Capsule Technologie 001 Neuron 2 User Manual IandM Neuron 2
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![Installation and Maintenance Guide [Chapter 1]15EnglishIntroducing the Capsule Neuron 2OverviewThe Capsule Neuron 2 is Capsule's point-of-care hardware platform for device connectivity. It is a flexible and scalable platform that you can configure to operate in various care areas of the hospital. In high acuity environments, such as the ICU, the Capsule Neuron 2 typically runs Capsule’s Status Application to enable continuous collection of vital signs for one patient from multiple devices. In low acuity, non-critical care settings (such as med-surg), the Capsule Neuron 2 typically runs Capsule's Mobile Vitals Plus Application to enable the automatic collection, validation, and transmission of vital signs from multiple patients to the EMR directly from the point of care. Note: Do not operate the Capsule Neuron 2 until after you read and understand these instructions. Pay particular attention to all warnings and cautions. Note: For information about the administration of DataCaptor software, IT personnel should refer to the DataCaptor System Administrator’s Guide. Note: To operate the Capsule Neuron 2, clinicians require training in the procedures described in the Capsule Neuron Status Application Clinical User’s Guide and the Capsule Neuron Mobile Vitals Plus Application Clinical User’s Guide. Note: To operate any medical device that connects to the Capsule Neuron, clinicians must be separately trained in the use of that device. Intended UseThe intended use of the DataCaptor™ system is for data collection and clinical information management, either directly or through networks with independent bedside devices. Capsule's hardware and software are not intended for monitoring purposes, nor is the software intended to control any of the clinical devices (independent bedside devices/information systems) to which it is connected. There is no other known contraindication for the use of the Capsule Neuron 2 system.Caution: Do not modify the Capsule Neuron 2, cables, or any part of the DataCaptor Connectivity software, or mount the device in any way other than instructed in Capsule documents. Any modification to the hardware or software can prevent proper functioning and cause damage to the connected medical device.](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-5.png)
![6EnglishIntroducing the Capsule Neuron 2 [Chapter 1]About this documentProduct The product described in this document is the “Capsule Neuron 2” (part number: DC-NU2-UMPC). For brevity and clarity, that product is referred to in the rest of this document as the “Capsule Neuron”. This means that all references to “Capsule Neuron” in this document shall be understood as applying to part number DC-NU2-UMPC.Purpose This document provides:• instructions for installing, mounting, and connecting the Capsule Neuron hardware• instructions for maintaining, cleaning, and storing the device and its accessories• details of technical characteristics and regulatory compliance of the deviceAudienceThe target audiences for this document are:Notes, cautions, warningsWhere necessary, Capsule documents highlight any applicable warnings, cautions, and notes to avoid risk of injury to individuals or damage to equipment. There are three levels of information:Note: Directions to clarify specific information to assist the user, and to avoid the risk of damage to the equipment described in this guide and/or any other equipment or goods, and/or cause environmental pollution.Audience DescriptionBiomedical staff The biomedical staff ensures that the medical equipment is safe, functional, and properly configured for the clinical environment. They install, inspect, and maintain biomedical devices and support systems to adhere to medical standard guidelines.Clinicians Clinicians are health care providers who interact with patients in a medical environment, such as a registered nurse, nurse technician, respiratory therapist, or anesthesiologist. Warning: Indicates a hazard with a medium level of risk which, if not avoided, could result in death or serious injury.Caution: Indicates a hazard with a low level of risk which, if not avoided, could result in minor or moderate injury or severe damage or malfunctioning of the equipment.](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-6.png)
![Introducing the Capsule Neuron 2 [Chapter 1] 7EnglishRelated documentsCapsule provides the following additional documents for use with the Capsule Neuron. Manufacturer’s informationDocument Description AudienceDataCaptor System Administrator's Guide (English only)provides information on deployment scenarios and instructions on how to install, upgrade, and configure the DataCaptor software solution, including troubleshooting tips. Available from the:•Help menu of the Web Administration Console •Capsule Customer PortalHospital IT staff Capsule Neuron Status Application Clinical User's Guideprovides information on how to use the Status application, along with troubleshooting advice and hardware cleaning instructions.Available from the:•Help menu of the Web Administration Console •Capsule Customer Portal• icon in the applicationClinicians Capsule Neuron Mobile Vitals Plus Application Clinical User’s Guideprovides information on how to use the MVP application, along with troubleshooting advice and hardware cleaning instructions.Available from the:•Help menu of the Web Administration Console •Capsule Customer Portal• icon in the applicationClinicians Capsule Tech, Inc. 300 Brickstone Square, Suite 203Andover, MA 01810 USAPhone: 1-978-482-2300Toll Free: 1-800-260-9537Capsule Technologie 9 Villa Pierre Ginier75018, Paris FrancePhone: (+33) 1 5334 1400](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-7.png)
