WS/T 658-2019Safety management of baby incubator (English PDF)

4.1 Management organization

Under the leadership of the medical institution, the medical business management department, the medical device management department, the baby incubator use department, and the logistics support the departments together form an infant incubator safety management organization.

4.2 Management responsibilities

4.2.1 The leaders of medical institutions shall perform the following duties.

a) Responsible for the leadership of clinical safety management of infant incubators;

b) The resources for ensuring the safe management of clinical use of infant incubators.

4.2.2 The medical service management department shall perform the following duties.

a) Responsible for the safety management of medical services in the clinical use of infant incubators;

b) Responsible for the coordination of the departments involved in the safety management of infant incubators.

4.2.3 The medical device management department shall perform the following duties.

a) Fully responsible for the safety management of clinical use of infant incubators;

b) Develop safety control plans and management systems for infant incubators;

c) Formulate technical operation specifications for quality control of infant incubators;

d) Responsible for the training and assessment of relevant technical specifications and management systems for the use departments and operators;

e) Responsible for organizing routine inspections and spot checks of safety and quality control, and handling issues related to safety and quality control;

f) arrange specialized medical engineering technicians to be responsible for the maintenance, repair and performance testing of the baby incubator;

g) responsible for the measurement and management of infant incubators;

h) Develop emergency plans and emergency deployment systems for infant incubators;

i) Collect safety and quality control information of infant incubators, conduct safety and quality control evaluations, Use safety management organizations and medical institution leaders to submit evaluation reports and suggest improvements.

4.2.4 The user department shall perform the following duties.

a) Organize the personnel in this department to study and implement the safety management system of the baby incubator;

b) organize operators to receive training in technical operation specifications and operate strictly in accordance with technical specifications;

c) Responsible for the daily maintenance and safety management of the baby incubator;

d) Any problems with the incubator should be reported to the medical device management department and recorded in a timely manner to ensure medical safety;

e) Set up full-time or part-time management personnel to be responsible for the daily management of the baby incubator in this department;

f) Cooperate with the supervision of the medical device management department to ensure the safe and effective use of baby incubators;

g) Carry out monitoring, evaluation and reporting of adverse and safety events in infant incubators.

4.2.5 The logistics support department shall perform the following duties.

a) the working environment required to ensure the safe use of the baby incubator;

b) equip the baby incubator with dual power or backup power;

c) Provide an uninterrupted supply of oxygen to the incubator.

4.3 Management System

4.3.1 Medical institutions should establish and improve the safety management system for clinical use of infant incubators, and publish the implementation.

4.3.2 The safety management system for the clinical use of infant incubators shall include an inspection system, a maintenance system, a maintenance management system, and an emergency response system.

Plan system, training assessment system, adverse event reporting system, safety and quality control evaluation system, and technical information and management of infant incubators Management data archives management system.

4.3.3 The inspection system should include the following.

a) inspectors;

b) inspection cycle;

c) Inspections, such as usage records, maintenance records, and equipment status;

d) inspection records;

e) Disposal of violations, including violations of maintenance, reporting and troubleshooting, emergency treatment, training Assessment, file management, etc.

4.3.4 The maintenance system shall include the following.

a) the person responsible for preventive maintenance, cycle and requirements;

b) the person in charge of routine performance testing, technical projects and cycles;

c) the person in charge of metrological management and the metrological testing/calibration cycle;

d) procedures and requirements for the treatment of hidden dangers and failures found in preventive maintenance, performance testing and metrological testing/calibration;

e) Management of preventive maintenance files, performance test files and measurement management files.

4.3.5 The maintenance management system shall include the following.

a) time limits and procedures for fault reporting;

b) Principles for medical engineering technicians to handle faulty equipment;

c) Safety and performance testing procedures and technical standards before the clinical use of the infant incubator after repair;

d) Record content and archiving requirements of maintenance information for infant incubators.

4.3.6 The emergency plan system should include the following.

a) The contact person responsible for initiating the emergency plan and its contact information maintained 24 hours a day;

b) emergency procedures;

c) Routine maintenance of emergency incubator.

