JUMPER SHA20 Fetal Doppler User Manual

User Manual for JUMPER models including: SHA20, SHA20 Fetal Doppler, Fetal Doppler, Doppler

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User manual

ShenZhen Jumper Medical Equipment Co.,Ltd SHA20 Fetal Doppler 2ADYL-SHA20 2ADYLSHA20 sha20

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User Manual
Fetal Doppler

Model: SHA20

Manual Version: 3.0 Issuing Date: 2024.4

Thank you for purchasing the Fetal Doppler made by Jumper Medical Before using the product, read this manual carefully and operate the product as specified in this manual.

SECTION 1: INTRODUCTION 1.1 PACKING LIST Main unit×1; Battery AA×2; Coupling agent×1Optional; User manual×1.
1.2 PRODUCT DESCRIPTION
The product is mainly used to detect the sound of the fetal heartbeat (SFH). Fetal heart rate (FHR) is important basis for checking whether a fetus is healthy. Recording the changes in FHR helps detecting signs of fetal hypoxia, fetal distress, fetal umbilical cord around neck, and so on. Fetal monitoring at home mainly includes listening to fetal heartbeat and checking FHR changes, which help greatly increase fertility safety.
1.3 OPERATING PRINCIPLE
Based on the Doppler's principle, a 3.0MHz ultrasonic probe is used to capture fetal heart signals from the belly of a pregnant woman. After signal processing of the backend circuit, Fetal heart signals are output to speakers to play sound.;audio signals are wirelessly sent by using the built-in Bluetooth module. A smartphone that has connected to the product receives the data and calculates and displays fetal heart rate information by using specified mobile phone software.
FCC ID:2ADYL-SHA20

SECTION 2: SAFETY GUIDANCE 2.1 INTENDED USE
The Fetal Doppler SHA20 is a hand-held, battery powered audio Doppler device used for detecting fetal heartbeats. The patient is an intended operator. 2.2 INDICATIONS FOR USE
The product is normally applied to fetus above 12 weeks growth, difference in pregnant mater.
Listen to SFH: Operator can listen to the sound of fetal heartbeat from the speaker.
Audio record: The sound of fetal heartbeat can be recorded by APP.
CAUTION: It should not be used in life supporting or life sustaining applications. 2.3 CONTRAINDICATIONS FOR USE The device has no side-effects if administered correctly and residual risk is acceptable. 2.4 NOTE FOR HOME USE
This device cannot replace a professional fetal monitor. If the fetal heart rate is abnormal or cannot be located by using this monitor, pregnant woman should immediately go to the hospital to seek the doctor's help. If fetal movement is not felt by the pregnant woman, immediately go to the hospital to seek the doctor's help. 2.5 SAFETY TERMS AND CONDITIONS
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. CAUTION: This alert identifies hazards that may cause minor personal injury, product damage, or property damage.
2.6 SAFETY ALERT DESCRIPTIONS
The following is a list of product safety alerts that appear in this section and throughout this manual. You must read, understand, and pay heed to these safety alerts before attempting to operate the product.
DANGER: Fire and Explosion Hazard Do not operate the product in the presence of flammable gases to avoid possible explosion or fire hazard. WARNING: Strangulation resulting from baby or child entanglement in monitoring cables. WARNING: Do not modify this equipment without authorization of the manufacturer. WARNING: Dust, light may affect the safety and performance of the instrument. WARNING: Degraded sensors and electrodes, or loosened electrodes, that can degrade performance or cause other problems. WARNING: The effects caused by pets, pests or children WARNING: Use only Approved Equipment Do not use batteries, gel, cables, or optional equipment other than those approved by manufacturer which may cause the product to function improperly during a rescue. WARNING: Adjacent and/or Stacked Equipment The Product should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Product should be observed to verify normal operation in the configuration in which it will be used. CAUTION: Check that the equipment does not have visible evidence of damage that may affect personnel's safety or examining capability before use. If damage is detected, replacement is recommended. CAUTION: The surface of the probe in contact with the patient may cause discomfort due to biocompatibility issues. The coupling agent may cause skin allergies in users. If the patient experiences any discomfort or allergic reactions, usage should be immediately discontinued and medical attention sought if necessary. CAUTION: Do not wrap the probe wire to avoid suffocation. CAUTION: Don't touch patient, power port ,and probe at the same time. CAUTION: This product is not recommended for use on ships and aircraft. CAUTION: Please keep the Fetal Doppler and batteries out of the reach of children to prevent them from playing with them. In the event that a child accidentally swallows a battery, seek immediate medical attention. 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 the local laws. To avoid fire and explosion hazard, do not burn or incinerate the battery. CAUTION: Possible Radio Frequency (RF) Susceptibility RF susceptibility from cellular phones, CB radios and FM 2-way radio may cause interference with the product. Do not operate wireless radiotelephones in the vicinity of the Product turn power OFF to the radiotelephone and other like equipment near the Product. CAUTION: Systems Statement Equipment connected to the product must be certified to the respective IEC Standards ( IEC 60601-1 for medical equipment). CAUTION: Case Cleaning Solutions

