Willow Innovations 07A Breast Pump User Manual
ExploraMed NC7, Inc Breast Pump
Contents
- 1. User manual
- 2. User_installation
User manual
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| Document ID | 3177050 |
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| Document Description | User manual |
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| Document Type | User Manual |
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| Date Submitted | 2016-10-27 00:00:00 |
| Date Available | 2017-04-24 00:00:00 |
| Creation Date | 2016-09-27 09:20:08 |
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| Document Lastmod | 2016-10-10 17:59:20 |
| Document Title | User manual |
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IFU-1004 REVISION A TITLE: INSTRUCTIONS FOR USE ECO: 2711 Effective Date: 9/18/16 CONTENT: Slides 2-4 = Cover Slides 5-31 = Internal Pages CONFIDENTIAL - DO NOT DISTRIBUTE Instructions for Use IFU-1004-A TABLE OF CONTENTS 1. Safety Information 2. Indications For Use 3. How Supplied 4. Product Parts & Description 5. Instructions for Use: a. Instructions Before Using b. c. d. e. f. g. h. 6. 7. 8. 9. 10. 11. Pump For First Time Wake-up Pump Milk / Ready For Use Get Set / Assembly Ready To Pump End Pumping Session Clean Flange + Flextube™ Charging Pump Troubleshooting Warranty Technical Specifications Operating Conditions Transport, Storage, Disposal Glossary & Symbols 10 15 22 30 32 33 38 40 48 49 50 1 SAFETY INFORMATION Read all instructions prior to use. Please follow guidelines below when using the Willow Breast Pump. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. WARNINGS: Use product only for its intended use as described in this Instructions For Use pamphlet. This is a personal care product for a single user and should not be shared between users. Only use Willow Breast Pump parts; do not substitute. Do not modify equipment. Close supervision is necessary when product is used near children. Do not operate where aerosol spray products are used or oxygen is being administered. Always break latch before removing pump from breast. Pump is not provided sterile. Do not wash or sanitize pump. Wipe with clean, damp cloth only. Do not immerse pump in water. Do not place pump in refrigerator or freezer. Boil flange and Flextube™ prior to first use. Do not use harsh chemicals to clean flange and Flextube™. Do not store damp components. Do not put flange or milk bag in microwave or microwave sterilizer bags. Milk bag is intended for single use only. Do not re-use. Do not place milk bag in refrigerator door to avoid temperature fluctuations. Do not microwave breast milk. 18. Do not use hot water to thaw breast milk. 19. Do not refreeze thawed breast milk. 20. If you are a mother who is infected with Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV), pumping breast milk will not reduce or remove the risk of transmitting the virus to your baby through your breast milk. 21. Do not use pump during takeoff or landing when traveling on an airplane. 22. Do not drop or insert any object into any openings on pump. 23. Do not attempt to open or repair pump or charger. No modification of this equipment is allowed. 24. Pump will not work when connected to charger; always disconnect pump from charger before using. 25. Only use charger supplied with Willow Breast Pump. 26. Plug charger into an electrical outlet that is visible and easily accessible. To remove line voltage (mains power), unplug the power supply from the wall. 27. Never operate product if cord or plug is damaged, it is not working properly, it has been dropped, damaged or immersed in water. 1. 2. 3. 4. 5. PRECAUTIONS: Ensure flange, Flextube,™ surface of pump and milk bag are clean. Ensure flange, Flextube™ and milk bag are securely assembled and connected to pump. Visually inspect pump, flange and Flextube™ to ensure there are no tears or indications of degraded performance. If any discomfort or pain is felt during pumping, stop pumping, break latch, then reposition pump or cease session. If package appears damaged or tampered with before use, do not use and call Customer Satisfaction Team. WILLOW BREAST PUMP INSTRUCTIONS FOR USE 2 INDICATIONS FOR USE Pump Flange (24mm) Milk Bag Charger Flextube™ Who should use the Willow Breast Pump? The Willow Breast Pump is intended to express milk from lactating women in order to collect breast milk from their breasts. The device is intended for a single user. 2A. CONTRAINDICATION Do NOT use this pump if you have an active implanted device that would be affected by a magnetic field (e.g., pacemaker, implantable cardioverter defibrillator). 