Contec Medical Systems CONTEC08A-BT Electronic Sphygmomanometer (Blood Pressure Monitor) User Manual
Contec Medical Systems Co., Ltd. Electronic Sphygmomanometer (Blood Pressure Monitor) Users Manual
Users Manual
Foreword Please read the User Manual carefully before using this product. The User Manual which describes the operating procedures should be followed strictly. This manual detailed introduce the steps must be noted when using the product, operation which may result in abnormal, the risk may cause personal injury and product damage and other contents, refer to the chapters for details. Any anomalies or personal injury and device damage arising from use, maintain, store do not follow requirements of the User Manual, Our company is not responsible for the safety, reliability and performance guarantees! The manufacturer’s warranty service does not cover such faults! Note: Please read the User Manual carefully before using this product. Described in this User Manual is in accordance with practical situation of the product. In case of modifications and software upgrades, the information contained in this document is subject to change without notice. The warning items Before using this product, you should consider the safety and efficacy of the following described: The safety classification of this product is class Ⅱ equipment, type BF. Described each measurement results combined with clinical symptoms by qualified doctors. The reliability and operation of using this product whether meets the operation of this manual relate to the maintenance instructions. Warning: Replace accessories which not provided by our company may lead to the occurrence of errors.Without our company or other approved maintenance organizations trained service personnel should not try to maintain the product. Responsibility of operator The operator must carefully read the User Manual before use this product, and strictly follow the operating procedure of the User Manual Fully consider the security requirements during product design, but the operator should not ignore the observation for the patient and the state of machine. The operator has the responsibility to provide the use condition of the product to our company. Responsibility for our company Our company have the responsibility to provide qualified product which conform to company standard of this product. Our company have the responsibility to complete product installation, debugging and technical training according to the contract. Our company have the responsibility to complete product maintenance according to the contract. Our company have the responsibility to respond the requirements of user in time. The User Manual is writen by our company. All rights reserved. Contents Chapter1 Functions and Purpose ............................................................................................. 1 Chapter2 Safety Precautions ................................................................................................... 2 2.1 Operation about AC Adapter ..................................................................................... 3 2.2 Operation about Batteries .......................................................................................... 4 Chapter3 Main Unit ................................................................................................................ 5 Chapter4 External Interfaces ................................................................................................... 7 Chapter5 Dry Battery/AC Adapter Installation ....................................................................... 8 5.1 Dry Battery Installation ............................................................................................. 8 5.2 Using the AC adapter ................................................................................................ 8 Chapter6 Button Functions ................................................................................................... 10 Chapter7 Set Date and Time ................................................................................................. 11 Chapter8 Unit and Language ................................................................................................ 13 8.1 Measurement Unit ................................................................................................... 13 8.2 Language ................................................................................................................. 13 Chapter9 Alarm Function ........................................................................................................ 1 9.1 Physiological Alarm .................................................................................................. 1 9.2 Technical Alarm ........................................................................................................ 1 Chapter10 Measurement Mode ............................................................................................... 