EDAN elite V5 User Manual page 17

Patient Monitor User Manual
6 The simultaneous use of cardiac pacemaker and other patient-connected equipment
may cause safety hazard.
7 The equipment can provide protective means to prevent the patient from being
burned when used with HF SURGICAL EQUIPMENT. The equipment can protect
against the effects of the discharge of a defibrillator. Use only EDAN-approved
accessories.
8 Do not come into contact with the patient, table, or the monitor during defibrillation.
9 Extreme care must be exercised when applying medical electrical equipment. Many
parts of the human/machine circuit are conductive, such as the patient, connectors,
electrodes, transducers. It is very important that these conductive parts do not come
into contact with other grounded, conductive parts when connected to the isolated
patient input of the device. Such contact would bridge the patient's isolation and
cancel the protection provided by the isolated input. In particular, there must be no
contact of the neutral electrode and ground.
10 Magnetic and electrical fields are capable of interfering with the proper performance
of the device. For this reason make sure that all external devices operated in the
vicinity of the monitor comply with the relevant EMC requirements. X-ray equipment
or MRI devices are a possible source of interference as they may emit higher levels of
electromagnetic radiation.
11 Route all cables carefully to avoid possible entanglement, apnea, or electrical
interference. For the device mounted over the patient, sufficient precautionary
measures should be taken to prevent it from falling on the patient.
12 Devices connecting with monitor should be equipotential.
13 If the protective grounding (protective earth) system is doubtful, the monitor must be
supplied by internal power only.
14 Two batteries must be used when the monitor uses internal power supply.
15 Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective IEC/EN standards. Furthermore all configurations shall
comply with the valid version of the standard IEC/EN 60601-1. Therefore anybody,
who connects additional equipment to the signal input or output connector to
configure a medical system, must make sure that it complies with the requirements of
the valid version of the system standard IEC/EN60601-1. If in doubt, consult our
technical service department or your local distributor.
16 Only use patient cable and other accessories supplied by EDAN. The performance
and electric shock protection cannot be guaranteed, and the patient may be injured
otherwise. Prior to use, check if the casing of a disposable or sterilized accessory is
intact. Do not use it if its casing is damaged.
17 Only recommended batteries can be used for the monitor.
WARNING
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Intended Use and Safety Guidance