ez-io insertion proximal tibia - in depth

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Proximal TibiaTraining Program

Proximal TibiaTraining Program

The Vidacare EZ-IO AD Training Program is designed to help you understand and use the EZ-IO infusion system. Throughout this PowerPoint™ presentation you will note civilian, military, hospital and pre-hospital medical professionals caring for those in need. This multi-specialty approach is important to you for two reasons: First, emergency care today, more than ever is about teamwork. Second, though each of us may work in different environments our approach to, and problems with vascular access are similar. With this in mind - sharing and participating in education and training programs such as this further enhances our combined ability to care for the most seriously ill or injured.

Our collective goal has long been rapid, safe vascular access for all critical patients. Vidacare’s approach to this goal is simple – the right equipment - in the best hands – where it’s needed most.

At the completion of this program if you still have questions or concerns please call us at 1.866.479.8500 or visit our web site at www.vidacare.com

We at Vidacare appreciate what you do and the time you devote to it. Thank you for inviting us to be a member of your team!

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Vidacare’s Training MaterialsTraining Manual

PowerPoint™ PresentationsWith comprehensive “notes section” co located behind each slide!

EZ-IO StarCast Presentations

Quick Reference Card

Insertion & Removal Poster

Training Mannequins

Training Needle Sets

Complete Web Site

Educator Support Hotline

“Immediate Vascular Access When You Need It Most”“Immediate Vascular Access When You Need It Most”

Vidacare’s training program includes ten specific items uniquely designed to compliment your training needs. This material was developed with an understanding of the multitude of teaching and learning styles, as well as the environments in which they will be applied.

The EZ-IO training program:• reduces liability• reduces training cost• Improves patient and provider safety

Our training program introduces the EZ-IO with confidence and attention to fiscal responsibility.

Vidacare’s goal, like yours: Comprehensive understanding with a maximum benefit over risk ratio.

Do you have any questions or specific needs? Contact one of Vidacare’s Clinical Specialist or the Education Department – We are ready to help – 1.866.479.8500 or www.vidacare.com

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Updates, Information & Resource Materialswww.vidacare.com

The Vidacare website contains important updates, information and resources for you!

By periodically browsing our website you can stay abreast of changes, breakthroughs and important updates.

Looking across the menu and then “clicking” on a specific topic will call up that categories information.

We invite you to explore our useful website and to become a frequent visitor!

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EZ-IO AD Training Objectives

• Briefly discuss the history of intraosseous use.

• Describe the non-collapsible vein principle.

• Identify 3 landmarks critical to EZ-IO AD Proximal tibial

insertion and discuss 2 additional insertion site options.

• List the indications for EZ-IO AD insertion.

• List the contraindications for EZ-IO AD use.

• Demonstrate the proper steps for EZ-IO AD insertion.

• Discuss care and maintenance of the EZ-IO AD driver.

• Briefly discuss the history of intraosseous use.

• Describe the non-collapsible vein principle.

• Identify 3 landmarks critical to EZ-IO AD Proximal tibial

insertion and discuss 2 additional insertion site options.

• List the indications for EZ-IO AD insertion.

• List the contraindications for EZ-IO AD use.

• Demonstrate the proper steps for EZ-IO AD insertion.

• Discuss care and maintenance of the EZ-IO AD driver.

These training objectives are a list of questions essentially outlining this program and what we will be doing!

A slight difference exists between the PowerPoint™ Training Objectives and Student Manual Training Objectives. This was necessary for clarity and brevity in the presentation format

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Why Go EZ-IO?Why Go EZ-IO?ImmediateEasySafeEffectiveShock

ImmediateEasySafeEffectiveShock

Why go EZ-IO?

Immediate. Precious time is often wasted looking for peripheral veins that may or may not be accessible. Equally frustrating in certain difficult situations is central venous access -which could mean more lost time and or a significant risk of infection for the patient. We know that without access the critical patient usually cannot receive drugs or fluids. Failing to gain access might mean the difference between pain and suffering or life and death. With the EZ-IO infusion system time is on your side!Easy. Multiple IV attempts usually means multiple providers and catheters – this spells exposure and infection risk for the providers and the patient. With one EZ-IO infusion system and a few seconds you will have. The EZ-IO virtually eliminates the pressure of IV failure.Safe. In hostile situations such as those in tactical environments, extrications, MCI’s or combative patients the EZ-IO limits your exposure and the effort needed to treat on the go! The bottom line, if time matters, then the EZ-IO in your hands is the answer!Effective. The EZ-IO has a research proven record of effectiveness when faced with the most critically ill and injured. Consider this: the next time you step out on the front line, dependable, immediate vascular access will no longer concern you!Shock. If the patient presents in shock the peripheral veins have often collapsed (usually the result of blood or fluid loss, lack of vascular tone, respiratory complications or cardiac failure). Gaining vascular access with the patient in this condition can be extremely difficult. The IO space is considered a Non-Collapsible vein (explanation to follow) and the EZ-IO helps you gain immediate, safe and effective access to it!

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1922 - Circulation of the sternum proposed as a route toadminister blood – Drinker.

1936 - Confirmation of long bone as a site for vascularaccess – Tocantins.

1942 - Circulation times between IV & IO routes confirmedas essentially the same – Papper.

1940’s - 1950’s - IO extensively used and written about. WW II - over 4000 cases.

1960’s - No civilian EMS - “ IO becomes the lost procedure”.

1980’s - Present - “Rediscovery” & IO development.

1922 - Circulation of the sternum proposed as a route toadminister blood – Drinker.

1936 - Confirmation of long bone as a site for vascularaccess – Tocantins.

1942 - Circulation times between IV & IO routes confirmedas essentially the same – Papper.

1940’s - 1950’s - IO extensively used and written about. WW II - over 4000 cases.

1960’s - No civilian EMS - “ IO becomes the lost procedure”.

1980’s - Present - “Rediscovery” & IO development.

