6
This device comprises sensitive components and must be
treated with caution. Observe the storage and operating condi-
tions described in the «Technical specifications» section.
The cuffs are sensitive and must be handled with care.
Only pump up the cuff once fitted.
Do not use this device if you think it is damaged or notice
anything unusual.
Never open this device.
Read the additional safety information provided within the indi-
vidual sections of this instruction manual.
The measurement results given by this device is not a diag-
nosis. It is not replacing the need for the consultation of a physi-
cian, especially if not matching the patient’s symptoms. Do not
rely on the measurement result only, always consider other
potentially occurring symptoms and the patient’s feedback.
Calling a doctor or an ambulance is advised if needed.
Ensure that children do not use this device unsupervised;
some parts are small enough to be swallowed. Be aware of
the risk of strangulation in case this device is supplied with
cables or tubes.
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Contra-indications
Do not use this device if the patient’s condition meets the following
contra-indications, to avoid inaccurate measurements or injuries.
The device is not intended for measuring blood pressure in pedi-
atric patients of age younger than 12 years old (children, infant,
or neonates).
Presence of significant cardiac arrhythmia during measurement
may interfere with blood pressure measurement and affect the
reliability of blood pressure readings. Consult with your doctor
about whether the device is suitable for use in this case.
The device measures blood pressure using a pressured cuff. If
the measuring limb suffers from injuries (for example open
wounds) or under conditions or treatments (for example intrave-
nous drip) making it unsuitable for surface contact or pressuriza-
tion, do not use the device, to avoid worsening of the injuries or
conditions.
Patient motions during measurement may interfere with the
measurement process and influence results.
Avoid taking measurements of patients with conditions, diseases,
and susceptible to environment conditions that lead to incontrol-
lable motions (e.g. trembling or shivering) and inability to commu-
nicate 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).
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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.
