Medic Therapeutics MT-BPM-001 User manual

1
BLOOD PRESSURE MONITOR
Prior to use, please read this manual
USER MANUAL

INTRODUCTION INTRODUCTION
Product Descripon:
The Medic Therapeucs blood pressure monitor measures heartrate and
blood pressure with an arm circumference ranging from 22cm to 32cm.
Readings are aligned with those taken by a medical professional with a
cu and stethoscope.
Features:
100mmx68mm Digital LCD Display
Stores up to 60 readings per user
Safety Precauons:
1. Should not be used if pregnant.
2. Not suitable for use on anyone with implanted electrical devices
such as, pacemaker or debrillator.
3. Intended for use by adults only.
Measurement Readings:
This product uses an Oscillometric Measuring method. Before each
measurement, the device establishes a ‘zero pressure’ equivalent to atmo-
spheric pressure. While the arm cu inates, the device detects pressure
oscillaons generated by, beat-by-beat pulsaon. This process detects
the systolic and diastolic pressure as well as the pulse rate.
CAUTION
* This device is intended for adult use in homes only.
* The device is not suitable for use on neonatal paents, pregnant women,paents with implanted,
electronical devices, paents with pre-eclampsia, premature ventricular beats, atrial brillaon, peripheral,
arterial disease and paents undergoing intravascular therapy or arterio-venous shunt or people who
received a mastectomy. Please consult your doctor prior to using the unit if you suer 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 paent 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 extremies other than the arm or for funcons other than obtaining a blood
pressure measurement.
Indicaons for Use:
The Medic Therapeucs blood pressure monitor is digital monitors intend-
ed for use in measuring blood pressure and heartbeat rate with arm circum-
ference ranging from 22 cm to 32 cm ( about 8¾˝-12½˝ ). It is intended for
adult indoor use only.
Contraindicaons:
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 paents with implanted,electrical
devices, such as cardiac pacemakers, debrillators.
Safety Informaon:
The signs below might be in the user manual, labeling or other component.
They are the requirement of standard and using.
32
Symbol for “THE OPERATION
GUIDE MUST BE READ”
Symbol for “MANUFACTURER”
Symbol for “SERIAL NUMBER”
Symbol for “TYPE BF APPLIED
PARTS”
Symbol for “DIRECT CURRENT”
Symbol for “ENVIRONMENT
PROTECTION - Electrical waste
products should not be disposed of
with household waste. Please recycle
where facilies exist. Check with your
local authority or retailer for recycling
advice”
Symbol for “MANUFACTURE
DATE”
Cauon: These notes must be
observed to prevent any damage
to the device.
SN
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 “RECYCLE”

