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

Product type	Portable fetal doppler
Brand	Luvion
Model	Deluxe80 (Deluxe-80)
Classification	Type B medical device (protection against electric shock)
Power supply	2 AAA alkaline batteries 1.5 V DC
Battery life	More than 6 hours of continuous use
Weight	Approximately 80 g (with batteries)
LCD screen dimensions	25 × 14 mm
FHR measurement range	50 to 240 BPM (beats per minute)
Measurement accuracy	±2 BPM
Probe frequency	2.0 MHz ±10%
Ultrasonic intensity (Ispta)	< 100 mW/cm²
Audio outputs	Dual headphone jacks (2x)
Recording	Connectable to a computer or recorder via cable
Display	LCD with auto-lock (15 s without signal)
Operating conditions	Temperature +5°C to +40°C, humidity ≤80%
Storage conditions	Temperature -10°C to +55°C, humidity ≤93%
Cleaning	Soft dry or soapy cloth; disinfection with 70% ethanol
Safety	Complies with IEC 60601-1; do not use in presence of flammable gas
Warranty	Repair by authorized personnel; standard warranty (details in manual)
Estimated service life	Approximately 5 years
Spare parts	Not user-serviceable; contact an authorized technician

Frequently Asked Questions - Doppler Deluxe80 Luvion

How to install the batteries?

Open the battery compartment cover on the back of the device. Insert two AAA batteries observing polarity (+ and -). Close the cover.

How to use the Deluxe80 Doppler to listen to the baby's heart?

Turn on the device by turning the Power/Volume knob. Plug in the headphones. Apply a generous amount of gel to the probe. Place the probe on the abdomen slightly tilted and move it slowly until you hear the heartbeat. Adjust the volume.

What to do if the sound is weak or distorted?

Check the volume, battery power, and gel application. Distorted sound may be due to volume too high, weak batteries, or electromagnetic interference. Move away from sources such as mobile phones.

How to clean the probe after use?

Turn off the device and remove the batteries. Wipe the probe with a soft cloth. If necessary, use a cloth dampened with soapy water, then dry. For disinfection, use 70% ethanol.

Can the Doppler be used at any stage of pregnancy?

This device is designed for fetal heartbeat detection from 12 weeks of pregnancy. Before that time, it may be difficult to detect the heart.

What are the important safety precautions?

Do not open the device, do not immerse it, do not use in presence of flammable gas, remove batteries if not used for a long time, and consult a doctor if in doubt about the readings.

How to interpret the displayed heart rate?

The screen displays the number of beats per minute (BPM). The normal range is generally between 120 and 160 BPM. Only a doctor can interpret the results.

Can I record the heartbeat?

Yes, the device can connect to a computer or recorder via a cable (not included). You can thus record the fetal heart sound.

What to do in case of failure or if the device does not work?

Consult the troubleshooting table in the manual. If the problem persists, do not attempt to repair it yourself. Contact an authorized technician.

What is the service life of the device and how to store it?

The estimated service life is approximately 5 years. Store the device in a dry and cool place, away from vibrations and interference sources. Remove batteries if not used for a long time.

USER MANUAL Doppler Deluxe80 Luvion

Abstract grayscale gradient bar with red, white, and blue vertical bars on the right (no text or symbols)

NL - Handleiding

INHOUDSOPGAVE

Veiligheidsnormen

Person holding a medical ECG device on a pregnant abdomen, no visible text or symbols

Model No.: Deluxe-80

Veiligheid: Voldoet aan: IEC 60601-1:1988A1:1991A2:1995

Klassificatie:

Anti-electroshock Degree: type B applied part

EMC: Group I Class B

Nominal Frequency: 2.0MHz

Working Frequency: 2.0MHz±10%

P-: <1MPa

lob<20 mW/cm2

Ispta: <100mW/cm2

Isata<5mW/cm2

Working Mode: Continuous wave Doppler

Effective Radiating Area of Transducer: 208mm2±15%

SCHOONMAKEN EN DESINFECTEREN

Schoonmaken

Acoustic output reporting table, cwD mode, Nominal frequency:2.0MHz Notes: This probe is not intended for transcranial or neonatal cephalic use

