Ligation Clip Applier-Changzhou 3R Medical Device Technology Co., Ltd

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Ligation Clip Applier

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Reusable Device

The product is currently expected to be sold in English speaking countries, such as Ireland, UK, Bulgaria, Cyprus and Latvia.

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Product Description
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Commodity name: Ligation Clip Applier
Commodity ID: 19

The product is currently expected to be sold in English speaking countries, such as Ireland, UK, Bulgaria, Cyprus and Latvia.

【Revision】A/0

【Effective】2019-06-29

【Language】English

【Expected Market】

The product is currently expected to be sold in English speaking countries, such as Ireland, UK, Bulgaria, Cyprus and Latvia.

【Product Name】Ligating Clip Appliers

【Product Model】

SRCA(A/B)5-S, SRCA(A/B)10-M, SRCA(A/B)10-L, SRCR E/O-SM, SRCR E/O-ML, SRCA C 20*9 S/M/L, SRCA C 20*70 S/M/L, SRCA C 27*9 S/M/L, SRCA C 27*70 S/M/L;

【Model description】

Ligating Clip Appliers classification		Code or specifications
Usage method	Endoscopic series	EC,CR E
Usage method	Opening surgery series	OC,CR O
Outer Shape	/	A,B,C
Application site	Inner diameter of the lumen	5mm,10mm
Applied Ligating clip	/	S,M,L

1)Model description

Manufacturer: Changzhou 3R Medical Device Technology CO., Ltd.

For example:

SRCA A10-S, indicated as: Ligating Clip Appliers, Laparoscopic series Type Model A10, Type S Applier Jaws, applied to LC-1 ligating Clips, manufactured by Changzhou 3R Medical Device Technology CO., Ltd.

CA C20*9-S, indicated as: Ligating Clip Appliers, Opening surgery series, length of applier is 20 cm, bending angle 9 degree, Specifications S, applied to LC-1 ligating Clips.

2)Model description

Manufacturer: Changzhou 3R Medical Device Technology CO., Ltd.

For example:

SRCR O –SM, indicated as: Ligating Clip Appliers, Opening surgery series, Type Model SM, applied to LC-1, LC-2 ligating Clips, manufactured by Changzhou 3R Medical Device Technology CO., Ltd.

【Structure and Components】

The product consists of Jaw, cannula, loop handle, handle, spring, and rotation knob.

The hardness of Jaw is 40HRC~48HRC, the Jaw can be reusable, should be sterilized before each use.

The figures are showed as follows:

1. Jaw 2. Cannula 3. Rotation knob 4. Handle 5. Loop handle 6. Spring

Figure 1 Ligating clip appliers CAA Endoscopic series (Type A)

1. Jaw 2. Cannula 3. Rotation knob 4. Shaft 5. Loop handle 6.Handle

Figure 2 Ligating clip appliers CAB Endoscopic series (Type B)

1. Jaw 2. Cannula 3. Rotation knob 4. Shaft 5. Loop handle 6.Handle

Figure 3 Ligating clip appliers CR E/O – SM/ML

1. Spring 2. Applier 1 3. Applier 2

Figure 4 Ligating clip appliers CAC Opening surgery series (Type C)

【Specifications】

Table 1. Specifications Unit: (mm)

Model Size	L	Tolerance	D	Tolerance	Disposable ligating clips Specification
SRCA（A/B）5-S	330	±50	Ф5	±0.5	LC-1
SRCA（A/B）10-M			Ф10		LC-2
SRCA（A/B）10-L			Ф10		LC-3

Model Size	L	Tolerance	D	Tolerance	Disposable ligating clips Specification
SRCR E/O-SM	330/240	±50	Ф5	±0.5	LC-1/LC-2
SRCR E/O-ML	330/240	±50	Ф10	±0.5	LC-2/LC-3

Model Size	L	Tolerance	A	Tolerance	Disposable ligating clips Specification
SRCA C 20*9 S/M/L	200	±50	9	±1°	LC-1/2/3
SRCA C 20*70 S/M/L	200	±50	70	±5°	LC-1/2/3
SRCA C 27*9 S/M/L	270	±50	9	±1°	LC-1/2/3
SRCA C 27*70 S/M/L	270	±50	70	±5°	LC-1/2/3

【Main parts and materials】

Table 2. main parts and materials

Part Name	Material Designation
Jaw	Stainless steel 20Cr13
Cannula	Stainless steel 12Cr18Ni9
loop handle, handle, Spring	Stainless steel 12Cr18Ni9
Rotation knob	ABS

【Intended use】

The Ligating Clip Appliers are designed for use as delivery devices for Disposable Ligating Clips.

The Ligating Clip Appliers are reusable instruments that manually load and deliver one clip at a time. The appliers are not designed for compatibility with ligating clip which made by any other manufacturer.

【Adverse effects】

1) Infections at surgical site;

2) Bleeding;

3) Difficult to remove clip from jaws/vessels.

【Warnings】

1) Always check the alignment of the applier jaws before use.

2) When closed, jaw tips should be directly aligned and not offset.

3) Alignment of the jaw is critical for safe application of the clip. If this is not done, patient injury may occur.

4) Proper maintenance, care and cleaning are necessary to ensure proper functionality.

