PUMP MEDICAL SYSTEM SFA Body Composition Analyzer and Scale User Manual

SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. Body Composition Analyzer and Scale

User manual

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Date Submitted2015-12-01 00:00:00
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Document Author: cai

Rev: A1
Body Composition Analyzer and Scale
SF1402B
Instruction Manual
Thanks for purchasing the Body Composition Analyzer and Scale manufactured by
Bpump.
Please read the instruction manual before usage;
Please dispose the Body Composition Analyzer and Scale and battery in accordance with
local regulations.
page1of23
Rev: A1
Table of Content
1. Safety Information ...................................................................................................................... 3
1.1. Danger ............................................................................................................................... 3
1.2. Warning............................................................................................................................. 3
1.3. Precaution ......................................................................................................................... 3
2. Indication for Use ........................................................................................................................ 4
3. Product Structure ........................................................................................................................ 5
4. Operation Instruction ................................................................................................................. 6
4.1. Precautions in Use ............................................................................................................ 6
4.1. Power On/Off.................................................................................................................... 6
4.2. Battery Installation and replacement ............................................................................. 6
4.3. Personal Data Setting....................................................................................................... 7
4.4. Take Measurement .......................................................................................................... 8
4.4.1. Precautions for Measurement .............................................................................. 8
4.4.2. Steps for Measurements ....................................................................................... 8
4.4.3. Display the Measurement Result ....................................................................... 10
4.4.4. Data Transmission .............................................................................................. 11
5. Reference Standards ................................................................................................................. 12
5.1. Weight Standard ............................................................................................................ 12
5.2. Body Fat Ratio Standard ............................................................................................... 12
5.3. Water Content Standard ............................................................................................... 12
5.4. Visceral Fat Index Standard ......................................................................................... 12
5.5. BMI (Body Mass Index)................................................................................................. 12
5.6. Muscle Mass.................................................................................................................... 13
5.7. The Average Bone Mass Presumption ......................................................................... 13
5.8. Basal Metabolism ........................................................................................................... 13
5.9. Physical Age .................................................................................................................... 13
6. Error Indication ........................................................................................................................ 14
7. Trouble Shooting ....................................................................................................................... 15
8. Product Specification ................................................................................................................ 16
9. CARE AND MAINTENANCE ................................................................................................ 18
9.1. Daily Maintenance ......................................................................................................... 18
9.2. Storage Tips .................................................................................................................... 18
◆Electromagnetic Compatibility Guide..................................................................................... 19
◆Product Registration Information ........................................................................................... 23
◆After-Sale Service ...................................................................................................................... 23
page2of23
Rev: A1
1. Safety Information
1.1. Danger
(Operation errors lead to death or serious injury)
Do not use in conjunction with following electronic medical device in avoid of life
threating.
● Implantable medical device such as pacemakers;
● Life-sustaining medical device such as artificial heart;
● Pregnant women are not suggested to use the device for physiological index
measurements such as body fat ratio.
1.2. Warning
(Operation errors may lead to death or serious injury)
Do not use in slippery, unsmooth, or wet places in avoid of user’s falling injury;
Do not use in when body or feet is wet in avoid of user’s falling injury, as well
as in avoid of water entering the device, which may cause inaccurate
measurement;
Do not tilt, drop the device, do not drop other objects to the device in avoid of
strong vibration or impact to the device.
Please carefully dealing with broken glass pieces if device broken in avoid of
hurt.
Do not stand on the edge of the devicein avoid of inaccurate measurement.
Do not jump on the device in avoid of falling injury or device damage.
Do not self-diagnosis on basis of the measurement results, it is important that
the users who want to lose weight or conduct kinesitherapy should consult
doctor or medical professional in avoid of body harm.
Do not mix old and new batteries in avoid of harm caused by battery leakage,
fever or broken.
People with disabilities must use the device under others’ help in avoid of
slipping damage.
Do not use in conjunction with certain medical electronic instruments such as
ECGin avoid of affecting measurement result.
1.3. Precaution
(Operation errors may lead to operator injury or device damage)
Do not attempt to disassemble, repair or modify the device in avoid of
inaccurate measurement.
Keep out of reach of infants, small children in avoid of harm caused by device
page3of23
Rev: A1
falling.
Please do not reverse the battery poles during battery replacement in avoid of
harm caused by battery leakage, fever or broken.
Please take out the battery in case of non-use for a long time (3 months above).
