BASELINE Wrist Electronic Blood Pressure Monitor Instruction Manual

Electronic Blood Pressure Monitor
Wrist Model 12-2151 U60E
Instruction Manual

Introduction

Thank you for purchasing the Baseline® Wrist Blood Pressure Monitor. Please read the manual carefully before you use the unit, and keep the manual after using.
The unit is compact and easy to use, and adopts the oscillometric principle. It measures your blood pressure using advanced “Intellisense” for comfortable controlled inflation without the need for pressure presetting or reinflation. This unit is only intended for users age 12 and older.
This unit stores results for 2 users, 90 measurement readings per user. Measurements are displayed on the screen and automatically stored. This unit has a blood classification index, it is easy to check your blood pressure.
Contraindication:
Do not use this product on patients with severe heart insufficiency to avoid risk of suffocation or death. This product is not suitable for infants and children.
INTENDED USE
This automatic blood pressure monitor intends to measure systolic pressure, diastolic pressure and pulse rate through the wrist. It is expected to be used at home or in the hospital, intended for people age 12 and older.

Safety Information

To ensure the correct use of the product, basic safety measures should always be followed including the warnings and the cautions listed in the instruction manual:
Symbol Descriptions
The following symbols may appear in this manual, on the label, on the device, or on its accessories. Some of the symbols represent standards and compliances associated with the device and its use.
WARNING: This alert identifies hazards that may cause serious personal injury or death.
CAUTION: This alert identifies hazards that may cause minor personal injury, product damage, or property damage.

Type BF applied part
Manufacturer
SN Specifies serial number
Authorized Representative in the European Community
 CE Mark: conforms to essential requirements of the Medical Device Directive 93/42/EEC.
  DISPOSAL: Do not dispose this product as unsorted municipal . waste. Collection of such waste separately for special treatment is necessary.
Direct Current
Follow instructions for use
CAUTION: Consult accompanying documents
Those with arrhythmia, diabetes, blood circulation or apoplexy problem, should only use the monitor under physician instruction.
Contact your physician for specific information about your blood pressure. Self-diagnosis and treatment using measured results may be dangerous. Follow the instructions of your physician or licensed health care provider.
Store in a high place where children cannot reach.
No modification of this equipment is allowed.
Do not modify this equipment without authorization of the manufacturer.
If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of equipment.
The cuff hose around neck may cause suffocation.
The swallowing of small part like packaging bag, battery, battery cover and so on may cause suffocation.
  Do not use a dilution agent, alcohol or petrol to clean the unit.
Do not hit heavily or Knock down the product from a high place.
Use the right cuff otherwise it will not work.
  Never leave alow battery in the battery compartment, as it may leak and cause damage to the unit.
  Remove the battery if you will not be using the device for 3 months
Replace batteries if the unit displays a low battery symbol.
Do not mix old and new batteries.
  Do not use a cellular phone near the unit. It may result in operational failure.
  Avoid use in high radiant area to ensure your measuring data is correct.
Do not use the equipment where flammable gas (such as anesthetic gas, oxygen or hydrogen) or flammable liquid (Such as alcohol) are present.
WARNING:
Do not dispose of electrical appliances as unsorted municipal  waste; use separate collection facillities. Contact your local government for information regarding the collection systems available. If electrical appliances are disposed of in landfills or dumps, hazardous substances can leak into the groundwater and get into the food chain, damaging your health and well-being.

Classification

1. Internally powered equipment:
2. Type BF applied part;
3. Protection against ingress of water or Particulate matter: IP21;
4. Not category AP / APG equipment;
5. Mode of operation: intermittent operation.

  The user must check that the equipment functions safely and see that it is in proper working condition before being used.

Product Structure

1. LCD Display

2. Start/Stop Button

3. Memory Button

4. Battery Cover

5. CUFF

6. User

7. Year/month/date/time

8. Systolic Blood Pressure

9. Irreqular Heart Beat

10. Diastolic Blood Pressure

11. Memory Times

12. Pulse

13. Memory Symbol

14. Low Battery

15. Pulse Rate

16. Blood Pressure Classification

Components

NOTE:
Please carefully read the warranty information at the back of the manual.

Battery Installation

Battery Installation And Replacement

1. Push the hook on the bottom of the battery cover as pictured.
2. Insert two 1.5V AAA batteries (included) in the battery compartment. Place the batteries “+” and “-” in the correct spots and facing in the right direction.
3. Push the battery cover back over the main unit.

Low battery and replacement
When the power is on, the low battery symbol will display and the unit will not work until the batteries are changed.
Battery type and replacement
Use (2) 1.5V AAA batteries. Do not use the batteries beyond their expiry date. If the monitor is not in use for a period of time, remove the batteries.
WARNING
Dispose the batteries in accordance with all federal, state and local laws. To avoid fire and explosion hazard, do not burn or incinerate the batteries.

