MEDCHECK SFBP01 Instruction Manual

Instruction Manual
Bluetooth Automatic Upper Arm
Blood Pressure Monitor
Model No. SFBP01
www.getmedcheck.com
Table of Contents
Intended Use…………………….......………...………...………..…03
About Blood Pressure………......……………...………...…………04
Precautions………………………………………...………...………06
Device Overview………………......………………...………...…….09
Symbol Definitions……………....……………………...………...….11
Features………………………………………………...………...…12
Installing Batteries……...……..…...…………….....……………….16
Applying the Cuff…………...….……...………....………………….18
Measurement Procedure…….....………...………......…………….19
Memory Function…………….……...………...…….….......……….21
Bluetooth Communication…..………...………...…..………………22 Storage and Maintenance….…….……...………...……………….23 Troubleshooting…………………………...………...……………….24
Limited Warranty……..….…..…….……………...……….......……26
Specifications………………………………………...………..……..27 Note………………………………………….………...………...…….29
Appendix…………………………………….…………...………....31
Blood Pressure Diary............……………….…………...………....35
2
This manual and product are not meant as a substitute for advice provided by your doctor.
You are not to use the information contained herein, or this product for diagnosing or treating a health problem or prescribing any medication. If you have or suspect that you have a medical problem, promptly consult your healthcare provider.
This device uses the oscillometric method to automatically measure systolic and diastolic blood pressure as well as heart rate.
The measurement position is at human being’s arm.
All values can be read out in one LCD panel.
The device is designed for home use and recommended for use by adults aged 18 years and older with upper arm circumference ranging from 9 ~13” (approx. 23 ~ 33 cm).
Medical Disclaimer
Intended Use
3
1. What is blood pressure?
Blood pressure is the measurement of the force of blood pushing against the walls of the arteries. Arterial blood pressure is constantly fluctuating during the course of the cardiac cycle. The highest pressure in the cycle is called the systolic blood pressure, and represents the pressure in the artery when the heart is beating. The lowest pressure is the diastolic blood pressure, and represents the pressure in the artery when the heart is at rest. Both the systolic and the diastolic pressure are necessary for a physician to evaluate the status of a patient's blood pressure.
Many factors such as physical activity, anxiety or the time of day, can influence your blood pressure. Blood pressure is typically low in the mornings and increases from the afternoon to the evening. It is on average lower in the summer and higher in the winter.
2. Why is it useful to measure blood pressure at home?
Having one's blood pressure measured by a doctor in a hospital or a clinic, is often associated with a phenomenon called “White Coat Hypertension” where the patient becomes nervous or anxious, thus raising his blood pressure. There are also numerous other factors that might cause your blood pressure to be raised at a specific time of day. This is why medical practitioners recommend home monitoring as it is important to get readings of blood pressure during different times of the day to really get an idea of your real blood pressure.
Medical practitioners generally recommend the “Rule of 3”, where you are encouraged to take your blood pressure three times in a row (at 3 ~ 5 minute interval), three times a day for three days. After three days you can average all the results and this will give you an accurate idea of what your blood pressure really is.
About Blood Pressure
4
A. WHO blood pressure classifications :
Standards for assessment of high or low blood pressure without regard to age, have been established by the World Health Organization (WHO), as shown in the chart.
However this chart is not exact for classification of blood pressure and it's intended to be used as a guide in understanding non-invasive blood pressure measurements. Please consult with your physician for proper diagnosis.
B. Variations in blood pressure :
Individual blood pressures vary greatly both on a daily and a seasonal basis. These variations are even more pronounced in hyper tense patients. Normally the blood pressure rises while at work and is at its lowest during sleeping period.
(hyper tense: means a person who has high blood pressure symptom.)
The graph below illustrated the variations in blood pressure over a whole day with measurement taken every five minutes.
The thick line represents sleep.
The rise in blood pressure at 4 PM (A in the graph) and 12 PM (B in the graph) correspond to an attack of pain.
Optimal
Normal
High normal
Mild hypertension
Moderate hypertension
Severe hypertension
120130
85 80
95
100
90
105
110
140150160170180
About Blood Pressure
(Direct arterial pressure recording in
unrestricted man. Beven, Honour & Stott:
Clin. Sci. 36:329. 1969)
5
Do not take a measurement in a low (less than 41°F /5°C ) and high (more than 104°F /40°C ) temperature, nor in a place outside humidity ranges (15 % ~ 93 % R.H.), and atmospheric pressure ranges (700 ~ 1060 hPa), or you may get inaccurate readings.
