X6003 Breast Pump by X6 Innovations SAS

app s				submitted / available
1	User manual	Users Manual	pdf	3.77 MiB	May 30 2023
1	Internal photos	Internal Photos	pdf	890.92 KiB	May 30 2023
1	External photos	External Photos	pdf	445.78 KiB	May 30 2023
1	Label and label location	ID Label/Location Info	pdf	290.50 KiB	May 30 2023
1	Agent attestation letter	Attestation Statements	pdf	599.44 KiB	May 30 2023
1	Antenna information	Test Report	pdf	668.33 KiB	May 30 2023
1	Appendix A test data BT LE	Test Report	pdf	2.40 MiB	May 30 2023
1	Block diagram	Block Diagram	pdf		May 30 2023	confidential
1	Confidentiality request letter	Cover Letter(s)	pdf	348.66 KiB	May 30 2023
1	Covered equipment identification letter	Attestation Statements	pdf	339.68 KiB	May 30 2023
1	Covered equipment letter	Attestation Statements	pdf	340.26 KiB	May 30 2023
1	Operation description	Operational Description	pdf		May 30 2023	confidential
1	RF exposure evaluation	RF Exposure Info	pdf	422.76 KiB	May 30 2023
1	Schematic	Schematics	pdf		May 30 2023	confidential
1	Test Report BT LE	Test Report	pdf	1.32 MiB	May 30 2023
1	Test setup photos	Test Setup Photos	pdf	797.83 KiB	May 30 2023

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User manual

Users Manual

pdf

3.77 MiB

May 30 2023

User Guide support@perifit.co 1 English Dont speak English? Scan this QR code with your smartphone for other languages Perifit - X6 Innovations 128 rue la Boetie, 75008 Paris, France TF-IFU-PF-v20230227 English user guide 1. User Recommendations 1.1 Intended use The Perifit breast pump is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user. 2. Getting started 2.1 Product Parts Washable components:

1. Diaphragm (anti-backflow) 2. Connector 3. Duckbill valve 4. Flange 5. Bottle Non-washable components:

6. Hub Accessories (not pictured):

Bra extender strap USB charging cable Extra O-ring Extra duckbill valve 1 2.2 Cleaning and Sterilizing The Perifit Pump is not provided sterile. It must be cleaned and sterilized prior to first use. Make sure all pump parts are dry before reassembly. Wet parts may affect pump performance or cause damage to the Hub. Before First Use: Sterilizing Non-Washable Parts:

isopropyl alcohol wipes). Washable Parts:

The Hub contains electronics and is not washable. The Hub can be wiped down with a disinfectant wipe (such as Sterilize the bottle, diaphragm, flange, duckbill valve, and connector by placing them into a pot of boiling water for 5 minutes. Do not exceed 5 minutes in boiling water. Keep a gentle boil, do not use a lid, and make sure the parts are not resting on the bottom of the pot. Do not use a steam or microwave sterilizer. Before Use and Between Uses: Cleaning Wash hands with soap and water before handling the pump. We recommend keeping a separate wash basin that is dedicated only to cleaning infant feeding items (including washable pump parts). Non-Washable Parts:

between uses. Washable Parts:

The Hub contains electronics and is not washable. The Hub can be wiped down with a damp cloth or disinfectant wipe

- Wash all Milk Assembly parts (Diaphragm, Connector, Duckbill valve, Bottle, Flange) with warm water and mild dish soap. Rinse well under running water and air dry completely before assembling. 1. Check that the duckbill valve is not sealed shut by pressing on the sides with your fingers. Its completely normal for it to look closed at rest, but if it is sealed shut even when you press on the sides as shown, contact us or try the spare that is in your Perifit Pump accessories. 2. Fit the silicone diaphragm onto the top of the connector. 3. Insert the duckbill valve into the hole at the bottom of the connector. Make sure it is fully inserted. 4. Insert the flange into the connector. Make sure to insert it fully (the thicker ring on the flange should be pressing against the connector without leaving any gap). Check the alignment of the flange in the connector. The small hole should face towards the top of the connector (towards the diaphragm), and the large hole should face the bottom of 2.3 Assembling the Perit pump Tip: Watch the assembly video on the Perifit App the connector (towards where the milk bottle will screw on), to allow for milk to flow. 5. Make sure the O-ring is positioned around the base of the connector and that it is securely in place. If you lose it, there is a spare in the accessory bag. increase suction intensity, and the - to reduce suction intensity. 5. Mode button: Press to switch between Stimulation and Expression modes. The Perifit pump will automatically switch into Expression mode after two (2) minutes of Stimulation. 6. Screw the bottle onto the bottom of the connector. 7. Slide your connector assembly into the shell. Start by lining up the circular part at the top of the connector, with the ring inside the shell. Rotate the bottom of the connector slightly towards the front of the hub. You will hear a small click!

