Chapter 7
Maintenance
System Maintenance......................................................................................................2
Installation Requirements ......................................................................................................2
Cleaning and disinfection.......................................................................................................3
Accuracy Check .....................................................................................................................4
Administration of Information..........................................................................................5
User Setting Back up .............................................................................................................5
Patient information Back-up...................................................................................................5
Software.................................................................................................................................5
7 - 2 SONOACE PICO Operation Manual
System Maintenance
NOTE
The user must ensure that the safety inspections are performed every 2 years
according to the requirements of safety standard EN 60601-1. Only trained
persons are allowed to perform the safety inspections mentioned above.
Installation Requirements
When installing:
■ Optimal conditions for the system are temperatures of 10° ~ 35° C and humidity of
30% ~ 75%.
■ Avoid humidity.
■ Avoid direct sunlight.
■ Avoid places with extreme temperature variations.
■ Avoid heat sources.
■ Avoid dusty and unventilated areas.
■ Avoid places where the system is likely to be exposed to vibration or impacts.
■ Avoid places where the system is likely to be exposed to chemical substances or gases.
CAUTION
Placing the system near generators, X-Ray machines, or broadcast cables may
result in screen noise and abnormal visual images. Using the power source with
other electric devices may also induce noise.
Chapter 7. Maintenance 7 - 3
Cleaning and disinfection
WARNING
Always use protective eyewear and gloves when cleaning and disinfecting
the equipment.
▐ Cleaning
1. Turn off the system and disconnect the system power cord from the wall outlet.
2. Use a soft cloth lightly dampened in a mild soap or detergent solution to clean exterior
surfaces on the system.
▐ Disinfection
CAUTION
Use only recommended disinfectants on system surfaces.
A disinfectant qualified by the FDA 510(k) process is recommended. The following disinfectants
are recommended because of both their biological effectiveness (as qualified through the FDA
510(k) process) and their chemical compatibility with MEDISON ultrasound products.
Solutions Country
Type Active ingredient FDA 510(k)
Cidex USA Liquid Gluteraldehyde K934434
Cidex Plus USA Liquid Gluteraldehyde K923744
1. Turn off the system and disconnect the system power cord from the wall outlet.
2. Mix the disinfection solution compatible with your system according to label instructions
for solution strength.
3. Wipe the system surfaces with the disinfectant solution, following the disinfectant label
instructions for wipe durations, solution strength, and disinfectant contact duration.
4. Air dry or towel dry with a sterile cloth according to the instructions on the disinfectant
label.
7 - 4 SONOACE PICO Operation Manual
Accuracy Check
The product’s maintenance status may affect the measurements obtained using the product.
The product should be maintained in an optimal state to ensure reliable measurements.
To ensure optimal operation of the product, perform an accuracy check every year. The equati-
ons and table related to measurement accuracy are included in “Chapter 5 Measurements” in
this manual.
Chapter 7. Maintenance 7 - 5
Administration of Information
CAUTION
You may lose information files on user settings or patients, because of shock on
the product or internal error. Thus, back-up on a regular basis.
User Setting Back up
- Always keep a backup copy of all information related to the user settings in case of data loss.
- Clients cannot back-up the user settings of the product. Contact the MEDISON Customer
Service Department to attain support for back-up.
- However, clients may back up the user setting on GA Table used in obstetrics diagnosis. For
further information please refer to “Chapter 3. Settings”.
Patient information Back-up
The SonoView program can be used for backing up patients’ basic information and scanned
images. The user can choose to save the data, and the data is also saved in the system by
default. If the system needs to be reinstalled due to product failure, etc., the MEDISON
customer support staff will restore the patients’ basic information and scanned images that are
saved in the system. For more information on this, see “Chapter 6 Image Managements.”
Software
The product software may be updated to enhance performance. The user cannot make any changes to
the software. Please contact the MEDISON customer service representative for help in software changes.
CAUTION
Minor software updates may be carried out without the prior notice from the
manufacturer.
Should errors occur in the operating system (Linux), and should you desire to upgrade the
operating system, please follow the instructions of the operating system manufacturer.
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