Avita BR10 Manual

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Breast Pump

Model:

BR10

MDSS GmbH

Schiffgraben 41

30175 Hannover Germany

AViTA Corporation

9F., No. 78, Sec. 1, Kwang Fu Rd.,

San Chung Dist., New Taipei City 24158, Taiwan, China

China, AViTA(WUJIANG)

Importer

Distributor

RoHS REACH

Table of Contents

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Page 1 Breast Pump Model: BR10 RoHS REACH MDSS GmbH Schiffgraben 41 30175 Hannover Germany AViTA Corporation 9F., No. 78, Sec. 1, Kwang Fu Rd., San Chung Dist., New Taipei City 24158, Taiwan, China China, AViTA(WUJIANG) Importer Distributor...
Page 2: Table Of Contents
INSTRUCTION MANUAL Please read this instruction manual carefully before operating this unit Contents Intended Use........................1 Important Information Before Use ................7 Product Identification ....................10 LED display description ....................12 Using the breast pump ....................13 Selecting the correct massage cushion ..............15 Assembling the breast pump ..................
Page 3 Cleaning and Disinfecting ................... 37 Technical Specification ....................42 EMC Tables ......................... 44 Explanation of Symbols ....................48...
Page 4: Intended Use
Intended Use This device is intended to express and collect milk from the breast of a lactating woman, and to alleviate engorgement of the breast. The device is intended for a single user. Warranty / Service center Read this user manual carefully before you use the breast pump and save it for future reference.
Page 5 Warnings Warnings to avoid choking, strangulation and injury: • Do not allow children or pets to play with the motor unit, the adapter, packaging materials or accessories. As strangulation may occur due to excessive length of the cables. • Always unplug the breast pump after use and when fully charged. •...
Page 6 • If you are a mother who is infected with Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV), expressing breast milk will not reduce or remove the risk of transmitting the virus to your baby through your breast milk. Warnings to avoid contamination and to ensure hygiene: •...
Page 7 damaged or broken. • There are no user serviceable parts inside the motor unit of the breast pump. • No modification of the breast pump is allowed. If you do so, your warranty becomes invalid. • Never use the breast pump while you are sleepy or drowsy to avoid lack of attention during use.
Page 8 Warnings to prevent damage and malfunction of the breast pump: • Portable radio frequency (RF) communications equipment (including mobile phones and peripherals such as antenna cables and external antennas) should not be used closer than 30 cm (12 in) to any part of the breast pump.
Page 9 • Always unplug the product when it is fully charged. • Do not burn products and their batteries and do not expose them to direct sunlight or to high temperatures (e.g. in hot cars or near hot stoves). Batteries may explode if overheated. •...
Page 10: Important Information Before Use
• Keep the silicone tubes away from heated surfaces to avoid overheating and deformation of these parts. Important Information Before Use If breastfeeding goes well, it is advisable (unless recommended otherwise by your healthcare professional) to wait until your milk supply and breastfeeding schedule are established (normally at least 2 to 4 weeks after giving birth) before you start expressing.
Page 11 The performance of the device can be affected by extremes of temperature, humidity and altitude, Please refer to the instructions for use. Using the product while charging may cause product shut down due to charging efficiency. It is recommended not to use the product while charging.
Page 12 CAUTION: • Avoid potential allergic reactions; please avoid the Massage cushion in direct contact with patient's wound. • User potential allergic reaction may occur due to skin contact with the plastic parts, please seek professional medical help if allergic reaction occurs.
Page 13: Product Identification
Product Identification A: Mode selection button B: 'Level down' button C: 'Level up' button D: On/off button with pause/play function E: Tubing port F: USB Type C power inlet G: Cap H: Silicone diaphragm I: Pump body J: Massage cushion K: Valve L: Bottle M: Tubing connector...
Page 14 Accessories • Breast pump kit including Cap, Silicone diaphragm, Pump body, Massage cushion, Valve and Bottle.
Page 15: Led Display Description
LED display description A: Stimulation phase indicator B: Expression phase indicator C: Vacuum level indicator D: Use time countdown E: Battery indicator F: Pause icon G: Time unit...
Page 16: Using The Breast Pump
Using the breast pump Charging the breast pump • Fully charge the battery before you use the breast pump for the first time and when the battery is low. • Fully charging the battery takes up to 4 hours. Charged battery operates approximately 4 pumping sessions.
Page 17 With decreasing battery capacity fewer bars appear. One bar: approx. 40 % of the capacity is remaining. When the outline of the battery display is flashing, the battery is very low, the device will stop operating, charging is needed. Battery lights light up one by one and go out all together. The battery is charging.
Page 18: Selecting The Correct Massage Cushion
