Drying; Maintenance, Inspection And Testing; Packaging - Hitachi UST-5550 Instruction Manual

Intraoperative electronic linear probe, compatible with waterproof cover
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MN1-5575 Rev. 11

5-9. Drying

A). Probe
1) Wipe the probe with single use, fluff free wipe or towel for removing moisture on the surface of the
equipment.
2) If using drying heater for medical equipment, the temperature limit is a maximum of 60 °C [140 °F].
Dry until no visible moisture is left.
3) If using natural drying, temperature range should be between 15-30 °C [59-86 °F] for a minimum time of
4 hours.
B). Protect tube MP-2485B
1) Wipe the protective tube with a single-use, fluff-free wipe or towel to remove moisture from the
surface of the protective tube.
2) Dry the lumen of the protective tube by applying compressed air. The compressed air should be
filtered by a sterile filter that removes air particles of less than 0.2 μm. Dry until no visible moisture
is left.
3) Dry the protective tube naturally in an ambient temperature between 15-30°C[59-86°F] for a minimum
of 4 hours. Alternatively the protective tube can be dried using a drying heater at a temperature of
less than 60°C[140°F]

5-10. Maintenance, inspection and testing

Confirm following items
1) the function of mechanical moving parts
2) the image performance when the probe is connected to the scanner
3) there are no abnormal exterior damages such as cracks on the surface of the equipment
4) Safety tests (See section 8-1)

5-11. Packaging

Store the disinfected probe and protect tube in a dustproof environment until next application. Before sterilization
it is necessary to pack all parts in a pouch suitable for sterilization, or in a tray with wrap according to ISO
11607-1 and ISO 11607-2 "Packaging for terminally sterilized devices" and ISO/TS 16775 "Packaging for
terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2" or the
local hospital procedure. Follow the pouch manufacturer's specifications or the local regulations for how to
pack and seal the pouches.
Check the sealing seam after heat sealing for any defects. In case of processing mistakes or defects the package
has to be opened again and the device has to be packed and sealed again.
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