HealthSmart 04-655-001 Digital Premium Blood Pressure Monitor Instruction Manual

: May 15, 2024
: healthsmart

PREMIUM SERIES
UPPER ARM BLOOD PRESSURE MONITOR
Item # 04–655–001
INSTRUCTION MANUAL

04-655-001 Digital Premium Blood Pressure Monitor

Please read this guidebook completely before operating the unit.

LIMITED 1-YEAR WARRANTY

The warrantor guarantees that its Digital Blood Pressure Monitor will be free from manufacturing defects under normal use for 1 year of the original purchaser from the original purchase date of the product. This warranty covers only normal use, and does not apply for use in any clinical or commercial applications. This warranty does not cover batteries or other power sources that may be provided with or used with the Digital Blood Pressure Monitor. The warranty is voided if the Digital Blood Pressure Monitor product is misused or abused in any manner.
If the Digital Blood Pressure Monitor fails to operate during the first year from the time originally purchased, please go to: www.livehealthsmart.com /contact-us or email us directly at [email protected] and we will try to resolve the issue as soon as possible. If the warrantor determines the unit failed to operate due to a manufacturing defect, the unit will be replaced at the option of the warrantor. Replacement of the product is the only remedy covered by the Limited 1-Year Warranty.
This warranty gives you specific legal rights, which vary from state to state. To be eligible for the warranty, please register your product online within 10 days of purchase date at www.LiveHealthSmart.com.
This warranty constitutes the warrantor’s only responsibility and obligation to replace materials or components of the product. We make no other express or implied warranties, arising by operation of law or otherwise, or any warranty of merchantability or fitness for a particular use or purpose whether or not the use or purpose has been disclosed to the warrantor in specifications, drawings or otherwise, and whether or not the warrantor’s products are specifically designed and/or manufactured by the warrantor for the buyer’s use or purposes, except for the limited warranty stated above. The warrantor will not be responsible for any indirect, incidental, special, consequential, or punitive damages or other loss, including, but not limited to, damage to or loss of other property or equipment and personal injuries, whether to purchaser or others. The warrantor shall in no event be liable to the purchaser for any amount in excess of the cost to replace the product.

INTRODUCTION

Thank you for purchasing this Digital Blood Pressure Monitor. With proper care and use, your monitor will provide you with many years of reliable readings.
To achieve the maximum benefit from your blood pressure monitor, we recommend that you first consult with your physician or trained healthcare professional.
The method of measurement that your digital monitor uses is called the oscillometric method. The monitor detects your blood’s movement through the artery in your arm and converts the movements into a digital reading. The oscillometric method does not require a stethoscope, making the monitor easy to use.
Blood pressure readings determined with this device are equivalent to measurements obtained by a trained observer using the cuff/stethoscope auscultation method, within the limits prescribed by the American National Standard for Electronic or Automated Sphygmomanometers.

PRODUCT IDENTIFICATION

Monitor

Digital Display

CAUTION:
You can stop the inflation or deflation process anytime by pressing the (POWER) button.
*Instantly compares your readings to standards set by the World Health Organization (WHO), ranging from optimal health to severe hypertension

GENERAL BLOOD PRESSURE INFORMATION

What is Blood Pressure?
Blood pressure is the pressure that is exerted by blood flowing against the walls of the blood vessels throughout your body.
Your heart, which is the center of the circulatory system, provides the force for the blood to flow or circulate. When your heart contracts or “beats,” the blood is forced through the blood vessels increasing the pressure. This is the highest pressure in the cycle or what is referred to as SYSTOLIC blood pressure. In-between beats your heart relaxes and your blood pressure decreases. This is referred to as DIASTOLIC blood pressure.
This complete series of events, which occurs in a single heartbeat, is known as the CARDIAC CYCLE.
Your digital blood pressure monitor will automatically read your blood pressure and display both systolic and diastolic readings on the screen. Your systolic will be positioned as the upper number and the diastolic reading will be the lower number.

