Calesca Instructions for Use Rev C Oct 2017

EN

Instructions for use

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DE

Gebrauchsanweisung

18

FR

Mode d‘emploi

32

IT

Istruzioni per l‘uso

46

NL

Gebruiksaanwijzing

60

EN

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Product Overview

Indicator light

Button description

On/Off

stop

start

Stop

Start

Audible indicator mute enter

Left arrow, to select

Right arrow, to select

Enter

Operation description Select mode

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Warming mode

4 3

Warming or thawing from

2

1

6

9

8 7

1. Completion Time

2. Completion Thawing mode Indicator

Room temperature ~20°C Fridge temperature ~4°C

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appears when warm or thaw mode is complete or interrupted 3. Elapsed Time 4. Elapsed Time Label 5. Pause Indicator 6. Error Indicator 7. Insert Liner Symbol 8. Lid Open Symbol 9. Alarm Mute Symbol 10. Mode 11. Milk Temperature 12. Volume amount in ml

Freeze temperature ~-20°C

Freeze temperature ~-20°C

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Quantity selection

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LCD display 5

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8

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7 4 3

2

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11 1

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EN

1. time 1. Completion Completion Time 2. indicator appears when 2. Completion Completion Indicator appears warm or when thaw warm modeoristhaw complete or mode is complete or interrupted interrupted 3. Elapsed Elapsed Time 3. time 4. Elapsed Time Label 4. Elapsed time indicator 5. Pause Indicator 5. indicator 6. Pause Error Indicator 6. 7. Error Insert indicator Liner Symbol 7. linerSymbol symbol 8. Insert Lid Open 9. Close Alarm Mute Symbol 8. lid symbol 10. Alarm Mode mute symbol 9. 11. Mode Milk Temperature 10. 12. Volume amount in ml Warming mode Thawing mode 11. Milk temperature Refrigerated start temperature Room start temperature Frozen start temperature 12. Volume in ml

Table of Contents Product Overview4 Table of contents5 Item numbers5 Contents5 Calesca Warming/Thawing Device6 Intended Use 6 Important Safeguards6-7 Assembly and Installation8 Operation9-13 Cleaning and Hygiene13-15 Warranty15 Disposal15 Troubleshooting16 Notes74

I

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.

II

Contents

Each Calesca Warming/Thawing Device is packaged and shipped separately. Contents include: – 1 Calesca Warming/Thawing Device – 1 power cord – 1 instructions and assembly manual

EN

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III Calesca Warming/Thawing Device This device can both warm and thaw breast milk or a 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 ± 4 °C) – whether they are frozen, chilled or at room temperature – or thaws them to a refrigerated temperature. The slow warming process helps to 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 paediatric ward, etc.

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

V

Important Safeguards

When using electrical devices, basic safety precautions should always be followed to reduce the 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 use. • 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. 6

EN

V

Important Safeguards

• 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 a socket with proper protective grounding equipment. Use/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 bath tub or sink. • Do not use while bathing or showering. • Do not place device on IV pole at a height over 1.5 m (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 containing 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 compliant 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/her own expense. SAVE THIS INSTRUCTION MANUAL

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VI 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 Pin not engaged

4 7

Pin engaged

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.

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 on the IV pole. Do not block vents on bottom or rear of unit.

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EN

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 the device to slide off the bracket. IV pole bracket does not interfere with countertop use of device if left attached.

VII IV 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 socket. Press the power button on the device display panel. The unit is set up with both a visual indicator located on the front of the unit and a low volume audible indicator. To mute mute button. To confirm the audible indicator, press the will appear that the audible indicator is muted, the symbol in the upper right portion of the LCD Display.

Insert installation

2 NEW IMAGE

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.

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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.

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Place the tray, flat side down, into the bottom of the device. NOTE: Always use tray when warming syringes or bottles.

EN

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VII IV Operation Warming or thawing in a container

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Always use a lid on the milk storage container. Make sure insert is in place and insert tray is properly seated in device. Place the container in the centre of the tray in the device and close the lid. The device will not operate if the insert is not positioned correctly. Note the volume of milk to be warmed. CAUTION: Use an appropriately sized container for 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 containing 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.

Warming or thawing in a container

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

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EN

Warming mode

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

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Select the milk starting temperature (refrigerated, room or / to highlight the desired frozen) by using the arrow keys to confirm starting temperature. Press the enter button starting temperature. enter

NOTE: The device initially defaults to the milk starting temperature (symbol refrigerated) (refrigerated) based on 4 ˚C or 39.2 ˚F.

