Salter BPW-9101-GB Instructions For Use Manual

BPW-9101-GB

AUTOMATIC WRIST BLOOD PRESSURE MONITOR

Instructions and Guarantee

E

2

INTRODUCTION

General Description

Thank you for selecting Salter wrist blood pressure monitor BPW-9101-GB. 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 BPW-9101-GB
are equivalent to those obtained by a trained observer using the cu and stethoscope
auscultation method.
This manual contains important safety and care information, and provides step by step
instructions for using the product. Read the manual thoroughly before using the product.

Features:

• Systolic blood pressure

• Diastolic blood pressure

• Pulse rate

• 60 records for one user

Indications for Use

The Salter 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.

Contraindications

1. The device is not suitable for use on pregnant women or women who think they may be
pregnant.

2. The device is not suitable for use on patients with implanted, electrical devices, such as
cardiac pacemakers, defibrillators.

Measurement Principle

This product uses the Oscillometric Measuring method to detect blood pressure. Before
every measurement, the unit establishes a “zero pressure” equivalent to the air pressure.
Then it starts inflating the cu, meanwhile, the unit detects pressure oscillations generated
by beat-to-beat pulsatile, which is used to determine the systolic and diastolic pressure,
and also pulse rate.

Safety Information

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

3

CAUTION

* This device is intended for adult use in
homes only.
* The device is not suitable for use on neonatal
patients, pregnant women, patients with implanted,
electronical devices, patients with pre-eclampsia,
premature ventricular beats, atrial fibrillation,
peripheral, arterial disease and patients
undergoing intravascular therapy or arterio-venous
shunt or people who received a mastectomy.
Please consult your doctor prior to using the unit if
you suer from illnesses.
* The device is not suitable for measuring the
blood pressure of children. Ask your doctor before
using it on older children.
* The device is not intended for patient transport
outside a healthcare facility.
* The device is not intended for professional use.
* This device is intended for no-invasive measuring
and monitoring of arterial blood pressure. It is
not intended for use on extremities other than the
wrist or for functions other than obtaining a blood
pressure measurement.
* Do not confuse self-monitoring with self-

diagnosis. This unit allows you to monitor your
blood pressure.Do not begin or end medical
treatment without asking a physician for
treatment advice.
* If you are taking medication,consult your
physician to determine the most appropriate time
to measure your blood pressure. Never change
a prescribed medication without consulting
your physician.
* Do not take any therapeutic measures on the
basis of a self measurement. Never alter the dose
of a medicine prescribed by a doctor. Consult
your doctor if you have any question about your
blood pressure.
* When the device was used to measure patients
who have common arrhythmias such as atrial or
ventricular premature beats or atrial fibrillation,
the best result may occur with deviation. Please
consult your physician about the result.
* When using this device, please pay attention
to the following situation which may interrupt
blood flow and influence blood circulation of
the patient, thus cause harmful injury to the
patient: connection tubing kinking too frequent
and consecutive multiple measurements; the

0123

Symbol for “THE OPERATION GUIDE
MUST BE READ”

Symbol for “TYPE BF APPLIED PARTS”

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

Symbol for “ENVIRONMENT PROTECTION

- Wast electrical products should not
be disposed of with household waste.
Please follow local guidelines.

Symbol for “MANUFACTURER”

Symbol for “SERIAL NUMBER”

Authorized Representative in the
European Community

Symbol for “DIRECT CURRENT” Symbol for “Recycle”

Symbol for “MANUFACTURE DATE”

The Green Dot is the license symbol of
a European network of industry-funded
systems for recycling the packaging
materials of consumer goods.

