St. Jude Medical is now Abbott Medical

PRESCRIPTION AND SAFETY INFORMATION

Read this section to gather important prescription and safety information. For specific indications, contraindications, instructions, warnings, precautions, and adverse effects about system components available in your country or region, see the approved clinician's manual for those components.

INTENDED USE

This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. The system is intended to be used with leads and associated extensions that are compatible with the system.

INDICATIONS FOR USE

United States:

The neurostimulation system is indicated for the following conditions:

• Bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinson’s disease that are not adequately controlled by medications.

• Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability.

International:

The neurostimulation system is indicated for the following conditions:

• Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinson’s disease.

• Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor.

• Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) for the management of intractable, chronic dystonia, including primary and secondary dystonia, for patients who are at least 7 years old.

CONTRAINDICATIONS

United States:

This system is contraindicated for patients who meet the following criteria:

• Are unable to operate the system

• Have unsuccessful test stimulation

The following procedures are contraindicated for patients with a deep brain stimulation system. Advise patients to inform their healthcare professional that they cannot undergo the following procedures:

• Diathermy (short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy)

• Electroshock therapy and transcranial magnetic stimulation (TMS)

International:

Implantation of this neurostimulation system is contraindicated for the following:

• Patients for whom test stimulation is unsuccessful.

• Patients who are unable to properly operate the system.

The following procedures are contraindicated for patients that have been implanted with this device:

Diathermy therapy. Do not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Energy from diathermy can be transferred through the implanted system and can cause tissue damage at the location of the implanted electrodes, resulting in a severe injury or death. Diathermy is further prohibited because it may also damage the neurostimulation system components. This damage could result in loss of therapy, requiring additional surgery for system replacement. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment.

MRI SAFETY INFORMATION

Some models of this system are Magnetic Resonance (MR) Conditional, and patients with these devices may be scanned safely with magnetic resonance imaging (MRI) when the conditions for safe scanning are met. Scanning under different conditions may cause device malfunction, severe patient injury, or death. For more information about MR Conditional deep brain stimulation (DBS) components and systems, including equipment settings, scanning procedures, and a complete listing of conditionally approved components, refer to the MRI procedures clinician's manual for DBS systems (available online at manuals.sjm.com). For more information about MR Conditional products, visit the Abbott product information page at sjm.com/MRIReady.

WARNINGS

The following warnings apply to this neurostimulation system.

Pregnancy and nursing. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Patients should not use this neurostimulation system if they are pregnant or nursing.

Magnetic resonance imaging (MRI). Some patients may be implanted with the components that make up a Magnetic Resonance (MR) Conditional system, which allows them to receive an MRI scan if all the requirements for the implanted components and for scanning are met. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Physicians should also discuss any risks of MRI with patients.

If any component of the implanted neurostimulation system, such as an IPG, lead, or extension, does not meet the requirements for an MR Conditional system, do not perform an MRI scan. If a system does not meet the MR Conditional requirements, consider it MR Unsafe.

High stimulation outputs and charge density limits. Avoid excessive stimulation. A risk of brain tissue damage exists with parameter settings using high amplitudes and wide pulse widths. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. If the programming of stimulation parameters exceeds the charge density limit of 30 μC/cm2, a screen will appear warning you that the charge density is too high. Charge density can be reduced by lowering the stimulation amplitude or pulse width. For more information, see the clinician programmer manual.

Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet.

Risk of depression, suicidal ideations, and suicide. Depression, suicidal ideation, and suicide have been reported in patients receiving deep brain stimulation therapy for movement disorders, although no direct cause and effect relationship has been established. Preoperatively assess patients for suicide risk and carefully balance this risk with the potential clinical benefit. Postoperatively monitor patients for the presence of any of the following symptoms and manage these symptoms appropriately: depression, suicidal thoughts or behaviors, changes in mood, and impulse control. Emphasize the importance of sustained follow-up and support with all patients and their caregivers and family members.

Poor surgical risks. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections.

Explosive or flammable gases. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. The operation of the clinician programmer or patient controller could cause them to ignite, causing severe burns, injury, or death.

Operation of machinery and equipment. Patients should not operate potentially dangerous machinery, power tools, or vehicles or engage in any activity that could be unsafe if their symptoms were to unexpectedly return.

Device components. The use of components not approved for use by Abbott Medical with this system may result in damage to the system and increased risk to the patient.

Electrosurgery. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Confirm the neurostimulation system is functioning correctly after the procedure.

During implant procedures, if electrosurgery devices must be used, take the following actions:

• Use bipolar electrosurgery only.

• Complete any electrosurgery procedures before connecting the leads or extensions to the neurostimulator.

• Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible.

• Set the electrosurgery device to the lowest possible energy setting.

• Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket.

Radiofrequency or microwave ablation. Careful consideration should be used before using radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system since safety has not been established. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage.

Implanted cardiac systems. Physicians need to be aware of the risk and possible interaction between a neurostimulation system and an implanted cardiac system, such as a pacemaker or defibrillator. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system, (1) maximize the distance between the implanted systems; (2) verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and (3) avoid programming either device in a unipolar mode (using the device’s can as an anode) or using neurostimulation system settings that interfere with the function of the implantable cardiac system.

Other active implanted devices. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system.

Case damage. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals.

Cremation. The IPG should be explanted before cremation because the IPG could explode. Return the explanted IPG to Abbott Medical.

Component disposal. Return all explanted components to Abbott Medical for safe disposal. IPGs contain batteries as well as other potentially hazardous materials. Do not crush, puncture, or burn the IPG because explosion or fire may result.

Coagulopathies. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. Physicians should also consider underlying factors, such as previous neurological injury or prescribed medications (anticoagulants), that may predispose a patient to the risk of bleeding.

Low frequencies. Stimulation frequencies at less than 30 Hz may cause tremor to be driven (meaning that tremor occurs at the same frequency as the programmed frequency). For this reason, programming at frequencies less than 30 Hz is not recommended.

