TRANSTEK LS810-B User Manual

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User Manual

Blood Pressure Monitor

LS810-B

Please do read the user manual carefully and thoroughly so as to ensure the safe usage of this product, and keep the manual well for your further reference in case you have problems.

Thank you very much for selecting TRANSTEK Blood Pressure Monitor LS810-B.

GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD

Wrist Type

Version:1.0

EC REP

Zone A, 5/F., Investment Building, No. 12, Huizhan East Rd., Torch Development District, Zhongshan, Guangdong, 528437, China

MEM

SET

FCC ID: OU9LS810-B01

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Table of Contents

INTRODUCTION .............................................................

Indications for Use LCD Display Signal Monitor Components

BEFORE YOU START ........................................................6

MEASUREMENT .............................................................

INFORMATION FOR USER.....................................................15

Tips for Measurement Maintenance

ABOUT BLOOD PRESSURE....................................................17

What are systolic pressure and diastolic pressure? What is the standard blood pressure classification? Why does my blood pressure fluctuate throughout the day? Why the blood pressure I get from the hospital is different from home? If the result is the same if measuring on the right wrist?

TROUBLESHOOTING .........................................................19

SPECIFICATIONS ............................................................. 20

CONTACT INFORMATION ...................................................... 21

Safety Information

Power Supply and Charge Power Setting Date and Time

Positioning the Cuff

Strat Measurement

Data Management ..................................

Recall the Records Delete the Records

.........................

COMPLIED EUROPEAN STANDARDS LIST ........................ 21

FCC STATEMENT ...................................................... 22......

Pair up the Blood Pressure Monitor with Your Device

Table of Contents

...............

Measurement Principle

General Description

EMC GUDIANCE ...................................................... 23......

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INTRODUCTION

Thank you for selecti ng TRANSTEK blood pressure Monitor (LS810-B). The monitor features blood pressure measurement, pulse rate measurement and auto-save the result. The design provides you with two years of reliable service.

Reading taken by the LS810-B are equivalent to those obtained by a trained observer using the cuff and stethoscope auscultation method.

This manual contains important safety and care information, and provides step by step instructions for using the product.

Read the manual thoroughly before using the product.

FEATURES:

Systolic Blood Pressure Diastolic Blood Pressure

Pulse Rate Memory: Up to 60 pieces of records

INTRODUCTION

Indications for use

The Transtek Blood Pressure Monitor is digital monitors intended for use in measuring blood pressure and heartbeat rate with wrist circumference ranging from 13.5 cm to 21.5 cm ( about 5-8.5 inches ). 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 15.

Measurement Principle

General Description

The below signs might be in the user manual, labeling or other components. They are the requirement of standard and using.

Safety information

Symbol for “THE OPERATION GUIDE MUST BE READ”

Symbol for “COMPLIES WITH MDD 93/42/EEC REQUIREMENTS”

Symbol for “MANUFACTURER”

Symbol for “SERIAL NUMBER”

Symbol for “TYPE BF APPLIED PARTS”

Symbol for “DIRECT CURRENT”

Symbol for “ENVIRONMENT PROTECTION - Wast 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 “Authorised Representative in the European Community

EC REP

The Bluetooth Combination Mark

Symbol for “MANUFACTURE DATE”

CAUTION

* Please do read this user manual carefully and thoroughly before use.

* It is intended for adult indoor use only. Pregnant women, neonatal patients, pre-eclamptic patients and patients with severe obesity should use the device under the guidance of doctor. * This device is intended for non-invasive measuring and monitoring of asterial blood pressure. It is not intended for use on extremities other than the wrist or for functions other than obtaining a blood pressure measurement. * Please use the device under specified environment by user manual, otherwise the accuracy of the device will be influenced. * Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood pressure. Please start or end medical treatment basing solely on physician’s treatment advice. * If you are taking medication, consult your physician to determine the most appropriate time for your measurement. Never change a prescribed medication without your physician’s consent. * This unit is not suitable for continuous monitoring during medical emergencies or operations. * If the pressure of the cuff exceeds 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not deflate when its pressure exceeds 40 kPa (300 mmHg), detach the cuff from the wrist and press the START/STOP button to stop inflation. * Do not use the monitor under the conditions of strong electromagnetic field (e.g. medical RF equipment) that radiates interference signal or electrial fast transient/ burst signal. * The maximum temperature that the applied part can be achieved is 42.5 ℃ while the environmental temperature is 40℃. * The device is not AP/APG equipment. It is not suitable for use in the presence of a flammable anesthetic mixture with air (or oxygen, nitrous oxide). * Please keep the unit out of reach of infants, children or pets, since inhalation or swallowing of small parts is dangerous or even fatal. * Please use ACCESSORIES and detachable parts specified / authorised by MANUFACTURER. Otherwise, it may cause damage to the unit or danger to the user / patient. * The patient is an intended operator. The patient can measure, transmit data and charge battery under normal circumstances and maintain the device and its accessories according to the user manual. * The blood pressure monitor, its adaptor, and the cuff are suitable for use within the patient environment. If you are allergic to dacron or plastic, please don’t use this device. * The device is not intended for PATIENT transport outside a healthcare facility. *This device cannot be used with HF surgical equipment at the same time. * There is a PTC current limiter in the monitor, which specification is 8V and 0.5A. When the voltage and current exceed the limiting value, the monitor will stop woring. * ME system consists of the blood pressure monitor and its adaptor. The adaptor is specified as a part of ME equipment.

