Smilecare U80H Upper Arm Electronic Blood Pressure Monitor Instruction Manual
- June 5, 2024
- Smilecare
Table of Contents
Smilecare U80H Upper Arm Electronic Blood Pressure Monitor Instruction Manual
Introduction
▲ Your new digital blood pressure monitor uses the oscillometric method of
blood pressure measurement. This means the monitor detects your blood’s
movement through your brachia I artery and converts the movements into a
digital reading. An oscillometric monitor does not need a stethoscope ,so the
monitor is simple to use.
▲ This automatic blood pressure monitor could measure the systolic pressure,
diastolic pressure and pulse, the components are included the body, cuff and
printed instruction manual. Batteries and adapter are optional. This unit is
intended for adult use.
▲ Intelligent inflation will reduce the uncomfortable feeling by incorrect
inflation, and shorten the measurement time, prolonged the cuff’s usage
lifetime.
▲ 2×90 sets memory function, each measurement result will be displayed on the
screen, and stored automatically. This unit has blood classification index,
could easy to check your blood pressure.
CONTRAINDICATION
This product can’t be used in patients who is with severe heart insufficiency
to avoid suffocation and death. This product is not suitable for infants and
children.
INTENDED USE
This automatic blood pressure monitor intends to measure the systolic
pressure, diastolic pressure and pulse rate through upper arm. It’s expected
to be used at home or in the hospital, intended for people over 12 years old.
Safety Information
▲To ensure the correct use of the product, basic safety measures should always be followed including the warning and the caution symbols listed in the instruction manual:
Symbols descriptions
The following symbols may appear in this manual, on the label, on the
device ,or on it’s accessories. Some of the symbols represent standards and
compliances associated with the device and its use.
Classification
- Internally powered equipment;
- Type BF applied part; .
- Protection against ingress of water or Particulate matter: IP22;
- Not category AP /APG equipment;
- Mode of operation: Continuous operation.
The user must check that the equipment functions safely and see that it is in proper working condition before being used.
Product structure
Body
Display
Cuff size and connection
The accessories cuff is L size, for upper-arm circumference 22-42cm use. The cuff is treated as the applied part.
Insert the connector with cuff tube into the hole which is on the left side of the device a picture.(Only provided cuff should be used, do not change to any other branded cuff.)
Battery installation
Battery installation
Remove the battery cover from the battery compartment, insert the battery.
- a) Remove the battery cover as picture showed.
- b) Insert 4 AAA powerful batteries into the compartment and ensure each battery is in the proper direction.
Low battery and replacement
When power on, the low battery symbol will display once the unit start to
work, and you must replace with new batteries, otherwise the unit can’t work.
Battery type and replacement .
Please use 4pcs AAA identical 1.5V alkaline bris. Do not use the batteries
beyond their expiry date. Please remove the batteries if you do not need to
use for long time.
WARNING:
Dispose of the battery in accordance with all federal, state and local laws.
To avoid fire and explosion hazard, do not burn or incinerate the battery.
Adapter usage (Optional)
- ■ When optional AC adapter should comply with the requirement of IEC 60601-1: 2005. Furthermore all configurations shall comply with the requirements for medical electrical systems (See IEC 60601-1-1 or clause16 of 3Ed. of IEC 60601-1 respectively). Anybody connecting additional equipment to medical electrical equipment configures a medical system and is therefore responsible that the system complies with the requirements for medical electrical systems. Attention is drawn to the fact that local laws take priority over the above mentioned requirements If in doubt, consult your local representative or the technical service department
- When using AC power, to avoid possible damage to the monitor, use only the exclusive AC adapter that can be purchased from authorized dealers. Other adapters may vary in output voltage and in polarities .
- ■ Insert the adapter plug into the hole on the backside of the unit as picture.
- ■ Insert the other side of the adapter into the outlet with 100-240V.
- ■To remove the AC adapter, disconnect the adapter plug from the outlet first and then disconnect the cord from the unit’s socket.
Adapter technical features:
Output voltage: 6V ± 5%
Max. output current: At least 600mA
Output plug polarity: <+> inner
External diameter: 5.5 mm 0.1 mm
Internal diameter: 2.1 mm 0.1 mm
Setting mode
Note:
– When use the AC adapter, the power of battery won’t be consumed.
– When suddenly stop during measurement (like the plug off from the outlet by
carelessness) ,it must be reinserted the plug into the unit, and restart the
measurement.
