUKDO 712 837 SOUTH KOREA TEL 82 53 856 0993 FAX 82 53 856 0995 VITAKO 20 0 UL MALEJ SYRENKI 2 71 790 SZCZECIN POLAND TEL 91 8522900 901 FAX 91 8522910 A TABLE OF CONTENTS diia KODO CON 4 1 INTENDED 4 T eta 4 CLASSIFICATION AND 4 5 ee 5 5 SAFETY SYMBOLS AND 8 6 Guidance for Electromagnetic compatibility EMC 10 TERMS OF EACH PART AND 15 IE RON PART 15 2 PRINTER nagara ani aa A a AP2. 17 D NGA AR eee eee a A aa a 18 Aa 20 OPTION cto 20 21 1 CONNECTING POWER CABLE nas sasa 21 2 ASSEMBLING OF ARM SUPPORTER oo oo W o W nh 21 LOADING THE PRINT PAPER mmm 22 4 CONNECTING 2 22 0000 0000000008 22 SETTING TIME AND DALE ab asi 23 e MEASUREMENT 25 1 CAUTIONS FOR 50 25 2 26 DATA ON MEASUREMENT 29 30 e 32 s AFTER SERVICE Na 33 To APTEIS SERVICE R 33 2 PACKING AND TRANS OR sa aa ea 33 SPECIFICATION oa 34 BA utan Bh 35 INTRODUCTION We highly appreciate that you chose our company s product You are kindly reguested to be familiar with these directions before using this product and always keep it together with the product In case you are not sure about any directions or problems arising while using the product please contact our service center We will provide you with detai
3. 8kV Air 8kV Air synthetic material the relative humidity should be at least 30 Electrical fast 2kV Power 2kV Power Mains power quality should be that of transition burst supply lines supply lines a typical commercial hospital IEC 61000 4 4 1kV 1kV environment 10 Input output lines Input output lines 1 kV differential 1 kV differential Mains power guality should be that of Surge mode mode a typical commercial or hospital 61000 4 5 2 kV common 42 kV common environment mode mode lt 5 UT lt 5 UT 295 dip in gt 95 dip in UT UT for 0 5 cycle for 0 5 cycle Mains power quality should be that of Voltage drops 40 UT 40 Yo UT a typical commercial or hospital dips and 60 dip in UT 60 Yo dip UT environment If the user of the FT 500 fluctuations of for 5 cycles for 5 cycles reguires continued operation during input power 70 9o UT 70 UT power mains interruptions it is supply line IEC 30 dip UT 30 dip UT recommended that the FT 500 be 61000 4 11 for 25 cycles for 25 cycles powered from uninterruptible lt 5 UT lt 5 UT power supply or a battery gt 95 dip in gt 95 dip in for 5 sec UT for 5 sec Magnetic field of Power freguency magnetic fields commercial should be at levels characteristic of a freguency 50 60Hz 61000 4 8 typical location in typical commercial or hospital en
4. not mount it close to the gas pipe water pipe lightening rod and connection of telephone XY Keep the unit dry and do not wet it Avoid direct sunshine humidity dust and Never immerse the main unit in the water extreme changes in temperature It could cause damage the electronic parts inside 3 Ba 30 Do not put heavy things on the unit Wipe the unit with a damp cloth Do not use benzine alcohol or liguid similar to solvents and wet cloth Do not use the unit under the condition of shock or vibration When you re use after long time please check the unit carefully When some problems are found please call our service center 31 ERROR 8 REPAIR ERROR PRESSURE pressure is high with When the message is jammed air hose repeated call for maintenance service ERROR CUFF pressure is low as air leaks When the message is repeated call for maintenance service ERROR MEASURE subject moves or speaks Dont move or speak while in testing When the message is repeated call for maintenance service 32 AM AFTER SERVICE 1 AFTER SERVICE qp If there is any problem with the unit please follow the steps below Contact our company s Overseas Service Department immediately After gathering the model name Serial Number date of purchase and description of the problem contact our company with information shown below x Try to solve the problem over th
5. period moga soon 1year main unit only Date of purchase Month Day Year Name TEL Customer Name TEL Dealer When you receive this warranty make sure that the name of the dealer and the month day and year of purchase are all completed This warranty will not be reissued please keep it in a safe place 35 Periodic Check List Management No em inspection Subject Requirements Judgment Remarks VisulCheck No scratch crack deformation and rust afres Nome mecanicien 3 1 Accessories 2 Recorder Smooth operation with no Pass Fail abnormal sound 00 Smooth operation Pass Fail Power cord Smooth operation and Pass Fail removal 1 Power supply Screen display upon Pass Fail 2 Display No abnormality and Pass Fail Copy this sheet for use Accessories Electrical Check Performance If repair is reguired write down so the Remarks column 36 Daily Check List Management No __ Inspection Subject Judgment Remarks Visual Check S Mainframe No scratch and damage Mechanical T ainframe aan Smooth operation with Passira abnormal sound Accessories Power cord EUN Pass Fail Electrical Check Power supply UPON Pass Fail Performance Display Pass Fail General Judgment instalation pas Da
