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Users Manual | Users Manual | 981.74 KiB | September 05 2007 | |||
1 | External Photos | September 05 2007 | ||||||
1 | Internal Photos | September 05 2007 | ||||||
1 | ID Label/Location Info | September 05 2007 | ||||||
1 | ID Label/Location Info | September 05 2007 | ||||||
1 | Cover Letter(s) | September 05 2007 | ||||||
1 | Test Report | September 05 2007 | ||||||
1 | Test Setup Photos | September 05 2007 |
1 | Users Manual | Users Manual | 981.74 KiB | September 05 2007 |
Polytel Data Transmission System USER MANUAL Version: R Polymap Wireless 310 S. Williams Blvd. Ste. 346 Tucson, Arizona 85711 Polytel Data Transmission System Table of Contents 1 INTRODUCTION......................................................................................................................................... 4 1.1 SYSTEM OVERVIEW ................................................................................................................................. 4 1.2 INTENDED USE AND USER........................................................................................................................ 4 2 SYSTEM COMPONENTS AND ACCESSORIES.................................................................................... 4 2.1 PWA-08-01 ACCESS POINT ..................................................................................................................... 5 2.2 REMOTE ACCESSORIES ............................................................................................................................. 5 2.3 PWR-08-01 REMOTE ............................................................................................................................... 6 2.4 PWR-08-02 REMOTE ............................................................................................................................... 6 2.5 PWR-08-03.............................................................................................................................................. 6 3 IDENTIFICATION OF MAJOR PARTS .................................................................................................. 7 4 OPERATING INSTRUCTIONS................................................................................................................. 9 4.1 INSTALLATION AND SETUP ....................................................................................................................... 9 4.2 LOCATION OF DEVICES............................................................................................................................. 9 4.3 A NOTE ON TELEPHONE LINES ................................................................................................................ 10 4.4 BATTERIES FOR THE PWR-08-03 ........................................................................................................... 10 4.5 USAGE OF PWA-08-01 ACCESS POINT................................................................................................... 10 4.6 INDICATOR LIGHT ON PWR-08-03 ......................................................................................................... 11 4.7 RETRY SCHEDULE.................................................................................................................................. 11 4.8 OPERATION IN FRANCE, SPAIN OR JAPAN............................................................................................... 11 4.9 TROUBLESHOOTING ............................................................................................................................... 12 4.9.1 PWA-08-01 Access Point............................................................................................................... 12 4.9.2 PWR-08-03 accessory ................................................................................................................... 13 5 SAFETY INFORMATION ........................................................................................................................ 13 5.1 PATIENT SAFETY.................................................................................................................................... 13 5.2 ELECTRICAL SAFETY.............................................................................................................................. 14 5.3 COMPLIANCE INFORMATION .................................................................................................................. 14 5.3.1 Compliance Requirements............................................................................................................. 14 5.3.2 Compliance Statement................................................................................................................... 14 5.4 LABEL DEPICTIONS AND LOCATIONS...................................................................................................... 15 5.4.1 Label locations .............................................................................................................................. 15 5.4.2 Nameplate and Symbols ................................................................................................................ 