PLUM Medical Solutions MD1 User Manual

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PUBLIC
MED-TAB v.1
USER MANUAL
PUB INT EN – 003TR
Copyright ® 2003-2015 IMAGE Information Systems Ltd.
Release date: 2015-09-02
MED-TAB v.1 User Manual PUB INT EN – 003TR
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TABLE OF CONTENTS
1 Introduction ......................................................................................................... 3
1.1 Scope of the document ......................................................................................... 3
1.2 Summary ........................................................................................................... 3
1.2.1 Intended medical indication ............................................................................ 4
1.2.2 Intended patient population ............................................................................ 4
1.2.3 Intended users and user groups ...................................................................... 4
1.2.4 Designated Conditions of Use .......................................................................... 4
1.2.5 Contraindications ........................................................................................... 4
1.2.6 Exclusions, warnings and precautions ............................................................... 4
2 First steps............................................................................................................. 5
2.1 Unpacking .......................................................................................................... 5
2.2 MED-TAB layout .................................................................................................. 6
2.3 Keys and Buttons ................................................................................................ 8
2.4 Charge the battery .............................................................................................. 8
2.5 Care and cleaning instructions ............................................................................... 8
2.6 Inserting of a memory card (optional) .................................................................... 9
2.7 Leather Case ....................................................................................................... 9
2.8 Pen .................................................................................................................. 10
2.9 Grayscale adjustment according to DICOM Part 14 GSDF ........................................ 10
2.10 Climatic and ambient conditions .......................................................................... 11
3 Getting started ................................................................................................... 12
3.1 Working position................................................................................................ 12
3.2 Turning on or off ............................................................................................... 12
3.3 Switching between DICOM and regular display modes ............................................ 12
3.4 Optimizing the display lifetime ............................................................................ 12
3.5 Using the touch screen ....................................................................................... 12
3.6 Lock or unlock the touch screen and the keys ....................................................... 13
4 DICOM GSDF Grayscale Adjustment using CALCON ............................................ 14
4.1 Introduction ...................................................................................................... 14
4.2 Main menu ........................................................................................................ 14
4.3 DICOM GSDF grayscale image adjustment ............................................................ 15
4.4 Adjustment results............................................................................................. 17
4.5 Determnation of Ambient Light ............................................................................ 18
4.5.1 Getting started ............................................................................................ 18
4.5.2 Ambient light classification ............................................................................ 18
5 Troubleshooting ................................................................................................. 19
6 Safety information .............................................................................................. 20
6.1 Precautions ....................................................................................................... 20
6.2 Environmental information .................................................................................. 22
7 Index .................................................................................................................. 23
MED-TAB v.1 User Manual PUB INT EN – 003TR
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1 Introduction
1.1 Scope of the document
This document represents the MED-TAB v.1 user manual provided by IMAGE Information Systems Ltd.
Disclosure level of this document is PUB, which means that this document is freely available to anyone interested, such as resellers, current end users as well as potential customers. Primary color is orange.
NOTICE:
The provided data was researched with the utmost care. Nevertheless, the author does not
accept any liability for the correctness, completeness and up-to-date nature of the information
contained in this document. It is the responsibility of the user or the local administrator to
verify the details by considering suitable sources.
1.2 Summary
MED-TAB is a 13.3” color LCD monitor including built in tablet computer for viewing and analysis of medical images other than those of mammography from a picture archiving and communication system (PACS). The color panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 1920 x 1080 pixels (2MP). There is one REGULAR display MODE to visualize non-medical images and one DICOM MODE factory calibrated display mode to display medical images according to DICOM GSDF regulations.
CALCON is application software which is preinstalled in each tablet offering quality control of the monitor. The software supports quantitative and visual tests.
