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Medela Waterless Milk Warmer ™

Maintenance & Technical Guide

Table of Contents General Description��1 Save These Instructions�� 2-3 Technical Description��4-5 Waterless Milk Warmer™ Controls��6-7 Inspection & Test Procedure��8-10 Troubleshooting ��11-12 Cleaning ��13-14 Replacement Parts�� 15 Terms of Guarantee�� 15

The Medela Waterless Milk Warmer has been designed to warm and thaw milk for hospital patients without the use of water. The Medela Waterless Milk Warmer has been developed to assist in the minimization of potential contamination risks associated with warming human milk with water in hospital environments. It is designed to meet the stringent demands of critical care environments where hygiene, durability, and reliability are critical. The Medela Waterless Milk Warmer operates by circulating heated air into an enclosed chamber which contains either a breastmilk storage container or syringe. Through forced convection, over time the milk contained in either the container or syringe warms to an acceptable temperature comparable to expressed breastmilk temperatures. The Warmer Insert is a disposable component to the warmer that assists in ease of cleaning by containing spills and reducing contact potential between patient containers and the warmer itself. The warmer will not work without the insert properly installed in the warmer cavity. The device is intended to be used as as a bedside unit. Inserts are single patient use items and are identified as such on the individual inserts themselves. The Medela Waterless Milk Warmer can accommodate breastmilk storage containers (glass and plastic) up to 250 mL and all major brands of syringes (plastic) up to 60 mL.

IMPORTANT SAFEGUARDS When using electrical devices, basic safety precautions should always be followed, including the following:

READ ALL INSTRUCTIONS BEFORE USE DANGER: To reduce the risk of electrocution: 1.

Always unplug electrical devices immediately after using. Separation from the mains is only assured through the disconnection of the plug and socket connection.

2.

Do not use while bathing or showering.

3.

Do not place in or drop motor unit into water or other liquid.

4.

Do not reach for any electrical device if it has fallen into water. Unplug immediately.

5.

Do not store or use this product where it can fall or be pulled into a tub or sink.

6.

Always use an outlet with proper protective earthing.

WARNING: To reduce the risk of burns, electrocution, fire or injury to persons: 1.

The warmer should never be left unattended when plugged into an electric outlet.

2.

Use the warmer only for its intended use as described in the instruction manual.

3. Do not use accessory attachments not recommended by the manufacturer, as this may create hazardous conditions. 4. Never operate an electrical device if it has a damaged cord or plug, if it is not working properly, if it has been dropped or damaged, or if it has been dropped into water. 5.

Keep the cord and all components away from heated surfaces.

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6.

Do not pour water into or on the warmer.

7.

Do not use outdoors.

8.

Only use the electric cord that comes with the Medela Waterless Milk Warmer™.

9. The Medela Disposable Inserts for the warmer are single patient use care items and are not to be shared between patients to help prevent the risk of cross contamination. 10. The warmer should be cleaned as needed with a Cavicide solution or other common hospital disinfectant using wipes or a lint-free cloth. Do not spray or poor liquid directly onto the warmer. 11.

Supervision is necessary when this product is used in the vicinity of children.

12.

Make sure the voltage of the device is compatible with the power source.

13.

Operate warmer only with the warmer in an upright position.

14.

Do not use while sleeping or overly drowsy.

15. There are no user-serviceable parts inside the Medela Waterless Milk Warmer. DO NOT ATTEMPT TO REPAIR THE WARMER YOURSELF. 16. ALWAYS FEEL CONTAINER/SYRINGE & CHECK MILK TEMPERATURE BEFORE FEEDING. 17. As with any IV pole mounted device, do not overload IV pole with excess equipment that may cause a tipping hazard. 18. Do not place warmer on IV pole at a height over 5 feet to minimize the potential for tipping during operation. 19.

While cleaning, warmer should be turned off and unplugged.

