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
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
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
VERIFICATION ONLY 4 NOT RELEASED
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
VERIFICATION ONLY 5 NOT RELEASED
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
VERIFICATION ONLY 6 NOT RELEASED
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
VERIFICATION ONLY 7 NOT RELEASED
•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
VERIFICATION ONLY 8 NOT RELEASED
•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.
VERIFICATION ONLY 9 NOT RELEASED
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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