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New Endoscopic stapler|Laparoscopic stapler

New Endoscopic stapler|Laparoscopic stapler

  • Disposable endoscope linear cutting stapler and components
  • Adaptive joint head can be operated with one hand
  • Manually release the button to retract the cutter head at any time
  • The staple cartridge has complete specifications to meet the requirements of tissue closure of diffe
  • Three point gap control system to ensure perfect B type nailing
  • Gecko claw shaped staple cartridge design less tissue overflow to ensure a more perfect anastomosis
  • New Endoscopic stapler|Laparoscopic stapler
  • New Endoscopic stapler|Laparoscopic stapler
  • New Endoscopic stapler|Laparoscopic stapler
  • New Endoscopic stapler|Laparoscopic stapler
  • New Endoscopic stapler|Laparoscopic stapler
  • New Endoscopic stapler|Laparoscopic stapler

product features:

CE certified
Compatible design ensure easy replacemen.
Grpping surface design provide outstanding stapling perfomance.
Multiple models can satify every damands of different surgeries.
Medical level materials ensure no tissue rejection.
Compatibility
Apply to ECEHLON Series 60mm Stapler


Product introduction

Instruction Manual

Structure and composition of laparoscopic stapler:
Linear cutting stapler and components for disposable endoscope are composed of body and assembly.
The body consists of a nail seat, joint head, rod, rotating button, adjustment paddle, blade direction switch button, firing indicator window, blade direction to the indicator window, release button, handle, close handle, firing handle.
It is composed of a cutting knife and a staple cartridge seat, and the components are composed of a staple cartridge and anastomosis nails.The product is provided in a sterile state and sterilized by ethylene oxide.
One time use.

Scope of laparoscopic stapler application:
Suitable for open or endoscopic surgical operations, lung and bronchial group, weaving and resection, transection and anastomosis of stomach and intestine.

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Disposable Laparoscopic Linear Cutter Stapler and Components

 

I. Product name, model, specification
Product name: Disposable endoscopic linear cutting stapler and components
Model specification: Disposable endoscopic linear cutting stapler: PESS35, PESS45, PESS60, PESM35, PESM45, PESM60, PESL35, PESL45, PESL60, PEPS35, PEPS45, PEPS60, PEPM35, PEPM45, PEPM60, PEPL35, PEPL45, PEPL60;
Disposable endoscopic linear cutting stapler components: PSGST35M, PSGST35W, PSGST35B, PSGST35D, PSGST35G, PSGST35T, PSGST45M, PSGST45W, PSGST45B, PSGST45D, PSGST45G, PSGST45T, PSGST60M, PSGST60W, PSGST60B, PSGST35G, PSGST60T, PSGST60B, PSGST60T, PSGST60D, PSGST60B, PSGST35G, PSGST60D, PSGST60B PPEPR60D, PPEPR60G, PPEPR60T.
II. Product performance
The stapler should be positioned accurately, the replacement components should be convenient, firm, and free of obstruction, and there should be sounds or other prompts when the components are in place. The staples should be stably loaded into the assembly, and the staples should not be exposed on the surface of the staple cartridge after being shaken. The opening and closing of the jaws of the stapler should be flexible and there should be no jamming. The joint structure and rotation structure of the stapler should be flexible and barrier-free. The connection between the stapler body and components should be firm and reliable. After the stapler swings its head to the maximum angle, it can successfully complete firing and reset. There is a certain clamping force after the jaws of the stapler are closed, and the clamping force should not be less than 4N. There is a certain closing force after the jaws of the stapler are closed, and the closing force should not be less than 30N. It has certain one-hand operability. The stapler should have good stapling and cutting performance. Replaceable components can be used for multiple cutting and stapling and not less than 8 times. The cutting edge after each stapling should be neat and free of burrs, and the length of the distal end of each stapling line should be longer than the cutting line The length should be at least 1.5 times the nail length, and the staples after each anastomosis should be shaped like a “B”. The staple line after anastomosis should have a certain staple line suture strength, and the staple line suture strength should not be less than 0.1N/mm. The stapler should have a firing process feedback indicator device that can indicate the firing process or status.
III. Main structure
Disposable endoscopic linear cutting stapler and components are composed of body and components, in which the body consists of anvil, joint head, rod, rotary knob, adjustment paddle, blade direction switching button, firing indicator window, blade direction Composed of an indicator window, a release button, a handle, a closing handle, a firing handle, a cutting knife, and a staple cartridge seat, the assembly is composed of a staple cartridge and staples.
IV. Scope of application
It is suitable for resection, transection and anastomosis of lung, bronchial tissue, stomach and intestine in open or endoscopic surgery.

