GIMA Colour Screen Pocket Doppler User Manual

Colour Screen Pocket Doppler

PROFESSIONAL MEDICAL PRODUCTS

Gima S.p.A. Via Marconi, 1 – 20060 Gessate (MI) Italy gima@gimaitaly.com – export@gimaitaly.com www.gimaitaly.com

DOPPLER PORTATILE CON SCHERMO A COLORI COLOUR SCREEN POCKET DOPPLER ÉCRAN PORTATIF COULEUR DOPPLER PANTALLA DE COLOR PORTÁTIL DOPPLER MONITOR A CORES DETECTOR DOPPLER DE BOLSO FARBBILDSCHIRM-TASCHENDOPPLER

Manuale d’uso – User manual – Manuel de l’utilisateur Guía de uso – Guia para utilização Gebrauchs- und instandhaltungsanleitung

ATTENZIONE: Gli operatori devono leggere e capire completamente questo manuale prima di utilizzare il prodotto. ATTENTION: The operators must carefully read and completely understand the present manual before using the product. AVIS: Les opérateurs doivent lire et bien comprendre ce manuel avant d’utiliser le produit. ATENCIÓN: Los operadores tienen que leer y entender completamente este manual antes de utilizar el producto. ATENÇÃO: Os operadores devem ler e entender completamente este manual antes de usar o produto. ACHTUNG: Diese Anleitung muss vor dem Einsatz des Produkts aufmerksam gelesen und vollständig verstanden werden.
29480 / Sonoline C
CONTEC MEDICAL SYSTEMS CO., LTD No.112 Qinhuang West Street, Economic & Technical Development Zone, Qinhuangdao, Hebei Province, PEOPLE’S REPUBLIC OF CHINA Made in China
Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537 Hamburg, Germany

0123

M29480-M-Rev.1-10.19

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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 modifications and software upgrades, the information contained in this document is subject to change without notice. The manufacturer makes no warranty of any kind with regard to this material, including, but not limited to the implied warranties of merchantability and fitness for a particular purpose. The manufacturer assumes no responsibility for any errors that may appear in this document, or for incidental or consequential damage in connection with the furnishing, performance or use of this material. No part of this document may be photocopied, reproduced or translated to another language without prior written consent of the manufacturer. The information contained in this document is subject to change without notice. Responsibility of the Manufacturer The manufacturer only considers itself responsible for any effects on safety, reliability and performance of the equipment if: Assembly operations, repairs are carried out by persons authorized by the manufacturer, and the device is used in accordance with the instructions for use.

WARNING: This device is not intended for treatment. The intended use is for detecting Fetal Heart Rate. If the fetal heart rate (FHR) result is distrustful, please use other methods such as stethoscope to verify immediately. 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 specifications as defined 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. Using This Label Guide This guide is designed to give key concepts on safety precautions.
WARNING: A WARNING label advises against certain actions or situations that could result in personal injury or death.
CAUTION: A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure. Note: A NOTE provides useful information regarding a function or procedure.

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Chapter 1 SAFETY GUIDANCE
This unit is internally powered equipment and the degree of shock protection
is type CF applied part . Type CF protection means that these patient
connections will comply with permitted leakage currents, dielectric strengths of IEC 60601-1. WARNING and CAUTION messages must be observed. To avoid the possibility of injury, observe the following precautions during the operation of the device.
WARNING: This device is not explosion-proof and can not be used in the presence of flammable anaesthetics. WARNING: Do not throw batteries in fire as this may cause them to explode. WARNING: Do not attempt to recharge normal dry-cell batteries, they may leak, and may cause a fire or even explode. WARNING: Don’t touch signal input or output connector and the patient simultaneously. WARNING: Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards (e.g. IEC 950 for data processing equipment and IEC60601-1 for medical equipment). Furthermore all configurations shall comply with the valid version of the system standard IEC60601-1-1. Everybody who connects additional equipment to the signal input connector or signal output connector configures a medical system, and is therefore responsible that the system complies with the requirements of the valid version of the system standard IEC 60601-1-1. If in doubt, consult our technical service department or your local distributor. WARNING: Pocket Fetal Doppler is a tool to aid the healthcare professional and should not be used in place of normal fetal monitoring. WARNING: Replacing battery shall only be done outside the patient environment (1.5m away from the patient). CAUTION: The device must be serviced only by authorized and qualified personnel. CAUTION: The main unit is designed for continuous operation and is `ordinary’. Do not immerse in any liquid (i.e. not drip or splash-proof). CAUTION: Keep the device clean. Avoid vibration. CAUTION: Do not use high temperature sterilizing process and E-beam or gamma radiation sterilization. CAUTION: Electromagnetic Interference-Ensure that the environment in which the device is operated is not subject to any sources of strong

