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Section: General

Defined

Dashboard

The landing page of vTrakr and Console apps. This contains quick links, analytics about inventory and cases, pending transfers, pending POs, and a quick reference lookup feature.

Navigation bar

Located along the bottom of the page for vTrakr, and the top of the page for the Console, the navigation bar allows the user to access the different domains of the platform: dashboard, inventory, cases, vTray, or account information. A secondary nvaigation bar appears on some screens such as "Inventory" with further navigation options.

Sales Order (Formerly referred to as the Device Usage Ticket (DUT))

The sales order is the document that accounts for all (billable) devices used or sold in a case. This can be printed or emailed to the relevant individuals or accounts (ex. Hospital billing department, manufacturer finance department). The Sales Order is produced as an outcome of a scheduled case (or other event type) being performed and device use recorded. Afterwhich it is used to generate other billing documents by the provider and manufacturer (Purchase order and invoice). The sales order can always be reviewed, revised, or reprinted from the Event Detail screen for that event.

Section: Event

Name

What the user will call the case to esily find and manage it in their records. This is a subjective name and can be any alphanumeric name. It is recommended that the customer determine a naming convention for Event Name to keep consistency across user data.

Procedure Name

The primary clinical name of the procedure being performed in a case. These records are stored in the directory so they may be selected easily by drop-down menu during case/event creation.

Facility

The facility where the surgical case/event will be performed. These records are stored in the directory so they may be selected easily by drop-down menu during case/event creation.

Physician

The primary physician associated with a case/Event record. These records are stored in the directory so they may be selected easily by drop-down menu during case/event creation.

Manufacturer

The manufacturer(s) with inventory being used in the case. These records are stored in the directory so they may be selected easily by drop-down menu during case/event creation.

Case

The name of a surgical case, a type of Event Record in ConnectSx where inventory use or sales are recorded. The case also records the relevant data such as facility, physician, procedure, time, date, etc. This can appear in a device's detail page if it is associated with that case. This can also appear in the case schedule and case detail pages.

Case Record

The record created by scheduling a case. This record holds all case details and allows the user to add inventory that was used, add the case to a calendar, or request inventory from the distributor/manufacturer for use in the case. It can also store photos or notes. And houses the device usage ticket and purchase order number.

Open (case)

An open case is a case that has not been closed yet, which means it has not been reviewed, signed, or PO number recorded.

Closed (case)

A closed case is a case that has been performed and device use has been recorded. Following the case the record was reviewed, signed for, and closed. The Purchase Order number has not yet been added. After the case has been closed, the sales order is available for download and sharing.

Completed (Case)

A Completed case is a closed case that has had the purchase order added to it. This is the final state of a case record.

Mark Used Inventory

This is where a user may record device usage information, such as sales, which will update the status of the item (ex. Used, implanted, damaged, etc.), as well as adding the item to the Sales Order if it is billable. While primarily done in vTrakr by the sales user, This can also be done in the Console by admins and other roles.

Add purchase order

the final step of the case workflow for the sales user, the user will input the purchase order number received from the provider. This will change the status of the case to "Complete". While primarily done in vTrakr by the sales user, This can also be done in the Console by admins and other roles.

Add to Calendar

Function which allows a user to add a scheduled case record to their personal calendars already loaded on their iPhone. vTrakr only.

Patient Info

Allows the user to store information such as Patient name, record ID, date of birth, and a picture of the patient sticker. This information must be protected according to HIPAA standards.

Case Notes

Any notes about the case, preparation or outcomes, surgeon preferences, etc. which will be stored in the case record.

Section: Inventory

Manufacturer

The entity creating and selling the device in question.

Product

The product line the device is associated with. This can also be thought of as brand name, or however you would like to manage your product categories. For instance you might opt to create 1 product line (ex. Bone Screws) or you could create product lines by size ( 3.5mm Bone Screws, 4.5mm Bone Screws, 5.5mm Bone Screws, etc.).

Name

The description of the device used in marketing and so the deivce can be easily found and managed in the users records. This should be an accessible name, but contain enough detail to ensure it can be distinguished from all other devices. Individual devices, by catalog number, are associated with Product Lines.

Reference Number

Sometimes also known as Catalog Number or Item number, this number is used by the manufacturer to identify a device. It is used in ordering, billing, post-market surveillance, etc. Catalog numbers roll up to the product line. Items with the same catalog number can be further differentiated by lot number, expiration date, etc.

Deactivate

Option in device detail screen to deactivate a device, this is the closest equivalent to inventory deletion in ConnectSx. The device will not show in inventory searches unless the user selects the "Show Inactive" filter. The history and associated information of an inactive device can always be looked up and reviewed, but inactive items cannot be made "active" again.

Inactive

device status referring to devices that have been deactivated (equivalent of deleted) or already used in a previous case.

Status

Indicates if this device has been used, implanted, damaged, etc.

