INSTRUCTIONS FOR USE PRODUCT INSERT (THE ‘IFU’)
Version 3_0-rc (11/2017)

Product Name

·         The VERTEBRAL MOTION ANALYZER (“VMA”) software (hereafter referred to as “VMA software”)

·         The MOTION NORMALIZER patient handling and data collection device (hereafter referred to as “VMA patient handling and data collection device” or “VMA hardware”)

Manufacturer Name

·         Ortho Kinematics, Inc.

Indications for Use

·         VMA software is a quantitative imaging software application intended to be used to process any diagnostic imaging modality except mammography from digital image files in DICOM format. It is designed for physicians and clinical professionals who are interested in the analysis of alignment and motion in medical images, particularly in musculoskeletal images of the spine. VMA software permits users to review static and dynamic digital lumbar, thoracic and cervical spine images. In the case of fluoroscopic images, these are acquired with the assistance of the MOTION NORMALIZER patient handling and data collection device, which is designed for use by imaging technicians and intended to assist with patient lumbar and cervical bending and data collection during imaging. VMA software also facilitates quantitative assessment of vertebral alignment and motion in digital medical images. Information about the alignment and motion of selected objects, such as bone structures, can be generated and presented in the form of a ‘motion analysis’ report containing graphics, charts, and text.

Intended Use

·         VMA software is intended to:

o   be used by physicians and clinical professionals interested in the motion and alignment of vertebral bodies and associated anatomy on radiographic images.

o   assist in the analysis of radiographic films to produce inter-vertebral motion and alignment measurements.

o   assist in analyzing both: (1) fluoroscopic cine “video”-type image sequences of the moving spine, as well as (2) snapshot-type still image pair corresponding to two opposing spine bending postures.

o   be compatible with medical images acquired using the VMA patient handling and data collection device or other digital x-ray medical image sources.

·         The VMA patient handling and data collection device is intended to:

o   be used by imaging technicians.

o   assist with and collect data about patient lumbar and cervical bending and alignment during motion imaging of the lumbar and cervical spine.

o   digitize image data from fluoroscopes during imaging by interfacing with the fluoroscope’s output video port.

o   create DICOM output files for storage to a removable media device, which can then be transferred and accessed by users of VMA software.

Device Description

·         VMA Image Processing Software:

o   is image processing software that is operated on an Off-The-Shelf (OTS) computer.

o   is operated outside the clinical setting by physicians and clinical professionals to review and enhance images, track moving objects across multiple images, and generate motion and alignment analysis reports

o   accepts DICOM images files created with the VMA patient handling and data collection device or other digital x-ray medical imaging source as input, and produces processed image files and report files as output

o   has five essential functions: (a) access and review DICOM images, (b) enhance contrast, (c) generate quantitative assessments via automated methods that require manual review and user acceptance, (d) generate motion and alignment analysis reports that integrate data from images with other sources, and (e) make these reports available to the end user either via a .pdf file that can be viewed or printed from Adobe Acrobat software, or via a set of output files readable by VMA Image Review Software (described below).

 

·         The VMA patient handling and data collection device (“VMA hardware”):

o   is a set of three devices: two electromechanical patient handling devices and a console mounted computer control system:

§  Upright Device: imaging table that articulates and assists a subject through a pre-configured type of lumbar (standing) or cervical bending (seated).

§  Table Device: a table top mounted device that requires a standard radiological table to rest upon, that articulates and assists a subject through a pre-configured type of lumbar bending.

§  Console: a computer control system that connects to and controls the Upright and Table. It also connects to and records data from a fluoroscope. It is capable of writing the test data to removable media.

o   is operated in a clinical imaging environment by an imaging technician.

o   assists with an imaging workflow to creates DICOM image files as output.

o   has four essential functions: (1) facilitate a controlled bending of the spine of the subject via the patient handling devices, (2) record the position of the patient handling devices during imaging, (3) capture digital or analog medical image signals from fluoroscopic imaging sources during imaging and, if analog, convert these analog signals into digital image files, and (4) save digital images and other collected data into DICOM-compatible output digital image files.