INTRODUCTION INTRODUCTION
CAUTION
* 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 medicaon, consult your physician to determine the most appropriate me to measure your
blood pressure. Never change a prescribed medicaon without consulng your physician.
* Do not take any therapeuc 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 queson about your blood pressure.
* When the device is used to measure paents who have common arrhythmias such as atrial or ventricular
premature beats or atrial brillaon, the best result may occur with deviaon. Please consult your physician
about the result.
* Don’t kink the connecon tube during use, otherwise, the cu pressure may connuously increase which
can prevent blood ow and result in harmful injury to the PATIENT.
* When using this device, please pay aenon to the following situaon which may interrupt blood ow and
inuence blood circulaon of the paent, thus cause harmful injury to the paent: connecon tubing
kinking too frequent and consecuve mulple measurements; the applicaon of the cu and its
pressurizaon on any arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is
present; inang the cu on the side of a mastectomy.
* Warning: Do not apply the cu over a wound;otherwise it can cause further injury.
Do not inate the cu on the same limb which other monitoring ME equipment is applied around
simultaneously, because this could cause temporary loss of funcon of those simultaneously-used monitoring
ME equipment.
* On the rare occasion of a fault causing the cu to remain fully inated during measurement, open the cu
immediately. Prolonged high pressure (cu pressure > 300mmHg or constant pressure > 15mmHg for more
than 3 minutes) applied to the arm may lead to an ecchymosis.
* Please check that operaon of the device does not result in prolonged impairment of paent blood
circulaon.
* When measurement, please avoid compression or restricon of the connecon tubing.
* The device cannot be used with HF surgical equipment at the same me.
* The ACCOMPANYING DOCUMENT shall disclose that the SPHYGMOMANOMETER was clinically
invesgated according to the requirements of ISO 81060-2:2013.
* To verify the calibraon 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 eects of this device on the fetus are unknown.
* Too frequent and consecuve measurements could cause disturbances in blood circulaon and injuries.
* This unit is not suitable for connuous monitoring during medical emergencies or operaons.Otherwise, the
paent’s arm and ngers will become anaesthec, 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 applicaon.
* This device comprises sensive components and must be treated with cauon. Observe the storage and
operang condions described in this booklet.
* The equipment is not AP/APG equipment and not suitable for use in the presence of a ammable
anesthec mixture with air of with oxygen or nitrous oxide.
* Warning: No servicing/maintenance while the ME equipment is in use.
* The paent is an intended operator.
* The paent can measure data and change baeries under normal circumstances and maintain the
device and its accessories according to the user manual.
* To avoid measurement errors, please avoid the condion of strong electromagnec eld radiated
interference signal or electrical fast transient/burst signal.
* The blood pressure monitor, and the cu are suitable for use within the paent environment. If you are
allergic to polyester, nylon or plasc, please don’t use this device.
* During use, the paent will be in contact with the cu. The materials of the cu have been tested and
found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any
potenal sensaon or irritaon reacon.
* Adaptor is specied as a part of ME EQUIPMENT.
* If you experience discomfort during a measurement, such as pain in the arm or other complaints, press
the START/STOP buon to release the air immediately from the cu. Loosen the cu and remove it from
your arm.
* If the cu pressure reaches 40 kPa (300 mmHg), the unit will automacally deate. Should the cu not
deate when pressure reaches 40 kPa (300 mmHg), detach the cu from the arm and press the
START/STOP buon to stop inaon.
* Before use, make sure the device funcons safely and is in proper working condion. Check the device,
do not use the device if it is damaged in any way. The connuous use of a damaged unit may cause
injury, improper results, or serious danger.
* Do not wash the cu in a washing machine or dishwasher!
* The service life of the cu may vary by the frequency of washing, skin condion, and storage state. The
typical service life is 10000 mes.
* It is recommended that the performance should be checked every 2 years and aer maintenance and
repair, by retesng at least the requirements in limits of the error of the cu pressure indicaon and air
leakage (tesng at least at 50mmHg and 200mmHg).
* Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local
guidelines.
* Manufacturer will make available on request circuit diagrams, component part lists, descripons,
calibraon instrucons,etc., to assist to service personnel in parts repair.
* The plug/adapter plug pins insulates the device from the main supply. Do not posion the device in a
posion where it is dicult to disconnect from the supply mains to safely terminate operaon of ME
equipment.
* The plug/adapter plug pins insulate the device from the main supply. Do not posion the device in a
posion where it is dicult to disconnect from the supply mains to safely terminate operaon of ME
equipment.
* The operator shall not touch output of baeries /adapter and the paent simultaneously.
* Cleaning :Dust environment may aect the performance of the unit. Please use the so cloth to clean
the whole unit before and aer use. Don’t use any abrasive or volale 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 seng up, maintaining or using, please contact the
SERVICE PERSONNEL of Medic Therapeucs. Don’t open or repair the device by yourself in the event of
malfuncons. The device must only be serviced, repaired and opened by individuals at authorized
sales/service centers.
* Keep the unit out of reach of infants, young children or pets to avoid inhalaon or swallowing of small
parts. It is dangerous or even fatal.
* Be careful to strangulaon due to cables and hoses, parcularly due to excessive length.
* At least 30 min required for ME equipment to warm from the minimum storage temperature between
uses unl it is ready for intended use. At least 30 min required for ME equipment to cool from the
maximum storage temperature between uses unl it is ready for intended use.
* This equipment needs to be installed and put into service in accordance with the informaon provided in
the ACCOMPANYING DOCUMENTS;
* Wireless communicaons equipment such as wireless home network devices, mobile phones, cordless
telephones and their base staons, walkie-talkies can aect 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 80
MHz 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 specied/ authorised by MANUFACTURE.
Otherwise, it may cause damage to the unit or danger to the user/paents.
* There is no luer lock connectors are used in the construcon of tubing, there is a possibility that they
might be inadvertently connected to intravascular uid 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 lifeme of the device will be impacted and reduced.
54

