{"id":1654,"date":"2024-10-28T20:26:14","date_gmt":"2024-10-28T20:26:14","guid":{"rendered":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/?page_id=1654"},"modified":"2024-10-30T21:17:59","modified_gmt":"2024-10-30T21:17:59","slug":"rjb-ifu","status":"publish","type":"page","link":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/?page_id=1654","title":{"rendered":"The RJB\u2122 IFU"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"1654\" class=\"elementor elementor-1654\" data-elementor-post-type=\"page\">\n\t\t\t\t<main class=\"elementor-element elementor-element-def821d e-flex e-con-boxed e-con e-parent\" data-id=\"def821d\" data-element_type=\"container\" id=\"Content\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-8733bac e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"8733bac\" data-element_type=\"container\" id=\"Top\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-15c8d09 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"15c8d09\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;lightSpeedIn&quot;,&quot;_animation_delay&quot;:200}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">The RJB\u2122 | IFU<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-390c235 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"390c235\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;_animation_delay&quot;:0}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">RJB-IFU1-01 Rev B \u2013 Released 10\/24\/2023<\/span><span style=\"font-weight: 400;\"><br \/><\/span><span style=\"font-weight: 400;\">US Patent No. 11,484,381; Additional US and foreign patents pending<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-61f41c8 elementor-widget elementor-widget-button\" data-id=\"61f41c8\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/ruthlessspine.com\/ruthless-spine-s\/wp-content\/uploads\/2024\/10\/RJB-IFU1-01-Rev-B.pdf\" download=\"IFU\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-file-download\" viewBox=\"0 0 384 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M224 136V0H24C10.7 0 0 10.7 0 24v464c0 13.3 10.7 24 24 24h336c13.3 0 24-10.7 24-24V160H248c-13.2 0-24-10.8-24-24zm76.45 211.36l-96.42 95.7c-6.65 6.61-17.39 6.61-24.04 0l-96.42-95.7C73.42 337.29 80.54 320 94.82 320H160v-80c0-8.84 7.16-16 16-16h32c8.84 0 16 7.16 16 16v80h65.18c14.28 0 21.4 17.29 11.27 27.36zM377 105L279.1 7c-4.5-4.5-10.6-7-17-7H256v128h128v-6.1c0-6.3-2.5-12.4-7-16.9z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Download as a  PDF<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2bb52e0 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"2bb52e0\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;_animation_delay&quot;:0}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">IMPORTANT INFORMATION FOR PHYSICIANS, SURGEONS, AND STAFF<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d7371a5 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"d7371a5\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><b>CAUTION: <\/b><span style=\"font-weight: 400;\">Federal (USA) law restricts this device to sale by or on the order of a physician.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cThis device complies with part 15 of the FCC rules. Operation is subject to the following two conditions.<\/span><span style=\"font-weight: 400;\"><br \/><\/span><span style=\"font-weight: 400;\">1. This device may not cause harmful interference.<\/span><span style=\"font-weight: 400;\"><br \/><\/span><span style=\"font-weight: 400;\">2. This device must accept any interference received, including interference that may cause undesired operation.\u201d<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2b2415c elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"2b2415c\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;_animation_delay&quot;:0}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Table of Contents<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d7d7017 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"d7d7017\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;_animation_delay&quot;:0}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Select any chapter directory below to navigate directly to its section.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-75c07f3 elementor-widget elementor-widget-text-editor\" data-id=\"75c07f3\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><strong><a href=\"#Device-Description\">Device Description<\/a><\/strong><\/p><p><a href=\"#Device-Characteristics\"><strong>Device Characteristics<\/strong><\/a><\/p><p><a href=\"#Wireless-Technology\"><strong>Wireless Technology<\/strong><\/a><\/p><p><a href=\"#Indications-for-Use\"><strong>Indications for Use<\/strong><\/a><\/p><p><a href=\"#Limitations\"><strong>Limitations<\/strong><\/a><\/p><p><a href=\"#Warnings\"><strong>Warnings<\/strong><\/a><\/p><p><a href=\"#Contraindications\"><strong>Contraindications<\/strong><\/a><\/p><p><a href=\"#Cleaning-and-Sterilization\"><strong>Cleaning and