Post questions, comments, reviews or page errors in the comment box below.

Click here to download ACCURAPULSE AP-WBPM810 (01) PDF MANUAL

PDF Content Summary:

****** Page 1 ****** Distributed By: Gurin Products LLC 2522 Chennbers Raed, Suite 100 Tustin. CA-ergo USA TMB-1580-006 Jf[1EEit mm Trans tek 70 g 70*95 mm 2018-05-10 2018-05-10 2018-05-10 Version: 1.0 User Manual Wrist Blood Pressure Monitor AP-WBPM810 Wrist Type sys 9&’/88 Thank you very much for selecting AccuraPulse Wrist Blood Pressure Monitor AP-W8PM810. • To use the monitor correctly and safely, please read the manual thoroughly. Please keep this manual v•ell in order to reference in future. Questions.Warranty: Support@gunnproducts com 2018-05-10 TMB-1580-006-GB-08 J! 16 4k Jfk *

****** Page 2 ****** CATALOGUE CATALOGUE INTRODUCTION • General Description • Indications for Use • Measurement Principle • Safety Information • LCD Display Signal • Monitor Components List BEFORE YOU START • Installing and Replacing the Batteries • Setting Date, Time MEASUREMENT Tie the Cuff • Select the user 10 • Stan the Measurernent DATA MANAGEMENT Recall the Records • Delete the Records • INFORMATION FOR USER Tips for Measurement • Maintenance • ABOUT PRESSURE • What are systolic pressure and diastolic pressure? • What the standard blcod pressure classification? • Irregular heartbeat detector • Why does my blood pressure fluctuate throughout the day? • Why do I get a different blood pressure at home compared to the hospital? • Is result the sanæ if measuring on the right wrist? TROUBLESHOOTING SPECIFICATIONS CONTACT INFORMATION FCC STATEMENT . COMPLIED STANDARDS LIST EMC GUIDANCE 2 12 .15 18 20 22 23 24 24 25 26 1

****** Page 3 ****** INTRODUCTION General Description Thank you for selecting AccuraPulse Wrist Blood Pressure Monitor (AP-WBPM810J. The monitor features blood pressure measurement, pulse rate measurement and the result storage. The design provides you with two years of reliable service. Readings taken by the AP-WBPM810 are equivalent to those obtained by a trained observer using the cuff and stethoscope auscultation method. This manual contains important safety and care information, and provides step by step instructions for using the product. Read the manual thoroughly before using the product. Features: •Systolic blood pressure •Diastolic blood pressure •Pulse rate •60 records per each user Indications for use The AccuraPulse Blood Pressure Monitor digital monitor is intended for use in measuring blood pressure and heartbeat rate with wrist circumference ranging from 13.5cm to 21.5 cm about It is intended for adult indoor use only. Measurement Principle This product uses the Oscillometric Measuring Method to detect blood pressure. Before every measurement, the unit establishes a “zero point” equivalent to the atmospheric pressure. Then it starts inflating the cuff. Meanwhile, the unit detects pressure oscillation generated by beat-to-beat pulsatile, which is used to determine the systolic pressure and diastolic pressure as well as pulse rate. The device also compares the longest and the shortest intervals of detected pulse wave to with the average value, and then calculates the standard deviation. The monitor will light up a warning symbol when the calculated standard deviation is larger than or equal to 25%. 2 INTRODUCTION • Safety Information The signs beluv’ mght be in the user manual, labeling or other component They are the requiretnent of standard and using. Symbol for ‘THE OPERATION GUIDE MUST BE READ” Symbol for “MANUFACTURER’ Symbol for “SERIAL NUMBER* Symbol fu “DIRECT CURRENT* Symbol for “MANUFACTURE OATE Symbol for “RECYCLE Symbol for *TYPE BF APPLIED PARTS” Symbol for *ENVIRONMENT PROTECTION – Electrical waste products should nat be disposed of with t-usehold waste. mease recycle where facilities exist. Check with your local authority or retailer for recycling advice* Caution: These mtes mL8t be observed ta prevent any damage ta the device. The Green Oot the license symbol of a European ætwork of industry-funded systems for recyc ling the packaging materials of cotwarner 3

