Gima LS808-BS User manual

MISURATORE DI PRESSIONE GIMA BLUETOOTH
GIMA BLUETOOTH B.P.MONITOR
TENSIOMÈTRE BLUETOOTH GIMA
MEDIDOR DE PRESIÓN DEL BLUETOOTH DEL GIMA
M32916-M-Rev.0-07.20
PROFESSIONAL MEDICAL PRODUCTS
Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No.105, Dongli Road,
Torch Development District,
Zhongshan, 528437, Guangdong, China
Made in China
32916 / LS808-BS
MDSS - Medical Device Safety Service GmbH
Schiffgraben 41, 30175 Hannover, Germany
0123
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com

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ENGLISH
Table of Contents
INTRODUCTION ......................................................................................................................31
General Description...................................................................................................................31
Indications for Use.....................................................................................................................31
Contraindications.......................................................................................................................31
Measurement Principle..............................................................................................................31
Safety Information .....................................................................................................................31
LCD Display Signal....................................................................................................................35
Monitor Components .................................................................................................................36
List.............................................................................................................................................36
BEFORE YOU START .............................................................................................................37
Power Supply and Charge Power .............................................................................................37
Setting the Time, Date and Unit.................................................................................................38
Pair-up the Blood Pressure Monitor with Your Device...............................................................40
Tie the Cuff ................................................................................................................................42
MEASUREMENT .....................................................................................................................43
Start Measurement....................................................................................................................43
DATA MANAGEMENT .............................................................................................................44
Recall the Records ....................................................................................................................44
Delete the Records....................................................................................................................46
INFORMATION FOR USER .....................................................................................................47
Tips for Measurement................................................................................................................47
Maintenance..............................................................................................................................48
ABOUT BLOOD PRESSURE...................................................................................................49
What are systolic pressure and diastolic pressure? .................................................................49
What is the standard blood pressure classication? ...............................................................49
Irregular Heartbeat Detector......................................................................................................49
Why does my blood pressure uctuate throughout the day? ...................................................50
Why do I get a different blood pressure at home compared to the hospital? ...........................50
Is the result the same if measuring on the right arm? ..............................................................50
TROUBLESHOOTING .............................................................................................................51
SPECIFICATIONS.....................................................................................................................52
ATHORIZED COMPONENT .....................................................................................................53
CONTACT INFORMATION .......................................................................................................53
COMPLIED STANDARDS LIST ...............................................................................................54
EMC GUIDANCE ......................................................................................................................55

31 ENGLISH
INTRODUCTION
General Description
Thank you for selecting Gima arm type blood pressure monitor (LS808-BS). The monitor features
blood pressure measurement, pulse rate measurement and the result storage. The design pro-
vides you with two years of reliable service.
Readings taken by the LS808-BS are equivalent to those obtained by a trained observer using the
cuff and stethoscope auscultation method.
This manual contains important safety and care information, and provides step by step instruc-
tions for using the product.
Read the manual thoroughly before using the product.
FEATURES:
• 86.1mm×24mm Digital LCD display
• Measure-during-inating Technology
• Up to 60 pieces of record stored per each user
Indications for Use
The Gima Blood Pressure Monitor is digital monitors intended for use in measuring blood pres-
sure 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 should not be used by any person who may be suspected of,or is pregnant .
2.The device is not suitable for use on patients with implanted,electrical devices, such as cardiac
pacemakers, debrillators.
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 atmoshperic pressure.
Then it starts inating the arm cuff, 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 signs below might be in the user manual, labeling or other component.
They are the requirement of standard and using.
Caution: read instructions
(warnings) carefully
Authorized represen-
tative in the European
community
Medical Device
complies with
Directive 93/42/EEC
Keep in a cool, dry place Keep away from
sunlight Serial number
Product code Lot number Direct Current
Manufacturer Class II applied Date of manufacture

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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 im-
planted, electronical devices, patients with pre-eclampsia, premature ventricular beats, atrial
brillation, peripheral, arterial disease and patients undergoing intravascular therapy or arte-
rio-venous shunt or people who received a mastectomy. Please consult your doctor prior to
using the unit if you suffer 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 public 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 ad-
vice.
• 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 is used to measure patients who have common arrhythmias such as atrial or
ventricular premature beats or atrial brillation, the best result may occur with deviation.
Please consult your physician about the result.
• Don’t kink the connection tube during use, otherwise, the cuff pressure may continuously in-
crease which can prevent blood ow and result in harmful injury to the PATIENT.
• When using this device, please pay attention to the following situation which may interrupt
blood ow and inuence 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 cuff and its pressurization on any arm where intravascular access or therapy, or an arte-
rio-venous (A-V) shunt, is present; inating the cuff on the side of a mastectomy.
