Vaginal Birth Virtual Reality Medical Simulation System

Here's the English translation of the provided product specifications for the "Normal Delivery Virtual-Actual Integrated Training System":

**Normal Delivery Virtual-Actual Integrated Training System**

**1. System Functions:**
1.1 The system consists of two parts: hardware (normal delivery pregnant woman simulator) and virtual-actual integrated training software. Data from operating the simulator is fed back to the training system in real-time. The system automatically analyzes the data and outputs the analysis results.
1.2 The maternity simulator (full-body, 160 cm) features a freely rotatable head and fully movable limb joints. The pregnant abdomen is made of imported silicone, offering a soft texture and realistic feel. Built-in high-sensitivity sensors transmit every operator action to the system for automatic analysis.
▲1.3 The system supports wireless connection not only to PCs but also to tablets and smartphones. Through a mobile app, users can access the 3D virtual-actual integrated software and interact with the comprehensive delivery pregnant woman simulator in a virtual-actual integrated manner. (A sample must be provided for on-site demonstration to visually showcase the above effects.)
1.4 The system integrates both practice mode and assessment mode, with automatic scoring for assessment content. Key and challenging steps in the operation process can be evaluated. Instructors can set up clinical cases and control the entire delivery process.
1.5 Free viewing angle: The maternal and fetal status can be observed from a 360° rotating perspective, with smooth, stutter-free operation. Operators can use the mouse to move the viewpoint up, down, left, and right, as well as zoom in and out.
1.6 The maternity simulator contains a simulated fetus inside, which can perform movements such as engagement, descent, and internal rotation within the pregnant body.
1.7 The simulated fetus connects via wireless Bluetooth. The rechargeable battery provides up to 7 hours of continuous use.
1.8 The system can detect changes in the maternal model’s posture.
1.9 Operators can freely adjust the delivery speed in the 3D virtual simulation software, and can stop, pause, or accelerate the delivery process at any time. The simulated fetus automatically completes movements such as descent, rotation, flexion, and extension according to the preset labor mechanism.
1.10 The head and buttocks of the delivery fetus have a realistic feel. Anatomical structures such as the fontanelles and sagittal suture can be palpated. The fetus has an oral cavity and nasal cavity. The limb joints are movable, allowing for positioning. The neck has good mobility, allowing for passive flexion and extension maneuvers.
1.11 The system can detect changes in the maternal model’s posture, enabling freedom of positioning during delivery, including left lateral delivery and kneeling delivery.
1.12 The simulated delivery process can simulate arrest of fetal descent.
1.13 The placenta is made of realistic material and includes an elastic, transparent amniotic membrane.
1.14 The silicone material of the simulator must be safe and non-toxic, with an SVHC concentration ≤ 0.1% (w/w). A test report for the silicone material, issued by a third-party testing institution in accordance with Regulation (EC) No 1907/2006 (REACH), must be provided.
▲1.16 The silicone material used for the simulator must have a tensile strength ≥ 5 MPa and an elongation at break ≥ 500% (a copy of a test report bearing the CMA mark from a third-party testing institution must be provided as evidence).
1.17 The silicone material used for the simulator must withstand low temperatures of -10°C for 10 hours and high temperatures of 200°C for 10 hours without significant visible changes. A copy of a third-party test report must be provided as evidence.
1.18 The silicone material used for the simulator must withstand UV aging under irradiance (340nm) of 0.76 W/m²·nm for 8 hours of illumination without significant visible changes. A copy of a third-party test report must be provided as evidence.
▲1.19 The knee joint must allow normal flexion (90°) and return to neutral. This must withstand ≥10,000 cycles without surface cracks or damage. (A copy of a test report from a third-party testing institution must be provided as evidence.)
▲1.20 The finger joints must allow forward flexion of 90° and return to neutral. This must withstand ≥5,000 cycles without surface cracks or damage. (A copy of a test report from a third-party testing institution must be provided as evidence.)
★1.21 Fetal position setting: The system software can set six different fetal positions (including left occiput anterior, right occiput anterior, left occiput transverse, right occiput transverse, left occiput posterior, right occiput posterior). After setting via software, the fetal model inside the pregnant woman simulator will automatically switch to the corresponding fetal position. (A sample must be provided for on-site demonstration of the above effects.)
★1.22 When the case sets the fetal position to occiput posterior or occiput transverse during the second stage of labor, a manual rotational maneuver (manual rotation of the fetal head) must be performed. The operator must insert their hand into the pregnant woman simulator and precisely manually adjust the fetal head to the correct position. During this process, the 3D virtual software will synchronize the rotation of the virtual fetal head inside the virtual pregnant woman in real-time, ensuring visualization and accuracy of the maneuver. (A sample must be provided for on-site demonstration to visually showcase the above effects.)
▲1.23 The system uses AI technology to detect the perineal disinfection process in real-time. Students must disinfect the simulated maternity patient according to the correct sequence and method, using real ovum forceps to grasp real iodine-soaked cotton balls for perineal disinfection. During the disinfection process, the system can detect and identify common disinfection errors made by the student, such as disinfection area, sequence, and number of times, and provide timely corrective feedback. The 3D simulation software synchronizes the disinfection process in real-time. (A sample must be provided for on-site demonstration to visually showcase the above effects.)

