Gauze Roll
product detail
product detail
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Device |
Non-Sterile gauze roll with X-Ray |
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Advice |
This device is supplied as non-sterile condition, in any condition that intended to be used in a sterile state, the end user should sterile the product before using!!! Always disposal this device after use, this is a disposable device. |
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Reprocessing Instructions |
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Preparation at the Point of Use: |
Check all packages if it integrity before sterilize. Always record the date and quantity of sterilization for remind. Always marke labels to distinguish between non-sterilized and sterilized |
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Packaging |
This device is provided in an appropriate packaging material (paper-plastic bag) for sterilization already. The packaging material and system are comply to ISO 11607 series. Repackaging is no need. Note: Always count the number of gauze pieces. |
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Cleaning and disinfection |
not applicable |
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Sterilization |
Sterilization of products by applying a EO sterilization process (according to EN ISO 11135: 2014) under consideration of the respective country requirements. Ethylene oxide sterilizers should comply to EN 1422. Following sterilization parameters are commonly used: Ethylene Oxide Sterilization: 80% Ethylene Oxide (EO),20% Carbon dioxide（CO2 ）with a concentration of 540~550 mg/L @ 55°C and 40% relative humidity for 480 minutes, 7days aeration time at 13.5 ºC. detail refer table below
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After sterilization |
Remove the product from the chamber. Let the product cool down at room temperature for at least 30 minutes. Inspect the sterilization package are not damaged. |
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Storage |
Storage of sterilized device in a dry, clean and dust free environment at room temperatures, use the device before expaire date. |
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Transport |
Use clean container for transfer device and be careful do not damage the package. |
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Additional Instructions |
None |
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It is the duty of the user to ensure that the reprocessing processes including resources, materials and personnel are capable to reach the required results. State of the art and often national law requiring these processes and included resources to be validated and maintained properly. |
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Warning
1）DO NOT use device that has not been properly cleaned and disinfected between uses. Failure to do so can result in the transmission of infectious agents and compromise patient safety.
2）DO NOT use a device if it is visibly damaged or has any foreign matter, breaks, moldy, or holes. Using this device may can cause cross-contamination and potentially lead to patient harm.
3）This product has a shelf life of 5 years. DO NOT use a device that is past its expiration date.
Caution
1）Always follow instructions for use.
2）Keep away from sunlight, Keep dry
3）Always count the number of gauze pieces.
4）Always record the date and quantity of device sterilized for remind.
5）Always make labels to distinguish between non-sterilized and sterilized
6）This is a disposable short-term use device which continuous use less than 24 hours.
7）Please inform the manufacturer and competent authority in case of any adverse events related to the device occur.
Storage conditions
Products should be stored in a sealed, moisture-proof, ventilated and dry place.
Shelf-life
The product shelf life is 5 years.
Disposal
Abdominal pads cannot be reused, and should be disposed of according to local waste disposal requirements after use
product detail
| Signs | Description | Signs | Description | Signs | Description |
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Trademark of Manufacturer | 
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Batch number | 
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Date of Manufacture |
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Medical device | 
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Model number | 
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Country of manufacturer |
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Use-by date | 
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Consult instructions for use | 
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Caution |
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Non-pyrogenic | 
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Catalogue number | 
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Unique Device Identifier |
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CE marking of conformity, and Notified Body Code | 
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Indicates a medical device that has not been subjected to a sterilization process | 
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Keep away from sunlight |
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Do not reuse | 
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Do not use if the package is damaged | 
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Keep dry |
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Indicates the entity importing the medical device into the locale | 
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Authorized representative in the European Community | 
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Manufacturer |
Manufacturer
Name: Haian Medigauze Co., Ltd.
Address: Jiaoxie Industry park,226633Haian, Jiangsu, PEOPLE'S REPUBLIC OF CHINA
Tel: +86-513-88240958
E-mail: medigauze@medigauze.com
SRN: CN-MF-000009960
European Authorized Representative
Name: Shanghai International Holding Corp. GmbH (Europe)
Add: Eiffestrasse 80, 20537 Hamburg, Germany
E-mail: shholding@hotmail.com
SRN: DE-AR-000000001
Incident reporting
The user and/or patient shall report any serious incident that has occurred in relation to the device to Haian Medigauze Co., Ltd. and the competent authority of the EU Member State in which the user and/or patient is established.