3 HOW SUPPLIED Pump is reusable for a single user, and has an expected operating life of 12 months. Cleaning Brushes Reusable parts – flange and Flextube™ – should be cleaned prior to use (see Instructions For Use – Section 5A). These parts are intended for use by a single user only, and should be replaced every 3 months. Milk bags are intended for single use only, disposable and should be discarded after each use. 4 PRODUCT PARTS & DESCRIPTION 4A. PARTS / The Willow Breast Pump contains the number of parts and accessories listed below and shown on the following page. Pump (2), Flange 24mm (2), Flextube™ (2), Milk Bag - 4oz. Disposable (24), Charger (1), Accessories: Cleaning Brushes (2), Carrying Bags (2) For missing or replacement parts, please call Customer Satisfaction Team. WILLOW BREAST PUMP INSTRUCTIONS FOR USE 4B DESCRIPTION / The Willow Breast Pump is a personal use, cordless breast pump for single and double pumping. The product includes: re-chargeable pump, flange, Flextube™ and disposable milk bags. Pump Exterior Pump/Pause Flextube™ Collar Flange Spout Door attaches to Milk Bag attaches to Flextube™ Tip Flange Exterior Button Suction Controls Increase/Decrease Flextube™ Flange Interior on both sides secure Flange to Pump Door Flextube™ Grips slide into grooves on Pump interior Button on both sides secure Flange to Pump On/Off Tunnel Milk Bag Flextube™ Tip attaches to Flange Spout Label Area space to mark date and volume Pump Interior Slot for Tab on Pump Power Port One-way valve lets milk in, but prevents leaks and spills. No cap needed. Reset Button Grooves Alignment Guides for Flextube™ Grips One-way Valve connects to Flextube™ Collar Volume Indicators approximate Serial Number Tab for Slot on Flange WILLOW BREAST PUMP INSTRUCTIONS FOR USE 2. BOIL FLANGE + FLEXTUBE™ – FOR FIRST USE ONLY 5 INSTRUCTIONS FOR USE BOIL flange and Flextube™ (only) to clean: CLEANING + MAINTENANCE / THE BASICS First Time Use Pump Flange + Flextube™ Milk Bag After Each Use Wake-up pump by plugging in for a few seconds. No cleaning required; wipe with damp cloth as needed. Do not immerse pump in water. Boil for 10 minutes. Do not microwave flange. See detailed instructions. Clean with mild dish washing soap and brushes provided. See detailed instructions. Milk bag is disposable and NOT for reuse. Do not microwave milk bag. Discard after each use and do not reuse. 5A. FLANGE + FLEXTUBE™ / PREP FOR FIRST USE 1. SEPARATE FLANGE FROM PUMP fig 1a Hold pump upright, then open by squeezing the two buttons on the top-sides of flange. fig 1b Pivot flange away from pump. a. Place flange and flextube™ in boiling water for 10 minutes. b. Place on clean surface or paper towel and allow to air dry. 5B. WAKE-UP PUMP / POWER ON FOR FIRST USE Remove pump and charger from package. Pump comes charged, though needs to ‘wake-up’. Plug charger into outlet, then into pump. Wait for a few seconds. Unplug charger from pump. 5C. MILK BAG / READY FOR USE • Disposable • One-way valve prevents leaks and spills; no cap needed • May be placed in refrigerator or freezer WARNINGS: DO NOT wash or sanitize pump. Wipe with clean, damp cloth, if needed. DO NOT use harsh chemicals to clean flange and Flextube™. Use mild dish washing soap. DO NOT put flange or milk bag in microwave or microwave sterilizer bags. Milk bag is disposable and NOT for reuse; discard after use. WILLOW BREAST PUMP INSTRUCTIONS FOR USE 5 INSTRUCTIONS FOR USE 5D. GET SET/ ASSEMBLY BEFORE USING PUMP Examine pump and parts for any damage, cracks, chips or wear. 1. CONNECT FLEXTUBE™ TO FLANGE fig 1a Push Flextube™ all the way down onto flange spout, making sure edges are flush. 10 2. ATTACH MILK BAG fig 1b Slide Flextube™ collar into top of flange. Listen for collar to ‘click’ into place. click! fig 2a Slide flange door open by pushing in on blue thumb pad, then sliding up. WILLOW BREAST PUMP INSTRUCTIONS FOR USE fig 2b After sliding door up and open, Pull open. 11 fig 2c Using new milk bag with “This side up,” drape over flange. Firmly press milk bag’s one-way valve onto Flextube™ collar. 12 fig 2d Make sure valve is securely attached to collar. fig 2e Close flange door by swinging closed and sliding down. WILLOW BREAST PUMP INSTRUCTIONS FOR USE fig 2f Tuck edges of milk bag into flange. 13 3. CONNECT FLANGE TO PUMP fig 3a Align bottom of pump (tab) with bottom of flange (slot). 