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SYSTOLIC

DIASTOLIC

MEM/UP BUTTON

SET/DOWN BUTTON

START/OFF BUTTON

CUFF (Type BF applied part)

PULSE RATE

TIME

USB Interface

INTRODUCTION INTRODUCTION

Monitor Components

LCD Display Signal

Systolic Blood Pressure

High blood pressure

Diastolic Blood Pressure

Low blood pressure

Pulse beat/minute

Unit Measurement unit of blood pressure

Time

Hour:Minute (Month/Day/Year)

Low Battery

Low battery and please charge the power.

Error

Memory

Recalling the history records

Bluetooth Successful Bluetooth Connection

IHB Detector

Irregular Heartbeat Detector

Error

Component List:

1. Micro Control Unit;

2. Amplifier;

3. Air Pipe;

4. Pump;

5. Valve.

List

1.Blood Pressure Monitor (LS810-B)

2.USB Cable and AC Adaptor ( Model: UE0WCP- 0501000SPC)

3.User Manual

MEM

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BEFORE YOU STARTBEFORE YOU START

1. The battery of LS810-B is built-in rechargeable lithium-ion battery, the battery current is 420 mAh.

2. Please use the AC adaptor and USB cable to charge the battery, just like the following picture:

Power Supply and Charge Power

Setting Date and Time

Charging the power under following circumstances:

displays on the LCD

The LCD display dims

When powering on the monitor, the LCD doesn’t light up.

2.As pictured in the right, the

blinking numeral “12” representing [HOUR]. Press “MEM” button to change the numeral. Each press will increase the numeral by one in a cycling manner.

1.When the monitor is OFF, press and hold “SET” button for 3 seconds to enter Time Setting Mode.

3.Press “SET” button again to

confirm [HOUR]. Then the numeral representing [MINUTE] blinks.

Please proceed to time setting before your initial use so as to ensure each piece of record are labled with a time stamp. (Year Range: 2012-2052; Time Format: 12 Hours)

AC adaptor

CAUTION

1. The battery of LS810-B is built-in rechargeable lithium-ion battery, please do not disassemble

it by the unauthorized maintenance personel.

2. Under the normal using, it can charge power about 300 times, if the battery cannot charge the power normally or the blood pressure monitor cannot use normally, please connect with the authorized maintenance personel.

3. Storge and use the blood pressure monitor at the cool, dry and ventilated environment. Avoid to approach to the fire and the heat source, or it will cause the battery explode.

4. Only can use the Transtek’s authorized AC Adaptor (Model: UE0WCP-0501000SPC) to charge the power. You cannot use the blood pressure monitor during the process of charging.

5. During the process of charging, the blood pressure monitor display When the

charging is finished, please pull the plug in time.

6. When charging, shall not touch charging connector and the patient simultaneously.

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BEFORE YOU START MEASUREMENT

Positioning the Cuff

1.Remove all accessories (watch, bracelet, etc) from your left wrist. If your physician has diagnosed you with poor circulation in your left wrist, use your right wrist.

2.Roll or push up your sleeve to expose the skin.

3.Apply the cuff to your left wrist with your palm facing up.

4. Position the edge of the cuff about 1-2 cm.

5. 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.

Resting for 5 minutes before measuring. Wait at least 3 minut es betwee n measurements. This allows your blood

circulation to recover.

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.

4.Repeat step 2 and 3 to confirm [MINUTE].

5.Repeat step 2 and 3 to confirm [MONTH], [DAY] and [YEAR].