(systolic) 120/80 (diastolic)

Blood pressure is measured in millimeters (mm) of mercury (Hg) and is generally recorded with the systolic pressure (120) listed first and the diastolic pressure (80) listed second. The numbers are typically separated by a slash mark ( / ) as shown.
Both pressure readings, the SYSTOLIC and DIASTOLIC, are necessary for a physician to evaluate the status of a patient’s blood pressure.
Please contact your physician for specific information regarding your own blood pressure.

What Influences Blood Pressure?
Many factors such as genetics, age, sex, altitude, physical activity, anxiety, muscular development, certain medications or even the time of day can influence blood pressure.
Influences such as sleep or relaxation decrease blood pressure, while anxiety or exercise increase blood pressure.

Why Monitor Your Blood Pressure at Home?
A visit to a physician’s office can be stressful for the patient and anxiety is a known factor in raising blood pressure. This temporary occurrence of elevated blood pressure at the physician’s office is commonly referred to as “white coat syndrome.”
Whether or not you experience “white coat syndrome,” home blood pressure monitoring provides you with the opportunity to supplement measurements taken at your physician’s office. These home readings, when taken over a period of time, can show an accurate indication of change. Furthermore, your records can assist your physician in evaluating your health and in making important decisions in the diagnosis and treatment of your condition.
Because of this, it is important to take consistent daily measurements of your blood pressure.
The variations in your individual readings should only be interpreted by your physician or a trained healthcare professional.

WHO Blood Pressure Classifications
Standards for assessment of high or low blood pressure have been established by the World Health Organization (WHO) as shown on the following chart:

Category| Systolic (mmHg)| Diastolic (mmHg)| Color Indicator
---|---|---|---
Optimal| <120| <80| Green
Normal| 120–129| 80–84| Green
High – Normal| 130–139| 85-89| Green
Stage 1 – Mild Borderline Hypertension| 140–159| 90–99| Yellow
Stage 2 – Moderate Hypertension| 160–179| 100-109| Orange
Stage 3 – Severe Hypertension| ≥180| ≥110| Red
Isolated Systolic Hypertension| ≥140
140–159
160–179
≥180| <90
<90
<90
<90| Yellow
Orange
Red

This chart is only a general guideline. Contact your physician or trained healthcare professional to determine your NORMAL blood pressure.

Variations in Blood Pressure
Blood pressure is influenced by many factors and can change from moment to moment.
Normally, blood pressure is lowest during sleeping periods and rises during the day. The graph below represents variations in blood pressure shown over a day with measurements taken every 5 minutes.

The dotted line represents the sleep period. The rise in blood pressure at 1 p.m. (A in the graph) reflects stressful occurrence, and at 7 p.m. (B in the graph), a period of exercise.

