Gurin Accura Pulse AP-WBPM810 User manual

User Manual
Wrist Blood Pressure Monitor AP-WBPM810
To use the monitor correctly and safely, please read the manual
thoroughly.
Thank you very much for selecting AccuraPulse Wrist Blood Pressure
Monitor AP-WBPM810.
Please keep this manual well in order to reference in future.
Questions/Warranty: [email protected]
Wrist Type
Version:1.0
Distributed By: Gurin Products LLC
2522 Chambers Road, Suite 100 Tustin, CA-92780 USA
Questions/Warranty: [email protected]
2018-05-10
技术要求：
1、黏合不可露胶
2、保持印刷面板上的清洁
3、注意套印的准确性
4、表面处理不可爆开
5、结构工艺以结构受控图为准
6、颜色参考：
产品型号 材质
尺寸
70g 书写纸
70*95 mm
单黑
产品名称 血压计
-
TMB-1580-006
李秋燕 2018-05-10
罗佳钰 2018-05-10
谭文昊 2018-05-10
TMB-1580-006-GB-08
PO#2F3133-TMB-1580-006-GB-08-说明书-A2
共 16 张 第 1 张
A/2
对应结构图纸 印色
1:1 -表面处理

INTRODUCTION ............................................................... 2
Safety Information
LCD Display Signal
Monitor Components
BEFORE YOU START
.......................................................... 9
Installing and Replacing the Batteries
Setting Date, Time
MEASUREMENT
............................................................... 12
Tie the Cuff
Select the User ID
Start the Measurement
DATA MANAGEMENT 15
Recall the Records
Delete the Records
INFORMATION FOR USER
..................................................... 18
Tips for Measurement
Maintenance
ABOUT BLOOD PRESSURE
.................................................... 20
What are systolic pressure and diastolic pressure?
What is the standard blood pressure classification?
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
......................................................... 22
SPECIFICATIONS
............................................................. 23
CONTACT INFORMATION
...................................................... 24
COMPLIED STANDARDS LIST
FCC STATEMENT
..................................................................... 25
EMC GUIDANCE
...................................................... 26
..........................................................
General Description
Indications for Use
............................................................. 24
Measurement Principle
List
Irregular heartbeat detector
1
CATALOGUE CATALOGUE

Features:
Systolic blood pressure
Diastolic blood pressure
Pulse rate
60 records per each user
General Description
Thank you for selecting AccuraPulse Wrist Blood Pressure Monitor
(AP-WBPM810). The monitor features blood pressure measurement, pulse rate
measurement and the result storage. The design provides you with two years of
reliable service.
Readings taken by the AP-WBPM810 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.
Indications for Use
The AccuraPulse Blood Pressure Monitor digital monitor is intended for use in
measuring blood pressure and heartbeat rate with wrist circumference ranging
from 13.5cm to 21.5 cm ( about 5⅓˝-8½˝ ).
It is intended for adult indoor use only.
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.
The device also compares the longest and the shortest intervals of detected
pulse wave to with the average value, and then calculates the standard deviation.
The monitor will light up a warning symbol when the calculated standard
deviation is larger than or equal to 25%.
Measurement Principle
Safety Information
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”
SN
Symbol for “TYPE BF APPLIED
PARTS”
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”
Symbol for “MANUFACTURER”
Symbol for “SERIAL NUMBER”
Symbol for “DIRECT CURRENT”
Symbol for “MANUFACTURE
DATE”
Caution: These notes must be
observed to prevent any damage
to the device.
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.
3
2
INTRODUCTION INTRODUCTION

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 was 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 cuff 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 cuff and its pressurization on any wrist where intravascular access or
therapy, or an Arteriovenous (A-V) shunt, is present; inflating the cuff on the side of a
mastectomy.
* 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.
*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.
CAUTION
* 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.
* The patient can measure 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 sensization 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 pressures 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.
5
4
INTRODUCTION INTRODUCTION

LCD Display Signal
* 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).
* 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 operator shall not touch output of batteries and the patient simultaneously.
* 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 AccuraPulse. 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 AccuraPulse 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 80 MHz to 5.8 GHz column of Table 4
and Table 9 of IEC 60601-1-2:2007, as appropriate.
* Please use ACCESSORIES and detachable partes 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 was provided in the user manual.
Otherwise, the performance and lifetime of the device will be impacted and reduced.
CAUTION
Systolic
blood pressure High blood pressure
Diastolic
blood pressure Low blood pressure
mmHg Measurement unit the blood pressure
(1mmHg=0.133kPa)
Current time
Irregular heartbeat
Low battery Batteries are low and need to be replaced.
SYMBOL DESCRIPTION EXPLANATION
Year/Month/Day,Hour/Minute
Heartbeat
User 1
User 2
Start measurement and save the
measuring results for user 1.
Start measurement and save the
measuring results for user 2.
Blood pressure monitor is detecting an
irregular heartbeat during measurement.
Blood pressure
level indicator Indicate the blood pressure level
Blood pressure monitor is detecting a
heartbeat during measurement.
Motion indicator Motion may result in an inaccurate
measurement.
7
6
INTRODUCTIONINTRODUCTION