Container

This is the "Parent" item that houses your device or inventory. For instance, a surgical implant contained within a surgical tray, or a product's package that may have a different reference number than the item itself. A container has a catalog number that identifies what it is, but it also must bear a unique "Container ID" that differentiates it from other containers with the same catalog number.

Billable

If a device can be billed for, i.e. it has a sale price, it should also have a billable status of "yes" or "billable". Commonly implants and biologics are considered billable, while surgical instruments are not since they are reused. If an item is marked billable, it will be added with a price to the Sales Order and charged for when it is marked as used in a case.

Price

This is the sale price of the device. ConnectSx currently only stores the base price, not contract-specific pricing. Any discounted prices have to be entered manually on the DUT.

Inventory

These are medical devices or surgical trays, inventory is usually used to refer to devices plural.

Inventory Request

(1). This is a request from the sales rep or distributor to their inventory provider (distributor or manufacturer) to provide devices or inventory, often for a specific upcoming case. The inventory provider will determine the inventory need and either fulfill completely, partially fulfill, or decline the request. Fulfillment of a request will result in a pending inventory transfer that the requester will need to accept in order to transfer custody of the inventory. (2). In other less-frequent cases, a manufacturer may make an inventory request of their external production facilities, similar to a Purchase Order to purchase new product, however, this workflow cannot result in the creation or transfer of inventory as the recipient of the request is not connected to the ConnectSx ecosystem.

Transfers

A record of a transfer of inventory from one user to another. Can be initiated ad-hoc or by fulfilling an inventory request.

Pending Transfers

An inventory transfer that has not yet been completed. Will need to be accepted or declined by the receiving user.

Accepted Transfer

A transfer that was accepted, completed, and the inventory has been added to the receiving user's account.

Declined Transfer

A transfer that was rejected by the receiving user. A declined transfer requires the user to provide a reason for rejecting the transfer. A declined transfer is then given a HOLD Status which must be confirmed by the manufacturer before the inventory is returned to its original custody.

Transfer HOLD

When a transfer is declined it is given a HOLD status which must be confirmed by the manufacturer before the inventory is returned to its original custody. This allows for shipping time to pass and inventory to be checked in person before the inventory is put back into stock.

Tags

Tags are user defined data points that can be created or deleted at will. They are fully searchable. Tags can be used to represent stages of a process, statuses that are not already available in the system, nick names, etc.

Basic Search (Search field)

Search field that allows you to search for inventory based on the reference number/catalog number, version/model, lot, or Tags

Scan Barcode Button

Allows a user to scan a barcode in order to search for a device, the device must exist in GUDID and the barcode data must be stored in ConnectSx. Additional options become available once a device is selected, like shipment status, sterilization status, or access support.

Status

Device's usage status: used, unused, implanted, explanted, damaged, missing, other

Type

inventory type: device or container

Expiration

the expiration date of the device, if it has one. Notificaitons are sent when devices are nearing expiration.

Expired (search field)

Search field for devices/products that have already expired

Expiring Soon (Search field)

search field for devices/products that are going to expire within 30 days.

Only Show Devices without Event (Search Field)

search field allowing you to search for devices that are not associated with a case only

Show Inactive (search field)

search field allowing you to filter for devices that have been deactivated (equivalent of deleted) or already used in a previous case.

Bill of Materials

A list record of items (by catalog #) that belong in a given type of container. For instance, for all containers that match the Bill of Materials "Configuration A" they must contain devices "X, Y, and Z". These Bill of Materials are then assigned to containers and are used to determine Par Levels, Overstocks, and Shortages for said containers.

Par Level

Determined by a Bill of Materials, this represents how many of a given catalog number/device belong in a container.

UDI (Unique Device Identifier)

The UDI is a unique number regulated by the FDA, assigned to all devices (eventually) to allow their identification and ensure traceability from the manufacturer to the patient. It is comprised of two different identifiers: the first is the Device Identifier (DI) which is refers to the catalog number level (example - items with the same catalog number will have the same DI), and the Production Identifier (PI) which is on the lot number level (Example - items with the same catalog number but different lot numbers will have different PIs, and thus different UDIs despite them sharing a DI). When UDI is loaded for a device then its barcode can be scanned to pull up the device using the UDI.

  1. (Note: If entering UDI, your lot # must match what is part of the UDI. The system will parse the UDI and populate the lot number automatically. If you have a different lot number than is part of your UDI, reach out to us to discuss options for loading that data)

Device Identifier (DI)

The device identifier is the first portion of the UDI and refers to all items from the same manufacturer that have the same catalog number.

Production Identifier (PI)

The production identifier identifies information about how and when the device was produced including, but not limited to: lot number, serial number, manufacture date, expiration date, etc. So, devices that share a DI may not share the same PI if they were produced at different times, and thus their UDIs will be different. ConnectSx does not store PI in its own field, but does store information related to the PI (Lot number, expiration date, serial number, etc.). Information that does not yet have a field in ConnectSx can be entered as Tags.

