Mediblink M480 Ultrasonic Nebulizer Instructions

Mediblink Ultrasonic nebulizer M480
INSTRUCTIONS FOR USE

M480 Ultrasonic Nebulizer

Please read this guidebook completely before operating this unit.

Introduction

Dear Customer,
Thank you for choosing Mediblink Ultrasonic Nebulizer M480, an ultrasonic aerosol therapy unit designed and manufactured according to the most up-to- date technologies.
Mediblink Ultrasonic Nebulizer M480 is a class IIa medical device which converts medicines from liquid or suspension form to aerosol form, so they can be administered directly to the airways.
Mediblink Ultrasonic Nebulizer M480 allows for deeper penetration of the medicine in the respiratory tract, ensured by the perfect size of the aerosol particles.
Warning!
This product must be assembled, maintained and handled by an adult. Never leave children alone during use: the unit contains small parts that could be swallowed. This product must remain in place for use only for the time strictly needed. Once treatment has been completed, the unit must be stored in a safe place out of reach of children. Before using the appliance, we highly recommend that you read the short list of warnings contained in this manual, to make sure you have correctly understood how to use it.

Accessories

The device includes the following parts, provided in a polyethylene envelope supplied with the device.
List of Accessories

No.| Component| Model no.| Item no.| Material| Quantity
---|---|---|---|---|---
1| Adult mask| PNEMAD| 180-S08MZ7| PVC+PP| 1
2| Pediatric mask| PNEMIN| 180-S09MZ8| PVC+PP| 1
3| Medicine cup| PNEBCAM3| XC-S02YB| PVC| 10
4| Sealed ring| PNEBUANL| 180-GO2DQ| Silicon| 3
5| Extension tube| PNEBTUB3| 180-S06SSG1| PP| 1
6| Adapter| 180240-W RSS1006- 2B-H| 180-DO2SPQ| /| 1
7| Mouthpiece| PNEMOU| 180-S01YZ| PP| 1
8| Nosepiece| PNEBNOS| 180-S08BC7| PP| 1

Picture 1: Nebulizer Accessories

Device Components

Your ultrasound Mediblink M480 system for aerosol therapy.
Picture 2: Nebulizer Components

1. Atomizing nozzle (or Blue Connector)
2. Medicine Cup
3. Sealed ring
4. Sensor for water level
5. Body of the device with water tank
6. Switch
7. Warning light

Introduction
Intended use: The Ultrasonic Nebulizer for Conscious Patients is intended for converting Albuterol Sulfate or saline solution fluid into an aerosol for inhalation by adult or pediatric patients.
Contraindication: Never use with unconscious patients.
Target user group: Legally certified medical experts, such as doctors, nurses and therapists or healthcare personnel or patients under the guidance of qualified medical experts for home treatment.
The medical conditions to be treated: The device is intended for use in the treatment of asthma, COPD and other respiratory ailments in which an aerosolized medication or saline solution is required during therapy.
The lifespan of the device is 5 years.
Warnings and precautions, operating cautions

1. Keep your eyes away from the output of medication mist. Change the water after each use.
2. The maximum capacity of the medication cup is 10ml and it should not be overfilled.
3. Dilute dense medications or medication volumes 2ml or less with distilled water or saline solution to obtain a volume of at least 4ml.
4. Do not use this unit while operating a vehicle.
5. If any discomfort or abnormality occurs, stop using the unit immediately.

