Kimberly-Clark ON-Q User manual

MANUFACTURED BY:
Kimberly-Clark
1400 Holcomb Bridge Road
Roswell, GA 30076
USA
Kimberly-Clark N.V.
Da Vincilaan 1
1935 Zaventem, Belgium
ON-Q*Catheters and Introducers
Instructions For Use

1
ON-Q*Catheters aNd INtrOduCers
Instructions For Use
eON-Q* Catheters and Introducers Instructions For Use 3
fCathéters et introducteurs ON-Q* Mode d’emploi 7
gON-Q* Katheter und Einführer Gebrauchsanweisung 12
sCatéteres e introductores ON-Q* Instrucciones de uso 17
iCateteri e introduttori ON-Q* Istruzioni per l’uso 21
nON-Q* katheters en -introducers Gebruiksaanwijzing 25
FON-Q*-katetrit ja sisäänviejät Käyttöohjeet 29
ON-Q* holleggir og ífarar Leiðbeiningar um notkun 33
vON-Q* katetrar och införare Bruksanvisning 37
NON-Q* katetere og innførere Bruksanvisning 41
PCateteres e introdutores ON-Q* Instruções de utilização 45
DON-Q* katetre og introducere Brugsanvisning 49
GΚαθετήρε και εισαγωγεί ON-Q* Οδηγιε χρηση 53
cKatetry a zavaděče ON-Q* Pokyny pro použití 58
tON-Q* Kateterler ve İntroduserleri Kullanma Talimatı 62
R   ON-Q*    66
pCewniki i intubatory ON-Q* Instrukcja użytkowania 71
j ON-Q*カテーテルおよびイントロデューサー 使用説明書 76
K ON-Q* 카테터 및 유도관 사용 설명서 81
C ON-Q*导管和引入器 使用说明 86

2
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Figure 1
Figure 2
Figure 3
Figure 4
Figure 5
Figure 6
Figure 7
Figure 8
Figure 9
Figure 10
Figure 11
Figure 12

3
eON-Q* Catheters aNd INtrOduCers
Instructions For Use
IMPORTANT INFORMATION
Please read the entire document before using ON-Q*
catheters and introducers. Follow all instructions
carefully to ensure the safety of patient and/or user.
USER INFORMATION
 

 www.io.com or contact your sales representative

including but not limited to:

 


 
ILLUSTRATION AND NOMENCLATURE
Figure 1
1. ON-Q* Pump
 
3. Dressing
 
 
DESCRIPTION
ON-Q* catheters contain multiple holes along the infusion
segment.The holes are distributed in a spiral pattern to


catheters are available in four design options.The type of

labels.
1. Soaker
2. SilverSoaker*
catheter. 
Additional Information for SilverSoaker* Models.
3. Epidural
4. Non-Soaker
pumps with bolus capability.

is a stainless steel trocar with hub.The second component is a

available in four design options.The type of introducer and its

Type of
Introducer Trocar Tip Hub Use
Introducer
Needle hollow  beveled
female
Luer
single
use
Tunneler &
 solid  rounded handle single use
Fluid
Tunneler &
 hollow 
rounded
handle w/
Luer
single
use
*See its product insert for additional important information.
Sheath sold separately.
INDICATIONS FOR USE
ON-Q* catheters are indicated for the delivery of medication



catheters below have the following additional indications:
 
indicated for perineural delivery.
 
agent which may destroy or inhibit the growth of
microorganisms on both the inner and outer surfaces of
the catheter. The antimicrobial agent is intended to reduce
the possibility that the catheter may become microbially
compromised. The antimicrobial agent is not intended to
be used as a treatment for existing infections.
 


introducers are not intended for epidural placement.
ON-Q* introducers are intended for the percutaneous
introduction and placement of ON-Q* catheters. Introducers
with a Luer hub may be used to aspirate or inject a bolus of
uid or medication prior to placing the catheter.
WARNINGS


particular:


build up as this may lead to ischemic injury or necrosis.

4


has shown a possible association between continuous intra-



uid diusion.
 

T-peel introducer sheath.
 

sheath removal.
 

 
Inadvertent intravascular delivery may result in systemic toxic

 
during removal.
 


delivery.To prevent infusion of drugs not indicated for

strongly recommended that devices used for administration
of medication via epidural routes be clearly dierentiated
from all other infusion devices.
 
patient is educated in the proper use of the system and the
patient guidelines provided.
 

introducershavethe potentialto causeinjury despitetip design.
 

and/or retention of catheter components on removal.
 

being retained in the patient. This may lead to an injury.
CAUTIONS
 Product is ethylene oxide sterilized.
 
 


 
 
 
 

ON-Q* pumps.Testing has not been performed on other
infusion pumps.
 






infants and children should be evaluated prior to use.
 


information for a more thorough understanding of
possible incompatibility problems.
 

Information regarding the site and route of administration


 

discontinue use.
CONTRAINDICATIONS
1. ON-Q* catheters are not indicated for intravascular delivery.
2. ON-Q* catheters arenot indicated forepidural useunless

3. ON-Q* introducers are not indicated for epidural placement.
 

 

contraindications.
INSTRUCTIONS FOR USE

PLACING THE CATHETER
1. Prime catheter with 5 ml syringe to ensure patency

 
3. Introducer Needle

Tunneler: Follow standard surgical practice to create an
entrance incision.
4. Advance introducer to desired location for catheter placement.


