Instruction for Use Arm Type Electronic Blood Pressure Monitor Model: BSX579B *Please thoroughly read the Instruction for Use before using the unit. *Please save this Instruction for Use for further reference Version: A/0 Ref. No.: 8187M579B1 Released Date:2021.10.26 Software Name: Electronic Blood pressure Monitor software Software version: V1.0 Manufacturer & Lay operator:Shenzhen BSX Technology Electronics Co., Ltd. Address: Rm101&2/F~4/F, Building No.
1 TABLE OF CONTENT 1 PRODUCT INTRODUCTION ............................................................................................................................ 3 2 INTENDED USE ................................................................................................................................................. 3 3 IMPORTANT INFORMATION ........................................................................................................................... 4 4 SAFETY INFORMATION ..
10.2 Error indicators (Error Code) .................................................................................................................... 16 11 NOTICE ...................................................................................................................................................... 17 12 MAINTENANCE, REPAIR AND CALIBRATION ................................................................................... 18 13 CLEANING AND DISINFECTION ...............................
IMPORTANT INFORMATION To ensure a reliable reading follow these recommendations before taking a measurement: All physical activity, excitement, stress, eating, drinking, smoking, body posture and many other activities or factors (including taking a blood pressure measurement) will influence blood pressure value. Because of this, it is mostly unusual to obtain identical multiple blood pressure readings. Blood pressure fluctuates continually (day and night).
SAFETY INFORMATION To assure the correct use of the product, basic safety measures should always be followed, including the warnings and cautions listed in this Instruction for Use. SAFETY SYMBOLS USED IN THIS INSTRUCTION FOR USE WARNING CAUTION Indicates a potentially hazardous situation Which, if not avoided, could result in death or serious injury.
Use only BSX authorized parts and accessories. Parts and accessories not approved for use with the device may damage the unit. Use only the factory specified battery with this device. Do not use other types of battery. This may damage the unit. Measurements outside the cuff range are inaccurate and cannot be made, and may cause the cuff to fall off during inflation or other unpredictable events. The Monitor must be recharged every 6 months, otherwise the Limited warranty and the shelf life will end.
your individual physiological characteristics. 8) Cleaning and disinfection of the unit following use to prevent PATIENT cross infection.
7 CONTRAINDICATION AND STATEMENT 7.1 Contraindication It is inappropriate for people with serious arrhythmia to use the unit. This device is only intended for use in measuring blood pressure and pulse rate in adult population. Do not use this unit for any other purpose. The unit is not intended to be a diagnostic device. Self-diagnosis and treatment using measured results may be dangerous. Follow the instructions of your physician.
8.2 LCD Display Introductions 9 INSTALLATION AND USE 9.1 Battery level Introduction In shutdown mode, Press the Start/Stop button/memory button/setting button, then enter into measuring pattern/recording pattern/setting pattern. When it displays, system will detect the battery level and will indicate the battery level on LCD display. Details are as follows: 1) Battery Level is full or enough: Display the battery full icon( ) or the battery icon ( ), user can take measurement and read the memory.
3) BatteryCharge Indicator The power insufficiency battery icon ( or )will flicker to reminder user the monitor battery under charging. The Power fully battery icon ( ) is fixed to display after the monitor battery is charged. WARNING Do not plug or unplug the power cord into the electrical outlet with wet hands. The Blood Pressure Monitor cannot measure when charging. CAUTION Do not overload power outlets. Plug the device into appropriate voltage outlet.
6) 7) The CUFF must be neither too tight nor too loose, tightly wrap the cuff, and fix it with cloth buckle. Leave a finger gap between the arm and the cuff. Adjust the upward direction of the machine body on the left upper arm. Note: Please refer to the CUFF circumference range in “PRODUCT SPECIFICATIONS” to make sure that the appropriate CUFF is used. – Please keep the CUFF clean.
Placing your Arm on the monitor’s plastic case as shown, in the picture to aid in maintaining a correct and still Arm position.
trembling, shivering). 9.5 Blood pressure measurement 1) In the state of shutdown or standby, press the [Start/Stop] for starting up, it will start measurement automatically, and the CUFF will inflate automatically. * When the CUFF starts to inflate, the Monitor will start to work automatically. In the process of inflation, the Monitor will also detect the pulse, so please do not move your Arm in the whole measurement process, and remain static throughout the process.
a) b) Please consult a health care professional for interpretation of pressure measurements. The pictures in the measurement interface are only for reference. 10 FUNCTION SPECIFICATION 10.1 User Setting 1) In shutdown state, long press the “ON/OFF” (or name: START/STOP) key to enter user selection, press “MEM” to switch users. 2) Then press the “ON/OFF” (or name: START/STOP) key to enter the date setting and press the " MEM " key to set the year.