Index label		MI	TIS		TIB	Non- scan	A _aprt 51cm ^2	A _aprt >1cm ^2	(a)
			Scan	Non-scan
Maximum index value		0.012	-	-	0.024	0.11	#
Associated acoustic parameters	P _Ca (MPa)	0.017
	P (mw)		-	-		3.8	#
	Min. of [P _a (z _s ), I _zplta,a,z_s ] (mw)				2.94
	Z _b (cm)					0.41
	Z _bp (cm)				2.94
	Z _s (cm)
	Z at max. I _pl,a (cm)	0.37				0.57
	d _aq (Z _b ) (cm)
	F _air (MHz)	1.99	-	-	1.99	1.99	#
	Dim of A _air	X (cm)		-	-	1.90	1.90	#
	td (lsec)	CW
	Prr (Hz)	CW
	Pr at max. I _pl (MPa)	0.018
	deg at max. I _pl (cm)						0.58
Other information	I _pa,q at max. MI (W/cm ^2 )	9.43
Operating control conditions		-	-	-	-	-	#

Overall Sensitivity
Distance (cm)	Reflection Loss (d)	Two-way Attenuation B=3 B0+Bm				V1(cm/s)mV	V2(cm/s)mV	C=2500-(F/cm2)/(S-A(d)+B+C)/dB	Overall Sensitivity (S-A(d)+B+C)/dB
1.58A=45.7dB@2MHz	50	T	20	4.8	4.0	-	0	57.6	186	94	5.93
	75	T	20	4.8	3.4	-	0	56.4	175	90	5.78
	100	Bt	40	9.6	6.8	-	0	56.4	174	89	5.82
200	45.7	T	20	4.8	3.4	-	0	49.6	173	90	5.68
50	43.2	Bt	40	9.6	6.8	-	0	60.8	178	89	6.02
75	43.2	Bt	40	9.6	6.8	2	0	58.4	170	90	5.52
100	45.7	T	20	4.8	-	-	0	49.6	173	90	100.9
238A=43.2dB@2MHz	75	T	20	4.8	-	-	0	56.4	174	89	107.9
	100	Bt	40	9.6	6.8	-	0	56.4	174	89	100.9
	50	T	20	4.8	-	-	0	49.6	173	90	100.9
	75	Bt	40	9.6	6.8	-	0	56.4	175	90	107.8
	100	T	20	4.8	-	-	0	49.6	173	90	100.9
2.38A=43.2dB@A=43.2dB@MHz	100	T	20	4.8	-	-	0	56.4	175	90	107.8
	10t	T	20	4.8	-	-	0	56.4	175	90	107.8
	10t	T	20	4.8	-	-	0	56.4	175	90	107.8
	10t	T	20	4.8	-	-	0	56.1	174	89	107.9
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	10t	T	20	4.8	-	-	0	56.4	174	89	107.9
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	10 t	T	20	4.8	-	-	0	56.4	174	89	107.9
	10t	T	20	4.8	-	-	0	56.4	174	89	107.9
	10t	T	20	4.8	-	-	0	56.1	173	90	100.9
	10t	T	20	4.8	-	-	0	56.4	173	90	100.9
	10t	T	20	4.8	-	-	0	56.4	173	90	100.9
	10t	T	20	4.8	-	-	0	56.4	173	90	100.9
	10 t	T	20	4.8	-	-	0	56.4	173	90	100.9
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	10t	T	20	4.8	-	-	0	56.1	173	90	100.9
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CONTENT

Safety Guidance 19

Introduction 20

Outlook and configuration 21

FHR Inspection 22

Symbols and Maintenance 23

Product specifications 24

Cleaning 26

Solutions for possible problems 27

Small tips 28

Appendix 29

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. 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 effects on safety, reliability and performance of the equipment if:

Assembly operations, extensions, readjustments, modifications 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 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.

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.

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.

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 government 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.

OUTLOOK AND CONFIGURATION

LCD Screen

FHR INSPECTION

1. Before the first use, please open the battery cover, install two AAA size batteries.

2. Plug headphone into the audio output socket.

3. Power ON: revolve the On-Off / 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 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.

Person holding a medical ECG device on a pregnant abdomen, no visible text or symbols

Attention: Don't adjust the knob to a very loud volume when you are trying to find the fetal heart position.

1. 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 flicker on the LCD screen. In addition, the heart rate (number of heart beats per minute) will be displayed on the screen.

