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Hygeia Express Manual

Powered breast pump
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Express
Powered Breast Pump
ART-70304-01-AA

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Summary of Contents for Hygeia Express

  • Page 1 Express Powered Breast Pump ART-70304-01-AA...
  • Page 2 The Hygeia Personal Accessory Set is a closed system that contains a diaphragm that keeps the air from the pump and tubing separate from the pump parts that are exposed to your breast milk, so your tubing stays dry. This diaphragm helps prevent milk backup into tubing.

  • Page 3: Table Of Contents

    TABLE OF CONTENTS WARNINGS & CAUTIONS ............................5 INTENDED USE ................................8 CONTRAINDICATIONS FOR USE ..........................8 PRODUCT DESCRIPTION............................. 9 SET-UP INSTRUCTIONS ............................10 Before First Use: Clean The Personal Accessory Set....................10 Assembling the Personal Accessory Set (PAS) Milk Collection System ..............11 INSPECTING BEFORE PUMPING ..........................
  • Page 4 Icon Glossary See reference detail in Section 15 Warning Unit of measure Class II electrical appliance Caution Temperature range For indoor (double insulated) Important use only Humidity range Type BF Applied Part Refer to Instruction Atmospheric pressure manual Waste electrical and range Non-ionizing Fragile, handle...

  • Page 5: Warnings & Cautions

    • If the power adapter casing or wiring becomes loose, separated, or frayed, stop use of the power adapter immediately and contact Hygeia Customer Service at 714-515-7571 Option #2. Stop using the device immediately if you note any smoke or burning from the pump unit or power adapter.
  • Page 6 Environmental Conditions That Affect Use • DO NOT use outdoors with electrical cord. • DO NOT operate where oxygen or aerosol spray products are being used. ENGLISH ART-70304-01-AA...
  • Page 7 Customer Service at 714-515-7571 Option #2 immediately. • DO NOT repair device by yourself. Do not modify the device or parts, please contact Hygeia Customer Service for help. • DO NOT continue pumping for more than 2 consecutive pumping sessions if breast milk is not collected.

  • Page 8: Intended Use

    The HYGEIA Express Powered Breast Pump is not safe for use in an MRI environment. • NOTE: The Express Breast Pump has been tested and found to comply with the limits for medical devices to IEC 60601-1-2:2014 4 edition. These limits and test levels are intended to provide reasonable safety with regard to electromagnetic disturbances when the device is used in a typical medical installation.

  • Page 9: Product Description

    NOTE: Only use the Hygeia Personal Accessory Set (PAS) and Hygeia replacement parts with this pump. The Express Powered breast pump may also be used with the Hygeia Wearable PAS. Using the Hygeia Wearable PAS may result in your having to select a different suction level to achieve maximum comfort during pumping.

  • Page 10: Set-Up Instructions

    If you see breast milk inside the tubing or tubing connector do not attempt to wash, clean or sterilize the tubing or tubing connector. Instead contact Hygeia Customer Service at 714-515- 7571 Option #2.

  • Page 11: Assembling The Personal Accessory Set (Pas) Milk Collection System

    5.2 Assembling the Personal Accessory Set (PAS) Milk Collection System Once your pump parts are completely dry before use, wash your hands thoroughly and assemble the Personal Accessory Set Milk Collection System (Pump Kit). Attach the Flange Funnel to the Flange Base Attach the Duckbill Valve into the bottom of the Flange base.
  • Page 12 Connect the 3-piece assembled Backflow protector to the top of the Flange Base pushing in firmly. NOTE: When removing the backflow protector, twist and pull it straight out, away from the flange base. Do not bend the backflow protector to remove it. Doing so may result in damage.

  • Page 13: Inspecting Before Pumping

    6. INSPECTING BEFORE PUMPING IMPORTANT: Before using the Hygeia Express and Personal Accessory Set system, check the parts for cracks, chips, tears, or wear. They can affect the function of the kit. If parts need replacing due to defects, please call Hygeia Customer Service at 714-515-7571 Option #2 OR visit www.hygeiahealth.com.

  • Page 14: Operating Instructions

    Choosing and checking your electrical source AC POWER ADAPTER WARNING: Use ONLY the AC power adapter recommended for the Hygeia Express Powered Breast Pump. WARNING: Always inspect the AC power adapter for damage such as kinking or twisting of cords or frayed or exposed wires.

  • Page 15: Lcd Icons & Modes

    C. SUCTION STRENGTH LEVEL Level of suction strength during pumping. The Hygeia Express Powered Breast Pump has 9 suction levels in each of the three pumping modes Increase suction by pressing the “+ “ button and decrease suction by pressing the “ - “ button.

  • Page 16: To Begin Pumping

    7.4 To Begin Pumping STEP 1: INSERT TUBING Insert Connector end of Tubing into the front port holes of the Hygeia Express Powered breast pump and gently push it to make sure it connects firmly. For DOUBLE PUMPING: Attach both connectors with tubing to the Hygeia Express Powered breast pump.
  • Page 17 Adjust the Massage (M) Vacuum Level between 1 and 9 to your preferred comfort level. Never set to an uncomfortable level. TIP: Start off with the suction low, and then gradually increase the suction setting to your most comfortable level. You may find that the level of comfortable suction varies day-to-day, during the day and even during the same expression session.