5E. READY TO PUMP • Wear nursing bra that is able to support pump. This is important to keep pump securely in place. • Do not slide pump directly into your bra; follow step-by-step instructions. • Disconnect from charger before use. 1. TURN ON PUMP Press and hold power (On/Off) button for 1 second to turn pump on. Power button will display light to confirm pump is on. Color of light indicates battery status: fig 3b Pivot closed, while ensuring milk bag is completely inside flange. ON/OFF Press and hold for 1 second Enough charge for 2+ sessions Green Solid Enough charge for 1 session. Orange Solid Low battery – inadequately charged for session Red Solid 14 WILLOW BREAST PUMP INSTRUCTIONS FOR USE 15 2. PREPARE BREAST Open bra flap and ensure fabric is out of the way. Holding pump with flange side up, lower tip of nipple into center of flange tunnel. IMPORTANT: Correct nipple alignment is key to comfort and performance. Nipple must be positioned correctly in flange tunnel before pumping to avoid discomfort. 3. ALIGN NIPPLE Center nipple in flange tunnel. TIP: Nipple position on breast varies from one person to another. Begin by taking a look at your breast to determine nipple placement and direction to help align flange tunnel with your anatomy. fig 3a Bend forward and point tip of nipple into exact center of flange tunnel. Center flange with nipple. Nipple points forward. Nipple points up. ALIGNED 16 Nipple points down. Nipple tip should not touch top, sides or bottom of flange tunnel. fig 3b Raise pump to meet breast; be careful not to shift pump’s position. fig 3c Hold pump on breast and sit upright taking care to prevent pump from shifting. TIP: When double-pumping, take a one-at-a-time approach. Start pumping with the first pump and then move on to the second pump. NEEDS REALIGNMENT WILLOW BREAST PUMP INSTRUCTIONS FOR USE 17 5. SECURE PUMP 4. INITIATE LATCH Press pump/pause button to initiate latch and begin pumping. Pump has two modes: Stimulation and Expression. In stimulation mode, pump will start with quick, light pumping to initiate flow of milk, then automatically switch to expression mode once milk is flowing. After pump is latched, keep pump firmly against breast and secure it in place by hooking nursing bra flap over pump. If necessary, tighten bra strap to secure pump in place. fig 4 fig 5 Trouble Initiating Latch? Follow instructions below or see Troubleshooting section. Orange Blinking Indicator: Separate flange from pump and check the 3 connections (reference Section 5D, page 10): 1. Milk bag one-way valve to Flextube™ 2. Flextube™ to flange spout 3. Flange slot to pump tab and pivot closed Orange Blinking + White Pulsing Indicators: Align pump to nipple with special attention to these tips (reference Section 5E Steps 3 - 5, page 15): 1. Bra is not between pump and breast 2. Tip of nipple is centered in flange tunnel 3. Pump is pressed securely against breast while trying to latch. Break latch, (See section 5F, Step 1, on page 22) remove and re-align pump to nipple. 18 What is happening? IMPORTANT: Always break latch before removing pump from breast. Suction Stimulation Mode Pump makes several short sounds and cycles quickly to encourage the breast to ‘let down’ • Suction level cannot be adjusted Expression Mode Sounds are very quiet and slower; the pump has detected let down and is collecting milk in the milk bag • Suction level can be adjusted • Suction level starts at 3 WILLOW BREAST PUMP INSTRUCTIONS FOR USE 19 6. ADJUST SUCTION Pump enters expression mode at level 3. Suction level cannot be adjusted until it enters expression mode. fig 6a Suction can be adjusted using increase/ decrease suction buttons; there are seven levels. fig 6b Expression mode automatically starts at Level 3. Increase to maximum level of suction that is still comfortable. TIPS: NIPPLE REALIGNMENT If any discomfort or pain is experienced during pumping, adjust suction to a more comfortable level. If discomfort is not alleviated, the nipple may need to be realigned as follows: • Pause pump and break latch – see section 5F, step 1, on page 22. • Remove pump from breast, keeping flange side up to avoid spilling milk not yet pumped into milk bag. • Realign nipple and initiate latch by pressing pump/pause button to resume pumping – see section 5E, steps 3 + 4, on pages 16 through 18. • Do not lift or move breast while pump is latching. IMPORTANT: Always break latch before removing pump from breast. 7. PAUSE PUMP To pause while pumping , press pump/pause button. Press it again to resume pumping. Pump stopped automatically? This happens when: White Pulsing Indicator – Auto-Pause: After 25 minutes of pumping, pump will pause. To continue pumping , press pump/pause button. IMPORTANT: Avoid setting suction at a level that causes discomfort. If any discomfort or pain is felt during pumping, stop pumping, break latch, then reposition pump or cease session. 