Indications For Use; Measurement Principle - Medel Elite Manual Del Usuario

EN
• It is intended for adult indoor use only. It is not intended for use with neonatal,
pregnant or pre-eclamptic PATIENTS.
• Warning: Be careful to regarding the effect of blood flow interference and resulting
harmful injury to the patient caused by continuous cuff pressure due to connection
tubing kinking; During measurement, please avoid compression or restriction of the
connection tubing.
• When using this device, please pay attention to the following situation which may
interrupt blood ow and inuence blood circulation of the patient, thus cause harmful
injury to the patient: connection tubing kinking too frequent and consecutive mul-
tiple measurements; the application of the cuff and its pressurization on any arm
where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present;
inating 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 inflate 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 simultaneously - used monitoring ME equipment.
• Please check that operation of the device does not result in prolonged impairment
of patient blood circulation.
• Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor
your blood pressure. Please start or end medical treatment basing solely on phy-
sician's treatment advice. If you are taking medication, consult your physician to
determine the most appropriate time for your measurement. Never change a pre-
scribed medication without your physician's consent.
• The device cannot be used with HF surgical equipment at the same time.
• The device is not intended for public use.
• The device is not suitable for continuous monitoring during medical emergencies
or operations, as when the cuff is inated for a long time the patient's blood supply
to their arm and ngers will be insufcient, causing anesthesia, distending pain and
ecchymosed.
• To verify the calibration of the AUTOMATED SPHYGMOMANOMETER please con-
tact the manufacturer.
• This device may be used only for the purpose described in this booklet. The manu-
facturer cannot be held liable for damage caused by incorrect application.
• The device comprises sensitive components and must be treated with caution. Ob-
serve the storage and operating conditions described in this booklet.
• Do not wash the cuff in a washing machine or dishwasher.
• If 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.
• The patient is an intended operator.
• Expected service life : 2 years
• The service life of the cuff may vary by the frequency of washing, skin condition,
and storage state. The typical service life is 10.000 times.

10. INDICATIONS FOR USE

The MEDEL ELITE Blood Pressure Monitor is a digital monitor intended for use in mea-
suring blood pressure and heartbeat rate with arm circumference ranging from 22cm
to 42cm (about 8¾˝-16½˝). It is intended for adult indoor use only.
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11. 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
air pressure. Then it starts inating 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.
The device also compares the longest and the shortest time intervals of detected pulse
waves to mean time interval then calculates standard deviation. The device will di-
splay a warning signal with the reading to indicate the detection of irregular heartbeat
when the difference of the time intervals is over 25%.
12. SYMBOLS
Refer to the instructions manual
Application part, type BF
For indoor use only
LOT Batch number
CAUTION!These notes must be
!
observed to prevent any dama-
ge to the device
Manufacturer's catalogue device
REF
number
SN
Serial number
Complies with the Medical Device Directive 93/42/EEC
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"
Direct current
Manufacturer
Manufacturer date
Class II Equipment
Keep dry
Temperature limitation for
transport and storage
Authorised Representative in
EC REP
the European Community
10/02/2017 19:03:00
EN
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