IPG placement. The IPG should be placed into the pocket, at a depth not to exceed 4 cm (1.57 in), with the logo side facing toward the skin surface. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller.

Return of symptoms and rebound effect. The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. In some cases, symptoms may return with a greater intensity than what a patient experienced before system implantation (rebound effect). In rare cases, this can create a medical emergency.

PRECAUTIONS

The following precautions apply to this neurostimulation system.

GENERAL PRECAUTIONS

Surgeon training. Implanting physicians should be experienced in stereotactic and functional neurosurgery.

Clinician training. Clinicians should be familiar with deep brain stimulation therapy and be experienced in the diagnosis and treatment of the indication for which the deep brain stimulation components are being used.

Patient selection. Select patients appropriately for deep brain stimulation. The patient should be able and willing to use the patient controller and correctly interpret the icons and messages that appear on the screen.

Especially consider the following additional factors when selecting patients:

• Level of available support from a caregiver.

• Expected effect from cessation of therapy, should disease symptoms return unexpectedly.

• Patient's age, as very young or very old patients may have difficulty performing required monitoring of the device.

• Patient's mental capacity, as patients with cognitive impairment or those prone to developing dementia would likely have difficulty performing device-related tasks without assistance.

• Patient's physical ability, as patients with higher degrees of motor impairment might have difficulty with the physical requirements of monitoring the device.

• Patient's visual ability to read the patient controller screen.

Infection. Follow proper infection control procedures. Infections may require that the device be explanted.

Electromagnetic interference (EMI). Some equipment in home, work, medical, and public environments can generate EMI that is strong enough to interfere with the operation of a neurostimulation system or damage system components. Patients should avoid getting too close to these types of EMI sources, which include the following examples: commercial electrical equipment (such as arc welders and induction furnaces), communication equipment (such as microwave transmitters and high-power amateur transmitters), high-voltage power lines, radiofrequency identification (RFID) devices, and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy).

Security, antitheft, and radiofrequency identification (RFID) devices. Some antitheft devices, such as those used at entrances or exits of department stores, libraries, and other public places, and airport security screening devices may affect stimulation. Additionally, RFID devices, which are often used to read identification badges, as well as some tag deactivation devices, such as those used at payment counters at stores and loan desks at libraries, may also affect stimulation. Patients should cautiously approach such devices and should request help to bypass them. If they must go through or near a gate or doorway containing this type of device, patients should move quickly and then check their IPG to determine if it is turned on or off.

Unauthorized changes to stimulation parameters. Caution patients to not make unauthorized changes to physician-established stimulation parameters.

Damage to shallow implants. Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions.

Keep programmers and controllers dry. The clinician programmer and patient controller are not waterproof. Keep them dry to avoid damage. Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing.

Handle the programmers and controllers with care. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground.

Battery care. Batteries can explode, leak, or melt if disassembled, shorted (when battery connections contact metal), or exposed to high temperature or fire.

Long-term safety and effectiveness. The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. Safety and effectiveness has not been established for patients with a neurological disease other than Parkinson’s disease or essential tremor, previous surgical ablation procedures, dementia, coagulopathies, or moderate to severe depression; patients under 22 years; implantation in targets other than the STN for Parkinson's disease and the VIM for essential tremor; patients with an active implantable device; patients requiring MRI.

STERILIZATION AND STORAGE

Single-use, sterile device. The implanted components of this neurostimulation system are intended for a single use only. Sterile components in this kit have been sterilized using ethylene oxide (EtO) gas before shipment and are supplied in sterile packaging to permit direct introduction into the sterile field. Do not resterilize or reimplant an explanted system for any reason.

Storage environment. Store components and their packaging where they will not come in contact with liquids of any kind. Detailed information on storage environment is provided in the appendix of this manual.

HANDLING AND IMPLANTATION

Expiration date. An expiration date (or “use-before” date) is printed on the packaging. Do not use the system if the use-before date has expired.

Care and handling of components. Use extreme care when handling system components. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components.

Package or component damage. Do not implant a device if the sterile package or components show signs of damage, if the sterile seal is ruptured, or if contamination is suspected for any reason. Return any suspect components to Abbott Medical for evaluation.

Exposure to body fluids or saline. Prior to connection, exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline can lead to corrosion. If such exposure occurs, clean the affected parts with sterile, deionized water or sterile water for irrigation, and dry them completely prior to lead connection and implantation.

Skin erosion. To avoid the risk of skin erosion, implant components at the appropriate depth and inform patients to avoid touching their skin where components are implanted. The IPG should be placed into the pocket, at a depth not to exceed 4.0 cm (1.57 in), with the logo side facing toward the skin surface.

System testing. To ensure correct operation, always test the system during the implant procedure, before closing the neurostimulator pocket, and before the patient leaves the surgery suite.

Device modification. The equipment is not serviceable by the customer. To prevent injury or damage to the system, do not modify the equipment. If needed, return the equipment to Abbott Medical for service.

Multiple leads. When multiple leads are implanted, route the lead extensions so the area between them is minimized. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI).

Abandoned leads and replacement leads. The long-term safety associated with multiple implants, leads left in place without use, replacement of leads, multiple implants into the target structure, and lead explant is unknown.

Placement of lead connection in neck. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture.

HOSPITAL AND MEDICAL ENVIRONMENTS

Electrical medical treatment. In the case that a medical treatment is administered where an electrical current is passed through the body from an external source, first deactivate the IPG by setting all electrodes to off, turning stimulation off, and setting amplitude to zero. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment.

High-output ultrasonics and lithotripsy. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. If lithotripsy must be used, do not focus the energy near the IPG.

Ultrasonic scanning equipment. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system.

External defibrillators. The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established.

Therapeutic radiation. Therapeutic radiation may damage the electronic circuitry of an implanted neurostimulation system, although no testing has been done and no definite information on radiation effects is available. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Damage to the system may not be immediately detectable.