4.3.7 The training assessment system should include the following.

a) content, methods, time, goals, plans of training;

b) assessment of training;

c) Pre-job training for new employees.

4.3.8 The system for reporting adverse events should include the following.

a) Adverse event reporting procedures;

b) Adverse event investigation and evaluation procedures;

c) Adverse event reports and investigation records;

d) Regular feedback on the implementation of the adverse event reporting system.

4.3.9 The safety and quality control evaluation system shall include the following.

a) the cycle of safety and quality control evaluation, the departments and personnel who organize and participate in the evaluation;

b) content of safety and quality control information, evaluation methods and evaluation reports;

c) Feedback of evaluation results and implementation and supervision procedures of rectification measures.

4.3.10 The archives management system shall include the following.

a) Management information shall include purchase application, evaluation and demonstration and approval documents, procurement documents, product qualification documents, acceptance records, training Training records, and disposal (transfer, scrap) assessment and approval reports.

b) Technical data shall include product inspection reports and certificates of conformity, instruction manuals, maintenance manuals, maintenance and repair of technical services Business records, performance testing records, clinical use safety situation assessment, evaluation analysis report, adverse event disposal report file.

c) archives shall be kept for 5 years after the equipment is terminated;

d) Archives inspection and registration system;

e) Archives destruction system when the storage period expires.

5.1 Acceptance of newly purchased infant incubators

5.1.1 The medical device management department shall work with the infant incubator user department and supplier in accordance with the order contract, configuration list and other relevant documents Acceptance.

5.1.2 The information provided by the supplier shall include product inspection reports and certificates of conformity, instruction manuals, and maintenance manuals.

5.1.3 Before the infant incubator is put into use, the using department and the medical device management department should carry out technical parameters and Use functional tests.

5.1.4 The testing items and technical requirements of technical parameters and application functions shall be in accordance with the requirements of Chapter 6.

5.1.5 The acceptance results shall be recorded and archived.

5.2 Use Management

5.2.1 The place of use shall meet the requirements of the instruction manual.

5.2.2 Users should be trained practitioners or nurses who have received training in the use of equipment, and should strictly abide by the operating regulations.

Cheng.

5.2.3 Before each use, the user should check the sensors and cables, and if they are damaged, they should be replaced in time; the self-inspection of the incubator, the clock system and the safety status are confirmed and recorded, and they can be used only when the status is qualified; and they should be cleaned, disinfected and sterilized.

5.2.4 During use, the display parameters of the incubator should be observed at least every 1 hour and recorded. If abnormality is found, stop using it immediately and Notify the medical device management department to arrange testing and maintenance at any time, and start emergency plans when necessary.

5.2.5 The incubator in the standby state should be opened continuously for at least 10 hours every month for the condition test.

5.2.6 Preventive maintenance of infant incubators shall be carried out in accordance with the requirements of the maintenance system, and shall be recorded and archived.

5.2.7 In accordance with the requirements of Chapter 6, medical engineering and technical personnel of the medical device management department Performance testing. Test at least once a year.

5.3 Maintenance

5.3.1 The medical device management department shall arrange special medical engineering technicians to be responsible for the maintenance of the baby incubator.

5.3.2 Infant incubator use department finds abnormal use of infant incubator should promptly notify medical device management department to arrange maintenance and stop Use of the baby incubator.

5.3.3 After the infant incubator is repaired, the performance test shall be performed in accordance with the requirements of Chapter 6.

5.4 Termination

Use should be terminated in any of the following situations.

a) If it exceeds the depreciation period and fails to meet the requirements for use, the measurement and quality testing are unqualified;

b) the depreciation period has not been exceeded, but serious damage cannot be repaired;

c) Depreciation period is not exceeded, but there are hidden dangers in use, which may endanger the personal safety and health of the user or baby;

d) The depreciation period is not exceeded, but the maintenance cost is too high.

6.1 General requirements

The safety test of the baby incubator should meet the requirements of GB 9706.1 and GB 11243. The test items and technical requirements of the baby incubator should be adopted.

