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CLARIUS HD3 - Precautions

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Clarius Scanner HD3 Product Usage
revision 9 18
Precautions
For Use in Surgical Environments
Before you use the Clarius Scanner HD3 for intra-operative procedures or in a surgical
environment, follow the instructions for high-level disinfection (for instructions see High-Level
Disinfection on page 38), then cover the Clarius Scanner HD3 with an approved third-party
manufactured sheath (according to the regulatory jurisdiction where it is available, such as but
not limited to the US, Canada, and the EU), following the usage instructions provided by the
manufacturer.
When you have finished using the Clarius Scanner HD3, immediately clean it (for instructions
see Cleaning the Clarius Scanner HD3 on page 36), followed by another high-level disinfection.
If the sheath breaks during the intra-operative procedure, dispose the sheath and follow the
same cleaning and high-level disinfecting process as above, then cover the Clarius Scanner
HD3 with a new sheath before continuing to use it.
For Use in Endocavitary Procedures
Before using the Clarius Scanner HD3 for endocavitary procedures (trans-vaginal and/or trans-
rectal), inspect the probe for any rough surfaces, sharp edges, or sharp corners that may cause
harm to the patient. Next, perform a high-level disinfection (for instructions see High-Level
Disinfection on page 38). The EC7 HD3 scanner shall be covered with an approved third-party
manufactured probe cover/sheath (according to the regulatory jurisdiction where it is
available, such as but not limited to the US, Canada, and the EU), following the usage
instructions provided by the manufacturer. Ensure the entire length of the end piece is
protected/covered by the sheath prior to use.
When you have finished using the Clarius Scanner EC7 HD3, immediately clean it (for
instructions see Cleaning the Clarius Scanner HD3 on page 36), followed by another high-level
disinfection. If a Clarius Power Fan HD3 (CIDN 50-02-00077) was used, remove the fan prior to
the high-level disinfection and follow the instructions for an intermediate-level disinfection (for
instructions see Disinfecting the Clarius Power Fan HD3 on page 39).
If the sheath breaks during an endocavitary procedure, dispose the sheath and follow the
same cleaning and high-level disinfecting process as above, then cover the Clarius Scanner
HD3 with a new sheath before continuing use.
When using a biopsy guide, use one of the following recommended products:
• Civco Reusable Endocavity Needle Guide (Product Number 613-198)
• Civco Disposable Endocavity Needle Guide (Product Numbers 667-089 and 667-090)
Follow the usage instructions provided by the manufacturer.
Do not reuse biopsy guides unless instructed by the manufacturer.

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