22/150 D9U001GKB-0101
2 General information
2.1 Standards
This product meets the requirements of current standards ČSN EN 60601-
1:2007, ČSN EN 60601-1-1 ed.2:2001, ČSN EN 60601-2-52:2010, ČSN EN
60601-1-2 ed.2:2008. According to the directive 93/42/ES of the Council of
Medical Devices, as amended, the chair is classified as class I medical device.
2.2 General Instructions
The chair operation is only permitted in areas that meet the conditions of current
standards for electric distribution in places intended for medical purposes.
According to the Council directive 93/42/ES, as amended, and the appropriate
national legislation, only a person with adequate qualification can operate the
product.
2.3 General Safety
• Pay attention to proper fastening of accessories (handle tightening, etc.).
• Do not carry out disassembly or unskilled repairs of motors, control units,
etc.
• Design changes are reserved!
• Threads of tightening screws or jointed points on Goepel leg supports can
be degreased in consequence of disinfecting agents working. In this case,
early greasing prevents from an expensive repair.
• The chair must be equipotentially connected with other medical devices to
prevent fire in combination with flammable substances and anesthetics
during minor surgical procedures using high-frequency (HF) instruments.
• Never use other than original accessories. All original accessories are
marked with original label containing the name and brand of the
manufacturer, serial number or batch ID and date of manufacture.
• Any serious incident that has occurred in relation to the device should
be reported to the manufacturer and the competent authority of the
Member State in which the user and/or patient is established!Only
authorised and trained person using the tool is allowed to change
fuses and power supplies!
• This medical device is not intended for oxygen enriched environment!
• This medical device is not intended for use with flammable
substances!
• This medical device is not portable medical electrical equipment!
• Make sure the duty cycle (2 min ON/18 min OFF) is not exceeded
during bed positioning!
• Patient is allowed to use selected control elements only if hospital
personnel had assessed that the patient´s physical and psychological
state is in accordance with use of them and only if the hospital
personnel had trained the patient in accordance with the instructions
for use!
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