Warnings

1. Do not expose the Nebulizer to: high temperatures, humidity, dust or direct light.
2. Do not drop it or shock it.
3. To avoid infections and contagions, the mask, medicine cup and extension tube must be treated as disposable.
4. Do not fill the tank above the volume specified in the manual.
5. Do not let the medicine remain in the nebulization chamber if the Nebulizer is not in use.
6. Disconnect the Nebulizer from the electric outlet before cleaning, filling with medicine and after each use.
7. Use the Nebulizer on an intermittent basis, i.e., after 20 minutes, discontinue use for 40 minutes and, if necessary, return it to use for no longer than 20 minutes.
8. Never wash, soak or submerge the nebulizer in water or any other liquid. To clean it, follow the precise instructions in the item MAINTENANCE AND CLEANING in this manual.
9. Do not use it with wet hands, as there is a risk of damaging the nebulizer and the user.
10. Never use the unit if it has damaged parts (including the power cord), or if it has been dropped or submerged in water. Send it immediately to technical assistance for tests and repairs.
11. Children must not use the Nebulizer without an adult’s supervision.
12. Do not deflect the nebulizer as there is a risk of medicine leakage and malfunction.
13. Please use the adult mask, a pediatric mask with a CE certificate with notified body number.
14. The accessories are disposable products that can’t be reused. If you need to replace them with new accessories, please contact local Mediblink distributor.
15. For hygiene reasons, each user must use their own accessories and accessories for single-use.

Aerosol output of NaF

1. Test method
   a) Air is used.
   b) The nebulizer is filled with the tested drug (2ml NaF 1.0% (M/V) and the flow rates are 2 L/min) for the aerosol output rate and aerosol output test.
   c) The aerosol output is expressed as millilitres of NaF 1.0% (M/V).
   d) The nebulizer is filled with the tested drug (2ml NaF 2.5% (M/V) and the flow rates are 2 L/min) for the particle sizing test.

2. NaF (minimum speed) test results
   Table 1: Summary of the test results for the proposed device (M480) Test| Features|
   ---|---|---
   Particle sizing| Total output particle mass (Mi. lig)| 26273.36 ± 3410.11
   Particle mass collected by the cascade impactor (M2, pg)| 354.63 ± 15.38
   Particle mass collected by the outlet filter (M3. pg)| 2228.35 ± 10835
   MMAD (gm)| 1.52 ± 0.1
   C.V for the MMAD between four tests (%)| 6.
   Geometric Std. Dev_ (GSD)| 1.65 ± 0.16
   C.V for the GSD between four tests (°/0)| 10.
   Respirable fraction (%, 0.5-5 pm)| 93.49 ± 0.9
   Respirable Mass (mg 0.5-5 pm)| 331.61 ± 17
   Treatment time (min)| 1
   Coarse particle Fraction (%) (> 4.7 pm)| 6.89 ± 1.22
   Fine particle Fraction (%) (c- 4.7 pm)| 93.11 ± 1.22
   Ultra-fine particle Fraction (%) (c 1 pin)| 13.33 ± 4.56
   Aerosol output and aerosol output rate| Aerosol output (ml)a| 2.06 ± 0.13
   Aerosol output rate (ml/min)b| 0.6 ± 0.04
   a : Continue the treatment until the medicine cup is empty or the mist stops.
   b : The treatment time for aerosol output rate is 1 min.

Table 2: Mass fraction of the drug collected on each stage of the Marple impactor

stage No.| Effective cutoff dia.
(Pm)| Cumulative fraction (%)| Mean collected mass per minute for each stage (pgimin)| Mean mass fraction for
each stage (%)
---|---|---|---|---
Test 1| Test 2| Test 3| Test 4| Mean
1| 21.3| 100.00| 100.00| 100.00| 100.00| 100.00| 9.40| 2.65
2| 14.8| 97.30| 97.27| 97.41| 97.41| 97.35| 9.55| 2.69
3| 9.8| 94.13| 94.87| 94.93| 94.66| 94.65| 10.90| 3.07
4| 6| 91.07| 91.64| 92.00| 91.58| 91.57| 33.85| 9.55
5| 3.5| 79.45| 83.50| 83.50| 81.98| 82.00| 85.10| 24.00
6| 1.6| 52.85| 60.81| 59.54| 58.59| 57.95| 186.20| 52.51
7| 0.93| 11.92| 0.00| 6.73| 3.99| 5.66| 19.28| 5.44
8| 0.53| 0.30| 0.00| 0.11| 0.00| 0.10| 0.35| 0.10
after filter| <0.53| 0.00| 0.00| 0.00| 0.00| 0.00| 0.00| 0.00
Total| | 354.63