Monitor Components
Component list of
pressure measuring
system:
1. PCBA;
2. Air Pipe;
3. Pump;
4. Valve;
5. Cuff.
List
1) Wrist Blood Pressure Monitor AP-WBPM810
2) 2×AAA batteries
3) User manual
•Slide off the battery cover.
•Install the batteries by matching the correct polarity, as
shown below. Always use the correct battery type (2 x AAA batteries).
•Replace the cover.
Installing and Replacing the Batteries
Replace the batteries whenever the below happen：
shows
Display is dim.
Display does not light up
CUFF
(Type BF applied part)
BATTERY
COMPARTMENT
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.
SYSTOLIC
DIASTOLIC
MEM BUTTON
SET BUTTON
START/STOP BUTTON
PULSE RATE
LCD DISPLAY
GRADE
TIME
9
8
BEFORE YOU STARTINTRODUCTION

4.Repeat steps 2 and 3 to confirm [HOUR] and [MINUTE].
5.Repeat steps 2 and 3 to confirm the [MONTH] , [DAY] and [YEAR].
.After confirming the meausrement unit, the LCD will
display “dOnE” and then turn off.
Setting Date, Time 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.
(year :2014—2054,time format:24 H/12 H)
1.
2. Press the “ ” button to change
the [TIME FORMAT] between
12 hours and 24 hours.
3.
When the monitor is off, hold pressing
“ ” button for about 3 seconds to set
the time format.
When you get the right time format,
press “ ” button to confirm your
selection and it will turn to the next
step.
6
11
10
BEFORE YOU START BEFORE YOU START

Select the User ID
1.When the blood pressure monitor is off, press and hold “ ”button
until the user ID blinks. Then press “ ” button to change the user ID
between user 1 and user 2. Press “ ” button to confirm your selection.
Before you start the measurement, please select the desired user ID first.
2. After confirming the user ID, the LCD will turn off. Then you can start
your measurement now.
Tie the Cuff
1.
2.
3.
4.
5.
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.
Roll or push up your sleeve to expose the skin.
Apply the cuff to your wrist with your palm facing up.
Position the edge of the cuff about 1cm~1.5cm from wrist joints.
Fasten the wrist cuff around your wrist, leaving no extra room between the
cuff and your skin. If the cuff is 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 at the same level as your heart. Turn your
palm upwards. Sit upright in a chair, and take 5-6 deep breaths.
Rest for 5 minutes before first measuring.
Wait at least 3 minutes between measurements. This allows your blood
circulation to recover.
The patient must relax as much as possible and do not move and talk during
the measurement procedure.
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.
Keep your back against the backrest of the chair.
6.
7.
Take the measurement in a silent room.
The cuff should maintain at the same level as the right atrium of the heart.
Please sit comfortably. Do not cross your legs and keep your feet flat on the
ground.
Helpful tips for patients, especially for patients with Hypertension:
13
12
MEASUREMENTMEASUREMENT

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.)
Adjust the zero.
LCD display
Inflating and measuring. Display and save the
result.
Start the Measurement
2.
Recall the Records
1.
2.
The date and time will
display alternately.
The corresponding
time is 9:10.
The corresponding
date is May 11 .
When the monitor is off, press “ ” button to show the average value
of the latest three measurement records. (Take User 1 for example.)
Press “ ” button to power off, otherwise it will turn off
within 1 minute.
Press “ ” button or “ ” button to get the record you want.
th
Tips: Maximum 60 records are both for User 1 and User 2.
15
14
DATA MANAGEMENTMEASUREMENT

1.
2.Press “”to confirm
deleting, the LCD displays
“ dEL dOnE” and the monitor
will turn off.
If you did not get the correct measurement, you can delete all
results by following steps below . (Take User 1 for example.)
Delete the Records
3.If there is no record, the
right display will show.
In the memory mode, hold
pressing “ ” button for
3 seconds, the flash display
“User ID+ dEL All” will show.
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.
CAUTION
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.
Note: To exit out of delete
mode without deleting any
records, press
button before pressing “ ” to
confirm any delete commands.
17
16
DATA MANAGEMENTDATA MANAGEMENT