Setting Mode

HOW TO SET USER
Press and hold the MEM button to turn on. The screen will display or .
Press the START/STOP button to change between users. The device will then enter into year-setting mode. YEAR SETTING
After the above step, the screen will display the year. Press the START/STOP button to increase the numbers. Press the MEM button to confirm the year. The device will then enter into date-setting mode. MONTH AND DATE SETTING
After the above step, the screen will display month-day (XX/XX). Press the START/STOP button to set the number from 01 to 12.
Press the MEM button to confirm  the month. Same as the month settings, press the START/STOP button to set the day number from 01 to 31. Press the MEM button to confirm the date. The device will then enter into time-setting mode. TIME SETTING
After the above step, the screen will display time (XX/XX). Press the START/STOP button to set the number from 0 to 23. Press the MEM button to confirm the hour. Same as the hour settings, press the START/STOP button to set the number from 00 to 59. Press the MEM button to confirm the minute. The time setting mode is now complete. Note:  You will need to reset the date and time if the battery has been removed for more than 30 seconds.

Proper Use of The Unit

Pre-measurement
Relax for about five to 10 minutes prior to the measurement.
Avoid eating, drinking alcohol, smoking, exercising and bathing for 30 minutes before taking a measurement. All these factors will influence the measurement results.
Remove any garment that fits closely to your wrist. Always measure on the same wrist (normally left).
Take measurements regularly at the same time every day, as blood pressure changes throughout the day.

Common factors of wrong measurement
All efforts by the patients to support their arm can increase blood pressure.
Make sure you are in a comfortable, relaxed position and do not activate any of the muscles in the measurement arm during measurement. Use a cushion for support if necessary.
If you put your wrist lower or higher than your heart, a false reading will occur.
Note:
Only use clinically-approved cuffs!
A loose cuff or a exposed bladder causes false reading.
With repeated measurements, blood accumulates in the arm, which can lead to false reading.
Consecutive blood pressure measurements should be repeated after 1 minute pause or after the arm has been held up in order to allow the accumulated blood to flow.

1. Roll up your sleeve. Make sure your sleeve is not rolled up too tightly on your arm; this may constrict the flow of blood in your arm.
2. Wrap the cuff directly against your skin. Hold the / bottom part of the cuff and wrap it around the wrist so it fits comfortably and securely around your wrist as the picture shows.
3. Sit in a chair and assume an upright body posture. Place the monitor at the same level as your heart.
4. Press the START/ STOP button; the monitor will measure your blood pressure automatically, remain still while the monitor is in use.

Note: If it is not possible to fit the cuff to your left wrist, it can be placed on your right wrist. However, all measurements should be made using the same wrist.

Measuring Procedure

1. Press the START/STOP button: all symbols appear on the display. Then 0 flashes for 2 secs, the pump begins to inflate the cuff and the rising pressure in the cuff is shown on the display.
2. fter the suitable pressure is reached, the pump stops and the pressure gradually falls. The cuff pressure is displayed. In case the inflation is not sufficient, the device will automatically reinflate to a higher pressure.
3. When the device detects a pulse, the heart symbol on the display will start to flash.
4. When the measurement is complete, systolic, diastolic and pulse rate will appear on the display.
5. Measurement readings remain on the display until you switch off the device. If no button is pressed for a period of 3 minutes, the device automatically turns off to save power.

NOTE:
The symbol is displayed along with the reading if an irregular heartbeat is detected during the measurement.
Discontinuing a measurement
If it is necessary to interrupt a blood pressure measurement for any reason (ex. the patient feels unwell) the START/STOP button can be pressed at any time. The device will immediately decrease the cuff pressure automatically.
Memory-recall of measurements
This blood pressure monitor stores measurements for 2 users, with 90 measurements recorded per user. The oldest measurement will be replaced by the latest measurement when each user exceeds 90 readings.
Read memory record
Press the MEM button when powered off; the average of the latest 3 readings will be shown. Press the MEM button again: the last measurement will be shown. Subsequent measurements can be displayed one after the other by pressing the MEM button each time.

Clear all measurements
If you are sure that you want to permanently remove all stored measurements. Long press the MEM button to enter into setting mode. When powered off, press the MEM button 6 times until CL appears. Press the START/STOP button; CL will flash 3 times to clear the measurements. Press MEM button again: M and “no” will be shown on the display, which means the memory has been cleared.

