Notes for Use of Blood Coagulation Analyzer-江苏鸿恩医疗器械有限公司

1. Labels  

• This product is an in-vitro diagnosis medical device for clinical assays.The clinical diagnosis based on this assay should be performed by the doctor and be confirmed based on the clinical symptoms and other assay results;

• This product is only for in-vitro diagnosis;

• The operators should have the basic knowledge of performing clinical coagulation assay. Other users should be trained by the staff of our company or the representatives;

• This device meets the requirements of GB/T18268.1-2010 and GB/T18268.26-2010 regulation for radiation emission and noise immunity. It is designed and tested according to the regulation of GB4824 category ‘A’ device. In the environment of home-use, this device may cause radiation interference. Protection is required;
  

• If unusual smell and smoke occurs, turn the power off immediately and unplug the power cable. Please file a report immediately to our after-sale service department, our agents, or representatives for maintenance application. Using this device in abnormal situation may cause fire, electric shock, and serious injury;

• Do NOT spill blood and reagent, or drop metal pieces into the device. Otherwise, short circuit, smoke, or fire may occur;

• In case of any unusual situation, turn the power off and unplug the power cable immediately. Please file a report to our after-sale service department, agents, or representatives for maintenance application;

• Do NOT touch electronic components inside the device. Contact with wet hands may cause electric shock;

• In order to prevent infection, electric shock, and burn, maintenance staff needs to wear rubber gloves, use specified tools/components, and wash hands with disinfectant;

• In order to prevent infection, please handle samples carefully and wear rubber gloves. In case of contact with eyes and wounds, rinse immediately with plenty of water and seek medical advice;

• Do NOT disassemble the device without permission;

• If faults occur and maintenance is needed, only use components provided by the manufacturer;

• If replacing fuses is needed, please turn off the system first, unplug the power cable, and then only use fuses with specification on the label, which is 5*20mm, glass fuse, F2.5AL 250V AC;

• The protective insulation uses specified ground wire colored with yellow-green.

3. Safety Notice for Power Supply and Grounding

• Only use 220V power supply; otherwise, fire or electric shock may occur;
  

• This device needs to be installed where the power switch is in reach of the operator. Only use the three-core cable given in the package, and check the effectiveness of grounding. Otherwise, fire or electric shock may occur;

• In order to prevent short circuit or open circuit, DO NOT damage the insulation sheath of the cable. DO NOT pull the cable or put heavy objects on it. Otherwise, electric shock and fire may occur.

• If connection of peripheral equipment is needed, please turn off the device first. Otherwise, electric shock and faults may occur.

•  When the device is working, please keep the power on. Otherwise, it may damage the memory. Uninterruptible Power Supply is recommended.

4. Working Conditions

•  Environment Temperature   18℃～30℃

• Relative Humidity               ≤85%

• Atmospheric Pressure          86KPA～106KPA

•  Power                     Voltage 220V±22V（AC）  Frequency 50HZ±1HZ

• Preheating Time           30 minutes