Instruction manual
A Overview Including the following aspects:
a) product characteristics;
b) the main purpose and scope of application, contraindications, precautions, and other need for warnings or tips;
c) the product name, model number, specifications;
d) the composition of the model number and its representative significance, interpretation of graphics, symbols, abbreviations and other content used in medical device labeling;
e) the use of environmental conditions;
f) the working conditions;
II Structural features and working principle
a) the overall structure and its working principle, operating characteristics;
b) the structure, role, and its working principle of the main components or functional units;
b) the main components or functional units structure, function and its working principle;
c) the electromechanical connection between the structure of each unit, the working principle of the system, the fault alarm system;
d) the functional structure of the auxiliary device and its working principle, working characteristics:
Three Technical Characteristics
a) the main properties;
b) the main parameters.
IV Dimensions, weight
a)Outline and installation dimensions
b)Weight.
V Installation, adjustment (or commissioning)
a)Equipment foundation, installation conditions and technical requirements for installation;
b)Installation procedures, methods and precautions;
c)Adjustment (or commissioning) procedures, methods and precautions;
d)Acceptance test items, methods and judgments after installation, adjustment (or commissioning);
e)Acceptance test items, methods and judgments;
e)Acceptance test items, methods and judgments after installation, adjustment (or commissioning);
e)Acceptance test items, methods and judgments after installation, adjustment (or commissioning);
e) Preparation before test operation, test operation startup, and test operation.
VI Use, operation
a) Preparation and inspection before use;
b) Safety and safety protection, safety signs and instructions before and during use;
c) Operation procedures, methods, precautions, and prone to faulty operation and precautions during startup and operation;
d) Monitoring and recording during operation;
e) Operating procedures, methods and precautions for shutdown.
VII Failure Analysis and Troubleshooting
a) Failure phenomena;
b) Cause analysis;
c) Troubleshooting methods.
Recommended form of the following table
Fault phenomenon Cause analysis Ruling out method Remarks
VIII Safety protection devices and accident handling
a) Safety protection devices and precautions;
b) Procedures and methods of handling in the event of a fault.
9 Maintenance and Repair
a) Routine maintenance, maintenance, and standards;
b) Maintenance and repair during operation;
c) Overhaul cycles;
d) Normal maintenance procedures;
e) Maintenance and repair during long-term parking.
X Transportation, storage
a) lifting, transportation precautions;
b) storage conditions, storage period and precautions.
xi . Unpacking and inspection
a) Precautions for unpacking;
b) Inspection contents;
XII . Other
a)Manufacturer's warranty, after-sales service matters, name of manufacturer, registered address, production address, contact information and after-sales service units;
Requirements:
1 Instruction manuals should be labeled with the number of the standard implemented by the product and the production license number, which can be labeled with the certification mark.
2 Instructions should be marked with the date of publication
3 medical device registration certificate number; "Medical Device Manufacturer License" number;
4 product standard number;
5 product standards should be marked in the instructions of other content.
Product name (common name)
(trade name)
Model, specification
Production license number
Certificate of registration number
Product standard number
Product performance
Main structure
Scope of application
Contraindications
Precautions, warnings, and other information should be indicated in the manual. p>Cautions, warnings and suggestive contents
Explanation of graphics, symbols, abbreviations and other contents used in labeling
Installation instructions or diagrams
Instructions or diagrams for use
Methods of product maintenance
Special storage conditions and methods
Expiry date
Other contents stipulated in the standard of the product that should be Other contents specified in the product standard should be indicated in the instructions
Name of manufacturer
Commissioned manufacturer
Registered address
Production address
Commissioned manufacturer
Contact information
After-sales service unit
Sealed with the seal of the enterprise and the signature of the legal representative