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

4

application of the cu and its pressurization on any
wrist where intravascular access or therapy, or an
arterio-venous (A-V) shunt, is present; inflating the
cu on the side of a mastectomy.
* Warning: Do not apply the cu over a wound;
otherwise it can cause further injury.
*Do not inflate the cu on the same limb which
other monitoring ME equipment is applied around
simultaneously, because this could cause temporary
loss of function of those simultaneously-used
monitoring ME equipment.
*On the rare occasion of a fault causing the cu to
remain fully inflated during measurement, open
the cu immediately. Prolonged high pressure
(cu pressure > 300mmHg or constant pressure >
15mmHg for more than 3 minutes) applied to the
wrist may lead to an ecchymosis.
*Please check that operation of the device does
not result in prolonged impairment of patient
blood circulation.
* When measurement, please avoid compression or
restriction of the connection tubing.
* The device cannot be used with HF surgical
equipment at the same time.
* The ACCOMPANYING DOCUMENT shall disclose
that the SPHYGMOMANOMETER was clinically
investigated according to the requirements of ISO
81060-2:2013.
* To verify the calibration of the AUTOMATED
SPHYGMOMANOMETER, please contact the
manufacturer.
* This device is contraindicated for any female
who may be suspected of, or is pregnant. Besides
providing inaccurate readings, the eects of this
device on the fetus are unknown.
* Too frequent and consecutive measurements
could cause disturbances in blood circulation
and injuries.
* This unit is not suitable for continuous monitoring
during medical emergencies or operations.
Otherwise, the patient’s wrist and fingers will
become anaesthetic, swollen and even purple due

to a lack of blood.
* When not in use, store the device in a dry room
and protect it against extreme moisture, heat, lint,
dust and direct sunlight. Never place any heavy
objects on the storage case.
* This device may be used only for the purpose
described in this booklet. The manufacturer cannot
be held liable for damage caused by incorrect
application.
*This device comprises sensitive components and
must be treated with caution. Observe the storage
and operating conditions described in this booklet.
* The maximum temperature that the applied part
can be achieved is 42.5ºC while the
environmental temperature is 40ºC.
* The equipment is not AP/APG equipment and not
suitable for use in the presence of a flammable
anesthetic mixture with air of with oxygen or
nitrous oxide.
* Warning: No servicing/maintenance while the ME
equipment is in use.
* The patient is an intended operator.
* The patient can measure data and change
batteries under normal circumstances and maintain
the device and its accessories according to the
user manual.
* To avoid measurement errors, please avoid the
condition of strong electromagnetic field radiated
interference signal or electrical fast transient/
burst signal.
* The blood pressure monitor and the cu are
suitable for use within the patient environment. If
you are allergic to polyester, nylon or plastic, please
don’t use this device.
* During use, the patient will be in contact with the
cu. The materials of the cu have been tested
and found to comply with requirements of ISO
10993-5:2009 and ISO
10993-10:2010. It will not cause any potential
sensization or irritation reaction.
* If you experience discomfort during a
measurement, such as pain in the wrist or other

5

complaints, press the START/STOP button to release
the air immediately from the cu.
Loosen the cu and remove it from your wrist.
* If the cu pressure reaches 40 kPa (300 mmHg),
the unit will automatically deflate. Should the cu
not deflate when pressures reaches 40 kPa (300
mmHg), detach the cu from the wrist and press
the START/STOP button to stop inflation.
* Before use, make sure the device functions safely
and is in proper working condition. Check the
device, do not use the device if it is damaged in any
way. The continuous use of a damaged unit may
cause injury, improper results, or serious danger.
* Do not wash the cu in a washing machine
or dishwasher!
* The service life of the cu may vary by the
frequency of washing, skin condition, and storage
state. The typical service life is 10000 times.
* It is recommended that the performance should
be checked every 2 years and after
maintenance and repair, by retesting at least the
requirements in limits of the error of the cu
pressure indication and air leakage (testing at least
at 50mmHg and 200mmHg).
* Please dispose of ACCESSORIES, detachable
parts, and the ME EQUIPMENT according to the
local guidelines.
* Manufacturer will make available on request
circuit diagrams, component part lists,
descriptions, calibration instructions,etc., to assist
to service personnel in parts repair.
* The operator shall not touch output of batteries
and the patient simultaneously.
* Cleaning :Dust environment may aect the
performance of the unit. Please use the soft cloth to
clean the whole unit before and after use. Don’t use
any abrasive or volatile cleaners.
* The device doesn’t need to be calibrated within
two years of reliable service.
* If you have any problems with this device, such
as setting up, maintaining or using, please contact
the SERVICE PERSONNEL of Salter. Don’t open