2 Chapter11 Application of the Sphygmomanometer ................................................................ 3 11.1 Accurate Measurement Way .................................................................................... 3 11.2 Applying the Cuff .................................................................................................... 3 11.3 BP Measurement ..................................................................................................... 4 Chapter12 Memory Fuction .................................................................................................... 6 12.1 Read Memory Values .............................................................................................. 6 12.2 Delete Memory Values ............................................................................................ 7 Chapter13 Bluetooth Data Sending ......................................................................................... 8 Chapter14 SpO2 Measurement Function ................................................................................. 9 Chapter15 SpO2 Measurement Method................................................................................. 11 Chapter16 Maintenance, Cleaning and Keeping ................................................................... 12 Chapter17 Error Message ...................................................................................................... 14 Chapter18 Troubleshooting ................................................................................................... 15 Chapter19 Meanings of Symbols .......................................................................................... 16 Chapter20 Specification ........................................................................................................ 17 II Chapter1 Functions and Purpose Description of functions: The Sphygmomanometer apply to measure the non-invasive blood pressure of human (adult, pediatrics, neonate), each user can store 100 items records of measurement results at most. Each record includes detailed measuring time, systolic pressure, diastolic pressure, average pressure, pulse rate and record number, etc. With 2.8 inch color LCD screen, clear interface, the function of data review is complete. User can implement ON/OFF, manual measuring, system setup, parameters change and other operations with seven buttons which are located on the front panel of the device. The device uses audible and visual alarm, when the battery power is low, the buzzer will intermittent buzzing and LCD screen displays "Low Power" to prompt user replace batteries. When the measurement data exceeds the set alarm limit, the font color of measurement results will change to red and the audible alarm will occur, user can open and close the alarm sound according to needs. Users can send measurement results which be automatically saved by device to mobile phone with bluetooth transmission function. Refer to the help or explication of the related software for specific operation. Purpose: The device apply to measure the non-invasive blood pressure and SpO2(optional) of human. Record parameter value of blood pressure to provide the reference for the health care professional Chapter2 Safety Precautions ●Before use, carefully read the "Safety Precautions" for a correct use. ●To prevent users suffered hurt or damnification due to improper use,see "Safety Precautions",and use this product properly. For safety reasons, be sure to comply with safety precautions. Note If not to use correctly, it exists that a potentially hazardous situation which may result in injury to the user or patient or damage to the equipment or other property. Note Human and the surrounding environment are in the range of electromagnetic radiation which generated by this device,there is no energy hazard to human or the surrounding environment, also not affected by the electromagnetic interference of the external device. This device has slight energy radiation,should be avoided too close to the high precision requirements equipment. Note Self-diagnosis and treatment using measured results may be dangerous.Follow the instructions of your physician. Please hand measurement results to the doctor who know your health to accept diagnosis. For severe blood circulation disorder or arrhythmia patients, please use the device under the guidance of a doctor. Otherwise it may lead to acute hemorrhage, or measurement error as a result of squeezed arm. Infant and the person who can't express oneself can't use the device Otherwise it may cause accident or dissension Please do not use for any other purpose. Otherwise it may cause accident or holdback. Please use special cuff. Otherwise it is possible that measurement result is incorrect. Please do not keep the cuff in the over-inflated state for a long time Otherwise it may cause risk Do not disassemble,repair and change the device Otherwise it can not measure correctly 2.1 Operation about AC Adapter Note Please use the dedicated AC adapter of this device. Otherwise it may cause trouble. Dedicated AC adapter must use AC 100V~220V. Otherwise it may cause fire or electric shock. When there is breakage of dedicated AC adapter plug or wire,please do not use it. Otherwise it may cause fire or electric shock. Please do not plug or unplug the adapter on the socket with wet hands Otherwise it may cause electric shock or injury. 