8. Check that the diaphragm is tightly pressed against the shell wall. 2.4 Taking apart the Perit pump 1. Rotate and remove the entire Milk Assembly (Diaphragm, Connector, Duckbill valve, Flange, and Bottle) from the Hub. 2. Unscrew the Bottle from the Connector. 3. Disassemble all remaining Milk Assembly elements for cleaning. Follow cleaning instructions in this User Guide. Plug USB charging cable (included) into the Pump, then into a USB charger (not included). The LED will blink to indicate 2.5 Charging charging. 2.6 Perit App Download the Perifit Pump (ex. Simone Pump) app for your smartphone, available for iOS (App Store) or Android

(Google Play Store). 3. Using the Perit Pump 3.1 User Controls 1. Power button:

Long press for Power On / Power Off; short press for Play /

Pause. A green light indicates battery is charged. A yellow light indicates enough battery for one pump session. A red light indicates insufficient battery for one pumping session. Light will blink while charging. 2. Level and Mode indicator LEDs:

Blinking light indicates stimulation mode, solid light indicates expression mode. 3. and 4. Intensity level control buttons. Press the + to 1. Make sure your hands and pump parts are clean and dry 2. Turn on pump: Press Power button (long press) to switch 3.2 How to Use before pumping. pump on. 3. Position the Perifit pump in your nursing bra so that your nipple is centered in the flange tunnel. Use the included bra extender strap to accommodate the Perifit pump in your nursing bra, if needed. The pump needs to be pressed firmly against the breast with no gap. 4. Press Power button again (short press) to start pumping. The Perifit pump has two modes: Stimulation and Expression. The pump will always start in Stimulation mode, which has faster cycles and lower suction to stimulate milk 6. When you are finished pumping, short-press the Power Do not substitute or modify pump parts. button again to stop the pump motor. let-down. After two (2) minutes in Stimulation mode, the Perifit pump will automatically switch to expression mode, with stronger cycles and slower suction to extract milk. You can switch between Stimulation and Expression modes at any time by pressing the Mode button. For more information on pump cycle speeds and suction strength, see Product Specifications section. Once powered on, the Perifit pump can be controlled using the buttons on the pump, or through the Perifit app. 5. Adjust intensity level to what feels comfortable for you. You may have to play with this over time to see which settings work best for your body. 7. Carefully remove the Perifit pump from your nursing bra. Unclip your bra and remove the Perifit pump. Long-press the power button to turn the pump off. 8. Clean all milk assembly components after each use as described in Cleaning and Sterilizing section. 4. Safety 4.1 Warnings in this manual. health risk. repairs to the hub.

- Use the Perifit Pump only for its intended use as described

- This product is intended for a single user and should not be shared. Use by more than one person may represent a

- Do not attempt to open the Hub or perform unauthorized

- This product contains small parts and a charging cable that may present a hazard. Keep out of reach of children.

- To protect against electric shock, injury, or fire, do not immerse the Hub or USB cable in water. Do not operate the Hub when wet.

- The Perifit Pump is not provided sterile and must be cleaned according to the Cleaning and Sterilization instructions in this manual.

- Inspect the Hub, all washable parts, and the USB charging cable before use. If there is damage to any part of the Perifit Pump, do not use.

- Clean all parts that come into contact with milk between each pumping session. Allow to dry before storage or reassembly.

- During normal use, the Perifit Pump may heat up. If the Hub or other components become unusually hot to the touch, or if you notice smoke or smell burning, stop using immediately and turn Power off.

- Do not use the Perifit pump while driving, operating machinery, when sleeping or drowsy, or while lying down.

- Only use Perifit Pump parts, including the charging cable.

- Do not operate or plug in the Perifit pump near flammable materials, where aerosol products are being sprayed, or where oxygen is being administered.

- The Perifit Pump uses Bluetooth technology. Portable or wireless equipment may affect breast pump function.

- Do not pump while pregnant unless directed to do so by a healthcare professional. Pumping during pregnancy may induce labor. 4.2 Precautions

- If packaging appears tampered with or damaged, contact Customer Service and do not use.

- Inspect all pump parts before each use. If pump parts appear damaged, do not use until a replacement part has been obtained.

- Contact a healthcare professional if pumping causes pain, if you express little or no milk.

- A lactation consultant or breastfeeding specialist may help you determine proper flange size.

- Use your finger to break the seal between the flange and the nipple before removing the Perifit pump. Do not attempt to pull the pump off of the nipple while suction is present. performance.

- Using the Perifit Pump on an aircraft is not recommended, as the pressurized environment may impact pump

- Ensure all parts are clean and dry before reassembly. Wet parts may impact pump performance or damage the Hub.

- Do not place the Hub in the fridge or freezer.