or repair the device by yourself in the event of
malfunctions. The device must only be serviced,
repaired and opened by individuals at authorized
sales/service centers.
* Please report to Salter if any unexpected
operation or events occur.
* Keep the unit out of reach of infants, young
children or pets to avoid inhalation or swallowing of
small parts. It is dangerous or even fatal.
* Be careful to strangulation due to cables and
hoses, particularly due to excessive length.
* At least 30 min required for ME equipment to
warm from the minimum storage temperature
between uses until it is ready for intended use. At
least 30 min required for ME equipment to cool from
the maximum storage temperature between uses
until it is ready for intended use.
* This equipment needs to be installed and put into
service in accordance with the information provided
in the ACCOMPANYING DOCUMENTS;
* Wireless communications equipment such as
wireless home network devices, mobile phones,
cordless telephones and their base stations, walkie­talkies can aect this equipment and should be
kept at least a distance d away from the equipment.
The distance d is caculated by the MANUFACTURER
from the 80MHz to 5.8 GHz column of Table 4 and
Table 9 of IEC 60601-1-2:2014, as appropriate.
* Please use ACCESSORIES and detachable parts
specified/ authorised by
MANUFACTURER. Otherwise, it may cause damage to
the unit or danger to the user/patients.
* There is no luer lock connectors used in the
construction of tubing, there is no possibility
that they might be inadvertently connected to
intravascular fluid systems, allowing air to be
pumped into a blood vessel.
* Please use the device under the environment
which was provided in the user manual. Otherwise,
the performance and lifetime of the device will be
impacted and reduced.

6

LCD DISPLAY SIGNAL

7

MONITOR COMPONENTS

1) Automatic Wrist Blood Pressure Monitor

2) 2 x AAA batteries

3) User manual

list of

8

INSTALLING AND REPLACING THE BATTERIES

• Slide o the battery cover.

• Install the batteries by matching the correct
polarity, as shown below. Always use the
correct battery type (2 x AAA batteries).

• Replace the battery cover.

CAUTION

• Do not use new and used batteries together.

• Do not use dierent types of batteries together.

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

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

• Worn batteries are harmful to the environment. Do not dispose with daily garbage.

• Remove the old batteries from the device following your local recycling guidelines.

CAUTION

Replace the batteries under following circumstances:

• displays on the LCD

• The LCD display dims

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

9

5. Repeat steps 2 and 3 to confirm [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 once again and
then turn o.

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. (The setting
range of the year: 2018—2058 time format: 24H)

1. When the monitor is o,
hold pressing “MEM”
button for about 3 seconds
to enter into setting mode.
The blinking numeral
represents [YEAR].

2. Press the “MEM” button to
change the [YEAR]. Each
press will increase the
numeral by one in a
cycling manner.

3. When you get the right
year, press “START/STOP”
button to confirm your
selection and it will turn to
the next step.

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

10

MEASUREMENT

Tie the Cu

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.

2. Roll or push up your sleeve to expose

the skin.

3. Apply the cu to your wrist with your

palm facing up.

4. Position the edge of the cu about

1cm~1.5cm from wrist joints.

5. Fasten the wrist cu around your wrist,

leaving no extra room between the cu
and your skin. If the cu is too loose,
the measurement will not be accurate.

6. Sit comfortably with your tested wrist

resting on a flat surface. Place your
elbow on a table so that the cu is at
the same level as your heart. Turn your
palm upwards. Sit upright in a chair,
and take 5-6 deep breaths.

7. Patients with Hypertension:

• The middle of the cu 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 wrist
supported.

•

Rest for 5 minutes before measuring.

• Wait at least 3 minutes between
measurements. This allows your blood
circulation to recover.

• Take the measurement in a silent room.

• The patient must relax as much as
possible and do not move and talk
during the measurement procedure.

• The cu should maintain at the same
level as the right atrium of the heart.

• Do not cross your legs and keep your
feet on the ground.

• Keep your back against the backrest of
the chair.

• 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.

11

Start the Measurement

1. When the monitor is o, press “START/STOP” button to turn on
the monitor, and it will finish the whole measurement.

2. Press “START/STOP’’ button to power o, otherwise it will turn o

within 1 minute.

LCD display

Inflating and measuring Display and save the results

Adjust the zero

12

DATA MANAGEMENT

Recall the measurements

1. When the monitor is o, press “MEM” button

to show the average value of the latest three
measurement records. If the records are less than 3
groups, it will display the latest record instead.