Please stand up straight and keep still during the measurement in avoid of
affecting measurement result.
Please do not place the device where has water, direct sunlight, direct air
condition wind, please do not place next to the fireworks. Otherwise it may
malfunction.
This device is in conformity with the relevant requirements of the
YY0505-2012 electromagnetic compatibility standard.
Users should install and use the device according to the electromagnetic
compatibility information in accompanying files.
Avoid strong electromagnetic interference during usage because portable and
mobile radio frequency communication equipments may affect the device
performance, do not close to the cell phones, microwave ovens.
Please refer to electromagnetic compatibility guidance for electromagnetic
compatibility detail and of manufacturer's declaration.
◆ Note:
The following population may unable to gain measurement values or gain inaccurate
measurement valuesbecause whose body composition may differ widely from the
mean value:
Children under the age of 18/ elders aging over 65/ menopause women/ patients in
fever due to cold/ pregnants/ patients with low bone mineral density(BMD)/ patients
with edema disease/ hemodialysis patients/ sportsmen.
2. Indication for Use
The device is used for the measuring and calculating of the body physiological
indexs such as body fat ratio, water content, body mass index (BMI), visceral fat
index, muscle mass, bone content, basal metabolism, physical age through
measuring electrical impedance changes in a region of the body.
page4of23
Rev: A1
3. Product Structure
Water contentratio
Numerical display
Bluetooth Battery symbol
Group
Muscle mass
Weight
Visceral fat index
Physical Age
Basal metabolism
Unit
Bone content
Measurement Indicators
Left Arrow: use to select mode or
Right Arrow: use to select mode
decreasenumericalvalues
or increase numericalvalues
SET Key
ON/OFF Key
Display
Right electrode slice
Left Electrode slice
Fig 1
page5of23
Rev: A1
4. Operation Instruction
4.1.Precautions in Use
Do not use the device under strong electrostatic or electromagnetic environment,
otherwise may cause inaccurate measurementor device failure;
Take measurement barefoot, otherwise it is unable to gain accurate physiological indexes
such as body fat ratio;
Do not use the device above soft surfaces such as mats or carpet, otherwise the device
surface may sunk due to impact stepped on, which may lead to inaccurate measurement;
In case of sharing device with patients havingpodiatric, dermatologic or other infectious
diseases, clean the device before your use (wipe the device with wrung soft cloth which
had been soaked with water or neutral detergent, then wipe the device with another dry
soft cloth), otherwise may cause infection;
The deviceis not intended to use except for the measurement of physiological indexes
mentioned above;
The deviceis not intended to use as items weighing for trade settlement purposes.
4.1. Power On/Off
Turn on the device and wait for a while, "0.0 kg" will displayon the screen (fig 2);
Long press the power button for more 3 seconds topower off the device;
Note: The device will automatically power off ifunattended for more than 1 minute;
Fig 2
4.2. Battery Installation and replacement
1)
Turn over the device and remove the battery cover;
2)
Installfour AAA alkaline batteries in correct direction,pole with
3)
and spring is cathode side;
Install back the battery cover;
symbol
◆Battery Life
1)
Four AAA alkaline batteries will last for approximately 200 measurements,
page6of23
Rev: A1
2)
3)
ifmeasurements are taken once a day at room temperature (23°C);
The batteries enclosed are used for trial, which may be used up soon;
Do not use rechargeable batteries, otherwise may cause misoperation.
‹ Battery symbol flashing means that the battery is running out, replace four
new AAA alkaline new batteries of same model if happens;
‹ Please replace the battery at power off status;
‹ The personal data seted in advance will be kept however battery replaced;
4.3.Personal Data Setting
Note:
z Set the “age, gender, height” informationbefore physiological indexes measuring
such as weight, body fat ratio, visceral fat index,BMI and others.The device can
store four groups personal dataat most;
z In addition to personal data setting, you can also use "guest" function to measure
physiological indexes such as weight, the body fat ratio, visceral fat index and
others;
z What is "guest" function? Instead of setting personal data in advance, user can also
measure physiological indexes such as weight, body fat ratio, visceral fat index and
othersafter temporary setting,but whose temporarysetting would not be stored;
1)
Power On
The device display "0.0 kg" after power on (fig 2);
2)
Select group
Press
buttons to reach the group/guest you selected, then pressSET button
for confirmation (fig3);
3)
Set Age
buttons to reach correct “Age”, then
The first setting item is “Age”; Press
press SET button for confirmation (fig4);
4)
Select Male/Female
The device enters Gender setting after Age setting in default;
Press
buttons to change from Female to Male,then press SET button for
confirmation (fig5);
5)
Set Height
The device enters Height setting after Gender setting in default;
Press
buttons to reach correct “Height”, then pressSET button for
page7of23
Rev: A1
confirmation (fig6);
Fig 3
Fig 4
Fig 5
Fig 6
Setting is complete till now, you can start physiological indexesmeasurement such
as weight, the body fat ratio, visceral fat index and others.