7.After confirming [YEAR], the LCD will display “dONE” and the monitor will shut off automatically.

6.Patients with Hypertension: The middle of the cuff should be at the level of the right atrium of the heart; Before starting measurement, please sit comfortably with legs uncrossed, feet flat on the floor, back and arm supported.

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MEASUREMENT MEASUREMENT

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START

STOP

1.After correctly positioning the cuff, press START button to turn on the monitor, and it will complete the measurement process automatically.

Adjust to zero.

Inflating and measuring.

Display and save the

measuring result.

Pair-up the Blood Pressure Monitor

with Your Device

Start Measurement

1.Turn on Bluetooth and the app. Make sure both are ON when pair-up is proceeding.

2.When the monitor is OFF, press and hold the START button to start pair-up. The symbol and the symbol will be shown on the LCD alternatively, indicating pair-up is proceeding.

If SUCCEED, symbol will

be shown on the LCD.

If FAIL, symbol will be

shown on the LCD.

3.The monitor will shut off automatically after Pair-up process is complete.

Bluetooth Module No.: AW2540MV1 RF Frequency Range: 2.4 GHz Output Power Range: 24 dB Supply Voltage: -0.3 V to 3.9 V Transmitting Distance: 10 meters

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START

STOP

4.Press STOP button to turn off the monitor. Otherwise it will power off automatically.

2.This device will proceed to data transmission automatically after measurement.

The Bluetooth symbol

blinks on the LCD indicates data is transmitting.

3.If the data is successfully transmitted, the LCD will then display “dONE”.

If the data transmission fails, the

LCD will display “ ” instead.

Recall the Records

1.Press “MEM” button to access the memory. The monitor will display the calculated average of the last three readings first.

2. Press “MEM/UP” button or “SET/DOWN” button to rotate the history records.

“MEM/UP” to go forward; “SET/DOWN” to go backward.

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

MEASUREMENT DATA MANAGEMENT

CAUTION

1. 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: too frequent and consecutive multiple measurements; the application of the CUFF and itspressurization on any wrist where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present; Inflating the cuff on the wrist on the side of a mastectomy.

2. Do not apply the cuff over a wound, otherwise it can cause further injury.

3. 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.

4. Using it in case to result in prolonged impairment of the circulation of the blood of the PATIENT.

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DATA MANAGEMENT

Tips for Measurement

INFORMATION FOR USER

Within 1 hour

after dinner or drinking

Within 20 minutes

after taking a bath

In a very cold enviroment

Immediate measurement after tea, coffee, smoking

When talking or moving your fingers

When you want to discharge urine

It can cause inaccuracy if the measurement is taken in the following circumstances.

When you did not obtain the accurate measurement, you can clear all the

measuring results by following below steps.

Delete the Records

1.Under Memory Recalling Mode, press and hold both the “MEM” button and the “SET” button for 3 seconds.

2.The LCD will display “dEL dONE”, indicating that memory clearing is complete.And then it will shutdown automatically.

Under Memory Recalling Mode, if you

wish to give up clearing, press “START/STOP” to turn off the monitor.

3.When there is no memory in the monitor, if you press the “MEM” button to look up history, the LCD will display as pictured to the right.

CAUTION

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MEM

SET

M EM

SET

MEM

SET

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ABOUT BLOOD PRESSUREINFORMATION FOR USER

What are systolic pressure and diastolic pressure?

press

artery

vein

blood discharging

Systolic

relax

blood entering

Diastolic

Maintenance

To obtain the best performance, please follow below instructions.

Put in a dry place and

avoid the sunshine

Avoid shaking and collision.

Use the slightly damp cloth

to remove the dirt.

Avoid immersing it in the water. Clean it with a dry cloth in case.

Avoid dusty environment and

unstable temperature surrounding

Avoid washing the cuff

What is the standard blood pressure classification?

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.

Irregular Heartbeat Detector

This Blood Pressure Monitor is equipped with an intelligent function of Irregular Heartbeat (IHB) Detector. 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 15, this equipment will light up the IHB symbol on the screen when displaying the measuring result.

CAUTION

The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heartbeat was detected during measurement. Usually this is NOT a cause for concern. However, if the symbol appears often, we recommend you seek medical advice. Please note that the device does not replace a cardiac examination, but serves to detect pulse irregularities at an early stage.

Only a physician can tell your normal BP range. Please contact a physician if your measuring result falls out of the range. Kindly note that only a physician could tell whether your blood pressure value has reached a dangerous point.

