CareTouch PSW01 User Manual

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CATALOGUE

INTRODUCTION ............................................................... 2

Safety Information

LCD Display Signal Monitor Components

BEFORE YOU START .......................................................... 5

Installing and Replacing the Batteries Setting Date, Time and Measurement Unit

MEASUREMENT ............................................................... 9

Tie the Cuff Start the Measurement

DATA MANAGEMENT 11

Recall the Records Delete the Records

INFORMATION FOR USER ..................................................... 13

Tips for Measurement Maintenance

ABOUT BLOOD PRESSURE.................................................... 15

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 ......................................................... 17

SPECIFICATIONS ............................................................. 18

CONTACT INFORMATION...................................................... 19

COMPLIED STANDARDS LIST...................................................19

FCC STATEMENT ...................................................... 19

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

General Description

Measurement principle

Indications for use

CATALOGUE

EMC GUIDANCE ...................................................... 20

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INTRODUCTION INTRODUCTION

The signs below might be in the user manual, labeling or other component.

They are the requirement of standard and using.

Safety Information

Features: Systolic blood pressure Diastolic blood pressure

Pulse rate Historic record of up to 60 measurements

General Description

Thank you for selecting CARE TOUCH Fully Automatic Wrist Blood Pressure Monitor (PSW01). 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 PSW01 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.

Symbol for “THE OPERATION GUIDE MUST BE READ”

Symbol for “SERIAL NUMBER”

Symbol for “TYPE BF APPLIED PARTS”

Symbol for “DIRECT CURRENT”

Symbol for “ENVIRONMENT PROTECTION Electrical waste products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice”

Symbol for “MANUFACTURE DATE”

CAUTION

Caution: These notes must be observed to prevent any damage to the device.

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

Indications for Use

The Blood Pressure Monitor is digital monitors 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 device is intended for adult use only.

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.

If the cuff pressure exceeds 40 kPa (300 mmHg),the unit will automatically deflate. Should the cuff not deflate when pressures exceeds 40 kPa (300 mmHg), detach the cuff from the wrist and press the START/STOP button to stop inflation.

To avoid measurement errors, carefully read this manual before using the product.

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.

The operator shall not touch output of batteries and the patient simultaneously.

Do not use the monitor under the conditions of strong electromagnetic field (e.g. medical RF equipment) that radiates interference signal or electrical fast transient / burst signal.

The user must check that the equipment functions safely and see that it is in proper working condition before being used.

Please use ACCESSORIES and detachable partes specified/ authorised by MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the user/patients.

Manufacturer will make available on request circuit diagrams, component parts list etc.

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.

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.

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 alergic reaction or contact injury.

The device doesn’t need to be calibrated within the two years of reliable service.

Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local guidelines.

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.

This device is contraindicated for any female subject who may be suspected of, or is pregnant. Besides providing inaccurate readings, the effects of this device on the fetus are unknown.

The device has been evaluated clinically using manual cuff/stethoscope auscultation as the reference. Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultatory method, within the limits prescribed by the American National Standard, Manual, electronic, or automated sphygmomanometers.”

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Systolic blood pressure

High pressure result

Diastolic blood pressure

Low pressure result

Pulse Pulse/minute; heartbeats/minute

mmHg

Measurement unit the blood pressure (1mmHg=0.133kPa)

kPa

Measurement unit of the blood pressure (1kPa=7.5mmHg)

Current time

Shaking reminding

Shaking will result in inaccurate

Irregular heartbeat Detection

Low battery

Batteries are low and need to be replaced

Grade

The grade of the blood pressure

LCD Display Signal

SYMBOL DESCRIPTION EXPLANATION

Month/Day,Hour/Minute

Heartbeat

Heartbeat detection during the measurement

CUFF (Type BF applied part)

BATTERY

COMPARTMENT

Monitor Components

Component List:

1. PCBA;

2. Air Pipe;

3. Pump;

4. Valve;

5. Cuff.

List

1) Fully Automatic Wrist Blood Pressure Monitor PSW01

2) 2×AAA batteries

3) User manual

4) Carrying case

INTRODUCTION INTRODUCTION

Memory

Display the serial number of the measurement

LCD DISPLAY

GRADE

TIME

SYSTOLIC

DIASTOLIC

MEM BUTTON

SET BUTTON

START/STOP BUTTON

PULSE RATE

Irregular heartbeat

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BEFORE YOU START

• .Open the battery cover.

• .Install the batter ies by matc hing the correct pol arity , as

shown below. Always use the correct battery type (2×AAA batteries).

• .Replace the cover.

Installing and Replacing the Batteries

Remove batteries if the device is not likely to be used for some time.

The old batteries are harmful to the environment, do not dispose with other daily trash.

Remove the old batteries from the device and follow your local recycling guidelines.

Replace the batteries whenever the below happen

The shows

The display dims

The display does not light up

Do not dispose of batteries in fire. Batteries may explode or leak.

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 :2010—2050,time format:24 H/12 H)

CAUTION

hold pressing “SET” for 3 seconds to enter the mode for year setting.

2.Press the “MEM” to

change the [YEAR].

3.Wh en you get the

right year, press

“SET” to set do wn

and turn to next step.

When the monitor is off, press “SET”button,it will display the time.Then

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Tie the Cuff

1.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.

