Dexcom G4 Professional Instrukcja Użytkownika Pobierz pdf (Strona 2)

Documentation of Site Training

• It is the responsibility of the Dexcom employee or

designee to return documentation of each trained

site, which includes:

• Completed Dexcom G4 PLATINUM Professional

Site Training Checklist

• Completed Dexcom G4 PLATINUM Professional

Site Training Verication Form

• Return BOTH documents to Dexcom

via fax at 1.866.348.6030 OR e-mail at

[email protected]

• For additional product support or training, see the

Dexcom website at www.dexcom.com, contact

your local Dexcom representative and/or Dexcom

Technical Support at 1.877.339.2664

performance of the system. Therefore, the use of this system in the critically ill population is not recommended.

• Sensor placement and insertion is not approved for sites other than the belly (abdomen).

• Do not expect alerts from the Dexcom G4 PLATINUM Professional System until after the 2-hour startup.

You will NOT get any sensor glucose readings or alerts until after the 2-hour startup ends AND you complete

the startup calibration. During this time you might miss severe hypoglycemia (low blood glucose) or

hyperglycemia (high blood glucose) events.

• If your transmitter or receiver case is damaged/cracked, do not use it. This could create an electrical safety

hazard or malfunction, which might cause electrical shocks.

• Store the sensor at temperatures between 36° F - 77° F for the length of the sensor’s shelf life. You may

store the sensor in the refrigerator if it is within this temperature range. The sensor should not be stored in

a freezer. Storing the sensor improperly might cause the sensor glucose readings to be inaccurate, and you

might miss a low or high blood glucose value.

• Low/high glucose alerts and the 55 mg/dL low glucose alarm are all disabled when using the Dexcom G4

PLATINUM Professional System in blinded mode and will not alert you when the glucose is low or high.

Check blood glucose meter if there are any signs or symptoms of low or high glucose.

PRECAUTIONS

• Before opening the sensor package, wash your hands with soap and water, and let them dry. You may

contaminate the insertion site and suffer an infection if you have dirty hands while inserting the sensor.

• Before inserting the sensor, clean the skin with a topical antimicrobial solution, such as isopropyl alcohol,

and allow to dry. This may help prevent infection. Do not insert the sensor until the cleaned area is dry so the

sensor adhesive will stick better.

• Change the site where you place the sensor with each insertion, if the system is used multiple times. Using

the same site too often might not allow the skin to heal, and might cause scarring or skin irritation.

• Avoid inserting the sensor in areas that are likely to be bumped, pushed or compressed or areas of skin with

scarring, tattoos, or irritation as these are not ideal sites to measure glucose. Insertion in those areas might

affect sensor performance, and you might miss a low or high blood glucose value.

• Avoid injecting insulin or placing an insulin pump infusion set within 3 inches of the sensor. The insulin might

affect sensor performance, and you might miss a low or high blood glucose value.

• Do not use the sensor if its sterile package has been damaged or opened. Using an unsterile sensor might

cause infection.

• To calibrate the system, enter the exact blood glucose value that your blood glucose meter displays within

5 minutes of a carefully performed blood glucose measurement. Entering incorrect blood glucose values or

blood glucose values from more than 5 minutes before entry might affect sensor performance, and you might

miss a low or high blood glucose value.

• Do not calibrate if your blood glucose is changing at a signicant rate, typically more than 2 mg/dL per

minute. Do not calibrate when your receiver screen is showing the rising single arrow or double arrow, which

indicates that your blood glucose is rising 2-3 mg/dL/min or more than 3 mg/dL/min. Also, do not calibrate

when your receiver screen is showing the falling single arrow or double arrow, which indicates that your blood

glucose is falling 2-3 mg/dL/min or more than 3 mg/dL/min. Calibrating during signicant rise or fall of blood

glucose may affect accuracy of sensor glucose readings.

• The system accuracy may be affected when your glucose is changing at a signicant rate (e.g., 2-3

mg/dL/min or more than 3 mg/dL each minute), such as during exercise or after a meal. Since the system will

not display your glucose rate of change in blinded mode, avoid calibrating after a meal or exercise.

• The transmission range from the transmitter to the receiver is up to 20 feet without obstruction. Wireless

communication does not work well through water so the range is much less if you are in a pool, bathtub, or

on a water bed, etc. Types of obstruction differ and have not been tested. If your transmitter and receiver

are farther than 20 feet apart or are separated by an obstruction, they might not communicate or the

communication distance may be shorter and you might miss a low or high blood glucose value.

• Do not use alternative blood glucose site testing (blood from your palm or forearm, etc.) for calibration.

Alternative site blood glucose values may be different than those taken from a ngerstick blood glucose

value and may not represent the timeliest blood glucose value. Use a blood glucose value taken only from

a ngerstick for calibration. Alternative site blood glucose values might affect sensor performance, and you

might miss a low or high blood glucose value.

• Do not discard your transmitter. It is reusable. The same transmitter is used for each session until you have

reached the end of the transmitter battery life. When healthcare professionals use one transmitter for multiple

patients, the transmitter must be returned to the healthcare professional.

• The Dexcom G4 PLATINUM Sensor, Transmitter, and Receiver are not compatible with the SEVEN

/SEVEN

PLUS Transmitter and Receiver. Different generations will not connect with each other and will not work. Also

make sure to use the correct version of Dexcom STUDIO with your system.

• If all 3 square seals have been used before the end of the session, return the receiver to the healthcare

professional ofce. Do not charge the receiver if you cannot seal it. Unsealed receivers could

spread contamination.

• Do not puncture the receiver shield for any reason. Punctured shields could spread contamination.