16 6 OPERATOR MAINTENANCE ................................................................................................................ 18 6.1 VISUAL INSPECTION............................................................................................................................... 18 6.2 CLEANING YOUR PWA-08-01 AND PWR-08-03: ................................................................................... 18 7 TECHNICAL SPECIFICATIONS ........................................................................................................... 19 7.1 ELECTRICAL INPUT REQUIREMENTS....................................................................................................... 19 7.1.1 PWA-08-01 Access Point............................................................................................................... 19 7.1.2 PWR-08-03.................................................................................................................................... 19 7.1.3 PWR-08-01 and PWR-08-02 ......................................................................................................... 19 7.2 OPERATING AND STORING YOUR ACCESS POINT AND ACCESSORIES ...................................................... 19 CONSULT WITH YOUR LOCAL GARBAGE DISPOSAL AGENCY TO DISPOSE OF USED BATTERIES..................... 19 7.3 ELECTROMAGNETIC COMPATIBILITY ..................................................................................................... 19 7.4 SYSTEM AVAILABILITY.......................................................................................................................... 20 7.5 DIMENSIONS OF YOUR PWA-08-01 ACCESS POINT................................................................................ 20 7.6 DIMENSIONS OF YOUR PWR-08-03 ACCESSORY: ................................................................................... 20 8 TRADEMARKS.......................................................................................................................................... 20 8-1500-R
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Polytel Data Transmission System APPENDIX I: IEC 60601 SECTION 6 ........................................................................................................ 21 8.1 PWA-08-01 ACCESS POINT ................................................................................................................... 21 8.2 PWR-08-0X REMOTE UNITS................................................................................................................... 24 8-1500-R
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Polytel Data Transmission System 1 Introduction 1.1 System Overview The Polytel Data Transmission system is designed to allow patients with chronic conditions to be monitored remotely. It consists of a series of wireless medical devices, an Access Point designed to forward data to the data center, and of a monitoring service. The PWA-08-01 is an Access Point, or hub that collects information from medical devices in the home and forwards them over a regular telephone line. The PWR-08-01 and PWR-08-02 are accessories that are incorporated into various host devices, providing a simple way for a host to transmit its data wirelessly to a receiving station. The PWR-08-03 is an in-pouch accessory that provides a simple way for host device to transmit its data wirelessly to a receiving station, allowing remote recording or monitoring of host values. When a measurement is taken on a compatible medical device, the radio module automatically retrieves the new measurement and tries to forward it to the Access Point. Should that Access Point be unreachable or unavailable, it will periodically retry the transmission, and eventually shut itself down automatically. 1.2 Intended Use and User The Polytel system is intended to be used for the home monitoring of the values of various host devices. Typical applications include remote monitoring of glucose levels in diabetic patients, or monitoring of weight and BP in congestive heart failure patients. The devices are intended to be operated by patients in their homes. NOTE: Polymap Wireless is not responsible for the measurement, diagnosis, or electrical safety of the Host Medical Devices. The Polytel System is a Data Transmission System only. 2 System components and accessories The Polytel System consists of an AC Adapter (Designated PWA-08-01-1 and PWA-08-
01-2) designed to connect to the Mains, Access Point (designated the PWA-08-01), designed to gather data transmitted from the different Polytel Remote units (accessories) located either inside of or attached to different medical devices (Authorized Applications). 8-1500-R