• Warning: Do not apply the cuff over a wound;otherwise it can cause further injury.
• Do not inate the cuff on the same limb which other monitoring ME equipment is applied around
simultaneously, because this could cause temporary loss of function of those simultaneous-
ly-used monitoring ME equipment.
• On the rare occasion of a fault causing the cuff to remain fully inated during measurement,
open the cuff immediately. Prolonged high pressure (cuff pressure > 300mmHg or constant
pressure > 15mmHg for more than 3 minutes) applied to the arm may lead to an ecchymosis.
Temperature limit Follow instructions
for use Type BF applied part
WEEE disposal For indoor use only Symbol for
“RECYCLE”
The Green Dot is the license symbol of a European network of industry-funded systems for
recycling the packaging materials of consumer goods.
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• 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 clin-
ically 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 effects 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 ngers will become anaesthetic, swollen and even purple due
to a lack of blood.
• When not in use, store the device with the adapter in a dry room and protect it against extreme
moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on the storage
case.
• This device may be used only for the purpose described in this booklet. The manufacturer
cannot be held liable for damage caused by incorrect application.
* This device comprises sensitive components and must be treated with caution. Observe the
storage and operating conditions described in this booklet.
• The maximum temperature that the applied part can be achieved is 42.8℃ while the environ-
mental temperature is 40℃.
• The equipment is not AP/APG equipment and not suitable for use in the presence of a amma-
ble anesthetic mixture with air of with oxygen or nitrous oxide.
• Warning: No servicing/maintenance while the ME equipment is in use.
• The patient is an intended operator.
• The patient can measure,transmit data and charge power under normal circumstances and
maintain the device and its accessories according to the user manual.
• To avoid measurement errors, please avoid the condition of strong electromagnetic eld radiat-
ed interference signal or electrical fast transient/burst signal.
• The blood pressure monitor, its adaptor, and the cuff 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 cuff. The materials of the cuff have been tested
and found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010.
It will not cause any potential sensation or irritation reaction.
• Adaptor is specied as a part of ME EQUIPMENT.
• If you experience discomfort during a measurement, such as pain in the arm or other com-
plaints, press any button to release the air immediately from the cuff. Loosen the cuff and
remove it from your arm.
• If the cuff pressure reaches 40 kPa (300 mmHg), the unit will automatically deate. Should the
cuff not deate when pressure reaches 40 kPa (300 mmHg), detach the cuff from the arm and
press any button to stop ination.
• 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 cuff in a washing machine or dishwasher!
The service life of the cuff may vary by the frequency of washing, skin condition, and storage
state. The typical service life is 10000 times.
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• It is recommended that the performance should be checked every 2 years and after mainte-
nance and repair, by retesting at least the requirements in limits of the error of the cuff 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, descrip-
tions, calibration instructions,etc., to assist to service personnel in parts repair.
• The plug/adapter plug pins insulate the device from the main supply. Do not position the device
in a position where it is difcult to disconnect from the supply mains to safely terminate opera-
tion of ME equipment.
• The operator shall not touch output of batteries /adapter and the patient simultaneously.
• Cleaning :Dust environment may affect 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 Gima. 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 Gima 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 affect this equipment and
should be kept at least a distance d away from the equipment. The distance d is calculated
by the MANUFACTURER from the 80MHz to 5.8 GHz column of Table 4 and Table 9 of IEC
60601-1-2:2014, as appropriate.
• Please use ACCESSORIES and detachable parts specied/ authorised by MANUFACTURE.
Otherwise, it may cause damage to the unit or danger to the user/patients.
• There is no luer lock connectors are used in the construction of tubing, there is a possibility that
they might be inadvertently connected to intravascular uid 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
SYMBOL DESCRIPTION EXPLANATION
Systolic
Blood Pressure High blood pressure
Diastolic
Blood Pressure Low blood pressure
Pulse display Pulse in beats per minute
+ Lo Low Battery Low battery and please charge the power.
kPa kPa Measurement Unit of the blood pressure
(1kPa=7.5mmHg)
mmHg mmHg Measurement Unit of the blood pressure
(1mmHg=0.133kPa)
Bluetooth icon The bluetooth icon blinks when the blue-
tooth is working
Average value The average value of the latest three
groups bood pressure value
Memory Query Indicate it is in the memory mode and
which group of memory it is.
User 1/User 2 Start measurement for User 1/User 2
Current time Year/Month/Day(Hour:Minute)
Motion indicator Motion may result in an inaccurate meas-
urement.
Heartbeat Blood pressure monitor is detecting a
heartbeat during measurement.
