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Fetal doppler
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Table of Contents
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Fetal Doppler
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Product Information
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Table of Contents
- Section 1: Instruction
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Contact Information
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Indication for Use
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Product Description
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Operating Principle
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Contraindications for Use
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Adverse Effects
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- Section 2: Safety Guidance
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Safety Alert Descriptions
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Symbols
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- Section 3: Getting Started
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Unpacking an Inspecting
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Accessories
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Indicator
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Knob
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Socket
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Battery
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- Section 5: Operation Procedure
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Preparation
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Detecting
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Recording
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- Section 6 Preventive Maintenance
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Maintenance
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Visual Inspection
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Cleaning Product and Accessories
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Disinfections
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Recycle Batteries
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Authorized Repair Service
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- Section 7: Technical Specifications
- Appendix A Emc Information
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JPD-100S
INSTRUCTION MANUAL
Manual Version: V1.1
Issuing Date: 2012.11.2
（mini）
Fetal Doppler
0482
Table ofContents
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Table of Contents
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Summary of Contents for AngelSounds JPD-100S
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Page 1: Fetal Doppler
0482 JPD-100S （mini） Fetal Doppler INSTRUCTION MANUAL Manual Version: V1.1 Issuing Date: 2012.11.2... -
Page 2: Product Information
Shenzhen Jumper Medical Equipment Co., Ltd has right to revise all contents of this book if needed, without prior notice. Shenzhen Jumper Medical Equipment Co., Ltd reserves the right of final interpretation of this book. "ANGELSOUNDS" is the registered trademark of Shenzhen Jumper Medical Equipment Co., Ltd. - Page 3 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. WARNING: This alert identifies hazards that may cause serious personal injury or death.
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Page 4: Table Of Contents
Table of contents SECTION 1: INSTRUCTION ............1 1.1 C ..........1 ONTACT NFORMATION 1.2 I ............2 NDICATION FOR 1.3 P ..........3 RODUCT ESCRIPTION 1.4 O ............3 PERATING RINCIPLE 1.5 C .........4 ONTRAINDICATIONS FOR 1.6 A ............4 DVERSE EFFECTS SECTION 2: SAFETY GUIDANCE ..........5 2.1 S ..........5 AFETY ALERT DESCRIPTIONS... - Page 5 4.5 B ..............11 ATTERY SECTION 5: OPERATION PROCEDURE ......12 5.1 P ..............12 REPARATION 5.2 D ..............14 ETECTING 5.3 R ..............16 ECORDING SECTION 6 PREVENTIVE MAINTENANCE ......16 6.1 M ..............16 AINTENANCE 6.2 V ............18 ISUAL NSPECTION 6.3 C ......19 LEANING RODUCT AND CCESSORIES 6.4 D .............21...
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Page 6: Section 1: Instruction
tion 1: Instruction Become familiar with the controls and how to use the PRODUCT properly before operating the product. CAUTION: Federal law restricts this device to be sold by or on the order of a physician or practitioner licensed by state law in which he/she practices to use or order the use of the device. -
Page 7: Indication For Use
Email: rghtty@sbcglobal.net Email: info@jumper-medical.com 1.2 Indication for Use The AngelSounds Fetal Doppler JPD-100S (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. -
Page 8: Product Description
1.3 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). -
Page 9: Contraindications For Use
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 signal demodulate unit to get the Doppler frequency signal, and process the signal become the signal that can be heard by human using headset. -
Page 10: Section 2: Safety Guidance
Section 2: Safety Guidance This product is internal powered equipment, and the degree of shock protection is BF. 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. - Page 11 We recommend that exposure to ultrasound should be kept as low as reasonably achievable principle. This is considered to be good practice and should be observed at all time. WARNING: Aid healthcare professional tool The product should not be used in place of normal fetal monitoring.
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Page 12: Symbols
requirements of the system standard IEC 601-1-1. The Product Service Port is only intended for use during maintenance by authorized service personnel. CAUTION: Case Cleaning Solutions When disinfecting the case, use a non-oxidizing disinfectant, such as ammonium salts or a glutaraldehyde based cleaning solution, to avoid damage to the metal connectors. -
Page 13: Section 3: Getting Started
Authorized Representative in the European Community CE Mark: The Product system conforms to essential requirements of the Medical Device 0482 Directive 93/42/EEC. Date of manufacture. Manufacturer 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. -
Page 14: Accessories
The product is designed for simplicity of operation and set-up and requires minimal assembly. The following item is packing list: Item Quantity Packed or Unpacked Packing List √ Instruction Manual √ Main Unit √ Line-in Cable √ Headset √ Carefully inspect each item as it is unpacked for any signs of damage which may have occurred during shipment. -
Page 15: Indicator
The headset socket can be connected with headset. The USB interface is used to connect Line-in Cable (NOTE: please refer to accessories). 4.5 Battery This device is internal powered. The power of JPD-100S (mini) comes from a 9V alkaline battery (IEC type No. 6F22 or equivalent). -
Page 16: Section 5: Operation Procedure
Section 5: Operation procedure This section provides the description for operation. 5.1 Preparation Follow these recommendations to preparation for operation: 5.1.1 Install Battery Open the battery cover, and install the 9V battery. Then, cover the battery cover. NOTE： You should push the battery cover backward like the figure upward. - Page 17 WARNING: Irregular treatment of batteries may be result in hazards to health and environment. 5.1.2 Connect headset Before you practice the product, you should prepare an earphone or a headset to hear the fetal heartbeat sound. We will give you a headset as a present. It can help you to hear the fetal heartbeat sound when you have not bought an earphone.
