ACCU-CHEK سمارٽ گائيڊ ڊيوائس

پيداوار جي ڄاڻ
وضاحتون
- پراڊڪٽ جو نالو: Accu-Chek SmartGuide ڊوائيس
- Intended Use: Continuous glucose monitoring device for real-time glucose level measurement
- Contents: 1 device (sensor applicator with 1 sensor inside), 1 package insert
- Additional Materials Required: Compatible mobile app, compatible mobile device, alternate method for glucose testing
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- هدايتون. 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.
ارادو استعمال
The continuous glucose monitoring device (CGM device) is intended for continuous measurement of real-time glucose levels in the subcutaneous interstitial fluid.
مطلوب استعمال ڪندڙ
- Adults, 18 years of age and older
- People with diabetes mellitus
- Caregivers of people with diabetes mellitus
اشارو
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 exampلي، فوجي علائقا، ڳرا صنعتي علائقا، ۽ طبي علاج جا علائقا جن ۾ اعليٰ طاقت وارا طبي برقي سامان (مقناطيسي گونج اميجنگ (ايم آر آءِ)، ڪمپيوٽيڊ ٽوموگرافي (سي ٽي)، ايڪس ري، ريڊيوٿراپي، يا ڊائيٿرميا) شامل آهن.
پيڪ جو مواد
- 1 device (sensor applicator with 1 sensor inside),
- 1 پيڪيج داخل ڪريو
اضافي مواد گهربل
- 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
عام حفاظت جي ڄاڻ
- پيداوار جو مقصد صرف هڪ واحد استعمال لاء آهي.
- 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.
خبردار
- 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. - دم ٿيڻ جو خطرو
ھن پراڊڪٽ ۾ ننڍا حصا آھن جيڪي نگل سگھجن ٿا. ننڍڙا حصا ننڍڙن ٻارن ۽ ماڻهن کان پري رکو جيڪي ننڍا حصا نگلجن. - 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.
احتياط
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.
- چمڙي جي جلن يا سوزش لاءِ درخواست واري جاءِ جو باقاعدي معائنو ڪريو. جيڪڏهن درخواست واري جاءِ تي سوزش ٿئي ٿي يا چمڙي جي رد عمل مقامي ٿي وڃي ٿي (مثال طورamp(جيڪڏهن الرجي، الرجي، ايگزيما) ٿئي ٿي، ته فوري طور تي سينسر کي هٽايو ۽ پنهنجي صحت جي سار سنڀار ڪندڙ سان صلاح ڪريو.
جزو ختمview and application sites
(Refer to the illustrations at the end of this package insert.)
ڇڪيو ٽيب
When you flip the pull tab, you can open the device. Apply the sensor immediately after removing the twist cap from the applicator.
ٽوڙيندڙ ٽوپي
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.
ان کان اڳ جو توهان شروع ڪريو
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.
ماحولياتي حالتون
- 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.
خاصيتون
Transport and storage conditions of the sensor in its unopened packaging:
- درجه حرارت جي حد: 2 کان 27 ° سي
- Humidity range: 10 to 90 % (non-condensing)
- Air pressure range: 549 to 1,060 hPa
Operating conditions of the sensor:
- درجه حرارت جي حد: 10 کان 40 ° سي
- Humidity range: 15 to 90 % (non-condensing, water vapor partial pressure less than 50 hPa)
- Air pressure range: 700 to 1,060 hPa
- وڌ ۾ وڌ اوچائي: 3,000 م (9,842 فوٽ)
Removal and disposal of components
Refer to the User’s Manual of the Accu-Chek SmartGuide device.
مطابقت جو اعلان
Roche hereby declares that the radio equipment type Accu-Chek SmartGuide sensor is in compliance with Directive 2014/53/EU.
EU جي مطابقت جي اعلان جو پورو متن هيٺ ڏنل انٽرنيٽ ايڊريس تي موجود آهي: http://declarations.accu-chek.com
- وچ آمريڪا ۽ ڪيريبين
- Local contact information at: www.accu-chekcac.com
سينسر کي لاڳو ڪرڻ
- تي هڪ مطابقت رکندڙ ايپ ڊائون لوڊ ڪريو 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
- ايپ ڊائون لوڊ ڪريو هتي

- 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.
نوٽ
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.
نوٽ
- 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
نوٽ
- 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.
ACCU-CHEK and ACCU-CHEK SMARTGUIDE are trademarks of Roche.
- © 2025 روچ ذیابيطس جي سنڀال
- ايم روچ ذیابيطس جي سنڀال GmbH
- Sandhofer Strasse 116
- 68305 Mannheim، جرمني
- www.accu-chek.com
- آخري تازه ڪاري: 2025-04
- 1000087598(01)
اڪثر پڇيا ويا سوال
مون کي ڪيترا ڀيرا سينسر کي تبديل ڪرڻ گهرجي؟
The sensor should be replaced according to the guidelines provided in the User's Manual and based on the use-by date printed on the packaging.
ڇا مان ڊوائيس آن رکڻ سان ترڻ يا شاور ڪري سگهان ٿو؟
Refer to the User's Manual for specific instructions regarding water exposure with the device. Some devices are waterproof, while others may need to be removed before swimming or showering.
جيڪڏهن مون کي ڊوائيس ۾ ڪا غلطي نظر اچي ته مون کي ڇا ڪرڻ گهرجي؟
If you experience any errors or issues with the device, refer to the troubleshooting section in the User's Manual or contact customer support for assistance.
دستاويز / وسيلا
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ACCU-CHEK سمارٽ گائيڊ ڊيوائس [pdf] هدايت نامو سمارٽ گائيڊ ڊيوائس، گائيڊ ڊيوائس، ڊيوائس |
