Spengler CARDIOMATE PC Manuel Utilisateur page 107

Note: if there is gel on the surface of patient cable or electrodes or electrode pins or metal
parts are wet, inaccurate recording of ECG waveform may occur.
6.3 Disinfection
It is recommended that disinfection should be only performed under the regulation of medical
institutions or under other proper situations; Disinfecting equipment must be disinfected
before cleaning the ECG machine.
Do not use high-temperature, high-pressure steam, ionizing radiation methods for
disinfection.
Do not use chlorine-containing disinfectant for disinfection, such as chlorinated lime and
sodium hypochlorite etc.
After the power is turned off, use a soft and clean lint free cloth to absorb a proper amount of
disinfectant (75% alcohol), wipe the external surface of accessories such as ECG acquisition
box and patient cable, chest electrode suction ball and limb electrode clamp, and use a dry
cloth to wipe off the residual disinfectant. After disinfection, please place the ECG acquisition
box and its accessories in a cool and ventilated place to dry thoroughly.
6.4 Care and Maintenance
This instrument needs to be maintained and repaired by trained and qualified professional
personnel; when the instrument functions abnormally, it should be clearly identified to avoid
the instrument running with faults.
6.4.1 General Maintenance
In addition to the care and maintenance methods recommended in this manual, other
measurement requirements and maintenance methods specified in local regulations shall be
followed at the same time.
Periodic safety test shall be carried out for the instrument. The test cycle shall be at least once
a year. The test contents mainly include:
a) Check whether there is mechanical and functional damage in the main unit and accessories;
b) Check whether the safety signs are damaged;
c) Verify the function of the instrument according to the Instructions for Use;
d) The following safety tests are carried out in accordance with EN 60601-1:2006:
Earth leakage current, limit: NC 50µA, SFC 1000µA
Enclosure leakage current, limit: NC 100µA , SFC 500µA
Patient leakage current, limit: 10 µA (CF type equipment)
Patient auxiliary current, limit: NC A.C. 10µA, D.C. 10µA; SFC A.C. 50µA, D.C. 50µA
Patient leakage current under single fault condition with mains voltage on the applied
part,Limit: 50 uA (CF Type)
Inspection and record shall be conducted by professional personnel with safety test knowledge
and qualified training, and practical experience to perform these tests. If the instrument has
any problems in the above tests, it must be repaired.
6.4.2 Care and Maintenance of ECG Acquisition Box
 Take out the battery to make the acquisition box in power off state (for PE-1204 and PE-
1204A);
 Clean the instrument, wipe the accessories and cover the dust cover;
 Prevent liquid from penetrating into the interior of the instrument, affecting the performance
and safety of the instrument;
 Ask the medical instrument maintenance department to verify the instrument regularly.
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