TM XMTR Module HLX-801 Operation Manual ● Before using this device, read this manual thoroughly. ● Store this manual near the deivce where it can be always referred.
CAUTION Federal Law restricts this device to sale by or on the order of a physician. 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-801 telemetry transmission module from Fukuda Denshi. Before use, read this operation manual thoroughly for correct handling and operation. Safety Precautions The safety precautions shown in this manual contain important details on the safe use of this product, and must be obeyed. Make sure to follow the precautions indicated below, as these are important messages related to safety.
Graphic Symbols Refer to the following for the meaning of the symbol indicated on the equipment. Symbols indicated on the main unit of the HLX-801 Symbol Description Caution; refer to accompanying documents Indicates the need to refer to related accompanying documents before operation. Refer to accompanying documents Indicates the need to refer to related accompanying documents before operation. Year of Manufacture Indicates the manufactured year.
Precautions for Safe Operation of Medical Electrical Equipment Cautions described here are regarding the general instructions for safety use to the patient and users. For cautions about the HLX-801, refer to the following pages. CAUTION 1. Do not use the equipment unless you are familiar with its operation. 2. Pay attention to the following when installing or storing the equipment. y Install or store in a place where the equipment will not be exposed to splashing water.
CAUTION 5. Cares after Operation y Return all operating switches or knobs to the position before using the equipment, and then switch off the power. y When unplugging the cables, do not apply excessive force by pulling on the cable. Pull from the connector part of the cable. y Clean the accessories and cables, and keep them together in one place. y Keep the equipment clean to ensure proper operation for the next use. y Make sure to remove the batteries if the equipment is not used for a long time.
Precautions about Magnetic Resonance Imaging (MRI) WARNING z Do not use this equipment in magnetic resonance imaging (MRI) environments. This equipment may be pulled towards the MRI device. The local heating by the induced electromotive force may cause burn injury to the patient or deteriorate the performance of this equipment. For details, refer to the operation manual for the MRI testing device.
Precautions about Alarm CAUTION z The alarm generation may be delayed between the bedside monitor and the central monitor depending on the communication specification (wired or wireless) between the bedside monitor and central monitor. Read the operation manual thoroughly and set the alarm. z The Alarm System is different between the bedside monitor and central monitor depending on the communication specification (wired or wireless). Read the operation manual thoroughly and set the alarm.
Precautions for Safe Operation of Medical Telemetry WARNING z The HLX-801 transmitter must not be co-located or operated in conjunction with any other antenna or transmitter. z The HLX-801 complies with FCC radiation exposure limits set forth for a controlled environment and meets the FCC radio frequency (RF) Exposure Guidelines in Supplement C to OET65. The HLX-801 has been confirmed to comply with maximum permissive exposure evaluation (MPE).
CAUTION • For management, make sure to follow the precautions below. The Institution should appoint a person (hereinafter referred to as the “Overall Manager”) to manage the wireless channels for the whole Institution. y And when using telemetry, which requires zone location, the Institution should nominate a person (hereinafter referred to as the “Zone Manager”) to manage the wireless channels in each zone. However, when using such telemetry in a local Institution, one person can perform both functions.
Electromagnetic Compatibility The performance of this device under electromagnetic environment complies with IEC60601-1-2 (2007). Precautions for Safe Operation under Electromagnetic Influence CAUTION If any sorts of electromagnetic wave, magnetic field, or static electricity exist around the equipment, noise interference or malfunction of the device may occur.
EMC Guidance This equipment complies with IEC60601-1-2 (2007). However, if portable transmitter or wireless LAN equipment is used extremely nearby, the electromagnetic influence may largely exceed the compliance level and may cause unexpected phenomenon such as noise interference on the waveform. Therefore, this equipment should be used in a location specified by each medical institution.
● Compliance to the Electromagnetic Immunity (1) The HLX-801 is intended for use in the electromagnetic environment specified in below tables. It should be assured that the HLX-801 is used in such an environment.
● Compliance to the Electromagnetic Immunity (2) The HLX-801 is intended for use in the electromagnetic environment specified below. It should be assured that the HLX-801 is used in such an environment.
● Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the HLX-801 The HLX-801 is intended for use in an environment in which radiated RF disturbances are controlled. The electromagnetic interference can be prevented by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the HLX-801 as recommended below, according to the maximum output power of the communications equipment.
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Contents Safety Precautions.................................................................................. i Precaution from Fukuda Denshi....................................................... i Graphic Symbols..............................................................................ii Precautions for Safe Operation of Medical Electrical Equipment ....iii Non-Explosion Proof .......................................................................iv Precautions about Magnetic Resonance Imaging (MRI)..
