Fimi Srl 802180 User Manual

FIMI Computing Platform NGP1
FCP NGP1 CP12L - MDT
User Manual
Contents
FCP NGP1 CP12L - MDT 1 1 Important 5
1.1 Copyright ____________________________________________________________ 5
1.2 Definitions, Acronyms, Terms, and Abbreviations _____________________________ 5
1.3 Safety and precautions __________________________________________________ 7
1.3.1 Intro __________________________________________________________________ 7
1.3.2 Read and follow these instructions when connecting and using your NGP1 Computing
Platform 7
1.3.3 Installation Locat ions _____________________________________________________ 8
1.3.4 Setup precautions ________________________________________________________ 8
1.4 FCC notice ____________________________________________________________ 9
1.4.1 Cables _________________________________________________________________ 9
1.5 FCC Radiation Exposure Statement ________________________________________ 9
1.6 Industry Canada notice __________________________________________________ 9
1.7 Approved for medical applications ________________________________________ 10
1.8 How to read this manual ________________________________________________ 10
1.8.1 Symbols _______________________________________________________________ 10
1.9 Biological Hazard and Returns ___________________________________________ 12
2 The FCP -NG P 1 Com put ing Platform 13
2.1 Introduction _________________________________________________________ 13
2.2 Overview ____________________________________________________________ 14
2.2.1 Dimensions (in mm) _____________________________________________________ 14
2.2.2 Battery dimensions (in mm) _______________________________________________ 15
2.2.3 Weight ________________________________________________________________ 15
2.2.4 Features and connectivity ________________________________________________ 16
2.2.5 Buttons, indicators, ______________________________________________________ 20
3 Getti ng started 21
3.1 Pre requisites ________________________________________________________ 21
3.1.1 Insert the battery _______________________________________________________ 21
Lift the door up by pressing upward on the battery door recess ______________________ 21 After hearing a click and with the door fully pulled up rotate clockwise the door ________ 22 Push the white hook fully downwards till the battery pack is released _________________ 22 Battery removal slip ________________________________________________________ 23
3.1.2 Connect the AC adapter __________________________________________________ 24
3.1.3 Turning the system on ___________________________________________________ 25
3.1.4 Charging the battery _____________________________________________________ 26
3.1.5 Battery pack indicators ___________________________________________________ 27
Dual function LED indicators _________________________________________________ 27 Battery charge / life monitor button ___________________________________________ 27
4 Us ing your NGP1 Computing Platform 28
4.1 Booting the system ____________________________________________________ 28
4.2 Connecting external peripherals __________________________________________ 28
4.2.1 External Monitor Connection _______________________________________________ 29
4.2.2 USB doors _____________________________________________________________ 30
4.2.3 Ethernet connection _____________________________________________________ 31
Orange LED : _____________________________________________________________ 31 Transmitting / receiving _____________________________________________________ 31 Green LED : Connected _____________________________________________________ 31
4.2.4 Express Card slot _______________________________________________________ 32
5 NG P 1 Com put ing Platform features 33
5.1 Display _____________________________________________________________ 33
5.2 Touch screen _________________________________________________________ 33
5.3 Using your stylus pen __________________________________________________ 33
5.3.1 Pen characteristics ______________________________________________________ 33
5.4 Using the RF-ID reader _________________________________________________ 33
5.5 Using the Wi-Fi (802-11 ABGN) __________________________________________ 35
5.6 Using the Bluetooth ___________________________________________________ 36
5.7 Using the Waveform Viewer (WFV) button and the Emergency Hot Key (EHK) ______ 37
5.8 Audio solution ________________________________________________________ 37
5.9 Docking connector ____________________________________________________ 38