Electrocardiograms. Ensure the neurostimulator is off before initiating an electrocardiogram (ECG). If the neurostimulator is on during an ECG, the ECG recording may be adversely affected, resulting in inaccurate ECG results. Inaccurate ECG results may lead to inappropriate treatment of the patient.

HOME AND OCCUPATIONAL ENVIRONMENTS

Patient activities and environmental precautions. Patients should take reasonable care to avoid devices that generate strong EMI, which may cause the neurostimulation system to unintentionally turn on or off. Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly. These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. Sudden loss of stimulation may cause patients to fall or lose control of equipment or vehicles, injure others, or bring injury upon themselves.

Control of the patient controller. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards.

Activities requiring excessive twisting or stretching. Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. Component fracture or dislodgement may result in loss of stimulation, intermittent stimulation, stimulation at the fracture site, and additional surgery to replace or reposition the component.

Component manipulation by patient. Advise your patient to avoid manipulating the implanted system components (e.g., the neurostimulator, the burr hole site). This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation.

Scuba diving or hyperbaric chambers. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician.

Skydiving, skiing, or hiking in the mountains. High altitudes should not affect the neurostimulator; however, the patient should consider the movements involved in any planned activity and take precautions to avoid putting undue stress on the implanted system. Patients should be aware that during skydiving, the sudden jerking that occurs when the parachute opens may cause lead dislodgement or fractures, which may require surgery to repair or replace the lead.

Wireless use restrictions. In some environments, the use of wireless functions (e.g., Bluetooth® wireless technology) may be restricted. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. If you are unsure of the policy that applies to the use of this device, please ask for authorization to use it before turning it on. (Bluetooth® is a registered trademark of Bluetooth SIG, Inc.)

Mobile phones. The effect of mobile phones on deep brain stimulation is unknown. Patients should be advised to avoid carrying mobile phones in their shirt pocket or otherwise placing them directly over the deep brain stimulation system components. If interference occurs, try holding the phone to the other ear or turning off the phone.

Household appliances. Household appliances that contain magnets (e.g., refrigerators, freezers, inductive cooktops, stereo speakers, mobile telephones, cordless telephones, standard wired telephones, AM/FM radios, and some power tools) may unintentionally cause the neurostimulation system to turn on or turn off.

Therapeutic magnets. Patients should be advised to not use therapeutic magnets. Therapeutic magnets (e.g., magnets used in pillows, mattress pads, back belts, knee braces, wrist bands, and insoles) may unintentionally cause the neurostimulation system to turn on or off.

ADVERSE EFFECTS

Deep brain stimulation potentially has the following adverse effects:

Possible surgical complications. Surgical complications include, but are not limited to, the following: intracranial hemorrhage (which can lead to stroke, paralysis, or death); subcutaneous hemorrhage or seroma; hematoma; cerebrospinal fluid leakage or cerebrospinal fluid abnormality; brain contusion; infection or inflammation; antibiotic anaphylaxis; skin disorder; edema; persistent pain at surgery site or IPG site; erosion; brachial plexus injury (nerves to chest, shoulder and arm); postoperative pain, stress, or discomfort; neuropathy (nerve degeneration); hemiparesis (muscular weakness or partial paralysis on one side of body); ballism or hemiballism (uncontrollable movements on both or only one side of the body); confusion—transient, nocturnal or ongoing; cognitive impairment, including delirium, dementia, disorientation, psychosis and speech difficulties; aphasia; deep vein thrombosis; complications from anesthesia; phlebitis (vein inflammation); pulmonary embolism (sudden blood vessel obstruction); aborted procedures (air embolism, unable to find target, surgical complication, etc.); complications from unusual physiological variations in patients, including foreign body rejection phenomena; pneumonia, seizure or convulsions; paralysis (loss of motor function, inability to move); stroke and death.

Possible deep brain stimulation complications. Deep brain stimulation complications include, but are not limited to, the following:

• Device-related complications
• Undesirable changes in stimulation related to cellular changes in tissue around the electrodes, changes in the electrode position, loose electrical connections, or lead fracture
• Loss of therapeutic benefit as a result of change in electrode positions, loose electrical connections, or lead or extension fracture
• Initial jolt or tingling during stimulation; jolting or shocking sensations
• Infection
• Paresthesia
• Lead fracture, migration, or dislodgement
• Misplaced lead
• Extension malfunction, fracture, or disconnect
• Deep brain stimulation system failure or battery failure within the device
• Deep brain stimulation system malfunction or dislodgement
• Spontaneous turning on or off of the IPG
• Allergic or rejection response to implanted materials
• Persistent pain, tightness, or redness at the incision sites or general pain
• General erosion or local skin erosion over the IPG
• Persistent pain, tightness, or discomfort around the implanted parts (e.g., along the extension path in the neck)
• Impaired wound healing (e.g., incision site drainage) or abscess formation
• Additional neurosurgical procedure to manage one of the above complications or to replace a malfunctioning component
• Stimulation-related complications or other complications
• Worsening of motor impairment and Parkinson’s disease symptoms including dyskinesia, rigidity, akinesia or bradykinesia, myoclonus, motor fluctuations, abnormal gait or incoordination, ataxia, tremor, and dysphasia
• Paresis, asthenia, hemiplegia, or hemiparesis
• Dystonia
• Sensory disturbance or impairment including neuropathy, neuralgia, sensory deficit, headache, and hearing and visual disturbance
• Speech or language impairment including, aphasia, dysphagia, dysarthria, and hypophonia
• Cognitive impairment including attention deficit, confusion, disorientation, abnormal thinking, hallucinations, amnesia, delusions, dementia, inability to act or make decisions, psychic akinesia, long term memory impairment, psychiatric disturbances, depression, irritability or fatigue, mania or hypomania, psychosis, aggression, emotional lability, sleep disturbance, anxiety, apathy, drowsiness, alteration of mentation, postural instability and disequilibrium
• Restless leg syndrome
• Supranuclear gaze palsy
• Hypersexuality or increased libido
• Decreased therapeutic response
• Urinary incontinence or retention
• Diarrhea or constipation
• Cardiac dysfunction (e.g., hypotension, heart rate changes, or syncope)
• Difficulty breathing
• Increased salivation
• Weight gain or loss
• Eye disorder including eye apraxia or blepharospasm
• Nausea or vomiting
• Sweating
• Fever
• Hiccups
• Cough
• Cramps
• Worsening existing medical conditions

The FreeStyle Libre Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device indicated for the management of diabetes in persons age 18 and older. It is designed to replace blood glucose testing for diabetes treatment decisions.