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Polytel Data Transmission System Polytel PWR-08-01-xxxxx Remote Board Polytel PWR-08-01-xxxxx Remote Board Polytel PWR-08-02-xxxxx Remote Board Modem Telephone Line Polytel PWR-08-01-xxxxx Remote Board Polytel PWA-08-01 Access Point AC Adapter PWA-08-01-1 or PWA-08-01-2 Polytel PWR-08-03-xxxxx Remote Board Polytel PWA-08-03-xxxxx Remote Board Figure 1: Polytel Data Transmission System Block Diagram: The core of the System is the Access Point connected to the Mains through an AC Adapter and connected to the telephone line and Modem, with different accessories (Remote Boards) communicating with the Access Point through radio signal. The Remote boards are either inside of or cabled to various medical devices 2.1 PWA-08-01 Access Point This represents the central component of the Polytel Data Transmission System, and is used to gather data from all of the accessories. It is pictured in Figure 2. 2.2 Remote accessories All the system accessories are built around the PWR-08 Remote module. Three different hardware configurations exist, the PWR-08-01 (board with no case, no battery, onboard antenna) the PWR-08-02 (board with no case, no battery, external antenna), and the PWR-
08-03 (which includes an onboard antenna, a case and a battery and incorporates special circuitry to interface with a host). The individual accessories differ mainly in what software is loaded on them. 8-1500-R
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Polytel Data Transmission System 2.3 PWR-08-01 Remote This accessory has an onboard antenna (see Figure 2), and is incorporated into hosts by device manufacturers. 2.4 PWR-08-02 Remote This accessory is incorporated into hosts by device manufacturers; it incorporates an external patch antenna for use in hosts that have metal shielding. 2.5 PWR-08-03 This accessory consists of a circuit board in a plastic housing intended to hold two batteries. The unit (Pictured in Figure 2) is designed to be connected by its cable to a host. 8-1500-R
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Polytel Data Transmission System 3 Identification of major parts PWA-08-01-1 AC Adapter Polytel PWA-08-01 Access Point Polytel PWR-08-01 module Polytel PWR-08-02 module with antenna Figure 2: Polytel System components. Polytel PWR-08-03 accessory The Access Point is powered by an AC Adaptor connected to the Mains Outlet, and is also connected to the household telephone line. The Polytel Data Transmission System consists of an Access Point (Figure 2), which acts as the hub or collector of information from one or more medical devices. The PWR-08-03 accessory has a visible LED indicator, as shown in figure 3. 8-1500-R
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Polytel Data Transmission System Figure 3: Please note the small indicator light located near the bottom right corner of the back side of the device. This allows the user to confirm whether the device is operating correctly Figure 4: Indicator lights on PWA-08-01 Access Point. Leftmost indicates power, then Radio, Modem, and Error. Figure 5: back side of PWA-08-01. This shows the power connector on the left, and the two
(interchangeable) telephone connectors to the right. Symbols:
Meaning DC Input (6V) Modem Telephone line 8-1500-R
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Polytel Data Transmission System 4 Operating Instructions 4.1 Installation and setup The effective radio range of the Access Point and the matching medical devices is around 330 feet (100 meters). Please choose a location in your house that is centrally located, or close to where the measuring devices will be used. CAUTION To reduce the risk of explosion or fire do not use this equipment in presence of flammable Anaesthetic mixture with Air or with Oxygen or Nitrous Oxide. 1) Connect a telephone cord between the Access Point and a telephone jack on the wall. An extra telephone outlet is provided on the back of the Access Point so you can plug a telephone into the same outlet. 2) CAUTION To reduce the risk of fire, use only No. 26 AWG or larger telecommunication line cord. 3) Connect the 6VDC power to the back of the unit, and plug the AC Adapter into a regular AC outlet. When the device is connected, expect all the front-panel LEDs to light momentarily, with the leftmost (Power) LED remaining on, and the 2nd LED (Radio) blinking at roughly one-second intervals (see Figure 4). 4) To mount the unit on the wall (OPTIONAL), two screws, mounted horizontally, on 1.5 (37mm) centers, can be used. Please use screws and anchoring systems appropriate to the wall material. The screw head size should be between and 3/8 (5-9 mm). 4.2 Location of devices For successful use of the system, it is vital to remember that at its core, the Polytel Data Transmission System is wireless. This means that the transmitting device must be located within radio range of the Access Point, normally 330 feet. Note that various types of physical barriers, including walls, can reduce the effective range of the devices. The variety of construction methods makes predicting the effective range in a particular setting difficult. Do not place Access Point on a metal surface or in a metal enclosure as this is likely to interfere with correct operation. FCC Radiation 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 equipment and your body. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. 8-1500-R
