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        Sales Instruction Training for ClampCut
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1.  ClampCut        If you are a Certified User  CU        You can train other hospital staff to become Trained  Users  TU       You are responsible for keeping a logbook of the TUs  you have trained  Logbooks are provided by your  sales representative       You are allowed to apply and purchase ClampCut        You must have a certificate with your name  date of  issue  issuing party and name of your hospital  The  certificate is personal and cannot be handed over to a  third party  The certificate must be renewed every 12  months     If you are a Trained User  TU       You can apply ClampCut       Page 2 of 8    Price Invena ApS     Kronprinsessegade 36 2 e DK 1306 Copenhagen K   Denmark    www priceinvena dk    How to apply ClampCut    The following is a step by step procedure describing how  to apply ClampCut       1  ClampCut   consists of two components  the white  clamp and green slider  amp  housing    2  ClampCut   can be applied using the Ishibashi   which are demonstrated in the pictures below    3  After the clamp has been applied  it is possible to   ClampCut   s    components count the 3 veins in the umbilical cord        CORRECT GRIP  BOTH HANDS    Grasp the umbilical cord using Making sure that the umbilical Cut the umbilical cord by pushing  one hand and position ClampCut   cord is placed correctly  see the the slider into the housing  Left   around the umbilical cord using arrow above   apply ClampCut   by handed users can use their left  the other hand  app  3 
2.  pulled out of the clamp  when  the slider is pushed into the housing  as demonstrated  below     Fi         Incorrect grip on ClampCut     Notice the Result of using the incorrect grip   the  umbilical cord is on the wrong side of the umbilical cord blocks the closure of the  index finger     it should have been clamp    between the index and middle fingers     Evacuating the placenta   ClampCut   can be used for evacuation of the  placenta and thereby save the use of an extra pair of  forceps     this is shown below        The umbilical cord is wound around the The slider and housing can then be  slider  used to pull when the placenta is being  evacuated     Page 5 of 8    Price Invena ApS     Kronprinsessegade 36 2   DK 1306 Copenhagen K   Denmark   www priceinvena dk    Frequently Asked Questions  This is a list of frequently asked questions     and their  corresponding answers     e Can  still control the 3 veins in the umbilical  cord  Yes  when the clamp is applied  it is easy to  count the veins in the umbilical cord    e Can Itake blood samples from the placenta   Yes  the placenta side of ClampCut   can be  opened and closed as needed      Can I use ClampCut   if I   m lefthanded  Yes   ClampCut   can be used with both hands    remember to show that in the demonstration      e When can the clamp be removed  After 12 14  hours  it is safe to remove the clamp  but  depending on the preferences of the hospital staff   the clamp can stay on the umbilical cord  indefinit
3. Price Invena ApS     Kronprinsessegade 36 2 e DK 1306 Copenhagen K   Denmark    www priceinvena dk       ClampCut   and ClampOff   User   s Manual       Page 1 of 8    Price Invena ApS     Kronprinsessegade 36 2   DK 1306 Copenhagen K   Denmark   www priceinvena dk    Certified Instructor  Cl       has been trained by Price  Invena to sell ClampCut    and to train and certify  Certified Users     Certified User  CU      has  completed the ClampCut     Training  can purchase and  apply ClampCut   and can  train staff to become a  Trained User     Trained User  TU      has  been trained by a CU and is  allowed to apply ClampCut          Purpose  The purpose of this manual is to describe how      ClampCut   and ClampOff   should be used  ClampCut   is    a disposable device used to clamp and cut the umbilical  cord of a newborn baby  Later  ClampOff   can be used to  remove the clamp again     The manual has been designed for Certified Users and  Trained Users and contains       Price Invena   s Certification Policy      astep by step procedure for using ClampCut   and  ClampOff        alist of frequently asked questions and  corresponding answers    Certification Policy   To ensure that all users of ClampCut   apply the product  correctly  Price Invena enforces a certification policy   which is described below     As described in the box to the left  there are 3 user levels   each of which has different degrees of training  The  following is a list of rules regarding the use of