![8EnglishIntroducing the Capsule Neuron 2 [Chapter 1]Getting additional informationFor more information, or to order additional products (Capsule Neurons, or accessories including batteries, power cables, printed copies of documents), contact your reseller or Capsule directly:Table of abbreviationsThe table provides an alphabetical list of the main abbreviations used in this document.USA EMEA & APACCapsule Tech, Inc.300 Brickstone Square, Suite 203Andover, MA 01810 USAPhone: 1-978-482-2300Toll Free: 1-800-260-9537Capsule Technologie9 Villa Pierre Ginier75018, Paris FrancePhone: (+33) 1 5334 1400US Technical SupportPhone: 1-800-260-9537 E-mail: support@capsuletech.comEMEA & APAC Technical SupportPhone: (+33) 1 5334 1400E-mail: emea.support@capsuletech.comAbbreviation MeaningAC Alternating CurrentCE Conformité Européenne (= European Conformity)CISPR Comité International Spécial des Perturbations Radioélectriques (= Special international committee on radio interference)DIM Device ID ModuleDTS DataCaptor Terminal ServerEN/IEC European Norm / International Electrotechnical CommissionFCC Federal Communications CommissionGB GigabyteLAN Local Area NetworkLED Light Emitting DiodeMVP Mobile Vitals PlusRoHS Restriction of the use of Hazardous SubstancesVAC Voltage in Alternating Current WEEE Waste Electrical and Electronic Equipment DirectiveWLAN Wireless Local Area NetworkWPA Wireless Protected Access](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-8.png)
![Installation and Maintenance Guide [Chapter 2]29EnglishSetting up the Capsule Neuron What’s in this chapterFollow the instructions in this chapter to setup the Capsule Neuron. Deployment follows these steps, in this order:•Unpacking and inspecting the package contents•Installing the batteries in the Capsule Neuron•Deploying the Capsule Neuron•Mounting the Capsule Neuron on the wall•Mounting the Capsule Neuron on a roll stand•Connecting the Capsule Neuron to the power supply•Before you use the Capsule Neuron for the first timeNote: This document does not describe the configuration of the Capsule Neuron on a local network. Refer to the DataCaptor System Administrator's Guide.Unpacking and inspecting the package contentsBefore you install the Capsule Neuron in a clinical setting, you must inspect and set it up according to instructions.Contents of a product shipmentThe table describes the contents of a Capsule Neuron shipment. Item Shipment characteristicsCapsule Neuron In one carton, you find the Capsule Neuron itself, wrapped in plastic and sandwiched between two blocks of polyethylene foam. Each Capsule Neuron is shipped along with:• Main batteryThe main battery is in position inside the Capsule Neuron, but the battery pins are not yet in contact with the battery socket on the Capsule Neuron, and the battery is not yet fixed in place.•Power brickThe power brick is shipped wrapped in plastic.• Screws and washersFour M4 Phillips-head screws and their associated washers are shipped in a plastic bag with the Capsule Neuron. These screws are available for attaching the Capsule Neuron to a mounting bracket, depending on the deployment selected.](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-9.png)
![Setting up the Capsule Neuron [Chapter 2]10EnglishUnpacking the cartonsNote: If the carton is broken, open, or damaged in any way, do not accept the shipment.1. Turn the carton so that the arrow on the package is pointing up.2. Cut the tape on the carton. 3. Take each item out of the carton. 4. Check all items against the packing list, and against the list in Contents of a product shipment above.5. Remove the packing material and examine each item for any signs of shipping damage. 6. Save all packing materials, the invoice and the bill of lading. You will require them if you need to process a claim with the carrier. Hardware installation prerequisites You need the following tools (not included) to install the Capsule Neuron:• a cruciform-tip screwdriver• a Phillips-head PH0 screwdriverIn addition, depending on how you intend to mount the Capsule Neuron, you could require certain hardware:• If you select to deploy the Capsule Neuron on a roll stand, you must source a roll stand pole extension with VESA 75 or VESA 100 interface suitable for the model of your roll stand. Contact your roll stand manufacturer for options. Power Cable The electrical cable that is used to connect the Capsule Neuron power brick to the electrical mains outlet is shipped in a separate carton from the Capsule Neuron. This cable is always adapted to local requirements.Extended battery (optional)If ordered, extended batteries are shipped in a separate carton, where possible, the same carton as for the cables. Each extended battery is packed in its own unit box.This document Printed copies of this Capsule Neuron 2 Hardware Installation and Maintenance Guide are shipped separately, in the same carton as the cables, where possible. The number of copies depends on the number of Capsule Neurons in the shipment.Additional elements Depending on the contents of your order, other connectivity elements such as serial cables, patch cables, and DIMs, could be present in the shipment. If yes, these are typically shipped in the same carton as for the cables. Caution: Be careful to cut only the tape and not, for example, the Capsule Neuron. Item Shipment characteristics](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-10.png)
![Setting up the Capsule Neuron [Chapter 2] 11English• If you select to deploy the Capsule Neuron on a wall-mount, then you require a mounting solution that is VESA 75/100-compatible. Installing the batteries in the Capsule NeuronInstalling the main battery in the Capsule Neuron The Capsule Neuron is shipped with the main battery in position but not yet fixed in place. 1. Push the main battery towards its connection port.2. Use a screwdriver or other tool to screw in the two screws that hold the main battery in place. 3. Tighten the screws until the battery is connected to its pins. Do not overtighten.Installing the optional extended battery in the Capsule Neuron 1. Turn the Capsule Neuron so that the screen is facing away from you.2. Use a screwdriver to unscrew the screw that holds the extended battery faceplate in position.3. Push the loose faceplate to the left, then lift the faceplate away from the Capsule Neuron.](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-11.png)
