Tunstall Healthcare A S RTX3320 RTX3320 – Wireless Telehealth Gateway User Manual Manual A3 Gateway RTX3320

Tunstall Healthcare A/S RTX3320 – Wireless Telehealth Gateway Manual A3 Gateway RTX3320

Manual

FUNCTIONALITYCALL FOR SERVICE:WIRELESS TELEHEALTH GATEWAYRTX3320RTX3320:The RTX3320 Wireless Telehealth Gateway is used for wireless reception of measurementstaken by on-site patient monitors such as a wireless blood pressure monitor or a wirelesspersonal weight scale.When the Gateway has received the measured values, it generates a call and conveys thedata to a remote facility via a public telephone line. In some cases the Gateway isprogrammed to deliver data at a specific time of day.The delivery of data will automatically be repeated if the attempt to deliver data fails. The Gateway works in fully automatic mode, and requires no user action.Cleaning and MaintenanceThe Gateway may be cleaned with a soft, dry cloth or a cloth dampened with tap waterand a mild detergent. A household glass cleaner on a soft, dry cloth may be used to cleanoff smudges. Never use any solvent, thinner, lighter fluid, alcohol, wet wipes or similarproducts on the Gateway.NOTEThis equipment has been tested and found to comply with the limits for a Class B digitaldevice, pursuant to Part 15 of the FCC Rules. These limits are designed to providereasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installedand used in accordance with the instructions, may cause harmful interference to radiocommunications. However, there is no guarantee that interference will not occur in a par-ticular installation. If this equipment does cause harmful interference to radio or televi-sion reception, which can be determined by turning the equipment off and on, the user isencouraged to try to correct the interference 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.This device complies with Part 15 of the FCC Rules. Operation is subject to the followingtwo conditions:(1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Modifications not expressly approved by this companycould void the user's authority to operate the equipment.■This device is for use at home.■Power requirementsMains: 100-240 VAC, 50-60Hz, 200 mA, Class II, No applied part. Only use the original power supply adapter with the type. designation FW7333M/06.■Range of temperaturesOperating 10° C to 40°C / 50° to 104° F. Storage: -10° C to +45°C / 14° to 114° F. Transport: -20° C to +60°C / -4° to 140° F.■Relative humidityOperating: 10% to 90% non-condensing.Storage/Transport: 10% to 95% non-condensing.■Barometric pressureOperating: 700 –1060 hPa.Storage/Transport: 700 –1060 hPa.■Dimensions: Ø140 x 35 mm / Ø5.5 x 1.4 inches.■Weight: 280 g / 10 oz including power supply adapter.■Radio Transmitter: Bluetooth compliance: Version 1.1. Operating frequency: 2.402 to 2.480 GHz.Output power: 1 to 100 mW / Bandwith: <1MHz.Antenna type: Internal, omni directional / Antenna gain: -0.8 dBi.Operational range: Up to 100 meters (indoor) depending of surroundings. ■The frequency band is not harmonized. Use of wireless Bluetooth technologycan be restricted in some countries. Contact local authorities for more information.■The internal antenna used for this mobile transmitter must provide a separation distance of at least 20 cm from all persons and must not be co-located or operating in conjunction with any other antenna or transmitter.■RTX Healthcare declares that this device is in compliance with the essentialrequirements and other relevant provisions of Directive 93/42/ECC. A copy of thedeclaration of conformity may be found at the RTX website: www.rtx.dk.■This device has been tested and found to comply with FCC Part 68. Please read the“US telephone network customer information” in this manual.■This device has been tested and found to comply with TBR21.■This device, including the power supply adapter, is certified to comply with EN60601-1.■This device, including the power supply adapter, is tested according to EN60601-1-2.■Data integrity and security: The privacy of data transmission with this device is secured bydata encryption and authentication (SSL), and meets authorized standards under the HIPAA.TECHNICAL SPECIFICATIONSRTX3320:The RTX3320 device is for use by patients at home. It is intended to be used incombination with a variety of patient monitors upon the prescription of a licensed physician or other authorized healthcare provider. RTX3320 serves as the remote communication link between compatible patient monitors, and the compatible healthcarefacility at another location. The healthcare facility could be at a disease managementcenter, or with the healthcare/wellness provider or other out-of-hospital caregivers.The purpose is to transmit selected medical information (such as weight, blood pressure,blood glucose) over a normal residential telephone line.RTX3320 is a “black box” device – it is not connected to the patient and not operated bythe patient. The installation must be performed by or under supervision of an authorizedprofessional healthcare company.This device does not measure, interpret or make any decisions on the vital data that itconveys. Precautions and warningsThis device is not intended for emergency calls, and may not be used for transmission or indication of any real-time alarms or time-critical data.Clinical judgement and experience are required to check and interpret the measurementscollected and transmitted.This device is not for use in systems which substitute for medical care.This device is not intended for patients requiring direct medical supervision or emergencyintervention.RTX Healthcare · Stroemmen 6 · DK-9400 Noerresundby · Denmark · Tel: +45 9632 2300 · www.rtx.dkRTX America, Inc. · 2099 Gateway Place · Suite 310 · San Jose · California 95110 · Phone:+1 (408) 441-8600 MEDIEHUSET WIEGAARDEN . 98 51 24 66 . TV . 100088USERS MANUALHOW TO INSTALL AND INSTRUCTIONS FOR USERTX3320 for PSTNINTENDED USE OF RTX3320IMPORTANT:Use only the original power supply adapter which comes with the device Part# 96100805 US/UK
