ISO 13485 Quality Management
Our entire 10,000m² manufacturing facility operates under the stringent ISO 13485 standard, ensuring consistent, high-quality production for every medical device that leaves our factory.
Safe and effective device for controlling life-threatening extremitybleeding.
Effectively applied over clothing as high on the arm or leg as possible.
Must NOT be applied over solid objects within the clothing.
As soon as the situation permits, the injured limb should be evaluatedand the tourniquet re-positioned 2-3 inches above the injury directly tothe skin.
XieHe presents the XH-16B Child Head Immobilizer, a purpose-built solution for pediatric cervical stabilization designed to meet the specific anatomical and clinical needs of infants and children. The XH-16B Child Head Immobilizer combines precise support, gentle fixation, and durable construction to deliver reliable EMS head support and hospital trauma immobilizer performance across pre-hospital, transport, and emergency department settings
Product Overview and Key Features
The XH-16B Child Head Immobilizer is engineered to provide comprehensive pediatric cervical stabilization without compromising patient comfort or caregiver usability. The product includes contoured foam blocks, adjustable straps, and a low-profile base compatible with standard stretchers and spinal boards. Lightweight and radiolucent, the XH-16B Child Head Immobilizer supports efficient imaging and transport while preserving immobilization integrity
Clinical Applications
The XH-16B Child Head Immobilizer is suitable for multiple clinical use cases where pediatric cervical stabilization is critical. Common applications include pre-hospital trauma care, ambulance transport, emergency department resuscitation, and inter-facility transfer. In mass-casualty incidents and disaster response, the XH-16B Child Head Immobilizer performs as an effective EMS head support device enabling rapid triage and secure stabilization for pediatric patients
Design Innovations and Technical Advantages
The XH-16B Child Head Immobilizer incorporates several design innovations that set it apart from conventional pediatric immobilization devices. First, the XH-16B Child Head Immobilizer uses anatomically contoured foam with variable density zones that cradle the occiput and lateral head while minimizing pressure points
Materials and Construction
Durable, medical-grade materials ensure that the XH-16B Child Head Immobilizer meets demanding clinical workflows. The radiolucent foam and polymer base preserve image quality during x-ray and CT scans, so pediatric cervical stabilization does not interfere with diagnostic evaluation. The foam’s closed-cell construction resists bodily fluids and is easy to disinfect, supporting infection control protocols in EMS and hospital environments
Compatibility and Integration
The XH-16B Child Head Immobilizer was developed to be compatible with a wide range of stretcher systems, spine boards, and immobilization devices used in EMS and hospital settings. The device can be anchored to standard rail systems and features adjustable mounting points to match different board widths and rail distances. Because the XH-16B Child Head Immobilizer is radiolucent, clinicians can perform diagnostic imaging without removing pediatric cervical stabilization, preserving immobilization during the assessment and reducing the risk of secondary injury
Regulatory Compliance and Quality Assurance
Manufactured under CE/FDA/ISO 13485-certified processes, the XH-16B Child Head Immobilizer aligns with international standards for medical device quality and safety. Rigorous quality control and materials testing ensure consistent performance under field conditions. XieHe’s global distribution network and commitment to customization enable responders and health systems to obtain versions of the XH-16B Child Head Immobilizer tailored to specific protocols or branding requirements
Training and Support
XieHe offers comprehensive training materials and optional in-person or virtual instruction to support effective deployment of the XH-16B Child Head Immobilizer. Training emphasizes correct pediatric cervical stabilization techniques, safe patient handling with EMS head support, and integration with hospital trauma immobilizer workflows. Ongoing technical support and replacement part availability help providers maintain readiness and maximize the device’s operational lifespan
The XH-T01 is based on the principle that rapid action is essential when extremity bleeding is severe. The acronym TIME in the source description points to the importance of time awareness during tourniquet use. Delay in applying a tourniquet can lead to continued blood loss and shock. The device is therefore designed to be applied quickly and securely. The instruction to apply it over clothing as high on the limb as possible allows the responder to act immediately without first exposing the wound. This can be critical when the scene is unsafe or when the patient must be moved urgently. However, the instruction also states that the tourniquet must not be applied over solid objects within the clothing. Objects such as a wallet, keys, or a phone can create a gap between the tourniquet and the limb, reducing its effectiveness. Responders should check for such objects and remove them if possible before tightening the tourniquet.
