Plum MED-TAB v.2 User manual

PUBLIC
MED-TAB v.2
INSTRUCTIONS FOR USE
PUB INT EN –002TR
© 2017 PLUM Medical Solutions GmbH
Release date: 22.05.2017

MED-TAB v.2 Instructions for Use PUB INT EN –002TR
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TABLE OF CONTENTS
1Introduction ......................................................................................................... 3
1.1 Manual Overview ................................................................................................. 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
2First steps............................................................................................................. 5
2.1 Unpacking your new MED-TAB .............................................................................. 5
2.2 MED-TAB layout .................................................................................................. 6
2.3 Charging the battery for initial use......................................................................... 8
2.4 Care and cleaning instructions............................................................................... 9
2.5 Usage of a memory card (optional) ........................................................................ 9
2.6 Leather Case..................................................................................................... 10
2.7 Touch Pen......................................................................................................... 10
2.8 Grayscale adjustment according to DICOM Part 14 GSDF........................................ 11
2.9 Climatic and ambient conditions .......................................................................... 11
2.10 MED-TAB Characteristics .................................................................................... 11
3Getting started ................................................................................................... 12
3.1 Working position................................................................................................ 12
3.2 Powering 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 ....................................................................................... 13
3.6 Locking and unlocking the touch screen and the keys............................................. 13
3.7 Opening App overview........................................................................................ 13
3.8 Navigation bar................................................................................................... 13
3.8.1 Go one step back ........................................................................................... 13
3.8.2 Jump to home screen ..................................................................................... 14
3.9 Close background apps....................................................................................... 14
3.10 Opening the ambient light indicator ..................................................................... 14
3.11 Connecting to a Wi-Fi network............................................................................. 15
4Safety information.............................................................................................. 16
4.1 Precautions ....................................................................................................... 16
4.2 Environmental information.................................................................................. 18

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1Introduction
1.1 Manual Overview
This document represents the MED-TAB v.2 instructions for use by PLUM Medical Solutions
GmbH.
Disclosure level of this document is PUB, which means that this document is freely available to
resellers, end users as well as potential customers.
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.
CAUTION
Please make sure to utilize the latest version of the instructions for use.
(H-No.: HW4.1.1)
1.2 Summary
MED-TAB is a 13.3” color LCD monitor including a built in tablet computer for viewing and
analyzing of medical images aside from 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 an application software which is preinstalled in each tablet offering quality control
over 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 incorrect image analysis results.
Read the entire manual in full detail to ensure safe and proper use, before using the device for
the first time.
(H-No.: HW4.2.1)
Incorrect use due to insufficient environmental conditions or incompatible software may lead to
incorrect image analysis results.
(H-No.: HW4.3.1)

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1.2.1 Intended medical indication
MED-TAB is a 13.3” color LCD monitor including a built in tablet computer for viewing and
analyzing of medical images, except of mammography, from a picture archiving and
communication system (PACS).
1.2.2 Intended patient population
The MED-TAB is intended for use by medical healthcare professionals only. This device is not
intended for use or operation by a patient.
1.2.3 Intended users and user groups
Users of the MED-TAB are medical healthcare professionals such as, trained medical practitioners
or veterinarians. Patients should not touch or operate this device. This device should not be used
by people with a known allergy to plastic as it can cause an allergic reaction (H-No.: HW2.3.1).
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 purposes (H-No.: HW4.1.3, HW4.1.4).
Usage at ambient light of more than 1000 lux.
Sterile use.
Usage in an infectious environment (H-No.: HW2.1.1 –HW2.1.4, HW2.2.2 –HW2.2.6,
HW2.2.8).
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
(H-No.: HW4.2.1).

