ELVIE TRAINER EL01 (01) PDF DOCUMENT

The ELVIE TRAINER EL01 is used to exercise and track pelvic floor muscle movement and tone. It is a single patient device, intended to be operated by adult females in a home environment.

The operating life of the ELVIE TRAINER EL01 is defined to be approximately 500 hours.

Do not use the ELVIE TRAINER EL01 if you have given birth within the last six weeks.

If you experience any of the following symptoms, stop using the ELVIE TRAINER EL01 and consult a healthcare professional:

• You experience difficulty or persistent pain when inserting the ELVIE TRAINER EL01, even with water-based lubricant.

• You experience abnormal bleeding.

• You experience sudden urine retention or incontinence.

Do not leave your ELVIE TRAINER EL01 inside your vagina for more than one hour at a time. It is not recommended to exercise with the ELVIE TRAINER EL01 for more than 15 minutes within a 24-hour period.

While there are no technical reasons not to use the ELVIE TRAINER EL01 during pregnancy, it is not recommended unless you have first consulted with a licensed healthcare professional.

It is recommended that you consult with a licensed healthcare professional before using the ELVIE TRAINER EL01 if you have an active implanted device that would be affected by a magnetic field (e.g., pacemaker, implantable cardioverter defibrillator).

Do not use the ELVIE TRAINER EL01 if you have an active urinary infection until symptoms have stopped. Use of the device with an active urinary tract infection may result in pain, tightness, or reinfection.

If you have a medical condition affecting your pelvic health (for example, abnormal vaginal discharge, severe prolapse, are self-catheterizing, neurological conditions or experience frequent urinary infections), consult with a pelvic floor specialist before using the ELVIE TRAINER EL01.

In the box you will find:

1. Pelvic Floor Trainer made with medical-grade silicone: Use to track your pelvic floor exercises.

2. Charging case: Keeps the ELVIE TRAINER EL01 safe and doubles up as a charger. Push to open.

3. Micro USB cable: Connects the charging case to a USB power supply for charging.

4. Custom size cover made with medical-grade silicone: Provides custom sizing for a better fit.

1. The charging case, with the ELVIE TRAINER EL01 inside, should be charged lying down lengthways.

2. Use the cable provided to connect the charging case to a USB power source, such as your computer or phone plug.

3. Check that the white light above the cable on the carry case turns on. The light will turn off when the ELVIE TRAINER EL01 is fully charged.

4. The battery level is shown within the app.

Before first use, please remember to:

1. Charge the ELVIE TRAINER EL01.

2. Get the Elvie Trainer app: Download the app through the App Store (for iOS) or Google play (for Android).

3. Clean the ELVIE TRAINER EL01: Please remember to wash your hands and the ELVIE TRAINER EL01 with warm, soapy water before use, rinsing thoroughly.

4. Switch on Bluetooth on your phone.

1. **Connect Elvie Trainer:** The ELVIE TRAINER EL01 connects to your phone using Bluetooth. To connect for the first time, simply squeeze it gently in your hand for 3 seconds.

2. **Insert Elvie Trainer:** The pebble-shaped part goes into your vagina and the tail remains outside, facing forward. Be sure to fully insert the pebble-shaped part, but not too high up. If you pull down gently, you will feel slight resistance against the vaginal opening. If it feels uncomfortable, try using some water-based lubricant.

3. **Find the right fit:** Many women prefer to use the optional cover to prevent the ELVIE TRAINER EL01 from falling out or moving about inside. Try with and without the cover to see what feels best. Thread the tail through the small hole in the cover and pull it over the device. Always remember to take the cover off when charging.

4. **Let’s start by lying down:** This relaxes the muscles in your thighs, buttocks, and tummy, allowing you to focus on your pelvic floor muscles. Lie down with your legs slightly apart and hold your phone by your tummy. For the best results, start in a lying position. When you feel confident, you can try exercising while standing or sitting.

If you aren’t sure what it feels like to exercise your pelvic floor, imagine that you are trying to stop yourself peeing mid-flow. This muscle movement, lifting inwards and upwards, is what you need to master.

When exercising, remember to:

• Make sure your stomach, buttocks and thighs remain relaxed and try not to hold your breath.

• Take a deep breath to relax and as you breathe out, squeeze your pelvic floor inwards and upwards.

The ELVIE TRAINER EL01 works best when it is able to connect easily with your phone. This means not obscuring the tail too much (for example by crossing your legs). Try to keep your legs open when exercising and your phone in the line of sight with the device.

At the beginning of each exercise, gently squeeze your ELVIE TRAINER EL01 so that it starts searching for your phone. It can take up to 30 seconds to connect.

If the ELVIE TRAINER EL01 disconnects during an exercise, it should reconnect automatically. If it doesn’t, please follow the on-screen instructions, remembering to squeeze the device for at least 3 seconds when trying to connect.

The ELVIE TRAINER EL01 is not provided sterile, so make sure you clean it before and after every use with warm, soapy water. Remember to rinse thoroughly. The charger carry case can be wiped clean with a damp cloth.

It is important the ELVIE TRAINER EL01 is completely dry before storing in the charging case.

Don’t:

1. Wash the ELVIE TRAINER EL01 in boiling water.

2. Use harsh cleaning agents.

3. Clean the ELVIE TRAINER EL01 in a sterilizer, microwave, dishwasher, or washing machine.

4. Leave the ELVIE TRAINER EL01 trapped under anything.

5. Use the ELVIE TRAINER EL01 in the bath.

Keep the ELVIE TRAINER EL01 clean, dry, and snug in its carry case. Make sure the tail is on top and facing outwards as per the diagram in the manual.

Things to avoid:

• Extreme heat

• Extreme cold

• Sustained pressure

Transport and Storage conditions: -20°C to +60°C / 15-90% RH / ambient pressure 70 – 106kPa.

Operating conditions: +5°C to +40°C / 15 – 90% RH / ambient pressure 70 – 106kPa.

The ELVIE TRAINER EL01 contains a Li-ion rechargeable battery. Please dispose of it at a designated collection point for the recycling of waste electrical and electronic equipment. The appropriate disposal will help conserve natural resources and ensure that it is recycled in a manner that protects human health and the environment.

Elvie Trainer:

IC: 20167-EL0115

FCC: 2AEHI-EL0115

CMIIT ID: 2020DJ7847

Charging case:

IC: 20167-EL0215

FCC: 2AEHI-EL0215

CMIIT ID: 2020DJ7847

IP Rating:

Elvie Trainer IPX7

Charging case IPX2