![Setting up the Capsule Neuron [Chapter 2]12English 4. Position the extended battery at the same point where you lifted the faceplate. Because of the arrangement of the pins, you cannot position the extended battery incorrectly.5. Slide the extended battery to the right. Continue sliding until the left side of the extended battery is flush with the left side of the extended battery slot. 6. Push the locking button on the extended battery to the down position.](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-12.png)
![Setting up the Capsule Neuron [Chapter 2] 13EnglishDeploying the Capsule NeuronIn typical deployments of the Capsule Neuron, you can mount it on the wall, or mount it on a roll stand or other mobile configuration. Note: For compliance with EN/IEC 60601-1, the Capsule Neuron is not classified as a portable device. Instead, the Capsule Neuron must be deployed as one of:- Mobile device - Fixed devicePrecautions for all deploymentsConsiderations for wall-mounted deploymentsWhen you are deciding where to place the Capsule Neuron at the point of care, Capsule recommends that you take account of the following considerations.• Mount the Capsule Neuron near the head of the bed or on the head wall in the patient room.• To allow clinicians easy access to the Capsule Neuron touch screen, mount the Capsule Neuron no more than 1.5 meters (5 feet) or less than 1 meter (3 feet, 3 inches) from the ground.• If there are medical devices connected to the ports on the Capsule Neuron, position the Capsule Neuron on the same side of the bed as those devices. • Make sure that you take account of the length of the cables required to connect the Capsule Neuron and the medical devices. Mounting the Capsule Neuron on the wallAttach the Capsule Neuron to your selected VESA 75/100 wall-mounted solution. Refer to the instructions from the solution manufacturer. Caution:• Do not place the Capsule Neuron inside furniture or inside any enclosed space. This could prevent correct cooling of the device and interfere with radio communications.• Operate the Capsule Neuron only within these environmental conditions:- Temperature: +10°C to +40°C (+32°F to °+104°F)- Atmospheric pressure: Atmospheric pressure: 700 hPa to 1060 hPa- Altitude: -100 meters to +2000 meters (-328 feet to +6560 feet)- Humidity: 10% to 95% RH non-condensing• Do not stack the Capsule Neuron or place it next to other equipment. If you do, then check it for normal operation running its usual configuration.• In semi-private rooms, connectors must be placed or labeled so that they clearly indicate the bed for which they collect data.Caution: For Capsule Neurons that are installed above the patient, take adequate precautions to prevent them from falling on the patient.](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-13.png)
![Setting up the Capsule Neuron [Chapter 2]14EnglishMounting the Capsule Neuron on a roll stand1. Mount the Capsule Neuron to the roll stand. Refer to the manufacturer’s instructions for the roll stand as required. 2. To fix the device to the mounting bracket, use the four screws and washers that are delivered with your Capsule Neuron, or the screws delivered with your roll stand pole extension.Connecting the Capsule Neuron to the power supplyOnce deployed, on a wall or roll stand for example, you can connect the Capsule Neuron to the power supply.Power requirementsThe Capsule Neuron is designed to use the IEC 60601-1-compliant, external DC power supply and power cables that are provided with the Capsule Neuron. For precise information, refer to the Technical Information in chapter 5 of this document.Cautions:• Always use the hospital-grade, AC power cable delivered with the product to connect the Capsule Neuron to an AC power source. Do not, under any circumstances, use any other cable than the one provided, even to provide extra cable length. The use of any other cable can result in increased emissions or decreased immunity of the device with regards to electromagnetic interference.• Do not connect the Capsule Neuron to an AC outlet that is controlled with a switch or dimmer.• Do not, under any circumstances, remove the grounding conductor from the power plug.• Do not use extension cords or adapters of any type.• The power cable, supply, and plug must remain intact and undamaged.• The power plug must remain accessible to unplug the device from the power supply mains if necessary.](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-14.png)
![Setting up the Capsule Neuron [Chapter 2] 15EnglishConnecting the Capsule Neuron to the power supply1. The power brick that was shipped with your Capsule Neuron has a power cable on one end, and an open plug on the other end. Plug that power cable into the Capsule Neuron at the DC-in power connector (as illustrated). 2. Tighten the locking mechanism on the DC-in power connector to lock the power plug in place.3. Plug the power cable that was shipped with your Capsule Neuron into the open plug on the power brick. 4. Plug the other end of that power cable into a grounded electrical outlet (generally 3-prongs). The Capsule Neuron switches on automatically.Before you use the Capsule Neuron for the first timeFor all deployments, before you use the Capsule Neuron for the first time, you must completely charge its battery. 1. Set up the Capsule Neuron as described in this chapter:• install the main battery• install the extended battery, if you use one • connect the Capsule Neuron to the electrical mains2. The battery/ies start to charge as soon as you plug the Capsule Neuron into the electrical mains. Allow the main battery to charge for about two hours. If you have installed both the main battery and the optional extended battery, allow the two batteries to charge for about six hours. For a fuller description of the batteries, and the charging / discharging process, refer to “Working with the batteries” on page 21.Caution: For safety, cables are designed to prevent inadvertent disconnection if someone accidentally pulls on them. However, make sure that you route cables so that they do not present a tripping hazard.Warning: You must only connect the Capsule Neuron’s power brick to an appropriate power source. To avoid risk of electric shock, use a grounded (3-prong) electrical power outlet.](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-15.png)