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Polytel Data Transmission System A good rule of thumb is that the access point should be located either in the same or an adjacent room to that where the measuring device is located. You can confirm that the devices are working together correctly by looking for the blinking light patterns on the access point to change within a minute after a measurement. 4.3 A note on telephone lines The PWA-08-01 Access Point is designed to operate over regular or traditional telephone lines. If you use a Voice over IP (VoIP) provider for your telephone service, you must confirm with your provider that fax and modem support is enabled for the telephone line you intend to use. VoIP service quality varies widely, and Polymap Wireless cannot guarantee that the device will operate correctly with every type of VoIP line. NOTE: this device is not designed for connection to digital PBX systems, such as might be found in an office. 4.4 Batteries for the PWR-08-03 The PWR-08-03 accessory is powered by two lithium cells (CR2 size). To open the battery compartment, slide the lid in the direction indicated by the arrow labeled OPEN on the lid, and allow the lid to open. Please insert each battery with the negative side () down and its positive end (+) up, as shown in figure 6. If the two negative ends or the two positive ends of the batteries touch one another, the device will not operate. A set of batteries is expected to last several months. To close the battery compartment, bring the lid gently down against the batteries, and slide it in the direction opposite the OPEN arrow until the lid stops. 4.5 Usage of PWA-08-01 Access Point In normal use, there is no intervention required by the user. Nonetheless, indicator lights are provided to give the user some sense of the correct operation of the device. There are four indicator lights on the front panel of the Access Point. These are, respectively:
POWER, RADIO, TELEPHONE, and ERROR (see figure 4) POWER (Green) RADIO (Green) Always on in normal operation Blinks roughly once per second, more blinking while data is being received Blinks when the device is connecting to the server to transfer its data. Solid while the device is connected and transferring data
(usually only a few seconds) Comes on when data was received by the Access Point but not successfully transferred to the data center. This will occur, for example, when the telephone is in use, or there is some other congestion on the network. The Access point will keep trying, every few minutes, until it succeeds in transferring the data. Note that the forty most recent measurements are stored until they are transmitted. A rapidly flashing red light indicates that the telephone cord is not TELEPHONE
(Green) ERROR (Red) 8-1500-R
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Polytel Data Transmission System correctly connected. In normal operation, the leftmost, or POWER light, will remain on, and the second light
(RADIO), will blink roughly once per second. During the data transfer, the RADIO light will blink in other patterns. The PHONE light is used to indicate usage of the telephone, and the ERROR light is used to indicate a data transfer error. Note that data transfer errors are expected to occur when phone lines or the network are congested, and should not be a concern unless they persist for more than one hour. Should the error light persist for more than an hour, please contact the agency that provided you with this equipment. If the ERROR light comes on the first time the device is used, the most likely explanation is that it is not correctly connected to a telephone jack. 4.6 Indicator light on PWR-08-03 The device contains a small LED. This indicator will light shortly after you take a measurement on the host. It will turn itself off completely after the data is successfully transmitted. Should the data fail to transmit immediately, the device will schedule multiple retries, and the light will come on again several times for short intervals. LED Solid (maximum 20 seconds) Fast blink (1 per second) Very fast blink (2 per second) Slow blink (1 every 10 seconds) Waiting for a retry (previous attempt did not find Meaning Retrieving data from host Looking for a receiver Transmitting data receiver) 4.7 Retry Schedule Immediately after a new measurement is taken, the unit will attempt to contact the receiver or access point. Should this fail, it will retry after waiting for one minute. Failing that, it will wait two minutes before retrying. Should all of these transmission attempts fail, the measurement will be stored and the device will turn itself off automatically. Stored measurements are time stamped and transmitted along with the next measurement. If you know you have measurements stored and not yet transmitted, you can wake up the device and transmit the stored measurements without taking a new measurement. Please consult the documentation of each device for specifics instructions on how to do this. 4.8 Operation in France, Spain or Japan The device uses a frequency hopping protocol in the 2.4GHz band. Some of the channels used are not allowed in France, though they are allowed elsewhere. Please notify Polymap Wireless of your intent to use the device in this country so that it can be reconfigured appropriately. 8-1500-R
