This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
All rights reserved. Coloplast A/S, 3050 Humlebaek, Denmark.
2016 - 000NGLOBALCATEN01
Gen
eral
Cat
alog
ue U
rolo
gy &
Gyn
aeco
logy
GENERAL CATALOGUEUrology & Gynaecology
Coloplast develops products and services that make life easier for people with very personal and private medical conditions.Working closely with the people who use our products, we create solutions that are sensitive to their special needs. We call this intimate healthcare.
Our business includes ostomy care, urology and continence care, wound and skin care.We operate globally and employ more than 10 000 employees.
INTRODUCTION
3 • Catalogue 2016
Introduction
With a world class innovative spirit and the ultimate objective of always being able to make your life easier, Coloplast presents its latest dedicated Urology Care catalogue including all of our disposables and implants for urology and gynaecology.
For over 120 years, we have supported the medical progress through the development of the latest techniques and devices in co-operation with our leading surgeon partners.
Our know-how and high quality industrial processes permit us to offer you medical materials of the very highest standards with worldwide recognition and expertise.
Within this catalogue you will find all of the latest products you will need for your daily operating practice:
• Endourology : A wide range of disposable products for stone management like Dormia stone extractors,Ureteral stents, Access sheath (Retrace) and guidewires. We have extended our line with a new innovativedigital solution to remove ureteral stents in one step: ISIRIS α . The product is a combination between asingle use flexible cystoscope with an integrated grasper and a reusable portable device
• Female Pelvic Health: slings (Altis, Aris), and lightweight meshes (Restorelle), to treat stress urinaryincontinence and pelvic organ prolapses.
• Men’s Health: male sling (Virtue), inflatable penile implants (Titan Touch), as well as malleable implants(Genesis) to treat erectile dysfunction.
• General Surgery: a wide range of drains and a high quality suction/irrigation device for laparoscopy(Elefant).
• Lower Urology: all disposable surgical devices required for handling Prostate disorders, from the diagnosisbiopsy (Cobra) to the treatment -prostatic catheters, (X-Flow, Prostaflow), bladder evacuator (Easivac),post operative bags (Cysto-Care); and also addressing bladder and suprapubic drainage, urethralstrictures, voiding dysfunctions, Bladder Outflow Obstruction and other urological conditions (Cystodrain).
Coloplast is exceedingly proud to provide you with the highest level of services, products and guarantees.
Customer Service and Sales representatives are available whenever you need them, to help you find the right solutions to your specific requirements.
ImaJin Silicone double loop ureteral stentsThe remarkable biocompatibility and flexibility of silicone makes it the material of choice for long-term implantation : improved patient comfort and less incrustation material. Duration of i mplantation: 12 months.
• Kit composition: each stent is supplied in a set with a pusher (simple or steerable) and with or without a guidewire depending on the model. Ø Guide: 0.035”. Steerable pusher: with or without radiopaque ring.
• Individually packaged (with a guidewire) • Sterile.
ImaJin Hydro-Coated Silicone double loop ureteral stentsThe remarkable biocompatibility and fl exibility of silicone makes it the material of choice for long-term implantation : improved patient comfort and less incrustation material.Hydro-coated stents to facilitate advancement.
• Kit composition: each stent is supplied in a set with a steerable pusher and with or without a guidewire depending on the model. Ø Guide: 0.035”.Steerable pusher : with or without radiopaque ring.
• Individually packaged (with a guidewire) • Sterile.
• Box of 5 (without a guidewire) • Sterile.
O/O
Terumo® guidewire OrchestraTM guidewire Without guidewireCh/Fr Length
Vortek Double loop ureteral stentsThe double layer structure makes it easy to insert over the guidewire, the stiffness of each size has been adapted in order to keep the mechanical properties. Duration of implantation: 12 months.
• Kit composition: each stent is supplied in a set with a pusher (simple or steerable), with or without a guidewire and with or without a Flush catheter depending on the model. Ø Guide: 0.035”. Steerable pusher: with or without radiopaque ring.
• Individually packaged, except for REF. ACB6 (box of 5) • Sterile.
Vortek Double loop ureteral stentsThe double layer structure makes it easy to insert over the guidewire, the stiffness of each size has been adapted in order to keep the mechanical properties. Duration of implantation: 12 months.
For patient comfortFor easy insertion and placement
Vortek Double loop ureteral stentsThe double layer structure makes it easy to insert over the guidewire, the stiffness of each size has been adapted in order to keep the mechanical properties. Duration of implantation: 12 months.
} Sets with steerable pusher
Catalogue 2016 • 17
For patient comfortSOFT
1 • ENDOUROLOGY1.4. Double loop ureteral stents
Vortek Hydro-CoatedDouble loop ureteral stentsSoft material for the patient comfort. The double layer structure makes it easy to insert over the guidewire. The hydrophilic coating facilitates the advancement of the stent.Duration of implantation: 12 months.
• Kit composition: each stent is supplied in a set with a pusher (simple or steerable), with or without a guidewire and with or without a Flush catheter depending on the model.Ø Guide: 0.035”.Steerable pusher: with or without radiopaque ring.
• Individually packaged (with a guidewire) • Sterile.
Biosoft duo Double loop ureteral stentsProduced by coextrusion of a flexible material and a rigid material, Biosoft duo was designed for easy insertion, while retaining great flexibility for the patient comfort. Duration of implantation: 12 months.
