Smilecare U81RH Upper Arm Electronic Blood Pressure Monitor Instruction Manual
- June 5, 2024
- Smilecare
Table of Contents
Smilecare U81RH 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! artery and converts the movements into a
digital reading. An oscillometric monitor does not need a stethoscope, so the
monitor is simple to use.
▲ Intelligent inflation will reduce the uncomfortable feeling by incorrect
inflation, and shorten the measurement time, prolong the cuff’s usage
lifetime.
▲ 2x500sets memory function, each measurement result will be displayed on the
screen, and automatically stored .This unit has blood classification index,
could easy to check your blood pressure. Please read the manual carefully
before you use the unit, and keep the manual well after using.
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.
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.
Safety Information
■ To assure the correct use of the product, basic safety measures should always be followed including the warning and the caution listed in the instruction manual:
Symbol 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.
WARNING:
Do not dispose of electrical appliances as unsorted municipal waste, use separate collection facilities. Contact you 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
- Internally powered equipment;
- Type BF applied part;
- Protection against ingress of water or Particulate matter IP21;
- 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
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 batteries. 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 (option)
- 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 clause 16 of the 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.
- This device is double insulated and protected against short circuit and overload by a primary thermal fuse. Make sure to take the batteries out of the compartment before using the mains part. Equipment class 2.
- 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 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: type-c 5V
Output current: At least 600 mA
Setting mode
Note:
- When use AC adapter, the power of battery won’ I 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
1. User setting:
2. Year setting:
Continue to above step, the screen will display and flash 20XX, the last
digit of the year will increase 1 when press button MEM each time, you could
choose from 2020 to 2099. Press button SET when you confirm the year, then ii
will enter into the month and date setting mode.
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 lime 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 increase 1 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 digits 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 , don’t legs uncrossed ,keep the feel flat on floor, back and arm supported 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 it 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 measurements can be display one after the other by
pressing the button MEM each lime.
About blood pressure
Memory -clear of measurements
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 the blood pressure classification by the WHO/ISH.
■ SYS lower than 100mmHg (13.3kPa) is considered as hypotension.
■ Blood pressure type
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
Specification
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 Non-invasive
sphygmomanometers, 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 patient and user can be lowered to acceptable level. 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 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 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 ii 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
Table 1
Smile care
Upper Arm Electronic Blood Pressure Monitor
[email protected]
www.konsungmedical.com
[email protected]