The System detects trends and tracks patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is intended for single patient use and requires a prescription.

CONTRAINDICATIONS:

The FreeStyle Libre Flash Glucose Monitoring System must be removed prior to Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The effect of MRI, CT scans, or diathermy on the performance of the System has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device which could cause incorrect readings.

WARNINGS:

• Do not ignore symptoms that may be due to low or high blood glucose: If you are experiencing symptoms that are not consistent with your glucose readings, consult your health care professional.
• Checking Sensor glucose readings with a blood glucose meter: Under the following conditions, Sensor glucose readings may not be accurate and you should conduct a fingerstick test using a blood glucose meter. You should not use Sensor glucose readings to make a diabetes treatment decision:
• If you suspect that your reading may be inaccurate for any reason
• When you are experiencing symptoms that may be due to low or high blood glucose
• When you are experiencing symptoms that do not match FreeStyle Libre System readings
• During times of rapidly changing glucose (more than 2 mg/dL per minute), when interstitial fluid glucose levels as measured by the Sensor may not accurately reflect blood glucose levels
• When the Sensor glucose reading does not include a Current Glucose number or Glucose Trend Arrow
• In order to confirm hypoglycemia or impending hypoglycemia as reported by the Sensor
• When you see the Check Blood Glucose symbol, you must check your blood glucose with a blood glucose meter before making any treatment decisions. Sensor readings may not accurately reflect blood glucose levels.
• Hypoglycemic unawareness: The FreeStyle Libre System has not been evaluated for use in patients with hypoglycemic unawareness and will not automatically alert you of a hypoglycemic event without you scanning your Sensor.
• No alarms without a Sensor scan: The FreeStyle Libre System does not have alarms that will automatically notify you when you are having a severe low (hypoglycemic) or high (hyperglycemic) glucose event unless you scan your Sensor. For example, the System does not have an alarm that can alert or wake you when you are sleeping in the case of low or high glucose.
• Choking hazard: The FreeStyle Libre System contains small parts that may be dangerous if swallowed.

CAUTIONS AND LIMITATIONS:

What to know about Alarms/Alerts:

• There are NO alarms or alerts unless you scan the Sensor.

What to know before using the System:

• Review all product information before use.
• Take standard precautions for transmission of blood borne pathogens to avoid contamination.

Who should not use the System:

• Do not use the System in people less than 18 years of age. The System is not approved for use in people under 18 years of age and Sensor readings in this population may be inaccurate. In general, continuous glucose monitoring systems are recognized to be less accurate in children than in adults.
• Do not use the System in critically ill patients. The System is not approved for use in these patients. It is not known how different conditions or medications common to the critically ill population may affect performance of the System. Sensor glucose readings may be inaccurate in critically ill patients.
• Do not use the System in pregnant women or persons on dialysis. The System is not approved for use in pregnant women or persons on dialysis and has not been evaluated in these populations.
• Performance of the System when used with other implanted medical devices, such as pacemakers, has not been evaluated.

What should you know about wearing a Sensor:

• After the 12 hour start-up period, the Sensor can be worn for up to 10 days.
• Some individuals may be sensitive to the adhesive that keeps the Sensor attached to the skin. If you notice significant skin irritation around or under your Sensor, remove the Sensor and stop using the FreeStyle Libre System. Contact your health care professional before continuing to use the FreeStyle Libre System.
• Intense exercise may cause your Sensor to loosen due to sweat or movement of the Sensor. Remove and replace your Sensor if it starts to loosen and follow the instructions to select an appropriate application site.
• Do not reuse Sensors. The Sensor and Sensor Applicator are designed for single use. Reuse may result in no glucose readings and infection. Not suitable for re-sterilization. Further exposure to irradiation may cause inaccurate results.
• If a Sensor breaks inside your body, call your health care professional.

How to Store the Sensor Kit:

• Store the Sensor Kit between 39°F and 77°F. Storage outside of this range may cause inaccurate Sensor glucose readings. While you don’t need to keep your Sensor Kit in a refrigerator, you can as long as the refrigerator is between 39°F and 77°F. Do not freeze.
• Store the Sensor Kit between 10-90% non-condensing humidity.

When not to use the System:

• Do NOT use if the Sensor Kit package, Sensor Pack, or Sensor Applicator appear to be damaged or already opened due to risk of no results and/or infection.
• Do NOT use if Sensor Kit contents are past expiration date.
• Do NOT use if the Reader appears to be damaged due to risk of electric shock and/or no results.

What to know before you Apply the Sensor:

• The Sensor Pack and Sensor Applicator are packaged as a set (separately from the Reader) and have the same Sensor code. Check that the Sensor codes match before using your Sensor Pack and Sensor Applicator. Do not use Sensor Packs and Sensor Applicators with different Sensor codes together as this will result in incorrect glucose readings.
• Clean the application site and ensure that it is dry prior to Sensor insertion. This helps the Sensor stay attached to your body.
• Clean hands prior to Sensor handling/insertion to help prevent infection.
• Change the application site for the next Sensor application to prevent discomfort or skin irritation.
• Sensor placement is not approved for sites other than the back of the arm. If placed in other areas, the Sensor may not function properly.
• Select an appropriate Sensor site to help the Sensor stay attached to the body and prevent discomfort or skin irritation. Avoid areas with scars, moles, stretch marks, or lumps. Select an area of skin that generally stays flat during normal daily activities (no bending or folding). Choose a site that is at least 1 inch away from an insulin injection site.

