This is considered to be good practice and should be observed at all time. 8 We recommend that exposure to ultrasound should be kept as low as reasonably achievable. X-ray equipment and magnetic resonance imaging (MRI) devices can emit high levels of electromagnetic radiation. For this reason, make sure that all external devices operated in the vicinity of this device comply with the relevant EMC requirements. 7 Magnetic and electrical fields are capable of interfering with the proper performance of the device. 6 This device is not explosion-proof and cannot be used in the presence of flammable anesthetics. The user should be trained in proper placement techniques either through acceptable Ob/Gyn training and individual state accreditation, or as being prescribed by such a trained clinician and trained in device placement. 5 Placement of the ultrasound transducer on the abdomen is critical to obtaining the fetal heart beat as opposed to maternal heart beat or other abdominal noise. It is not intended for treatment or use during labor and delivery. 4 The Doppler is a tool to aid the user in hospitals, clinics or at home and should not be used in place of normal fetal detection. 3 Home fetal heart rate detection has not been shown to prevent the onset of preterm labor nor will it prevent the occurrence of preterm birth. 2 Before the SD2 is prescribed for home use, the user (patient) must be instructed/trained in proper use of the equipment. WARNING 1 It is to be used by health care professionals and patients on the order of a physician. To avoid the possibility of injury, observe the following precautions during the operation of the device. WARNING and CAUTION messages must be observed. Type BF protection means that the connection between the equipment and personnel complies with permitted leakage currents and dielectric strength of IEC/EN 60601-1. This unit is internally powered equipment, and it is an IEC/EN 60601-1 Type BF applied part. Therefore, your model may or may not have some of the parameters and functions described, depending on what you have ordered. This user manual is written to cover the maximum configuration. Safety Precautions Federal (U.S.) Law restricts this device to sale by or on the order of a physician CAUTION NOTE: NOTE A NOTE provides useful information regarding a function or a procedure. CAUTION A CAUTIONlabel advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure. WARNING AWARNING label advises against certain actions or situations that could result in personal injury or death. Product Information Product Name:Ultrasonic Pocket Doppler Model:SD2, SD2Pro, SD2 Plus, SD2 Lite, SD2 Basic Terms Used in this Manual This guide is designed to give key concepts on safety precautions. EDAN will make available on request circuit diagrams, component part lists, descriptions, calibration instructions, or other information that will assist service personnel to repair those parts of the equipment that are designated by EDAN as repairable by service personnel. Responsibility of the Manufacturer EDAN only considers itself responsible for any effect on safety, reliability and performance of the equipment if:Īssembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons authorized by EDAN, and The electrical installation of the relevant room complies with national standards, and The instrument is used in accordance with the instructions for use. EDAN holds the rights to modify, update, and ultimately explain this manual. The user shall understand that nothing in this manual grants him, expressly or implicitly, any right or license to use any of the intellectualproperties of EDAN. Materialsprotected by the copyright law, including but not limited to confidential information such as technical information and patent informationare contained in this manual, the user shall not disclose such information to any irrelevant third party. Without prior written consent of EDAN, any materials contained inthis manual shall not be photocopied, reproduced or translated intoother languages. (hereinafter called EDAN)cannot be held liable. Users operation failing to comply with this manual may result in malfunction or accident for which Edan Instruments, Inc. It is reminded that the product shall be used strictly complying with this manual. Statement This manualwill help you understand the operation and maintenance of the product better. SD2 Ultrasonic Pocket Doppler User Manual About this Manual P/N: 45 MPN: 45010 Release Date:Mar.
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