SAVE THESE INSTRUCTIONS

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Medela Waterless Milk Warmer™ Technical Description SAFETY INSTRUCTIONS Caution Hot Surface

Power Supply Inlet V~ Hz A

IEC C6 100-240 50/60 2.5

DISPOSAL:

The Medela Waterless Milk Warmer is made of technical plastics and metals that cannot be separated. It must be disposed of in accordance with local regulations.

WARRANTY:

The warranty for the unit is 1 year from the date of delivery. The manufacturer is not liable for any damage or consequential damage caused by incorrect operation, inappropriate usage or use by unauthorized persons. Routine checks and servicing may only be carried out by Medela authorized personnel.

DIMENSIONS: Width: Height: Depth:

7.6 inches 9.6 inches 9.3 inches

WEIGHT (without packing materials): 4.2 lb

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IV Pole Bracket (sold separately):

• Quick release spring plunger. • Mounts to either side of unit to provide mounting flexibility. • Does not interfere with countertop use of warmer if left attached.

ENVIRONMENTAL CONDITIONS FOR OPERATION: Temperature: +15 °C to +30 °C (+59 °F to +86 °F) Relative Humidity: 20% to 80% Atmospheric Pressure: 70 kPa to 106 kPa

ENVIRONMENTAL CONDITIONS TRANSPORT AND STORAGE: Temperature: -20 °C to +50 °C (-4 °F to +122 °F) Relative Humidity: 20% to 95% Atmospheric Pressure: 70 kPa to 106 kPa

STANDARDS:

This product has been tested to the requirements of CAN/CSA-C22.2 No. 61010-1, second edition, including Amendment 1. ISO 13485 FDA (QSR) UL/CSA 61010-1

ELECTROMAGNETIC OR OTHER INTERFERENCE:

Complies with IEC 61326-1. Unlikely to interfere with other electrical equipment.

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Medela Waterless Milk Warmer™ Controls LCD display

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8

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7 4 3

2

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11 1

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1. Completion Time 2. Completion Indicator appears when warm or thaw mode is complete or interrupted 3. Elapsed Time 4. Elapsed Time Label 5. Pause Indicator 6. Error Indicator 7. Install Insert Symbol 8. Lid Open Symbol 9. Audible Indicator 10. Mode 11. Milk Temperature 12. Volume amount in mL

Warming mode Thawing mode Refrigerated start temperature Room start temperature Frozen start temperature

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Medela Waterless Milk Warmer™ Control Panel

Power

Enter L/R Arrows

Mute Stop Indicator Light

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Start

Inspection & Test Procedure A visual and functional check of the Waterless Milk Warmer™ should be performed on a periodic basis for optimal performance. If maintenance or repairs are needed, this guide will walk you through the steps. Please contact Medela Customer Service with any questions at 800-435-8316.

Inspection • Housing: Inspect housing for damage. If housing is damaged contact Medela for repairs. • Hinge: Lid should open and hold itself upright for access to inner chamber. If lid fails to stay open contact Medela for repairs. Note: Grease is normal on metal hinge parts, do not remove or it will shorten life of hinge. • Screw cover plugs: 4 rubber screw cover plugs should be installed on the underside of the lid. If any are missing or damaged, contact Medela for replacement part #820.7064. • Power cord: Inspect power cord for damage to plug, damage to insulation, and missing or bent prongs. If the cord is damaged, contact Medela for replacement part #928.7013. • Control panel membrane: Inspect buttons for tears, cuts, and legibility. If control panel is damaged contact Medela for repairs. • LCD display: Inspect LCD for proper backlight and symbol illumination. If LCD is damaged or showing excessive bleed, spotting, or fading contact Medela for repairs.