The History of Intraosseous UseThe History of Intraosseous Use

Listed here are some of the important research and developmental milestones in the evolution of IO use.

A comprehensive bibliography is located a www.vidacare.com

To date there are more than 450 papers related to IO use.

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Anatomy & PhysiologyAnatomy & Physiology

Let’s start with the Anatomy & Physiology.

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DSB1

Here we can identify the structures of the tibia. Important points to note include the thin cortex at the Epiphysis (Our EZ-IO AD proximal tibial insertion site) versus the thick compact bone on the Diaphysis. Note also the vasculature crossing between the cancellous bone, through the thin cortex and into the veins – this makes IO infusion possible!

DSB1 Scotty Bolleter, 4/11/2004

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PatellaAdult Right Leg Tuberosity Insertion Site

EZ-IO Inserted Stylet Removed

Note catheter locationidentifying structuresand tissue thickness

These images were created during an anatomical study at the University of Texas Health Science Center - San Antonio

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Note the distance from the proximal

aspect of the tibia to the middle ofthe tuberosity

Note the average skin thickness atthe insertion site

This image was also created during the anatomical study at the University of Texas Health Science Center - San Antonio

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The non-collapsible vein principle

The non-collapsible vein principle is integral to understanding IO usage and is central to the EZ-IO training program.

Inside the Epiphysis of the tibia (under the thin cortex) lay structures called Cancellous bone (a spongy framework). These structures interconnect with canals that ultimately connect with veins. This is the Intraosseous space. Drugs or fluids placed here are immediately propelled into the central circulation via progressively larger veins.

Research has proven that all drugs or fluids administered via the IO route are available in equal strength and speed to those given via a peripheral IV.

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Watch the vein “appear” as contrast (fluid) is pushedWatch the vein “appear” as contrast (fluid) is pushed

Note (upper left hand corner) the cancellous bone (spongy framework) of an actual human tibia. In the four images at the bottom of this slide you can observe fluid as it is pushed via the EZ-IO infusion system. The elapsed time of this 5 ml bolus is 1.5 seconds. (this particular study demonstrates a bolus rate of 200 ml/min) 120 ml/min syringe boluses on average adult patients have routinely been observed.

Tibial IO fluid administration drip rates average between 2 - 40 ml/min when using pressure (this equals 120 – 2400 ml/hr). It is important to consider that flow rates vary greatly and are dependant on multiple factors such as: The patient’s Anatomy, adequate pre-infusion syringe Flushing and infusion system Pressure. NOTE: THERE IS A DISTINCT DIFFERENCE BETWEEN THE TERM “SYRINGE FLUSH OR BOLUS” AND FLUID “GIVEN OR PUSHED WITH AN ADMINISTRATION SET”. This difference relates specifically to: The pressures generated by the syringe - Versus - the “supportive administration” of fluids given over time (which are administered with significantly less pressure). Slide numbers 40 & 41 discuss this in more detail.Important Teaching Point: Demonstrate the “feeling” of pushing an IO Bolus by attaching a 24 ga catheter to various syringes. (5 – 60 ml standard syringes as well as various 5 – 50 ml pre-filled syringes). You will note that the “mechanics” of pushing changes as the syringe size varies. REMEMBER – this is a “feeling” exercise – HOWEVER the question of blood being hemolyzed by the 24 ga catheter might be posed – remind the participant that the EZ-IO catheter is 15 ga and will not disrupt or damage blood cells.

Next - Demonstrate various flow rates using 10 gtt, 15 gtt, and 60 gtt sets. You can engage the participants by having them set (by sight and watch) the following: Example 120 ml/hr 10 gtt set = 20 gtts/ min

15 gtt set = 30 gtts/min60 gtt set = 120 gtts/min

This important exercise described above will set REALISTIC EXPECTATIONS for EZ-IO usage! Failing to engage the participant in these activities may lead to perceived infusion failure!

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This EZ-IO study at the University of Texas Health Science Center provides an exceptional presentation of a concept once considered difficult, impossible or non-existent. *IO fluid administration reaches the vascular spaces within seconds!

You can clearly see the EZ-IO catheter attached to an extension set with fluid being pushed in real time. Syringe bolus rates of up to 120 ml/min have been observed in humans.

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Intraosseous usage and pain

It is important to discuss pain as it relates to IO usage. Preconceived or misinformed viewpoints can lead to misunderstanding and possible complications.

There are two types of pain to consider with IO insertion. At the risk of oversimplification here is a working description:

Somatic pain could be described as the pain that you feel on the surface of your body while visceral pain could be summarized as the pain that you feel internally.

Somatic pain:EZ-IO insertion is fast. The insertion speed coupled with a specific, small insertion site limits the amount of somatic pain or nerve stimulation that occurs. The pain is considered tolerable by the vast majority of conscious patients and the use of a local anesthetic is not usually indicated or recommended.

Visceral pain:Once the catheter is in position one should be aware that infusion pain is visceral in nature and the stimulation of nerves extends to a wide area. This pain can be extremely diffuse, perceived as extreme and may also produce nausea. For this reason we recommend that conscious patients (those with a GCS of > 8) receive 20 – 40 mg of 2 % Preservative Free Lidocaine slowly via the EZ-IO catheter prior to any fluid flush, bolus or infusion. You mayconsider “priming your extension set” with Lidocaine in certain situations.

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Blood flow through theintraosseous space

The intraosseous space is a specialized area of the vascular system. Blood flow is steady and generally continues even in shock.

Pressure in the IO space is approximately 1/3 of the systemic pressure. (This can actually be monitored with a pressure transducer!)

We can withdraw bone marrow and blood from the IO space but generally cannot deposit anything permanently into the meduallary area for any length of time secondary to continuous blood flow.

During IO infusions, we are specifically delivering fluid and medication into the vascular system thorough via the intraosseous space, thus the term “IO Vascular Access”.