6. power cable to the AC INPUT slot on the rear and turn the POWER ON OFF switch on the lower part of the rear See the picture 2 ASSEMBLING OF ARM SUPPORTER The arm supporter consists of two parts The first part 1 is attached to the main body when it is manufactured in the factory while the second part 2 is assembled to the first part as shown in the picture ARM RESTI ARM RESTU 2 3 LOADING THE PRINT PAPER Check and see if power is turned on Turn the nut with driver the groove in the middle on the lower printer cover clockwise to 90 degrees and open the cover Load the print paper as shown in the picture Insert the paper edge deep under the black roll then it comes out above the CUTTER Balance the paper in the right place Cut the paper by pressing the FEED button o 0 Close the cover and turn the nut counterclockwise back FEED Being thermal type printing is photocopied on one side of the paper slippery side without using printing ink Please check remainder of the paper always and then replace it Please use exclusive paper 58mm Keep paper rolls dark and ventilated place Avoid any dust on the paper Do not pull the paper during printing It could cause jam When printing paper is not loaded in correct place it may cause the malfunction of the printer or paper will be shoved out After the exchange of paper to the printer cover do
7. to read and understand the following information 1 Guidance and manufacturer s declaration electromagnetic emissions FT 500 is intended for use the electromagnetic environment specified below The customer or the user of the FT 500 should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance The FT 500 uses RF energy only for its internal RF emissions function Therefore its RF emissions are very low and CISPR 11 are not likely to cause any interference in nearby electronic equipment RF emissions Class B CISPR 11 Harmonic The FT 500 is suitable for use in all establishments emissions Class A including domestic establishments and those directly IEC 61000 3 2 connected to the public low voltage power supply Voltage network that supplies buildings used for domestic fluctuations Compliance flicker emissions 61000 3 3 2 Guidance and manufacturer s declaration electromagnetic immunity FT 500 is intended for use in the electromagnetic environment specified below The customer or the user of the 500 should assure that itis used in such an environment IEC 60601 test Compliance Electromagnetic environment Immunity test level level guidance Floors should be wood concrete or Electrostatic discharge ESD 61000 4 2 6kV Contact 6kV Contact ceramic tile If floors are covered with
8. Ordinary eguipment without protection against ingress of water Equipment not suitable for use in presence of a flammable anesthetic mixture by standard of EN 60601 1 2006 Basic safety and essential performance of Medical Electrical Equipment 2 This device is complied with Class A for Noise Emission Level B for Noise immunity by standard of IEC 60601 1 2 2007 Electromagnetic Compatibility Requirements 3 This device is complies with the EN 1060 1 1995 A2 2009 Non invasive Sphygmomanometers general requirements as well as EN 1060 3 1997 A2 2009 supplementary requirements for electro mechanical blood pressure measuring systems 4 SAFETY PRECAUTIONS This device is designed and manufactured with consideration of safety of the operator and subject and also to the reliability of the unit The following precautions must be observed for additional safety A 1 The unit must be operated only by or under supervision of a qualified person with our company or our distributors 2 This device is specified as Class 1 type BF unit under the standard of IEC 60601 1 2005 Safety of Medical Electrical Equipment Do not touch or handle inner side of the system at any time AN The INTERNAL ELECTRICAL POWER SOURCE is to be used if the integrity of the PROTECTIVE EARTH CONDUCTOR or the protective earthing system in the installation is in doubt 3 Do not modify the unit If any modification is needed ask our company or its authorized dealer for serv
9. e costs for return of defective unit must be prepaid by the users 5 SAFETY SYMBOLS AND INFORMATION International Electrotechnical Commission IEC has established set of symbols for medical electrical eguipment which classifies a connection or warning of any potential hazard The classifications and symbols shown below Save these instructions for your safety Degree of protection against electric shock TYPE BF Please observe operating instructions General warning sign General prohibition sign General mandatory action sign Caution Waste Electrical and Electronic Equipment WEEE The device could be sent back to the manufacturer for recycling or proper disposal after their useful lives Alternatively the device shall be disposed in accordance with national laws after their useful lives OFF only for a part of equipment ON only for a part of eguipment This symbol is used inside system Identifies the point where the safety ground of the system is fastened to the chassis Do not open This is for factory only Alternating current Date of manufacture Manufacturer Non ionizing radiation Authorized representative in the European community 4 Po Keep dry RoHS2 0 6 Guidance for Electromagnetic compatibility Details about the electromagnetic compatibility of the FT 500 are given below Before using the 500 be sure