20 White Solid Indicator – Full Milk Bag: When bag is full, pump stops pumping. Break latch, remove pump, perform easy empty (see 5F, Step 2, page 22) replace milk bag. To resume pumping, follow instructions starting with section 5E, step 3, page 16. WILLOW BREAST PUMP INSTRUCTIONS FOR USE 21 5F. END PUMPING SESSION 1. BREAK LATCH Follow the steps below to remove pump: fig 1a Pause pump by pressing pump/ pause button. 22 fig 1b Unhook bra and bend forward; support bottom of pump with one hand. TIP: There will be a little milk in the flange; the pump’s Easy Empty will help you capture it. fig 1c Break latch by placing a few fingers between pump and breast. WILLOW BREAST PUMP INSTRUCTIONS FOR USE fig 1d Rotate pump, keeping flange side up. 23 2. EASY EMPTY To automatically move the last bit of milk from flange tunnel into milk bag, rotate pump upside down (blue thumb pad pointing to floor) and hold it in that position until it stops making any sounds (6 cycles). fig 2a With flange side up, turn so top of pump is pointing toward you. 24 fig 2b Slowly rotate pump upside down (blue thumb pad pointing to floor), so milk runs into deepest part of flange. TIP: The pump is designed to move any milk remaining in the flange tunnel and Flextube™ into the milk bag. Just follow these simple instructions and the pump will know exactly what to do. fig 2c As pump rotates it will automatically transfer remaining milk into bag. WILLOW BREAST PUMP INSTRUCTIONS FOR USE fig 2d Continue to rotate pump until completely upside down. Hold there until it stops pumping to capture all milk. 25 3. TURN PUMP OFF Pump will turn off automatically after it moves remainder of milk into bag. Pump may also be turned off manually by pressing On/Off button. 4. OPEN PUMP fig 4a Hold pump upright, then open pump by squeezing the two buttons on top-sides of flange. 5. REMOVE MILK BAG fig 4b Pivot flange away from pump. fig 5a Slide flange door up and pull open. fig 5b Detach milk bag’s one-way valve from Flextube™ collar. fig 5c Remove filled milk bag and store in refrigerator, freezer or cooler. The one-way valve allows it to be laid flat without leaking. TIP: The milk bag can be stored in the freezer for up to six months. 26 WILLOW BREAST PUMP INSTRUCTIONS FOR USE 27 MILK STORAGE GUIDELINES La Leche League International Storage Duration Guidelines For Breast Milk for use with healthy full term babies. WHERE TEMPERATURE TIME Room Temperature 66 to 78°F (19 to 26°C) 4 hours (ideal) up to 6 hours (acceptable)* Refrigerator Freezer Deep Freezer <39°F (<4°C) 0°F (-18°C) -4°F (-20°C) 6. EMPTY MILK BAG fig 6a Open bag and place spout into bottle and slowly tilt bag. fig 6b Pour milk into bottle. To release as much as possible, squeeze bag. Discard milk bag. 72 hours (ideal) up to 8 days (acceptable)** 3-6 Months 6 months up to 12 months Source: La Leche League International 2014 * The preference is to refrigerate or chill milk right after it is expressed. ** Eight days acceptable if collected in a very clean, careful way WARNINGS: DO NOT microwave breast milk. DO NOT use hot water to thaw frozen breast milk. DO NOT place filled milk bag in refrigerator door to avoid temperature fluctuations. 28 7. CLEAN flange and Flextube™ as instructed (Section 5G). 8. CHARGE Check battery level after each use by pressing On/Off button. If the battery level is low, charge pump with charger provided. WILLOW BREAST PUMP INSTRUCTIONS FOR USE 29 5G. CLEAN FLANGE + FLEXTUBE™ After every use, follow these directions: 1. RINSE Immediately Separate flange from pump, then seperate Flextube™ from flange, and rinse both parts with water to avoid buildup of breast milk residue and prevent bacterial growth. 2. SOAK For 5 Minutes Using mild dish washing soap, soak both parts in very warm, soapy water for 5 minutes (minimum). 3. Wash + Brush Thoroughly Using the two cleaning brushes provided, wash each part separately in soapy water for 60 seconds (minimum) and brush for 30 seconds (minimum) as follows: fig 3c Use small brush to clean inside top opening and area under collar. fig 3d Insert small brush into tip at bottom and clean. 4. RINSE FOR 20 SECONDS Rinse both parts thoroughly with hot water for 20 seconds (minimum). Visually inspect parts to ensure each is clean. If any signs of residual milk, repeat cleaning process. 5. AIR DRY + STORE Place both parts on clean paper towel or drying rack and allow to air dry. For best results: Avoid using cloth towels; store dry parts in clean, cool place; do not store wet or damp parts. To maintain cleanliness, avoid touching inside of parts. TIP: FLANGE AND FLEXTUBE™ ARE DISHWASHER SAFE USING TOP-RACK ONLY. fig 3a Insert small brush into spout and clean. 