****** Page 4 ****** INTRODUCTION CAUTION * Thß device is intended for adult use in t’ünes only. * The device is not suitable far use on neonatal patients, pregnant women,patiants with implanted: electronical devices, patients with preeclampsia: premature vantricular beats, atrial fibrillation, peripheral, arterial disease and patients undergoing intravascular therapy or aderio-venous shunt or people who received a mastectomy. Please consult your doctor prior to using the unit if you suffer from illnesses. * The device is not suitable far measuring the blood pressure of children. Ask your doctor before using it older children. * The device is not intended for patient transport outside a faciliti- * The device is not intended for public Ilse. * Thß device is intended for no-invasive measuring and monitoring of arterial blood pressure. It is nat intended for use on extremities other than tha wrist or for functions other than obtaining a blood pressure measuremant. * 00 rot confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood pressure. 00 mt begin or end medical treatrnent without asking a physician for treatment advice. * If you are taking nnedicatian ,consult your physician to determine the mast appropriate time to measure your blood pressure. Never change a prescribed medication without consulting your physician. * 00 rot take any therapeutic measures on the basis of a self measurernent. Never alter the dosa of a rnedicina prescribed by a doctor. Consult your doctor if you have any question about your blood pressure. * When the device was used to measure patients who have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, the best result may mcur with deviation. Please consult your physician about the result. * Dont kink the connection tube during use, otherwise: the cuff pressure may continuously increase which can prevent blood flaw and result in harmful injury to the PATIENT. * When using this device, O/RRSa pay atte.ntion to the following situation which may interrupt blood flow and influence blood circulation of the patient, thus cause harmful injury to the patient connection tubing kinking taa fraquant and consecutive multiple measurements; the application of the cuff and its vessurizatian on am,’ wrist where intravascular access or therapy, or an Arteriovenous IA-V) shunt, is present; inflating the cuff on the side ofa rnastectomy. * Warning: Do not apply the cuff over a wound;otherwæ it can cause further injury. rot inflate the cuff on the same limb which other monitoring ME equipment is applied around simultaneously: because this could cause temporary loss of function of those simultaneously-used monitoring ME equimnent. *On the rare occasion afa fault caLÆing the cuff to remain fully inflated during measurement, open the cuff immediately. Prolonged high pressure (cuff pressure > 300mmHg or constant pressure > 1SmmY# for (‘mre than 3 minutes) applied to the wrist may lead to an ecchymosÄ *Please check that operation of the device does not result in prolonged impairrnent of patient Wood circulation. 4 INTRODUCTION CAUTION * When please avoid compression or restriction of the connection tubing. * The device cannot be nsad with HF surgical equipment at the same time. * The ACCOMPANYING OOCUMENT shall disclose that the SPHYGMOMANOMETER was clinically investigated according to the requirernents af ISO 81080 22013. verify the calibration the AUTOMATED SPHYGMOMANOMETER, please contact the manufacturer. * This device is contraindicated for any female who may be suspected of, or is pregnant. Besides providing inaccurate readings, the effects aftiis device on tha fetus are unknown. * Too frequent and consecutive measurements could cause disturbances in blood circulation and injuries. * This unit is not suitable for continuous monitoring during rnedical ernergencies or operations.Other,vise, tha patients wrist and fingers will become anaesthetic, swollen and even purple due to a lack of blood. * When rot in use, store the device in a dry room and protect it against extrema rnoisture, heat, lint, dust and direct sunlight. Never place any heawj’ objects on the storage case. * This device may ba used only for the purpose described in this booklet The manufacturer cannot be held liable far damage caused by incorrect application *This device comprises sensitive cornponents and must be treated with caution. Observe the storage and operating conditions describad in this booklet * The maximum temperature that the applied part can be achieved is 42.5C while the environm.ental temperature is 40 C * The equipn-tent is natAPAPG equipment and not suitable for use in the presence of a flarr.mable anesthetic mixture with air of with oxygen or nitrous oxide. * Warning: No servicing/maintenance while the ME equipmant is in use. * The patient is an intended operaton * The patient can measure data and change batteries under norrnal circumstances and maintain tha device and its accessories according to the user manual. * To avoid measurem.ent errors, please avoid the condition of strong electromagnetic field radiated interference signal or electrical fast transient/burst signal. * The blood pressure monitor and tha cuff are suitable for use within the patient environm.ent- If you are allergic to polyester, nylon or plastic, please don’t use this device. * During use, the patient will be in contact with the cuff. The materials af the cuff have been tested and found to conwy with requirem.ents of ISO 10993-S:200El and ISO 10gg3-10:2010. It will not cause any potential sensization or irritation reaction. * If you experience discomfott during a measurement, such as pain in the wrist ar other complaints, press the START/STOP button to releasa the air immediately from the cuff. Loosen the cuff and rernova it from your wrist. * If tha cuf pressure reaches 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not delate when pressures reaches 40 kPa (300 mmHg), detach the cuff from the wrist and press the START/STOP button to stop inflation. * defore use, make sure tha device functions safely and is in proper working condition. Check the device, do not use the device if it is damaged in any way. The continuous use of a damaged unit may cause injury, improper results: or serious danger. 5

