Manufactured for Zewa, Inc.
12960 Commerce Lakes Drive#29
Fort Myers, FL 33913 USA
www.zewa.com
Toll Free Customer Service:
1-888-993-3592
warranty@zewa.com
User Manual
Wrist Blood Pressure Monitor WS-380
Thank you very much for selecting ZEWA Wrist Blood Pressure Monitor
WS-380.
To use the monitor correctly and safely, please read the manual
Please keep this manual well in order to reference in future.
Wrist Type
thoroughly.
Version:1.0
CATALOGUE
INTRODUCTION .............................................................................................
General Description
Indications for Use
Contraindications
Measurement Principle
Safety Information
LCD Display Symbol
Monitor Components
List
BEFORE YOU START
Installing and Replacing the Batteries
Setting Date, Time and Measurement Unit
Select the User ID
MEASUREMENT
Tie the Cuff
Start the Measurement
DATA MANAGEMENT 25
Recall the Records
Delete the Records
INFORMATION FOR USER
Tips for Measurement
Maintenance
ABOUT BLOOD PRESSURE
What are systolic pressure and diastolic pressure?
What is the standard blood pressure classification?
Irregular heartbeat detector
Why does my blood pressure fluctuate throughout the day?
Why do I get a different blood pressure at home compared to the hospital?
Is the result the same if measuring on the right wrist?
TROUBLESHOOTING
SPECIFICATIONS
CONTACT INFORMATION
FCC STATEMENT ................................................................................. 39
COMPLIED STANDARDS LIST
EMC GUIDANCE
...................................................................................... 13
.............................................................................................. 21
......................................................................................
................................................................................ 29
............................................................................... 31
..................................................................................... 34
........................................................................................... 36
................................................................................. 38
............................................................................................. 42
.......................................................................... 40
2
1
INTRODUCTION INTRODUCTION
General Description
Thank you for selecting ZEWA Blood Pressure Monitor (WS-380).
The monitor features blood pressure measurement, pulse rate measurement
and the result storage.
Readings taken by the WS-380 are equivalent to those obtained by a trained
observer using the cuff and stethoscope auscultation method.
This manual contains important safety and care information, and provides
step by step instructions for using the product.
Read the manual thoroughly before using the product.
Features:
Systolic blood pressure
Diastolic blood pressure
Pulse rate
60 records for one user
Indications for Use
The ZEWA Blood Pressure Monitor is a digital monitor intended for use in measuring blood
pressure and heartbeat rate with a wrist circumference ranging from 13.5cm to 21.5 cm (
about 5⅓˝-8½˝ ). It is intended for adult indoor use only.
Contraindications
1.The device should not be used by any person who may be suspected of,or is pregnant .
2.The device is not suitable for use on patients with implanted,electrical devices,
such as cardiac pacemakers, defibrillators.
Measurement Principle
This product uses the Oscillometric Measuring Method to detect blood pressure. Before
every measurement, the unit establishes a “zero point” equivalent to the atmospheric
pressure. Then it starts inflating the cuff. Meanwhile, the unit detects pressure oscillation
generated by beat-to-beat pulsatile, which is used to determine the systolic pressure and
diastolic pressure as well as pulse rate.
32
INTRODUCTION INTRODUCTION
Safety Information
The signs below might be in the user manual, labeling or other component.
They are the requirement of standard and using.
Symbol for “THE OPERATION
GUIDE MUST BE READ”
Caution: These notes must be
observed to prevent any damage
to the device.
Symbol for “MANUFACTURER”
Symbol for “SERIAL NUMBER”
SN
Symbol for “RECYCLE”
The Green Dot is the license symbol of
a European network of industry-funded
systems for recycling the packaging
materials of consumer goods.
Symbol for “TYPE BF APPLIED
PARTS”
Symbol for “ENVIRONMENT
PROTECTION - Electrical waste
products should not be disposed of with
household waste. Please recycle where
facilities exist. Check with your local
authority or retailer for recycling advice”
Symbol for “DIRECT CURRENT”
Symbol for “MANUFACTURE
DATE”
4 5
CAUTION
* This device is intended for adult use in homes only.