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Test Procedure The Waterless Milk Warmer™ continually performs background self-diagnostic checks during normal operation to ensure the warmer is functioning as intended. The following test procedure outlines steps to verify general operations and temperatures. 1. Plug in the warmer. Warmer should be in cooled, room temperature initial state. For best results, the warmer should also be located in an area that has adequate ventilation and the ambient temperature is 18-25 °C (64-77 °F). Ensure vents are not blocked and the warmer is away from other heat generating equipment. 2. Open lid to upright position and remove all items from inside warmer, including the insert. Lid must remain in an open position and internal sensors must remain unobstructed. Ensure interior of unit is clean. a. Turn power on. b. Enter Warm-Refrigerated-1 mL and attempt to start unit. c. Verify that unit says “error” and that with the lid open that the Install Insert symbol is flashing. 3. Check internal temperature with Medela test probe kit part #87125. a. Place insert into warmer ensuring bag portion is smoothed out against the inner walls of the chamber. Do not place a bottle or syringe in the unit as this will affect temperature readings. b. Close lid. c. Remove cap from test probe to expose the sensor tip.

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d. Inspect test probe to verify that the sensor tip, wires, and plug are undamaged. Verify the sensor tip is straight and extends approximately 3/4” from plug as shown. Order replacement test probe part #87126 if necessary.

Test Procedure (cont.) e. Install tester plug into the insert syringe port. f. Ensure thermometer is within calibration. Medela recommends the Omega HH11B digital thermometer (Medela part #87125) for K type thermocouples. g. Enter Warm-Refrigerated-250 mL settings and start warmer. h. Verify that the exhaust vent is closed (no exhaust) immediately after starting the warming cycle. i. Verify temperature at 10 minutes elapsed time: the warmer temperatures will vary over time, spiking at the beginning of the cycle before stabilizing, this is normal operation. When the elapsed time counter on the display reaches the 10 minute point, verify the temperature on the thermometer is 65 +/- 7 ºC. IMPORTANT: Bag portion of the insert must be thoroughly smoothed in step “a” and verified that the airflow to the sensor tip will not be impeded, otherwise temperature readings will be affected. j. Allow unit to finish warming cycle and run an additional 1/2 hour afterwards to execute a complete warming hold cycle. When the 1/2 hour hold period is complete, the fan will stop and the warmer will beep more frequently. k. Verify that no error codes were generated during the test.

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Troubleshooting Problem

Indicators

Light indicator is flashing red.

Error indicator & insert indicator on LCD panel are illuminated.

Light indicator is flashing red.

Error indicator & close lid indicator on LCD panel are illuminated.

Unit will not power up. IV pole clamp slips out of the warmer after installed into the pole mount slot on the side of the warmer. Milk too warm.

Hot to the touch.

Milk too cool.

Cold to the touch.

Thawed milk has no ice. Cannot resume from pause mode.

“Pause” indicator

Unexpected pause mode during operation.

“Pause” indicator

Light indicator is flashing red.

Error indicator & error code in the lower left section of the LCD panel where the large timer would be. Error Code: 01-08, 11, 12 Error Code: 09 Error Code: 13 Error Code: 14

If in the US, call Medela at 800-435-8316 or 815-363-1166. In Canada, call Medela at 800-435-8316 or 905-608-7272. Visit us on the internet at www.medela.com.

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Possible Solution Ensure insert is installed. Open the lid to the warmer and properly install the insert. Press start. Close the lid and press start. Check to see if plug in the back of the warmer is pushed completely in. Unplug the device from the wall outlet and try another outlet. Make sure that the IV pole adapter pin is engaged prior to installation and snaps into place when the adapter slides into the pole mount slot. Allow milk to cool before feeding. Ensure proper settings are used. Note: High temperatures may damage some active immunological properties of breastmilk. Place milk back into unit within 60 seconds and press start to continue warming. Do not initiate another warming cycle. Ensure proper settings are used. Retrieve milk promptly when thawing cycle is complete. Ensure lid is closed and insert is fully seated. If using a syringe, ensure it is replaced before hitting start. Ensure insert is fully seated and syringe is centered. If unit is near an intense infrared emitting light source such as sunlight or heat lamps, move to another location. Hold power button for at least 4 seconds or unplug the device, wait ten seconds, plug the device back into the wall, and press the power button. Contact Medela Customer Service at 1-888-633-3528. Return for service. Ensure fan is not blocked. Allow unit to warm up to room temperature before use. Ensure unit is in an area with adequate room temperature ventilation. Ensure vents on bottom and rear of unit are not blocked.

