FCP NGP1 CP12L - MDT FIMI Computing Platform NGP1 User Manual
Contents FCP NGP1 CP12L - MDT 1 Important 5 1.1 1.2 1.3 1 Copyright ____________________________________________________________ 5 Definitions, Acronyms, Terms, and Abbreviations _____________________________ 5 Safety and precautions __________________________________________________ 7 1.3.1 Intro __________________________________________________________________ 7 1.3.2 Platform Read and follow these instructions when connecting and using your NGP1 Computing 7 1.3.
4.2.2 USB doors _____________________________________________________________ 30 4.2.3 Ethernet connection _____________________________________________________ 31 Orange LED : _____________________________________________________________ 31 Transmitting / receiving _____________________________________________________ 31 Green LED : Connected _____________________________________________________ 31 4.2.
8.2 8.3 8.4 8.5 8.6 8.7 8.8 8.
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..
Term/Acronym Definition/Usage IEEE Institute of Electrical and Electronic Engineers LCD Liquid Cristal Display 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).
1.3 Safety and precautions 1.3.1 Intro Product safety information, setup precautions and incorrect use of NGP1FCP 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 WARNING: Use of controls, adjustments or procedures other than those specified in this documentation may result in exposure to shock, electrical hazards and/or mechanical hazards.
• • • When recharging the NGP1 Computing Platform batteries, make sure 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 door opened as objects or dirt may enter in the slot. IMPORTANT: Depending on the application, it is advised to activate a power management scheme or a screen saver.
• • • • 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 temperature. Do not use the NGP1 Computing Platform AC adapter for other 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.
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.
Conformitè Europène Compliance with Underwriters Laboratories Compliance with Demko IEC/EN 60601 Table 3 – Symbols used in the Product label 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.
2 The FCP-NGP1 Computing Platform 2.1 Introduction The FCP-NGP1 is a component of the Medtronic Care Link Encore Programmer 29901. This latter system is a implantable medical device programmer used to communicate with an implantable cardiac pacemaker or an implantable cardio-verter defibrillator. The Medtronic System Care Link Encore Programmer 29901 shall be battery powered or line powered by a medical external PSU.
2.2 Overview 357.5 2.2.
2.2.2 Battery dimensions (in mm) 215.5 2.2.3 Weight Your NGP1 Computing Platform has a total weight of 3.6 Kg with battery and stylus pen inserted 13.
2.2.
Ventilation slots MPI Bay MPI connector VERIFICATION ONLY 17 NOT RELEASED
Pen receptacle Express card door VGA and USB ports doors DC jack and LAN door VERIFICATION ONLY Battery door 18 NOT RELEASED
Pen receptacle Tether hook Docking connector Docking pins VERIFICATION ONLY 19 NOT RELEASED
2.2.5 Buttons, indicators, The NGP1 Computing platform has several buttons and indicators, all grouped on a membrane keyboard located on the top of the front part. The buttons and the indicators can be operated both in FW and SW mode. While the installed application manages the SW mode ( not covered in this manual) here below you can find a description of the buttons and indicators while in the FW mode.
3 Getting started 3.1 Pre requisites The NGP1 Computing Platform is a component (or subsystem) of Medtronic Carelink Encore Programmer and other subsystems are the Medtronic Patience Interface(MPI) and associated Firmware, cables and software. The operation of the computing platform is then depending on the loaded OS and applications. So the following user information are covering only functionalities that are minimally depending on the final use and configuration. 3.1.
After hearing a click and with the door fully pulled up rotate clockwise the door Push the white hook fully downwards till the battery pack is released VERIFICATION ONLY 22 NOT RELEASED
Battery removal slip In the very unlikely event of a battery pack blocked in its compartment (due to shocks or other abnormal usage conditions) While keeping the hook fully downwards, the removal slip can be used to pull out the pack. The battery pack can be reinserted by reversing the process. Warning: To avoid personal injury, handle the battery with care.
3.1.2 Connect the AC adapter As the battery is delivered with around 50% of the charge, it is recommended to charge it fully for the first time. The battery is charged by connecting the NGP1 Computing Platform to its AC adapter as illustrated below. The DC plug must be connected by lifting the lower part of the rubber door placed on the bottom left part of the NGP1 Computing Platform.
The AC adapter allows to power the Computing Platform and to charge the battery pack, if present. Note: When there is the AC adapter inserted, the NGP1 Computing Platform is losing its IP21 grade. It is then recommended, when using the NGP1 Computing Platform disconnected from the AC adapter, to carefully close the rubber door. The AC adapter must not be used in wet environments or when the NGP1 Computing Platform is cleaned with liquids.
3.1.4 Charging the battery When the NGP1 Computing Platform is connected to AC power (or docked into its docking station), the battery automatically charges until it reaches a full charge. This happens in any power state of the NGP1 Computing Platform, either when the unit is hibernated or fully operating or OFF. Typically an empty battery can be fully charged in less than two hours.