Lot Number

An identifying number assigned to a batch of goods, typically from the same production run, to identify when and how they were produced. Lot number should be recorded at the point of use to help identify it on the patient record. The Lot number is typically included in the PI portion of the UDI.

  1. (Note: If entering UDI, your lot # must match what is part of the UDI. The system will parse the UDI and populate the lot number automatically. If you have a different lot number than is part of your UDI, reach out to us to discuss options for loading that data)

Serial number

A unique identifying number assigned to a device to differentiate it from other products that may share the same catalog number or lot number. A serial number is unique to that individual unit.

Location

The physical location of a device or tray, used by searching google for a location. Often this function is used when a device or tray is left with a hospital, but is still considered in a sales rep's custody.

Custody Status

Statuses assigned based on who has the device at a given time: posession, consigned, loaned, other.

Posession (Status)

Custodian status indicating a device or container is in a user's posession. Inventory is always held in a user's custody (meaning ultimately they are accountable for it), but this status indicates whether it has been stored, loaned, consigned, etc. or if it is physically in the user's possession.

Consigned (Status)

Custodian status indicating a device or container is consigned to another entity's custody for an extended period of time. Inventory is always held in a user's custody (meaning ultimately they are accountable for it), but this status indicates whether it has been stored, loaned, consigned, etc. or if it is physically in the user's possession.

Loaned (Status)

Custodian status indicating a device or container is loaned to another entity for a short period of time, often carrying penalties for late return of product. Inventory is always held in a user's custody (meaning ultimately they are accountable for it), but this status indicates whether it has been stored, loaned, consigned, etc. or if it is physically in the user's possession.

Fulfill Inventory Request

The ability/function of a manufacturer or admin user to fulfill an inventory request from their existing body of inventory. Requests may be fulfilled completely, partially fullfilled, or declined. When a request is partially fulfilled the admin may return to it at a later date to complete its fulfillment.

Deactivate

The deacivate button/status triggers the inventory to become inactive. It is no longer able to be marked as used or any other status, and can no longer be transferred or interacted with. For all intents and purposes it becomes a static record. It can be searched for by filtering for inactive items.

Import (Navigation Heading)

This section of the console allows the user to import inventory data via spreadsheet, mapping specific column headings from that spreadsheet to specific inventory data fields in ConnectSx.

Products (Navigation Heading)

The products section of the console is where you may add and modify product line data. Every inventory item needs a product line, and the product line guides how inventory is requested in the field.

Transfers (Navigation Heading)

The transfers section of the console shows all open and past inventory transfers. Action can be taken from this section to initiate a transfer or to accept/decline a transfer.

Requests (Navigation Heading)

The requests section of the console shows all open and past inventory requests. Action can be taken from this section to decline an inventory request or fulfill an inventory request.

Catalog (Navigation Heading)

The catalog reflects each item that is included in your inventory at a catalog number level. It houses base item information for each catalog number and is tied to the product line.

Directory

Physician

The physicians that will be performing cases where products will be sold. Create these records in the directory so they can be selected from drop-down menus when creating a case. Enter contact information and associated facilities, procedures, products, and comments.

Facility

The facilties, hospitals or ASCs, where cases will be performed and products will be sold. Create these records in the directory so they can be selected from drop-down menus when creating a case. Enter point of contact information and billing contact information as well as contract pricing.

Contract Price

The pricing negotiated for certain faciltities. These prices will be loaded, by catalog number, to a faciltity record in a .CSV file. Contract pricing overwrites the base/list price on a sales order and is not editable by Sales Users. This pricing must be updated/edited in the facility directory record by Admins.

Procedure

The procedures that will be associated with each case. Create these records in the directory so they can be selected from drop-down menus when creating a case.

Manufacturer

The manufacturers who produce and provide sellable product. A Manufacturer using ConnectSx will often only have one (themselves) and will be represented by the Organization. Other organizations, such as distributors, may have many manufacturers in their directory.

USERS

Invitations

Email invitations sent by the manufacturer or admin to link users with their account

Sales User

A sales user primarily uses vTrakr and is able to create cases, add directory records for their account, and manage inventory that is in their custody.

Admin

An Admin primarily uses the Console and is able to edit/manage all cases, inventory, users, and directory records associated with their organization.

Distributor

A distributor user uses the console and vTrakr and while they may create cases and make sales, they share certain similarities with Admin users. A distributor can take action on all cases and inventory in their custody or in the custody of their associated sales users.

Operations User

An Operations user is focused on managing inventory and the movement of inventory to support the caseload. They can add/edit directory record, can add inventory, can modify inventory, can transfer inventory, request inventory, fulfilli nventory, modify cases, etc. However, they cannot edit user accounts or modify organization settings.

Finance User

The finance user is focused on billing and shares certain permissions with that of an admin. A finance user may edit price information, add POs to a case, retrieve billing documents, read COG and Par level info, and can mark an event as Paid.