Spectra Synergy Gold Portable
Premium Electric Breast Pump
Instruction for use
1. Important Safeguards
These symbols identify all instructions that are important to the safety of the user. Failure to observe these instructions can lead to injury or damage to the breast pump.
❗ WARNING can lead to serious injury or death.
General prohibition sign
⚠️ CAUTION can lead to minor injury.
NOTE can lead to material damage.
? TIP useful or important information that is not related to safety.
These instructions apply to the Spectra Gold Portable Breast Pump, models MM011450 and MM011460. Model MM011450 is the retail model, which includes the breast pump Part # IMP-0032, double collection kit, ac adapter, and 2 collection bottles. MM011460 is a model which includes the breast pump Part # IMP-0032 and ac adapter only. It is used with separately purchased breast pump kits.
1. IMPORTANT SAFEGUARDS
1. If you are infected with Human Immunodeficiency Virus (HIV), pumping breast milk will not reduce or remove the risk of transmitting the virus to your baby through your breast milk.
2. Before each use, visually inspect each individual component for cracks, chips, tears, discoloration or deterioration. If component damage is observed, please discontinue use until the parts have been replaced.
❗ READ THIS ENTIRE MANUAL BEFORE USING PUMP AND KEEP IT FOR FUTURE REFERENCE. When using electrical products, basic safety precautions should always be followed.
2. TO REDUCE THE RISK OF ELECTROCUTION:
- Do not use while bathing.
- Do not place or store product where it can fall or be pulled into water or other liquids.
- Do not place in or drop into water or other liquids.
- Never reach for a product that has fallen into water or other liquids; unplug the product immediately.
- Never immerse pump unit in water.
- Always unplug electrical devices immediately after using.
- Inspect cords and electrical components before each use. Never use the product if insulation damage, exposed wiring, kinking, abrasion, or other mechanical damage is noted.
❗ TO REDUCE THE RISK OF BURNS, ELECTROCUTION, FIRE, OR INJURY TO PERSONS.
- This product should never be left unattended when plugged into an electrical outlet.
- Do not leave this product unattended around infants or children. Close supervision is necessary when this product is used near infants or children.
- Use this product only for its intended use as described in this manual. Do not use any attachments or accessories not recommended by the Uzinmedicare Co./Spectra Baby USA.
- Never operate this product if it has a damaged cord or plug.
- Do not use the product if it is not working properly, if it has been dropped or damaged, dropped into water, or if any parts are broken or missing.
- Keep the cord away from heated surfaces.
- Never use while driving, sleeping or if drowsy.
- Do not use outdoors or operate where aerosol spray products are being used or where oxygen is being administered.
- Do not disassemble or modify the product.
- Do not place small parts in mouth. Do not inhale or swallow small parts.
3. Important Safeguards (Continued)
- Allergic reactions may occur. Immediately discontinue use of the product if allergic reactions occur.
- The product must be stored properly, away from excessive lint, dust, light (including sunlight), etc. Improper storage can adversely affect the safety and essential performance of this product.
- The AC/DC adaptor must be in a position that is easy to unplug from power outlet.
- Use only the power cord that comes with the Spectra Synergy Gold Portable breast pump. Before using, check to be certain that the voltage of the power cord is compatible with the power source.
- If the power adapter outer casings become loose or are separating, stop using the product immediately and contact Spectra Baby USA - separation of the casing can result in electric shock.
- This breast pump should not be operated while traveling on an airplane.
- Plug the power cord into the breast pump first and then into the wall outlet.
- Dry all parts thoroughly after cleaning. Do not store wet or damp part(s) as they may develop mold.
- When cleaning the pump unit, unplug it before you start.
- Pumping can induce labor; do not use when pregnant.
❗ NOTE: If you feel pain in your breast or nipple, please try one of the following options:
- Lower your pump suction (vacuum suction setting) to a comfortable level.
- Turn the pump off, pull the adapter plug out of wall outlet, and break the suction by inserting a finger between your breast and the breast shield before you remove the breast shield from your breast.
- Make sure you are using the correct breast shield size--https://www.spectrababyusa.com/guide/.
