
X-era Smart Installation Manual Ver. 3.00 iii
Precautions Concerning the Use of Medical Electrical
Equipment (Safety and Accident Prevention)
1. Equipment should only be operated by qualied personnel.
2. The following must be observed when installing equipment:
(1) Install in a location free of moisture.
(2) Install in a location where there is no risk of detrimental effects due to air pressure, temperature, humidity,
ventilation, sunlight, dust, salt or air containing chemicals such as sulfur.
(3) Install in a stable situation and surroundings away from inclines or any exposure to vibrations or impacts
(including during transportation).
(4) Do not install in a location where chemicals or pharmaceuticals are stored or where there is exposure to
gas.
(5) Use the correct power supply frequency, voltage and permitted current (or power consumption).
(6) Check the status of battery power supplies (level of discharge, polarity, etc.).
(7) Ensure that the equipment is properly grounded.
3. The following items must be checked before the equipment is used:
(1) Test all switch contacts, polarities, dial settings and meter readings to conrm that the equipment is operat-
ing properly.
(2) Check that the equipment is fully grounded.
(3) Check that all cables are properly and securely connected.
(4) Take great care to ensure that the equipment does not share a power source with other equipment since
this can lead to errors in accurate diagnosis and other hazards.
(5) Re-inspect any external circuits that come into direct contact with patients.
(6) Check any battery power supplies.
4. Note the following during equipment use:
(1) Do not exceed the required time or quantity for diagnosis or treatment.
(2) Continuously monitor both the equipment and the patient for any abnormalities.
(3) When an abnormality is noticed in the equipment or patient, take appropriate measures, such as shutting
down the equipment, while also ensuring the safety of the patient.
(4) Take care to ensure that the patient does not touch the equipment.
5. Note the following after using the equipment:
(1) Return all operating switches, dials and other components to their status prior to use in accordance with the
designated procedure before turning off the power.
(2) When disconnecting cords, pull out the cord while holding onto the plug body so as not to apply excessive
force to the cord itself.
(3) Note the following when selecting the equipment storage location:
i Store in a location free from moisture.
ii Store in a location where there is no risk of detrimental effects due to air pressure, temperature, humid-
ity, ventilation, sunlight, dust, salt or air containing chemicals such as sulfur.
iii Store in a stable situation and surroundings away from inclines or any exposure to vibrations or impacts
(including during transportation).
iv Do not store in a location where chemicals or pharmaceuticals are stored or where there is exposure to
gas.
(4) Clean off all accessories, cords, leads and other components and then store in an orderly manner.
(5) Always make sure to clean the equipment so that it functions properly the next time it is used.
6. In the event that the equipment should malfunction, do attempt to correct the problem yourself. Clearly indicate
that the equipment is not operating properly and await repairs by qualied personnel.
7. Never attempt to disassemble or modify the equipment.
8. Maintenance and Inspection
(1) All equipment and components should be inspected regularly.
(2) When resuming use of equipment that has been unused for a long period, be sure to check that the equip-
ment operates properly and safely before use.