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Page 18: Detecting
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. The position of the fetal heart in abdomen of pregnant woman you can contrast the figure below. - Page 19 Gestation Antepartum Parturition...
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Page 20: Recording
5.2.2 Calculate the fetal heartbeat rate Count the fetal heartbeat sound in one minute, the number you counted is the fetal heartbeat rate. Repeat count at least 3 times, you will get the range of fetal heartbeat rate. 5.3 Recording When you hear the fetal heartbeat sound, you can connect one socket with a headset, and another can connect with computer. - Page 21 responsibility for performing the recommended maintenance schedule. The sole responsibility rests with the individuals, hospitals, or institutions utilizing the product. The transducer acoustic surface is frangible and must be handle with care .Gel must be wiped off from the transducer after use. These precautions will prolong the life of the unit.
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Page 22: Visual Inspection
6.2 Visual Inspection The product and its accessories should be carefully inspected prior to installation, once every 12 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 ... -
Page 23: Cleaning Product And Accessories
WARNING: After the visual inspection, if the Product and/or its accessories are damaged please contact our Customer Service. The Product will need to be returned back to us for repair. The accessories should disposed appropriately replacement parts shall be ordered. 6.3 Cleaning Product and Accessories Listed below are recommendations for cleaning the Product and its accessories. - Page 24 unit with a dry, soft cloth .if necessary, clean it with a soft cloth soaked in a solution of soap and wipe dry with a clean cloth immediately. Wipe the transducer body with soft cloth to remove any remaining coupling gel .Clean with soap only Wring any excess moisture from the cloth before cleaning.
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Page 25: Disinfections
6.4 Disinfections Cleaning the unit surface and the transducer as the above mentioned, then wipe the surface of transducer with 70% ethanol or alcohol, clean the transducer surface with a dry, soft cloth. * Don’t use low temperature steam sterilization or other way to sterilize * Don’t use high temperature sterilizing process 6.5 Recycle Batteries The battery is recyclable. - Page 26 Product name: Fetal Doppler Mode: JPD-100S(mini) Safety: Complies with IEC 60601-1: 1990 + A1:1993 + A2:1995, EN 60601-1: 1990 + A1:1993 + A2:1995 + A13:1996, EN60601-1-2:2001, IEC 61266:1994 Classification: Anti-electric shock type: Internal powered equipment Anti-electric shock degree: Type BF equipment...
- Page 27 The acoustic coupling medium for normal use: ph: 5.5~8, Acoustic 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/USB interface Recommended battery type: 9V DC alkaline battery (IEC Type No. 6F22 or equivalent) Stand-by Time: >4hours Suitable gestation: 12 gestational weeks or later, difference in pregnant mater.
- Page 28 CAUTION: Environment of use Product is designed for indoor use. Operator must confirm that 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.
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Page 29: Appendix A Emc Information
Appendix A EMC Information A1.1 Electromagnetic Emissions The Fetal Doppler is intended for use in the electromagnetic environment specified below. The customer or the user of the Fetal heart monitor should assure that it is used in such an environment. Emissions test Compliance... - Page 30 Electrostatic ±6 ±6 Floors should discharge contact contact wood, concrete (ESD) ±8 ±8 kV air ceramic tile. If floors IEC 61000-4- covered with synthetic material, the relative humidity should be at least 30 %. A 1.3 Electromagnetic Immunity (not life-supporting) Doppler is intended for use in the electromagnetic environment specified The customer or the user of the Fetal Doppler should assure that it is used in environment.
- Page 31 power rating of the transmitter in watts according transmitter manufacturer and d is recommended separation distance in metres (m). Field strengths from fixed transmitters, as determined by an electromagnetic site survey, should less than compliance level each frequency range. b. Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range...
- Page 32 b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 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.
- Page 33 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.
- Page 35 Manufacture: Shenzhen Jumper Medical Equipment Co. Ltd. Address: 5th Floor Building No. 34, Baoyuan Industrial Zone, Xixiang Street,Baoan District, Shenzhen 518102,P.R. China Tel: 86-755-26696279/26692192 Fax: 86-755-26852025 Website: www.jumper-medical.com E-mail: info@jumper-medical.com...