Sterilization<\/strong><\/a><\/p><p><a href=\"#Storage-and-Handling\"><strong>Storage and Handling<\/strong><\/a><\/p><p><a href=\"#Tablet-and-App-Requirements\"><strong>Tablet and App Requirements\u00a0<\/strong><\/a><\/p><p><a href=\"#Tablet-and-App-Installation-Instructions\"><strong>Tablet and App Installation Instructions<\/strong><\/a><\/p><p><a href=\"#RJB-Operating-Instructions\"><strong>RJB Operating Instructions<\/strong><\/a><\/p><p><a href=\"#Product-Complaints\"><strong>Product Complaints\u00a0<\/strong><\/a><\/p><p><a href=\"#Label-Symbols\"><strong>Label Symbols<\/strong><\/a><\/p><p><a href=\"#AppendixA\"><strong>Appendix A &#8211; System Component Identification<\/strong><\/a><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-587ace3 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"587ace3\" data-element_type=\"widget\" id=\"Device-Description\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;_animation_delay&quot;:0}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Device Description<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7b2b9be elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"7b2b9be\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The Ruthless Spine RJB device is an intraoperative surgical angle measurement guide that attaches to surgical instruments to measure the angle of the instrument relative to a vertical plumb line in line with gravity. The device can measure the axial and sagittal angles relative to gravity. The RJB system only provides measurements for angles in two planes relative to the vertical gravitational plumb line. As such, the RJB device does not provide surgical assistance, guidance, or navigation against patient anatomy. The RJB device is not intended to replace a surgeon\u2019s clinical judgement and has not undergone clinical evaluation. No clinical benefit has been demonstrated or is claimed.<\/span><\/p><p><span style=\"font-weight: 400;\">The RJB device is provided sterile for single use and utilizes Bluetooth Low Energy (BLE) to connect to a tablet computer and display the angle measurements via the RJB Application (App). A set of handles and instruments compatible with the RJB are provided with the device for use in lumbosacral pedicle screw placement. The following components are part of the RJB system:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">RJB Device<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Quick Connect Axial Ratcheting Handle<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Straight Probe<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Duckbill Probe<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">RJB Application<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">Note, a Tablet Computer is required to operate the device. The Tablet is not provided to the end user.<\/span><\/p><p><span style=\"font-weight: 400;\">See <a href=\"#AppendixA\">Appendix A<\/a> for a complete listing of system components, part numbers, and accompanying images\/illustrations.<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-86920d3 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"86920d3\" data-element_type=\"widget\" id=\"Device-Characteristics\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;_animation_delay&quot;:0}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Device Characteristics<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-edbbb53 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"edbbb53\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\"><strong>Model:<\/strong> RJB6<\/span><span style=\"font-weight: 400;\"><br \/><\/span><span style=\"font-weight: 400;\"><strong>Precision of Displayed Values:<\/strong> User choice of 0.5 or 1\u00b0 in app<\/span><span style=\"font-weight: 400;\"><br \/><\/span><span style=\"font-weight: 400;\"><strong>Procedural Measurement Accuracy*<\/strong>: \u00b13\u00b0<\/span><span style=\"font-weight: 400;\"><br \/><\/span><span style=\"font-weight: 400;\">*Measurements made relative to a vertical plumb line in line with gravity. This measurement accuracy was determined through simulated use testing of the device in a lumbar pedicle screw placement procedure.<\/span><\/p>\n<p><span style=\"font-weight: 400;\"><strong>Operating Condition:<\/strong> -18 \u2013 55\u00b0C, 15 \u2013 90% relative humidity, 70 \u2013 106 kPa<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6633317 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"6633317\" data-element_type=\"widget\" id=\"Wireless-Technology\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;_animation_delay&quot;:0}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Wireless Technology<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-760f6c9 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"760f6c9\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">RJB uses low energy Bluetooth (Bluetooth Core Specification 4.0) Bluetooth module FCC ID: SH6MDBT42Q<\/span><span style=\"font-weight: 400;\"><br \/><\/span><span style=\"font-weight: 400;\">RJB has a Qualified Design ID (QDID) of 125047<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1975fae elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"1975fae\" data-element_type=\"widget\" id=\"Indications-for-Use\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;_animation_delay&quot;:0}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Indications for Use<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d408c3a elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"d408c3a\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The Ruthless Spine RJB device is intended to measure the angle of surgical instruments in two planes relative to a vertical plumb line in line with gravity. It is indicated for use during lumbosacral pedicle screw implantation in conjunction with applicable spinal instrumentation and as an adjunct to fluoroscopy or intraoperative x-ray. The RJB device is not intended to replace a surgeon&#8217;s judgment and has not undergone clinical evaluation. No clinical benefit has been demonstrated or is claimed.<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5c27b7e elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"5c27b7e\" data-element_type=\"widget\" id=\"Limitations\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;_animation_delay&quot;:0}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Limitations<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-eb425a9 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"eb425a9\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">No clinical studies, Real World Data (RWD) or Real World Evidence (RWE), or other information are available to evaluate the effect of patient demographics, such as race and ethnicity, on RJB device performance.<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9027de2 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"9027de2\" data-element_type=\"widget\" id=\"Warnings\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;_animation_delay&quot;:0}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Warnings<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5a6c453 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"5a6c453\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">RJB devices are provided STERILE and must never be reused under any circumstances. Discard any devices that are opened in the operating room but are not used. Re-use of this device may result in serious cross infection or be harmful to the patient.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Do not re-sterilize. Re-sterilization may adversely affect material properties and device performance.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Do not use devices that are received damaged or missing a pull tab.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">No modification of the RJB system is allowed.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The RJB device shall only be used by physicians or surgeons trained in lumbosacral pedicle screw procedures. The RJB app may be used by a designated, trained user outside of the sterile field.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">During RJB use, the instrument may be tilted in the axial and sagittal planes simultaneously but should not be axially rotated about the slotted handle shaft. Rotation of the RJB device around the handle axis during intraoperative angle measurement can introduce significant error.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The RJB system provides measurements for angles in two planes (axial and sagittal) relative to the vertical gravitational plumb line and does not consider patient anatomy or orientation. The RJB is a spatial tool and not a navigation system providing trajectory guidance.<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-03a0fc8 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"03a0fc8\" data-element_type=\"widget\" id=\"Contraindications\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;_animation_delay&quot;:0}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Contraindications<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d1369a0 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"d1369a0\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The device is contraindicated for use in any procedure except for those listed in the Indications for Use.<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-15abcc8 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"15abcc8\" data-element_type=\"widget\" id=\"Cleaning-and-Sterilization\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;_animation_delay&quot;:0}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Cleaning and Sterilization<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cecd983 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"cecd983\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">RJB devices are provided sterile (ethylene oxide sterilization) and are single use. Do not clean or re-sterilize devices. Unused or contaminated devices should be disposed of in accordance with facility protocol. Following use, devices should also be disposed of in accordance with facility protocol.