Pearl Vena TMB-988 User manual

Version 1.0
Guangdong Transtek Medical Electronics Co., Ltd.
Zone B, No.105 ,Dongli Road, Torch Development
District, Zhongshan,528437,Guangdong,China
Thank you for choosing the Vena Blood Pressure
Monitor. To use the monitor correctly and safely,
please read the manual thoroughly. Please keep
this manual well in order to reference in future.
AVG
SYS
kPa mmHg
AVG
DIA
PM
Pul/min
START/STOP
SET
MEM
Vena
Blood Pressure Monitor
TMB-988 User Manual
Pearl ® Inc. 120-1231 Burdette Street,
Richmond BC Canada, V6V 2Z2
LifeWithPearl.com

INTRODUCTION
Safety Information
LCD Display Signal
Monitor Components
BEFORE YOU START
Installing and Replacing the Batteries
Setting Date, Time, Positioning Symbol and Measurement Unit
MEASUREMENT
Tie the Cuff
Start the Measurement
DATA MANAGEMENT
Recall the Records
Delete the Records
INFORMATION FOR USER
Tips for Measurement
Maintenance
ABOUT BLOOD PRESSURE
What are systolic pressure and diastolic pressure?
What is the standard blood pressure classification?
Why does my blood pressure fluctuate throughout the day?
Why do I get a different blood pressure at home compared to the hospital?
Is the result the same if measuring on the right wrist?
TROUBLESHOOTING
SPECIFICATIONS
CONTACTINFORMATION
COMPLIED STANDARDS LIST
EMC GUIDANCE
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8
11
13
15
17
20
19
21
21
22
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General Description
Setting the User ID
Indications for Use
Measurement Principle
List
FCC STATEMENT
CONTENTS CONTENTS
1

General Description
CAUTION
Indications for Use
The Vena Blood Pressure Monitor is digital monitors intended for use
in measuring blood pressure and heartbeat rate with wrist circumference
ranging from 13.5cm to 21.5 cm ( about 5⅓˝-8½˝ ).
It is intended for adult indoor use only.
This product uses the Oscillometric Measuring Method to detect blood
pressure. Before every measurement, the unit establishes a “zero point”
equivalent to the atmospheric pressure. Then it starts inflating the cuff.
Meanwhile, the unit detects pressure oscillation generated by beat-to-beat
pulsatile, which is used to determine the systolic pressure and diastolic
pressure as well as pulse rate.
The device also compares the longest and the shortest intervals of
detected pulse wave to with the average value, and then calculates the
standard deviation. The monitor will light up a warning symbol when the
calculated standard deviation is larger than or equal to 25%.
Measurement Principle
Safety Information
Symbol for “ENVIRONMENT
PROTECTION - Electrical waste
products should not be disposed of
with household waste. Please recycle
where facilities exist. Check with your
local authority or retailer for recycling
advice”
SN
Symbol for “TYPE BF APPLIED
PARTS”
The signs below might be in the user manual, labeling or other component.
They are the requirement of standard and using.
Symbol for “THE OPERATION
GUIDE MUST BE READ”
Symbol for “MANUFACTURER”
Symbol for “SERIAL NUMBER”
Symbol for “DIRECT CURRENT”
Symbol for “MANUFACTURE
DATE”
Caution: These notes must be
observed to prevent any damage
to the device.
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.
* This device is intended for adult use in homes only.
* The device is not suitable for use on neonatal patients, pregnant women,patients
with implanted, electronical devices, patients with pre-eclampsia, premature
ventricular beats, atrial fibrillation, peripheral, arterial disease and patients undergoing
intravascular therapy or arterio-venous shunt or people who received a mastectomy.
Please consult your doctor prior to using the unit if you 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 wrist or for functions
other than obtaining a blood pressure measurement.
* Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor
your blood pressure. Do not begin or end medical treatment without asking a
physician for treatment advice.
* If you are taking medication, consult your physician to determine the most
appropriate time to measure your blood pressure. Never change a prescribed
medication without consulting your physician.
* Do not take any therapeutic measures on the basis of a self measurement. Never
alter the dose of a medicine prescribed by a doctor. Consult your doctor if you have
any question about your blood pressure.
* When the device was used to measure patients who have common arrhythmias
such as atrial or ventricular premature beats or atrial fibrillation, the best result may
occur with deviation. Please consult your physician about the result.
* When using this device, please pay attention to the following situation which may
interrupt blood flow and influence blood circulation of the patient, thus cause harmful
injury to the patient: connection tubing kinking too frequent and consecutive multiple
measurements; the application of the cuff and its pressurization on any wrist where
intravascular access or therapy, or an arterio-venous (A-V) shunt, is present; inflating
the cuff on the side of a mastectomy.
* Warning: Do not apply the cuff over a wound;otherwise it can cause further injury.
Thank you for selecting the VENA Blood Pressure Monitor TMB-988.
The monitor features blood pressure measurement, pulse rate
measurement and the result storage. The design provides you with
two years of reliable service.
Readings taken by the Vena 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 instructions for using the product.
Read the manual thoroughly before using the product. Features:
Systolic blood pressure, Diastolic
blood pressure, Pulse rate, and up
to 60 groups of measuring records
3
2
INTRODUCTION INTRODUCTION

