Doppler Deluxe80 - Medical device Luvion - Free user manual and instructions

USER MANUAL Doppler Deluxe80 Luvion

EN - Instruction manual18 Attention: This user manual is written and compiled in accordance with the council directive MDD93/42/EEC for medical devices and harmonized standards. In case of modications and software upgrades, the information contained in this document is subject to change without notice. This user manual includes special documents, which under protection of copyright law. All rights reserved. Without written announcement from our company, the user manual should not be transferred, copied or translated into other language. Our company assumes no responsibility for incidental or consequential damage in connection with the furnishings, performance or use of this material. The information contained in this document is subject to change without notice.

MANUFACTURER’S RESPONSIBILITY

Our company only consider itself responsible for any eects on safety, reliability and performance of the equipment if: Assembly operations, extensions, readjustments, modications or repairs are carried out by persons authorized by Our company, and the electrical installation of the relevant room compiles with national standard, and the document is used in accordance the instruction for use. WARRANTY The unit can not be repaired by users themselves. All services must be done by the engineers approved by manufacturer. We warrant that each product we sell you is free from defects in labor and materials and shall conform to its product specications as dened in the user documentation. If the product doesn’t function as warranted during the warranty period, we will repair or replace it without charge. Misuse, improper maintenance may void the warranty.

Warning: This device is not intended for treatment. The intended use is

for clinical use.If the FHR result is distrustful, please use other methods such as stethoscope to verify immediately.19 SAFETY GUIDANCE To avoid any possible danger, please operate the instrument according to following safety guidance:

1. It is a precision instrument, Please don’t open it by yourself.

2. This instrument can be cleaned by non-corrosiveness cleanser,

please don’t disinfect this device with high-temperature or clean it with corrosiveness cleanser. The probe can be cleaned with 70% ethanol.

3. If this instrument non-use for a long time, please take out the battery

from instrument. The used battery should be disposable according to local law of environmental protection.

4. The instrument should be kept from violent concussion.

5. The instrument should be kept from water and humidity.

6. The service life of this instrument is 5 years. Proper maintenance can

prolong its service life.20 INTRODUCTION LUVION® Premium Doppler Deluxe-80 is a hand held equipment for inspecting Fetal Heart Rate(FHR) which is specially designed for family of pregnant women to conduct daily inspection of FHR by themselves. Pregnant women can operate by themselves to hear fetal heart sound and calculate FHR to re-alize the purpose of pre-monitoring and fetus caring. Main Features:

• The probe and main units integrated together.

• Delicate and compact design, portable to use.

• Particular 2 audio output socket design can let expectant mother and father hear the baby fetal heart sound at the same time.

• High sensitive doppler probe .

• Low ultrasound output intensity, much lower than the relative govern- ment standard, and with very high safe quality.

• Low power consumption, two AAA size batteries can last more than 6 hours for continuous use (depend on battery type and volume).

• Can connect to a computer or recorder to record the baby heart sound with recording Cable at the same time of monitoring fetal heart sound.

• LCD FHR Display with high accuracy.

• Screen will be locked automatically without signal for 15s, which is convenient for pregnant women to operate individually.21

1. Before the rst use, please open the battery cover, install two AAA

2. Plug headphone into the audio output socket.

3. Power ON: revolve the On-O / Volume Knob on the left side panel

upwards to power on the equipment, the LCD screen will display

4. Find the position of fetus: At rst, please feel the position of the fetus

by hand. Find out the best direction for inspecting the fetal heart. Apply a liberal amount of gel to the faceplate of probe; place the faceplate of probe at the best position for detecting fetal heart. Ad- just the probe to obtain an optimum audio signal ideally by angling the probe around. Adjust the volume according to requirements. Attention: Don’t adjust the knob to a very loud volume when you are trying to nd the fetal heart position.

5. FHR (fetal heart rate) calculation: the FHR is calculated when the

Doppler detects fetal heart sounds. The fetal heart signal symbol will then start to icker on the LCD screen. In addition, the heart rate (number of heart beats per minute) will be displayed on the screen.

6. After operation, revolve down the On-O / Volume Knob on the left

side panel to power o.