- If the issue persists, contact a healthcare/lactation professional. You can make an appointment with one of our lactation consultants for an online consult at www.spectrababyusa.com/lactationservices.
2. IMPORTANT SYMBOLS
Graphic of the Symbol | Standard from which the symbol was referenced | Reference/ Registration Number | Symbol Title | Symbol Description |
---|---|---|---|---|
❗ | IEC 60601-1 | Table D2-9 | General Action sign | General mandatory action sign |
☡ | IEC 60601-1 | Table D1-20 | Type BF | Type BF Applied Part |
⏻ | IEC 60417 5009 | Power On / Off | To identify the switch or switch position by means of which part of the equipment is switched on in order to bring it into the stand-by condition. | |
~93% 15% |
ISO 15223-1:2016 5.3.8 | Transport/Storage/ Operation Humidity | Indicates the range of humidity to which the medical device can be safety exposed. | |
~ | ISO 15223-1:2016 5.3.1 | Fragile | Indicates a medical device that can be broken or damaged if not handled carefully. | |
☍ | ISO 15223-1:2016 5.1.3 | Date of Manufacture | Indicates the date when the medical device was manufactured. | |
⬆️⬆️ | ISO 7000 0623 | This Way Up | To indicate correct upright position of the transport package. | |
❗ | IEC 60601-1 | Table D2-2 | Danger, Warning | Can lead to serious injury or death. |
Graphic of the Symbol | Standard from which the symbol was referenced | Reference/ Registration Number | Symbol Title | Symbol Description |
---|---|---|---|---|
----- | IEC 60417 5031 | DC | Direct current | |
-40°C +40°C |
ISO 15223-1:2016 5.3.7 | Operation Temperature | Indicates the temperature limits to which the medical device can be safety exposed. | |
☔ | ISO 15223-1:2016 5.3.4 | Keep Dry | Indicates a medical device that needs to be protected from moisture. | |
♺ | EN 50419:2006 | - | This product should not be mixed with other commercial wastes for disposal. WEEE—Subject to waste electrical and electronic equipment regulations, i.e. not for general waste. | |
ISO 13485 |
ISO logo | - | Quality System | These trademarks for the ISO logo. |
? | ISO 7010 P001 | General Prohibition Sign | General prohibition sign and template for constructing a prohibition sign. | |
□ | IEC 60417 5172 | Class II | CLASS II equipment. |
Graphic of the Symbol | Standard from which the symbol was referenced | Reference/ Registration Number | Symbol Title | Symbol Description |
---|---|---|---|---|
⏻ | ISO 15223-1:2016 5.1.1 | Manufacturer | Indicates the medical device manufacturer. | |
70 kPa 106 kPa |
ISO 15223-1:2016 5.3.9 | Operation Atmospheric Pressure | Indicates the range of atmospheric pressure to which the medical device can be safety exposed. | |
SN | ISO 15223-1:2016 5.1.7 | Serial Number | Indicates the manufacturer's serial number so that a specific medical device can be identified. | |
? | ISO 7000 2403 | Stacking Limit by Number | To indicate that the items shall not be vertically stacked beyond the specified number, either because of the nature of the transport packaging or because of the nature of the items themselves. | |
ℹ️ | IEC 60601-1 Table D.2-10 | Refer to IFU | Refer to Instructions for use that should be followed. |
3. Indication for use
The Synergy Gold (SG) Portable (Models MM011450 and MM011460) is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Synergy Gold (SG) Portable (Models MM011450 and MM011460) breast pump is intended for home use by a single user.
4. COMPONENTS AND ASSEMBLY
Components:
- ① Pump unit
- ② Tubing
- ③ Backflow Protector
- ④ Breast Flange
- ⑤ Silicone Valve
- ⑥ Cover
- ⑦ Cap
- ⑧ Bottle
- ⑨ Adapter
- ⑩ Nipple
- ⑪ Disk
Prior to using the breast pump for the first time, sanitize the breast shield, backflow protectors, bottles, bottle caps and disks. See Section 11 for instructions.
The kits are designed for individual use. Never share the kits.