Maintenance
In order to get the best performance, please follow the
instructions below.
Put in a dry place and avoid the sunshine
Avoid intense shaking
and collisions
Using wet cloths to remove dirt
Avoid touching water,
clean it with a dry cloth in case
Avoid dusty and unstable-
temperature environment
Avoid washing the cuff
Tips for Measurement
CAUTION
• If you have any problems with this device, such as setting up, maintaining or using,
please contact the SERVICE PERSONNEL of AccuraPulse. Don’t open or repair
the device by yourself.
• Please report to AccuraPulse if any unexpected operation or events occur.
Measurements may be inaccurate if taken in the following
circumstances.
Within 1 hour
after dinner or drinking
Within 20 minutes
after taking a bath
In a very cold environment
Immediate measurement
after tea, coffee, smoking
When talking or moving your fingers
When you want to discharge urine
19
18
INFORMATION FOR USER INFORMATION FOR USER

Why does my blood pressure
fluctuate throughout the
day?
What are systolic pressure and diastolic pressure?
What is the standard blood pressure classification?
press
artery vein
blood discharging
Systolic
relax
blood entering
Diastolic
The chart on the right is the
standard blood pressure
classification published by
American Heart Association
(AHA).
CAUTION
Only a physician can tell your normal BP range. Please contact a physician if your
measuring result falls out of the range. Please note that only a physician can tell
whether your blood pressure value has reached a dangerous point.
CAUTION
Irregular Heartbeat Detector
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.
An irregular heartbeat is detected when a heartbeat rhythm varies while the unit is
measuring the systolic and diastolic blood pressure.During each measurement,
this equipment records the heartbeat intervals and works out the standard deviation.
If the calculated value is larger than or equal to 25%, the irregular heartbeat symbol
appears on the symbol when the measurement results are displayed.
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.
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.
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.
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.
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.
Blood Pressure Category
Normal
Elevated
High Blood Pressure
(Hypertension) Stage 1
High Blood Pressure
(Hypertension) Stage 2
Hypertensive Crisis
(Consult your doctor immediately)
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 Association.
and less than 80
21
20
ABOUT BLOOD PRESSURE ABOUT BLOOD PRESSURE

Battery powered mode:
2*AAA batteries (3V DC)
Blue LCD with backlight V.A.35mm×46mm
Approx.106g (Excluding the batteries)
Approx.61mmx88mmx27.5mm (Exclude the cuff)
2*AAA batteries, user manual
A10
This section includes a list of error messages and frequently
asked questions for problems you may encounter with your wrist
blood pressure monitor. If the products 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.
Batteries are exhausted. Replace with new batteries.
Insert the batteries
correctly.
Replace with new batteries.
Batteries are inserted
incorrectly.
Show on
the display Batteries are low.
Err 1 shows The cuff is too loose. Refasten the cuff and then
measure again.
Err 2 shows The cuff is very tight.Refasten the cuff and then
measure again.
Err 3 shows The pressure of the
cuff is excess.
Relax for a moment
and then measure again.
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.
Power supply
Display mode
Measurement mode Oscillographic testing mode
Measurement range
Accuracy
Normal working condition
Storage & transportation
condition
Measurement perimeter
of the wrist About 13.5cm-21.5cm
Weight
External dimensions
Attachment
Mode of operation Continuous operation
Degree of protection Type BF applied part
Protection against
ingress of water
Software version
Device classification Internally Powered ME Equipment
WARNING: No modification of this equipment is allowed.
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
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.
Temperature: -20°C to 60°C
Relative humidity: 10%RH to 93%RH
Atmospheric pressure: 50kPa to 106kPa
Temperature: 5°C to 40°C
Relative humidity: ≤85%RH
Atmospheric pressure: 86kPa to 106kPa
23
22
SPECIFICATIONSTROUBLESHOOTING

Contact Information
For more information about our products, please visit www.gurinproducts.com.
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.
FCC Statement
Complied Standards List
Risk management
Labeling
User manual
General Requirements
for Safety
Electromagnetic
compatibility
Performance
requirements and
Clinical investigation
Software life-cycle
processes
ISO/EN 14971:2012 Medical devices — Application of
risk management to medical devices
ISO/EN 15223-1:2012 Medical devices. Symbols to
be used with medical device labels, labelling and
information to be supplied. General requirements
IEC 60601-1: 2005+A1：2012 Medical electrical
equipment - Part 1: General requirements for basic safety
and essential performance
IEC 60601-1-11 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
IEC/EN 60601-1-2:2007 Medical electrical equipment -
Part 1-2: General requirements for basic safety and
essential performance - Collateral standard:
Electromagnetic compatibility - Requirements and tests
IEC 80601-2-30:2009 Medical electrical equipment-
Part 2-30: Particular requirements for the basic safety
and essential performance of automated non-invasive
sphygmomanometers
IEC/EN 62304:2006+AC: 2008 Medical device
software - Software life cycle processes
Usability
IEC 62366 Medical devices - Application of usability
engineering to medical devices (IEC 62366:2007)
IEC 60601-1-6 Medical electrical equipment - Part 1 -
6: General requirements for basic safety and essential
performance - collateral standard : Usability
ANSI/AAMI SP10:2002/A2: 2008 Manual, electronic,
or automated sphygmomanometers
EN 1041:2008 Information supplied by the manufacturer
of medical devices
Distributed By: Gurin Products LLC
2522 Chambers Road, Suite 100 Tustin, CA-92780 USA
Questions/Warranty: [email protected]
24 25
CONTACT INFORMATION COMPLIED STANDARDS LIST

