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OsteoSys SONOST 3000 User Manual

OsteoSys SONOST 3000
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Users Manual (Confidential)
OsteoSys Co., Ltd.
Model Designation : SONOST 3000 DOC. No. : OT-IFU-S3K
1
SONOST 3000
User Manual
Model: SONOST 3000
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND
OF THE COUNCIL
Doc Version : 12.2_MDR (2022.09.05)
http://www.osteosys.com
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OsteoSys SONOST 3000 Specifications

General IconGeneral
BrandOsteoSys
ModelSONOST 3000
CategoryMedical Equipment
LanguageEnglish

Summary

1 Introduction

2 Configuration of Device

2.1 Composition of Device

Overview of the device's components and structure.

2.2 Installation of SONOST 3000

3 Using SONOST 3000

3.1 Daily Test

Procedure for performing a daily system calibration test.

3.2 Shutting Down Processing

3.3.3 Patient Measurement Procedure

3.3.6 Correct Patient Position

3.4 Using S/W

3.4.3 Setting Environment

3.4.4 User Registration

3.4.5 Measurement of Bone Mineral Density

Patient Registration

Process for registering new patient information.

Patient Measurement Process

Measure Screen and Temperature Selection

Interface for initiating measurement and selecting temperature.

3.4.6 Patient Information Management

Modifying Patient Information

Procedure to edit existing patient data.

Patient Data Deletion and Worklist

Deleting Patient Information

Steps to remove patient records from the system.

3.4.7 Clinical History Inquiry & Deletion

Inquiry of Clinical History

Retrieving and viewing the clinical history of patients.

3.4.8 Daily Test of SONOST 3000

3.4.9 Printing Clinical History Results

3.4.11 Setup Worklist

3.4.12 PACS Setup and Sending

3.4.13 FRAX Mode

4 Maintenance and Repair

4.1 Resolution to Problems

Troubleshooting guide for common device issues.

4.2 Maintenance and Cleaning

4.2.1 Cleaning Procedures

Instructions for cleaning the device and its components.

4.3 Safe Use of SONOST 3000

4.3.1 Safety Rules

General safety instructions for operating the product.

4.3.2 Electronic Medical Equipment Cautions

Specific precautions for using electronic medical equipment.

5 Specifications and Software Updates

5.1 Specifications

Technical specifications for the SONOST 3000 device.

6 Reference

6.1 Parameter Terminology

Definitions and explanations of key measurement parameters.

7 Product Warranty

Scope and Period of Warranty

Details the warranty coverage and duration for the product.

8 Security

SEC.1 Introduction to Security

Overview of security features and requirements for the system.

Security Features and Access Control

SEC.2 Security Features

Description of security features for flexible access and integrity.

SEC.3 Access Control

Mechanisms for determining and enforcing access rights.

Audit Control

SEC.4 Audit Control

Capability to record and examine system activity via audit trails.

Certification and Password Management

SEC.6 Password Management

Guidelines and rules for creating and managing secure passwords.

Software Hardening and Unauthorized Access

SEC.12 Software and Application Hardening

Prohibiting unauthorized programs and securing system services.

SEC.13 Unauthorized Network Access

Responsibility for protecting networked devices from malicious attacks.

Virus Protection and System Security

SEC.14 Virus Protection Software

Procedures and recommendations for virus protection software.

SEC.15 System Security

Setting up screensavers with password protection for system access.

Data Protection and Health Data Integrity

SEC.16 Data Protection

Measures for implementing data protection and privacy.

SEC.17 Health Data Integrity and Authenticity

Ensuring the integrity and authenticity of health data.

Health Data Storage and De-Identification

Network Security, Business Continuity, Data Backup

Media Access, Remote Service, Network Interface

Network Interface Specs and Information Flow

Transmission Integrity, Required Characteristics, Potential Risks

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