7. Use soft cloth to wipe o the gel left on the probe.23

SYMBOLS Symbol Description Type B product Attention Headset Volume switch ON/OFF Power ON/OFF Heart Rate MAINTENANCE The device is frangible and must be handled with care.Gel must be wiped from the probe after use. These precautions will prolong the life of the unit. The user must check that the equipment does not have visible evi- dence of damage that may aect patient safety or Pocket Fetal Doppler capability before use. The recommended inspection interval is once per month or less. If damage is evident, replacement is recommended before use. The device should undergo periodic safety testing to insure proper patient isolation from leakage currents. This should include leakage cur- rent measurement. The recommended testing interval is once every two years or as specied in the institution’s test and inspection protocol. The accuracy of FHR is controlled by the equipment and can not be adjusted by user. If the FHR result is distrustful, please use other methods such as stethoscope to verify immediately or contact local distributor or manu- facture to get help.24 PRODUCT SPECIFICATIONS Product name: LUVION Premium Doppler Model No.: Deluxe-80 Safety: Complies with: IEC 60601-1:1988~A1:1991~A2:1995 Classication: Anti-electroshock Type: Internally powered equipment. Anti-electroshock Degree: Type B equipment Harmful Liquid Proof Degree: Ordinary equipment (sealed equipment without liquid proof) Degree of Safety in Presence of Flammable Gases: Can not be used in area of re and gass. Worksystem: permanent EMC: Group I Class B Suitable Using Range: Suitable for use after the 12th week of pregnancy. Physical Characteristic: Size: (L)110mm × (W)55mm × (H)16.8 mm (the space between probe culmination and upper panel is 26mm) Weight: About 80g (including batteries) Environment: Working: Temperature: +5˚C + 40˚C Humidity: ≤ 80 % Atmospheric Pressure: 70 kPa ~ l06kPa Transport and Storage: Temperature: -10˚C + 55˚C Humidity: ≤93 % Atmospheric Pressure: 50 kPa ~ l06kPa Power Supply: 1.5V Battery ×2 (Size: AAA)25 LCD Display: 25×14 mm FHR Performance: FHR Measuring Range: 50~240BPM (BPM: beat per minute) Resolution: 1BPM Accuracy: ±2 BPM Power consumption:<0.8W Probe: Nominal Frequency: 2.0MHz Working Frequency: 2.0MHz±10% P-: <1MPa Iob<20 mW/cm2 Ispta: <100mW/cm2 Isata<5mW/cm2 Working Mode: Continuous wave Doppler Eective Radiating Area of Transducer: 208mm2±15%26

CLEANING AND DESINFECTION

Cleaning Before cleaning, switch o and take out the batteries. Keep the outside surface of the device clean and free of dust and dirt, clean exterior surface of the chassis with a dry, soft cloth. If necessary, clean the chassis with a soft cloth soaked in a solution of soap, or water and wipe dry with a clean cloth immediately. Note: Wipe the surface of probe with 70% ethanol , self-air dry, or clean with a clean, dry cloth. Desinfection

1. Don’t use strong solvent, such as acetone.

2. Never use an abrasive such as steel wool or metal polish.

3. Do not allow any liquid to enter the product, and do not immerse

any parts of the device into any liquids.

4. Avoid pouring liquids on the device while cleaning.

5. Don’t remain any cleaning solution on the surface of the device.

1. Never try to sterilize the equipment by low temperature steam or

2. Do not use high temperature sterilizing process and E-beam or

gamma radiation sterilization.27

SOLUTIONS FOR POSSIBLE PROBLEMS

If it appears below problems when you use the Baby Sound , please solve them as below: Problem Possible reason Solution Weak sound • Volume is to low

• Daub the gel Noise • Volume is to high

• Disturbance from the outside signal

• Keep far away from the outside signal Low sensitivity • Position of the probe is not correct

• Adjust the position of the probe

• Daub the gel28 SMALL TIPS Essentially of Fetal Domestic Monitor:Modern medicine think that, FHR is an important gist to identify fetal health, by recording FHR changes can observe fetal hypoxia, fetal distress and the umbilical cord around the neck, and other symptoms. Fetal domestic monitor test FHR rate changes by listening to fetal heart sound mainly; Fetal domestic monitor is a powerful guarantee to improve generational safety. Fetal heart rate changes most obviously in the following three periods:

1. within 30 minutes after pregnant women get up

2. within 60 minutes after pregnant women nish lunch

3. within 30 minutes before pregnant women go to bed