medela 46030 Calesca Warming/Thawing Device Instructions

medela 46030 Calesca Warming/Thawing Device

Product Overview

LCD display

1. Completion Time
2. Completion Indicator appears when warm or thaw mode is complete or interrupted
3. Elapsed Time
4. Elapsed Time Indicator
5. Pause Indicator
6. Error Indicator
7. Insert Liner Symbol
8. Close Lid Symbol
9. Alarm Mute Symbol
10. Mode
    • Warming mode
    • Thawing mode
11. Milk Temperature
    • Refrigerated start temperature
    • Room start temperature
    • Frozen start temperatur
12. Volume amount in mL

Item numbers

1. Disposable Inserts (4 boxes of 25 pcs. each) 020.0002
2. IV Pole Adapter 020.0001
3. Power Cord Euro 200.3719
4. Power Cord CH 200.3720
5. Power Cord UK 200.3721
6. Power Cord AUS/NZ 200.3722
7. Power Cord JA 200.4202
   Inserts and IV Pole Adapters are sold separately. For further information about Medela products, visit www.medela.com and look for location finders in your country.

Contents

Each Calesca Warming/Thawing device is packaged and shipped seperately.

Contents include:

• 1 Calesca Warming/Thawing device
• 1 Power cord
• 1 Instructions and assembly manual

Calesca Warming/Thawing Device

This device can both warm and thaw breast milk or supplement in a hospital environment and operates by circulating heated air in an enclosed chamber which contains either a breast milk storage container or a syringe. Calesca heats liquids in most commonly used containers to approximately 34°C (34°C ±1 4°C) – be they frozen, out of the fridge or at room temperature or thaws it to a refrigerated temperature. The slow warming process helps preserve nutrients and vitamins. The device‘s functions, features, and design are especially developed to fit into NICUs (Neonatal Intensive Care Units) as a single bedside unit. However, the device can also be used in the maternity, on the pediatric ward, etc.

Intended Use

Calesca is a device to warm and thaw milk.

• Used to warm breast milk or supplement for hospital patients without the use of water to an ideal feeding temperature (approximately 34° C).
• Used to thaw breast milk or supplement from a completely frozen state for hospital patients without the use of water (to a refrigerated temperature).
• Breast milk or supplement can be defrosted and then portioned to be refrigerated and used during the day.

Important Safeguards

When using electrical devices, basic safety precautions should always be followed to reduce risk of burns, electrocution, fire or injury to persons. Read all instructions carefully before use.

Product

• Use the product only for its intended use as described in this instruction manual.
• Only use the power cord that comes with the device (choose the correct plug for your country).
• Keep appliance dry and do not place in direct sunlight.
• Do not place in or drop unit into water or other liquid.
• Only use the Medela components supplied with the unit.
• Do not use accessories not recommended by the manufacturer, as this may create hazardous conditions.
• Check components for wear or damage.
• To prevent damage to the unit or injury, do not lift or carry unit by its lid.
• There are no user-serviceable parts inside the device. Do not attempt to repair the device yourself.
• If an IV pole adapter is used with the device, do not overload IV pole with excess equipment that may cause a tipping hazard.

Electrical

• Make sure the voltage of the device is compatible with the power source.
• Plug the power cord into the device first and then into wall socket.
• Always unplug electrical devices immediately after using.
• Separation from the mains is only assured through the disconnection of the power cord from the wall socket outlet.
• Keep the power cord and all components away from heated surfaces.
• 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.
• Do not reach for any electrical device if it has fallen into water. Unplug immediately.
• Always use an outlet with proper protective earthing.

Using/Operation

• Supervision is necessary when this product is used in the vicinity of children.
• This appliance is not intended for use by persons with reduced physical, sensory or mental capabilities, or lack of experience or knowledge, unless they have been given supervision or instruction concerning use of the appliance by a person responsible for their safety.
• Operate the device only in an upright position.
• The device should never be left unattended when plugged into an electric outlet.
• Do not use while sleeping or overly drowsy.
• Do not use outdoors.
• Do not store or use this product where it can fall or be pulled into a tub or sink.
• Do not use while bathing or showering.
• Do not place device on IV pole at a height over 1.5m (5 feet) to minimize the potential for tipping during operation.
• Do not warm breast milk storage bags
• Do not place the device on a soft surface.
• Use caution when warming milk in containers and/or with lids that contain metal.
• Do not warm milk with a feeding device (e.g. Calmita or teat) on the bottle.
• Always check milk temperature before feeding.
• Warming small amounts of breast milk or supplement in large bottles can reduce warming efficiency.
• If the device is switched on and not running a cycle, it will automatically turn off after 10 minutes.

