Table of Contents SECTION 1: INTRODUCTION ................1 1.1 OVERVIEW ..................... 1 1.2 PRODUCT DESCRIPTION............... 1 1.3 OPERATING PRINCIPLE................. 1 SECTION 2: SAFETY GUIDANCE............... 2 2.1 INDICATIONS FOR USE ................2 2.2 CONTRAINDICATIONS FOR USE ............3 2.3 NOTE FOR HOME USE ................3 2.4 SAFETY TERMS AND CONDITIONS............
SECTION 1: INTRODUCTION 1.1 OVERVIEW Become familiar with the controls and how to use the product properly before operating the product. CAUTION: It should not be used in life supporting or life sustaining applications 1.2 PRODUCT DESCRIPTION The product is a lightweight, portable, detector. It is designed to meet your detecting and hearing needs by providing advanced detecting functions and a full range of sound of the fetal heartbeat.
signal. And the Doppler frequency is consistent with the rhythm of the fetal systole and diastole. Once cardiac valves vibrate and a Doppler frequency excursion is formed. It is transmitted an output signal of cardiac valves vibrating, and it is sent to the loudspeaker for getting a rhythmical sound with the fetal heartbeat.
The detected fetal heartbeat signal will be calculate once every five seconds for the average FHR and the value of the result will be displayed. Audio record: The sound of fetal heartbeat can be recorded by a recorder which is connected with the product.
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Do not operate the Product in the presence of flammable gases to avoid possible explosion or fire hazard. CAUTION: Temperature/Humidity/Pressure Extremes Exposing the Product to extreme environmental conditions outside of its operating parameters may compromise the ability of the Product to function properly. CAUTION: Battery Disposal Recycle or dispose of the battery in accordance with all federal, state and local laws.
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Equipment connected to the product must be certified to the respective IEC Standards (i.e. IEC 950 for data processing equipment 601-1 medical equipment). Furthermore, all configurations shall comply with the system standard IEC 601-1-1. Anybody who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore, responsible that the system complies with the requirements of the system standard IEC 601-1-1.
2.6 SYMBOL DESCRIPTIONS The following symbols may appear in this manual, on the Product, or on it’s accessories. Some of the symbols represent standards and compliances associated with the Product and its use. Consult instructions for use of the Product Humidity and/or it’s accessories.
SECTION 3: USING THE PRODUCT This section presents information on unpacking and setting up the product. 3.1 UNPACKING AND INSPECTING Every attempt is made to ensure your accurate and complete order. However, to be sure that your correct order, verifying the contents of the box against your packing slip.
3.2 CONTROLS AND DISPLAY 3.2.1 Structure and shape Main body ① Switch/Volume ② Earphone Jack ③ USB Socket ④ LCD ⑤ Probe ⑥ Battery Cover Lock ⑦ Label ⑧ Battery Cover ⑨ Indicator Holder ⑩ USB Speaker Socket...
3.2.2 Specification ① Switch/Volume Function: Turn on or off the device, change the volume. ② Earphone Jack Function: Connect to the earphone to play fetal heartbeat or connect to the record devices, such as computer or cellphone , to record heartbeat sound and save it on the record devices .
Function: It’s used to connect to USB socket in Main body with USB cable, then the heartbeat sound can be played through the speaker in Base. CAUTION: Remove the battery if the device is not likely to be used for some time.
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the site of heart of fetus is 1/3 below of navel line at its earlier stage, it then moves upward with increasing of gestational period, and the site of heart of fetus will be a little deviation to left or right with different fetus. Pls.
SECTION 4: MAINTENANCE & AFTER-SALES SERVICE Proper maintenance of the product is very simple, yet it is an important factor of its reliability. The section describes the maintenance and service required for the product and its accessories. 4.1 MAINTENANCE WARNING: Failure on the part of all responsible individuals, hospitals or institutions, employing the use of Product, to implement the recommended maintenance schedule may cause equipment failure and possible health hazards.
Correction: manually calculate the FHR with hearing fetal heartbeat sound for qualification. 4.2 RECOMMENDED MAINTENANCE AND CARE It is important that the product is stored at the operating temperature range if it is expected to be used. Optimal battery life will be obtained if stored and operated at room temperature.
wear, broken or bent connectors and pins, after bending and flexing the cable Examine Expired PRODUCT Replace any products disposable or Product PADS approaching or past their accessories expiration dates. WARNING: After the visual inspection, if the product and/or its accessories are damaged please contact our Customer Service.
4.5 CLEANING INSTRUCTIONS 4.5.1 Before cleaning the product, turn the device off and disconnect the power cord. 4.5.2 Before cleaning, remove all adherent soil (tissue, fluids, etc.) and wipe thoroughly with a cloth dampened with water before applying the cleaning solution. 4.5.3 When cleaning, do not immerse.
* Do not allow any liquid to enter the product, and do not immerse any parts of the device into and liquids. * Avoid pouring liquids on the device while cleaning. * Don’t remain any cleaning solution on the surface of the device. Wipe the surface of sensor of transducer with 70% ethanol or alcohol, self-air dry or clean with a clean, dry cloth.
NOTE: The warranty will be void upon unauthorized disassembly or service of the product. SECTION 5: SPECIFICATIONS AND SAFETY This section presents the specifications and safety standards of the product. 5.1 SPECIFICATIONS NOTE: The following specifications are subject to change and are only noted as a point of reference.
Humidity: 10% - 95% RH, non-condensing Atmospheric pressure: 50kPa to 106kPa CAUTION: Environment of use Product is designed for indoor use. Operator must confirm that the environment of use meets the required operating environmental specifications before using. CAUTION: Cold Environments If the Product is stored in an environment with a temperature below the operating temperature, the unit should be allowed to warm up to the needed operating temperature before using.
Appendix A: EMC Information-Guidance and Manufacture’s Declaration CAUTION: Fetal Doppler needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided for in the ACCOMPANYING OCUMENTS. Portable and mobile RF communications equipment can affect Fetal Doppler.
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Electrostatic ± 6 kV ± 6 kV Floors should be wood, discharge contact contact concrete or ceramic tile. If (ESD) ± 8 kV ± 8 kV air floors are covered with synthetic material, the 61000-4-2 relative humidity should be at least 30 %. The Fetal Doppler is intended for use in the electromagnetic environment specified below.
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equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a.
0.38 0.38 0.73 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
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3.There is fetal the fetal heartbeat movement,which sound is the means the position of oudest.means the fetal heart changes position of fetal heart changes Cat. No. : EZD-100S5...
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