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1. Instrument should be operated only by qualified personnel.
2. The following precautions must be observed when installing the instrument:
(1) Install at a location free of moisture.
(2) Install at a location where there is no risk of detrimental effects caused by atmospheric pressure, temperature,
humidity, ventilation, sunlight, dust, salt, or air containing sulfur and so forth.
(3) Install the instrument in a stable manner, avoiding inclines, vibrations and shock (including those during transport).
(4) Do not install in locations where chemicals or pharmaceuticals are stored or where there is generation of gas.
(5) Use the proper power supply, frequency, voltage and allowable current values (or power).
(6) Check the status of battery-operated power supplies (degree of discharge, polarity, etc.).
(7) Be sure that the instrument is properly grounded.
3. The following precautions must be observed before using the instrument:
(1) The instrument must be inspected for switch contact, polarity, dial settings and meter readings to confirm its proper
operation.
(2) Be sure that the instrument is properly grounded.
(3) Be sure that all cords are connected properly and securely.
(4) Avoid combined use of instruments since this can lead to inaccurate diagnosis and hazards.
(5) Re-inspect any external circuits that come in direct contact with patients.
(6) Check all battery-operated power supplies if applicable.
4. The following precautions must be observed while using the instrument:
(1) Do not exceed the time and quantity required for diagnosis and treatment.
(2) Continuously monitor the instrument for any abnormalities as well as the condition of the patient.
(3) When an abnormality is noticed in the instrument or the patient, take appropriate measures, such as to terminating
operation of the instrument while ensuring the safety of the patient.
(4) Do not allow the patient to touch the instrument.
5. The following precautions must be observed following use of the instrument:
(1) Follow the specified procedures to return all operating switches, dials and other components to their positions prior
to use; then turn OFF the main power.
(2) When disconnecting cords, hold the plug body firmly so as not to apply excessive force to the cord itself.
(3) The following items must be observed with respect to the location where the instrument is stored.
(a) Store in a location free from moisture.
(b) Store in a location where there is no risk of detrimental effects caused by atmospheric pressure, temperature,
humidity, ventilation, sunlight, dust, salt, or air containing sulfur and so forth.
(c) Store in a stable manner while paying attention to inclines, vibrations and shock (including those during trans-
port).
(d) Do not store in locations where chemicals or pharmaceuticals are stored or where there is generation of gas.
(4) Store all accessories, cords, leads and other components in an organized manner after cleaning.
(5) Be sure to clean the instrument so that it functions properly the next time it is used.
6. If the instrument should malfunction, the operator should not attempt to correct the problem. Appropriately indi-
cate that the instrument is not operating properly and await repairs by qualified personnel.
7. Never attempt to disassemble or modify the instrument.
8. Maintenance and inspection
(1) All instrument and components should be inspected regularly.
(2) When resuming use of instrument that has not been used for a long period of time, always confirm that the instru-
ment operates properly and safely before use.
9. Beware that strong electromagnetic waves may cause the instrument to operate incorrectly.
This instrument has been tested based on JIS T0601-1-2:2002 and IEC60601-1-2:2001. The purpose of these
standards is to maintain safety against the dangerous obstacle in typical medical facilities.
However, the instrument may affect or be affected by certain equipment such as cellular phones and pace
makers.
In case this instrument is influenced by other equipment, or it affects other equipment, or there is such fear,
relocate and/or increase the distance between FM-600 and affecting equipment.
Should there be any further questions and/or unknown points, please consult your Kowa sales representative
or dealership beforehand.
Precautions (Safety Precautions and Hazard prevention) Concerning Use of Medical Electrical Instrument