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EXHIBIT D: User Manual

FCC ID DV8HLX561

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Содержание HLX-561

Страница 1: ...EXHIBIT D User Manual FCC ID DV8HLX561 ...

Страница 2: ...Telemetry Transmitter Module HLX 561 Operation Manual Read this manual prior to use of the HLX 561 Store this operation manual in an easily accessible place near the unit for future reference ...

Страница 3: ...ysician NOTE Only a physician or a person under the guidance of a physician can use this device Copyright 2001 by Fukuda Denshi Co Ltd No part of this document may be copied or transmitted in any form without the prior written permission of Fukuda Denshi Co Ltd Printed in Japan ...

Страница 4: ...e operates in the 600MHz UHF band The exact frequency of operation depends on designation and each individual county s wireless service regulation To assure safe and reliable operation observe the following precautions Be sure that no other devices are using the frequency assigned to this transmitter This device is susceptible to interference from electrosurgical knives and other computerized equi...

Страница 5: ... and determine if other or your transmitter frequencies that may cause interference CAUTION The manufacturers installers and users of Wireless Medical Telemetry System equipment are cautioned that the operation of this equipment could result in harmful interference to other nearby medical devices ...

Страница 6: ...tion These instructions are described under the following message headings Understand the meaning of the different types of messages while reading this operation manual WARNING Erroneous operation by failure to observe instructions when this message is printed may result in death or serious injury to the patient operator or create a fire hazard CAUTION Erroneous operation by failure to observe ins...

Страница 7: ...and humidity and provide adequate ventilation Avoid direct sunlight The equipment should not be installed or stored in a location where it may be adversely affected by air containing dust saline or sulfur Avoid inclination vibration and shock even during transport to ensure stable operating conditions Do not install or store the equipment where chemicals are stored or gases are generated 3 Precaut...

Страница 8: ...gs Do not apply excessive force to cords and cables by pulling to disconnect Keep the equipment clean in preparation for the next use 6 If the equipment gets out of order ensure patient safety by immediately turning the equipment off and disconnecting electrodes and or transducers from the patient Contact your nearest Fukuda representative and label the device as OUT OF ORDER 7 Do not disassemble ...

Страница 9: ...f the electrosurgical unit Some types of equipment may be damaged by the energy discharged by a defibrillator Ensure a thorough understanding of the precautionary instructions described in the operation manual of the equipment before using a defibrillator Some types of equipment other than electrosurgical units and defibrillators may cause accidental hazards to the patient and operator when operat...

Страница 10: ...ment iv 1 General Description 1 2 Controls and Indicators 2 3 Mounting the HLX 561 to the Bedside Monitor Mounting into the DS 5100 4 Mounting into the DS 5300 7 4 Setting the Receiving Channel of the Monitor 10 5 Cleaning Sterilization and Disinfection 11 6 Maintenance and Inspection 12 7 Specifications 14 8 Accessories 16 ...

Страница 11: ......

Страница 12: ...tegrated telemetry patient monitoring system in combination with a central telemetry receiver and central monitor such as the DS 5800N For compatibility with monitors other than DS 5000 series contact your Fukuda Denshi representative WARNING Operation of this equipment requires the prior coordination with a frequency coordinator designated by the FCC for the Wireless Medical Telemetry Service Ext...

Страница 13: ...2 2 Controls and Indicators Antenna Channel Label Connector Wire Adapter Mounting Hole Mounting Fixture option Wire Adapter option Connector option ...

Страница 14: ...ctor Connects to the bedside monitor Wire Adapter Mounting Hole Connects to the optional wire adapter OA 287 Wire Adapter OA 287 option Allows for mounting the HLX 561 onto a bedside monitor Connector option Allows for external connection of the HLX 561 to the bedside monitor Connect to the F LINK connector of the bedside monitor Mounting Fixture option For mounting the HLX 561 into the bedside mo...

Страница 15: ...it is recommended the channel label be changed in advance Mounting to the DS 5100 NOTE Before starting the mounting work turn the main power switch on the DS 5100 OFF and disconnect the power cable from the wall outlet The transmission module housing is located at the upper left of the DS 5100 as viewed from the rear Remove the screw that holds the cover in place and remove the cover as shown ...