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Cleaning IMPORTANT: Before using any cleaning or decontamination method except those recommended by the manufacturer, users should check with the manufacturer to ensure the proposed method will not damage the equipment. Equipment user has the responsibility for carrying out appropriate decontamination if hazardous material is spilled on or inside the equipment. IMPORTANT: Do not submerge, autoclave, heat, steam, ETO, or radiation sterilize the warmer. NOTE: These recommendations are not substitutes for official procedures that may differ among institutions. IMPORTANT: Grease on metal hinge may be visible and is considered normal. DO NOT remove grease as it may shorten the life of the hinge.

Acceptable cleaning agents: • Cavicide® cleaner and/or wipes

• Isopropyl alcohol

• Sani-cloth® cleaner and/or wipes

• Soap and water

Acceptable milk containers: • Bottles up to 250 mL (plastic or glass). Maximum height 162 mm. • Syringes up to 60 mL (plastic).

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Between each patient use: • Remove Medela Disposable Insert and clean with Cavicide® or other common hospital disinfectant using wipes or a lint-free cloth. Do not spray or pour liquid directly into or onto the warmer. • Allow to air dry before use.

Hygiene:

Wash hands before operating the warmer, opening inserts, and/or installing inserts.

Preparation:

The Medela Waterless Milk Warmer™ should be cleaned prior to first use. It should be cleaned between patients. This product’s inserts are single-patient use items and should not be shared. Use of the warmer by more than one user without proper cleaning may pose a health risk.

In use:

Medela Disposable Inserts are a limited use item. Medela recommends changing the inserts every 12 hours. Inserts should be changed if human milk comes in contact with the inserts. Inserts should also be changed if visible damage has occurred that would offer the potential for human milk to come in direct contact with the warmer.

Insert care:

Inspect insert after each warming and/or thawing session for condensation and/or milk. Inserts are single patient use items.

If condensation appears in insert:

Condensation may appear in the insert if the frozen bottle placed and thawed in the warmer had frost on its outside. To eliminate condensation after you have completed the warming and/or thawing cycle, allow to air dry.

If milk appears in insert:

Immediately dispose of the insert. Inspect the warmer for any signs of milk contamination and clean if necessary. Install a new insert in the warmer for next use.

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Replacement Parts Item

Part No.

Rubber Screw Cover Plugs ��820.7064 IV Pole Adapter ��500.7005 WMW Power Cord ��928.7013 Warmer Disposable Inserts �� 87116-100 Test Probe Kit (thermometer and probe) ��87125 Test Probe ��87126

Terms of Guarantee The manufacturer may only be held responsible for inadequate safety, reliability, and performance of the unit if assembly, additional items, adjustments, alterations and/or repairs have been carried out by persons authorized by the manufacturer and: • The electrical installation within the room concerned satisfies IEC requirements (in the course of preparation). • The unit is used as specified in the manufacturers instructions and assembly manual. • Disposable inserts used on the Medela Waterless Milk Warmer™ are authorized by Medela.

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Medela, Inc., P.O. Box 660, 1101 Corporate Drive McHenry, IL 60051-0660, USA Ph: (800) 435-8316 or (815) 363-1166 Fax: (815) 363-1246 Email: [email protected]

www.medela.com

Medela is a registered trademark and Medela Waterless Milk Warmer is a trademark of Medela. Cavicide® is a registered trademark of Micro Aseptic Products, Inc. Sani-cloth® is a registered trademark of Professional Disposables International, Inc.