Wait 30 ~ 45 minutes before measurement if you’ve just consumed caffeinated beverages or smoked cigarettes.
Rest at least 5 ~ 10 minutes before taking a measurement.
To allow your blood vessels to return to the condition prior to taking the
measurement, please wait at least 3 ~ 5 minutes in between measurements. You may need to adjust the wait time according to your personal physiological situation.
We recommend you using the same arm (preferably the left arm) and measuring around the same time each day.
Sit down comfortably and place your elbow on the table with your feet flat on the floor. Please do not cross your legs during measurements.
* Do not use this manual and product as a substitute for advice,
diagnosing or treating a health problem or prescribing any medication by your doctor. If you have a medical problem, promptly consult your healthcare provider.
* Read the Instruction Manual thoroughly before measuring and keep it
at hand for your reference at any time.
* This device uses the oscillometric method to measure systolic and
diastolic blood pressure as well as your heart rate. It’s recommended for use by people over the age of 18 and not to be used on infant or children.
* The device is designed for home use and not suitable for clinical use.
* This monitor is not intended for use in the MR environment.
Precautions
6
Precautions
Keep the cuff at heart level. Relax your hand with the palm facing up.
Perform measurements in a quiet and relaxed environment at room
temperature.
Do not move or shake the device during a measurement. Please keep quiet and do not talk during measurements.
This product is not suitable for:
Pregnant women
People with arrhythmias
Undergoing intravenous injection on any limb
Currently in a dialysis treatment
In pre-eclampsia condition
For those who have had mastectomy surgery (especially whose’
lymph nodes removed), it’s recommend take a measurement on the unaffected side.
When used among medical electronic equipments on the same limb, pressurization of the cuff may cause temporarily malfunction to other devices.
Keep in mind that blood pressure naturally varies from time to time throughout the day and is affected by lots of different factors such as stress, eating, smoking, alcohol consumption, medication, and physical activity, etc.
Normally the blood pressure rises while at work and is at its lowest during sleeping period.
Blood pressure measurements should be interpreted by a physician or a trained health professional who is familiar with your medical history. Using the unit and recording the results regularly for your physician to interpret, you will keep your physician informed of the continuing changes in your blood pressure.
7
Precautions
*Attention !
1. Do not use the device on infants, children, or those who cannot express their own intention. To avoid accidental strangulation, keep this product away from children and do not drape tube around neck.
2. The medical device should not used adjacent to or stacked with other equipment. In case adjacent or stacked use is necessary. The medical device should be observed to verify normal operation in the configuration in which it will be used.
3. Consider the electromagnetic compatibility of the device (ex. power disturbance, radio frequency interference etc.) Please use it indoor only.
4. Over high frequency measurements may result in blood flow interference, which is likely to cause uncomfortable sensations, such as partial subcutaneous hemorrhage, or temporary numbness to your arm. In general, these symptoms should not last long. However, if you do not recover in time, please seek your medical practitioners for help.
If you have one of the circulatory problems as arteriosclerosis, diabetes, liver disease, kidney disease, severe hypertension, peripheral circulation….., please consult your healthcare professional before using the device.
Results are not intended for direct diagnosis. Please consult with a physician if you have any questions or concerns about your results.
Blood pressure measurements taken with this device are equivalent to those obtained by a trained observer using the cuff / stethoscope auscultation method and are within the accuracy limits prescribed by the Standard of EN 1060-4.
8
ARM CUFF WITH TUBE
AAA “ LR03” (1.5V) ALKALINE BATTERY X 4
BP CATEGORY INDICATOR
LCD DISPLAY
ARM CUFF HOLE
DOWN BUTTON
MODE BUTTON
MEMORY BUTTON
6V 1A AC/DC adapter (Excluded)
DC JACK
START/ STOP BUTTON
UP BUTTON
BLUETOOTH INDICATOR
Part names and product components
*Caution !
Substitution of a component different from that supplied might result in measurement error.