10. e phone with the personnel of local service department If the problem cannot be solved over the phone just return to service department directly x Our company or local distributor will make available on request circuit diagrams component part list descriptions calibration or other information which will assist your appropriately qualified technical personnel to repair those parts of unit which are designated by our company as repairable How to contact our company Write us at JAWON MEDICAL CO LTD 29 Gongdan 4 ro Jillyang eup Gyeongsan si Gyeongsangbuk do Korea TEL 82 53 856 0993 FAX L 82 53 856 0995 You can also contact the following representative or your local distributor 2 PACKING AND TRANSPORT Our company follows his packing ways to protect any impact during transporting etc So please do not transport or move the unit without our company s packing condition as your wishes The normal storage environment 20 C 60 of temperature Humidity is less than 95 condensing 33 SPECIFICATION FT 500 R FT 500 L Measuring Method Oscillometric Display mode LED display Result Contents Systolic Diastolic Mean blood pressure Pulse P R P Measuring ranges Pressure 30 300mmHg Pulse 30 200beats minute Measuring parts FT 500 R Right arm FT 500 L Left arm Printer Thermal printer optional 34 A WARRANTY WARRANTY Automatic Blood Pressure Monitor Warranty
11. es not close properly the alarm sounds LED on the is displayed Please check the status of the printer cover 4 CONNECTING PORT To transmit the data connect a computer or other external options to the unit Connect the USB cable both to port of the unit and to the computer jack or other external options See the picture PART OF 292 5 SETTING TIME AND DATE Turn the power of the unit on Open the printer cover Sequence HOUR MINUTE MONTH DAY YEAR 1 Press SET button then indicator says its counts that have been measured since keeping button ON Press SET button one more First 2 figures will blink To set the current hour press PRINT button to make the number goes up or press FEED button to make the number goes down 1 After setting the hour press the SET button again In this time last 2 figures will blink 3 As the same way as above set the current minute with PRINT and FEED button 1 After setting the minute press SET button again 2 First 2 figures will blink 3 Set the current month with PRINT and FEED button 1 After setting the month press SET button again 2 Last 2 figures will blink 3 Set the current day with PRINT and FEED button buttons 1 After setting the day press SET button again 2 First 2 figures will blink 3 Set the current year with PRINT and FEED button 23 If you want to mea
12. hese guidelines may not apply all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 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 in the location in which the FT 500 is used exceeds the applicable RF compliance level above the FT 500 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the FT 500 Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 4 Recommended separation distances between portable and mobile RF communications equipment and the FT 500 The FT 500 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the FT 500 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the FT 500 as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance acc
13. ice 4 The unit has previously been adjusted in the factory for optimum performance 9 Do not attempt to adjust switches or any other things except those specified in this manual for operation A 5 If you have experienced any trouble with the unit switch it off immediately and contact our company or its authorized dealer for assistance 6 If you plan to connect any device of other manufacturers electrically or mechanically to the unit contact our company or its authorized dealer for instructions before doing so When you connect computer or other system to the unit RS 232C the attached systems should be those certified by IEC 60950 or equivalent standards for data processing equipment Configurations shall comply with the system standard IEC 60601 1 2005 Everybody who connects additional equipment to the signal input part or signal output part configures a medical system standard IEC 60601 1 2005 If in doubt consult the A S department of local distributor ae 7 Avoid the following environments for storage gt Where the ambient temperature falls 20 C or exceeds 60 C Where the atmospheric pressure falls below 700 or exceeds 106kPa 1060mbar Where the humidity is over 95 non condensing Where the unit is exposed to spray or splashing water Where the unit is exposed to dust Where the unit is exposed to water vapor Where the unit is exposed to salty atmosphere Where the unit is exposed to e