****** Page 5 ****** INTRODUCTION CAUTION * 00 rot wash the cuff in a washing machine or * The service life of the cuff may vary by the frequency of washing: skin condition, and storage state. The typical service life is 10000 times. * It is recommended that the performance should be checked every 2 years and after maintenance and repair, by retesting at least tha requirernents in limits of the error of the cuff pressure indication and air leakage (tasting at least at 50mmHg and 200mmHg). * Please dispose of ACCESSORIES, detachable pans, and the ME EQJIPMENT according to the local guidelines. * Manufacturer will make available on request circuit diagrams, component pan lists, descriptions, calibration instructions,etc., to assist to service personnel in parts repair. * The operator shall not tuch output of batteries and the patient simultaneoLÆty. * Cleaning Dust environment affect the performance of the unit. Please use the soft cloth to clean the whole unit before and after use. Don’t use am,’ abrasive or volatile cleaners. * The device doesn’t need to be calibrated within two years of reliable service. * If you have any problems with this device, such as setting up, maintaining using, please contact the PERSONNEL of AccuraPuIse. Don’t open repair the device by yourself in the eve.nt of The device mßt only be serviced, repaired and opened by individuals at authorized salesJservice centers. * Please report to AccuraPuIse if any unexpected operation or events occur. * Keep tha unit aut of reach of infants, young children or pets to avoid inhalation or swallowing of small parts. It is dangerous or even fatal. * Be careful to strangulation due to cables and hoses. particulany due to excessive length. * At least 30 min required far ME equipment to warm fram the minimum storage temperature between until it is ready for intended use. At least 30 min required for ME equipment to coal from the maximum storage temperature between uses until it is ready for intended use. * Thß equiprnent needs to be installed and put into service in accordance with the inforn-,ation provided in the ACCOMPANYING DOCUMENTS; * Wireless communications equiprnent such as wireless homa network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least a d away from the equipm.ent. The distance d is calculated by the MANUFACTURER from tha 80 MHz ta 5.8 GHz column of Table 4 and Table g of IEC ec801-1-2:2007, as appropriate. * Please use ACCESSORIES and detachable pertes specified/’ authorised by MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the user/patients. * There is no luer lock connectors are used in the construction of tubing, there is a possibility that they might be inadvertently connected to intravascular fluid systems, allowing airta be pumped into 8 blood vessel. * Please use the device under the environment which was provided in tha user nwnual. Otherwise, the perforrnance and lifetime of the device will be impacted and reduced. 6 INTRODUCTION • LCD Display Signal SYS I DIA PUL SYMBOL SYS DIA mmHg +1-0 É8i88′ DESCRIPTION Systolic blood pressure Diastolic blood pressure mmHg Motion indicator Low battery User 1 User 2 I rregular heartbeat Current time alcad pressure level indicator Heartbeat EXPLANATION High blood pressure Low blood pressure Measurement unit the blood pressure (1 mmHg=O.133kPa) Motion may result in an Inaccurate measurement Batteries are law and need to be replaced. Stan measurement and sava tha measuring results for user 1. Stan measurement and sava tha measuring results for user 2. Blood pressure monitor IS detecting an Irregular headbeat during measurement. Year/MonthJOay, Hour/Mlnute Indicate the blood pressure level Blood pressure monitor IS detecting a healtbaat during measurement. 7