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">RJB instruments and handles are provided visually clean and non-sterile and must be sterilized prior to use. None of the provided instruments or handles are reusable. The following sterilization cycle has been validated for the instruments and handles:<\/span><\/p>\n<p><b>Method: Steam<\/b><\/p>\n<p><b>Cycle: Pre-Vacuum<\/b><\/p>\n<p><b>Temperature: 270\u00b0F (132\u00b0C)<\/b><\/p>\n<p><b>Exposure Time: 4 Minutes<\/b><\/p>\n<p><b>Dry time: 20 Minutes<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Instruments should be placed in an FDA-cleared tray and double wrapped in an FDA-cleared sterilization wrap both indicated for the sterilization parameter included in the Instructions for Use. Instruments should be positioned to allow the steam to come into contact with all surfaces. Remove all packaging material prior to sterilization. Only sterile instruments should be used in surgery.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Do not clean or re-sterilize instruments. Unused or contaminated instruments should be disposed of in accordance with facility protocol. Following use, instruments should also be disposed in accordance with facility protocol.<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b01f147 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"b01f147\" data-element_type=\"widget\" id=\"Storage-and-Handling\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;_animation_delay&quot;:0}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Storage and Handling<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8316b17 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"8316b17\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Store sterile packaged devices in a manner that provides protection from dust, moisture, insects, vermin, and extremes of temperature and humidity.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Storage Condition: -18 \u2013 50\u00b0C, 15 \u2013 90% relative humidity, 70 \u2013 106 kPa<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3d3c079 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"3d3c079\" data-element_type=\"widget\" id=\"Tablet-and-App-Requirements\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;_animation_delay&quot;:0}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Tablet and App Requirements <\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-25ae6f0 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"25ae6f0\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The tablet used for running the RJB App is supplied by the user and must be dedicated to RJB App use and not be used for any other purpose. The following are the minimum tablet specifications required for the RJB App:<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Minimum Tablet Requirements:<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-54cc3dc elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"54cc3dc\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;_animation_delay&quot;:0}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Apple<\/h4>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9079774 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"9079774\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">iPad Pro 11\u201d (4th Generation) and above<\/span><span style=\"font-weight: 400;\"><br \/><\/span><b>Storage:<\/b><span style=\"font-weight: 400;\"> 128GB<\/span><span style=\"font-weight: 400;\"><br \/><\/span><b>iOS:<\/b><span style=\"font-weight: 400;\"> 14 and above<\/span><span style=\"font-weight: 400;\"><br \/><\/span><b>Camera:<\/b><span style=\"font-weight: 400;\"> Camera access is desirable but not required (device barcode may be input manually) Bluetooth: 4.0 and above<\/span><\/p>\n<p><b>Wi-Fi:<\/b><span style=\"font-weight: 400;\"> Is required to download the app but is not necessary for App usage Cellular connectivity: Not required<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0bd1234 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"0bd1234\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;_animation_delay&quot;:0}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Android<\/h4>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6071912 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"6071912\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><b>Storage:<\/b><span style=\"font-weight: 400;\"> 32GB<\/span><span style=\"font-weight: 400;\"><br \/><\/span><b>Android OS:<\/b><span style=\"font-weight: 400;\"> 10 and above<\/span><span style=\"font-weight: 400;\"><br \/><\/span><b>Processor Specifications:<\/b><span style=\"font-weight: 400;\"> 2.0 GHz<\/span><span style=\"font-weight: 400;\"><br \/><\/span><b>Memory:<\/b><span style=\"font-weight: 400;\"> 2GB RAM<\/span><span style=\"font-weight: 400;\"><br \/><\/span><b>Camera: <\/b><span style=\"font-weight: 400;\">Camera access is desirable but not required (device barcode may be input manually).