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Additional Insertion Sites

For more information on these FDA cleared insertion sitesPlease review the appropriate “In Depth” training programs

Distal Tibia Proximal Humerus

While this program is directed at the proximal tibia as well as a comprehensive look at the EZ-IO product system – additional insertion sites should be considered and reviewed. The additional insertions sites include the DFA cleared Distal Tibia and Proximal Humerus. Please become familiar with each site by reviewing the associated “In Depth” training.

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Finding the EZ-IO AD tibial insertion site

Finding the EZ-IO AD tibial insertion site

OK, now it is time to look at the EZ-IO AD tibial insertion site.

Do you have our EZ-IO Tibial Training mannequin? To see all of our mannequins visit our website Training Section at www.vidacare.com.

To order any of our mannequins visit the “EZ-IO” company page at SAWBONES® -either by linking from our Vidacare website mannequin area or by directly visiting www.sawbones.com

Our mannequins offer a realistic, cost effective, safe platform to routinely teach EZ-IO placement!

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Here we can identify the major structures of the upper and lower leg as well as the three EZ-IO AD proximal tibia landmarks, the Tibia (anterior or most forward lower leg bone), Patella(knee cap) and Tibial tuberosity (bump or raised area on the anterior aspect or front of the tibia)

Can you identify the proximal tibia landmarks on the medial view?

1. The Patella (knee cap)2. The Tibial Tuberosity (bump or raised area on the tibia)3. The actual target site - one finger width medial (toward the inside) to the Tibial Tuberosity.

Can you identify the landmarks on yourself or someone else?

Helpful reminders: “If you want to get in – think in!” (rational – If you want to get inside (the IO space or bone) – think inside – (the medial aspect of the leg.)“Big Toe – Go EZ-IO” (rational – the EZ-IO AD is placed on the medial (inside) aspect of the leg – the Big toes are found on the medial (toward the inside) aspect of the body or feet.

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Anterior (front) view(Fingers on tibial tuberosities)

Actual insertion sites located(Fingers on insertion sites)

The EZ-IO AD should be inserted Medial to the Tibial Tuberosity. The insertion site can also be identified two finger widths (2 cm) bellow the patella (kneecap) and one finger (1 cm) medial (toward the inside) to the tibial tuberosity.

“IF YOU WANT TO GET IN (side the bone) – THINK IN (side the leg)!”

“Big Toe (side of the leg) GO - EZ-IO”

Proper identification of the insertion site is crucial. Failure to identify the appropriate location could result in:

1. Improper placement – such as the knee joint or soft tissue.2. Prolonged insertion – resulting from an attempt to insert the EZ-IO AD through compact

(thick) bone on the Diaphysis (shaft) rather than the Cortex (thin) bone closer to the epiphysis (end).

3. Complete bone perforation – resulting from an improper placement attempt along the Diaphysis (shaft) of the tibia.

Can you locate the insertion site on yourself or partner now?• Here is an important training tip – Have a student “cross” his or her legs. Now can the

“provider” identify the insertion site! Initially this might seem tricky because the relative position of the legs and insertion site has changed!

For the morbidly obese patient – consider rotating the foot to the mid-line position (foot straight up and down). With the knee slightly flexed, lift the foot off of the surface allowing the lower leg to “hang” dependant. This maneuver may improve your ability to visualize and access the proximal tibial insertion site. You should also consider an alternate site such as the distal tibia or the proximal humerus.

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Anterior (front) Medial (middle) Insertion site located

Finger on tibial tuberosity Finger medial to tibial tuberosity Finger on actual insertion site

Here is another view. Again the EZ-IO AD should be inserted Medial to the Tibial Tuberosity or two finger widths below the patella (kneecap) and one finger medial (toward the inside) to the tibial tuberosity.

“IF YOU WANT TO GET IN (side the bone) – THINK IN (side the leg)!”

“Big Toe (side of the leg) – GO EZ-IO”

Proper identification of the insertion site is crucial. Failure to identify the appropriate location as specified could result in:

1. Improper placement – such as the knee joint or soft tissue.2. Prolonged insertion – resulting from an attempt to insert the EZ-IO AD through compact




“provider” identify the insertion site! Initially this might seem tricky because the relative position of the legs and insertion site has changed!

For the morbidly obese patient – consider rotating the foot to the mid-line position (foot straight up and down). With the knee slightly flexed, lift the foot off of the surface allowing the lower leg to “hang” dependant. This maneuver may improve your ability to visualize and access the tibial insertion site. You should also consider an alternate site such as the distal tibia or the proximal humerus.

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This is a 3 D animation of the EZ-IO AD proximal tibial insertions process.You can clearly see the insertion site on the anterior (front) medial (toward the inside) tibia.In addition to an excellent view of the insertion site this 3D animation demonstrates the major steps and science behind the EZ-IO.Important points:1. Identification of insertion site2. Cleaning the insertion site3. Removing the safety cap from the sterile needle set4. Placement of the EZ-IO AD needle set into the proximal tibial target area5. Removal of the stylet6. Attachment of the extension set7. The 3D animation gives a tremendous view of the progression of fluid.

Discussion Point: What is missing from this animation? 1. The removal of the EZ-IO AD driver and cartridge from the storage case2. Removal of the EZ-IO AD needle set from the cartridge3. (Once catheter is in position) A 10 ml IO flush or bolus with a syringe prior to starting the infusion4. (Lastly) the securing of the extension set.

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11 22 33

77 9988

44 55 66

This slide is a step by step break down of the EZ-IO AD 3D animation.

Important points:1. Identification of insertion site2. Cleaning the insertion site3. Removing the safety cap from the sterile needle set4. Placement of the EZ-IO AD needle set into the proximal tibial target area5. Removal of the stylet6. Attachment of the extension set with 10 ml SYRINGE FLUSH

Can you identify what is missing from these images? 1. The removal of the EZ-IO AD driver and cartridge from the storage case2. Removal of the EZ-IO AD needle set from the cartridge3. (Lastly) the securing of the extension set.