2.2 Operation about Batteries Note Please use 4 "AA" manganese or alkaline batteries, do not use batteries of other types. Otherwise it may cause fire. New and old batteries, different kinds batteries can not be confusion. Otherwise it may cause battery leakage, heat, rupture, and damage to Electronic Sphygmomanometer. Please don't put wrong the positive and negative of battery. When the batteries power exhausts, replace with four new batteries at the same time. Please take out the dry batteries when you do not use the device for a long time. Otherwise it may cause battery leakage, heat, rupture, and damage to Electronic Sphygmomanometer. If electrolyte of the batteries immodestly get in your eyes, immediately rinse with plenty of clean water. It will cause blindness or other hazards,Should immediately go to the nearest hospital for treatment If electrolyte of the batteries immodestly glues on the skin or the clothes, immediately rinse with plenty of clean water. Otherwise it may hurt the skin. Advice Do not subject the device to strong shocks, such as dropping the unit on the floor; Do not inflate before the cuff wrapps around the arm; Do not inflect the cuff and the air tube forcibly. Chapter3 Main Unit Display Cuff Plug Cuff Air Plug Up/Down button Memory button AC adapter socket Menu button USB socket On /Off button Start /stop button Accessories: Adult Cuff Dry Battery (Cuff specification: limb circumference 22-32cm (middle part of upper arm)) User Manual Optional Accessories: AC adapter Input: voltage: AC 100V~220V frequency: 50Hz/60Hz Rated current:AC 150mA Output: DC 6.0V±0.2V 1.0A or DC5.0V±0.2V 1.0A SpO2 Probe: Y10UCH150 A. SpO2 measurement Range:0%~100% Error: 70~100%:±2%;Below 70%:unspecified B. Pulse rate measurement Range:30bpm~250bpm Error: ±2bpm or ±2%(select the larger) C. Optical sensor: red light(wavelength: 660nm, 6.65mW) infrared light(wavelength: 880nm, 6.75mW) Chapter4 External Interfaces Note Please hold the air plug to remove the NIBP cuff. ①Cuff Socket Left side The right side of the device is USB socket and AC adapter socket USB socket AC adapter socket Right side Note The cuff socket and AC adapter socket of the sphygmomanometer only connect to the stated equipment which accord with the requirements of IEC 60601-1: 1988 “Medical electrical equipment-Part 1: General requirements for safety”. Chapter5 Dry Battery/AC Adapter Installation This product can use dry batteries as well as AC adapter. ① ② ③ 5.1 Dry Battery Installation ① Demount the battery cover in the direction of the arrow. ② Install "AA" dry batteries according to ③ Slide to close the battery cover. Icon “ ” polarities. : the batteries power will exhaust. Replace with four new batteries (the same sort) at the same time. Test while low power may cause data deviation and other problems. Turn the unit off before replacing the batteries. Note Dispose of the batteries according to applicable local regulations about environmental. 5.2 Using the AC adapter ① Connect sphygmomanometer and the AC adapter. Insert the AC Adapter Plug into the AC Adapter socket on the right side of the device. ② Please insert the power plug of AC adapter into the AC 100V~240V socket. Note When cut off the power, first cut off the connection of power socket and the regulated power supply, then cut off the connection of regulated power supply and the sphygmomanometer. Please be sure to use dedicated AC adapter. Note When regulated power supply and dry batteries are both used at the same time, the dry battery power will not be consumed. Switch regulated power supply and dry batteries when the device is off, otherwise, the device may shutdown due to power failure. Chapter6 Button Functions All the operations to the Electronic Sphygmomanometer are through buttons. The names of the buttons are above them. They are: 【 ON/OFF】 ON/OFF button. press it to turn on/off the device. 【 START/STOP 】 Press to inflate the cuff and start a blood pressure measurement. When measuring, press to cancel the measurement and deflate the cuff. Long press this button can connect the network fleetly . The three buttons correspond with the hint in the LCD screen downside, pressing any button will carry on corresponding function, eg:【MENU】 【ENTER】【LIST】 etc. Up and down buttons respectively carry on the functions of moving the cursor up and down, changing the parameters and switching the status. 