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Spectra Wearable Instructions For Use Manual

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Wearable
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INSTRUCTIONS FOR USE

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Summary of Contents for Spectra Wearable

  • Page 1 Wearable ® INSTRUCTIONS FOR USE...

  • Page 2: Table Of Contents

    Table of Contents ��. GLOSSARY ��. INDICATIONS FOR USE ��. DEVICE DESCRIPTIONS ��. CONTRAINDICATIONS ��. WARNINGS ��. PRECAUTIONS ��. BREAST MILK STORAGE AND THAWING ��. HOW TO THAW AND USE STORED BREAST MILK ��. TROUBLESHOOTING ��. USE AND STORAGE ENVIRONMENT ��.

  • Page 3: Glossary

    ��. GLOSSARY Definition of Terms Warning This section describes serious adverse reactions and potential safety hazards, limitations in use imposed by them, and steps that should be taken if they occur. Precaution This section describes information regarding any special care to be exercised by the patient for the safe and effective use of the device.
  • Page 4 • Glossary of Symbols Standard from Reference/ Graphic of which the symbol Registration Symbol Description Symbol Title the Symbol was referenced Number IEC �����-� Table D�-� General Action sign General mandatory action sign IEC �����-� Table D�-�� Type BF Type BF Applied Part To identify the switch or switch position by means of which part of the equipment is switched on in order IEC �����...
  • Page 5 Standard from Reference/ Graphic of which the symbol Registration Symbol Description Symbol Title the Symbol was referenced Number Direct current IEC ����� ���� Indicates the temperature limits to which the ISO �����-�:���� �.�.� Operation Temperature medical device can be safety exposed Indicates a medical device that needs to be protected ISO �����-�:����...

  • Page 6: Indications For Use

    Refer to Instructions for use that should be followed ��. INDICATIONS FOR USE The Spectra Wearable is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Spectra Wearable is intended for a single user.

  • Page 7: Device Descriptions

    �. Bottle Clip - helps the wearable bottle and the bottle connector to be more securely fastened �. Airtight Cap - a lid that seals the bottle so you can store the pumped breast milk immediately (wearable feeding bottle, or Spectra milk storage bottle is compatible) ��.

  • Page 8: How To Assemble

    Combine the wearable cover (�) with the wearable flange (�). c. Insert the wearable bottle (�) into the wearable flange (�). d. Connect the assembled wearable breast flange with the wearable breast pump (�) and start using the product.
  • Page 9 Mode : Massage Mode - / Expression Mode - The SPECTRA WEARABLE has two modes. Massage Mode and Expression Mode. Massage mode has � levels of massage for natural suckling. Expression mode has � levels and � selectable rhythms. The � selectable rhythms use different suction patterns.
  • Page 10 �) PUMPING GUIDE �. Relax, clear your mind, listen to relaxing music. If your baby is not present, look at pictures or videos of your baby. �. Sit in a comfortable chair and if needed to support lower back, use a pillow. �.
  • Page 11 ※ At this time, connect the upper part of the bottle clip so that it can cover the bottle connector. a. feeding breast milk b. storing breast milk Airtight cap Nipple mounting ring and nipple Bottle connector Bottle connector Bottle clip Bottle clip Wearable bottle Wearable bottle ��...

  • Page 12: How To Clean

    NOTE: Use a designated basin to clean your pump parts; do not wash them in the sink. a. How to clean �) Do not wash the wearable pump or power adapter assembly and wipe them with a dry towel. �) Other components are washable. After separating them, wash them with warm soapy water.
  • Page 13 • Clean the wash basin and bottle brush. Rinse the wash basin and brush well and allow them to air-dry after each use. Wash them every few days, either in a dishwasher with hot water and a heated drying cycle (if they are dishwasher -safe) or by hand with soap and warm water.
  • Page 14 - See below chart for boiling times. - Carefully remove items with clean tongs. - PA (Wearable bottle): up to � minutes - PP (all plastics except Wearable bottle): up to � minute - Silicone (Backflow protector, Duckbill valve, Nipple): up to �� seconds WARNING Exceeding boiling times or extended exposure to heat may damage your accessories.

  • Page 15: Contraindications

    WARNING • Microwaving your parts can result in distortion and/or discoloration of the parts. Discoloration is cosmetic and does not affect the chemical composition of the parts. Microwave bags can be used if the proper amount of water is added. Follow the instructions of the bag manufacturer.

  • Page 16: To Reduce The Risk Of Burns, Electrocution, Fire, Or Injury To Persons

    �. Use this product only for its intended use as described in this manual. Do not use any attachments or accessories not recommended by the Uzinmedicare Co., Ltd / Spectra Baby USA. �. Never operate this product if it has a damaged cord or plug.
  • Page 17 ��. The power adaptor must be in a position that is easy to unplug from power outlet. ��. Use only the power adapter that comes with the SPECTRA WEARABLE breast pump. Before using, check to be certain that the voltage of the power source is compatible.