 

 

·         VMA Image Review Software:

o   is image review software that is operated on an Off The Shelf (OTS) medical imaging and review workstation (i.e., a computer with hard drive and display monitor) via a standard internet browser.

o   is operated outside the clinical setting by physicians and clinical professionals to review the processed results that are the output of VMA Image Processing Software (described above).

o   accepts files created with VMA Image Processing Software as input.

o   has five essential functions: (a) provides manual review and user acceptance of all vertebral template locations, (b) allows users to review image, template, and quantitative motion measurement data generated via VMA Image Processing Software, (c) allows users to view and print summary motion analysis reports, (d) allows users to view “physician alerts”, which are alerts that can be configured by users to indicate whenever specific types of user-defined anomalies are present in patient results, and (e) allows users to auto-generate “read reports”, which are text reports that summarize the findings of a patient study based on a user-defined configuration.

 

·         VMA DataLink Software:

o   is browser-based, cloud-hosted custom software that affords for the online operation of the VMA system.

o   is operated by all users of the VMA system, allowing them to accomplish testing workflow via standard internet browser software.

o   allows users to create and maintain online accounts, from which the various components of the VMA system can be accessed and through which all data can be transferred, processed, and stored in the execution of all steps of the testing workflow.

o   has different essential function for the various users of the VMA system:

o   Users of the VMA hardware:  These users are able to take the DICOM output files stored to removable media, and upload these files to a cloud-hosted database for processing.

o   DICOM Images—spinal radiographic views—may be uploaded from a PACS system for processing.  These can include plain x-ray images of bending, or full spine lateral x-rays.

o   Users of VMA Image Processing Software:  These users are able to access uploaded files, and use the Image Processing software to generate processed testing results.

o   Users of VMA Image Review Software:  These users are able to access processed testing results via a browser-based user interface that affords for the capability to stream results on demand.  These users are also able to set and change the thresholds that trigger the “physician alerts” described in the section above.

 

 

·         The Ortho Kinematics, Inc. (OKI) Image Processing Service for the VMA system:

o   is a required component of the VMA system.

o   OKI pre-processes images, using the VMA Image Processing software, to apply templates to images.  The user then confirms these templates (using the VMA Image Review software) and afterward can access the ‘motion and alignment analysis’ reports.

Contraindications

·         VMA software: None

·         VMA patient handling and data collection device: The system is not to be used with pregnant patients.

 

Warnings & Precautions

·         CAUTION – US Federal law restricts this device to sale by, or on the order of, a physician.

·         The system is only intended for use by trained personnel.

·         VMA software utilizes an algorithm that can be characterized as automated with a forced manual review.

·         The VMA patient handling and data collection device includes mechanically actuated imaging tables intended to guide a patient through a preset range of motion during image acquisition.

·         Users must be trained radiology professionals with knowledge of all risks associated with radiographic imaging.

·         Standard radiology imaging techniques must be employed during the image event.

·         The moving devices feature an automatic manual override button that is controlled by the patient during use. Users are advised to properly instruct the patient regarding this safety override feature. The system also features a secondary manual override button that is prominent on the control console. This feature will stop the moving parts. These manual override buttons will not affect or control the imaging device.

·         The device is not appropriate for patients who are not sufficiently ambulatory to accomplish the desired bending routines, or who cannot accomplish the desired bending without unacceptable motion-induced pain and/or risk of injury. As a result, a physical examination of a patient’s lumbar or cervical range of motion by a physician is required prior to prescribing the radiographic bending evaluation.

·         Use with extreme caution in the setting of acute trauma.  The device should only be used in trauma patients in whom fracture has been radiographically excluded and then only under the direct supervision of the treating physician. Should pain or neurological symptoms be encountered during the examination, that examination should be immediately discontinued and the patient re-assessed. 

·         Prior to obtaining cervical flexion/extension imaging with the VMA system, patients should be instructed to practice unassisted flexion and extension bending in the presence of a healthcare provider. Following this unassisted bending, the patient should then practice device-assisted bending in the presence of a healthcare provider prior to actual imaging. Should pain or neurological symptoms be experienced, the examination should be discontinued and the patient re-assessed. 