❗ NOTE: To prevent distortion or damage, do not boil for more than 5 minutes during sanitization process, as parts may become distorted.
How to Assemble Backflow Protector
1. Insert the white silicone membrane into the lower case. The lower case has a larger port than the upper case.
2. The lip on the silicone membrane must be firmly seated over the rim of the lower case to ensure proper suction.
3. Place upper case over assembled lower case, making sure all 3 pieces fit securely to form a perfect seal.
How to assemble the Power Cord
1. Hold power cord base and slide the adapter onto the 2 flat prongs.
2. You should hear a loud click once the 2 parts are well-connected.
3. When assembled correctly, the 2 parts cannot be easily separated, and the assembly looks like a one-piece power cord.
Charging the battery
The battery should be charged prior to operation by battery or when the battery power indicator flashes. To charge the battery, insert the power adapter into the pump motor, and then plug it into the outlet. Charge the battery for at least 4 hours. The battery indicator will show three bars when fully charged.
How to assemble Pump Kit
Always wash hands with soap and water and make sure your pump accessories are clean and dry before you assemble and use your pump kit. The part number in the drawings below refer to Table1, Components and Assemblies.
- Press and twist ⑤ valve into ④ breast shield to attach.
- Gently press and twist ③ backflow protector assembly into ④ breast shield.
- Screw ⑧ bottle onto ④ assembled breast shield.
- Twist ② tubing into ③ backflow protector.
❗ NOTE: There are two ports on the backflow protector. The larger port goes into the breast shield, the smaller connects to the tubing.
5. DISPLAY
The display shows:
- Vacuum Level: Indicates the suction strength.
- Time: Displays the pumping duration.
- Massage Mode: Indicated by a 3-wave symbol (~).
- Expression Mode: Indicated by a drop symbol ().
- Mute: A [Mute] symbol (?) appears when the beep sound is turned off.
- Battery power indicator: Shows remaining battery life.
6. BUTTON CONTROL
The control panel includes:
- L/R buttons: Select the left or right breast for vacuum adjustment.
- [Plus]/[Minus] buttons: Adjust vacuum level.
- Wave button (~) / Drop button (): Switches between Massage Mode and Expression Mode. Press and hold for 3 seconds to mute/unmute beep sounds.
Vacuum strength levels vary from L01-L12 in Expression Mode and L01-L05 in Massage Mode, adjustable independently for each side.
❗ NOTE: Cycle speed is not adjustable. Expression mode: 26 cycles per minute. Massage mode: 100 cycles per minute.
7. PUMPING GUIDE
- Relax, clear your mind, listen to relaxing music. If your baby is not present, look at pictures or videos of your baby.
- Sit in a comfortable chair and if needed to support lower back, use a pillow.
- Stimulate your letdown reflex before pumping. Some women have found that gently massaging their breasts with circular motion from the wall of their chest toward the nipple or applying a warm compress on their breasts prior to pumping triggers their letdown reflex.
- Make certain that your breast shield/flange is the appropriate size for your nipple.
- Always wash hands well with soap and water before pumping. Clean and disinfect the pump (see Section 11) and clean countertop with disinfectant spray or wipes prior to each use.
Spectra encourages breastfeeding whenever possible, even when using the breast pump.
8. GETTING STARTED
❗ NOTE: Your Spectra Synergy Gold Portable breast pump has two separate vacuum setting options, for the left and right breast, allowing each side to be adjusted individually.
1. Center the breast shield on your nipple so that the nipple is fit freely in the center of the tunnel opening.
2. Insert the power adapter into the pump motor, and then plug it into the outlet.
3. Press the power button. Your pump is on; the timer displays 00:00. The display also shows the settings used during your last pumping session: sound mode, phase mode (massage or expression), and cycle speed.
4. When your pump is on, prior to starting to pump, your control panel will display your last pumping session settings. You can change the setting before you start your new session. Press the 3-wave button (~) once to switch from massage mode to expression mode (vice versa). Hold it for 3 seconds to mute or unmute the beep sound that occurs when a touch button is pressed.