****** Page 6 ****** INTRODUCTION • Monitor Components LCD OISPLAY GRADE TIME MEM aUTTON Component list of pressure measuring system: 1. PCdA; 2. Air Pipe; 3. Pump; 4. Valve; Cuff. aATTERY CONIPARTMENT List 1) Wrist Blood Pressure Monitor AP-WBPM810 2) 2xAAA batteries 8 3) user manual SYSTOLIC DIASTOLIC PULSE RATE ET BUTTON START,’STOP aUTTON CUFF (Type BF applied part) BEFORE YOU START • Installing and Replacing the Batteries • Slide off the battery cover. • Install the batteries by matching the correct polarity, as shown below. Always use the correct battery type (2 x AAA batteries). Replace the cover. Replace the batteries whenever the below happen +LO shows •Display is dim. • Display does not light up CAUTION • • • • • Do mt use new and used batteries together. Do mt use different types of batteries together. Do mt dispose the batteries in fire. Batteries may explode or leak. Rennove batteries if the device is not likely to be for same time. Worn batteries are harmful to the environment. 00 not dispose wfth daily garbage. Rennove the old batteries from the device following your local recycling guidelines. 9

****** Page 7 ****** BEFORE YOU START Setting Date, Time and Measurement Unit It is important to set the clock before using your blood pressure monitor, so that a time stamp can be assigned to each record that is stored in the memory. (year :2014—2054,time format:24 H/12 H) 1 When the monitor is off, hold pressing “O” button for about 3 seconds to set BEFORE YOU START the time format. 2. Press the ” Q” button to change the [TIME FORMAT] between 12 hours and 24 hours. 3. When you get the right time format: press ” button to confirm your selection and it will turn to the next step. 10 4.Repeat steps 2 and 3 to confirm [HOUR] and [MINUTE]. 5 .Repeat steps 2 and 3 to confirm the [MONTHI [DAYI and [YEAR]. 6 After confirming the meausrement unit: the LCD will display “dOnE” and then tum off. 7 II

****** Page 8 ****** MEASUREMENT • Tie the Cuff 1. Remove all accessories (watch: bracelet,etc) from your wrist. If your $.ysiaan has diagnosed you with poor circulation in your wrist: use the other one. 2. Roll or push up your sleeve to expose the skin 3. Apply the cuff to your wrist with your palm facing up. 4• Position the edge of the cuff about lcm—1.5cm from wrist joints. 5, Fasten the wrist cuff around your wrist: leaving no extra room between the cuff and your skin. If the cuff is too loose, the measurement will not be accurate. 6. Sit comfortably with your tested wrist resting on a fiat suäace. Place your elbow on a table so that the cuff is at the same level as your heart. Tum your palm upwards. Sit upright in a chair, and take 5-6 deep breaths. 7• Helpful tips for patients, especially for patients wth Hypertension: • Rest for 5 minutes before first measuring. • Wait at least 3 minutes between measurements. This allows your blood circulation to recover. Take the measurement in a silent room. • The patient must relax as much as possible and do not move and talk during the measurement procedure. • The cuff should maintain at the same level as the right atrium ofthe heart • Please sit comfortably. Do not cross your legs and keep your feet flat on the ground. • Keep your back against the backrest of the chair. • For a meaningful comparison: try to measure under similar conditions. For example: take daily measurements at approximately the same time: on the sanne wrist or as directed by a physician. 12 MEASUREMENT • Select the User ID Before you start the measurement, please select the desired user 10 first. 1 -When the blood pressure monitor is off: press and hold Q”buüon until the user 10 blinks. Then press • QC button to change the user 10 between user 1 and user 2 Press ” button to confirm your selection 2. After confirming the user 10, the LCD will tum off. Then you can start your measurement now. 13