Blood pressure
level indicator Indicate the blood pressure level
Irregular heartbeat Blood pressure monitor is detecting an
irregular heartbeat during measurement.
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Monitor Components
Component list of
pressure measuring system
1 PCBA
2 Air pipe
3 Pump
4 Valve
5 Cuff
List
1. Blood Pressure Monitor 2. AC Adaptor
(LS808-BS) (Model: BLJ06L060100P-V)
3. User Manual 4. Cuff (22cm-42cm )
(Type BF Applied Part)
(Please use Gima authorized cuff.
The size of the actual cuff please
refer to the label on the attached cuff.)
DC POWER SOCKET
ON/OFF BUTTON
USER 2 BUTTON
QUERY/UP BUTTON
USER 1 BUTTON
CUFF
(Type BF applied part)
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BEFORE YOU START
Power Supply and Charge Power
1.The battery of LS808-BS is built-in rechargeable li-polymer battery, the battery current is 1000
mAh.
2. Please use the AC adaptor to charge the battery, just like the following picture:
Charging the power under following circumstances:
• + Lo displays on the LCD
• The LCD display is dim.
• When powering on the monitor, the LCD doesn’t light up.
CAUTION
• The battery of LS808-BS is built-in rechargeable lithium-ion battery, please do not disassemble
it by the unauthorized maintenance personel.
• Under the normal using, it can charge power about 300 times, if the battery cannot charge
the power normally or the blood pressure monitor cannot use normally, please connect with
the authorized maintenance personel. If measured three times per day, and the battery is fully
charged, it can be used for about 20 days.
• Storge and use the blood pressure monitor at the cool, dry and ventilated environment. Avoid
to approach to the re and the heat source, or it will cause the battery explode.
• Only can use the Gima’s authorized AC Adaptor (Model: BLJ06L060100P-V) to charge the
power. You cannot use the blood pressure monitor during the process of charging.
• During the process of charging, the blood pressure monitor display .
When the charging is nished, please pull the plug in time.
• When charging, shall not touch charging connector and the patient simultaneously.
• Do not attempt to replace your blood pressure monitor’s battery. It is built-in and not changea-
ble.
• Only charge the battery in accordance with the user instructions supplied with the blood pres-
sure monitor.
• Avoid charging your blood pressure monitor in extremely high or low temperatures.
• Do not use your blood pressure monitor while you are charging it.
• Do not attempt to disassemble the blood pressure monitor or force open the built-in battery.
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AC adaptor

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• Do not clean the blood pressure monitor when it is being charged. Always unplug the charger
rst before cleaning the blood pressure monitor.
• Do not dispose of your blood pressure monitor in a re. The battery could explode causing
injury or death.
• Batteries (battery pack or batteries installed) shall not be exposed to excessive heat such as
sunshine, re or the like.
Setting the Time, Date and Unit
To ensure the stored measurement result has correct time record, please set time and unit before
device is used.
Before use, switch the button to the “ON” side to turn on the monitor.
Note: If the button is on the “OFF” side, there is no reaction when you press any button.
1.When the monitor is on , press and hold
User 1 button for 3 seconds to enter Year Setting Mode.
2. As below picture shown , the blinking numeral representing [YEAR].
Press “Query” button to change the numeral.
Each press will increase the numeral
by one in a cycling manner.
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3. Press “User 1” button again to conrm [YEAR].
Then the numeral representing [MONTH] blinks.
4.Repeat step 2 and 3
to conrm [MONTH ] and [DAY ].
5.Repeat step 2 and 3
to conrm [HOUR] and [MINUTE].
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6. Repeat step 2 and 3 to conrm unit.
7. After conrming the [UNIT],
the LCD will display “dONE”
then the monitor will shut off.
Pair-up the Blood Pressure Monitor with Your Device
1.Turn on Bluetooth and the app. Make sure both are ON when pair-up is proceeding.
2.In the search device interface, please select the device to pair up.
3. When the monitor is OFF, press and hold the User 2 button to start pair-up. The symbol and
will be shown on the LCD alternatively, indicating pair-up is proceeding.
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4.Then please select the user ID you want to connect with your smartphone on the app to contin-
ute the pair-up.
If SUCCEED, symbol If FAIL , symbol
will be shown on the LCD. will be shown on the LCD.
4.The monitor will shut off after Pair-up process is complete.
Bluetooth Module No.: LS51802
RF Frequency Range: 2402 MHz to 2480 MHz
Output Power Range: ≤0 dBm
Supply Voltage: 1.8-3.6 V
Transmitting Distance: 10 meters
List of compatible devices:
For iOS devices:
The operating system must be iOS 8 or more, such as iPhone
4S, iPhone 5/5C/5S, iPhone 6/6 Plus and so on.