·         Inadequate tracking of the vertebral bodies across radiographic images can lead to erroneous results. Image data and template placement must be reviewed prior to accepting any measurement results. If any templates are found to be incorrectly placed on the vertebral bodies, any associated measurements should not be utilized in clinical decision making. These images are provided in the front section of the printed report, prior to the quantitative data.

·         When being viewed on a computer, a diagnostic-quality image review station should be used.

·         Ortho Kinematics recommends that users of the System take all necessary precautions to protect patient data created and stored using this System. Institution data management personnel should be consulted regarding the proper security measures to be implemented to ensure the protection of Protected Health Information (PHI).

 

 

Important Additional Information

·         In these Instructions for Use, the use of the VMA patient handling and data collection device with a fluoroscope is described.  Please note that in place of a fluoroscope, any other imaging device may be used so long as it is: (1) commercially-available, (2) able to interface with the VMA patient handling and data collection device, and (3) able to produce radiographic images suitable for the clinical evaluation of the lumbar and cervical spine.

·         Currently, VMA Image Processing Software is only commercially available as a centralized image processing service.  Please contact the manufacturer for more information about how to arrange for access to the software via this service.  See the section above “OKI Image Processing Service.”

 

Accuracy of Intervertebral Motion Measurements

As is standard practice for assessing accuracy of intervertebral motion measurement systems, cadaveric vertebral specimens were used in an in vitro testing apparatus.  The testing protocols involved imaging each specimen multiple times under multiple testing conditions by a fluoroscope, to produce radiographic image sequences of the cadaveric motion.  The resulting image sequences were processed by three observers using the VMA System to produce measurements of intervertebral rotation and translation for each image sequence. For this study, lumbar images were captured at a frame rate of 4 frames per second, the images were sized at 1k x 1k pixels, and each pixel was captured as an 8 bit value. After being captured, these images were then lossy-compressed using JPEG compression configured at a 90% quality level. Cervical images were captured with the same parameters except for the frame rate, which was 8 frames per second.

These motion measurements created via the VMA software were then compared to the known reference motion recorded directly from the in vitro testing apparatus, with any difference constituting an error in accuracy.

The accuracy results are summarized below in Table 1 and demonstrate the accuracy of the VMA System, as all results are within the typical rounding error for each variable (to the nearest degree or to the nearest 0.5 millimeter).

 

Table 1:  Accuracy of VMA System: Lumbar and Cervical Measurements

 


Measurement

VMA

Lumbar Measurements

VMA

Cervical Measurements

IVR (Sagittal) from null motion

0.3° ± 0.5° (max: 1.2°)

0.1° ± 0.2° (max: 0.7°)

IVR (Sagittal) from known motion

0.8° ± 0.7°

0.4° ± 0.4° (max: 1.0°)

IVT (Sagittal) from known motion*

0.5 ± 0.4 mm*

0.5 mm ± 0.3 mm

 

*Note:  This table reports the accuracy of IVT measurements made using the Meyerding method for lumbar measurements. 

Note that for thoracic measurements, repeatability and accuracy are comparable to the ranges listed above for cervical measurements, based on literature analysis demonstrating comparable levels of repeatability and accuracy between measurements of cervical and thoracic intervertebral motion measurements. 

 

Repeatability of Intervertebral Motion Measurements

Ortho Kinematics Inc. conducted in vivo repeatability testing for intervertebral motion measurements.  The repeatability study involved a prospective analysis of retrospectively collected image data from 40 cervical and 62 lumbar patients representative of the expected clinical population for the VMA system.  Two types of Inter-vertebral Rotation (IVR) and Inter-vertebral Translation (IVT) measurements were created: (i) VMA software based measurements; and (ii) standard of care hardcopy, ruler, and protractor-based method.  Each of the two measurement approaches was performed by three observers for each of the patients in the study. For this study, lumbar images were captured at a frame rate of 4 frames per second, the images were sized at 1k x 1k pixels, and each pixel was captured as an 8 bit value. After being captured, these images were then lossy-compressed using JPEG compression configured at a 90% quality level. Cervical images were captured with the same parameters except for the frame rate, which was 8 frames per second.