![Operating the Capsule Neuron [Chapter 3]163EnglishOperating the Capsule NeuronComponents on the Capsule NeuronLegends on the drawingsIn the legend for the drawings that follow:• Individual components keep the same numbers on each drawing. For example, the USB ports on the bottom of the Capsule Neuron are shown with the number . When you see the number , you know that it represents only these ports. • Colors have meaning. A blue circle indicates a medical-grade connector. A yellow circle indicates network connection (Ethernet). All other components are indicated with red circles.View from the front6 6 Light sensor Touch screen Status LED RFID badging area Serial ports USB ports1234 5 6 1 2 3 5 6 4](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-16.png)
![Operating the Capsule Neuron [Chapter 3] 17EnglishView from the bottom3/4 view from the back 5 67 8 10 9 Serial ports (4) - front-accessible USB ports (2) - front-accessible USB ports (2) - rear-accessible Serial port (1) - rear-accessible Ethernet connection DC power-in connector567 8 9 105 6 7 8 10 9 Serial ports (4) - front-accessible USB ports (2) - front-accessible USB ports (2) - rear-accessible Serial port (1) - rear-accessible Ethernet connection DC power-in connector5 6 78910](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-17.png)
![Operating the Capsule Neuron [Chapter 3]18EnglishView from the backViews from the side ConnectivityThe ports on the Capsule Neuron are used to connect medical or other devices. A blue line on these ports indicates a medical-grade connection port. A yellow line indicates the Ethernet connection port. The tables describe the ports.11 13 12 12 12 12 15 Extended battery emplacement Mounting plate screwholes (VESA 75/100 configuration) Main battery Covered USB port Aeration vents Speaker11121314151614 16 17 13 14 Main battery Covered USB port Anti-theft slot131417](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-18.png)
![Operating the Capsule Neuron [Chapter 3] 19EnglishSerial Ports USB Ports Ethernet PortPowering on the Capsule NeuronFor information on connecting the Capsule Neuron to the power supply, refer to “Connecting the Capsule Neuron to the power supply” on page 14.Power on the Capsule NeuronThe Capsule Neuron switches on automatically when you plug it into any power source. For manual operation, press the Power On/Off button, shown at position on this illustration of the top view of a Capsule Neuron:Location Characteristics Number PurposeFront Galvanic isolated RS-232 with RJ45 connector4Used to connect medical devices with serial interfacesRear Galvanic isolated RS-232 with RJ50 connector1Used to connect medical devices with serial interfacesLocation Characteristics Number PurposeFront Galvanic isolated, Type A USB 2.0 full-speed2Used to connect medical devices with USB interfacesRear Galvanic non-isolated, Type A USB 2.0 high-speed2Used to connect external USB, non-medical devices such as barcode scannersSide (left) Galvanic non-isolated, Type A USB 2.0 high-speed1Additional USB, non-medical device connectionLocation Characteristics Number PurposeBack RJ45 connector 1Used to connect to the hospital-internal, wired network (Ethernet)A](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-19.png)
![EnglishOperating the Capsule Neuron [Chapter 3]20Power Off the Capsule NeuronTo power off the Capsule Neuron, press the On/Off button again. If the Capsule Neuron does not shut down properly for any reason, you can do a hard shutdown. Press and hold the power button for four seconds.Working with the Capsule Neuron touch screenThe Capsule Neuron screen is a 10.1-inch (25.6-centimeter) touch screen. It is antiglare treated, and readable from multiple angles. Screen brightness adjusts automatically to the level of ambient light, dimming or brightening in parallel with the current level of luminosity in the room. If the screen goes completely dark, the Capsule Neuron is said to be in ‘sleep’ mode, and you can wake it up by touching the screen.Reading the status LEDThe Capsule Neuron provides a single LED, located on the front of the device below the screen. LED Capsule Neuron StatusOff Capsule Neuron is not running.Blue - Blinking Capsule Neuron is booting.Blue Capsule Neuron has finished booting, and is EMR-connected.Red Capsule Neuron has finished booting, and is not EMR-connected.APower On/Off button](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-20.png)
![Operating the Capsule Neuron [Chapter 3] 21EnglishWorking with the batteriesFor instructions on installing the main battery, and the optional extended battery, refer to “Installing the batteries in the Capsule Neuron” on page 11.Note: Before you use each Capsule Neuron for the first time, you must fully charge its battery/ies, as described in “Before you use the Capsule Neuron for the first time” on page 15. Battery Lifetime TerminologyWhen describing the Capsule Neuron, the following terms are used:•Battery autonomy refers to the amount of time that the Capsule Neuron can remain fully functional in case of a disconnect from the electrical mains. •Battery life span refers to the total time that the battery lasts before you must replace it. Battery SummaryCharacteristic Main Battery Extended BatteryAutonomy 150 minutes (2 hours 30 minutes) of functional operation when unplugged from AC mains, with a new, fully-charged battery240 minutes (4 hours) of functional operation when unplugged from AC mains, with a new, fully-charged batteryWhen used together, the two batteries together provide about 360 minutes (6 hours) of autonomy.Charging time 120 minutes (2 hours) 240 minutes (4 hours) for the extended battery alone360 minutes (6 hours) to charge both batteriesCharging First charged / Last discharged Last charged / First dischargedLife span After 500 complete charging cycles, remaining capacity is about 80%.Alternatively, after 12 months of continuous use, remaining capacity is about 50%.After 500 complete charging cycles, remaining capacity is about 80%.Alternatively, after 12 months of continuous use, remaining capacity is about 50%.Shelf-life 3 months 3 monthsReplaceability By biomed user - requires no tools other than a screwdriverBy clinical user - requires no tools other than a screwdriver](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-21.png)