30 fig 3b Use large brush to clean inside top opening and body being careful NOT to push brush all the way through tip at bottom. IMPORTANT: Take care not to damage parts when cleaning. Replace flange, Flextube™ and/or cleaning brushes after signs of excessive wear. WILLOW BREAST PUMP INSTRUCTIONS FOR USE 31 5H. CHARGING PUMP 1. Plug charger into pump’s power port. ONLY USE charger supplied with the Willow Breast Pump. 2. Plug other end of charger into any standard electrical outlet (120 V). Once pump is charged, remove charger from pump and unplug from electrical outlet. 6 TROUBLESHOOTING Use chart to help solve any problems that may arise. If problem persists or to report unexpected operation or events, call Customer Satisfaction Team. PUMP POWER LEVEL INDICATORS: CHARGING TIMES: • QUICK CHARGE Takes approximately 20 minutes to charge (1 session). • FULL CHARGE Takes approximately 2 hours and light indicator will turn solid green when fully charged (approximately 5 sessions). Enough charge for 2+ sessions. Pump is ready to pump. • Pulses while charging • Solid when fully charged (approximately 5 sessions) Enough charge for 1 session. Pump is ready to pump. Recharge soon. • Pulses while charging Low battery / inadequately charged for session. In order to pump for a full session, charge immediately. • Single Session - Charge time approximately 20 minutes. • Full Charge - Charge time approximately two hours. Light turns solid green when fully charged. Pump does not wake-up. To resolve issue: • Hold On/Off button for 1 second to turn pump on. • Plug into charger to ensure battery has enough charge. Green Orange IMPORTANT: Pump will not operate while plugged into electrical outlet. Red No Color 32 WILLOW BREAST PUMP INSTRUCTIONS FOR USE 33 WHEN PUMP IS IN USE: Orange Blinking Milk bag, Flextube™ or flange not assembled correctly. Separate flange from pump and check the 3 connections (reference Section 5D, page 10): 1. Milk bag one-way valve to Flextube™ 2. Flextube™ to flange spout 3. Flange slot to pump tab and pivot closed. If the issue persists, call Customer Satisfaction Team. No latch / Pump cannot achieve or has lost suction. Align pump to nipple with special attention to these tips (reference Section 5E Steps 3 - 5, page 15): 1. Bra is not between pump and breast 2. Tip of nipple is centered in flange tunnel 3. Pump is pressed securely against breast while trying to latch. If the issue persists, complete steps for orange blinking alert (Milk Bag, Flextube™ or Flange not assembled correctly). White Pulsing and Orange Blinking Milk bag is full. OTHER ISSUES Milk in flange or Flextube™ after easy empty. • Turn on pump. • Press pump/pause button. • Rotate pump as shown in section 5F, step 2, page 24. Pump does not “pump.” • Check that pump is not plugged into charger. • Confirm that pump is powered on by holding the On/Off button for 1 sec. • Confirm battery level is orange or green. If red, recharge pump. Milk does not flow. • Check nipple alignment - remove pump from breast and reposition taking care to align nipple in center of flange tunnel (reference Section 5E, Steps 3 - 5). • If letdown has not yet occurred, consider leaving pump on breast for longer period of time to observe for possible delayed letdown. Note: Initial milk letdown time and milk flow rate vary for each person. Discomfort while pumping. It is important that pumping is comfortable. If experiencing any discomfort try the following (reference Section 5E, Steps 3 - 5, page 15): • Adjust suction level. • Adjust flange placement. • Check nipple alignment - pause pump, break latch, remove pump from breast and reposition taking care to align nipple. • Adjust bra. • Stop and see medical professional or breastfeeding specialist. Remove full bag and store properly. Change bag and continue pumping. White Solid White Pulsing 34 Pump paused and waiting for next command, or Pumping time exceeded 25 minutes, so automatically paused. • To continue pumping, press pump/pause button. • To end session, break latch and remove pump. TO RESOLVE ISSUE WILLOW BREAST PUMP INSTRUCTIONS FOR USE 35 OTHER ISSUES Decreased (low) pump suction. TO RESOLVE ISSUE • The pump has seven suction settings; push up arrow to increase suction. • If that does not work, try the following: * Check connections between flange, Flextube™ and milk bag to ensure all are secure. * Visually inspect flange, Flextube™ and milk bag and replace if damaged. * Check that power is on and battery has sufficient charge. * Press pump securely against breast. Note: Suction level can be adjusted in Expression mode. Pump stops pumping. • Pump stops automatically after 25 minutes pump/pause button pulses - press pump/pause to re-start pump. • Pump may have stopped because milk bag is full pump/pause button solid - check milk bag. • Pause/pump button may have been pressed pump/pause