ADOUT BIOOd Pressure

About Blood Pressure
Blood pressure is the pressure that is exerted in the arteries.
Systolic blood pressure value represents the blood pressure produced by contraction of the heart muscle.
Diastolic blood pressure value represents the blood pressure produced by relaxation of the heart muscle.

About Blood Pressure
◼ According to the blood pressure classification by the WHO/ISH.
◼ SYS lower than 100mmuHg is considered hypotension. Blood Pressure Type

**Exceptional Situation

**

Error indicators
The following symbols will appear on the display when measuring is abnormal.

Remeasure the correct way.
| External strong disturbance| When near cell phone or other high radiant device
the measurement will fail
Keep quiet and no talking while measuring
| An error occurs during the process of inflating| Wrap the cuff properly.
Make sure that the air plug is properly inserted in the unit.
Remeasure.
| Abnormal blood pressure| Repeat the measurement after relaxing for 30 min. Ff you
get an unusual reading 3 times, please contact your doctor.
| Low battery| Replace old batteries with new ones.

Trouble removal

polarization
Error and stops working| Moved the wrist when inflating| Keep the body still
Check if talking when measuring| Keep quiet when measuring
Cuff leak| If the cuff wrap is too loose| Wrap the cuff tightly
If the cuff is broken| Change to a new cuff
Please contact the distributor if you cannot solve the problem.
Do not disassemble the unit by yourself!

Care and Maintenance

Keep the unit in the storage case when not inuse.
Clean the unit with a soft. dry cloth.
Do not use any abrasive or volatile cleaners.
Never immerse the unit or any component in water.|
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※We are not responsible for any quality-related problems if the device is not maintained as instructed.

Make sure the monitor is off prior to cleaning.
Use a mixture of distilled water and 10 percent bleach.
Using a spray bottle, moisten a soft cloth towel with the bleach or detergent mix until it is fully saturated. Squeeze any excess moisture from the cloth to avoid dripping or potential oversaturation of the cuff.
Wipe all surfaces of the blood pressure monitor cuff thoroughly, making sure to clean the inside and outside of the cuff. Be cautious  not to get any mositure in the main unit.
Using a dry cloth, gently wipe away any excess moisture that may remain on the blood pressure cuff. Lay the cuff flat in an unrolled position and allow the cuff to air dry.|
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Maintenance

Do not clean the body and cuff with gasoline or other flammable substances| Do not wet the cuff or attempt to clean the cuff with water.
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|
Store the unit in a clean and dry location.
Do not subject the unit to extreme hot or cold temperature, humidity or direct sunlight.| Remove the batteries if the unit will not be in use for 3 months or longer.
|
※ We are not responsible for any quality-related problems if the device is not maintained as instructed.

Specification

sun or water exposure during transporation.
Cuff size| Wrist circumference approx. Size 13.5-21.5CM

Warranty Information

Statement

• The intended use: the unit is intended to be used by adults at home or at a medical center to measure blood pressure and pulse rate from the wrist.
• The device meets the requirements of IEC 80601-2-30 Part 2 for non-invasive blood pressure monitors.
• Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer.
• The cuff/stethoscope auscultatory method is within the limits prescribed by the American National Standard, manual, electronic, or automated sphygmomanometers.
• The risk of patient and user can be lowered to an acceptable level.

Warranty Information

• The unit is guaranteed to be free of defects in workmanship and materials under normal use for a period of two years from the date listed on the purchase record.
• For repair under this warranty, our authorized service agent must be advised of the fault with the period of the warranty. This warranty covers part and labor only under normal operations. Any defect resulting from natural causes, eg. flood, hurricane etc, is not within this guarantee. This guarantee does not cover damage incurred by use of the unit not in accordance with the instructions, accidental damage, or being tampered with or serviced by unauthorized service agents.
• Monitor subjected to misue, abuse, and neglect of these manual content, non-instructional purposes; unauthorized repair or modifications will be excluded from this warranty.

The device is not repairable and contains no user-serviceable parts.

EMC Declaration

IEC 60601-1-2 2014 ΜΕ EQUIPMENT and ME SYSTEMS identification, marking and documents for Class B product
Instructions for use
The ME EQUIPMENT or ME SYSTEM is suitable for home health care environments and so on.
Warning Do not use near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, when the intensity of EM disturbances is high.
Warning Use of this equipment adjacent to or stacked with other equipment should be avoided because it may result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
Warning Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment may result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
Warning Portable RF communications equipment (included peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the blood pressure monitor, included cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
If any a list of all cables and maximum lengths of cables (if applicable), transducers and other ACCESSORIES that are replaceable by the RESPONSIBLE ORGANIZATION and that are likely to affect compliance of the ME EQUIPMENT or ME SYSTEM with the requirements of Clause 7 (EMISSIONS) and Clause 8 (IMMUNITY). ACCESSORIES may be specified either generically (e.g. shielded cable, load impedance) or specifically (e.g. by MANUFACTURER and EQUIPMENT OR TYPE REFERENCE).
If any the performance of the ME EQUIPMENT or ME SYSTEM that was determined to be ESSENTIAL PERFORMANCE and a description of what the OPERATOR can expect if the ESSENTIAL PERFORMANCE is lost of degraded due to EM DISTURBANCES (the defined term “ESSENTIAL PERFORMANCE” need not be used).

