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Safety management for high frequency surgical unit
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Basic data
| Standard ID | WS/T 602-2018 (WS/T602-2018) |
| Description (Translated English) | Safety management for high frequency surgical unit |
| Sector / Industry | Health Industry Standard (Recommended) |
| Classification of Chinese Standard | C05 |
| Word Count Estimation | 16,18 |
| Date of Issue | 2018-08-17 |
| Date of Implementation | 2019-08-01 |
| Regulation (derived from) | National Health Newsletter (2018) No.15 |
| Issuing agency(ies) | National Health Commission |
WS/T 602-2018: Safety management for high frequency surgical unit
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Safety management for high frequency surgical unit
ICS 11.020
C 05
WS
People's Republic of China Health Industry Standard
High-frequency electric knife safety management
Published on.2018 - 08 - 17
2019 - 08 - 01 implementation
National Health and Wellness Committee of the People's Republic of China
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard was drafted. Peking University Third Hospital, China Medical Equipment Association, China Institute of Metrology, Beijing Medical Devices
Inspection Institute, General Logistics Department, Ministry of Health, Institute of Pharmaceutical Instruments.
Drafters of this standard. Xu Feng, Tian Jin, Xu Heng, Liu Wenli, Shao Haiming, Sun Jingsheng, Meng Jianguo, Jia Jiange, Li Ming, Wang Dong, Li
Yi Lin, Liu Xiaohua.
High-frequency electric knife safety management
1 Scope
This standard specifies the safety management requirements and safety technical requirements for high-frequency electrosurgical instruments used in medical institutions before and during clinical use.
And safety detection cycle.
This standard applies to the safety management of high frequency electric knives for clinical use in medical institutions.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this document.
For undated references, the latest edition (including all amendments) applies to this document.
GB 9706.1 Medical electrical equipment - Part 1. General requirements for safety
GB 9706.4 Medical electrical equipment - Part 2-2. Particular requirements for safety of high-frequency surgical equipment
JJF 1217 high frequency electric knife calibration specification
3 Terms and definitions
The following terms and definitions as defined in GB 9706.1 and GB 9706.4 apply to this document.
3.1
High frequency leakage current
The non-functional current of the output electrode of the high-frequency electric knife to the ground.
3.2
Protective earth impedance
A device with a power input jack between the protective earth connection point in the socket and all accessible metal parts of the protected ground
Impedance; or equipment with a non-removable power cord, protective grounding pin in the network power plug and all accessible metal with protective grounding
The impedance between the parts.
4 Management requirements
4.1 Management Organization
4.1.1 There should be the head of the medical institution, the medical business management department, the medical device management department, the high-frequency electric knife use department, and the logistics guarantee.
A medical device safety management organization composed of a barrier department.
4.1.2 Safety management of high frequency electric knives should be included in the medical device safety management system.
4.2 Management responsibilities
4.2.1 The person in charge of the medical institution shall perform the following duties.
a) has leadership responsibility for the safety management of high-frequency electric knives;
b) Determine the level of safety responsibility, organize the implementation of the management system and safe operating procedures;
c) Guarantee the right amount of medical engineering and technical staff.
4.2.2 The medical business management department shall perform the following duties.
a) Organize the implementation of safety management plans and regulations for high-frequency electrosurgical knives;
b) Coordinate the safety management of high-frequency electric knives.
4.2.3 The medical device management department (including biomedical engineering, equipment, equipment, equipment, etc.) shall perform the following duties.
a) Fully responsible for the safety technical work of high frequency electric knives;
b) Formulate safety management systems and plans for high-frequency electric knives;
c) develop operational specifications for the safety of high-frequency electric knives;
d) Train the use department and operators on the contents of items b) and c), and operate the high-frequency electric knife after passing the examination;
e) organize regular safety inspections and spot checks to address safety related issues;
f) Responsible for the maintenance and regular inspection of high frequency electric knives;
g) develop an emergency plan;
h) Collect high-frequency electric knife safety management information, conduct annual safety evaluation, and submit to the hospital safety management organization and the head of the medical institution
Evaluation report and suggestions for improvement.
