Babytone P600L Baby Heartbeat Monitor User Manual

Babytone P600L Baby Heartbeat Monitor

Warnings and Symbols

Warnings

• Before using the device, carefully examine the Fetal Doppler [hereinafter ca lied device) and the accessories to ensure the main unit and accessories do not have any visible damage evidence that may affect patient safety and device performance. The recommended examination period is once per week.

• The device is not feasible to use in the environment with electrical surgical equipment.

• The d evl ce Is used for fetal heart rate test, and not Intended for any treatment. If the test FHR result is useless, please try to test by other clinical test methods.

• Installment, adjustment, maintenance and reparation can be carried out cnly by qualified or authorized personnel from manufacturer.

• The device uses very low power ultrasound doppler. It Is confirmed by design calculation, laboratory test, clinical test and cllnlcal application the device doppler energy is safe for fetus, pregnant women and other personnel. Even so, it is not appropriate to use the device continuously or with long term .

• Before using the devfce, please rEad this manual carElully andassure to be familiar with the controls, displays, features and operating techniques.ManufacturE and dealer will not be responsible
  for any abnormal fault or safety accident caused by Incorrect operation.
  • This device Is not explosion-proof and can not be used In the presence of f\arr,mable anaesthetics equipment.
  • Do net throw battery lntc fire as this may explode and cause danger.

• Do not touch signal input/output connector and the patient simultaneously to avoid device damage.

• The device is a tool to aid the FHR inspection and should not be used ln place of normal fetal monitoring.

• The device is designed for continuous operation and is ordinary.

• Do not immerse in any liquid (i.e. n<:>t drip or splash-proof).

• Keep the device clean. Avoid vibration.

• Do not use high temperature sterilizing process and E-beam or g;,m ma radiation sterilization.

• The device is not subject to any sources of strong electromagnetic interfere nee, such as radio transmitters and mobile telephones because of electromagnetic interference.

• The user must check that the equipment dces not have visible damage that may affect patient safety <:>r monitoring capability before use. The recommended inspection interval is once per month or less. II damage is evident, replacement is rerommended before use.

• The device can not be used when some equipment are used, such as high frequency electrlcal senerator, microwave oven.

• Do not use the device In the presence of flammable anesthetic mi><ture with oxygen or other flammable agents,

• The device is feasible for relatives such as operator, rEsponsible organization and environmental restriction, which do not need special skills, training and knowledge. This operation manual is written at a level without special education, training and other needs of individual for whom they are intended. For using in hospital and clinic, the operator needs to have relative qu alifkation certificate such as nurse certificate. For using at home, when the test data are used to diagnose, it should be analyzed by speclallzed medical wcrkins person.

• This minimum qualincatlons of service personnel Is to be familiar with our device operation and service technique.

• The suitable environment is not for that for near active HF SURGICAL EQUIPMENT and the RF shielded room.

• Use of this equipment adjacent to or stacked with other equipment shou Id be avoided because It could result In Im pro per operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

Cautions

• The battery must be properly disposed accordlns to local regu latl on alter use.
• Please use the adapter according relevant nationa I standard, do not use the device when charglns.
• The TnformatJon In this manual Is subject to modify without notice.
• The device usage life is 3 years, after whkh please treat acrording to relative local resulations.
• Do not use strong solvent (for example, acetone) and abrasion material to clean the device,
• Do not allow any liquid to enter the device, and do not immerse any parts of the device into any liquids.
• Please choose the accessories and expendable authorized by manufacturer.
• Never try to sterilize the probe or euipment by low temperature steam or other methods.
• Pay attention tc u ltrasonJc output safety, practice AL.ARA principle (As Low as Reasonably Achievable), apply as low as possible emission power to achieve satisfying exam result .Extra unnecessary ultrasonic output may Increase risk of biological effects. You must always take responsibility for the safety cl your patient,

Symbols

Introduction

The device is high performance fetal heart rate detector which satisfies the requirement of hospital, dinic, community and home FHR eKamination. The devicelt is an all-in-one machine composed of probe and main unit.

