eversense CGM Sensor Insertion And Removal Instructions
CGM Sensor Insertion and Removal Instructions
IMPORTANT:
• Only physicians who have successfully completed the Eversense CGM Insertion and Removal Training Program and have read and understood the Eversense CGM Sensor Insertion and Removal
Instructions may perform the insertion and removal procedure on patients. Contact Senseonics (in the US toll free at 844-SENSE4U (844-736-7348)) if training has yet to be conducted or if you
experience any diculty or issues with the insertion or removal procedure. Calls received after business hours (8am to 8pm Eastern US time) will be returned within two business days.
To see a list of certified Eversense providers, go to https://www.eversensediabetes.com/find-a-provider/
• All symptoms of infection (e.g., increased temperature, inflammation, redness, pain, tenderness, warmth, swelling or purulence) at the insertion or removal area should be reported. If any of the
above occurs, please advise patients to contact their physician immediately.
• Store the sensor pack refrigerated at the labeled temperature range.
• Review the Eversense CGM System User Guide to help facilitate your patient’s understanding of their new Eversense CGM System and determining their personalized glucose settings.
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Eversense CGM Sensor Insertion and Removal Instructions
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Eversense CGM Sensor Insertion and Removal Instructions
1. Overview of the Eversense
Continuous Glucose Monitoring (CGM) System
Congratulations on having Eversense CGM technology to assist your patients in managing their diabetes. The Eversense CGM System is for people with diabetes to continually measure glucose levels
for up to 90 days from the time of sensor insertion.
Some of the features of the Eversense CGM System:
• Wireless communication with the sensor, smart transmitter and app.
• Long-term sensor wear in the upper arm for up to 90 days.
• Alerts when pre-set Low or High Glucose Alert levels (hypoglycemia or hyperglycemia) are passed.
• Predictive alerts to alert the patient before reaching pre-set Low or High Glucose Alert levels.
• Use of mobile device (e.g., smartphone) to display glucose readings.
• On-body vibe alerts with the smart transmitter even when mobile device is not nearby.
• Provides readings within 40-400 mg/dL (2.2-22.2 mmol/L) range every 5 minutes.
• Trend arrows that show whether glucose values are rising or falling and how fast.
• Graphs and statistics that show glucose results in easy-to-understand formats.
• Removable and rechargeable smart transmitter.
• Event entry capabilities (like meals, exercise and insulin).
• Stores glucose data in the app and on the smart transmitter.
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Eversense CGM Sensor Insertion and Removal Instructions
Eversense CGM System Components
The System includes:
1) a small sensor inserted subcutaneously by a doctor,
2) a removable smart transmitter worn over the sensor, and
3) a mobile app to display the glucose readings.
Eversense Sensor
The sensor is inserted under the skin (upper arm) and measures glucose in interstitial fluid for up to 90 days. These glucose levels are then calculated
by the smart transmitter and sent to the app.
The Eversense Sensor lasts up to 90 days. The sensor has a silicone ring that contains a small amount of dexamethasone acetate, an anti-inflammatory
steroid drug. The dexamethasone acetate minimizes inflammatory responses, very similar to common medical devices, such as pacemakers.
Specially designed sensor insertion tools are provided for subcutaneous insertion of the sensor. Other equipment necessary for the procedure, but not
included in the Eversense Insertion Tool Pack, is listed in Section 4.
Eversense Smart Transmitter
The removable smart transmitter is worn externally over the sensor and powers the sensor. It wirelessly sends glucose data (via Bluetooth) to the
mobile device app. The smart transmitter also provides on-body vibe alerts based on the pre-set glucose level settings. It has a rechargeable battery
and is reusable for up to one year. Adhesive patches included with the Eversense Insertion Tools Pack are provided for the patient to replace daily.
Eversense App
The Eversense App is a software application that runs on a mobile device (e.g., smartphone) and displays glucose data in a variety of ways. It also
provides alerts based on the pre-set glucose level settings.