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Polytel Data Transmission System 4.9 Troubleshooting 4.9.1 PWA-08-01 Access Point The PWA-08-01 Access Point incorporates a red ERROR LED. This light indicates that the device has received data from a measuring device but has not yet been able to transmit it. This failure may be a normal occurrence (the phone number the unit dialed was busy and its waiting to try again) or it may indicate a failure that requires user interaction. Note that Access Points will try repeatedly to deliver the data they are holding until they are successful. The process of troubleshooting the operation of an Access Point involves being able to watch the colored LEDs on its front panel. Troubleshooting can be made significantly easier if an ordinary telephone is plugged into the second telephone jack, allowing you to listen to the operation of the device. Error Red LED flashes several times immediately after measurement Solid red LED after measurement Corrective Action Replace telephone cord or check telephone outlet Bad telephone jack or cord Cause No dialtone Plug a telephone into 2nd jack of Access Point. Hang up. Unplug power cord to AP and plug it in again. Wait until modem light (3rd green light) comes on, then pick up telephone and listen. If you dont a dialtone, check cord or telephone outlet Solid red LED after measurement Solid red LED after measurement Solid red 8-1500-R Busy signal Defective AP Follow instructions above. If you hear a dialtone but do not hear a telephone number being dialed, the AP needs to be replaced. If this happens repeatedly, there may be a telephone company issue with 800 number access. Remove power from AP and dial 1-800-
420-6565 from the telephone. If you hear a modem PBX or VoIP
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Polytel Data Transmission System LED after measurement line Solid red LED after measurement Server-side configuration issues answer (this sounds like a fax machine), the problem may be due to your telephone line. If you have VoIP service, ensure that fax and modem support is selected. If none of the above helps resolve your issue, please contact your service provider. A number of different service-side errors can lead to the data being retained on the Access Point. Corrective Action Replace batteries 4.9.2 PWR-08-03 accessory Error LED does not light LED does not light No PC indicated on host No PC indicated on host No PC indicated on host Cause Batteries missing or low Cable not connected to host Batteries missing or low Cable not connected to host Cable not firmly plugged into host Cable frayed No PC indicated on host 5 Safety Information 5.1 Patient Safety Warnings and Cautions Connect cable to host Replace batteries Connect cable to host Plug cable firmly into host If visual inspection shows cable is frayed, unit must be repaired 8-1500-R
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Polytel Data Transmission System WARNING: Modifications made to the product, unless expressly approved by Polymap Wireless, LLC could void the users license for and the warranty of the device. CAUTION: Risk of explosion if battery is replaced by an incorrect type. Dispose of used batteries according to the instructions. 5.2 Electrical Safety Only authorized maintenance staff may remove the covers from the PWR-08-03 Remote Device. Always refer servicing to Polymap Wireless-authorized personnel. The Polytel Data Transmission System is classified as CLASS II equipment as per IEC60601-1 and Class II Medical Devices per 21CFR. There are no patient connected parts in the Polytel Data Transmission System. The Host Medical Devices are approved for use by their respective manufacturers and agencies monitoring them. Polymap Wireless is not responsible for their diagnostic accuracy or their electrical safety. There are no special provisions to protect the system from flammable anesthetics or ingress of liquids WARNING! Never operate this device in zones where there is a risk of explosion. Electrical equipment used in the presence of flammable anesthetics or oxygen may cause an explosion. 5.3 Compliance Information This section details the telemetry system compliance requirements and the manufacturers responsibilities. 5.3.1 Compliance Requirements The manufacturer is responsible for the effects of safety, reliability, and performance of this equipment with the following provisions:
The equipment is used in accordance with instructions for use Assembly operations, extensions, modifications, or repairs are performed by authorized persons only. 5.3.2 Compliance Statement The manufacturer states that this device conforms to:
FDA 21 CFR Parts 820 IEC 60601-1: Medical Electrical Equipment General Requirements for Safety. IEC 60601-1-1: Medical Electrical Equipment Collateral standard: Safety requirements for medical electrical systems IEC 60601-1-2: Medical Electrical Equipment Collateral standard:
Electromagnetic compatibility for medical electrical systems 8-1500-R
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Polytel Data Transmission System IEC 60601-1-4: Medical Electrical Equipment Collateral standard: Programmable medical electrical systems UL 60601: Medical Electrical Equipment, Part 1 General Requirements for Safety CSA: Medical Electrical Equipment, Part 1: C22.2601 No. 601.1 M9 General Requirements for Safety The manufacturer of this device complied with the following requirements applicable at time of manufacture:
o ISO 13485:2003 o ISO 13485/8 under Canadian Medical Device Conformity Assessment System (CMDCAS) 5.4 Label depictions and Locations 5.4.1 Label locations Label on 120V power supply Label on 230V power supply Label on PWA-08-01 PWR-08-01 label PWR-08-02 label Figure 6 Label locations PWR-08-03 label 8-1500-R
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Polytel Data Transmission System 5.4.2 Nameplate and Symbols Model:
PWA-08-01-1 RoHS 2002/95/EC Input: 120V~, 60Hz, 14VA Output: 6V ---, 1.0A Model:
PWA-08-01-2 RoHS 2002/95/EC Input: 230V~, 50Hz, 14VA Output: 6V ---, 1.0A IEC/EN/UL/CAN/CSA 60601-1 60601-1-2 Assembled USA Date of Manufacture:
S/N:
IEC/EN/UL/CAN/CSA 60601-1 60601-1-2 Assembled USA Date of Manufacture:
S/N:
Label for 120V power supply The label on the bottom of The Access Point PWA-08-01 or PWR-08-03 shows the unique radio ID of the dev This label also shows the seals that denote the principal regulatory approvals :
Label for 230V power supply FCC ID:QYPPWA0801 ICES-003-B/ NMB-003B RoHS 2002/95/EC Model: PWA-08-01 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. IC: 4552A-PWA0801 6V 1000mA IEC/EN/UL/CAN/CSA 60601-1 60601-1-2 Manufactured in USA Date of Manufacture:
S/N:
Label for PWA-08-01 Access Point 8-1500-R
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Polytel Data Transmission System Model: PWR-08-03 IEC/EN/UL/CAN/CSA 60601-1 60601-1-2 FCC ID: QYPPWR0801 IC: 4552A-PWR0801 Use two CR2 Lithium batteries Assembled in USA Mfg Date:
S/N:
Label for PWR-08-03 accessory IEC/EN/UL/CAN/CSA 60601-1 Model: PWR-08-01 60601-1-2 FCC ID: QYPPWR0801 IC: 4552A-PWR0801 Assembled in USA Mfg Date:
S/N:
Label for PWR-08-01 wireless module IEC/EN/UL/CAN/CSA 60601-1 Model: PWR-08-02 60601-1-2 FCC ID: QYPPWR0801 IC: 4552A-PWR0801 Assembled in USA Mfg Date:
S/N:
Label for PWR-08-02 Wireless Module Figure 7: Labels. Indicates that the device was tested to comply with the US and Canadian safety directives. Indicates that the device was tested to comply with the CE MDD directive. Indicates that you should read accompanying documents before use. 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 8-1500-R
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Polytel Data Transmission System undesired operation. Indicates Class II equipment under the IEC 60601-1 safety standard Indicates that the transformer incorporates a fuse designed to protect against temperatures in excess of 130C Indicates that the device complies with both the safety and the radio requirements of these respective standards Indicates the FCC listing numbers for the device Indicates the Industry Canada listing numbers for the device Serial number IEC/UL/CAN/CSA 60601-1 60601-1-2 FCC: QYPPWR0801 IC: 4552A-PWR0801 S/N 6 Operator Maintenance 6.1 Visual Inspection The user should perform a periodic inspection (once a month) of the system to identify any component that may have become damaged or is not performing correctly. WARNING: All parts of this System are repairable. The Repair of any damaged or incorrectly operating item should be performed ONLY by Polymap Wireless authorized personnel!
Contact Polymap Wireless promptly to maintain the equipment in the safest possible condition. Specific attention should be paid to the cable used to connect the unit with the host. 6.2 Cleaning your PWA-08-01 and PWR-08-03:
These units should be cleaned once a year. The batteries in the PWR-08-03 should be replaced once in 6 months. Take the following steps:
1. Disconnect your PWR-08-03 from its host before cleaning. 2. Remove the batteries from your PWR-08-03, or disconnect the PWA-08-01 from 3. Never use any spray on your units. Sprays may penetrate the unit and damage the 4. Dampen a soft cloth with water, or a weak solution of household dishwashing liquid the power outlet internal electronic components. mixed with water, and wipe the unit. 5. Never immerse your units in any liquid. 6. Insert the batteries after cleaning the unit and reconnect your PWR-08-03 to its host, or reconnect your PWA-08-01 to the wall outlet, as appropriate. 8-1500-R
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Polytel Data Transmission System 7 Technical Specifications 7.1 Electrical Input Requirements 7.1.1 PWA-08-01 Access Point The PWA-08-01 is powered by an AC adapter. Two different adapters are available:
120V~ 60Hz, PWA-08-01-1 230V~ 50Hz. PWA-08-01-2 Both configurations have the same output rating:
6VDC, 1000ma (Maximum power, 6VA) WARNING: There is an additional Power source inside the Access Point:
3V Lithium Battery. 7.1.2 PWR-08-03 The PWR-08-03 is powered by two CR2 Lithium cells in series (3V each). Max. Power consumption: 1W 7.1.3 PWR-08-01 and PWR-08-02 These remote boards are powered from their Host devices. Input Voltage: 5VDC Input current: 180mA max Max Power consumption: 0.9W 7.2 Operating and Storing your Access Point and accessories WARNING: Remove batteries from the equipment if not intending to use for more than 3 months!