Vacuum strength can be set independently on each side. To adjust vacuum strength, first select the side by pressing the [Left] or [Right] button; then, press the [Plus]/[Minus] buttons to find a comfortable level. Find the right combination of vacuum/cycle best for your body for optimum pumping session.
When you wish to stop expressing, press the [Left] or [Right] button then remove the milk collection kit from your breast.
Once you stop pumping, twist to detach the backflow protector from the breast shield. Remove the breast shield from the milk collection bottle and close the bottle tightly with the bottle lid and store safely.
❗ NOTE: The Spectra Synergy Gold Portable pumps are designed to turn off automatically after 30 minutes and to remember your current settings for your next pumping session.
9. Vacuum Suction Setting
The vacuum level refers to how strongly the pump will "suckle" – a higher number is higher vacuum. Please be careful when setting the vacuum level on the Spectra Synergy Gold Portable. Some women find that milk expression is faster on higher vacuum levels. However, it is important not to set the vacuum level so high that it makes you uncomfortable, as the resulting pain can impact your milk flow.
Therefore, it is suggested to start with the vacuum level on low and then gradually increase the vacuum suction to a comfortable level. The level of vacuum you are comfortable with may vary significantly from day to day, during the day, and even during the same expression session.
Remember: Only your vacuum strength level can be set independently on the left and right side during your pumping session.
10. Cycle Speed
The cycle speed is measured in CPM (cycles per minute) on your breast pump and refers to how many times the pump 'suckles' and releases per minute.
11. Massage and Expression Modes
Massage Mode: Features cycle speed 100 and 5 vacuum strengths (L01-L05). The 3-wave symbol (~) is displayed on the left side of the timer.
Expression Mode: Features cycle speed 26 and 12 vacuum strengths (L01-L12). In expression mode, a drop symbol () is displayed on the right side of the Timer Display. After letdown begins and milk is flowing, switch to expression mode for slower, deeper suckles to draw down milk. This mode has a slower cycle speed and higher vacuum suction level.
Adjust vacuum strength in expression and massage modes to find the setting that works best for you.
? TIP: The Spectra Synergy Gold Portable remembers your settings automatically for your next session. If you want to start pumping on different settings than those used during your previous session, adjust the settings once you turn on your pump before you start pumping. Remember you will need to adjust each side – left and right – separately.
12. How to Use Single or Double Pumping
- Remove the air cap.
- Connect tubing from each milk collection kit to an air nozzle.
❗ NOTE: For single pumping, connect only one collection kit to either the left or right air nozzle.
13. Finding Your Breast Shield Size
Use a ruler, a measuring tape, or a breast shield measurement guide. Measurement must be in millimeters (mm).
A guide is available on spectrababyusa.com.
Measure the diameter of your nipple at the base, do not include the areola.
- Up to 16mm: use 20mm flange
- Up to 20mm: use 24mm flange
- Up to 24mm: use 28mm flange
- Up to 28mm: use 32mm flange
Your pump comes with a set of 24mm and 28mm flanges. If you need one of the other sizes, please contact Spectra customer care or visit www.spectrababyusa.com.
14. Sanitizing and Cleaning
Sanitizing, once a day, is especially important if your baby is less than 3 months old, was born prematurely, or has a weakened immune system due to illness or medical treatment.
Sanitize Accessories Prior To First Use:
⚠️ CAUTION: Do not wash/sanitize the tubing. It should never come into contact with breast milk since the Spectra Synergy Gold Portable pumps are closed-system pumps.
❗ NOTE: Use a designated basin to clean your pump parts; do not wash them in the sink.
First, wash all parts that contact milk in warm soapy water and rinse well. Next, sanitize as detailed below. To avoid tearing or damaging the seals, never insert anything into the silicone valves when cleaning them.
Accessories (clear/pink): breast shield/flange, upper and lower case of backflow protector, bottle, bottle ring, bottle cover, and disk:
- Use a pot large enough to fit all your parts; if the pot is too small, parts discoloration and/or distortion may occur.
- Fill with water so that when your parts are added, the water is at least 4" above the parts.
- Place lid on the top and bring to boil.
- Once the water reaches boiling point, turn off the heat and submerge accessories in boiling water – the water should continue to boil.