Figure A: Plot of the cumulative size distribution of the results in table 2

3. NaF (medium speed) test results
   Table 3: Summary of the test results for the proposed device (M480)Table 4: Mass fraction of the drug collected on each stage of the Marple impactorFigure B: Plot of the cumulative size distribution of the results in table 4

4. NaF (maximum speed) test results
   Table 5: Summary of the test results for the proposed device (M480)Table 6: Mass fraction of the drug collected on each stage of the Marple impactorFigure C: Plot of the cumulative size distribution of the results in table 6

Reference
Rubow, K. L., Marple, V. A., Olin, J., and Mccawley, M. A., 1987, “A Personal Cascade
Impactor: Design, Evaluation and Calibration”, Am. Ind. Hyg. Assoc. J. (48): 532-538.

Symbol use

http://www.mediblink.com/f/m480.pdf
| Manufacturer
| Date of manufacture
| Authorized Representative in the European community
| Medical Device
*| Batch code
**| Serial number
| Use-by date
| The marking of electrical and electronic devices is according to Directive 2002/96/EC. The device, accessories and packaging must be disposed of correctly after usage. Please follow the Local Ordinances or Regulations for disposal.
| Non-sterile
| Do not re-use
| CE marking
| Protected against solid foreign objects of 12.5mm diameter and greater.
| Number of products in one packaging
| Storage temperature limit
| Storage humidity limitation
| Storage atmospheric pressure limitation
| This way up
| Fragile, handle with care
| Keep dry
| Stacking limit of 6
| Caution!

*Date of manufacture: the first pair of LOT numbers presents month of manufacture, the second pair of numbers presents the year of production. Example: LOT 1025 = October 2025.
Follow the precise use instructions contained in this manual and do not use the Nebulizer in any way not described in this manual (such as using accessories not provided by the manufacturer, inserting objects or opening it) at risk of accidents and loss of warranty.
ATTENTION – Instructions for the correct disposal of the product
This symbol indicates that the product must not be disposed of with domestic waste after use, but in accordance with the legal provisions in force, in order toavoid negative health and environmental implications.

Storage Cautions

Do not store the unit in direct sunlight, high temperature or humidity.
Keep the unit out of reach of small children.
Always keep the unit unplugged while not in use.

Instructions

1. Consult your family doctor before using this device.
2. Keep the device out of children’s reach.
3. Once the treatment is over, disconnect the device from the socket by unplugging the adapter.

For the correct use and maintenance time of your new system for aerosol therapy, we recommend reading the following indications carefully.
How to use your M480 nebulizer for aerosol therapy
Make sure that the device and all the accessories are thoroughly clean, then proceed consecutively with the following operations:

1. Position the device on a stable, bare flat surface (table without a tablecloth or other covering) near a power point.
2. Open the device cover.
3. Remove the upper part as shown in Fig.1.
4. Fill the tank with cold tap-water (distilled water or filtered water are not allowed, using a small container as shown in Fig.2, to the level indicated inside the tank (Fig.9): this water allows the conduction of ultrasound waves to the medicine and is never nebulized.
5. Take a medicine cup with the medicine in it as shown in Fig.3.
6. Put the sealed ring on the machine around the mouth of the tank before placing the medicine cup in.
7. Place the medicine cup with the medicine in its slot under the upper part of the device (Fig.4), without spilling the drug from the medicine cup.
8. Place the upper part onto the body of the device by carefully joining the two parts.
9. Match the connector with the extension tube, then connect the free end of the connector to the mask for nebulized drug emission (Fig.5), and apply the free end of the extension tube to either of the two masks, the mouthpiece or the nasal piece, according to the treatment required and to the mode of administration selected.
10. Insert the current adapter into the socket on the back of the device.
11. Warning! The air outlet is strictly prohibited from entering water. Please see Fig.8.
12. Note the line for the water level in the water tank (see Fig.9); the water tank must be used with tap-water, distilled water or filtered water are not permitted because the sensor cannot work with them.

Now the device is ready for use.