• Return the receiver to the healthcare professional if the acoustic spacer moves away from the upper right

corner. The entire receiver shield must be discarded and replaced. The spacer allows the receiver speaker

to work properly when the shield is in place. If the spacer moves and the receiver speaker volume is low, you

might miss alerts or alarms.

• Inspect the receiver shield, seals and spacer for tears or other damage or defects before you place the

components on the receiver. Do not use any parts of the receiver shield pack that are damaged or defective.

If the receiver shield, seals and spacer are torn, damaged or otherwise defective after giving to the patient,

the patient should return the receiver to the healthcare professional for a replacement. The damaged or

defective receiver shield should not be taken off by the patient. If a defect or malfunction is suspected, the

healthcare professional should retain the shield and contact Dexcom Technical Support. The shield helps

protect the user and healthcare professionals from contamination and allows the receiver to function properly.

CAUTION

U.S. (Federal) law restricts the sale of the Dexcom G4 PLATINUM Professional System to sale by or on order

of a physician.

INDICATIONS FOR USE

The Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System is a glucose monitoring

device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. The

system is intended for multiple patient use and requires purchase by a healthcare provider. The system is not

intended for use in a hospital setting.

The Dexcom G4 PLATINUM Professional System is indicated for use as an adjunctive device to complement,

not replace, information obtained from standard home glucose monitoring devices.

The Dexcom G4 PLATINUM Professional System aids in the detection of episodes of hyperglycemia

and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these

excursions. Interpretation of the Dexcom G4 PLATINUM Professional System results should be based on the

trends and patterns seen with several sequential readings over time.

IMPORTANT USER INFORMATION

Please review your product instructions before using your continuous glucose monitoring system. Indications,

contraindications, warnings, precautions, cautions, and other important user information can be found

in your product instructions. Discuss with your healthcare professional how you should use your sensor

trend information to help manage your diabetes. Your product instructions contain important information on

troubleshooting your system and on the performance characteristics of the device.

CONTRAINDICATIONS

• Remove the Dexcom G4 PLATINUM Sensor, Transmitter, and Receiver before Magnetic Resonance

Imaging (MRI), Computed Tomography (CT) scan, or diathermy treatment. The device is MR

Unsafe. Do not bring any portion of the device into the MR environment. The Dexcom G4 PLATINUM

Professional System has not been tested during MRI or CT scans or with diathermy treatment. The magnetic

elds and heat could damage the device so that it might not display sensor glucose readings or provide

alerts, and you might miss a low or high blood glucose value.

• Taking medications with acetaminophen (such as Tylenol

) while wearing the sensor may falsely raise your

sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen active in your

body and may be different for each person.

WARNINGS

• Thoroughly review the training materials included with your CGM system before using the Dexcom G4

PLATINUM Professional CGM System. Incorrect use might lead to you misunderstanding the information

provided by your system, or might affect system performance, and you might miss a low or high blood

glucose value.

• Do not use the Dexcom G4 PLATINUM Professional System for treatment decisions, such as how much

insulin you should take. The Dexcom G4 PLATINUM Professional System does not replace a blood glucose

meter. Always use the values from your blood glucose meter for treatment decisions. Blood glucose values

may differ from sensor glucose readings. Using the sensor glucose readings for treatment decisions could

lead to low or high blood glucose value.

• Do not ignore symptoms of high and low glucose. If your sensor glucose readings do not match your

symptoms, measure your blood glucose with a blood glucose meter even if your sensor is not reading in the

high or low range, so you do not miss a low or high blood glucose value.

• Calibrate at least once every 12 hours. Calibrating less often than every 12 hours might cause sensor

glucose readings to be inaccurate, and you might miss a low or high blood glucose value.

• Users need to adhere to Standard Precautions when handling or using this device. All parts of the

system should be considered potentially infectious and are capable of transmitting blood-borne

pathogens between patients and healthcare professionals. For more information, refer to “Guideline

for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings 2007,”

http://www.cdc.gov/hicpac/2007ip/2007isolationprecautions.html.

• The transmitter should be cleaned and disinfected after use on each patient. This system may only be used

for testing multiple patients when Standard Precautions and the manufacturer’s cleaning and disinfection

procedures are followed.

• Replace the receiver shield and acoustic spacer when transferring the receiver to a new patient. Wear gloves

when handling the receiver. Handling the receiver without a shield or with a damaged shield could lead to

contamination, which could cause infection.

• Sensors may fracture on rare occasions. If a sensor breaks and no portion of it is visible above the

skin, do not attempt to remove it. Seek professional medical help if you have symptoms of infection or

inammation—redness, swelling or pain—at the insertion site. If you experience a broken sensor, please

report this to our Technical Support department at 1.877.339.2664 or 1.858.200.0200.

• The Dexcom G4 PLATINUM Professional System is not approved for use in children or adolescents,

pregnant women or persons on dialysis.

• It is not known how different conditions or medications common to the critically ill population may affect the

Dexcom G4 PLATINUM Professional Site Training Checklist

Becoming a Dexcom CGM Trained Site

Dexcom, Dexcom G4, Dexcom G4 PLATINUM, Dexcom G4 PLATINUM Professional, Dexcom

STUDIO, One Step Ahead and SEVEN are either registered trademarks or trademarks of

Dexcom, Inc. in the United States and/or other countries. All other product or company names

that may be mentioned in this publication are tradenames, trademarks or registered trademarks of

their respective owners.

Dexcom, Inc.

6340 Sequence Drive

San Diego, CA 92121

Technical Support: 1.877.339.2664 / 1.858.200.0200

www.dexcom.com

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