This operation manual is for the HLX-801(G) Ver. 01. 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.
Thank you for purchasing the HLX-801(G) telemetry transmitter 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(G) Symbol Description Follow operating instructions (Information) Indicates the need to refer to related accompanying documents before operation. U Year of Manufacture Indicates the manufactured year. Serial Number WEEE (Waste Electrical and Electronics Equipment) Indicates a separate collection for electrical and electronic equipment.
Precautions for Safe Operation of Medical Electrical Equipment Cautions described here are regarding the general instructions for safety use to the patient and users. Precautions unique to this device are detailed throughout the manual. CAUTION 1. Users should have a thorough knowledge of the operation before using this equipment. 2. Pay attention to the following when installing or storing the equipment. Do not install or store in an area where the unit will be subject to splashing water.
CAUTION 5. After using the device, verify the following items. Return all operating switches or knobs to the position before using the equipment, and then switch off the power. When unplugging the cables, do not apply excessive force by pulling on the cable. Pull from the connector part of the cable. Clean the accessories and cables, and keep them together in one place. Keep the equipment clean to ensure proper operation for the next use.
Precautions about Magnetic Resonance Imaging (MRI) WARNING Do not use this equipment in magnetic resonance imaging (MRI) environments. This equipment may be pulled towards the MRI device. And 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 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. 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 The HLX-801(G) transmitter must not be co-located or operated in conjunction with any other antenna or transmitter. This equipment complies with FCC/IC radiation exposure limits set forth for an uncontrolled environment and meets the FCC radio frequency (RF) Exposure Guidelines and RSS-102 of the IC radio frequency (RF) Exposure rules.
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. If any unintended malfunction or noise occurs in monitoring, check the magnetic influence and take appropriate countermeasures.
EMC Guidance This equipment complies with IEC 60601-1-2 (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(G) is intended for use in the electromagnetic environment specified below. It is recommended that the HLX-801(G) be used in such an environment.
●Compliance to the Electromagnetic Immunity (2) The HLX-801(G) is intended for use in the electromagnetic environment specified below. It is recommended that the HLX-801(G) be used in such an environment.
●Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the HLX-801(G) The HLX-801(G) 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(G) as recommended below, according to the maximum output power of the communications equipment.
Contents Safety Precautions.................................................................................. i Precaution from Fukuda Denshi....................................................... i Graphic Symbols..............................................................................ii Precautions for Safe Operation of Medical Electrical Equipment .... iii Non-Explosion Proof .......................................................................
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1. General Description The HLX-801(G) is a transmitter module to wirelessly transmit vital signal waveforms and numeric data which are monitored on the DS-8100 series bedside 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(G), also read the operation manuals of the patient monitor and central monitor thoroughly.
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2. Name of Parts and Their Functions Antenna Refer to the safety precautions in the preface of this manual.
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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 The HLX-801(G) 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. Do not connect the HLX-801(G) to a device other than the bedside monitor manufactured by Fukuda Denshi Co., Ltd.
4. Operation ■ Operation Procedure For operation procedure, refer to the operation manual of the bedside monitor to which the HLX-801(G) is connected. ■ Changing the Transmitter Channel The HLX-801(G) 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.
5. Troubleshooting If the measurement waveform is not properly displayed on the central monitor, check the following items. If the phenomenon cannot be improved, contact your local Fukuda Denshi service representative. Pattern on the central monitor Cause The radio waves are not transmitted. Noise is interfering. Solution The connection is not properly set. Check the connection between the HLX801(G) and bedside monitor. The power of the bedside monitor is turned OFF.
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6. Cleaning and Disinfection Clean and disinfect the HLX-801(G) as shown below. CAUTION Do not sterilize the HLX-801(G) in any manners since it is not ready for sterilization. ■ Cleaning Clean the HLX-801(G) using squeezed gauze or an absorbent cotton cloth dampened with alcohol or a neutral detergent. CAUTION Clean the equipment frequently so stains can be removed easily. 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(G) 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 HLX801(G) 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 Model Type: HLX-801(G) Serial No. Item Date of Purchase Criteria Judgement External Appearance Visually inspect for damage, cracks, breaks, and chips of the exterior, peeling label, and loose screws. No remarkable abnormalities should be found. OK/NG Transmitting Function Connect to the bedside monitor, operate under normal operating conditions, and check the communication function and operation on the central monitor.
8. Accessories WARNING Use only the accessories specified by Fukuda Denshi for the HLX-801(G). Otherwise, the HLX-801(G) 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.
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9. Specification ■ Specification CAUTION For quality improvement, specifications are subject to change without prior notice. Standard Specification Size: 41(W) × 93(D) × 16(H) mm (excluding the antenna, protrusion, and option unit) Weight: Approx. 70g Communication method Modulation method: F1D Frequency: 1395MHz to 1400MHz, 1427MHz to 1432MHz Transmitter Chnnel One from the following channels.
Safety IEC 60601-1: 1988 + Am1: 1991 + Am2: 1995 Medical Electrical Equipment - Part 1: General Requirements for Safety EMC Standard: IEC 60601-1-2: 2007 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests) General Standard: Operating Environment Temperature: 10°C to 40°C Humidity: 30% to 85%RH (non-condensing) Atmospheric Pressure: 70kPa to 106kPa Transport and Storage E