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electromagnetic interference, such as radio transmitters, mobile telephones, etc. Keep them far away. CAUTION: The user must check that the equipment does not have visible evidence of damage that may affect patient safety or monitoring capability before use. The recommended inspection interval is once per month or less. If damage is evident, replacement is recommended before use. CAUTION: The following safety checks should be performed once every two years or as specified in the institution’s test and inspection protocol by a qualified person who has adequate training, knowledge, and practical experience to perform these tests. · Inspect the equipment for mechanical and functional damage. · Inspect the safety relevant labels for legibility. · Verify that the device functions properly as described in the instructions for use. · Test the patient leakage current according to IEC 60601-1: Limit: 10 uA (CF). The leakage current should never exceed the limit. The data should be recorded in an equipment log. If the device is not functioning properly or fails any of the above tests, the device has to be repaired. CAUTION: The battery must be properly disposed: The battery must be properly disposed according to local regulation CAUTION: The device shall only be used if the battery cover is closed. Battery must be stored in cool and dry piace. If use rechargeable battery, to insure capability and life, please fully charge batteries before first use, normally, batteries must be continuously charged over 14 hours or charged according to the guidance displayed on the battery. CAUTION: Please don’t set anode and cathode of the battery wrongly. CAUTION: The valid period of this product is five years. After the service life, please return the products to the manufacture or disposeal the products according to local regulations. When cleaning the machine: CAUTION: Don’t use strong solvent, for example, acetone. CAUTION: Never use an abrasive such as steel wool or metal polish. CAUTION: Do not allow any liquid to enter the product, and do not immerse any parts of the device into any liquids. CAUTION: Avoid pouring liquids on the device while cleaning. CAUTION: Don’t remain any cleaning solution on the surface of the device.

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When disinfecting the machine: WARNING: Never try to sterilize the probe or equipment by low temperature steam or other methods.

Refer to accompanying documents.

Chapter 2 INTRODUCTION 2.1 Overview
Pocket Fetal Doppler is a hand-held obstetrical unit, which can be used in hospital, clinic and home for daily self-check by pregnant woman. The device uses color LCD of high resolution to display the fetal heartbeat waveform, and figure out the FHR to help the doctor diagnose in time. It contains components of ultrasonic signal transmitter and receiver, analog signals processing unit, FHR calculating unit, LCD display control unit etc. It has 3 work modes: real- time FHR display mode, averaged FHR display mode, and manual mode. It also has audio output, and can be connected with earphone or recorder with audio input.
2.2 Features
· Beautiful shape, portable, easy operation. · The probe has bending structure which is easy to operate and can increase
the ease of the pregnant women, embodies the human care design. · Fetal heart rate values, bar graph and heartbeat waveform color screen
display. · Alarming in red when the fetal heart rate range is out of the norma! range. · Battery status indicator. · The probe can be changeable. · Probe inspection. · Built-in speaker. · Output for headphone. · Auto shut off. · Two pieces of standard 1.5V alkaline battery available which can work no less
than 8 hours.