Instructions
How to perform aerosol therapy

1. Plug the current adapter into a suitable socket (see the label on the bottom of the device).
2. Press the switch on the top of the device: the warning light on the top lights up (green light) indicating that the device is working.
3. During therapy, keep the device in a vertical position to allow the correct functioning of the device, and to achieve the greatest effectiveness.
4. The drug nebulization speed may be controlled by pressing ‘MIN’, ‘MID’ and ‘MAX’. During child treatment, we mostly advise turning the knob to the ‘MIN’ position, in order to help airway deposition.
5. Continue the treatment until a light mist is visible (drug nebulization generated by the device).
6. After one treatment session, it is necessary to refill the water in the tank for the next treatment.

Caution: normally, at the end of the treatment, a small amount of medicine remains in the Medicine holder: this amount, called the residual volume, cannot be nebulized.

Once the treatment is over:

1. Switch the device off by pressing the switch control.
2. Disconnect the current adapter from the power point.
3. Remove the current adapter from the socket on the back of the device.
4. Remove the blue connector from the nebulizer body, and the mask (or other accessory) from the end of the extension tube.
5. Remove the blue connector from the extension tube.
6. Remove the medicine cup and sealed ring from the body of the device.
7. Remove the water from the water tank.
8. Wipe the water tank carefully with a soft cloth, and make sure that the water tank and blue connector are completely dry.
9. Place the medicine cup, sealed ring and blue connector onto the body of the device.
10. Place all the accessories into the box, together with the device.

Cleaning and maintenance

Cautions:
Check the medication cup and air filter before each use. Dirty or worn parts should be replaced. Do not immerse the unit in water.
It is important to clean your Ultrasonic Nebulizer before it is used for the first time and after each use. Remember to disconnect the unit from the electrical outlet. Never immerse the unit in water. It may damage the unit.
Do not use any powdered cleaners or soap pads, which may damage the finish.
Cleaning the device

1. Disconnect the unit from the electrical outlet before cleaning.
2. The surface of the main unit should be cleaned with a soft cloth moistened with a non-abrasive cleanser and water below 30°C. Don’t put the main unit directly into water. The ultrasonic part can be wiped with a cotton stick with clean water below 30°C.
3. Clean the atomizing nozzle with hot water after each use and clean with a mild detergent after the last treatment of the day.

Caution! During cleaning procedure, do not press on the ultrasonic membrane, because it can be permanently damaged.

Filter change

1. Do not use cotton or any other materials. Do not wash or clean the filter. Only use filters supplied by your distributor. And do not operate without a filter.
2. Change the filter every 30 days or when it turns grey.
3. Changing procedure:
   a) Remove the filter cover
   b) Replace the used filter with a new one
   c) Replace the filter cover

How to preserve the effectiveness of your device

1. Your M480 ultrasound system for aerosol therapy does not require any particular maintenance care; you only need to:
   – avoid hitting or dropping it;
   – avoid opening it under any circumstances;
   – keep it in a suitable place, avoiding high temperatures, direct sunlight, humidity and dust;
   – avoid using the device for more than 30 minutes uninterruptedly.

2. After all sessions, carefully clean all the accessories used.
   Accessories may be washed under running water. If you want to sterilize them, a cold solution suggested by your family doctor may be used.

3. We recommend performing a maximum of 2 treatments using a single medicinal holder (cup) before replacing it.

4. We strongly recommend replacing the air filter after 15/20 treatments, or when the filter becomes grey. For the substitution, proceed as follows:
   – remove the cap from its slot under the base of the device;
   – remove the old filter and introduce the new one;
   – replace the cap inside its slot.

Technical features

Name and model number| Mediblink Ultrasonic Nebulizer M480,
Model: ULTRANEB DESK 2
---|---
Power| 100–240 VAC 50/60 Hz, 0.6 A
Ultrasonic Frequency| 2.4 MHz ± 50 kHz
Nebulization rate (NaF)| MIN: 0.4–0.64 ml/min MED: 0.6–0.8 ml/min
MAX: 0.65–0.9 ml/min
Particle Size MMAD (NaF)| 1.19-1.52 μm, depending on nebulization rate setting
Medicine Cup Capacity| Approximately 10 ml maximum
Noise level| 32,9 dB
Dimensions| 164 x 97 x 140 mm
Weight| Approximately 425 g
Operating Temperature and Humidity| 10 °C to 40 °C (50 °F to 104 °F); 10 to 85 % RH
Temperature and Humidity of Storage and Transportation| -20 °C to 70 °C (-4° to 158° F); 10 to 95 % RH

Figure 1: the distribution of atomized particles (Albuterol sulfate)The above technical features may be subject to change at the discretion of the producer.