4.2.4 The use department shall perform the following duties.
a) Study and implement the safety management system for high-frequency electric knives;
b) Organize the operator to receive the training of the operation specification and operate after passing the examination to ensure that the operator meets the requirements of the operation specification.
begging;
c) responsible for the daily maintenance of high frequency electric knives;
d) It is found that the high-frequency electric knife is reported in time and the emergency plan is implemented when necessary to ensure medical safety;
e) Establish registration records and maintenance records for the daily use of high-frequency electric knives;
f) Collaborate with the medical device management department to ensure the high-frequency electric knife's integrity.
4.2.5 The logistics management department shall perform the following duties.
a) provide electricity;
b) Guarantee the qualified environmental conditions required for high frequency electric knives.
4.3 Management System
4.3.1 The hospital shall, in conjunction with the characteristics of the unit's high-frequency electrosurgical unit, establish and improve the safety management system for high-frequency electric knives and publish them.
4.3.2 The safety management system for high-frequency electric knives should include inspection inspection system, maintenance and maintenance system, emergency response system, and training assessment.
System, new high-frequency electric knife pre-use acceptance system, adverse event reporting system and archival data management system.
4.3.3 The inspection system should include the following.
a) inspection personnel;
b) inspection inspection cycle;
c) inspection inspection contents, such as usage records, maintenance records and equipment status;
d) inspection inspection records;
e) Disposal of violations.
4.3.4 The repair and maintenance system shall include the following.
a) maintenance person in charge;
b) maintenance intervals and requirements;
c) hidden dangers and fault handling procedures and requirements;
d) Maintain the management of the files.
e) Before the repaired high-frequency electric knife is put into use, the medical device management department shall perform performance test before passing the test.
Into use. See Appendix B for test records.
4.3.5 The emergency plan system should include the following.
a) the person responsible for the emergency plan;
b) emergency procedures;
c) Routine maintenance of emergency high frequency electric knives.
4.3.6 The training assessment system should include the following.
a) the content, method, time, objectives and plans of the training;
b) assessment of training;
c) Pre-employment training for newly hired employees.
4.3.7 The pre-use acceptance system for newly purchased high-frequency electric knives shall meet the following requirements.
a) Acceptance is carried out by engineering and technical personnel of the medical device management department;
b) Acceptance should check and ensure that the following information is complete.
-- Factory inspection report or certificate of high frequency electric knife;
--The instruction manual and maintenance manual of the high frequency electric knife;
-- Acceptance test record for high frequency electric knife, see Appendix B.
4.3.8 The adverse event reporting system should include the following.
a) Designated departments and equipped with special (part-time) personnel to undertake the management of high-frequency electrosurgical adverse events of the organization;
b) Adverse events should be documented. The content of the record shall include the date, time and place of occurrence, the serial number of the high-frequency electric knife, the name of the injured patient,
Medical record number and department, damage location, degree and disposal, analysis of damage causes, use of electric knife;
c) The medical institution shall report to the higher management department the high frequency electric knife failure that has occurred or may cause serious injury or death.
event.
4.4 File Management
4.4.1 The file shall be kept by a special person in the medical device management department or be kept in a unified manner by the file management department of the institution.
4.4.2 The archives should be detailed and comprehensively reflect the safety management of high-frequency electric knives; the necessary charts are attached and updated in accordance with the changes.
4.4.3 The requirements for the establishment, use and renewal of various files for the safety management of high-frequency electric knives should be clarified.
4.4.4 The files should be stored neatly, easy to find, check, and a list of materials should be established.
4.4.5 The administrative file should include the following.
a) Maintenance and maintenance records of high frequency electric knives;
b) personnel training and assessment materials;
c) records of accidents and emergency response;
d) Safety evaluation.
4.4.6 The technical file should include the following.
a) High frequency electrosurgical manual;
b) high frequency electric knife repair manual;
c) factory inspection report or certificate;
d) Corresponding records for safety inspection, use handover, inspection, maintenance, etc.