Device Overview
9
Unit display
Systolic Rate
Diastolic Rate
Bluetooth Symbol
Low Battery Symbol
Memory Record
Number
Hour : Minute (Also represents YEAR in Setting Mode)
Month/ Date
BP Category Indicator
Blood Pressure Unit
Pulse Symbol
Irregular Heartbeat
Detector
Heart Rate
PM
Device Overview
10
SYMBOLS
Definitions
Pulse
Symbol
Irregular
Heartbeat
Detector
BP Category Indicator
Bluetooth Symbol
Low Battery
Symbol
This symbol appears when the battery power is excessively low or the polarity reverses. We suggest you replace all batteries with new ones, and make sure the +/- polarities are properly positioned.
Once pulse is detected, the symbol flashes with each pulse beat. Our suggestion: Please do not talk or move during measurements.
This symbol appears for 1 minute when the user was talking, moving, shaking, or an irregular heart beat was detected during measurements. Our suggestion: Please do not talk or move during measurements. Repeat the measurement after resting for at least 5 minutes, and restart your measurement while sitting down comfortably and quietly.
The arrowhead points out the specific BP Category that your measurement reading fits in.
LCD displays this symbol when Bluetooth Function turns ON.
Symbol Definitions
11
BP Category Indicator
This device is equipped with BP Category Indicator which classifies your blood pressure measurements into six stages (Optimal to Severe hypertension) as shown in below chart:
After each measurement is completed, LCD display will show your position automatically on the six segments of the bar indicator which corresponds to BP Category Indicator.
Features
Color
Red
Red
Red
Orange
Yellow
Green
*Source: WHO, 1999
Stages of Blood
Pressure Levels
Systolic
(mmHg)
Diastolic
(mmHg)
Grade 3
Grade 2
Grade 1
Severe
Hypertension
Moderate
Hypertension
Mild
Hypertension
180
160~179
140~159
130~139
120~129
<120
High-Normal
Normal
Optimal
110
100~109
90~99
85~89
80~84
<80
Recommendations by
SIGN 49: Hypertension in older people
Confirm immediately and repeat BP in one day and again within one week depending on clinical situation.
Serial blood pressures repeated within one month.
Provide advice about lifestyle modification and confirm within two months.
Provide advice about lifestyle modification and recheck in one year.
Recheck in 2 - 5 years. (patients aged > 75 years offered annual health check)
Optimal
Red
Red Red
Orange
Yellow Green
Normal
High normal
Mild hypertension
Moderate hypertension
Severe hypertension
120 130
85 80
95
100
90
105
110
140 150 160 170 180
*Note!
When a person’s systolic and diastolic pressures fall into different categories, the higher category should apply.
e.g. systolic rate 181 & diastolic rate 99 => Red category (Severe
Hypertension)
e.g. systolic rate 110 & diastolic rate 95 => Red category (Mild
Hypertension)
12
Features
*Note!
The above table is not exact for classification of blood pressure and it's intended to be used as a guide in understanding non-invasive blood pressure measurements.
Usually this is not a cause for concern; however we recommend you consult with your physician for proper diagnosis or seek medical advice according to our recommendation mentioned above. Please note that the device does not appropriate to diagnose hypertension, and it is only for user reference on blood pressure monitoring.
The symbol will appear on screen indicating a certain heartbeat irregularity was detected during measurement.
The heartbeat rhythm that is more than or less than 25% from the average rhythm is usually defined as an irregular heartbeat rhythm. Talking, moving, shaking or an irregular pulse during the measurement can result in the appearance of this symbol.
Usually this is not a cause for concern, however if the symbol appears often, we recommend you seek medical advice.
And please note that the device does not replace a cardiac examination, but serves to detect pulse irregularities at an early stage.
Irregular Heartbeat Detector
13
*Note !
The pulse display is not suitable for checking the frequency of heart pacemakers. If a certain pulse irregularity is detected during measurement often, we recommend you seek medical advice.
As a safeguard, we recommend that if you have arrhythmias such as atrial or ventricular premature beats and atrial fibrillation or any other special conditions you should check with your physician before using your device.
The IHB function is not designed for use by people with arrhythmias nor for diagnosing or treating an arrhythmic problem. In order to filter the unstable status of user and avoid affecting the detection of heart rate from any movement, shaking or talking in the beginning of measurement, the method of averaging heart beat intervals of subject device is calculated with the three proper heart beat pulses detected in the beginning of measurement and that is different from a strict mathematical averaging of all recorded intervals.
At least 3 beats with at least 25% difference from the average heart beat interval will generate the IHB icon on the screen.
