EasyManua.ls Logo

Samsung GEMS-H User Manual

Samsung GEMS-H
79 pages
To Next Page IconTo Next Page
To Next Page IconTo Next Page
Page #1 background imageLoading...
Page #1 background image
GEMS‐H
InstructionsforUse


Questions and Answers:

Samsung GEMS-H Specifications

General IconGeneral
ConnectivityBluetooth
BatteryRechargeable
CompatibilitySamsung devices
TypeMotion controller
TrackingMotion and orientation tracking

Summary

Chapter 1. General

1.1. About these instructions for use

Explains the purpose and importance of reading the instructions for use.

1.2. Explanation of symbols

Describes safety notes and their meanings using symbols and signal words.

Chapter 2. Introduction

2.1. Indications for use

Details the intended population and conditions for using the GEMS-H exoskeleton.

2.2. Training

Specifies that only medically trained personnel should use the device.

2.3. Safe environments

Lists suitable environments for device operation, including facility types and surface conditions.

2.4. Intended user profile

Outlines the qualifications and abilities required for physical therapists using the device.

2.5. Operating principle

Explains how the GEMS-H exoskeleton assists users in walking using its components and algorithm.

2.6. Contraindications

Lists medical conditions and situations where the device should not be used.

Chapter 3. Safety

3.1. Symbols

Explains various symbols used in the manual and their meanings.

3.2. Safety

Provides critical safety warnings regarding modification, misuse, improper environments, and patient distraction.

3.3. Safety standards

Lists international standards the GEMS-H conforms to for safety and compliance.

3.4. Environmental conditions

Details temperature, humidity, and pressure requirements for operation and storage.

3.5. Disposal

Instructs on proper disposal of the device as electronic waste according to regulations.

3.6. Patient environment

Specifies the safe distance for devices within the patient's environment.

Chapter 4. Device description

4.1. Package contents

Lists all items included in the GEMS-H sales package.

4.2. Device overview

Provides a detailed breakdown of the GEMS-H device components with front, back, and left views.

4.3. Accessory: waist extension belt

Explains how to use the waist extension belt to increase waist belt length.

4.4. Accessory: thigh support frame

Describes the thigh support frames and their available sizes and dimensions.

4.5. Accessory: thigh support strap

Details the thigh support straps and their available sizes and lengths.

4.6. Marking plate

Shows the information present on the device's marking plate, including model and manufacturer details.

Chapter 5. Preparation

5.1. Device fitting procedure

Outlines the step-by-step process for fitting the GEMS-H device to a wearer.

5.2. Determine the waist part size

Explains how to determine the correct waist part size based on hip width and other measurements.

5.3. Adjust the waist part width

Provides instructions and warnings for adjusting the waist part width using screws and a torque wrench.

5.4. Wear the waist belt & fasten thigh support frames

Warns about improper sizing and begins the procedure for wearing the waist belt and attaching thigh support frames.

5.5. Fasten both thigh support straps

Provides warnings and instructions for securely fastening the thigh support straps.

5.6. Waist part position

Explains the correct and incorrect positioning of the waist part and thigh support frames.

5.7. Check prior to use/operation of the device

Details checks before use, including screws, fastening, battery level, and patient comfort.

Chapter 6. Operating the device

6.1. Turn on the device

Explains how to turn on the device and interpret LED indicators.

6.2. Opening and closing the GEMS-H application

Details how to launch and close the GEMS-H application on the tablet PC.

6.3. Login screen

Discusses the login screen and password management for users and administrators.

6.4. Overall GEMS-H user interface

Provides an overview of the main tabs (Patient Info, Device Connect, Device Control) in the GEMS-H application.

6.5. The 'Patient Info' tab

Explains how to manage patient information within the application.

6.6. The 'Device Connect' tab

Details the process for connecting the GEMS-H device to the tablet PC via Bluetooth.

6.7. The 'Device Control' tab

Introduces the 'Device Control' tab and its main sections: Monitoring Area, Assist Control Area, Parameter Control Area.

6.7.1. Monitoring area

Explains how to select and view monitoring data in graph or text format.

6.7.2. Assist control area

Explains the assist control area and its functions.

6.7.3. The parameter control area

Introduces the parameter control area and its functions, with illustrations.

6.8. Safety features

Discusses safety features and risk mitigation strategies for the device.

6.8.1. Mitigation of risks related to a fully discharged Lithium Ion battery

Explains battery level warnings and recommended actions for low battery.

6.8.2. Mitigation of risks due to excessive power output

Addresses risks of excessive torque and the "EXCEEDED TORQUE LIMIT" error.

6.8.3. Mitigation of risks due to excessive joint angle movement

Discusses risks of excessive joint movement and the "EXCEEDED JOINT LIMIT" warning.

6.8.4. Mitigation of risks due to disconnection from the tablet PC

Explains risks and procedures related to Bluetooth disconnection.

6.8.5. Mitigation of risks due to abnormal actuator module status

Covers risks and error messages related to abnormal actuator status.

Chapter 7. Shutdown

7.1. Stop the assistance

Details how to stop the device's assistance function using the tablet PC.

7.2. Turn off the device

Explains how to power off the device.

7.3. How to take off the device

Provides step-by-step instructions for removing the GEMS-H device from the wearer.

Chapter 8. Maintenance

8.1. Storage

Provides recommendations for storing the device and its environmental conditions.

8.2. Regular maintenance (Weekly Checklist)

Outlines a weekly checklist for regular device maintenance.

8.3. Cleaning

Provides instructions and warnings for cleaning the GEMS-H device.

8.4. How to charge the GEMS-H

Explains the procedure for charging the GEMS-H device and related indicators.

Chapter 9. Troubleshooting

9.1. Troubleshooting

Lists common issues and recommended actions for troubleshooting the GEMS-H.

9.2. Device messages

Details specific error and status messages from the device and their causes/solutions.

Chapter 10. Technical specifications

10.1. Specifications

Lists detailed technical specifications of the GEMS-H device, including sizes, battery, weight, and range of motion.

10.2. EMC (Electromagnetic Compatibility)

Discusses electromagnetic compatibility and warnings related to radiation and equipment use.

10.3. FCC

Covers FCC compliance statements, interference statements, and radiation exposure.

Chapter 11. Clinical studies

11.1. Introduction

Introduces the clinical study conducted on the GEMS-H device for stroke rehabilitation.

11.2. Adverse events

Reports on adverse events observed during clinical studies, noting they were skin-related.

11.3. Summary of studies

Provides a summary of the clinical trial, including objectives, endpoints, subjects, and environment of use.