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The EZ-IO Infusion System


Let’s look at the EZ-IO infusion system!

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The EZ-IO Needle Set

Catheter & Stylet

Connecting point betweenStylet hub and Catheter hub

Needle SetSafety Cap

Catheter &Catheter Hub

Stylet

StyletHub

Metal Disc

EZ-IO Needle Set (safety cap removed)

EZ-IO Needle Set (“X-Ray View” with safety cap)

Note the tip design

This image is a piece by piece break down of the EZ-IO needle set. The picture insets on the left are of the assembled needle sets (the top inset is without the needle set Safety Cap while the bottom inset has the Safety Cap in position). The inset picture on the top left is a representation of what the needle set will look like prior to insertion.Note that the needle sets have multiple parts. Each part has a specific function.The needle set safety cap attaches ONLY to the catheter hub. This cap comes on the sterile needle set and is discarded once the sterile needle set is opened and prepared for use. THE NEEDLE SET SAFETY CAP SHOULD NEVER BE REPLACED. IF THE NEEDLE SET SAFETY CAP IS NOT IN POSITION WHEN OPENING A NEW EZ-IO CARTDIGE –DISCARD THE NEEDLE SET AND OPEN A NEW CARTRIDGE.The Catheter is a 15 gauge and made of 304 stainless.The Catheter Hub is connected to the catheter and provides an adapter for the EZ-Connect®or tubing. The adapter is a standard luer lock connection.The Stylet is found inside the catheter when the needle set is first opened. The stylet provides a cutting edge for the catheter during insertion. The stylet is connected to the stylet hub and is initially found attached to the catheter hub. Once the needle set is inserted the stylet hub is unscrewed and the stylet is removed and placed into the stylet shuttle or bio hazard container. The metal disc (located inside the stylet hub) is used to attach the magnetized drive shaft to the needle set.

Metal discs may become dislodged after multiple training sessions (with Training Needle Sets) or excessive insertion force. The small metal disc might remain attached to the drive shaft. Simply pull the metal disc off and dispose of properly.

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The EZ-IO Lithium Driver

Designed for 1000 human insertions

Sealed capLithiumBatteries

The EZ-IO driver is produced with Lithium Ion batteries and is delivered sealed from the factory. Do not attempt battery replacement or adjustment.

The driver is designed for 1000 human insertions.

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Needle Set & CartridgeNeedle Set & Cartridge

Hard CaseHard Case

Vascular Access PackVascular Access Pack

Needle Set DispensersNeedle Set Dispensers

AD & PD Needle SetsAD & PD Needle Sets

EZ-Connect EZ-Connect

WristbandWristband

The EZ-IO Infusion system. Consisting of the:

EZ-IO Driver (Shown in the Hard Case and in the Vascular Access Pack)

EZ-IO Needle Sets (AD and PD) – contained in individual boxes within a dispenser. Note that needle sets are provided in safety sealed cartridges

EZ-IO Wrist bands

EZ-Connect extension sets

IMPORTANT SAFETY CONSIDERATION – The EZ-IO infusion system has a separate TRAINING NEEDLE SET. This training needle set is colored RED and IS NOT FOR PATIENTUSE.

Training needle sets are not sterile or safety sealed. They are intended for training only and should NEVER be placed inside a kit intended for actual patient care.

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The EZ-IO Training Driver and Needle Sets

IMPORTANT SAFETY CONSIDERATION – The EZ-IO infusion system has a separate TRAINING NEEDLE SET. This training needle set is colored RED and IS NOT FOR PATIENT USE.

Training needle sets are not sterile or safety sealed. They are intended for training only and should NEVER be placed inside a kit intended for actual patient care.

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Precise cylindrical hole created byEZ-IO insertion

This actual cross section of a bone following EZ-IO removal demonstrates the precise cylindrical insertion and subsequent tight catheter fit.

This “tight catheter fit” lessens the likelihood of extravasation.

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Using the EZ-IOUsing the EZ-IO

OK, Let’s talk about using the EZ-IO infusion system.

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The EZ-IO AD is intended forpatients weighting 40 kg and more!

The EZ-IO AD is intended forpatients weighting 40 kg and more!

For patients weighting between 3 and 39 kg consider the EZ-IO PD

IMPORTANT! The EZ-IO AD is primarily for patients 40 kg and above.

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EZ-IO AD IndicationsTo Gain Immediate Vascular Access in an Emergency

EZ-IO AD IndicationsTo Gain Immediate Vascular Access in an Emergency

Altered level of consciousness

Respiratory compromise

Hemodynamic instability

Altered level of consciousness

Respiratory compromise

Hemodynamic instability

Listed here are the primary indications. Can you think of specific conditions that would fit each indications?

Examples of disease states often meeting these criteria include, but are not limited to the following:

Cardiac arrest, Status epilepticus, All shock states, Arrythmias, DehydrationBurns, Drug Overdose, DKA (diabetic), Renal failure, Stroke, AMI, Coma, OB complications, Thyroid crisis, Trauma, Anaphylaxis, CHF, Emphysema, Respiratory arrest, Hemophiliac crisis.

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EZ-IO AD ContraindicationsEZ-IO AD ContraindicationsFracture (targeted bone)

Previous orthopedic procedures near insertion site

Infection at the insertion site

Inability to locate landmarks or excessive tissue

Fracture (targeted bone)

Previous orthopedic procedures near insertion site

Infection at the insertion site

Inability to locate landmarks or excessive tissue

These are the contraindications. Recent fractures may cause fluid or drugs to escape into inappropriate areas – thus not reaching target tissue and possibly causing additional significant injury. Certain Orthopedic procedures at or near the insertion site. One example would be a total knee replacement. This would render the IO space inaccessible secondary to the indwelling device. Another example would be a recent (within the past 24 hours) IO placement in the same extremity. This “extra penetration” might allow extravasation (leakage) into surrounding soft tissue from the initial IO site (that has not yet closed) . Not all orthopedic procedures pose a contraindication or concern to EZ-IO usage. Examples include: prior knee surgery or even mid-shaft tibial amputations (that have completely healed).Infections at the insertion site pose a risk because they could be introduced into the bone and systemic circulation. Inability to locate the landmarks could result in an attempted placement that is unacceptable and dangerous. Lastly, Excessive tissue may result in the needle set failing to reach the intraosseous space.