Use the provisions of JJF 1260.

6.2 Environmental requirements

6.2.1 The temperature should be in the range of 20 °C ~ 26 °C, and the control temperature is 3 °C higher than the ambient temperature

6.2.2 Relative humidity is in the range of 30% to 85%;

6.2.3 Air pressure is in the range of 86kPa ~ 106kPa;

6.2.4 Avoid direct sunlight.

6.3 Load conditions

The test is performed under the condition that the baby incubator is empty.

6.4 Measuring standard and other equipment

Should comply with the provisions of JJF 1260.

6.5 Test items and technical requirements

6.5.1 Testing items for baby incubators

6.5.1.1 General testing items include alarm function and electrical safety inspection.

6.5.1.2 The special testing items shall meet the requirements of 6.5.2, 6.5.3.

6.5.2 Testing items and technical requirements of the incubator for air temperature control

6.5.2.1 The temperature deviation shall not exceed ± 0.8 °C.

6.5.2.2 The temperature uniformity shall not exceed ± 0.8 °C when the mattress is horizontal, and the temperature uniformity shall not exceed ± 1.0 °C when the mattress is inclined.

6.5.2.3 The temperature fluctuation shall not exceed ± 0.5 °C.

6.5.2.4 The difference between the average incubator temperature and the control temperature shall not exceed ± 1.5 ° C.

6.5.2.5 Temperature overshoot <= 2 °C.

6.5.2.6 For incubators with humidity control function, the relative humidity deviation shall not exceed ± 10%.

6.5.2.7 Under normal use, the noise in the infant cabin (A-weighted sound pressure level) shall be <=60dB.

6.5.2.8 When the alarm sounds, the noise in the infant cabin (A-weighted sound pressure level) shall be <=80dB, and the noise outside the box (A-weighted sound pressure level) shall be >= 65dB.

6.5.3 Incubator testing items and technical requirements for infant temperature control

6.5.3.1 The minimum display range of the skin temperature sensor shall include at least the range of 33 °C ~ 38 °C.

6.5.3.2 The accuracy of the skin temperature sensor shall be within ± 0.3 ° C.

6.5.3.3 The difference between the temperature measured by the skin temperature sensor and the control temperature shall not exceed ± 0.7 ° C.

6.5.3.4 For incubators with humidity control function, the relative humidity deviation shall not exceed ± 10%.

6.5.3.5 Under normal use, the noise in the infant cabin (A-weighted sound pressure level) shall be <=60dB.

6.5.3.6 When the alarm sounds, the noise in the infant cabin (A-weighted sound pressure level) shall be <=80dB, and the noise outside the box (A-weighted sound pressure level) shall be >= 65dB.

6.6 Alarm function check

6.6.1 Power interruption alarm

6.6.1.1 When the baby incubator is started, the power supply is interrupted, and the alarm shall give a corresponding audible and visual alarm.

6.6.1.2 After the power supply is interrupted and restored, the control temperature or other preset values shall not be changed.

6.6.2 Fan alarm

6.6.2.1 If the incubator is equipped with an air circulation fan, the incubator should automatically cut off the power to the heater when the fan stops or the air duct is blocked.

At the same time, the corresponding sound and light alarm is issued.

6.6.2.2 Detection of fan alarms shall be carried out in the following ways.

a) Set the incubator to work with air temperature control;

b) Set the control temperature to 34 °C;

c) After the incubator enters a stable temperature state, the air outlet and the air inlet should be blocked by artificial means (such as densely woven cloth) and cultured.

The box should be able to issue corresponding audible and visual alarms.

6.6.3 Box temperature alarm

Note. This item applies to infant incubators with air temperature control.

6.6.3.1 When the temperature of the box exceeds ± 3 °C of the control temperature, the incubator should be able to issue a corresponding audible and visual alarm.

When approaching, the incubator should automatically eliminate the sound and light alarm.

6.6.3.2 The detection box temperature alarm shall be carried out in the following ways.

a) Set the box temperature control temperature to 34 °C;

b) After the incubator enters a stable temperature state, use a heat source (hair dryer or soldering iron) to heat the temperature sensor of the incubator.

