gbo HiToP 1touch Instructions For Use Manual

gbo HiToP 1touch Instructions For Use Manual Manual pdf 37 page image

HiToP 1touch 37 gbo Medizintechnik AG Version 1.213 Appendix B - EMC HintsComments according to the Medical Device DirectiveThe HiToP 1touch is a mains operated current stimulation device of protection class I.The device is in accordance with the EC Medical Device Directive (93/42/EEC) and therefore carries the CE-signwith the number of the ”notified body for medical devices”. The respective graphical symbol is placed on the typeplate.According to the Medical Device Directive, HiToP 1touch is a device of class IIa.The manufacturer is responsible for the security, operational reliability and functionality of the device under thefollowing conditions only: the device is used in accordance with the user manual; the electrical installation of the location where the device will be used corresponds to the respectivecurrent requirements of electrical safety; the device is not used in hazardous environments and humid locations; the mountings, add-ons, internal adjustments, modifications or repairs are realized only by personnelauthorized by the manufacturer; the operator regulation of this EC-directive is observed within the scope of the Medical DeviceDirective.You may obtain technical support by the manufacturer or the dealers or service authorized by the manufacturer.The manufacturer projects a product life of 10 years.HiToP 1touch is an electronic device. Waste disposal is to be done according to the regulations for electronicdevices. Consumables have to be disposed as residual waste.On request, the manufacturer will provide you with further technical descriptions for all serviceable parts of thedevice, such as circuit diagrams, spare part lists and adjustment instructions as far as these are of use for thequalified technical staff of the user.Comments on electromagnetic compatibility (EMC)Medical electrical devices are subject to special precautions concerning the EMC. They must be installed andoperated according to the EMC-advice given in the accompanying documents. In particular medical electricaldevices may be influenced by portable and mobile RF-communication devices.The manufacturer guarantees the conformity of the unit with the EMC-requirements only if accessories which arelisted in the EC declaration of conformity are used. The use of other accessories may cause an increased emissionof electromagnetic disturbances or may lead to a reduced electromagnetic immunity.The unit must not be arranged physically close to other devices or stacked with them. If such an order isnecessary nevertheless, the unit must be observed in order to check it for the intentional operation.You find more EMC-comments in the chapter “Warnings and Safety Precautions” of this manual as well as theTechnical Information on the next two pages.