5.10 Security _____________________________________________________________ 39
5.10.1 Built-in features _________________________________________________________ 39
5.11 Power adapter ________________________________________________________ 39
5.12 Battery _____________________________________________________________ 40
5.12.1 Storing main batteries ____________________________________________________ 42
5.12.2 Battery and energy management. __________________________________________ 42
6 NGP1 Computing Platform Maintenance 43
6.1 Cleaning ____________________________________________________________ 43
6.1.1 Tested substances _______________________________________________________ 43
6.1.2 To clean the screen ______________________________________________________ 43
6.1.3 To clean the cabinet: _____________________________________________________ 44
6.1.4 To clean the fan_________________________________________________________ 44
6.2 Disposal _____________________________________________________________ 44
6.2.1 General warning ________________________________________________________ 44
6.2.2 For Countries in the European Union ________________________________________ 44
6.2.3 For countries outside the European Union ____________________________________ 44
6.2.4 Disposal of your NGP1 Computing Platform ___________________________________ 44
6.2.5 Dispose of Lithium ion battery (Li-ion) _______________________________________ 45
6.2.6 Dispose of coin battery inside of the NGP1 Computing Platform (Mounted on main board):45
7 Troubleshooting 46
7.1 My NGP1 Computing Platform is not turning ON. _____________________________ 46
7.2 My NGP1 Computing Platform Power on LED is ON, but nothing happens. _________ 46
7.3 My NGP1 Computing Platform does not run smoothly _________________________ 46
7.4 How do I turn off my NGP1 Computing Platform _____________________________ 46
7.5 When I use the touch screen. ____________________________________________ 46
7.5.1 the cursor is not following the pen movement. _________________________________ 46
7.5.2 . the system does not respond to taps._______________________________________ 46
8 Specification 47
8.1 System Specifications __________________________________________________ 47 VERIFICATION ONLY 3 NOT RELEASED
8.2 Display _____________________________________________________________ 47
8.3 Connectivity and Controls _______________________________________________ 47
8.4 Docking Station Connectivity ____________________________________________ 48
8.5 Power ______________________________________________________________ 48
8.6 Physical Characteristics _________________________________________________ 48
8.7 Optional Configurations ________________________________________________ 48
8.8 Environmental Specifications ____________________________________________ 48
8.9 Applicable International Standards ________________________________________ 49
9 Options 50
9.1 Docking station _______________________________________________________ 50
9.2 Optional additional battery pack _________________________________________ 50
9.3 Optional spare AC adapter ______________________________________________ 50
10 Cus t om e rs care and warranty 50
10.1 Contacts ____________________________________________________________ 50
11 Labels and stickers 51 12 Y our notes 52
Tables
Table 1 - Terms and Acronyms 5 Table 2 – Table of symbols used in this manual 10 Table 3 – Symbols used in the Product label 11 Table 4 – Button primary FW functionality description 20 Table 5 - Status and battery conditions vs. NGP1 Computing Platform status 26 Table 6 - Connector layout specifications 38 Table 7 - Table of tested substances 43
Term/Acronym
Definition/Usage
FCP - NGP1
FIMI Computing Platform – New Generation programmer 1. In this manua l is also referred as NGP1 Computing Platform
BIOS
Basic Input Output System: the lowest level software (firmware) used to run a computing system.
system hang where the application software is no longer the screen with a blue backgrou nd.
CP
Computing Platfor m
Desktop
The software user interface presented to the user when a specific device application is not a c tive or loaded.
EHK
Emergency Hard Key – A physical button that causes delivery of “emergency” thera py.
EMC
Electromagnetic Compatibility
Express Card
External port for connectivity options. Uses a PCIe and USB interface. Typically u s ed for GSM / £g / Storage media etc.
FW
Firmware
HW
Hardware
HDD
Hard Disk Drive
ID
Identification
IP
Ingress Protection
IEC
International Electro-technical Commission
1 Important