****** Page 9 ****** MEASUREMENT Start the Measurement 1 When the monitor is off: press ” button to turn on the monitor, and it will finish the whole measurement (Take user 1 for example.) DATA MANAGEMENT Recall the Records 1. When the monitor is off: press ” button to show the average value of the latest three measurement records. (Take User 1 for example.) LCD display F888 Inflating and measuring. Adjust the zero. Display and save the result. m 116 2. Press “Q ” button or ” O” The date and time will display alternately. button to get the record you want 83 The corresponding tine is 2:10. 2. Press ” button to power off, otherwise it will tum off within 1 minute. Tips: Maxmum 60 records are both for user 1 and user 2. 14 83 The corresponding d8te is Mey 1 lth. 15

****** Page 10 ****** DATA MANAGEMENT 3. If you want to c ck other user’s measurement records, please press ” button to turn off the blood pressure monitor. Then press and hold Q” button to enter the selecting user mode, press” Q ‘t again to change the user, when the desired user 10 blinks, press “O” button to confirm. Then press” Q ” button to check the records of the selected user. R 81 ACAUTION The most recent record (1) is shown first. Each new measurement is assigned to the first (1) record. All other records are pushed back one digit (e.g., 2 becomes 3, and so on), and the last record (60) is dropped from the list. 16 DATA MANAGEMENT Delete the Records If you did not get the correct measurement, you can delete all results by following steps below . (Take User 1 for example.) I. In the memory mode, hold pressing ” q ” button for a seconds, the flash display “User 10+ dEL All” will show. 2.Press to confirm deleting, the LCD displays ” dEL dOnE” and the monitor will tum off. Note: To exit out of delete mode without deletin any records: press g “O” to button before pr confirm any delete commands. 3.1f there is no record, the right display will show EEL dEL 17

****** Page 11 ****** INFORMATION FOR USER Tips for Measurement Measurements may be inaccurate if in the following INFORMATION FOR USER • Maintenance In order to get the best performance, please follow the Within 1 hour after dinner or drinking Within 20 minutes after taking a bath In a very cold environme 18 Immediate measurement after tea, coffee: smoking When talkinq or movinq vour fingers O 0 When you want to discharge urine instructions below. 0 Put in a dry place and avoid the sunshine Avoid intens shaking and collisions using wet cloths to remove dirt ACAI-JTION Avoid touching water, clean it with a dry cloth In case Avoid dusty and unstable- temperature environment Avoid washing the cuff If you have any problems With this device, such as setting up, maintaining or using, please contact the SERVICE PERSONNEL of AccuraPulse. Oon’t opan or repair the device by yourself. • Please report to AccuraPulsa if any unexpected operation or events occur.

****** Page 12 ****** ABOUT BLOOD PRESSURE What are systolic pressure and diastolic pressure? ABOUT BLOOD PRESSURE Why does my blood pressure When ventricles contract and pump blood out of the heart, blood pressure reaches its nnaximum value, the highest pressure in the cycle is known as systolic pressure. When the heart relaxes between heartbeats, the lowest blocd pressure is diastolic pressure. Systolic blood discherging ert iastolic blood entæing ven relax What is the standard blood pressure classification? The chart on the right is the standard blood pressure classification published by American Heart Association ACAUTION Th’ $ e rt relets :ztewies pressure C3tEPIY HE” gressure Stage 1 Pressure rrrnH! trsn IZO IN-IE IN-lag IZ ngrer COEIE I-ICIErtrsn IE srsc•r mm-ig tess n 120 Only a physician can tell your nrmal BP range. Please contacta physician if your measuring result falls out of the range. Please note that only a physician can tell whether your blood pressure value has reached a dangerous point. Irregular Heartbeat Detector An irregular heartbeat is detected when a heartbeat rhythm varies while the unit is measuring the systolic and diastolic blood pressure.Ouring each nneasurement, this av.’lprnent records the heartbeat intervals and works out the standard deviation. If the calculated value is larger than cr equal to 25%, the Irregular heartbeat symbol appears on the symbol when the measurement results are displayed. CAUTION The appearance of the IHB icon indicates that a pulse IrregulariW consistent with an Irregular heartbeat was detected during measurement. Usually this is NOT a cause for concern. However, if the symbol aptEars often, we recommend you seek medical advice. Please note that the device does not replace a cardiac examination, but serves to detect pulse irregularities at an early stage. 20 fluctuate throughout the day? 1. Individual blood pressure varies multiple times everyday. It is also affected by the way you tie your cuff and your measurement position, so please take the ræasurement under the same conditions. 2.1fthe person takes medicine, the pressure will vary more. 3.Wait at least 3 minutes for another measurernent. • Why do I get a different blood pressure at home compared to the hospital? The blood pressure is different even throughout the day due to weather, emotion, exercise etc, Also, there is the “‘White coat” effect, which means blood pressure usually increases in clinical settings. Is the result the same if measuring on the right wrist? It is 0k for both wrists: but there will be sot-ne different results for different people. We suggest you measure the same wrist every time. What you need to pay attention to when you measure your blood pressure at home: If the cuff is tied properly. If the cuff is too tight or too loose. If the cuff is tied on the wrist. If you feel anxious. Taking 2-3 deep breaths before beginning will be better for measuring. Advice: Relax yourself for 4-5 minutes until you calm down. 21