Consult with your local Garbage Disposal Agency to dispose of used batteries The recommended operating temperatures for your units are 10 to 40 Celsius (50 to 104 Fahrenheit). The recommended storage temperatures are -40 to +70 Celsius (-40 to 158 Fahrenheit). If you move your devices from a cold location to a warm location, please allow it to come up to room temperature before powering it on. The equipment can be shipped via commercial transportation (Air and land) in packaging designed for this purpose. The recommended transportation temperatures are -40 to +70 Celsius (-40 to 158 Fahrenheit). Altitude:10,000m 7.3 Electromagnetic Compatibility Like other electrical medical equipment, the PWA-08-01, PWR-08-01, PWR-08-02, PWR-
08-03 units require special precautions to ensure electromagnetic compatibility with other 8-1500-R
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Polytel Data Transmission System electrical medical devices. To ensure electromagnetic compatibility (EMC) the device must be installed and operated according to the information provided in this manual. NOTE: the entire Polytel Data Transmission System wit all its components has been tested to comply with IEC 60601-1-2:2001 requirements for EMC with other devices. 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 particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try and correct the interference by one or more of the following measures:
Reorient or locate the receiving antenna. Connect the equipment into an outlet on a circuit different from that to which the Increase the separation between the equipment and receiver. receiver is connected. Consult the dealer or an experienced radio/TV technician for help. 7.4 System Availability The PWR-08-03 is designed to attempt delivery of each measurement from the host for several minutes after a measurement is taken. The system is immediately available to retrieve additional measurements in the case where they are taken before the previous measurement(s) have been transmitted. The PWA-08-01 Access Point is always available to receive measurements from measuring devices, and will store them until it is able to forward them to your service provider 7.5 Dimensions of your PWA-08-01 Access Point 144mm x 97mm x 27mm (5.67 inches x 3.81 inches x 1.06 inches 7.6 Dimensions of your PWR-08-03 accessory:
72mm x 20mm x 45mm (2.85 inches x 0.8 inches x 1.8 inches) 8 Trademarks Bluetooth word mark and logos are owned by the Bluetooth SIG, Inc. Polytel is a registered trademark of Polymap Wireless LLC. This product was designed solely by Polymap Wireless, independent of any of the host device manufacturers 8-1500-R
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Polytel Data Transmission System Appendix I: IEC 60601 Section 6 8.1 PWA-08-01 Access Point 8-1500-R
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Polytel Data Transmission System 8-1500-R
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Polytel Data Transmission System 8-1500-R
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Polytel Data Transmission System 8.2 PWR-08-0x Remote units 8-1500-R
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Polytel Data Transmission System 8-1500-R
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Polytel Data Transmission System 8-1500-R
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Polytel Data Transmission System Index Access Point, 4 Availability, 20 Batteries, 19 Inserting, 10 Blink. See Indicator Cautions, 13 Cleaning, 18 Communications Hub, 4 Compliance, 14 Devices Cleaning, 18 Electrical Safety, 14 Electromagnetic compatibility, 19 EMC, 19 France, operation in, 11 Hub, Communications, 4 Indicator light, 11 Indicator Lights, 7, 8 Installation, 9 Labels, 16, 17 LEDs, 7, 8 Light Indicator, 11 Lights, Indicator, 7, 8 Location of devices, 9 Metal enclosure, 9 Metal surface, 9 Nameplate, 16 Operation in France, 11 Patient Safety, 13 PBX lines, 10 Power Brick, 19 Regulatory Compliance, 14 Retries, 11 Safety, Electrical, 14 Safety, Patient, 13 Setup, 9 Symbols, 16 Telephone Cord, 9 Telephone lines, 10 Temperature Operating, 19 Trademarks, 20 Troubleshooting, 12, 13 Voice over IP lines, 10 VoIP, 10 Wall Adapter, 19 Warnings, 13 8-1500-R
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frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2007-05-09 | 2402 ~ 2480 | DSS - Part 15 Spread Spectrum Transmitter | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2007-05-09
|
||||
1 | Applicant's complete, legal business name |
Polymap Wireless LLC
|
||||
1 | FCC Registration Number (FRN) |
0006971899
|
||||
1 | Physical Address |
310 S. Williams Blvd. Ste. 230
|
||||
1 |
Tucson, Arizona 85711
|
|||||
1 |
United States
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
k******@emcc.de
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
QYP
|
||||
1 | Equipment Product Code |
PWA0801
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
P****** L********
|
||||
1 | Title |
President
|
||||
1 | Telephone Number |
520 7********
|
||||
1 | Fax Number |
520 7********
|
||||
1 |
p******@polymap.net
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DSS - Part 15 Spread Spectrum Transmitter | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Bluetooth Access Point | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Power output listed is peak conducted. The antenna(s) used for this transmitter must be installed to 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. End-users and installers must be provided with antenna installation instructions and transmitter operating conditions for satisfying RF exposure compliance. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
TUV Rheinland of North America
|
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1 | Name |
M****** M******
|
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1 | Telephone Number |
919-5******** Extension:
|
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1 | Fax Number |
919-5********
|
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1 |
m******@us.tuv.com
|
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Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0370000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC