8
Avoid taking measurements of patients with conditions,
diseases, and susceptible to environment conditions that lead
to incontrollable motions (e.g. trembling or shivering) and
inability to communicate clearly (for example children and
unconscious patients).
The device uses oscillometric method to determine blood pres
-
sure. The arm being measure should have normal perfusion.
The device is not intended to be used on a limb with restricted
or impaired blood circulation. If you suffer with perfusion or
blood disorders, consult your doctor before using the device.
Avoid taking measurement on the arm on the side of a mastec
-
tomy or lymph node clearance.
Do not use this device in a moving vehicle (for example in a car
or on an aircraft).
m
WARNING
Indicates a potentially hazardous situation, which if not avoided,
could result in death or serious injury.
This device may only be used for the intended uses described
in this Instructions for Use. The manufacturer cannot be held
liable for damage caused by incorrect application.
Do not change the patient medication and treatment based the
result of one or multiple measurements. Treatment and medica
-
tion changes should be prescribed only by a medical profes
-
sional.
Inspect the device, cuff, and other parts for damage. DO NOT
USE the device, cuff or parts if they appear damaged or oper
-
ating abnormally.
Blood flow of the arm is temporarily interrupted during measure
-
ment. Extended interruption of blood flow reduces peripheral
circulation and may cause tissue injury. Beware of signs (for
example tissue discoloration) of impeded peripheral circulation
if taking measurements continuously or for an extended period
of time.
Prolonged exposure to cuff pressure will reduce peripheral
perfusion and may lead to injury. Avoid situations of extended
cuff pressurization beyond normal measurements. In the case
of abnormally long pressurization, abort the measurement or
loose the cuff to depressurize the cuff.
Do not use this device in oxygen rich environment or near flam
-
mable gas.
The device is not water resistant or water proof. Do not spill or
immerse the device in water or other liquids.
Do not dissemble or attempt to service the device, accessory
and parts, during use or in storage. Access to the device
internal hardware and software is prohibited. Unauthorized
access and servicing of the device, during use or in storage,
may compromise the safety and performance of the device.
Keep the device away from children and people incapable of
operating the device. Beware of the risks of accidental ingestion
of small parts and of strangulation with the cables and tubes of
this device and accessories.
m
CAUTION
Indicates a potentially hazardous situation which, if not avoided,
may result in minor or moderate injury to the user or patient, or
cause damage to the device or other property.
The device is intended only for measuring blood pressure at
upper arm. Do not measure other sites because the reading
does not reflect your blood pressure accurately.
After a measurement is completed, loosen the cuff and rest for
> 5 minutes to restore limb perfusion, before taking another
measurement.
Do not use this device with other medical electrical (ME) equip
-
ment simultaneously. This may cause device malfunction or
measurement inaccuracies.
Do not use this device in proximity of high frequency (HF)
surgical equipment, magnetic resonance imaging (MRI) equip
-
ment, and computerized tomography (CT) scanners. This may
cause device malfunction and measurement inaccuracies.
Use and store the device, cuff and parts in temperature and
humidity conditions specified in the »Technical specifications«.
Usage and storage of the device, cuff and parts in conditions
outside ranges given in the »Technical specifications« may
results in device malfunction and the safety of usage.
Protect the device and accessories from the following to avoid
damaging the device:
- water, other liquids, and moisture
- extreme temperatures
- impacts and vibrations
- direct sunlight
- contamination and dust
This device has 2 user settings. Please ensure it is cleaned and
disinfected between users to prevent any cross contamination.
Stop using this device and cuff and consult with your doctor if
you experience skin irritation or discomfort.
