Perform period safety testing to insure proper patient safety. Identical replacement parts must be used. The user must be serviced only by authorized and qualified personnel, The manufacturer can not accept responsibility for safety compliance, reliability and performance if modifications or repairs are carried out by unauthorized personnel. If damage is evidence, replacement is recommended before use. The recommended inspection interval is once per week or less. The user must check the equipment, cables and transducers do not have visible evidence of damage that may affect patient safety or monitoring capability before use. Allow at least 2 inches (5cm) clearance around the instrument for proper air circulation. Ambient temperatures that exceed these limits could affect the accuracy of the instrument and cause damage to the modules and circuits. Switching within 1 minute, at ambient temperatures between 5 and 40. The CMS800G Ultrasonic Fetal Doppler Monitor (Monitor) is Class I equipment and designed to comply with IEC 60601-1. Note: A NOTE provides useful information regarding a function or procedure. This guide is designed to give key concepts on safety precautions.Ī WARNING label advises against certain actions or situations that could result in personal injury or death.Ī CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure. If the FHR result is distrustful, please use other method such as stethoscope to verify or contact the local distributor or manufacture to get help. The accuracy of FHR is controlled by the equipment and can not be adjusted by user.
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If there is doubt as to fetal well-being after using the unit, further investigations should be undertaken immediately using alternative techniques. WARNING : This device is not intended for treatment. Note: This device is not intended for home use. The information contained in this document is subject to change without notice.ĬONTEC only considers itself responsible for any effects on safety, reliability and performance of the equipment if:Īssembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons authorized by CONTEC, and the electrical installation of the relevant room complies with national standards, and the instrument is used in accordance with the instructions for use.
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No part of this document may be photocopied, reproduced or translated to another language without prior written consent of CONTEC.ĬONTEC assumes no responsibility for any errors that may appear in this document, or for incidental or consequential damage in connection with the furnishing, performance or use of this material. This document contains proprietary information protected by copyright law.