4.4. Take Measurement
4.4.1. Precautions for Measurement
Personal data setting is needed if you want to use under “Group” function to
track your measurement results; “Guest” function is an option if you do not
need to store the personal data.
Please take measurement onsmooth, hard ground, take measurementabove soft
surfaces such as mats or carpet may lead to inaccurate measurement;
4.4.2. Steps for Measurements
4.4.2.1. Whole physiological Indexes Measurement
1)
Power On/Off
Turn on the device and wait for a while, then "0.0 kg" will show on the screen (fig
2);
2)
Personal Data Setting
Set the personal data as section 3.3 instructs;
3)
Physiological Indexes Measurement
(1) Step onto the platform with correct posture barefoot, otherwise the device is unable
to display correct physiological indexes (fig 10, fig 11);
(2) Stand still and keep your posture for a while, the weight value will display on the
screen automatically;
(3) Don’t move after weight measuring, the device will automatically measure
thefollowing physiological indexes such as body fat ratio, visceral fat index and
others;
(4) Step off the platform after the measurement done;
page8of23
Rev: A1
Note:
on the screen indicates the device has finished measurement (fig 12);
barefoot
step on the electrode slice double foot at the same time
Fig 10
Fig 11
Fig 12
4.4.2.2. Weight Measurement Only
1)
Power On/Off
Power on the device and wait for a while, "0.0 kg" will appearon the screen (fig 2);
Note: automaticpower on can be triggered in casea person/thingupon weighting over
page9of23
Rev: A1
10kg on the device.
2)
Weight Measurement
(1) Step onto the platform with correct posture barefoot, otherwise the device is unable
to display correct physiological indexes (fig 10, fig 11);
(2) Stand still and keep your posture for a while, the weight value will display on the
screen (fig 13);
(3) Step off the platform after the measurement done;
Fig 13
4.4.3. Display the Measurement Result
4.4.3.1. Physiological Indexes Display
The device will automatically circular display the measuring values,
press
forreviewing previous datainsequenceasfig14.
Body fat ratio
BMI
Water content
Visceral fat index
Weight
Physical age
Muscle mass
Fig 14
page10of23
Bone content
Basal metabolism
Rev: A1
4.4.3.2. Unit Switch
Under standby status (showing "0.0 kg" on the screen), you can enter “unit switch”
interface by long pressing "SET" button; use
buttons to select the unit,
then press SET button for confirmation; The available units are metric and imperial
such as "cm , kg","ft, lb "(fig15, fig 16).
Fig 15
Fig 16
4.4.4. Data Transmission
The bluetooth function turns on in accompany with the powering on of the device,
which can be searched by corresponding app used for physiological indexes
management on cellphone. The measurement result will be transmitted to the app
automatically.
page11of23
Rev: A1
5. Reference Standards
5.1. Weight Standard
Weight
Result
≤-10.0%
-9.9%~9.9%
10.0%~19.9%
Low
Normal
Mild
High
≥20.0%
5.2. Body Fat Ratio Standard
Body Fat Ratio is the proportion of fat to the total body weight.
Body Fat Ratio
Male
Female
2.0~13.9%
10.0~20.9%
14.0~17.9%
21.0~24.9%
18.0~24.9%
25.0~31.9%
≥25.0%
≥32.0%
Result
Low
Normal
Mild
High
5.3. Water Content Standard
Total Body Water is the total amount of fluid in the body expressed as a percentage of total
weight.
By weight, the average human adult male is approximately 60% water.
By weight, the average human adult female is approximately 50% water.
5.4. Visceral Fat Index Standard
Visceral fat is located deep in the core abdominal area, surrounding and protecting the vital
organs.
Visceral Fat index
Result
1~9
Normal
10~14
Mild
15~30
High
*Visceral fat index is always a rough number, the relevant medical diagnosis, consult a doctor.