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">If camera function is utilized, minimum camera resolution is an 8MP main camera with auto-focus. <\/span><b>Bluetooth:<\/b><span style=\"font-weight: 400;\"> 4.0 and above<\/span><\/p>\n<p><b>Wi-Fi:<\/b><span style=\"font-weight: 400;\"> Is required to download the app but is not necessary for App usage Cellular connectivity: Not required<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b0ade0f elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"b0ade0f\" data-element_type=\"widget\" id=\"Tablet-and-App-Installation-Instructions\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;_animation_delay&quot;:0}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Tablet and App Installation Instructions<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-283b0a5 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"283b0a5\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Do not download or install any applications or programs on the tablet apart from the RJB App and security-based tablet software. A Wi-Fi connection is not required for RJB App usage but must be enabled for app installation and updating. Install all tablet operating system updates prior to App use using only known safe and secure networks outside of the hospital. App updates should only be performed when the user is directed to update the app. The user will be informed directly by Ruthless Spine of the need for an update and does not need to rely on Apple or Google Play store update notifications. Do not enable Wi-Fi or connect the tablet to any network during App use. Turn off all other Bluetooth devices in the operating room (use environment) during RJB pairing with the tablet. Do not allow the tablet to be plugged into any external USB computers, networks, or other peripherals during App use. Only factory delivered charging cables and adapters should be used.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">1. Download the RJB App from the iTunes store (Apple tablets) or from a one-way download link provided directly to the user (Android tablets) using a known safe and secure Wi-Fi network outside of the hospital.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">2. Turn on Do Not Disturb Mode on tablet.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\"><em><strong>Apple:<\/strong><\/em> Go to Settings -&gt; Do Not Disturb and turn it ON. The options should be as follows: Scheduled is OFF, Silence is \u201cAlways\u201d, Phone is \u201cAllow Calls From No One\u201d, Repeated Calls is OFF.<\/span><\/p>\n<p><span style=\"font-weight: 400;\"><em><strong>Android:<\/strong><\/em> Go to Settings -&gt; Notifications -&gt; Do Not Disturb and turn it ON. The options should be as follows: Turn On as Scheduled is OFF, Duration is \u201cUntil I Turn it Off\u201d, Hide Notifications -&gt; Hide All is ON, Allow exceptions -&gt; Calls From is \u201cNone\u201d, Repeat Callers is OFF, Messages From is \u201cNone\u201d, Alarms is OFF, Media Sound is ON, Touch Sounds is ON, Calendar Events is OFF, Reminders is OFF.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">3. Turn off Wi-Fi on tablet.<\/span><span style=\"font-weight: 400;\"><br \/><\/span><\/p>\n<p><span style=\"font-weight: 400;\"><em><strong>Apple:<\/strong><\/em> Go to Settings -&gt; Wi-Fi, Wi-Fi is OFF.<\/span><span style=\"font-weight: 400;\"><br \/><\/span><\/p>\n<p><span style=\"font-weight: 400;\"><em><strong>Android:<\/strong> <\/em>Go to Settings -&gt; Connections, Wi-Fi is OFF.<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5d242ea elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"5d242ea\" data-element_type=\"widget\" id=\"RJB-Operating-Instructions\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;_animation_delay&quot;:0}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">RJB Operating Instructions<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d618fa5 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"d618fa5\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ol>\n<li><span style=\"font-weight: 400;\"> Turn on the RJB device by removing and discarding the battery pull tab.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Insert the RJB device into the handle slot. Follow the markings for device orientation. The slot should only allow the device to be inserted in one way.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Deploy the Ruthless RJB app on a tablet.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">When the app is opened, a tablet screen prompts to pair the RJB device. The RJB identifier can be scanned from the label or manually inputted.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">After pairing the device, a prompt will appear to select the instrument type.