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

4. Position the edge of the cuff about 1-1.5cm.

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.

Rest for 5 minutes before measuring. Wait at le ast 3 minutes betw een measure ments.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.

MEASUREMENT

BEFORE YOU START

4.Repeat steps 2 and 3 to confirm [MONTH] and [DAY].

5.Then the monitor diverts to time setting. Select the time format. Repeat steps

2 and 3 to confirm the time format , [HOUR] and [MINUTE].

6.Repeat steps 2 and 3 to confirm the measurement unit.

7.After confirming the meausrement unit, the LCD will

display all the settings you have done one by one and then the monitor will shut off.

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MEASUREMENT

DATA MANAGEMENT

1.When the monitor is off, press the START/STOP to turn on the monitor, and it will finish the whole measurement.

Adjust the zero.

LCD display

Inflating and measuring.

Display and save the result.

Start the Measurement

2.Press the START/STOP to

power off ,otherwise it will turn off within 1 minute.

Recall the Records

2. Press the “ME M”

or “SET” to get the record you want.

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

The date and time will display alternately.

DOWN

The corresponding time is 10:38.

The corresponding date is 5th January.

When the monitor is off, press “MEM” button to show the latest measurement record.

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DATA MANAGEMENT

INFORMATION FOR USER

Tips for Measurement

2.Pr ess “S ET” t o con fi rm deleting and the monitor will turn off.

3.If you don’t want to delete the records, press START/STOP to escape.

If you did not get the correct measurement, you can delete all

results by following steps below.

Delete the Records

4.If there is no record, the right display will show.

In the memory mode, hold pressing “MEM” button for 3 seconds, the flash display will show.

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

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ABOUT BLOOD PRESSURE

INFORMATION FOR USER

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

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.

What are systolic pressure and diastolic pressure?

What is the standard blood pressure classification?

press

artery

vein

blood discharging

Systolic

relax

blood entering

Diastolic

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.

The chart on the right is the standard blood pressure classification published by American Heart Association (AHA).

AHA Home Guideline for Upper Limit of Normal BP

Please consult a physician if your measuring result falls outside the range. Please note that only a physician can tell whether your blood pressure value has reached a dangerous point.

CAUTION

SYS 135 mm Hg

DIA 85 mm Hg

Blood Pressure Category

Normal

Prehypertension

High Blood Pressure

(Hypertension) Stage 1

High Blood Pressure

(Hypertension) Stage 2

Hypertensive Crisis

(Emergency care needed)

Systolic mmHg (upper#)

Diastolic mmHg (lower#)

less than 120

120-139

140-159

160 or higher

Higher than 180

and

less than 80

80-89

90-99

100 or higher

Higher than 110

This chart reflects blood pressure categories defined by AHA

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

• Please report to CARE TOUCH if any unexpected operation or events occur.

CAUTION

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%,t he irregular heartbeat symbol appears on the symbol when the measurement results are displayed.

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TROUBLESHOOTING

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.

ABOUT BLOOD PRESSURE

PROBLEM SYMPTOM CHECK THIS REMEDY

No power

Low

batteries

Error

message

Display is dim

or 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.

E 1 shows

The cuff is not secure.

Refasten the cuff and then

measure again.

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 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 wrist and then measure again.

Measure incorrectly.

Why does my blood pressure fluctuate throughout the day?

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 condition.

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.

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.

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.

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1918

Power supply

Battery powered mode:

2*AAA batteries (3V DC)

Display mode

Digital LCD V.A.35mm×41mm

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.100g(Excluding the dry cells)

External dimensions

Attachment

Approx.73mmx67.5mmx22.5mm

2*AAA batteries,user manual,Carrying case

Mode of operation

Continuous operation

Degree of protection

Type BF applied part

Protection against ingress of water

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) times/minute

SPECIFICATIONS

CONTACT INFORMATION

Contact Information

Complied Standards List

Pressure:

5℃-40℃within±0.4kPa(3mmHg)

pulse value:±5%

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

Atmospheric pressure: 86kPa to 106kPa

Temperature:-20℃ to 60℃

Relative humidity: 10%RH to 93%RH

Atmospheric pressure: 50kPa to 106kPa

IP22

Risk management

Labeling

User manual

General Requirements for Safety

Electromagnetic compatibility

Non-invasive Sphygmomanometers General Requirements

ISO 14971:2007

ISO/EN 15223-1:2012

EN 1041:2008

IEC 60601-1:2005

IEC 60601-1-2:2007

AASI/AAMI SP10:2002/A1:2003/A2:2006/(R)2008

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.

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EMC GUIDANCE

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.

Table 1 Guidance and MANUFACTURER’s declaration – ELECTROMAGNETIC EMISSIONS- for all ME EQUIPMENT and ME SYSTEMS

Guidance and manufacturer’s declaration – electromagnetic emissions

RF emissions

CISPR 11

Group 1

Class B

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.

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

±2 kV for power supply lines

Not applicable

±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 s

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 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

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.

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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 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 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:

80 MHz to 800 M Hz

=d 2,3

800 MHz t o 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.

Field 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.

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 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 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

100

0.12 0.12

0.38

1.2

3.8

0.23

0.73

2.3

7.3

=d 1,2

2,3

0.38

1.2

3.8

1,2