• Kit composition: each stent is supplied in a set with a pusher (simple or steerable), with or without a guidewire and with or without a Flush catheter depending on the model. Ø Guide: 0.035”. Steerable pusher: with or without radiopaque ring.
• Individually packaged (with a guidewire) • Sterile.
For patient comfortFor easy insertion and placement
FIRM SOFT
Catalogue 2016 • 19
1 • ENDOUROLOGY1.4. Double loop ureteral stents
Biosoft duo Multi-length Hydro-Coated ureteral stentsProduced by coextrusion of a fl exible material and a rigid material, Biosoft duo was designed for easy insertion, while retaining great fl exibility for the patient comfort.Duration of implantation: 12 months.
• Kit composition: each stent is supplied in a set with a pusher (simple or steerable) and a guidewire.Ø Guide: 0.035”.Steerable pusher: with or without radiopaque ring.
The global stent is between 22 to 28 cm when the multi-length is straightened.
Sets with steerable pusher
Sets with simple pusher
Sets with steerable pusher
O/C
Fixed core
guidewire
Movablecore
guidewire
BCAB62
BCAB63 BCAE63
BCAB64 BCAE64
BCAB65 BCAE65
BCAB66
BCAB77
BCAB73
BCAB74 BCAE74
BCAB75 BCAE75
BCAB76
BCAB84
BCAB85
BCAB86
For patient comfort
For patient comfortSOFT
For easy insertion and placement
FIRM
Multi-length Hydro-Coated ureteral stents
Hydrophilic coating
UROLOGY
20 • Catalogue 201620 • Catalogue 2016
1 • ENDOUROLOGY1.4. Double loop ureteral stents
Ch/Fr Length O/C
6
24cm AC4NH3
26cm AC4NH4
28cm AC4NH5
30cm AC4NH6
726cm AC4NK4
28cm AC4NK5
8
24cm AC4NL3
26cm AC4NL4
28cm AC4NL5
Biosoft Minute stentDouble loop ureteral stentsDouble loop ureteral stent O/C pre-connected. Ready to use product: the stent is in place over the guidewire and connected to the pusher. Duration of implantation: 6 months.
• Kit composition: each stent is supplied in a set with a pusher (simple or steerable) and with or without a guidewire depending on the model. Ø Guide: 0.035”. Steerable pusher: with or without radiopaque ring.
• Individually packaged (with a guidewire) • Sterile.
• Box of 5 (without a guidewire) • Sterile.
• Kit composition: each stent is supplied in a set with a pusher (simple or steerable) and a guidewire. Ø Guide: 0.035”. Steerable pusher: with or without radiopaque ring.
• Kit composition: each stent is supplied in the same peel pouchwith a simple pusher and with or without a guidewire dependingon the model.Ø Guide: 0.035”.
• Box of 5 • Sterile.
O/O O/C
Fixed core guidewire
Withoutguidewire
Fixed coreguidewire
WithoutguidewireCh/Fr Length
4.8
24cm BNBA53 BNBJ53 BNBB53 BNBK53
26cm BNBA54 BNBJ54 BNBB54 BNBK54
28cm BNBA55 BNBJ55 BNBB55 BNBK55
30cm BNBA56 BNBJ56
6
24cm BNBA63 BNBJ63 BNBB63 BNBK63
26cm BNBA64 BNBJ64 BNBB64 BNBK64
28cm BNBA65 BNBJ65 BNBB65 BNBK65
30cm BNBA66 BNBJ66
7
24cm BNBA73 BNBJ73 BNBB73 BNBK73
26cm BNBA74 BNBJ74 BNBB74 BNBK74
28cm BNBA75 BNBJ75 BNBB75 BNBK75
30cm BNBA76 BNBJ76
8
26cm BNBA84 BNBJ84 BNBB84 BNBK84
28cm BNBA85 BNBJ85 BNBB85 BNBK85
30cm BNBA86 BNBJ86 BNBB86 BNBK86
Sets with simple pusher
UROLOGY
24 • Catalogue 2016
1 • ENDOUROLOGY1.5. Double loop ureteral stents: special models
Double loop ureteral stents Special ureteral stenosis
STENOSTENT • Silicone for long-term implantation. 12 Ch/Fr reinforced body for maximum resistance to stenosis, 8 Ch/Fr loops for patient comfort.Duration of implantation: 12 months.
• Kit composition: each stent is supplied in a set with a steerable pusher and a guidewire. Ø Guide: 0.035” (fixed core guidewire).
• Individually packaged • Sterile.
O/O
Length 16cm 24cm 26cm 28cm 30cm
REF. AJ4W81 AJ4W83 AJ4W84 AJ4W85 AJ4W86
Sets with steerable pusher
Catalogue 2016 • 25
Double loop ureteral stents Special ureteral stenosis
STENOSTENT • Silicone for long-term implantation.12 Ch/Fr reinforced body for maximum resistance to stenosis, 8 Ch/Fr loops for patient comfort.Duration of implantation: 12 months.
1 • ENDOUROLOGY1.5. Double loop ureteral stents: special models
Double loop ureteral stentsFor pyeloplasty
PYELOSTENT • Silicone for long-term implantation.12 Ch/Fr reinforced part in renal pelvis for a better healing, 8 Ch/Fr loops for patient comfort.Duration of implantation: 12 months.