When disinfecting the case, use a non-oxidizing disinfectant, such as ammonium salts or glutaraldehyde based cleaning solution, to avoid damage to the metal connectors. CAUTION: Environment of use The 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. CAUTION:Do not use the device with HF surgical equipment.
2.7 SYMBOL DESCRIPTIONS 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.
Consult instructions for use of the product and/or its accessories.
Medical Device
Warning Information.
Authorized Representative in the European Community.
This product complies with the Regulation (EU) 2017/745 requirements.
Date of manufacture.

Manufacturer information.

type BF applied part

IP22

Specifies serial number of the Product
Batch code
The environmental protection use period is 5 years. Degree of protection against ingress of water and particulate matter. It indicates that the equipment should be sent to the special agencies according to local regulation for separate collection after its useful life.
Storage Temperature

Humidity

Atmospheric Pressure

SECTION 3: USING THE PRODUCT This section provides the description for operation.
3.1 PRODUCT STRUCTURE

1TFT Display

2Power/Mode button

3Volume up button 4Volume down button

5Ultrasonic probe

6Speaker

7Battery compartments

3.2 INTERFACE DISPLAY

1Bluetooth 3Battery indicator 5Ultrasonic frequency 7The curve of FHR

2Volume 4FHR 6Beat per minute

3.2.1 Power on/off

Power on: Press and hold button for about 2s and the screen lights up,

and the device is powered on. In power on state, short press button to

switch the display mode.

Power off: In the power-on state, press and hold

button for about 2s, the

screen goes out, and the device is powered off.

3.2.2 Volume adjustment button

While monitoring, the volume increases by press "+" button, and the volume

decreases by press "-" button. There are 7 volume levels.

3.2.3 Icons

: In curve mode, when a heartbeat is detected, the fetal heartbeat symbol

will light up and flash with the heart rate. In value mode, this symbol signifies

the quality of the detected fetal heart signal. Three stars represent the best

signal quality, while zero stars indicate that no fetal heartbeat signal was

detected. It is important to follow the correct method to locate the optimal

fetal heart position.

: The number next to the volume symbol indicates the volume and can be

adjusted from 0-7.

: When the icon displays in red , it means that the battery is about

to run out and needs to be replaced in time.

: The bluetooth icon is green when the bluetooth is connected, and is white

when disconnected.

3.3 USING PRODUCT TO DETECT
Locate the position of the fetus by hand touching, firstly to find out the best direction to the fetal heart. Place the faceplate of probe at the best position for detecting fetal heartbeat. Adjust the transducer to obtain an optimum audio signal ideally by angling the transducer around. Generally, 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 fetuses. Please make sure that the surface of the probe should be fully contacted with the skin. After the sound become clear, it is the proper functioning. If no coupling gel, water can be used. Note: The normal range of fetal heart rate is 110 bpm-160 bpm. During measurement, values are displayed in white within the normal range and in red when they are out of range.