5.5. BMI (Body Mass Index)
A standardised ratio of weight to height, used as a general indicator of health.
page12of23
Rev: A1
BMI
18.8~22.9
24~27
≤28
Result
Normal
Mild
High
5.6. Muscle Mass
Muscle Mass (including skeletal and smooth muscle) make up 70% of weight in
ordinary population.
5.7. The Average Bone Mass Presumption
≤60k
bone
mass 3.2kg
presumption
Weight
Male
60kg~75kg
3.95kg
≥75kg
4.4kg
≤45kg
2.2kg
Female
45kg~60kg
2.8kg
≥60kg
2.9kg
5.8. Basal Metabolism
Age
18~29
30~49
50~69
70≤
Male
ideal body Basal
weight(kcal metabolism
standard
values
(kcal/kg/da
y)
64.7
24
67
22.3
62.5
21.5
56.7
21.5
Basal
metabolism
amount
(kcal/day)
1550
1500
1350
1220
5.9. Physical Age
Physical age, namely the actual metabolic age.
page13of23
Female
ideal body Basal
weight(kcal metabolism
standard
values
(kcal/kg/da
y)
51.2
23.6
54.2
21.7
53.8
20.7
48.7
20.7
Basal
metabolism
amount
(kcal/day)
1210
1170
1110
1010
Rev: A1
6. Error Indication
Error
Err
Cause
1) The user sways or leaves the
device during measurement;
2) Do not take measurement
barefoot;
Correction
Do not sway or leave during
measurement;
Take measurement barefoot;
3) The device is unable to detect the
human impedance.
Step onto the platform with correct
posture barefoot to take
measurement.
Exceeds the biggest weighing
range;
Use within the measuring range of
device;
page14of23
Rev: A1
7. Trouble Shooting
PROBLEM
Device shows "0.0 kg", or
almost no value. increase
after stepping on;
Abnormally high or low
measurement value;
Abnormally high or low
measurement value;
The measurement value
differs widely for each
measurements;
CAUSE
Step onto the device before
"0.0" displayed;
Step onto the device after
"0.0" displayed;
Wrong Posture;
Please follow the correct
posture measurement.
Take Measurement on soft or
unsmooth ground such as
carpet;
Please measure on the
smooth, hard ground.
Foot or body is too cold due
to bad blood circulation;
Electrode is too cold.
The soles of foot are too dry.
Measurement Values
disappears immediately after
displayed;
CORRECTION
Battery runs out;
Take measurement after
blood circulation back to
normal state;
Place the device in warm
indoor place for a while,
Take measurement after
electrode become warm.
Slightly humidify the feet by
wiping the feet with a wet
towel;
Take measurement after
electrode become
Change the battery;
No battery;
Install the battery;.
No display after pressing the Incorrect installation of
Install the batteries correctly;
ON/OFF button
battery;
Battery runs out.
Please change the battery;
*Malfunction means unable to measure correctly after taking action according to above
solutions, please call the after-sales service hotline 4006 755 009 for help;
page15of23
Rev: A1
8. Product Specification
Product Name
Body Composition
Analyzer and Scale
Model
SF1402B
Power Supply
4 AAA battery
≤50kg: ±0.4kg
50kg~100kg: ±0.5kg
≥100kg: ±0.6kg
Auto power off
Unattended 1min
Memory
4 groups parameters which
have been seted up
Accuracy
Setting Item
Age: 7~99 years old
Sex: Male/Female
Height:100~220cm
Display Range
Display
accuracy
Weight: 0.1kg
Body Fat Rate: 0.1%
Water Content: 0.1%
Muscle Mass: 0.1kg
Bone Content: 0.1kg
Basal Metabolism: 1Kcal
BMI: 0.1
Physical Age: 1year
Visceral Fat Index: 1
SubregionalDeter
mination
Applied Part
Type BF
Operating
Environment
Weight: 0.0kg~150.0kg
Body Fat Ratio:2.0%~
75.0%(user: 7 to 99 years old)
Water Content: 15.0%~
75.0%(user: 18 to 99 years
old)
Bone Content: 1.0kg~
5.0kg(user: 7 to 99 years old)
Basal Metabolism:
500Kcal~3000Kcal
(user: 18 to 99 years old)
BMI:2.0~90.0
(user: 7 to 99 years old)
Physical Age: 15~85 years
(user: 18 to 99 years old)
Visceral Fat Index: 1~30
(user: 18 to 99 years old)
1、Weight:
Low/Normal/Mild/High
(user: 18~65 years of age and
pregnant women or the height
of the abnormal population
are not applicable)
2、Body Fat Rate:
Low/Normal/Mild/High
3、BMI:
Low/Normal/Mild/High
(user: 18 to 99 years old)
4、Visceral Fat Index:
Normal/Mild/High
Temperature:+5℃~+40℃
Humidity:15%~93%
Pressure: 70.0kPa~
106.0kPa;
Altitude: ≤3000 m
Temperature:-25℃~+70℃
External
Humidity:10%~95%
320mm×320mm×28mm
Dimension
Pressure: 50.0kPa~
106.0kPa
Useful life
4 years
Weight
Approx 2.0kg
Contents
4 AAA test battery/Instruction Manual/Certificate
This device is intended for home use and the specification may be changed without prior notice.