****** Page 13 ****** TROUBLESHOOTING This section includes a list of error messages and frequently asked questions for problems you may encounter with your wrist blood pressure monitor. If the products not operating as you think it should, check here before arranging for servicing. PROBLEM SYMPTOM Display is dim or No power will not light up. Low batteries Error Show on +1.0 the display Err 1 shows Err 2 shows Err 3 shows CHECK THIS Batteries are exhausted. Batteries are inserted incorrectly. Batteries ara low. The cuff is too loose The cuff is very tight The pressure of tha cuff is excess- A calibration error occurred message EEA, shows on the display. 22 REMEDY Replace With naw batteries. Insen the batteries correctly. Replace with new batteries. Refasten the cuff and then measure again. Refasten the cuff and then measure agavn. Relax for a moment and then measure again. Retake the measurem.ent. Ifthe problem persists: contact the retailer ar our service department for further assistance. Refer to the warranty for contact information and retum instructions. Power supply Display mode Measurement mode Measurement range Accuracy Normal working condition Storage & transportation condition Measurement perimeter of the wrist Weight External dimensions Attachment Mode of operation Degree of protection Protection against ingress of water Software version Device classification SPECIFICATIONS aattary powered made: batteries alue LCD with backlight V A.35mmx46mm testing mode Rated cuff pressure: OmmHg-zegmmHg (0kPa Measurement pressure: SMS: aommHg-230mmHg ca.OkPa-30 7kPa) OIA: 40mmHg-130mmHg (5.3kPa-17.3kPa) Pulse value: Pressure: s•c-40-c Pulse value: ±5% Temperature: to 40’C Relative humidity: S85%RH Atmospheric pressure: 86kPa to 106kP8 Temperature: -20’C to 60’C Relative humidiW: IO%RH to 93%RH Atmospheric pressure: SOkPa to 106kP8 About 13.Scm-21 .Scm Approx.10•8g (Excluding the batteries) Approx.61 mmx88mrnx27.5mm (Exclude the cuff) 2*AAA batteries, user manual Continuous operation Type BF applied part 1922: The first numbar 2: Protected against salid foreign objects of 12,5mm O and greater. Tha second number: Protected against vertically falling water drops when enclosure titled up to 15′. Vertically falling drops shall hava no harmful effects when tha enclosure is titled at any angle up to ISO on either side ofthe vertical. AIO Internally Powerad ME Equipment WARNING: No modification of this equipment is allowed. 23

