ACCU-CHEK Glucose Monitoring Device
Kenya sephutheloana
Accu-Chek SmartGuide device
Read this package insert and the User’s Manual of the Accu-Chek SmartGuide device before using this product. The User’s Manual is available online at go.roche.com/CGM-instructions. Follow all instructions, safety information, technical data, and performance data in the User’s Manual and this package insert. For compatibility information, see the compatibility document. The package insert and compatibility document are also available online at go.roche.com/download-portal
Tšebeliso e reriloeng
The continuous glucose monitoring device (CGM device) is intended for continuous measurement of real-time glucose levels in the subcutaneous interstitial fluid.
Basebelisi ba reriloeng
- Adults, 18 years of age and older
- People with diabetes mellitus
- Caregivers of people with diabetes mellitus
Lipontšo
The device is indicated for people with diabetes mellitus (not in a clinical setting).
Contraindications
The device shall not be used by critically ill patients or patients on dialysis. The sensor must be removed prior to entering environments with strong electromagnetic fields, according to IEC 60601-1-2. Environments with strong electromagnetic fields include, for example, libaka tsa sesole, libaka tsa liindasteri tse boima, le libaka tsa phekolo ea meriana tse nang le lisebelisoa tsa motlakase tsa bongaka tse matla haholo (magnetic resonance imaging (MRI), computed tomography (CT), X-ray, radiotherapy, kapa diathermia).
Litaba tsa pakete
1 device (sensor applicator with 1 sensor inside), 1 package insert
Lisebelisoa tse ling tse hlokahalang
- A compatible app installed on your mobile device
- A compatible mobile device
- An alternate method for glucose testing, for example, for use in emergencies when the app or sensor is not working
Boitsebiso bo akaretsang ba polokeho
- Sehlahisoa se reretsoe tšebeliso e le 'ngoe feela.
- Apply the sensor only once.
- Apply the sensor only in trusted environments.
- Visually inspect the packaging and product for damages or manipulation. If the pull tab is sticking out before use, the so-called sterile barrier is broken. The product is unsterile. Discard damaged products.
- Visually inspect the sensor and the needle for damages. If you notice anything unusual, don’t use the sensor. Use a new sensor.
- Don’t use the product in case of known allergic reactions when using adhesive pads on your skin.
- In rare cases, the needle can remain in your body after you have applied the sensor. This may lead to adverse reactions to a foreign body, encapsulations, infections, or abscesses. In case of an adverse reaction, seek medical attention.
TLHOKOMELO
Risk of serious harm
Don’t modify the product. Always follow the instructions. Otherwise, the product doesn’t work as intended. This may lead to one or several harms, including adverse reactions of the skin, reactions to a foreign body, encapsulations, infections, or abscesses.
Kotsi ea ho bipetsana
Sehlahisoa sena se na le likaroloana tse nyenyane tse ka metsoang. Beha likaroloana tse nyane hole le bana ba banyenyane le batho ba ka 'nang ba koenya likaroloana tse nyane.
Risk of pain
Applying and removing the sensor may cause slight pain. The pain usually stops after application. If the pain remains, seek medical attention.
TLHOKOMELO
Risk of prolonged bleeding
Coagulation disorders or anticoagulant medications can lead to prolonged bleeding at the application site. Consult your healthcare professional before using the product.
Hlahloba sebaka sa kopo kamehla bakeng sa ho ruruha ha letlalo kapa ho ruruha. Haeba sebaka sa ts'ebeliso se ka ruruha kapa ho hlaha ha letlalo sebakeng sa heno (mohlalaample, allergic reaction, eczema) etsahala, tlosa sensor hang-hang 'me u buisane le setsebi sa tlhokomelo ea bophelo.
Karolo e felileview and application sites
(Refer to the illustrations at the end of this package insert.)
- Hula tab
When you flip the pull tab, you can open the device. Apply the sensor immediately after removing the twist cap from the applicator. - Sotha cap
The label on the bottom of the twist cap shows the 6-digit PIN that is required to pair your sensor with the app. - Sensor applicator
The sensor applicator contains the sensor with a needle. The sensor is sterilized by irradiation. The needle is retracted into the sensor applicator after application. Keep the used sensor applicator away from children. If the sensor applicator housing is damaged and the needle becomes accessible, discard the sensor applicator according to local regulations, so that no one is injured by it. Also discard the sensor applicator if you have dropped it or something has dropped on the sensor applicator after you pull off the twist cap. - Application sites
Select an application site on the back of your upper arm: If the application site is hairy, shave it. Wash the application site to clean the skin. Disinfect the application site with an alcohol wipe. Avoid recently used application sites, as well as scars, stretch marks, liver spots, knots, or blood vessels. Stay at least 7.5 cm (3 inches) away from insulin injection sites.
