2 Revision B Safety ApexPro Telemetry System 2001989-134 2-1
For your notes 2-2 ApexPro Telemetry System 2001989-134 Revision B
Safety: For Your Safety For Your Safety Intended Use The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations.
Safety: For Your Safety System Safety The safety statements presented in this chapter refer to the equipment in general and, in most cases, apply to all aspects of the telemetry system. There are additional safety statements in other chapters that are specific to the information presented in that chapter. The order in which safety statements are presented in no way implies order of importance. Dangers There are no dangers that refer to the equipment in general.
Safety: For Your Safety WARNINGS ALARMS — Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off during patient monitoring may result in a hazard to the patient. Do not rely exclusively on the alarm pause breakthrough feature for alarm notification during an alarm pause. This may result in a hazard to the patient. Only crisis alarms break through an alarm pause.
Safety: For Your Safety WARNINGS CONDUCTIVE CONNECTIONS — Extreme care must be exercised when applying medical electrical equipment. Many parts of the human/machine circuit are conductive, such as the patient, connectors, electrodes, transducers. It is very important that these conductive parts do not come into contact with other grounded, conductive parts when connected to the isolated patient input of the device.
Safety: For Your Safety WARNINGS LEAKAGE CURRENT TEST — When interfacing with other equipment, a test for leakage current must be performed by qualified biomedical engineering personnel before using with patients. NETWORK INTEGRITY — The clinical information center resides on the hospital’s computer network, and it is possible that inadvertent or malicious network activity could adversely affect patient monitoring. The integrity of the computer network is the responsibility of the hospital.
Safety: For Your Safety WARNINGS RATE METERS — Keep pacemaker patients under close observation. Rate meters may continue to count the pacemaker rate during cardiac arrest and some arrhythmias. Therefore, do not rely entirely on rate meter alarms. SITE REQUIREMENTS — For safety reasons, all connectors for patient cables and sensor leads are designed to prevent inadvertent disconnection, should someone pull on them. Do not route cables in a way that they may present a stumbling hazard.
Safety: For Your Safety CAUTIONS BEFORE INSTALLATION — Compatibility is critical to safe and effective use of this device. Please contact your local sales or service representative prior to installation to verify equipment compatibility. DEFIBRILLATOR PRECAUTIONS — Patient signal inputs labeled with the CF and BF symbols with paddles are protected against damage resulting from defibrillation voltages. To ensure proper defibrillator protection, use only the recommended cables and leadwires.
Safety: For Your Safety CAUTIONS EMC — Magnetic and electrical fields are capable of interfering with the proper performance of the device. For this reason make sure that all external devices operated in the vicinity of the monitoring system comply with the relevant EMC requirements. X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation.
Safety: For Your Safety CAUTIONS OPERATOR — Medical technical equipment such as this monitor/monitoring system must only be used by persons who have received adequate training in the use of such equipment and who are capable of applying it properly. POWER REQUIREMENTS — Before connecting the device to the power line, check that the voltage and frequency ratings of the power line are the same as those indicated on the unit's label.
Safety: For Your Safety Notes Put the system in a location where you can easily see the screen and access the operating controls. This product is not likely to cause abnormal operation of other patient-connected equipment such as cardiac pacemakers or other electrical stimulators. Exceptions are noted in the pacemaker monitoring section, if applicable. This product is protected against the effects of cardiac defibrillator discharges to ensure proper recovery, as required by test standards.
Safety: For Your Safety Classification The telemetry system is classified, according to IEC 60601-1, as: Type of protection against electrical shock Transmitter — Internally powered Receiver system — Class I Degree of protection against electrical shock ApexPro Transmitter — Type B applied part ApexPro CH Transmitter—Type CF Defibrillation proof applied part (not for sale outside of the U.S.
Safety: For Your Safety FCC Compliance Information Statement This equipment complies with Part 95 Subpart H of the FCC rules to be used in wireless medical telemetry service. Operation of this equipment requires prior coordination with a frequency coordinator designated by the FCC for the Wireless Medical Telemetry Service. This device is also certified for RSS-210 of Industry Canada.
Safety: For Your Safety Equipment Symbols NOTE Some symbols may not appear on all equipment. ATTENTION: Consult accompanying documents. CAUTION: To reduce the risk of electric shock, do NOT remove cover. Refer servicing to qualified service personnel. NOTE The rating of protection against electric shock (indicated by symbol for CF or BF) is achieved only when used with patient applied parts recommended by GE Medical Systems Information Technologies.
Safety: For Your Safety PRESS Indicates where to press to open the door on the 7160 DDW. Silence Alarms keyboard key.
