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Surtex Expansys™ II Skin Graft Mesher With Sterilization Case ,
Product Code: SG-200-00
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Surtex Expansys™ II Skin Graft Mesher System With Sterilization Case


 Advantages

Unique design eliminates need to change the cutter during surgery.

Easy adjustment for think and thick skin grafts.

Skin graft carrier plates in two popular expansion ratios, 1.5:1 and 3:1. 

 Ease of Use

Single cutter cuts skin graft into geometrical shaped mesh & enlarges skin surface.

Graft expansion predetermined by graft carrying plates, eliminating need to change cutter during operation.

Continuous feed design prevents graft carrying plate from being loaded incorrectly and allow multiple plates to be used without interruption.

Graft thickness adjustment features allow expansion on thin and thick skin grafts.

Easy availability of replacement parts.

Legend
  1. Carrying Handle
  2. Fastening Screws for Carrying Handle
  3. Cutting Roller
  4. Knurled Feed Roller
  5. Graft Thickness Adjustment Knob
  6. Graft Thickness Adjustment Scale
  7. Transmission Gears
  8. Shaft of Cutting Roller
  9. Side Plate
  10. Fastening Screws for Side Plate
  11. Ratchet Handle
  12. Graft Carrier Plate
  13. Guidance Plateau
  14. Insertion Tray for Graft Carrier Plates
  15. Oil less Bearings

Contents

  1. Safe Handling (Page 2)
  2. Product Description (Page 2)
  3. Warnings & Precautions (Page 2)
  4. Preparation & Setup (Page 2)
  5. Working with Surtex (Page 3)
  6. Processing the Skin Graft (Page 3)
  7. Care & Handling (Page 4)
  8. Maintenance (Page 4)
  9. Troubleshooting List (Page 5)
  10. Technical Service (Page 5)
  11. Accessories / Spares (Page 5)
  12. Technical Data (Page 5)
  13. Disposal (Page 5)


1.         Safe Handling

­­­­­­­­

  • Prior to use, check for proper condition and functioning of the product.
  • To avoid damaging the product through improper setup or operation and mitigating the warranty and liability on the part of the product’s manufacturer:

ü             Use the product only according to these instructions for use.

 ü           Follow the safety instructions and maintenance advisories.

ü            Only combine recommended products with Surtex products.

  • Only have the products and accessories operated and used by persons who possess the requisite training, knowledge or experience.
  • Keep the instructions accessible for O.R. staff.

    2.        Product Description

 2.1      ­­­­­­­­­­­­­­System Components

Description of Product

Code No.

Expansys® II Complete with Sterilization Case

SG-200-00

Surtex Expansys® II Instrument Only

SG-200-90

Ratchet Handle

SG-200-92

Sterilization Case for Surtex Expansys® II

SG-200-95

Graft Carrier Plates Factor 1.5:1 (Box of 20)

SG-210-15

Graft Carrier Plates Factor 3:1 (Box of 20)

SG-210-30

Graft Carrier Plates Factor 6:1 (Box of 20)

SG-210-60

Ratchet Handle: The ratchet handle has been designed and manufactured to use with the Surtex Expansys® II skin graft mesher. The ratchet handle can be disassembled easily and is fully autoclavable.

Graft Carrier Plates: The graft carrier plate is disposable specially formulated board 7.8 cm wide and 20.4cm long. Each carrier is sterile packed and available in a box of 20. The packaging maintains the sterility of the skin graft carrier and ensures they are ready to be used once removed.

2.2      Intended Use

The Expansys® II Tissue Expansion System is intended to perforate skin grafts so that it may cover a recipient larger than a donor site. The Expansys II also provides enhanced drainage, increased edge exposure, minimum contracture and conformance to irregular body surfaces.

2.3      Contraindications

Meshed grafts may not be suitable for patients known to form keloids, or in areas subject to constant trauma (e.g popliteal fossa). Use in these areas has resulted in severe scar contractures.

2.4     Mode of Operation

The cutting roller 3 is turned anticlockwise with ratchet handle 11. Graft Carrier Plate 12 transports the skin graft between cutting roller 3 and knurled feed roller 4. During this transport the skin graft cuts into geometrical pattern. The cutting depth is set with adjustment knob 5, using scale 6. The staggered slits in the skin graft allow expanding the graft into rhombic skin mesh. The skin mesh can be used for covering defects of up to 6 times the size of grafting site.

