Warnings and precautions

Before attempting to use NilRead, you must read this manual thoroughly, paying particular attention to all Warnings and Cautions incorporated in it.

WARNING		Directions, which if not followed, could cause fatal or serious injury to an operator, patient or any other person, or could lead to a misdiagnosis or mistreatment.
CAUTION		Directions, which if not followed, could cause damage to the equipment described in this Instructions for Use and/or any other equipment or goods, and/or cause environmental pollution.

General usage

Caution: Federal law restricts this device to sale by or on the order of a physician.

NilRead is intended for use by physicians trained in reviewing and interpreting medical images.

Users are to ensure that the appropriate study is loaded based on the identification on the timeline and in the viewport.

It is recommended that NilRead be installed on the minimum hardware requirements (see Hardware requirements). Users are to ensure guidelines and warnings (including maintenance provisions) provided by the hardware manufacturer are adhered to, and that hardware is used under safe operating conditions. Users shall not install any additional third party software on the NilRead server to prevent compromising the software performance.

A user’s access to the NilRead software is dependent upon the connectivity of their computer or mobile device to the NilRead server. A NilRead site should maintain the network integrity since the network is a critical part of the distributed image viewing system.

NilRead uses compressed images during interactive manipulation. The diagnostic quality image is presented at the end of the manipulation, as part of a progressive refinement display. Lossless images are marked with an HD label.

NilRead has been qualified on a variety of operating system and browsers (see Device specifics). However, operating system and browser version updates may affect the NilRead software. We recommend verifying the NilRead functionality after a modification to the operating system or browser.

NilRead could be used as a temporary data cache and local changes might be out of synch with the master database. If NilRead is configured as a temporary cache, it is recommended that either the data correction functions are disabled or that an appropriate data lifecycle policy is setup to propagate changes to the master database.

Patient data may be incorrectly removed by improperly configuring a data lifecycle policy. The system administrator shall make sure that when NilRead is used as primary data storage, data lifecycle is setup to include hierarchical storage endpoints, including a long term archive. This will prevent purging policies from automatically deleting studies when the local cache is full.

The system administrator shall ensure that when NilRead is used as primary data storage, that the site implements an appropriate backup and recovery procedure of the NilRead database.

The system administrator shall ensure that Data QC privileges are assigned to users familiar with the hospital’s workflow.

The stitched image is created to allow accurate measuring of distances and angles by qualified medical practitioners. Any incidental clinic findings that are seen on the source of stitched images should be verified or further evaluated by additional diagnostic methods.

A misconfigured Auto Reconciliation can have a direct impact on patient safety, including incorrect diagnosis due to the patient information/image mismatch and/or delay in diagnosis due to images not being available in the patient record. The system administrators shall ensure that sufficient parameters (such as First name, last name, DOB, Gender) are configured.

The data upload may result in illegal or inappropriate images being ingested into the system that can potentially introduce cybersecurity risks. The hospitals are responsible to implement the cybersecurity best practices.

The uploading/Patient portal can only be activated under the consensus of hospital and/or the healthcare provider, and distributed under this consensus.

Non-compliant Dicom data can have a direct impact on patient safety including the incorrect or delayed diagnosis. The hospitals are responsible to monitor and ensure Dicom compliance of connected entities.

Referential Pathology Studies are not intended for diagnostic image review. The use of this feature is intended for information purposes such as multidisciplinary patient management meetings or patient consultation.

When using the option to Auto-load and visually merge studies with the same Accession Number, the system will group together series, annotations, labeling, and other artifacts from multiple independent studies under a single view in various areas of the software and can result in incorrect diagnosis. Please ensure that the data is suitable for this option and that users receive adequate training.

Use on mobile devices

Users are to ensure guidelines and warnings provided by the mobile device manufacturers are adhered to regarding care and operation of the mobile devices.

Measurements

On MPR and 3D views, interpolation may be done depending on the spacing between the original slices (as the spacing increases, the amount of interpolated data increases). For any image, when displaying images on the monitor at a scale other than 100%, data is interpolated. Measurement results are affected when interpolation is done. Interpolation always implies a certain inaccuracy.

Do not perform pixel value measurement on compressed images. Compressed images are marked as “Compressed” on the screen.

NilRead allows 3D measurements to be performed. 3D measurements can change significantly with small changes in a line’s location or with changes in opacity.

The accuracy of any measurement also depends on the user’s ability to select appropriate measurement points on the display device.

The accuracy of calibrated measurements should be visually verified with the size of an anatomical object.