4.4.7 All archival materials should be kept for 5 years after the termination of the use of the high-frequency electrosurgical unit.
5 high frequency electric knife safety technical requirements
5.1 Appearance and functional requirements
5.1.1 The identification of the high frequency electric knife shall include the manufacturer, model, date and number of the factory, rated supply voltage or voltage range, power frequency,
The type of security, the type of application part, etc. should be clear and complete.
5.1.2 The control buttons on the high-frequency knife panel function normally.
5.1.3 The complete accessories are complete.
5.2 Test conditions
5.2.1 Ambient temperature should meet the requirements of JJF 1217
5.2.2 Relative humidity should meet the requirements of JJF 1217.
5.2.3 The voltage and frequency of the power supply shall comply with the requirements of GB 9706.1.
5.2.4 There should be no mechanical vibration and electromagnetic interference around the inspection work. The protection grounding should meet the requirements of GB 9706.4.
5.2.5 The testing personnel should pass the training of high-frequency electric knife and safety management and pass the test.
5.2.6 The testing equipment shall be a high-frequency electric knife tester with metered traceability and a resistance-capacity network integration that meets the requirements of GB 9706.1.
General Electric Safety Tester.
5.3 Testing items
5.3.1 Electrical safety requirements
5.3.1.1 Protective earthing impedance shall meet the following requirements.
a) Equipment with a power input jack, the protective earth connection point in the socket and all accessible metal parts of the protected ground
The impedance between them should not exceed 0.1 Ω;
b) Equipment with non-removable power cord, protective grounding pin in the network power plug and all accessible metal with protective earthing
The impedance between the parts should not exceed 0.2 Ω.
5.3.1.2 The allowable value of earth leakage current shall comply with the requirements of Appendix A.
5.3.1.3 The allowable leakage current of the casing shall comply with the requirements of Appendix A.
5.3.1.4 The allowable leakage current of patients should meet the requirements of Appendix A.
5.3.1.5 The patient auxiliary current tolerance value shall comply with the requirements of Appendix A.
5.3.2 Special requirements for safety
5.3.2.1 High frequency leakage current should meet the following requirements.
a) When the neutral electrode is isolated from the ground at high frequency, the high-frequency leakage current flowing from the neutral electrode through the.200 Ω non-inductive resistor to the ground is not greater than
150mA; when the neutral electrode is grounded, the high-frequency leakage current flowing from the neutral electrode through the.200 Ω non-inductive resistor to the ground is not more than 150 mA;
b) When the neutral electrode is isolated from the ground at high frequency, the high-frequency leakage current flowing from the monopolar electrode through the.200 Ω non-inductive resistor to the ground is not greater than
150mA;
c) The high-frequency leakage current of the bipolar electrode is not greater than (
Ω200
01.0 0
×1000) mA (from each electrode through.200Ω non-inductive
The high-frequency leakage current flowing to the ground is prevented, and the power generated at the impedance is not more than 1% of the maximum bipolar rated output power 0P).
5.3.2.2 The relative error between the output power and the set value under rated load shall be ≤±20%.
5.3.3 Other safety requirements
5.3.3.1 Clinical users should perform the following checks before each use of high-frequency electric knives.
a) Check attachments (surgical electrodes, neutral electrodes, etc.) and their leads to ensure that the attachment is intact and intact. Use in accordance with national standard specifications
The power cord of the power supply ensures that the power plug is grounded and the grounding terminal of the high-frequency electric knife is grounded through the ground wire;
b) Check and ensure that the neutral electrode alarm function of the high frequency electric knife is normal;
c) Make sure that the high frequency electric knife is placed on the operation surface, and it is forbidden to stack other equipment on top of the high frequency electric knife;
d) prohibit contact with flammable anesthetics or other flammable and explosive gases or liquids in the operating room;
e) When using multiple accessories at the same time, ensure that the wires of the accessories are separated from each other to prevent twisting and bundling of the wires.
The wires are not allowed to be wrapped around metal objects.
