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About safety Isolation Bag

Overview

Warning & Precautions

  • Product Summary

    Safety Isolation Bag™ Single-use Pneumoperitoneum Device comprises of a medical grade flexible device with a wide mouth opening and non return valves attached to the walls of the device which is made up of single or multi layer construction. Safety Isolation Bag™ is provided with an Obturator with a thumb handle and blunt tip for easy insertion of Safety Isolation Bag™ through the laparoscopic port/ incision.

    The Safety Isolation Bag™ Pneumoperitoneum Device and introducer (obturator) are disposable components and are supplied sterile for one time use only. In the fully deployed condition, the multi layer construction of the device helps in easy-opening of the device. This mouth end is utilised for insertion of the pelvic masses into the device which are to be morcellated or extracted using an electromechanical morcellator. The non return valves and the multilayer leak proof construction helps the surgeons to perform the morcellation with multiple instruments through the existing incisions.

  • Description

    The main parts of the Safety Isolation Bag™ Pneumoperitoneum Device are shown in Figure 1 The Safety Isolation Bag™ has markings for easy identification and visualization during surgery. The markings on the Safety Isolation Bag™   are given in Figure 2 Markings labelled in the Figure 2 have the following interpretations:
    1. Black thick line mark on the neck end of the Safety Isolation Bag™ . This marking indicates that the device should be pulled out only till the end of the marking after placing the surgical specimen for morcellation.
    2. Small black line at the neck end of Safety Isolation Bag™   This marking indicates that the Safety Isolation Bag™ should not be pulled out beyond this line during the morcellation procedure.
    3. Non return valves –color coded This valves are provided to insert trocars directly into the Pneumoperitoneum Device through the abdominal incisions for using multiple instruments for the surgery without gas leakage once the trocars are  penetrated the device and in place.
    4. Safety Isolation Bag™ logo on  the mouth opening  & inside the body of the device .This marking / logo indicate inner side of the Pneumoperitoneum Device  and this helps surgeon in understanding inner side of the device while inserting tissue inside the Safety Isolation Bag™ and also during the procedure.
  • Introducer (Obturator) Description

    The introducer obturator is a tubular part made of rigid plastic tube. Figure 3 is a representative image of the obturator. The distal end of the Introducer obturator is blunt, which help in easy and safe insertion of the Safety Isolation Bag™ in to the abdominal cavity by pushing the device through the abdominal incision. 5A. FLEXIBLE WASHERS – OPTIONAL: (12mm, 8mm & 4mm) The flexible washers can be used as a means to prevent any unexpected gas leakage through the skin incision sites by passing the instruments (trocars or morcellator hand piece) through the respective washers first and then introduce into the Safety Isolation Bag™.
  • Technical Specification - Safety Isolation Bag

    The volume of Safety Isolation Bag™ can be adjusted with the markings printed in the neck. For small sized lumps or tumors, the Safety Isolation Bag™ can be pulled out till the last marking labelled “Small”. Like the same, for removing medium sized and large tumors, the Safety Isolation Bag™ should be pulled to the respective markings labelled as “medium” & “large”.

  • Technical Specification - Introducer (Obturator)

    Introducer (Obturator) with Blunt tip: Size- 10 mm OD x 250 mm length Flexible washers: Size- 12 mm, 8 mm & 4 mm
  • General Precautions

    The Instructions for Use – manual should be thoroughly studied and ensured that all the instructions given in this user manual are followed while using the device. This product is intended for use only by clinicians with adequate training, knowledge and experience in the use of laparoscopic endoscopic procedures. The clinician is advised to consult the medical literature regarding techniques, complications and hazards associated with the intended procedures.

    Failure to carefully follow all applicable instructions may result in significant injury to the patient, surgeon or attendants and may have an adverse effect on procedural outcomes. Good surgical practices should be followed for management of contaminated or infected wounds.

    Use of Safety Isolation Bag™ should be considered in patients whom the physician determines are not high-risk surgical candidates.

  • Procedural Precautions

    The sharp blade of the Morcellator should be kept completely covered or in “OFF” configuration during its insertion and removal through the Safety Isolation Bag™. Insertion of Safety Isolation Bag™ through the laparoscopic port, morcellation of tissue masses inside Safety Isolation Bag™  and removal of Safety Isolation Bag™  from the abdominal cavity should be performed under direct visualization at all times. Safety Isolation Bag™ is devised to act as a complete Pneumoperitoneum Device, a containment receptacle during endoscopic morcellation or tissue extraction procedures of a benign pelvic tissue masses after the tissues have been detached from its stalk.

    Caution should be exercised when introducing or removing sharp instruments to prevent inadvertent damage to device. Special care should be exercised when inserting sharp or angled-edged endoscopic /laparoscopic instruments to prevent tearing of the device.

  • Device Related Precautions

    Careful inspection of the Safety Isolation Bag™ and all associated equipments prior to use is extremely essential. If the sterile packaging of Safety Isolation Bag™ appears to be damaged or if the seal is opened, please DO NOT attempt to use it as the sterility of the device may have been compromised.

    Safety Isolation Bag™ and its introducer are single use disposable devices. DO NOT re-sterilize or re-use.

    Do not use any part of Safety Isolation Bag™ or introducer beyond the indicated expiration date. Safety Isolation Bag™ is intended for only one-time use in surgery. Safety Isolation Bag™ should be constantly monitored by video when used for morcellation or tissue extraction.

    Follow aseptic techniques, while introducing the Safety Isolation Bag™ into the abdominal cavity. It is recommended to use blunt instruments for holding or pulling out the device so as to prevent damaging integrity of the product.  Laparoscopic Power Morcellator should be introduced inside Safety Isolation Bag™ while in ‘off’ configuration and with a clockwise spiral movement. Obturator  of the morcellator should always be used for while introducing a tissue morcellator into the Safety Isolation Bag™.

    While using Safety Isolation Bag™ in conjunction with exposed blades or cutting instruments, care should be taken to avoid contact with Safety Isolation Bag™ device as this may rupture the device.

    Safety Isolation Bag™ should not be used with vacuum-assisted Morcellator.

    After use disposal should be done in the safe manner in accordance with the applicable regulations or as per the disposal procedure followed in your healthcare institution.

  • Adverse Events & Potential Complications

    Safety Isolation Bag™ system may get ruptured during surgery and may cause spillage of tissues, blood or fluids in the patient. If this happens, the tissue could get left in the body and cause an infection, pain, or tissue growth, including cancerous growths. As with any surgical procedure, there are also risks of damage to surrounding tissues or having to convert to open surgery (with bigger incisions).

  • Contraindications

    Safety Isolation Bag™ should not be used for morcellation or removal of tissue which is suspected or confirmed to be cancerous.

Figure 1

figure 1

. . . .
  1. Mouth opening of Safety Isolation Bag™.
  2. Retractor Means.
  3. Non Return valves.
  4. Retrieval space of the device.
  5. Long looped thread attached to the upper wall of the device.
  6. Neck end of the Safety Isolation Bag™.
  7. Indication to adjust the volume (small, medium & large).
  8. Blunt tip Obturator for inserting the device.