10 Chapter7 Set Date and Time It is necessary to set date and time after power on. The Electronic Sphygmomanometer can automatically stores measurement results with date and time If dry batteries power exhausts or removed, the time to stop. At the moment, please reset date and time. Short-term(less than 5 minutes) power cut does not affect time.(such as replacing batteries) The Electronic Sphygmomanometer stores 100 groups of measurement results at most. If the date and time are set correctly, the date and time when measuring will be correct in the memory, otherwise it may not be correct. Note Correctly use data upload function: 1. First, make sure the time is right, there are three modes of time setting: (1)When using the Sphygmomanometer for the first time or after the Sphygmomanometer has been placed without power supply for a certain time(more than 5 minutes), after power on, there is a prompt of time error on the main interface, set date and time with 【UP】, 【DOWN】 and 【ENTER】 button. (2)Press 【MENU】 button on the main interface to enter system menu, then enter 【SYSTEM TIME】 item, the current time will be displayed on the screen. Set date and time with 【UP】, 【DOWN】 and 【ENTER】 button 11 (3)When the Sphygmomanometer is ON, users manually search and connect it through mobile phone software, the time of the Sphygmomanometer will be synchronized. 2. After setting, select 【CONFIRM】 option and press 【ENTER】 button to confirm the setting value. If you do not want to change the time, select 【EXIT】 option and press 【ENTER】 button to return to the previous menu. 12 Chapter8 Unit and Language 8.1 Measurement Unit There are two units: "mmHg" and "kPa". The default is "mmHg". Enter 【SYSTEM SETUP】 submenu in 【MENU】, then select 【UNIT】 option to switch units between "mmHg" and "kPa". 8.2 Language The sphygmomanometer supports both English and Chinese, the default is Chinese, enter 【SYSTEM SETUP】 submenu in 【MENU】 and select 【LANGUAGE】 can switch languages. 13 Chapter9 Alarm Function Alarms are classified into two categories: technical alarm and physiological alarm. 9.1 Physiological Alarm User can press 【MENU】 button to enter system menu, select 【ALARM SETUP】 option to enter its interface, and then set alarm on-off and the high and low alarm limits, during setting alarm parameter, if the high limit lower than the low limit, the device will display a prompt, users allow or reset it according to the actual situation. When the measurement result is higher than the high limit or lower than the low limit, the physiological alarm will occur. Under physiological alarm, press any button to cancel this alarm, and it does not affect the next alarm; the alarm can be closed permanently with alarm switch of the alarm setup menu until the alarm switch be opened again. 9.2 Technical Alarm When the battery is low and the alarm is on, the device will sound an alarm. This alarm can not be cancelled, unless you turn off the alarm switch or replace the power supply. Chapter10 Measurement Mode The sphygmomanometer can be set to neonate, pediatrics and adult three modes. Press 【MENU】button to enter 【SYSTEM SETUP】 interface, then users can set different modes through 【USER TYPE】 option. Chapter11 Application of the Sphygmomanometer 11.1 Accurate Measurement Way Measurement in quiet and relaxing state. 1.Place your elbow on a table. 2.The cuff is level with your heart. 3.The palm of the hand is up, and the body relax. Try to measure your blood pressure at the same time each day with the same arm and the same pose for consistency. The high and low location of cuff will cause changes in measurement results. Do not touch Electronic Sphygmomanometer, cuff and windpipe during measurement. Measurements should be taken in a quiet place and the body relax. Remain still 4~5 minutes before measurement. Relax the body, do not let the muscle activity. Do not talk and movement during the measurement. Wait 4~5 minutes between measurements. Please use the sphygmomanometer at an environment of suitable temperature and humidity(refer to Chapter20), otherwise it will cause measurement error. 11.2 Applying the Cuff The measurement can be carried out by applying the cuff on left or right arm. Bare your arm or cloth close-fitting clothing during measurement. Carry out the operation in a room with comfortable temperature. When measuring, take the thick clothes off instead of rolling up the sleeves. In order to measure accurately, pay attention to applying the cuff properly (left arm). ① Insert the arm cuff air plug in the cuff socket of sphygmomanometer. ② Stretch cuff into a barrel for the arm can conformable enter into the barrel. ③ Left arm penetrate through the cuff, the air tube of the cuff will pass the top of your palm. ④ Wrap the cuff to your upper arm. Make the air tube inside the forearm and aligned with your middle finger. ⑤ The bottom of the cuff should be approximately 2cm~3cm above your elbow. ⑥ Be fixed with cloths, and wrapped tight cuff, the arm and the cuff should not have gaps. 11.3 BP Measurement 错误!未找到引用源。