INTERSON ViewBladder 10 - 3.5.1. Cleaning and Disinfection; 3.5.1.1 Probe Cleaning; 3.5.1.2 Probe Disinfecting

01-9932-00 ViewBladder 10 User Guide Revision 2 4
3.5.1. Cleaning and Disinfection
Y
WARNING
Always disconnect the ultrasound probe from the host computer system before performing
maintenance or cleaning. Always follow the manufacturer’s instructions when cleaning and
disinfecting probes and biopsy guide adapters. Do not use a surgeon’s brush when cleaning
probes. The use of even soft brushes can damage the probe.
3.5.1.1 Probe Cleaning
1. Wear protective gloves when performing the cleaning process.
2. Disconnect the probe from the system.
3. Remove any sheaths, biopsy guide adapters, and biopsy needle guides.
4. Discard sheaths (sheaths are a single-use item) in a biohazard container.
5. Use a soft cloth lightly dampened in a mild soap or compatible cleaning solution to remove
any particulate matter or body fluids that remain on the probe or cable.
6. To remove remaining particulates, rinse with water up to probe’s USB cable connection.
7. Wipe with a dry cloth; or wipe with a water-dampened cloth to remove soap residue, and
then wipe with a dry cloth.
3.5.1.2 Probe Disinfecting
A 10-6 reduction in pathogens should be reached following the disinfecting
procedures in this manual and using the following recommended solutions.
The following disinfectants are recommended because of both biological
effectiveness (as qualified through the FDA 510(k) process) and their compatibility
with Interson ultrasound product materials.
Solutions
Country
Type
Active ingredient
FDA 510(k)
Cidex®
USA
Liquid
Gluteraldehyde
K934434
Cidex Plus®
USA
Liquid
Gluteraldehyde
K923744
1. Wear protective gloves when performing the disinfecting procedure.
2. Check the expiration date on the solution that is being used. Use only solutions that are
within the expiration date.
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WARNING
The type of tissue it will contact during use dictates the level of disinfection required for a device.
Ensure that the solution strength and duration of contact are appropriate for disinfection. Be sure
to follow the manufacturer’s instructions.
Y
WARNING
Using a non-recommended disinfection solution, incorrect solution strength, or immersing a probe
deeper or for a period longer than recommended can damage or discolor the probe and will void
the probe warranty.
Y
WARNING
Do not immerse probes longer than one hour. Probes may be damaged by longer immersion.