Product Features

• Cclor display
• Build-in speaker
• Curve display
• Auto power off
• Volume Adjustment
• Bluetooth

Intended Use

• The device Is used to detect the fetal heart rate •
• It’ s not a medical device and should not be used for any medical
• purpose or any medical rondition • This product is intended only for general wellness use,

Appearance

LED Display

The explanation of display content

Basic Operation

Preparing to Use

• Carefully check if the device has any damage and if the accessories are integrated. If so, please contact distributor. Keep the package for future transportation or st<:>rage,

Charge

1. First time use the device or after long ti me no use, sha II charge for the device, please use charser with specification <:>f DC 5V input .

2. Insert the Type-C inlet into the charging socket on maln unlt.(When
   the power is low,battery icon a on _, ___.
   the display screen will flick to prompt charging, icon flicking when the device is being charged);

3. After charging is completed, <B icon will light on, you can
   unplug the charging cable,and remove the charger from power sockt.

Power on/off
Power on:Long press the power O key, the display screen will enter test interface “D” after boot screen. Power off, Long press the 0 key for 3s under power on state.

Download and Use the App
Download App: Vi Health ros, App Store  Android: Google Play When using the Heart Monitor, run App to connct Monitor via Bluetooth. App will record your fetal heart rate and sound. You can also review/share your history data in App.

Inspecting and Recording

Inspecting FHR

1. We advise you to follow the below steps to start measure FHR. Q) Pregnant woman stays happy, Lie flat or en your back;
2.  Daub ultrasonic gel on the probe face plate to decrease noise and boost up test result;
3. Long press the power button cf fetal heart monitor to power 00.
4. Touch the abdomen of pre11nant woman to confirm the general position of fetus_

Note:

1. I.Early pregnancy ( Before 20 weeks)
2. Pregnant metaphase(20-32 weeks)
3. Late pregnancy [32-40 weeks)
4. Put the probe against pregnant women abdominal wall, move slowly within the scope cf the fetu> location, until hear clearly and rhythmic cardiac sound and see a stable heart rate value.
5.  Adjusting Volume :When device Is working, you can adjust volume by pressing Up or Oown key to adjust volume.

CAUTIONS

• Do not compress probe too tightly an abdomen surface tc avoid to weaken •ignal.
• When searching for the fetal heartbeat, do not pull the probe on the abdominal surface to avoid the noise.
• Do not put the probe en the position where there Is strons Placental lllood Sound or strong umbilical Sound.
• Do not mistake mother’s heart rate as FHR.
•  Do not wear glov,,s to operate buttons of this device,if there are water and ultrasonic gel on your fingrs ,please wash your hand lir.t,ctherwise it maybe affect inspection effect.
  NOTE: Do not measure FHR unless audible and identifiable fetal sound has been heard, usually it needs 5 seconds.The normal value of the fetal heart rate is 120-I50hpm. 100-120bpm and 150-ll!Obpm are the critical values which should be paid some attention to. And lower than lOObpm and mrr,ore than 180bpm are danger values which shculd be paid more attention to.

Attachment: different gestation period fetal position reference
Due to the fetus in the womb mobile at any time, the position of the heart Is not fixed, you can refer to the following different gestation period at the end of uterine height to determine the  scope of the fetus is roughly:

CAUTIONS

• The probe should be placed in the best position to achieve high quality detection signa L
• Unless clear ca rd iac sound signals are detected, otherwise can’t set the right heart rate; When calculating the heart rate and cardiac sound of the beat is inconsistent, the auscultation cardiac sound results shall prevail.
• When extend the dtection time, pay attention to prevent pregnant women of low bleed pressure. At this time can be prEsnant women pillow high head, high or leg pad.
• On access to the pregnant woman body, when using ultrasonic transducer may be a slight warming(not more than 20″C) than the surrounding temperature.
• On but not tome into contact with pregnant women, the ultrasonic sensor may be a slight warming (net more than s O c::) than the environment• I temperature.