* The device is not suitable for use on neonatal patients, pregnant women,patients with implanted,
electronical devices, patients with pre-eclampsia, premature ventricular beats, atrial fibrillation,
peripheral, arterial disease and patients undergoing intravascular therapy or arterio-venous shunt or
people who received a mastectomy. Please consult your doctor prior to using the unit if you suffer from
illnesses.
* The device is not suitable for measuring the blood pressure of children. Ask your doctor before using it
on older children.
* The device is not intended for patient transport outside a healthcare facility.
* The device is not intended for public use.
* This device is intended for no-invasive measuring and monitoring of arterial blood pressure. It is not
intended for use on extremities other than the wrist or for functions other than obtaining a blood pressure
measurement.
* Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood
pressure.Do not begin or end medical treatment without asking a physician for treatment advice.
* If you are taking medication,consult your physician to determine the most appropriate time to measure
your blood pressure. Never change a prescribed medication without consulting your physician.
* Do not take any therapeutic measures on the basis of a self measurement. Never alter the dose of a
medicine prescribed by a doctor. Consult your doctor if you have any question about your blood
pressure.
* When the device is used to measure patients who have common arrhythmias such as atrial or
ventricular premature beats or atrial fibrillation, the best result may occur with deviation. Please consult
your physician about the result.
* Warning: Do not apply the cuff over a wound;otherwise it can cause further injury.
*Do not inflate the cuff on the same limb which other monitoring ME equipment is applied around
simultaneously, because this could cause temporary loss of function of those simultaneously-used
monitoring ME equipment.
CAUTION
*On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, open the cuff
immediately. Prolonged high pressure (cuff pressure ＞ 300mmHg or constant pressure ＞ 15mmHg for
more than 3 minutes) applied to the wrist may lead to an ecchymosis.
*Please check that operation of the device does not result in prolonged impairment of patient blood
circulation.
* When measurement, please avoid compression or restriction of the connection tubing.
* The device cannot be used with HF surgical equipment at the same time.
* The ACCOMPANYING DOCUMENT shall disclose that the SPHYGMOMANOMETER was clinically
investigated according to the requirements of ISO 81060-2:2013.
* To verify the calibration of the AUTOMATED SPHYGMOMANOMETER, please contact the manufacturer.
* This device is contraindicated for any female who may be suspected of, or is pregnant. Besides providing
inaccurate readings, the effects of this device on the fetus are unknown.
* Too frequent and consecutive measurements could cause disturbances in blood circulation and injuries.
* This unit is not suitable for continuous monitoring during medical emergencies or operations.Otherwise,
the patient’s wrist and fingers will become anaesthetic, swollen and even purple due to a lack of blood.
* When not in use, store the device in a dry room and protect it against extreme moisture, heat, lint, dust
and direct sunlight. Never place any heavy objects on the storage case.
* This device may be used only for the purpose described in this booklet. The manufacturer cannot be held
liable for damage caused by incorrect application.
*This device comprises sensitive components and must be treated with caution. Observe the storage and
operating conditions described in this booklet.
* The maximum temperature that the applied part can be achieved is 42.5℃ while the environmental
temperature is 40℃.
* The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable
anesthetic mixture with air of with oxygen or nitrous oxide.
* Warning: No servicing/maintenance while the ME equipment is in use.
* The patient is an intended operator.
INTRODUCTIONINTRODUCTION
CAUTION
* The patient can measure ,transmit data and change batteries under normal circumstances and maintain
the device and its accessories according to the user manual.
* To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated
interference signal or electrical fast transient/burst signal.
* The blood pressure monitor and the cuff are suitable for use within the patient environment. If you are
allergic to polyester, nylon or plastic, please don't use this device.
* During use, the patient will be in contact with the cuff. The materials of the cuff have been tested and
found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any
potential sensation or irritation reaction.
* If you experience discomfort during a measurement, such as pain in the wrist or other complaints, press
the START/STOP button to release the air immediately from the cuff. Loosen the cuff and remove it from
your wrist.
* If the cuff pressure reaches 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not
deflate when pressure reaches 40 kPa (300 mmHg), detach the cuff from the wrist and press the
START/STOP button to stop inflation.