Rapid rise, when the temperature rises to 3 °C higher than the control temperature, the incubator should be able to issue an audible and visual alarm;

c) Remove the heating tool, the display value of the temperature of the box will drop. When the temperature drops close to the control temperature, the incubator should automatically eliminate sound and light.

Call the police;

d) In the stable temperature state, open the front door and side door of the infant compartment, and the displayed value of the box temperature drops rapidly. When the temperature drops below the control temperature, when the temperature is lower than 3 ° C, the incubator should be able to issue audible and visual alarms;

e) Close the front door and side door of the infant compartment, the temperature of the box rises rapidly, and the incubator should automatically disappear when the temperature rises close to the control temperature.

In addition to sound and light alarm.

6.6.4 Skin temperature alarm

Note. This item applies to the baby incubator of the baby temperature control mode.

6.6.4.1 When the connector connected to the skin temperature sensor is not electrically connected, has an open circuit connection, or has a short circuit connection, etc .;

The alarm should give an audible and visual alarm. At the same time, the heater should be automatically disconnected, or the incubator should be automatically switched to the air temperature control mode.

And the control temperature is 36 °C ± 0.5 °C or the control temperature set by the user.

6.6.4.2 Whether the skin temperature alarm meets the requirements shall be detected by simulating the specified fault state and observing the effect.

6.6.4.3 In order to detect if there is any intermediate position that prevents the alarm from alarming, the plug of the sensor recommended by the manufacturer shall be Slowly plug into the corresponding socket of the control unit to make the connection.

6.6.4.4 When the skin temperature exceeds ± 1 ° C of the control temperature, the incubator shall be able to issue a corresponding audible and visual alarm. When the temperature returns to the control temperature when approaching, the incubator should be able to automatically eliminate the sound and light alarm.

6.6.4.5 The detection of skin temperature alarm shall be performed as follows.

a) Set the incubator as the working mode for temperature control of the baby, and set the control temperature at 36 °C;

b) After the incubator enters a stable temperature state, heat the skin temperature sensor with a heat source (hair dryer or soldering iron), and the skin temperature display value will quickly change.

Rapid rise, when the temperature rises to 1 °C higher than the control temperature, the incubator should be able to issue an audible and visual alarm;

c) Remove the heating tool, the skin temperature display value will drop, and when the temperature drops close to the control temperature, the incubator should automatically eliminate sound and light Call the police;

d) In the stable temperature state, open the front door and side door of the infant compartment, the skin temperature display value drops rapidly, and when the temperature drops below the control temperature when the temperature is lower than 1 °C, the incubator should be able to give an audible and visual alarm;

e) Close the front door and side door of the infant compartment, and the skin temperature display value rises rapidly. When the temperature rises close to the control temperature, the incubator should be able to Automatic elimination of sound and light alarm.

6.7 Testing method and evaluation of baby incubator

6.7.1 Electrical safety inspection

It shall be tested with an electrical safety analyzer and shall comply with GB 9706.1.

6.7.2 Temperature and overload control

6.7.2.1 Incubator for air temperature control

6.7.2.1.1 The incubator for air temperature control shall have a thermal cut-off device. The action of the thermal cut-off device should be independent of infant training all thermostats in the box should be able to cut off the power supply to the heater when the temperature of the incubator reaches 38 ° C. The incubator should also be able to issue audible and visual alarms.

6.7.2.1.2 Detection of overload control shall be carried out as follows.

a) Set the box temperature control temperature to 35 °C;

b) After the incubator enters a stable temperature state, use a heat source (hair dryer or electric iron) to heat the inside of the incubator or the over-temperature monitoring sensor;

c) When the temperature of the incubator reaches 38 ° C, the incubator should be able to issue an audible and visual alarm.

6.7.2.1.3 For the incubator whose temperature is controlled to exceed 37 ° C and reach 39 ° C, it shall be separately equipped to operate when the incubator temperature reaches 40 ° C the second overheating cut-off device. In this case, t...