The repeatability is measured by the mean absolute error. Mean absolute error is defined as the average of the absolute differences between two measurements taken from the same patient across a set of patients. A higher mean absolute error measurement indicates a less repeatable measurement system. The mean absolute error is summarized below in Table 2. The repeatability seen in both the lumbar and cervical spine is adequate for clinical decision-making.

 

Table 2:  Repeatability of VMA System: Lumbar and Cervical Measurements

 


Measurement

VMA

Lumbar Measurements

VMA

Cervical Measurements

Inter-vertebral rotation measurements

2.5°

3.4°

Inter-vertebral translation measurements

1.2 mm

0.8 mm

Note that for thoracic measurements, repeatability and accuracy are comparable to the ranges listed above for cervical measurements, based on literature analysis demonstrating comparable levels of repeatability and accuracy between measurements of cervical and thoracic intervertebral motion measurements.

 

Repeatability of Alignment Measurements

Ortho Kinematics Inc. conducted in vivo repeatability testing for alignment measurements.  The repeatability study involved a prospective analysis of retrospectively collected image data from 62 plain x-ray long films of the entire spine (cranium to the pelvis) drawn from a representative of the expected clinical population for the VMA system.  Each of the alignment measurements was measured by three observers for each of the patients in the study.

The repeatability is measured by the Interclass Correlation Coefficient (ICC), and also expressed in terms of mean absolute disagreement. A higher ICC value and a lower mean absolute disagreement value indicate a more repeatable measurement system. The ICC and mean absolute disagreement data is summarized below in Table 3. The repeatability seen in alignment measures coming from the VMA system is adequate for clinical decision-making.

 

Table 3:  Repeatability of VMA System: Alignment Measurements

 


VMA Measurement

VMA Measurement Repeatability (ICC)

VMA Measurement Repeatability (mean absolute disagreement)

Sagittal Vertical Axes

 

 

C2-C7 SVA

0.99

1.1 mm

C2-S1 SVA

0.99

1.5 mm

C7-S1 SVA

0.99

2.0 mm

Pelvic Incidence (PI)

0.98

3.4

Pelvic Tilt (PT)

0.99

1.0

Sacral Slope (SS)

0.97

2.9

Thoracic Kyphosis (TK)

0.99

4.5

T1 Pelvic Angle (TPA)

0.99

0.7

 

Note that the values provided in Table 3 are based on a study of measurements taken from plain x-ray images.  The VMA system can also generate certain of these parameters from fluoroscopic images (PI, PT, and SS).  In the case of fluoroscopic images note that the repeatability may be worse than what is listed in Table 3 above, as fluoroscopic imaging can involve poorer contrast images which can reduce measurement repeatability.

 

 


 

Instructions for Use

All components of the system must be ready for use:

·         The VMA patient handling and data collection device (VMA hardware) must be installed at a clinical site and put into service by an authorized Ortho Kinematics Inc. representative. Users must be appropriately trained.

·         Access to the centralized image processing service that runs the VMA Image Processing service must be obtained. Please contact the manufacturer for more information about how to arrange for access to the software via this service.

 

Image Acquisition: May be achieved using the VMA hardware or via PACS from any digital x-ray unit.

 

Image generation using the VMA hardware.

 

This step is initiated when a clinical imaging technician receives a test order form from a physician or other duly-authorized clinical professional. The testing process can occur once the imaging technician has received the complete test order form and the imaging technician and testing subject are together in a clinical fluoroscopy procedure room with an appropriate fluoroscope and radiological table. Listed below are the major steps of the testing process. Refer to the VMA Image Acquisition User’s Manual for complete instructions.

·         Prepare for testing:

o   Prepare workspace with mobile C-arm fluoroscopy unit or other appropriately configured fluoroscopy unit.

o   Transport the stored rollable components of the VMA hardware into the procedure room.

o   Configure the room for workflow; connect, power up, and initialize all system components.