INTRODUCTION INTRODUCTION
LCD Display:
SYMBOL DESCRIPTION
Systolic blood pressure High blood pressure
Diastolic blood pressure Low blood pressure
EXPLANATION
mmHg
kPa
Measurement Unit of the blood pressure
Measurement Unit of the blood pressure
Low baery Baeries are low and need to be replaced
Current Time Year/Month/Day, Hour : Minute
(1kPa=7.5mmHg)
(1mmHg=0.133kPa)
Heartbeat
User 1
User 2
Irregular heartbeat
Start measurement,save and transmit the
measuring results for User 1
Start measurement,save and transmit the
measuring results for User 2
Pulse in beats per minutePulse display
Blood pressure monitor is detecng an
irregular heartbeat during measurement.
Blood pressure
level indicator Indicate the blood pressure level
Blood pressure monitor is detecng a
heartbeat during measurement.
Average value The average value of blood pressure
Moon indicator Moon may result in an inaccurate
measurement
Indicate it is in the memory mode and
which group of memory it is.
Memory
1 Cuff
2 Air pipe
3 PCBA
4 Pump
5 Valve
CUFF
AIR HOSE
AIR CONNECTOR PLUG
LCD DISPLAY
DC POWER SOCKET
MEM BUTTON
START/STOP
SET BUTTON
BATTERY COMPARTMENT
Monitor Components:
Parts Overview:
1. Blood Pressure Monitor
4. User manual 5. Carry bag
2. Cu (Type BF applied part)
(22cm~32cm)
3. 4×AAA baeries
76

INTRODUCTION BEFORE YOU START
Power Supply:
Baery-Powered :
6VDC 4×AAA baeries.
Seng Time, Date, Measurement Unit:
It is important to set the clock prior to use so a me stamp can be
accurately assigned to each reading and stored in the device’s memory.
1. While o, press and hold the
SET buon for 3 seconds to
set the year.
2. Press the MEM buon to
change the year. Each press
will increase the year by one.
Installing and Replacing Baeries:
1. Open baery cover.
2. Install baeries according to polarity symbols.
3. Replace baery cover.
Replace Baeries When:
• The Low Baery icon appears.
• The display is dim.
• The display does not light up.
AC adaptor
Cauon
In order to get the best eect and protect your
monitor, please use the right baery and special power
adaptor which complies with local safety standard.
Cauon
• Do not use new and used baeries together.
• Do not use dierent types of baeries together.
• Do not dispose the baeries in re. Baeries may explode or leak.
• Remove baeries if the device is not likely to be used for some me.
• Worn baeries are harmful to the environment. Do not dispose with daily garbage.
• Remove the old baeries from the device following your local recycling guidelines.
98
Authorized Component:
1. Please use the authorized adapter (not included).
2. AC adaptor powered mode:
6V 1A (not included)
(Please only use the recommended AC adapter model).
Please unplug the adaptor to depart from the using ulity power. Input: AC 100-240V:
50/60Hz 0.2A Max
Output: 6V 1000Ma

BEFORE YOU START BEFORE YOU START
3. When you reach the correct year, press the SET buon and move to
the next step.
7. Aer the device is set, the LCD will display ‘Done’, then display the
sengs and turn o.
4. To set month and day, repeat steps 2 and 3.
5. Again repeat steps 2 and 3 to set the hour and minute.
6. Repeat steps 2 and 3 to set the Unit.
1110

