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Product Information Product Name: Fetal Doppler Model: MSLJB08(mini) Copyright Copyright 2016. All rights reserved. Precaution Labels Definition The signal words shown below, left, identify the potential hazard categories. The definition of each category is as follows: DANGER: This alert identifies hazards that will cause serious personal injury or death.
Table of contents SECTION 1: INSTRUCTION........... 3 1.1 I ............1 NFORMATION 1.2 I ..........3 NDICATION FOR 1.3 P ...........3 RODUCT ESCRIPTION 1.4 O ..........4 PERATING RINCIPLE 1.5 C ....... 4 ONTRAINDICATIONS FOR 1.6 A ........... 4 DVERSE EFFECTS SECTION 2: SAFETY GUIDANCE.........
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6.3 C ....14 LEANING RODUCT AND CCESSORIES 6.4 D ............16 ISINFECTIONS 6.5 R ..........16 ECYCLE ATTERIES 6.6 A ......16 UTHORIZED EPAIR ERVICE SECTION 7: TECHNICAL SPECIFICATIONS.....16 SECTION 8 : TROUBLESHOOTING......18 APPENDIX A EMC INFORMATION......19...
This guide will show you how to use your Fetal Doppler to listen to the sound of your baby's heartbeat. 1.2 Indication for Use The AngelSounds Fetal Doppler MSLJB08 (mini) is a prescription from licensed physician in hospitals, clinics and private offices. It is intended to be used by care professionals including practical nurses, midwives, relative technicians, and physician assistants.
The growth and development of a fetus can be found out through examination of these indices. It is applicable for department of gynaecology and obstetrics and clinic daily. In accordance with classification criteria in Annex IX on “Medical Device Directive 93/42/EEC”, the product is class IIa based on rule 10, “Devices for Direct Diagnosis or Detection on physiological process”.
Section 2: Safety Guidance This product is internal powered equipment, and the degree of shock protection is B applied part. It means that these person connections will comply with permitted leakage currents, dielectric strengths of IEC/EN60601. 2.1 Safety alert descriptions The following is a list of product safety alerts that appear in this section and throughout this manual.
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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 battery in accordance with all federal, state and local laws. To avoid fire and explosion hazard, do not burn or incinerate the battery.
CAUTION: Product recycling or disposal The product could be sent back to the manufacturer for recycling or proper disposal after their useful lives. 2.2 Symbols The following symbols may appear in this manual, on the Product, or on its accessories. Some of the symbols represent standards and compliances associated with the Product and its use.
Upward Specifies serial number of the Product LOT Number It indicates that the equipment should be sent to the special agencies according to local regulation for separate collection after its useful life. Type B applied part Ingress Protection. IPX4 Section 3: Getting Started This section presents information on unpacking the Product.
Product √ Recording Cable √ Headset √ Battery √ Carefully inspect each item as it is unpacked for any signs of damage which may have occurred during shipment. Check the components according to the packing list. Check for any damage or defects. Do not attempt to setup the Product if ...
The USB interface is used to connect recording Cable (NOTE: please refer to accessories). 4.5 Battery This device is internal powered. The power of MSLJB08 (mini) comes from a 9V alkaline battery (IEC type No. 6F22 or equivalent). Section 5: Operation procedure This section provides the description for operation.
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Open the battery cover, and install the 9V battery. Then, Install the battery cover. NOTE:You should push the battery cover backward like the figure upward. Then you can open the battery cover. Battery type: Alkaline battery 9V CAUTION: Remove the battery if the device is not likely to be used for some time.
5.1.5 Applying couple gel to the faceplate ( ) of probe or abdomen of pregnant woman. 5.2 Detecting 5.2.1 Find the fetal heart and listen the fetal heartbeat sound Locate the position of the fetus by hand touching, firstly to find out the best direction to the fetal heart.
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. 6.1 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.
6.2 Visual Inspection The product and its accessories should be carefully inspected prior to installation, once every 16 months thereafter and each time the equipment is serviced. Carefully inspect the equipment for physical damage Inspect all external connections for loose connectors or frayed cables. ...
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Recommended cleaning product: The following cleaning products may be used to clean the exterior surfaces of the Product as well as the batteries. Do not use abrasive cleaners or strong solvents such as acetone or acetone-based cleaners. Do not mix disinfecting solutions (such as bleach and ammonia) as ...
* Don’t use strong solvent, for example, acetone. * Never use an abrasive such as steel wool or metal polish. * 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.
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Product name: Fetal Doppler Mode: MSLJB08(mini) Safety: Complies with IEC 60601- 1, EN 60601- 1, EN60601-1-2, IEC 61266 Classification: Anti-electric shock type: Internal powered equipment Anti-electric shock degree: Type B applied part. Classification of protection against harmful ingress of water: Ordinary...
Suitable gestation: 16 gestational weeks or later, difference in pregnant mater. Physical Characteristic: Size: 104.5mm(length) * 50mm(width) * 70mm(height) Weight: 69.5g (only main unit, not including battery) Environmental Requirements: Operating Conditions: Temperature: 5C to 40C Humidity: 0 to 80% RH, non-condensing Atmospheric pressure: 86kPa to 106kPa Storage and Shipping Conditions: Temperature: - 20C to 55C(-4℉-131℉)...
battery Incorrect probe Locate the correct Low sensitivity position position Insufficient gel Add gel Appendix A EMC Information 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 DOCUMENTS.
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A 1.2 Electromagnetic Immunity The Fetal Doppler is intended for use in the electromagnetic environment specified below. The customer or the user of the Fetal Doppler should assure that it is used in such an environment. Immunity test Compliance Electromagnetic 60601 level environment guidance...
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a. Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range.
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A 1.4 Recommended Separation Distances Recommended separation distances between portable and mobile RF communications equipment and the Fetal Doppler. The Fetal Doppler is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Fetal Doppler can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Fetal Doppler as recommended below,...
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