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Chapter 3 OUTLOOK AND CONFIGURATION

LCD
Mode Button Power Button

Start/Stop Button Probe

Fig. 3-1 Front Panel

Fig. 3-2 Rear Panel

Speaker Battery Compartment

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Headphone

Fig. 3-3 Top Panel

Headphone Socket

3.1 Display
The LCD display is as follows: Probe Nominal Frequency
Work Mode

Battery Status Indicator

FBR Value

FHR Bar Graph

Fig. 3-4 LCD Display

FHR Heartbeat Waveform

3.2 Push Button
There are three push button (Power, Mode, and Start/Stop) and a volume control button on Pocket Fetal Doppler. The primary functions are as follows:

3.2.1 Power Button

Function: Power on/off. Power on: Push the button once. Power off: Push down the button and hold 3 seconds to power off.

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3.2.2 Mode Button

Function: Mode selection, press once to enter next working mode under working status. For the Fetal Doppler has memory function, when turning on the machine, it will enter the mode selected before last power off automatically after self testing.
3.2.3 Start/Stop Button

Function: Start/Stop control. Under model 3, press this button the fetal heart rate counting starts, press this button again the counting stops.
3.2.4 Volume Control Indicator
Volume adjusting direction indicator. From left to right means that the sound level is from high to low.

3.3 Headphone Socket
Headphone Socket: a socket for audio output, and can be connected with earphone or recorder with audio input to record.
The socket, terminal post, or switch that connected with the headphones.
Accessory equipment connected to the analog and digital interfaces must be certified according M the respective IEC standards (e.g. IEC 950 for data processing equipment and IEC 60601-1 for medical equipment). Furthermore all configurations shall comply with the valid version of the system standard IEC60601-1-1. Everybody who connects additional equipment to the signal input connector or signal output connector configures a medical system, and is therefore responsible that the system complies with the requirements of the valid version of the system standard IEC60601-1-1. If in doubt, consult our technical service department or your local distributor.

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Headphone Socket Signal Interface:

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1 2

3
4 Fig. 3-5 Headphone Socket for Audio Output

Headphone socket showed as Fig.3-5, the definition of pins showed as below:

Pin Definition

1

Signal

2

Signal

3

Signal

4

Signal

Chapter 4 GENERAL OPERATION 4.1 FHR Inspection
1. Power on by pressing the Power button. The LCD display is as Fig.3-4. 2. Find the position of fetus: At first, 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. Adjust the probe to obtain an optimum audio signal ideally by angling the probe around. Adjust the volume according to requirements. 3. FHR Calculation: LCD displays fetal heart rate values, bar graph and fetal heartbeat waveform. 4. Turn off the machine: Keep pressing the power button 3 seconds to turn off.
CAUTION 1. Put the probe on the best detecting position to get better detecting effect. 2. Don’t put the probe on the position where have strong Placental Blood Sound (PBS) or strong Umbilical Sound (UMS).

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3. If pregnant woman adopts horizontal position and the fetus position is normal, put the probe on the position of lower navel midline to get the clearest FHR sound. 4. Do not measure FHR unless audible fetal sound has been heard. 5. Please reduce the time of ultrasonic radiation as possible as you can.

4.2 Mode Selection 4.2.1 Real-time FHR Display Mode (Mode 1)
The moment when the fetal heart rate signals are detected, the fetal heart rate bar graph on LCD indicates the strength of the fetal heart rate signals, and meanwhile shows the fetal heart rate values and fetal heartbeat waveform.
4.2.2 Averaged FHR Display Mode (Mode 2) This model is able to acquire more stable fetal heart rate, displaying on LCD the latest acquisition of eight points fetal heart rate on average. When the fetal heart rate is shown, the fetal heart rate bar graph on LCD indicates the strength of the fetal heart rate signals, the shown fetal heart rate values and heartbeat waveform changes slowly.
4.2.3 Manual Mode (Mode 3) Press the start / stop button starts counting, fetal heart rate reads as ” – – -“, the moment when the fetal heart rate signals are detected, the fetal heart rate bar graph indicates the fetal heart rate strength. Once again press the start / stop button to stop counting, the equipment will automatically calculate the average fetal heart rate acquired from the beginning to the end, and also the result will be displayed. Numerical fetal heart rate will always remain until a repeated measurements or patterns of change.

