Directions for Use

Directions for UseVidacare.com

Immediate Vascular Access... When You Need It.®

INTRAOSSEOUS INFUSION SYSTEM

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INDIcATIONS FOR USE:For intraosseous access anytime in which vascular access is difficult to obtain in emergent, urgent or medically necessary cases. ADUlTS PEDIATRIcS • Proximal humerus. • Proximal tibia. • Proximal tibia. • Distal tibia. • Distal tibia. Proximal humerus should only be used in patients whose landmarks can clearly be identified.

cONTRAINDIcATIONS FOR USE:• Fracture. • 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

48 hours, prosthetic limb or joint).

WARNINgS AND PREcAUTIONS: cAUTION: Use aseptic technique.cAUTION: Check skin adipose and muscle thickness before insertion. cAUTION: Increased dwell time may lead to increased complications.cAUTION: Use caution with chemotherapeutic agents.cAUTION: Monitor insertion site frequently for extravasation.cAUTION: 24 hour use only.cAUTION: Single use only. cAUTION: Do not recap Needle Sets or separated components. Use biohazard and sharps disposal precautions.cAUTION: Stylet and catheter are NOT MRI compatible.

EZ-IO Power Driver and Needle Sets: Description

EZ-IO 45mm(>40 kg, excessive tissue, humerus)

EZ-IO 15mm(3-39 kg)

EZ-IO 25mm(>40 kg)

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STORAgE: -20°C to 50°C (-4°F to 122°F).

EZ-IO NEEDlE SETS: DEScRIPTION• Comprised of catheter with Luer-lock connection, stylet, safety cap. • 15 gauge, 304 stainless steel in 15mm, 25mm and 45mm.• Sterile, non-pyrogenic, in protective packaging.• Intended for use with EZ-IO Power Driver.

5 mm

5 mm

AD

PD

LD5 mm

5 mm

5 mm

AD

PD

LD5 mm

Proximal Tibia Distal Tibia Proximal Humerus

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1. clean insertion site per hospital protocol.

2. Remove needle safety cap.

IMPORTANT: Only handle Needle Set by the plastic hub.IMPORTANT: Control patient movement prior to and during procedure.

3. gently press Needle Set through skin until tip touches bone.

4. At least 5mm of the catheter must be visible.

5. Squeeze Driver trigger and apply gentle, steady pressure. Release trigger when sudden “give” or “pop” is felt, indicating entry into medullary space. Humerus site: To improve stability, needle should be advanced 2 cm after contact with bone. In adults, advance needle until catheter hub is against the skin.

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IMPORTANT: Use gentle-steady pressure. DO NOT USE ExcESSIVE FORcE. Allow

Needle Set rotation and gentle downward pressure to penetrate bone. Note: If Driver stalls and will not penetrate the bone you may be applying too much downward pressure.

Note: In the unlikely event of a driver failure, remove the Power Driver, grasp the Needle Set by hand and advance the Needle Set into the medullary space while twisting the needle set.

6. Remove Power Driver and stylet; confirm catheter stability.

IMPORTANT: Confirm placement with at least three of the following four methods: • Stability of catheter • Ability to aspirate • Physiologic or pharmacologic changes • Adequate flow rate

7. Use of the EZ-Stabilizer is strongly recommended for the humerus site and for pediatrics.

8. Attach EZ-connect® extension set. Prior to attaching the EZ-Connect®: a. Ensure clamp is open. b. Prime set and purge air. c. Attach set firmly to catheter hub.

DO NOT ATTAcH A SYRINgE DIREcTlY TO THE EZ-IO cATHETER HUB ExcEPT WHEN DRAWINg BlOOD FOR lABORATORY ANAlYSIS (STABIlIZE NEEDlE SET).

9. Flush the EZ-IO catheter with normal saline (10ml for adults; use appropriate weight-based dose for smaller patients).

Education and training materials available at Vidacare.com

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IMPORTANT: • Prior to flush, confirm placement as noted in Step 6.

• For patients responsive to pain, consider 2% lidocaine IO without preservatives or epinephrine (cardiac lidocaine) prior to flush. Follow institutional protocols/policy.

• Local anesthetics intended for the medullary space must be administered very slowly until desired anesthetic effect is achieved.

• NO FlUSH = NO FlOW. Failure to appropriately flush the EZ-IO catheter may result in limited or no flow. REPEAT FlUSH AS NEEDED.

• Once EZ-IO catheter has been flushed, administer fluids or medications as indicated.

cAUTION: Frequently monitor the insertion site for extravasation.

10. Apply EZ-IO wristband; apply dressing if needed. 11. To remove catheter from patient: Attach Luer-lock syringe. Rotate syringe and catheter clockwise while

using traction to withdraw catheter – DO NOT ROck OR BEND THE cATHETER DURINg REMOVAl.

Once removed, immediately place catheter in appropriate sharps container. Dress site as appropriate.

cAUTION: Do not leave the catheter inserted for longer than 24 hours.

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VID05 – 8016 REV F

4350 Lockhill Selma, Suite 150

Shavano Park, Texas 78249

Customer Service: +1 866 479 8500

For further assistance, contact your local Vidacare distributor:

Vidacare.com

Emerge EuropeMolenstraat 152513 BH, The HagueThe Netherlands

EC REP© 2006, 2009, 2011 Vidacare corporation, all rights reserved.Vidacare, EZ-IO® Product System, EZ-connect® and EZ-IO® Intraosseous

Infusion System are trademarks of the Vidacare corporation.

