DrKea 48920 Blood Pressure Monitor Upper Arm User Manual

DrKea 48920 Blood Pressure Monitor Upper Arm

Overview

❶ Battery indicator
❷ Ready for inflation
❸ Arrhythmia indicator
❹ Blood pressure indicator
❺ Date/time
❻ Memory indicator
❼ Systolic pressure
❽ Diastolic pressure
❾ Saved value

❶ Cuff
❷ Air tube
❸ Air tube connector
❹ Blood pressure indicator
❺ LCD-display
❻ MEM button
❼ START button

Important information

• Read the entire manual before using the blood pressure monitor.

• The blood pressure monitor is designed for adults and should not be used on infants or young children. Consult a physician before using the blood pressure monitor on older children.

• All physical activity (including blood pressure measurements) affects the blood pressure. The pressure also fluctuates between night and day. It is therefore recommended to measure at the same time of day every time.

• Relax for at least five minutes between measurements to restore the blood flow. Repeated measurements in a short span of time may affectthe blood flow.

• Keep in mind that it is unusual to get the exact same measurement every time. This is why the memory bank also displays an average.

• Always consult medical staff for a correct interpretation of the measurements.

• Persons with serious arrhythmia (irregular heartbeat) should not use this blood pressure monitor.

• Avoid measuring close to strong magnetic disturbances, such as cell phones or micro wave ovens.

• Remove the batteries if the blood pressure monitor won’t be used for a month or more to avoid battery leakage that may damage the device.

• Do not use other cuffs than the one provided.

• Do not share the cuff with ill or otherwise infected persons to avoid cross infection.

• This blood pressure monitor complies with the following standards:
  EN 1060-1: 1995 + A2: 2009
  EN 1060-3: 1997 + A2: 2009
  EN 60601-1: 2006/Al: 2013
  ISD81060-2: 2013
  EN 60601-1-2: 2015
  EN 80601-2-30:2019

• The Electronic Sphygmomanometers corresponds to the below standards: IS081060-2 :2013 (Non-Invasive Sphygmomanometers – Part 2: Clinical Validation Of Automated Measurement Type)

• All components belonging to the pressure measuring system, including accessories: Pump, Valve, LCD, Cuff and Sensor.

Intended use

This fully automatic blood pressure monitor is intended for use by medical professionals or home users. It is a noninvasive blood pressure measurement system intended to measure diastolic and systolic blood pressure as well as the pulse rate of an adult individual by using an inflatable cuff that wraps around the upper arm.

Maintenance

Do not drop the monitor or subject it to strong impacts. high temperatures. direct sunlight or water immersion.
If the monitor is stored in very low temperatures, allow it to acclimate to room temperature before using it. Remove the batteries before storing the monitor for longer periods of time

If you need to clean the monitor, use a dry, soft cloth. Dilute disinfectants and/or detergents. Do not use abrasive or volatile detergents. The cuff should be disinfected every two weeks if used in a hospital, clinique or similar environments.
The inner side can be cleaned with a moistened and squeezed with ethyl alcohol (75-90 %) and then dried by air. The cuff must not be machine washed, tumble dried or ironed. It is recommended to clean the cuff after every 200 uses. The monitor requires 6 hours to warm from the minimum storage temperature between uses until the monitor is ready for its INTENDED USE when the ambient temperature is 20 °C. Do not disassemble the monitor. No components should be repaired by the end user. Circuit diagrams, component part lists, descriptions, calibration instructions and other information can be supplied by the manufacturer for use by qualified personnel only. The monitor maintains these safety and performance characteristics for a minimum of 10000 measurements or three years. The cuff maintains its integrity for 1000 opening and closing procedures.

Specifications

continuous operatio.n
Ooeration temoerature| 10-40 ° C (50-104 °F)
Ooeration humiditv| $85%RH
Storaae and transport temperature| -20 °C to 50 °C (-4 °Fto 122°F)
Storaae and transport humiidtv| $85%RH
Pressure| 80 kPa- 105kPa
Machinesize| 150x95x41 mm
Cuff circumference| 22cm-42 cm
Weight| 235 a.
Measuring method| Oscillometric method, automatic air inflation and measurement
Memory volume| 30 measurements incl. time and date
Batteries| 4x AAA batteries (1.5V)
Batterv time| Uo to 100 measurements
Cuff pressure ranqe| 0-300 mmHq
Range of measurement| SYS 60-260 mmHgm,DIA: 40-199 mmHg, Pulse: 40-180 bpm
Measuirngaccuracy pressure/pulse| ±3 mmHg/Less than 60: ±3 bpm. More than 60:+ 5%

Installation

Batteries

Start by inserting the batteries. Open the lid on the back of the blood pressure monitor and insert four AAA batteries. Close the battery compartment. Replace all batteries when the display shows the battery symbol . Rechargeable batteries are not recommended.