2. After operation, revolve down the On-Off / Volume Knob on the left side panel to power off.

3. Use soft cloth to wipe off the gel left on the probe.

SYMBOLS

Symbol

Description

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 evidence of damage that may affect 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 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 methods such as stethoscope to verify immediately or contact local distributor or manufacture to get help.

PRODUCT SPECIFICATIONS

Product name: LUVION Premium Doppler

Model No.: Deluxe-80

Safety: Complies with: IEC 60601-1:1988\~A1:1991\~A2:1995

Classification:

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 fire 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 \~ 106kPa

Transport and Storage:

Temperature: -10^ + 55^

Humidity: ≤93 %

Atmospheric Pressure: 50 kPa \~ 106kPa

Power Supply: 1.5V Battery ×2 (Size: AAA)

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

lob<20 mW/cm2

Ispta: <100mW/cm2

Isata<5mW/cm2

Working Mode: Continuous wave Doppler

Effective Radiating Area of Transducer: 208mm2±15%

CLEANING AND DESINFECTION

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 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.

Note:

1. Never try to sterilize the equipment by low temperature steam or other methods.
2. Do not use high temperature sterilizing process and E-beam or gamma radiation sterilization.

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• Power is to low• Not daub the gel	• A djust the volume louder• Change the battery• Daub the gel
Noise • Volume is to high• Power is low• Disturbance from the outside signal	• Adjust the volume louder• Change the battery• Keep far away from the outside signal
Low sensitivity • Position of the probe is not correct• Not daub the gel	• Adjust the position of the probe• Daub the gel

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 finish lunch
3. within 30 minutes before pregnant women go to bed

For the three periods described above, 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.

This Doppler can hear the fetal heart sound for fetuses above 12 weeks, and calculate the FHR. You can listen to the fetal heart sound. Pregnant women can also write down the recorded data, this can be a reference for doctors to ensure the health of the fetus.

APPENDIX

Acoustic output reporting table, cwD mode, Nominal frequency:2.0MHz Notes: This probe is not intended for transcranial or neonatal cephalic use.

Index label		MI	Scan	TIS		TIB	Non- scan
				A_apt ≤slant 1 cm^2	A_apt > 1 cm^2		PIC
Maximum index value		0.012	-	-	0.024	0.11	(a)
Associated acoustic parameters	P_a (MPa)	0.017
	P(mw)		-	-		3.8	#
	Min.of P_a( z_s) ,I_ZPTA,dz_s ( mw)				2.53
	Z_s (cm)				2.94
	Z_bp (cm)				2.94
	Z_b (cm)					0.41
	Z_at . I_pl,o (cm)	0.37				0.57
	d_aq( Z_b) (cm)
	F_avr (MHz)	1.99	-	-	,99	1.99	#
	Dim of A _apri	Y(cm)		-	-	,01	1.01	#
	p_r at max. I_pl (MPa)	0.018
	d_eq at max. I_pl (cm)						0.58
	I_pa,a at max. MI (W/cm ^2 )	9.43
Operating control conditions		-	-	-	-	-	#

Overall Sensitivity
Distance (km)	Reflection Loss (d) (cm)	Two-way Attenuation B=3 B+B.				V1(cm/s)mV	V2(cm/s)mV	C=2000-(P-1/m2)/(S-A(d)+B+C)dB	Overall Sensitivity (S-A(d)+B+C)dB
1.58A=45.7dB@2MHz	50	T	20	4.8	4.0	-	0	57.6	186	94	5.93
	75	T	20	4.8	3.4	-	0	56.4	175	90	5.78
	100	B, T	40	9.6	6.8	-	0	56.4	174	89	5.82
200	45.7	B, T	40	9.6	6.8	-	0	49.6	173	90	5.68
50	43.2	T	20	4.8	3.4	2.2	0	60.8	178	89	6.02
75	43.2	B, T	40	9.6	6.8	2	0	58.4	170	90	5.52
100	45.7	T	20	4.8	-	-	0	49.6	173	90	100.9
238A=43.2dB@2MHz	75	T	20	4.8	-	-	0	56.4	174	89	107.9
	100	B, T	40	9.6	6.8	-	0	56.4	174	89	107.9
	50	T	20	4.8	3.4	-	0	56.4	174	89	107.9
	75	B, T	40	9.6	6.8	-	0	56.4	175	90	107.8
	100	T	20	4.8	3.4	-	0	56.4	175	90	107.8
	50	B, T	40	9.6	8.0	-	0	57.6	186	94	5.93