Press 【START/STOP】 button to take a measurement. Start measurement Measurement result During measurement, please keep correct pose and quiet state, do not move. Wish to stop measurement During measurement, press 【START/STOP】 button, stop press,release the air from the cuff. 错误!未找到引用源。Confirm the Measurement Value The measurement value can be stored automatically, using [memory function] (refer to Chapter12). *Self-diagnosis and treatment using measured results may be dangerous. Follow the instructions of your physician. Note Wait 4-5 minutes between measurements. When repeated measurements, because, the arm appears congestion, it may not get correct blood pressure measurement. After the blood flow, take a measurement once again. When some factors affect the measurement results in measurement process, error messages will appear on the screen, you can obviate the malfunction and restart a measurement. 错误!未找到引用源。In no physiological alarm state, press any button to carry on the corresponding button function; in audio alarm state, press any button (except 【ON/OFF】 button) to clear up the audio alarm. ④Take off the cuff, press 【ON/OFF】 button to turn the device off. *The device will automatically turn off after 1 minute in which there is no operation to the device and no connection with SpO2 probe, even if you forget to turn the power off. Chapter12 Memory Fuction The devicer is designed to store and display the blood pressure, pulse rate values and the date and time when measured, which are up to 100 groups. If there have been stored 100 groups, the earliest results will be deleted when saving the 101 group of measurement results. 12.1 Read Memory Values 1. In the main interface (interface when boot-strap), press 【MEMORY】 button to review the most recent measurement values in large-print, press 【LIST】 button to enter data list interface. The device displays memory value with the number from 1 to 100. The little dot which is behind serial number represent that the data has been uploaded or the data was measured at wrong device time. 2. Press 【UP】/【DOWN】 button to circularly switch the former measurement values. *The right figure shows that there is no Measurement result Press 【LIST】 button to enter the data list interface. The little dot which is before serial number represent that the data has been uploaded or the data was measured at wrong device time. 3. Press 【TREND】 button to enter the trend graph interface. Finish displaying the measurement values. Press 【EXIT】 button to return to the main interface or long press 【ON/OFF】 button to turn the power off. *The device will automatically turn off after 1 minute in which there is no operation to the device and no connection with SpO2 probe, even if you forget to turn the power off. 12.2 Delete Memory Values Users can delete all memory values of users instead of separately delete the special item. 1. Press 【MENU】 button to enter the system menu, select 【DELETE DATA】 to enter the confirm interface, after confirming again, all measurement results will be deleted. 2. Finish Operation Select 【CONFIRM】 or 【EXIT】 to return to the previous menu, or long press 【ON/OFF】 button to turn the power off. *The device will automatically turn off after 1 minute in which there is no operation to the device and not connect SpO2 probe , even if you forget to turn the power off. Chapter13 Bluetooth Data Sending The sphygmomanometer can send the storage BP value to PC through bluetooth.(refer to software help for details) Users connect the sphygmomanometer to PC after searching it on PC client, after completing the connection, data will transmit to PC through bluetooth. After the sphygmomanometer finished data transmission, it will mark in the measurement review interface. This mark is a green dot, it on the right side of the top right corner serial number in memory interface; it on the left side of left serial number in BP list interface. Note: when sphygmomanometer time error, the device manage measurement data but does not upload it, now the dot in memory interface is red. Chapter14 SpO2 Measurement Function Precaution for SpO2 measurement Warning ◎Pulse oximeter can overestimate the SpO2 value in the presence of Hb-CO, Met-Hb or dye dilution chemicals. ◎ES (Electrosurgery) equipment wire and SpO2 cable must not be tangled up. ◎Do not put the sensor on extremities with arterial catheter or venous syringe. ◎Do not perform SpO2 measuring and NIBP measuring on the same arm at one time, because obstruction of blood flow during NIBP measuring may adversely affect Note ◎Make sure the nail covers the light window. The wire should be on the backside of the hand. ◎SpO2 value is always displayed in the fixed place ◎The fingers which are too thin or too cold may affect the measure accuracy, please insert the thicker finger such as thumb or middle finger deeply enough into the probe. ◎The SpO2 probe is suitable for children above four years old and adults(Weight should be between 15Kg to 110Kg). The device may not work for all patients. If you are unable to achieve stable