Beka Hospitec 921077000, Оригинальное руководство

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Safety
Operating manual NORA Pro V0.1 E Page 9 of 60
4.5 General warning and safety instructions
General notes
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The product may only be used for the purpose specified in chapter 4.1 Intended and
appropriate use.
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The product may only be installed, maintained, and put into operation by persons
authorised by the manufacturer who meet the requirements according to §2 Para. 2
the MPBetreibV (German Medical Devices Operator Ordinance). Observe your
applicable national / local legislation on operating medical devices.
▪
The company reserves the right to make modifications to the device 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 the occupational
health and safety regulations, the accident prevention regulations (UVV) and the
generally recognised rules of technology. For use outside Germany, observe the
respective national legislation.
▪
This product is a medical device according to Medical Device Regulation (EU)
2017/745 (MDR) and DIN EN 60601-1. For operators in Germany, the MPBetreibV
(German Medical Devices Operator Ordinance) is binding. In other countries, the
corresponding national laws apply. The insulation distances 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 safety.
Operating Environment
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The product is exclusively fit for indoor use.
▪
The product is not protected against the effects of greater mechanical forces and only
to a limited extent against the penetration of splash water into the housing, motor,
control unit and battery.
▪
The device is not authorised for use in potentially explosive atmospheres or in
atmospheres with flammable mixtures or increased oxygen content.
▪
Electromagnetic or other interference between the product and other devices cannot
be ruled out. If there is a risk of alternating influences, disconnect the product / battery
charger from the mains. The use of short-wave or microwave therapy devices in the
immediate vicinity of the device is strictly forbidden. Cellular phones can also cause
interference.
▪
Protect the product against direct sunlight and heat.
Functional safety
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The product as well as the slings may only be used and operated by trained staff.
▪
Supervision of the caregiver is required throughout the treatment. Never leave the
resident unattended in the sling.
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The patient must not be the user / operator!
▪
Prior to each use of the device and its accessories, the user must check their
functional safety and good condition (visual check, functioning). Also check the used
sling for visible damage. The product and the accessories must not be used if any
parts are damaged or malfunctioning. There is a risk of injury!
▪
Only operate this medical device with original accessories according to chapter 13.5.