How to set
3. Month and date setting
Continue to above step, the screen will display xxMxxD and xxxx, and keep
flashing on month, the digit will increase 1 when press button MEM each time
,you could choose from 1 to 12. Press button SET when you confirm the month,
then it will set the date. Same as the month setting, each time you press
button MEM, the digit will keep changing from 01 to 31.Press button SET when
you confirm the date, then it will enter into the time setting mode.
4.Time setting
Continue to above step the screen will display xxMxxD and xx: xx, and keep
flashing on the digits of hour, the digit will increase1 when press button MEM
each time, you could choose from Oto 23.Press button SET when you confirm the
hour, then the digits of minute start to flash, same as the hour setting, each
time you press button MEM the digit will keep changing from 00 to 59.Press
button SET when you confirm the minute, then the total setting mode is
completed.
Proper use of the unit
Measurement
Pre-measurement
- Relax for about five to ten 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 result.
- Remove any garment that fits closely to your upper arm
- Always measure on the same arm (normally left).
- Take measurement regularly at the same time of every day, as blood pressure changes even during the day.
Common factors of wrong measurement
- All efforts by the patient to support their arm can increase blood pressure.
- Make sure you are in a comfortable, relax position and do not activate any of the muscles in the measurement arm during measurement. Use a cushion for support if necessary.
- If the arm artery lies lower or higher than the heart ,a false reading will be obtained.
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 away.
Fitting the Cuff
Measuring Procedure:
Discontinuing a measurement
if ii is necessary to interrupt a blood pressure measurement for any
reason(eg. the patient feels unwell)the START/STOP button can be pressed at
any time. The device immediately decrease the cuff pressure automatically.
Memory-recall of measurements
This blood pressure monitor automatically stores 2×90 sets measurements value,
the oldest record will be replaced by the latest measurement value when more
than 90 sets each user.
Read memory record
Press the button MEM when power off, the latest 3 times average value will be
shown, press the button MEM again, the last measurement value will be shown,
as well as subsequent measurement can be displayed one after the other by
pressing the butting MEM each time.
About blood pressure
Memory-clear of Measurement
If you are sure that you want to permanently remove all stored memories. Press
the button SET for 7 times until CL appears when power off, press the
START/STOP button, CL will flash for 3 times to clear all the memories. After
this press button MEM, [M] and “no” will be shown on the display which mean
that no memory in store.
About Blood Pressure
Blood pressure is the pressure exerted the arteries. The systolic blood
pressure value represents the blood pressure produced by contraction of the
heart muscle.
The diastolic blood pressure value represents the blood pressure produced by
relaxation of the heart muscle.
■ According to blood pressure classification by the WHO/I SH.
■ SYS lower than 100mmHg (13.3kPa) is considered as hypotension.
■ Blood pressure types
Exceptional Situation
Error indicators
The following symbol will appear on the display when measuring abnormal
Trouble removal
Care and maintenance
Care for the main unit and blood pressure monitor cuff
Maintenance
Specifications
Warranty information
Statement
■ The intended use: the unit is intended to be used by adults at home or
medical center to measure blood pressure and pulse rate from the upper arm.
■ The unit satisfies the requirements of EN ISO 81060-1 Part 1 Nanina
sivesphygmomanometers, EN 1060-3: 1997+A2:2009 Non-invasive
sphygmomanometers. IEC80601-2-30 Part 2 Non-invasive sphygmomanometers.
■ Blood pressure measurements determined with this device are equivalent to
those obtained by a trained observer using the cuff/stethoscope auscultatory
method, within the limits prescribed by the American National Standard,
manual, electronic, or automated sphygmomanometers.
■ The risk of patent and user can be lowered to 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 parts and
labor only under normal operations. Any defect resulting from natural causes,
eg, flood, hurricane etc. is not within this guarantee. This guaranty does not
cover damages 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 misuse, abuse, and neglect of these manual content,
non-instructional purposes; unauthorized repair or modifications will be
excluded
from this warranty.
The device requires no calibration.
The device is not repairable and contains no user serviceable parts.
EMC Declaration
IEC 60601-1-2: 2014 ME 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 healthcare environments and
so on.
Warning: Don’t near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high.
Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could 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 could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.”
Warning: Portable RF communications equipment (including 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, including 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 or degraded due to EM DISTURBANCES (the defined term “ESSENTIAL PERFORMANCE” need not be used).
Technical description
- All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the excepted service life.
- Guidance and manufacturer’s declaration -electromagnetic emissions and immunity
Smile care
Upper Arm Electronic Blood Pressure Monitor
[email protected]
www.konsungmedical.com
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