5
aspirate or inject a bolus of uid or medication.
5. While holding T-handle 12from sheath

WARNING: Do not reinsert a partially or completely

in patient upon sheath removal.
6. Advance catheter through sheath until entire infusion segment

WARNING: Place catheter such that obstruction will not


caught in sutures. Assure that catheter is not in a vein or artery.
7. CAUTION:While holding catheter tip 1
sheath completely from puncture site prior to splitting to
2
peel away from catheter 3
8. Prime catheter again with 5 ml syringe to ensure patency

9. Discard introducer per standard hospital protocol.
CATHETER SECUREMENT
 
2. Apply occlusive dressing over insertion site and coiled


 
CATHETER REMOVAL


 

 


CAUTIONS:


 

body movements may relieve the catheter to allow
easier removal.
 


 
 


 
4. Discard catheter per standard hospital protocol.
CATHETER SPECIFICATIONS
Catheter Type† Infusion
Segment
Total Length
(with Luer)
inch cm inch cm
  1.25 24 61

1 inch 1 2.5 24 61
2.5 inch 2.5 6.5 26.5 67
5 inch 5 12.5 26.5 67
7.5 inch 7.5 19 35 89
  25 35 89
† Dimensions are approximate. Outer diameter is 19 GA (1.1 mm).
Catheters are radiopaque.
STORAGE REQUIREMENTS

sources and heat. Keep dry.

6
ADDITIONAL INFORMATION FOR
SILVERSOAKER* MODELS
DURATION OF EFFECTIVENESS



SILVAGARD* ANTIMICROBIAL MATERIAL

with silver on both the inner and outer surfaces of the catheter.
The silver acts as the antimicrobial agent by releasing silver ions


 
of microorganisms on both the inner and outer surfaces of
the catheter. The antimicrobial agent is intended to reduce
the possibility that the catheter may become microbially
compromised.
 
as a treatment for existing infections.
 ntimicrobial agent gives the catheter a golden color
which is normal.
SILVAGARD* ANTIMICROBIAL ACTIVITY
In vitro testing has determined the average daily silver release


per day.
In vitro testing has demonstrated antimicrobial eectiveness


per challenge organism when treated catheters were compared



infection rates has not been evaluated.



antimicrobial agents.
CONTRAINDICATIONS
 
or silver components.
 
populations.
 
the epidural space.
 
intra-artricular spaces because silver has not been evaluated
for interaction with the synovial membrane.
CAUTIONS
 
large neurovascular bundles.
 
are very limited data on prolonged and repeated use of silver
containing products and particularly in children.
Rx only
sale by or on the order of a physician.





For more information, please call
+1.949.206.2700 • 1.800.448.3569 (English only) or visit
www.io.com for the latest product information and
Technical Bulletins.

7
INFORMATIONS IMPORTANTES

cathéters et introducteurs ON-Q*. Observer avec


INFORMATIONS DESTINÉES À L’UTILISATEUR
 

 www.io.com ou contacter un
représentant commercial pour les dernières informations

autres:
 

 
le système ON-Q*
 
ILLUSTRATION ET NOMENCLATURE
Figure 1
1. Pompe ON-Q*
 
3. Pansement
 
 
DESCRIPTION








1. Soaker
distribution régulière du médicament.
2. SilverSoaker*

consulter la section: Informations supplémentaires pour les
modèles SilverSoaker*.
3. Péridural

4. Non-Soaker

Les introducteurs ON-Q* se composent de deux éléments.
Le premier élément est un trocart en acier inoxydable avec




conditionnement.
Type d’intro-
ducteur Trocart Extrémité Embase Usage
Aiguille
introductrice creux  biseautée
raccord
Luer
femelle
à usage

Tunneliseur
et gaine plein  arrondie poignée à usage 
Tunneliseur
et gaine pour
 creux 
arrondie
poignée
avec
raccord
Luer
à usage

*Voir la notice du produit pour des informations supplémentaires
importantes. Gaine vendue séparément.
INDICATIONS D’EMPLOI





ont les indications supplémentaires suivantes :
 

 






 


pour la mise en place du cathéter. Les introducteurs ON-Q*


percutanée et la mise en place des cathéters ON-Q*. Les

fCathéters et INtrOduCteurs ON-Q*
Mode d’emploi

8

médicament avant la mise en place du cathéter.
AVERTISSEMENTS
 
concentrations de médicaments les plus faibles nécessaires

 



ou une nécrose.
 


association possible entre les perfusions intra-articulaires

développement ultérieur de chondrolyse.
 

Ne pas introduire le cathéter à travers la canule en acier



Ne pas réinsérer une aiguille partiellement ou totalement

dans le corps du patient au moment du retrait de la gaine.
 

cathéter.
 
dans une veine ou dans une artère. Une administration


fabricant.
 

Perfusions péridurales :





de nettement diérencier les dispositifs utilisés pour

tous les autres dispositifs de perfusion.
 


fournies.
 



lésions malgré la conception de leur extrémité.
 


rétention de composants du cathéter lors du retrait.


segment de la gaine se casse ou soit retenu dans le patient.

MISES EN GARDE
 
 Ne pas utiliser si le conditionnement a été ouvert ou

  
réutiliser.
 

 

 
 
hospitalier standard.
 



perfusion.










enfants avant leur utilisation.
 



