Pylo Health PY-802-LTE User manual

Guangdong Transtek Medical Electronics Co., Ltd.
Zone B, No.105 ,Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
User Manual
LTE Blood Pressure Monitor PY-802-LTE
Thank you for choosing Pylo Health!
This manual outlines how to use your Pylo blood pressure
monitor safely and correctly. Please be sure to read it
thoroughly and keep it for future reference.
Pylo Health
28632 Roadside Drive
Suite 215
Agoura Hills, CA 91301
[email protected]om | [phone]
Distributed by:
Arm Type

CATALOGUE CATALOGUE
Table of Contents
INTRODUCTION 2
ABOUT BLOOD PRESSURE 16
TROUBLESHOOTING 18
SPECIFICATIONS 19
AUTHORIZED COMPONENT 20
CONTACT INFORMATION 20
FCC STATEMENT 21
COMPLIED STANDARDS LIST 22
EMC GUIDANCE 23
INFORMATION FOR USER 14
MEASUREMENT 11
BEFORE YOU START 9
General Description
Indications for Use
Contraindications
Measurement Principle
Safety Information
LCD Display Signal
Components of the Device
Included Parts List
What are systolic pressure and diastolic pressure?
What is the standard blood pressure classification?
Irregular heartbeat detection
Why does my blood pressure fluctuate throughout the day?
Why do I get a dierent blood pressure readings at home compared to the hospital?
Is the result the same if measuring on either arm?
Tips for measurement
Maintenance
Tie the Cu
Taking a Measurement
The Choice of Power Supply
Installing and Replacing the Batteries
1

Symbol for “THE OPERATION
GUIDE MUST BE READ”
Symbol for “TYPE BF APPLIED
PARTS”
Symbol for “MANUFACTURER” 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 “SERIAL NUMBER”
Symbol for “DIRECT CURRENT”
Symbol for “RECYCLE” Symbol for “MANUFACTURE DATE”
Caution: These notes must be
observed to prevent any damage
to the device.
SN
INTRODUCTION INTRODUCTION
General Description Measurement Principle
Safety Information
Indications for Use
Contraindications
Thank you for selecting the Pylo PY-802-LTE arm type blood pressure monitor.
The monitor features blood pressure measurement, pulse rate measurement and digital result
storage. Readings taken by the PY-802-LTE are equivalent to those obtained by a trained observer
using the cu and stethoscope auscultation method. This manual contains important safety and
care information, and provides step by step instructions for using the product.
Please read this manual thoroughly before using the product.
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 prior to inflating the cu. 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.
The signs below might be in the user manual, labeling or other components.
They are the requirement of standard and using.
Features:
• 78*92mm Digital LCD display
• Measuring during inflation technology
• LTE-M wireless communication
The Pylo PY-802-LTE is a digital blood pressure monitor intended for use in measuring blood
pressure and heartbeat rate on users with an arm circumference ranging from 22cm to 42cm
(about 8¾˝-16½˝).
It is intended for adult indoor use only.
1.The device should not be used by any person who is suspected to be or is pregnant .
2.The device is not suitable for use on patients with implanted electrical devices such as cardiac
pacemakers or defibrillators.
32

INTRODUCTION INTRODUCTION
54
CAUTION 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 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 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 arm 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.
* Don’t kink the connection tube during use, otherwise, the cu pressure may continuously
increase which can prevent blood flow and result in harmful injury to the PATIENT.
* When using this device, please pay attention to the following situation which may interrupt
blood flow and influence blood circulation of the patient, thus cause harmful injury to the
patient: connection tubing kinking too frequent and consecutive multiple measurements; the
application of the cu and its pressurization on any arm where intravascular access or therapy,
or an arterio-venous (A-V) shunt, is present; inflating 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 inflate the cu 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.
*On the rare occasion of a fault causing the cu to remain fully inflated 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 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 eects 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 arm 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 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.
* The patient can measure, and charge power 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 cu 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 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 potential sensation or irritation reaction.
* Adaptor is specified as a part of ME EQUIPMENT.
* If you experience discomfort during a measurement, such as pain in the arm or other complaints,
press any button 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 automatically deflate. Should the
cu not deflate when pressure reaches 40 kPa (300 mmHg), detach the cu from the arm and
press any 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 cu in a washing machine or dishwasher!