![EnglishOperating the Capsule Neuron [Chapter 3]22Charging the batteriesTo charge the batteries, plug the cable from the Capsule Neuron power brick into the AC power mains (wall socket). To monitor the batteries during the charging process, check the battery information displayed on the screen, and described in the Capsule document, Clinical User’s Guide for the Mobile Vitals Plus application. Removing a batteryRemoving the main batteryRefer to the illustrations for Installing the main battery in the Capsule Neuron on page 11.1. Use a screwdriver or similar tool to unscrew the two screws that hold the battery in place.2. Pull the battery gently away from the Capsule Neuron to disconnect the battery from the pins.3. Remove the battery.Removing the extended batteryRefer to the illustrations for Installing the optional extended battery in the Capsule Neuron on page 11.1. To release the extended battery, push the locking button to the up position. 2. Slide the extended battery to the left. 3. Lift the battery out and away. 4. If desired, and if you have retained the faceplate, you can replace the faceplate on the empty battery slot. Use a screwdriver and the screw that you removed when you installed the extended battery.Swapping a batteryTo swap a charged battery in place of a discharged battery, or to swap a new replacement battery for a depleted battery:1. Make sure that the Capsule Neuron is plugged into the electrical mains outlet. Alternatively, if you are working with both the main battery and an extended battery, make sure that the battery that you are not replacing is charged and continues to supply power to the Capsule Neuron at all times. 2. Remove the battery, as described above under Removing a battery.3. Install the new battery, as described in “Installing the batteries in the Capsule Neuron” on page 11.Caution: Before you remove a battery, make sure that the Capsule Neuron is receiving power, either from the electrical mains, or from at least one charged battery that is installed in the Capsule Neuron.](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-22.png)
![Operating the Capsule Neuron [Chapter 3] 23EnglishConnecting the Capsule Neuron to the networkConnecting to a wired network1. Plug one end of the LAN cable into the Ethernet connector, located on the rear panel of the Capsule Neuron, and marked with a yellow line. In the illustrations, on page 17 for example, this connector is labeled .2. Plug the other end of the same cable into the network socket (typically on the wall).Connecting to a wireless networkNo special procedures are required on the Capsule Neuron for wireless connection. However, each Capsule Neuron must be configured in the Web Administration Console to use the wireless network. Refer to the “DataCaptor System Administrator’s Guide” for more.Checking the wired connectionOn the Ethernet jack, there are two small LEDs. When you plug in the Ethernet connection cable, you can check the connection through the behavior of these LEDs: Checking the wireless connectionYou cannot check the wireless connection using Capsule Neuron hardware components. You must use the network connection information displayed on the screen, and described in the Clinical User’s Guide for the Mobile Vitals Plus application or the Status application. Connecting a vital signs monitor to the Capsule NeuronBefore you connectBefore you connect a vital signs monitor to the Capsule Neuron, you must program its Capsule Device ID Module (DIM). A Capsule DIM is required for all devices connected to the Capsule Neuron. For information on how to program a Capsule DIM, refer to the “DataCaptor System Administrator’s Guide”. The Device ID Module (DIM) supports plug-and-play connectivity. Its automatic device identification feature allows users to connect and re-connect any biomedical device to the Capsule Neuron with ease. The separate DIM attached to each device through a cable assembly allows the Capsule Neuron to:• automatically identify the attached deviceLEDs State MeaningLink/Act Off The Capsule Neuron is not connected to the LANBlinking Network activityOn Link is active10/100/1000 Off Connected to the LAN at 10 MB speed, or Not connected Green Connected at 100 MB speedOrange Connected at 1000 MB speed 9](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-23.png)
![EnglishOperating the Capsule Neuron [Chapter 3]24• initialize the appropriate DataCaptor Device Interface (DDI)• detect when the device is disconnected and re-connectedConnecting the cables1. Attach the device cable from the device to the DIM (Device ID Module).2. Attach the DIM patch cable to the RJ45-end of the DIM.Connecting the devices1. Attach the RJ45-end of the cable assembly into one of the ports of the Capsule Neuron. Refer to the description of “Connectivity” on page 18 for the set of available ports. 2. Connect the other end of the cable assembly to the back of the vital signs monitor.3. Tighten the thumb screws and secure the assembly behind the monitor. For more on using the Capsule Neuron with the vital signs monitorThis manual does not describe the use of the Capsule Neuron with vital signs monitors. Instead, refer to the following documents:Caution: If you use unapproved cables to connect medical devices to the Capsule Neuron, you could cause damage to or malfunctioning of the medical device.Device cable DIM DIM patch cableSubject Where to lookHow to configure Capsule Neuron DataCaptor System Administrator’s GuideHow to operate Capsule Neuron Capsule Neuron Status Application Clinical User’s GuideCapsule Neuron Mobile Vitals Plus Application Clinical User’s Guide](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-24.png)
