Instructions for Use - BoneCT

The information provided by the manufacturer to inform the `User` of a device's `Intended Purpose` and proper use and of any `Precautions` to be taken.

Date of issue

2024-04-08

Device

[Medical Device: BoneCT]

Manufacturer

[Manufacturer: Floy]

Authorised Representative

N/A

Responsible Person

N/A

Clinical investigation

False

Clinical Benefits

[Clinical Benefit: Identify Patients at Risk]

Summary of Safety & Clinical Performance (SSCP)

N/A

Performance characteristics

[Device Data: BoneCT Device Data]

Residual risks

[

Risk Evaluation: Wrong Calibration to Unnecessary DEXA Scan;

Risk Evaluation: Unavailable Device To Unimproved Reading Evaluation;

Risk Evaluation: Credential Leak to PHI Deletion Evaluation;

]

Contra-indications

[

Contraindication: Metallic Implants;

Contraindication: Contrast-Enhanced;

]

Warnings

N/A

Disclaimers

[

Disclaimer: CT only;

Disclaimer: Native only;

Disclaimer: Spine only;

]

Precautions

[

Precaution: No children;

Precaution: No implants;

Precaution: No replacement;

Precaution: Second reader;

Precaution: Only Native;

]

---

Adverse Device Effects

N/A

Device Deficiencies

N/A

Limitation

• Inference time takes on average 2min and 52s but may take longer for larger series

Preparatory steps

• Add "Floy" as a new node within the established radiology network. This might require contacting your PACS provider.

Maintenance

• Regularly patch the underlying virtual machine provided to the manufacturer to maintain security.

Facility requirements and restrictions

• The IT network provided by the radiology office shall be secured and contain protection against malware.

Accessory and combination

[Accessory: Integration Engine]

Training requirements

No training necessary.

Qualification requirements

Users must be qualified healthcare professionals, e.g., radiology technologists, radiologists.

Consulting healthcare professionals

False

Serious incident reporting

Notice

Any serious incident that has occurred in relation to the device shall be reported to the manufacturer.

Any serious incident that has occurred in relation to the device shall be reported to the competent authority of the Member State in which the user and/or patient is established.

Procedure

Report serious incidents to the manufacturer by email info@floy.com or phone +4989244136090.

Special handling and storage

[Label: BoneCT Label [Special handling and storage]]

Device information

Installation statement

Installation must by performed by the manufacturer

Hardware requirements and restrictions

[Software Requirement Functional Capabilities: Hardware Environment]

Software requirements and restrictions

[Software Requirement Functional Capabilities: Software Environment]

Installation instructions

Install Floy Edge Relay on virtual machine provided by radiology clinic and connect securely with Floy.

Installation verification

Send a study to Floy and observe whether a Floy result is returned as attached DICOM series to the original study.

Critical dependencies

Requires connection with the [Accessory: Integration Engine].

Configuration requirements

Set AET title and IP address at defined here: https://www.floy.com/setup

System interface requirements and restrictions

Send applicable DICOM study from original PACS to Floy Edge Relay via DICOM Network (as usual by "Send to modality").

Start-up procedure

No startup procedure.

Shutdown procedure

No shutdown procedure.

Operating instructions

• Medical device returns a self-explanatory DICOM PDF Report as secondary capture.

• Radiology customer must ensure a secure IT network.

Glossary

AI: Artifical Intelligence

Security options

Provide the PACS AE title to Floy for whitelisting.

Failure

In case of failure to maintain security, immediately contact the manufacturer. As this represents a second reader device which provides add-on information, the core clinical workflow or patient remains unaffected.

Decommissioning

Contact the manufacturer for uninstallation and decommissioning.

Messages

[Instructions for Use Message: Not Supported Scan]

Website

www.floy.com

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