Symphony Maintenance and Technical Guide 2009

Table of Contents Save These Instructions...1 Symphony® Technical Description...2 Symphony® Breastpump Controls & Parts...3 Symphony Diagram... 3 Symphony Kit Diagram... 3

Visual & Functionality Checklist...4 Vacuum Check...5 Recommendations for Replacement . ...6 How to Check Pump Total Running Hours...7 Error Codes... 8-9 Battery Care & Maintenance... 10-11 Inspect & Replace Diaphragms... 12-13 Low or No Suction... 14-15 Trolley Repair... 16-17 No Power... 18-19 Reseating Cover... 20-21 Replace and Load Program Card... 22-23 Proper Use of Vacuum Gauge... 24-25 Inspect & Replace Power Cord... 26-27 Correct Separated Housing... 28-29 Cleaning... 30-31 Terms of Guarantee...32

Save These Instructions The Medela® Symphony® Breastpump has been specially developed to meet the most stringent demands where hygiene and mobility are concerned. The operating principle of the Medela Symphony is to simulate the natural, physiological conditions encountered in breastfeeding. The pump’s kit is separate from the pumping mechanism and protected from overflow by a specially designed membrane. Kit components which could come in contact with the milk are part of the accessories and can be very easily disconnected for cleaning and sterilization. A carrying case is available, offering ample space for the pump and the accessory kit. There are two different models of Symphony with the following general specifications: Symphony Breastpump, article no. 0240108 n one knob control for both vacuum and suction cycles n powered by regular electric outlet (100240 VAC) Symphony Breastpump Plus, article no. 0240208 *same as above (0240108), but with 2 internal rechargeable 6 volt batteries

Both models can be used for single and for double pumping by using the appropriate accessory kit. Refer to the separate accessory kit user’s instructions for further details.

IMPORTANT SAFEGUARDS WARNING: To reduce the risk of burns, electrocution, fire, or injury to persons: 1. Separation from the power outlet is only assured through the disconnection of the plug and socket connection. 2. This equipment is not suitable for use in the presence of a flammable anesthetic mixture. 3. Use only in a dust-free environment. 4. Do not place in or drop motor unit into water or other liquid. 5. Do not reach for any electrical device if it has fallen into water. Unplug immediately. 6. 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. 7. Only use the electric cord that comes with the Symphony Breastpump. 8. Make sure the voltage of the device is compatible with the power source.

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Symphony Technical Description Safety Instructions Medical Equipment With Respect to Electrical Shock, Fire and Mechanical Hazards Only In Accordance With IEC 60601 -1 CAN/CSA 22.2 No. 601.1 22PL C

D

Protection class II SSIFIE LA (Double Insulation) C US

Follow Instructions Alternating Current

Type B

Direct Current

Dimensions : With Stand Without Stand Length 16.1” 8.5” Width 16.1” 6.1” Height 35.4” 9.6”

Vacuum: -50mmHg – -250mmHg -7kPa – -33kPa

Weight: With Battery: 6 lbs. 7 oz. Without Battery: 5 lbs. 1 oz.

Power Supply: Conventional Outlet: 100V - 240VAC 50/60 Hz 0.5 A

Environmental Conditions for Operation: Temperature: +41°F to +104°F Relative Humidity: 20% to 80% Atmospheric Pressure: 70 kPa to 106 kPa

DC Connection: 12 VDC 25 W T=2,5A

Environmental Conditions Use only with Medela® Vehicle Lighter Adapter #67173

Battery: 2 x 6 V, 1.2 Ah Type: Yuasa NP 1.2-6 Battery(optional): Battery, DC powered Charging time=12 hours Full battery pumping time=approx. 60 minutes ESD-Use ESD protection when servicing pump. Disposal: This breastpump is made of technical plastics and metals that cannot be separated. It must be disposed of in accordance with local regulations.

Transport and Storage: Temperature: -4°F to +122°F Relative Humidity: 20% to 95% Atmospheric Pressure: 70 kPa to 106 kPa Standards: FDA (GMP) ISO 9001 ISO 13485 CE (93/42/EEC) Electromagnetic or Other Interference: Complies with IEC 60601-1-2. Unlikely to interfere with other electrical equipment.

Warranty: 3-years for the unit from the date of delivery, excluding pump set and batteries. The manufacturer is not liable for any damage or consequential damage caused by incorrect operation, inappropriate usage or use by unauthorized persons. Routine checks, servicing and battery exchange may only be carried out by Medela authorized personnel.