SYMBOL DESCRIPTION EXPLANATION
Systolic blood pressure High pressure result
Diastolic blood pressure Low pressure result
Pulse Pulse/minute
Current Time Time (year:month:day:hour:minute)
Heartbeat Heartbeat dectetion during measurement
mmHg Measurement Unit of the blood pressure
Battery Indicator Indicate the current battery
Irregular heartbeat Irregular heartbeat
Data transmission indication Indicates that the data is being sent. oH will
show on screen to indicate success.
Shocking reminder Sudden movement will result in inaccurate
readings
Signal indication Indicates the signal situation in the
communication process.
INTRODUCTION INTRODUCTION
76
CAUTION
* The service life of the cu 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 aer maintenance
and repair, by retesting at least the requirements in limits of the error of the cu pressure
indication and air leakage (testing 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, descriptions,
calibration instructions,etc., to assist to service personnel in parts repair.
* The plug/adapter plug pins insulate the device from the main supply. Do not position the device
in a position where it is diicult to disconnect from the supply mains to safely terminate
operation of ME equipment.
* The operator shall not touch output of batteries /adapter and the patient 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 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 Pylo. 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 Pylo 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 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 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 MANUFACTURER.
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 Signal

1.Battery powered mode:
6VDC 4*AA batteries
2.AC adaptor powered mode:
6V 1A (not included)
(Please only use a manufacturer authorized AC adapter.)
See picture on right hand side for power port location.
If this is your first time using the device:
1.Slide open the battery door on the back of the device.
2.Install the batteries provided with the device. Follow the diagram inside the battery
compartment for correct placeme—the springs should align with the negative sign
on the batteries.
3.Slide the battery door closed.
Replace the batteries whenever the
following occurs:
• The icon displays
• The display dims
• The display does not light up
In order to get the best eect and protect your monitor,
please use the the right batteries and special power adapter
which complies with local safety standard.
• Do not use new and used batteries together.
• Do not use dierent 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.
• Used batteries are harmful to the environment.
Do not dispose with daily garbage.
• Remove the old batteries from the device following your
local recycling guidelines.
CUFFTUBE
CUFF
START/STOP BUTTON
DC POWER SOCKET
CUFF TUBE CONNECTOR
BATTERY COMPARTMENT
BATTERY DOOR
AC adaptor
INTRODUCTION BEFORE YOU START
98
Components of the Device
Included Parts List
The Choice of Power Supply
Installing and Replacing the Batteries
Component list of
pressure measuring system:
1 Cu
2 Air pipe
3 PCBA
4 Pump
1. Cellular Blood Pressure
Monitor (PY-802-LTE)
3. User manual
2. Cu (22~42cm)
(Type BF applied part)
4. Four (4) AA batteries
CAUTION
CAUTION