* Before use, make sure the device functions safely and is in proper working condition. Check the device,
do not use the device if it is damaged in any way. The continuous use of a damaged unit may cause injury,
improper results, or serious danger.
* Do not wash the cuff in a washing machine or dishwasher!
* The service life of the cuff may vary by the frequency of washing, skin condition, and storage state. The
typical service life is 10000 times.
* It is recommended that the performance should be checked every 2 years and after maintenance and
repair, by retesting at least the requirements in limits of the error of the cuff pressure indication and air
leakage (testing at least at 50mmHg and 200mmHg).
* Manufacturer will make available on request circuit diagrams, component part lists, descriptions,
calibration instructions,etc., to assist to service personnel in parts repair.
* The operator shall not touch output of batteries and the patient simultaneously.
76
INTRODUCTION INTRODUCTION
CAUTION
* Cleaning :Dust environment may affect the performance of the unit. Please use the soft cloth to clean the
whole unit before and after use. Don’t use any abrasive or volatile cleaners.
* The device doesn’t need to be calibrated within two years of reliable service.
* If you have any problems with this device, such as setting up, maintaining or using, please contact the
SERVICE PERSONNEL of ZEWA. Don’t open or repair the device by yourself in the event of malfunctions.
The device must only be serviced, repaired and opened by individuals at authorized sales/service centers.
* Please report to ZEWA if any unexpected operation or events occur.
* Keep the unit out of reach of infants, young children or pets to avoid inhalation or swallowing of small
parts. It is dangerous or even fatal.
* Be careful to strangulation due to cables and hoses, particularly due to excessive length.
* At least 30 min required for ME equipment to warm from the minimum storage temperature between
uses until it is ready for intended use. At least 30 min required for ME equipment to cool from the
maximum storage temperature between uses until it is ready for intended use.
* This equipment needs to be installed and put into service in accordance with the information provided in
the ACCOMPANYING DOCUMENTS;
* Wireless communications equipment such as wireless home network devices, mobile phones, cordless
telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least a
distance d away from the equipment. The distance d is calculated by the MANUFACTURER from the
80MHz to 5.8 GHz column of Table 4 and Table 9 of IEC 60601-1-2:2014, as appropriate.
* Please use ACCESSORIES and detachable parts specified/ authorised by MANUFACTURE. Otherwise,
it may cause damage to the unit or danger to the user/patients.
* There is no luer lock connectors are used in the construction of tubing, there is a possibility that they
might be inadvertently connected to intravascular fluid systems, allowing air to be pumped into a blood
vessel.
* Please use the device under the environment which is provided in the user manual. Otherwise, the
performance and lifetime of the device will be impacted and reduced.
LCD Display Symbol
SYMBOL DESCRIPTION EXPLANATION
Systolic pressure
Diastolic pressure
Pulse display
Motion indicator
Low battery
High blood pressure
Low blood pressure
Pulse in beats per minute
Motion may result in an inaccurate measurement
Batteries are running low and need to be replaced
8 9
INTRODUCTION INTRODUCTION
SYMBOL DESCRIPTION EXPLANATION
kPa
mmHg
Irregular heartbeat
Current time
Average value
Heartbeat
Memory
User 1
User 2
Blood pressure
level indicator
Data storage
Bluetooth icon Indicate the Bluetooth is working.
10 11
Measurement unit of the blood pressure
Measurement unit of the blood pressure
(1kPa=7.5mmHg)
Measurement unit the blood pressure
(1mmHg=0.133kPa)
Blood pressure monitor is detecting an
irregular heartbeat during measurement.
Month/Day,Hour/Minute
The average value of lastest 3 groups blood pressure
Blood pressure monitor is detecting a
heartbeat during measurement.
Indicate it is in the memory mode
Start measurement and save the results for user 1
Start measurement and save the results for user 2
Indicate the blood pressure level
Indicate the data is waiting to be transmitted.
Monitor Components
SYSTOLIC
PRESSURE
DIASTOLIC
PRESSURE
PULSE RATE
SET BUTTON
GRADE
LCD DISPLAY
MEMORY BUTTON
START/STOP BUTTON
INTRODUCTION BEFORE YOU START
Component list of pressure measuring system:
1. PCBA;
2. Air Pipe;
3. Pump;
4. Valve;
5. Cuff.
BATTERY
COMPARTMENT
CUFF
(Type BF applied
part)
Installing and Replacing the Batteries
Slide off the battery cover.