Technical Data
| Model: | XH-T01 |
| Product Type: | Extremity tourniquet |
| Primary Application: | Control of life-threatening extremity bleeding |
| Initial Placement: | Over clothing, as high on the limb as possible |
| Restriction: | Do not apply over solid objects within clothing |
| Reassessment: | Reposition 2-3 inches above injury directly to skin as soon as situation permits |
| Intended Users: | Trained medical personnel, first responders, tactical medics |
| Use Environment: | Pre-hospital, hospital, tactical, disaster response |
Once the immediate bleeding is controlled and the situation allows, the injured limb should be evaluated. The tourniquet should then be re-positioned 2-3 inches above the injury directly to the skin. This step improves the contact between the tourniquet and the limb and allows the responder to confirm that bleeding is controlled. Direct skin placement also makes it easier to monitor the limb for changes in color, temperature, or pulse. The re-positioning should be done carefully to avoid unnecessary movement of the injured limb. If the tourniquet is not effective, it may need to be tightened or repositioned again. The XH-T01 is designed to support this process with a secure mechanism that maintains tension once applied. The exact tightening method depends on the specific design of the device, and users should follow the manufacturer’s instructions and their local protocols.
The XH-T01 is intended for use by individuals who have received appropriate training in tourniquet application. Tourniquets are not simple bandages, and incorrect use can cause harm. Training should cover indication, placement, tightening, time documentation, and reassessment. The device should be applied only when bleeding from an extremity is severe and cannot be controlled by direct pressure or other methods. Once applied, the time of application should be recorded and communicated to receiving medical staff. The patient should be transported to a facility where definitive care can be provided. The XH-T01 can be included in trauma kits, tactical medical bags, ambulance supplies, and emergency response equipment. It is suitable for use in pre-hospital care, hospital emergency departments, military operations, and disaster response.
The XH-T01 should be stored in a clean, dry place and inspected before use. Damaged or expired devices should not be used. After application, the tourniquet should remain in place until a medical professional determines that it can be safely removed. Removing a tourniquet too early can lead to renewed bleeding and shock. The device should be used only as part of a complete bleeding control protocol that includes direct pressure, wound packing, and rapid transport. The XH-T01 is not intended to replace surgical hemostasis or definitive vascular repair. It is a temporary tool for emergency hemorrhage control. Users should be familiar with the device before an emergency occurs, and regular training is recommended to maintain skill and confidence.
The XH-T01 is suitable for a range of emergency situations. In pre-hospital care, it can be used by paramedics to control severe bleeding from an arm or leg after trauma. In hospital emergency departments, it provides a rapid means of hemorrhage control before surgical intervention. In military and tactical medicine, the tourniquet is a standard item for managing extremity wounds. In disaster response, it can be included in medical kits for treating casualties in remote or damaged areas. In industrial and construction settings, it can be part of first aid supplies for managing severe injuries. The device is also useful in sports medicine and outdoor rescue, where severe limb trauma may occur.
The XH-T01 offers a practical solution for controlling life-threatening extremity bleeding. Its design supports rapid application over clothing, followed by reassessment and repositioning to the skin. The device is intended for use by trained responders and is suitable for pre-hospital, hospital, tactical, and disaster settings. Xiehe Medical has over two decades of medical device production experience and holds CE, FDA, and ISO 13485 certifications for its manufacturing operations. For more product information, sample requests, or partnership inquiries, please contact the Xiehe Medical sales team. We are ready to provide professional, efficient support for your business needs.
Safe and effective device for controlling life-threatening extremitybleeding.
Effectively applied over clothing as high on the arm or leg as possible.
Must NOT be applied over solid objects within the clothing.
As soon as the situation permits, the injured limb should be evaluatedand the tourniquet re-positioned 2-3 inches above the injury directly tothe skin.
XIEHE MEDICAL stands behind every product with a 1-year warranty against material and workmanship defects, plus lifetime supply of all replacement parts at factory cost. Our multilingual support team is available 24/7 via email to assist with maintenance and repairs, ensuring your equipment stays operational and your technicians are never left without support.
Backed by internationally recognized manufacturing standards and an unwavering commitment to quality, we help our customers minimize procurement risk and buy with confidence.