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1. General Description The HLX-801 is a transmitter module to wirelessly transmit vital signal waveforms and Numeric Data which are monitored on the DS-8000 series bed side monitors. A telemetry monitoring system is constructed in combination with a central monitor such as DS-7700 system. A telemetry channel can be set with an arbitrary channel on the bedside monitor. Before using the HLX-801, also read the operation manuals of the patient monitor and central monitor thoroughly.
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2. Name of Parts and Their Functions Anntena Used to send and receive radio waves.
Attachment cover To fix the HLX-801 to the monitor.
3. Preparation ■ Installation to the Bedside Monitor For procedure to install to the bedside monitor, refer to the operation manuals of the bedside monitor and optional mounting bracket. WARNING z The HLX-801 is a module dedicated to the bedside monitor manufactured by Fukuda Denshi Co., Ltd. The use of the power separated from the commercial power guarantees the safety. z Do not connect the HLX-801 to a device other than the bedside monitor manufactured by Fukuda Denshi Co., Ltd.
■ Installation to the Patient Monitor DSL-8001 c Loosen the screw on the rear of the DSL-8001 and remove the maintenance cover. The removed maintenance cover is not used when the HLX-801 is installed. Make sure to store the cover because it is needed when the HLX-801 is removed. d Connect the connection cable of the DSL-8001 maintenance part to the HLX-801 connector. Pay attention to the connector orientation and connect the connector.
4. Operation ■ Operation Procedure For operation procedure, refer to the operation manual of the bedside monitor to which the-HLX-801 is connected. ■ Changing the Transmitter Channel The HLX-801 is a synthesizer type transmitter module which the transmitter channel can be changed. It can be set up with an arbitrary channel among the channels assigned by the Telemetry Laws (according to each country). For details on the setting procedure, see the operation manual of the bedside monitor.
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5. Troubleshooting If the measurement waveform is not properly displayed on the central monitor, check the following items. If the phenomenon cannot be improved, refer to your local Fukuda Denshi service representative. Pattern on the central monitor Cause The radio waves are not transmitted. The connection is not properly set. The power of the bedside monitor is turned OFF. The channel numbers between the transmitter and the receiving monitor are not the same.
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6. Cleaning and Disinfection Clean and disinfect the HLX-801 as shown below. CAUTION Do not sterilize the HLX-801 in any manners since it is not ready for sterilization. ■ Cleaning Soak a piece of gauze or absorbent cotton in alcohol or a neutral detergent, wring the gauze or cotton, and wipe the HLX-801 using it. CAUTION z Clean the equipment frequently so stains can be removed easily. z To prevent injury, it is recommended to wear gloves when cleaning the equipment.
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7. Maintenance Check Periodic check must be performed. When reusing the HLX-801 which was left unused for a while, always check that the unit operates properly and safely before use. In this section, the maintenance check items that must be performed for the HLX-801 are explained. To ensure safety, reliability, and high performance, a “Daily Check” and “Periodic Check” must be performed. Be aware that Fukuda Denshi is not liable for any accidents arising from the lack of maintenance check.
Daily Check List No. Checked Date Checked by Location Model: HLX-801 Serial No. Date of Purchase Item External appearance Transmitting function Telemetry Channel Zone location Periodic Check Comment 14 Check Details Visually inspect for damage, cracks, breaks,and chips of the exterior, peeling label, and loose screws. Connect to the bedside monitor, operate under normal operating conditions, and check the communication function and operation on the central monitor.
8. Accessories / Optional Accessories WARNING Use only the accessories specified by Fukuda Denshi for the HLX-801. Otherwise, the HLX-801 cannot deliver its maximum performance and may be damaged, resulting in a safety hazard. CAUTION For quality improvement, specifications are subject to change without prior notice. ■ Standard Accessories No.
■ Optional Accessories (sold separately) The following accessories are available as optional for the HLX-801. Purchase them as required. In order to satisfy product performance requirements, always use the accessories specified by Fukuda Denshi. When ordering spare parts, inform Fukuda Denshi of the Model Type.
9. Specification ■ Specification CAUTION For quality improvement, specifications are subject to change without prior notice. Standard Specification 42(W)×93(D)×16(H) mm Size: (not including the antenna, protrusion, and option unit) Approx. 60g Weight: Communication method Modulation method: F1D Frequency: 608MHz to 614MHz Oscillation method: PLL Synthesizer method by crystal control Channel spacing: 12.5kHz Occupied bandwidth: Within 8.5kHz Frequency deviation: Within ±2.
Operating Environment Temperature: 10 to 40°C Humidity: 30 to 85%RH (non-condensing) Vibration/Shock: Comply with IEC60068-2-64：2008, IEC60068-2-32 Ed.2:1975 Amd.1:1982 Amd.
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