IMPORTANT INFORMATION BEFORE USE

Blood pressure readings should be interpreted by a physician or trained healthcare professional, who is familiar with your medical history.
Measure your blood pressure in a quiet place. You should be seated and relaxed.
Avoid smoking, eating, taking medication, alcohol consumption or physical activity 30 minutes prior to taking a reading. If you are exhibiting signs of stress, avoid measuring your blood pressure until the feeling subsides.
Rest 15 minutes prior to measuring your blood pressure.
Remove any constrictive clothing or jewelry that may interfere with the cuff placement.
Keep the monitor stable during measurements. Remain still; do not talk during measurements.
Record your daily readings on the chart provided.
Take your readings at the same time, each day (or as recommended by your physician).
Wait a minimum of 15 minutes between readings. The wait time may vary depending on individual physiological characteristics.
This device is intended for adult use only (12 years and older). This Electronic Sphygmomanometer should never be used on infants or young children. Consult your physician or other health care professionals before use on older children. Never use on infants or individuals that cannot express themselves.
The inflation or deflation process can be stopped by pressing the POWER button.
People suffering from arrhythmias such as atrial or ventricular premature beats or atrial fibrillation should only use this unit after consulting with their doctor. In certain cases the oscillometric measurement can produce incorrect readings.
In people with irregular or unstable circulation resulting from diabetes, liver disease, arteriosclerosis or other medical conditions, there may be variations in blood pressure values measured at the wrist versus at the upper arm. Monitoring the trends in your blood pressure taken at either the arm or the wrist is nevertheless useful and important.
People suffering from vascular constriction, liver disorders or diabetes, people with cardiac pacemakers or a weak pulse, and women who are pregnant should consult their physician before measuring their blood pressure themselves. Different values may be obtained due to their condition.
Use only the approved arm cuff for this unit. Use of other arm cuffs may result in incorrect measurement results.
To avoid cross contamination, do not share the cuff with an infectious person.
Prolonged over-inflation (cuff pressure exceed 300 mmHg or maintained above 15 mmHg for longer than 3 minutes) of the bladder may cause ecchymoma of your arm.
The cuff should not be applied over a wound as this can cause further injury.
DO NOT attach the cuff to a limb being used for IV infusions or any other intravascular access, therapy or an arterio-venous (A-V) shunt. The cuff inflation can temporarily block blood flow, potentially causing harm to the patient.
The cuff should NOT be placed on the arm on the side of a mastectomy. In the case of double mastectomy use the side of the least dominant arm.
Pressurization of the cuff can temporarily cause loss of function of simultaneously used monitoring equipment on the same limb.
A compressed or kinked connection hose may cause continuous cuff pressure resulting in blood flow interference and potentially harmful injury to the patient.
Check that operation of the unit does not result in prolonged impairment of the circulation of the patient.
The monitor might not meet its performance specifications if stored or used outside the specified temperature and humidity ranges in specifications.
If you are taking medication, consult with your physician to determine the most appropriate time to measure your blood pressure. NEVER change a prescribed medication without first consulting with your physician.
Do not use cell phones and other devices, which generate a strong electrical or electromagnetic fields, near the device, as they may cause incorrect readings and interference or become an interference source to the device.

FCC STATEMENT AND EMC COMPATIBILITY

This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna.
Increase the separation between the equipment and receiver.
Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
Consult the dealer or an experienced radio/TV technician for help.

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.

VISUAL BP GUIDE

The Visual BP Guide, located on the left side of the Display, will identify your reading within a range in accordance with the guidelines set by the World Health Organization. See the chart below for reference.

| Stage 3 Hypertension
Systolic pressure: ≥180 mmHg
-or-
Diastolic pressure: ≥110 mmHg
---|---
| Stage 2 Hypertension
Systolic pressure: 160-179 mmHg
-or-
Diastolic pressure: 100-109 mmHg
| Stage 1 Hypertension
Systolic pressure: 140-159 mmHg
-or-
Diastolic pressure: 90-99 mmHg
| High Normal
Systolic pressure: 130-139 mmHg
-or-
Diastolic pressure: 85-89 mmHg
| Normal
Systolic pressure: 120-129 mmHg
-or-
Diastolic pressure: 80-84 mmHg
| Optimal
Systolic pressure: <120 mmHg
-and-
Diastolic pressure: <80 mmHg

IRREGULAR HEARTBEAT DETECTION

Your Digital Blood Pressure Monitor features Irregular Heartbeat Detection (IHB). If the monitor detects an irregular heartbeat two or more times during the measuring process, the IHB symbol will appear on the display, Fig. 1. An irregular heartbeat is defined as a rhythm that is either 25% slower or faster than the average rhythm detected while measuring systolic and diastolic blood pressure.

NOTE: Please consult with your physician or trained healthcare professional for further information regarding an irregular heartbeat if this symbol appears frequently at the end of a reading.
If an Irregular Heartbeat caused by common arrhythmias is detected in the process of the blood pressure measurement, the IHB symbol will be displayed. Under this condition, the Electronic Sphygmomanometers will function, but the results may not be accurate and it’s suggested that you consult your physician for accurate assessment.

BATTERY INSTALLATION/REPLACEMENT

Slide the cover upward and remove the cover.
Insert or replace 4 “AA” batteries into the compartment, matching the indicated polarity symbols, Fig. 1.
To close, replace cover and slide downward until cover clicks into position.
** The monitor, the batteries and the cuff, must be disposed of according to local regulations at the end of their usage.
NOTE:** Replace the batteries when the Low Battery symbol appears on the display or when the display remains blank when the POWER button is pressed.
It is recommended to remove the batteries if the unit will not be used for an extended period of time.

