Mercury - Prostate Biopsy Navigation Robot
*Medical Device Registration No.: NMPA 20253012743
Device info
- ◆ Product Name: Prostate Biopsy Navigation System
- ◆ Product specifications Model: FARH-UR-P
- ◆ Software release version: V1
- ◆ Product Scope: It is intended to assist surgeons in navigation and positioning during transperineal prostate biopsy for adult male patients under transrectal ultrasound guidance, for use in medical institutions.
- ◆ Indications: Examination of prostate diseases such as prostatitis and prostate cancer.
- ◆ Target patient population: Adult males suffering from prostate diseases (such as prostatitis and prostate cancer) who require prostate biopsy upon clinical physician assessment.
- ◆ Intended users: Physicians with professional training and valid qualifications.
- ◆ Contraindications: Not applicable.
- ◆ Date of manufacture: Please refer to the product main unit label.
- ◆ Expiry date: 8 years
- ◆ Basic UDI-DI: 06976622640020
Product Safety Features
2.1 Safety Category
- ◆ Classified by type of electric shock protection: Class I Equipment;
- ◆ Classification by degree of electric shock protection: Type B Application section;
- ◆ Classified according to the level of protection against liquid ingress: Whole machine IPX0;
- ◆ Classification according to the Safety level when used with flammable anaesthetic gases mixed with air or with oxygen or nitrous oxide. Equipment that cannot be used in the presence of flammable anaesthetic gases mixed with air or flammable anaesthetic gases mixed with oxygen or nitrous oxide;
- ◆ Classified by Run Mode: Continuous run equipment;
- ◆ Permanently installed equipment or non-permanently installed equipment: Non-permanent installation equipment.
2.2 Compliance with Safety Standards
- ◆ EN 60601-1 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance》,EN IEC 80601-2-77《Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment》
- ◆ EN 60601-1-2 "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests》
- ◆ EN IEC 80601-2-77 《Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment》
Safety Warning
3.1 Basic Safety
Warning
- ◆ This instruction manual does not cover clinical puncture techniques; the correct puncture surgery plan must be chosen based on professional training knowledge and clinical experience.
- ◆ Only professional doctors who have been trained by our company are permitted to use this product to perform puncture surgery on patients.
- ◆ Prior to surgery, the surgeon must verify the compatibility of the surgical plan, ultrasound equipment, puncture instruments and this device. This product shall only be used for prostate biopsy when the product itself, combined accessories and surgical scenarios are all within the intended scope of this device. If incompatible equipment is found or the surgical scenario exceeds the intended scope, the use of this product is prohibited to avoid clinical risks.
- ◆ This product must be installed, debugged and maintained by our company or personnel authorised by our company. Do not attempt to disassemble, replace, modify or damage any safety devices on this product without permission. Tampering with safety devices may cause fatal or other serious personal harm.
- ◆ Do not use this product in environments where flammable anaesthetic gases or other flammable liquids are present, as this may cause an explosion. This product is not suitable for AP/APG environments.
- ◆ Please do not use ultrasound equipment, probes, puncture needles, etc. that are not compatible with this product.
- ◆ Please do not use power cables with incorrect specifications.
- ◆ Movement of the patient during surgery can result in incorrect positioning. Patient movement must be controlled throughout the entire surgery process.
- ◆ This product must not be used outside the applicable scope.
- ◆ This equipment must not be modified.
- ◆ Lubricate the rectal passage with appropriate ultrasound gel.
- ◆ Insert the ultrasound probe into the patient's rectum.
- ◆ Do not apply excessive force when inserting the ultrasound probe, nor make excessive lateral motion during or after the insertion process, as this can cause tissue damage and injury to the patient.
- ◆ During surgery, do not insert the puncture needle into the patient when the robotic arm is moving.
- ◆ During surgery, if the equipment loses power, please slowly and steadily withdraw the ultrasound probe from the patient’s body, then move the equipment away.
3.2 Electrical Safety
Warning
- ◆ To avoid the risk of electric shock, this equipment must be connected to a power supply network with protective grounding. Never connect the earth wire to any gas pipe or water pipe, as this may cause poor protective earthing or the Danger of explosion.
- ◆ The application parts of other medical electrical equipment used in conjunction with this product shall be of type F application parts.
- ◆ Before use, please ensure to check the compatibility of this product with the application parts of other medical electrical equipment.
- ◆ When other ME equipment is used in conjunction with this product, patient leakage current may accumulate.
- ◆ Please plug the product's plug into a hospital-grade standard socket, and the socket must meet the rated power requirements. To avoid overload and interference, when using a movable multi-socket, it should only be used to supply power to the system composed of this equipment.
- ◆ It is prohibited to allow live components of this product or products used in conjunction with this product to come into contact with the patient, as a fault in this product or the products used with it may pose a danger of electric shock to the patient.
- ◆ Never use this product simultaneously with electronic equipment such as high-frequency electrosurgical knives, high-frequency treatment equipment, or defibrillators. Otherwise, it may cause an electric shock to the patient.
- ◆ Personnel not authorised by this company or the company itself must not open the casing of this equipment, as it may cause a short circuit or electric shock.
- ◆ When the circuit breaker trips frequently or the fuse blows frequently, please do not operate this product and contact the maintenance personnel promptly.
- ◆ Before cleaning this product, please be sure to close the power and disconnect the power connection, otherwise it may cause electric shock.
