Zeiss VISUFIT 1000 Platform User Manual

VISUFIT 1000 Platform
User Manual
Version: 1.8
Software Version: 1.4 and following

Zeiss VISUFIT 1000 Platform Specifications

General

Category	Medical Equipment
Manufacturer	Carl Zeiss Vision
Model	VISUFIT 1000
Technology	3D Imaging
User Interface	Touchscreen
Data Output	Digital
Capture Method	Multi-camera Array
Data Export	Network
Additional Features	Virtual Try-On

Summary

1 Introduction

1.1 General description

Overview of the VISUFIT 1000 Platform and its functions.

1.2 Intended user / Target group

Identifies the target audience for the user manual.

1.3 Patient group

Specifies the age and capabilities of patients for use.

1.4 Intended use

Details the primary application of the VISUFIT 1000 Platform.

1.5 Normal use

Describes how the device is typically operated and installed.

1.6 Indication

Specifies the conditions for which the device is indicated.

1.7 Contra indication

Lists any conditions where the device should not be used.

1.8 Purpose of the documentation

Explains the manual's objective and prerequisites for users.

2 Safety notes

2.1 Symbols

Explains various safety symbols used in the manual and on the device.

2.2 Device label

Details the information presented on the device's type plate.

2.3 General warnings and error messages

Covers hazards like electric shock and general error handling.

2.4 Combining devices

Guidelines for using approved accessories and spare parts.

2.5 Cyber, network and data security

Addresses network requirements and security measures for the device.

3 VISUFIT 1000 Platform

3.1 Product overview

Provides a visual and textual overview of the device components.

3.1.1 Computer housing

Details the computer housing, ventilation, and connection panel.

3.1.2 Connection to software

Explains how the device connects to software.

3.2 Scope of delivery

Lists the accessories included with the VISUFIT 1000 Platform.

4 Installation

5 Operation

5.1 Safety during operation

Covers safety precautions during the use of the device.

5.2 Requirements

Lists prerequisites for operating the VISUFIT 1000 Platform.

5.3 Room conditions

Specifies environmental conditions for optimal device operation.

5.4 Switching the device on

Step-by-step guide to powering on the VISUFIT 1000 Platform.

5.5 Position the patient

Instructions for correctly positioning the patient for image capture.

5.6 Take pictures

Details the process of capturing patient images.

5.7 Switching the device off

Instructions for safely powering down the device.

5.8 Settings

Explains how to adjust device settings via VISUCONSULT 500.

6 Cleaning

6.1 Safety during cleaning

Safety precautions before cleaning the device.

6.2 Cleaning

Procedures for cleaning the device surface and components.

6.3 Filter

Instructions for cleaning or replacing the device filter.

7 Maintenance

7.1 Maintenance schedule

Information on recommended maintenance intervals.

7.2 Remote service

Details on accessing remote support for maintenance and troubleshooting.

7.3 Update routine

Explains how software updates are delivered and installed.

7.4 Repair

Guidance on what to do if the device malfunctions.

8 Troubleshooting

8.1 Faults with messages

How to handle error messages and warnings displayed by the system.

8.2 Faults without messages

Addresses issues that occur without specific error messages.

8.2.1 Problems with electromagnetic compatibility

Troubleshooting interference with other electronic devices.

8.2.2 Problems with power supply

Solutions for issues related to the device's power supply.

8.3 Service Contact

Information on how to contact ZEISS service personnel.

9 Technical specifications

9.1 Main data

Key technical data and specifications of the device.

9.2 System requirements

Details the network, PC, and iPad requirements for operation.

Network

Specifies network connection and configuration requirements.

Wireless Access Point

Requirements for the wireless access point.

PC

Specifies the operating system and hardware for PCs.

iPad

Specifies the operating system and models for iPads.

9.3 Electromagnetic compatibility (EMC and ICES-003)

Information on EMC compliance and guidelines.

9.3.1 Electromagnetic emissions

Details the electromagnetic emission testing and compliance.

9.3.2 Electromagnetic immunity

Information on the device's immunity to electromagnetic interference.

9.4 Electromagnetic immunity for medical electrical equipment

Immunity guidelines for medical electrical equipment.

9.4.1 Recommended separation distances

Recommended distances for RF communication devices.

10 Disposal

10.1 Disposal of the device

Instructions for proper disposal of the device according to regulations.

10.2 Disposal of the packaging

Guidelines for disposing of the product packaging.

11 Manufacturer's declaration

11.1 Regulatory information

Details the device's compliance with medical device regulations.

11.2 Standards and regulations

Lists the standards and directives the device complies with.

11.3 FCC and ICES-003 compliance

States compliance with FCC and ICES-003 standards.

Glossary / Abbreviations

Figures