Development and Innovation of
Medical Equipment

Products

 

     
  ClampCut SCC23 ClampOff  

 

Once you have tried the ClampCut - SCC23, you will never return to the traditional method for clamping, cutting and tying the umbilical cord.

The ClampCut - SCC23 is a disposable obstetric instrument that cuts the umbilical cord and simultaneously clamps and secures the severed ends.

The traditional four-stage clamping, cutting and/or tying process is replaced by one easy action.

The procedure is not only simpler and faster; it is also safer - both for the newborn infant, mother and for nursing staff - and more cost effective than the traditional procedure.

Advantages:

  • One instrument - one easy action

  • No blood spray

  • Reduces danger of infection

  • From traditional four-stage procedure to one

  • Secures both ends of the umbilical cord simultaneously

  • No sterilisation

  • Disposable 

How it works

The ClampCut - SCC-23 is ready to use immediately after it has been removed from its sterile peel-pack.

The umbilical cord is inserted in the open end of the instrument about 1 cm from the infant's stomach. Thereafter, the index and middle fingers are hooked around the rests on either side of the instrument and the thumb is placed on the flat end of the piston. Minimal pressure with the thumb pushes the piston forward, cutting the cord.

As the cord is cut, a small white clamp closes tightly around the end of the cord attached to the infant and separates from the rest of the instrument.

The same action clamps the main body of the instrument around the end of the cord attached to the placenta. This clamp can be reopened to permit the drawing of blood from the placenta for examination, should this prove necessary.

 

       
  ClampCut round cord   Fingers and thumb in position   Cord is cut and clamps separated

If desired, the ClampOff tool can be used to remove the white clamp from the enfant side of the umbilical cord. This is however not required, since the cord will dry up and fall off within a few days as normal.

 

Safe and sure

The obstetricians and midwives at the University Hospital of Copenhagen who carried out the clinical testing of the ClampCut - SCC-23 have described it as a valuable innovation that significantly increases safety for infant, mother and staff in both normal and caesarean deliveries.

Because the cord is cut and its ends are clamped simultaneously, there is no risk of blood splatter. This substantially reduces the danger of infection of staff from diseases carried by the blood. The risk of infection of the infant's navel is eliminated.

 

 

A high quality product

Quality approvals:

  • Clinically tested at the University Hospital and approved by Scientific Ethics Committee in accordance with Good Clinical Practice

  • Produced in compliance with Good Manufacturing Practice

  • Manufacturers certified as conforming to ISO 9001:2000

  • Approved in conformity with Council Directive

  • Notified by the Danish Medical Device Certification (DGM0543)

  • Produced in compliance with FDA’s Quality System Regulation 510(K) 

 

Friendly to the environment

The ClampCut - SCC23 is an environment-friendly instrument. Its plastic components are manufactured from polyamid 6.6, which when incinerated, converts into vapour water.

 

 

The ClampCut - SCC23 Story

The idea for a single-action cutter-clamp came to the Danish inventor Knud Lykke Jensen in 1990. Discussions with obstetricians encouraged him to develop the concept.

A patent was applied for in 1993 and Price Invena ApS was established in the following year to develop a commercially viable product.

By December 1995, the project was far enough advanced to permit the commissioning of a detailed manufacturing design from Institute for Product Development at the Technical University of Denmark.

A pilot production series was manufactured and clinical tests began in the Department of Gynaecology and Obstetrics at the University Hospital of Copenhagen in January 1997.

Following the successful conclusion of these tests in May 1997, GCP recognition was obtained from the Scientific Ethics Committee of Copenhagen and Frederiksberg, under the Danish Ministry of Health. European Standard approval qualifying the SCC-23 to be "CE" marked followed in December 1997.

Apart from private capital, the project has been supported with funds from the Unibank Foundation, private foundations and the Danish Ministry of Research.

 

Product Specifications

Materials: Polyamid 6.6. and stainless steel knife
Weight: Total 23 grammes - the clamp 2.8 grammes
Packaging: Peel-Pack with ethylen oxideindicator
Approvals CE and FDA approved
  Disposable