I. What is a medical device instruction manual?
Medical Device Manual refers to produced by medical device registrars or recorders，Provides users with the product，Covering the basic information of the product's safe and effective information，Used to guide the correct installation、debug、Operation、Use、Maintenance、Maintenance technical file。

2. What is the requirements of medical device manuals and labels?
Medical Device Manuals and labels shall comply with the relevant requirements of the "Medical Device Manual and Label Management Regulations" (the General Administration of Food and Drug Administration)。 

Three, the main content of the medical equipment instructions
According to the "Regulations on the Manual and Label Management of Medical Devices" (Order No. 6 of the General Administration of Food and Drug Administration)，Medical Device Manuals should generally include the following:
(1) Product name, model, specifications;
(2) The name of the registner or the recorder、Residence、Contact information and after -sales service units，stake sports betting appImported medical devices should also indicate the name of the agent、Residence and contact information;
(3) The name of the manufacturer、Residence、Production address、Contact information and production license number or production filing voucher number，The name of the entrusted production should also My stake betting appbe marked with the name of the trustee company、Residence、Production address、Production license number or production filing voucher number;
(4) Registration certificate number or filing voucher number of medical device;
(5) The number of product technical requirements;
(6) Product performance、Main structure composition or ingredients、Scope of application;
(7) Contraindications、Note、Warning and prompt content;
(8) Installation and use instructions or illustrations，Medical devices that consumers use their own self -use should also have a special explanation of safe use;
(9) Product maintenance and maintenance method，Special storage、Transportation conditions、Method;
(10) Production date，Usage or failure date;
(11) Accessories list，Including accessories、Affairs、Losses replacement cycle and explanation of replacement methods, etc.;
(12) The graphics used in the label of medical device、Symbol、Abbreviation and other content interpretations;
(13) The preparation or revision date of the manual;
(14) Other content that should be marked.
For the reused medical equipment，According to the "Regulations on the Manual and Label Management of Medical Device" (Article 6 of the General Administration of Food and Drug Administration)，It should be clearly reused processing process in the manual，Including cleaning、Disinfection、Packaging and sterilization methods and the number of reuse or other restrictions。 

4、Precautions in the medical device manual、Warning and prompt content
According to the "Regulations on the Manual and Label Management of Medical Device"，Precautions in the medical device manual、Warning and prompt content mainly includes:
(1) Objects used by the product;
(2) Potential safety hazards and use restrictions;
(3) When an accident occurs during the correct use of the product，For the operator、Users' protection measures and emergency and corrective measures that should be taken;
(4) The necessary monitoring, evaluation, and control methods;
(5) Disposal use of the product should indicate the word "one -time" or symbol，The sterilization product should indicate the sterilization method and the treatment method after the damage of the sterilization packaging，The method of disinfection or sterilization before using the need to disinfect or sterilize before use;
(6) The product needs to be installed or used in combination with other medical equipment，It should be indicated that the requirements of the joint use of the equipment、How to use、Note;
(7) During the use process，The mutual interference and the hazards that may occur with other products;
(8) The components or auxiliary materials that may cause side effects in the use of adverse events or product composition in the product;
(9) Matters that should be paid attention to should be paid when medical device is abandoned，The product needs to be treated after use，The corresponding processing method should be indicated;
(10) According to product characteristics，It should be prompted by the operator、Other matters that users pay attention to。 

5. The content of the medical device label includes
According to the "Regulations on the Manual and Label Management of Medical Devices"，Medical equipment labels should generally include the following:
(1) Product name, model, specifications;
(2) The name of the registner or the recorder、Residence、Contact information，stake sports betting appImported medical devices should also indicate the name of the agent、Residence and contact information;
(3) Registration certificate number or filing voucher number of the medical device;
(4) The name of the manufacturer、Residence、Production address、Contact information and production license number or production filing voucher number，The name of the entrusted production should also My stake betting appbe marked with the name of the trustee company、Residence、Production address、Production license number or production filing voucher number;
(5) Production date，Usage or failure date;
(6) Power connection conditions, input power;
(7) The graphic that should be marked according to the product characteristics、symbols and other related content;
(8) The necessary warnings and precautions;
(9) Special storage, operating conditions or explanations;
(10) Medical equipment that destroys or negatively affects the environment during use，Its labels shall include a warning signs or Chinese warning instructions;
(11) Medical equipment with radiation or radiation，Its labels should include a warning signs or Chinese warning description。
The label of the medical device cannot indicate all the above content due to the location or size of the medical equipment，At least the product name should be marked、Model、Specification、Production date and use period or failure date，and in the label clearly "see the details of the instructions for details"。

6. What content is prohibited in the manual and labels
According to the "Regulations on the Manual and Label Management of Medical Device" (Order No. 6 of the General Administration of Food and Drug Administration)，Medical Device Manual and Tags must not have the following content:
(1) Contains "the best effect"、"Guarantee Treatment"、"Package"、"Ren"、"Over -the -time results"、"Complete non -toxic side effects" and other expressed effort to assert or guarantee;
(2) Contains "the highest technology"、"Most Scientific"、"Most advanced"、"Best" and other absolute languages ​​and representations;
(3) Explain the healing rate or efficiency;
(4) Compared with the efficacy and safety of other enterprise products;
(5) Contains "insurance company insurance"、"Effective refund" and other promised language;
(6) Use the name of any unit or individual、Image proof or recommendation;
(7) Contains misleading instructions，Makes people feel that it has a certain disease，or make people misunderstand that the medical device will suffer stake sports betting appfrom a certain disease or aggravate the illness，and other false、Exaggerated、misleading content;
(8) Other content prohibited by laws and regulations.