Страница 16: ...ition disables the external F LINK connector Connect the cable from the bottom of the module housing to the connector at the bottom of the HLX 561 Remove the cap which covers the antenna hole in the top of HLX 561 transmission module housing cover Place the HLX 561 into the housing taking care not to jam the cable in the inside HLX 561 DS 5100 Rear panel ...

Страница 17: ...ator designated by the FCC for the Wireless Medical Telemetry Service To check the system and verify proper transmission from the HLX 561 to the telemetry receiver check the central receiver and monitor to ensure the waveforms and alphanumeric data are properly displayed The wireless network system is now functioning properly Place the cover back in its original position while at the same time ins...

Страница 18: ...t the optional OA 287 adapter to the HLX 561 connector to connector Attach the adapter to the HLX 561 with the accessory screw M2 6 x 8 Attach the optional mounting fixture onto the HLX 561 with two accessory screws M2 6 x 6 Attach the assembly consisting of the HLX 561 OA 287 and mounting fixture to the DS 5300 with the two accessory screws M3 x 6 HLX 561 OA 287 ...

Страница 19: ...rocedure refer to the operation manual for to the DS 5300 WARNING Operation of this equipment requires the prior coordination with a frequency coordinator designated by the FCC for the Wireless Medical Telemetry Service WARNING Setting or changing the telemetry channel may cause interference with another telemetry system Be sure to consult engineering for telemetry channels to select the proper ra...

Страница 20: ...ify proper transmission from the HLX 561 to the telemetry receiver check the central receiver and monitor to ensure the waveforms and alphanumeric data are properly displayed The wireless network system is now functioning properly ...

Страница 21: ...ecting the channel and group code refer to the operation manual for the appropriate monitor If the selected channel number does not correspond to the frequency that is actually received an alarm waveform will be displayed to alert the staff to interference see example below NOTE The interference prevention function is not effective unless the receiver has the interference detection function Verify...

Страница 22: ...oluene and benzene Such chemical solutions may damage the resin casing Sterilization and Disinfection For Disinfection wipe the HLX 561 and accessories using a gauze or sanitary cotton moistened with inert soap or alcohol Do not moisten allow moisture inside of the connector to avoid contact failure For sterilization use a gas sterilization method Sterilization methods utilizing high temperatures ...

Страница 23: ...1 Routine Inspection It is recommended that a routine inspections be performed daily A sample Routine Inspection Record is provided on the next page Periodical Inspection Periodic inspections are necessary to prevent trouble and accidents and to maintain the safety and efficacy of medical electrical equipment Ensure normal operation of the equipment by correcting adverse environmentalconditions if...

Страница 24: ...ches breaks cracks loose screws or labels Check the antenna for bends or breaks No abnormalities Pass Fail Function Under normal operating conditions check the functions at the central monitor Waveforms and data received in normal manner Pass Fail Periodic Inspection Check the data of the most recent inspection Periodic Inspections should be performed per the institutions standard operating proced...

Страница 25: ... etc Status Information Low Battery Electrode fail Group code 64 types Alarm Alarm suspend Remote record Model ID number Transmitter channel No Interface Communications Method RS 232C Serial Interface Radio Frequency Specification Modulation Method Digital Frequency Shift Keying FSK RF Output Power 15 dBm Standard 0 dBm MAX Transmission Frequency 608 614 MHz Channel spacing 12 5 kHz Power Requirem...

Страница 26: ...mm Weigh Approximately 100 grams Environmental Conditions Operating Temperature 10 to 40 C Operating Humidity 30 to 85 R H no dew condensation Storage Temperature 10 to 60 C Storage Humidity 30 to 95 R H at 60 C Specifications subject to change without notice ...

Страница 27: ...ries specify the part name and model number Standard Accessories No Item Model Q ty Remarks Operation Manual 1 Optional Accessories The following item is not included in standard accessories Purchase it separately No Item Model Remarks Wire Adapter OA 287 Comes complete with the mounting fixture for the DS 5300 and mounting screws M2 6x6 2 pcs And M3x6 2 pcs all with washer ...

Страница 28: ...Head office 39 4 Hongo 3 chome Bunkyo ku Tokyo Japan Phone 81 3 3815 2121 Telex 23498 FUKUMED J Fax 81 3 5684 3791 4L2869 200102E ...

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