  • Page 18: How To Fit Your Flange

    7.5 How to Fit Your Flange Check breast flange fit, if pumping causes discomfort a larger or smaller breast flange size may be needed. GOOD FIT FLANGE TOO SMALL FLANGE TOO LARGE During pumping, your nipple moves During pumping, some or all of your During pumping, more areola is freely in the breast flange tunnel.

  • Page 19: Cleaning

    If breast milk is seen inside the tubing or tubing connector, they should not be washed, cleaned, or sterilized. Instead, contact Hygeia customer service at 714-515-7571 Option #2 for a replacement. HOW TO WASH TUBING: 1.

  • Page 20: After Every Use

    8.3 After Every Use 1. Wash hands well with soap and water for 20 seconds. 2. Store milk safely. Cap milk collection bottle or seal milk collection bag, label with date and time, and immediately place in a refrigerator, freezer*, or cooler bag with ice packs.
  • Page 21 6. CLEAN PUMP KIT PARTS BY HAND cleaning steps Place pump parts in a clean wash basin used only for infant feeding items. Do not place pump parts directly in the sink! Add soap and hot water to basin. Scrub items carefully to carefully clean accessible surfaces.

  • Page 22: After Cleaning

    If you see breast milk inside the tubing or tubing connector do not attempt to wash, clean or sterilize the tubing or tubing connector. Instead contact Hygeia Customer Service at 714-515-7571 Option #2. IF YOU DISINFECT PARTS BY BOILING DO NOT allow boiling parts to contact bottom of pot.

  • Page 23: Maintenance

    9. MAINTENANCE The breast pump base does not require service or maintenance. 9.1 Breast Pump Valve and Diaphragm Check Inspect the valves and diaphragms for tears or holes. Replace any damaged valves and diaphragms prior to pumping. Wash valves and diaphragms per the instructions in Cleaning Section 8.2 above, “After Every Use”. Do not insert a bottle brush or something similarly rough into the valves.
  • Page 24 (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Caution: Changes or modifications to this device not expressly approved by Hygeia may void the user's authority to use the device.

  • Page 25: Warranty

    Hygeia’s sole obligation under this limited warranty shall be to replace, at Hygeia’s option, any Product that is determined to be defective by Hygeia and determined to be covered by this express limited warranty.

  • Page 26: Technical Data

    IEC 60601-1 (electrical safety of medical electrical equipment); IEC 60601-1-11 (home healthcare medical electrical equipment) and IEC 60601-1-2 (electromagnetic compatibility). The Hygeia Express Powered Breast Pump and Personal Accessory Sets are manufactured in a facility certified to the International Quality Management Standard, ISO 13485:2016.

  • Page 27: Electromagnetic Compatibility

    12.2 Electromagnetic Compatibility The essential performance of the Hygeia Express Powered Breast Pump is to maintain suction level at maximum setting and not exceed 275 mmHg. The pump was tested for immunity to electromagnetic disturbances and passed according to these criteria.
  • Page 28 TABLE 2 Guidance and declaration of manufacturer-electromagnetic immunity. (For home healthcare environment) The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment Electromagnetic environment - IMMUNITY test IEC 60601 test level...
  • Page 29 0.15- 80MHz 0.15- 80MHz than 30 cm (12 inches) to any part of 80% AM at 1kHz 80% AM at 1kHz the Express, including cables specified by the manufacturer. Otherwise, degradation of the 10V/m, 80MHz - 10V/m, 80MHz - Radiated RF performance of this equipment could 2.7GHz, 80% AM at...
  • Page 30 TABLE 4 IEC 60601-1-2:2014 Table 9 — Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test Maximum IMMUNITY Band Distance frequency power TEST LEVEL Service Modulation (MHz) (MHz) (V/m) Pulse modulation 380 - TETRA 400 18 Hz 430 - GMRS 460, FRS 5 kHz deviation...

  • Page 31: Product Disposal

    WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Express, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

  • Page 32: Symbols Reference

    15. SYMBOLS REFERENCE ISO 15223-1, Medical devices – Symbols to be used ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labelling and information with medical device labels, labelling and information to be supplied, Part 1: General requirements, Clause to be supplied, Part 1: General requirements, Clause 5.3.1, Fragile, handle with care / ISO 7000-0621, 5.1.7 Serial number / ISO 7000-2498, Graphical...
  • Page 33 Manufactured for: Hygeia II Medical Group, Inc. 6241 Yarrow Drive Suite A Carlsbad, CA 92011 714.515.7571 www.hygeiahealth.com Hygeia II Medical Group Inc. 6241 Yarrow Drive Suite A Carlsbad, CA 92011 ©2023 Hygeia, Inc. ESPAÑOL | 33 ART-70304-01-AA...

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