Selecting the correct massage cushion Make sure to use the correct massage cushion size. It is an essential component of effective pumping, helping to optimize milk flow. Understanding massage cushion sizing • Pumping should not hurt. For maximum comfort and pumping efficiency, we offers multiple breast shield sizes.
Page 19 Step 1 • Using a ruler or measuring tape, measure the diameter of the nipple at the base (across the middle) in millimeters (mm). Step 2 • Based on the measurement, determine the massage cushion size. • Example: If the nipple size measures 18mm in diameter, the recommended massage cushion size is 24mm.
Page 20 level. • Refer to the images below while pumping in the expression phase (after the stimulation phase).
Page 21: Assembling The Breast Pump
• The nipple rubs • The nipple is • The nipple and along the side of the centered and moves excessive areola are funnel. freely. pulled into the •Try a larger size. funnel. •Try a smaller size. Assembling the breast pump Make sure you have cleaned and disinfected the parts of the breast pump that come into contact with milk.
Page 22 • Wash your hands thoroughly with soap and water before you touch breast pump parts and breasts to prevent contamination. Avoid touching the inside of containers or lids. CAUTION: • Before each use, visually inspect the individual components for cracks, chips, tears, discoloration or deterioration. In the event that damage to the device is observed, discontinue use until the parts have been replaced.
Page 23 Note: 1. Correct placement of the cushion, silicone diaphragm and silicone tube is essential for the breast pump to form a proper vacuum. 2. Make sure that you clean and sterilise the pump as instructed in this user manual. 3. Make sure that you assemble the pump correctly as instructed in this user manual.
Page 24: Accessories Assembly
Accessories assembly Step 1 Step 2 Step 3 Connect and Done Assemble the assemble the parts bottle and cap in the picture Such as Step 4 Such as Step 2...
Page 25 Step 4 Step 5 Step 6 Done Connect the Connect the silicone tube silicone tube to the host...
Page 26: Operation Instructions
Operation instructions Step 1 Step 2 Step 3 Press and hold the Stimulation mode In stimulation On/Off Button for (2 minutes mode, press the 3 seconds to turn countdown) Level up Button to increase the Such as Step 2 vacuum adjustment in five levels.
Page 27 Step 4 Step 5 Step 6 In stimulation Auto switch: In expression mode, press the stimulation mode, press the Level down mode(2 minutes) Level up Button to Button to reduce then switch to increase the the vacuum expression mode vacuum adjustment in five (20 minutes) adjustment in five...
Page 28 Step 7 Step 8 Step 9 In expression It will Press the Mode mode, press the automatically shut Button to switch Level down down three between Button to reduce minutes after the stimulation mode the vacuum end of the and expression adjustment in five expression mode.
Page 29 Step 10 Step 11 You can also press done and hold the On/Off Button for 3 seconds to shut down. Such as Step 11...
Page 30 Pumping instructions Warnings • Before you remove the pump body from your breast, always switch off the breast pump to release the vacuum. • Do not continue pumping for more than 5 minutes at a time if you do not succeed in expressing any milk. Try to express at another time during the day.
Page 31: Using The Breast Pump When You Have Symptoms Of Engorgement
Note: When symptoms of engorgement are present, make sure you empty your breasts completely during each expression session. Error Codes Error code list for BR10 Possibly occur when working: • Er: Battery Charger IC error • E1: Pump control circuit error...
Page 32: Recycling
Recycling Do not throw away the product with the normal household waste at the end of its life, but hand it in at an official collection point for recycling. By doing this, you help to preserve the environment. Follow your country’s rules for the separate collection of electrical and electronic products.
Page 33: Troubleshooting Table
Troubleshooting table Problem Solution I experience pain when I use the • Choose a suction level that is breast pump. comfortable for you. • Check if the silicone diaphragm is not damaged (does not have small cracks, holes etc.). • Make sure that your nipple is placed in the center of the cushion.
Page 34 Problem Solution The breast pump does not • Make sure that the adapter has switch on while it is connected been inserted correctly into the to power outlet. power outlet and that the small plug has been inserted correctly into the motor unit.
Page 35 Problem Solution The breast pump is not • Make sure that the adapter has charging. been inserted correctly into the power outlet and that the small plug has been inserted correctly into the motor unit. • The breast pump is too cold or too hot for charging.
Page 36 Problem Solution Charging the breast pump takes • Make sure that the adapter has a very long time. been inserted correctly into the power outlet and that the small plug has been inserted correctly into the motor unit. • The breast pump is too cold or too hot.
Page 37 Problem Solution I do not feel any suction/the • If possible, try a higher suction suction level is too low. level. • Check if the silicone diaphragm is assembled correctly. • Check if the white valve is not damaged and assembled correctly. •...