•
•
Install the batteries by matching the correct polarity, as shown
below. Always use the correct battery type (2×AAA batteries.)
•
Replace the cover.
List
1) Blood Pressure Monitor WS-380
2) 2×AAA batteries
3) User manual
1312
BEFORE YOU STARTBEFORE YOU START
Replace the batteries whenever the below happens
The shows
The display is dim.
The display does not light up
CAUTION
Do not use new and used batteries together.
Do not use different types of batteries together.
Do not dispose the batteries in fire. Batteries may explode or leak.
Remove batteries if the device is not likely to be used for some time.
Worn batteries are harmful to the environment. Do not dispose with daily garbage.
Remove the old batteries from the device following your local recycling guidelines.
Setting Date, Time, Positioning Symbol and
Measurement Unit
It is important to set the clock before using your blood
pressure monitor, so that a time stamp can be assigned to
each record that is stored in the memory. (The setting range
of year is 2019 ~ 2059. Time format: 24H)
When the monitor is off, press “ ” button, it will display the time.Then
1.
press and hold “ ” button to enter the mode for year setting.
1514
BEFORE YOU START BEFORE YOU START
Notes:
1.During the process of setting, you can press “ ” button to stop
setting at any time.
2. If there is no operation during the process of setting, it will turn off
within 1 minute.
2. Press “ ” button to change the
[YEAR]. Each press will increase
the numeral by one in a cycling
manner.
.
3 When you get the right year,
press “ ” button to confirm
and it will turn to next step.
INFORMATION FOR USER
4.Repeat step 2 and 3 to confirm [MONTH] and [DAY].
5 2 and 3 to confirm [HOUR] and [MINUTE].
1716
BEFORE YOU START BEFORE YOU START
6
.Repeat step 2 and 3 to confirm the measurement unit.
7
.After confirming the meausrement unit, the LCD will display “donE”,
then the monitor will turn off.
Select the User ID
Before you start the measurement, please select the desired user ID first.
1.
When the blood pressure monitor is off, press and hold “ ” button until
the user ID blinks.
2.
Then press “ ” button to change the user ID between user 1 and user 2.
1918
3.
Press “ SET ” button to confirm your selection，the LCD will display “User
ID+donE” and then turn off.
MEASUREMENTBEFORE YOU START
Tie the Cuff
1.
Remove all accessories (watch, bracelet,etc) from your wrist. If your physician has diagnosed you with
poor circulation in your wrist, use the other one.
2.
Roll or push up your sleeve to expose the skin.
3.
Apply the cuff to your wrist with your palm facing up.
Position the edge of the cuff about 1cm~1.5cm from wrist joints.
4.
Fasten the wrist cuff around your wrist, leaving no extra room between the cuff and your skin. If the cuff is
5.
too loose, the measurement will not be accurate.
Sit comfortably with your tested wrist resting on a flat surface. Place your elbow on a table so that the cuff is
6.
at the same level as your heart. Turn your palm upwards. Sit upright in a chair, and take 5-6 deep breaths.
7.
Patients with Hypertension:
The middle of the cuff should be at the level of the right atrium of the heart; Before starting measurement,
please sit comfortably with legs uncrossed, feet flat on the floor, back and wrist supported.
Rest for 5 minutes before measuring.
Wait at least 3 minutes between measurements. This allows your blood
circulation to recover.
Take the measurement in a silent room.
The patient must relax as much as possible and do not move and talk
during the measurement procedure.
The cuff should maintain at the same level as the right atrium of the
heart.
Do not cross your legs and keep your feet on the ground.
Keep your back against the backrest of the chair.
For a meaningful comparison, try to measure under similar conditions.
For example, take daily measurements at approximately the same time,
on the same wrist, or as directed by a physician.
2120
MEASUREMENT MEASUREMENT
Start the Measurement
1.
When the monitor is off, press “ ” button to turn on the monitor, and it
will finish the whole measurement. (Take user 1 for example.)