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Use the arrows to enter the volume of milk to be warmed. to confirm volume. Press the enter button enter

NOTE: If you hold down the left or right arrow key, it will decrease or increase in increments of 10 ml.

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The LCD display will flash the information that was entered into the device and display the completion time. Confirm that to the information is correct and press the start button begin warming. start

NOTE: If the information is incorrect, press the stop button and repeat programming steps above. stop

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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 can be is placed back into the unit, the start button pressed, and the cycle will continue to completion. If the 60 seconds are exceeded, the unit will stop and reset. start

NOTE: Open the lid to activate pause mode while using a syringe.

EN

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VII IV Operation 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 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 the holding cycle time expires. Remove the milk before the holding cycle expires.

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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 can be pressed, and the holding cycle unit, the start button will continue until completion. Once the holding cycle has expired, the unit will no longer maintain the 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. start

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

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

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

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The LCD display will flash the information that was entered into the device and display the completion time. Confirm that to the information is correct and press the start button begin thawing. start

NOTE: If the information is incorrect, press the stop button and repeat programming steps above. stop

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EN

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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 can be pressed, and the cycle will continue to completion. If the 60 seconds is exceeded, the unit will stop and reset. start

NOTE: Open the lid to activate pause mode while using a syringe.

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When the thawing cycle is complete, warming will automatically stop. 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 still 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.

VIII Cleaning and Hygiene CAUTION: • Always unplug the appliance from the mains before cleaning it. • Use drinking water quality for any of the cleaning procedures described below. • 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*

• Cavicide® cleaner and/or wipes • 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. EN

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VIII Cleaning and Hygiene 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.

Singlepatient 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.

Multiplepatient 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 be wiped down with an acceptable cleaning agent between patients.

Disposable Inserts Handling

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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.

If 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 (rips or tears). If the insert is damaged, immediately discard and replace it to prevent breast milk or supplement from coming into 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.

IX 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 unauthorised persons. Routine checks and servicing may only be carried out by Medela authorised personnel.

X

Disposal

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

EN

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XI Troubleshooting Problem

Indicators

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 operation

“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 16

EN

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 at the back of the device is pushed in completely. Unplug the device from the wall socket and try another socket. 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 breast milk or supplement 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 complete. Ensure lid is closed and insert is positioned properly. If using a syringe, ensure it is replaced before pressing start. Ensure insert is fully seated and syringe is centred. 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 generated frequently, 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. EN

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Notes

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Technical specifications Technische Daten Caractéristiques techniques Specifiche tecniche Technische specificaties

EN DE FR IT NL

100 – 240 V 50 / 60 Hz 2.5 A IEC C6 Inlet

244 x 193 x 236 mm

kg

1.9 kg

S

AS

CL

Protection class I

EMC Directive 2004/108/EC Low Voltage Directive 2006/95/EC +30 +15 °C

Operation Betrieb Fonctionnement Funzionamento Bediening

+50

Transport/Storage Transport/Lagerung Transport/entreposage Trasporto/Conservazione Transport/Opslag

80

Operation Betrieb Fonctionnement Funzionamento Bediening

-20 °C

20 95

20

Transport/Storage Transport/Lagerung Transport/entreposage Trasporto/Conservazione Transport/Opslag

106

70

kPa

IEC 61010-1 IEC 61010-2-010

Safety standards: IEC 61010-1 and IEC 61010-2-010 safety requirements for electrical equipment for measurement, control, and laboratory use. Part 1: General requirements

Safety instructions Sicherheitsanweisungen Consignes de sécurité Istruzioni di sicurezza Veiligheidsinstructies

Must not be disposed of together with household waste Darf nicht mit Haushaltsabfällen entsorgt werden. Ne doit pas être jeté parmi les ordures ménagères Non smaltire insieme ai rifiuti domestici Mag niet samen met huishoudelijk afval worden verwijderd

Medela AG Lättichstrasse 4b 6341 Baar, Switzerland www.medela.com International Sales Medela AG Lättichstrasse 4b 6341 Baar Switzerland Phone +41 41 562 51 51 www.medela.com Australia Medela Australia Pty Ltd, Medical Technology 3 Arco Lane, Heatherton, Vic 3202 Australia Phone +61 3 9552 8600 Fax +61 3 9552 8699 [email protected] www.medela.com.au France Medela France SAS 14, rue de la Butte Cordière 91154 Etampes cedex France Phone +33 1 69 16 10 30 Fax +33 1 69 16 10 32 [email protected] www.medela.fr

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© Medela AG/200.3846/2017-10/C

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