- Remove accessories after 3-5 minutes.
Silicone accessories: silicone valves, backflow protector membranes, and bottle nipples:
- Soak them in boiling water for no more than 2 minutes.
? TIP: Do not expose silicone accessories to high heat to prevent melting, warping, or damaging them.
Place all cleaned and sanitized parts to dry on a clean paper towel. Once the parts are dry, assemble the pump before you store or use it.
? WARNING: Do not boil your accessories for more than 5 minutes, as extended exposure to heat may damage your accessories.
After Each Use:
- Disassemble all parts that come into contact with the breast and breast milk – breast shields/flanges, valves (duckbill or valve with membrane, bottles, and backflow protectors).
- Rinse parts with cool water.
- Wash each piece in warm soapy water and rinse with hot water.
- Place parts to air dry on a clean paper towel.
- Once the parts are dry, assemble the pump before you store it or use it.
Using non-antibacterial soap is recommended to ensure that you are not leaving a film on your flanges that can impede the natural secretions from your mammary glands.
⚠️ CAUTION: NEVER wash or sanitize your tubing as it will never come into contact with your breast milk. DO NOT use the breast pump with wet tubing as it will damage the breast pump. If tubing becomes moldy, discontinue using and replace immediately.
? WARNING:
- Microwaving your parts can result in distortion and/or discoloration of the parts. Discoloration is cosmetic and does not affect the chemical composition of the parts. Microwave bags can be used if the proper amount of water is added. Follow the instructions of the bag manufacturer.
- If using a dishwasher, place items on wash cycle on the top rack using a close top basket or a mesh bag, and air dry. Do not use heat dry.
❗ NOTE: The above guidelines are for healthy, term babies. If your baby was born prematurely, has a weakened immune system due to illness, has other health challenges or is hospitalized, follow the recommendation of the hospital and your child's health care provider.
15. Breast Milk Storage and Thawing
It is important that you store your expressed breast milk properly to help it stay fresh and maintain its anti-bacterial properties as well as its nutritional and immunological qualities.
STORAGE RECOMMENDATION OF FRESHLY EXPRESSED BREAST MILK
Guidelines for Healthy, Full-Term Babies
LOCATION | TEMPERATURE | STORAGE TIME |
---|---|---|
Countertop | 77°F/25°C or colder (room temperature) | Up to 4 hrs |
Refrigerator | 40°F/4°C | Up to 4 days |
Freezer | 0°F/-18°C or colder | Up to 6 months (12 months is acceptable) |
Insulated Cooler Bag | 59°F - 15°C | 24 hrs. (refrigerate or freeze after 24 hrs.) |
Source: CDC - Human Milk Storage Guidelines (https://www.cdc.gov/breastfeeding/recommendations/handling_breastmilk.htm)
Storing Thawed Breastmilk
Room temperature (up to 77° F) | Refrigerator (40° F) | Freezer (0°F or colder) | |
---|---|---|---|
Thawed breastmilk | 1 to 2 hours | Up to 1 day (24 hours) | Do not refreeze |
Source: Office of Women's Health (OWH) Milk Storage Recommendations (https://www.womenshealth.gov/breastfeeding/pumping-and-storing-breastmilk)
16. How to Thaw and Store Breast Milk
- Always make sure to check the date on the milk's container before using. Do not use undated milk, or milk that has been stored too long.
- Thaw the oldest breastmilk first. Thaw frozen milk in the refrigerator or under cool, running water.
- Breastmilk does not need to be warmed. Some moms prefer to serve it at room temperature. Some moms serve it cold.
- If you decide to warm the breastmilk:
- Keep the container sealed while warming.
- Hold it under warm, not hot, running water, or set it in a container of water that is warm, not hot.
- Never put a bottle or bag of breastmilk in the microwave. Microwaving creates hot spots that could burn your baby and damage the milk.
- Test the temperature before feeding it to your baby by dropping some on your wrist. The milk should feel warm, not hot.
- Gently swirl the container to mix the cream part of the breastmilk that may rise to the top back into the rest of the milk. Do not shake the milk. This can make some of the milk's valuable parts break down.