When is Sensor Glucose different from Blood Glucose:

• Physiological differences between the interstitial fluid and capillary blood may result in differences in glucose readings between the System and results from a fingerstick test using a blood glucose meter. Differences in glucose readings between interstitial fluid and capillary blood may be observed during times of rapid change in blood glucose, such as after eating, dosing insulin, or exercising.

What to know about interfering substances such as Vitamin C and Aspirin:

• Taking ascorbic acid (vitamin C) while wearing the Sensor may falsely raise Sensor glucose readings. Taking salicylic acid (used in some pain relievers such as aspirin and some skin care products) may slightly lower Sensor glucose readings. The level of inaccuracy depends on the amount of the interfering substance active in the body.
• Test results did not indicate interference for methyldopa (used in some drugs to treat high blood pressure) or tolbutamide (infrequently used in some drugs to treat diabetes in the US) at maximum circulating levels. However, concentrations of potential interferents in interstitial fluid are unknown compared to circulating blood.

What to know about X-Rays:

• The Sensor should be removed prior to exposing it to an X-ray machine. The effect of X-rays on the performance of the System has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device to detect trends and track patterns in glucose values during the wear period.

When to remove the Sensor:

• If the Sensor is becoming loose or if the Sensor tip is coming out of your skin, you may get no readings or unreliable readings, which may not match how you feel. Check to make sure your Sensor has not come loose. If it has come loose, remove it and apply a new one.
• If you believe your glucose readings are not correct or are inconsistent with how you feel, perform a blood glucose test on your finger to confirm your glucose. If the problem continues, remove the current Sensor and apply a new one.

What to do if you are dehydrated:

• Severe dehydration and excessive water loss may cause inaccurate Sensor glucose readings. If you believe you are suffering from dehydration, consult your health care professional immediately.

What to know about the Reader’s Built-in Meter:

• The FreeStyle Libre Flash Glucose Monitoring System has a built-in blood glucose meter that is designed to be used only with FreeStyle Precision Neo blood glucose test strips and MediSense Glucose and Ketone Control Solution. Using other test strips with the Reader’s built-in meter will produce an error or cause the Reader’s built-in meter to not turn on or start a test. The Reader's built-in meter does not have ketone testing functionality.
• The Reader’s built-in meter is not for use on people who are dehydrated, hypotensive, in shock, or for individuals in hyperglycemic-hyperosmolar state, with or without ketosis.
• The Reader’s built-in meter is not for use on neonates, in critically-ill patients, or for diagnosis or screening of diabetes.
• See Using the Reader’s Built-in meter section of the User’s Manual for additional important information on the use of the Reader’s built-in meter.

Where to charge your Reader:

• Be sure to select a location for charging that allows the power adapter to be easily unplugged. Do NOT block access to the charger due to the potential risk of electrical shock.

FreeStyle Libre 14 day Indications and Important Safety Information

The FreeStyle Libre 14 day Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device indicated for the management of diabetes in persons age 18 and older. It is designed to replace blood glucose testing for diabetes treatment decisions. The System detects trends and tracks patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is intended for single patient use and requires a prescription.

CONTRAINDICATIONS:

The FreeStyle Libre 14 day Flash Glucose Monitoring System must be removed prior to Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high frequency electrical heat (diathermy) treatment. The effect of MRI, CT scans, or diathermy on the performance of the System has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device which could cause incorrect readings.

WARNINGS:

• Do not ignore symptoms that may be due to low or high blood glucose: If you are experiencing symptoms that are not consistent with your glucose readings, consult your health care professional.
• Check Sensor glucose readings by conducting a fingerstick test with a blood glucose meter under the following conditions, when Sensor glucose readings may not be accurate and should not be used to make a diabetes treatment decision:
• If you suspect that your reading may be inaccurate for any reason
• When you are experiencing symptoms that may be due to low or high blood glucose
• When you are experiencing symptoms that do not match the Sensor glucose readings
• During the first 12 hours of wearing a FreeStyle Libre 14 day Sensor
• During times of rapidly changing glucose (more than 2 mg/dL per minute)
• When the Sensor glucose reading does not include a Current Glucose number or Glucose Trend Arrow
• In order to confirm hypoglycemia or impending hypoglycemia as reported by the Sensor
• When you see the Check Blood Glucose symbol, you must check your blood glucose with a blood glucose meter before making any treatment decisions. Sensor readings may not accurately reflect blood glucose levels.
• Hypoglycemic unawareness: The System has not been evaluated for use in patients with hypoglycemic unawareness and will not automatically alert you of a hypoglycemic event without you scanning your Sensor.
• No alarms without a Sensor scan: The System does not have alarms that will automatically notify you when you are having a severe low (hypoglycemic) or high (hyperglycemic) glucose event unless you scan your Sensor. For example, the System does not have an alarm that can alert or wake you when you are sleeping in the case of low or high glucose.
• Choking hazard: The FreeStyle Libre System contains small parts that may be dangerous if swallowed.

CAUTIONS AND LIMITATIONS:

Below are important cautions and limitations to keep in mind so you can use the System safely. They are grouped into categories for easy reference.

What to know about Alarms/Alerts:

• There are NO alarms or alerts unless you scan the Sensor.

What to know before using the System:

• Review all product information before use.
• Take standard precautions for transmission of blood borne pathogens to avoid contamination.

Who should not use the System:

• Do not use the System in people less than 18 years of age. The System is not approved for use in people under 18 years of age and Sensor readings in this population may be inaccurate. In general, continuous glucose monitoring systems are recognized to be less accurate in children than in adults.
• Do not use the System in critically ill patients. The System is not approved for use in these patients. It is not known how different conditions or medications common to the critically ill population may affect performance of the System. Sensor glucose readings may be inaccurate in critically ill patients.
• Do not use the System in pregnant women or persons on dialysis. The System is not approved for use in pregnant women or persons on dialysis and has not been evaluated in these populations.
• Performance of the System when used with other implanted medical devices, such as pacemakers, has not been evaluated.