5.3.3.2 For patients with cardiac pacemakers or other active implants, the use of high-frequency electrosurgical instruments may be dangerous and should be evaluated
It is estimated that relevant physicians should be present when necessary.
5.4 Testing methods and requirements
5.4.1 Protective grounding impedance detection
The high-frequency electric knife protection grounding impedance detection connection is shown in Figure 1. High-frequency electric knife is measured by the General Electric Safety Tester in the off state
The impedance between the protective grounding pin in the power plug and the accessible metal part of the protected ground. Among them, MD represents the general electrical safety tester.
Power supply application section
MD
Figure 1 Protective Ground Impedance Detection Diagram
5.4.2 Ground leakage current detection
The connection of the high-frequency electric knife to the ground leakage current is shown in Figure 2. In the standby state, in the normal state and the single fault state, respectively
The detector measures the current flowing into the protective earthing conductor of the high frequency electric knife.
-- The normal state includes the following.
The power supply zero line is connected normally;
Power supply zero-fire line inverting connection.
-- A single fault condition includes the following.
The power supply zero line is connected normally, and a power supply wire is disconnected;
The power supply is connected in reverse phase and the power cable is disconnected.
L(N)
N(L)
Power supply application section
MD
PE
Figure 2 Ground leakage current detection diagram
5.4.3 Shell leakage current detection
The leakage current detection connection of the high-frequency electrosurgical case is shown in Figure 3. In the standby state, in the normal state and the single fault state, respectively
The detector measures the unprotected ground of the high-frequency knife housing to reach a portion of the current flowing into the earth.
-- The normal state includes the following.
The power supply zero line is connected normally;
Power supply zero-fire line inverting connection.
-- A single fault condition includes the following.
The power supply zero line is connected normally, and a power supply wire is disconnected;
The power supply zero-wire is connected normally, and the protective grounding conductor is disconnected;
The power supply zero-fire line is connected in reverse, disconnecting a power supply lead;
Connect the power zero line to the reverse phase and disconnect the protective earth conductor.
L(N)
N(L)
Power supply application section
MD
PE
Unprotected grounding part of the housing
Figure 3 shell leakage current detection diagram
5.4.4 Patient leakage current detection
The leakage current detection connection of the high-frequency electrosurgical patient is shown in Figure 4. In standby mode, in normal state and single fault state, all
The application is short-circuited, and the current flowing into the earth by the application part is measured by the detector.
The high frequency electrosurgical application part includes a surgical electrode and a neutral electrode.
-- The normal state includes the following.
The power supply zero line is connected normally;
Power supply zero-fire line inverting connection.
-- A single fault condition includes the following.
The power supply zero line is connected normally, and a power supply wire is disconnected;
The power supply zero-wire is connected normally, and the protective grounding conductor is disconnected;
The power supply zero-fire line is connected in reverse, disconnecting a power supply lead;
Connect the power zero line to the reverse phase and disconnect the protective earth conductor.
L(N)
N(L)
Power supply application section
MD
PE
Note. For the detection of BF type high frequency electrosurgical bipolar electrodes, the bipolar should be shorted together.
Figure 4 Patient leakage current detection chart
5.4.5 Patient assisted current detection
The auxiliary current detection connection of the high-frequency electrosurgical patient is shown in Fig. 5. In the normal state and the single fault state, respectively, through the detector
Measure the current between any one of the application sections and all other application sections that are shorted.
The high frequency electrosurgical application part includes a surgical electrode and a neutral electrode.
-- The normal state includes the following.
The power supply zero line is connected normally;
Power supply zero-fire line inverting connection.
-- A single fault condition includes the following.
The power supply zero line is connected normally, and a power supply wire is disconnected;
The power supply zero-wire is connected normally, and the protective grounding conductor is disconnected;
The power supply zero-fire line is connected in reverse, disconnecting a power supply lead;
Connect the power zero line to the reverse phase and disconnect the protective earth conductor.