- After thawing, milk should be stored in the refrigerator for no more than 24 hours. If warm water is not available, heat a pan of water on the stove. Once the water is warm, not boiling, remove the pan from the stove and place the milk container in the pan. It may take approximately 20 minutes to bring cold milk to room temperature. Never warm the milk container directly on the stove.
- Never refreeze thawed milk. Throw away previously frozen milk that is not used within 24 hours.
- If you are combining expressed breast milk to cold, make sure all the milk is at the same temperature.
Feeding Breast Milk
It is recommended that you establish and maintain your milk supply prior to introducing the bottle to your baby (approximately 6 weeks.)
- Inspect bottle, nipple, and other feeding tools before and after each use. Stop using and replace damaged—cracked and/or torn—nipples immediately.
- When bottle feeding, paced feed only to prevent flow confusion.
- Do not attempt to enlarge the nipple hole.
- Do not bottle feed an infant without adult supervision.
- Do not use your bottle nipple as a pacifier.
17. Troubleshooting
Condition | Possible Causes | Checks | Solutions |
---|---|---|---|
No Power | Power cord/AC Adapter | Check if the power cord is not connected or it is damaged. | Make sure Power cord is attached to pump unit. Plug into the outlet. If it is damaged, replace it. |
Battery discharged | Check the battery indicator. | Using the power cord/AC Adapter, connect the pump to an appropriate power source. Charge pump. | |
No Suction | Air tube | Check the tubing is connected to the pump unit. Check if air tube is not damaged. | Connect the air tube to the pump unit. If air tube is damaged, replace it. |
Valve | Check if they are connected to breast shield properly. | Attach valve to flange—Twist valve into breast shield to attach. If duckbill valve check for tear/damage. If clear valve check membrane. | |
Low Suction | Vacuum Level | Check vacuum level. | Increase vacuum level. |
Defective assembly kit | Check the kit assembly. | Disassemble and reassemble accessory kit. | |
Breast shield* | Check if there is a problem with the breast shield—is it the right size; is it damaged. | Confirm your flange size using the flange measurement guide on spectrababyusa.com; If breast shield is damaged, replace it. | |
Pain | Valve | Check if there is damage in duckbill valve head—tear or other damage or if clear valve membrane is damaged. | Replace the valve. |
Vacuum Level | Too high suction. | Set to a lower suction level. | |
Breast shield | Check if there is a problem with the breast shield—is it the right size. | Confirm your flange size using the flange measurement guide on spectrababyusa.com. |
If a suggested solution does not resolve the issue, turn off the pump, stop pumping, and break suction to remove the flange. If your pump appears to be malfunctioning, contact the warranty team at warranty@spectrababyusa.com. If you have questions on how to properly use your pump or on lactation issues, consult a lactation or health professional. You can make an appointment with one of their lactation consultants for an online consult at www.spectrababyusa.com/lactationservices. If pain persists, seek medical attention from a qualified health professional.
18. Use and Storage Environment
Charge the battery before storing your breast pump. For long-term storage, recharge the battery every three months.
Environment to Use:
- Temperature: -10°C to 40°C
- Humidity: 20% to 95%
- Pressure: 70 kPa to 106 kPa
Environment to storage:
- Temperature: -20°C to 60°C
- Humidity: 20% to 95%
- Pressure: 70 kPa to 106 kPa
19. Specifications
Protection Type: Class II
Weight: 670g
Power consumption: 25VA
Expected Spectra Synergy Gold Portable Service Life: 3 years
Adapter Used:
- Manufacturer: Dongguan Shilong Fuhua Electronic Co., Ltd.
- Model: UES12LCP-050200SPA
- Input: 100-240 V~50/60 Hz, 500 mA
- Output: 5V 2A
Battery: Li-Polymer 7.4Vdc 1700mAh
Note 1: Or alternative as approved and supplied by Spectra.
Electrical Safety:
- Type of protection against electric shock: Class II equipment
- Degree of protection against electric shock: Type BF applied parts
- Classification according to the degree of protection against ingress of water: IP22
- This equipment is not suitable for use in the presence of flammable anesthetics or oxygen.
- Mode of operation: continuous operation.
