V Series Operating Instructions xvii
Warnings Introduction
WARNING: Use of the V 12/V 21 is restricted to one patient at a time.
WARNING: Electrode polarization: some electrodes may be subject to large offset
potentials due to polarization. Use only electrodes as recommended by
Mindray. Recovery time after application of defibrillator pulses may be
especially compromised. Squeeze bulb electrodes commonly used for
diagnostic ECG recording may be particularly vulnerable to this effect.
Electrodes of dissimilar metals should not be used unless the amplifier
can handle polarization potentials as high as 1 volt (V).
WARNING: No modification of this equipment is allowed.
WARNING: Do not open the equipment housings. All servicing and future
upgrades must be carried out by the personnel trained and authorized
by Mindray only.
WARNING: Do not touch the patient and live parts simultaneously. Live parts
include, but are not limited to device connectors, recorder print head,
and battery connector. Otherwise, you will be subject to electric shock.
WARNING: To reduce the hazard of burns in the high-frequency surgical neutral
electrode connection, the electrodes should not be located between
the surgical site and the electro-surgical unit return electrode.
WARNING: Be sure to select the correct patient category setting for your patient
before measurement. Applying the adult settings to a pediatric or
neonatal patient may present a safety hazard.
WARNING: Patients with fragile skin, dermal allergies, or a history of skin reactions
to adhesive tapes may show a dermatitis type reaction to ECG
electrodes and SpO
2
sensors.
WARNING: Reliably attach Potential Equalization connector to the safety ground
when interconnecting V 12/V 21 with other medical or non-medical
electrical equipment to minimize the risk of excessive leakage current
and/or shock hazard.
WARNING: This unit uses a common isolation path for the ECG leads and the
Invasive Pressure Channels. Ensure that conductive parts of the ECG
electrodes do not contact other conductive parts including earth
ground. Do not connect any non-isolated accessories to the unit or to
the ECG or invasive pressure channel inputs when connected to a
patient. Insure that the total chassis leakage currents of all connected
units does not exceed 100μA in normal conditions and does not exceed
300μA in a single fault condition. Use an IEC 60601-1 approved
isolation / separation transformer if required. Do not operate the
equipment with any cover removed. Do not simultaneously touch the
patient and any piece of electrical equipment if any cover has been
removed from the equipment.
WARNING: When using the 12 lead ECG device cable, the device is not protected
against Electro Surgical Unit (ESU) interference.
WARNING: While monitoring the heart rate (HR), all arrhythmia detection is
disabled when an ESU event is detected.
WARNING: The ST algorithm has been tested for accuracy of the ST segment data.
The significance of the ST segment changes need to be determined by a
clinician.
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