Note: Not actual size
Sensor
Eversense App
Smart Transmitter
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Eversense CGM Sensor Insertion and Removal Instructions
Continuous glucose monitoring aids in the management of diabetes and glucose control, which can improve your patient’s quality of life. Best results are achieved when the user is fully informed about the
risks and benefits, insertion procedure, follow-up requirements, and self-care responsibilities. Patients should not have the sensor inserted if they cannot properly operate the CGM System.
The CGM System measures glucose in interstitial fluid (ISF) between the body’s cells. Physiologic dierences between ISF and blood from a fingerstick may result in dierences in glucose measurements.
These dierences are especially evident during times of rapid change in blood glucose (e.g., after eating, dosing insulin, or exercising). Glucose levels in ISF lag behind glucose levels in blood by
several minutes.
The sensor has a silicone ring that contains a small amount of an anti-inflammatory drug (dexamethasone acetate). It has not been determined whether the risks associated with injectable dexamethasone
acetate apply to the dexamethasone acetate elution ring inside the sensor. The elution ring releases a small amount of dexamethasone acetate when the sensor comes in contact with body fluids and serves
to minimize the body’s inflammatory response to the inserted sensor. Dexamethasone acetate in the ring may also cause other adverse events not previously seen with the injectable form.
Indications for Use
The Eversense CGM System is indicated for continually measuring glucose levels in adults (18 years or older) with diabetes for up to 90 days.
The system is intended to:
• Provide real-time glucose readings.
• Provide glucose trend information.
• Provide alerts for the detection and prediction of episodes of low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia).
The system is a prescription device. Historical data from the system can be interpreted to aid in providing therapy adjustments. These adjustments should be based on patterns and trends seen over time.
The system is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home blood glucose monitoring devices.
2. Benets and Risks
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Eversense CGM Sensor Insertion and Removal Instructions
MRI Safety Information
Non-clinical testing has demonstrated the Eversense Sensor is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:
• Static magnetic field of 1.5T or 3.0T
• Maximum spatial field gradient of 2000 gauss/cm (20 T/m)
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4 W/kg (First Level Controlled Operating Mode)
Under the scan conditions defined above, non-clinical testing results indicate the Eversense Sensor is expected to produce a maximum temperature rise of less than 5.4 °C after 15 minutes of continuous
scanning.
In non-clinical testing, the image artifact caused by the device extends approximately 2.83 inches (72 mm) from the Eversense Sensor when imaged with a gradient echo pulse sequence and a 3T MR system.
The Eversense Smart Transmitter is MR Unsafe and MUST BE REMOVED before undergoing an MRI procedure. Before you undergo an MRI procedure, tell the MRI sta that you have an Eversense Sensor and
Smart Transmitter.
Contraindications
The smart transmitter is incompatible with magnetic resonance imaging (MRI) procedures. The smart transmitter is MR Unsafe and MUST BE REMOVED before undergoing an MRI (magnetic resonance
imaging) procedure. For information on the sensor, please see MRI Safety Information.
The system is contraindicated in people for whom dexamethasone or dexamethasone acetate may be contraindicated.
Mannitol or sorbitol, when administered intravenously, or as a component of an irrigation solution or peritoneal dialysis solution, may increase blood mannitol or sorbitol concentrations and cause falsely
elevated readings of the patient’s sensor glucose results. Sorbitol is used in some artificial sweeteners, and concentration levels from typical dietary intake do not impact sensor glucose results.
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Eversense CGM Sensor Insertion and Removal Instructions
Warnings
• The Eversense CGM System has not been tested using insertion sites other than the upper arm.
• Patients should always test glucose with a blood glucose meter before making a treatment decision. Using the sensor glucose value to make a treatment decision could result in a high or low
blood glucose.
• If at any time there are symptoms of a low or high glucose level OR if patient symptoms are not consistent with the sensor glucose readings, patients should test glucose levels with a blood
glucose meter.