End FHR inspect and shutdown
After ending FHR inspection, long Press the power button to power off. II n<:> any operation within 1 minute, this monitor will auto  power off.Please use clean soft cloth or tissue to wipe the remaining  gel an the abdomen and surface of the probe.

Cleaning and Disinfecting

Cleaning
BeforE clean I n11 the device, swltch off th Is devlce ; Lise a soft cloth to wipe up the ultrasonic gel on the probe Keep the outside surface of the device clean and free of dust and dirty, clean erte rlor surface with a dry, soft doth (in dude LCO display screen). If necessary, clean the chassis with a soft cloth soaked in a soluti <:>n <:>f soap, or alcohol and wipe dry with a clean cloth immediately.

Disinfecting

• Each time before and after use,wlpe the equipment enclosure surlace(lncludlng LCD display screen) with an alcohol Impregnated soft cloth (75% ethanol or 10% isopropanol),then use clean soft cloth to wipe dry at once.
• Wipe the probe with a clean, dry cloth to remove any remaining ultrasound gel.and wipe with an alcohol impregnated soft cloth (75% ethanol or 70% isopropanol),then use dean soft cloth to wipe dry at once or air drying,

Warning

• Do not use acetone and other strong solvent to dean .
• It is prohibited to use abrasive materlal.s (such as steel wool er silver polish).
•  The waterproof degree of this device is IPXI, only provide
• Do not remain any cleaning fluid on the surface of the instrument.

Maintenance

• Before each use, must check whether equipment may affect their safety or instrument performance obvious damage. If any darr,age was found, please make the necessary repairs or replacement.
• This device is precision instruments, must be handled with sreat care. Instruments must be wiped after use of the excess of ultrasound gel on the ultrascnlc probe- The maintenance measures will extend the service life of equipment.
• Production date see label, expected life span Is 3 years (life only ma In u n lt, exclud Ing replaceable parts, and accessories).
• Manufacture wi II provide circuit diagram and other information in the user request , to help users to maintain the instrument parts which classified as electricity user maintenance of instrument parts by Manufacture, maintenance shculd be conducted by qualified technical personnel.

Troubleshooting

When using, ii 1t appears fol lowing problems, please treat by following instruction. If fa i I to treat, please contact customer service personnel.

Warranty and After-sale Service

Dear Customer,
Thank you for choosing cur product. Our company guarantees the new Instrument on the material and technological qualification for this product within 1 year (12 months) since the purchasing day, whlle consumables are not Included In the guarantee . Within the warranty period, Any equipment parts which break down caused by materials or product technology.we will repair or replace for free.
This warranty is inapplicable to the products undergoing any modifications, disassembles, refittings <:>r self-repai rings without the permission of our company. We’re not responsible of the products damased by accidents such as fire, thunder and lightning, flood and other disasters, intentiona I damage,improper installation, and improper usage.

After-sale Service
If you have any questions of use, maintenance, technical specifications or malfunction of device, please contact us.
Website: www.mybabytone.com

FCC Warnning:

Any Changes or modifications not expressly approvd by the party responsible for compliance could void the user’s authority to operate the equipment.
This device complies with part 15 of the FCC Rles. 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.
Note: 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 reucnable protection against ha rmfu I 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 interfurence to radio communications. However, there is no guarantee that interfurence wi 11 not occur in a particular installation. If this equipment does cause ha rmlul interference to radio or televlsion reception, whlch can be determined by turnln11 the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures,

• Reorient er relocate the recelvl ng antenna.
• Increase the separation between the eq ulpment 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 rad lo/TV tech nldan for help. The device has been evaluated to meet general RF exposure requirement. The device can be used in portable exposure condition without restriction.

Manufacturer
LEPU ZHIXIN MEDICAL TECHNOLOGY(TIANJIN)CO.,LTD
Room 1-301, building, LI Gang zone, Industrial park, Shuang Gang Town, Jinn a District, Tianjin
www.mybabytone.com

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