Pele o qala
If the use-by date has passed, the sensor can no longer be paired with the app. Don’t use a device that is past the use-by date as it may cause infections and abscesses. The use-by date is printed next to the E symbol on the packaging of the product. The use-by date applies for new, unopened products.
Maemo a tikoloho
The sensor is protected against the effects of temporary immersion in water at a depth of 1 meter for up to 60 minutes (IP28).
Make sure that you only store unopened products. Insert the sensor immediately after opening the packaging.
Transport and storage conditions of the sensor in its unopened packaging:
- Sebaka sa mocheso: 2 ho isa ho 27 °C
- Humidity range: 10 to 90 % (non-condensing)
- Air pressure range: 549 to 1,060 hPa
Operating conditions of the sensor:
- Sebaka sa mocheso: 10 ho isa ho 40 °C
- Humidity range: 15 to 90 % (non-condensing, water vapor partial pressure less than 50 hPa)
- Air pressure range: 700 to 1,060 hPa
- Boholo ba bophahamo: 3,000 m (9,842 ft)
- Removal and disposal of components
- Refer to the User’s Manual of the Accu-Chek SmartGuide device.
Phatlalatso ea ho lumellana
- Roche hereby declares that the radio equipment type Accu-Chek SmartGuide sensor is in compliance with Directive 2014/53/EU.
- Mongolo o felletseng oa phatlalatso ea EU ea tumellano e fumaneha atereseng e latelang ea inthanete: http://declarations.accu-chek.com
- Amerika Bohareng le Caribbean
- Call center Accu-Chek®:
- Costa Rica 800 007 6278
- Panama 800-9898
- Jamaica: 1 844 972 4706
- Trinidad & Tobago: 1 844 613 1709
- Bahamas: 1 800 300 0415
- Barbados: 1 833 857 0252 www.accu-chekcac.com
Ho sebelisa sensor
- Khoasolla sesebelisoa se lumellanang ho go.roche.com/smartguideapp. Or scan this QR code with the camera on your mobile device. Open the app and follow the instructions on the screen.
Khoasolla sesebelisoa mona. 
Hold the device upright. Notice the pull tab (A). The white sensor applicator (C) is at the top. The blue twist cap (B) is at the bottom.
- Select an application site (D) on the back of your right or left upper arm: If the application site is hairy, shave it. Wash the application site to clean the skin. Disinfect the application site with an alcohol wipe and let the skin dry completely. Avoid recently used application sites, as well as scars, stretch marks, liver spots, knots, or blood vessels. Stay at least 7.5 cm (3 inches) away from insulin injection sites.
Slightly flip the pull tab (A) open. If the pull tab has already been opened before use, discard the device and use a new one.
- Don’t press on the device. Turn the blue twist cap of the white sensor applicator to open the sterile barrier. You will feel a slight resistance and hear a cracking sound. Pull the blue twist cap from the white sensor applicator. Don’t touch the needle inside. Don’t put the blue twist cap back on after you have removed it.
HLOKOMELA
Save the 6-digit PIN on the twist cap in a secure location to prevent another person from accessing it. The PIN is required to pair your sensor with the app. You also need the PIN when pairing to a different mobile device. If you discard the blue twist cap before the sensor has expired, make sure the 6-digit PIN is unreadable. This reduces the chance of another person pairing your sensor with their mobile device. - Place the hand of the disinfected arm on your opposite shoulder. This helps to tighten the skin.
- Reach under your arm and place the white sensor applicator on the application site. Don’t touch the inner part. Hold the white sensor applicator by the external housing, as shown in the picture. Make sure the entire bottom of the applicator is flat against your skin.
- Press down firmly to apply the sensor.
- Remove the white sensor applicator in the same direction without rotating or wiggling it. Swipe over the adhesive pad firmly with your finger to make sure the adhesive pad is properly attached.
HLOKOMELA
Normally the sensor applicator can be easily removed. If you have trouble removing the sensor applicator, press it back down firmly and attempt to remove it again.
- The sensor is now ready to be paired to the app on your mobile device. Follow the instructions in the app to pair and calibrate your sensor.
- After applying a new sensor, pair it with the app within 30 minutes. After 30 minutes, the sensor will take longer to pair, in order to save battery life. The sensor should also be paired with the app within 30 minutes after the connection has been lost.
- The sensor must be active for a certain period before CGM values are displayed and calibration is possible. This is called warm-up time.
LBH
Can the sensor be reused?
No, the sensor is intended for single use only. Do not attempt to reuse it.
How do I know if the product is damaged?
Visually inspect the packaging and product for any signs of damage or manipulation. If in doubt, do not use the sensor and discard it.
What should I do if I experience prolonged pain after applying the sensor?
Seek medical attention immediately if you experience prolonged pain or any other adverse reactions after applying the sensor.
Litokomane / Lisebelisoa
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ACCU-CHEK Glucose Monitoring Device [pdf] Buka ea Taelo Glucose Monitoring Device, Monitoring Device, Device |