The monitor, batteries and cuff must be disposed of according to local regulations at the end of their usage.

Time and date settings

Once you insert the battery, the monitor will enter the time and date adjustment mode. If the time is already set and needs to be changed, press and hold the START/ STOP and MEM buttons for 2 seconds in standby mode. The numbers will start blinking, change the values with MEM and confirm with START. The monitor turns off automatically after 1 minute if no buttons are pressed.

The cuff

1. Connect the air tube to the hole on the left side of the monitor. Make sure it is tight.
2. Insert the cuff through the loop so that it can be locked with the velcro.
3. Place the cuff around a bare upper arm, about 1-2 cm above the elbow.
4. Lock the cuff. One finger should fit between the skin and the cuff to make sure it is not too tight.

Measuring

Sitting

Sit down with your feet to the floor, do not cross your legs. Rest your arm and hand against a surface, e.g. a table, and let the air tube run along your arm. The cuff should be at the same height as your heart.

Lying down

Lie down on your back. Hold your arm along your body with your palm turned up. The cuff should be at the same height as your heart.

Measuring

Always measure on the same arm.

1. Press START.
2. The display soon shows the chosen memory bank (U1 – U4). Press MEM to switch. Each memory bank can contain 30 measurements.
3. The blood pressure monitor seeks zero pressure before it starts to inflate the cuff. The cuff is then deflated and the measurement is made.
4. The monitor calculates blood pressure and pulse and displays the result. If an irregular heartbeat is discovered, the heart symbol is also displayed. The measurement is saved to the memory bank.

The blood pressure monitor shuts down automatically if no button has been pressed for one minute. Press START to manually shut down the monitor during or after the measurement.

Memory function

The blood pressure monitor is equipped with four memory banks, U1- U4. Each bank
can store up to 30 measurements each.

Choose memory group

From the standby mode, press START. The display will show all symbols as a test.
After this it will show the current memory group (1-4). Press MEM to navigate between the four groups. Press START to confirm the chosen group or wait five seconds. Press START to return to the standby mode.

Show saved measurements

Press MEM while in standby mode to show saved measurements. The current memory bank will blink and the amount of measurements will be displayed.
Keep pressing START to navigate between the four memory groups and pressing
MEM to confirm. The meter will show the average value of the latest saved measurements taken between 05 – 09 the last seven days for the current memory bank. If no results are stored within this timespan the display will show zeros. Press MEM again to show the average value of the latest saved measurements taken between 18 – 20 the last seven days for the current memory bank. If no results are stored within this timespan the display will show zeros. Press MEM once more to show the most recent result, blood pressure and pulse will be displayed individually and eventual warning symbols. You can keep pressing MEM to browse through the next separate result. Press the START button to turn the display off or wait a minute without pressing any buttons.

Delete saved measurements

While watching measurements as described above, press and hold MEM for three seconds to delete all measurements.
New measurements will replace the oldest measurements if the current memory bank already contains 30 measurements.

Troubleshooting

Solution: Try measuring anew.
Er 3| Obstructed air system
Er 4| Air system leakage
Solution: Adjust the cuff and try measuring anew.
Er 5| Pressure over 300 mmHg
Er 6| 15 mmHg over 3 minutes
Er 7| Access error, EEPROM
Er 8| Control error, device
Er A| Control error, pressure sensor

Solution: Try measuring again in five minutes. Contact the supplier if the error remains.

Abnormal results may have several causes. The cuff might be worn wrongly, wrong posture, physical activity (or speech) during measuring or irregular heartbeat. Read the instructions and measure again. Persons with serious irregular heartbeat (arrhythmia) should not use the blood pressure monitor.

