
R40 EEG Amplifier User Manual
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2.4 Use with other equipment
Defibrillators and HF surgical equipment
The equipment is not defibrillator proof and should not be used in situations where a defibrillator is
likely to be used.
The equipment should not be used with high frequency surgical equipment.
Other patient-connected equipment
When used simultaneously with other patient-connected equipment, for example a cardiac pace-
maker or other electrical stimulator, it is unlikely that a safety hazard will arise. However always
consult the documentation supplied with the other patient-connected equipment to ensure that all
hazards, warnings and cautions are considered before the equipment is used together.
WARNING: Non-medical equipment, when used with the system, should comply with IEC/ISO
safety standards relevant to that equipment. IT equipment should comply with IEC 60950.
Leakage current
This system is designed to comply with IEC 60601-1, the international standard for medical elec-
tronic equipment, which specifies the permissible levels of leakage current. A potential hazard ex-
ists in the summation of leakage currents caused by connecting several pieces of equipment to-
gether. Because this system can be used in conjunction with standard electronic devices, the total
leakage current should be tested whenever the system is modified.
There should be no electrical connections between the system equipment, which is powered via the
isolation transformer, and any other equipment powered from a non-isolated mains supply.
2.5 Interference
The R-40 will continue to operate in the presence of radio frequency magnetic fields (RF) and the
effects of electrostatic discharges (ESD) and other interference, in accordance with the require-
ments of EN60601-1-2. However, the R-40 amplifier records signals of very low amplitude, and
these signals themselves are not immune to the effects of RF, ESD and low-frequency magnetic
field interference. Such interference may cause signal artefacts.
The R-40 may have internal radios fitted. These are approved industry-standard Bluetooth and Wi-
Fi types which present minimal risk of reciprocal interference with other equipment.
Caution: when in close proximity to the amplifier, do not use mobile phones, transmitters, power
transformers, motors, or other equipment that generates magnetic fields. Refer to the Appendix for
more information.
Note: Medical electrical equipment needs special precautions regarding EMC and needs to be in-
stalled and put into service according to the EMC information provided in the Appendix.
2.6 Maintenance and cleaning
The R-40 Amplifier requires no routine testing, calibration or maintenance procedures apart from
occasional cleaning and checking for wear and damage to all parts including the accessories.
Cleaning
All the outer surfaces of the R-40 Amplifier may be cleaned using a soft cloth moistened with water
and a mild detergent solution. A low-pressure air-line or a vacuum cleaner can also be used.
Disinfection of the equipment can be carried out by the use of QAC-based disinfectants. Wipes are
recommended in order to prevent the ingress of any liquid into the equipment. Suitable products
include Mikrozid Sensitive Wipes (Schülke & Mayr GmbH), Microbac forte (Paul Hartmann AG), Dis-
tel Wipes (Tristel Ltd.), Mikro-Kill disinfectant wipes (Medline Industries, Inc.), Sani-Cloth HB Ger-
micidal Wipes (PD International, Inc).
Caution: Do not allow any liquid to enter the case of any instrument or connector. Do not use ace-
tone on any of the instruments.