readings, discontinue use it. Do not use the device on infant or neonatal patients. ◎The update period of data is less than 5 seconds, which is changeable according to different pulse rate values. ◎Pulse rate waveform through the normalization, when pulse rate waveform becomes smooth and stable, the read value is optimal value, and the waveform at the moment is the most standard one. ◎The maximum temperature for the contact surface of the device with the body is less than 41℃, and the temperature is measured by a temperature measuring device. ◎The SpO2 probe does not have an alarm function. ◎The SpO2 probe has been calibrated before leaving factory. Warning ◎Please don't measure this device with function tester for the device's related information. ◎The person who is allergic to rubber can not use this device. ◎Check if the cable of SpO2 probe is in normal condition before monitoring. After unplugging the SpO2 probe cable from the socket, SpO2% and bmp on the screen will disappear. ◎Do not use the SpO2 probe once the package or the probe is found damaged. Instead, you shall return it to the vendor. ◎The uncomfortable or painful feeling may appear if using the device ceaselessly, especially for the microcirculation barrier patients. It is recommended that the sensor should not be applied to the same finger for over 2 hours. ◎Prolonged and continuous monitoring may increase jeopardy of unexpected change of dermal condition such as abnormal sensitivity, erubescence, vesicle, repressive putrescence, Particularly in newborns or in a Perfusion disorders and changes or immature skin form of the patient. According to skin quality change, correct optical path alignment and attachment methods to regularly check the place of SpO2 probe, and change the attachment position when the quality of skin decline. More frequent examinations may be required for different patients. 10 Chapter15 SpO2 Measurement Method 1. Attach the sensor to the appropriate site of the patient finger as following figure. Place SpO2 probe 2. Plug the connector of the SpO2 probe cable into the USB socket in the lower right of the device. The main interface will switch to SpO2 interface. This operation brings no affection to other functions. Measurement Limitation During operation, the accuracy of oximeter readings can be affected by: High-frequency electromagnetic interference such as electrosurgical apparatus connected to the system; Intravenous dyestuff; Excessive patient movement; Outside ray radiation; Improper SpO2 probe installation or incorrect contact position of the patient; SpO2 probe temperature (optimal temperature between 28°C and 40°C) Place the SpO2 probe on an limb that has a blood pressure cuff, arterial catheter, or intravascular line. Concentrations of dysfunctional hemoglobin, such as carboxyhemoglobin(COHb) and methemoglobin(MetHb); SpO2 is too low; Bad circular injection of the part being measured; It is required to use SpO2 probe which is provided by our company, contact with our sale department when changes SpO2 probe. 11 Chapter16 Maintenance, Cleaning and Keeping *Please follow the instructions in the user manual. If you do not comply, our company will not assume responsibilities of the quality. Warning Must remove batteries and cut off the alternating power supply before cleaning the sphygmomanometer, accessories must be clean separately. Caution Do not high pressure disinfect the sphygmomanometer and accessories. Do not immerse the sphygmomanometer and accessories into any liquid. Do not use any sphygmomanometer and accessories that may be damaged or deteriorated. Cleaning: If there is something dirty on the sphygmomanometer and accessories, please wipe it with a dry and soft cloth. If the sphygmomanometer and accessories are very dirty, you can clean them with a soft cloth dampened with water or neutral detergent after the cloth can be full twisted. Maintenance: Frequently clean the Sphygmomanometer and accessories. The device should be calibrated regularly( or according to the calibration procedure of hospital). Users can go to the inspection agency designated by the state to calibrate it, or compared with the standard pressure gauge, at any measuring point, the maximal error of measuring the pressure in cuff should be ±0.4kPa(±3mmHg); also can contact with our company. Advice Do not use any naphtha, thinner or gas to clean. Do not attempt to clean or wash the cuff. 12 Keeping: Advice Do not place the device in the following areas: Easy to splash water areas. Direct sunlight, extreme hot, humidity, dust, causticity gas areas. Lean or the area which can cause vibration, impact. Chemicals or corrosive gas storage areas. Remove the batteries if the device will not be used for long time. Note The service life of the device is five years. When the product and accessories described in this manual are about to exceed the period of use, they must be disposed according to relevant product handling specification. If you want to know more information, please