• Kit composition: each stent is supplied in a set with a steerable pusher and a guidewire.Ø Guide: 0.035” (fi xed core guidewire).
• Individually packaged • Sterile.
O/O
Length 26cm 28cm 30cm
REF. AJ4Y84 AJ4Y85 AJ4Y86
Sets with steerable pusher
UROLOGY
26 • Catalogue 2016
1 • ENDOUROLOGY1.5. Double loop ureteral stents: special models
Double loop ureteral stentsWithout eyes on the straight sectionVortek: its two-layer structure makes it easy to insert. Silicone: the biocompatibility of silicone makes it the material of choice for long-term implantation.Duration of implantation: 12 months.
• Kit composition: each stent is supplied in a set with a pusher (simple or steerable with or without radiopaque ring) and a guidewire. Ø Guide: 0.035” (fixed core guidewire). Steerable pusher: with or without radiopaque ring.
• Individually packaged • Sterile.
O/O Vortek O/O Silicone
Ch/Fr Length Steerable pusher
Simple pusher
Steerable pusher
6
24cm ACB763
26cm ACB764 ACB864
28cm ACB765 ACB865
30cm ACB866
7
24cm ACB773
26cm ACB774 ACB874 AJ4U74
28cm ACB775 ACB875 AJ4U75
30cm ACB776 ACB876
8
24cm ACB783
26cm ACB784
28cm ACB785 AJ4U85
30cm ACB786
O/O Vortek O/O Silicone
Ch/Fr Length Steerable pusher
Simple pusher
Steerable pusher
6
24 cm ACB763
26 cm ACB764 ACB864
28 cm ACB765 ACB865
30 cm ACB866
7
24 cm ACB773
26 cm ACB774 ACB874 AJ4U74
28 cm ACB775 ACB875 AJ4U75
30 cm ACB776 ACB876
8
24 cm ACB783
26 cm ACB784
28 cm ACB785 AJ4U85
30 cm ACB786
Catalogue 2016 • 27
1 • ENDOUROLOGY1.5. Double loop ureteral stents: special models
Vortek Tumor stentsWithout eyes on the straight sectionThe inner layer is reinforced compared to the standard Vortek ureteral stent. It allows passing through stricture and the stiffness of material offers an excellent resistance to compression.Duration of implantation: 12 months.
• Kit composition: each stent is supplied in a set with a steerable pusher and a guidewire.Ø Guide: 0.035” (hydrophilic nitinol guidewire).
IsirisInnovative digital solution to remove ureteral stent in one step. The product is a combination between a single use fl exible cystoscope with an integrated grasper and a reusable portable monitor.
• Monitor: individually packaged
• Scope: box of 5 • Sterile.
ISIRIS description Brand name REF.
Single use scope with an integrated grasper Isiris™ ALFA01
Monitor Isiris™ Monitor MN0001
Spare part description
Bracket (Hook+key) NA BR0001
Bracket to attach to the IV pole
1 • ENDOUROLOGY1.6. Digital cystoscopic solution
Monitor
Catalogue 2016 • 29
UROLOGY
DIGITAL VISION >
INTEGRATED SOLUTION >
HIGH MANOEUVRABILITY >
EFFICIENT GRASPER >
Digital quality imagery to navigate in the urinary tract up to the bladder.
Integrated system allows to manipulate the scope alone with no assistant needed.
Design for an optimal user comfort with a fl exible insertion cord.
Grasper design to remove any Fr/Ch 4.8 to Fr/Ch 9 ureteral double loop stent.
30 • Catalogue 2016
1 • ENDOUROLOGY1.7. Single loop ureteral stents
Vortek Single loop ureteral stentsDevice for drainage and urine collection.
• Kit composition:
• Single loop ureteral stent 90 cm.
• Seldinger fixed core 0.035’’ guidewire.
• Clamp.
• Connector for urine bag.
• Individually packaged • Sterile.
O/O
Ch/Fr 6 7 8
REF. ACA206 ACA207 ACA208
Eyes on loop and body. O/O
Ch/Fr 6 7 8
REF. ACA106 ACA107 ACA108Eyes on loop only.
O/C
Ch/Fr 6 7 8
REF. AC4406 AC4407 AC4408
Eyes on loop and body.
Eyes on loop and body.
Catalogue 2016 • 31
1 • ENDOUROLOGY1.8. Subcutaneous ureteral bypass
DetourSubcutaneous ureteral bypass for ureteral obstruction.Long term palliative treatment.
• Kit composition:
• Detour bypass.
• Amplatz sheath.
• Tunneling device.
• Individually packaged • Sterile.
Prothesis material: Silicone and Polyester
Length 840mm
REF. AE2002
UROLOGY
32 • Catalogue 2016
1 • ENDOUROLOGY1.9. Guidewires
Hydrophilic Nitinol guidewires
• Box of 5 • Sterile.
• Box of 5 • Sterile.
Tip REF.
Straight AEAD35
Angled AEAE35
Straight AECD35
Angled AECE35
Rigidity
Standard
Stiff
Diameter Length
0.035” 150cm
Orchestra™ guidewires*Designed for atraumatic and frictionless navigation and enhanced manoeuvrability (excellent torque control).
* For speci�c countries only
Radifocus® Terumo® guidewires*Its configuration and the combination of Nitinol and hydrophilic properties allow the Terumo® guidewires to reach difficult access sites in complete safety.
