Spengler CARDIOMATE PC Manuel Utilisateur page 68

1. Safety Guidance
1.1 Safety Warning
This instrument is suitable for the detection and recording of routine human ECG.
This system is not designed for intracardiac use or direct cardiac application.
This instrument is not intended for home use.
This instrument is not intended for treatment or monitoring.
This instrument is provided for the use of qualified physicians or personnel professionally
trained.
The operator is supposed to be familiar with the contents of this User Manual before
operation.
Do not use this instrument near anesthetic gases, oxygen, hydrogen or other flammable
and corrosive chemicals,otherwise there will be a risk of explosion.
Do not use this instrument in the hyperbaric oxygen chamber, otherwise there will be a risk
of explosion.
Do not use this instrument near high-voltage, high- static, otherwise it may discharge
instantly and produce sparks.
Only service engineers authorized by the manufacturer can open the shell.
Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective IEC/EN standards (e.g. IEC/EN 950 for data processing
equipment and EN 60601-1 for medical equipment). Furthermore all configurations shall
comply with the valid version of the standard EN 60601-1-1. 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 EN 60601-1-1. If in doubt, please consult our service department or
the local agent on your side.
When defibrillator is used simultaneously with the instrument, the operator should not
touch patient and bed. All the electrodes (whether connected to the patient or not)
and the patient do not need to be grounded. AgCl coated chest electrode and patient
cable with the function of defibrillation should be selected. If the defibrillation time is
more than 5 seconds, disposable chest electrode should be used to avoid skin burn of
patients by metal electrode. Please do not use it at the same time with other electrical
stimulation equipment. If it is necessary to use them at the same time, professional and
technical personnel shall be present for guidance, and the selected accessories shall be the
accessories designated by the manufacturer.
Be careful when patient is connected to multiple equipments, the total leakage current
might cause the injury. Only equipment compliant with IEC60601-1:2006 is allowed to
connect with this instrument, when it is connected with other equipments. Meanwhile,
reliable connection between the potential equalization needs to be carefully considered.
After the connection, the users must measure the total leakage current by themselves to
determine whether it meets the requirements or usage condition.
The pacemaker (if installed) may influence the accuracy and analysis result. Under this
situation, it is suggested that the doctors should identify and analyze it according to the
waveform.In addition, it will also increase the potential risk. In this case, when recording
ECG, pay special attention to safety issues, and appropriate measures must be taken to
ensure that the leakage current is at a safe level.
This instrument can not be used with high-frequency electrotome.
The operator should not touch patient, patient bed, table or instrument when it is used
simultaneously with the defibrillator or pacemaker.
Please use the patient cable and other accessories supplied by ECGMAC. Otherwise, it will
affect the performance and function, even damage the ECG instrument.
Be sure that all electrodes have been connected to the correct position of human body
before operation. Avoid electrodes (including neutral electrodes) and patient to be
contacted with any conducting parts or earth.
This instrument is equipped with corresponding user permission. Please properly keep
the authorized account and password information, and do not disclose the account and
password information to others.
The patient's health information can only be used by authorized medical personnel for
cardiac function diagnosis and analysis, and shall not be disclosed to a third party.
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