The blood pressure classification published by World Health Organization (WHO) and International Society of Hypertension (ISH) in 1999 is as follows:

SYS

DIA

<120

<80

120-129

80-84

130-139

85-89

140-159

90-99

160-179

100-109

≥180

≥110

Level

Blood Pressure (mm Hg)

Optimal Normal

High-normal

Mild Moderate Severe

CAUTION

MEM

SET

MEM

SET

MEM

SET

CAUTION

1. Please make sure the unit functions safely and it is in proper working conditions before use. Don’t service or maintain while the device is in use.

2. If you have any problems with this device, such as setting up, maintaining or using, please contact with SERVICE PERSONNEL of Transtek. Don’t open or repair the device by yourself.

3. Please report to Transtek if any unexpected operation or events occur.

4. Cleaning: Dust environment may affect the performance of the unit. Please use the soft cloth to remove the dirt of the device and cuff before and after use.

5. Calibration: The manufacturer does not require such preventive inspections or calibration by other persons and will make available on request of circuit diagrams, component part list, etc.

6. Disposal: Degraded sensors may result in inaccurate measurement while loosened electrodes may cause the monitor’s failure to power on. Please dispose of ACCESSORIES, detachable parts, and ME EQUIPMENT according to local guidelines.

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1918

ABOUT BLOOD PRESSURE TROUBLESHOOTING

1. Ind ividual blood pressure vari es every in one day, it also affected by the way y o u t i e yo ur cuf f and t he y o ur measurement position, so please take the measurement at the same condition.

2.T he varies of the pressure is

greater if the person take medicine.

3.Waiting at least 4-5 minutes for

another measurement.

Why my blood pressure is varies even in one day?

If the result is the same i f mea s u r i n g o n t h e right wrist?

It is ok for both wrists, but there wil l b e some dif ferent res ults for dif ferent pers on, so suggest you measure the same wrist every time.

Why the blood pressure I get from the hospital is different from home?

The blood pressure is di fferent even during 24 hour because of the we ather ,emo ti on , ex erci se etc, specially the “white coat” in hospital which makes the results are higher than the ones at home.

The attention need to pay when you measure you 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 pressured.

You had better take deep breath 2-3 times before beginning.

Advice:adjust yourself for 4-5 minutes until you calm down.

This section includes a list of error messages and frequently asked questions for problems you may encounter with your 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 massage

Display is dim or

will not light up.

Show on the display

shows

Data communication has failed

Make sure that phone’s Bluetooth is on or within the distance range

E 2 shows The cuff is very tight

Refasten the cuff and then measure again.

E 3 shows

The pressure of the cuff is excess.

Relax for a moment and then measure again.

E 9 shows

Product has not been activated.

Reactivated

E 10 or E 11 shows

The monitor detected motion while measuring.

movement can affect the measurement.Relax for a moment and then measure again.

E 20 shows

E 21 shows

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.

The measurement process does not detect the pulse signal.

Loosen the clothing on the arm and then measure again.

Measure incorrectly.

Power is exhausted. Charge the power

Power is low. Charge the power

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SPECIFICATIONS

Power supply

3.7V 420mAH Built-in rechargeable lithium-ion battery, 5V / 1A USB AC Adaptor

Display moder

Digital LCD V.A.46.5x36.5mm

Measurement mode

Oscillographic testing mode

Measurement range

Accuracy

Normal working condition

Storage & transportation

condition

Measurement perimeter

of the wrist

About 13.5cm-21.5cm

Net Weight

Approx.110g

External dimensions

Attachment

Approx.79.8×72.5×13.2mm

USB cable, AC Adaptor user manual

Mode of operation

Continuous operation

Degree of protection

Type BF applied part

Protection against ingress of water

IP22, It means the device could protected against solid foreign objects of 12.5 mm and greater, and against vertically falling water drops when ENCLOSURE tilted up to 15°

Software version

Device classification

V01

Internally Powered ME Equipment

WARNING: No modification of this equipment is allowed.

Pressure: 0kpa-40kpa（0mmHg-300mmHg）

pulse value:(40-199)beat/minute

Pressure:

5℃-40℃within±0.4kpa(3mmHg)

0℃-45℃(out of 5℃-40℃)

within±0.7kpa(5mmHg)

pulse value:±5%

Temperature:-20℃ to 60℃ RH: 10% to 93%

Atmospheric pressure: 50kPa to 106kPa

Temperature:5℃ to 40℃ Relative humidity ≤85%

Atmospheric pressure: 86kPa to 106kPa

CONTACT INFORMATION

For more information about our products, please visit www.transtek.cn.you can get customer service, usual problems and customer download, transtek will serve you anytime.