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Symphony Breastpump Controls & Parts ®

Symphony Diagram

Symphony Kit Diagram Kit shown is Symphony Double Pumping Kit (67099S)

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1. PersonalFit™ Breastshield, Standard (24mm)... 87073 2. PersonalFit Breastshield Connector... 87071 3. Valve & Membrane... 87089 4. Collection Connector... 8117009 5. Solid Container Lid ... 8107057 6. Tubing... 8007213 7. Membrane Cap... 8100769 8. Protective Membrane... 8200094 9. Breastfeeding Information Guide... 1907200 10. Symphony Instruction Manual... 1907724 11. Symphony Container Stand... 8100552 12. Symphony Vehicle Lighter Adapter... 67173

Call for pricing

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Call Customer Service at 800.435.8316 for ordering information.

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Visual & Functionality Checklist The Symphony® Breastpump Maintenance & Technical Guide is a resource and tool to be used to perform maintenance and troubleshoot issues on the Symphony Breastpump. A visual and functional check of the Symphony breastpump should be performed for optimal performance on a periodic basis. If maintenance or repairs are needed, this guide will walk you through the steps. If you have any questions, please contact Customer Service at 800.435.8316.

4 Cleaning – Use a soft cloth to wipe with warm soapy water, Quick Clean

™

Wipes may be used between uses with the same mother. Use Cavicide® to disinfect between different mothers. (Refer to Cleaning Technical Bulletin on pages 30-31 for detailed instructions.)

4 Cover – Inspect for damage and that cover closes and locks shut. If cover is damaged, please send back to Medela for repairs.

4 Housing – Inspect for damage, cracks or if housing is separated. (Refer to Correct Separated Housing Technical Bulletin on pages 28-29 for detailed instructions.)

4 Rubber Feet – Inspect for damage or missing rubber feet (4 total). If any

are missing, contact Medela Customer Service to order Part # 8000596.

4 Pump Diaphragms – Inspect for damaged diaphragms.

(Refer to Inspect/Replace Diaphragms Technical Bulletin on pages 12-13 for detailed instructions.)

4 Power Cord – Inspect power cord for damage.

(Refer to Inspect/Replace Power Cord on pages 26-27 for detailed instructions.)

4 If you have a Symphony Plus, check battery status by referring to Battery Care & Maintenance Technical Bulletin on pages 10-11.

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Vacuum Check Performing a vacuum check on your pump ensures your Symphony® is operating correctly for breastpumping mothers. Follow the instructions in the Proper Use of Vacuum Gauge Technical Bulletin on pages 24-25 for detailed instructions. The following values will guide you through gauging your Symphony vacuum levels:

The following values should read: Stimulation

min* - 41 - 47 - 50 - 53

Expression

max* - 166 - 187 - 200 - 213

max* - 207 - 234 - 250 - 266

min* - 41 - 47 - 50 - 53

Elevation + 6600’ + 3300’ + 1600’ Sea Level

OFF

*± 20 mmHg Stimulation mode changes to Expression mode after 2 minutes unless the button is pushed.

If you experience values outside of the normal limits reference refer to Technical Bulletin – Low or No Suction on pages 14-15.

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Recommendations for Replacement Over the life of the Symphony® it is possible that certain items may have to be replaced. The more preventative maintenance that is conducted on the Symphony, the less parts will have to be replaced. The following are recommended guidelines for when certain parts should be replaced.

Item

Recommendations for Replacement/Repair

Membranes

As needed after inspection. (Refer to Low or No Suction Technical Bulletin on pages 14-15 for detailed instructions.)

Diaphragms

As needed after inspection or low suction.

(Refer to Inspect/Replace Diaphragms on pages 12-13 for detailed instructions.)

Motor

6,000 hrs (or as needed)*

Gear Box

6,000 hrs (or as needed)*

Battery

As needed.

(Refer to Battery Care & Maintenance Technical Bulletin on pages 10-11 for detailed instructions.)

Main Boards

As needed.

(If pump does not turn on and after troubleshooting*. Refer to Error Codes Technical Bulletin on pages 8-9.)

Housing

(Refer to Correct Separated Housing Technical Bulletin on pages 28-29 for detailed instructions.)

If broken or separated.

*Must be replaced or repaired at Medela.