VACUUM SUCTION PRESSURE (millimeters of mercury - mmHg)
Expression Mode | Massage Mode | CYCLE SPEED (Cycle/Min. - CPM) | |||
---|---|---|---|---|---|
Level | Pressure | Level | Pressure | Level | Speed |
1: 50 | 6: 160 | 11: 260 | 1: 50 | 1: 26 | 1: 100 |
2: 80 | 7: 180 | 12: 270 | 2: 70 | 2: 26 | 2: 100 |
3: 100 | 8: 200 | 3: 90 | 3: 26 | 3: 100 | |
4: 120 | 9: 220 | 4: 110 | 4: 26 | 4: 100 | |
5: 140 | 10: 240 | 5: 130 | 5: 26 | 5: 100 |
Traveling Outside of the U.S.A
The Spectra Synergy Gold Portable is compatible with multiple voltages and can be used anywhere in the world. The pump adjusts itself to the voltage it receives. The main issue is whether the power cord/AC adapter physically interfaces with the socket/wall outlet in the destination country. To resolve this, an international/universal power adapter is needed; a voltage converter is not required. The Spectra Synergy Gold Portable uses a two-pronged power cord and does not require a grounded outlet.
For information about traveling with your breast pump and expressed breast milk, visit www.tsa.gov.
20. Warranty
This product is warranted by SPECTRA BABY USA to the purchaser to be free from defects in material and workmanship for a maximum period of two (2) years from the date of purchase. In the event of a defect or failure to conform to this warranty, SPECTRA BABY USA will, at its option, replace this product without charge for such replacement or parts at the SPECTRA BABY USA office listed below.
The purchaser shall bear all responsibility and expense for returning this product, including risk of loss prior to receipt by SPECTRA BABY USA, as well as shipping, packing, and insurance costs.
Any and all implied warranties are limited to the duration of two (2) years from the date of purchase. Some states do not allow limitations on how long an implied warranty lasts, so the above limitations may not apply to you.
The liability of SPECTRA BABY USA for breach of any written or implied warranty is limited to the replacement of this product. SPECTRA BABY USA will have no liability under any circumstances for any incidental or consequential damages. Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitations may not apply to you.
This warranty gives you specific legal rights. You may also have other rights which vary from state to state.
SPECTRA BABY USA will have no obligation under this warranty to replace this product and/or its components due to any malfunction or damage caused by accident or arising from misuse, abuse, improper maintenance, unauthorized modification, or connection to an improper power supply. Without limiting the generality of the foregoing, bending or dropping of this product or its components and visible cracking of the equipment housing will be presumed to be defects resulting from misuse or abuse. Accessories that are not expressly manufactured by SPECTRA BABY USA and intended for use with the Spectra Synergy Gold Portable breast pump will immediately void this warranty. A charge will be made for replacement of damaged parts.
If you wish to make a claim under this warranty, please contact the warranty team at warranty@spectrababyusa.com for instructions. You will be required to provide proof of purchase or receipt.
21. Electromagnetic Compatibility (EMC)
This equipment needs to be installed and put into service in accordance with the information provided in the user manual [IEC/EN 60601-1-11:2010 Clause 12.3a].
Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least 1.0 m away from the equipment. [IEC/EN 60601-1-11:2010 Clause 12.3b]
This equipment has been tested and found to comply with the limits for medical devices in IEC 60601-1-2:2014. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses, and can radiate radio frequency energy and if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
- Reorient or relocate the receiving device.
- Increase the separation between the equipment.
- Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected. Consult the manufacturer or field service technician for help.
Essential Performance:
- Vacuum level setting: Expected value ± 50mmHg (Max. 270mmHg)
- Cycle setting: Expected value ± 10%
- Backflow protection: Backflow mechanism works at all stages of the pumping session whether the milk collection container is full or not.
It has been tested for immunity to electromagnetic disturbances and passed testing based on certain criteria, such as component failures, changes in programmable parameters or operating mode, cessation or interruption of any intended operation or initiation of any unintended operation.