With each of the possible complications above the provider should consider alternate appropriate sites. Additionally, a risk versus benefit assessment should always be considered prior to any IO placement.

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Observe Body Substance Isolation procedures

Anytime you are providing care to the public it is important to protect yourself as well as the patient. Practicing proper Body Substance Isolation (BSI) is vital to quality patient care and is recommended anytime the EZ-IO infusion system is in use.

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Identify EZ-IO AD tibial insertion site

Finger on insertion siteFinger on insertion site

The EZ-IO AD should be inserted Medial to the tuberosity or two finger widths (2 cm) bellow the patella (kneecap) and one finger width (1 cm) medial (toward the inside) to the tibial tuberosity.

“IF YOU WANT TO GET IN (side the bone) – THINK IN (side the leg!)”“Big Toe – GO – EZ-IOProper identification of the insertion site is crucial. Failure to identify the appropriate

location as specified could result in:1. Improper placement – such as the knee joint or soft tissue.2. Prolonged insertion – resulting from an attempt to insert the EZ-IO AD through compact




“provider” identify the insertion site! Initially this might seem tricky because the relative position of the leg has changed!

For the morbidly obese patient – consider rotating the foot to the mid-line position (foot straight up and down). With the knee slightly flexed, lift the foot off of the surface allowing the lower leg to “hang” dependant. This maneuver may improve your ability to visualize and access the tibial insertion site.

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Clean site using aseptic technique

Clean the insertion site using aseptic technique per your local protocol.

NOTE: Following your cleaning of the insertion site you may consider administration of a local anesthetic. Infiltration of 1% Lidocaine has proven effective should this be deemed necessary (THIS PROCEDURE MUST BE APPROVED BY YOUR AGENCY, SERVICE OR INSTITUTION – INSURE THAT THE PATIENT DOES NOT HAVE ASSOCIATED ALLERGIES PRIOR TO ANY DRUG ADMISISTRATION!)

The extensive evaluation of numerous conscious patients suggest that the actual insertionof the needle set is no more painful than the insertion of a standard IV catheter - thus a local anesthetic is not usually recommended in an emergent setting.

The primary source of pain (for conscious patients) associated with this device is predominately related to the increase in intra-medullary pressure. This can be mitigated with the infusion of 2% (Preservative Free) Lidocaine given through the EZ-IO port (Adults 20-40mg IO slow push. Pediatrics 0.5 mg/kg IO slow push).

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Retrieve EZ-IO driver and cartridge from case. Open cartridge & attach driver to needle set

Remove the EZ-IO driver and AD needle set cartridge from the case.

You should note an intact safety seal indicating a previously unopened cartridge. As you open the Cartridge you will hear a “pop”. This, in combination with the safety seal, is your primary indication that a sterile needle set has been opened and is now being prepared for use.

Attach the EZ-IO driver to the Needle Set – you should “feel” a snap - as the drive shaft attaches to the needle set coupling magnet.

At this point you should prepare (prime) your EZ-Connect extension set or tubing and be prepared to Flush the inserted catheter.

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Remove needle set safety cap

ROTATE SAFETY CAP CLOCKWISE TO REMOVE

Remove the needle set from the cartridge (DO NOT DISCARD THE CATRIDGE).Remove the needle set safety cap. (Remove safety cap only when you are certain of immediate use) While holding the EZ-IO driver in your hand - grasp the safety cap and rotate it clockwise. This will break the seal and allow you to pull the cap away. Rotation of the safety cap in the wrong direction will only loosen the connection between the catheter hub and stylet. If this should inadvertently occur – simply retighten the loosened connection. Another technique you may employ to loosen the safety is to momentarily power the driver while firmly holding the cap. Allow the driver and needle set to stop turning and then remove the needle set cap as previously mentioned. Be cautious of exposed needle set tip!

CAUTION: IF THE NEEDLE SET SAFETY CAP IS NOT IN POSITION DURING PREPARATION – DO NOT ATTEMPT INSERTION - DISCARD THE POTENTIALLY UNSTERILE NEEDLE SET - AND PERPARE ANOTHER NEEDLE SET IMMEDIALTY!

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Stabilize leg

Guard against unexpected patient movement!

Make certain that you have located the appropriate insertion site.

Stabilize the leg.

Guard against any unexpected patient movement.

Place the needle set tip on the insertion site at a 90 degree angle to the bone and prepare to power the driver.

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Power EZ-IO AD Needle Set, at a 90 degree angle to the bone – check the 5 mm mark!

Check the 5 mm mark !

Insure that the needle set is at a 90 degree angle to the bone. (This would be directly perpendicular to the bone itself).

Power the driver (by squeezing the trigger) advancing the needle set tip to the bone.

At this point (with the needle set tip touching the bone) verify that you can see the 5 mm mark on the EZ-IO catheter (This is the mark closest to the EZ-IO hub).

If the 5 mm mark is visible continue with insertion.

If the 5 mm mark is not visible you should abandon the procedure, (the catheter may not reach the IO space) This situation is the result of excessive “pre-tibial tissue”. (see the image in the bottom right corner of this slide) Obesity is a potential cause for excessive “pre-tibial tissue” but other conditions could present in this manner.

Return the Needle Set to the cartridge for temporary safety and then dispose of the needle set in an FDA approved bio hazard container and dress the site according to protocol. WARNING – NEVER PLACE A “USED” or OPENED CARTRIDGE BACK INTO ANY JUMP KIT, CRASH CART OR OTHER LOCATION CONSIDERED CLEAN OR STERILE – Doing so poses a potential contamination risk for both patient and provider.