4. cm  from closing the white clamp around hand for this procedure    the infants stomach   the umbilical cord        Page 3 of 8    Price Invena ApS     Kronprinsessegade 36 2 e DK 1306 Copenhagen K   Denmark    www priceinvena dk    FATHER CUT    Making sure that the umbilical The father can cut the umbilical  cord is placed correctly  see the cord by simply pushing the slider  arrow above   apply ClampCut   by into the housing  while the midwife  closing the white clamp around holds ClampCut      the umbilical cord     Positioning ClampCut   for the  father using Ishibashi Grip        4  Sometimes  the father wishes to cut the umbilical  cord  If this is the case  simply use Ishibashi grip  on ClampCut   and let the father push the slider  into the housing  as shown in the pictures above    5  To remove the clamp  when and if this is  necessary depends on the hospital   s procedure   use ClampOff    as demonstrated below     REMOVAL OF THE CLAMP USING CLAMPOFF      Place ClampOff   in the hole of the Cut the clamp by pressing the  handles together  The clamp can    now be opened     Hold the umbilical cord with one  hand and ClampOff   with the clamp  other        Page 4 of 8    Price Invena ApS     Kronprinsessegade 36 2 e DK 1306 Copenhagen K   Denmark    www priceinvena dk    Incorrect grip   There is one way in which ClampCut   can be used  incorrectly     by using the grip incorrectly  If the  umbilical cord is not placed between the index and  middle fingers  it will be
5. ely or be removed with ClampOff        Can ClampCut   be used more than once  No   ClampCut   is a disposable product      How should I apply ClampCut    The white  clamp must always face the infant s stomach    e Can the proud father still cut the umbilical  cord  Yes  if the obstetrician and or midwife holds  the device as shown in figure the father can cut the  cord by simply sliding ClampCut      e What if the umbilical cord is too big   ClampCut   has been designed to fit a   sizes and     types of umbilical cords    The father can cut the e How close to the infant should   apply   umbilical cord by pushing the ClampCut    The recommended distance from the   slider  while the midwife   holds the housing  infant s stomach IS 3 5 cm            e What if the umbilical cord is covered with gel   ClampCut   should not be placed over the gel   Instead  place ClampCut   further away from the  infant s stomach      e How far away from the infant can   apply  ClampCut    Although the recommended distance  is 3 5 cm  it can easily be applied 5 10 cm  or  more  from the infant   s stomach    e What if  want to remove the clamp  The clamp  can easily be removed using ClampOff     a  specially designed clamp remover  also sold by  Price Invena   Notice that other Clamp removers  cannot be used to remove the clamp  but  ClampOff    is capable of removing existing clamps  on the market           Checking the 3 veins          ClampoOff      Page 6 of 8    Price Invena ApS     Kronprinse
6. r  ClampCut   prevents this  from happening     lf you have a question which is not on the list  please ask  your local Price Invena sales representative or send an e     mail to info priceinvena dk     Page 7 of 8    Price Invena ApS     Kronprinsessegade 36 2 e DK 1306 Copenhagen K     Denmark   www priceinvena dk    ClampCut   was tested at  Rigshospitalet in  Copenhagen  Denmark and  the results were published  in an article in Acta    Obstetricia      0  blood splashing     0  repositioning of clamp    0  alternative method    necessary        Advantages using ClampCut    Compared to the competing products  ClampCut   has  many advantages     among these are       When ClampCut   is used correctly the risk of  blood splashing is eliminated    e Each device is assembled and tested 100  before  it is packaged and sterilized     no risk of faulty  devices    e Clinically proven that there is a 0  risk of blood  splashing     no risk of HIV and Hepatitis  contamination    e Disposable product     guaranteed sterililty and  razor sharp blade     every time  No re sterilizing  necessary    e Fast and efficient     application in less than 2  seconds in one easy movement     Questions   lf you have any questions or comments  please feel free  to contact Price Invena at info priceinvena dk  or your  local Price Invena sales representative     Page 8 of 8    
7. ssegade 36 2   DK 1306 Copenhagen K   Denmark   www priceinvena dk      Is ClampCut   packed in a sterile packaging   Yes  ClampCut   is sterilized using ethylene oxide   ETO       Does ClampCut   contain latex or PVC  No   ClampCut   only consists of environmentally  friendly materials such as nylon 6 6 and stainless  steel  When the product is destructed the material       ClampCut   s   packaging with the will turn into water vapour   yellow label  indicating that it is a e How does the clamp differ from what   use  sterilized product now  The actual clamp is virtually the same as the    existi ng clamps on the market  which have been  on the market for more than 30 years      Can I still use ClampCut   during a Caesarian  section  Yes  ClampCut   is particularly  advantageous during a Caesarian section   because it can be applied in less than 2 seconds      Can I use ClampCut   when the child is born  with the umbilical cord around its neck  Yes   as shown in the figure to the left  using ClampCut    is a quick way to remove the umbilical cord from  the child s neck      There is already a lot of blood when a child is  born  What difference can a little blood from  the umbilical cord do  The blood that is normally  present during a delivery  that is coming from the  vagina and which flows vertically in a controlled  manner  Cutting the umbilical cord can be  compared to cutting a pressurized garden tube      the blood can splash in all directions in an  uncontrolled manne
    
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