Technical alarm

The monitor shows ‘HI’ or ‘Lo’ on the display if the measured blood pressure (systolic or diastolic) is outside the rated range specified in the specifications. Consult a physician or check if the measurement was done incorrect. The values are preset from the factory and can not be altered. This alarm condition is assigned as low priority according to IEC 60601-1-8. The alarm will go away on the monitor automatically after 8 seconds.

Electromagnetic compatibility information

Emissions/Enclosure Port/Proximity fields from RF wireless communications equipment
The blood pressure monitor is intended for use in the electromagnetic environment specified below. The customer/user should make sure that it is used in such an environment.
Emission

environment
Enclosure Port

Phenomenon

| Basic EMC standard| immunity test levels
Home Healthcare Environment
Electrostatic Discharge| IEC61000-4-2| ±8 kV contact ±2kV,+4kV,+BkV. +15kVair
Radiated RF EM field| IEC 61000-4-3| 10V/m B0MHz-2.7GHz 80% AM at1kHz
Phenomenon| Basic EMC standard| Immunity test levels
Home Healthcare Environment
Proximity fields from RF wireless communications equipment| IEC 61000-4-3| Refer to table 3
Rated power frequency magnetic fields| IEC 61000-4-8| 30A/m 50Hz or 60Hz

Proximity fields from RF wireless communications equipment

Professional healthcare facility environment
385| 380-390| Pulse modulation18Hz, 27V/ m
450| 430-470| FM, ±5kHz deviation,1kHz sine, 28V/ m
710| 704-787| Pulse modulation217Hz, 9V/ m
745
780
810| 800-960| Pulse modulation18Hz,28V/ m
870
930
1720| 1700-1990| Pulse modulation217Hz,28V/m
1845
1970
2450| 2400-2570| Pulse modulation 217Hz, 28V/m
5240| 5100-5800| Pulse modulation217Hz.9V/m

Safety information

Do not perform maintenance or service on the device while it is in use. The patient is an intended operator of the device.
Avoid strong electrical or electromagnetic fields in the direct vicinity of the device (e.g. mobile telephones, microwave ovens) while it is in operation, as inaccurate measurements may result. To prevent such interference, use the unit at least 30 cm from such devices or turn the devices off.
The device must not be used near active high-frequency surgical equipment or in a shielded room used for for magnetic resonance imaging.
Swallowing batteries and/or battery fluid can be extremely dangerous. Keep the batteries and the unit out of reach of children and disabled persons.
If you are allergic to plastic/rubber, please do not use this device.
The monitor may need up to 6 hours to cool down/warm up if stored at maximum/ minimum storage temperature until it is ready for it’s intended use (20 °C ambient temperature).
Replace all batteries in the device when the display shows the battery warning.
The device is not intended for use on neonates, children or pregnant women. (Clinical testing has not been conducted on neonates, children or pregnant women).
Avoid compression or restriction of the connection tubing during measurement, which may cause inflation errors or harmful injury due to continuous cuff pressure. Avoid taking measurements too often as it can cause injuries due to interference of the blood flow.
Consult your physician if you have any doubt regarding the following cases:
Application over a wound or inflammatory diseases. Application of the cuff on any limb where intravascular access or therapy, or an arterioveous (A-V) shunt is present.
Application of the cuff on the arm on the side of a mastectomy or lymph node clearance. Simultaneous use with other monitoring medical equipment on the same limb. Need to check the blood circulation of the user. Avoid speaking or moving during a measurement. Stay still, calm and rest for 5 minutes before taking a measurement.

Package Contents

Blood pressure monitor, cuff and storage bag.

THE OPERATION GUIDE MUST BE READ

The sign background colour is blue and the symbol is white.
Warning
Patient connected part, type BF (cuff)
WEEE (must be recycled)
Manufacturer
Complies with MDD93/42/EEC demands
IP20 The first characteristic numeral symbol for “Degrees of protection against access to hazardous parts and against solid foreign objects “.The second characteristic numeral symbol for “Degrees of protection against ingress of water”
Manufacturing date
 European Union authorized
Serial number
Keep dry

ANDON HEALTH CO., LTD.
No. 3 Jinping Street, YaAn Road, Nankai District, Tianjin 300190, China Tel: 86-22-87611660

iHealthlabs Europe SAS
36 Rue de Ponthieu, 75008, Paris, France

References

• Rubicson | Kjell.com

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