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Once the instrument type is selected, the starting screen will appear. From here, the user can see the angle of the device, hold the angle, offset the angle, edit the instrument name, choose display precision, and watch tutorial videos. <\/span>Hold and offset features are controlled via touchscreen buttons in the tablet app.<\/li>\n<li><span style=\"font-weight: 400;\"> For use, the instrument should be oriented such that the face of the RJB (marked with \u2018UP\u2019 and \u2018DOWN\u2019 and visible through the front of the handle slot) is in a plane parallel with the plane of the operating table, without introducing rotation about the instrument shaft. During use, the instrument may be tilted in the axial and sagittal planes simultaneously but should not be rotated about its own shaft. Use the marked face of the RJB to reference the position of the instrument throughout the procedure.<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> When using the RJB, it is recommended that the surgeon follow standard fluoroscopy-guided technique, utilizing fluoroscopy as necessary to confirm pedicle screw trajectory intraoperatively. The RJB is a spatial tool and not a navigation system providing trajectory guidance.<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> If Bluetooth connection is lost (displayed angles disappear or freeze), restart app. <\/span>If RJB device does not pair, turn on, or app does not restart, discard the device by disposing in <span>accordance with facility protocol. Revert to standard fluoroscopy-guided technique to complete the <\/span><span>procedure.<\/span><\/li>\n<\/ol>\n<ol start=\"10\">\n<li><span style=\"font-weight: 400;\"> To terminate operation of the device, close the RJB app. Remove RJB from the instrument handle and dispose <\/span>in accordance with facility protocol.<\/li>\n<\/ol>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-39dd188 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"39dd188\" data-element_type=\"widget\" id=\"Product-Complaints\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;_animation_delay&quot;:0}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Product Complaints <\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3f93064 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"3f93064\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"page\" title=\"Page 5\">\n<div class=\"layoutArea\">\n<div class=\"column\">\n<p>Any healthcare professional (e.g., customer or user) who has a complaint or who has experienced any dissatisfaction in the product quality, durability, reliability, safety, effectiveness, and\/or performance should notify the distributor and\/or Ruthless Spine:<\/p>\n<p>Ruthless, LLC dba Ruthless Spine<\/p>\n<p>1438 Arrow Hwy, Ste F Irwindale, CA 91706<\/p>\n<p>855-496-3454<\/p>\n<p>info@ruthlessspine.com<\/p>\n<p>When reporting a complaint, please provide the unique identification number (UDI) or the lot number, your name and phone number, and the nature of the problem.<\/p>\n<p>The surgical technique is available at no charge upon request.<\/p>\n<\/div>\n<\/div>\n<\/div>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-53ff8b3 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"53ff8b3\" data-element_type=\"widget\" id=\"Label-Symbols\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;_animation_delay&quot;:0}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Label Symbols<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2a190e4 elementor-invisible elementor-widget elementor-widget-image\" data-id=\"2a190e4\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1080\" height=\"1520\" src=\"https:\/\/ruthlessspine.com\/ruthless-spine-s\/wp-content\/uploads\/2024\/10\/Labeling.webp\" class=\"attachment-full size-full wp-image-1673\" alt=\"Label Symbols Page from Ruthless Spine RJB IFU manual. ISO 15223-1 Medical device \u2013 Symbols to be used with medical device labels, labelling and information to be supplied \u2013 Part 1: General Requirements\" srcset=\"https:\/\/ruthlessspine.com\/ruthless-spine-s\/wp-content\/uploads\/2024\/10\/Labeling.webp 1080w, https:\/\/ruthlessspine.com\/ruthless-spine-s\/wp-content\/uploads\/2024\/10\/Labeling-213x300.webp 213w, https:\/\/ruthlessspine.com\/ruthless-spine-s\/wp-content\/uploads\/2024\/10\/Labeling-728x1024.webp 728w, https:\/\/ruthlessspine.com\/ruthless-spine-s\/wp-content\/uploads\/2024\/10\/Labeling-768x1081.webp 768w, https:\/\/ruthlessspine.com\/ruthless-spine-s\/wp-content\/uploads\/2024\/10\/Labeling-600x844.webp 600w\" sizes=\"(max-width: 1080px) 100vw, 1080px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fba9f06 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"fba9f06\" data-element_type=\"widget\" id=\"AppendixA\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;_animation_delay&quot;:0}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Appendix A - System Component Identification<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0dfe614 