AC Power Adapter (optional)
Use the AC adapter (DC 6.0V, 600mA) for battery-free operation. The AC adapter plugs into the back of the unit as shown, Fig. 2. Please remember to practice electrical safety precautions while using the adapter. Use of any other type of adapter may harm the unit.

SETTING THE DATE /TIME

Select the appropriate user bank.

When the unit is OFF, press the SET button to enter into the user mode. The User 1 symbol will begin to flash, Fig. 1.
Press the MEMORY button to select User 1 or User 2 and move into the date/time setting. Press SET to confirm.
NOTE: Setting the date / time for User 1 will automatically keep the same date / time for User 2.
Setting the Date / Time
The year will begin to flash Fig. 2.
Press the MEMORY button to change until the desired number appears.
NOTE: To scroll through the numbers quicker, hold down the MEMORY button.
Press SET to confirm.
The date followed by the hour and minutes will blink. Repeat steps 4 and 5 to adjust the date/time setting.
After setting the minutes, select the desired date format by pressing the MEMORY button to switch between “US” for standard date and 12-hour formatting or “EU” for standard European date and 24-hour formatting, Fig. 3.
Press SET to confirm.
NOTE : You will now automatically enter into the Voice Setting and Volume Control mode. Please see page 14 to continue the setup.

VOICE LANGUAGE SETTING

Voice Setting

Press the MEMORY button to cycle through L1, L2, and OFF as shown in Fig. 4.
L1 – English
L2 – Spanish
L3 – Voice function turned off
The monitor will say the corresponding language with the displayed language code.
Press SET to confirm.
Volume Control
Adjust the volume by pressing the MEMORY button until the desired volume level is achieved. There are six volume levels to choose from as indicated by the number of triangles appearing on screen, Fig 5.
Press SET to confirm.
NOTE: While in any setting mode, press the POWER button to turn the unit OFF and all information will be saved. The unit will automatically turn OFF after 3 minutes if not in use and all information will be saved.

APPLYING YOUR BLOOD PRESSURE CUFF

Before applying your blood pressure cuff, confirm the included Universal Cuff fits the circumference of your arm.
Universal Cuff fits arm circumference 8.66” – 16.53” (22cm – 42cm) Included.
Large Cuff fits arm circumference 16.53″ – 18.89″ (42cm – 48cm) Not included. Available at www.LiveHealthSmart.com

NOTE: If for any reason you are unable to or should not use your left arm, please modify the following instructions and apply the cuff to your right arm. Your physician can tell you which arm is best for you to use.

Remove any constrictive clothing or jewelry that may interfere with the cuff placement.
Be seated with your feet flat on the floor.
Position the cuff on a solid surface with the tubing facing UP and AWAY from you, Fig. 1. The metal bar on the cuff should be to the left of the tubing.
Widen or open the cuff by pulling or rolling the bottom of the cuff towards the right, Fig. 2. This should open the cuff, creating a cylinder. Do not extend the cuff beyond the metal bar.
Insert your arm into the cuff (cylinder). Position the (Φ) mark over themain artery (on the inside of your arm), Fig. 3.
The bottom edge of the cuff should be positioned approximately one inch ABOVE the elbow joint, Fig. 4.
Reaching underneath your left arm with your right hand, pull the end of the cuff towards your body to tighten the cuff, Fig. 5. Wrap and secure the cuff making sure that the (Φ) mark remains as shown, Fig. 3.
The cuff should fit comfortably, yet snugly around your arm.
You should be able to insert two fingers between your arm and the cuff.

NOTE: The cuff size is suitable for use when the vertical “Index” mark is within the horizontal “OK” range. A different sized cuff is needed if the “Index” mark is outside of the “OK” range.

TAKING YOUR BLOOD PRESSURE READING

Proceed only after reading the previous sections of this manual.