****** Page 14 ****** CONTACT INFORMATION Contact Information For more information about our products, please visit Distributed By. Gurin Products LLC 2522 Chambers Road, Suite 100 Tustin, CA-92780 USA Questionsmarranty FCC Statement This device cornplias with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including inteäerence that may cause undesirec:l operation. 24 COMPLIED STANDARDS LIST Complied Standards List Risk management Labeling user manual General Requirements for Safety Electromagnetic compatibility Performance requirements and Clinical investigation Software life-cycle processes Usability’ ISOEN 14g71:2012 b,ledical davicas — Å$ication af risk rænagement to n-tedical devices ISO/EN 15223-12012 Medical Symbols to be I-sed with nzdical device lab—Ming and information to be supplied. Gåneral requirements EN 1041 •2008 Information supplied by the manufacturer of nzdical devices IEC 60601-1: 2005+A1 2012 Medical aquipment- Part 1: General requiremenE for basic safety and essential perforrænce IEC 60601-1-11 b,ledical electrical equipment – Part 1-11: General requirements for hasic safety and essential performance – Cdlateral standard: Requirernents far medical electrical equipment and medical electrical systems used in the hame healthcare ewironment IEC/’EN8C€01-1Z2007 equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard. Electromagnetic compatibility – Requirements ard tests IEC Medical electrical aqui.-nent- Part 2-30: Particular for tha basic safety and essential performance of automatad s.hygrnomanometers ANSIIAAMI 2008 Manual, electronic, or autoræted sphygmomanornetars IEC/EN software – Software life cyc le processa IEC 82366 Medical devices – Application of usabilitj’ engineering to medical devices (IEC 62.E6:2Cff) IEC 80801-1-6 Medical electrical equipment – Pan 1 – 8: General requirem•nts for basic safety and essential performance – collateral standard Usabifty 25

****** Page 15 ****** EMC GUIDANCE EMC Guidance 1) * This product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided, and this unit can be affected by portable and mobile RF communications equipment. 2) * Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit This may result in incorrect operation of the unit. 3) * Cautiom This unit has been thoroughly tested and inspected to assure proper performance and operation! 4) * Cautiom This machine should not be used adjacent to or stacked With other equipment and that if adjacent or stacked use is necessary, this machine should be observed to verify normal operation in the configuration in which it will be USal. Table 1 Guidance and MANUFACTURER’s declaration – ELECTROMAGNETIC EMISSIONS- for all ME EQUIPMENT and ME SYSTEMS Guidanæ and manuiseurer’s declarstion — electromagrætic emissions The device is intended for use in the electrrnagneti: environment specified below. The custc•ner the user of the should thst it is in EMC GUIDANCE Table 2 Guidance and MANUFACTURERs declaration — electromagnetic MMUNITY – for all ME EQUIPMENT and ME SYSTEMS Guidsr:vze n-snuiaeurer’E eclaration — electromagrætic immuniPj’ The device is intended for use in the e—ctrorrsgnetic environment tEBw The customer or the user of the deve should assure that it is used in so:h an such an environment. E missins test RF emissions CISPR 11 RF emisszns CISPR 11 Harmonic emissions IEC Voltage fluctuations/ flicker emissions IEC 26 C•npliance Group 1 Not agø:able Not agpzable Electron-—gnetic environment – guidarc:e The device uses RF e•-ergy only for its internal functin. Therefore, iE RF emissions are very are not likely to C.SUSE any interference in nearby electronic eguipment. The devi:e is suitable fu use in all establishments, Including donnestic establishrr=nts and those direct unnected to the public low-vol* power su netvvork thst supplies buildings used ior domestic purposes. dischsrge (ESC’) IEC 01003-4-2 fast tans•nfturst IEC surge IEC Voltage dips. short inærruptions voltage variations on gv.ver supply input lines IEC Power frequency magnetic IEC610CO-4-8 NOTE UT IEC test kV kV air pct.ver supply lines ±1 W for input/output lines ±1 W line(s) to inels) W line(s) to EAt-th dip in LY for 0.5 cycle dip in for cyc:æ dip in for 25 cye:s dip in LY for: s Campliance Evel kV untact kV air Not applics& Not applics& Not applics& 3A,’m Electron-s.gnetic enuirnment – guidance Floors should cmncretear cersmic tile. If fo•rs are covered with synthetic maærisl, the relstive humidifi synuld be Mains power synuld that of a typical cmmmercial zr hospital environment. Mains power pusliPi synuld that of a typical cmmme•-cial zr hospital environment. Mains power pusliPi synuld that of a typical ammercial zr hospital environment. lithe user of the device —uire:s antinued c•perstion during pmver rrläirrs interruptions, it is recommend—S that the device be powered from —n uninterruptible gv.ver soy or a battery. Povær frequency magnetZ fields synuld be at levels characteristic oi 3 typical location in a typical cmmmercisl hospital enuirnment. a.’ msins veage prZr to apßicaticn of the test level. 27