4.3 Probe Operation 4.3.1 Inspecting Probe
When the probe falls away from the the device, LCD screen displays the “- – -” and displays “Probe fall !”.The probe frequency data disappeared. At this moment the probe needs to be reconnected. After connected well, LCD screen will clear away the “Probe fall !”and display the probe frequency data.

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4.3.2 Replacing Probe
There has been a probe connected to device while packaged by the manufacturer. If users need to replace it with another probe, power off the device at first, then take out the probe from the parking of device. And then pull out the plug of the probe from its socket. Then connect the plug of the probe which needs to be displaced with the socket. Note: Place the temporarily unused probe carefully and avoid falling off, stress, etc. When the device is not used for a long time, users are recommended to connect the plug of one probe to device socket and put the probe in the parking. Then pack the device with the probe in the wrapping box.

4.3.3 Taking out Probe and Placing Probe 1. Taking Out The Probe Hold the main unit with one hand, and hold the handle of the probe with another hand to take out the probe. (See Fig.4-1).

Fig. 4-1 Taking out Probe
2. Placing Probe It is opposite to take out probe. Hold the main unit with one hand, and hold the top of the probe with another hand, then push the probe into the probe holder.

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4.4 FHR Alarm
The normal fetal heart rate range is 120 BPM-160 BPM, LCD displays the fetal heart rate numerical values as green; when the fetal heart rate is too fast or too slow, beyond the normal range, the fetal heart rate numerical values red alarm to remind pregnant women to go to hospital for further checks to ensure the fetal safety.

4.5 Battery Status Indicator
When it works normally, the LCD screen displays the status of the battery as follows:
Battery power is full
Battery power is not full

Battery power is about to run out, it needs replacing batteries.

When this machine detected the battery power is not able to maintain the

normal working of the system, LCD indicates “Low Power!”, and meanwhile the

battery power state indicative marks

is flashing, later the system will

automatically shut down.

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4.6 Replacing Battery
1. The rear panel is upturned. First open the battery compartment, then take out the battery from the battery compartment (see Fig.4-2).

Fig. 4-2 Replacing Battery
2. Put two AA size batteries into the battery compartment (as for the direction of battery, please refer to the instruction inside the battery compartment), at last close the battery compartment.
CAUTION: The battery must be taken out from the battery compartment if the device will not be used for a long time.

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Chapter 5 KEY OF SYMBOLS
Symbol Description

Symbol Description

Type CF applied part

Product code

Follow instructions for use Headphone socket Volume adjust

Lot number Serial number Manufacturer

WEEE disposal
Authorized representative in the European community
Medical Device complies with Directive 93/42/EEC
Caution: read instructions (warnings) carefully

Date of manufacture Keep in a cool, dry place Keep away from sunlight Direct current

Chapter 6 PRODUCT SPECIFICATION
Product Name: Pocket Fetal Doppler Safety: Complies with: IEC 60601-1:2005 Classification: Anti-electroshock Type: Internally powered equipment. Anti- electroshock Degree: Type CF applied part Harmful Liquid Proof Degree: Main unit: Degrees of protection provided by enclosure: IPXO. Probe: Prevent from water splashing, degree of protection: IPX4. Degree of Safety in Presence of Flamrnable Gases: Equipment not suitable for use in presence of flammable gases. Working System: Continuous running equipment.