1.1 Copyright

This manual is copyrighted with all rights reserved. Under the copyrights law, this manual may not be copied, in whole or part, without written consent of FIMI Barco. Under the law, copying includes translating into another language or format. The device described in this manual, has been certified/registered by the safety agencies/regulatory authorities as model number CP12L-MDT
Bluetooth is a registered trademark owned by the Bluetooth SIG, Inc., U.S.A.. Wi-Fi is a registered trademark of the Wi-Fi Alliance.
FIMI Barco has made every effort to identify trademarked properties and owners on this page. All brands and product names use d in this document are for identification purposes only and may be trademarks or registered trademarks of their respective companies.

1.2 Definitions, Acronyms, Terms, and Abbreviations

The following acronyms, terms, and abbreviations are used in this and subordinate documents.
Table 1 - Terms and Acronyms
Blue Screen Refers to an unintentional application crash, system erro r, or
available to the user. Typically di splays an error message on
Term/Acronym
Definition/Usage
IEEE
Institute of Elec tr ical and Electronic Engineers
LCD
Liquid Cristal Disp la y
Medtronic Inc. or MDT
Refers, in this document, to the Cardiac Rhythm Management business unit which produce implantable cardiovascular devices (i.e. pacemakers, implantable defibrillators, pacing leads).
MPI
Medtronic Patient Interface (includes functions that connect the CP to the patient such as ECG and device telemetry).
Operational Service Lifetime
Availability Lif etime + Service Lifetime
OS
Operating System
PCIe
Peripheral Component Interconnect Express. Used by the Express Card interface.
RF
Radio Frequency
SN#
Serial Number
SSD
Solid State (Disk) Drive
SW
Software
TCO
Total Cost of Owne r s hip
TPM
Trusted Platform Module (TPM) is both the name of a published specification detailing a secure cryptographic processor that can store cryptographic keys that protect information, as well as the general name of implementations
Security Device"
USB
Universal Seria l Bus
VGA
Video graphics adapter - that part of a computer which turns data into a signal th a t the monitor can display .
WES
Windows Embedded Standa r d ( oper a ting system)
WEP
Wired Equivalent Privacy –Wi-Fi security scheme. Replaced by WPA
WPA and WPA2
Wi-Fi Protected Access. WPA2 implements the full IEEE
802.11 security protocol
WFV
Waveform Viewer
of that specification, often called the "TPM chip" or "TPM
Product safety information, setup precautions and incorrect use of NGP1-
WARNING: Use of controls, adjustments or procedures other than those
not put excessive pressure on it, especially in the area of the LCD
from its battery charger and
release the battery pack if you are not going to use it for an
is not suitable for use in presence of
The degree of protection against harmful ingress of water and
NGP1 Computing
Due to the possible interference caused by this product to an
rplane is against the law in most
Even if this product has been certified according to medical
fore using this device in a medical environment
contact and ask permission to the local hospital authority.

1.3 Safety and precautions

1.3.1 Intro

FCP and its accessory are signalled by the word WARNING and by the Warning symbol

1.3.2 Read and follow these instructions when connecting and using your NGP1 Computing Platform

specified in this documentation may result in exposure to shock, electrical hazards and/or mechanical hazards.
The NGP1 Computing Platform is a Class 1 device, internally powered and it has been designed for continuous operation.
To protect your NGP1 Computing Platform from possible damage, do panel.
When moving your NGP1 Computing Platform, use its handle or hold it tightly by placing your hand or fingers outside the LCD panel area.
Unplug the NGP1 Computing Platform extensive period of time.
Unplug the NGP1 Computing Platform from its AC adapter and close all the doors if you need to clean it, while keeping the battery pac k in place.
Consult a service technician if the NGP1 Computing Platform does not operate normally after following the instructions in this manual.
The casing should be opened only by qualified service personnel.
Keep the NGP1 Co mputing Platform o ut of direct sunlight and away
from stoves or any other concentrated heat source.
The NGP1 Computing Platform flammable mixtures, either in vapours or liquids.
The NGP1 Computing Platform can be cleaned with several detergent and disinfectants (see Paragraph 6.1), but not sterilized.
Remove any object that could fall into the vents or prevent proper cooling of the NGP1 Computing Platform electronics.
Do not block the inlet or outlet ventilation holes on the rear part of the cabinet.
particles is IP21, but, it is suggested to use the Platform in a dry and clean environment, whenever possible.
aircraft's navigation system and its communications network, using this product on board an ai countries.
standards requirements, the use of radio devices in specific clinical environment may interfere or cause the malfunction of some medical equipment. Be
When recharging the NGP1 Computing Platform batteries, make sure
the slot.
IMPORTANT: Depending on the application, it is advised to activate a
screen saver. If a still image in high
image' or 'ghost image' on front of the screen. This is a well
afterimage symptom cannot be repaired and is not covered under warranty.
Do not place the NGP1 Computing Platform in an unsteady location. ed in an unsteady location,
NGP1 Computing
large temperature differences. Choose a site that falls within the
subject it to other mechanical shocks or high impact
Take care not to mishandle this product by either knocking or
upon collision
damage; in this case, please refers to qualified personnel.
the power plug and outlet are easily accessible.
Detach the power cable or DC power cord only when the unit is off or when there is a charged battery inserted.
Do not use the NGP1 Computing Platform without battery pack inserted and the battery do or o pe ne d as o bj e cts or dirt may enter in
power management scheme or a contrast remains on the screen for an extended period of time, it may leave an 'after­known phenomenon that is caused by the shortcomings inherent in LCD technology. In most cases, the after image will disappear gradually over a period of time after the power has been switched off. Be aware, that the