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2First steps
2.1 Unpacking your new MED-TAB
Please check the product box for the following items:
MED-TAB v.2
MED-TAB USB-Adjustment Tool with a Micro USB plug
Leather case with rotating stand
Touch pen
Switching Power Adaptor for MED-TAB v.2 incl. plugs for US, UK, EU and CN
Micro USB to USB cable
Quick start guide
We recommend operating 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.
(H-No.: HW3.1.1, HW3.1.3)

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2.2 MED-TAB layout
Ambient light sensor
Volume keys
DICOM touch button
Touch Screen
Speaker
Power / Lock Button

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Camera
Microphone
Power connector
Headset jack
USB-Connector
USB-Connector
Mini HDMI connector
Micro SD Slot
Reset
Volume keys
Power / Lock Button

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Keys and Buttons
Key
Action
Power/Lock
To power on/off the device (press and hold);
to lock/unlock (press)
Volume
For adjusting the volume of the device
DICOM-Touch button
Hold to activate/deactivate the DICOM-Mode
2.3 Charging the battery for initial use
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.2 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.
(H-No.: HW1.1.1)
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 has been charged or the device is connected to a power source.
(H-No.: HW3.1.2)

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2.4 Care and cleaning instructions
CAUTION
Danger of incorrect image analysis results.
Frequent cleaning of the display using a display cleaner is recommended.
Finger prints and dirt may lead to incorrect image analysis results.
Use of rough tissues for cleaning may damage the surface which can impair the image quality.
Incorrect display cleaners may dull the surface and impair the image quality.
Do a new image acceptance test if you are unsure after any damage to the surface.
(H-No.: HW3.1.1, HW3.1.3, HW3.2.3, HW3.2.4)
Periodic cleaning is recommended to keep the display clean and to prolong its operational
lifetime.
Never use thinner, benzene, alcohol (ethanol, methanol, or isopropyl alcohol), abrasive cleaners,
acid, steel wool or other strong solvents, as these may cause damage to the cabinet or LCD
panel.
The surface can be cleaned with a soft display-cloth, such as cotton or lens paper and special
display cleaner. If necessary, stubborn stains can be removed by moistening part of a cloth with
water to enhance its cleaning power.
CAUTION
Danger of incorrect image analysis results.
Do not scratch the display surface. Be careful with rings, keys or jewelry which could scratch
the display surface. Do not use touch pens other than the original one.
Scratches may damage the display and impair the image quality.
Do a new image acceptance test if you are unsure after damaging the surface.
(H-No.: HW4.2.1)
2.5 Usage of a memory card (optional)
The MED-TAB only accepts microSDTM and microSDHC memory cards with a maximum capacity of
128GB. Not all memory cards are compatible with MED-TAB. MED-TAB only supports the FAT file
system.
If you insert a card with a different file structure, the device will ask to reformat the memory
card before use. The file directory of inserted memory cards appears in the extSdCard folder of
the MED-TAB.
If you want to remove a memory card, please be sure that the device is not currently accessing
the memory card. Open “Settings” in the application list, choose the category “Storage” and
select “Unmount SD card”. After confirming this process, you can unmounts or remove the
memory card.

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2.6 Leather Case
The MED-TAB should be used while sheltered in its leather case (H-No.: HW1.4.1, HW1.4.2).
The business card cover is thought to identify the owner or user of a device, e.g. by inserting a
business card.
The rotating stand of the MED-TAB can be turned over 360° to enable both landscape and portrait
views.
2.7 Touch Pen
The supplied touch pen allows a dirt-free usage of the MED-TAB and hence preserves its image
quality. The supplied touch pen will provide the most accurate measurements for diagnostic
purposes.
CAUTION
Danger of incorrect image analysis results.
Use the original touch pen to control the MED-TAB for image analysis in order to avoid image
quality impairment by finger prints.
Wash your hands before using MED-TAB to reduce oil remaining on the surface.
(H-No.: HW4.2.1)
WARNING
Be aware that PLUM Medical Solutions GmbH cannot be held responsible for any use of the
Touch Pen other than described in this document!
(H-No.: HW4.2.1)