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EMC: Group I Class B. Suitable Using Range: Suitable for use after the 12th week of pregnancy. Physical Characteristic Size: 135mm (Length) X 92mm (Width) X 29 mm (Height) Weight: About 245g (including batteries) Environment Working: Temperature: +5°C~+40°C Humidity: <80% Atmospheric Pressure: 70 kPa~106 kPa Transport and Storage: Temperature: -10°C~+55°C Humidity: 93% Atmospheric Pressure: 50 kPa~106 kPa Display: 1.77″262K TFT display FHR Performance FHR Measuring Range: 50-240BPM (BPM: beat per minute) Resolution: 1BPM Accuracy: +-2BPM Power Consumption: <1 W Auto Shut-OFF: After 1 minute no signal, power off automatically. Battery Type Recommended: Two pieces of 1.5 V DC battery (SIZE AA LR6). Probe: Nominal Frequency: 2.0MHz Working Frequency: 2.0 MHz±10% P-: < 1 MPa Iob: < 20 mW/cm2 Ispta: < 100 mW/cm2 Ultrasonic Output Power: P < 20 mW Working Mode: Continuous wave doppler Effective Radiating Area of Transducer: < 157mm2 Note: In all working application modes, mechanical index: MI<1, thermal index: TI<1.

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Chapter 7 MAINTENANCE 7.1 Maintenance
The probe acoustic surface 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 evidence of damage that may affect patient safety or Pocket Fetal Doppler capability before me. The recommended inspection interval is once per month or less. If damage is evident, replacement is recommended before use. The equipment should undergo periodic safety testing to insure proper patient isolation from leakage currents. This should include leakage current measurement. The recommended testing interval is once every two years or as specified 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 method such as stethoscope to verify immediately or contact local distributor or manufacturer to get help.

7.2 Cleaning
Before cleaning, switch off and take out the batteries. Keep the outside surface of the device clean and free of dust and dirt, clean exterior surface (display screen included) 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. Wipe the probe with soft cloth to remove any remaining ultrasound coupling gel. Clean with soap and water only.
CAUTION: Don’t use strong solvent, for example, acetone. CAUTION: Never use an abrasive such an steel wool or metal polish. CAUTION: Do not allow any liquid to enter the product, and do not immerse any parts of the device into any liquids. CAUTION: Avoid pouring liquids on the device while cleaning. CAUTION: Don’t remain any cleaning solution on the surface of the device
Note: Wipe the surface of probe with 70% ethanol, self-air dry, or clean with a clean, dry cloth.

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7.3 Disinfecting and Sterilization
Clean the equipment case, probe, etc. as above, and then wipe the probe with an alcohol impregnated wipe (70% ethanol). Wipe the probe with a clean, dry cloth to remove any remaining moisture. NOTE: 1. The recommended periods of cleaning, sterilization and disinfecting is once per month. 2. After cleaning, sterilization and disinfecting, users must inspect whether have any obvious damage which may affect the patient safety and instrument performance.
WARNING: Never try to sterilize the probe or equipment by low temperature.

Chapter 8 SOLUTIONS FOR POSSIBLE PROBLEMS
If it appears following problems when you use the device, please solve them as below:

Problems Weak sound

Possible reasons
· Volume is too low · Power is low · Did not daub the gel

Solutions
· Adjust the volume louder · Change the battery · Daub the gel

Noise

· Probe is too near from the main unt
· Disturbance from the outside signal
· Power is low

· Make the distance between the probe and the main unit a little further
· Keep far away from the outside signal
· Change the battery