3.1.5 Battery pack indicators Besides any indication given by the keyboard LEDs on the battery charge, the battery pack itself can give some indications to the user about life and charge Dual function LED indicators In fact , by pressing the button on the front side of the pack for less than two seconds, the 5 LEDs are lighted on displaying the “relative State of Charge”with these criteria: First four LEDs represent a 20% of the total charge. The fifth LED represent a minimum 15% of the charge.
4 Using your NGP1 Computing Platform 4.1 Booting the system When the system starts up, the selected splash screen is displayed and prior to that, indications of BIOS and FW versions area shown on the top right corner. The CMOS menu setup is locked and allowed only to service personnel. 4.2 Connecting external peripherals The computing platform is offering a large deal of connectivity through a series of interfaces that are compliant with the most popular IT standards.
4.2.1 External Monitor Connection On the left side of the Computing platform , under the specifically designated rubber door, there is a D-sub connector meant for an analog video connection to an external VGA monitor. This VGA output is permanently enabled in clone mode, so the output format is 1024 x 768 dots @. 60 Hz – 16 million colors Warning: The IP 21 performance requires that the VGA door is fully closed.
When connecting external equipments to the VGA door , follow the IEC 60601-1-1 requirements in order to guarantee patient or bystander safety. Verify the current leakages 4.2.2 USB doors The NGP1 Computing Platform has two USB 2.0 standard Type A connection, located at its left side, under the same rubber element that covers the VGA connector. These USB connections can deliver power to the plugged device according to the USB specifications: 0.5 Ampere max on a +5V supply line.
When connecting external equipments to the USB ports , follow the IEC 60601-1-1 requirements in order to guarantee patient or bystander safety. Verify the current leakages USB and VGA ports requires a check of the total patient leakage current also using a device meeting the IEC 60601-1 requirements 4.2.3 Ethernet connection On the top left side of the Computing platform , under the specifically designated rubber door, there is 8 pin RJ45 LAN door (10/100 Mbit) that supports standard Ethernet cables.
When connecting external equipments to the LAN jack , follow the IEC 60601-1-1 requirements in order to guarantee patient or bystander safety. Verify the current leakages 4.2.4 Express Card slot On the top right side of the Computing platform , under the specifically designated rubber door, there is a slot for Express Card 34 devices. Several types of peripherals are supported by the standard ( Phone cards, Storage media, etc.).
5 NGP1 Computing Platform features 5.1 Display Your NGP1 Computing Platform has a sturdy 12.1" XGA TFT LCD display with the following features: • highly readable LCD (liquid crystal display) panel with a wide viewing angle ( typical +/-50°on both horizontal and vertical directions). • resolution of 1024 x 768 pixels • Minimum output brightness ( with control set at 100%) of 400 cd/m2 • Long life LED backlight 5.
When the RF-ID button is pressed than the blue LED turns ON and the RF-ID section is energized. Depending on the supporting SW application .
5.5 Using the Wi-Fi (802-11 ABGN) The NGP1 Computing Platform has an on-board 802.11a/b/g/n PCIe* Mini Card network adapter that operates in both the 2.4 GHz and 5.0 GHz spectra. The on board module is a highly integrated wireless local area network (WLAN) solution to let users data content exchange through the latest wireless technology without using the extra cables and cords. It enables a high performance, cost effective, low power, compact solution. Compliant with the IEEE 802.
5.6 Using the Bluetooth The NGP1 Computing Platform delivers a built in Bluetooth module designed according the Bluetooth wireless technology 2.1 specifications, and including AFH (advanced frequency hopping), EDR (enhanced data rate) functions, "HID Proxy" boot-time keyboard support mode (if enabled) and other capabilities. You have to touch the Bluetooth button for enabling or disabling the Bluetooth functionality, is this is not put under control of a SW application.
5.7 Using the Waveform Viewer (WFV) button and the Emergency Hot Key (EHK) These two buttons are under direct control of the Customer SW application and /or are directly managed by the piggy-bagged MPI HW. 5.8 Audio solution The NGP1 Computing Platform has a built-in high definition audio solution. The system uses a couple of 2Watt speakers with a IP65 grade. There is no embedded microphone or microphone input on the NGP1 Computing Platform.
5.9 Docking connector Even though the NGP1 Computing Platform has no docking station planned at the moment, it offers docking provisions. In fact a docking connector is present on the bottom of the NGP1 computing platform , sided by two metal docking / ground pins. The NGP1 Computing Platform can be docked on its docking unit without any locking mechanism.
5.10 _________________________________________________________ Security 5.10.1 Built-in features Your NGP1 Computing Platform includes several features that are dedicated to increase the level of security of your data. Among them: • • BIOS is accessible only by authorized personnel TPM (Trusted Platform Module) 1.2. The Trusted Platform Module (TPM) is a specific protection against malware intelligent attacks.
meet the requirements of those countries. Provide the right cord-set. In US and Canada “hospital grade” cord-set has to be used, provided with instructions to indicate that grounding reliability can be achieved only when the equipment is connected to an equivalent receptacle marked hospital only or hospital grade. These instructions need to be marked either on the equipment or on a tag on the power cord.
