There are certain symbols on the system components that contain further product information:
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Description of the |
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Manufacturer alea as a digital assistance system is manufactured by AssistMe GmbH Bachstr. 12, 10555 Berlin, Germany. |
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Retailer The alea-compatible incontinence products including sensor strips are provided by the respective manufacturers and retailers, or by AssistMe in the context of the customer's application of the alea sensor strip. |
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Medical device alea as a digital assistance system consists of medical device software (medical device class I) and the accessory components alea-Clip, alea-Station and alea-Sensor-Strips. |
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Instructions for use It is recommended that you read the instructions for use provided by the manufacturer before use. |
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European conformity alea fulfils the relevant requirements of applicable Union legislation |
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Temperature limits Specifies the lower and upper temperature limits to which the product/component can be safely exposed. The alea hardware should be stored and operated between -20 °C and +65 °C. |
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IP65 |
Protection against intrusion The product/component is protected against solid and liquid substances: 6 = dust-tight. No ingress of dust. 5 = protected against water jets from any angle. |
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Single care recipient - multiple use alea components can be used multiple times per care recipient. The alea-compatible smart ICP will be disposed of normally. |
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Unique device identifier Each alea component has a so-called "Unique Device Identifier", which contains the corresponding information. |
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Recycle: Electronic devices alea hardware components contain electrical and electronic components and must be disposed of in accordance with the manufacturer's instructions. This labelling corresponds to Article 11 Paragraph 2 of Directive 2002/96/EC (WEEE). For alea, this means that we take back all components that are no longer required at any time. Disposal by users and customers is not intended or desired. |
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Serial number Each alea component or part has its own serial number so that each specific element can be reliably identified and tracked at any time for quality assurance purposes. |
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No application in MRI Avoid interactions between the alea clip and the magnetic field (e.g. heating, malfunction or projectile hazard). Therefore, it must not be used in MRI or CT. |
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Avoid direct sunlight in the long term The alea-Clip including base, hinge and lid must not be exposed to excessive direct sunlight during use and storage. Shorter periods and outside high summer temperatures are generally harmless. |
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Do not reuse alea sensor strips or smart IKP All alea components can be used multiple times, except for the alea-compatible smart ICP with the alea sensor strip. These must be disposed of in the same way as normal ICP after a single use. |