Tip ORDER REF.
Straight AE0N35
Angled AE0T35
Straight AE0P35
Angled AE0X35
Rigidity
Standard
Stiff
Diameter Length
0.035” 150cm
Catalogue 2016 • 33
1 • ENDOUROLOGY1.9. Guidewires
PTFE-coated guidewiresSeldinger guidewires.
• Box of 5 • Sterile.
Fixed core guidewiresStraight tip
Fixed core guidewires“J” tip
150cm 90cm
Standard Stiff StandardDiameter
0.032” AE0032 AE0E32
0.035” AE0035 AE0C35
0.038” AE0038 AE0E38
5cm fl exible tip.
80cm
StiffDiameter
0.038” AE1138
5cm fl exible tip.
Movable core guidewiresStraight tip 150cm
Standard Stiff Diameter
0.032” AE0A32
0.035” AE0A35 AE0D35
0.038” AE0A38
5cm fl exible tip.
UROLOGY
34 • Catalogue 2016
1 • ENDOUROLOGY1.9. Guidewires
Stainless steel guidewiresSchüller and Lunderquist guidewires.
• Box of 5 • Sterile.
100cm
Straight “J”Diameter
0.035” AE0435 AEJ435
7cm flexible tip with rigid part 30cm long.
Schüller
6cm flexible tip for AE0535. 7cm flexible tip for AEJ535.
80cm
Straight “J”Diameter
0.035” AE0535 AEJ535
Lunderquist
Catalogue 2016 • 35
1 • ENDOUROLOGY1.10. Ureteral catheters
Drainage cathetersWide range of tips. Two types of stylets, depending on the rigidity required for optimum drainage.
• Each catheter is supplied with a stylet (metal or polyester) and a connector.
• Material: Neoplex, except for REF. AC5B: Polyamide.
Interventional catheters Floppy Tip Hydro-Coated cathetersThe fl exible open tip is designed for smooth passage through the ureter.The hydrophilic coating over 15cm makes catheter insertion and advancement easier.The grey part at the distal end improves the visualisation of the catheter.
• Each catheter is supplied with a polyester stylet and a Luer-lock syringe connector.
• Material: Neoplex.
• Length: 70cm.
• Catheters are individually packed.
• Box of 5 • Sterile.
Ch/Fr 5 6 7
Guidewire recommended 0.035” 0.035” 0.035”
REF. ACR205 ACR206 ACR207
Straight open ureteric catheters without side eye
Chevassu catheters for Retrograde UreteroPyelography (RUP)The shaped bulb of Chevassu catheters allows effective injection of contrast medium.
• Each catheter is supplied with a metal stylet and a Luer-lock syringe connector.
Chevassu ureteric catheters compatible with a 0.035” guidewire
Chevassu ureteric catheters
UROLOGY
REF. Ch/Fr Length
RBD010 8 and 10 48cm
RBD014 12 and 14 48cm
12 CH 14 CH
8 CH 10 CH
38 • Catalogue 2016
1 • ENDOUROLOGY1.11. Ureteral dilators
Ureteral dilatorsUsed for dilatation of the ureter during ureteroscopic procedures (ureteral orifi ce or stricture, passage of endoscopes and other instruments into the urinary tract).
• Compatible with a 0.038’’ guidewire.
• Diameter (Ch/Fr) indicated at each tip.
• Box of 10 • Sterile.
Catalogue 2016 • 39
1 • ENDOUROLOGY1.12. Occlusion balloon catheters
Occlusion balloon cathetersObstruction of the ureter during in situ stone fragmentation.
• Each catheter is supplied with a metal stylet, a tap and 1 ml syringe.
• Material: Polyamide and latex.
• Length: 90cm.
• Balloon: 0.2 or 1ml.
• Individually packaged • Sterile.
Occlusion catheter,single lumen
0.2ml balloon.
Occlusion catheter,2 lumens, 1ml balloon
2 side eyes above balloon.
Ch/Fr 3 4.5
REF. AC5K03 AC5L45
UROLOGY
40 • Catalogue 2016
1 • ENDOUROLOGY 1.13. High pressure ureteral balloon catheters
In-Ka, high pressure ureteral balloon cathetersPET balloon for an effective and uniform dilatation of the ureteral meatus or stenosis during endoscopic procedures. Compatible with a 0.035” guidewire.
• Kit composition: each In-Ka catheter is supplied with an inflating device.
• Individually packaged • Sterile.
Inflating device
Catheter Balloon Screw syringe with a manometer
Screw syringe with luer-lockCh/Fr Length Ch/Fr Diameter Length
5 75cm
12 4mm
4cm
BD4044 BD4144
15 5mm BD4045 BD4145
18 6mm BD4046 BD4146
Manometer
Balloon catheter
Catalogue 2016 • 41
UROLOGY
2 • PERCUTANEOUS ACCESS2.1. Percutaneous nephrostomy set
Kolibri set with J catheterComplete range of drainage set with J catheter.
• Kit composition:
• 2 Chiba needles: 18 and 22G.
• 1 Seldinger or Schüller J-tip guidewire.
• 1 set of dilators according to the catheter size with or without working sheath.
Removable Luer-lock and universal urine bag adapter
REA000
Fixation disc
Ch/Fr 10 RDA010
48 • Catalogue 2016
2 • PERCUTANEOUS ACCESS2.3. Direct puncture
Set with J catheterPercutaneous set. Each component of the kit is supplied in the same peel pouch.
