EZ-IO® Power Driver

Device Description: The EZ-IO Power Driver consists of a sealed, handheld, lithium-battery powered driver within a customized storage case.

It is intended for rapid insertion of a single lumen intraosseous needle set into human bone.

Storage: The EZ-IO Power Driver and accessories may be stored at temperatures between -20°C to 50°C (-4°F to 122°F).

Cleaning, Disinfection and Maintenance of the EZ-IO® Power Driver

Cleaning Procedure:

1. Observe BSI precautions.

2. Wipe the entire exterior surface of the EZ-IO power driver with a soft, clean moistened cloth. Use a soft bristled brush to remove any visible soil.

3. Spray the exterior surface with an anti-microbial solution following the manufacturer’s specific recommendations.

4. Gently wipe all exterior surfaces with gauze pads until all visible debris is removed.

5. Manipulate the trigger and clean this area using a clean cloth moistened with anti-microbial solution.

6. Using sterile swabs, moisten with anti-microbial solution and gently clean inside the opening around the metal drive shaft.

7. After cleaning, inspect to ensure that no visible debris remains on, and that no damage has occurred to the EZ-IO Power Driver.

8. Dry the driver with a soft, clean, dry cloth and return the driver to the

appropriate case.

Do not immerse or soak the driver or use an excess amount of liquid when performing the cleaning and disinfecting.

Tibial Access

1. EZ-IO® AD (40 kg and greater) and EZ-IO® PD (3-39 kg)

Device Description: EZ-IO needle set contains a stylet and catheter. When the stylet is removed a standard luer lock is exposed. The catheter of the EZ-IO AD is 15 gauge 25 mm. The EZ-IO PD is 15 gauge 15 mm. Both catheters are made of 304 stainless steel, provided sterile, non-pyrogenic and in a protective canister.

indications for Use:

The EZ-IO Product System is indicated whenever traditional vascular access techniques are not possible. This may include:

• Altered level of conscious

• Respiratory compromise

• Hemodynamic instability

Contraindications for Use:

• Fracture (fluid may extravasate into subcutaneous tissue)

• Excessive tissue and/or absence of adequate anatomical landmarks

• Infection at the area of insertion

• Previous, significant orthopedic procedure at the site (IO in past 24 hours, prosthetic limb or joint)

Warnings and Precautions:

Caution: Use aseptic technique for insertion of the EZ-IO needle set.

Caution: Check skin thickness before insertion of the EZ-IO needle set into

bone. (See Figure 1)

Caution: Do not leave the EZ-IO catheter inserted in a patient for longer

than 24 hours.

Caution: EZ-IO AD is intended for insertion into proximal humerus and tibia only.

Caution: The EZ-IO PD is intended for use in the proximal tibia only.

Caution: EZ-IO needle sets are intended for single use only.

Caution: Do not recap needle sets or any separated component. Use proper biohazard and sharps disposal precautions when discarding.

Caution: Power Driver should never be used to withdraw the needle set from the body.

Storage: The EZ-IO product system and accessories should be stored at temperatures between -20°C to 50°C (-4°F to 122°F).

Insertion Steps:

1. Observe BSI precautions.

2. Maintain aseptic technique during usage.

3. Locate proximal tibia insertion site. (See Figure 2)

4. Prepare insertion site. (See Figure 3)

5. Prepare infusion system.

6. Ensure that the driver and needle set are securely seated. (See Figure 4)

7. Remove and discard the needle set safety cap from the IO needle set installed on the EZ-IO power driver (See Figure 5).

8. Insert EZ-IO needle set into tibial site.

Important: Do not touch the needle set with your hand or fingers.

Important: Control the patient’s movement prior to and during needle set insertion.