• Patients should not use a smart transmitter if it is damaged or cracked as this could result in electrical shock.
• Patients should avoid close contact with electromagnetic interference (EMI) while wearing the smart transmitter.
• Antibiotics of the tetracycline class may falsely lower sensor glucose readings. Patients should not rely on sensor glucose readings while taking tetracyclines.
• The bandage should remain covering the incision for 48 hours as this is a standard of care to allow formation of a water-tight seal to help protect against infection. Until it has healed, patients
should always cover the insertion site with a sterile bandage before placing the smart transmitter adhesive over the sensor. Failure to do so could result in infection at the insertion site.
Risks and Side Eects
The glucose alerts and notifications will not audibly notify the user when the sound on their mobile device is turned o. If the system cannot display a glucose value, it also cannot provide glucose alerts.
If the patient is unable to feel the vibration of the smart transmitter he/she may not notice the alerts. The system’s calculated glucose can be slightly dierent from a blood glucose meter. This may cause
an alert to activate at a dierent time than they would have if the system’s values always matched the blood glucose meter values. If the patient does not take frequent blood glucose measurements and
misses an alert, he/she may not be aware of high or low glucose levels. Medical attention may be needed in the event that he/she has high or low glucose and is unaware of it. If the patient does not test
their glucose with a blood glucose meter when symptoms of a low or high blood glucose level appear OR when symptoms are not consistent with the sensor glucose readings, he/she may miss a high or
low glucose event. If a patient does not always test glucose with a blood glucose meter before making a treatment decision, he/she may inadvertently cause a high or low blood glucose value because
actual glucose values can be slightly dierent than the system’s displayed values.
The sensor is inserted by making a small incision and placing it under the skin. This process may cause infection, pain or skin irritation. Additionally, the adhesive may cause a reaction or skin irritation.
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Eversense CGM Sensor Insertion and Removal Instructions
Precautions
• The sensor and sensor holder are sterile in the unopened, undamaged, sterile package. The sensor should not be used if the sterile package has been opened or damaged.
• A sensor should not be inserted if it has been dropped from a height greater than 30 cm.
• Use only the insertion tools provided in the insertion tool kit to insert the sensor. Other insertion tools may damage the sensor.
• Instruct patients to notify airport security personnel of the presence of the device when going through the security system.
• Patients should NOT exchange smart transmitters with another person. Each smart transmitter can be linked to only one sensor at a time. The system is to be used by a single patient in the home
environment.
• The following medical therapies or procedures have not been tested with the Eversense Sensor and may cause permanent damage to the sensor particularly if used in close proximity to the
device:
– Lithotripsy – The use of lithotripsy is not recommended for people who have an inserted sensor because the eects are unknown.
– Diathermy – DO NOT use diathermy on people who have an inserted sensor. Energy from the diathermy can transfer through the sensor and cause tissue damage in the insertion area.
– Electrocautery – The use of electrocautery near the inserted sensor may damage the device. DO NOT use electrocautery near the sensor.
• Patients should NOT wear the smart transmitter during medical x-rays or computed tomography (CT) scans. To avoid interference with results, the smart transmitter should be removed before
undergoing medical x-ray or CT scans.
• The sensor and smart transmitter should be linked the day of insertion. Failure to link the sensor and smart transmitter could result in a delay in receiving glucose readings.
Warnings (continued)
• The system should only be calibrated using a fingerstick blood sample. Alternative sites (such as forearm or palm) should not be used to calibrate the system.
• Insulin should not be injected and infusion sets for insulin pumps should not be inserted within 4 in (10.16 cm) of the sensor site. If the insulin delivery site is within 4 in (10.16 cm) of the sensor
site, it may interfere with sensor glucose readings and can cause inaccurate glucose readings.
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Eversense CGM Sensor Insertion and Removal Instructions
Precautions (continued)
• Steroid use – It has not been determined whether the risks usually associated with injectable dexamethasone acetate apply to the use of this dexamethasone acetate elution ring, a highly
localized, controlled-release device. The dexamethasone acetate ring could cause other adverse events not listed or previously seen.