1. Plug the connector into the ‘Cu Port’ as labeled on
the device.
2. Expose your upper arm by removing or adjusting
clothing and jewelry. Make sure blood flow is not
constricted by a rolled up sleeve.
3. Open the cu and loosen fully.
4. Orient the cu so that the tube exits towards the hand.
5. Place your arm through the cu loop, with your palm
facing up.
6. Position the cu’s edge about an inch (2–3 cm) above
the elbow.
7. Align the  marker (located to the right of the tube
exit) with the center of your arm.
8. Tighten the cu evenly around your arm by pulling
on the end—make sure the  marker stays aligned
with the center of your arm.
9. Wrap the end of the cu over your arm to secure it in
place. Don’t make it too tight—allow a finger to fit
between the cu and your arm.
10. If possible, relax and rest for at least 5 minutes
before taking a measurement.
11. Lay your arm on a table with your palm facing up.
The cu should be at the same height as your heart.
Sit up straight and rest your feet flat on the ground.
Make sure the tube is not kinked or pinched.
When you insert or replace batteries into the device, the symbol
and will be shown on the LCD. This indicates that
the device is searching and pairing with a mobile network. You
can long press “ START/STOP ” button to end pairing and use
the device. If you manually cancel pairing, the device may take
longer to send a measurement aer use..
When pairing is successful,
the symbol is shown
on the display. You can then
utilize the device as normal
by pressing “START”.
2~3cm
BEFORE YOU START MEASUREMENT
1110
Tip: Tie the Cu

3.If the data is successfully transmitted,
the symbol will disappear and the
LCD will display before the device
turning o.
If the data transmission fails, an error
message will be shown (E6 as an example)
on the display for several seconds then
the device will turn o.
MEASUREMENT MEASUREMENT
1312
Taking a Measurement
1. When the monitor is o, press the
“ START/STOP ” button to turn on
the monitor. The cu will begin to inflate and
the measurement will be taken and saved.
2. Once measurement is taken, the device will
connect to the network and start transmission.
The symbol will blink while the device is
transmitting.
LCD display
Inflating and measuring
Adjust the zero
Display and save the results
You can press “ START/STOP ” button at any time to stop measuring during the process of
measurement.
Tip:
In the case of a data transmission failure
(E5 or E6), up to 60 measurements are
saved on the device and will be sent when
a successful connection is achieved.

INFORMATION FOR USER INFORMATION FOR USER
1514
Tips for Measurement Maintenance
Measurements may be inaccurate if taken in the following circumstances:
Within an hour
aer dinner or drinking
Store device in a dry place
away from direct sunlight.
Within 20 minutes
aer taking a bath
Avoid shaking or dropping
the device.
In a very cold
environment
When cleaning device, use a
lightly moist cloth without
soap or detergent.
Aer drinking tea, coee
or using tobacco products.
Keep away from water. If splashed,
immediately dry with a clean towel.
While talking, gesturing or
while in a loud environment.
Store device in a place that avoids
quick changes in temperature.
When you have to go to
the bathroom.
Do not wash or immerse
the cu in water.
In order to get the best performance, please follow the instructions below.
X
X
X
X
X
X

press
artery
blood discharging
Systolic
press
artery
blood discharging
Systolic
INFORMATION FOR USER INFORMATION FOR USER
17
16
What are systolic pressure and diastolic pressure?
Irregular Heartbeat Detection
What is the standard blood pressure classification?
Why does my blood pressure
fluctuate throughout the day?
Why do I get a dierent blood
pressure at home compared to
the hospital?
Is the result the same if
measuring on dierent arms?
When ventricles contract and pump blood out
of the heart, the blood pressure reaches its
maximum value in the cycle, which is called
systolic pressure. When the ventricles relax,
the blood pressure reaches its minimum value
in the cycle, which is called diastolic pressure.
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 dierence between each interval and the average is more than the
average value of ±25% , or there are four or more pulse intervals, the dierence 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.
The chart on the right
is the standard blood
pressure classification
published by American
Heart Association (AHA).
1. Individual blood pressure varies throughout the
day. It is also aected by the way you tie your cu
and your measurement position. It is important
to take measurements in the same conditions.
2. If the person takes medicine, the pressure may
vary even more.
3. Wait at least 3 minutes between measurements.
What you need to pay attention to when
you measure your blood pressure at home:
• If the cu is tied properly.
• If the cu is too tight or too loose.
• If the cu is tied on the upper arm.
• If you feel anxious.
• Taking 2-3 deep breaths before
beginning will be better for measuring.
Advice:
Relax yourself for 4-5 minutes prior to
taking a measurement.
It is acceptable to use either arm but results might
dier between arms for some people.
It is suggested that you measure on the same arm
every time.
The blood pressure is dierent even
throughout the day due to weather,
emotion, exercise etc.
Also, there is a phenomenon called
the “white coat” eect, which means
blood pressure usually increases when
measured in clinical settings.
This chart reflects blood pressure categories defined by American Heart Association.
Blood Pressure Category Systolic
mmHg upper#)
Diastolic
mmHg (lower#)
Normal less than 120 and less than 80
Prehypertension 120-129 and less than 80
High Blood Pressure
(Hypertension) Stage 1
130-139 or 80-89
High Blood Pressure
(Hypertension) Stage 1
140 or higher or 90 or higher
Hypertensive Crisis (Consult
your doctor immediately)
Higher than 180 and /or Higher than 120
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.
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 oen, 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.
CAUTION
CAUTION