    3.        Warning & Precautions

  • The user of Surtex Expansys® II System must be thoroughly aware and familiar with its function, application and instructions for use so to avoid serious injury to the patient and operating staff.
  • The operating staff and user must follow diligently the care & handling instructions, manual disinfection & cleaning instructions, sterilisation methods and parameters and maintenance routine of the system. Failure to follow these instructions may damage the Surtex Expansys® II System.
  • Surtex advises to use only Surtex Graft Carrier Plates with Surtex Expansys® II System. Use of any other carrier will damage the device and the skin graft.
  • The Graft Carrier Plates are intended for single use only and should be disposed of safely after use. Reusing the Graft Carrier Plates may result in unsatisfactory mesh pattern.
  • The graft carrier plates should only be placed into the device with grooved pattern facing up and skin must also only be placed on this side. If the skin is placed upside down on to the flat surface, it will result in the skin being meshed in to long strips rendering it unusable.
  • The Graft Carrier Plates are to be used at room temperature and they should not be exposed to heated solutions, which may alter the material properties and result in unsatisfactory skin grafting. The Graft Carrier Plates must not be placed in an autoclave as it will result in the plastic melting and bonding to the metal surface.

    4.        Preparation & Setup

   Surtex Expansys® II System should be inspected thoroughly prior to each use.

   Non-compliance with these rules will result in complete exclusion of liability on the part of Surtex Instruments.

4.1      Visual Inspection

  •   Observe the following rules when setting up and operating the product:

     ü  Prior to use, inspect the Surtex Expansys® II System and its accessories for visible damage.

    ü  Only use the Surtex Expansys® II System and its accessories if they are in perfect condition.

    ü  Be certain that the Surtex Expansys® II system is setup on sufficiently stable support (e.g. table, equipment cart, etc.).

  4.2     Functional Check

  • Ensue smooth intended operation by checking action of moving parts through the entire motion by carrying out a trial run of Surtex Expansys® II System prior to use:
  • Verify the gears for transmission 7 is moved when turning ratchet handle 11.
  • Make certain that adjustment knob 5, once disengaged, can be easily rotated through the range of scale 6.
  • Only use the device if it is in perfect condition.

     Note: If damage and wear is noticed do not use the device and contact Surtex Instruments at the address given in this usage guide for a Repair or Replacement.

      5.        Working with Expansys® II System

  5.1      System Setup

  • Surtex Expansys® II System should be cleaned and sterilised as per instructions in this usage guide prior to first use.
  • The user must observe sterile field precautions as per hospital protocol.
  • Place the Surtex Expansys® II System on a sufficiently stable support table with the extension of the knurled feed roller 4 facing up.
  • The ratchet handle 11 is placed on the extension of knurled feed roller 4.
  • The ratchet handle 11 is fully inserted when the end of the knurled roller 4 extension is flush with opposite side of the ratchet 11. Be careful not to force the ratchet handle 11 on the Surtex Expansys® II System.
  • If there is trouble with insertion it may be that the roller end of the ratchet may be misaligned with the similarly shaped end of the ratchet handle. To enable alignment grasp the knurled roller to keep it stationery and turn the ratchet handle until both shapes match allowing pushing the ratchet on completely.
  • Once the ratchet handle is attached, the Surtex Expansys® II system is ready to use.

Risk of of infection and contamination!

The device and its accessories are delivered in unsterile condition.

Sterilize the device and accessories as per the instructions in this usage guide.

  5.2     Graft Thickness Adjustment

Make certain that the Graft Carrier Plate is not engaged between cutting and knurled roller when attempting to adjust the graft thickness scale as this would cause damage to the cutting roller.

  • Slightly pull out adjustment knob 5 until it disengages.
  • Turn adjustment knob 5 to the required position.
  • Slightly push in adjustment knob 5 until it engages.

     6.        Processing the Skin Graft

Note: Only place individual Graft Carrier Plates on the guidance plateau, one after the other. For long skin grafts, sequentially insert several Graft Carrier Plates.

Coiling of the skin graft! The skin graft can be lifted off from carrier plate as soon as it has been cut into by the cutting roller!

Press the skin graft onto the Graft Carrier Plate, using fine forceps, directly behind the cut-in line.

  • Choose the appropriate Graft Carrier Plate 12 for desired expansion ratio.
  • Ensure the Graft Carrier Plate 12 is aseptically removed from the sterile packaging and introduced into the sterile field.
  • Place the Graft Carrier Plate on a flat surface with the grooved side facing upwards.
  • Position the graft carefully on the Graft Carrier Plate with grooved side up and the smooth side down to ensure proper mesh graft.
  • Align the Graft Carrier Plate on the guidance plateau 13 pushing gently against the guidance plateau to ensure proper alignment.
  • Introduce the leading edge of the graft carrier plate into the Surtex Expansys® II System by applying a little pressure on the opposite end of the Graft Carrier Plate to assist in initial engagement while turning the ratchet handle 11 slightly anti-clockwise. The Graft Carrier Plate is now transported.
  • As the Graft Carrier Plate is transported through the Surtex Expansys® II system check to ensure that if the graft has not disengaged from the cutting roller 3 otherwise use fine forceps to grasp the leading end of the graft and disengage the meshed portion from the cutting roller. Care should be taken to avoid damaging the cutting roller blades when attempting to disengage.
  • Ensure the uncut portion is kept straight and taut at all times while the Graft Carrier Plate is transported through the Surtex Expansys® II System.
  • Constant downward pressure on the graft carrier plate while it is transported through the device will ensure that the Graft Carrier Plate does not attach itself to the cutting roller. Rotating the handle from the 10 o’ clock position to 2 o’ clock position will cause the carrier to exit out of the back of the Surtex Expansys® II System.
  • Remove the meshed skin graft from the Graft Carrier Plate and apply to the required site.