Direct puncturepercutaneous nephrostomy setsDirect puncture set with Vortek catheter and trocar needle.
• Kit composition:
• Chiba needle 18G.
• Seldinger guidewire 0.038”.
• 1 set of dilators depending on the catheter size.
• Vortek J catheter with a metal stylet (29cm).
• Box of 5 • Sterile.
• Kit composition:
• Vortek J catheter (29cm).
• Trocar needle 19G.
• Universal bag connector.
• Locking sleeve.
• Individually packaged • Sterile.
Ch/Fr 6 8 10 12 14
REF. RJE106 RJE108 RJE110 RJE112 RJE114
Ch/Fr 8 10
REF. RJD108 RJD110
Catalogue 2016 • 49
UROLOGY
2 • PERCUTANEOUS ACCESS2.4. High pressure nephrostomy balloon catheters
In-Ka, high pressure nephrostomy balloon cathetersPET balloon allowing an inflation pressure up to 17 ATM for effective and uniform dilatation of tissues throughout the length of the duct wall. Compatible with a 0.038” guidewire.
• Kit composition: each In-Ka catheter is supplied with an Amplatz sheath and with or whithout an inflation device depending on the model.
Straight short tip X-Flow Silicone AB6J18 AB6J20 AB6J22 AB6J24
With 30ml balloon • Box of 5
With 75ml balloon • Box of 10
All PVC and Neoplex catheter have a latex balloon (codes: AB7xxx)
Latex with silicone elastomer coating
SiliconeX-Flow
Silicone short tipX-Flow
PVCProstafl ow
66 • Catalogue 2016
5 • LOWER URINARY TRACT5.1. Prostatic catheters
Turpy kitAfter transurethral resection of prostate:
X-Flow Dufour30-50ml prostate catheter
2-wayirrigation line
Bladder evacuator Easivac
4 litre bagCystocare 4000
Resectoscope brand
Ch/Fr Storz Olympus Wolf
18 TU6318Z TU6318L TU6318W
20 TU6320Z TU6320L TU6320W
22 TU6322Z TU6322L TU6322W
24 TU6324Z TU6324L TU6324W
• Sterile.
• With:
• X-Flow Dufour 30-50 ml prostate catheter,
• 4 litre bag Cystocare 4000,
• Bladder evacuator Easivac,
• 2-way irrigation line.
• Box of 10 packs
Catalogue 2016 • 67
UROLOGY
5 • LOWER URINARY TRACT5.2. Urine bags
Cysto-Care4L Post operative urine bags.
• Box of 20 • Sterile.
REF. 558530
Cysto-Care PLATINUM 4000 • With washout pump
Urine bag 4 L, with needle free sampling port,bed sheet clip, clamp, drip chamber, anti-refl ux valve and washout pump, large diameter stopcock.
REF. 558510
Cysto-Care SILVER 4000 • Standard
Urine bag 4 L, with sampling port, bed sheet clip and clamp,large diameter stopcock.
Cysto-Care GOLD 4000 • With drip chamber
Urine bag 4 L, sampling port, bed sheet clip, clamp, drip chamber, anti-refl ux valve,large diameter stopcock.
REF. 558520
68 • Catalogue 2016
5 • LOWER URINARY TRACT5.3. Bladder evacuator
EasivacProstate and bladder chips evacuator.
Connector Wolf Storz Olympus ACMI
REF. E80103 E80203 E80303 E80403
• For evacuation of the bladder after transurethral resection of the prostate or resection of bladder tumour. Rapid and effective recovery of fragments by means of the fi lter and non-return valve. Latex-Free.
• Box of 20 • Sterile.
Catalogue 2016 • 69
UROLOGY
5 • LOWER URINARY TRACT5.4. Prostatic and urethral stents
UrospiralProstatic stent for the treatment of BPH.
• Tight coils: no tissue ingrowth - easily removable.
Retractor System without Frame Retractor System with Frame
Ø mm
REF. QB5559 8 9 10 11 12 13 14
Catalogue 2016 • 91
PROSTHESIS
92 • Catalogue 2016
Virtue male sling4 arm male sling for male stress urinary incontinence
• Knitted monofi lament polypropylene.
• Bidirectional compression and elevation of the bulbous urethra with 2 transobturator arms and 2 prepubic arms.
• Individually packaged • Sterile.
3 MALE SLING
Virtue1 sling, 1 single use introducer
50020
Catalogue 2016 • 93
PROSTHESIS
94 • Catalogue 2016
URODYNAMICS
Catalogue 2016 95
URODYNAMICS
URODYNAMICS
1 • Urethrocystometry 96
2 • Cystometry 98
3 • Urethral pressure 99
4 • Abdominal pressure 100
5 • Lines and accessories 101
1 • URETHROCYSTOMETRY
UrethrocystometrySoft Neoplex.
Proximal Luer tips colour-marked to make it easy to connect to urodynamics system. Blue = Bladder Red = Urethra Black = Filling. Stoppers to close off unused lumens. Centimetre markings to mark position of catheter in urethra. X-Ray visible material.
Box of 5 - Reusable Sterile.
Length of body: 37 cm for Ch 08 / 40 cm for Ch 12 • Total length: 60 cm
Ch/Fr 8 12
REF. AH5308 AH5312
3-lumen catheter, straight.