Power supply Battery powered mode: 6VDC 4×AA batteries
AC adaptor powered mode: 6V 1A (not included)
(Please only use the recommended AC adaptor model).
Display mode Digital LCD V.A.78mm*92mm
Measurement mode Oscillographic testing mode
Measurement range Rated cu 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
Accuracy Pressure: 5C-40Cwithin±3mmHg(0.4kPa) Pulse value:±5%
Normal working condition 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
Storage &
transportation condition
Temperature:-20°C to +60°C
A relative humidity range of ≤ 93%, non-condensing, at a water
vapour pressure up to 50hPa
Measurement perimeter
of the upper arm
About 22cm~42cm
Weight Approx.393g(Excluding the batteries)
External dimensions Approx.154.3mm*121.5mm*68.1mm
Attachment 4×AA batteries,user manual
Mode of operation Continuous operation
Degree of protection Type BF applied part
Protection against
ingress of water
IP21 It means the device could protected against solid foreign
objects of 12.5mm and greater, and protect against vertically
falling water drops.
Device Classification Battery Powered Mode: Internally Powered ME Equipment
AC Adaptor Powered Mode: Class II ME Equipment
Soware Version A01
Problem SYMPTOM CHECK THIS REMEDY
No
power
or Low
batteries
Display will not
light up
or
show
Batteries are exhausted. Replace with new batteries
Batteries are inserted
incorrectly.
Insert the batteries correctly
AC adaptor is inserted
incorrectly.
Insert the AC adaptor tightly
Error
message
E 1 shows The cu is not secure
or inflation is abnormal.
Refasten the cu and then
measure again.
E 2 shows The monitor detected
motion, talking or the
pluse is not readable
while measuring.
Movement can aect the
measurement. Relax for a
moment and then measure
again.
E3 shows The measurement
process does not detect
the pulse signal.
Loosen the clothing on the
arm and then measure again
E4 shows The treatment of the
measurement failed.
Relax for a moment and
then measure again.
E5 shows Failed to communicate
with the server
Contact customer service
E6 shows Radio communication
failure
Contact customer service
EExx,shows on
the display.
A calibration error
occurred.
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
Warning
message
‘out’ shows Out of measurement
range
Relax for a moment. Refasten
the cu and then measure
again. If the problem persists,
contact your physician.
This section includes a list of error messages and frequently asked questions for problems you may
encounter with your blood pressure monitor. If the device is not operating as you think it should,
check here before arranging for servicing.
WARNING: No modification of this equipment is allowed.
TROUBLESHOOTING SPECIFICATIONS
1918

Adaptor:
Type: BLJ06L060100P-U
Input: 100-240V 50-60Hz,0.2Amax
Output: 6V 1000mA
TROUBLESHOOTING SPECIFICATIONS
2120
Authorized Component
Contact Pylo Health
FCC Statement
If plug in power functionality is desired,
only use a Pylo authorized AC adapter
(not included).
For more information about our products, please visit www.pylo.com. You can get customer
service, usual problems and customer download, Pylo will serve you anytime.
Contact Information: Pylo Health
28632 Roadside Drive
Suite 215
Agoura Hills, CA 91301
[email protected]om | [phone]
contains FCC ID: XMR2020BG95M2
This device complies with Part 15 of the FCC Rules. Operation is subject to the 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 o 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 dierent 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.