BEFORE YOU START MEASUREMENT
User Selecon: Placing the Arm Cu:
1. Remove any jewelry from your le
arm. *Note: Use the right arm if user
has been diagnosed with poor
circulaon.*
2. Roll or push up any sleeve and
ensure the sleeve isn’t too ght.
3. With your arm extended and hand
facing up, wrap the cu securely around
your upper arm. Posion the tube
o-center toward the inner arm.
Or posion the artery mark directly over
the main artery of the inner arm. *Note:
Locate the main artery by pressing 2 n-
gers approx. 2cm above the bend of your
elbow on the inside on your le arm.*
4. The cu should be snug but not
too ght. You should be able to slide a
nger between your cu and your arm.
5. Sit comfortably with your arm
resng on a at surface. Place your
elbow on a table so that the cu is level
with your heart. Sing fully upright, turn
your palm upwards and take 5 to 6 deep
breaths.
1. When the monitor is o, press and hold the ‘MEM’ to enter the user
seng mode. The User ID will blink.
2. Press the ‘MEM’ buon again to select User 1 or User 2.
3. Aer User ID selecon, press the ‘SET’ buon to conrm. The User ID
will stop blinking and the device will turn o. Tips for Users with Hypertension:
• Rest for 5 minutes prior to measuring.
• Take measurement in a quiet room.
• Wait 3 minutes between measurements so blood circulaon can recover.
• Relax and do not talk or move while taking measurement.
• Keep the cu level with the heart’s right atrium.
• Sit comfortably with uncrossed legs and keep feet at on the ground.
• Keep back against the chair.
• For accurate comparison, take all measurements under similar condions:
Same me, same posion, same arm, etc…
2~3cm
2~3cm
1312

MEASUREMENT DATA MANAGEMENT
The current No. is No. 1.
Ten records in total.
The corresponding
me is 9:37.
The corresponding
date is May 25 .
th
Measurement Reading: Reading Recall:
1. When the monitor is o, press the
“MEM”, buon to display the last
3 readings. *Note: If fewer than 3
readings are stored, the most recent
will be displayed.*
2. Press the “MEM” or “SET” buon to
locate the desired record. The
order, date and me will be shown
alternately.
2. Press ‘Start/Stop’ buon to turn o the device or the device will turn
o automacally aer 1 minute.
Tips:
• A Maximum of 60 records are stored for both User 1 and User 2.
• 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 the word “out”.
1. With the device o, press the ‘Start/Stop’ buon and the full
measurement will be taken.
1514

DATA MANAGEMENT DATA MANAGEMENT
3. To check another user’s record, press the “Start/Stop” buon to turn
o the monitor. Press and hold the “MEM” buon to enter User
Selecon Mode. Then press and hold the “MEM” buon to select, User
1 or User 2 and press “SET” to conrm selecon. Next, press “MEM”
buon to recall the records.
* Please Note: The most recent record is shown 1st. With each new
reading, all other records will be pushed back a digit with the last being
dropped if the number of readings surpasses 60.
Deleng Records:
1. When the monitor is in Recall
Mode, press and hold the
“MEM” buon for 3 seconds.
The display will ash,
“User ID+dEL ALL” will show.
* Note: To exit Delete Mode
without removing any records,
press the “Start/Stop” buon
before pressing “SET” buon to
conrm any deleons. *
2. Pres “SET” buon to conrm
deleon. The monitor will dis
play “dEL + donE” and turn o.
3. If there is no record, the
following will appear on the
display:
1716

INFORMATION FOR USER ABOUT BLOOD PRESSURE
Standard Blood Pressure
The chart on the right details the standard classicaon published by the
American Heart Associaon (AHA).
Irregular Heartbeat Detector:
An irregular heartbeat is detected when the rhythm varies while measur-
ing the systolic and diastolic pressures. During each measurement, pulse
intervals are recorded and calculated to provide an average. If there are
2 or more intervals where the dierence between each interval and the
average is more than the average value of ±25%, or 4 intervals where the
average exceeds the value of ±15%, the irregular heartbeat symbol will
appear on the display with the measurement result.
press
artery vein
blood discharging
Systolic
relax
blood entering
Diastolic
Warning
Consult your physician if your measuring falls outside the AHA range. Only your doctor can
determine and conrm whether blood pressure has reached a dangerous point.
Warning
While the detecon of the IHB is generally not cause for concern, if it does appear, always
consult your physician. The monitor should not be used to diagnose or treat any condion.
Blood Pressure Category
Normal
High Blood Pressure
(Hypertension) Stage 1
High Blood Pressure
(Hypertension) Stage 2
Systolic
mmHg (upper#)
Diastolic
mmHg (lower#)
less than 120
120-129
130-139
140 or higher
Higher than 180
and
or
or
and/or
less than 80
80-89
90 or higher
Higher than 120
This chart reflects blood pressure categories defined by American Heart Associaon.
and less than 80
Elevated
Hypertensive Crisis
(Consult your doctor immediately)
For Accurate Readings, DO NOT Use:
1. Within an hour of eang or drinking.
2. Aer smoking or drinking coee or tea.
3. Withing 30 minutes of taking a bath.
4. When talking or using your ngers.
5. In a cold environment.
6. While using the bathroom.
Maintenance:
1. Store in a dry, cool place.
2. Avoid shaking or bumping/striking a hard surface.
3. Use a so cloth to clean.
4. Do Not use or submerge on water or liquid.
5. Avoid dirty/dusty environments and avoid environments with
uctuang circumstances.
Systolic vs. Diastolic Pressure
When ventricles contract and pump blood out of the heart, the blood
pressure reaches its maximum value in the cycle, systolic pressure.
When the ventricles relax, the blood reaches its minimum cycle, diastolic
pressure.
1918

