CONTENT 1 : I ECTION NTRODUCTION 1.1 C ONTACT NFORMATION 1.2 P RODUCT ESCRIPTION 1.3 O PERATING RINCIPLE 1.4 C ONTRAINDICATIONS FOR 2 : S ECTION AFETY UIDANCE 2.1 S AFETY ERMS ONDITIONS 2.2 S AFETY LTER ESCRIPTIONS 2.3 S YMBOLS 3 : G ECTION...
1.1 Contact Information Distributed By: L orte Technologies Inc 1616 Barclay Blvd. Buffalo Grove, lL 60089 USA Email: w ebmaster@facelake.com Website: www.FaceLake.com Authorized US Representative: Facelake.com 1616 Barclay Blvd, Buffalo Grove, IL 60089 USA...
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. The product is mainly used to detect the fetal heartbeat rate (FHR) and the sound of the fetal heartbeat (SFH).
1.4 Contraindications for Use Normally none, as a particular case, please consult your doctor. Section 2: Safety Guidance 2.1 Safety Terms and Conditions The signal words shown below, left, identify the potential hazard categories. The definition of each category is as follows: DANGER: ...
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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 batteries in accordance with all federal, state and local laws. To avoid fire and explosion hazard, do not burn or incinerate the batteries .
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 60601-1-11. The product Service Port is only intended for use during maintenance by authorized service personnel. CAUTION: ...
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product system conforms essential requirements Medical Device Directive 93/42/EEC. manufacture. turer Temperature limit limitation eric Pressure limitation serial number of the product Production batch es that the equipment should be sent to the special agencies according to local regulation for separate collection after its useful life.
FHR Display: Here displays the fetal heart rate value, whose unit is bpm (beat per minute) Warning: When the FHR is in the restrict scope, the symbol will display, And the State symbol will display in a few moments. Battery Indicator: When the batteries are low, the Battery Indicator and State symbol will twinkle.
Section 5: Operation This section provides the description for operation 5.1 Installation 5.1.1 I nstalling a probe ① Insert the probe plug into the socket which is on the main unit. ② Place the probe into the probe stand. 5.1.2 ...
Press switch button , the device will turn on and self check, then the Blue Indicator light will light. when the FHR display "000", the self-check is finished and get into use. 2. D etect FHR Put the gel on the surface of the ultrasonic probe, then press the probe on the detect position softly and ensure it has a good touch surface.
deviation to left or right with different fetus. Pls. make sure that the surface of probe should be contacted fully with the skin. After the sound become clear and stays stable for a few seconds, the FHR value will appear on the LCD in real time.
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● Mild soap and water ● Sodium hypochlorite (chlorine bleach) (3% solution in water) ● Quaternary ammonium compounds (such as Lysol) (10% solution in water) ● Do not use abrasive cleaners or strong solvents such as acetone or acetone-based cleaners. ●...
abrasive or flammable cleaning agents. Do not steam, autoclave, or gas-sterilize the product or accessories. CAUTION: C leaning liquids: DO NOT submerge the device in liquids or pour cleaning liquids over, into or onto the device. * Don’t use strong solvent, for example. Acetone. * Never use an abrasive such as steel wool or metal polish.
2. To ensure the product is always functional when required, the following maintenance shall be performed: ● Visual Inspection ● Cleaning the product and its accessories ● Check the battery fuel gauge ● Testing product Performance Correction: manually calculate the FHR with hearing fetal heartbeat sound for qualification.
NOTE: T he following specifications are subject to change and are only noted as a point of reference. Product name: Fetal Doppler Mode: JPD-100B Safety: Complies with IEC 60601-1, EN 60601-1, EN60601-1-2, IEC 61266 Physical Dimensions: 129mm W x 83mm D x 34 mm H, Wt: 0.24kg (not including battery)
Effective area of the ultrasonic transducer active element: 3.07cm The acoustic coupling medium for normal use: ph: 5.5~8, Acoustic 5 2 impedance: ≤1.7*10 g /cm ·s Working mode: Continuous wave doppler Audio output: Audio output power: <0.5 W Audio out Socket: Φ3.5mm Recommended battery type: AA X 2, dry batteries Continuous working time: ...
The models JPD-100B are intended for use in the electromagnetic environment specified below. The customer or the user of the models JPD-100B should assure that it is used in such an environment. Electromagnetic environment- Emissions Compliance guidance The models JPD-100B use RF energy only for its internal function.
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Guidance & Declaration—electromagnetic immunity The models JPD-100B are intended for use in the electromagnetic environment specified below. The customer or the user of the models JPD-100B should assure that it is used in such an environment. Immunity IEC 60601 Compliance...
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NOTE U is the a.c. mains voltage prior to application of the test level. The models JPD-100B is intended for use in the electromagnetic environment specified below. The customer or the user of the Fetal Heart Rate Doppler Detector should assure that it is used in such an environment.
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Radiated RF 3 V/m recommended IEC 61000-4-3 3 Vrms 80 separation distance MHz to 2.5 calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance 1/2 d=1.2×P 80 MHz to 800 MHz 1/2 d=1.2×P 800MHz to 2.5 GHz Where P is the...
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RF communications equipment and the models JPD-100B. The models JPD-100B is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the models JPD-100B can help prevent electromagnetic interference by maintaining a minimum distance between...
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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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C=20log(Vs/Vn)=6.4dB S: Overall Sensitivity S=A+B+C=97.1db Supplementary information: -- Distance for the probe face 100mm Nominal acoustic working frequency 3.0MHz Doppler frequency 293Hz Target Velocity 12cm/s A(d): Target reflection loss 44.5dB B: two-way attenuation over the acoustic 46.8dB pathway C: Signal-to-noise Ratio Vs: 227mV Vn: 109mB C=20log(Vs/Vn)=6.4dB...
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Lorte Technologies Inc Address: 1616 Barclay Blvd. Buffalo Grove, lL 60089 USA Email: w ebmaster@facelake.com Website: www.FaceLake.com...
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