EMC GUIDANCE EMC GUIDANCE
2322
Complied Standards List 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 PY-802-LTE, 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 3
Guidance and manufacturer’s declaration - electromagnetic emissions
Emissions Compliance
RF emissions
CISPR 11
Group 1
RF emissions
CISPR 11
Class [ B ]
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Comply
Risk management EN ISO 14971:2012 / ISO 14971:2007 Medical devices - Application of risk management
to medical devices
Labeling 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
User manual EN 1041:2008 +A1:2013 Information supplied by the manufacturer of medical devices
General
Requirements
for Safety
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
Electromagnetic
compatibility
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
Performance
requirements
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
IEC 80601-2-30:2018 Medical electrical equipment- Part 2-30: Particular requirements
for the basic safety and essential performance of automated non-invasive
sphygmomanometers
Clinical investi-
gation
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
Usability 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
Soware life-cycle
processes
EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical device soware -
Soware life-cycle processes
Bio-compatibility 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

EMC GUIDANCE EMC GUIDANCE
2524
Table 2 Table 3
Guidance and manufacturer’s declaration – electromagnetic Immunity
Immunity Test IEC 60601-1-2 Test level Compliance level
Electrostatic
discharge
(ESD)
IEC 61000-4-2
±8 kV contact
±2 kV, ±4kV, ±8 kV, ±15 kV air
±8 kV contact
±2 kV, ±4kV, ±8 kV,
±15 kV air
Electrical fast
transient/
burst
IEC 61000-4-4
±2 kV for power supply lines
±1 kV signal input/output
100 kHz repetition frequency
±2 kV for power supply lines
±1 kV signal input/output
100 kHz repetition frequency
Surge
IEC61000-4-5
±0.5 kV, ±1 kV dierential mode
±0.5 kV, ±1 kV,±2 kV common mode
±0.5 kV, ±1 kV dierential mode
±0.5 kV, ±1 kV,±2 kV common mode
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
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
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
Power
frequency
magnetic field
IEC 61000-4-8
30 A/m
50Hz/60Hz
30 A/m
50Hz/60Hz
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
Radiated RF
IEC61000-4-3
10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
NOTE UTis the a.c. mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration - electromagnetic Immunity
Radiated RF
IEC61000-4-3
(Test
specifications
for
ENCLOSURE
PORT
IMMUNITY to
RF wireless
commu-
nications
equipment)
Test
Frequency
(MHz)
Band
(MHz)
Service Modulation Modulation
(W)
Distance (m) IMMUNITY
TEST
LEVEL
(V/m)
385 380-
390
TETRA
400
Pulse
modulation
b) 18Hz
1.8 0.3 27
450 430-
470
GMRS 460,
FRS 460
FM c) ±
5kHz
deviation
1kHz sine
2 0.3 28
710 704-
787
LTE Band
13, 17
Pulse
modulation
b) 217Hz
0.2 0.3 9
745
780
810 800-
960
GSM
800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation
b) 18Hz
2 0.3 28
870
930
1720 1700-
1990
GSM 1800;
CDMA
1900;
GSM 1900;
DECT;
LTE
Band 1,
3, 4,25;
UMTS
Pulse
modulation
b) 217Hz
2 0.3 28
1845
1970
2450 2400-
2570
Bluetooth,
WLAN,
802.11
b/g/n,
RFID
2450, LTE
Band 7
Pulse
modulation
217 Hz
2 0.3 28
5240 5100-
5800
WLAN
802.11
a/n
Pulse
modulation
217 Hz
0.2 0.3 9
5500
5785