See Figure 1, Figure 2, Table 1, and Table 2 for the types and basic dimensions of endoscopic linear cutting staplers and cutting components.

V. Product appearance and structure

/endoscopic-stapler-product/

 

1—Anti-nail seat, 2—Joint head, 3—Rod; 4—Rotation knob; 5—Adjustment paddle;6—Blade direction switch button; 7—Firing indicator window; 8—Blade direction indicator window; 9—Release button ; 10—handle;11—closing handle; 12—firing handle; 13—cutting knife; 14—nail cartridge seat

 Figure 1 The body of the linear cutting stapler for disposable endoscopy

 /endoscopic-stapler-product/

1-Staple bin   2-staple

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 Figure 2 Linear cutting stapler assembly for disposable endoscope

 

Table 1 Basic dimensions of the body

Model Specifications

L(mm)

Tolerance (mm)

Bending angle W (°)

Tolerance (°)

PESS35

190

±5

45

±10

PESM35

250

PESL35

350

PESS45

190

PESM45

250

PESL45

350

PESS60

190

PESM60

250

PESL60

350

PEPS35

190

PEPM35

250

PEPL35

350

PEPS45

190

PEPM45

250

PEPL45

350

PEPS60

190

PEPM60

250

PEPL60

350

 Table 1 Basic dimensions of the body

Note: The components with a matching length of 35 can only be used for a body with a matching length of 35, the components with a matching length of 45 can only be used for a body with a matching length of 45, and the components with a matching length of 60 can only be used for a matching length The body is 60.

Table 2 Basic dimension unit of components: mm

model

color

The longest single-row staple line length of the assembly (L1)

Toler

ance (mm)

Original height of staple (H)

Tolerance (mm)

model

color

The longest single-row staple line length of the assembly (L1)

Toler

ance (mm)

Original height of staple (H)

Tolerance (mm)