Features
Bluetooth Communication Function
SFBP01 features a built-in Bluetooth Communication function, which enables the device to automatically transmit results to paired Smartphone. After connection is established, device will transmit memory data such as Measure Date, Systolic Pressure, Diastolic Pressure and Pulse Rate to the Smartphone via MedCheck App.
For step-by-step guide on how to use the MedCheck App, please visit www.getmedcheck.com.
If paired Bluetooth device is not working or is not within RF range of this device, the measuring results will be stored in the blood pressure monitor's memory. For more details, please refer to “Bluetooth Communication” page.
14
Bluetooth compatibility with blood pressure monitor for Bluetooth-enabled device is:
Bluetooth 4.0 for Android 4.4 or above,
Bluetooth 4.0 for iOS 8.0 or above
*Note !
● SFBP01 is subject to and complies with electromagnetic
compatibility (EMC) standard of EN 60601-1-2, EN 301 489-1, EN 301 489-17, EN 300 328 and U.S. federal guidelines, Part 15 of the FCC (Federal Communications Commission) rules for devices with RF capability. These guidelines help ensure that your device will not affect the operation of other nearby devices. Additionally, other devices should not affect the use of your device.
● Other wireless devices that are in use nearby, such as a cell or
mobile phone, or a wireless network, may prevent or delay the transmission of data from your device to paired Bluetooth device. Moving away from the source of the interference or turning off these devices will resolve the problem.
● Make sure SFBP01 and paired Bluetooth device are within
acceptable distance (no more than 10 meters) with each other. If not, put them closer.
● If you plan to transmit test results to paired Bluetooth device, be
sure to select User 1, 2, or 3 before measurements, in case other people’s results may be transmitted to your paired Bluetooth device or included in your past results.
The Bluetooth communication function might not be workable to some Bluetooth devices because of the compatibility of Android system.
About Bluetooth Communication Function
Features
15
● Batteries are hazardous waste. Do not dispose of them together
with the household garbage. Please discard worn-out batteries to the recycling site according to local regulations.
● Keep the battery away from children in case they choke on it.
● To prolong the battery life and prevent damage caused by leakage,
remove the batteries from the device if the device is not to be used for a long period.
● The device will keep the last measuring results after changing
batteries, please reset date and time.
● Please replace all worn-out batteries with new ones when you are
operating the Bluetooth communication function, and the LOW BATTERY SYMBOL appears on the display.
When Low Battery Symbol appears on the display, or if there is no response, please change batteries. Replace all worn-out batteries with new ones and do not mix new and used batteries. Do not mix alkaline, standard (carbon-zinc) or rechargeable (cadmium) batteries either. Such action may shorten he battery life or cause the device to malfunction. Slide the battery cover and insert 4 AAA (LR03) alkaline batteries into the battery compartment as shown on the figure below. Make sure the polarities “+” and “-” ` ends are coinciding with similar markings engraved on the battery housing.
*Attention !
Installing Batteries
16
*Note !
When you use the blood pressure monitor with AC adapter, do not position the device to make it difficult to disconnect the adapter plug.
*Note !
● No batteries are needed when operating with an AC adapter.
● Please unload the batteries when operating with an AC
adapter for an extended period of time.
● Leaving the batteries in the compartment for a long time may
cause leakage, which may lead to damage of the unit.
● Recommend Adapter specification, do not use otherwise:
Model: SINPRO, HPU15-102 Rating: Input: 100 ~ 240V, AC, 47 ~ 63 Hz, 0.4 ~ 0.2 A Output: 6V, DC, 1A,
This monitor is also designed for operation with AC/DC adapter. Please use only a compatible AC/DC adapter with required voltage and current as indicated in this manual.
Installing Batteries
Using the AC Adaptor
17
● Press your brachial artery approximately 1 inch (2 ~ 3 cm) above
the elbow on the inside of your left arm to determine where your strongest pulse is.
● Slide the end of arm cuff furthest from the tube through the metal
ring to a loop. The smooth cloth should be on the inside of the cuff.
● If the cuff is located correctly, the velcro will be on the outside of
the cuff and metal ring will not touch your skin.
● Put left arm through the cuff loop.
The bottom of the cuff should be approximately 1 inch (2 ~ 3 cm) above the inner elbow. The tube should lie over the brachial artery on the inner part of the arm.
● Pull the cuff so that the top and bottom edges are tightened around
your arm.