Page 38 Problem Solution The suction of the breast pump • If possible, try a lower suction level. is too strong. When you express for the first time, start with the default suction level and increase/decrease the level when needed. During different expression sessions, different levels may feel most comfortable for you.
Page 39 Problem Solution The breast pump exterior got • Unplug the breast pump from the wet. power source and switch it off. • Dry off the exterior of the breast pump. The breast pump has been • Unplug the breast pump from the submerged in water.
Page 40: Cleaning And Disinfecting
Cleaning and Disinfecting Overview Clean and disinfect the parts that come into contact with the breast and breast milk as described below: When Clean and disinfect Refer to 'Cleaning the before first use and accessories'. after every use.
Page 41 The following parts do not come into contact with the breast and breast milk; clean them as described below: When Clean when needed. Refer to 'Cleaning the motor unit'. Clean when needed. Refer to 'Cleaning the tubing'.
Page 42 Cleaning the accessories Step 1: Disassembling • Disassemble the breast pump, bottle completely. • Also remove the white valve from the breast pump. Warnings • Do not use antibacterial or abrasive cleaning agents to clean the breast pump parts as this may cause damage.
Page 43 Step 2: Cleaning 1. Completely disassemble the baby bottle accessories (as shown in the figure). 2. Prepare mild detergent. 3. Use cold drinking water (around 20°C) to rinse the disassembled parts, excluding the pipes, for approximately two minutes. 4. Use mild detergent to clean each part. The cleaning process should take about five minutes.
Page 44 1. Switch the breast pump off. 2. Unplug the breast pump from the power source. 3. Wipe the motor unit with a clean towel moistened with dringing-quality water. 4. Wipe the motor unit dry with a clean, dry towel. CAUTION: •...
Page 45: Technical Specification
Technical Specification • Vacuum level: -60 to -360 mbar (-45 to -270 mmHg) • Motor unit rated input : 5 V d.c. / 2 A • Battery : Li-Ion 3.7 V, 2900 mAh (non-replaceable) • Battery SHELF LIFE: 3 Years •...
Page 46 Ambient Pressure: 700~1060 hPa • Weight : approx. 258g (only motor unit) • Dimensions : approx. L 126 mm x W 100 mm x H 44.2 mm • Life time: 500 hours • Interval usage: 30 minutes ON / 30 minutes OFF •...
Page 47: Emc Tables
EMC Tables BR10 is intended for use in the electromagnetic environment specified below. The customer or the user of AViTA BR10 must make sure that it is used in such an environment. Guidance and manufacturer’s declaration - Electromagnetic emissions CISPR 11...
Page 48 Voltage CISPR 11 fluctuations and Group 1 Class A (Not BLE Function) flickering Group 2 Class A (With BLE Function) a) The equipment is suitable for use in Home Health Environments and Professional Health Care Environments limited to patient rooms and respiratory treatment facilities in hospital or clinics.
Page 49 facility environment ELECTROSTATIC IEC 61000-4-2 ± 8kV contact DISCHARGE ± 2 kV, ±4kV ±, ±8 kV, ±15 kV air Radiated RF EM IEC 61000-4-3 10 V/m 80MHz - 2.7 fields GHz 80% AM at 1kHz Proximity fields IEC 61000-4-3 COMPLIANT from RF wireless NOTE: Further information about communications...
Page 50 minimise possible interference. RATED power IEC 61000-4-8 30 A/m frequency 50 Hz or 60 Hz magnetic fields. a) The equipment is suitable for use in Home Health Environments and Professional Health Care Environments limited to patient rooms and respiratory treatment facilities in hospital or clinics. The more restrictive IMMUNITY acceptance limits have been considered and applied.
Page 51: Explanation Of Symbols
Explanation of Symbols The CE marking with the Registration Number of the Notified Body. This denotes the compliance of Regulation (EU) 2017/745 Medical Device Manufacturer...
Page 52 Authorized representative in the European Community Date of manufacture (YYYY-MM-DD or YYYY-MM or YYYY) Batch code LOT WWWXXXXX LOT: Lot Number; WWW: working sheet; XXXXX: serial no. Serial number SN YYMWWWXXXXX YY: year; M:month; WWW: working sheet; XXXXX: serial...
Page 53 Keep dry Temperature limit Humidity limitation Atmospheric pressure limitation...
Page 54 Caution Consult the instruction for use Disposal information: Should you wish to dispose of the article, do so in accordance with current regulations. Details are available from your local authority. WEEE 2012/19/EU Directives This product fulfilling the requirements of the RoHS Directive 2011/65/EU.
Page 55 This product fulfilling the requirements of the REACH Directive EC 1907/2006 and its amendments, do not contain Substances of Very High Concern in concentration above the limit of 0.1 %. No substance(s) is/are present in REACH the parts of the product above the concentration of 0.1 % weight by weight.
Page 56 This product meets the basic safety and essential performance requirements indicated in the IP22 conditioning test (protection against solid foreign objects of 12.5mm ∅ and greater and against vertically falling water drops when enclosure tiled up to 15°) The empty, completely flat batteries must be disposed of through specially designated collection boxes, recycling points or electronics retailers.
Page 57 Distributor Model Number Country of Manufacturer Unique Device Identifier Keep away from sunlight Electronic IFU available at http://www.avita.com.tw BR10P-22867AV 2022-03-14...