Important: Make sure hand and fingers are away from insertion site and path of needle set.

a.     Position the driver at the insertion site with the needle set at a 90-degree angle to the bone surface. (See Figure 6). Gently power the needle set until the needle set tip touches the bone.

b. Check to ensure that at least 5 mm of the catheter is visible as indicated by the proximal depth indicator (See Figure 1). If less than 5 mm of the catheter is showing, the patient may have excessive soft tissue over the tibial site and the needle set may not reach the medullary space. The site you have selected my not be appropriate for the EZ-IO – consider an alternate location for insertion.

c. Penetrate the bone cortex by squeezing the driver’s trigger and applying gentle, steady downward pressure  (See Figure 6).

d. Release the driver’s trigger and stop the insertion process when:

1. A sudden “give” or “pop” is felt upon entry into the medullary space.

2. When desired depth is obtained.

Important: During intraosseous catheter insertion use gentle-steady pressure. Do not use excessive force on the needle set. Allow the catheter tip rotation and gentle downward pressure to provide the

penetrating action. “STOP WHEN YOU FEEL THE POP”.

Note: If the driver stalls and will not penetrate the bone you may be

applying too much downward pressure.

Caution: If catheter insertion into the site cannot be properly completed, remove and dispose of the needle set in appropriate sharps-biohazard container. Repeat the procedure in the patient’s opposite extremity or appropriate site with a new needle set.

9. Remove power driver and stylet. (See Figure 7)

10. Confirm catheter stability.

11. Attach EZ-Connect® extension set to catheter hub’s luer lock. (See Figure 8)

DO NOT ATACH A SYRINGE DIRECTLY TO THE EZ-IO AD CATHETER HUB – Doing so may cause enlargement of the hole at the insertion site and possible extravasation.

12. Flush the EZ-IO AD catheter with 10 ml of Normal Saline. Flush the EZ-IO PD catheter

with 5 ml of Normal Saline.

Important: Prior to flush consider the aspiration of a small amount of blood to confirm placement.

• Consider IO Lidocaine (preservation free) for conscious patients prior to flush.

• NO FLUSH = NO FLOW Failure to appropriately flush the IO catheter

may result in a limited or no flow treatment situation.

• Once the IO catheter has been flushed, administer fluids or medications

as indicated.

Note: Frequently monitor the insertion site for extravasation.

13. Apply dressing.

14. Remove catheter from patient. Gently twist clockwise while slowly applying traction to the catheter. Do not

rock or bend the catheter during this procedure. (See Figure 9)

Once removed, immediately place the catheter in an appropriate sharps container. Dress the insertion site as needed (A small Band-Aid™ will usually accomplish this task). Monitor the site for bleeding or signs of infection.

Caution: Do not leave the catheter inserted in

a patient for longer than 24 hours.

Adult Alternative Site Access

1. Adult Humeral Head Access EZ-IO® AD (40 kg and greater)

Insertion Steps:

1. Observe BSI precautions.

2. Maintain aseptic technique during usage.

3. Locate proximal Humeral insertion site. (See Figure 1, 2, and 3)

4. Prepare insertion site.

5. Prepare infusion system.

6. Ensure that the needle set is securely attached to the Power Driver.

7. Remove and discard the needle set safety cap from the IO needle set installed on the EZ-IO power driver.

8. Insert the needle set into the humeral head site. (See Figure 4)

9. Remove power driver and stylet. (See Figure 5)

10. Confirm proper catheter tip positioning.

Note: If the insertion site fails the above tests, reassess the insertion site landmarks and consider removal and disposal of the needle set. Repeat procedure using new needle set in opposite extremity or other appropriate site.

11. Attach EZ-Connect® extension set to catheter hub’s luer lock. (See Figure 6)

DO NOT ATTA CH A SYRINGE DIRECTLY TO THE EZ-IO AD CATH ETER HUB – Doing so may cause enlargement of the hole at the insertion site and possible extravasation.

12. Flush the catheter with 10 ml of Normal Saline.

Important:

• Consider IO Lidocaine (preservation free) for conscious patients prior to flush

• NO FLUSH = NO FLOW

13. Apply dressing.

14. Remove catheter from patient. DO NOT ROCK OR BEND THE CATHETER DURING THIS PROCEDURE. (See Figure 7 & 8) Extravasation caused by “rocking”