Troubleshooting

Unit does not operate when the ON/OFF
button is pressed.| Check the AC adapter connection to the outlet and/or check the AC plug in the unit’s AC port. Check whether the water tank is filled to the correct level.
No misting or a low rate of misting| Check whether there is medication in the medication cup.
Check the medication cup for damage.
Check whether the transducer is clean.
Fan is not working properly| Device must be sent to authorized service company to check whether the fan is firmly and properly mounted on the motor shaft.

EMC Declaration

Guidance and manufacturer’s declaration – electromagnetic emission
This device is intended for use in the electromagnetic environment specified below. The customer of the user of the device should ensure that it is used in such an environment.

Emission test| Compliance| Electromagnetic environment – guidance
---|---|---
RF emissions CISPR 11| Group 1| The device only uses RF energy for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference with nearby electronic equipment.
RF emissions
CISPR 11| Class B| The device is suitable for use in all establishments, other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2| Compliant
Voltage fluctuations / flicker emissions
IEC 61000-3-3| Compliant

Guidance and manufacturer’s declaration – electromagnetic emission
This device is intended for use in the electromagnetic environment specified below. The customer of the user of the device should ensure that it is used in such an environment.

Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance
---|---|---|---
Electrostatic discharge (ESD) covered IEC 61000-4-2| Contact: +8 kV
Air: +2,+4,+8,+15 KV| Contact: +8 kV
Air: +2,+4,+8,+15 KV| Floors should be wood, concrete or ceramic tile. If the floor is with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/burst IEC 61000-4-4| The input a.c. power ports: ±2 KV
The input d.c. power ports: ±2 KV
Signal input/output ports: ±1 KV| The input a.c. power ports: ±2 KV
The input d.c. power ports: ±2 KV
Signal input/output ports: ±1 KV| The mains power quality should be that of a typical commercial or hospital environment.
Surge
IEC 61000-4-5| Input power ports: +0.5,+1.0 KV
Signal input/ output:+2.0 KV| Input power ports:+0.5, +1.0 KV
Signal input/ output:+2.0 KV| The mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations in power supply input lines
IEC 61000-4-11| 0.5 cycles for

95% (sync angle
(degrees):0, 45, 90, 135, 180,225, 270, 315)
1 cycles for >95% UT (sync angle (degrees):0)
25 (50Hz)/30 (60Hz)
cycles for 30% U T (sync angle (degrees):0) 250
(50Hz)/300 (60Hz)
cycles for >95% UT (sync angle (degrees):0)| 0.5 cycles for
95% (sync angle
(degrees):0, 45, 90, 135, 180,225, 270, 315)
1 cycles for >95% UT (sync angle (degrees):0)
25 (50Hz)/30 (60Hz)
cycles for 30% U T (sync angle (degrees):0) 250
(50Hz)/300 (60Hz)
cycles for >95% UT (sync angle (degrees):0)| The mains power quality should be that of a typical commercial or hospital environment. If the user of the device requires continued operation during mains interruptions, it is recommended that the device be powered using an uninterruptible power supply or a battery.
Power frequency (50Hz/60Hz) magnetic field
IEC 61000-4-8| 30 A/m| 30 A/m| Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE: UT is the a.c. mains voltage prior to the application of the test level.
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3| 3 Vrms
150 kHz to
80 MHz
Professional healthcare environment: 3 V/m
Home healthcare environment:
10 Vm
80 MHz to
2700 MHz| Same as left
Same as left| Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated
using the equation applicable to the frequency of the transmitter.
Recommended separation distance d = 1,2
d = 1,2     80 MHz to 800 MHz
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:
---|---|---|---
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device.
b. Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than 3.
Recommended separation distances between portable and mobile RF communications equipment and the device.