ABOUT BLOOD PRESSURE TROUBLESHOOTING
Why Blood Pressure Fluctuates Throughout the Day:
1. Mild uctuaon is normal. However, readings can vary depending
on how you e the cu so always take the measurement in the same
posion.
2. Medicaon can cause variaons.
3. Wait at least 3 minutes between measurements.
Why Your Measurement at Home is Dierent Compared
to the Hospital or Doctor’s Oce:
Weather, acvity, and emoon can impact readings. Also, blood pressure
usually increases in clinical sengs.
Is the Result the Same if Measuring on the Right Arm?
The use of both arms is ok, but we suggest measuring with the same arm
each me.
Tips for At-Home Measurement:
• Ensure cu is ed properly.
• Ensure t (not too loose or too ght).
• Ensure cu is place in the correct spot on the upper arm.
• Ensure you are relaxed.
• Take 2-3 deep breaths before measuring.
Troubleshoong:
This secon includes a list of error messages and frequently asked
quesons for problems you may encounter with your blood pressure
monitor. If the product is not operang as you think it should, check here
before arranging for servicing.
PROBLEM SYMPTOM CHECK THIS REMEDY
No power
Low
baeries
Error
message
Display will not
light up.
Check Baeries’
Life & Baery
Placements.
Replace baeries &
ensure proper posion.
Replace Baeries.
Display is dim or
show Low Baery.
Soluon: Refasten cuff.E 01 shows
E 02 shows
E 03 shows Loosen clothing
on the arm.
EExx,shows on
the display.
If persistent, refer to the
warranty and contact
the retailer.
Retake measurement and
contact your physician.
E 04 shows Relax and try again.
Relax for a
moment and then
measure again.
Warning
message
“out” appears
on display.
Your Measurement
results fall out of
measurement range
(SYS:60mmHg to
230mmHg; or DIA:
40mmHg to 130mmHg;
or Pulse: 40-199
pulse/minute).
Cuff is not secure.
Moon, talking, poor
pulse is detected.
No pulse detected.
Measurement fail.
A calibraon error
occurred.
2120

SPECIFICATIONS AUTHORIZED COMPONENT
Type BF applied part
Power supply
Mode Number:
Baery powered mode:
MT-BPM-001
6VDC 4×AAA baeries
AC adaptor powered mode: 6V 1A (not included)
(Please only use the recommended AC adaptor
model).
Display mode
Measurement mode Oscillographic tesng mode
Measurement range
Measurement perimeter
of the upper arm
Weight
External dimensions
Aachments
Mode of operaon Connuous operaon
Degree of protecon
Protecon against
ingress of water
Accuracy
Normal working condion
Storage & transportaon
condion
Soware Version A01
Pressure:
5°C-40°C within±3mmHg(0.4kPa)
Pulse value:±5%
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
Device Classificaon Baery Powered Mode:
Internally Powered ME Equipment
AC Adaptor Powered Mode: Class II ME Equipment
Digital LCD V.A.100mm×68mm
Approx.154.6mm×106mm×57.1mm
Temperature:-20°C to +60°C
A relave humidity range of ≤ 93%, non-condensing,
at a water vapour pressure up to 50hPa
About 22cm~32cm
Approx.281g(Excluding the dry cells and cuff)
4×AAA baeries, user manual and a carrying bag
IP21 It means the device could protected against
solid foreign objects of 12.5mm and greater,
and protect against vercally falling water drops.
A temperature range of :+5°C to +40°C
A relave humidity range of 15% to 90%,
non-condensing, but not requiring a water vapour
paral pressure greater than 50 hPa
An atmospheric pressure range of :
700 hPa to 1060 hPa
Specicaons: FCC Statement:
This device complies with Part 15 of the FCC Rules. Operaon is subject
to the following two condions: (1) this device may not cause harmful
interference, and (2) this device must accept any interference received,
including interference that may cause undesired operaon.
WARNING: No modicaon of this equipment is allowed.
2322

