Superior and Stable Quality Endoscopy Kyphoplasty Balloon

• Type: Disposable Medical Supplies
• Material: TPU
• Ethylene Oxide Sterilization: Ethylene Oxide Sterilization
• Quality Guarantee Period: Two Years
• Group: Adult or Children
• Logo Printing: We Can Do OEM
• Model NO.: JHY-KP
• Certification: CE, FDA, ISO13485
• O.D: 10mm, 15mm, 20mm
• Channel: 3.65mm
• Transport Package: 1PC/Bag
• Specification: ISO13485, ISO9001, CE0197, CMDCAS
• Trademark: OEM, Jiuhong, Global
• Origin: Changzhou, Jiangsu
• HS Code: 9018909010
• Production Capacity: 100000PCS

Product Description

1 General
1.1 Brief introduction
Along with the social development and raise of people's living standard, osteoporosis caused by many reasons has become common. Percutaneous Kyphoplasty, PKP is very effective to relieve or remove the pain caused by vertebral compression fracture, as well as to improve or prevent kyphosis. After being developed for more than ten years, the therapy is very mature now and with rich clinical experience.  PKP has become a confessedly safe, reliable and mini-invasive therapy.  
To cooperate with PKP operations, Kyphoplasty Balloon Catheter is developed, and it is widely used in PKP operations. Nowadays Kyphoplasty Balloon Catheters used in domestic hospitals are mainly imported.  Our company is specializing on Tech-development of Kyphoplasty Balloon Catheter. The quality of Kyphoplasty Balloon Catheters developed by our company is equal with imported one, and with cheap price. It can completely match the purpose of being single used in clinic hospitals.  
1.2 Intended use
Used in combination with Balloon Kyphoplasty Kit, this product is mainly used in a Percutaneous Kyphoplasty, PKP operation, to dilate vertebral body and form a cavum which is for injecting bone cement to recover and stabilize vertebral body.  
1.3 Product Classification
In terms of Rule 6, Annex IX in Medical Device Directive (MDD), Kyphoplasty Balloon Catheter is an EO sterilized and invasive device, the classification is Class IIa.
1.4 Types
According to the description in the registered standard, Kyphoplasty Balloon Catheter is classified into three types in terms of tip length: 20mm, 15mm and 10mm.
1.5 Product features
Our kyphoplasty balloon catheter can bear high-pressure, and it is easily operated.
1.6 Contraindications

1.  Painless VCFs, or VCFs is not the major cause of pain.
2. There is osteomyelitis or whole-body infection.
3. There is a backward protruding bone, or a back tumor may imperil vertebral canal.  
4. Perisporium of diseased vertebra, especially the paries posterior is destroyed or incomplete;
5. Fracture of vertebral pedicle;
6. Vertebral fracture with nerve injury;
7. Patients with osteogenic or metastatic tumor;
8. Patients who has bleeding trend or coagulation disorder;
9. Patients with serious cardiopulmonary disease, or with a very delicate health which can't bear the operation;
10. Patients with a fever above 38ºC or with inflammation at the puncture point;
11. Patients with vertebral compression fractures;
12. Patients not suitable for this operation.

1.7 Complications
Increase the fracture rate of segments near the vertebral body.
1.8 Preparation before use      
(1) Take the product from the package, check if there is any bend or damage.
(2) Used in combination with Balloon Kyphoplasty Kit.  Connect the three-way valve with kyphoplasty balloon catheter, and inflate the balloon to see any leak before use.  Don't use the instrument if any leak happens, please use a spare one.
(3) Prepare the instruments and kits demanded by the operation.

1. Cautions

1.  Don't use the instrument when the package is damaged.

1. Don't use the instrument when the valid period is exceeded.
2. Disposable product, please destroy it after using and repeat using is strictly forbidden.
3. Iodine allergy test is required before operation.
4. The quantity of contrast medium used during the operation should meet the following requirements (contrast medium quantity used in model JH-KP-10-A and JH-KP-15-A should be less than 4ml, while JH-KP-20-A should be less than 6ml.) ;
5. The balloon pressure in the operation should be within 220psi.
6. The instrument should be operated by trained and experienced physicians.
7. It is recommended to prepare another kyphoplasty balloon catheter before the operation.Materials

The materials of Kyphoplasty Balloon Catheter should be in accordance with the requirements in Table 1:
                              Table1    Materials

Component	Material	Standard
Balloon	TPU	ISO 16365-1-2014
Spring sheath	TPU	ISO 16365-1-2014
Core tube	TPU	ISO 16365-1-2014
Handle components	PC, silicon rubber	EN ISO 7391-1-2006 ,YY/T 0031-2008
Support wire components	X5CrNi18-10, PC	EN 10088-1-2005,EN ISO 7391-1-2006
Radiopaque ring	Pt90/Ir10	Pt90%  Ir10%
Sheath	TPU	ISO 16365-1-2014
Protective sleeve	PTFE	ISO 13000-200II

3.Specification
 

Model
	Balloon Size	Tolerance	Max Volume	RBP(psi)
	(mm)	(mm)	(CC)
JHY-KP-10-A	10	±2	≥4	≥400
JHY-KP-15-A	15	±2	≥6	≥400
JHY-KP-20-A	20	±2	≥6	≥400