PSGST35M

Ash

35.2

±2

2

±0.2

PSEPR35M

Ash

35.2

±2

2

±0.2

PSGST35W

White

35.2

2.6

PSEPR35W

White

35.2

2.6

PSGST35B

blue

35.2

3.6

±0.15

PSEPR35B

blue

35.2

3.6

±0.15

PSGST35D

gold

35.2

3.8

PSEPR35D

gold

35.2

3.8

PSGST35G

green

35.2

4.1

±0.1

PSEPR35G

green

35.2

4.1

±0.1

PSGST35T

black

35.2

4.2

PSEPR35T

black

35.2

4.2

PSGST45M

Ash

47.2

2

±0.2

PSEPR45M

Ash

47.2

2

±0.2

PSGST45W

White

47.2

2.6

PSEPR45W

White

47.2

2.6

PSGST45B

blue

47.2

3.6

±0.15

PSEPR45B

blue

47.2

3.6

±0.15

PSGST45D

gold

47.2

3.8

PSEPR45D

gold

47.2

3.8

PSGST45G

green

47.2

4.1

±0.1

PSEPR45G

green

47.2

4.1

±0.1

PSGST45T

black

47.2

4.2

PSEPR45T

black

47.2

4.2

PSGST60M

Ash

59.3

2

±0.2

PSEPR60M

Ash

59.3

2

±0.2

PSGST60W

White

59.3

2.6

PSEPR60W

White

59.3

2.6

PSGST60B

blue

59.3

3.6

±0.15

PSEPR60B

blue

59.3

3.6

±0.15

PSGST60D

gold

59.3

3.8

PSEPR60D

gold

59.3

3.8

PSGST60G

green

59.3

4.1

±0.1

PSEPR60G

green

59.3

4.1

±0.1

PSGST60T

black

59.3

4.2

PSEPR60T

black

59.3

4.2

PPGST35M

Ash

35.2

2

±0.2

PPEPR35M

Ash

35.2

2

±0.2

PPGST35W

White

35.2

2.6

PPEPR35W

White

35.2

2.6

PPGST35B

blue

35.2

3.6

±0.15

PPEPR35B

blue

35.2

3.6

±0.15

PPGST35D

gold

35.2

3.8

PPEPR35D

gold

35.2

3.8

PPGST35G

green

35.2

4.1

±0.1

PPEPR35G

green

35.2

4.1

±0.1

PPGST35T

black

35.2

4.2

PPEPR35T

black

35.2

4.2

PPGST45M

Ash

47.2

2

±0.2

PPEPR45M

Ash

47.2

2

±0.2

PPGST45W

White

47.2

2.6

PPEPR45W

White

47.2

2.6

PPGST45B

blue

47.2

3.6

±0.15

PPEPR45B

blue

47.2

3.6

±0.15

PPGST45D

gold

47.2

3.8

PPEPR45D

gold

47.2

3.8

PPGST45G

green

47.2

4.1

±0.1

PPEPR45G

green

47.2

4.1

±0.1

PPGST45T

black

47.2

4.2

PPEPR45T

black

47.2

4.2

PPGST60M

Ash

59.3

2

±0.2

PPEPR60M

Ash

59.3

2

±0.2

PPGST60W

White

59.3

2.6

PPEPR60W

White

59.3

2.6

PPGST60B

blue

59.3

3.6

±0.15

PPEPR60B

blue

59.3

3.6

±0.15

PPGST60D

gold

59.3

3.8

PPEPR60D

gold

59.3

3.8

PPGST60G

green

59.3

4.1

±0.1

PPEPR60G

green

59.3

4.1

±0.1

PPGST60T

black

59.3

4.2

PPEPR60T

black

59.3

4.2

 

VI. Contraindications
1). Severe mucosal edema;
2). It is strictly forbidden to use this device on liver or spleen tissue. Due to the compressive properties of such tissues, the closure of the device may have a destructive effect;
3). Cannot be used in parts where hemostasis cannot be observed;
4). Gray components cannot be used for tissues with a thickness of less than 0.75mm after compression or for tissues that cannot be properly compressed to a thickness of 1.0mm;
5). White components cannot be used for tissues with a thickness of less than 0.8mm after compression or tissues that cannot be properly compressed to a thickness of 1.2mm;
6). The blue component should not be used for tissue that is less than 1.3mm thick after compression or that cannot be properly compressed to a thickness of 1.7mm.
7). Gold components cannot be used for tissues with a thickness of less than 1.6mm after compression or tissues that cannot be properly compressed to a thickness of 2.0mm;
8). The green component should not be used for tissue that is less than 1.8mm thick after compression or that cannot be properly compressed to a thickness of 2.2mm.
9). The black component should not be used for tissue that is less than 2.0mm thick after compression or that cannot be properly compressed to a thickness of 2.4mm.
10). It is strictly forbidden to use on the tissue on the aorta.

VII. How to use
Staple cartridge installation instructions:
1). Take out the instrument and the staple cartridge from their respective packages under aseptic operation;
2). Before loading the staple cartridge, ensure that the instrument is in an open state;
3). Check whether the staple cartridge has a protective cover. If the staple cartridge does not have a protective cover, it is forbidden to use it;
4). Attach the staple cartridge to the bottom of the jaw staple cartridge seat, insert it in a sliding manner until the staple cartridge is aligned with the bayonet, fix the staple cartridge in place and take off the protective cover. At this time, the instrument is ready to fire; (Note: Before the staple cartridge is installed in place, please do not remove the staple cartridge protective cover.)
5). When unloading the staple cartridge, push the staple cartridge toward the direction of the nail seat to release it from the staple cartridge seat;
6). To install a new staple cartridge, repeat steps 1-4 above.

Intraoperative instructions:
1). Close the closing handle, and the sound of “click” indicates that the closing handle has been locked, and the occlusal surface of the staple cartridge is in a closed state; Note: Do not hold the firing handle at this time
2). When entering the body cavity through the cannula or incision of the trocar, the occlusal surface of the instrument must pass through the cannula before the occlusal surface of the staple cartridge can be opened;
3). The instrument enters the body cavity, press the release button, open the occlusal surface of the instrument, and reset the closing handle.
4). Turn the rotary knob with your index finger to rotate, and it can be adjusted 360 degrees;
5). Select an appropriate surface (such as a body structure, an organ or another instrument) as the contact surface, pull the adjustment paddle back with the index finger, use the reaction force with the contact surface to adjust the appropriate bending angle, and ensure that the staple cartridge is in the within the field of vision.
6). Adjust the positioning of the instrument to the tissue to be anastomosed/cut;
Note: Make sure that the tissue is placed flat between the occlusal surfaces, there are no obstructions in the occlusal surfaces, such as clips, brackets, guide wires, etc., and the position is appropriate. Avoid incomplete cuts, poorly formed staples, and/or failure to open the occlusal surfaces of the instrument.
7). After the instrument selects the tissue to be anastomosed, close the handle until it is locked and hear/feel the “click” sound;
8). Firing device. Use the “3+1″ mode to form a complete cutting and suturing operation; “3″: grasp the firing handle fully with smooth movements, and release it until it fits the closing handle. At the same time, observe that the number on the firing indicator window is “1″ “This is a stroke, the number will increase by “1″ with each stroke, a total of 3 consecutive strokes, after the third stroke, the blade direction indicator windows on both sides of the white fixed handle will point to the proximal end of the instrument, indicating that the knife is in the Return mode, hold and release the firing handle again, the indicator window will display 0, indicating that the knife has returned to its starting position;
9). Press the release button, open the occlusal surface, and reset the firing handle of the closing handle;
Note: Press the release button, if the occlusal surface does not open, first confirm whether the indicator window shows “0″ and whether the blade direction indicator window is pointing to the proximal side of the instrument to ensure that the knife is in the initial position. Otherwise, you need to push down the blade direction switching button to reverse the direction of the blade, and fully hold the firing handle until it fits the closing handle, and then press the release button;
10). After releasing the tissue, check the anastomosis effect;
11). Close the closing handle and take out the instrument.