COMPLIED STANDARDS LIST EMC GUIDANCE
Complied Standards List: EMC Guidance:
The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments
Warning:
Don’t acve this device near HF surgical equipment or near the RF shielded room of an ME system for
magnec 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 operaon. If such use is necessary, this equipment and the other equipment should
be observed to verify that they are operang normally.
Warning:
Use of accessories, transducers and cables other than those specied or provided by the manufacturer
of this equipment could result in increased electromagnec emissions or decreased electromagnec
immunity of this equipment and result in improper operaon.”
Warning:
Portable RF communicaons 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 TMB-1585-S,
including cables specied by the manufacturer. Otherwise, degradaon of the performance of this
equipment could result.
Technical Descripon of the Blood Pressure Monitor:
EN ISO 14971:2012 / ISO 14971:2007 Medical devices -
Applicaon of risk management to medical devices
EN 1041:2008 +A1:2013 Informaon 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
essenal performance
EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical electrical
equipment - Part 1-11: General requirements for basic safety and
essenal 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
essenal performance - Collateral standard: Electromagnec
disturbances - Requirements and tests
EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1:
Requirements and test methods for non-automated measurement type
EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers -
Part 3: Supplementary requirements for electro-mechanical blood
pressure measuring systems
EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test
procedures to determine the overall system accuracy of automated
non-invasive sphygmomanometers
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 essenal performance - Collateral standard: Usability
IEC 62366-1:2015 Medical devices - Part 1: Applicaon of
usability engineering to medical devices
EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical
device soware - Soware life-cycle processes
Risk management
Labeling
User manual
General Requirements
for Safety
Electromagnec
compability
Performance
requirements
Clinical invesgaon
Usability
Soware life-cycle
processes
Bio-compability
ISO 10993-1:2009 Biological evaluaon of medical devices- Part
1: Evaluaon and tesng within a risk management process
ISO 10993-5:2009 Biological evaluaon of medical devices - Part
5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluaon of medical devices -
Part 10: Tests for irritaon and skin sensizaon
EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices.
Symbols to be used with medical device labels, labelling and
informaon to be supplied. Part 1 : General requirements
IEC 80601-2-30:2009+A1:2013 Medical electrical equipment-
Part 2-30: Parcular requirements for the basic safety and essenal
performance of automated non-invasive sphygmomanometers
ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2:
Clinical validaon of automated measurement type
Guidance and manufacturer’s declaraon - electromagnec emissions
RF emissions
CISPR 11 Group 1
Class [ B ]
Class A
Comply
Compliance
Harmonic emissions
IEC 61000-3-2
Voltage fluctuaons/
flicker emissions
IEC 61000-3-3
RF emissions
CISPR 11
Emissions test
2524