- Read all of the instructions before using the Perifit Pump. 5. Product Specications 5.1 Technical Specications 5.2 Troubleshooting 5.3 Transportation, storage, and disposal Transportation and Storage Always make sure pump parts are clean and dry before transportation and storage. Charge the Perifit pump battery prior to long-term storage. Temperature: -20 to +60oC (-4 to +140oF) Relative humidity: 15% to 90%

Ambient pressure: 80 to 106kPa Disposal The Perifit pump contains a rechargeable lithium ion battery. Dispose of the Hub and USB charging cable according to your local return and collection regulations for electronic equipment. All other components can be disposed of according to your local waste management requirements. 5.4 Precautions The operating life of the Hub is approximately 500 hours. The operating life for the washable parts is approximately 3 months. The duckbill valve and diaphragm should be changed regularly to maintain pump performance. 5.5 Precautions The Perifit pump complies with all requirements of the relevant standards and regulations with regard to electromagnetic emission and immunity to interference. The Perifit breast pump should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Perifit breast pump should be observed to verify normal operation in the configuration in which it will be used. Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect the breast pump and should be kept at a distance from the device. 5.6 Symbols 6. Warranty The Perifit Pump is backed by a limited manufacturers warranty against any defects in materials and/or workmanship: the Hub for twelve (12) months from the date of Pump purchase, and ninety (90) days from the date of purchase for washable components and accessories. The duration of this Warranty may be extended as a function of applicable local law. This warranty does not cover cosmetic deterioration nor damage caused by accident, misuse, normal wear and tear, improper use, unauthorized maintenance or repair, or failure to follow written instructions for use. This warranty terminates if you sell or otherwise transfer this product to another person. The warranty does not cover purchases from non-authorized resellers. Defects discovered during the warranty period should be reported to X6 Innovations, SAS. Any warranty claims must be supported by proof of date of purchase. In the event that X6 Innovations provides you with a replacement product, this does not extend the duration of the warranty. 7. Contact Us We love feedback! If you have questions, comments, or need support: support@perifit.co 1. User Recommendations 1.1 Intended use The Perifit breast pump is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user. 2. Getting started 2.1 Product Parts Washable components:

1. Diaphragm (anti-backflow) 2. Connector 3. Duckbill valve 4. Flange 5. Bottle 2.2 Cleaning and Sterilizing The Perifit Pump is not provided sterile. It must be cleaned and sterilized prior to first use. Make sure all pump parts are dry before reassembly. Wet parts may affect pump performance or cause damage to the Hub. Before First Use: Sterilizing Non-Washable Parts:

The Hub contains electronics and is not washable. The Hub can be wiped down with a disinfectant wipe (such as isopropyl alcohol wipes). Washable Parts:

Sterilize the bottle, diaphragm, flange, duckbill valve, and connector by placing them into a pot of boiling water for 5 minutes. Do not exceed 5 minutes in boiling water. Keep a gentle boil, do not use a lid, and make sure the parts are not resting on the bottom of the pot. Do not use a steam or microwave sterilizer. Before Use and Between Uses: Cleaning Wash hands with soap and water before handling the pump. We recommend keeping a separate wash basin that is dedicated only to cleaning infant feeding items (including washable pump parts). Non-Washable Parts:

The Hub contains electronics and is not washable. The Hub can be wiped down with a damp cloth or disinfectant wipe between uses. Washable Parts:

- Wash all Milk Assembly parts (Diaphragm, Connector, Duckbill valve, Bottle, Flange) with warm water and mild dish soap. Rinse well under running water and air dry completely before assembling. 2 1. Check that the duckbill valve is not sealed shut by pressing on the sides with your fingers. Its completely normal for it to look closed at rest, but if it is sealed shut even when you press on the sides as shown, contact us or try the spare that is in your Perifit Pump accessories. 2. Fit the silicone diaphragm onto the top of the connector. 3. Insert the duckbill valve into the hole at the bottom of the connector. Make sure it is fully inserted. 4. Insert the flange into the connector. Make sure to insert it fully (the thicker ring on the flange should be pressing against the connector without leaving any gap). Check the alignment of the flange in the connector. The small hole should face towards the top of the connector (towards the diaphragm), and the large hole should face the bottom of 2.3 Assembling the Perit pump Tip: Watch the assembly video on the Perifit App the connector (towards where the milk bottle will screw on), to allow for milk to flow. 5. Make sure the O-ring is positioned around the base of the connector and that it is securely in place. If you lose it, there is a spare in the accessory bag. increase suction intensity, and the - to reduce suction intensity. 5. Mode button: Press to switch between Stimulation and Expression modes. The Perifit pump will automatically switch into Expression mode after two (2) minutes of Stimulation. 6. Screw the bottle onto the bottom of the connector. 7. Slide your connector assembly into the shell. Start by lining up the circular part at the top of the connector, with the ring inside the shell. Rotate the bottom of the connector slightly towards the front of the hub. You will hear a small click!