Low sensitivity

· Position of the probe is not correct
· Did not daub the gel

· Adjust the position of the probe
· Daub the gel

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Appendix 1
Essentiality of Fetal Domestic Monitor Modem 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: · Within 30 minutes after pregnant women get up · Within 60 minutes after pregnant women finish lunch · Within 30 minutes before pregnant women go to bed For the above three periods, because of the change of the body status of pregnant women, the activity of food digesting needs the body to provide more oxygen, relatively, the oxygen for fetus become less. It is easy to arose symptoms such as fetus anoxia. Testing the FHR at this time can display the healthy status for the fetus best. The above three periods can only be tested at home by pregnant women themselves, so FHR domestic monitor is very important. We advise the pregnant women to measure every day respectively at early, middle and late time, every time measuring the fetal heart rate and listening to the fetal heart rate for about one minute, and recording the measurement results for the medical reference when go to the hospital. Generally, the medicine deems the normal fetal heart rate as: 120BPM~160BPM; slightly too fast: 161BPM~180BPM; heavily too fast: above 181BPM; slightly too slow: 119BPM~100BPM; heavily too slow: below 99BPM. This device can hear the fetal heart sound for fetus above twelve weeks, and check the LCD display. Finding too fast or too slow should go to hospital for further checks to ensure safety.

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Appendix 2
Overall Sensitivity

Diameter of Target Reflector (mm)

Distance Reflection

(d)

Loss

(mm)

A(d)

Two-way Attenuation
B= Ba +Bw

Ba
(T:mm Ba:dB)

Bw B (dB) dB

Vs r.m.s mV

( ) Vn
r.m.s

C=20 log10

Vs (r.m.s) Vn (r.m.s)

Overall Sensitivity

mV

(S=A(d)+B+C)

dB

dB

1.58

50

45.7 T 20 4.8 4.0 – 0 57.6 186 94

5.93

A=45.7dB@ 2MHz

Ba 40 9.6 8.0 –

75

45.7 T 20 4.8 3.4 – 0 56.4 175 90

5.78

109.2 107.8

Ba 40 9.6 6.8 –

100

45.7 T 20 4.8 3.4 – 0 56.4 174 89

5.82

107.9

Ba 40 9.6 6.8 –

200

45.7 T 20 4.8 – – 0 49.6 173 90

5.68

100.9

Ba 40 9.6 – –

2.38

50

43.2 T 20 4.8 3.4 2.2 0 60.8 178 89

6.02

A=43.2dB@ 2MHz

Ba 40 9.6 6.8 4.4

75

43.2 T 20 4.8 3.4 1 0 58.4 170 90

5.52

110.0 107.1

Ba 40 9.6 6.8 2

100

43.2 T 20 4.8 3.4 – 0 56.4 165 85

5.76

105.3

Ba 40 9.6 6.8 –

200

43.2 T 20 4.8 1 – 0 51.6 160 85

5.49

100.2

Ba 40 9.6 2 –

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Doppler Frequency

333

Velocity

12.5

(Hz)

of Target

(cm/s)

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Disposal: The product must not be disposed of along with other domestic waste. The users must dispose of this equipment by bringing it to a specific recycling point for electric and electronic equipment. For further information on recycling points contact the local authorities, the local recycling center or the shop where the product was purchased. If the equipment is not disposed of correctly, fines or penalties may be applied in accordance with the national legislation and regulations.

GIMA WARRANTY CONDITIONS
Congratulations for purchasing a GIMA product. This product meets high qualitative standards both as regards the material and the production. The warranty is valid for 12 months from the date of supply of GIMA. During the period of validity of the warranty, GIMA will repair and/or replace free of charge all the defected parts due to production reasons. Labor costs and personnel traveling expenses and packaging not included. All components subject to wear are not included in the warranty. The repair or replacement performed during the warranty period shall not extend the warranty. The warranty is void in the following cases: repairs performed by unauthorized personnel or with non-original spare parts, defects caused by negligence or incorrect use. GIMA cannot be held responsible for malfunctioning on electronic devices or software due to outside agents such as: voltage changes, electro-magnetic fields, radio interferences, etc. The warranty is void if the above regulations are not observed and if the serial code (if available) has been removed, cancelled or changed.The defected products must be returned only to the dealer the product was purchased from. Products sent to GIMA will be rejected.

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