• CV010 Patient cables are thin and flexible for improved handling. It is necessary to avoid both tugging
and bending them at a sharp angle so as not to damage them.
• This device is intended exclusively for use by medical / paramedical personnel in a medical environment.
• Do not use the device in the operating room and in any case in the presence of flammable gases /
substances.
• Do not use the device for intracardiac applications or in direct contact with internal parts of the body.
• The processing of the recorded data and the diagnosis are exclusive to the doctor.
• Do not sterilize the device either in an autoclave or with liquid substances.
• Do not subject the pressure sensor of the wTn1 probe to mechanical shocks such as bumps or falls.
• Keep the wTn1 and wEc1 units, with its patient cable, at a distance from the computer no less than 1.5
meters and the computer itself at a distance of no less than 1.5 m from the patient.
• Avoid touching any part of the computer at the same time, including the wRs1 unit, and one or both
units wEc1 (with its patient cable) and wTn1.
• Do not immerse any part of the device in water or other substances or subject it to splashes. Never use
Gel on the wTn1 pressure probe.
• Do not carry out maintenance on the device that involves opening it; in case of device malfunction
contact DiaTecne s.r.l.
• If there are any abrasions, breaks in the sheath or any defect in the CV010 patient cable, use of the
device must be immediately suspended and the defective part sent to DiaTecne s.r.l. for repair /
replacement.
• Do not use the device in case of breakage of any part, do not proceed with repair attempts but contact
DiaTecne s.r.l. for repair / replacement.
• Do not make any modifications of any kind to the device and do not use any accessories other than those
supplied.
• Keep the wTn1 tonometric probe and the CV010 patient cable terminals away from power outlets and
surfaces where potentially dangerous voltages are present.
• Use a battery-powered computer (laptop) or alternatively a mains-powered computer that complies with
current medical standards.
• Use the device away from electromagnetic interference sources such as for example “cordless”
telephones operating at radio frequency, cellular phones, Bluetooth and WiFi devices or other devices
that emit high frequency electromagnetic waves.
• During the examination, keep the wEc1 unit at least 20 cm from the patient and operator and limit the
duration of contact of the wTn1 unit with the patient and operator to the time necessary to perform the
exam: all this to reduce electromagnetic radiation exposure due to the transmission of signals via radio,
even if they are of very low intensity.
• Use only 1.5V batteries of the indicated type. Insert them as shown and check their condition before
each use (dead or damaged batteries can cause acid leakage).
• Do not turn on or use the device if the battery compartment caps are not properly closed.
• Connect the CV010 patient cable connectors only to the corresponding sockets of the wEc1 unit. Do not
make any different types of connections to these connectors.
• The device must never be used together with a defibrillator as it was not designed for this use.
• During the recording of the carotid pressure curve, compression of the carotid bulbs could accidentally
induce a reduction in heart rate. This phenomenon may be more pronounced in elderly patients with
accentuated vagal sensitivity. It is strongly recommended that the examination be interrupted when
14
User Manual
PulsePen
- V. 5.0_b