![Installation and Maintenance Guide [Chapter 4]425EnglishMaintaining the Capsule NeuronCapsule recommends that you carry out regular maintenance activities as described in this guide to ensure correct operation of the device.Periodic cleaning and disinfectionPeriodically clean and disinfect the elements in the Capsule Neuron, including cables and batteries, by wiping the outer case with a lint-free cloth, lightly moistened with warm water and a mild, non-abrasive cleaning solution containing any of the compatible cleaning agents below (follow the manufacturer’s guidelines):Cleaning Precautions Caution: When cleaning or disinfecting the Capsule Neuron, batteries, and cables, you must power off the device first. However, you can use standard computer screen solution to wipe down the Capsule Neuron touch screen (for example, to remove fingerprints) during normal operation, while it is powered on.• 70% isopropyl alcohol • 10% bleach solution• CaviCide® • Clorox® Disinfecting Wipes• Clorox Healthcare™ Bleach Germicidal Cleaner • Sani-Cloth®, Sani-Cloth® Plus, Super Sani-Cloth®, Sani-Cloth® HB, Sani-Cloth® Bleach Wipe• ANIOSURF Premium, Bacteranios SF, SURFA’SAFE, WIP’ANIOS Caution:• To avoid damage to the Capsule Neuron, try to limit contamination and minimize the need for disinfectants.• Since the Capsule Neuron is not completely watertight:- Do not spray cleaning liquid or foam on the Capsule Neuron, or submerge or soak it for cleaning.- Never spray or squirt any type of liquid directly on the Capsule Neuron; spray the liquid, gel, or foam on a cloth and then use that cloth to rub on the device.- Do not spill liquids on or around the unit.- Do not expose the power cable or power brick to liquid.- Make sure that the cover on the USB port is securely fastened.• Do not use any other agent than those listed. (Contact Capsule for assistance if your cleaning agent is not on the list.)• Do not use harsh solvents.• Do not clean, disinfect, or sterilize any part of the system by autoclaving or with the use of ethylene oxide gas (gas sterilization).• Do not touch, press, or rub the display panel with abrasive cleaning compounds, instruments, brushes or rough-surface materials.](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-25.png)
![Maintaining the Capsule Neuron [Chapter 4]26EnglishPeriodic maintenance of the Capsule NeuronAuthorized AccessCertain components on the Capsule Neuron are only accessible to Capsule technical support personnel. These elements are held in place using special screws referred to as “hexalobular internal”. However, other components on the Capsule Neuron, such as the main battery, can be removed by biomed staff, for purposes of maintenance or cleaning, for example. These elements are held in place using Philips screws. InspectionsOnce per year, carry out an inspection of:• the power cable• the power brickLook for any visible or other damage, overheating, or corrosion. A damaged power cable or power brick can affect the operation of the Capsule Neuron. Replace damaged components with new components.Storing the Capsule NeuronIf the Capsule Neuron is not in use, make sure that you respect its storage conditions: • Temperature: -20°C to +60°C (-4°F to +140°F)• Humidity: 0% to 95% RH non-condensing• Atmospheric pressure: 500 hPa to 1060 hPaMaintenance of the Capsule Neuron batteriesCleaningWhen cleaning the Capsule Neuron batteries, apply the cleaning procedures and precautions described above under “Periodic cleaning and disinfection”.Short-term maintenanceFor daily usage purposes, it is recommended that you keep the batteries in charge mode; that is, keep the batteries installed in the Capsule Neuron, and keep the Capsule Neuron connected to the electrical mains.Caution: Power off the Capsule Neuron before you inspect the power cable and power brick.](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-26.png)
![Maintaining the Capsule Neuron [Chapter 4] 27EnglishLong-term storage and maintenanceShelf life of the batteriesBoth the main and the extended batteries for Capsule Neuron have a shelf life of three months. This limit applies to batteries that are not in use (that is, if they are not either in the process of charging, or being used to supply power to the Capsule Neuron). If the battery fully discharges, during storage for example, then you must replace it. Storing the batteriesIf the Capsule Neuron is not in use for an extended period of time, we recommend that you:1. Charge the battery completely.2. Remove the fully charged battery from the Capsule Neuron (refer to “Removing a battery” on page 22).3. To maximize the battery life span, make sure that you store the battery within the recommended parameters:• Temperature: -20°C to +60°C (-4°F to +140°F)• Humidity: 0% to 95% RH non-condensing• Atmospheric pressure: 500 hPa to 1060 hPa4. Store the battery and the Capsule Neuron separately.Caution: Both the main battery and the extended battery have shelf lives of three months from the date of manufacture. You must install a newly received battery in a Capsule Neuron, and fully charge the battery within three months of receipt. Refer to the Capsule Neuron packaging for the battery expiration date.](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-27.png)
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![Installation and Maintenance Guide [Chapter 5]529EnglishTechnical InformationGuidance and manufacturer’s declarationElectromagnetic EffectsThe Capsule Neuron radiates and consumes radio frequency energy. It has been designed and evaluated to comply with the emission and immunity requirements of EN/IEC 60601-1-2, but electromagnetic interference may occur if not installed correctly and used in accordance with the instructions in this manual. Refer to the Tables in this chapter for detailed information regarding declaration and guidance related to emission, immunity, and separation distances.Electromagnetic EmissionsThe Capsule Neuron is intended for use in the electromagnetic environment specified below. The customer or the user of the Capsule Neuron should make sure that it is used in such an environment. Note: UT is the AC mains voltage prior to application of the test level.Electromagnetic Immunity (ESD, EFT, Surge, Dips and Magnetic Field)The Capsule Neuron is intended for use in the electromagnetic environment specified below. The Caution:• Portable and mobile radio frequency devices, such as mobile phones, can impact the correct functioning of this device and should not be used in close proximity of this device.• Use of accessories, power adapters and cables other than those specified may result in increased emission and/or decreased immunity of the Capsule Neuron.Emissions test Compliance Electromagnetic environment – guidanceRF emissions CISPR 11 Group 1 The Capsule Neuron uses RF energy only for its internal function; its RF emissions are therefore very low and are not likely to cause any interference to nearby electronic equipmentRF emissions CISPR 11 Class A Class A: The Capsule Neuron is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.Harmonic emissions IEC 61000-3-2Class AVoltage fluctuations/flicker emissions IEC 61000-3-3Complies](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-29.png)