What should you know about wearing a Sensor:

• The Sensor can be worn for up to 14 days.
• Some individuals may be sensitive to the adhesive that keeps the Sensor attached to the skin. If you notice significant skin irritation around or under your Sensor, remove the Sensor and stop using the System. Contact your health care professional before continuing to use the System.
• Intense exercise may cause your Sensor to loosen due to sweat or movement of the Sensor. Remove and replace your Sensor if it starts to loosen and follow the instructions to select an appropriate application site.
• The System uses all available glucose data to give you readings so you should scan your Sensor at least once every 8 hours for the most accurate performance. Scanning less frequently may result in decreased performance.
• Do not reuse Sensors. The Sensor and Sensor Applicator are designed for single use. Reuse may result in no glucose readings and infection. Not suitable for re-sterilization. Further exposure to irradiation may cause inaccurate results.
• If a Sensor breaks inside your body, call your health care professional.

How to Store the Sensor Kit:

• Store the Sensor Kit between 39°F and 77°F. Storage outside of this range may cause inaccurate Sensor glucose readings. While you don’t need to keep your Sensor Kit in a refrigerator, you can as long as the refrigerator is between 39°F and 77°F. Do not freeze.
• Store the Sensor Kit between 10-90% non-condensing humidity.

When not to use the System:

• Do NOT use if the Sensor Kit package, Sensor Pack, or Sensor Applicator appear to be damaged or already opened due to risk of no results and/or infection.
• Do NOT use if Sensor Kit contents are past expiration date.
• Do NOT use if the Reader appears to be damaged due to risk of electric shock and/or no results.

What to know before you Apply the Sensor:

• The Sensor Pack and Sensor Applicator are packaged as a set (separately from the Reader) and have the same Sensor code. Check that the Sensor codes match before using your Sensor Pack and Sensor Applicator. Do not use Sensor Packs and Sensor Applicators with different Sensor codes together as this will result in incorrect glucose readings.
• Clean the application site and ensure that it is dry prior to Sensor insertion. This helps the Sensor stay attached to your body.
• Clean hands prior to Sensor handling/insertion to help prevent infection.
• Change the application site for the next Sensor application to prevent discomfort or skin irritation.
• Sensor placement is not approved for sites other than the back of the arm. If placed in other areas, the Sensor may not function properly.
• Select an appropriate Sensor site to help the Sensor stay attached to the body and prevent discomfort or skin irritation. Avoid areas with scars, moles, stretch marks, or lumps. Select an area of skin that generally stays flat during normal daily activities (no bending or folding). Choose a site that is at least 1 inch away from an insulin injection site.

When is Sensor Glucose different from Blood Glucose:

• Physiological differences between the interstitial fluid and capillary blood may result in differences in glucose readings between the System and results from a fingerstick test using a blood glucose meter. Differences in glucose readings between interstitial fluid and capillary blood may be observed during times of rapid change in blood glucose, such as after eating, dosing insulin, or exercising.

What to know about interfering substances such as Vitamin C and Aspirin:

• Taking ascorbic acid (vitamin C) while wearing the Sensor may falsely raise Sensor glucose readings. Taking salicylic acid (used in some pain relievers such as aspirin and some skin care products) may slightly lower Sensor glucose readings. The level of inaccuracy depends on the amount of the interfering substance active in the body.
• Test results did not indicate interference for methyldopa (used in some drugs to treat high blood pressure) or tolbutamide (infrequently used in some drugs to treat diabetes in the US) at maximum circulating levels. However, concentrations of potential interferents in interstitial fluid are unknown compared to circulating blood.

What to know about X-Rays:

• The Sensor should be removed prior to exposing it to an X-ray machine. The effect of X-rays on the performance of the System has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device to detect trends and track patterns in glucose values during the wear period.

When to remove the Sensor:

• If the Sensor is becoming loose or if the Sensor tip is coming out of your skin, you may get no readings or unreliable readings, which may not match how you feel. Check to make sure your Sensor has not come loose. If it has come loose, remove it and apply a new one.
• If you believe your glucose readings are not correct or are inconsistent with how you feel, perform a blood glucose test on your finger to confirm your glucose. If the problem continues, remove the current Sensor and apply a new one.

What to do if you are dehydrated:

• Severe dehydration and excessive water loss may cause inaccurate Sensor glucose readings. If you believe you are suffering from dehydration, consult your health care professional immediately.

What to know about the Reader’s Built-in Meter:

• The FreeStyle Libre 14 day Reader has a built-in blood glucose meter that is designed to be used only with FreeStyle Precision Neo blood glucose test strips and MediSense Glucose and Ketone Control Solution. Using other test strips with the Reader’s built-in meter will produce an error or cause the Reader’s built-in meter to not turn on or start a test. The Reader's built-in meter does not have ketone testing functionality.
• The Reader’s built-in meter is not for use on people who are dehydrated, hypotensive, in shock, or for individuals in hyperglycemic-hyperosmolar state, with or without ketosis.
• The Reader’s built-in meter is not for use on neonates, in critically-ill patients, or for diagnosis or screening of diabetes.
• See Using the Reader’s Built-in meter section for additional important information on the use of the Reader’s built-in meter.

Where to charge your Reader:

• Be sure to select a location for charging that allows the power adapter to be easily unplugged. Do NOT block access to the charger due to the potential risk of electrical shock.

FreeStyle Libre 2 Indications and Important Safety Information

Indications and Important Safety Information

The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.

The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.

The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions.

CONTRAINDICATIONS

Automated Insulin Dosing: The System must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems.

MRI/CT/Diathermy: The System must be removed prior to Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The effect of MRI, CT scans, or diathermy on the performance of the System has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device which could cause incorrect readings.