button pulses white - press pump/pause button to continue pumping. • Check to see if low battery - On/Off button light is solid red. Pump does not stop pumping. • Press pump/pause button. Break latch and remove pump. • If issues persists, break latch and remove pump. Then hold On/Off button for 1 second to turn pump off. OTHER ISSUES TO RESOLVE ISSUE Pump or charger gets wet (immersed in water). • Dry pump off immediately. Do not use pump or charger. • Call Customer Satisfaction Team. Pump is not charging. • Ensure charger is fully plugged into pump power port. Device needs to be reset. • Call Customer Satisfaction Team for instruction on use of reset button. Please do not use reset button without these instructions. The Willow Breast Pump is not a serviceable device. Align pump to nipple with special attention to these tips (reference Section 5E Steps 3 - 5, page 15): A lot of air in milk bag. 36 1. Bra is not between pump and breast 2. Tip of nipple is centered in flange tunnel 3. Pump is pressed securely against breast while trying to latch. If the issue persists, complete steps for orange blinking alert (Milk Bag, Flextube™ or Flange not assembled correctly). WILLOW BREAST PUMP INSTRUCTIONS FOR USE 37 7 WARRANTY Under our limited warranty, Exploramed NC7 warrants to the original consumer purchaser (the “purchaser”) to be free from defects in material and workmanship for the period of 9 months from the date of purchase on the pump mechanism and the period of 90 days on all other product components under normal use and conditions (the “Warranty Period”). This limited warranty does not cover damage caused by accident, misuse, normal wear and tear, improper use, unauthorized maintenance or repair, or failure to follow written instructions for use. The pump can not be submerged in water, washed or sanitized, placed in the refrigerator or freezer, used during takeoff or landing when traveling on an airplane, or used with any charger that is not provided with the pump. The flange can not be placed in microwave or microwave sterilizer bags. Doing so voids this limited warranty. Warranty coverage terminates if you sell or otherwise transfer this product to another person. This warranty gives you specific legal rights and you may also have other rights, which vary, by location. Exploramed NC7 Inc. MAKES NO EXPRESS WARRANTY OF ANY KIND REGARDING THE PRODUCT OTHER THAN THOSE WARRANTIES EXPLICITLY SET FORTH HEREIN. ANY IMPLIED WARRANTY, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY, NON-INFRINGEMENT, QUIET ENJOYMENT, OR ANY IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE, TO THE EXTENT PERMITTED BY LAW, SHALL BE LIMITED IN DURATION TO A PERIOD OF 90 DAYS FROM THE DATE OF PURCHASE BY THE ORIGINAL PURCHASER. In the event the product is found by Exploramed NC7 to not meet the above limited warranty in the Warranty Period, as purchaser’s sole and exclusive remedy ExploraMed NC7 will repair or, at the option of Exploramed NC7, replace this product without charge for such replacement or parts or labor. NOTE: The purchaser shall bear all expense for returning this product to Exploramed NC7. This limited warranty does not apply to any product that has been used commercially, subjected to misuse, abuse, or alteration. 38 Only Willow brand replacement parts are recommended for use with Exploramed NC7 Willow breastfeeding products. Improper or incorrectly performed maintenance or repair, or use of non-Exploramed NC7 brand replacement parts may invalidate this limited warranty. TO THE EXTENT PERMITTED BY LAW, Exploramed NC7 SHALL NOT BE LIABLE FOR ANY INDIRECT, SPECIAL, PUNITIVE, EXEMPLARY INCIDENTAL OR CONSEQUENTIAL DAMAGES INCLUDING, BUT NOT LIMITED TO, REPLACEMENT COSTS RESULTING FROM THE BREACH OF ANY WRITTEN OR IMPLIED WARRANTY. If you wish to make a claim under this limited warranty, you must return the product to ExploraMed Willow prepaid, together with your dated bill of sale or other dated proof of purchase and a brief statement of the problem, along with a Returned Goods Authorization number. You may obtain the appropriate Authorization number and shipping address by calling the phone number or sending an email to the email address provided below. Items returned without an associated Returned Goods Authorization Number will be returned to sender. To obtain the address to return goods or a Returned GoodsAuthorization Number contact the Customer Satisfaction Team. We recommend recording your serial number here when you first open your pump for easy reference when contacting Exploramed NC7 Customer Satisfaction Team. The serial number can be found on the pump interior. Record the Serial Number(s) here for easy reference: Pump 