LCD display
Inflating and measuring.
22 23
Adjust the zero point.
Display and save the result.
The year, date and time will
dispaly alternately.
2.After finishing the measurement, the LCD displays the blinking
icon ‘ ’,and transmits the data.
Note:
(1). The symbol “ ” will disappear after successful data transmission, and you
may check your personal health data stored in your mobile device.
(2). If the data transmission fails, the symbol “ ” will remain. The pending
measurement data will be transmitted to your mobile device when next
measurement is complete.
During the measurement or when the measurement is finished,
3.
press “ ”button to turn off the monitor. Otherwise it will power
off in one minute.
Tips:
1. There are two users in total. Each user has 60 records.
2. You can press “ ” button to stop measuring during the process
of the measurement at any time.
3. If the measurement result is out of the measurement range (SYS:
60mmHg to 230mmHg; or DIA: 40mmHg to 130mmHg;or Pulse:
40-199 pulse/minute), the LCD will display “out”.
MEASUREMENT DATA MANAGEMENT
CAUTION
Interference may occur in the vicinity of equipment marked with the following symbol . And
WS-380 may interfering vicinity electrical equipment.
Sensitive people, including pregnant women pre-eclamptic and those who implanted medical
electronic instruments, should avoid using the unit whenever possible.
Keep the monitor at least 20 centimeters away from the human body (especially the head) when the
data transmission is proceeding after measurement.
To enable the data transmission function, this product should be paired to Bluetooth end at 2.4
GHz.
How to mitigate possible interference?
1.
The range between the device and BT end should be reasonably close, from 1 meter to 10 meters.
Please ensure no obstacles between the device and BT end so as to obtain quality connection and
to lower the RF output range.
2.
To avoid interference, other electronic devices (particularly those with wireless transmission /
Transmitter) should be kept at least 1 meter away from the monitor.
Recall the Records
1.
When the monitor is off, press “ ”
button to show the average value of the
latest three measurement records. If the
records are less than 3 groups, it will
display the latest record instead.
2.
Press “ ” button or “ ” button to
get the record you want.
The record
number is
No.1. Two
records in
total.
The record number, date and
time of the measurement records
will display alternately.
The
corresponding
time is 6:35.
The
corresponding
date is 25th
December.
SET
2524
DATA MANAGEMENT DATA MANAGEMENT
3.
If you want to check the other user’s
measurement records, please press
” button to turn off the blood pressure
“
monitor. Then press and hold “ ” button to
enter the selecting user mode, press “ ”
again to change the user, when the desired
user ID blinks, press “ ” button to confirm.
Then press“ ” button to check the records
of the selected user.
CAUTION
The most recent record (1) is shown first. Each new
measurement is assigned to the first (1) record. All other records
are pushed back one digit (e.g., 2 becomes 3, and so on), and
the last record (60) is dropped from the list.
DATA MANAGEMENT
Delete the Records
If you did not get the correct measurement, you can delete
all the results for the selected user by following steps.
(Take user 1 for example.)
1.
Hold pressing “ ” button about 3
seconds when the monitor is in the
memory recall mode , the “dEL All
+User ID ” will flash on the display.
2.
Press “ ” button to confirm ,the
LCD displays “ User ID+dEL donE”
and then turn off.
Note: To exit out the delete mode
without deleting any records, press
” button before pressing “ ”
“
button to confirm any delete
commands.
2726
DATA MANAGEMENT INFORMATION FOR USER
3.
If there is no record, press “ ” button he below display will be shown.
Tips for Measurement
Measurements may be inaccurate if taken in the following circumstances.
Within 1 hour
after dinner or drinking
When talking or
moving your fingers
Immediate measurement
after tea, coffee, smoking
In a very cold environment
Within 20 minutes
after taking a bath
When you want to
discharge urine
2928
INFORMATION FOR USER
Maintenance
To obtain the best performance, please follow the instructions below.
Put in a dry place and
avoid the sunshine
TROUBLESHOOTING
Avoid dusty environment and
unstable temperature surrounding
Avoid immersing it in the water.
Clean it with a dry cloth in case.