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Complete insertion

In the unlikely event of a driver failure consider manual insertion

“Stop when you feel the pop”

Complete the insertion. Do Not Push Down with excessive force on the driver and needle set during insertion. Moderate pressure while allowing the driver and the needle set to do the work is the safest method.

You will know you have reached the IO space when:1. There is a sudden lack of resistance -“stop when you feel the pop”2. The catheter flange gently touches the skin.

*In the unlikely event of driver failure during the insertion process - consider manual completion. This can be accomplished by grasping the catheter as shown. Be certain that you have a firm grasp on both the stylet and catheter hubs. Twist the needle set back and forth (maintaining a 90-degree angle) while gently pushing into position.

* Manual insertion is considerably slower and the following should be considered:• Failure to hold both the stylet and the catheter hubs during insertion process may

lead to inadvertent catheter separation and insertion failure.• Failure to maintain a 90-degree angle while inserting the needle set manually may

lead to extravasation (Caused by the creation of a larger than needed pathway for the catheter.

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Remove driver from needle set

Stabilize needle set while disconnecting

Stabilize the needle set by holding it in position. Gently and slowly remove the driver by pulling it directly up and off. Do not “rock, twist or turn” the driver during this process as this will “lock” the catheter into the needle set by tightening the connection.Place the driver back in its case or cradle to prevent unintentional activation.

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Remove stylet from catheter

Never attempt to replace the stylet once removed from the catheter!

Remove the stylet from the catheter by rotating (unscrewing) the coupling end counter clockwise. Once the stylet has been released - remove it from the catheter by stabilizing the hub and then gently pulling the stylet out. Be cautious with the sharp stylet. At this point you may note blood begin to slowly fill the catheter hub. This will serve as additional confirmation of placementThe stylet tip may also be checked for the presence of blood or marrow by wiping the tip on a 4x4 or sheet. This may additionally aid in confirmation of EZ-IO placement.

Once the stylet has been removed from the catheter - do not attempt stylet replacement. Attempted stylet replacement is contraindicated and could cause significant illness or injury!

You now have access to the vascular space! Insure that you protect the patient and the sterile connection point on the catheter hub!

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Secure stylet in ShuttleClose and place in FDA approved

bio-hazard container

Place the stylet in the opened needle set cartridge (now called the stylet shuttle).

Placing the stylet into the stylet shuttle may not be necessary if an approved bio hazard container is close at hand (example - ED treatment room or EMS Unit); and directly depositing the stylet into the bio hazard container does not pose any risk.Be certain that you do not place your fingers or hand in front of the stylet at anytime. Additionally, do not hold the stylet shuttle while placing the stylet inside. Placing the stylet inside the shuttle while holding the shuttle is similar to “recapping” and could cause injury.

Once the stylet is in the shuttle close the shuttle lid. Make certain the stylet shuttle is placed in an FDA approved bio hazard container as soon as possible.

The stylet shuttle is for temporary storage and safe transport only – The Shuttle is NOT a bio hazard container!

NEVER PLACE THE STYLET SHUTTLE (and used stylet) BACK INTO ANY JUMP KIT, CRASH CART OR OTHER LOCATION CONSIDERED CLEAN OR STERILE – Doing so poses a potential contamination risk for both patient and provider.

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Attach EZ-Connect & Confirm Placement

Prepare to give a 10 ml syringe flush

* Any IV compatible extension set will attach to the standard luer lock on the EZ-IO hub

Attach the EZ-Connect extension set to the standard Luer lock & confirm placement of the catheter. This can be accomplished by identifying several important findings.

1. The catheter is firmly seated and does not move.2. You note blood at the catheter hub. 3. You are able to aspirate blood or marrow from the catheter (We recommend aspiration of only a

small amount of blood due to its extremely viscous nature). 4. Drugs or fluids flow without difficulty – there are no signs of extravasation (leakage) in or

around the tissue. CAUTION : Conscious patients will experience pain with infusion prior to Lidocaine! Flow rates may be slow or non existent prior to the 10 ml bolus.

• You may have checked the stylet tip for blood prior to placing it in the stylet shuttle or bio hazard container.

Other indicators of proper placement include:• You may notice the effects of administered drugs• X-Ray confirmation

Protect the sterile connection point on the catheter hub!

Four Important points to consider once the EZ-IO has been established:

1. Routinely reconfirm that the EZ-IO catheter is secure and in position.2. Maintain appropriate protection at the insertion site.3. Frequently monitor the EZ-IO, fluid administration and the extremity.4. Remove the EZ-IO within 24 hours.

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DO NOT ATTACH A SYRINGE DIRECTLY TO THE EZ-IO CATHETER!

Attaching a syringe may leadto an increase in the

diameter of the insertion hole

Extravasation

DO NOT ATTACH A SYRINGE DIRECTLY TO THE EZ-IO CATHETER!

Attaching a syringe directly to the catheter may lead to:

1. A fracture in the catheter/hub assembly with subsequent removal difficulty.2. An increase in the diameter of the catheter entry point and possible extravasation.

These problems occur primarily as the result of several factors:A. The position of the provider over the patientB. Patient movement during treatmentC. Inadvertent hand movement during injection

Immediately following EZ-IO insertion and preliminary confirmation attach the provided EZ-Connect extension set to the catheter hub’s standard luer lock to avoid complications!

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Push a 10 ml Syringe Flush or Bolus

NO FLUSH = NO FLOW* If you need a blood sample for lab analysis – we recommend drawing blood directly

from the EZ-Connect with a syringe. Be certain to adequately flush the tubing afterthe sample is obtained.

Prior to any drug or fluid administration be certain to Syringe flush the EZ-IO catheter with 10 ml of fluid. NOTE: THERE IS A DISTINCT DIFFERENCE BETWEEN THE “SYRINGE FLUSH OR BOLUS” DESCRIBED ABOVE AND FLUID “GIVEN OR PUSHED WITH AN ADMINISTRATION SET”. This difference relates specifically to: The pressures generated by the syringe – clearing the “pathway for treatment”(Necessary because of the anatomy and nature of the IO space) Versus the relatively slow, low pressure “supportive administration” of fluids given over time.