● When the cuff is positioned properly, press the velcro firmly
against the pile side of the cuff.
● Sit on a chair and lay your forearm on the table so
that the cuff is at the same level as your heart.
● Relax your arm and turn your arm upward.
● Make sure there are no kinks in the air tube.
*Note !
● Fit the cuff snugly, leaving enough space for 1 inch (2 ~ 3 cm)
between the inner elbow and the lower edge of the cuff, or the measurement may not be accurate.
● This monitor comes with one size of arm cuff: 9” ~ 13” (23 ~ 33
cm).
● In case the cuff kept pumping up non-stop, open the cuff at once.
● Do not wrap the cuff around any body part other than your arm.
● The device is not supposed to be used when your arm is wounded
or injured.
Applying the Cuff
18
*Note !
● The Bluetooth Feature Switch default setting is ON
● Once Bluetooth Feature turns ON, the LCD appears Bluetooth
symbol in any mode.
A. Press button to switch on the monitor. B. All segments appear on the screen.
Bluetooth feature ON
Bluetooth feature OFF
User can press and hold button 3 seconds to turn the Bluetooth feature ON/ OFF in Standby Mode.
Switch on the Monitor
A. Press button ("YEAR" flashes). Press or button to adjust
YEAR value.
B. Press button ("MONTH" flashes). Use or button to adjust
MONTH (1, 2, 3,……, 12).
C. Adjust DATE (1, 2, 3,…, 31), HOUR (1, 2, 3,……..12PM,1 PM,…,
12) and MINUTE (00,01,02,03,.....59) as described in Step A above.
D. When settings are done, press button to confirm the settings.
The device turns to standby mode.
Setting Year, Date and Time
Turning Bluetooth Feature ON/OFF
PM
A. Before measurement, press
or button to select User 1, 2, or 3.
V
V
Taking a Measurement
Measurement Procedure
V
V
V
V
19
*Note !
●If the cuff does not stop inflating, remove the cuff at once.
● To stop measurement, press button. The cuff will deflate
immediately after the button is pressed.
*Note !
Do not inflate the cuff until it is wrapped around your upper arm.
B. With the cuff wrapped around your upper arm,
press button to start measurement. All display units appear on the screen.
PM
C. After inflation of the cuff, the pressure will slowly
decrease. When pulse is detected, PULSE SYMBOL flashes.
D. LCD screen displays your systolic
rate, diastolic rate, pulse, BP Category Indicator, and Irregular Heartbeat Detector symbol (if any) with date and time for 1 minute. (Year and Date / Time display alternate automatically)
E. Without any operation for 1 minute, device automatically shuts
off.
After all symbols disappear, the display will show
“00”. The monitor is “Ready to Measure” and will automatically inflate to the level that is right for you.
Measurement Procedure
20
Note: Once deleted, your data can NOT be restored.
After each measurement, the systolic and diastolic pressure, heart rate, pulse, BP Category Indicator, and Irregular Heartbeat Detector symbol (if any) with date and time will be automatically stored. The monitor can store up to 120 memories for 3 users, and automatically replace the oldest data with new one.
Storing data
A. Press or button to select User 1, 2, or 3. B. Press M button to enter Memory Mode.
LCD displays average of last 3 measuring results first.
C. Press M button again, LCD displays the latest
measuring result. Use or button to scroll through all stored measuring results. (Year and Date / Time display
D. To stop reading memories, press button, and
switch to Standby Mode.
Recalling data
A. Press or button to select User 1, 2, or 3. B. Press M button to enter Memory Mode. C. Press and hold and buttons at the same time,
the data will be erased automatically.
D. To confirm the data in the selected user has been
erased, press M button and no data should appear.
Erasing data
Memory Function
V
V
V
V
V
V
V
21
To perform the Bluetooth Communication, please follow these steps:
For all features of MedCheck App and step-by-step guide, please visit www.getmedcheck.com.
1. To activate Bluetooth function, please make sure you have downloaded MedCheck App on your Android or iOS Smartphone.
2. Turn on Bluetooth in your Smartphone.
3. When connection is established, SFBP01 will light Bluetooth indicator if it’s in a reachable range (no more than 10 meters) with each other.
Bluetooth Indicator lit constantly
Bluetooth Communication
*Note !
● Without any operation in 1 minute, the device shuts off
automatically and Bluetooth Connection OFF.