14. led instructions 1 INTEDED USE FT 500 R L Automatic Blood Pressure Monitor is designed to measure systolic and diastolic blood pressure and pulse rate of Persons who are 18 years and older using the oscillometric method on a cuffed arm FT 500 L measure the Left arm FT 500 R measure the Right arm Target user Persons who are 18 years and older This medical device is not for home use 2 WORD DEFINITIONS To ensure safe operation and long term performance stability it is essential that you fully understand the functions operating and maintenance instructions by reading this manual before operating your unit Particular attention must be paid to all warnings cautions and notes incorporated herein The following conventions are used throughout the manual to denote information of special emphasis Warning indicates important information to the presence of a hazard which may cause severe personal injury death of substantial property damage if the warning is ignored Caution indicates important information to the presence of a hazard which may cause minor personal injury or property damage if the caution is ignored Notice indicates important information to notify installation operation or maintenance of this device Notice is important but not hazard related Hazard warnings are not included here 3 CLASSIFICATION AND COMPLIANCE 1 This device is classified as Class 1 type BF against electric shock
15. n you print out the data f you set ON at the rear PRINT ON OFF switch the data is printed automatically even when you do not press PRINT button Normally when you press this button all the data output after you turn the power on will be printed If you turn it off all memorized data would be deleted When you set the date and time the number goes up with this button pressed 2 FEED button Use this button for setting the paper When you set the date and time the number goes down with this button pressed 3 SET button Set the date and time The functions are as follows when pressing this before or after measurement It does not work during measurement Sequence HOUR MIN gt MON gt DAY YEAR Within 5seconds Setting of the date and time finished See the page 15 for detailed method PRINT BUTTON d FEED BUTTON Sl bes SETBUTTON LT ine MODE For an additional function 17 3 REAR PART CD POWER It is used to turn the power on and off 2 AC INPUT It is used to connect with the power code 3 FUSE Two 250V 1 6AL fuses are installed to prevent overload CAL This is only for inspection Never open it 5 EARTH POTENTIAL EQUALIZATION TERMINAL Please make sure for safety 6 COMMUNICATION PORTS RS 232C It is for connecting between the main body and a computer or other equipment with cable RS 232C to transfer the data collected or measured And it i
16. one more time press STOP button and start all procedures from the beginning 97 When the PRINT ON OFF switch on the rear is set OFF the result will not be printed even if the measurement is completed For the card users six previous results stored in the card can be recalled to compare with the current ones newly checked Seven results altogether could be printed out This device is only for adult 28 3 DATAON MEASUREMENT BY PRINTER V Results on Printing Paper Classification of the blood pressure National High Blood Pressure Education Program National Heart Lung and Blood institute NIH JNC7 2003 DiastolicimmHgl 100 90 80 120 140 160 Systolic mmHg When pressure is high with the jammed air hose message appears on the printer as ERROR PRESSURE When the message is repeated call for maintenance service When pressure is low as air leaks message appears on the printer as ERROR CUFF When the message is repeated call for maintenance service When the subject moves or speaks while in testing message appears on the printer as ERROR MEASURE Try to retest after a while If the message is repeated call for maintenance service 29 This unit is for 230V If you want 110V please Remind the permitted current 60 VA contact to a service center To prevent electric shock please make sure the earth When grounded do
17. ording to frequency of transmitter output power of transmitter 150 kHz to 80 MHz 80 MHz to 900 MHz 900 MHz to 2 5 GHz d 1 P d 1 P d 1 P 0 12 0 23 0 38 0 73 2 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 is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer 1 At 80 MHz and 900 MHz the separation distance for the higher freguency range applies 2 These guidelines may not apply all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 14 TERMS OF EACH PART AND FUNCTIONS 1 FRONT PART 1 START Press START button after being ready to measure the cuff will be wrapped automatically and begins to pressurize 2 STOP BUTTON Press STOP button if you want to stop it during measurement Pressurizing will stop and the air will exhaust from the cuff 3 SYSTOLIC DISPLAY It indicates systolic blood pressure values 4 DIASTOLIC DISPLAY It indicates diastolic blood pressure values 5 PULSE DISPLAY It indicates pulse rate 6 TIMER It indicates time EMERGENCY STOP BUTTON When your arm is oppressed due to high pressurizing or irregular operation is done press this button then the cuff will be exha
