1. Background

The EasyDraw is a vacuum-based sample collection device. Skin prep and proper device placement are essential to success.

2. Prepare workspace

Remove all contents from the box.

3. Freeze cold pack

Please make sure that the cold pack is already cooling off in your freezer before proceeding further.

1. Hydrate

Drink a glass of water before you do anything else. You can add a pinch of salt or a sugar-free hydration pack to improve health.

2. Wash hands

Wash your hands with soap.

3. Get active

Jumping jacks or squats are both great exercises to warm your hands and get your blood flowing, which will make collection easier. Please avoid strenuous workouts for 24 hours before collection.

1. Select collection site

Locate a flat area on the outside of your arm, as shown in the diagram, about 10 fingers below the top of your shoulder.

2. Remove hair from collection site

(Optional) Use the provided razor to remove excess hair from the shoulder region where the device will be applied.

Note: The EasyDraw is a vacuum-based device, and excessive hair may prevent it from forming a good seal.

3. Warm your shoulder

Activate the heat pack by bending the coin back and forth. You will hear a click and the gel inside will slightly change color. Place the heat pack vertically on the upper arm for THREE minutes.

Note: The heat pack may be taken on and off if the temperature becomes uncomfortable.

4. Clean collection site

Clean your heated shoulder with the provided alcohol pad to disinfect and remove oils, make sure the alcohol dries before proceeding to the next step.

1. Remove the safety guard

Pull off the cardboard tab guarding the device's activation lever.

2. Prepare EasyDraw device

Remove the EasyDraw device from the packaging. Unscrew the tube cap and press the tube into the end of the device. Use a slight twist for a secure fit.

Note: The tube's lip must face the back of the device. A small gap will remain after tube is installed.

3. Remove adhesive liner

Peel the paper off the bottom of the device using the tab on the back of the device.

4. Place device on skin

Stick the device FIRMLY to the center of the heated portion of your arm with the tube facing down.

Note: The adhesive's main role is to maintain the device's stored vacuum once activated.

1. Activate device

To activate, press the lever down while pushing the device firmly into your skin.

Note: Movement during activation can break the seal and lead to failure.

2. Check indicator

The button on the device will turn green to indicate the draw has started.

3. Wait for blood flow

The flow of blood may take between 30-90 seconds to begin.

1. Remove device

Remove the device by peeling it off your arm when...

1. The blood level reaches the TOP FILL LINE
   (top marking on the collection tube)
   or
2. Three (3) minutes have passed whether you have collected enough blood or not.

Do not overfill or leave the device on longer than recommended as this can lead to issues processing your sample.

2. Remove collection tube

Remove the tube by gently pulling and twisting the tube off of the device.

Note: If your tube contains less than 400 uL, proceed to Step 3 and then use hte backup kit to obtain an additional tube. Even if your tube doesn't have enough blood, please send it in along with the tube from the backup kit.

3. Cap collection tube

Press the cap onto the tube firmly until a click is heard.

4. Flip collection tube 10 times

Tap the tube on a table and then vigorously flip the tube 10 times to mix contents. Liquid should move from the cap to the bottom of the tube.

Note: Contents should be liquid and not clumpy after flipping.

1. Wipe collection site

Use the provided gauze to wipe the blood from the collection site.

2. Apply bandage

Apply a bandage to the collection site.

3. Wash hands

After use, wash your hands with warm water and soap.

1. Place sample into specimen bag

Place the sample into the plastic specimen bag and seal.

Remember to write your name, date of birth, and collection date on the included card.

Place the card into the front pocket of the specimen bag. Make sure to fill out the collection card with the same information you used during registration.

Missing or incorrect details can cause delays in processing your sample.

2. Pack cold pack and sample

Take out the cold pack from the freezer and place it into the insulated silver bag along with the sample and seal.

3. Place into box

Place the silver bag into the same box your kit came in and close the box. Then, place the box into the return mailer.

4. Prepare for pickup

Place the package outside. Please text a picture of the package to (888) 200-1228. This will help us to coordinate the pickup.

Note: You can also return directly at an indoor FedEx location. Do not use drop boxes as these get extremely hot during the day. Ensure that you are shipping your sample prior to the FedEx Express shipping cut off.

Warnings

• Not intended for more than one use
• Do not use on more than one patient
• Discard the entire device after use
• Do not use after the expiration date
• Keep out of reach of children
• Not for use on infant heels
• Do not re-sterilize
• For external use only
• Minor bruising or residual marks may occur at the sample collection site
• Use while seated, as fainting may occur during any blood sampling procedure. Intended for self use by a healthcare provider
• Refer to the manufacturer's instructions for individual components
• Do not use if the pouch has been opened or damaged
• Users must validate the use of the product for their specific diagnostic assay
• Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, especially in settings where multiple patients are tested

Do not use this kit if:

• You are at an increased risk of fainting or loss of consciousness during blood sample collection, including if you have an arrhythmia, a history of vasovagal syncope (fainting), or a fear of blood.
• You have a bleeding disorder or are taking medication that increases the risk of bleeding, including(but not limited to) untreated hemophilia or blood-thinning medications.
• You have impaired lymphatic circulation in both upper limbs. Collect the sample from a limb without lymphatic drainage.
• You have a skin disorder that may result in poor healing, an increased risk of infection, or skin ulceration, including (but not limited to) Raynaud’s, Scleroderma, peripheral vascular disease, or peripheral neuropathy.