Use the slightly damp cloth
to remove the dirt.
Avoid shaking and collision.
Avoid washing the cuff
ABOUT BLOOD PRESSURE
What are systolic pressure and diastolic pressure?
When ventricles contract and pump blood out of the heart, blood pressure reaches its maximum
value, the highest pressure in the cycle is known as systolic pressure. When the heart relaxes
between heartbeats, the lowest blood pressure is diastolic pressure.
What is the standard blood pressure classification?
The chart on the right is the
standard blood pressure classification published by American
Heart Association (AHA).
MM
CAUTION
Please consult a physician if your measuring result falls outside the range.
Please note that only a physician can tell whether your blood pressure value
has reached a dangerous point.
This chart reflects blood pressure categories defined by American Heart Association.
Blood Pressure Category
High Blood Pressure
(Hypertension) Stage 1
High Blood Pressure
(Hypertension) Stage 2
Hypertensive Crisis
(Consult your doctor immediately)
Normal
Elevated
Systolic
mmHg (upper#)
less than 120
120-129
130-139
140 or higher
Higher than 180
Diastolic
mmHg (lower#)
and
less than 80
and less than 80
or
80-89
or
90 or higher
Higher than 120
and/or
3130
ABOUT BLOOD PRESSUREABOUT BLOOD PRESSURE
Irregular Heartbeat Detector
An irregular heartbeat is detected when a heartbeat rhythm varies while the device is measuring
systolic pressure and diastolic pressure. During each measurement, blood pressure monitor will
keep a record of all the pulse intervals and calculate the average value of them. If there are two
or more pulse intervals , the difference between each interval and the average is more than the
average value of ±25% , or there are four or more pulse intervals ,the difference between each
interval and the average is more than the average value of ±15%, then the irregular heartbeat
symbol will appear on the display with the measurement result.
CAUTION
The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular
heartbeat was detected during measurement. Usually this is NOT a cause for concern.
However, if the symbol appears often, we recommend you seek medical advice. Please
note that the device does not replace a cardiac examination, but serves to detect pulse
irregularities at an early stage.
32 33
Why does my blood pressure
1. Individual blood pressure varies multiple times everyday. It is also
affected by the way you tie your cuff and your measurement position, so
please take the measurement under the same conditions.
2.If the person takes medicine, the pressure will vary more.
3.Wait at least 3 minutes for another measurement.
fluctuate throughout the day?
Why do I get a different blood
pressure at home compared
to the hospital?
The blood pressure is different even throughout the day
due to weather, emotion, exercise etc, Also, there is the
“white coat” effect, which means blood pressure usually
increases in clinical settings.
Is the result the same if
measuring on the right
wrist?
It is ok for both wrists, but there will be
some different results for different
people. We suggest you measure the
same wrist every time.
What you need to pay attention
to when you measure your blood
pressure at home:
If the cuff is tied properly.
If the cuff is too tight or too loose.
If the cuff is tied on the wrist.
If you feel anxious.
Taking 2-3 deep breaths before
beginning will be better for
measuring.
Advice: Relax yourself for 4-5
minutes until you calm down.
TROUBLESHOOTING
TROUBLESHOOTING
This section includes a list of error messages and frequently asked questions for
problems you may encounter with your blood pressure monitor. If the product is not
operating as you think it should, check here before arranging for servicing.
PROBLEM SYMPTOM CHECK THIS REMEDY
No power
Low
batteries
Error
message
Display is dim or
will not light up.
Show on
the display
E 01 shows
E 02 shows
E 03 shows
E 04 shows
E 12 shows
Batteries are exhausted.
Batteries are inserted
incorrectly.
Batteries are low.
The cuff is not secure or
very tight.
The monitor detected motion,
while measuring.
The measurement process
does not detect the pulse
signal.
Can't calculate blood pressure
Data communication
has failed
Replace with new batteries
Insert the batteries correctly
Replace with new batteries
Refasten the cuff and then measure again.
Relax for a moment and then measure
again.
Loosen the clothing on the arm and then
measure again.
Relax for a moment and
Make sure that phone’s Bluetooth is on or
within the distance range
then measure again.