Please contact Customer Service at 800.435.8316 for instructions on how to have your pump repaired or replaced.

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How to Check Pump Total Running Hours

Checking Pump Total Running Hours

1. Turn the pump on.

2. Go to service menu by pushing the “On” button again while turning the vacuum control knob.

3. Turn the vacuum control knob until you get “Htot” (hours total). This is the total hours the pump has run throughout its life.

4. Use these hours to check to see if maintenance is required per recommendations on page 6.

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Error Codes There are two ways in which a Symphony® Breastpump will communicate that the unit has an issue. If the Symphony is experiencing an issue, an error code will be displayed on the LCD screen (see fig. 1). Previous problems are recorded in the Menu function under “Err:”. To retrieve a history of errors, hold down the “On” button while turning the vacuum control knob, then continue to move the knob until you reach “Err” (see fig. 2). If you continue to experience issues with your Symphony, please contact Customer Service at 800.435.8316. fig. 1

fig. 2

LCD Display

LCD Display Messages The following describes LCD messages that may be displayed indicating an issue with the unit, the potential causes, and action steps to correct the issue.

Potential Issue

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Actions

Program card isn’t a Symphony card

Check if correct program card is used (See Technical Bulletin No. 109A)

Program card is incorrectly inserted

Check that card is positioned correctly (See Technical Bulletin No. 109A)

Program card is damaged and not working

Replace program card (See Technical Bulletin No. 109A)

Program card isn’t inserted

Insert program card (See Technical Bulletin No. 109A)

Program card isn’t completely inserted

Push card in all the way (See Technical Bulletin No. 109A)

Battery needs charging soon, will beep every 20 seconds (15 minutes of pumping time remaining from when the indication started)

Be sure power cord is plugged into back of pump (See Technical Bulletin No. 106A)

Battery is completely discharged

Charge the batteries, but you may continue to pump (See Technical Bulletin No. 101A)

Motor is drawing too much current

Send Symphony pump to Medela®service center if this happens repeatedly

Software configuration

Replace program card if experiencing error (See Technical Bulletin No. 109A)

Potential fault in electronics of gear control

Send Symphony pump to Medela service center if this happens repeatedly

Potential fault in electronics of power supply

Send Symphony pump to Medela service center if this happens repeatedly

Menu Codes The following are Menu Codes and descriptions indicating historic error activity and steps you can take to address the issue.

Battery Care & Maintenance

Directions on how to read Menu Codes

1. Turn the pump on. 2. Push the “On” button again while turning the vacuum control knob. 3. To see Menu Codes turn the vacuum control knob and refer to the Menu Codes chart listed below.

Menu Codes

Description

Solution

M/F

Motor Fault

1. Unplug and plug back in. 2. Reboot pump. (see below) 3. Replace program card and reboot. 4. Send to Medela, Inc. for repair if this does not solve the issue.

M/O

Motor Overload

1. Return to Medela, Inc. for repair if this happens repeatedly.

C/I

Invalid Card

C/N

No Card

B/F

Battery Flat

1. Charge for full 12 hours. 2. Return to Medela, Inc. for repair if this does not solve the issue.

B/L

Battery Low

1. Charge for full 12 hours. Pump will charge during use if plugged in. 2. Return to Medela, Inc. for repair if this does not solve the issue.

P/F

Power Fault

1. Verify pump plugged in properly at both ends. 2. Plug pump into another outlet. 3. Return to Medela, Inc. for repair if this does not solve the issue.

C/F

Configuration

1. Reboot pump. 2. Replace program card and reboot. 3. Return to Medela, Inc. for repair if this does not solve the issue.

1. Reboot pump. (see below) 2. Verify proper program card orientation. Correct as needed. 3. Replace program card and reboot. 4. Return to Medela, Inc. for repair if this does not solve the issue. 1. Install program card. 2. Verify that card is pushed in all the way. 3. Replace program card and reboot.

Quick Fixes The following is a list of potential issues and steps you can take to readily address the issue.

Reboot Pump

1. Press the let-down button and hold. 2. While holding the let-down button press the on/off button. 3. Release both buttons when pump reads “please wait”.

Error Messages

1. Turn off pump and restart unit. 2. Reboot pump. 3. Replace program card and reboot pump. (refer to Technical Bulletin No. 109A to replace program card) 4. Send pump to Medela, Inc if this does not solve the issue.

