hazard analysis

Hazard Analysis

Exceed Doctor Software System

Version: 2.0 Date: October 14, 2014

Document History and Distribution

1. Revision History

Revision # Revision Date

Description of Change Author

1.0 June 18, 2014 Preliminary draft Dmitry Kotleev

1.1 August 5, 2014

R&D review Michael Sidorenko

1.2 September 25, 2014

Sales & Marketing review Nir Danai

2.0 October 14, 2014

Final draft Vladimir Lucenko

2. Distribution

Recipient Name Recipient Organization Distribution Method

Dave Garver Great Lakes Orthodontics Email

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Table of Contents

1. Introduction 1

1.1. Scope 1

1.2. Definitions, Acronyms, and Abbreviations 1

1.3. References 2

1.4. Severity Index 3

1.5. List of Hazardous Events 4

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1. Introduction

1.1. Scope

This document lists out the possible hazardous events that could be encountered during the utilization of the Exceed Doctor Software system with the severity and likelyhood pointed out for every type of event.

1.2. Definitions, Acronyms, and Abbreviations

Bracket/s (appliance/s) Small objects, typically made of metal, ceramic or composite, that are cemented onto the teeth to be used as anchorage points for the wires, as part of an orthodontic correction.

3D Model (model) 3D computer replica of the patient's teeth, produced by digitizing dental casts or impressions of the patient's mouth or by direct, intra-oral scanning. Refers to a specific order.

Data Exchange Server A computer used to store data about Orders and information exchange between EDS, DPO (see below) and the Exceed Center. The Data Exchange Server is part of Exceed Software System.

DPO Doctor's Personal Office - a web application allowing to upload patient records, submit, manage and track Orders. The DPO is part of Exceed Software System.

ECS Exceed Center Software System - the software used by Exceed Center employees to generate Rx and Tx Placement Plans. The ECS is part of Exceed Software System.

EDS Exceed Doctor Software System - the software used by the treating clinician to analyze, modify and approve Rx and Tx Placement Plans. The EDS is part of the Exceed Software System.

ES Exceed Software System - System formation, registration procurement and fulfillment of Orders for the production of bracketing trays

Exceed Center An office where employees are using the ECS to generate Rx and Tx Placement Plans.

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Order/s (Case/s) Request for a virtual bracket placement plan and the subsequent production of bracketing trays. Each request is linked to a 3D-model of the patient's dentition.

Placement Modification/s (Modification/s)

Dr.-adjusted modification of the Placement Plan. Refers to a specific order. Each Placement Plan can be modified a few times.

Placement Plan/s (Plan/s) Layout of the brackets positioned on the patient's teeth, originally prepared by the Exceed Center. Refers to a specific order.

Rx Case Order of the Rx service

Rx Plan/s Mathematical calculation displaying the recommended positioning of Brackets on the patient's teeth, based on the pre-treatment 3D Model, the type of orthodontic brackets utilized, and the clinician's general pre-treatment bracketing preferences.

Rx Service Production of bracketing trays based on the Doctor-approved Rx Plan.

Scene 3D virtual space to display the 3D Model, as well as the Placement Plans.

Tx Case/s Order of a Tx service

Tx Plan/s A mathematical calculation of the recommended positioning of Brackets on the patient's malocclusion, based on dynamic tooth movement from the pre-treatment malocclusion to a desired post-treatment outcome. It is based on the pre-treatment 3D Model, the type of brackets utilized, the treatment plan prescribed by the clinician, the clinician's general post-treatment treatment preferences, as well as intra-oral images, facial photos and panoramic radiographs of the patient.

Tx Service Production of bracketing trays based on the doctor-approved Tx Plan.

Wire/s Ligament, typically made of metal or smart alloys that are attached to orthodontic brackets and are used to apply forces on the teeth, as part of an orthodontic correction.

1.3. References

Software Requirements Specification Document, version 2.0 dated May 29, 2014

Test Scenarios (Verification and Validation Document), version 2.0 dated September 17, 2014.

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1.4. Severity Index

The table below describes all suggested possible values of the severity index of hazardous events in general.

Probability of Occurrence

Severity I Catastrophic

(Death, serious injury)

Severity II Significant (Reversible

serious injury)

Severity III Marginal

(inconvenience)

Severity IV

Negligible

Frequent 1 3 7 13

Probable 2 5 9 16

Occasional 4 6 11 18

Remote 8 10 14 19

Improbable 12 15 17 20

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1.5. List of Hazardous Events

In general, the likelihood of the Exceed Doctor Software system causing any harm or an injury to a doctor, patient or staff member is extremely low. We have attempted to list all the possible inconveniences related to utilization of this software in the table below:

Function or Component

Identification of the

hazardous event

Severity of the

hazard

Cause(s) of the hazard

Method of control Corrective measures taken

Verification that the method of control was

implemented correctly

Communication to Data Exchange Server

No communication

14 Server or Internet connection are down

Using the Internet connection indicator implemented in the GUI of the Exceed Doctor Software system

Data Exchange Server is hosted by a reputable and reliable service provider to gurantee minimal "down time".

Robust internet connection is recommended for users

Test Case 3. "Running the Program with an established Internet Connection" (see Verification and Validation Document)

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hazardous event

Severity of the

hazard





Placement plan acceptance

Virtual appliances do not match the physical ones

14 Incorrect appliances files are initially used by Exceed Center

Visual control of initial oral cavity models being provided by Exceed Center.

Visual control of a placement plan by a doctor before its acceptance.

Initial control of appliances' physical placement inside patient's oral cavity by a doctor.

Regular examination of patient's oral cavity by a doctor to control the treatment process

The incorrect files are being replaced by correct ones in case of a mismatch

Monitoring the number of user requests and complaints by technical support

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hazardous event

Severity of the

hazard






Incorrect initial oral cavity 3D model

14 Impressions or intra-oral scans are distorted

Visual control of initial oral cavity models being provided by Exceed Center.

Visual control of a placement plan by a doctor before its acceptance.

Initial control of appliances' physical placement inside patient's oral cavity by a doctor.

Regular examination of patient's oral cavity by a doctor to control the treatment process

Regular maintenance of 3D- desktop nd intra-oral scanners


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hazardous event

Severity of the

hazard





General functioning

User PC does not function properly

14 Hardware and software issues

The program does not run or function properly (according to the SRS)

Minimal system requirements are requested

Testing and quality control of software implementation is in use


General functioning

User PC has no power

14 Electricity is not available to power the PC

User PC does not start up

Robust electricity supply and UPS devices are recommended

User PC starts up

General functioning

A customer is not trained enough on using the software

14 Lack of orthodontic knowledge and computer skills

Visual control of adjusted by a customer and accepted placement plans being provided by Exceed Center

Communication between Exceed Center and customers is being provided in all controversial cases

Visual control of adjusted by a customer and accepted placement plans being provided the by Exceed Center

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hazardous event

Severity of the

hazard






Exceed Center does not fully understand users' instructions and / or revision requests

14 The lack of clarity in the users' instructions and / or revision requests

Control of accepted / revised placement plans being provided by Exceed Center

Communication between Exceed Center and customers is being provided in all controversial cases

Monitoring accepted / revised placement plans being provided by the Exceed Center

Teeth and appliances movement, providing measurements

Software algorithms do not work properly

14 Analytics and software developers' errors

The program does not run or function properly (according to the SRS)

Testing and quality control of software implementation is in use


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