For Android devices:
The operating system must be 4.3 or more.
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CAUTION
• Interference may occur in the vicinity of equipment marked with the following symbol . And
LS808-BS may interfering vicinity electrical equipment.
• Sensitive people, including pregnant women pre-eclamptic and those who implanted medical
electronic instruments, should avoid using the unit whenever possible.
• Keep the monitor at least 20 centimeters away from the human body (especially the head)
when the data transmission is proceeding after measurement.
• To enable the data transmission function, this product should be paired to Bluetooth end at 2.4
GHz.
How to mitigate possible interference?
1.The range between the device and BT end should be reasonably close, from 1 meter to 10
meters. Please ensure no obstacles between the device and BT end so as to obtain quality
connection and to lower the RF output range.
2.To avoid interference, other electronic devices (particularly those with wireless transmission /
Transmitter) should be kept at least 1 meter away from the monitor.
Tie the Cuff
1.Remove all accessories (watch, bracelet, etc.) from your arm. If your physician has diagnosed
you with poor circulation in your arm, use the other one.
2.Roll or push up your sleeve to expose the skin.
3.Apply the cuff to your arm with your palm facing up.
4.Position the edge of the cuff about 2cm~3cm from elbow.
5.Fasten the cuff around your arm, leaving no extra room between the cuff and your skin. If the
cuff is too loose, the measurement will not be accurate.
6. Sit comfortably with your tested arm resting on a at surface. Place your elbow on a table so
that the cuff is at the same level as your heart. Turn your palm upwards.
Sit upright in a chair, and take 5-6 deep breaths.
7.Helpful tips for Patients, especially for Patients with Hypertension:
• Rest for 5 minutes before rst measurement.
• 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 measure-
ment procedure.
• The cuff 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 at 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 phy-
sician.
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MEASUREMENT
Start Measurement
When the monitor is off, press User 1 button to turn on the monitor and it will nish the whole
measurement, and then save the measure data .
(Take User 1 for example.)
(Note: Select the same user on your app and BPM to take the measurement, or the measurement
data won’t be transmitted to the app.)
1. When the monitor is off, press the User 1 button to turn on the monitor.
LCD display Adjust to zero point.
Inating and measuring. Display and save the results.
The data transmission will proceed.
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If the data transmission succeeds,
the Bluetooth symbol will appear
then the device will turn off.
Tips:
A. Maximum 60 records are both for user 1 and user 2.
DATA MANAGEMENT
Recall the Records
1. When the monitor is off, please press the “Query” button to show the average value of the latest
three records. If the records are less than three groups,it will display the latest record rst. (Take
User 1 for example.)
If the data transmission fails,
the Bluetooth symbol will not appear
then the device will turn off.
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2. Press the “Query” button again to get the record you want.
The date and time of the
record will be shown alternately.
The current No. The corresponding date The corresponding time
is No 1. is January 2nd. is 8:00.
CAUTION
The most recent record (1) is shown rst. Each new measurement is assigned to the rst (1)
record. All other records are pushed back one digit (e.g., 2 becomes 3, and so on), and the last
record (60) is dropped from the list.
3. When in the User 1 memory
mode, press the User 1 button to
turn off the device, or press User 2
button to enter in User 2 memory
mode.
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4. If there is no record, press “Query” button,
the below display will be shown.
CAUTION
The most recent record (1) is shown rst. Each new measurement is assigned to the rst (1)
record. All other records are pushed back one digit (e.g., 2 becomes 3, and so on), and the last
record (60) is dropped from the list.
Delete the Records
1. Hold pressing “Query” button for 3 seconds when
the monitor is in the memory recall mode , the “dEL
ALL+User ID” will ash on the display.
2. Press “Query” to conrm deleting and “dEL donE+Us-
er ID” will be shown then the monitor will turn off.
Note: To exit out the delete mode, please press “User
1” button or “User 2 ” button before you press the “Que-
ry” button. If there is no operation within 1 minute, the
device will turn off.
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INFORMATION FOR USER
Tips for Measurement
Measurements may be inaccurate if taken in the following circumstances.
Within 1 hour
after dinner or drinking
Immediate measurement
after tea, coffee, smoking
Within 20 minutes
after taking a bath
When talking or moving
your ngers
In a very cold
environment When you want to
discharge urine
X X
X X
X X
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Maintenance
To obtain the best performance, please follow instructions below.
Put in a dry place
and avoid the sunshine
Avoid immersing it in the water.
Clean it with a dry cloth in case.
Avoid intense shaking and collisions.
Avoid dusty environment and unstable
temperature surrounding
Use the slightly damp cloth
to remove the dirt. Avoid washing the cuff
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