ASP motioncare LIANA, User Manual

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Gebrauchsanweisung LIANA
| Version 1.0
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4.5. General warning and safety instructions
General
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The product may only be used for the purpose specified in Chapter 4.a Intended purpose.
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The product may only be installed, commissioned and maintained by persons authorised by the manufacturer
who fulfil the requirements of Section 2 Para. 2 of the Medical Devices Operator Ordinance (MPBetreibV).
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The company reserves the right to make modifications to the unit without prior notice.
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When using the device, observe all regulations of the German Medical Devices Implementation Act (MPDG)
and all related ordinances as well as occupational health and safety regulations, accident prevention
regulations (UVV) and the generally recognised rules of technology. For use outside Germany, please
observe the respective national legislation.
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This product is a medical device according to Medical Device Regulation (EU) 2017/745 (MDR) and DIN EN
60601-1. The Medical Devices Operator Ordinance is binding for operators in Germany. In other countries, the
relevant national laws apply. The insulation sections present in the product meet the requirements of the
standard: DIN EN 60601-1 (IEC 60601-1) Medical electrical equipment, Part 1: General requirements for basic
safety.
Operating environment
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The product is only permitted for indoor use.
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The product is not protected against the effects of major mechanical forces and only has limited protection
against the penetration of splashing water into the housing, motor, control unit and battery. However, if liquids
get over/into the control box, operate the safety switch on the unit or open the door to the battery. Dry the wet
spots on the unit manually.
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In the event of excessive overheating, disconnect the battery from the unit/charging device immediately and
notify the device manufacturer.
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After disconnecting the battery from the charging unit, make sure that the battery contacts do not come into
contact with conductive elements. This can result in damage to the battery and cause a fire.
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Hazardous substances are included in the battery. To avoid the risk of fire and explosion and leakage of
these substances, do not open the batteries or handle them mechanically in any way! Never expose the
batteries to open fire, excessive heat (e.g. through heaters) or solar radiation!
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Make sure that the battery is charged in a well-ventilated place.
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Route the mains and connection cable in such a way that it cannot be damaged.
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Damaged mains cables can cause fire or a life-threatening electric shock and must not be used.
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The device is not approved for operation in potentially explosive atmospheres or in atmospheres with
flammable mixtures or an increased oxygen content.
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Only use the device if there is no mechanical damage to the device or to the electrical wiring.
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Electromagnetic or other interferences between the product and other equipment cannot be excluded. If there
is a risk of mutual interference, disconnect the product or charger from the mains. The simultaneous use of
short-wave or microwave treatment devices in the immediate vicinity is not permitted. Mobile radio can also
result in interference.
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The device must not be used for patient transport!
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Protect the product from direct sunlight and heat.
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Only use the stabilisation aid on flat surfaces if all four wheels are touching the ground.