18. rm or left arm into the cuff An optimal arm circumference for this equipment is 9 to 14 Place your arm on the arm supporter with the palm facing up through the cuff deeply Adjust the height of the chair so that the arm is leveled off with the heart When the arm is placed lower than the heart blood pressure will become higher than actual value and vice versa 4 Press the START button Checking blood pressure begins as the cuff is automatically pressurized with the LED screen displaying animations of the checking in process When the measurement is started the voice message iS announced Starting measurement don t move or speak please When you feel painful and want to stop the measurement press EMERGENCY BUTTON 5 The LED screen displays the results of checking upon finishing along with a voice message of Measurement completed pull your arm out please Thank you The cuff will automatically release your arm and resume the original position When the measurement is not satisfactory the voice message comes out as Cannot measure we will try again At this time let your arm stay into the cuff and start over again from the beginning 6 The results are printed out and a voice message also announces the results as Your blood pressure is systolic 000 diastolic 000 and pulse 000 7 Pull your arm out from the cuff When you want to measure
19. s for connecting between the main body and the coin slot with RS 232C cable to transfer the data too 7 SENSOR ON OFF Human sensor is switched on and off SOUND ON OFF Music and voice output functions are activated with the switch ON and vice versa 9 CARD ON OFF ID card is usable when the switch ON and vice versa PRINT ON OFF Measured results are printed out when switched ON and vice versa 1 VOLUME ANNOUNCE ON OFF It controls volume output when switch is on while all volume is OFF 12 INFORMATION BOARD FIXER Fix the information board here 1 While sound switch is activated on so sound is functioning place the VOLUME ON OFF switch to OFF for deactivation of voice message and music play 2 Printer card reader human sensor and reverse monitor is optional The operator shall not contact the parts SIP SOP and the patient simultaneously and SIP SOP shall be available to operator only 18 REAR PART INFORMATION BOARD FIXER Ty VOLUME ANNOUNCE ON OF 5 3 PRINT ON OFF NL amp PORT CARD ON OFF 5 232 SENSOR ON OFF 5 SOUND EARTH POTENTIAL ON OFF EQUALIZAT ON TERMINAL 19 4 ACCESSORIES Earth Power Fuse Manual OWNERS MANAL Arm rest o OPTIONS Cart Chair Card reader Card writing device Cards AY Printer paper Printer Human sensor 20 A INSTALLATION 1 CONNECTING POWER CABLE Just connect the
20. sure blood pressure during setting the date and time press STOP button Then you can measure again immediately You should set all data at once hour minute month day and year In case of stopping setting the values return to previous ones which you have done before The calendar and time functions work without plugging power cord in Calendar program is inputted for 100 years and it would be adjusted automatically even at a leap year 24 MEASUREMENT 1 CAUTIONS FOR MEASUREMENT Take off heavy sweater or shirts Before measurement take it easy and have a rest for a while Do not measure in bad positions such as standing half seat or sitting with your legs crossed When you fold your sleeves up please make Put your arm deeply in order to fit to the arm sure not to press your arm rest If you strain to your arm there will be some differences Please relax your arm and have a seat correctly If it is not easy to check your pulse with the stethoscope the measurement cannot go on 25 2 MEASUREMENT o Check the voltage and turn the power on With the human sensor attached optionally the LED screen is automatically turned on as it detects a user coming to the range The sensor should be placed ON 2 For non ID card users a background music flows as power is turned on and there appears the stand by scene on the LED screen 3 Please put either the right a
21. t of purchase Ohekedby Copy this sheet for use If repair is required write down so in the Remarks column Service center TEL 82 2 587 4056 82 53 856 0993 If the problems continue call the service center When you ask for service the manufacturer s label serial number date of original purchase and explanation of malfunction will be reguired For purpose of improvement specifications and subject to change without notice P1JAWON MEDICAL www awon com Our company name will be changed to JANEX MEDICAL HEAD OFFICE 29 Gongdan 4 ro Jillyang eup Gyeongsan si Gyeongsangbuk do Korea TEL 82 53 856 0993 FAX 82 53 856 0995 EUROPEAN REPRESENTATIVE VITAKO Sp 2 UL MALEJ SYRENKI 2 71 790 SZCZECIN POLAND TEL 91 8522900 901 FAX 91 8522910 JW FT500E 20151001 Rev 4 0