2. Press “MEM” button again, it will display the latest

measurement result, date and time. Press “MEM”
button again, it will display the next record,and so
on. During the process of displaying the results, if
there is no operation, the blood pressure monitor
will turn o in one minute. Or you can press “START/
STOP” button to turn it o.

CAUTION

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 (eg 2 becomes 3, and so on), and the last
record (60) is dropped.

It means the total records
is 5, the current No. is No. 1.

The corresponding
date is May 14.

The corresponding
time is A.M. 8:16.

The record number, date
and time will display
alternately.

13

DATA MANAGEMENT

Delete the Records

If you did not get the correct measurement, you can delete
all results by following steps below.

1. In the memory mode, hold pressing “MEM”

button for 3 seconds, the flash display “dEL All”
will show.

2. Press “MEM” to confirm deleting , the LCD displays “

dEL dOnE” and the monitor will turn o.

Note: To exit out of delete mode without deleting

any records, press “START/STOP” button before
pressing “MEM” to confirm any delete commands.

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

14

INFORMATION FOR USER

Tips for Measurement

Measurements may be inaccurate if taken in the following circumstances.

15

INFORMATION FOR USER

Maintenance

In order to get the best performance, please follow the instructions below.

16

ABOUT BLOOD PRESSURE

What are systolic pressure and diastolic pressure?

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.

What is the standard blood pressure classification?

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

CAUTION

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.

Irregular Heartbeat Detector

An irregular heartbeat is detected when a heartbeat rhythm varies while the unit is measuring the systolic and
diastolic blood pressure. During each measurement, the monitor records all the pulse intervals and calculate the
average; if there are two or more pulse intervals, the dierence between each interval and the average is more than
the average value of ±25%, or there are four or more pulse intervals, the dierence between each interval and the
average is more than the average value of ±15%, the irregular heartbeat symbol appears on the display when the
measurement results have appeared.

Optimal Normal High-normal Mild Moderate Severe

SYS <120 120–129 130–139 140–159 160–179 ≥180

DIA <80

80–84 85–89 90–99 100–109 ≥110

Level

Blood
pressure (mm Hg)

Systolic

press

relax

Diastolic

blood discharging

artery

blood entering
vein

Grade 3 hypertension (severe)

Systolic blood pressure (mmHg)

Diastolic blood pressure (mmHg)

High-normal blood pressure

Normal blood pressure

Optimal blood

pressure

Grade 1 hypertension (mild)
Subgroup: borderline

Grade 2 hypertension (moderate)

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.

17

Why does my blood pressure fluctuate
throughout the day?

1. Individual blood pressure varies

multiple times everyday. It is also
aected by the way you tie your cu
and your measurement position, so
please take the measurement under
the same conditions.

2. If the person takes medicine, the
pressure will vary more.

3. Wait at least 3 minutes for another
measurement.

Why do I get a dierent blood
pressure at home compared to the
hospital?

The blood pressure is dierent even
throughout the day due to weather,
emotion, exercise etc, Also, there is
the “white coat” eect, 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 arms, but there will be
some dierent results for dierent
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 cu is tied properly.

• If the cu is too tight or too loose.

• If the cu 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.

18

TROUBLESHOOTING

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 is not operating as you think it should, check here before
arranging for servicing.

PROBLEM SYMPTOM CHECK THIS REMEDY

No power

Display will not
light up.

Batteries are exhausted. Replace with new batteries

Batteries are inserted incorrectly. Insert the batteries correctly

Low batteries

Display is dim
or show

Batteries are low. Replace with new batteries

Error message

E 1 shows The cu is not secure.

Refasten the cu and then
measure again.

E 2 shows The cu is too tight.

Refasten the cu and then
measure again.

E 3 shows The pressure of the cu is excess.

Relax for a moment and then
measure again.

E 10 or E11 shows

The monitor detected motion,
while measuring.

Movement can aect the
measurement. Relax for a moment
and then measure again.

E 20 shows

The measurement process does not
detect the pulse signal.

Loosen the clothing on the wrist
and then measure again.

E 21 shows

Measure incorrectly.