● Standby Mode: Press button under Date/Time, Measuring,
or Memory Mode, and the device will turn to Standby Mode.
● SFBP01 can only pair up with one Bluetooth device at a time.
22
General Use
● Do not in any way twist the cuff.
● Do not press button if the cuff is not wrapped around your upper arm.
● Do not drop the product and avoid any strong impacts.
Maintenance
● Use a piece of cloth with water or mild cleansing agent to wipe the device
and dry it immediately with a dry cloth.
● Do not use detergent or any strong chemicals to clean the device.
● Disinfection - Use a piece of cloth with 75% alcohol to wipe the surface of
the cuff for 10 seconds.
● Make sure the cuff is completely dry before using.
● Do not attempt to disassemble or change any parts of the monitor,
including arm cuff, due to substitution of a component different from that supplied might result in measurement error.
● If any suggestion or service is requested, please contact Smartfuture Pte
Ltd.
● Do not implement the maintenance procedures for equipment during
measurement.
● Only trained technicians are allowed to repair and dissemble the device,
including software upgrades, patches and maintenance.
Storage
● If the device is not to be used for a long time, please remove the batteries
from the device (leaking of battery acid can cause the device to malfunction).
● Always store the unit in the storage case after use. It is intended to be
transported or stored in a carrying case between uses.
● Do not place the device directly under sunlight, in high temperature, or in
humid or dusty places.
● Do not store the device in extremely low (less than –13 °F /–25 °C) and
high (more than 158 °F /70 °C) temperature, nor in a place where humidity exceeds 93% R.H.
Storage and Maintenance
*Note ! Water quality required for cleaning: Tap water.
23
Unit does not turn on when button is pushed.
Measuring Error Symbol appears when blood pressure value displayed is excessively low or high.
SYMBOLS/
SYMPTOMS
Worn-out batteries.
Battery polarities have been positioned incorrectly.
Cuff has been placed incorrectly.
Shaking of the arm with the cuff on.
Did you talk or move during measurement?
CONDITIONS/
CAUSES
INDICATION/
CORRECTION
Replace them with 4 new AAA (LR03) alkaline batteries.
Re-insert the batteries in the correct positions.
Wrap the cuff properly so that it is positioned correctly.
Measure again. Keep arm steady during measurement.
Measuring Error Symbol
Air circuit abnormality. Cuff tube may not be plugged into monitor correctly.
Check cuff connection. Measure again.
Measuring Error Symbol
Inflation pressure exceeding 300 mmHg.
Switch the unit off, then measure again.
Measuring Error Symbol
Can’t determine blood pressure measurement data.
Wrap the cuff properly and keep steady. Measure again.
Troubleshooting
24
Paring has not been completed.
Bluetooth function is not turn on.
The distance between BPM and Bluetooth device is out of transmitting range.
Use an incompatible Bluetooth device.
Use non-Bluetooth device.
Unexpected loss of electrical/ mechanical integrity.
Re-insert the batteries and try again.
Return the device to local distributor or Smartfuture Pte Ltd.
Please try to pair BPM and Bluetooth device with each other
Please refer to Page 19 “Measurement Procedure” and Page 22 “Bluetooth Communication” to turn on the Bluetooth function.
Please make sure the devices are within 10 meters of each other.
Please refer to Page 15 “Bluetooth compatibility” & Page 28 "RF Specification”
Note: If "EP" appears on the display, just return the device to your local distributor.
BPM cannot communicate with Bluetooth device
Troubleshooting
SYMBOLS/
SYMPTOMS
CONDITIONS/
CAUSES
INDICATION/
CORRECTION
25
To ensure continued measurement precision, all digital blood pressure monitors require recalibration regularly. After 2 years from the manufacturing date, we recommend you have your monitor recalibrated at the local distributor.
Please contact your distributor for the details about the recalibration service and the charge of shipping and handling.
Please also note that this service does not cover damage caused by misuse or abuse; accident; the attachment of any unauthorized accessory; alteration to the product; improper installation; unauthorized repairs or modifications; improper use of electrical/power supply; loss of power; dropped product; malfunction or damage of an operating part from failure to provide manufacturer’s recommended maintenance; transportation damage; theft; neglect; vandalism; or environmental conditions; loss of use during the period the product is at a repair facility or otherwise awaiting parts or repair; or any other conditions whatsoever that are beyond the control of distributors.