·         When the subject arrives, prepare the subject for testing.

o   Refer to the VMA hardware User’s Manual. 

o   All patients should wear a hospital gown when in contact with the VMA hardware

o   Standard imaging practices should be followed and general patient condition should be monitored to ensure the patient is capable of undergoing image acquisition. If, at any time, the patient experiences pain or discomfort, the image acquisition event should be stopped and the patient’s physician consulted.

·         Ensure the imaging device is properly configured and operational. Ensure the proper bolsters and accessories are being used as appropriate for lumbar vs. cervical assessments.  Refer to the imaging device’s user manual for specific instructions.

·         If appropriate, set specific bending parameters, such as rate or range, as prescribed.

·         Initiate a testing imaging event on both the image device and the Console by inputting data into both devices.

·         Conduct bending and imaging routines as prescribed, recording and aggregating data on the Console.

·         Multiple types of bending / imaging routines may be accomplished:

o   Device-assisted lumbar or cervical bending routines during live fluoroscopic imaging:

§  For Lumbar: this can be either recumbent (with the Table) or standing (with the Upright). Both the Table and Upright can do either flexion/extension bending (lateral imaging) and/or left/right bending (anterior/posterior imaging).

§  For Cervical: this can be done seated (on the Upright) for flexion/extension only. Remember to always place a hospital sheet, pillow cover, gown, or some other clean fabric cover over the face cradle on the upright to prevent contact with patient’s facial skin and the face cradle.

§  Testing process: (1) conduct practice unassisted lumbar or cervical bending with subject before engaging the subject with the device to confirm spinal mobility; (2) engage subject with the device, position patient, and instruct patient handling device on use of stop switch (in the case of using the Upright, don’t forget to position the calibration marker in the field of imaging as per the instructions in the User’s Manual); (3) take patient through practice device-assisted bending; (4) conduct device-assisted bending while capturing live fluoroscopic images; (5) review and accept image data on Console; and (6) repeat as necessary to capture all prescribed routines.

o   Still imaging with the patient prone or supine on the Table (Lumbar only)

§  Testing process: (1) It is suggested to acquire these images prior to collecting the flexion and extension cines on the table; (2) place the patient supine on the table; (3) position the C-arm in order to acquire cross-table lateral still images, and capture a live fluoroscopic image; (4) switch the patient to a prone position and acquire another cross-table lateral still image (if desired).

o   Unassisted standing fluoroscopic stills. 

§  This could be any view of the lumbar or cervical spine.  This could include (but is not limited to): bending images, images in a neutral posture, oblique views, pelvic views (lateral), calibration views (see User Manual), and others.

§  For lumbar:

·         Testing process: (1) have patient stand against fluoroscope in the desired posture; (2) capture a still fluoroscopic image frame; (3) interact with the Console to record and label the image; and (4) repeat as necessary to capture all prescribed images.

·         In the case of a lateral pelvic view, assure that both the sacrum and both femoral heads are in view, and that the plumb line indicator accessory is engaged. Lateral pelvic views are collected so that they can be processed to produce spino-pelvic parameters.

§  For cervical

·          Testing process: (1) have patient sit on a stool with their left shoulder against fluoroscope in the desired posture; (2) capture a still fluoroscopic image frame; (3) interact with the Console to record and label the image; and (4) repeat as necessary to capture all prescribed images.

·         Testing subject leaves and testing event is finished.

·         Subsequent to the exit of the testing subject:

o   Images are transferred to a removable media, as directed by the imaging technician.

o   The imaging technician logs onto VMA DataLink Software using the username and password supplied by Ortho Kinematics Inc. and uploads the image data for processing.

o   VMA Image Acquisition system devices are configured for storage and transported to a storage location.

·         Refer to the VMA Image Acquisition User’s Manual for more detailed instructions.

 

Digital x-rays via PACS

Images may be uploaded for processing from a PACS system. Contact Ortho Kinematics to establish the appropriate connection.

Image Processing occurs subsequent to image generation using VMA Image Processing Software operated via a centralized service. 

This step is initiated by the transfer of DICOM image files by a physician or other clinical professional to the centralized image processing service via VMA DataLink Software. Image processing can occur once the DICOM files generated during image generation are received by the centralized processing facility.  The user of the software at the centralized facility then performs the following steps:

·         Logs into VMA DataLink Software using the username and password supplied by Ortho Kinematics Inc. to establish an image processing session.