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.

Warning message “out ” shows Out of measurement range

the measurement result
is out of the measurement
range (SYS:60mmHg to
230mmHg; or DIA:
40mmHg to 130mmHg;or
Pulse: 40-199 pulse/minute)

19

SPECIFICATIONS

Power supply Battery powered mode: 2*AAA batteries (3V DC)

Display mode Digital LCD V.A.32mm×45mm

Measurement mode Oscillographic testing mode

Measurement range

Rated cu pressure:
0mmHg~299mmHg(0kPa ~ 39.9kPa)
Measurement pressure:
SYS: 60mmHg~230mmHg (8.0kPa~30.7kPa)
DIA: 40mmHg~130mmHg (5.3kPa~17.3kPa)
Pulse value: (40-199)beat/minute

Accuracy

Pressure:
5°C-40°C within±3mmHg(0.4kPa)
Pulse value:±5%

Working condition

A temperature range of :+5°C to +40°C
A relative humidity range of 15% to 90%, non-condensing, but not
requiring a water vapour partial pressure greater than 50 hPa
An atmospheric pressure range of : 700 hPa to 1060 hPa

Storage & transportation condition

Temperature:-20°C to +60°C
A relative humidity range of ≤ 93%, non-condensing, at a water vapour
pressure up to 50hPa

Measurement perimeter of the upper arm About 13.5cm-21.5cm

Net Weight Approx.104g(Excluding the batteries)

External dimensions Approx.85mmx67mmx23mm (Exclude the cu)

Attachment 2*AAA batteries,user manual

Mode of operation Continuous operation

Degree of protection Type BF applied part

Device Classification Internally Powered ME Equipment

IP Classification

IP22: The first number 2: Protected against solid foreign objects of 12,5mm

and greater. The second number: Protected against vertically falling
water drops when enclosure titled up to 15º. Vertically falling drops shall
have no harmful eects when the enclosure is titled at any angle up to 15º
on either side of the vertical.

Software version A01

WARNING: No modification of this equipment is allowed.

20

COMPLIED STANDARDS LIST

Risk management EN ISO 14971:2012 / ISO 14971:2007 Medical devices - Application of risk management to medical devices

Labeling

EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices. Symbols to be used with medical device labels,
labelling and information to be supplied. Part 1 : General requirements

User manual EN 1041:2008 Information supplied by the manufacturer of medical devices

General
Requirements
for Safety

EN 60601-1:2006+A1:2013/ IEC 60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for
basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and
medical electrical systems used in the home healthcare environment

Electromagnetic
compatibility

EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic
safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests

Performance
requirements

EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for
non-automated measurement type
EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro­mechanical blood pressure measuring systems
IEC 80601-2-30:2009+A1:2013 Medical electrical equipment- Part 2-30: Particular requirements for the basic
safety and essential performance of automated non-invasive sphygmomanometers

Clinical
investigation

EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system
accuracy of automated non-invasive sphygmomanometers
ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type

Usability

EN 60601-1-6:2010+A1:2015/IEC 60601-1-6:2010+A1:2013 Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance - Collateral standard: Usability IEC 62366-1:2015
Medical devices - Part 1: Application of usability engineering to medical devices

Software life-cycle
processes

EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical device software - Software life-cycle processes

Bio-compatibility

ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk
management process ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro
cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

CONTACT INFORMATION

Manufactured by

21

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 aected 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.

EMC GUIDANCE

Table 1

Guidance and manufacture’s declaration – electromagnetic emission

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.

Emission test Compliance Electromagnetic environment - guidance

RF emissions
CISPR 11

Group 1

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.

RF emission
CISPR 11

Class B

The device is suitable for use in all establishments,other
than domestic 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

Complies

22

Table 2

Guidance and manufacture’s declaration – electromagnetic immunity

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.

Immunity test IEC 60601 test level Compliance level

Electromagnetic

environment - guidance

Electrostatic
discharge (ESD)
IEC 61000-4-2

±15 kV air
±8 kV contact

±15 kV air
±8 kV contact

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

input/output lines:
±1 kV
power supply lines:
±2 kV

power supply lines:
±2 kV

Mains power quality should be that
of a typical commercial or hospital
environment.