Cleaning and Hygiene

• The device should be cleaned prior to first use.
• The device should be cleaned between patient use or as needed with a common hospital disinfectant using wipes or a lint-free cloth. See care & cleaning section for approved cleaning agents. Do not spray or pour liquid directly onto the device.
•  While cleaning, device should be turned off and unplugged.
• The Medela Disposable Inserts for the device are single patient use care items. To prevent cross contamination do not share inserts between patients.
  NOTE : This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense.

Assembly and Installation

Remove Calesca from packaging. Allow unit to reach room temperature before use. Review instructions and assembly. Place sticker with display explanation in your language on Calesca if needed.

1. Connect the power cord provided (choose the correct plug for your country) with the device in the socket located on the back of the unit. Push the wire cord retainer located around the device power socket down over the plug until secure.
   NOTE : For an ideal sound pressure level, we recommend to place the device 1 meter or more away from the patient. Installation on a counter space or other hard surface

2. Make sure that surface is clean and dry. Place the device on a solid surface. Ensure the device is secure on the surface to avoid tipping or falling. Place the device on a surface low enough for staff to see into the device cavity.
   Do not block vents on bottom or rear of device. Do not place on a soft surface.
   Optional: Installation on an IV pole

3. Remove IV pole adapter from packaging (sold separately). Locate the two IV positioning slots on either side of the device. Verify the pin on the IV pole adapter is engaged (see picture). If pin is not engaged, turn the round knob clockwise until the pin engages.

4. While securely holding the device in one hand, carefully slide the U-shaped portion of the adapter into the desired IV slot located on the device until it clicks into place. Position the adapter onto the desired IV pole. Make sure the device does not interfere with any other equipment on the IV pole. To secure, turn the triangular knob clockwise until the clamp is tight onto the IV pole.

5. To remove the device from the IV pole bracket, pull pin out, turn ¼ turn, and release. The pin will remain disengaged and allow for device to slide off the bracket. IV pole bracket does not interfere with countertop use of device if left attached.

Operation

Acceptable breast milk containers:

• Bottles up to 250 ml (plastic or glass) with a maximum height of 161 mm.
• Syringes up to 60 ml (plastic).
  NOTE : The Calesca Warming/Thawing Device is designed to warm only one container at a time.

1. Plug the hospital grade plug into a wall outlet. Press the power button on the device display panel. The unit is setup with both a visual indicator located on the front of the unit and a low volume audible indicator. To mute the audible indicator, press the mute button. To confirm that the audible indicator is muted, the symbol will appear in the upper right portion of the LCD Display.
   Insert installation

2. Remove Medela Disposable Inserts from plastic bag. For proper identification, patient labels can be placed on the bag portion of the insert; or using a permanent marker patient information can be written on the hard surface of the insert, including date and time.

3. Open the lid of the device. Expand the insert prior to installing it into the device. Bend the insert at the hinge and place it into position. Securely install insert using the tabs located on the back and front of the device cavity.
   NOTE : Device will not operate if insert is not installed correctly.

4. Evenly spread liner within warmer cavity.
   IMPORTANT : For good air flow and accurate warming, insert should be spread out against the inner walls of the device.

5. Place the tray, flat-side down, into the bottom of the device.
   NOTE : Always use tray when warming syringes or bottles.
   Warming or thawing in a container

6. Always use a lid on the milk storage container. Make sure insert is installed and insert tray is properly seated in device. Place the container on the center of the tray in the device and close the lid. The device will not operate if the insert is not installed correctly. Note the volume of milk to be warmed.
   CAUTION : Use the proper size container in comparison to the volume of breast milk or supplement being warmed. Small amounts of breast milk or supplement in large containers can reduce warming efficiency.
   WARNING :

   • Use caution when warming milk in containers and/or with lids that contain metal.
   • Do not warm milk with a feeding device (e.g. Calmita or teat) on the bottle.
   • Do not warm using breast milk storage bags.
   • Always feel container/syringe and check milk temperature prior to feeding

7. Warming or thawing in a container
   Always use a cap on the syringe. Make sure insert is installed and insert tray is properly seated in device. Close the lid of the device. The device will not operate if the insert is not installed correctly. Note the volume of milk to be warmed.
   WARNING : Always feel container/syringe and check milk temperature prior to feeding.
   Warning mode

8. Press On/Off button to turn on the device. Look at the LCD display to confirm the device is in WARM mode.
   NOTE : The device defaults to warm mode.