      7.        Care and Handling

   Note: For patient with Creutzfeldt – Jakob disease (CJD), suspected CJD or possible variants of CJD, the relevant national regulations concerning the reprocessing of the products     must be observed.

   7.1      Manual Disinfection & Cleaning

  • Wipe off the product with a clean, lint-free cloth soaked in cleaning and disinfecting agent

OR

In order to prevent formation of sticky or encrusted residues, spray the product with a disinfecting agent.

  • Wipe off the component surface with a clean, lint-free cloth.
  • Follow the disinfectant manufacturer’s instructions.
  • To avoid damage to cutting roller 2, clean the cutting roller with a soft brush.

   7.2      Mechanical Cleaning & Disinfection


               Damage to the Expansys® II system caused by incorrect mechanical cleaning!

Only clean the Expansys® II system in a suitable storage aid.

Always use a suitable cleaning and disinfection program for mechanical cleaning.

Do not use alkaline cleaning agents.

  • Carry out mechanical cleaning immediately after the operation.
  • To avoid abrupt changes in temperature, use a single-chamber washer disinfector.
  • Select a cleaning and disinfecting cycle according to the following criteria:

                 ü  Neutral detergent.

                 ü  Cleaning temperature ≤ 50 °C.

                 ü  Final rinse with simultaneous thermal disinfection with demineralized water.

     7.3      Care & Inspection

               Allow the product to cool down to room temperature.

              Inspect the product after each cleaning and disinfecting cycle to be sure it is clean, functional and undamaged.

    7.4     Sterilization Method and Parameters

           Note: The Graft Carrier Plates are ETO/Gamma sterilized single use products. These products must not be steam-sterilized and are intended for single use only.

           The Expansys® II system can be sterilized in its sterilization case.

  • Sterilize the Expansys® II system immediately after cleaning.
  • Store the Expansys® II system in a suitable wire basket.
  • Sterilize with steam, taking note of the following:

Carry out steam sterilization via an approved steam sterilization procedure (e.g. sterilizer in conformance with EN 285/ANSI/AAMI/ISO 11134-1993, ANSI/AAMI ST46-1983 and validated in conformance with EN 554/ISO 13683). In the fractioned vacuum process, the sterilization must be performed using the 134 °C / 2 bar program with a minimum holding time of 5 minutes.

     8.        Maintenance

    To ensure reliable operation Surtex Expansys® II system should be returned every 12 months for inspection and preventive maintenance. Annual factory calibration is essential to ensure and verify continued accuracy.

For service, maintenance and repairs, please contact the Surtex Instruments representative in your country, see Technical Services.



      9.        Troubleshooting List

­­­­Error

Finding

Cause

Remedy

Cutting roller 2 fails to rotate

Foreign body in device

Cutting roller jammed

Remove foreign body

-

Ratchet handle 9 not engaged.

Engage ratchet handle 9

Cutting roller 2  moves stiffly

Strong force required on ratchet handle 9

Defective bearing

Repair by manufacturer

Skin not cut through completely

Symbol on scale 13 shows cutting; incorrect fine adjustment

Incorrect Setting

Select the required fine adjustment, see Safe Operation

Cutting tips shiny, ratchet handle 9 stiff

Cutting roller 2 worn

Repair by manufacturer

Cutting tips broken off

Cutting cylinder 2 defective

Repair by manufacturer


    10.      Technical Service

     For service, maintenance or repairs contact your Surtex Instruments representative.

     Carrying out modifications on medical equipment renders the guarantee, and any licenses, null and void.

             Service Address

               Surtex Instruments Ltd.

               47 Kingston Hill

               London KT2 7PS

                England

                Phone: +44 (0) 208 123 3513

                 Email: aftercare@surtex-instruments.co.uk

       11.       Accessories & Spare Parts

Expansys® II Complete with Sterilization Case

SG-200-00

Surtex Expansys® II Instrument Only

SG-200-90

Ratchet Handle

SG-200-92

Sterilization Case for Surtex Expansys® II

SG-200-95

Graft Carrier Plates Factor 1.5:1 (Box of 20)

SG-210-15

Graft Carrier Plates Factor 3:1 (Box of 20)

SG-210-30

Graft Carrier Plates Factor 6:1 (Box of 20)

SG-210-60

      12.      Technical Data

­­­­­­­­­Model

SG-200-00

Dimension (L x W x H)

16 x 11.6 x 12.5 cm

Weight

Approx. 4.00 KG

Length of Graft Carrier

7.8 cm

Width of Graft Carrier

20.4 cm

       13.      Disposal

                 The Expansys® II system is made of aluminium and stainless steel.

  • Dispose of the device with other recyclable metals.