Surge
IEC 61000-4-5

100 kHz repetition
frequency
line(s) to earth: ±2 kV
line(s) to line(s): ±1 kV

100 kHz repetition
frequency
line(s) to line(s): ±1 kV

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

0%UT; 0.5 cycle
At 0°, 45°, 90°, 135°,
180°,225°,270°
and 315°
0%UT ; 1 cycle
and
70%UT ; 25/30 cycles
Single phase: at 0°
0% UT ; 300 cycle

0% UT ; 0.5 cycle
At 0°, 45°, 90°, 135°,
180°,225°,270° and
315°
0% UT ; 1 cycle
and
70% UT ; 25/30 cycles
Single phase: at 0°
0% UT ;300 cycle

Mains power quality should be that
of a typical commercial or hospital
environment.

Power frequency
(50Hz/60Hz)
magnetic field
IEC 61000-4-8

30 A/m
50Hz/60Hz

30 A/m
50Hz/60Hz

Power frequency magnetic
fields should be at levels
characteristic of a typical location
in a typical commercial or hospital
environment.

NOTE UT is the a.c. mains voltage prior to application of the test level.

23

Table 3

Guidance and manufacturer’s declaration – electromagnetic immunity

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.

Immunity test

IEC 60601

test level

Compliance

level

Electromagnetic

environment - guidance

Conducted RF
IEC 61000-4-6

150 kHz to
80 MHz:
3 Vrms
6Vrms (in ISM
and amateur
radio bands)
80% Am at
1kHz

150 kHz to
80 MHz:
3 Vrms
6Vrms (in ISM
and amateur
radio bands)
80% Am at
1kHz

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:
d = 0.35

√

—

P

d = 1.2

√

—

P

Radiated RF
IEC 61000-4-3

10V/m, 80% Am
at 1kHz

10V/m, 80% Am
at 1kHz

80 MHz to 800
MHz: d=1.2

√

—

P

800 MHz to 2.7
GHz: d=2.3

√

—

P

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,a should be
less than the compliance level in each
frequency range.

b

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

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 aected by
absorption and reflection from structures, objects and people.

a

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 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.

b

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

24

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 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)

150 kHz to 80 MHz

d = 3.5

√

—

P

80 MHz to 800 MHz

d = 1.2

√

—

P

800 MHz to 2.7 GHz

d = 2.3

√

—

P

0.01 0.12 0.12

0.23

0.1 0.37 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 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 2 These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and

reflection from structures, objects and people.

25

Table 5

26

Table 5 (cont)

2 YEAR GUARANTEE

FKA Brands Ltd guarantees this product from defect in material and workmanship for a period of
2 years from the date of purchase, except as noted below. This FKA Brands Ltd product guarantee
does not cover damage caused by misuse or abuse; accident; the attachment of any unauthorised
accessory; alteration to the product; or any other conditions whatsoever that are beyond the control
of FKA Brands Ltd. This guarantee is eective only if the product is purchased and operated in the
UK / EU. A product that requires modification or adaptation to enable it to operate in any country
other than the country for which it was designed, manufactured, approved and / or authorised,
or repair of products damaged by these modifications is not covered under this guarantee. FKA
Brands Ltd shall not be responsible for any type of incidental, consequential or special damages.
To obtain guarantee service on your product, return the product post-paid to your local service
centre along with your dated sales receipt (as proof of purchase). Upon receipt, FKA Brands Ltd
will repair or replace, as appropriate, your product and return it to you, post-paid. Guarantee is
solely through Salter Service Centre. Service of this product by anyone other than the Salter Service
Centre voids the guarantee.
This guarantee does not aect your statutory rights.
For your local Salter Service Centre, go to www.salterhousewares.co.uk/servicecentres

IB-BPW9101GB-0718-02

Version: 2.0

Guangdong Transtek Medical Electronics Co., Ltd.

Zone A, No 105, Dongli Road, Torch Development District,
Zhongshan, 528437, Guangdong, China

MDSS - Medical Device Safety Service GmbH
Schigraben 41, 30175 Hannover, Germany

EC REP

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Somerhill Business Park, Tonbridge, Kent TN11 0GP, UK
Customer Support: [phone] I [e-mail]