• If the sensor, insertion site or smart transmitter feels warm, the patient should remove the smart transmitter immediately and contact his/her physician for further advice. A warm sensor could
mean there is an infection or a sensor malfunction.
• Patients should NOT attempt to use the Eversense App while operating a motor vehicle.
• Patients should not receive massage therapy near the inserted sensor site. Massage therapy near the sensor site could cause discomfort or skin irritation.
• Patients should use only the AC power adapter and USB cable provided with the smart transmitter when charging the smart transmitter battery. Use of another power supply could damage the
smart transmitter, not allowing glucose readings to be received properly, and could result in voiding the warranty.
• If the patient has any concerns about allergic reaction to adhesive products containing silicone, he/she should contact the physician prior to use. The Eversense adhesive patch should be
discarded after each use of up to 24 hours.
• Patients should not change the unit of measurement unless they have discussed it with their physician. Using the incorrect unit of measure could result in missing a high or low glucose event.
• Entering incorrect blood glucose values for calibration can result in inaccurate sensor glucose readings, which may result in the user missing a high or low glucose event.
• Patients should follow their health care provider’s recommendation for setting their glucose alerts. Incorrectly setting the glucose alerts can result in the user missing a high or low glucose event.
• Patients should pay attention to the glucose alerts the system provides. Failure to appropriately respond to an alert might result in the user missing a high or low glucose event.
• The Eversense NOW Remote Monitoring App does not replace the monitoring regimen as directed by the health care provider.
• The Eversense CGM System has not been tested in the following populations: women who are pregnant or nursing, people under the age of 18, critically ill or hospitalized patients, people
receiving immunosuppressant therapy, chemotherapy or anti-coagulant therapy, those with another active implantable device, e.g., an implantable defibrillator (passive implants are allowed,
e.g., cardiac stents), those with known allergies to or using systemic glucocorticoids (excluding topical, optical or nasal, but including inhaled). The system’s accuracy hasn’t been tested in these
populations, and sensor glucose readings may be inaccurate, resulting in missing a severe low or high glucose event.
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Eversense CGM Sensor Insertion and Removal Instructions
3. Eversense CGM System Candidates
and Pre-Insertion Activities
Candidate Selection
Per ACE/AACE guidelines*, potential candidates for CGM include those patients:
• Taking insulin to treat their T1 or T2 diabetes, and motivated to optimize their blood glucose management with the addition of new glucose monitoring technology.
• Able to follow device labeling and use their blood glucose meter results to make treatment decisions.
• Have hypoglycemic unawareness/frequent hypoglycemia.
• With their hemoglobin A1c (HbA1c) over target, or with excess glycemic variability – requiring HbA1c lowering without increased hypoglycemia.
Eversense CGM System Candidates
• Must have a compatible Android or IOS device, be familiar with its functionality and have WiFi connectivity. For a list of compatible devices, visit eversensediabetes.com.
• Willing to enter a calibration blood glucose (BG) into the app twice a day.
• Discuss appropriate placement of sensor insertion and smart transmitter wear.
• No known contraindication to dexamethasone acetate.
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Eversense CGM Sensor Insertion and Removal Instructions
• Is not receiving mannitol or sorbitol, administered intravenously, or as a component of an irrigation solution or peritoneal dialysis solution, as this may increase blood mannitol or sorbitol concentrations
and cause falsely elevated readings of sensor glucose results. Sorbitol is used in some artificial sweeteners, and concentration levels from typical dietary intake do not impact sensor glucose results.
• Is not pregnant or under the age of 18.
* Blevins T, Bode B, Garg S, Grunberger G, Hirsch I, Jovanovic L, et al. Statement by the American Association of Clinical Endocrinologists Consensus Panel on Continuous Glucose Monitoring. Endocrine
Practice, 2010; 16(5): A.