Length of body: 37 cm • Total length: 60 cm
Ch/Fr 8
REF. AH5608
3-lumen catheter, straight.
Length of body: 35 cm • Total length: 55 cm
Ch/Fr 6 8 10
REF. AH5106 AH5108 AH5110
2-lumen catheter, straight, Dantec-type catheter.
Length of body: 35 cm • Total length: 55 cm • Paediatric use
Ch/Fr 6
REF. AH5406
2-lumen catheter, straight. 2.5 cm between the urethral eye and the bladder eye.
96 Catalogue 2016
1 • URETHROCYSTOMETRY
Semi-rigid PVC.
Proximal Luer-lock tips colour-marked to make it easy to connect to urodynamics system. Blue = Bladder Red = Urethra Transparent = Filling.Centimetre markings to mark position of catheter in urethra.
Box of 10 Single use Sterile.
Length of body: 40 cm • Total length: 56 cm
Ch/Fr 10
REF. AH2309
3-lumen catheter, straight
Length of body: 40 cm • Total length: 160 cm
Ch/Fr 10
REF. AH9309
3-lumen catheter, straight
Length of body: 40 cm • Total length: 55 cm
Ch/Fr 8
REF. AH2108
2-lumen catheter, straight.
Length of body: 40 cm • Total length: 163 cm
Ch/Fr 8
REF. AH9208
2-lumen catheter, straight.
Female catheter Male catheter
Ch/Fr 8 9
Length of body (cm) 16 42
Total length (cm) 37 57
REF. AH24F8 AH24M9
2-lumen catheter, straight, 4 urethral eyes for fi lling or measurement (multi-point catheter).
URODYNAMICS
Catalogue 2016 97
2 • CYSTOMETRY
CystometrySoft Neoplex.
Proximal Luer tips colour-marked to make it easy to connect to urodynamics system. Blue = Bladder Black = Filling. Stoppers to close off unused lumens. Centimeter markings to mark position of the catheter in the urethra. X-Ray visible material.
Semi-rigid PVC.
Proximal Luer-lock tips colour-marked to make it easy to connect to urodynamics system. Stoppers to close off unused lumens. Centimeter markings to mark position of catheter in urethra.
Box of 5 Single use Sterile.
Length of body: 41 cm • Total length: 65 cm
Ch/Fr 12
REF. AH4212
2-lumen catheter, coudé.
Length of body: 35 cm • Total length: 57 cm
Ch/Fr 12
REF. AH5212
2-lumen catheter, latex balloon 10 ml. Single use.
Length of body: 35 cm • Total length: 55 cm
Ch/Fr 10
REF. AH5010
2-lumen catheter. Reusable.
Box of 5 Reusable Sterile.
98 Catalogue 2016
3 • URETHRAL PRESSURE
Pressure fl ow ratePolyurethane.
Length of body: 40 cm
Ch/Fr 8
REF. AH5908
J catheter, 2-lumen. Stylet for catheter placement.
Box of 10 Single use Sterile.
URODYNAMICS
Catalogue 2016 99
4 • ABDOMINAL PRESSURE
Abdominal pressureDisposable.
AH31: Proximal Luer tip.
AH48 / AH47: Stoppers to close off unused lumens.
Single use Sterile.
Length: 150 cm • Material: PVC • Box of 10
Latex balloon Latex free
Ch/Fr 10 10
REF. AH3110 AH3111
Catheter, single lumen, 3 ml balloon.
2-lumen catheter, 3 ml balloon.
Length: 33,5 cm • Material: Neoplex • Box of 5
Latex balloon Latex free
Ch/Fr 10 10
REF. AH4810 AH4811
Length: 26,7 cm • Material: PVC and Latex • Box of 5
Ch/Fr 22
REF. AH4722
2-lumen catheter, latex balloon.
100 Catalogue 2016
5 • LINES AND ACCESSORIES
Lines and accessoriesLines and accessories that can fi t urodynamic devices.
Single use Sterile.
Material: PVC, PC, ABS, PE • Length: 200 cm • Box of 10
REF. AH1222
Perfusion line
Perfusion line 2-lumen, with spike with protective cap and roller clamp.
Material: PVC, Silicone, ABS, PE • Length: approx. 3.3 meter • Box of 10
REF. AH111M
Filling line
Material: PVC, ABS, PE • Tube Length: 10 cm • Total Length: 14,2 cm• Box of 60 units (20 x 3)
REF. AH1303
Non-return valve
URODYNAMICS
Catalogue 2016 101
102 • Catalogue 2016
FEMALE PELVIC HEALTH
Female Pelvic Health
1 • Urinary incontinence 104
2 • Pelvic organ prolapse 107
3 • Gynaecology 110
Catalogue 2016 • 103
FEMALE PELVIC HEALTH
1 • URINARY INCONTINENCE
Aris & Supris Full-length slingsMid-urethral slings to treat female stress urinary incontinence. Designed for predictable accurate placement and tensioning. Transobturator and retropubic routes.
• Made from knitted, monofilament polypropylene.
• Lightweight, macroporous with low elasticity.
• Individually packaged or kitted
• Sterile.