Technical description

1. All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the excepted service life.
2. Guidance and manufacturer’s declaration -electromagnetic emissions and Immunity

Table 1

Guidance and manufacturers declaration – electromagnetic emissions

Emissions test| Compliance
RF emissions
CISPR 11| Group 1
RF emissions
CISPR 11| Class B
Harmonic emissions
IEC 61000-3-2| Not application
Voltage fluctuations/flicker emissions
IEC 61000-3-3| Not application

Table 2

Guidance and manufacturer’s declaration – electromagnetic Immunity

Immunity Test| IEC 60601-1-2
Test level| Compliance level
Electrostatic discharge (ESD) IEC 61000-4-2| ±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air| ±8 kV contact ±2 kV, ±4 kV, ±8 kV, ±15 kV air
Electrical fast transient/burst IEC 61000-4-4| Power supply lines ±2 kV input/output lines ±1 kV 100 kHz repetition frequency| Not application
Surge
IEC 61000-4-5| line(s) to line(s) ±0.5 kV ±1 kV.| Not application
Voltage dips, short interruptions and voltage variations on power supply input lines
IEC 61000-4-11| 0% 0.5 cycle
At 0°, 45°, 90°, 135°, 180° 225°, 270° and 315°
0% 1 cycle
And
70% 25/30 cycles Single phase:
at 0 0% 300 cycle| Not application
Power frequency magnetic field
IEC 61000-4-8| 30 Aim
50Hz/60Hz| 30 A/m
50Hz/60Hz
---|---|---
Conduced RF
IEC61000-4-6| 150KHz to 80MHz
3Vrms
6Vrms (in ISM and amateur radio bands)
80% Am at 1kHz| Not application
Radiated RF
IEC61000-4-3| 10 V/m
80 MHz 2,7 GHz
80% AM at 1 kHz| 10 V/m
80 MHz 2,7
GHz
80% AM at 1 kHz
NOTE UT is the a.c. mains voltage prior to application of the test level.

Table 3

Guidance and manufacturer’s declaration – electromagnetic Immunity

| Test Frequency
(MHz)| Band
(MHz)| Service| Modulation| Modulati on
(W)| .
Distance
(m)| IMMUNITY TEST
LEVEL
(V/m)
385| 380-390| TETRA 400| Pulse
modulation
18 Hz| 1,8| 0.3| 27
450| 430-470| GMRS 460
FRS 460| FM
±5 kHz
deviation
1 kHz sine| 2| 0.3| 28
Radiated
RF
IEC6100
0-4-3
(Test specifications for ENCLO SURE
PORT IMMUNITY to RF wireless communi cations
equipment)| 710| 704
—
787| LTE Band 13, 17| Pulse modulation
217 Hz| 0,2| 0.3| 9
---|---|---|---|---|---|---|---
745
780
810| 800
—
960| GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5| Pulse modulation
18 Hz| 2| 0.3| 28
870
930
1720| 1700
1990| GSM 1800; COMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS| Pulse modulation
217 Hz| 2| 0.3| 28
1845
1970
2450| 2400
—
2570| Bluetooth, WLAN,
802.11 b/g/n,
RFID 2450, LTE Band 7| Pulse modulation
217 Hz| 2| 0.3| 28
5240| 5100
_
5800| WLAN
N 802 11
a/n| Pulse modulation
217 Hz| 0,2| 0.3| 9
5500
5785

Distributed by:
Fabrication Enterprises Inc
250 Clearbrook Road, Suite 240
Elmsford, NY 10523 (USA)
tel: +1-914-345-9300800-431-2830
fax: +1-914-345-9800800-634-5370
FabEnt.com

Manufacturer
Shenzhen Urion Technology Co., Ltd.
Floor 4-6th of Building D, Jiale Science & Technology Industrial Zone,
No. 3, ChuangWei Road, Heshuikou Community, MaTian Street,
Guang Ming New District, 518106 ShenZhen, PEOPLE’S REPUBLIC OF CHINA

Eu representative
Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg, Germany

©2024 FEI, all rights reserved.
Baseline is a trademark of Goldberg.
rev0424

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