IMS - Integrated Medical Systems International, Inc.

Flexible Endoscope Repair Technical Excellence - Page 3


Service Turn-Around Time and Equipment Protection

Incoming Inspection

Disassembly and Repair Process

Final Inspection and Test

Personnel and Training

Quality System

Value-Added Programs



Disassembly and Repair Process

Describe the disassembly process - including work environment, tools, methods and procedures.

Disassembly is conducted in a clean environment using procedures that maintain the performance standards of the endoscope. Functionality testing of all endoscope components occurs following reassembly to ensure that the endoscope meets manufacturer performance standards.

Repair Process

What materials and processes are used for bending sheath replacement?

IMS uses a more expensive fluoroelastomer (Viton®) bending sheath replacement. This is the same material used by the OEMs, and its use ensures that the angulation performance is the same as the OEM performance. Bending sheath size specifications are comparable in length and wall thickness to the original manufacturer's components. Bending sheath epoxy is USP Class VI, measured precisely to the epoxy manufacturer specifications, including weighing components to 1/100th of a gram prior to mixing.

Is Teflon® tape ever used in bending section repair?

IMS does not use Teflon® tape in bending section repair.

What materials and processes are used for biopsy channel replacement?

IMS uses a Teflon® biopsy channel in its endoscope repairs. This is the same material used by the OEM's. Biopsy channels are manufactured to meet the OEM inner and outer diameter standards. Biopsy channels are of one-piece construction with uniform wall thickness.

How are endoscope housings and gaskets repaired?

Many O-rings and gaskets used in flexible endoscope construction are commercially available. IMS tests all O-rings and gaskets for material and durometer (hardness) properties to ensure an appropriate match.

Through the use of its Advanced Component Engineering™ protocol, IMS can obtain O-rings and gaskets that are not universally available by defining the component's properties for commercial manufacturers.

IMS does not use flexible sealants in place of O-rings or gaskets. Flexible sealants are used only to replace the flexible sealants used in the original construction of the endoscope.

How are flexible endoscope angulation systems repaired?

Wire / Stopper Tension TesterAll materials used for angulation system repairs are fully compatible with the OEM design. Wire / Stopper Tension TesterIMS verifies angulation cable tensile strength through testing with a calibrated force gauge. Torque testing of the angulation system using proprietary fixtures also ensures that angulation torque of IMS repairs are consistent with measured OEM performance.Single wire replacements and coil pipe shortcut repairs are not performed by IMS. All incoming and outgoing scopes are tested against known angulation standards.

How is optical quality maintained?

IMS has a dedicated Optics Department that ensures that all optical components are manufactured using the correct glass type, coatings and physical dimensions. Through Advanced Component Engineering™ (ACE), IMS is able to determine these critical design features and have lenses made that are fully compatible with the original design.

How are distal end repairs conducted?

IMS provides quality distal end repairs relative to both the materials used and the processes employed:

  • IMS distal end C-covers meet the same performance standards as the OEM and have been successfully used for years.
  • Sealing of the distal end objective lens with adhesive is accomplished without creating an overlap of adhesive. When an adhesive overlap is present, a risk of chipping the lens is created during future repair processes. The IMS process eliminates leaks and prevents microbial contamination.

What types of epoxies are used in the repair of flexible endoscopes?

A prime example of our commitment to quality in material selection is the adhesives used in endoscope repair. Many criteria go into this selection, including:

  • Biocompatibility


  • Functional Characteristics
    • Ability to withstand sterilization / reprocessing chemicals and / or high-level disinfection
    • Impact resistance
    • Color and Smoothness
    • Adherence / Ability to bond dissimilar materials (where appropriate)
    • Thermal expansion / contraction

As an example, the adhesive that IMS utilizes on bending sheath repair is a high performance, Class VI epoxy resin that meets OEM chemical, mechanical, and physical properties. It has been tested against repeated autoclaving, chemical sterilization, radiation, and ethylene oxide gas (EtO). It has been tested to withstand a temperature range of -60 to +400 degrees Fahrenheit. IMS chooses to only use adhesives that are proven to be biocompatible and functionally equivalent to the adhesives used in the original manufacture of the endoscope.

Adhesive used by IMS is impervious to normal reprocessing processes.

Provide information on insertion tubes used in flexible endoscope repairs.

The insertion tubes used by IMS are materially and functionally equivalent to the insertion tubes used by the OEM. Functional and material parameters include:

  • Physical Length and Diameter
  • Flexibility / Stiffness
  • Outer Covering
  • Markings
  • Double Coil Construction

IMS precisely measures the basic flexibility / stiffness of insertion tubes at known points along the tube using a proprietary force-displacement apparatus (shown below).

IMS precisely measures the basic flexibility / stiffness of insertion tubes.

A known amount of force is placed on the tube and the amount of displacement or "flex" is measured. This is accomplished for both OEM insertion tubes and IMS insertion tubes to ensure that flexibility / stiffness is consistent between the IMS tube and the OEM tube.

Can you repair the variable stiffness function of a flexible endoscope?

IMS can repair all facets of the flexible endoscope variable stiffness function.

The variable stiffness function is created by the use of a constriction wire within a coil pipe assembly. It is much like a biopsy forcep that does not have the forcep function in place.

When the variable stiffness control knob is turned for an increased stiffness, the wire constricts, causing it to straighten - and thus stiffen the insertion tube.

IMS has the expertise and all of the parts necessary to perform repairs on the flexible endoscope variable stiffness function.

Is the installation of a boot extender offered as a repair option?

IMS does offer the installation of a boot extender as a non-original specified repair alternative for our customers.

The boot extender covers a damaged area of the insertion tube and prolongs the life of the insertion tube.

This repair is made only with the customer's full knowledge and consent and will not be performed if the endoscope's internal components might be compromised.

This repair is also completed in conjunction with providing education on the cause of the original problem.

What type of lubricants do you use in flexible endoscope repairs?

IMS uses four types of lubricants on flexible endoscopes.

For dry lubricant applications, we use boron nitride powder and molybdenum disulfide powder (depending on the specific application). For wet (grease) lubricant applications, we use molybdenum disulfide in a grease form for moving components, and a water resistant silicone compound for sealing gaskets and other non-moving parts.

 

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