Aris sling
REF. UR3101
Single use Aris trans-obturator sling systemAris sling + helical and flat curved tunnellers
REF. UR3105
Helical tunnellersreusable
REF. TU3100
Flat curved tunneler reusable
REF. TU3001
Long tunneler • Obese patients reusable
REF. TU3003
Single use Supris retropubic sling system + retropubic tunnelers
REF. Supris sling 519560
104 • Catalogue 2016
1 • URINARY INCONTINENCE
Altis single-incision sling systemTransobturator placement with a single incision approach.
• Sling material based on the Aris & Supris sling.
• Helical type tunneller leads anchor placement.
• Support for patient with urethral hypermobility and intrinsic sphincter defi ciency.
• Static and dynamic anchors allow intra-operative adjustability.
• Sold as a kit.
• Sterile.
AltisAltis single-incision sling + single use helical tunnellers
REF. 519650
Catalogue 2016 • 105
FEMALE PELVIC HEALTH
2 • PELVIC ORGAN PROLAPSE
Restorelle
106 • Catalogue 2016
2 • PELVIC ORGAN PROLAPSE
Restorelle meshRestorelle Smartmesh is designed in a full array of customized shapes and fl at grafts specifi cally designed for pelvic fl oor repair procedures.
• Ultralight weight mesh —19 g/m².
• Uniform macro and interstitial pores.
• Individually packaged • Sterile.
Restorelle single-incision meshes
Restorelle Direct Fix Anterior 501450
Restorelle Direct Fix Posterior 501460
Restorelle Y mesh
Restorelle Y - 24cm x 4cm 501420
Restorelle Y-XL - 27cm x 4cm 501430
For transvaginal repair
For trans-abdominal repair
RestorelleDirect Fix Anterior
RestorelleDirect Fix Posterior
For customization based on physician preference
Restorelle fl at meshes
Restorelle M Flat Mesh - 15cm x 10cm 501320
Restorelle L Flat Mesh - 24cm x 8cm 501440
Restorelle XL Flat Mesh - 30cm x 30cm 501330
Catalogue 2016 • 107
FEMALE PELVIC HEALTH
2 • PELVIC ORGAN PROLAPSE
• Single use.
• Sterile.
Digitex suture delivery device This single incision transvaginal system delivers a suture to the operative site, when direct visualization or anatomical location is difficult to access. The device assists in suturing by passing a needle through the tissue to capture the suture ligation.
Flexishaft™ Reaches Deep Pelvic Structures
• Safely position multi-directional device head 15 degrees when direct visualization or anatomical location is difficult to access.
• Comfortable and ergonomic handle.
108 • Catalogue 2016
SutureSmart™ System forProcedural Effi ciency
• « Smooth suture cap placement and preloaded eliminates unnecessary OR set-up time »
• Cartridge contains crescent needle for procedural convenience.
Packaging Part number
Di gitex Suture Delivery Device
4 individually packaged per box 52025
0 Nonabsorbable monofi lament polypropylene sutures with NSH taper point crescent needle
12 individually packaged per box 52026
2-0 Nonabsorbable monofi lament polypropylene sutures with NSH taper point crescen-t needle
0 Nonabsorbable monofi lament polypropylene sutures with NSH taper point crescent needle
12 individually packaged per box 52026
2-0 Nonabsorbable monofi lament polypropylene sutures with NSH taper point crescent needle
12 individually packaged per box 52027
0 Absorbable PDO Sutureswith NSH taper point crescent needle
12 individually packaged per box 52030
2-0 Absorbable PDO Sutureswith NSH taper point crescent needle
12 individually packaged per box 52031
0 Absorbable PGA Sutureswith NSH taper point crescent needle
12 individually packaged per box 52032
2-0 Absorbable PGA Sutureswith NSH taper point crescent needle
12 individuallypackaged per box 52033
3 • PELVIC ORGAN PROLAPSE
Digitex suture delivery device This single incision transvaginal system delivers a suture to the operative site, when direct visualization or anatomical location is diffi cult to access. The device assists in suturing by passing a needle through the tissue to capture the suture ligation.
MILLIMETER: abbreviation «mm» = 1mm GAUGE: abbreviation G. 14 G = 2,1 mm INCH:
abbreviation '' = 25,4mm
Guarantee and conditions of use
Without prejudice to your legal guarantee against all the consequences of defects or hidden defects, our guarantee shall apply under the following conditions:
The duration of the normal guarantee of the equipment against any manufacturing defects or malfunctions, and against any other defects in materials shall be a maximum of six months from the date of delivery, with the onus being on the Purchaser to prove the said defects or malfunctions.
The Company’s guarantee shall be strictly limited to the equipment supplied and shall have as its sole effect the repair or replacement at the Company’s expense and in its workshops of all those parts rendered unusable as a result of defects or malfunctions. Parts replaced free of charge shall remain the property of the Company.
The guarantee shall not apply to replacements or repairs resulting from normal wear and tear of the devices, to deterioration or accidents due to negligence, to any failure to respect the storage or sterilization conditions, or to any failure to monitor, maintain or use the devices correctly.
The guarantee shall not extend to any consequential damage that may result from using a device that has a manufacturing defect. No compensation shall be payable by way of damages for any reason whatsoever. The storage conditions of the equipment shall be the sole responsibility of the Purchaser. We recommend that the products be stored in their original packaging with this packaging intact, away from light in a dry place, and at an ambient temperature.