Pre-Insertion Training Activities for Patient
• Download Eversense App to compatible mobile device (requirements are listed in User Guide) and become familiar with functionality.
• Discuss the importance of setting the correct “Unit of Measure” in the Eversense App.
• Go to eversensediabetes.com – view insertion animation video, download Quick Reference Guide (QRG) and/or User Guide for review.
To pair Smart Transmitter with Compatible Mobile Device
• Confirm the patient has downloaded the Eversense CGM App from the App Store or Google Play store.
• Charge smart transmitter for 15 minutes
• Pair smart transmitter to mobile device.
• Set system preferences according to doctor recommendations.
• Instruct patients to bring smart transmitter and mobile device to clinic if it was shipped to patient’s home.
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Eversense CGM Sensor Insertion and Removal Instructions
The Eversense CGM System Kit comes in three packages: 1) Sensor Pack, 2) Insertion Tools Pack, and the 3) Smart Transmitter Pack.
IMPORTANT: The Sensor Pack and Insertion Tools Pack contain components that are packaged sterile. Both packs are designed for single patient-use only. DO NOT re-use, re-process or re-sterilize
the sensor, blunt dissector, or insertion tool.
Items Not Included: Other procedure instruments, tools and equipment are not included and must be provided by the clinic.
4. Eversense CGM System Kit
1. Eversense Sensor Pack (Sensor in holder)
The Sensor is shipped sterile inside a protective holder for safe handling purposes. You will need to transfer the sensor to the insertion tool before use.
The pouch that holds the sensor is not sterile.
The sensor is approximately 3.5 mm x 18.3 mm and is subcutaneously inserted using the insertion tool. The sensor has a silicone ring that contains an
anti-inflammatory steroid drug (dexamethasone acetate). Upon exposure to body fluids the dexamethasone acetate is eluted from the ring in the area near
the sensor. The dexamethasone acetate minimizes inflammatory responses, very similar to some already available medical devices (e.g., pacemaker leads).
IMPORTANT: Store the sensor pack refrigerated at the labeled temperature range.
Sensor Sensor
holder
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Eversense CGM Sensor Insertion and Removal Instructions
2. Eversense Insertion Tools Pack
(Incision Template , Blunt Dissector, Insertion Tool, Tray, Adhesive Patches, and Insertion/Removal Instructions)
The Incision Template is used to guide and mark the incision area on the skin surface by aligning the marking
template to the marked outer edges of the smart transmitter when placed in a comfortable position.
The Blunt Dissector is used to create the subcutaneous pocket for insertion of the sensor. This tool has two depth
guards to help prevent the pocket from being made too deep in the skin. The depth guards have guide marks to
assist in determining the length of the subcutaneous pocket for placing the sensor.
The Insertion Tool is used to insert the sensor inside the subcutaneous pocket created with the blunt dissector. It has
two guide marks on the cannula to assist in proper placement.
The Adhesive Patch (90 patches in pack) has an adhesive side that attaches to the back of the smart transmitter and
a silicone adhesive side that attaches to the skin intended to be changed daily.
3. Eversense Smart Transmitter Pack
(Smart Transmitter, Power Supply, User Guide, Quick Reference Guide)
The Smart Transmitter is the reusable and rechargeable device worn externally over the sensor. The smart transmitter
wirelessly powers the sensor. Use only the Power Supply included in this kit to charge the smart transmitter.
The User Guide and Quick Reference Guide are designed for the patient to learn about their Eversense CGM System.
Incision Point
Marking Template
Blunt Dissector
Guide Marks
Depth Guards
Guide Marks
Insertion Tool
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Eversense CGM Sensor Insertion and Removal Instructions
The sensor package, blunt dissector, and insertion tool have been sterilized by the method indicated on the package labels.
Inspect the condition of the sterile package before opening and using the contents.
• DO NOT use the contents if the package is broken or torn, or if contamination is suspected because of a defective sterile package seal.
• DO NOT re-sterilize the sensor or the components by any sterilization method.