CAUTION
*Do not inflate the cuff on the samb limb which other monitoring ME equipment is
applied around simultaneously, because this could cause temporary loss of function of
those simultaneously-used monitoring ME equipment.
*On the rare occasion of a fault causing the cuff to remain fully inflated during
measurement, open the cuff immediately. Prolonged high pressure (cuff pressure ＞
300mmHg or constant pressure ＞ 15mmHg for more than 3 minutes) applied to the
wrist may lead to an ecchymosis.
*Please check that operation of the device does not result in prolonged impairment of
patient blood circulation.
* When measuring, please avoid compression or restriction of the connection tubing.
* The device cannot be used with HF surgical equipment at the same time.
* The ACCOMPANYING DOCUMENT shall disclose that the SPHYGMOMANOMETER
was clinically investigated according to the requirements of ISO 81060-2:2013.
* To verify the calibration of the AUTOMATED SPHYGMOMANOMETER, please
contact the manufacturer.
* This device is contraindicated for any female who may be suspected of, or is
pregnant. Besides providing inaccurate readings, the 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 wrist and fingers will become anaesthetic, swollen
and even purple due to a lack of blood.
* When not in use, store the device in a dry room and protect it against extreme
moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on the
storage case.
* This device may be used only for the purpose described in this booklet. The
manufacturer cannot be held liable for damage caused by incorrect application.
*This device comprises sensitive components and must be treated with caution.
Observe the storage and operating conditions described in this booklet.
* The maximum temperature that the applied part can be achieved is 42.5℃while the
environmental temperature is 40℃.
* The equipment is not AP/APG equipment and not suitable for use in the presence of a
flammable anesthetic mixture with air of with oxygen or nitrous oxide.
* Warning: No servicing/maintenance while the ME equipment is in use.
* The patient is an intended operator.
* The patient can measure data and change battery under normal circumstances and
maintain the device and its accessories according to the user manual.
* To avoid measurement errors, please avoid the condition of strong electromagnetic
field radiated interference signal or electrical fast transient/burst signal.
* The blood pressure monitor and the 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 sensization or irritation reaction.
* If you experience discomfort during a measurement, such as pain in the wrist or other
complaints, press the START/STOP button to release the air immediately from the cuff.
Loosen the cuff and remove it from your wrist.
* If the cuff pressure reaches 40 kPa (300 mmHg), the unit will automatically deflate.
Should the cuff not deflate when pressures reaches 40 kPa (300 mmHg), detach the
cuff from the wrist and press the START/STOP button to stop inflation.
* Before use, make sure the device functions safely and is in proper working condition.
Check the device, do not use the device if it is damaged in any way. The continuous
use of a damaged unit may cause injury, improper results, or serious danger.
* Do not wash the 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.
* It is recommended that the performance should be checked every 2 years and after
maintenance and repair, by retesting at least the requirements in limits of the error of
the 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,
descriptions, calibration instructions,etc., to assist to service personnel in parts repair.
* The operator shall not touch output of batteries and the patient simultaneously.
* Cleaning :Dust environment may 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 Pearl. 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 Pearl 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, and walkie-talkies can affect this
equipment and should be kept at least a distance d away from the equipment. The
distance d is caculated by the MANUFACTURER from the 800 MHz to 2.5 GHz column
of Table 6 of IEC 60601-1-2:2007, as appropriate.
* Please use ACCESSORIES and detachable partes specified/ 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 fluid systems,
allowing air to be pumped into a blood vessel.
* Please use the device under the environment which was provided in the user manual.
Otherwise, the performance and lifetime of the device will be impacted and reduced.
CAUTION
4
INTRODUCTION INTRODUCTION
5

Systolic
blood pressure
Diastolic
blood pressure
mmHg Measurement unit the blood pressure
(1mmHg=0.133kPa)
kPa Measurement unit of the blood pressure
(1kPa=7.5mmHg)
Current time
Low battery Batteries are low and need to be replaced
LCD Display Signal
SYMBOL DESCRIPTION EXPLANATION
Month/Day,Hour/Minute
Indicates your maximum arterial pressure
Indicates your minimum arterial pressure
Pulse in beats per minute
Pulse display
Motion indicator Motion may result in an inaccurate
measurement.
Blood pressure monitor is detecting an
irregular heartbeat during measurement.
Irregular heartbeat
Blood pressure
level indicator Indicate the blood pressure level
Heartbeat Blood pressure monitor is detecting a
heartbeat during measurement.
Memory Indicate it is in the memory mode and
which group of memory it is.
CUFF
(Type BF applied part)
BATTERY
COMPARTMENT
Monitor Components
Component List:
1. PCBA;
2. Air Pipe;
3. Pump;
4. Valve;
5. Cuff.
List
1) Wrist Blood Pressure Monitor TMB-988
2) 2×AAA batteries
3) User manual
LCD DISPLAY
GRADE
TIME
SYSTOLIC
DIASTOLIC
MEM BUTTON
SET BUTTON
START/STOP BUTTON
PULSE RATE
7
INTRODUCTION
INTRODUCTION
6