WARNINGS

Before you use the FreeStyle Libre 2 System, review all the product instructions and the Interactive Tutorial. The Quick Reference Guide and Interactive Tutorial give you quick access to important aspects and limitations of the System. The User’s Manual includes all safety information and instructions for use. Talk to your health care professional about how you should use your Sensor glucose information to help manage your diabetes.

Failure to use the System according to the instructions for use may result in you missing a severe low blood glucose or high blood glucose event and/or making a treatment decision that may result in injury. If your glucose alarms and readings from the System do not match symptoms or expectations, use a fingerstick blood glucose value from a blood glucose meter to make diabetes treatment decisions. Seek medical attention when appropriate.

• Do not ignore symptoms that may be due to low or high blood glucose: If you are experiencing symptoms that are not consistent with your glucose readings, consult your health care professional.
• Use your blood glucose meter to make diabetes treatment decisions when you see the Check Blood Glucose symbol during the first 12 hours of wearing a Sensor, if your Sensor glucose reading does not match how you feel, or if the reading does not include a number. 
• Choking hazard: The System contains small parts that may be dangerous if swallowed.

CAUTIONS AND LIMITATIONS

Below are important cautions and limitations to keep in mind so you can use the System safely. They are grouped into categories for easy reference.

What to know about Glucose Alarms:

• For you to receive alarms, they must be on and your Reader should be within 20 feet of you at all times. The transmission range is 20 feet unobstructed. If you are out of range, you may not receive glucose alarms.
• To prevent missed alarms, make sure the Reader has sufficient charge and that sound and/or vibration are turned on.
• Alarms you receive do not include your glucose reading so you must scan your Sensor to check your glucose.

What to know before using the System:

• Review all product information before use.
• Take standard precautions for transmission of blood borne pathogens to avoid contamination.
• Make sure that your Reader and Sensor kits are kept in a safe place, under your control. This is important to help prevent anyone from accessing or tampering with the System.

Who should not use the System:

• Do not use the System in people less than 4 years of age. The System is not cleared for use in people under 4 years of age.
• Do not use the System if you are pregnant, on dialysis, or critically ill. The System is not cleared for use in these groups and it is not known how different conditions or medications common to these populations may affect performance of the System. 
• Performance of the System when used with other implanted medical devices, such as pacemakers, has not been evaluated.

What should you know about wearing a Sensor:

• Wash application site on the back of your upper arm using a plain soap, dry, and then clean with an alcohol wipe. This will help remove any oily residue that may prevent the Sensor from sticking properly. Allow site to air dry before proceeding. Carefully preparing the site according to these instructions will help the Sensor stay on your body for the full 14 day wear period and help prevent it from falling off early.
• The Sensor can be worn for up to 14 days. Remember to always have your next Sensor available before your current one ends so you can keep getting your glucose readings.
• You must scan the Sensor to get your real-time current glucose level as the Reader will not provide this information without a scan.
• In the event that your Sensor stops working and you do not have another Sensor readily available, you must use an alternate method to measure your glucose levels and inform your treatment decisions.
• The System is designed to detect certain conditions which may occur where the Sensor is not working as intended and shut it off, telling you to replace your Sensor. This may occur if the Sensor gets knocked off from the skin or if the System detects that the Sensor may not be performing as intended. Contact Customer Service if you receive a Replace Sensor message before the end of the 14 day wear period. Customer Service is available at 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Standard Time.
• Some individuals may be sensitive to the adhesive that keeps the Sensor attached to the skin. If you notice significant skin irritation around or under your Sensor, remove the Sensor and stop using the System. Contact your health care professional before continuing to use the System.
• Intense exercise may cause your Sensor to loosen due to sweat or movement of the Sensor. If the Sensor is becoming loose or if the Sensor tip is coming out of your skin, you may get no readings or unreliable low readings. Remove and replace your Sensor if it starts to loosen and follow the instructions to select an appropriate application site. Do not attempt to reinsert the Sensor. Contact Customer Service if your Sensor becomes loose or falls off before the end of the wear period. Customer Service is available at 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Standard Time.
• Do not reuse Sensors. The Sensor and Sensor Applicator are designed for single use. Reuse may result in no glucose readings and infection. Not suitable for re-sterilization. Further exposure to irradiation may cause unreliable low results.
• If a Sensor breaks inside your body, call your health care professional.

How to Store the Sensor Kit:

• Store the Sensor Kit between 36°F and 82°F. Storage outside of this range may cause inaccurate Sensor glucose readings.
• If you suspect that the temperature may exceed 82°F (for example, in an un-airconditioned home in summer), you should refrigerate your Sensor Kit. Do not freeze your Sensor Kit.
• Store your Sensor Kit in a cool, dry place. Do not store your Sensor Kit in a parked car on a hot day.
• Store the Sensor Kit between 10-90% non-condensing humidity.

When not to use the System:

• Do NOT use if the Sensor Kit package, Sensor Pack, or Sensor Applicator appear to be damaged or already opened due to risk of no results and/or infection.
• Do NOT use if Sensor Kit contents are past expiration date.
• Do NOT use if the Reader appears to be damaged due to risk of electric shock and/or no results.

What to know before you Apply the Sensor:

• The Sensor Pack and Sensor Applicator are packaged as a set (separately from the Reader) and have the same Sensor code. Check that the Sensor codes match before using your Sensor Pack and Sensor Applicator. Do not use Sensor Packs and Sensor Applicators with different Sensor codes together as this will result in incorrect glucose readings.
• Wash application site on the back of your upper arm using a plain soap, dry, and then clean with an alcohol wipe. This will help remove any oily residue that may prevent the Sensor from sticking properly.
• Allow site to air dry before proceeding. Carefully preparing the site according to these instructions will help the Sensor stay on your body for the full 14 day wear period and help prevent it from falling off early.
• Clean hands prior to Sensor handling/insertion to help prevent infection.
• Change the application site for the next Sensor application to prevent discomfort or skin irritation.
• Only apply the Sensor to the back of the upper arm. If placed in other areas, the Sensor may not function properly.
• Select an appropriate Sensor site to help the Sensor stay attached to the body and prevent discomfort or skin irritation. Avoid areas with scars, moles, stretch marks, or lumps. Select an area of skin that generally stays flat during normal daily activities (no bending or folding). Choose a site that is at least 1 inch away from an insulin injection site.