L(N)
N(L)
Power supply application section
MD
PE
Figure 5 Patient assisted current detection chart
5.4.6 High frequency leakage current detection
5.4.6.1 Neutral electrode (when the neutral electrode is grounded) high frequency leakage current
The high-frequency electric knife is connected with the high-frequency electric knife detector as shown in Figure 6. The high-frequency electric knife output is set to the maximum, and is measured by the high-frequency electric knife tester.
The neutral electrode flows through the high-frequency leakage current of the.200Ω non-inductive resistor to the ground, and the detection condition remains unchanged. The measurement is repeated 3 times, and the maximum value is taken as the middle.
High-frequency leakage current I1 of the electrode.
200Ω
200Ω
High frequency electric knife high frequency electric knife tester
Surgical electrode
Neutral electrode
Figure 6 High-frequency leakage current detection diagram of the neutral electrode based on ground
5.4.6.2 Neutral electrode (when the neutral electrode is isolated from the ground) high frequency leakage current
The high-frequency electric knife is connected with the high-frequency electric knife detector as shown in Figure 7. The high-frequency electric knife output is set to the maximum, and is measured by the high-frequency electric knife detector.
The neutral electrode flows through the high-frequency leakage current of the.200Ω non-inductive resistor to the ground, and the detection condition remains unchanged. The measurement is repeated 3 times, and the maximum value is taken as the middle.
High-frequency leakage current I2 of the electrode.
200Ω
High frequency electric knife high frequency electric knife tester
Surgical electrode
Neutral electrode
Figure 7 High-frequency leakage current detection diagram of neutral electrode and ground isolation
5.4.6.3 High-frequency leakage current of monopolar electrode
The connection between the high-frequency electrosurgical knife and the detector is shown in Figure 8. The output of the high-frequency electrosurgical knife is set to the maximum, and the monopolar electrode is measured by the high-frequency electrosurgical detector.
The high-frequency leakage current flowing through the.200Ω non-inductive resistor to the ground, keeping the detection conditions unchanged, repeating the measurement 3 times, taking the maximum value of the monopolar electrode
High frequency leakage current I3.
200Ω
High frequency electric knife high frequency electric knife tester
Monopolar electrode
Neutral electrode
Figure 8 High-frequency leakage current detection diagram of monopolar electrode
5.4.6.4 Bipolar electrode high frequency leakage current
The high-frequency electric knife is connected with the detector as shown in Figure 9. The output of the high-frequency electric knife is set to the maximum, and the bipolar is measured by the high-frequency electric knife detector.
The two output electrodes of the electrode flow through the high-frequency leakage current of the.200Ω non-inductive resistor to the ground, keep the detection conditions unchanged, repeat the measurement 3 times, take the most
The large value is the high frequency leakage current I4 of the bipolar electrode.
200Ω
High frequency electric knife high frequency electric knife tester
Bipolar electrode
Neutral electrode
Figure 9 Bipolar electrode high-frequency leakage current detection diagram
5.4.7 Rated output power detection
5.4.7.1 Output power in unipolar mode
According to the rated load requirement of cutting, coagulation and other working conditions in the unipolar mode of high-frequency electric knife (refer to the power load curve), set
The non-inductive resistance value R of the high-frequency electrosurgical detector. Take the common power point within the rated output power range, keep the detection conditions unchanged, repeat each point
The measurement was performed 3 times, and the average value ijP was taken as the output power in this state. High frequency electric knife and high frequency electricity
The knife detector connection is shown in Figure 10.
Note. i is the working state of high-frequency electric knife, i=1, 2, 3, respectively indicating cutting, coagulation, mixed working state;
j is the selected common power point, j = 1, 2, 3.
Monopolar electrode
Neutral electrode R
High frequency electric knife tester
Figure 10 Output power detection diagram in unipolar mode
5.4.7.2 Output power in bipolar mode
According to the rated load requirement of the high-frequency electric knife bipolar mode (refer to the power load curve), set the non-inductive resistance of the high-frequency electric knife detector
The value R. Take the common power point within the rated output power range, keep the detection conditions unchanged, repeat the measurement 3 times at each point, and take the average value jP.
As the output power in this mode. Th...
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