The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of the transmitter (W)| Separation distance according to the frequency of the transmitter (m)
150 KHz to 80 MHz
d = 1,2√p| 80 MHz to 800 MHz
d = 1,2√p| 800 MHz to 2.7GHz
d = 2,3√p
0.01| 0.12| 0.12| 0.23
0.1| 0.38| 0.38| 0.73
1| 1.2| 1.2| 2.3
10| 3.8| 3.8| 7.3
100| 12| 12| 23
For transmitters rated with a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Warranty

Product: Mediblink Ultrasonic Nebulizer M480
Manufactured for (also EU importer): Mediblink d.o.o., Gubčeva cesta 19,
8210 Trebnje, Slovenia; info@mediblink.com; www.mediblink.com
Sellers name, address, signature and stamp:
Date of extradition/sales:
*If the invoice is accompanied by this warranty, and if all above information can be seen from the invoice, it is not necessary to fill in this field.
WARRANTY TERMS
Dear customers!
The warranty period is 3 years and starts from the day of product purchase. The warranty period on spare parts: masks, mouthpiece, tube and filters is 1 year. In case of product claim, you have to show the invoice. We kindly ask you to save the invoice!
Unfortunately, wrong handling with the device is a reason for 95% of customer complains. You can easily avoid any problem, by getting useful information provided by our special service department. To reach our service department, you can call or send e-mail to Mediblink local distributor.
Before sending the product back to retailer, we kindly ask you to call our service department, to get help about how to use the device to save you with unneeded trips.
The manufacturer guarantees free elimination of all imperfections due to defects in material or manufacturing procedure by repairing or replacing the product. In case that the product can not be repaired or replaced, the customer will get the money refund. The guarantee is not valid in case of the force majeure, accidents or unexpected events (such as lightning, water, fire etc.), incorrect use or incorrect transport, non-compliance with safety and maintaining regulations or in case of unprofessional product intervention.
Traces of every day product usage (scratches, abrasions) and not subject to claim. The warranty does not eliminate the customer rights, which originate from seller responsibility for product flaws. By accepting the claimed product by the service department, the service department does not take responsibility for loss of saved data or settings on the product. All product repairs, which are performed out of product warranty period, have to be paid by customer by prior notice.
The manufacturer guarantees the product quality and flawless product operation in the warranty period, which starts with the day of product purchase. If the product can not be repaired in 45 days, the product will be replaced with a new one. In case that the product can not be replaced, the money will be refunded to the customer.
In case of product claim, call or send e-mail to Mediblink local distributor.
Any serious incident that has occurred in relation to the device should be reported to the manufacturer (Foshan City Shunde Toplife Electronic Technology Co., Ltd), company Mediblink d.o.o. and the competent authority of the Member State in which the user and/ or patient is established.
Exclusive representative for Slovenia:
Prolat d.o.o.
Praproče 9
8210 Trebnje – SLO
Tel: +386-(0)7-30-44-555
info@prolat.si
Service and claims: servis@prolat.si
www.prolat.si
Exclusive representative for Croatia:
Golia d.o.o.
XI Vrbik 3
10000 Zagreb
Tel: (01) 61-98-496
info@golia.hr
Service and claims: servis@golia.hr
www.golia.hr
Manufactured for
(EU importer):
Mediblink d.o.o.
Gubčeva cesta 19
8210 Trebnje
Slovenia
info@mediblink.com
www.mediblink.com
**** Foshan City Shunde Toplife Electronic Technology Co., Ltd
7F, 6BLG, Zhifu Industrial Zone, Xingtan Town,
Shunde District, Foshan City,
Guangdong Province, 528325, P.R. China
Lotus NL B.V.
Koningin Julianaplein 10, 1e Verd, 2595AA,
The Hague, Netherlands
Tel: +31644168999
Email: peter@lotusnl.com

Instructions for use version number.: A/8
Instruction for use issue date: 01.02.2020
Date of last correction: 14.12.2021
Software version: V1.0
Document number: HSH-CE-01-016
SRN: CN-MF-000002235

References

• Golia.hr
• Mediblink.com
• Mediblink.si
• Prolat.si

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