TABLE 1: Electromagnetic Emissions (IEC 60601-1-2:2014)
This equipment is intended for use in the electromagnetic environment specified below. It is the responsibility of the user of the Spectra Synergy Gold Portable breast pump to ensure that it is used in such an environment.
Emission test | Compliance | Electromagnetic environment - Guidance |
---|---|---|
RF Emissions CISPR 11 | Group 1 | This equipment uses RF energy only for internal function. Its RF emissions thus are very low and are not likely to cause interference with nearby electronic equipment. |
RF Emissions CISPR 11 | Group B | This equipment is suitable for use in all establishments, including domestic establishments and those directly connected to public low-voltage power supply networks that supply buildings used for domestic purposes. |
RF Emissions CISPR 11 | Group A | |
RF Emissions CISPR 11 | Complies |
? WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
TABLE 2: Electromagnetic Immunity (IEC 60601-1-2:2014)
This equipment is intended for use in the electromagnetic environment specified below. It is the responsibility of the user of the Spectra Synergy Gold Portable breast pump to ensure that it is used in such an environment.
Immunity test | IEC 60601 test level | Compliance level | Electromagnetic environment - guidance |
---|---|---|---|
Electrostatic discharge IEC 61000-4-2 | Contact ± 8 kV, Air ± 2, 4, 8, 15 kV | Contact ± 8 kV, Air ± 2, 4, 8, 15 kV | Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. |
Electrical fast transient/burst IEC 61000-4-4 | ± 2 kV for power supply lines ± 1 kV for input/output lines | ± 2 kV for power supply lines ± 1 kV for input/output lines | Mains power quality should be typical of a commercial or hospital environment. |
Surge IEC 61000-4-5 | ±0.5 kV, ±1 kV line(s) to line(s) ± 2 kV line(s) to earth | ±0.5 kV, ±1 kV line(s) to line(s) ± 2 kV line(s) to earth | Mains power quality should be typical of a commercial or hospital environment. |
Power frequency and magnetic field IEC 61000-4-8 | 30 A/m at 50 and 60 Hz | 30 A/m at 50 and 60 Hz | Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. |
Voltage dips and interruptions IEC 61000-4-11 | 0% UT: 0.5 cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° 0% UT; 1 cycle and 70% UT; 25/30 cycles Single phase: at 0° 0% UT; 250/300 cycle |
0% UT: 0.5 cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° 0% UT; 1 cycle and 70% UT; 25/30 cycles Single phase: at 0° 0% UT; 250/300 cycle |
Mains power quality should be typical of a commercial or hospital environment. During a power outage, the equipment should be powered from battery or other constant, appropriate power supply. |
Conducted RF IEC 61000-4-6 | 3 VRMS ISM & Amateur Bands 6 VRMS | 3 VRMS ISM & Amateur Bands 6 VRMS | Portable and mobile RF communications equipment should be used no closer to the Spectra Synergy Gold Portable breast pump (including cables) than the recommended separation distance (d), based on the following equations: d = [3.5/V1] P for 150 KHz-80 MHz d = [3.5/E1] P for 80 MHz-800 MHz d = [7/E1] P for 80 MHz-2.7 GHz P is maximum output power rating of the transmitter in watts. d is the recommended separation distance in meters. Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol. ? |
Radiated RF IEC 61000-4-3 | 10 V/m 80 MHz-2700 MHz | 10 V/m 80 MHz-2700 MHz |
a Field strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted accurately. If you wish to use the equipment in the vicinity of fixed RF transmitters and you are uncertain about the electromagnetic environment, please consider obtaining an electromagnetic site survey.
If the measured field strength in the location where the equipment is being used exceeds the applicable RF compliance level above, it is the user's responsibility to verify that the equipment is operating normally. If abnormal performance is observed, additional measures, such as re-orienting or relocating the equipment, may be necessary.
b. Over the frequency range 150kHz to 80 MHz, field strengths should be less than 3 V/m.
? WARNING: Portable RF communication equipment (including peripherals such as antenna cables and external antenna) should be used no closer than 30 cm (12 inches) to any part of the Spectra Synergy Gold Portable, including cables specified by Uzinmedicare Co. Otherwise, degradation of the performance of this equipment could result.