Medical Devices; Exemption From Premarket Notification; Class II Devices; Electric Positioning Chair. Final order.

The Food and Drug Administration (FDA or the Agency) is publishing an order granting a petition requesting exemption from premarket notification requirements for electric positioning chair devices. An electric positioning chair is a device with a motorized positioning control that is intended for medical purposes and that can be adjusted to various positions. These devices are used to provide stability for patients with athetosis (involuntary spasms) and to alter postural positions. This order exempts electric positioning chairs, class II devices, from premarket notification, subject to certain conditions for exemption. This exemption from premarket notification, subject to these conditions (and the limitations in the physical medicine devices limitations of exemptions from premarket notification section of the device regulations), is immediately in effect for electric positioning chairs. FDA is publishing this order in accordance with the exemption from class II premarket notification section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

[The peculiarities of deposition of foreign particles in the skin region experimentally damaged by the electrical saw cutting element].

The objective of the present study was to detect the deposition of foreign particles and other introduced objects in the human skin region damaged by the electrical saw cutting elements and to use the data thus obtained for the estimation of the speed and the type of the instrument, the main characteristics of the cutter covering and/or composition of its surface. The experiments included the sawing of the skin fragments using the small steel saws differing in the type of the surface cover, such as the uncoated (steel), stained, nickel- or chromium-plated, blue-finished saws with the movement speed of the cutting element 500, 1000, 2500, 2,000, and 3,000 revolutions per minute. The study provided information about the peculiarities of deposition of foreign particles and other introduced objects in the damaged regions of the human skin that allow not only to establish the fact of using the electrical saw with a high-speed back-and-forth movements of the cutting element but also the type of the instrument and the main characteristics of its cover and/or the composition of its surface.

Investigation of complexity of the instruction manuals for electrical coffeepots.

BACKGROUND: Electrical coffeepots are commonly used in professional and residential environments. Their instruction manuals are related to issues that involve the user's safety and ability to operate the machine correctly. To provide the best product performance to the user, one must indicate or inform the correct usability, to turn the interaction easier. OBJECTIVE: This research proposes to investigate the instruction manuals of the electrical coffeepots. METHODS: Four coffee pot instruction manuals were analyzed in relation to the complexity through the heuristic evaluation. For that, eight experts of the Graphic Design were chosen to answer twenty four questions with the aim of analyzing: images; texts; layout development; information and warnings. RESULTS: This study shows the results of the 04 (four) items analyzed: a) images; b) texts; c) layout development; d) information and warnings, together with the suggestions of improvements for each manual. CONCLUSIONS: It is believed that the methodological procedures for the application of the heuristic evaluation have facilitated the diagnosis of fragilities and barriers that the users find during the interaction with electrical coffeepot manuals.

A model for estimation of potential generation of waste electrical and electronic equipment in Brazil.

Sales of electrical and electronic equipment are increasing dramatically in developing countries. Usually, there are no reliable data about quantities of the waste generated. A new law for solid waste management was enacted in Brazil in 2010, and the infrastructure to treat this waste must be planned, considering the volumes of the different types of electrical and electronic equipment generated. This paper reviews the literature regarding estimation of waste electrical and electronic equipment (WEEE), focusing on developing countries, particularly in Latin America. It briefly describes the current WEEE system in Brazil and presents an updated estimate of generation of WEEE. Considering the limited available data in Brazil, a model for WEEE generation estimation is proposed in which different methods are used for mature and non-mature market products. The results showed that the most important variable is the equipment lifetime, which requires a thorough understanding of consumer behavior to estimate. Since Brazil is a rapidly expanding market, the "boom" in waste generation is still to come. In the near future, better data will provide more reliable estimation of waste generation and a clearer interpretation of the lifetime variable throughout the years.

Recycling-oriented characterization of small waste electrical and electronic equipment.

As a result of the continuous change in the design and function of consumer electrical and electronic products, the mechanical and material properties of the obsolete products, called waste electric and electronic equipment (WEEE), are highly variable. The variability within WEEE is explained by the number of different appliances, and the heterogeneity in composition of any given appliance. This paper reports on an extended investigation of the properties of WEEE, in particular small appliances. The investigation focuses on the analysis of the composition of about 700 single appliances. Firstly, analytical methods to characterize the waste equipment are described. The results of the experimental analyses show that the mechanical properties, the material composition, the polymer composition and the chemical composition of WEEE vary not only between equipment types with different functions, but also between single appliances within one equipment type. Data on hazardous and valuable substances in selected equipment types are presented. Using detailed data on the composition of individual appliances to calculate rates of recovery for assumed recycling processes demonstrates that the performance of recycling processes depends strongly on the composition of WEEE. Recycling-oriented characterization is, therefore, a systematic approach to support the design and the operation of recycling processes.