  • Page 18: Precautions

    ��. PRECAUTIONS • If discomfort is felt, then suction can be broken by inserting a finger between the breast and the flange. • If irritation or discomfort occurs, discontinue use and see a healthcare provider. • 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, please discontinue use until the parts have been replaced.
  • Page 19 STORAGE RECOMMENDATION OF FRESHLY EXPRESSED BREAST MILK Guidelines for Healthy, Full-Term Babies Storage Location and Temperatures Countertop Freezer Refrigerator Type of Breast Milk ��°F (��°C) or colder �°F (-��°C) or colder ��°F (�°C) (room temperature) Within � months is best Freshly Expressed or Pumped Up to �...
  • Page 20 • Storage times may vary for premature or sick babies. Please contact your health care provider for instructions. • When storing breast milk, use breast milk storage bags, which are made for freezing human milk. You can also use clean glass or hard BPA-free plastic bottles with tight-fitting lids.

  • Page 21: How To Thaw And Use Stored Breast Milk

    ��. HOW TO THAW AND USE STORED BREAST MILK • Always make sure to check the date on the milk's container before using. Do not use undated milk, or milk that has been stored too long. • Thaw the oldest breast milk first. Thaw frozen milk in the refrigerator or under cool, running water. •...

  • Page 22: Feeding Breast Milk

    - Feeding Breast Milk It is recommended that you establish and maintain your milk supply prior to introducing the bottle to your baby (approximately � weeks.) • Inspect bottle, nipple, and other feeding tools before and after each use. Stop using and replace damaged--cracked and/or torn--nipples immediately.

  • Page 23: Troubleshooting

    Attach silicone valve to breast shield Check if they are connected to No Suction Duckbill Valve - Twist valve into breast shield to attach. the Wearable Flange properly If silicone valve check for tear/damage Vacuum Level Increase vacuum level. Check vacuum level Low Suction Check for damage.

  • Page 24: Use And Storage Environment

    ��. USE AND STORAGE ENVIRONMENT Environment to use Temperature Pressure Humidity Storage environment Temperature Humidity Pressure ��...

  • Page 25: Technical Specifications

    ��. TECHNICAL SPECIFICATIONS Protection Type: Class Ⅱ Weight: ���g Power consumption: ��VA Expected SPECTRA WEARABLE Service Life is � years. The following adapter must be used Manufacturer: Dongguan Shilong Fuhua Electronic Co., Ltd. Model: UES��LCP-������SPA Input: ���-���V~ ��/�� Hz, ���mA Output: �V �A...

  • Page 26: Warranty

    SPECTRA BABY USA office listed below. The purchaser shall bear all responsibility and expense for returning this product, including risk of loss prior to receipt by SPECTRA BABY USA, as well as shipping, packing and insurance costs.

  • Page 27: Electromagnetic Compatibility(Emc)

    ��. ELECTROMAGNETIC COMPATIBILITY (EMC) This equipment needs to be installed and put into service in accordance with the information provided in the user manual. Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least �.�m away from the equipment. This equipment has been tested and found to comply with the limits for medical devices in IEC �����-�-�:����.
  • Page 28 �) Guidance and manufacturer’s declaration ‒ Electromagnetic emissions. This equipment is intended for use in the electromagnetic environment specified below. It is the responsibility of the user of the SPECTRA WEARABLE breast pump to ensure that it is used in such an environment. Emission test...
  • Page 29 �) Guidance and manufacturer’s declaration ‒ electromagnetic immunity This equipment is intended for use in the electromagnetic environment specified below. It is the responsibility of the user of the SPECTRA WEARABLE breast pump to ensure that it is used in such an environment. Immunity test IEC �����...
  • Page 30 P is maximum output power rating of the transmitter in watts. d is the recommended separation distance in meters. 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.
  • Page 31 �) Immunity to proximity fields from RF wireless communications equipment Test frequency Band Modulation Immunity Test Level (V/m) Compliance Level (MHz) (MHz) ��� ���-��� Pulse modulation �� Hz, ��% �� ���-��� MHz �� V/m; PM �� Hz, ��% ��� ���-��� FM ±�...
  • Page 32 Uzinmedicare Co., Ltd. UZ-IFU-WR(US) 54, 56, Dongtansandan 5-gil, Hwaseong-si, Gyeonggi-do, Rev.000 18487, Republic of Korea Tel :+82-70-5228-0983 / www.uzinmedicare.com 2025.03...