Contact Information

Authorized European Representative:

Manufactured by:

GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD

Company:

GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD

Address:

Zone A, 5/F., Investment Building , No. 12, Huizhan East Rd., Torch Development District, Zhongshan, Guangdong, 528437, China

Company:

MDSS - Medical Device Safety Service GmbH

Address:

Schiffgraben 41, 30175 Hannover, Germany

Complied European Standards List

EN 60601-1:2006/AC:2010 EN 60601-1-11:2010

EN 1060-1:1995+A2:2009

EN 1060-3:1997+A2:2009

EN 60601-1-2:2007/AC:2010

EN/ISO 14971:2007

EN/ISO 15223-1:2012

EN 1041:2008

Risk Management

Labeling

User Manual

General Requirements for Safety

Performance Requirements

Electromagnetic Compatibility

Clinical Investigation EN 1060-4:2004

Usability EN 60601-1-6 : 2010

EN 62366:2008

Software life-cycle processes

EN 62304:2006/AC:2008

EN 80601-2-30:2010

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EMC Guidance

Table 1 Guidance and manufacturer’s declaration – electromagnetic emissions-

for all EQUIPMENT and SYSTEMS

Guidance and manufacture’s declaration – electromagnetic emission

RF emissions CISPR 11

Group 1

Class B

Not applicable

Compliance

The LS810-B is intended for use in the electromagnetic environment specified

below. The customer of the user of the LS810-B 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 emission CISPR 11

Emission test Electromagnetic environment - guidance

The LS810-B must emit electromagnetic energy in order to perform its intended function. Nearby electroic equipment may be affected.

FCC Statement

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

Caution: The user is cautioned that changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.

NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation.

If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

-- Reorient or relocate the receiving antenna.

-- Increase the separation between the equipment and receiver.

-- Connect the equipment into an outlet on a circuit different from that to

which the receiver is connected.

-- Consult the dealer or an experienced radio/TV technician for help.

FCC Radiation Exposure Statement:

This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.

This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.

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Table 4 Guidance and manufacturer’s declaration – electromagnetic immunity –

for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING

Guidance and manufacture’s declaration – electromagnetic immunity

Immunity test

N/A

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 LS810-B, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

d = 1.167

80 MHz to 800 MHz

= 2.333

800 MHz to 2.5 GHz

The LS810-B is intended for use in the electromagnetic environment specified below. The customer or user of LS810-B should assure that it’s used in such an environment.

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacture and d is 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.

Interference may occur in the vicinity of equipment marked with the following symbol:

Guidance and manufacture’s declaration – electromagnetic immunity

Immunity test

±6 kV contact ±8 kV air

±2 kV for power supply lines

N/A

±1 kV line(s) to line(s) ±2 kV line(s) to earth

<5% U

(>95% dip in UT) for 0.5 cycle

40% U

(60% dip in UT) for 5 cycles

70% U

(30% dip in U

)

for 25 cycles

<5% U

(>95% dip in UT) for 5 sec

3A/m

NOTE UT 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 Co mpliance 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 (50Hz) 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 61

000-4-4

Surge IEC 61000-4-5

The LS810-B is intended for use in the electromagnetic environment specified below. The customer of the user of the LS810-B should assure that it is used in such an environment

N/A

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150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

d = 1.167

d = 2.333

Table 6 Recommended separation distances between portable and mobile

RF communications equipment and the EQUIPMENT or SYSTEM –

for ME EQUIPMENT or ME SYSTEM that are not LIFE-SUPPORTING

Recommended separation distances

between portable and mobile RF communications equipment at the LS810-B.

The LS810-B is intended for use in an electromagnetic environment in which radiated RFdisturbances are controlled. The customer or the user of the LS810-B can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmittters) and the LS810-B 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 recommend

ed separation distance d in metres (m) can be determined 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 At 80MHz and 800MHz, the separation distance for the higher frequency range applies. NOTE 4 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

100

N/A

0.117

0.369

1.167

3.690

11.67

0.233

0.738

2.333

7.377

23.33

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.

Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and land mobile radios, amateur radio, AM and FM radio 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 LS810-B is used exceeds the applicable RF compliance level above, the LS810-B should be observed to verify normal operation. If abnormal performance is observe

d, additio-

nal measures may be necessary, such as re-orienting or relocating the LS810-B.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.