Carilex DualFlex, Инструкция по эксплуатации, Страница: 8 / 28

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1.3.2 Qualification requirements hygiene staff
Hygiene measures
The nature of hygiene measures are determined by the use environment of the device.
• If the device is used in clinical areas (e.g. in hospitals, doctors' offices, etc.) the
cleaning and disinfection must be carried out on the product or parts only by
appropriately qualified personnel, who are familiar with the relevant hygiene
regulations
.
• When using the device in non-clinical areas the users or trained cleaning
personnel can perform cleaning of the device.
1.3.3 Availability of the instructions for use
Obligation to provide information
1.4 Purpose of the device
To ensure the security of patients and users, the device may only be used for its
intended use.
1.4.1 Intended use
Intended use
Anti-decubitus Hybrid Alternating Mattress Replacement System intended to treat and/or
prevent decubitus ulcers otherwise known as bed sores, pressure sores, and
pressure ulcers. Always consult a physician or health professional before using this
device.
Contraindications:
Certain patient conditions (e.g. unstable cervical fracture, fracture of unstable
vertebrae and illness of unstable vertebrae) are contraindicated for use with this
device. Always consult a physician or health professional before using this device.
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Important notes for safe use
The Instructions for use are an integral part of the device and must be stored in a
place so that the safety instructions and other important information are accessible
at any time and can reviewed by the users.
Do not pass the device to a third party without these Instructions for use. Using the
edition version as a guide always ensure that a current and valid Instructions for use
document is supplied with the device.
Instructions for Use | Hybrid alternating pressure mattress replacement system DualFlex