EMC Guidance
Table 1 Guidance and MANUFACTURER’s declaration – ELECTROMAGNETIC
EMISSIONS- for all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacturer’sdeclaration – electromagnetic emissions
RF emissions
CISPR 11 Group 1
Class B
Not applicable
Not applicable
Compliance
The device is intended for use in the electromagnetic environment specified
below. The customer or the user of the device should assure that it is used in
such an environment.
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions IEC
61000-3-3
RF emissions
CISPR 11
Emissions test Electromagnetic environment - guidance
The device uses RF energy only for its
internal function. Therefore, its RF
emissions are very low and are not likely
to cause any interference in nearby
electronic equipment.
1) * This product needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided, and
this unit can be affected by portable and mobile RF communications equipment.
2) * Do not use a mobile phone or other devices that emit electromagnetic
fields, near the unit. This may result in incorrect operation of the unit.
3) * Caution: This unit has been thoroughly tested and inspected to assure
proper performance and operation!
4) * Caution: This machine should not be used adjacent to or stacked with other
equipment and that if adjacent or stacked use is necessary, this machine should
be observed to verify normal operation in the configuration in which it will be
used.
The device is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes.
Guidance and manufacturer’s declaration – electromagnetic immunity
IMMUNITY test
±6 kV contact
±8 kV air ±6 kV contact
±8 kV air
±2 kV for
power supply lines Not applicable
±1 kV line(s)
to line(s)
±2 kV line(s)
to earth
<5% U
T
(>95% dip in U
T
)
for 0.5 cycle
40% U
T
(60% dip in U
T
)
for5cycles
70% U
T
(30% dip in U
T
)
for 25 cycles
<5% U
T
(>95% dip in U
T
)
for 5 s
3A/m
NOTE U
T
is the a.c. mains voltage prior to application of the test level.
Table 2 Guidance and MANUFACTURER’s declaration – electromagnetic
IMMUNITY – for all ME EQUIPMENT and ME SYSTEMS
IEC 60601 test level Compliance level
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electromagnetic
environment - guidance
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
3A/m
Power frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
Voltage dips,
short interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
Electrical fast
transient/burst
IEC 61000-4-4
Surge IEC
61000-4-5
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an
environment
±1 kV for
input/output lines
Not applicable
Not applicable
Mains power quality should
be that of a typical
commercial or hospital
environment.
Mains power quality should
be that of a typical
commercial or hospital
environment.
Mains power quality should
be that of a typical
commercial or hospital
environment. If the user of
the device requires
continued operation during
power mains interruptions,
it is recommended that the
device be powered from an
uninterruptible power supply
or a battery.
26 27
EMC GUIDANCE EMC GUIDANCE

Table 4 Guidance and MANUFACTURER’s declaration – electromagnetic IMMUNITY –
for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacturer’s declaration – electromagnetic immunity
IMMUNITY test
Not applicable
3 V/m
Compliance
level
IEC 60601
TEST LEVEL
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz
3 Vrms
150 kHz to
80 MHz
Electromagnetic environment -
guidance
Portable and mobile RF communications
equipment should be used no closer to
any part of the device, including
cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Recommended separation distance
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environment.
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and dis the recommended separation
distance in metres (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey, should be
less than the compliance level in each
frequency range.
a
b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
P
=d
P
=d 80 MHz to 800 MHz
P
=d 2,3 800 MHz to 2,5 GHz
1,2
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and people.
aField strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broad-cast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in
the location in which the device is used exceeds the applicable RF compliance level above, the
device should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the device.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
b
1,2
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
Table 6 Recommended separation distances between portable and mobile
RF communications equipment and the ME EQUIPMENT or ME SYSTEM –
for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Recommended separation distances
between portable and mobile RF communications equipment and the device.
The device is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the device
can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmittters) and the
device as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum output
power of transmitter
(W)
Separation distance according to frequency of transmitter(m)
For transmitters rated at a maximum output power not listed above, the recommended
separation distance din metres (m) can be estimated using the equation applicable to
the frequency of the transmitter, where Pis the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80MHz and 800MHz, the separation distance for the higher frequency
range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects and people.
0.01
0.1
1
10
100
0.12 0.12
0.38
1.2
3.8
12
0.23
0.73
2.3
7.3
23
=d P
=d 1,2 2,3 P
=d
0.38
1.2
3.8
12
P
1,2
28 29
EMC GUIDANCE EMC GUIDANCE