**2. System Parameters:**
2.1 Practice Mode: Guides the operator through normal delivery procedures with prompts, determines if the operation is correct, and provides feedback to the operator.
★2.2 During head crowning with visible presenting part (becoming visible between contractions), the simulated fetus will actually retract, achieving a realistic effect of visible presenting part. The 3D virtual simulation software synchronizes the dynamic changes of the visible presenting part in real-time. The system will automatically sense if the operator is ready to perform appropriate perineal protection. If the operator performs the perineal protection maneuver, the 3D virtual simulation software will synchronize the perineal protection operation in real-time. (A sample must be provided for on-site demonstration of the above effects.)
2.3 During head crowning (when the head remains visible even between contractions), the system can detect if the operator correctly applies downward pressure on the fetal head. If the operator does not correctly apply downward pressure to assist fetal head flexion, the fetal head will deliver faster than normal. The 3D virtual simulation software synchronizes the operation in real-time.
★2.4 When the fetal occiput is under the mother's pubic arch, the system can intelligently recognize if the operator correctly assists with fetal head extension, allowing the forehead, nose, mouth, and chin to deliver sequentially. It also determines if the operator correctly clears the newborn's oral and nasal secretions. The 3D virtual simulation software synchronizes the operation in real-time. (A sample must be provided for on-site demonstration of the above effects.)
★2.5 The fetal model can autonomously perform restitution and external rotation. The 3D virtual simulation software synchronizes restitution and external rotation in real-time. (A sample must be provided for on-site demonstration of the above effects.)
★2.6 Monitoring Contractions: The intensity of uterine contractions can be palpated. The operator can feel the contraction changes by touching the abdomen of the pregnant woman simulator. (A sample must be provided for on-site demonstration of the above effects.)
★2.7 Immediate Newborn Care: The system can recognize if the newborn is immediately placed on the mother's abdomen. If performed correctly, the 3D virtual simulation software will display the newborn being placed on the virtual mother's abdomen in real-time. (A sample must be provided for on-site demonstration of the above effects.)
2.8 Whole-body drying of the newborn can be performed. The 3D simulation software synchronously displays the drying action.
★2.9 A real umbilical cord scissors can be used to cut the umbilical cord. The system will recognize that the umbilical cord has been cut and synchronize this action in the 3D virtual simulation software. The cut end of the umbilical cord should reveal 2 arteries and 1 vein. (A sample must be provided for on-site demonstration of the above effects.)
★2.10 Observation of Signs of Placental Separation: Allows for determining if the placenta has separated. When the operator uses the ulnar side of the hand to apply gentle pressure on the uterine segment just above the maternal simulator's pubic symphysis, the uterine body rises while the exposed umbilical cord does not retract. The 3D virtual simulation software synchronizes this effect in real-time. (A sample must be provided for on-site demonstration of the above effects.)
2.11 Assisting Placental Delivery: Allows for correct execution of placental delivery maneuvers. The 3D virtual simulation software synchronizes the placental delivery operation in real-time.

**3. Virtual-Actual Integrated 3D Simulation Software Parameters:**
3.1 Allows operators to freely create different cases. The system can set the case name and save the configured cases.
★3.2 The software allows configuration of the following parameters related to the normal delivery process: guidance on pushing, visible presenting part (between contractions), crowning, extension, restitution, external rotation, delivery of the anterior shoulder, delivery of the posterior shoulder, delivery of the body, drying the baby, mother-baby contact, preparation before cord clamping, timing of placental separation, placental separation, assisting placental delivery, duration or number of contractions, and duration of contraction intervals. Stage settings for the normal delivery process can be saved as different cases and recalled as needed. (A sample must be provided for on-site demonstration of the above effects.)
3.3 Throughout the process, software allows X-ray vision (transparent view) to observe the relative positions of the pregnant woman's pelvis, uterus, placenta and membranes, and the fetus.
3.4 Guidance on Pushing: Displays fetal engagement, descent, internal rotation, flexion, and internal rotation.
3.5 Visible Presenting Part: Synchronizes the number of times and duration of each visible presenting part event according to the case settings.
3.6 Crowning: Displays the crowning process using 3D virtual simulation.
3.7 The software displays the correct technique for appropriate perineal protection throughout the delivery process.
3.8 Assisting Delivery of the Fetal Head: Displays the change in hand maneuvers during assisted delivery of the fetal head, including specific steps for delivering the head and clearing mucus and amniotic fluid from the mouth and nose.
3.9 Assisting Delivery of the Fetal Body: Displays the change in hand maneuvers during assisted delivery of the fetal body, illustrating the specific steps for delivering the anterior shoulder followed by the posterior shoulder.
3.10 Cord Clamping: Displays the procedure of placing hemostats followed by cord clamping using 3D virtual simulation, synchronously recognizing the cord clamping operation.
3.11 Mother-Baby Contact: Displays removing the wet towel, placing the newborn in a prone position with head turned to one side, covering with a dry towel, putting on a cap, and performing mother-baby skin-to-skin contact using 3D virtual simulation.
3.12 Placental Separation: Displays signs of placental separation using 3D virtual simulation, including the uterus becoming firm and globular, the fundus rising to above the umbilicus; the exposed umbilical cord outside the vagina lengthening spontaneously; when pressing gently on the uterine segment just above the maternal symphysis pubis, the uterine body rises while the exposed umbilical cord does not retract; and slight vaginal bleeding.
3.13 Assisting Placental Delivery: Displays the procedure of holding the uterine fundus with the left hand, thumb on the anterior uterine wall, and the other four fingers on the posterior uterine wall applying pressure. Simultaneously, the right hand gently pulls the umbilical cord. When the placenta reaches the vaginal opening, the deliverer cups the placenta with both hands, rotates it in one direction, and slowly pulls it outward to assist in the complete, intact delivery and expulsion of the placenta and membranes using 3D virtual simulation.

**4. Hardware Configuration:**
**(1) Configuration List:**
① Normal Delivery Virtual-Actual Integrated Pregnant Woman Simulator (including delivery fetus simulator) – 1 unit.
② Normal Delivery Virtual-Actual Integrated 3D Simulation Software – 1 set.

③Tablet computer -1 set.