Limited Warranty
26
Model Number Measurement Method Rated Range of Cuff Pressure Rated Range of
Determination Measurement Range of
Heart Rate Accuracy
Inflation Deflation Display Memory Unit Dimensions
Unit Weight
Cuff Size Storage/ Transportation
Environment Operation Environment
Power Supply
Battery Life Product Life Sleeping Mode
Accessories
SFBP01 Oscillometric 0 ~ 300 mmHg 40 ~ 280 mmHg
40 ~ 199 Beats/Minute
Pressure: ± 3 mmHg Pulse: ± 5 % Max.
Automatic Inflation (Air Pump) Automatic Air Release Control Valve Liquid Crystal Display 120 Memory Total for 3 Users
97.92 X 139.95 X 56.75 mm (L X W X H)
3.86 X 5.51 X 2.23 inch (L X W X H) 291 g ± 10 g (10.26 oz ± 0.35 oz)
(Cuff & Batteries Excluded) 23 ~ 33 cm (approx. 9 ~ 13 inch) Temperature: -25 °C ~ 70 °C (-13 °F ~ 158 °F)
Humidity: ≤ 93 % R.H.
Temperature: 5 °C ~ 40 °C (41 °F ~ 104 °F) Humidity: 15 % ~ 93 % R.H. Atmospheric pressure: 700hPa ~ 1060hPa
1. AAA “LR03” (1.5V) alkaline battery x 4
2. 6V 1A AC/DC adapter (Excluded) Approx. 200 Measurements (Bluetooth ON) 5 Years (4 times per day) Without any operation for 1 minute, device
automatically shuts off. 4 AAA (LR03) Alkaline Batteries, Arm Cuff with
Tube, Instruction Manual, Storage Pouch
*The contents of this manual and the specifications of the device covered by this manual are subject to change for improvement without notice.
Specifications
27
RF Type
RF Modulation
Effective Radiated Power
Data Throughput
Expected Delay (Latency Range) in Wireless (RF) Communication
Integrity
Security
Wireless Operation Distance
RF Frequency / Need for Spectrum Management
Maximum Limitation
Maximum Permitted Power
Proximity of Other In-band Transmitters Used in Vicinity
Wireless Communication Profile
Wireless Coexistence
System requirement of the Bluetooth device
Bluetooth 4.0 BLE
GFSK
0dBm
0.2Mbps
The latency time is less than 0.3ms second from sender to receiver.
Channel Quality-Driven Data Rate (CQDDR) technology increases the effective data rate and integrity in noisy environments.
AES-128 and application layer user defined
Class 2 (Maximum: 10 meter)
2402 - 2480 MHz (allowing for guard bands)
Unlimited
2.5 mW
Up to 40 bands (2 MHz spacing; centered from 2402 to 2480 MHz)
GATT – Client and Server
Support for 802.11 Coexistence
Bluetooth 4.0 for Android 4.4 or above Bluetooth 4.0 for iOS 8.0 or above
Specifications
28
0197
This blood pressure monitor complies with the EC Directive (93/42/EEC) and bears the CE mark. This blood pressure monitor also complies with mainly following standards (included but not limited):
Note
Safety standard: EN 60601-1 Medical electrical equipment part 1: General requirements for safety EMC standard: EN 60601-1-2 Medical electrical equipment part 1-2: General requirements for safety-
Collateral standard: Electromagnetic compatibility- Requirements and
tests Performance standards: EN 1060-1 Non-invasive sphygmomanometers - General requirements EN 1060-3 Non-invasive sphygmomanometers - Supplementary requirements for
electromechanical blood pressure measuring systems
EN 1060-4 Non-invasive sphygmomanometers - Test procedures to determine the
overall system accuracy of automated non-invasive sphygmomanometers
Explanation of symbols :
CE conformity marking -
-
-
-
-
Notified Body (NB) number Refer to instruction manual/
booklet
TYPE BF Applied Part
To avoid inaccurate results caused by electromagnetic interference
Waste of electrical and electronic equipment (WEEE)
Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30cm (12 inches) to any part of the SFBP01 , Otherwise, degradation of the performance of this equipment could result.
