PLUM Medical Solutions MD2 User Manual

PUBLIC

MED-TAB v.2

INSTRUCTIONS FOR USE

PUB INT EN – 002TR

© 2017 PLUM Medical Solutions GmbH

Release date: 22.05.2017

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TABLE OF CONTENTS

1 Introduction ......................................................................................................... 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

2 First 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

3 Getting 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

4 Safety information .............................................................................................. 16

4.1 Precautions ....................................................................................................... 16

4.2 Environmental information .................................................................................. 18

MED-TAB v.2 Instructions for Use PUB INT EN – 002TR

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1 Introduction

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 built­in 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)

MED-TAB v.2 Instructions for Use PUB INT EN – 002TR

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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).

MED-TAB v.2 Instructions for Use PUB INT EN – 002TR

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2 First 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)

MED-TAB v.2 Instructions for Use PUB INT EN – 002TR

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2.2 MED-TAB layout

Ambient light sensor

Volume keys

DICOM touch button

Touch Screen

Speaker

Power / Lock Button

MED-TAB v.2 Instructions for Use PUB INT EN – 002TR