1: Pump 2: WILLOW BREAST PUMP INSTRUCTIONS FOR USE 39 Electromagnetic Compatibility Compliance Statement Information 8 TECHNICAL SPECIFICATIONS The Willow pump may be used at home, office, or other general areas. Special consideration should be given to use: POWER REQUIREMENTS • During Medical Procedures: Do not use the Willow pump during any medical procedure or during imaging. For example, do not use pump during RF ablation of a skin anomaly, x-ray, MRI, or ultrasound. Only use the Willow Breast Pump Charger Manufacture: Delta Electronics Inc., Part Number MDS-030AAC05 ZB Specifications: 100 - 240 vac, 50-60Hz, 0.5A-0.3A • With other Equipment: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, the pump and the other equipment should be observed to verify that they are operating normally. SPECIFICATIONS Pump dimensions 141mm x 85mm x 112mm Pump weight 355 g Vacuum Strength 60-245 mmHg Cycle Speed 60-90 cycles/minute Motor Life 273 hours (Defined to be approximately three 15 minute sessions per day for one year.) Date of Manufacture: The date of manufacture can be located within the serial number of the pump. The serial number is an 11 digit number formatted as: xxxYM xxxxxx where “Y” is the year and “M” is the month. Use the tables to determine the year and month of manufacture. 40 Date of Manufacture: Year Code 2016 2017 2018 2019 2020 Month Code Jan Feb Mar Apr May Jun Jul 2021 Aug 2022 2023 Sep Oct Nov Dec • In High Electrostatic Discharge Environments: If the air is very dry, use the pump where floors are wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. If you notice shocks when you touch things, as sometimes happens in very dry winter months, be sure to touch a metal item such as a table before handling the Willow pump. • In Industrial Settings: Avoid using the pump near arc welding equipment, radar installations, and similar industrial settings. • Near RF Emitters: Keep devices that use WiFi, Bluetooth, and other intentional RF emitters at least 30 cm from the pump during operation. This includes communications equipment peripherals such as antenna cables and external antennas. Otherwise, degradation of the performance of the Willow pump could result. If you know the power output the RF emitter, the table labeled “Electromagnetic Compatibility Compliance Statement Information” can be used for more precise information about separation distances. WILLOW BREAST PUMP INSTRUCTIONS FOR USE 41 Warning: Use of accessories other than those specified by Exploramed NC7 may result in increased emissions or decreased immunity of the Willow Breast Pump. The Willow Breast Pump has no essential performance; however, it was tested for immunity to electromagnetic disturbances. The Willow Breast Pump passed with the following acceptance criteria: pumping vacuum does not exceed a safe level and no components fail. Electromagnetic Compatibility Compliance Statement Information Recommended separation distances between portable and mobile RF communications equipment and the Willow Breast Pump Rated maximum output power of transmitter This equipment uses wireless communication: Frequency (transmit and receive): 2400 – 2483.5 MHz Separation distance according to frequency of transmitter (m) 150kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz 0.01 0.12 0.12 0.23 0.1 0.37 0.37 0.74 1.17 1.17 2.33 10 3.69 3.69 7.38 100 11.67 11.67 23.33 Modulation: frequency hopping with GFSK Effective radiated power: 4 mW This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (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. 42 WILLOW BREAST PUMP INSTRUCTIONS FOR USE 43 GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS The Willow Breast Pump is intended for use in the electromagnetic environment specified below. The customer or user of the Breast Pump should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment – Guidance RF emissions CISPR 11 Group 1 The Willow Breast Pump uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Class B Harmonic emissions IEC 61000-3-2 Voltage fluctuations/flicker emissions IEC 61000-3-3 Class A Complies The Willow Breast Pump is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS The Willow Breast Pump is intended for use in the electromagnetic environment specified below. The customer or user of the Breast Pump should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment – Guidance Electrostatic discharge (ESD) IEC 61000-4-2 ±8 kV contact ±15 kV air ±8 kV contact ±15 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. ±2 kV for power supply lines The Willow Breast Pump is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. ±1 kV line to line The Willow Breast Pump