elementor-invisible elementor-widget elementor-widget-image\" data-id=\"0dfe614\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1064\" height=\"1801\" src=\"https:\/\/ruthlessspine.com\/ruthless-spine-s\/wp-content\/uploads\/2024\/10\/Parts.webp\" class=\"attachment-full size-full wp-image-1674\" alt=\"Appendix A \u2013 System Component Identification With Part Number, System Component Description and Image\/Illustration\" srcset=\"https:\/\/ruthlessspine.com\/ruthless-spine-s\/wp-content\/uploads\/2024\/10\/Parts.webp 1064w, https:\/\/ruthlessspine.com\/ruthless-spine-s\/wp-content\/uploads\/2024\/10\/Parts-177x300.webp 177w, https:\/\/ruthlessspine.com\/ruthless-spine-s\/wp-content\/uploads\/2024\/10\/Parts-605x1024.webp 605w, https:\/\/ruthlessspine.com\/ruthless-spine-s\/wp-content\/uploads\/2024\/10\/Parts-768x1300.webp 768w, https:\/\/ruthlessspine.com\/ruthless-spine-s\/wp-content\/uploads\/2024\/10\/Parts-907x1536.webp 907w, https:\/\/ruthlessspine.com\/ruthless-spine-s\/wp-content\/uploads\/2024\/10\/Parts-600x1016.webp 600w\" sizes=\"(max-width: 1064px) 100vw, 1064px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/main>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Read the IFU ( instructions for use ) for our RJB device. Ensure proper setup and safe, FDA-compliant usage during spinal procedures.<\/p>\n","protected":false},"author":3,"featured_media":349,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"om_disable_all_campaigns":false,"inline_featured_image":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_uf_show_specific_survey":0,"_uf_disable_surveys":false,"footnotes":""},"class_list":["post-1654","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>The RJB\u2122 IFU<\/title>\n<meta name=\"description\" content=\"Read the IFU ( instructions for use ) for our RJB device. Ensure proper setup and safe, FDA-compliant usage during spinal procedures.\" \/>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The RJB\u2122 IFU\" \/>\n<meta property=\"og:description\" content=\"Read the IFU ( instructions for use ) for our RJB device. Ensure proper setup and safe, FDA-compliant usage during spinal procedures.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/ruthlessspine.com\/ruthless-spine-s\/?page_id=1654\" \/>\n<meta property=\"og:site_name\" content=\"Ruthless Spine\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RuthlessSpine\/\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-30T21:17:59+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/ruthlessspine.com\/ruthless-spine-s\/wp-content\/uploads\/2023\/09\/RJB1.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1758\" \/>\n\t<meta property=\"og:image:height\" content=\"980\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"9 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/ruthlessspine.com\/ruthless-spine-s\/?page_id=1654\",\"url\":\"https:\/\/ruthlessspine.com\/ruthless-spine-s\/?page_id=1654\",\"name\":\"The RJB\u2122 IFU\",\"isPartOf\":{\"@id\":\"https:\/\/ruthlessspine.com\/ruthless-spine-s\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/ruthlessspine.com\/ruthless-spine-s\/?page_id=1654#primaryimage\"},\"image\":{\"@id\":\"https:\/\/ruthlessspine.com\/ruthless-spine-s\/?page_id=1654#primaryimage\"},\"thumbnailUrl\":\"https:\/\/ruthlessspine.com\/ruthless-spine-s\/wp-content\/uploads\/2023\/09\/RJB1.jpg\",\"datePublished\":\"2024-10-28T20:26:14+00:00\",\"dateModified\":\"2024-10-30T21:17:59+00:00\",\"description\":\"Read the IFU ( instructions for use ) for our RJB device. Ensure proper setup and safe, FDA-compliant usage during spinal procedures.\",\"breadcrumb\":{\"@id\":\"https:\/\/ruthlessspine.com\/ruthless-spine-s\/?page_id=1654#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/ruthlessspine.com\/ruthless-spine-s\/?page_id=1654\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/ruthlessspine.com\/ruthless-spine-s\/?page_id=1654#primaryimage\",\"url\":\"https:\/\/ruthlessspine.com\/ruthless-spine-s\/wp-content\/uploads\/2023\/09\/RJB1.jpg\",\"contentUrl\":\"https:\/\/ruthlessspine.com\/ruthless-spine-s\/wp-content\/uploads\/2023\/09\/RJB1.jpg\",\"width\":1758,\"height\":980,\"caption\":\"Ruthless Spine RJB Bluetooth measurement tool\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/ruthlessspine.com\/ruthless-spine-s\/?page_id=1654#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/ruthlessspine.com\/ruthless-spine-s\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"The RJB\u2122 IFU\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/ruthlessspine.com\/ruthless-spine-s\/#website\",\"url\":\"https:\/\/ruthlessspine.com\/ruthless-spine-s\/\",\"name\":\"Ruthless Spine\",\"description\":\"It&#039;s time to bring zen back to spine surgery\",\"publisher\":{\"@id\":\"https:\/\/ruthlessspine.com\/ruthless-spine-s\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/ruthlessspine.com\/ruthless-spine-s\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/ruthlessspine.com\/ruthless-spine-s\/#organization\",\"name\":\"Ruthless