The MED-TAB has been precisely calibrated to comply with DICOM Part 14 at factory. With built-in brightness stabilization circuit, USB adjustment tool and ambient light sensor, stable brightness and persistent calibration can be guaranteed. The MED-TAB can support both landscape and portrait mode. The anti-reflection coated protective screen can prevent display from damage under heavy operating conditions. The tablet-PC is designed in conformity with IEC60601-1, IEC60601-1-2 and CCC standards.
CAUTION
Danger of wrong image analysis results.
Read the entire manual in full detail to ensure safe and proper use, before using the device
first time.
Incorrect use due to insufficient environmental conditions or incompatible software might lead
to incorrect results of image analysis.
MED-TAB v.1 User Manual PUB INT EN – 003TR
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1.2.1 Intended medical indication
MED-TAB is a 13.3” color LCD monitor including built in tablet computer for viewing and analysis of medical images other than those of mammography from a picture archiving and communication system (PACS).
1.2.2 Intended patient population
The device is not intended for use by a patient.
1.2.3 Intended users and user groups
Users of the MED-TAB are trained medical practitioners or veterinarians. Patients shall not touch the device.
1.2.4 Designated Conditions of Use
Designated conditions of use are:
Only intended for medical healthcare professionals. It is recommended to place the device on a desk using the rotating case stand either in
portrait or landscape mode without direct flare on the screen.
The ambient should be less than 100 lux for image analysis. The intention of the device is for repeated but not continuous use. The operating Temperature is +10°C to +35°C. The operating air pressure is 600 hPa to 1100 hPa.
1.2.5 Contraindications
The MED-TAB is not intended for:
Mammography for diagnostic use. Use at ambient light of more than 1000 lux. Sterile use. Use in an infectious environment.
1.2.6 Exclusions, warnings and precautions
Perform a medical display acceptance test with the PACS before clinical use according to
local laws and regulations using a calibrated luminance meter.
No use for emergency procedures in case of unreliable data connections. No handheld use for image analysis. Regularly clean the device to remove dirt. Only use a pen or a mouse to perform measurements using a PACS. Do not use fingers.
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2 First steps
2.1 Unpacking
Please check the product box for the following items:
MED-TAB v.1 MED-TAB CALIBRATOR with a Micro USB plug Leather case with rotating stand Touch pen Switching Power Adaptor for MED-TAB v.1 incl. plugs for US, UK, EU and CN Micro USB to USB cable USB OTG cable Warranty card Quick start guide
We recommend to operate the MED-TAB using the leather case to protect the device.
CAUTION
Danger of incorrect image analysis results.
Always transport MED-TAB in the original case or in the original packaging box.
The antiglare sheet on the surface of the tablet is soft. Scratches can impair the image quality.
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2.2 MED-TAB layout
Power/Lock Button
Volume key
DICOM-Switch
Ambient light sensor
Front camera Touch screen
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Camera
DICOM Switch
Volume key
Power/Lock Button
Headset jack
Micro SD Slot
Mini HDMI connector
USB connector
Microphone
Kensington lock
Power connector
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Key
Action
Power/Lock
To turn on/off the device (press and hold); to
lock/unlock
Volume
For adjusting the volume of the device
DICOM-Switch
To activate/deactivate the DICOM-Mode
2.3 Keys and Buttons
2.4 Charge the battery
Before using the MED-TAB for the first time, charge the battery for 8 hours.
WARNING
Danger of electrical shock, fire and device malfunction.
Always use the Switching Power Adaptor for MED-TAB v.1 for charging and operation. Make
sure the power connector is fully connected to the power socket.
The power adaptor must be used at specified electric voltage, only.
CAUTION
Danger of delayed treatment due to unavailable image analysis device.
A warning will appear along with an alert when the battery charge is low. The battery must be
charged for wireless operation. Once the battery is completely discharged, the device cannot
be turned on until the battery was charged for a few minutes until the battery has been
charged.
2.5 Care and cleaning instructions CAUTION
Danger of wrong image analysis.
Frequent cleaning of the display using a display cleaner is recommended.
MED-TAB v.1 User Manual PUB INT EN – 003TR
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