Vidacare.com

EMERgENcY NUMBER:

+1-800-680-4911

8016 Rev J

Intraosseous Infusion System

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Vidacare.comT427 REV C

Immediate Vascular Access... When You Need It.®

To Insert Needle Set: • Locatelandmarks .................................1

• Cleansite ............................................... 2

• InsertEZ-IO®NeedleSet ....................... 3

• Removestyletfromcatheter .................4

• AttachprimedEZ-Connect®

• ConsiderIO2%lidocainewithoutpreservatives orepinephrine(cardiaclidocaine)forpatients responsivetopain–priortoflush

Follow institutional protocols/policy

• Medicationsintendedtoremaininthemedullary space,suchasalocalanesthetic,mustbe administeredveryslowlyuntilthedesired anestheticeffectisachieved

• Syringebolus(flush)IOwith10ml normalsaline .......................................5

• Startinfusionunderpressure ................6

A Medical Director or qualified prescriber must authorize appropriate dosage range.

To Remove Catheter:• Stabilizepatient’sextremity

• ConnectsterileLuerlocksyringetohubofcatheter

• Rotatecatheterclockwise–whilepullingstraightback

• Whencatheterhasbeenremoved,immediatelyplace inappropriatebiohazardcontainer.

DO NOT ROCK thecatheterwhileremoving.Rockingorbendingthecathetermaycausethecathetertoseparatefromthehub.

Emergency contact in US or Canada call: 1-800-680-4911ForinternationalassistancecontactyourlocalVidacareDistributor

Do Not Leave the EZ-IO catheter in for more than 24 hours.

Immediate Vascular Access... When You Need It.®

EZ- IO AD® (40 kg and over ) & EZ- IO PD® (3 – 39 kg) I N T R A - O S S E O U S I N S E R T I O N

I n d i c a t i o n s C o n t r a i n d i c a t i o n s E q u i p m e n t C o n s i d e r a t i o n s / P r e c a u t i o n s P r o c e d u r e N u r s i n g C a r e

1. Immediate vascular access in emergencies. 2.Urgent need for IV or medications and a peripheral IV cannot be established in 2 attempts or 90 seconds

AND one or more of the following: a. An altered mental status (GCS of 8 or less) b. Respiratory compromise (SaO2 90%, respiratory rate < 10 or > 40 min) c. Hemodynamic instability

IO in same limb within past 24 hours Fracture of tibia or femur @ site considered for use Inability to locate anatomical landmarks – excessive tissue or edema Previous significant orthopedic procedures in limb considered for use (joint replacement, pins, etc) Medical conditions such as PVD, tumor in limb considered Infection @ site considered for use POSSIBLE IO SITES Multiple sites are FDA cleared including – Proximal Tibia Distal Tibia Proximal Humerus

EZ-IO® Driver EZ-IO AD® or EZ-IO PD® Needle Set EZ-IO® Yellow wristband Alcohol or Betadine Swab EZ-Connect ® or Baxter IV Connector Loop and standard IV tubing 10 ml Syringe Normal Saline (or suitable sterile fluid) Pressure Bag or Infusion Pump 2 % Lidocaine (preservative free)

24 HOUR USE ONLY!

Single Use Only

Do Not Attach a syringe directly to

the EZ IO hub! (can break hub) If the patient is conscious obtain

informed consent EZ-IO insertion causes pain similar to

insertion of a large bore IV INFUSION of fluids can cause

severe discomfort; use preservative-free Lidocaine prior to flushing if no contraindications

Flush the IO prior to infusion.

NO FLUSH = NO FLOW Repeat a NS flush as needed.

To improve flow rates of continuous

infusions always use a syringe, pressure bag or infusion pump.

M D … 1. Choose insertion site 2. Use aseptic technique 3. Prepare the EZ-IO® driver + needle 4. Stabilize site and insert 5. Remove driver from needle while stabilizing catheter hub, then 6. Remove stylet from catheter by rotating stylet counter-clockwise M D / R N … 7. Confirm placement by checking if…

IO is seated firmly & won’t move. Blood is visible on the stylet tip Blood visible at the catheter hub. Blood or marrow can be aspirated Drugs or fluids flow without difficulty & no signs of leakage in or around site

8. Connect primed EZ-Connect® or IV Connecting Loop and tubing 9. Slowly administer preservative-free Lidocaine 2% IO to conscious patients if no contraindications

EZ-IO AD® : 20 – 40 mg Lidocaine 2% EZ-IO PD® 0.5 mg /kg Lidocaine 2%

10. Flush with preservative free NS.

EZ-IO AD®: 10 ml NS EZ-IO PD® : 5 ml NS

11. Use pressure bag or infusion pump for continuous infusions 12. Use syringe into connecting loop to give boluses of fluids 13. Dress site, secure tubing and apply wristband.

Apply y e l l o w I O b a n d +

record date of insertion Monitor site and fluid flow Regularly confirm that the EZ-IO®

catheter is secure and in position.

Protect insertion site against injury Remove the EZ-IO® within 24

hours. R E M O V A L

1. Remove extension set/tubing 2. Attach 5-10ml syringe to hub 3. Rotate syringe + IO catheter

CLOCKWISE while keeping 90° angle + pulling gently

4. Apply direct pressure @ site if bleeding occurs

5. Apply bandaid or small dressing 6. If catheter of hub separate or

break, simply grasp exposed cath tip w/hemostat and pull gently.

Do Not Rock, Bend, or Use Excessive Force on the Exposed

Catheter! POSSBILE COMPLICATIONS: Extravasation Dislodgement Compartment Syndrome Fracture Pain Reduced Flow Rate Infection *Note – Use of prophylactic antibiotic is NOT recommended following routine EZ-IO usage

Source: EZ-IO ® Training Manual by VidaCare Corp. Prepared by Peg Pedone RN, CEN