RTX RTX3320 User manual

FUNCTIONALITY
CALL FOR SERVICE:
WIRELESS TELEHEALTH GATEWAY
RTX3320
RTX3320:
The RTX3320 Wireless Telehealth Gateway is used for wireless reception of measurements
taken by on-site patient monitors such as a wireless blood pressure monitor or a wireless
personal weight scale.
When the Gateway has received the measured values, it generates a call and conveys the
data to a remote facility via a public telephone line. In some cases the Gateway is
programmed 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 Maintenance
The Gateway may be cleaned with a soft, dry cloth or a cloth dampened with tap water
and a mild detergent. A household glass cleaner on a soft, dry cloth may be used to clean
off smudges. Never use any solvent, thinner, lighter fluid, alcohol, wet wipes or similar
products on the Gateway.
NOTE
This equipment has been tested and found to comply with the limits for a Class B digital
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 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 is
encouraged 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 following
two 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 requirements
Mains: 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 temperatures
Operating 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 humidity
Operating: 10% to 90% non-condensing.
Storage/Transport: 10% to 95% non-condensing.
■Barometric pressure
Operating: 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 technology
can 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 essential
requirements and other relevant provisions of Directive 93/42/ECC. A copy of the
declaration 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 by
data encryption and authentication (SSL), and meets authorized standards under the HIPAA.
TECHNICAL SPECIFICATIONS
RTX3320:
The RTX3320 device is for use by patients at home. It is intended to be used in
combination 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 healthcare
facility at another location. The healthcare facility could be at a disease management
center, 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 by
the patient. The installation must be performed by or under supervision of an authorized
professional healthcare company.
This device does not measure, interpret or make any decisions on the vital data that it
conveys.
Precautions and warnings
This 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 measurements
collected 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 emergency
intervention.
RTX Healthcare · Stroemmen 6 · DK-9400 Noerresundby · Denmark · Tel: [phone] · www.rtx.dk
RTX America, Inc. · 2099 Gateway Place · Suite 310 · San Jose · California 95110 · Phone:[phone]
MEDIEHUSET WIEGAARDEN . 98 51 24 66 . TV . 100088
USERS MANUAL
HOW TO INSTALL AND INSTRUCTIONS FOR USE
RTX3320 for PSTN
INTENDED USE OF RTX3320
IMPORTANT:
Use only the original power supply adapter which comes with the device
Part# 96100805 US/UK

SIGNALING:
1
Light Indicator
“GATEWAY STATUS”
Telephone connector
Slot for wall mounting
Service cover (DO NOT OPEN)
Service connector
PARTS IDENTIFICATIONINSTALLATION STEP BY STEP
2
4
3
SYMBOL SIGNAL GREEN AMBER On
Gateway Status
On Power on – System initiating –
Gateway ready not ready
ABC Communication
with patient monitors
Flashing Gateway waiting for uninstalled
(-- -- -- --) patient monitor to appear
On Communication with
patient monitor
ABCCommunication via
telephone line
Flashing Dialing Error related to dialing
(-- -- -- --) (no dial tone or line is busy)
Quick flashing Initiating transmission Error related to
(- - - - - - - -) of data data transmission
On Transmitting data
The green light indicator on the power supply adapter indicates that power is connected.
US telephone network customer Information
This equipment complies with Part 68 of the rules and requirements adopted by ACTA. On the bottom side of this
equipment 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 jack
USOC for the equipment is RJ11C. A plug and jack used to connect this equipment to the premises wiring and
telephone network must comply with the applicable FCC Part 68 rules and requirements adopted by the ACTA. A
compliant telephone cord and modular plug is provided with this product. It is designed to be connected to a
compatible modular jack that is also compliant. See installation instructions for details. The REN is used to
determine the number of devices that devices that may be connected to a telephone line. Excessive RENs on a
telephone line may result in the devices not ringing in response to an incoming call. In most but not all areas, the
sum 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 the
local telephone company. For products approved after July 23, 2001, the REN for this product is part of the product
identifier that has the format US:AAAEQ##TXXXX. The digits represented by ## are the REN without a decimal
point (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 that
temporary discontinuance of service may be required. But if advance notice is not practical, the telephone company
will notify the customer as soon as possible. Also, you will be advised of your right to file a compliant with the
FCC if you believe it is necessary. The telephone company may make changes in its facilities, equipment, operations
or procedures that could affect the operation of the equipment. If this happens the telephone company will provide
advance notice in order for you to make necessary modifications to maintain uninterrupted service. If trouble is
experienced 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 telephone
network, 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 service
commission or corporation commission for information.
If your home has specially wired alarm equipment connected to the telephone line, ensure the installation of this
equipment US:RTX3320 does not disable your alarm equipment. If you have questions about what will disable
alarm 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 connector
POWER CONNECTOR
5
6
CONNECT TO THE TELEPHONE SYSTEM
OR
CONNECT THE POWER SUPPLY ADAPTER TO AN ELECTRICAL
OUTLET
IMPORTANT: 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 GREEN
The Gateway is now ready for use with compatible patient monitors.
SERVICE PUSH BUTTONS:
IMPORTANT:Only use these push buttons under the supervision of service personnel
IMPORTANT
Before installation, please read all the information on both sides of this sheet!
UNPACKING
Inspect 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-specific
telephone plug
converter
■This manual
IMPORTANT: Always keep the original package for return shipment.
PLACING THE GATEWAY
Place the Gateway in a level position.
It is important that the cables be carefully arranged and secured to avoid unintended
disconnection, or the possibility of tripping or blocking the path of a wheelchair or
other moving object. Be careful not to use a power socket which may be switched
off unnoticed. Do not install or service the device, power adapter or cables during
an 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 set
beverages near the equipment as spills may easily result in serious damage.
Protect the device and cables from damage. Keep pets and small children away
from the area where the Gateway and cables are located.