Position the monitor on a flat, stable surface with the digital display panel in view. Insert the cuff tubing connector into the left side of the monitor, Fig. 1. Avoid compression or restriction of the connection tubing during measurement which may cause inflation error, or harmful injury due to continuous cuff pressure.
Rest your elbow on a solid surface with your palm facing upward.Elevate your arm so that the cuff is at the same level as your heart, Fig. 2. Relax your left hand. Sit comfortably and don’t cross your legs. The middle of the cuff should be at the level of the right atrium of the heart.
To select the correct User bank, press the SET button. The User symbol will begin to blink. Then press the MEMORY button to switch between User 1 & 2. Once the desired User is selected, press and hold the POWER button until the unit powers OFF. Press the POWER button again to turn the unit ON and begin the measurement.
This unit will first run a self-test, Fig. 3. If there is any residualair in the cuff, the monitor will flash “ ” until pressure is stabilized as shown in Fig. 4.
When the display appears as shown, Fig. 5, the monitor is ready. The cuff will automatically begin to inflate.
Once the cuff inflates to the appropriate pressure level, the measurement will begin.
The unit will begin to automatically deflate and the numbers appearing on the display will decrease.
When all the air is deflated, the measurement is complete. The unit will display your blood pressure (systolic and diastolic) measurements and pulse rate, Fig. 6. Record your readings in a chart.
Your measurements will automatically be saved in memory.
Press the POWER button to turn the power OFF, or the unit will automatically shut OFF after approximately 2 minutes.
Disconnect the tubing from the monitor prior to storing.

NOTE: The measurement can be stopped at anytime by pressing the POWER button.
NOTE: The default setting of this monitor is to inflate the cuff to approximately 190 mmHg. After three readings, the cuff will inflate to approximately 40 mmHg higher than the average of the last three systolic test reading averages stored in memory. If the system detects that the cuff needs additional pressure, it will automatically re-inflate to approximately 40 mmHg higher than the last pressure level.

RECALLING MEASUREMENTS IN MEMORY

You can recall up to 120 total measurements in memory (60 per bank).

First, select the correct User bank, press the SET button. The User symbol will begin to blink. Then press the MEMORY button to switch between User 1 & 2. Once the desired User is selected, press and hold the POWER button until the unit powers OFF.
Press and release the MEMORY button. It will display the average of the last three readings, Fig. 2.
Press the MEMORY button again to scroll through the saved measurements.

NOTE: When the number of readings exceeds 60 per bank, the oldest data will be replaced with the new record.

To erase all stored measurements:

Press and release the MEMORY button to enter into the memory bank mode. Be sure the correct memory bank is selected.
Press and hold down the SET button until three horizontal lines flash. This indicates that all measurements have been erased, Fig. 3.

DESCRIPTION OF DISPLAY SYMBOLS

| Indicates a measurement within Stage 3 Hypertension.
---|---
| Indicates a measurement within Stage 2 Hypertension.
| Indicates a measurement within Stage 1 Hypertension.
| Appears when batteries should be replaced.
| Shows the pulse rate per minute.
---|---
| Occurs when an error was made during measurement.
| Appears when there is an irregular heartbeat detected during measurement.
| Appears when the cuff is unstable or it has too much air left in it. Once the arrow stops flashing, the unit is ready to take a measurement.
| Appears when the unit is ready or a measurement error has occurred. Restart the measurement if an error occurs.
No| “Number”. Appears when recalling a measurement from memory.

DESCRIPTION OF SYMBOLS

| Symbol for “THE OPERATION GUIDE MUST BE READ” (The sign background color: blue. The sign graphical symbol: white)
---|---
| Symbol for “CAUTION”
| Symbol for “TYPE BF APPLIED PARTS” (The cuff is type BF applied part)
| Symbol for “ENVIRONMENT PROTECTION” – Waste electrical 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 “KEEP DRY”
| Symbol for “KEEP OUT OF DIRECT SUNLIGHT”

TROUBLESHOOTING

If any abnormality occurs during use, please check and correct the following:

Condition	Correction
Display is blank when power is on.	Check and correct the polarity of the

installed batteries. Reinstall or replace batteries.
Measurement incomplete or abnormally low or high values displayed.| Review and follow “Applying Your Blood Pressure Cuff” and “Taking Your Blood Pressure Reading” sections. Replace the batteries.
Err symbol displays.| Do not talk or move during the measurement. Review “Applying Your Blood Pressure Cuff” section.
Measurements are different from those typically measured by physician or every measurement reading is different.| Remember, blood pressure readings are influenced by physical and mental conditions and/or even the time of day. Daily measurements should be interpreted by your physician.

