Rubicson Blood pressure monitor Wrist User Manual

manual
Blood pressure monitor
Wrist
Item No: 48919

www.rubicson.com
Box 50435
Malmö, Sweden
2019-07-05
Rubicson®

**

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 affect the 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 arrhythmia (irregular heartbeat) should not use this blood pressure monitor.

• Avoid measuring close to strong magnetic disturbances, such as cell phones or microwave 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/A11: 2013
  EN 60601-1-2: 2015

• The Electronic Sphygmomanometers corresponds to the below standards:
  18081060-2:2013 (Non-Invasive Sphygmomanometers – Part 2: Clinical Validation OfAutomated 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 non-invasive 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 wrist.

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. Make sure that the monitor works as intended after repair and every two years. Please contact the service center.
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 inner side of the cuff can be cleaned with a cloth, 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 operation.
Operation temperature| 10 °C 40 °C (50 °F —104 °F)
Operation humidity| g 85% RH
Storage and transport temperature| -20 °C — 50 °C (-4 °F –122  09
Storage and transport humidity| g 85% RH
Pressure| 80 kPa -105 kPa
Machine size| 84 mm x 60 mm x 29 mm
Cuff circumference| 14 cm 19.5 cm (51/2′ —711/16′)
Weight| 67 q (batteries excl.)
Measuring method| Oscillometric method, automatic air inflation and measurement.
Memory volume| 120 times incl. time and date
Power source| 2x 1.5 V = size AM batteries
Battery time| ~200 measurements
Cuff pressure range| 0-300 mmHg
Range of measurement| SYS: 60-2 60 mmHg, DIA: 40-199 mmHg, Pulse: 40-180 bpm
Measuring accuracy| ±3 mmHq
Heart pulse rate range| 40-180 times/min (accuracy: ±5

Overview

1. Battery indicator
2.  Ready for inflation
3. Arrhythmia indicator
4. Blood pressure indicator
5. Date/time
6. Memory indicator
7. Systolic pressure
8. Diastolic pressure

1. LUD-Display
2. Cuff
3. MEM button
4. START button

Installation

Batteries

Start by inserting the batteries. Open the lid on the back of the blood pressure monitor and insert two 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
At first, the blood pressure monitor is totally off, once you insert the battery, the blood pressure monitor will enter clock and date adjustment mode.
If the time of the device is already set and need to be changed, adjustment can be reached by pressing both the “START/STOP” and “MEM” button for 3 seconds in standby mode. In clock and date adjustment mode, the time format will blink at first. The default time format is 24h.
Press the button “START” repeatedly, the year, month, day, hour and minute will blink in turn. While the number is blinking, press the button “MEM” to increase the number, keep on pressing the button “MEM”, the number will increase faster.

Connect the cuff to the monitor

The blood pressure monitor comes pre-assembled. To connect the parts (e.g. after cleaning), align the four brackets and two plugs and press gently. Make sure that the cuff is sufficiently fastened before using the monitor.

Measuring

The cuff
Always measure on the same arm.
Wear the cuff around a bare wrist, about 1-2 cm above the wrist. The blood pressure monitor should be on the inside of the wrist. The cuff should not be too loose or tight, but comfortable.

Body posture

1. Sit down with a straight back, with your feet to the Don’t cross your legs.

2. Rest your arm and hand against a surface, e.g. a

3. The cuff should be held at about the same height as your Use the storage case as a wrist rest if needed.

Measuring

1. Press START.
2. The blood pressure monitor seeks zero pressure before it starts to inflate the cuff. The cuff is then deflated and the measurement is made.
3. 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.

Show saved measurements

Press MEM while in standby mode to show saved measurements. The current memory bank will blink and the number of measurements will be displayed. Keep pressing START to navigate between the four memory groups and pressing MEM to confirm. The LCD will display the average value of all results in the current user memory zone. If no result is stored in the current user memory zone, the LDC will display “0” for blood pressure and pulse rate. 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 memory bank already contains 120 measurements.

Troubleshooting

Solution: Try measuring anew

Solution: Adjust the cuff and try measuring anew.

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 an irregular heartbeat (arrhythmia) should not use the blood pressure monitor.

Technical alarm

The monitor will show ‘HI’ or to’ 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 incorrectly. The values are preset from the factory and can not be altered. This alarm condition is assigned as a 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

Immunity test levels/ Home Healthcare

Phenomenon| Basic EMC
standard **
| Environment**
---|---|---
Electrostatic Discharge| IEC 61000-4-2| ±8kV contact

±2kV, ±4kV, ±8kV, ±15kV air

Radiated RF EM field| IEC 61000-4-3| 10V/m
80MHz-2.7GHz
80% AM at 1kHz
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

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. The device should be kept at least 30 cm away from other wireless devices, such as WLAN units, microwave ovens, etc to prevent inaccurate readings. 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 can need up to 6 hours to cool down/warm up if stored at maximum/minimum storage temperature until it is ready for its 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 arteriovenous (A-V) shunt is present. Application of the cuff on the arm on the side of a mastectomy. 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 measurement. Stay still, calm, and rest for 5 minutes before taking a measurement.

Package Contents
Blood pressure monitor, cuff, and storage box.

*The sign background color is blue and the symbol is white. Caution! Read the manual Ls manualen grundigt inden brug Observer: Les manualen for bruk Las hela manualen noggrant

Warning
Advarsel
Advarsel
Yarning

Patient connected part, type BF (cuff)
Apparatklasse: type BF
Apparatklasse: BF
Patientansluten del typ BF (manschett)

WEEE (must be recycled)
Afleveres til genbrug
Leveres til gjenvinning
WEEE (maste lamnas till atervinning scentral)

Manufacturer Producent Produsent Tillverkare

Complies with MDD93/42/EEC demands
Overensstemmelse med MDD93/42EEC- krav
Overensstemmer med MDD93/42/ EEC-krav
Overensstammer med MDD93/42/ EEC-krav

Manufacturing date
Produktionsdato
Produksjonsdato
Tillverkningsdatum

European Union authorized
Autoriseret i Europa
Godkjent i Europa
Auktoriserad i EU

Serial number
Serienummer
Serienummer
Serienummer
The first characteristic numeral symbol for “Degrees of protection against access to hazardous parts and against solid foreign objects “.The second characteristic  numeral the symbol for “Degrees of protection against ingress of water”

health labs Europe SAS

36 Rue de Ponthieu, 75008, Paris, France

ANDON HEALTH CO., LTD.
No. 3 Jinping Street, YaAn Road, Nankai District, Tianjin 300190, China
Tel: 86-22-60526081

References

• Rubicson | Kjell.com

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