EXHIBIT D: User Manual FCC ID DV8HLX561
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.
CAUTION Federal law restricts this device to sale by or on the order of a physician. 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.
Telemetry Precautions For proper management of the telemetry installation, consult your Fukuda Denshi representative concerning the following: • Plan the installation of your telemetry system taking into account your entire medical facility needs and plant requirements. • Be sure the antenna system installed meets the facility and plant requirements. WARNING This Radio Frequency device is susceptible to interference from outside sources.
CAUTION Users are advised to periodically contact the FCC or specified frequency coordinator 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.
Thank you for purchasing the HLX-561 telemetry transmission module from Fukuda Denshi. Before use, read this operation manual thoroughly for correct handling and operation. If you are familiar with a similar type of product, it is recommended this operation manual be read and understood since the HLX-561 has unique operation and handling methods. Safety Information and Messages Be sure to observe the warning and cautionary messages related to important safety information.
Safety Considerations in Using Medical Electrical Equipment Contents described here are general safety considerations to be taken for proper operation of medical electrical equipment and for the safety of both the patient and operator. Safety considerations specific to the use of the HLX-561 telemetry transmission module are described on the next page. CAUTION 1. Do not use the equipment unless familiar with its operation. 2.
CAUTION 4. Precautions during Operation • Do not to operate the equipment beyond the time period necessary that is required for diagnosis, monitoring or treatment. • Observe the equipment and patient constantly for any abnormality. • If the equipment or patient indicates any abnormality, stop the equipment from operating or take proper measures (e.g. disconnect transducers and electrodes) to ensure patient safety. • Instruct the patient not to contact the equipment. 5.
CAUTION 9. When using an electrosurgical unit or defibrillator in conjunction with this equipment, take care of the following. • The high-frequency energy produced by electrosurgy equipment may result in burns to the patient or possible damage to the equipment. Be sure to observe the precautionary instructions described in the operation manual of the electrosurgical unit. • Some types of equipment may be damaged by the energy discharged by a defibrillator.
Contents Telemetry Precautions i Safety Information and Messages iii Safety Considerations in Using Medical Electrical Equipment iv 1. General Description 1 2. Controls and Indicators 2 3. Mounting the HLX-561 to the Bedside Monitor Mounting into the DS-5100 Mounting into the DS-5300 4 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.
1. General Description The HLX-561 is a telemetry transmission module to transmit physiological parameters monitored by a bedside monitor in the DS-5000 series via wireless technology. Thus, the HLX-561 allows the user to configure an integrated 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.
2.
Antenna Transmitting antenna for the physiological parameters. Channel Label Contains the channel identification number of the transmitter. The receiver must be set to the same channel number. If the channel number is changed, the channel label must be replaced. Connector 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.
3. Mounting the HLX-561 to the Bedside Monitor Described here are the procedures for mounting the HLX-561 to the DS-5100 and DS-5300 as typical bedside monitors. If the radio channel is changed, 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.
F-LINK/HLX Switch HLX-561 The F-LINK / HLX switch is now accessible. Switch to the HLX position to effect internal communication (Setting this switch to the HLX position disables the external F-LINK connector.) DS-5100 Rear panel 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 cover back in its original position while at the same time inserting the antenna into the antenna hole. Replace the cover onto the DS-5100 by replacing the screw at the bottom. Reconnect the power cord and turn the DS-5100 ON. Set the telemetry channel from the telemetry set-up display on the DS-5100. For details in selecting the telemetry channel, refer to the operation manual for the DS-5100.
Mounting into the DS-5300 NOTE: Before starting, be sure to turn the main power switch of the DS-5300 OFF and disconnect the power cable from the wall outlet. HLX-561 OA-287 Connect 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).
Connect the cable from the OA-287 to the F-LINK connector of DS-5300. Reconnect the power cord and turn the DS-5300 ON. Select the telemetry channel from the telemetry set-up display on the DS-5300. For details on the telemetry channel set-up procedure, 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.
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.
4. Setting the Receiving Channel of the Monitor Select the telemetry receiver channel to match that of the telemetry transmission module. The monitor will display the channel number. If the transmission module has a different group code than that of the receiver, set the telemetry receiver group code to correspond to the telemetry transmission module. (For details on selecting the channel and group code, refer to the operation manual for the appropriate monitor.
5. Cleaning, Sterilization and Disinfection Clean, sterilize and disinfect the HLX-561 and accessories as follows. Cleaning Use a clean, soft cloth dampened with alcohol or a weak acid/alkalescent/neutral cleanser. Clean the HLX-561 and accessories with the dampened cloth, taking care that the cleaning solution does not enter into any connectors or get inside the HLX-561. Do not use cleaning agents containing organic solutions, thinner, toluene and benzene.
6. Maintenance and Inspection To maintain the safety and reliable functionality and performance of the HLX-561, it is preferable to perform routine and periodic inspections before use. A recommendation is described in this section. Failure to perform routine maintenance and inspection may void the responsibility of Fukuda Denshi. CAUTION Persons other than your authorized Fukuda Denshi service representative must not remove the external casing of the HLX-561.
Routine Inspection Record No. Inspection Date: Inspected by: Location: Model: HLX-561 Serial No.: Purchase Date: Items External appearance Function Periodic Inspection Inspection Judgement criteria Check the external No abnormalities appearance for scratches, breaks, cracks, loose screws, or labels. Check the antenna for bends or breaks. Under normal operating conditions, check the functions at the central monitor. Waveforms and data received in normal manner.
7. Specifications Transmitting Information (will depend on bedside monitor used) Waveforms : ECG × 1, 5 additional waveforms (e.g. Respiration, pulse, 2 blood pressure waveforms) Numeric Parameters : NIBP, SpO2, Temp 1, Temp 2, BP1, BP2, Heart Rate, Respiration Rate, etc. Status Information : Low Battery, Electrode fail, Group code (64 types), Alarm, Alarm suspend, Remote record, Model ID number, Transmitter channel No.
Dimensions and Weight Dimensions Weigh : 61.5(W) × 108.5(H) × 20.5(D) mm : Approximately 100 grams Environmental Conditions Operating Temperature Operating Humidity Storage Temperature Storage Humidity : 10 to 40 °C : 30 to 85 %R.H. no dew condensation : −10 to 60 °C : 30 to 95 %R.H.
8. Accessories To ensure the HLX-561 will perform to its published specifications, use only those accessories specified by Fukuda Denshi. When ordering spare parts or accessories, specify the part name and model number. Standard Accessories No. Item Operation Manual Model Q'ty 1 Remarks Optional Accessories The following item is not included in standard accessories. Purchase it separately. No.
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