Salter BPA-9201-EU Product information sheet

AUTOMATIC ARM BLOOD PRESSURE MONITOR
Instructions and Guarantee
BPA-9201-EU

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INTRODUCTION
General Description
Thank you for selecting Salter arm blood pressure monitor. 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 blood pressure monitor 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:
• 60mm x 40.5 mm LCD
• Maximum 60 records
• Measuring during inflation
Indications for Use
The Salter Blood Pressure Monitor is digital monitors intended for use in measuring blood pressure and heartbeat
rate with arm circumference ranging from 22cm to 42cm (about 8¾˝-16½˝).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 arm 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.
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
- Waste 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

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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
arm or for functions other than obtaining a blood pressure
measurement.
• Do not confuse self-monitoring with self-diagnosis. This
unit allows you to monitor your blood pressure. Do not
begin or end medical treatment without asking a physician
for treatment advice.
• If you are taking medication,consult your physician to
determine the most appropriate time to measure your
blood pressure. Never change a prescribed medication
without consulting your physician.
• Do not take any therapeutic measures on the basis of
a self measurement. Never alter the dose of a medicine
prescribed by a doctor. Consult your doctor if you have any
question about your blood pressure.
• When the device was used to measure patients who
have common arrhythmias such as atrial or ventricular
premature beats or atrial fibrillation, the best result may
occur with deviation. Please consult your physician about
the result.
• Don't kink the connection tube during use, otherwise, the
cu pressure may continuously increase which can prevent
blood flow and result in harmful injury to the PATIENT.
• When using this device, please pay attention to the
following situation which may interrupt blood flow and
influence blood circulation of the patient, thus cause
harmful injury to the patient: connection tubing kinking
too frequent and consecutive multiple measurements; the
application of the cu and its pressurization on any arm
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 arm 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
arm 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 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.

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• Warning: No servicing/maintenance while the ME
equipment is in use.
• The patient is an intended operator.
• The patient can measure data and change batteriesunder
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 arm or other complaints, press the
START/STOP button to release the air immediately from the
cu. Loosen the cu and remove it from your arm.
• 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 arm 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, walkie-talkies 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 80 MHz 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.

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LCD display signal

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Monitor Components
CUFF
AIR HOSE
AIR
CONNECTOR
PLUG
LCD DISPLAY
BATTERY COMPARTMENT
START/STOP
BUTTON
Component list of pressure
measuring system
1 Cu
2 Air pipe
3 PCBA
4 Pump
5 Valve
SET BUTTON
MEM BUTTON
Installing and replacing the batteries
• Open the battery cover.
• Install the batteries as indicated in the battery compartment.
(Always select the authorized / specified battery:
4 x AAA-size batteries).
• Replace the battery cover.
Replace the batteries under the
following circumstances:
• displays on the LCD
• The LCD display is dim
• When powering on the monitor,
the LCD doesn’t light up.
List
1. Automatic Arm Blood pressure monitor
4. User manual
2. Cu (Type BF applied part) 22cm-42cm)
(Please use Salter
Authorized cu. The size
of the actual cu please
refer to the label on the
attached cu.)
3. 4×AAA batteries
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.

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5. Repeat steps 2 and 3 to set the [HOUR] and
[MINUTE].
6. Repeat steps 2 and 3 to set the [UNIT].
7. After the unit is set,the LCD will display
“donE”first,then display all the settings you have
done and then it will 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: 12H/24H)
1. When the monitor is o,
hold pressing “SET”
for 3 seconds to enter
the mode for year
setting.
Or when the monitor is o,
press “SET” button shortly,
it will display the time. Then
hold pressing “SET” button
to enter the mode for year
setting.
2. Press the “MEM” to
change the [YEAR].
Each press will increase the
numeral by one in a cycling
manner.
3. When you get the right
year, press “SET” to set
down and turn to next
step.Repeat steps 2 and
3 to set the [MONTH] and [DAY].
4. Repeat steps 2 and 3 to confirm the time format [12H] and
[24h].
Monitor Components
2. Cu (Type BF applied part) 22cm-42cm)

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BEFORE YOU START
Select the User
1. When the monitor is o , press and hold the MEM button
to enter user setting mode. The user ID will blink.
2. Then press MEM button again, select the user ID user 1 ,
user 2 or user G.
3. After selecting the suitable user ID, press SET button to
confirm. Then the LCD will turn o.
MEASUREMENT
Tie the Cu
1. Remove all jewelry, such
as watches and bracelets from
your left arm. Note: If your
doctor has diagnosed you
with poor circulation in your
left arm, use your right arm.
2. Roll or push up your sleeve to
expose the skin. Make sure your sleeve
is not too tight.
3. Hold your arm with your palm facing up and
tie the cu on your upper arm, then position the tube
o-center toward the inner side of arm in line with the
little finger. Or position the artery mark over the main
artery (on the inside of your arm). Note: Locate the main
artery by pressing with 2 fingers approximately 2 cm
above the bend of your elbow on the inside of your left
arm. Identify where the pulse can be felt the strongest.
This is your main artery.
4. The cu should
be snug but not too
tight. You should be
able to insert one
finger between the
cu and your arm.
5. Sit comfortably with your tested arm 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.
6. Helpful tips for Patients, especially for patients with
Hypertension:
• Rest for 5 minutes before first 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.
• Please sit comfortably. Do not cross your legs and
keep your feet flat 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 arm, or as
directed by a
physician.

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Start the Measurement
1. When the monitor is o,press
the “START/STOP” to turn on the
monitor, and it will finish the whole
measurement. (Take User 1 for example)
DATA MANAGEMENT
Recall the Records
1. When the monitor is o, please press the “MEM” to show
the average value of the latest three records.If the records are
less than three groups,it will display the latest record first.
2. Press the “MEM” or “SET” to get the record you want.
Adjust the zero
Inflating and
measuring
Display and save
the results.
2. Press the “START/STOP” to power
o, otherwise it will turn o within
1 minute.
The date and
time of the
record will
be shown
alternately
The current
no. is no.2 The corre- sponding date
is January 1st
The corre-
sponding time
is pm 10:08
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.
LCD display

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Delete the records
If you did not get the correct measurement, you can delete all
results by following steps.
1. Hold pressing “MEM” for 3 seconds when the monitor is in
the memory recall mode ,the flash display will show.
2. Press “SET” to confirm deleting and the monitor will turn
o.
3. If you don’t want to delete the records, press “START/STOP”
to escape.
4. If there is no record, the above display will show.
Within 1 hour after dinner
or drinking
Within 20 minutes after
taking a bath
In a very cold environment
Immediate measurement
after tea, coee, smoking
When talking or moving
your fingers
Put in a dry place and
avoid the sunshine
Avoid intense shaking and
collisions
Using wet cloths
to remove dirt
Do not attempt to clean the
reusable cu with water and
never immerse the cu in water.
Avoid dusty and unstable
temperature environment
Avoid touching water,
When you want to discharge
urine
INFORMATION FOR USER
Tips for Measurement
Measurements may be inaccurate if taken in the following
circumstances.
Maintenance
In order to get the best performance, please follow the
instructions below.

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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)
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.
Systolic
press relax
Diastolic
blood discharging
artery
blood entering
vein

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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 arm?
It is ok for both arms, but there will be some
dierent results for dierent people.
We suggest you measure the same arm
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 upper arm.
• 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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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 01 shows The cu is too tight or too loose. Readjust the cu ,not too loose or
too tight and then measure again.
E 02 shows The monitor detected motion, talking or the pluse is too poor
while measuring.
Relax for a moment and then
measure again.
E 03 shows The measurement process does not
detect the pulse signal. Loosen the clothing on the arm and then measure again
E 04 shows The treatment of the measurement
failed. 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 Relax for a moment message measure again. If the problem
persists, contact your physician.

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SPECIFICATIONS
Power supply 6VDC 4*AAA batteries
Display mode LCD V.A.60mm×40.5mm
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: 5ºC-40ºC within±0.4kpa(3mmHg)
pulse value:±5%
Normal 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 22cm~42cm
Net Weight Approx.169g (Excluding the dry cells)
External dimensions Approx.110mm×110mm×41mm
Attachment 4×AAA batteries,user manual
Mode of operation Continuous operation
Degree of protection Type BF applied part
Protection against ingress of water IP21 It means the device could protected against solid foreign objects of
12.5mm and greater, and protect against vertically falling water drops.
Device Classification Battery Powered Mode: Internally Powered ME Equipment
Software version A01
WARNING: No modification of this equipment is allowed.

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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
electro-mechanical 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
For more information about our products, please visit www.salterhousewares.co.uk
Model: BPA-9201-EU
Manufactured by: Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No.105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China
Authorized European Representative:
MDSS - Medical Device Safety Service GmbH
Schigraben 41,
30175 Hannover,
Germany
Imported into the UK by:
FKA Brands Ltd, Somerhill Business Park, Tonbridge, Kent, TN11 0GP
Imported into the EU by:
FKA Brands Ltd, 29 Earlsfort Terrace, Dublin 2, IE
Customer Support: [phone] [e-mail]

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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 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

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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.
(50Hz/60Hz)
magnetic field Power
frequency
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 UTis the a.c. mains voltage prior to application of the test level.

18 IGB
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,ashould 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.
aField 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.

19 IGB
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 0.38 0.38
0.73
11.2 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.
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

Table 5
20 IGB
5500
430-470