- ◆ During transportation, be sure to disconnect the power, disconnect from other equipment, and remove the monitor.
- ◆ Electromagnetic Compatibility: Electromagnetic compatibility requirements must be taken into account, and the installation and maintenance of this product must be carried out in accordance with the electromagnetic compatibility information provided in the appendix of this instruction manual.
- ◆ Electromagnetic interference: Using portable telephones or other radio frequency (RF) radiation equipment near the product may cause unexpected or adverse consequences.
- ◆ Electromagnetic Interference: Patients using implanted devices may be affected by electromagnetic interference.
3.3 Mechanical Safety
Warning
- ◆ When this product crosses obstacles, do not push the main unit from the side, as this may cause the System to topple.
- ◆ Attachments, other medical electrical equipment, or non-medical electrical equipment not designated or authorised by our company must not be connected to the mechanical interfaces and other interfaces of this product.
Caution
- ◆ Before moving this product, you must first confirm that it has been disconnected from other equipment. Otherwise, other equipment may topple and cause harm.
- ◆ Please use the handle to move this product. Before moving, please check whether the casters have been unlocked, and avoid all cables while moving.
- ◆ If the caster wheels are obviously damaged or do not rotate smoothly, please contact the maintenance personnel promptly.
- ◆ Please do not place any items on the monitor or Robotic arm, as items may fall and cause harm.
3.4 Information Safety
Warning
- ◆ To prevent information loss, users are advised to perform data backup promptly.
- ◆ If any serious adverse event related to this device occurs, it shall be reported to the manufacturer and the competent authority of the EU Member State where the user/patient is located.
Identification of graphic symbols
This product, its packaging, labels, and accompanying documents use the following symbols, with the list below to explain their meanings.
| No. | Identification Name | Graphic Symbols | Meaning |
|---|---|---|---|
| 1 | Fragile items |  | Indicates that the transport packaging contains fragile items and should be handled with care. |
| 2 | Upwards |  | The table indicates that the transport packaging should be kept upright during transportation. |
| 3 | Afraid of rain |  | The table indicates that this transport packaging is afraid of rain. |
| 4 | No tumbling allowed |  | Indicates that the transport package must not be rolled during handling. |
| 5 | No stacking allowed |  | Indicates that this package can only be placed in a single layer. |
| 6 | Watch your head. |  | Watch your head. |
| 7 | Do not reach in |  | Do not reach in |
| 8 | Warning, electric shock risk |  | Beware of electric shock |
| 9 | No trampling allowed |  | Stepping on this System is prohibited |
| 10 | No sitting allowed |  | Sitting or lying on this System is prohibited. |
| 11 | No pushing allowed |  | Do not push the main unit when the casters are locked. |
| 12 | Prohibited from relying on |  | Do not lean on this System. |
| 13 | Emergency disable |  | Emergency disable |
| 14 | Equipment Category |  | Type B Application Section |
| 15 | Follow the operation instruction manual |  | The User must refer to the Explanation for use. |
5. Main Performance Indicators
| No. | Indicator | Details |
|---|---|---|
| 2 | Electromagnetic Compatibility Performance | Compliant with EN 60601-1-2 "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests, EN IEC 80601-2-77 Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment |
| 3 | Effective working space | 300mm × 200mm × 200mm |
| 4 | System Accuracy | Within the effective working space of the equipment, the puncture precision does not exceed 1.0mm. |
| 5 | Effective Operating Force of Robotic Arm | Under normal working conditions, the effective operating force of the robotic arm should not be less than 20N. |
| 6 | Position Accuracy of Robotic Arm | Within the effective working space of the equipment, the distance between the location where the end effector of the robotic arm approaches the commanded posture from the same direction and the centre of the actual location cluster does not exceed 0.8mm. |
| 7 | Position Repetability of Robotic Arm | Within the effective working space of the equipment, the distance by which the end effector of the robotic arm's reference point repeatedly reaches the objective location from the same direction with the same command posture does not exceed 0.5mm. |
| 8 | Degree of Freedom of Robotic Arm | 7 degrees of freedom |
| 9 | Rated Payload of Robotic Arm | 7kg |
| 10 | Puncture Accuracy | The distance from the point on the straight line of the image displayed by the puncture needle within the intended Scope to the puncture guide line should not exceed 0.5mm. |
| 11 | Software Function | Equipped with systematic biopsy function, import MR data function, targeted biopsy function, biopsy report function, and user management function. |
6. Company info
| Registrant/Manufacturer/Technical support and service | Wuxi AMIT Intelligent Medical Technology Co., Ltd. |
| Registrant/Manufacturer address | Room A709, Building 530, No.18 Qingyuan Road, Xinwu District, Wuxi City, Jiangsu Province, People’s Republic of China |
| Production address | Room A709 and A807, Building 530, No.18 Qingyuan Road, Xinwu District, Wuxi City, Jiangsu Province, People’s Republic of China |
| Registrant/Contact information of manufacturer | 0510-83561636 |
| Technical support and service number | 0510-83561636 |
| CE marking |  2797 |
| European Authorised Representative information. | |
|---|---|
| Company | Lotus NL B.V. |
| Address | Koningin Julianaplein 10, 1st Floor, 2595AA, The Hague, Netherlands. |
| Tel | +31644168999 |
| info@lotusnl.com | |
| Contact | Feifei Cao |