****** Page 16 ****** EMC GUIDANCE Table 4 Guidance and MANUFACTURER’s declaration — electromagnetic IMMUNITY — for ME EOLJA,IENT and ME SYSTEMS tl-Et are rot LIFE-SUPPORTING —rd msnufacturers declaraticn — ±ztrornagnetz immunity The device is intended ior use in the electromagnetic environment specified below The custc•ner the USE ofthe should 3ESUre thst it is used in sw:ål —n environment. EMC GUIDANCE Table 6 Recommended separation distances between ponsble and •mabile RF communications equipment and the ME EQUIPMENT or ME SYSTEM — for ME EQUIPMENT ME SYSTEMS that not LIFE-SUPPORTING Recommended separation distances between portä&eand mobile RF communications equipment and the device. The deviæ is intended fw use in an electromsgng,ic environment in which radiates RF disturb-nces are controlled. The custc•ner zr the user of the device csn help prevent interference Sy maintaining a minimum •iistsr:væ beüeen —rd mobile RF crnrrunicaticns equipment (transmittters} and the device recmmmended —cording to the rrsximu•rn output power ofthE ummuni:ations equipment. test CWIductEd RF IEC Radiated RF IEC 01000-4-3 IEC TEST LEVEL 3 Vrn-as 150 kHz to 80 MHz 2.5 GHz Compliance level Nat applicable Electromagnetz envirnment – Fcaable and RF corrmunications equipment Should be used no c:Zser to any the device, including cables, than the recommended separati•n distance caZulatEd from the equation applicable to the frequency of the transmitter. Recommended separatim distame d = 1.20 d = 2.3 MHZ where P is the maximu•rn power rsting of the trsnsmitter in watts according to the transmitter manufszturer —rd d is the recommended separation distsnce in metres Field strengths from fixed RF trsnsmit•ters, as determined by an elect-rnagneticsite survey. -should less than the compliance level in each frequency nteHerenæ may occur in the viciniti of equipment msrked with the fohwing symbol: Rated maximum outPJt power of transmitter 0.01 0.1 10 distance according to frequency oi trsnsmitte- 1m) 80 MHz _ 1.2 o. 12 0.38 1.2 3.3 12 80 MHz d=lüi 0.12 0.38 3.8 12 8WMHzt02.5GHz 0.78 7.3 NOTE 1 NOTE 2 80 MHz and MHz, the hi$ær frequency range applies. These gui&lires msy in 311 situations Electrur•gnetic prop—ustin is by 3bsorpti•n and refiection from structures, people. strerzihs from fixed transmitters. such as base ststions for radii’ (cellular cm-dless} and land mobile radios, smateur radio, AM and FM radic broad and TV hadzast canne predicted theoretically with accuracy To assess Electramagng,ic environment to fixed RF trsnsmit•ters, —n Electramagnetic site survey should be considered. Ifthe measured strength in the IzcatZn in vatich the device is exceeds appli:able RF corr.plisme level above, the device be observed to u•-ify normal c•perstin. If abnormsl perforn-l.:m-e is observed, additional measures msy be necessary, such ss re-orienting or relocsting the devi:æ. Overthe frequency range ISO kHz to SO MHz, strengths should less than 3Wm. 28 Far trsnsrritters rsted msximum output gma•er not list—S above, the recommended segsrstion d in metres (m} can be estim3,ed using the equation —pplZable to the trsnsrr•itær, P is the maximum output power ‘Sting of the trsnsmitter in ‘Watts according to the transmitter rrsnuiacturer. NOTE 1 At 80MHz a.CdNHz, the separation distance for the frequency rsnge apÄies NOTE 2 These guidelines may not apply in 311 situatZrrs. Electromagnetic propagatbn is affecæd by 3bsorpti•n and relection from structures, objects people. 29








Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.