• DO NOT use the product if the labeled “Use By” date has passed.
Handling and Storage
• Handle the sensor and all other components with care, using appropriate aseptic technique.
• DO NOT open any of the sterile packages until ready for use.
• Keep sharp instruments away from the kit components.
• DO NOT use the sensor or any kit component if it has been dropped on a hard surface from a height of more than 30 cm.
• Store the sensor package refrigerated at the labeled temperature range.
• Dispose of product packaging in accordance with clinic, administrative and/or local government policy.
5. Product Handling
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Eversense CGM Sensor Insertion and Removal Instructions
6. Suggested Equipment
Items Not Included: Other procedure instruments, tools and equipment are not included in insertion tool kit and must be provided by the clinic. Please see list of suggested equipment below.
Materials (or equivalent) suggested for sensor insertion/removal:
• Chlorhexidine OR Betadine solution
• 2-3 Sterile Gauze Pads
• 1 Disposable Sterile Scalpel (e.g., Disposable Sterile Scalpel, #15)
• 1 Sterile Syringe and Needle (for lidocaine injection)
• Steri-Strip Adhesive Skin Closure and/or available sutures (physician preference)
• 1 sterile scissors (e.g., disposable) to cut steri strips
• 1 Sterile Towel Drape
• 1 Sterile Drape with aperture approximately 22 in x 25 in
• 2 Tegaderm™ + Pad Film Dressing
• 1 Lidocaine HCL without epinephrine (1-2 mL)
• 1 Surgical skin marker
• 3 Sterile, non-latex surgical gloves, physician-preferred size
• 1 10 mL sterile saline filled syringe (for insertion only)
• 1 Sterile surgical clamp 10-16cm
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Eversense CGM Sensor Insertion and Removal Instructions
Before inserting the sensor, confirm that the patient:
• Does not have allergies to the antiseptic and local anesthetic to be used during insertion.
Note: The procedure below assumes a right handed physician with the patient facing (left arm insertion) or looking away from (right arm insertion) the physician. The dimensions indicated in the
instructions are approximate to give a conceptual context of the insertion.
7. Insertion Procedure
Acromion
Process
Suggested
Insertion
Area
Epicondyle
A. Prep the Insertion Area
1.
With the subject seated on the procedure table, position the smart transmitter on the patient’s arm to select the insertion location for the sensor.
It is recommended to alternate arms for subsequent insertion sites.
Suggested insertion location is approximately at the midway point between the acromion process and the lateral epicondyle.
Things to consider when choosing insertion location:
• It must be comfortable for the user to wear 24/7 for 90 days. Place the smart transmitter on the intended site and confirm that the patient is
comfortable with the placement.
• Not too lateral such that patient cannot easily apply adhesive patch.
• Avoid area with loose skin such as back of arm.
• Avoid areas with scar tissue, tattoo, nevus, or apparent or noticeable blood vessels that could be incised.
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Eversense CGM Sensor Insertion and Removal Instructions
B. Open the Sensor Pack and Insertion Tools Pack
Over the prepared sterile field, remove the sensor holder from the Sensor pouch and remove the sterile inner tray with tools from the Insertion Tools Pack and place in the sterile procedure field created for
the procedure. Note that the inner tray of the Sensor Insertion Package is sterile and can be placed within the sterile procedure field.
Precautions
• The sensor and sensor holder are sterile in the unopened, undamaged, sterile package. The sensor should not be used if the sterile package has been opened or damaged.
• DO NOT insert a sensor if it has been dropped from a height of 30 cm or more.
• Use only the insertion tools provided in the insertion tool kit to insert the sensor. Other insertion tools may damage the sensor.
2. Once the position for the smart transmitter is selected, mark the corners on the skin.
3. Using the non-sterile incision template, align the template inside the marked lines and mark the skin for the incision using the incision template’s slot.
4. Position the patient in a reclined position preferably on their side, with the elbow flexed up to 90 degrees and the palm resting on the chest or abdomen.
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