·         Access and review DICOM images via the VMA DataLink Software:

o   View the set of DICOM files from a subject’s testing event.

o   Select the DICOM file to process.

·         For processing cine sequences of device-assisted bending:

o   Generate quantitative motion assessments that require manual review and user acceptance:

§  Place reference templates, and blankouts on each vertebra identified by the user.

§  Run tracking.

§  Review tracking data, edit template position or remove data that is judged by the user to be incorrect and/or conduct re-tracking as deemed appropriate by the user.

§  Accept or reject tracking data.

·         For processing still images from unassisted bending:

o   Place reference templates on all vertebral bodies visible for images in the image set, and view motion measurement report on the screen. When the report is complete, the testing process has terminated.

o   Refer to VMA Image Processing User’s Manual for more detailed instructions. 

·         Generate motion and alignment analysis reports that integrate data from images with all other sources.

 

Image Review occurs subsequent to Image Processing.

This step is initiated when a prescriber or other clinical professional logs into the VMA DataLink Software using the username and password supplied by Ortho Kinematics Inc. to establish an image review session. Image review can occur once the DICOM files generated during image generation have been processed. The user is able to view all tests prescribed by each user as well as the tests’ processing status. Once the user selects a processed test for viewing, the user then performs the following steps:

·         Access and review processed images:

o   Template confirmation by end user (prescriber or authorized radiologist)

o   View the set of report files from a subject’s testing event.

o   Print reports in PDF format.

o   View processed cine files in VMA viewer.

o   Print screenshots of any screen in VMA viewer (subject to HIPAA regulations).

·         Access and review “physician alerts”, which are alerts that can be configured by users to indicate whenever specific types of user-defined anomalies are present in patient results.

o   “physician alerts” must first be configured by the user via VMA DataLink Software. 

o   Once configured, these “physician alerts” can be accessed and reviewed in two ways: (1) on the physician portal screen, which is the screen that appears to the user immediately after the user logs in, alert icons are presented to indicate the presence or absence of alerts, and (2) via Image Review software by clicking on the button that says “physician alerts” located on the navigation panel on the left side of the screen.

o   Once all templates have been reviewed, it is possible to auto-generate “read report” text based on user-defined parameters that are configured at the time that “physician alerts” are configured via VMA DataLink Software. The user has the ability to edit this text, and to “sign” the text, which creates a PDF report that includes the edited text that can be accessed by other users of  VMA DataLink Software that have access to the patient test results.

·         In addition to accessing processed testing results via VMA Image Review Software, it is also possible to access patient test results via the physician portal screen, which is the screen that appears to the user immediately after the user logs in.  Via this screen, it is possible to access the same PDF reports that are accessible via VMA Image Review Software, as well as any “read reports” which have been previously “signed” by any user.

·         Refer to the VMA hardware User’s Manual for more detailed instructions.

 

Technical Specifications

VMA Patient Handling and Data Collection Device:

·         The Console accepts standard 120V/60Hz power via a medical-grade 3-prong connecter, and can be configured by the manufacturer to accept 240V/50Hz power. 

·         Dimension:

§  Console: 31” wide, 31” deep, 71” tall and weighs approximately 199 lbs (90 kg). If the console is configured for use with 240V/50Hz supply mains, the weight is approximately 231 lbs (105 kg).

§  Upright Device: 45” wide, 31” deep, 53-80” tall (adjustable height) and weighs approximately 258 lbs (117 kg).

§  Table Device: 87” wide, 52” deep, 5-14” tall and weighs approximately 88 lbs (40 kg).