PROBLEM SYMPTOM CHECK THIS REMEDY
Error
EExx,shows on
message
the display.
Warning
out shows Out of measurement
message
A calibration error occurred.
(XX can be some digital
symbol,such as 01,02,etc.,
if this similarsituation appear,
all belong to calibration error.)
range
Retake the measurement.If the problem
persists,contact the retailer or our customer
service department for further assistance.
Refer to the warranty for contact information
and return instructions.
Relax for a moment. Refasten the cuff and
thenmeasure again. If the problem persists,
contact your physician.
34 35
SPECIFICATIONS
SPECIFICATIONS
Power supply
Display mode
Measurement mode
Measurement range
Accuracy
Working condition
Storage & transportation
condition
Measurement perimeter
of the wrist
Weight
External dimensions
Attachment
Battery powered mode: 2*AAA batteries
Digital LCD V.A.45mmx33mm
Oscillographic testing mode
Rated cuff pressure:
0mmHg~299mmHg(0kPa ~ 39.9kPa)
Measurement pressure:
SYS: 60mmHg~230mmHg (8.0kPa~30.7kPa)
DIA: 40mmHg~130mmHg (5.3kPa~17.3kPa)
Pulse value: (40-199)beat/minute
Pressure:5°C-40°C within±3mmHg(0.4kPa)
Pulse value:±5%
A temperature range of :+5°C to +40°C
A relative humidity range of 15% to 90%, non-condensing,
but not requiring a water vapour partial pressure greater
than 50 hPa
An atmospheric pressure range of : 700 hPa to 1060 hPa
Temperature:-20°C to +60°C
A relative humidity range of ≤ 93%, non-condensing,
at a water vapour pressure up to 50hPa
About 13.5cm-21.5cm
Approx.100g(Excluding the batteries)
Approx.86mm×66mm×22mm(Excluding the cuff)
2*AAA batteries,user manual
Mode of operation
Continuous operation
Degree of protection Type BF applied part
Device Classification
IP Classification
Software Version
Internally Powered ME Equipment
IP22: The first number 2: Protected against solid foreign
objects of 12,5mm Ф and greater. The second number:
Protected against vertically falling water drops when enclosure
titled up to 15º. Vertically falling drops shall have no harmful
effects when the enclosure is titled at any angle up to 15º on
either side of the vertical.
A01
WARNING: No modification of this equipment is allowed.
36 37
CONTACT INFORMATION
COMPLIED STANDARDS LIST
Contact Information
For more information about our products or online support, please visit www.zewa.com. To
contact our customer service, please call 888-993-3592 or support@zewa.com.
Manufactured for Zewa, Inc.
12960 Commerce Lakes Drive#29
Fort Myers, FL 33913 USA
www.zewa.com
Toll Free Customer Service:
1-888-993-3592
warranty@zewa.com
38 39
FCC Statement
FCC ID: OU9TMB159
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) this device may not cause harmful interference, and (2) this device must accept
any interference received, including interference that may cause undesired operation.
Caution: The user is cautioned that changes or modifications not expressly approved by the party
responsible for compliance could void the user's authority to operate the equipment.
NOTE: This equipment has been tested and found to comply with the limits for a Class B digital
device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable
protection against harmful interference in a residential installation. This equipment generates,
uses and can radiate radio frequency energy and, if not installed and used in accordance with the
instructions,may cause harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation.
If this equipment does cause harmful interference to radio or television reception, which can be
determined by turning the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
-- Reorient or relocate the receiving antenna.
-- Increase the separation between the equipment and receiver.
-- Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
-- Consult the dealer or an experienced radio/TV technician for help.
FCC Radiation Exposure Statement:
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled
environment. This transmitter must not be co-located or operating in conjunction with any other
antenna or transmitter.
COMPLIED STANDARDS LIST
COMPLIED STANDARDS LIST
Complied Standards List
Risk management
Labeling
User manual
General Requirements
for Safety
Electromagnetic
compatibility
Performance
requirements
40
EN ISO 14971:2012 / ISO 14971:2007 Medical devices -
Application of risk management to medical devices
EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices.