![Technical Information [Chapter 5]30Englishcustomer or the user of the Capsule Neuron should ensure that it is used in such an environment. Immunity Test IEC 60601 test level Compliance levelElectromagnetic environment - GuidanceElectrostatic discharge (ESD) IEC 61000-4-2±6 kV contact ±6 kV contact Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. ±8 kV air ±8 kV airElectrical fast transient/burst IEC 61000-4-4±2 kV for power supply lines±2 kV for power supply linesMains power quality should be that of a typical commercial or hospital environment.±1 kV for input/output Lines±1 kV for input/output LinesSurge IEC 61000-4-5 ±1 kV line(s) to line(s)±1 kV line(s) to line(s)Mains power quality should be that of a typical commercial or hospital environment.±2 kV line(s) to earth±2 kV line(s) to earthVoltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11<5% UT (>95% dip in UT) for 0.5 cycle>95% voltage dips in UT for 0.5 cyclesMains power quality should be that of a typical commercial or hospital environment. If the user of the Capsule Neuron requires continued operation during power mains interruptions, it is recommended that the Capsule Neuron be powered from an uninterruptible power supply.40% UT (60% dip in UT) for 5 cycles60% voltage dips in UT for 5 cycles70% UT (30% dip in UT) for 25 cycles30% voltage dips in UT for 25 cycles<5% UT (>95% dip in UT) for 5 sec>95% voltage interruption in UT for 5 secondsPower frequency (50/60 Hz) magnetic field IEC 61000-4-83 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical hospital environment.](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-30.png)
![Technical Information [Chapter 5] 31EnglishElectromagnetic Immunity (RF Conducted and Radiated)The Capsule Neuron is intended for use in the electromagnetic environment specified in the table. The customer or the user of the Capsule Neuron should make sure that it is used in such an environment.Note: At 80 MHz and 800 MHz, the higher frequency range applies.Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be pre-dicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF trans-mitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Capsule Neuron is used exceeds the applicable RF compliance level above, the Capsule Neuron should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Capsule Neuron 2.b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.Immunity TestIEC 60601 test levelCompliance level Electromagnetic environment - GuidanceConducted RF IEC 61000-4-63 Vrms 150 kHz to 80 MHz3 V Portable and mobile RF communications equipment should be used no closer to any part of the Capsule Neuron, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance 80 MHz to 800 MHz800 MHz to 2.5 GHzWhere P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with this symbol:Radiated RF IEC 61000-4-33 V/m 80 MHz to 2.5 GHz3 V/m](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-31.png)
![Technical Information [Chapter 5]32EnglishRecommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Capsule NeuronThe Capsule Neuron is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Capsule Neuron can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Capsule Neuron as recommended below, according to the maximum output power of the communications equipment.Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.Rated maximum output power of transmitter (W)Separation distance in meters according to frequency of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz0.01 0.12 0.12 0.230.1 0.37 0.37 0.7411.17 1.17 2.3310 3.70 3.70 7.37100 11.70 11.70 23.30](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-32.png)
![Technical Information [Chapter 5] 33EnglishCapsule Neuron technical specificationsCapsule Neuron Part Number: DC-NU2-UMPCDimensions Width: 265 mm (10.4 inches)Height: 210 mm (8.3 inches)Depth: 45 mm (1.8 inches)Weight 2.3 kg (3.5 kg with batteries)Mounting options VESA 75/100 standard mounting bracketElectrical ratings 20 V DC, 3.53 AExternal power supply 100-240 V AC, 1.22-0.68 A, 47-63 Hz, 60 W maxBattery Main: Lithium-lon Battery Pack 3S1P 2600 mAExtended: Lithium-lon Battery Pack 3S2P 5200 mAOperation conditions ContinuousProtection against ingress of waterIPX2EN60601-1 Classification No classification, no applied partsDisplay size 10.1 inch (25.6 centimeter), resistive touch screen, resolution 1024x600Display brightness 375 cd/m²Contrast 400:1Memory 1 GBStorage 16 GB SSDNetwork connectivity 10/100/1000 base-T LANWLAN IEEE 802.11 a/b/g/nWLAN security WPA & WPA2 personal, WPA & WPA2 enterpriseEncryption: TKIP, AESWireless range 10-20 meters, depending on Wi-Fi network configurationCooling Passive cooling system (fanless)Operating environment • Temperature: 0°C to +40°C (+32°F to +104°F)• Humidity: 10% to 95% RH non-condensing• Atmospheric pressure: 700 hPa to 1060 hPaTransport and storage environment• Temperature: -20°C to +60°C (-4°F to +140°F)• Humidity: 0% to 95% RH non-condensing• Atmospheric pressure: 500 hPa to 1060 hPa](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-33.png)