·         Range of motion possible:

o   Upright Device:  40 degrees from top dead center in both directions

o   Table Device:  40 degrees from top dead center in both directions

·         Required Off-The-Shelf Accessories

o   Standard surgical fluoroscope (C-arm)

o   Standard fluoroscopic procedure table

§  Able to accommodate at least 374lbs (170 kg)

§  Radiolucency as per industry standards

o   Standard removable media like USB media

VMA DataLink Software (and access to the Image Review software):

·         System requirements for OTS components:

o   Image review workstation (PC)

§  Process: Pentium 4 equivalent or better

§  Ram Memory: 4 GB

§  Monitor:  Resolution of 1280x800 pixels or greater suitable for medical diagnostic image review

o   Required installed software

§  Internet Browser i.e. Internet Explorer, Firefox, etc., that supports HTML5

§  PC running Microsoft Windows 7 Professional or newer with the latest security patches installed

§  Recommended use of firewall and installation of the latest anti-virus software with updated definitions

§   

§  NOTE: It is important to regularly update anti-virus definitions and check for new Windows security patches!

Materials

·         The VMA patient handling and data collection device features electromechanical table top and free-standing components that guide the patient through normal bending motions. The components that physically contact the patient (via the patient’s clothes) are manufactured from standard radiograph table materials (nylon covers, padded grips).  Other materials used in the construction of the device include: stainless steel, PVC plastic, and the electrical wiring/components that allow for motion. Note that the patient must be wearing clothes or a hospital gown during testing, such contact between the device and the patient’s skin is limited to the patient’s hands. Note that when configured for cervical assessments, a sheet, pillow case, or some other type of single use covering must be applied to the face cradle to prevent contact between the patient’s skin and the face cradle.

Software Statement

·         The system software has been validated and demonstrates confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.

Installation & Training

·         The components of VMA software accessible by users via a standard internet browser require no installation. The components that operate on cloud-hosted servers must be professionally installed by an Ortho Kinematics Inc. representative or designee. See “Additional Information” section above regarding software availability.

·         All components of VMA hardware are shipped complete and installed on site by an Ortho Kinematics Inc. representative. 

·         Training of users is conducted by an authorized Ortho Kinematics, Inc. representative.

Cleaning & Sterilization

·         The cleaning and sterilization requirements of the system should follow the standard protocol for cleaning and sterilizing patient tables and imaging equipment that comes into contact with a patient in the user facility. This shall include, but not be limited to, use of an antiseptic wipe or disinfectant spray, cleaning with antibacterial soap, and thorough rinse/wipe.

 

 

Disclaimers

 

·         Patients must be advised by their physician or the responsible clinical professional regarding the risks associated with medical imaging.

·         Patients should be advised prior to image acquisition in conjunction with the VMA patient handling and data collection device about the range of motion and physical requirements of the motion they will undergo during image acquisition.

·         All users of VMA software and the VMA patient handling and data collection device must be properly trained to the use of the system, prior to use.

·         All data and information generated by VMA software must be reviewed and assessed by a physician or clinical professional.

·         Ortho Kinematics Inc. cannot be held responsible for misuse of the system, or for mis-diagnosis with the reports or information generated by the VMA software.

·         All uses of the VMA system must be within an environment that complies with all applicable regulations regarding patient information privacy and security.

Complaints

·         Any physician or clinical professional who has a complaint or is dissatisfied with the quality, operation, reliability, safety, efficacy, and/or performance of system should notify Ortho Kinematics Inc. In the event of an incident or risk of a serious incident liable to result in, or to have resulted in, the death or serious deterioration in the health condition of a patient or user, telephone, fax, email or letter should notify Ortho Kinematics Inc. as soon as possible. All complaints should be accompanied by the name(s), reference(s), and batch number(s) of the component(s). The person reporting the complaint should give as many details as possible about the event, and provide contact information.

 

To order paper copy of this IFU

Paper version of this IFU may be ordered in English or French version from the manufacturer per the contact information provided below. Please consider the environmental impact before ordering.

·         If requesting by email, include in subject line: “User Manual”

·         If requesting by mail, send to “Attn: Compliance”

·         Si vous demandez version française, s'il vous plaît préciser dans la demande. If requesting French language version, please specify this in request.

IMPORTANT! - Please include return address and any other pertinent shipping information with request.

 

Contact Information / Coordonnées:

 

Ortho Kinematics, Inc.

110 Wild Basin Rd.

Suite 250                                                                                                                      

Austin, TX 78746

Phone:  (512) 334 5490

Fax:  (512) 334 5500

Email: compliance@orthokinematics.com