VIII. Product maintenance and maintenance methods

1. Storage: Store in a room with a relative humidity not greater than 80%, well ventilated, and no corrosive gases.
2. Transportation: The packaged product can be transported with normal tools. During transportation, it should be handled with care and avoid direct sunlight, violent collision, rain and gravity extrusion.
IV. Expiration date
After the product is sterilized by ethylene oxide, the sterilization period is three years, and the expiration date is shown on the label.

X. Parts list
none

XI, Precautions, Warnings
1. When using this product, aseptic operation specifications should be strictly followed;
2. Please check the packaging of this product carefully before use, if the blister packaging is damaged, please stop using it;
3. This product is sterilized by ethylene oxide, and the sterilized product is for clinical use. Please check the disk indicator on the sterilization packaging box of this product, “blue” means that the product has been sterilized and can be directly used clinically;
4. This product is used for one operation and cannot be sterilized after use;
5. Please check whether the product is within the validity period before use. The sterilization validity period is three years. Products beyond the validity period are strictly prohibited;
6. The laparoscopic cutting assembly produced by our company must be used in conjunction with the corresponding type and specification of the disposable laparoscopic linear cutting stapler produced by our company. See Table 1 and Table 2 for details;
7. Minimally invasive operations should be performed by persons who have received sufficient training and are familiar with minimally invasive techniques. Before performing any minimally invasive surgery, the medical literature related to the technique, its complications and hazards should be consulted;
8. The size of minimally invasive equipment from different manufacturers may vary. If minimally invasive surgical instruments and their accessories produced by different manufacturers are used in one operation at the same time, it is necessary to check whether they are compatible before the operation;
9. Radiation therapy before surgery may cause tissue changes. For example, these changes may cause tissue thickening beyond what is specified for the chosen staple. Any treatment of a patient prior to surgery should be carefully considered and may require changes in surgical technique or approach;
10. Do not release the button until the instrument is ready to fire;
11. Be sure to check the safety of the staple cartridge before firing;
12. After firing, be sure to check the hemostasis at the anastomotic line, check whether the anastomosis is complete and whether there is any leakage;
13. Ensure that the tissue thickness is within the specified range and that the tissue is evenly distributed within the stapler. Too much tissue on one side can cause poor anastomosis, and anastomotic leakage may occur;
14. In the case of excess or thick tissue, attempting to force the trigger may result in incomplete sutures and possible anastomotic rupture or leakage. In addition, instrument damage or failure to fire may occur;
15. One shot must be completed. Never partially fire the instrument. Incomplete firing may result in improperly formed staples, incomplete cut line, bleeding and leakage from the suture, and/or difficulty removing the instrument;
16. Be sure to fire to the end to ensure that the staples are correctly formed and the tissue is cut correctly;
17. Squeeze the firing handle to expose the cutting blade. Do not press the handle repeatedly, which will cause damage to the anastomosis site;
18. When inserting the device, ensure that the safety is in the closed position to avoid inadvertent activation of the firing lever, resulting in accidental exposure of the blade and premature partial or full deployment of the staples;
19. The maximum firing times of this product is 8 times;
20. Using this device with anastomotic line reinforcement materials may reduce the number of shots;
21. This product is a single-use device. Once the device is opened, no matter whether it is used or not, it cannot be sterilized again. Make sure to lock the safety lock before handling;
22. Safe under certain conditions of nuclear magnetic resonance (MR):
·Non-clinical tests show that implantable staples with the material grade of TA2G can be used for MR conditionally. Patients can safely be scanned immediately after staple insertion in the following situations:
·The range of static magnetic field is only between 1.5T-3.0T.
·The maximum spatial magnetic field gradient is 3000 gauss/cm or below.
·The largest reported MR system, scanning for 15 minutes, the whole body average absorption ratio (SAR) is 2 W/kg.
·Under scanning conditions, the maximum temperature rise of staples is expected to be 1.9°C after scanning for 15 minutes.
Artifact information:
When nonclinically tested using gradient echo pulse sequence imaging and a static magnetic field 3.0T MR system, staples caused artifacts approximately 5 mm from the implant site.
23. See the label for the production date;


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