1.3.3 Installation Locations

The NGP1 Computing Platform is a transportable device, but not a portable equipment. Then its use is stationary, leant on a table, in the positions sets by its kickstand, w ith the screen facing the user. The kickstand is part of the Medtro nic Patient Interface component and then further instructions on location and use of the NGP1 Computing Platform will be given with the overall user manual of the Medtronic Carelink Encore Programmer. The NGP1 Computing platform is a component of it and other subsystems are the Medtronic Patience Interface(MPI) and associated Firmware, cables and software. Anyhow, in any circumstance, please follow the below recommendations:
If the NGP1 Computing Platform is plac such as on an unstable stand or incline, the Platform may drop or tip over and cause injury
Do not store or use the NGP1 Computing Platform in locations exposed to heat, direct sunlight or extreme cold.
Avoid moving the NGP1 Computing Platform between locat ions with following temperature and humidity ranges.
Temperature: 5- 40°C equivalent to 41-104°F
Humidity: 15-93% RH
The NGP1 Computing Platform is a semi-ruggedized device but it is
strongly recommended to not subject it to severe vibrations, do not drop it or conditions.
dropping it during operation or transportation
The enclosure of NGP1-FCP has to be checked

1.3.4 Setup precautions

Instructions on Setup precautions of the NGP1 Comput ing Platform will be given with the overall user manual of the Medtronic Care link Encore Programmer. The NGP1 Comput ing platform is a component of it Anyhow, in any circumstance, please follow the below recommendations
When you move the NGP1 Computing Platform between environments with very different humidity and/or temperature ranges, allow sufficient time to adjust to the new humidity or
er for other
your eyes can cause eye strain, headaches and other discomforts.
temperature.

1.4 FCC notice

Any change or modification not expressly approved by the party responsible for compliance could void the user’s authority to operate this equipment This equipment has been tested and fo und to comply with the limits for a C lass B di gital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interfere nce to radio or television reception, which can be determined by turning the equipment o ff and on, the user is encouraged to try to correct the interf er ence by one or more of the following measures:
-- Reorient or relocate the receiving antenna.
-- Increase the separation between the equipment and receiver.
-- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
-- Consult the dealer or an experienced radio/TV technician for help.
Do not use the NGP1 Computing Platform AC adapt equipment. This can generate heat or fire.
Do not use other AC adapters with the NGP1 Computing Platform rather than the one supplied with it.
When using a display for long and continuous periods of time, rest your eyes for approximately five minutes every hour. Failing to rest

1.4.1 Cables

Connections to this device must be made with shielded signals cables with metallic RFI/EMI connector hoods to maintain compliance with FCC Rules and Regulations.

1.5 FCC Radiation Exposure Statement

This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment . End users must follow the specific operating instructions for satisfying RF exposure compliance. Please follow the operation instructions in this manual to maintain compliance with FCC RF exposure requirements. T his RFID equipped computing platform meets FCC RF exposure guidelines when used in handheld or desktop situation

1.6 Industry Canada notice

This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.
This Class [B] digital apparatus complies with Canadian ICES-003. Cet appareil numérique de la classe [B] est conforme à la norme NMB-003 du Canada. Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes : (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement.
Warning symbol
exclamation mark is intended to
alert the user of the presence of important
in this
users, bystanders or patients
Note symbol
tion and tips

1.7 Approved for medical applications

The NGP1 Computing Platform meets the medical safety requirements UL/cUL 60601-1 1st Ed., ANSI-AAMI-ES60601-1, IEC 60601-1:1988 + A1:1991 + A2:1995, EN 60601-1:1990+A1:1993+ A2:1995 , IEC 60601-1: 2005 EN 60601-1: 2006 and electromagnetic requirements: EN/IEC 60601-1-2, EN301 489-3, EN 301 893, EN 300 330-2, CFR 47 part 15

1.8 How to read this manual

If you are viewing this PDF document on the sc ree n, you c an use the fo llow ing methods to find information:
by using the var ious Navigation panels that various pdf readers are offering under the View menu
using the “find” tool
navigating with internal links, when offered.