3.4 CONNECTING THE INSTRUMENT TO THE SMARTPHONE VIA BLUETOOTH
Software Downloading: 1.Download and install the mobile phone APP software "JUMPER Health" by scanning the QR code on the packing box or searching for the APP in application stores such as APP Store/Google Play. 2.This software supports IOS 7.0 and later versions, and Android 4.3 and later versions. In addition, hardware of the smartphone needs to support Bluetooth 4.0. Bluetooth connection: Start "JUMPER Health" on the smartphone, turn on the smartphone's Bluetooth function to search for the Bluetooth signal and pair the device. Software Usage: Detailed see software operation manual of JUMPER Health.
SECTION 4: MAINTENANCE & CLEANING AND DISINFECTION
4.1 MAINTENANCE
4.1.1 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. 4.1.2 To ensure the product is always functional when required, the following maintenance shall be performed. Visual Inspection Clean the product and its accessories Check the battery fuel gauge Test product performance Remove the battery if it is not used for a long time. The product requires no calibration. Note: No service and maintenance while the equipment is in use. Manufacturer will make available on request circuit diagrams, component part lists, descriptions, calibration instructions ,or other information that will assist to service personnel in parts repair.
4.2 CLEANING PRODUCT AND ACCESSORIES
The following cleaning products may be used to clean the exterior surfaces of the product. Isopropyl alcohol (70% solution in water) Mild soap and water Sodium hypochlorite (chlorine bleach) (3% solution in water). Quaternary ammonium compounds (such as Lysol) (10% solution in water). WARNING: Do not use abrasive cleaners or strong solvents such as acetone or acetone-based cleaners. WARNING: Do not use mixing disinfecting solutions (such as bleach and ammonia) as hazardous gases may result. WARNING: Do not use acid, alkaline, or corrosive detergent. WARNING: Do not clean electrical contacts or connectors with bleach.
4.3 CLEANING INSTRUCTIONS
1. Before cleaning the product, turn off the product. 2.Before cleaning, remove all adherent soil (tissue, fluids, etc.) and wipe thoroughly with a cloth dampened with water before applying the cleaning solution. 3.When cleaning, do not immerse. Keep the exterior surface of the device clean and free of dust and dirt, clean exterior surface of the 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.
CAUTION: To prevent damage to the product, do not clean any part of the Product or Accessories with phenolic compounds. Do not use abrasive or flammable cleaning agents. Do not steam, autoclave, or gas-sterilize the Product or accessories.

CAUTION: Cleaning liquids: do not submerge the product in liquids or pour cleaning liquids over, into or onto the product.
4.4 DISINFECTION Cleaning the unit surface and the transducer as the above mentioned, then wipe the surface of transducer with 75% ethanol or alcohol, clean the transducer surface with a dry, soft cloth. WARNING: Don't use low temperature steam sterilization or other way to sterilize. WARNING: Don't use high temperature sterilizing process. After cleaning or disinfection, check if the Doppler function well. If any problem is detected, please contact the manufacturer for service before reusing them. Visual CheckCheck if the Doppler probe and host are damaged Function Check 1. Check if the Doppler can be switched on or off properly; 2. Check if the TFT works normally; 3. Rub the surface of the probe with your hand to check if the Doppler is producing sound properly

SECTION 5: SPECIFICATIONS & TROUBLESHOOTING 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.

Technical Specifications

Acoustic working frequency: 3.0MHz±5%

Overall sensitivity (200 mm off the probe surface): not lower than90 dB

Spatial-peak temporal-peak acoustic pressure: < 0.1 Mpa

Ultrasound output power: 20mW

FHR display range: 50 210 bpm

Resolution: 1 bpm

Precision: ± 2 bpm

Curve display range: 90 190 bpm

Battery: AAx2

Work mode: continuous (The device can work continuously for over 4 hours) Dimension: 142.6mm x 40.5mm x 42.5 mm

Weight: 130± 5 g

Ultrasound coupling agent requirement: density = 1.0g/cm2; speed 1.7m/s; impedance 1.7×105g/cm2.s; attenuation 0.02dB/mm

P_ < 1MPa; Iob < 20 mW/cm2; Ispta < 100mW/cm2 Manufacturing date: See the label.