The fact that an item is mentioned in this catalogue does not necessarily mean that it can be supplied. Committed to continually improving product quality, Coloplast reserves the right to make changes at any time, without notice, to its items, their specifications, packaging and presence in its range.
The purchase or use of our products implies acceptance of the general conditions of sale set out in the price list.
129 Catalogue 2016
Material used
Coloplast uses various types of raw materials, depending on the various diagnostic or therapeutic indications for its devices.
The biocompatibility of the medical devices is in accordance to EN ISO 10993-1: 2009 + AC 2010 standard.
Before being used in manufacturing, raw materials are controlled in our laboratories batch by batch, using the control methods defined by our internal procedure.
All materials and components used by Coloplast are controlled and used in accordance with procedures and the requirements of standard EN ISO 13485: 2012 + AC: 2012
The manufacturing processes depend on the material and include extrusion, injection or compression-molding, assembly and soaking.
We use three main types of material:
Silicones
Latex
Thermoplastics: Vortek®, Biosoft®Duo, Neoplex, Polyamide, PVC and Polyurethane.
SILICONE: this is a flexible material with optimum biocompatibility. Silicone comes in different degrees of rigidity; it may be transparent, may contain radiopaque lines and may be opaque to X-rays.
After use, it degrades only to silica (sand) and water, with no chlorine or carbon derivatives. It is very stable over time.
VORTEK: an original formulation designed by Coloplast. The material is biocompatible; it comes in different degrees of rigidity and is opaque to X-rays. Mastery of the co-extrusion of this material has made it possible to produce dual-hardness JJs which are rigid in contact with a guide wire to facilitate glide and assembly, while having a flexible exterior for patient comfort.
BIOSOFT DUO: a flexible biocompatible polymer which is particularly well tolerated by patients.
NEOPLEX: a specific formulation developed by Coloplast based on PVC and plasticizer.
Its behavior over a long period of time is remarkable.
POLYAMIDE (PA): particularly rigid material suitable for accessories such as funnels, tips, sheaths, etc.
POLYPROPYLENE (PP): is a synthetic material made of macromolecules. It is low density and exhibits excellent mechanical properties over time, with a high level of chemical inertness and biocompatibility.
POLYVINYLCHLORIDE (PVC): a transparent polymer which may contain radiopaque lines and/or pigments.
It has been used for many years for the manufacture of various medical devices.
POLYURETHANE (PU): a material which does not contain plasticizer and which is very resistant, and with different range of elasticity available.
LATEX: a natural latex compound stabilised by vulcanisers and by hardeners used to induce rigidity; it comes in various degrees of hardness.
It has been used for many years because of its low cost and natural elasticity. It may be coated with various substances which do not modify its intrinsic properties. It may also be reinforced with a spiral wire to resist crushing and folding.
Catalogue 2016 130
Latex componentsColoplast hereby confirms that the products listed below contain latex
AAAA14
AA15
AA16
AA1B
AA31
AA32
AA36
AA38
AA39
AA3A
AA48
AA5618
AA57
ABAB31
AB32
AB33
AB34
AB35
AB36
AB37
AB39
AB3A
AB3B
AB3C
AB3D
AB3E
AB3G
AB3J
AB3R
AB3T
AB3U
AB3W
AB70
AB72
AB75
AB76
AB77
AB78
AB79
AB7A
AB7C
AB7E
AB7H
AB7K
AB7L
ACAC44
AC5K03
AC5L45
ACA1 - CONNECTOR
ACA2 - CONNECTOR
AEAE1900
AE3A
AE42
AE51
AHAH3110
AH4722
AH4810
AH5212
AJAJ6110 - CONNECTOR
AJ6210 - CONNECTOR
AJ6516
AJ89 - CONNECTOR
AJ9A - CONNECTOR
AKAK30
AK31
AK32
AK33
AMAM30
AM31
AM32
AM33
AM34
AM35
AM36
AM37
AM38
AM3G
GAGA30
GA31
GA32
GCGC30
LBLB71
LB72
LB76
QSQSM1
Product family
131 Catalogue 2016
ALTIS®
ARIS®
BIOFLEX®
BIOSOFT®
BONEE®
BONEE® FLEXCOBRA®
COELIODRAIN®
CYSTO-CARE®
CYSTODRAIN®
DETOUR®
DIABOLO®
DIGITEX®
DORMIA®
DUOWIRE TM
ELEFANT®
EXAIR®
FLEXISHAFT TM
FOLATEX®
FOLYSIL®
GENESIS®
HILINE TM
HELIKAL®
HILINE®
HYDROCOATS®
IMAJIN®
IN-KA®
ISIRISTM
KIWEE®
KOLIBRI®
N.STONE®
NOVASILK®
ORCHESTRA TM
PICKSTONE®
PORGES®
PROSTAFLOW®
PYELOSTENT®
RESIST®
RESTORELLE®
RESURINE®
RETRACE®
STENOSTENT®
STERILIC®
SUPRAFLOW®
TITAN®
T.O.T®
U2®
URETHROSPIRAL®
URIOPE®
URISTIL®
URISTOM®
UROCARE®
UROCARE SUPRA®
UROQUICK®
UROSPIRAL®
VIRTUE®
VORTEK®
X-FLOW®
are registered trademarks of Coloplast A/S.
Note: our trademarks are widely protectedthrough the world.
Some products may not be available for worldwidesales. For more information, please contact yourColoplast representative