1.8.1 Symbols

Throughout this guide, blocks of te xt may be accompanied by an icon and printed in bold or italic type. These blocks contain notes, cautions, tips or warnings. They are used as indicated in the below table:
The symbol of operating and maintenance instructions
manual that could also generate a safety risk for
This icon indicates important informa that help you make better use of your NGP1 Computing Platform and this manual
Table 2 – Table of symbols used in this manual
Some warnings may appear in alternate formats and may not be accompanied by an icon. In such cases, the specific presentation of the warning is mandated by the relevant regulatory authority. Furthermore the following symbols may appears on the product or its accessories
Product complies with 2002 / 96 / EC
Notice of proper disposal
VERIFICATION ONLY 10 NOT RELEASED
Table 3 – Symbols used in the Product label
Conformitè Europène
Compliance with Underwriters Laboratories
Compliance with Demko IEC/EN 60601
VERIFICATION ONLY 11 NOT RELEASED

1.9 Biological Hazard and Returns

The structure and the specifications of this device as well as the materials used for manufacturing makes it easy to wipe and clean and therefore suitable to be used for various applications in hospitals and other medical environments, where procedures for frequent cleaning are specified. However, normal use shall exclude biological contaminated environments, to prevent spreading of infections. Therefore use of this device in such environmen t s is at the exclusive risk of C u stomer. In case this device is used where pote ntial biological contamination cannot be excluded, Customer shall implement the decontamination process as defined in the latest edition of the ANSI/AAMI ST35 standard on each single failed Product that is returned for servicing, repair, reworking or failure investigation to Seller (or to the Authorized Service Provider) . At least one adhesive yellow label shall be attached on the top site of the package of returned Product and accompanied by a declaration statement proving the Product has been successfully decontaminated. Returned Products that are not provided with such external deco ntamination label, and/or whenever such declaration is missing, can be rejected by Seller (or by the Authorized Service Provider) and shipped back at Customer expenses.
VERIFICATION ONLY 12 NOT RELEASED
2 The FCP-NGP1 Computing Platfor m

2.1 Introduction

The FCP-NGP1 is a component of the Medtronic Care Link Encore Programmer 29901. T his latter system is a implantable medical device programmer use d to communicate with an implantable cardiac pacemaker or an implantable cardio-verter defibrillator. The Medtronic System Care Link Encore Programmer 29901 shall be battery power ed or line powered by a medical external PSU. The MPI includes the device telemetry provi ding two-way communication with an implantable cardio-verter-defibrillator (ICD) or cardiac pacemaker and ECG. Computing Platform FCP-NGP1 is designed, certified and produced by FIMI. Care Link Encore Programmer 29901 is certified by M edtronic and produced by P lexus. The external PSU is produced and certified by APS (Mod. APS100EM-190530). The custom battery FBT3S2P is certified and produced by STL - Pegatron Corp . Below the illustration of how the FCP-NGP1 mates with MPI part that carries a foldable kickstand.
VERIFICATION ONLY 13 NOT RELEASED

2.2 Overview

353
102 357.5

2.2.1 Dimensions (in mm)

VERIFICATION ONLY 14 NOT RELEASED

2.2.2 Battery dimensions (in mm)

215.5
13.7

2.2.3 Weight

Your NGP1 Computing P latform has a total weight of 3.6 Kg with battery and stylus pen inserted
VERIFICATION ONLY 15 NOT RELEASED
Loudspeaker
RF-ID Battery door
Front Keyboard and indicators

2.2.4 Features and connectivity

The below figures show the key features of The NGP Computing Platform
Transportation handle
detection area
VERIFICATION ONLY 16 NOT RELEASED
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