22. to service according to the EMC information provided in the ACCOMPANYING DOCUMENTS NM a statement that portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT Please consult physician trained health professional for interpretation of measurement results A 13 No phthalates are used for this product and its container AA 14 The cuff is not made with natural rubber latex 1 Measurements be impaired if this device is used near televisions microwave ovens X ray equipment or other devices with strong electrical fields To prevent such interference use the meter at a sufficient distance from such devices or turn them off 2 Incorrect operation or failure of user to maintain the unit spares the manufacturer or his agent of the responsibility for system s non compliance with specifications or responsibility for any damage or injury This manual is made for informational purpose and this manual and product are not meant to be a substitute for the advice provided by your own physician or other medical problem You should not use the information contained in the product for diagnosis or treatment of health problem or prescription of medication by yourself If you have or suspect that you have a medical problem consult with your physician promptly Defective unit or accessories must be packed in the replacement cartons to be shipped off from you to our company shipping and insuranc
23. usted rapidly PRINTER COVER It protects the printer 9 AUTOMATIC CUTTER printing paper let out slot Printing paper is automatically cut off when it comes out through the slot CUFF It wraps and releases the arm automatically for measurement 17 ARM REST When the arm is placed on the cuff the arm supporter sustains the arm and makes the right position 2 HUMAN SENSOR When a user approaches power is automatically turned on and vice versa 19 CARD READER When card is inserted it reads information in it and stores the measured results then the cuff will be exhausted rapidly The cuff and the buttons START and STOP button of this device are located at reverse side by R and L type FRONT PART 4 ARM REST q CUFF SYSTOLIC DISPLAY DIASTOLIC DISPLAY PULSE DISPLAY TIMER STOP BUTTON START BUTTON HUMAN SENSOR 8 CARD READER EMERGENCY AN 2 PRINTER COVER PAPER OUTPUT Printer card reader and human sensor are optional ID card can be issued either by the machine manager or by the manufacturer of the model The card stores six previous measured results and can contain seven measured results with the current one altogether When the model manager writes the card please refer to the manual and specifications for operation and programs attached to the card writing device at purchase 16 2 1 PRINT button Use it whe
24. vironment UT is the a c mains voltage prior to application of the test level 11 3 Guidance and manufacturer s declaration electromagnetic immunity 2 The FT 500 is intended for use in the electromagnetic environment specified below The customer or the user of the FT 500 should assure that it is used in such an environment Compliance Immunity test 60601 test level TM Electromagnetic environment guidance eve and RF Portable mobile communications equipment should be used no closer to any part of the FT 500 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2V P d 1 2 P 80 MHz to 900 MHz Conducted RF 3 Vrms 3 Vrms IEC 61000 4 6 150 kHz to 80 MHz d 2 NP 900 MHz to 2 5 GHz where P is the maximum output power Radiated RF 3 V m 3 V m rating of the transmitter in watts W 61000 4 3 80 MHz to 2 5 GHz according to the transmitter manufacturer 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 12 1 At 80 MHz 900 MHz the higher freguency range applies 2 T
25. xplosive gas Where the unit is exposed to excessive shocks or vibrations Where the angle of inclination of mounting surface exceeds 10 degrees Where the unit is exposed to direct sunlight This eguipment has been tested found to comply with the limits for medical devices to the 60601 1 2 2007 These limits are designed to provide reasonable protection against harmful interference a typical medical installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to other devices in the vicinity However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to other devices which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving device Increase the separation between the equipment Connect the equipment into an outlet on a circuit different from that to which the other device s are connected Consult the manufacturer or field service technician for help 9 9 Do not to touch signal input signal output or other connectors and the patient simultaneously N10 a statement that MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be installed and put in
Download Pdf Manuals
Related Search