Person holding a medical device on a pregnant abdomen, no visible text or symbols

Tipo

B

Atención

Auricular

Volumen

Acoustic output reporting table, cwD mode, Nominal frequency:2.0MHz

Notes: This probe is not intended for transcranial or neonatal cephalic use

Index label		MI	TIS		TIB	Non- scan	Non- scan	(α)
			Scan	A_aprt ≤ 1 cm^2
Maximum index value		0.012	-	-	0.024	0.11	(α)
Associated acoustic parameters	P_Ca (MPa)	0.017
	P(mW)		-	-		3.8	≠
	Min.of P_Ca( Zs_s) ,I_ZDTA,Qz_s ( MW)				2.53
	Z_b (cm)					0.41
	Z_bp (cm)					2.94
	Z_s (cm)					2.94
	Z_b (cm)					2.94
	Z_avr (MHz)	1.99	-	-	1.99	1.99	≠
	F_avr (MHz)
	C_av (Zb) (cm)	1.99	-			0.57
	C_av( Z_b) (cm)
	t_d (lsec)	CW
	Pr(Hz)	CW
	Pr(MPa)	CW
	Cev at max. Ipl(cm)	Y(cm)		-	-	1.01	1.01	≠
	Cev aat max. Ipl(cm)	0.018				1.90	1.90	≠
	Pr at max. Ipl(MPa)	0.018
	Other information	I_Pa,o at max. MI (W/cm2)		9.43
		Operating control conditions		-	-	-	-	#

Doppler Frequency (Hz)			333						Velocity of Target (cm/s)		12.5
2.38A-43.2dB@2MHz	200	43.2	Hg	40	9.6	2	-		0	51.6	160	85
			T	20	4.8	1	-
			Hg	40	9.6	6.8	-
			T	20	4.8	3.4	-
			Hg	40	9.6	6.8	2
			T	20	4.8	3.4	1
			Hg	40	9.6	6.8	2
			T	20	4.8	3.4	1
			Hg	40	9.6	6.8	4.4
			T	20	4.8	3.4	2.2
			Hg	40	9.6	-	-
			T	20	4.8	-	-
			Hg	40	9.6	-	-
			T	20	4.8	-	-
			Hg	40	9.6	-	-
			T	20	4.8	-	-
			Hg	40	9.6	-	-
			T	20	4.8	-	-
			Hg	40	9.6	-	-
			T	20	4.8	-	-
			Hg	40	9.6	6.8	-
			T	20	4.8	3.4	-
			Hg	40	9.6	6.8	-
			T	20	4.8	3.4	-
			Hg	40	9.6	6.8	-
			T	20	4.8	3. 4	-
			Hg	40	9.6	6.8	-
			T	20	4.8	3.4	-
			Hg	40	9.6	6.8	-
			T	20	4.8
			Hg	40	9.6	8.0	-
			T	20	4.8	3.4	-
			Hg	40	9.6	8.0	-
			T	20	4.8	3.4	-
			Hg	40	9.6	8.0	-
			T	20	4.8	3. 4	-
			Hg	40	9.6	6.8	-
			T	20	4.8	3.4	-
			Hg	40	9.6
			T	20	4.8	3.4	-
			Hg	40	9.6	6.8	-
			T	20	4.8	3.4	-
			Hg	40	9.6	6. 8	-
			T	20	4.8	3.4	-
			Hg	40	9.6	6.8	-
			T	20	4.8	3.4	-
			Hg	40	9.6
			T	20	4.8	3.4
			Hg	40	9.6	6.8	-
			T	20	4.8	3.4	-
			Hg	40	9.6
			T	20	4.8	3.4
			Hg	40	9.6
			T	20	4.8	3.4
			Hg	40	9.6
			T	20	4.8	3.4
			Hg	40	9.6
			T	20	4.8	3.4

Overall Sensitivity

Person holding a medical ECG device on a pregnant abdomen, wearing patterned clothing (no visible text or symbols)

SPÉCIFICATIONS DU PRODUIT

Taille: (L)110mm × (W)55mm × (H)16.8 mm

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