Invalid Card

1. Check program card. a. Chip side up. b. Chip end inserted into pump first. 2. (refer Replace program card. Reboot pump with new card. See reboot instructions. to Technical Bulletin No. 109A to replace program card) 3. Return pump to Medela, Inc. for repair if this does not solve the issue.

No Card

1. If program card is missing: a. Install new program card. (refer to Technical Bulletin No. 109A to replace program card) b. Reboot pump with new card. See reboot instructions. 2. If program card is present: a. Remove card and reseat. b. Send to Medela Inc, for repair if reseat does not correct.

No Power

1. Check if the pump is properly connected to the electric supply or that the battery is charged. 2. Inspect power cord and replace if it is damaged. (refer to Technical Bulletin No. 111A to replace power cord) 3. Inspect fuse and replace if needed. (refer to Technical Bulletin No. 106A to replace fuse) 4. Send to Medela Inc, for repair if issue is not resolved.

Check Battery (if present)

1. Check battery connections by removing battery caps and inspecting wires. 2. Refer to Technical Bulletin No. 101A for further Battery Care & Maintenance instructions.

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Battery Care & Maintenance Symphony® Plus needs battery care and maintenance. If you are unable to resolve your Symphony battery issues, please contact Customer Service at 800.435.8316.

Charging Battery 1. The Symphony Plus should be charged: • upon receipt of pump (for approximately 12 hours).

3. “Battery Flat” appears when the battery has been depleted. The breastpump will issue a long beep and the pump will switch off. The battery should be re-charged using the above instructions. 4. Check battery connections by removing battery caps and inspecting wires.

• daily after having run from battery. • before battery completely discharges. • every two (2) months when pump is not in use. (The battery is continually charging when the breastpump is plugged into an outlet, even during a pumping session.)

Battery Status 2. “Battery Low” warning appears on LCD display when the battery is low. The breastpump will beep every 20 seconds. (The breastpump still has approximately 15 minutes of pumping time left.) The battery should be re-charged using the above instructions.

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Helpful Hints Extreme temperature, charging rates, and state of charge play a part in the life span of your battery. To help maintain the life, please do the following: • completely recharge the battery after each use. • do not allow the battery to fully drain on a regular basis. • during use, the Symphony can run on battery for up to one (1) hour.

If the above steps do not correct the issue, please contact Customer Service at 800.435.8316.

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2 Battery Care & Maintenance

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Battery Check (if battery model) 1. Charge pump for 12 hours. *NOTE: Display switches from charging to Symphony 2.0 when battery reaches 80% charge. It takes the full 12 hours to get 100% charge.

2. Turn the pump on. 3. Go to the service menu by pushing the “On” button again while simultaneously turning the vacuum control knob clockwise until S/N is displayed. 4. Release the power button and continue to turn the vacuum control knob until locating “Hres” (resettable hours) then press the let-down button to reset it back to zero. 5. Let the pump run until the batteries are drained and the screen reads “Battery flat.” (The pump turns off automatically after 30 mins and may need to be restarted to fully drain the batteries.) 6. Once the batteries are drained, plug the pump into a wall outlet and go back to “Hres” on the service menu to check how long the pump ran. The time will give an indication of the battery’s condition. A new battery lasts for about 60 minutes of pumping time.

If the above steps do not correct the issue, please contact Customer Service at 800.435.8316.

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Inspect & Replace Diaphragms Symphony® diaphragms need to be inspected periodically to ensure proper suction levels. If you experience issues replacing the diaphragms, please contact Customer Service at 800.435.8316.

Replace

Tools Required

6-7. Clean area with soft cloth and Cavicide (or like product) by spraying on cloth before replacing diaphragms.

Flathead Screwdriver

3. Remove diaphragm screws with flathead screwdriver. 4-5. Gently pry and remove each diaphragm with flathead screwdriver.

Replacement Diaphragms Kit Item #8007199

8. Align new diaphragms with openings.

Cavicide (or similar product)

9. Apply equal pressure downwards to snap diaphragm in place.

Soft Cloth Warning - Please be sure to unplug Symphony prior to troubleshooting.

10. Install screws with flathead screwdriver. Do not over tighten.

Directions Inspect 1-2. Press gently on diaphragm. An undamaged diaphragm will roll along the edge, which does not affect suction. If the rolled edge appears to be torn, replace. If holes or tears appear in diaphragm, suction can be reduced and diaphragm needs to be replaced.