is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 44 ±2 kV for power supply lines ±1 kV line to line WILLOW BREAST PUMP INSTRUCTIONS FOR USE 45 GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS The Willow Breast Pump is intended for use in the electromagnetic environment specified below. The customer or user of the Breast Pump should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 <5 % UT (>95 % dip in UT) for 0.5 cycle 30% reduction, 25/30 periods at 0° > 95% reduction, 0.5 period at 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° > 95% reduction, 1 period at 0° > 95% reduction, 250/300 periods <5 % UT (>95 % dip in UT) for 0.5 cycle 30% reduction, 25/30 periods at 0° > 95% reduction, 0.5 period at 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° > 95% reduction, 1 period at 0° > 95% reduction, 250/300 periods The Willow Breast Pump is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 30 A/m The Willow Breast Pump is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 30 A/m NOTE UT is the a.c. mains voltage prior to application of the test level. 46 Electromagnetic Environment – Guidance GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS The Willow Breast Pump is intended for use in the electromagnetic environment specified below. The customer or user of the Breast Pump should assure that it is used in such an environment. Immunity Test Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 IEC 60601 Test Level Compliance Level Electromagnetic Environment – Guidance 3 V; 150 kHz to 80 MHz 3 V; 150 kHz to 80 MHz 6 V; ISM and amateur radio bands between 0.15 MHz and 80 MHz 6 V; ISM and amateur radio bands between 0.15 MHz and 80 MHz 3V/m 80 MHz to 2.7 GHz 3V/m 80 MHz to 2.7 GHz Portable and mobile RF Communications equipment should be used no closer to any part of the Willow Breast Pump, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.2√P d = 1.2√P 80 MHz to 800 MHz d = 2.3√P 800 MHz to 2.5 GHz 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 meters (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 80MHz and 800MHz, 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. WILLOW BREAST PUMP INSTRUCTIONS FOR USE 47 GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS 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 Willow Breast Pump is used exceeds the applicable RF compliance level above, the Willow Breast Pump should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Willow Breast Pump. DISPOSAL INFORMATION The breast pump contains rechargeable lithium ion batteries. Use your local return and collection system for electrical waste and electronic equipment (including batteries). Flange and milk bags can be disposed of in your home’s recycling container. Flextube™ should be disposed of in your home’s waste management container. b. Over the frequency range 150 kHz to 80MHz, field strengths should be less than 3 V/m. 11 GLOSSARY & SYMBOLS 9 Operating Conditions PUMP CONTROL BUTTONS OPERATING CONDITIONS BUTTON Operating Temperature 5 to 40 °C Relative Humidity 15% - 90%; non-condensing Pressure 70 hPa to 1060 hPa FUNCTION ON / OFF PUMP / PAUSE 10 Transport, Storage, Disposal TRANSPORT AND STORAGE 48 Temperature - 25 to 70 °C Relative Humidity 0%-93%; non-condensing Pressure 50 hPa to 1060 hPa UP ARROW = INCREASE Suction Strength DOWN ARROW = DECREASE Suction Strength WILLOW BREAST PUMP INSTRUCTIONS FOR USE 49 SYMBOLS SYMBOL SYMBOLS DEFINITION DEFINITION SYMBOL DEFINITION SYMBOL DEFINITION Manufacturer Keep away from heat Keep dry Type BF Applied Part Date of Manufacture Temperature Limit Class II Equipment – Device does not rely on earth plug or power cord. Ingress Protection Lot Number Humidity Limitation Indoor use only Do not throw in trash. Send to a recycling center. Do not reuse. Radiation Recycling Product tested by Intertek and found in compliance with standards listed. Catalog Number Serial Number Do not use if package is damaged 50 SYMBOL Atmospheric Limitation Consult instructions for use Caution WILLOW BREAST PUMP INSTRUCTIONS FOR USE 51 Manufactured For: 201 San Antonio Circle Suite 172 Mountain View, CA 94040 United States Contact Information: Customer Satisfaction Team 1-844-6-WILLOW ©2016 Exploramed NC7, Inc. All rights reserved. Willow and Flextube are Trademarks of the Exploramed NC7, Inc. CAREFULLY READ ALL INSTRUCTIONS PRIOR TO USE Save instructions and sales receipt for future reference. The Bluetooth ® word mark and logos are registered trademarks owned by the Bluetooth SIG, Inc. and any use of such marks by Exploramed NC7 is under license. Other trademarks and trade names are those of their respective owners 52
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