4. Operational safety
page 11 / 96 Issue date 18.05.2021, rev. 1.0
If further transport of the device is required, use the delivery packaging. Transport shall be performed with
covered transport means.
Recommended transport conditions:
• ambient temperature between -10°C to +45°C,
• humidity between 20 and 95%,
• atmospheric pressure between 700 and 1060 hPa (70-106 kPa).
The above conditions refer also to the battery module.
WARNINGS and safety notes
The PhysioGo.Lite Electro unit has been designed and manufactured in such a way that its use does not cause
a hazard to the health and safety of patients, operators and third parties, as well as the unit provides
therapeutic benefits to patients if it is operated in appropriate conditions and in accordance with its intended
purpose.
General:
• PhysioGo.Lite Electro unit may be operated by qualified personnel in compliance with instructions (see
2.1).
• No modification of this equipment is allowed!
• The treatment station (bed, couch, chair) shall be located away from other electric devices and water
supply / sewerage installation / central heating system, so that it is impossible for the patient to touch
any of them during treatment procedure.
• Do not position PhysioGo.Lite Electro so that it is difficult to operate the disconnection of the device from
the supply mains.
• Do not remove warning signs and labels put by the manufacturer on the unit casing and accessories.
• The unit shall be protected against high temperatures and atmospheric conditions (e.g. direct sunlight).
• Damaged cables shall be replaced immediately. Pay special attention to the threadbare insulation and
partially torn interconnecting cables.
• Prevent any fluid from penetrating inside the unit. In case of any fluid getting inside the unit, switch the
unit immediately off, isolate from the mains and contact service to inspect the unit.
• By any means do not cover the vents. Do not insert any objects into the ventilation sockets.
• The unit may be only used with accessories, spare parts, disposable items which have been determined
to be safe and appropriate inspection bodies have not issued contraindications against their use.
• After switching the unit off, wait for 10 seconds before you switch it on again.
• Each serious incident concerned with the device should be reported to the manufacturer and competent
authority of the country, where the user or patient resides. Serious incident means any incident that
directly or indirectly led, might have led or might lead to any of the following:
the death of a patient, user or other person,
the temporary or permanent serious deterioration of a patient's, user's or other person's state of
health,
a serious public health threat.
Therapeutic:
• The device is intended for adult patients (patient has to be conscious). Minor patients – only on the
doctor's explicit recommendation, after considering contraindications.
• It is impermissible for the patient to carry out the treatment on their own.
• Patients with implanted electronic devices (e.g. cardiac pacemakers, cardioverter defibrillator, spinal
cord stimulator) or other metal implants should be consult a physician prior to treatment.
• Before treatment it is necessary to interview the patient, including the occurrence of relative and
absolute contraindications to conduct therapy.
• Do not perform treatments on patients under the influence of alcohol.
• Do not perform treatments on patients under the influence of intoxicants.
• It is necessary to ensure the adequate interval between treatments for the patient, in order to avoid an
increase of the risk of complications.
• It is necessary to continuously update knowledge and follow literary activities in the scope of therapy.
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