9. Select the milk starting temperature (refrigerated, room, or frozen) by using the arrow keys / to highlight the desired starting temperature.Press the enter button enter to confirm starting temperature.
   NOTE : The device initially defaults to the milk starting temperature (symbol refrigerated) (refrigerated) based on 4 ˚C or 39.2 ˚F.

10. Use the arrows to enter the volume of milk to be warmed. Press the enter button enter to confirm volume.
    NOTE : If you hold down the left or right arrow key, it will decrease or increase in increments of 10 mL.

11. The LCD display will flash the information that was entered into the device and display the completion time. Confirm that the information is correct and press the start button start to begin warming.
    NOTE : If the information is incorrect, press the stop button stop and repeat programming steps above.

12. There are two timers located on the LCD display. The lower left display will show the total cycle time and will count down to zero. The upper left display shows the total elapsed time the breast milk or supplement has been in the device. If the lid is opened during the warming cycle, the unit will go into a pause mode for 60 seconds. The visual indicator on the front of the unit will flash orange. If the syringe or container is placed back into the unit, the start button start can be pressed, and the cycle will continue to completion. If the 60 seconds is exceeded, the unit will stop and reset.
    NOTE : Open the lid to activate pause mode while using a syringe.

13. When the warming cycle is complete, the visual indicator on the unit will flash green and the audible indicator (if not muted) will chime. When the warming cycle is complete, the device will automatically go into a holding cycle for up to 30 minutes. During the holding cycle, warm air that is maintained at body temperature will continue to circulate in the unit to ensure that the milk does not cool prior to feeding. The visual indicator will continue to flash green. The audible indicator (if not muted) will chime every 5 minutes until hold cycle time expires. Remove the milk before the hold cycle expires.

14. If the lid is opened during the holding cycle, the visual indicator will flash orange, and the unit will go into a pause mode for 60 seconds. If the syringe or container is placed back into the unit, the start button start can be pressed, and the holding cycle will continue to completion. Once the hold cycle has expired, the unit will no longer maintain temperature. It will beep every 15 seconds (if not muted) until the lid is opened or unit is stopped. Gently mix breast milk or supplement and press stop upon removal.
    NOTE : Open the lid to activate pause mode while using a syringe.
    WARNING : Always feel container/syringe and check milk temperature prior to feeding. NOTE : Calesca was designed to warm milk from refrigerator temperatures (approximately 4 ˚C/39.2 ˚F). If milk contains any ice at the beginning of the cycle, the final temperature of the milk at the end of the warming cycle may fall below the designed range of the device.
    Thawing mode

15. Press On/Off button to turn on the device. The device defaults to the warm mode . Press the right arrow key to highlight the thaw mode . Press the enter button enter to confirm thaw mode. The device defaults to frozen when in thaw mode.

16. Use the arrows to enter the volume of milk to be thawed. Press the enter button enter to confirm volume.
    NOTE : If you hold down the left or right arrow key, it will decrease or increase in increments of 10 mL.

17. The LCD display will flash the information that was entered into the device and display the completion time. Confirm that the information is correct and press the start button start to begin thawing.
    NOTE : If the information is incorrect, press the stop button stop and repeat programming steps above.

18. There are two timers located on the LCD display. The lower left display will show the total cycle time and will count down to zero. The upper left display shows the total elapsed time the milk or supplement has been in the device. If the lid is opened during the thawing cycle, the unit will go into a pause mode for 60 seconds.The visual indicator on the front of the unit will flash orange. If the syringe or container is placed back into the unit, the start button start can be pressed, and the cycle will continue to completion. If the 60 seconds is exceeded, the unit will stop and reset.
    NOTE : Open the lid to activate pause mode while using a syringe.

19. When the thawing cycle is complete, the warming action will automatically shut off. The visual indicator will continue to flash green and the audible indicator (if not muted) will chime every 15 seconds. Remove milk immediately while ice crystals are present.
    IMPORTANT : If no ice crystals are present, refer to your hospital breast milk handling and storage policy.
    NOTE : Calesca was designed to thaw milk from recommended freezer temperatures (approximately -20˚C/-4˚F). If milk contains any liquid, the final temperature of the milk at the end of the thawing cycle may fall above the designed range of the device. Milk should be thawed from a completely frozen state.

Cleaning and Hygiene

CAUTION:

• Always unplug the appliance from the mains before cleaning it.
• Use drinking water quality for any of the following described cleaning procedures.
• Check with the manufacturer prior to using any cleaning or decontamination method outside of manufacturer’s recommendations.
• Do NOT submerge, autoclave, heat, steam, ETO, or radiation sterilise the warmer.
• Grease on metal hinge may be visible and is considered normal. DO NOT remove grease as it may shorten the life of the hinge.
• Use of the warmer by more than one user without proper cleaning may pose a health risk. Inserts are single-patient use items. Use of inserts for more than one patient may pose a health risk.
• Equipment user has the responsibility for carrying out appropriate decontamination if hazardous material is spilled on or inside the equipment.