5) This device is for reusable, it should be cleaned, disinfected and sterilized before each use.

6) After each use, the device should be cleaned to ensure no stains and foreign substances inside and outside it; after cleaning, it shall be wiped clean and dried, and rust prevention shall be done.

7) The device should be returned to the manufacturer for maintenance within 50 times usage; after maintenance, it shall be used after passing the inspection.

8) The product shall be stored in a room with relative humidity no more than 80%, no corrosive gas and good ventilation.

9) The device should be discarded as medical waste after damaging.

【Cautions】

1) Proceed carefully when inserting the instrument through a cannula.

2) DO NOT apply lateral pressure on the applier as damage to the working tip may occur.

3) Before use, examine the instrument for bent, broken, cracked or worn parts. In order to avoid unnecessary gas loss, ensure the cleaning port cap fits tightly on the Luer-Lock flush port. A spare cap is provided for your convenience.

4) Always confirm that the clip remains in the applier after insertion of the applier and clip through a cannula.

5) Do not attempt to close the jaws on a vessel or anatomic structure without a clip properly loaded into the jaws.

6) Closure of empty jaws on a vessel or anatomic structure may result in patient injury.

7) Before applying a clip, verify the structural size and condition of the vessel or structure and use the proper clip size.

8) Rotation knob should only be activated with jaws in open position. Failure to do this may result in damage to the applier.

9) The specification and model of the device shall not be mixed use with the ligating clips, They shall be matched with each other. If not, the surgery maybe failure.

【Directions For Use】

The operator should be trained and qualified, and familiar with product performance, scope of application, can operate the device safely.

Please read the Instructions for Use before use. The Directions for Use are showed as follows:

Type (CA A/B/C) match with Ligating clip, closure the tissue, vessels:

1) Select the suitable Ligating clip applier to match with the ligating clip, and take out the Ligating clip from the substrate.

Make sure that there is Ligating clip in the Jaw before inserting the Applier into the puncture cannula.

Warning: When there is no ligating clip in the Jaw, inserting the Applier into the puncture cannula may cause the Applier to enter the patient body and injury tissues and organs.

2) The axis of the device can rotate 360 ° in any direction. Adjust either direction of the rotating button by thumb and index finger to adjust the maximum visibility of the Jaw.

3) Before placing the applier around the tissue to be closed, the loop handle is forced to clamp the tissue or blood vessel.

4) When placing the Clip around the tissue to be closed, ensure that the tissue fully conforms to the scope of the Jaw.

Warning: when the tissue and blood vessel are completely closed by Applier, please pay attention to the occurrence of bleeding or leakage. Before firing, make sure that the Ligating clip to be struck has enough distance of more than 5mm from other Ligating clip and other obstacles. Firing on another Ligating clip will cause bleeding, insufficient hemostasis, or damage the Jaw of the Applier.

5) Press the handle to the bottom when firing the Applier. When the handle is squeezed, the Jaw firmly closes the tissue or blood vessels.

Warning: if the handle is not fully squeezed, it may cause Ligating Clip deformity, or bleeding and leakage.

6) Release the handle to separate from the Ligating clip, and remove the Applier from the blood vessel or tissue.

7) If it is necessary to use the Ligating clip again, and carry out the above 1-6 steps again.

Ligating Clip Applier (CR E/O), releasing the Ligating clip:

1) Loosen the tissue clamp, determine the specification, model and size of the tissue clamp, select the matching application clamp, align the tissue clamp and apply pressure, the tissue clamp will automatically spring open and take out the tissue clamp.

Warning: when releasing Ligating clip after applying force, remember to take the released Ligating clip out of the body. If the released Ligating clip is left in the body, maybe injury other tissues and organs.

2) Take the loosened Ligating clip out of the body, and it is not recommended to use it again.

【Maintenance】

Inspect instruments after each sterilization cycle and prior to each use as they may be damaged during transit to the customer, during receiving at the customer’s site, during use in a previous procedure or during the cleaning or sterilization processes.

All moving parts must be inspected for wear and confirmed to be functional. Confirm smooth operation during opening and closing of instrument handle and reinforcing screw. Inspect instruments for readability of device markings, as applicable, rust, pitting, cracking or burrs, staining or discoloration and worn or broken parts. Repair or replace any instrument found not to be acceptable.

Immediately following each complete sterilization cycle the instrument should be inspected prior to use. The instruments should be inspected for signs of rust, cracking, pitting, breaking, staining and/or discoloration, burrs, sharp edges or protrusion as well as any other signs of defect.

Special attention should be paid to ensure the instrument shaft is perpendicular to the instrument cap.

Instruments found with any signs of the aforementioned defects are not safe for use with patients and should be immediately discarded.

【Ligating system compatibility】

There are a number of ligating clips on the market today in addition to Ligating Clip Appliers from 3R Medical. Your 3R Ligating Clip Appliers have been designed for use exclusively with Ligating Clip Appliers made by 3R. Applier color coding matches the color of the ligating clip substrate with which it is to be used. 3R Medical does not assume responsibility for unsatisfactory results caused by the use of any equipment or clips not specifically identified by 3R Medical as an integral part of this specific system.

【Signs and Symbols Used on Labels and Marks and Their descriptions】