““NO FLUSH = NO FLOWNO FLUSH = NO FLOW””Failure to “flush” may result in a limited or no flow IO situation

* If the adult patient is conscious slowly administer 20 - 40 mg of 2% (Preservative free) Lidocaine IO prior to the initial bolus (Pediatric dosage is 0.5 mg/kg). IO fluid administration causes pain for conscious patients and is related to intramedullary pressure. Lidocaine has proven to be an extremely effective treatment for this complication. (Utilizing a Lidocaine pre-filled syringe simplifies this process but must be approved by protocol)

Ensure that you protect the patient and the sterile connection point on the catheter hub!

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Administer fluid or drugs

Important Reminder - flush prior to infusion&

Use pressure to improve IO flow

Flow rates may be slow with gravity infusing only. Consider using pressure to administer fluid or drugs. We recommend using a 250 - 300 mmHg pressure bag or infusion pump. Bolus injections generally produce the highest flow rates. High flow rates may cause pain in conscious patients. Consider appropriate pain management. 2 % (Preservative fee) Lidocaine is recommended IO.

IO flow rates average 2 - 40 ml/min when using a pressure bag (REMEMBER –ANATOMY, FLUSHING and PRESSURE will affect flow). During treatment, monitor the site for complications as you would any other IV or IO device.

Discontinue any treatment if complications develop with the EZ-IO infusion system.

If fluid administration set does not produce appropriate flow consider: 1. A second IO bolus of 10 ml through the EZ-IO catheter.2. Gently backing the catheter out approximately 1 mm. This can be accomplished

with a 5 or 10 ml syringe. (See DEVICE REMOVAL PRIOR TO ATTEMPTING THIS MANEUVER)

3. Placement of a second EZ-IO Needle Set in the opposite extremity.

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Secure the EZ-IO ADaccording to protocol

Monitor the infusion site

Attach wristbandAttach wristband

Once the EZ-IO is in position and treatment has begun it is important to secure the tubing and, to a lesser degree, the catheter. This can be accomplished with a commercially available securing systems or tape. You may also consider a lightly rapped rolled gauze or similar bandage in situations where adhesives will not stick. (Be extremely careful that you do not create excessive circumferential pressure on the leg!)

Remember to place the EZ-IO identification bracelet on the patients wrist! This will alert future members of the health care team to the presence of an EZ-IO.

If your insertion attempt failed for any reason place the EZ-IO identification bracelet on the patient, report the complication and document accordingly. Your report, documentation and bracelet placement may prevent a repeated IO attempt on the same leg (A repeated insertion, without knowledge of the previous IO attempt, might cause extravasation and subsequent injury to the patient).

Vidacare does not recommend repeated IO attempts or placement on the same extremity within 24 hours. This recommendation appears to allow for appropriate clotting at the insertion site thus preventing the possibility of extravasation..

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Insertion Summary

This is an insertion summary. Note the simplicity of the EZ-IO infusion system.

LOCATE– CLEAN – INSERT – OPEN – FLUSH – TREAT

In seconds, complicated vascular access will become a problem of the past.

The EZ-IO provides you with “rapid vascular access when you need it most”.

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Actual EZ-IO InsertionsActual EZ-IO Insertions

This slide contains a short movie of three actual EZ-IO AD insertions. The initial two placements you will watch are the very first “battery powered” IO insertions in history. They were placed on July 8, 2004 at the Vidacare office in San Antonio Texas. The third insertion on this clip was placed on July 23, 2004.There was no pre-medication or local anesthetic used for these insertion procedures. Each placement assisted Vidacare with a better understanding of the device and it’s future use.

The first placement on the clip shows an average insertion time. Dr. Larry Miller is placing the EZ-IO AD in the leg of Paramedic Scotty Bolleter. An interesting side note to this particular placement: Dr. Miller has the EZ-IO AD in his leg during this insertion. His EZ-IO AD is saline locked and doing fine. The drip rate you will notice with Scotty’s IO infusion is 900 ml/hr (150 drops per minute through a 10 drop set with a pressure bag). This was accomplished after 40 mg of 2 % (Preservative Free) Lidocaine - given slowly through IO and following a saline flush. The leg was partially shaved for observation of the skin.

The second placement on this clip shows a slow insertion time. Paramedic Scotty Bolleter is placing the device in the leg of Dr. Larry Miller. Interestingly both Dr. Miller and Mr. Bolleter saline locked their EZ-IO AD for nearly one hour. They walked around the office with no discomfort. They subsequently flushed and used each device again without complication.

The third placement shows a fast insertion time. Paramedic Scotty Bolleter is placing the device in the leg of Nurse Yvonne Bettis.

The EZ-IO AD has a proven record of being safe, immediate and effective. Clinical experience has proven that the EZ-IO truly gives you “Immediate Vascular Access When You Need It Most”.

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EZ-IO RemovalMaintain a 90 degree angle

Maintain 90 degree angle, Rotate clockwise and gently Pull

Removal of the EZ-IO® catheter from any location is straight forward and simple!

Follow these steps to ensure that you have no complications:

Step 1: Remove the attached EZ-Connect® extension set (note the inset pictures in addition to the illustrations) CAUTION: The patient may bleed from the exposed catheter hub and you now have an open portal to the patient’s vascular system – thus maintain sterility.

FROM THIS POINT FORWARD ENSURE THAT YOUMAINTAIN A 90 DEGREE ANGLE

Step 2: Attach a sterile 5 or 10 cc Luer lock syringe that is “zeroed out” (The syringe will act as longer handle easing the removal process)

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Rotate the syringe clockwise



Step 3: Rotate the syringe (and catheter) clockwise (this relieves the “tension between the catheter and the bone).