Device life expectancy: 5 years

Waterproofing grade: IP22 Safety type: Internally powered equipment, type BF applied part

Software version:1.0
Operation conditions: Temperature: 5C to 40C; Humidity 80%RH; non-condensing Atmospheric pressure:70kpa to 106kpa

Transportation & Storage conditions: Temperature: -20C to 55C; Humidity:10%RH 93%RH; non-condensing Atmospheric pressure:50kpa to 106kpa; indoor ventilated place that has no corrosive gas
Equipment heating time -the time required for the equipment to warm from the minimum storage temperature between uses until it is ready for intended use: 30min. -the time required for the equipment to cool from the maximum storage temperature between uses until it is ready for intended use: 30min. 5.2 Troubleshooting

Symptom

Possible cause

Troubleshooting

Power-on failure Low battery

Charge the instrument

Symptom

Possible cause

Troubleshooting

No sound

Low volume Low power

Increase the volume Replace the battery

Fetal heart cannot be found

Low volume The coupling agent is not coated

Increase the volume Coat the coupling agent or water

Low sensitivity

Incorrect probe location The coupling agent is not coated

Adjust the probe location Coat a proper amount of coupling agent

Bluetooth

Bluetooth on

Manually turn on the

connection

phone is not turned Bluetooth function of the

failed

mobile phone

EMC Information

1* WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally." 2* WARNING: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation." 3* WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the ME equipment, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result."

Table 1

Emissions test RF emissions CISPR 11

declaration - electromagnetic emission Compliance Group 1

RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions IEC 61000-3-3
Table 2

Class B Not applicable Not applicable

Immunity test

declaration - electromagnetic immunity IEC 60601 test level

Electrostatic discharge (ESD) IEC 61000-4-2

±8 kV contact ±2 kV, ±4 kV, ±8 kV, ±15 kV air

Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power frequency (50/60 Hz)

± 2 kV for power supply lines ± 1 kV for input/output lines
± 0.5kV, ± 1 kV line(s) to lines ± 0.5kV, ± 1 kV, ± 2 kV line(s) to earth 0 % UT; 0.5 cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270°and 315° 0 % UT; 1 cycle and 70 % UT; 25/30 cycles Single phase: at 0° 0 % UT; 250/300 cycles 30 A/m

Compliance level ±8 kV contact ±2 kV, ±4 kV, ±8 kV, ±15 kV air
Not applicable
Not applicable
Not applicable
30 A/m

magnetic field IEC 61000-4-8
NOTE: UT is the a.c. mains voltage prior to application of the test level.

Table 3

Immunity test Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3

declaration - electromagnetic immunity

IEC 60601 test level

Compliance level

Not applicable

0.15 MHz to 80 MHz

6 V in ISM bands between 0.15

MHz and 80 MHz

10V/m

80 MHz to 2.7 GHz

Table 4

declaration - IMMUNITY to proximity fields from RF wireless

communications equipment

Immunit

IEC60601 test level

y test

Test

Modulation Maxi Immun

frequency

mum

ity

powe

level

Radiated

385 MHz

**Pulse

1.8W

Modulation

V/m

IEC

: 18Hz

61000-4-

450 MHz

*FM+ 5Hz

deviation:

V/m

1kHz sine

710 MHz

**Pulse

0.2

9 V/m

745 MHz

Modulation

780 MHz

: 217Hz

810 MHz

**Pulse

870 MHz

Modulation

V/m

930 MHz

: 18Hz

1720 MHz

**Pulse

1845 MHz

Modulation

V/m

1970 MHz

: 217Hz

Com plian
ce level
27 V/m
28 V/m
9 V/m
28 V/m
28 V/m

2450 MHz

**Pulse

Modulation

V/m

: 217Hz

5240 MHz

**Pulse

0.2

9 V/m

5500 MHz

Modulation

V/m

5785 MHz

: 217Hz

Note* - As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case. Note** - The carrier shall be modulated using a 50 % duty cycle square wave signal. FCC Statement This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: -- Reorient or relocate the receiving antenna. -- Increase the separation between the equipment and receiver. -- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. -- Consult the dealer or an experienced radio/TV technician for help. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:

(1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.
* RF warning for Portable device: The device has been evaluated to meet general RF exposure requirement. The device can be used in portable exposure condition without restriction. IC STATEMENT This device contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canada's licence-exempt RSS(s). Operation is subject to the following two conditions: (1) This device may not cause interference. (2) This device must accept any interference, including interference that may cause undesired operation of the device
SECTION 6: CONTACT INFORMATION 6.1 Ultrasound Intensity and Safety 6.1.1 Ultrasound in Medicine
The use of diagnostic ultrasound has proved to be a valuable tool in medical practice. The ultrasound output of the device is controlled internally and cannot be changed by the user during the inspection process. Although no confirmed bioeffects on patients caused by exposure from present diagnostic ultrasound equipment have ever been reported, the potential exists that such bioeffects may be identified in the future. Therefore, the ultrasound should be used prudently. High levels of acoustic output and long exposure time should be avoided while acquiring necessary clinical information.
6.1.2 Explanation of MI/TI 6.1.2.1 MI (Mechanical Index)
When ultrasound waves penetrate and contact tissues, cavitation effects may occur, causing local instantaneous high temperatures. The occurrence of this effect depends on various factors and has a threshold phenomenon. Currently, there are no reports of harmful mechanical effects from human use of ultrasound diagnostic equipment, and the threshold for cavitation effects is unclear. As the peak sound pressure of ultrasound waves increases, the occurrence rate of mechanical effects increases, but decreases with increasing frequency. The American Institute of Ultrasound in Medicine and the National Electrical Manufacturers Association have established the Mechanical Index (MI) to characterize the probability of ultrasound mechanical effects.
6.1.2.2 TI (Thermal Index)
Heating of tissues is caused by absorption of ultrasound when the ultrasound energy is applied. The temperature rise is determined by the acoustic intensity, exposed area and thermophysical properties of the tissue. According to different thermophysical properties of the tissue, TI is divided into three kinds: TIS, TIB and TIC. TIS (Soft Tissue Thermal Index): It provides an estimate of potential temperature rise in soft or similar tissues. TIB (Bone Thermal Index): It provides an estimate of potential temperature rise when the ultrasound beam passes through soft tissue and a focal region is in the immediate vicinity of bone. TIC (Cranial Bone Thermal Index): It provides an estimate of potential temperature rise in the cranial bones or superficial bones.
6.1.3 Ultrasonic output limitation
The acoustic output parameter meets the provision freedom from publication in IEC 61157 Requirement for the declaration of the acoustic output of medical diagnostic ultrasonic equipment: Pr<1MPa; the output power divided by the 12dB output beam area is not less tan 20mW/cm2; Ispta<100mW/cm2. Note: For all equipment settings, the thermal index and mechanical index are less than 1.0.
6.2 Statement:
The lay operator or lay responsible organization should contact the manufacturer or manufacturer's representative on the following issues Assistance in setting up, using, or maintaining the equipment or system when needed.

Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authorities of your Member State. 6.3 Manufacturer ManufacturerShenzhen Jumper Medical Equipment Co., Ltd Address: D Building, No. 71, Xintian Road, Fuyong Street, Baoan,Shenzhen,Guangdong,China ,518103 Tel: +86-755-26696279 E-mail: info@jumper-medical.com Website: www.jumpermmed.com
www.jumper-medical.com 6.4 Authorized European Representative
MedPath GmbH
Mies-van-der-Rohe-Strasse 8, 80807 Munich, Germany
FCC This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: -- Reorient or relocate the receiving antenna. -- Increase the separation between the equipment and receiver. -- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. -- Consult the dealer or an experienced radio/TV technician for help. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment * RF warning for Portable device: The device has been evaluated to meet general RF exposure requirement. The device can be used in portable exposure condition without restriction.
Shenzhen Jumper Medical Equipment Co., Ltd D Building, No. 71, Xintian Road,Fuyong, Street,Baoan,Shenzhen,Guangdong,China,518103 Tel: +86-755-26696279 E-mail: info@jumper-medical.com Website: www.jumpermmed.com
www.jumper-medical.com

References

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