Symbols to be used with medical device labels, labelling and
information to be supplied. Part 1 : General requirements
EN 1041:2008 +A1:2013 Information supplied by the
manufacturer of medical devices
EN 60601-1:2006+A1:2013/ IEC 60601-1:2005+A1:2012 Medical
electrical equipment - Part 1: General requirements for basic safety
and essential performance
EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical electrical
equipment - Part 1-11: General requirements for basic safety and
essential performance - Collateral standard: Requirements for
medical electrical equipment and medical electrical systems used in
the home healthcare environment
EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical
equipment - Part 1-2: General requirements for basic safety and
essential performance - Collateral standard: Electromagnetic
disturbances - Requirements and tests
EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part
1: Requirements and test methods for non-automated measurement
type
Clinical investigation
Usability
Software life-cycle
processes
Bio-compatibility
EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers - Part
3: Supplementary requirements for electro-mechanical blood pressure
measuring systems
IEC 80601-2-30:2009+A1:2013 Medical electrical equipment- Part
2-30: Particular requirements for the basic safety and essential
performance of automated non-invasive sphygmomanometers
EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test
procedures to determine the overall system accuracy of automated
non-invasive sphygmomanometers
ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2:
Clinical validation of automated measurement type
EN 60601-1-6:2010+A1:2015/IEC 60601-1-6:2010+A1:2013 Medical
electrical equipment - Part 1-6: General requirements for basic safety
and essential performance - Collateral standard: Usability
IEC 62366-1:2015 Medical devices - Part 1: Application of usability
engineering to medical devices
EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical
device software - Software life-cycle processes
ISO 10993-1:2009 Biological evaluation of medical devices- Part 1:
Evaluation and testing within a risk management process
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5:
Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices - Part
10: Tests for irritation and skin sensitization
41
EMC GUIDANCE
EMC GUIDANCE
EMC Guidance
The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments
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 equipment WS-380, including cables specified by the manufacturer. Otherwise, degradation
of the performance of this equipment could result.
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 manufacturer’s declaration - electromagnetic emissions
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Compliance
Group 1
Class B
Not application
Not application
4342
EMC GUIDANCE
EMC GUIDANCE
Table 2
Immunity Test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Guidance and manufacturer’s declaration – electromagnetic Immunity
IEC 60601-1-2
Test level
±8 kV contact
±2 kV, ±4kV, ±8 kV, ±15 kV air
Not application
Not application Not application
Not application
Compliance level
±8 kV contact
±2 kV, ±4kV, ±8 kV,
±15 kV air
Not application
Not application
Power frequency
magnetic field
IEC 61000-4-8
Conduced RF
IEC61000-4-6
Radiated RF
IEC61000-4-3
NOTE UT is the a.c. mains voltage prior to application of the test level.
30 A/m
50Hz/60Hz
Not application
10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
30 A/m
50Hz/60Hz
Not application
10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
4544
EMC GUIDANCEEMC GUIDANCE
Table 3
Guidance and manufacturer’s declaration - electromagnetic Immunity
Radiated RF
IEC61000-4-3
(Test
specifications
for
ENCLOSURE
PORT
IMMUNITY to
RF wireless
communicatio
ns equipment)
Test
Frequency
(MHz)
385
450 430-470
710 704-787
745
780
810
870
930
Band
Service Modulation Modulation
(MHz)
380-390 TETRA
800-960
400
GMRS 460，
FRS 460
LTE Band
13,17
GSM
800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation b)
18Hz
FM c) ± 5kHz
deviation 1kHz
sine
Pulse
modulation b)
217Hz
Pulse
modulation b)
18Hz
(W)
Distance (m)
0.3 27
1.8
2 0.3 28
0.2 0.3 9
2
0.3 28
IMMUNITY
TEST
LEVEL
(V/m)
1720
1845
1970
5240
5500
5785
17001990
2570
51005800
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1,
3,
4,25; UMTS
Bluetooth,
WLAN,
802.11
b/g/n, RFID
2450, LTE
Band 7
WLAN
802.11
a/n
Pulse
modulation b)
217Hz
Pulse
modulation
217 Hz
Pulse
modulation
217 Hz
2
2
0.2
0.3 28
0.3 282450 2400-
0.3 9
46 47
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