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Rotate the syringe clockwise

Gently pull



Step 4: While continuing to rotate begin gently pulling the catheter out. AVOID EXCESSIVE FORCE WHILE PULLING. A slow steady rotation and gentle axial pulling will safely remove the catheter. Use of excessive force may cause “recoil” injuring you or the patient.

Immediately upon removal place the catheter in an approved biohazard sharps container.

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Once catheter has been removed – cover site and monitor patient

Once the catheter has been removed and placed in an approved biohazard sharps container return your attention to the insertion site.

Experience demonstrates that there is minimal bleeding after the majority of IO removals and a small Band Aid™ will usually suffice as coverage.

THIS HOWEVER IS NOT THE RULE.

Some patients may continue to slowly bleed following catheter removal. Holding direct pressure or applying a small pressure dressing for a short period of time will elevate this complication.

Monitor your patient for complications.

Prophylactic antibiotic administration is not recommended following routine EZ-IO®usage.

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Possible Complications

If breakage occurs Grasp the exposed catheter with a hemostat – rotate and pull

Rocking, Bending or inadvertently Strikingthe catheter may cause it to break

24 hour emergency support 1.800.680.4911

Complications resulting from EZ-IO® catheter removal are extremely rare.

One complication that has been noted occurs following inadvertent, awkward or untoward catheter manipulation. This would include accidental striking, rocking or bending – which will loosen the “catheter/hub” connection and cause separation.

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Possible Removal Complications

If breakage occurs Grasp the exposed catheter with hemostats – rotate and pull

Rocking, Bending or inadvertently Strikingthe catheter may cause it to break

24 hour emergency support 1.800.680.4911

If the catheter and hub separate or break simply grasp the exposed catheter tip (similarly to an impaled object) with a hemostat (always maintaining the catheter at a 90 degree angle) then rotate the catheter (clockwise / counter clockwise) while gentle pulling.

DO NOT ROCK, BEND OR USE EXCESSIVE FORCE ON THE EXPOSED CATHETER!

If you have any removal questions please call the 24 hour emergency support line at 1.800.680.4911

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Possible complications of IOExtravasationDislodgment

Compartment Syndrome

Fracture

Pain

Reduced Flow

Infection

Extravasation: (leakage) The EZ-IO reduces this possibility because of the precise rotational method used to insert the needle set –the EZ-IO catheter has a very snug fit once placed in the bone. Dislodgment: The EZ-IO infusion system is designed to be low profile – this limits accidental movement, additionally the actual method of insertion also enhances the catheter fit against the bone – this, including the flat aspect of the flange, limits motion oraccidental dislodgment. Compartment Syndrome: Because the EZ-IO insertion method decreases the possibility of extravasation, the likelihood of swelling to the point of compartment syndrome (excessive constricting pressure in the soft tissue - leading to a decrease in circulation and possible loss of extremity) is significantly diminished. As with any vascular access device one MUST always maintain a watchful eye for complications. Fracture: The EZ-IO infusion system is unique in that the insertion method requires limited pressure on the bone. The driver itself utilizes an orthopedically proven safe technique to power through the bone without the use of excessive force in any direction. As Dr. Larry Miller puts it – “A kinder, gentler way”. Pain: IO placement and its use can cause discomfort. You could consider a local anesthetic for conscious patients (caution –allergies) however, clinical experience has demonstrated that EZ-IO insertion is no more painful than a standard IV catheter placement. One important facet about the EZ-IO infusion system is it’s speed of insertion (average insertion is approximately 3 seconds). Less time inserting translates to less pain. We have noted in clinical studies that there is considerable pain for conscious patients associated with the infusion of fluid. 20 – 40 mg of 2% (Preservative free) Lidocaine IO has proven helpful in reducing or eliminating the adults patients discomfort (Pediatric dosage – 0.5mg/kg). Additional findings suggest that the initial administration of Lidocaine or fluid for conscious patients should be given slowly.Reduced Flow Rate: At times you may experience flow rates significantly lower than expected, The first consideration should be the possibility of inadequate initial flushing. Consider a second 10 ml Syringe Flush or Bolus. You may additionally try gently backing out the catheter approximately 1mm. Lastly, the establishment of a second EZ-IO catheter on the opposite leg should also be considered as a viable option.Infection: Extensive experience with thousands of children and adults demonstrates a low incidence of infection (0.6%). These infections are usually not serious and can be treated with device removal and antibiotics. Once the EZ-IO has been placed (and the patient stabilized) consideration for antibiotic therapy should be made by the practitioner based on the presence or absence of complications. The EZ-IO should be removed within 24 hours

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Cleaning Instructions:

•Use Body Substance Isolation (BSI) Precautions•Wipe clean with moistened cloth - removing large contaminants•Spray with anti-microbial solution - follow manufacturer instructions•Momentarily depress trigger several times during cleaning •Clean around drive shaft with cotton applicator - check drive shaft tip to ensure

nothing has attached to the magnetic tip•Wipe dry•Inspect driver and return to case

DO NOT SUBMERGE DRIVER AT ANY TIME

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QuestionsQuestions

Do you have any questions?

Consider referring to the training manual, your instructor or to Vidacare (Either by calling 1.866.479.8500 or visiting our web site at www.vidacare.com

We are interested in your experiences with this training system and the EZ-IO and look forward to hearing from you!

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www.vidacare.com1.866.479.8500

“Immediate Vascular AccessWhen You Need It Most”

Thank you for providing compassionate, competent care to those in need. We at Vidacaresincerely appreciate your participation in this training program!

We would further like to encourage you to complete the short EZ-IO Online “Evaluation”each time you use our device. The information you provide guides us in our never ending quest to provide you with the very best products.

www.vidacare.com

If you do not have access to a computer or cannot otherwise fill out the online form please feel free to call us with your input. We would be happy to complete an evaluation with you over the phone.

Toll free - 1.866.479.8500

ez-io insertion proximal tibia - in depth

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