NOTE : These recommendations are not substitutes for official hospital procedures that may differ among institutions. Refer to hospital policy for cleaning of shared capital equipment.

**Acceptable cleaning detergents**
• PDI® Sani-Cloth® cleaner and/or wipes
• Isopropyl alcohol
• Hydrogen Peroxide 3% liquid or wipes
• Soap and water
Not responsible for formula changes by disinfectant wipe manufacturers. Hygiene Wash hands before operating the device, opening inserts, and/or installing inserts.

Device Care

• Preparation: Calesca should be cleaned prior to first use and between patients. This product’s inserts are single- patient use items and should not be shared. Use of the device by more than one user without proper cleaning may pose a health risk. Wash hands before operating the warmer, opening inserts, and/or installing inserts.
• Between each patient use: Remove Medela Disposable Insert and clean with an acceptable cleaning agent using wipes or a lint-free cloth. Do not spray or pour liquid directly into or onto the device. Allow to air dry before use.
• Single patient use: The device should be wiped down with an acceptable cleaning agent prior to use and between patients. If milk is spilled on the device, remove insert and wipe down unit.
• Multiple patient use: If the device is used for more than one patient, inserts should stay with the patient with clear and legible indicators of patient name, date and time. Inserts are single patient use items. It is recommended that the outer surface of the device is wiped down with an acceptable cleaning agent between patients.

Disposable Inserts Handling

• In use: Medela Disposable Inserts are a single-patient and limited use item. Medela recommends changing the inserts every 12 hours. Inserts should be changed if human breast milk or supplement comes in contact with the inserts. Inserts should also be changed if visible damage has occurred that would offer the potential for human breast milk or supplement to come in direct  contact with the device.
• Insert care: Inspect insert after each warming and/or thawing session for condensation and/or milk. Inserts are single patient use items. Remove and discard the Disposable Insert if patient identified on label no longer requires feed warming.
• If condensation appears in insert: Condensation may appear in the insert if the frozen bottle placed and thawed in the device had frost on its outside. Leave the lid to the warmer open to allow the insert to air dry in between uses.
• If milk appears in insert: Discard insert immediately. Install a new insert prior to next use.
• It milk appears on the device: Inspect the device for any signs of milk and clean if necessary. Install a new insert in the device for next use.
• Damaged inserts: Inspect the inserts for visible damage (ripos or tears). If the insert is damaged, immediately discard and replace it to avoid breast milk or supplement coming in contact with the device.
  CAUTION: Use of the warmer by more than one user without proper cleaning may pose a health risk. Inserts are single-patient use items. Use of inserts for more than one patient may pose a health risk.

Warranty
The warranty for the unit is 2 years from the date of delivery, excluding disposable liners and accessories. 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.

Disposal
The unit is made of technical plastics and metals that cannot be separated. It must be disposed of in accordance with local regulations.

Troubleshooting

Light indicator is flashing red

| Error indicator and insert indicator on LCD panel are illuminated

Light indicator is flashing red

| Error indicator and close lid indicator on the LCD panel is illuminated

Unit will not power up.

|
IV pole clamp slips out of the device after installed into the pole mount slot on the side of the device|

Milk too warm

|

Hot to the touch

Milk too cool

|

Thawed milk has no ice

|

Cannot resume from pause mode

|

“Pause” indicator

Unexpected pause mode during opera- tion|

“Pause” indicator

Light indicator is flashing red

| Error indicator and 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

Possible Solution

Ensure insert is installed. Open the lid to the device and properly install the insert. Press start. Refer to Insert Installation section on page 9.

Close the lid and press start.

Check to see if plug in the back of the device 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 is slid 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 breast milk.

• Ensure that insert is installed properly. Refer to insert installation section on page 9.

• Use the proper size container in comparison to the volume of breastmilk or sup- plement being warmed. Refer to warming and thawing in a container section on pages 10–13.

• Place milk back into device 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 com- plete.
Ensure lid is closed and insert is fully seated. If using a syringe, ensure it is replaced before pressing 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.

Return for service.

Ensure fan is not blocked.

Turn off and unplug warmer, allow unit to cool down for up to 30 minutes. Warmer should resume operation. If Error Code 13 is frequently generated, contact Medela customer service.
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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