SIGNALING:1Light Indicator “GATEWAY STATUS”Telephone connectorSlot for wall mountingService cover (DO NOT OPEN)Service connectorPARTS IDENTIFICATIONINSTALLATION STEP BY STEP243SYMBOL SIGNAL GREEN AMBER OnGateway StatusOn Power on – System initiating –Gateway ready not readyABC Communication with patient monitorsFlashing Gateway waiting for uninstalled(-- -- -- --) patient monitor to appearOn Communication with patient monitorABCCommunication via telephone lineFlashing Dialing Error related to dialing(-- -- -- --) (no dial tone or line is busy) Quick flashing Initiating transmission Error related to(- - - - - - - -) of data data transmissionOn Transmitting dataThe green light indicator on the power supply adapter indicates that power is connected.US telephone network customer InformationThis equipment complies with Part 68 of the rules and requirements adopted by ACTA. On the bottom side of thisequipment is a label that contains, among other information, a product identifier in the format US:RTXMM00B3320. If requested, this number must be provided to the telephone company. The registration jackUSOC for the equipment is RJ11C. A plug and jack used to connect this equipment to the premises wiring andtelephone network must comply with the applicable FCC Part 68 rules and requirements adopted by the ACTA. Acompliant telephone cord and modular plug is provided with this product. It is designed to be connected to acompatible modular jack that is also compliant. See installation instructions for details. The REN is used todetermine the number of devices that devices that may be connected to a telephone line. Excessive RENs on atelephone line may result in the devices not ringing in response to an incoming call. In most but not all areas, thesum of RENs should not exceed five (5.0).To be certain of the number of devices that may be connected to a line, as determined by total RENs, contact thelocal telephone company. For products approved after July 23, 2001, the REN for this product is part of the productidentifier that has the format US:AAAEQ##TXXXX. The digits represented by ## are the REN without a decimalpoint (e.g., 03 is a REN of 0.3). For earlier products the REN is separately shown on the label.If this equipment US:RTX3320 causes harm to the network, the telephone company will notify you in advance thattemporary discontinuance of service may be required. But if advance notice is not practical, the telephone companywill notify the customer as soon as possible. Also, you will be advised of your right to file a compliant with theFCC if you believe it is necessary. The telephone company may make changes in its facilities, equipment, operationsor procedures that could affect the operation of the equipment. If this happens the telephone company will provideadvance notice in order for you to make necessary modifications to maintain uninterrupted service. If trouble isexperienced with this equipment US:RTX3320, for repair or warranty information, please contact RTX America,Inc., 2099 Gateway Place, Suite 310, San Jose, California 95110. If the equipment is causing harm to the telephonenetwork, the telephone company may request that you disconnect the equipment until the problem is resolved.Connection to party line service is subject to state tariffs. Contact the state public utility commission,public servicecommission or corporation commission for information.If your home has specially wired alarm equipment connected to the telephone line, ensure the installation of thisequipment US:RTX3320 does not disable your alarm equipment. If you have questions about what will disablealarm equipment, consult your telephone company or a qualified installer.Light Indicator“COMMUNICATION BY TELEPHONE LINE”Light Indicator“COMMUNICATION WITH PATIENT MONITORS”Service push button “TEST” (To perform a test for service purposes) Service push button “CONNECT”(To force a connection to the remote facility) Line connectorPOWER CONNECTOR56CONNECT TO THE TELEPHONE SYSTEM ORCONNECT THE POWER SUPPLY ADAPTER TO AN ELECTRICALOUTLETIMPORTANT: Never disconnect the power supply adapter from the Gateway.Make sure that the power source cannot be switched off unnoticed.CHECK THAT THE GATEWAY STATUS INDICATOR IS GREENThe Gateway is now ready for use with compatible patient monitors.SERVICE PUSH BUTTONS:IMPORTANT:Only use these push buttons under the supervision of service personnelIMPORTANTBefore installation, please read all the information on both sides of this sheet!UNPACKINGInspect the package for any damage. In the event of damage, please call for service. Ensure that the package contains:■Gateway■Power supply adapter■Telephone cable■Country-specifictelephone plug converter ■This manualIMPORTANT: Always keep the original package for return shipment.PLACING THE GATEWAYPlace the Gateway in a level position.It is important that the cables be carefully arranged and secured to avoid unintendeddisconnection, or the possibility of tripping or blocking the path of a wheelchair orother moving object. Be careful not to use a power socket which may be switchedoff unnoticed. Do not install or service the device, power adapter or cables duringan electrical storm.Do not place the Gateway in extreme climatic conditions (excessive heat or humidity,in direct sunlight or where it may be exposed to large amounts of dust). Do not setbeverages near the equipment as spills may easily result in serious damage.Protect the device and cables from damage. Keep pets and small children awayfrom the area where the Gateway and cables are located.

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