OsteoSys SONOST-2000 User Manual page 6

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User's Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST-2000
- Working Humidity: Within 20~ 80%
- Air Pressure: Within 800 ~ 1060hPa
(2) Pre-operation Checklist
- Check the switch connection and polarity indicator status to ensure the device works
properly.
- Check all cable connections for correct and safe operation of the device.
- Double-check the areas that make direct contact with the patient.
- Check the device and the patient for any abnormal conditions.
- If any uncertainty is witnessed with the device or the patient, take appropriate actions
including suspending device operation under safe conditions.
(3) Cautions for Storage
- Do not apply excessive force when connecting or disconnecting cables.
- Auxiliary devices should be maintained clean, and in working conditions.
- Devices should be positioned in their proper positions, so as not to interfere with
operator's or patient's movement.
(4) Cautions regarding specialist prescription
This device is designed for the diagnosis of osteoporosis and therefore should only be
used for diagnosis performed by doctors. Its use must be prescribed and managed by
specialists.
(5) Biocompatibility - Ultrasound gel, etc.
To prevent damage to skin and cells, use commercially available ultrasound gels that
have passed ISO 10993-5(Cytoxicity), ISO 10993-10(Skin sensitization), and ISO
10993-23(Skin irritation) tests.
DOC. No. : OT-IFU-S2K
6

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