TRANSTEK Medel Soft TMB-1581-S User Manual
USER MANUAL
Wrist blood pressure monitor
MEDEL SOFT
Model: TMB-1581-S
EN
1
A
LCD DISPLAY
GRADE
D
MEM BUTTON
C
SET BUTTON
SYSTOLIC
E
DIASTOLIC
F
PULSE RATE
G
START/STOP BUTTON
B
2
+
-
-
+
4
A B
1
3
EN
C
D
E
G
F
H
2
EN
I
5
A B
C D
3
6
A B
7
A B
C
EN
4
EN
(DISPLAY SYMBOL (PIC. 3
SYMBOL DESCRIPTION EXPLANATION
SYS
DIA
INTRODUCTIONS
Dear customer,
ank you for choosing one of our products. Our name stands for high-quality, thoroughly tested products. Please read these instructions for
use carefully and keep them for later use, be sure to make them accessible
to other users and observe the information they contain.
With kind regards,
Your Medel team
INDICATIONS FOR USE
Medel So is a digital monitor intended for use in measuring blood pressure and heartbeat rate with a wrist circumference ranging from 13.5cm
to 21.5 cm ( about 5½˝-8½˝ ).
It is intended for adult indoor use only.
Systolic blood pressure High blood pressure
Dystolic blood pressure Low blood pressure
Pulse display Pulse in bests per minutes
Excessive Body Motion
Detector
Low battery Batteries are running low and
mmHg (1mmHg=0.133kPa)Measurement
Irregular heartbeat Detects an irregular heartbeat
Current time Month/Day/Year,Hour : Minute
Blood pressure level
indicator
Heartbeat Month/Day/Year,Hour : Minute
Motion may result in an inaccurate measurement
need to be replaced
unit the blood pressure
during measurement.
Indicate the blood pressure level
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CONTRAINDICATION
1.e device should not be used by any person who may be suspected
of,or is pregnant .
2.e device is not suitable for use on patients with implanted,electrical
devices, such as cardiac pacemakers, debrillators.
MEASUREMENT PRINCIPLE
is product uses the Oscillometric Measuring Method to detect blood
pressure. Before every measurement, the unit establishes a “zero point”
equivalent to the atmospheric pressure. en it starts inating the cu.
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.
SAFETY INFORMATION
e signs below might be in the user manual, labeling or other component.ey are the requirement of standard and using.
Symbol for “THE OPERATION
GUIDE MUST BE READ”
Symbol for “COMPLIES WITH
MDD 93/42/EEC
REQUIREMENTS”
Symbol for “MANUFACTURER”
Symbol for “SERIAL NUMBER”
SN
Symbol for “RECYCLE”
Symbol for “MANUFACTURE
DATE”
The Green Dot is the license symbol of
a European network of industry-funded
systems for recycling the packaging
materials of consumer goods.
Symbol for “TYPE BF APPLIED
PARTS”
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”
Symbol for “DIRECT CURRENT”
Symbol for “Authorised Representative
EC REP
in the European Community
Caution: These notes must be
observed to prevent any damage
to the device.
ATTENTION!
is device is intended for adult use in homes only.
* e device is not suitable for use on neonatal patients, pregnant women,patients with implanted, electronical
devices, patients with pre-eclampsia, premature ventricular beats, atrial brillation, periph ral, 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 suer from illnesses.
* e device is not suitable for measuring the blood pressure of children. Ask your doctor before using it
on older children.
* e device is not intended for patient transport outside a healthcare facility.
* e device is not intended for public use.
* is 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. is 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.
EN
6
EN
* 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 brillation, the best result may occur with deviation. Please consult your physician about
the result.
* Warning: Do not apply the cu over a wound;otherwise it can cause further injury.
*Do not inate the cu on the same limb which other monitoring ME equipment is applied around simultaneously,
because this could cause temporary loss of function of those simultaneously-used monitoring ME equipment.
*On the rare occasion of a fault causing the cu to remain fully inated during measurement, open the cu
immediately. Prolonged high pressure (cu 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 measurement, please avoid compression or restriction of the connection tubing.
* e device cannot be used with HF surgical equipment at the same time.
* e 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.
* is device is contraindicated for any female who may be suspected of, or is pregnant. Besides providing
inaccurate readings, the eects of this device on the fetus are unknown.
* Too frequent and consecutive measurements could cause disturbances in blood circulation and injuries.
* is unit is not suitable for continuous monitoring during medical emergencies or operations.Otherwise,
the patient’s wrist and ngers 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.
* is device may be used only for the purpose described in this booklet. e manufacturer cannot be held
liable for damage caused by incorrect application.
*is device comprises sensitive components and must be treated with caution. Observe the storage and
operating conditions described in this booklet.
* e maximum temperature that the applied part can be achieved is 42.5°C while the environmental
temperature is 40°C.
* e equipment is not AP/APG equipment and not suitable for use in the presence of a ammable
anesthetic mixture with air of with oxygen or nitrous oxide.
* Warning: No servicing/maintenance while the ME equipment is in use.
* e patient is an intended operator.
* e patient can measure data and change batteries 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 radiated
interference signal or electrical fast transient/burst signal.
* e blood pressure monitor and the cu are suitable for use within the patient environment. If you are
allergic to polyester, nylon or plastic, please don’t use this device.
* During use, the patient will be in contact with the cu. e materials of the cu have been tested and
found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any
potential sensization or irritation reaction.
* If you experience discomfort during a measurement, such as pain in the wrist or other complaints, press
the START/STOP button to release the air immediately from the cu. Loosen the cu and remove it from
your wrist.
* If the cu pressure reaches 40 kPa (300 mmHg), the unit will automatically deate. Should the cu not
deate when pressures reaches 40 kPa (300 mmHg), detach the cu from the wrist and press the
START/STOP button to stop ination.
* 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. e continuous use of a damaged unit may cause injury,
improper results, or serious danger.
* Do not wash the cu in a washing machine or dishwasher!
* e service life of the cu may vary by the frequency of washing, skin condition, and storage state. e
typical service life is 10000 times.
* It is recommended that the performance should be checked every 2 years and aer maintenance and
repair, by retesting at least the requirements in limits of the error of the cu pressure indication and air
leakage (testing at least at 50mmHg and 200mmHg).
* Manufacturer will make available on request circuit diagrams, component part lists, descriptions,
calibration instructions,etc., to assist to service personnel in parts repair.
* e operator shall not touch output of batteries and the patient simultaneously.
Cleaning :Dust environment may aect the performance of the unit. Please use the so cloth to clean the
whole unit before and aer use. Don’t use any abrasive or volatile cleaners.
* e 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 Transtek. Don’t open or repair the device by yourself in the event of
.
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