Storage and
transport
Environment
page16of23
Rev: A1
Disposal
This product must not be disposed together with the domestic waste.
All users are obliged to hand in all electrical or electronic devices, regard less of
whether or not they contain toxic substances, at a municipal or commercial
collection point so that they can be disposed of in an environ mentally accept able
manner.
Please remove the battery before disposing of the equipment. Do not dispose of old
batteries with your house hold waste, but dispose of them at a battery collection
station at are cycling site or in a shop.
Consult your municipal authority or your dealer for information about disposal.
FCC statement:
Warning: Changes or modifications to this unit not expressly approved by the party
responsible for compliance could void the user’s authority to operate the equipment.
This device complies with Part15 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.
Note: This equipment has been tested and found to comply with the limits for a
Class B digital device, pursuant to part 15 of the FCC Rules. These limits are
designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates uses and can radiate radio
frequency energy and, if not installed and used in accordance with the instructions,
may cause harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If this
equipment does cause harmful interference to radio or television reception, which
can be determined by turning the equipment off and on, the user is encouraged to try
to correct the interference by one or more of the following measures:
-Reorient or relocate the receiving antenna.
-Increase the separation between the equipment and receiver.
-Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
-Consult the dealer or an experienced radio/TV technician for help.
FCCID: 2AAS7-SFA
The device has been evaluated to meet general RF exposure requirement. The
device can be used in portable exposure condition without restriction.
page17of23
Rev: A1
9. CARE AND MAINTENANCE
9.1. Daily Maintenance
The device should be cleaned before storage;
Soft dry cloth can be used to remove dirt on the device;
Do not wash the device, otherwise it may malfunction;
Do not use volatile and harsh detergent to remove dirt, or device will be faded or
malfunctioned;
In case that device needing clean, wipe the device with wrung soft cloth which had
been soaked in water or neutral detergent, then wipe the device with another dry soft
cloth;
9.2. Storage Tips
Please do not storage in the following places:
Where there is water;
Location dusty, high salty;
Exposed to high heat, high humidity or direct sunlight;
Exposed to strong shock or vibration;
Close to heating equipment;
Close to explosive chemicals or corrosive gases.
Under heavy objects or with device back on;
Do not place heavy objects on the device.
page18of23
Rev: A1
◆ Electromagnetic Compatibility Guide
Important information regarding Electro Magnetic Compatibility (EMC)
With the increased number of electronic devices such as PC’s and mobile (cellular) telephones,
medical devices in use may be susceptible to electromagnetic interference from other devices.
Electromagnetic interference may result in incorrect operation of the medical device and create a
potentially unsafe situation.
In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with the aim to
prevent unsafe product situation, the IEC60601-1-2 standard has been implemented. This standard
defines the levels of immunity to electromagnetic interferences as well as maximum levels of
electromagnetic emissions for medical devices.
This medical device manufactured by pump conforms to this IEC60601-1-2:2007 standard for both
immunity and emissions.
Nevertheless, special precautions need to be observed:
·Do not use mobile (cellular) telephones and other devices, which generate strong electrical or
electromagnetic fields, near the medical device. This may result in incorrect operation of the unit
and create a potentially unsafe situation. Recommendation is to keep a minimum distance of 7 m.
Verify correct operation of the device in case the distance is shorter.
Further documentation in accordance with IEC60601-1-2:2007 is available at pump at the address
mentioned in this user manual.
Guidance and manufacturer’s declaration Guidance and manufacturer’s declaration –
electromagnetic emissions
The [EQUIPMENT or SYSTEM] is intended for use in the electromagnetic environment
specified below. The customer or the user of the [EQUIPMENT or SYSTEM] should assure
that it is used in such an environment.