REPLACEMENT PARTS & ACCESSORIES

To order replacement parts and accessories, please log onto www.LiveHealthSmart.com.

CARE AND MAINTENANCE

Disconnect the cuff tubing from the monitor and remove batteries prior to storing.
To clean the monitor, use a soft cloth and mild detergent to lightly wipe clean. Use a damp cloth (water) to remove dirt and excess detergent.
To clean the cuff, do NOT soak in water. Apply a small amount of rubbing alcohol to a soft cloth to clean the cuff’s surface. Use a damp cloth (water) to wipe clean. Allow cuff to air dry at room temperature. Do not use petrol, thinners or other similar solvents. Never dry the cuff in clothes dryer or iron it.
Do not store the unit where it will be exposed to direct sunlight, dust or humidity. Avoid extreme temperatures.
Never disassemble the monitor or cuff.
Dropping or subjecting your blood pressure monitor to strong shocks should be avoided.
No component of the monitor should be serviced by the user.

PRODUCT SPECIFICATIONS

Name and Item Number| Premium Series Upper Arm Blood Pressure Monitor, 04-655-001
---|---
Display System| Digital display/LCD
Size: 4.02” x 2.71” (102mm x 68.9mm)
Measuring Method| Oscillometric
Power Source| 4 x 1.5 V “AA” batteries or AC Adapter (DC6.0v, 600mA)
Measuring Range| Pressure: 0-300 mmHg
Pulse: 30-180 beats/minute
Accuracy| Pressure: ±3 mmHg or ±2% of readings above
200 mmHg / Pulse: ±5% of reading
Diastolic Range| 30-200 mmHg
Systolic Range| 60-280 mmHg
Inflation| Automatic Inflation
Deflation| Automatic Pressure Release Valve/Manual fast release
Memory| Built-in memory enabling display of up to 120 measurements total (60 per bank)
Automatic Shut-Off| Approximately 3 minutes after last button operation
Battery Life| Approximately 2 months with 3 tests per day
Operation Environment| Temperature 50˚ F – 104˚ F (10˚ C – 40˚ C)
Humidity 15% – 90%
Storage Environment| Temperature -4˚ F – 131˚ F (-20˚ C – 55˚ C)
Humidity ≤ 15% – 90%
Monitor Dimensions| 6.54″ x 4.49” x 2.83″ (166mm x 114mm x 72mm)
Weight| 17.21 oz. (488g) – without batteries
Arm Circumference Range| Universal cuff fits arm circumference: 8.66” – 16.53” (22cm – 42cm)
Ingress Protection Rating| IP22
Classification| Internal Powered Equipment, type BF ****.Cuff is Applied Part
Contents| Monitor, Zippered Case, (4) AA Batteries, (1) AC Adapter, Universal Cuff, Detailed Guidebook, Quick Start Guide

Specifications are subject to change without notice.

ELECTROMAGNETIC COMPATIBILITY

Technical Description
The device satisfies the EMC requirements of the international standard IEC 60601-1-2.
The requirements are satisfied under the conditions described in the table below. The device is an electrical medical product and is subject to special precautionary measures with regard to EMC which must be published in the instructions for use. Portable and mobile HF communications equipment can affect the device. Use of the unit in conjunction with non-approved accessories can affect the device negatively and alter the electromagnetic compatibility. The device should not be used directly adjacent to or between other electrical equipment.