When is Sensor Glucose different from Blood Glucose:

• Physiological differences between the interstitial fluid and capillary blood may result in differences in glucose readings between the System and results from a fingerstick test using a blood glucose meter.
• Differences in glucose readings between interstitial fluid and capillary blood may be observed during times of rapid change in blood glucose, such as after eating, dosing insulin, or exercising.

What to know about X-Rays:

• The Sensor should be removed prior to exposing it to an X-ray machine. The effect of X-rays on the performance of the System has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device to detect trends and track patterns in glucose values during the wear period.

When to remove the Sensor:

• If the Sensor is becoming loose or if the Sensor tip is coming out of your skin, you may get no readings or unreliable readings, which may not match how you feel. Check to make sure your Sensor has not come loose. If it has come loose, remove it, apply a new one, and contact Customer Service.
• If you believe your glucose readings are not correct or are inconsistent with how you feel, perform a blood glucose test on your finger to confirm your glucose. If the problem continues, remove the current Sensor, apply a new one, and contact Customer Service. Customer Service is available at 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Standard Time.

What to know about the Reader’s Built-in Meter:

• The FreeStyle Libre 2 Reader has a built-in blood glucose meter that is designed to be used only with FreeStyle Precision Neo blood glucose test strips and MediSense Glucose and Ketone Control Solution. Using other test strips with the Reader’s built-in meter will produce an error or cause the Reader’s built-in meter to not turn on or start a test. The Reader’s built-in meter does not have ketone testing functionality.
• The Reader’s built-in meter is not for use on people who are dehydrated, hypotensive, in shock, or for individuals in hyperglycemic-hyperosmolar state, with or without ketosis.
• The Reader’s built-in meter is not for use on neonates, in critically-ill patients, or for diagnosis or screening of diabetes.
• See Using the Reader’s Built-in meter section for additional important information on the use of the Reader’s built-in meter.

Where to charge your Reader:

• Be sure to select a location for charging that allows the power adapter to be easily unplugged. Do NOT block access to the charger due to the potential risk of electrical shock.

Interfering Substances

Taking ascorbic acid (vitamin C) supplements while wearing the Sensor may falsely raise Sensor glucose readings. Taking more than 500 mg of ascorbic acid per day may affect the Sensor readings which could cause you to miss a severe low glucose event. Ascorbic acid can be found in supplements including multivitamins. Some supplements, including cold remedies such as Airborne® and Emergen-C®, may contain high doses of 1000 mg of ascorbic acid and should not be taken while using the Sensor. See your health care professional to understand how long ascorbic acid is active in your body.

IMPORTANT SAFETY INFORMATION

Rx Only

Indications: The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation. The Confirm Rx™ ICM has not been specifically tested for pediatric use.

Contraindications: There are no known contraindications for the insertion of the Confirm Rx™ ICM. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated.

Adverse Events: Possible adverse events (in alphabetical order) associated with the device, include the following: Allergic reaction, Bleeding, Chronic nerve damage, Erosion, Excessive fibrotic tissue growth, Extrusion, Formation of hematomas or cysts, Infection, Keloid formation and Migration. Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.

Additional information: Clinicians must log onto Merlin.net™ Patient Care Network to view transmissions from patients’ Confirm Rx™ ICM. On Merlin.net™ PCN they can configure transmission schedules and enable or disable features on a patient’s myMerlin™ for Confirm Rx™ ICM mobile app. Review of transmissions is dependent on the clinician and may not happen immediately following delivery of such transmissions.

Limitations: Patients may use their own Apple‡ or Android‡ mobile device to transmit information from their Confirm Rx™ ICM using the myMerlin™ for Confirm Rx™ mobile app. To do so the device must be powered on, app must be installed, Bluetooth^® wireless technology enabled and data coverage (cellular or WiFi‡) available. The myMerlin™ for Confirm Rx™ mobile app provides periodic patient monitoring based on clinician configured settings. Data is resent if the transmission was not sent successfully. However, there are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of ICM and patient information as intended by the clinician. These factors include: patient environment, data services, mobile device operating system and settings, ICM memory capacity, clinic environment, schedule/configuration changes, or data processing.

An Abbott mobile transmitter is available for patients without their own compatible mobile device.

INDICATIONS, SAFETY & WARNINGS

Rx Only

Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

CardioMEMS™ HF System Indications and Usage: The CardioMEMS HF System is indicated for wirelessly measuring and monitoring pulmonary artery (PA) pressure and heart rate in New York Heart Association (NYHA) Class III heart failure patients who have been hospitalized for heart failure in the previous year. The hemodynamic data are used by physicians for heart failure management and with the goal of reducing heart failure hospitalizations.

CardioMEMS HF System Contraindications: The CardioMEMS HF System is contraindicated for patients with an inability to take dual antiplatelet or anticoagulants for one month post implant.

CardioMEMS HF System Potential Adverse Events: Potential adverse events associated with the implantation procedure include, but are not limited to, the following: infection, arrhythmias, bleeding, hematoma, thrombus, myocardial infarction, transient ischemic attack, stroke, death, and device embolization.

myCardioMEMS™ Mobile App Limitations: Patients must use their own Apple‡ or Android‡ mobile device to receive and transmit information to the myCardioMEMS Mobile App. To do so the device must be powered on, app must be installed and data coverage (cellular or Wi-Fi‡) available. The myCardioMEMS App can provide notification of medication adjustments and reminders, requests for lab work and acknowledgement that the PA pressure readings have been received. However there are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of the notifications and patient information as intended by the clinician. These factors include: patient environment, data services, mobile device operating system and settings, clinic environment, schedule/configuration changes, or data processing.