Emissions test
Compliance
Electromagnetic
environment - guidance
RF emissions
Group 1
The [EQUIPMENT or
CISPR 11
SYSTEM] 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 emissions
Class B
CISPR 11
Harmonic emissions
Not applicable
IEC 61000-3-2
Voltage fluctuations/flicker
Not applicable
emissions
IEC 61000-3-3
page19of23
Rev: A1
Guidance and manufacturer’s declaration – electromagnetic immunity
The [EQUIPMENT or SYSTEM] is intended for use in the electromagnetic environment
specified below. The customer or the user of the [EQUIPMENT or SYSTEM] should assure
that it is used in such an environment.
Immunity test
IEC 60601 test Compliance Electromagnetic environment level
level
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV
contact
±8 kV air
Electrical fast
transient/burst IEC
61000-4-4
±2 kV for
power supply
lines
Not
applicable
Surge
IEC 61000-4-5
±1 kV
differential
mode
±2 kV common
mode
< 5% UT
(>95% dip in
UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
< 5% UT
(>95% dip in
UT)
for 5 sec
3 A/m
Not
applicable
Mains power quality should be that
of a typical commercial or hospital
environment.
Not
applicable
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
[equipment or system] requires
continued operation during power
mains interruptions, it is
recommended that the [equipment or
system] be powered from an
uninterruptible power supply or a
battery.
3 A/m
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical
commercial or hospital environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field IEC
61000-4-8
page20of23
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%. If
ESD interfere with the operation of
equipment, counter measurements
such as wrist strap, grounding shall
be considered.
Mains power quality should be that
of a typical commercial or hospital
environment.
Rev: A1
Guidance and manufacturer’s declaration – electromagnetic immunity –
for EQUIPMENT and SYSTEMS that are not LIFE – SUPPORTING
Guidance and manufacturer’s declaration – electromagnetic immunity
The [EQUIPMENT or SYSTEM] is intended for use in the electromagnetic environment specified
below. The customer or the user of the [EQUIPMENT or SYSTEM] should assure that it is used in
such an environment.
Immunity test
IEC 60601 test level
Compliance
Electromagnetic environment level
guidance
Conducted RF
3 Vrms
Not applicable
Portable and mobile RF
IEC 61000-4-6
150 kHz to 80 MHz
3V/m
communications equipment
Radiated RF
3 V/m
should be used no closer to any
IEC 61000-4-3
80 MHz to 2.5 GHz
part of the [EQUIPMENT or
SYSTEM], including cables,
than the recommended separation
distance calculated from the
equation applicable to the
frequency or the transmitter.
Recommended separation
distance
d = 1.2 p
d = 1.2 80 MHz to 800 MHz p
d = 2.3 800 MHz to 2.5 GHz p
Where P is the maximum output
power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and d is
the recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,
should be less than the
compliance level in each
frequency range.
Interference may occur in the
vicinity of equipment marked
with the following symbol:
page21of23
Rev: A1
Recommended separation distances between portable and mobile
RF communications equipment and the EQUIPMENT or SYSTEM –
For EQUIPMENT and SYSTEMS that are not LIFE – SUPPORTING
Recommended separation distances between portable and mobile RF communications equipment and the
[EQUIPMENT or SYSTEM]
The [EQUIPMENT or SYSTEM] is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the [EQUIPMENT or SYSTEM] can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the [EQUIPMENT or SYSTEM] as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum output
Separation distance according to frequency of transmitter
power of transmitter
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to2.5 GHz
d = 1.2p
d = 1.2p
d = 2.3p
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
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
meters (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 80 MHz and 800 MHz, 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.
page22of23
Rev: A1
◆ Product Registration Information
Production license No.: Guangdong FDA Device Production: 20081657
Registration certificate No/product specification No: Guangdong Device Registration: xxxxxxxx
◆After-Sale Service
Manufacturing Enterprises: Shenzhen Pump Medical System Co., Ltd.
ADD: 2/F, M-7 SinosteelBuilding, Maqueling Estate, Hi-Tech Industrial Park, Nanshan District,
Shenzhen, People’s Republic of China
Zip Code: 518057
Tel: 86-755-26710795/26067119
Fax: 86-755-26012025
ServiceLine: 86-4006 755 009
E-mail:service@bpump.com.cn
Production date: see the label.
page23of23

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