Table 1

Guidance and declaration of manufacturer-electromagnetic emissions

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.
Emissions test| Compliance| Electromagnetic environment -guidance
RF emissions CISPR 11| Group 1| The device uses RF energy only for its internal function. Therefore, its emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11| Class B| 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.
Harmonic emissions IEC 61000-3-2| Class A
Voltage fluctuations/ flicker emissions IEC 61000-3-3| Compliance

Table 2

Guidance and declaration of manufacturer-electromagnetic immunity

I MMUNITY test| IEC 60601 test level| Compliance level| Electromagnetic environment -guidance
Electrostatic discharge (ESD) IEC 61000-4-2| ± 6 kV contact ± 8 kV air| ± 6 kV contact ± 8 kV air| Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.
Electrical fast transient/burst IEC 61000-4-4| ±2 kV for power supply lines| ±2 kV for power supply lines| Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5| ±1 kV line(s) to line(s)| ±1 kV line(s) to line(s)| Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11| <5 % U T
(>95 % dip in U T)
for 0.5 cycle 40 % U T
(60 % dip in U T)
for 5 cycles 70 % U T
(30 % dip in U T)
for 25 cycles <5 % U T
(>95 % dip in U T) for 5 s| <5 % U T
(>95 % dip in U T)
for 0.5 cycle 40 % U T
(60 % dip in U T)
for 5 cycles 70 % U T
(30 % dip in U T)
for 25 cycles <5 % U T
(>95 % dip in U T) for 5 s| 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.
Power frequency (50/60 Hz)
magnetic field IEC 61000-4-8| 3 A/m| 3 A/m| Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial or hospital environment.

Table 3

Guidance and declaration of manufacturer-electromagnetic immunity

I MMUNITY test| IEC 60601 test level| Compliance level| Electromagnetic environment -guidance
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3| 3 Vrms 150
kHz to 80 Mhz
3 V/m 80
MHz to 2.5 Ghz| 3V
3 V/m| 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.
d=1.2 80 MHz to 800 MHz
d=2.3 800 MHz to 2.5 Ghz
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked with the following symbol:

Table 4

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 therefore 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 (transmitters) 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
---|---
150 kHz to 80 Mhz d=1.2 √p| 80 MHz to 800 MHz d=1.2 √p| 800 MHz to 2.5 GHz d=2.3 √p
0.01| 0.12| 0.12| 0.23
0.1| 0.38| 0.38| 0.73
1| 1.2| 1.2| 2.3
10| 3.8| 3.8| 7.3
100| 12| 12| 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 To calculate the recommended separation distance of transmitters in the frequency range of 80 MHz and 800 MHz to 2.5 GHz, an additional factor of 10/3 has been used in order to reduce the probability of a mobile/portable communications device unintentionally introduced into the patient area causing a fault.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

INTERNATIONAL STANDARDS

AAMI / ANSI SP10:2002/(R) 2008 & 2002/A1:2003/(R)2008 & 2002/A2:2006/(R)2008 Manual, electronic, or automated sphygmomanometers
EN 60601-1 Medical electrical equipment part 1: General requirements for safety
EN 60601-1-2 Medical electrical equipment part 1-2: General requirements for safety- Collateral standard:
Electromagnetic compatibility- Requirements and tests
EN 1060-1 Non-invasive sphygmomanometers – General requirements
EN 1060-3 Non-invasive sphygmomanometers – Supplementary requirements for electromechanical blood pressure measuring systems.
EN 1060-4 Non-invasive sphygmomanometers – Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers.

Correct Disposal of This Product (Waste Electrical & Electronic Equipment)

This marking shown on the product indicates that it should not be disposed with other household waste at the end of its life. To prevent potential harm to the environment or to human health, please separate this product from other types of wastes and recycle it responsibly. When disposing this type of product, contact the retailer where product was purchased or contact your local government office for details regarding how this item can be disposed in an environmentally safe recycling center. Business users should contact their supplier and check the terms and conditions of the purchasing agreement. This product should not be mixed with other commercial wastes for disposal. This product is free of hazardous materials.

Satisfaction Guaranteed

Manufactured for:
HealthSmart® International
1931 Norman Drive
Waukegan, IL 60085
Register this product atLiveHealthSmart.com