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If the above steps do not correct the issue, please contact Customer Service at 800.435.8316.

2 3 Battery Care & Maintenance

1

DAMAGED

UNDAMAGED

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5

6

7

8

9

DO NOT SPRAY PUMP WHILE DIAPHRAGMS ARE REMOVED

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Warning

If you experience other issues regarding suction reference Technical Bulletin 103A.

• Stop when screws stop turning. • Do not over tighten or internal sensor may get damaged.

If the above steps do not correct the issue, please contact Customer Service at 800.435.8316.

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Low or No Suction In the event that your Symphony® breastpump is producing low or no suction this technical bulletin will guide you through the steps to troubleshoot your issue. If you continue experiencing issues with low or no suction, please contact Customer Service at 800.435.8316.

Tools Required Technical Bulletin No. 102A (Inspecting and Replacing Diaphragms) Flathead Screwdriver Symphony Diaphragm Kit Item #8007199 (if needed) Symphony Membrane Cap Item #8100769 (if needed) Symphony Membrane Item #8200094 (if needed)

Directions 1. Inspect Symphony Membranes. If membranes do not appear to have a rip or tear move to next step. If membranes do appear to be worn or have a tear, replace prior to next step. 2. Inspect Symphony Diaphragms by following Technical Bulletin 102A. If diaphragms do not appear to have a rip or tear move to next stop. 3. Make sure Symphony lid completely closes before pump is in use. 4. Make sure the hard yellow ends of the tubing fit securely into breastshield connectors.

Vacuum Gauge Item #1977005 (if needed)

5. Make sure the yellow triangular end fits into the membrane cap.

Warning – Please be sure to unplug

6. Make sure yellow valve on breastpump kit is fitted correctly into the breastshield connector.

Symphony prior to troubleshooting.

7. Make sure white membrane is lying flat against yellow valve head. 8. Check Symphony vacuum levels by following Technical Bulletin 110A Proper Use of Vacuum Gauge.

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If the above steps do not correct the issue, please contact Customer Service at 800.435.8316.

Battery Care & Maintenance 1

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If the above steps do not correct the issue, please contact Customer Service at 800.435.8316.

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Trolley Repair In the event that your Symphony® trolley becomes loose, this technical bulletin will guide you through methods to resolve this issue. If you continue to experience issues with your Symphony trolley, please contact Customer Service at 800.435.8316.

5.

Tighten rod by using 13mm socket wrench while holding nut, which is located on bottom of trolley with adjustable wrench. (See image #4))

Tools Required

6-7. Place Symphony back on trolley and tighten four (4) screws with 3.0mm Allen wrench.

3.0mm Allen Wrench

8.

13mm Socket Wrench

Your Symphony trolley is now tightened and ready for use.

Adjustable Wrench Trolley Repair Kit Item #6007116 (if necessary)

Directions 1-2. Remove Symphony from trolley by removing four (4) screws with 3.0mm Allen Wrench. 3-4. Turn trolley on side and hold nut by using adjustable wrench. Nut should be Nylok . (Nut provided in Repair Kit.) TM

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If the above steps do not correct the issue, please contact Customer Service at 800.435.8316.

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Battery Care & Maintenance 3 2

Bottom of Trolley

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8

6

If the above steps do not correct the issue, please contact Customer Service at 800.435.8316.

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No Power In the event that your Symphony® breastpump does not have power, this technical bulletin will guide you through methods to resolve the issue. If you continue to experience issues with loss of power, please contact Customer Service at 800.435.8316.

5. Remove fuse holder from bottom of the Symphony using a small flathead screwdriver and gently turn clock wise. 6-7. If the fuse appears shorted, remove shorted fuse. (Item #9310035) 8-9. Replace with new fuse. (Item #9310035)

Tools Required Fuse - Item #9310035

10. Insert fuse holder (black round cap) back into the bottom of the Symphony.

Flathead Screwdriver (small)

Directions 1. Inspect power cord and replace if damaged. Refer to Technical Bulletin No. 111A - Inspect/Replace Power Cord if power cord needs to be replaced. 2. Make sure pump is plugged into a wall outlet. 3. Make sure short black cord is plugged into back of Symphony. 4. Check power outlet for functionality. Attempt to use in another power outlet.

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If the above steps do not correct the issue, please contact Customer Service at 800.435.8316.