![Technical Information [Chapter 5]34EnglishDevice Identification Module (DIM) technical specificationsDIMs do not require an external power supply and use standard DB9 and RJ45 connections. The Device ID Module is a medical grade product compliant with IEC 60601-1 requirements.Device ID Module P/N B1-DIM-CT-01Features • Provides Automatic Device Identification•DB9 Serial Port Input• RJ45 Serial Port Output• Powered from the Capsule Neuron, Terminal Server, or DTS and RTS linesDimensions • Length: 69 mm (2.7 inches) • Width: 38 mm (1.5 inches) • Height: 22 mm (0.9 inches) • Weight: 50 grams (1.76 ounces) Power requirements • +/- 6V output voltage• 3 to 8 milliamp power consumptionTemperature • Operating: 0° C - 55° C (32° F to 130° F) • Storage: -30° C to +85° C (-22° F to +185° F)Relative humidity • Operating: 0 to 99% non-condensing• Storage: 0 to 99% non-condensingAtmospheric pressure • Operating: 700 hPa to 1060 hPa• Storage: 500 hPa to 1060 hPaCertifications • EN60601-1, EN60601-1-2•CE Marking, RoHS-compliant](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-34.png)
![Technical Information [Chapter 5] 35EnglishRegulatory InformationExplanation of Device and Packaging SymbolsSymbol DescriptionRead the operating instructions before using the medical device. Lot numberQuantityProduct part numberProduct serial numberProduct revisionGross weightNet weightTemperature limitation for transport and storageAir pressure limitation for transport and storageShelf-life of Capsule Neuron’s battery (with date three months after manufacture)Manufactured dateManufactured forDo not use if package is damaged2017-06](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-35.png)
![Technical Information [Chapter 5]36EnglishFire hazardRelative humidity (non-condensing) for transport and storageEthernet MAC addressEthernetWi-Fi MAC addressCaution: consult accompanying documents before usingPower symbolNon-ionizing radiationCompliance with FCC RegulationsCompliance with European directivesRx Only Caution: United States Federal Law restricts this device to sale by or on the order of a physician or licensed practitionerSeparate collection for electrical and electronic waste (WEEE directive and Battery directive)Direct current (DC)USB connectionSerial connectionSymbol Description](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-36.png)
![Technical Information [Chapter 5] 37EnglishSafety and Regulatory ComplianceEN/IECCapsule Neuron complies with EN/IEC 60601-1 and EN/IEC 60601-1-2. • Data Integrity: Capsule Neuron does not compromise the data coming from the medical device. This does not include data not being delivered or delays in data delivery.• Medical Device Integrity: Capsule Neuron does not compromise the operation of the connected medical devices. Federal Communications CommissionCapsule Neuron complies with Part 15 of the FCC Rules. Operation is subject to two conditions:• This device may not cause harmful interference.• This device must accept any interference received, including interference that may cause undesired operation.Note: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense.Note: For operation within 5.15 ~ 5.25GHz / 5.47 ~5.725GHz frequency range, Capsule Neuron 2 is restricted to indoor environment. The band from 5600-5650 MHz will be disabled by the software during the manufacturing and cannot be changed by the end user. This device meets all the other requirements specified in Part 15E, Section 15.407 of the FCC Rules.Address of the legal representative for the European marketCaution: Capsule is not responsible for any radio or television interference caused by unauthorized changes or modifications to this equipment. Unauthorized changes or modifications could void the user’s authority to operate the equipment.FCC Caution:Any changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate this equipment.This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.Symbol Description](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-37.png)
![Technical Information [Chapter 5]38EnglishRadiation Exposure Statement:This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This equipment should be installed and operated with minimum distance 20 cm between the radiator and your body.Note: The country code selection is for non-US model only and is not available on all US models. Per FCC regulation, all Wi-Fi products marketed in the USA must fixed to US-operation channels only.Declaration CEThe Capsule Neuron are class I devices that comply with the requirement of the Council Directive 93/42/EEC of June 14, 1993 concerning medical devices and carry CE-marking accordingly.The Capsule Neuron complies with the requirement of the Council Directive 1999/5/EC of March 9, 1999 concerning radio equipment and telecommunications terminal equipment and carry CE-marking accordingly.The DataCaptor ID Module (DIM) complies with the requirement of the Council Directives 2006/95/EC of December 12, 2006 concerning electrical equipment designed for use within certain voltage limits and 2004/108/EC of December 15, 2004 concerning electromagnetic compatibility.Batteries in the Capsule Neuron are not based on mercury, lead or cadmium technologies. The batteries used in this product are in compliance with the Council Directive 2006/66/EC.Chromium, lead, mercury, or cadmium are not intentionally added to packaging materials and are not present in a cumulative concentration greater that 100 ppm as incidental impurities. No halogenated plastics or polymers are used for packaging material. Packaging is compliant with the Council Directive 94/62/EC.RoHS and WEEE ComplianceThe Capsule Neuron, and DIM do NOT contain any of the following substances (in concentrations exceeding legal threshold limits):•Lead•Mercury•Cadmium• Hexavalent Chromium• Polybrominated Biphenyls (PBB)• Polybrominated Diphenyl Ethers (PBDE)In the European Union, Capsule Neuron, DIM and cables should be collected separately and not disposed of with household waste. Refer to the next section on Recycling and the Environment for more details.Recycling and the EnvironmentImproper disposal of IT equipment can have a negative impact on health and the environment. The Capsule Neuron, DIM and serial cables should be deposited at an appropriate facility to enable recovery and recycling. Packaging and manuals can also be recycled according to your local recycling](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-38.png)
![Technical Information [Chapter 5] 39Englishscheme.](https://usermanual.wiki/Capsule-Technologie/001/User-Guide-2134800-Page-39.png)