Spine\",\"url\":\"https:\/\/ruthlessspine.com\/ruthless-spine-s\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/ruthlessspine.com\/ruthless-spine-s\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/ruthlessspine.com\/ruthless-spine-s\/wp-content\/uploads\/2023\/06\/ruthless_rufus2.png\",\"contentUrl\":\"https:\/\/ruthlessspine.com\/ruthless-spine-s\/wp-content\/uploads\/2023\/06\/ruthless_rufus2.png\",\"width\":2550,\"height\":2714,\"caption\":\"Ruthless Spine\"},\"image\":{\"@id\":\"https:\/\/ruthlessspine.com\/ruthless-spine-s\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.facebook.com\/RuthlessSpine\/\",\"https:\/\/www.instagram.com\/ruthlessspine\/\",\"https:\/\/www.linkedin.com\/company\/ruthless-spine\"]}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"The RJB\u2122 IFU","description":"Read the IFU ( instructions for use ) for our RJB device. Ensure proper setup and safe, FDA-compliant usage during spinal procedures.","robots":{"index":"noindex","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"og_locale":"en_US","og_type":"article","og_title":"The RJB\u2122 IFU","og_description":"Read the IFU ( instructions for use ) for our RJB device. Ensure proper setup and safe, FDA-compliant usage during spinal procedures.","og_url":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/?page_id=1654","og_site_name":"Ruthless Spine","article_publisher":"https:\/\/www.facebook.com\/RuthlessSpine\/","article_modified_time":"2024-10-30T21:17:59+00:00","og_image":[{"width":1758,"height":980,"url":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/wp-content\/uploads\/2023\/09\/RJB1.jpg","type":"image\/jpeg"}],"twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"9 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/?page_id=1654","url":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/?page_id=1654","name":"The RJB\u2122 IFU","isPartOf":{"@id":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/#website"},"primaryImageOfPage":{"@id":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/?page_id=1654#primaryimage"},"image":{"@id":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/?page_id=1654#primaryimage"},"thumbnailUrl":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/wp-content\/uploads\/2023\/09\/RJB1.jpg","datePublished":"2024-10-28T20:26:14+00:00","dateModified":"2024-10-30T21:17:59+00:00","description":"Read the IFU ( instructions for use ) for our RJB device. Ensure proper setup and safe, FDA-compliant usage during spinal procedures.","breadcrumb":{"@id":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/?page_id=1654#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/ruthlessspine.com\/ruthless-spine-s\/?page_id=1654"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/?page_id=1654#primaryimage","url":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/wp-content\/uploads\/2023\/09\/RJB1.jpg","contentUrl":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/wp-content\/uploads\/2023\/09\/RJB1.jpg","width":1758,"height":980,"caption":"Ruthless Spine RJB Bluetooth measurement tool"},{"@type":"BreadcrumbList","@id":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/?page_id=1654#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/"},{"@type":"ListItem","position":2,"name":"The RJB\u2122 IFU"}]},{"@type":"WebSite","@id":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/#website","url":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/","name":"Ruthless Spine","description":"It&#039;s time to bring zen back to spine surgery","publisher":{"@id":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/#organization","name":"Ruthless Spine","url":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/#\/schema\/logo\/image\/","url":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/wp-content\/uploads\/2023\/06\/ruthless_rufus2.png","contentUrl":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/wp-content\/uploads\/2023\/06\/ruthless_rufus2.png","width":2550,"height":2714,"caption":"Ruthless Spine"},"image":{"@id":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/RuthlessSpine\/","https:\/\/www.instagram.com\/ruthlessspine\/","https:\/\/www.linkedin.com\/company\/ruthless-spine"]}]}},"_links":{"self":[{"href":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/index.php?rest_route=\/wp\/v2\/pages\/1654","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1654"}],"version-history":[{"count":72,"href":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/index.php?rest_route=\/wp\/v2\/pages\/1654\/revisions"}],"predecessor-version":[{"id":1945,"href":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/index.php?rest_route=\/wp\/v2\/pages\/1654\/revisions\/1945"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/index.php?rest_route=\/wp\/v2\/media\/349"}],"wp:attachment":[{"href":"https:\/\/ruthlessspine.com\/ruthless-spine-s\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1654"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}