View AllMANUFACTURING PROCESS
STEPS
1. Steel
The quality of steel is very important in the production of quality instruments. The best you select the best you produce. In order to ensure the finest of quality steel, we have imported or best quality local steel as required by valued customers.
2. Forging
Forging is a process of cutting shaped raw instruments with the help of dyes and hammers. Here, the skilled hands give life to the metal and give it the rudimentary shape that will go through series of complicated processes.
3. Machining
In this process forging is cut or shaped by machines i.e. cutting sharp edges and raw material in the shape. Here instruments are given their shape through grinding and hammers. For this purpose, extremely skilled labor is required and this process is carried out by instrument specialists only.
4. Milling
Drilling of holes in the instruments where required for screws. Different kids of screwing machines are used and instruments are made pairs here. Instruments with even the slightest difference in whole positions will suffer otherwise.
5. Filing & Fitting
At this stage, the steel is not too hard so the filing is used to shape the instruments in the exact shape they are required to be. The workers match the shape exactly with the samples provided at this stage. So the instruments get most of their shapes at this stage. After filling the inspection is made and measurements and shapes are checked according to samples.
6. Boil Treatment
The technician uses boiling water to sterilize metal tools, rubber, or plastic when water starts to boil the item goes in for 20 minutes. At the end of 20 minutes, the technician carefully removes the items with sterilized tongs. The items are immediately moved to a sterilized container.
7. Heat Treatment
Surgical instruments are exposed to extreme environmental conditions when in use and still have to fulfill the highest quality criteria in terms of hygiene. Technological advancements have led to substantial progress in providing the latter. The right choice of material sets the foundation for meeting quality requirements.
8. Hardness Test
After annealing as well as heat-treatment, the instruments are tested using diamond-tipped Rockwell hardness test fixtures to ensure the proper hardness of instruments.
Surgimax quality control team sends instruments to independent testing institutes as well to validate the results.
9. Acid Pickling
Pickling is performed by submerging metal in pickle liquor. After working on a piece of metal, the manufacturing company will submerge it in the acid solution. The pickle liquor will then eat away at any oxide or other impurities lingering on the surface of the metal.
10. Joint Grinding
For this reason, the field of Medical Orthopedic Implant grinding has become an attractive diversification strategy for existing and new players in the CNC tool cutting business. Joint reconstructive surgery is largely dominated by knee, hip and shoulder procedures, all of which involve orthopedic implants and associated instrumentation that typically require grinding during the manufacturing process.
11. Electro Chemical 1
The present invention concerns an electro-chemical surgical knife comprising in a single instrument both a chemically assisted mechanical dissector and an electrical knife.
12. Final Setting
There are a wide array of instruments available for use during a surgical procedure, each with its specific uses and advantages (and disadvantages). As a surgeon, it is important to know not only their names but when they should be used, and each specialty will have its own specific kit.
13. Surface Grinding
The basic shape of the tool is often machined on Swiss-type lathes in a more pliable state. This includes the driving notch, which is the quick-disconnect and driver feature at the end of the shank. This operation is followed by hardening or by centerless grinding.
14. Ring Grinding
Hardened instruments are next ground (using fine and extra fine wheels and belts) to remove deep scratches from the medium-coarse grinding/sizing in the previous stages. This step is also used to size the product as per the requirements. Typical tolerances of ± 2 millimeters are achieved at this stage of processing.
15. Beveling
16. Electro Chemical 2
After 2 grinding instruments are then electro-polished which is a process of smothering the surface anodically of instruments in the required chemical solution and gives a shiny look which also removes burs from instruments.
17. T.C Welding
Tungsten carbide (TC) is classed as a carbide, which you’ll find in the overall group of ceramics, but we thought it worth a mention in this article too. It is composed of tungsten and carbon atoms and is used in the manufacture of various instruments. These include:
- Needle holders
- Scissors
- Pin cutters
- Pliers
- Wire tighteners
Since tungsten carbide is harder than steel, it offers exceptional durability. Usually, the TC is soldered or welded to the jaws/working ends of instruments. TC inserts that are soldered can be separated from the instrument and replaced.
18. Alignment
The procedure of surgical instrument alignment:
(a) Target in the surgical area;
(b) Move the tip of the surgical instrument to the insertion point;
(c) Rotate the surgical instrument and adjust its orientation ;
(d) Surgical instrument aligned to the target orientation by identifying coaxial point or parallel projection lines the surgical instrument or parallel projection straight lines on the cylindrical surface of the surgical instrument.
(e) Stabilize the surgical instrument after achieving the surgical path by the alignment of the insertion point and orientation.
19. Initial Polishing
When instruments get electro-polished, they are moved to the polishing section where El Mar International experienced workers give the finish shape to the instrument and make it smoother through the use of different polishing equipment.
20. Sand Blasting
After passivation, the polished instruments are transferred to sandblasting unit where the joint, teeth, and ratchet of instruments are sandblasted to give them a matt look and protect them from corrosion while usage. Sandblasting is effective for removing light or dark spots over instruments’ surfaces.
21. Final Pollishing
After the alignment and inspection process, all the instruments are polished as per the final requirements either to a mirror polish, satin, or sand finish.
22. Final Sand Blasting
This is the process where sharp edges are removed through the use of specialized machines to make the instruments smooth in all ways to avoid any failure during use.
23. Ultrasonic Cleaning
Once an instrument gets to this stage, it is primarily a finished product and is next subjected to deep cleansing and decreasing of oils and finishing materials in water or chemical-based ultrasonic cleaning machines before sending it for a final inspection.
24. Copper Sulfate Test
25. Passivation
Passivation is the removal of iron compounds from the surface of the steel, by means of chemical treatment. A Nitric Acid solution is used, which removes any surface contamination and forms a protective passive layer. The layer itself is very thin, typically 30 to 50 micron (µ) for stainless steel.
26. Boil Test A/B
The Boil Test is performed to check the presence of corrosion in surgical instruments resulting either due to some process faults or some material composition problem disturbing the passivation layer of the stainless steel surgical instruments.
27. Lab Testing
After the boiling test, instruments used for the lab testing.
28. Device Adjustment
Surgical instruments were the earliest products of biomedical engineering. Principal knowledge of the surgical tools used in classical (open) surgery is a precondition to understanding the mode of action and design of even more sophisticated instruments as used in flexible endoscopy, laparoscopy, or NOTES. In this chapter, the most important items, such as forceps, clamps, scissors, retractors, and needle holders are explained. The therapeutic use of electrosurgery is described as well as new tissue dissection techniques like ultrasound and water jet dissection. A detailed description of stapling devices is followed by an overview of suture materials and meshes.
29. Gold Plating
Some instruments are too much important and should be gold plated for proper use in surgery.
30. Final Inspection
After final cleaning / decreasing, instruments are thoroughly hand-examined with a microscope and tested by a highly qualified team of QC inspectors. Each and every
the aspect of an instrument is examined including serrations, ratchets, jaws, and teeth while testing the cutting, grasping, and moving functions.
31. Device Marking
All the instruments that are approved by the final inspection department are finally laser or stencil marked with the product code. El Mar International also provides OEM services where instruments are supplied with customer brand names under their exclusive packaging.
32. Packaging & Labeling
Instruments are then packed in polythene bags and thermal labeled with the item name, code, description, and batch/lot number to give maximum information to consumers while usage.