EMC GUIDANCE EMC GUIDANCE
Guidance and manufacturer’s declaraon – electromagnec Immunity
Immunity Test
±8 kV contact
±2 kV, ±4kV, ±8 kV, ±15 kV air
±8 kV contact
±2 kV for power supply lines
±0.5 kV, ±1 kV differenal mode
0 % UT; 0,5 cycle. At 0°, 45°, 90°, 135°,
180°, 225°, 270° and 315°.0 % UT;
1 cycle and 70 % UT; 25/30 cycles;
Single phase: at 0°.0 % UT; 250/300 cycle
30 A/m
50Hz/60Hz
NOTE U
T
is the a.c. mains voltage prior to applicaon of the test level.
Compliance level
Electrostac
discharge (ESD)
IEC 61000-4-2
30 A/m
50Hz/60Hz
Power frequency
magnec field
IEC 61000-4-8
Voltage dips, short
interrupons and
voltage variaons
on power supply
input lines
IEC 61000-4-11
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC61000-4-5
±1 kV signal input/output
100 kHz repeon frequency
IEC 60601-1-2
Test level
0 % UT; 0,5 cycle. At 0°, 45°, 90°, 135°,
180°, 225°, 270° and 315°.
0 % UT; 1 cycle and 70 % UT;
25/30 cycles; Single phase: at 0°.
0 % UT; 250/300 cycle
±2 kV, ±4kV, ±8 kV,
±15 kV air
±2 kV for power supply lines
±1 kV signal input/output
100 kHz repeon frequency
±0.5 kV, ±1 kV,±2 kV common mode
±0.5 kV, ±1 kV differenal mode
±0.5 kV, ±1 kV,±2 kV common mode
Conduced RF
IEC61000-4-6
3 V
0,15 MHz – 80 MHz
6 V in ISM and amateur radio bands
between 0,15 MHz and 80 MHz
80 % AM at 1 kHz
3 V
0,15 MHz – 80 MHz
6 V in ISM and amateur radio bands
between 0,15 MHz and 80 MHz
80 % AM at 1 kHz
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
Radiated RF
IEC61000-4-3
Guidance and manufacturer’s declaraon - electromagnec Immunity
Test
Frequency
(MHz)
385 0.3 27
Radiated RF
IEC61000-4-3
(Test
specificaons
for
ENCLOSURE
PORT
IMMUNITY to
RF wireless
communica-
ons
equipment)
Band
(MHz)
Service Modulaon Modulaon
(W)
Distance (m)
IMMUNITY
TEST
LEVEL
(V/m)
380-390 TETRA
400
Pulse
modulaon b)
18Hz
1.8
450 430-470
GMRS 460，
FRS 460
FM c) ± 5kHz
deviaon 1kHz
sine
20.3 28
710 704-787
745
780
LTE Band
13,
17
Pulse
modulaon b)
217Hz
0.2 0.3 9
810
870
930
800-960
GSM
800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulaon b)
18Hz
20.3 28
1720
1845
1970
1700-
1990
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1,
3,
4,25; UMTS
Pulse
modulaon b)
217Hz
20.3 28
20.3 282450 2400-
2570
Bluetooth,
WLAN,
802.11
b/g/n, RFID
2450, LTE
Band 7
Pulse
modulaon
217 Hz
5240
5500
5785
5100-
5800
WLAN
802.11
a/n
Pulse
modulaon
217 Hz
0.2 0.3 9
2726

Limited Lifeme Warranty:
Your Medic Therapeucs Blood Pressure Monitor is backed by a limited
lifeme manufacturer’s warranty. Medic Therapeucs will repair or
replace your device at any me should it fail due to a defect in material or
workmanship, subject to the certain limitaons.
This limited warranty does not cover any damage that results from un-
authorized or improper use, service, or repair. Further, it does not cover
damage caused by accident, impact, negligence, or normal wear and tear.
Should you discover your Medic Therapeucs Blood Pressure Monitor is
not funconing properly, please send your device to our repair center for
evaluaon. If your product cannot be repaired or serviced, we will reserve
the right to change it for a similar or newer model.
Please note that a at rate of $35.00 will be charged to cover a service
evaluaon fee and return shipping of your device. All warranty claims
must be accompanied by a copy of your proof of purchase from an autho-
rized retailer. Please send your device, proof of purchase, and a check or
money order in the amount of $35.00 made out to Medic Therapeucs to:
Address:
Medic Therapeucs Service Center
3069 Ta Street
Hollywood, FL 33021
Contact:
warranty@medictherapeucs.com
Distributor Informaon:
HUB Emergency Services, LLC
Medic Therapeucs
3069 Ta Street,
Hollywood, FL 33021