Symbol Explanation Details
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Note
Atmospheric pressure limitation
Atmospheric pressure: 700hPa~1060hPa
Humidity limitation Humidity limitation: R.H.: 15 % ~ 93 %
Temperature limit Temperature: 5°C ~40°C
Symbol Explanation Health & Life Information
Date of manufacture
Serial number
Ingress Protection Rating
First characteristic numeral- Degree of protection against access to hazardous parts and against solid foreign objects N1=2 (Protected against solid foreign objects of 12.5 mm Ø and greater) Second characteristic numeral- Degree of protection against ingress of water N2=2 (Protected against vertically falling water drops when ENCLOSURE tilted up to 15°)
YYMMXXXXXX
Authorized representative in the European Community
EMERGO EUROPE Prinsessegracht 20, 2514 AP The Hague, The Netherlands
YYYY-MM
Smartfuture Pte Ltd
#06-01, 178 Paya Lebar Road,
Singapore 409030
support@oursmartfuture.com
www.oursmartfuture.com
Ph: +65-68487962
www.getmedcheck.com
Manufacturer
HEALTH & LIFE Co., Ltd. 9F, No. 186, Jian Yi Road, Zhonghe District, New Taipei City, Taiwan www.healthandlife.com.tw
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Guidance and manufacturer’s declaration – electromagnetic emissions
The device is intended for use in the electromagnetic environments listed below, and should only be used in such environments:
Emissions test
Compliance
Electromagnetic environment – guidance
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions IEC 61000-3-2
Voltage fluctuations/ flicker emissions IEC 61000-3-3
Group 1
Class B
Class A
Complies
Appendix
RF energy is used only to maintain device’s operation. Therefore, its RF emissions are so low that it’s not likely to cause any interference in nearby electronic equipment.
The device is suitable for use in all establishments, including domestic establishments, and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environments listed below, and should only be used in such environments:
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment – guidance
The relative humidity should be at least 5 %.
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Recommended separation distance
where I is the current in amperes in a power bus or an appliance wire and r is the recommended separation distance between your device and the power bus or appliance wire, in meters (m).
± 8 kV contact discharge ± 15 kV air discharge
30 A/m 50 or 60 Hz
± 8 kV contact discharge ± 15 kV air discharge
30 A/m 50 or 60 Hz
Electrostatic discharge (ESD) IEC 61000-4-2
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8
I r = (m) 188
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Appendix
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment – guidance
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment.
± 2 kV for power supply lines ± 1 kV for input/ output lines
±2 kV Power lines
± 2 kV for power supply lines ± 1 kV for input/ output lines
± 2 kV Power lines
Electrical fast transient/burst IEC 61000-4-4
Surge IEC 61000-4-5
Mains power quality should be that of a typical commercial or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or a battery.
0% UT; 0.5 cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°.
0 % UT; 1 cycles
70 % UT; 25/30 cycles
0 % UT; 250/300 cycle
0% UT; 0.5 cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°.
0 % UT; 1 cycles
70 % UT; 25/30 cycles
0 % UT; 250/300 cycle
interruptions and voltage variations on power supply input lines IEC 61000-4-11
32
Appendix
Recommended separation distances between portable and mobile RF communication equipment and the device.
Rated maximum
output power
of transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz 80 MHz to 800 MHz
800 MHz to 2.5 GHz
0.01
0.1 1
10
100
0.12
0.38
1.2
3.8 12
0.12
0.38
1.2
3.8 12
0.23
0.73
2.3
7.3 23
The device is intended for use in an electromagnetic environment where radiated RF disturbances are under control. User can help prevent electromagnetic interference by keeping the device at a minimum distance from portable and mobile RF communications equipment (transmitters). Below table details the maximum output power of transmitter:
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 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.
d = 1.2 d = 1.2 d = 2.3
33
Appendix
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment – guidance
Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
Not Applicable3V rms
At 0.15-80 MHz
6V rms At ISM & Radio Amateur Freq.
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3
d = 1.2 d = 1.2 80 MHz to 800 MHz d = 2 .3 800 MHz to 2.5 GHz
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,
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:
3 V/m at 80-2700 MHz (10V/m Home Healthcare) AM Modulation And 9-28V/m at 385-6000MHz,Pul se Mode and other Modulation
3 V/m at 80-2700 MHz (10V/m Home Healthcare) AM Modulation And 9-28V/m at 385-6000MHz, Pul se Mode and other Modulation
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
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 reorienting or relocating the device.
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environments listed below, and should only be used in such environments:
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Blood Pressure Diary
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P/N323103070 VER001
www.getmedcheck.com
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