contact our company or representative organization 13 Chapter17 Error Message Error message will be displayed in the screen if there is something wrong when measuring. The causes and solutions are shown as follows: Error message Causes Solutions Function abnormal Please contact us Loose cuff Cuff is not connected correctly Correctly connect cuff(refer to chapter11) Air leakage Cuff plug fall off Air pressure error Air pressure error Self-test failure System error Weak signal overpressure Excessive movement Over range Saturated signal Time out Inserted the cuff plug in the windpipe correctly(refer to chapter11) Keep arm, body still, measure again The pulse is too weak or the cuff is loose Cuff is blocked or squeezed Correctly connect cuff(refer to chapter11) Correctly connect cuff(refer to chapter11) The signal extent is too big owing to the arm or body moving or other reasons when Keep arm, body still, measure again measuring It takes too much time 14 Chapter18 Troubleshooting Abnormal Phenomenons BP measurement values too high or too low No pressure Cuff deflates in short time Causes Solutions Cuff is not connected correctly Correctly connect cuff(refer to chapter11) Talk or move arms when measuring Keep quiet and restart a measurement The turnup clothing presses the arm Take off the clothing which presses the arm, and restart a measurement Cuff leakage Buy a new cuff The cuff windpipe is not correctly connected with cuff Correctly connect Loose cuff Correctly connect It can not carry on measurement when press the measurement button Power off suddenly when inflating Display nothing after hold the ON/OFF button Switch on the power once again and restart a measurement No use for a long time, the power of batteries can be exhausted owing to the changed temperature Charge batteries Power of batteries can be exhausted Charge batteries The battery polarities is reversed Correctly put in batteries Please hold the on/off button and restart an operation. Other phenomenon Please charge batteries If no, please contact us. 15 Chapter19 Meanings of Symbols Symbol Description Warning – refer to User Manual Refer to the accompanying document(the User Manual) SYS Systolic pressure MAP Mean pressure DIA Diastolic pressure PR Pulse rate (bpm) ADU Adult INFO Information The alarm is ON The alarm is OFF Low-power Full-power 1.no finger inserted to SpO2 probe 2.An indicator of signal inadequacy ClassⅡ equipment WEEE (2002/96/EC) Type BF Applied Part SN Serial number This item is compliant with Medical Device Directive 93/42/EEC of June 14, 1993, a directive of the European Economic Community. European Representative USB socket connect SpO2 probe(this item only applies to EU market) 16 Chapter20 Specification Name The Electronic Sphygmomanometer degree protection of against ingress of liquid Display mode Ordinary sealing device, without the function of preventing liquid from entering 2.8"color LCD Display NIBP Specifications Measurement Method Oscillometric method Working mode Manual operation Measurement Range Pressure adult 0~290mmHg(0~38.6kPa) pediatric 0~235mmHg(0~31.3kPa) neonatal 0~140mmHg(0~18.6kPa) Pulse: 40~240/min Inflation Overpressure protect adult 160mmHg pediatric 120mmHg neonatal 70mmHg adult mode 295±5mmHg pediatric mode 240±5mmHg neonatal mode 145±5mmHg Resolution Pressure: 1mmHg(0.133kPa) Accuracy Static pressure: ±3mmHg(±0.4kPa) The BP Value of the device is equivalence with the measurement value Error of Stethoscopy. The error meets all the conditions in the ANSI/AAMI SP-10:2002+A1:2003 +A2:2006. Operating Temperature/ Humidity Transport Storage +5ºC~40 ºC 15%RH~80%RH Transport by general vehicle or according to the order contract, avoid pounded, shake and splash by rain and snow in transportation. Temperature: -20ºC~+55ºC; Relative humidity: ≤95%; No corrosive gas and drafty. Atmospheric pressure 700hPa~1060hPa Battery 4 "AA" alkaline batteries, AC Adapter(AC, 100V-240V, optional) Dimensions 130(L)*110(W)*80mm(H) Unit Weight 300g(not including batteries) 17 Safety classification class Ⅱ, type BF applied equipment The service life of the device is five years or 10000 times of BP Service life measurement. FCC Cautions: 1) This device complies 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 interference that may cause undesired operation. 2) Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential 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 radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, 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 antenna. -Increase the separation between the equipment and receiver. -Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. -Consult the dealer or an experienced radio/TV technician for help. 3) Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. The device has been evaluated to meet general RF exposure requirement. The device can be used in portable exposure condition without restriction. 18
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