Note: The NGP1 Computing Platform OFF status is actually a minimum power quiescent state that anyhow draws energy from the battery. If the NGP1 Computing Platform is left OFF on battery for more than two weeks, it is possible that the completely charged battery can be found depleted.
5.12.1 Storing main batteries 5.12.2 Battery and energy management. In case of long inactivity of the battery packs not inserted in the NGP1 Computing Platform, it is preferable to store them neither fully charged nor totally empty. As the battery will lose gradually its charge, it is recommended to recharge if the charge drops below 20% or after a few months and possibly re-use it for a few recharge cycles. As already mentioned in paragraph 3.1.
6 NGP1 Computing Platform Maintenance 6.1 Cleaning The NGP1 Computing Platform is designed for being subjected to periodic cleaning and disinfection, as typical for infection control, in a healthcare environment, Materials and shapes as such that the unit can be cleaned with sprays and liquids. Recommended cleaning solutions have to follow specific institutional recommendations and are depending on the environmental situations in which the NGP1 Computing Platform is used.
If the display has become greasy, use isopropyl alcohol. 6.1.3 To clean the cabinet: For normal cleaning, use a soft cloth wetted or sprayed with disinfectant For heavy duty cleaning, also a small brush can be used for cleaning the ventilation apertures. 6.1.4 To clean the fan The fan is not removable by the user. The clean of the fan could be done only by the authorized Service Personnel.
6.2.5 Dispose of Lithium ion battery (Li-ion) Lithium-ion battery should never be incinerated or disposed in fire in order to avoid the risk of explosion. Do not disassemble batteries as this can generate a gas that may irritate the throat and lungs. If the battery is opened, lithium in the battery may react with moisture and generate heat or fire, which could result in injury. Special precautions must be taken to avoid Li-ion battery fire up or explosion that can cause serious injuries.
7 Troubleshooting 7.1 My NGP1 Computing Platform is not turning ON. Make sure that the battery is properly inserted and latched or the AC adapter is fully connected or that the unit is well docked. Plugging the AC adapter into the DC in jack located under the protective cover on the bottom of the unit, makes sure that the Adapter is also plugged into the wall socket. If running with battery only, be sure that the inserted battery pack has some capacity left. 7.
8 Specification 8.1 System Specifications • • • • • CPU CPU Speed RAM Size Solis State Disk size Operating System Intel® Atom TM Z530P 1.6 GHz 2 GB DDR2 SDRAM 32 GB SSD Microsoft® Windows® XP Embedded (not supplied) 8.2 Display • • • • Touch panel Screen Type Screen Size Screen Resolution • • • • • Active Screen Area Brightness Contrast Ratio Display Color Backlight Touch Sensor Transmissive TFT LCD 12.1 inch / 310 mm diagonal XGA, 1024 x 768 (4:3 aspect ratio) 245.7 mm x 184.
8.4 Docking Station Connectivity • I/O Interfaces USB ports (x 2) 18 - 26.5 VDC Power Input Jack TBD 8.5 Power • • • • • AC/DC Adapter In AC/DC Adapter Out Battery type Battery capacity Charge duration 100-240 VAC 1.5 A @ 50/60 Hz 19 VDC 5.3 A Li-ion, rechargeable 4000 mAh Stand-by 15 days Operating 2hrs (min.) 8.6 Physical Characteristics • Dimensions Width: 353.0 mm Height: 357.0 mm Depth: 102 mm • Weight • Shock Resistance (non operating) • Dust/Water Protection 3.
8.9 Applicable International Standards • Safety • Marks ANSI/AAMI ES 60601-1:2005 EN / IEC 60601-1 CAN/CSA-C22.2 nr. 601-1-M90 FCC CFR 47 P.15 Sub B - Class A CISPR 22 - Class A EN / IEC 60601-1-2 EN 55011/ CISPR11 - Class A FCC CFR 47 P.
9 Options 9.1 Docking station The NGP1 Computing Platform has a companion docking station: the Mod. 26904 ( cod: XXXXXXXXXXXXXX) It delivers a “grab and go” undocking process (no release buttons or levers), allows the user to store the unit while charging the battery and provides convenient desk-top access by placing the display at a comfortable height. The docking station can be powered with the same power adapter of the NGP1 Computing Platform. 9.
11 Labels and stickers A group of labels is placed on the lower part of the back of the unit.
12 Your notes VERIFICATION ONLY 52 NOT RELEASED
FIMI S.r.l. Via Saul Banfi 1 21047 Saronno (VA). Italy Note: This Product has been designed to make it able to withstand certain mechanical stresses and/or to withstand exposure to harsh, wet and dusty environment in accordance to the applicable industrial standards (IP grade). These measures are taken to enhance its durability. However, it cannot be guaranteed that this Product will not be damaged when dropped or when subjected to liquid spill or alike.