10.3 Memory Deletion In view of the memory, press and holding down the “MEM” button for about 2 to 5 seconds, and when the screen is fully displayed as “--”, then the memory is deleted. Memory deletion is a one-time removal of all measurement data under all users. 10.
No power. No display appears on the unit. Re-charge battery. Measurement values appear too high or too low. Blood pressure varies constantly. Many factors including stress, time of day, and how you wrap the CUFF, may affect your blood pressure, where you position your Arm, may affect your blood pressure. Review the sections “BLOOD PRESSURE MEASUREMENT METHOD ”. 11.2 Error indicators (Error Code) SYMBOL CAUSE CORRECTION When measuring, avoid the environment (e.g.
The Err7 CUFF Pressure Range was inflated above 295mmHg 295mmHg (39.3kPa), Refer to the clause “BLOOD when inflating the CUFF manually. PRESSURE MEASUREMENT METHOD”. The Systolic was measured out of the Err8 Do not inflate the CUFF Pressure Range above 1. Check whether the CUFF joint is loose. 2. The SYSTOLIC Blood Pressure is over range measurement range, please contact your doctor and follow his or her instructions. The Diastolic was measured out of the Err9 range. 1.
10) The CUFF should be placed at the same level as your heart. 11) During measurement, neither speak nor move your body and Arm. 12) Use on same Arm for each measurement. 13) This Monitors is designed for adults and should never be used on infants or young children. Consult your physician or other health care professionals before use on older children.
the Monitor on the ground). e) Please do not use volatile liquid to clean the Monitor. Please use soft and dry cloth to clean the outer shell. f) Clean the monitor with a soft dry cloth. Do not use any abrasive or volatile to clean the monitor. Do not attempt to clean the CUFF. g) Please do not use water to clean or moisten the CUFF, and when necessary, absorbent cotton dipped with 75% medical alcohol can be used to wipe it gently, so as to conduct disinfection. h) Drop, collision and bending, etc.
2) After cleaning, use dry medical gauze to remove water and dry thoroughly. 14.2 Disinfection Clean the Monitor with medical gauze in 75% medical alcohol to wipe the Monitor shell and CUFF for disinfection, dry thoroughly and then store or for taking a measurement. 15 DISPOSAL TREATMENT STATEMENT The product manufacturing date can be seen on the nameplate of the Monitor, and the product life is 5 years. WARNING: Do not throw away batteries with uncontrolled daily waste.
TYPE BF APPLIED PART Waste electrical and electronic product recycling icon. Rating for ME EQUIPMENT or an ME EQUIPMENT part complying with specified AP requirements on construction, marking and documentation in order to protect against HAZARDS of ignition of flammable anaesthetic mixtures. Rating for ME EQUIPMENT or an ME EQUIPMENT part complying with specified APG requirements on construction, marking and documentation in order to protect against HAZARDS of ignition of flammable anaesthetic mixtures.
WARNING. General warning sign, Indicates a potentially hazardous situation Which, if not avoided, could result in death or serious injury. CATION. Indicates a potentially hazardous situation Which, if not avoided, may result in minor or moderate injury to the user or patient or damage to the equipment or other property. Refer to instruction manual/booklet, to signify that the instruction manual/ booklet must be read.
Mode of operation Continuous operation CUFF circumference Approx. 220mm to 320mm Weight Approx. 370g (containing CUFF, Battery) Physical Dimensions(mm) Approx. 106 x 145 x 68.5 (Length*Width*Height) Measurement method Oscillometric method Pressure Range Pressure: 0mmHg to 295mmHg (0kPa to 39.3kPa) Systolic pressure:(8.0~34.0)kPa, [(60~255) mmHg] Measurement Range Diastolic pressure:(4.0~26.0)kPa, [(30~195) mmHg] Pulse rate: (40 to 180) beats/minute Blood pressure: ±3mmHg (±0.
18 LIMITED WARRANTY (Warranty Card) The Blood Pressure Monitor, excluding the Cuff, not including batteries, is warranted to be free from defects in materials and workmanship appearing within 5 years from the date of purchase when used in accordance with the instructions provided with the monitor.
FCC Warning Statement Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. 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.