Coloplast TFL Drive 2.0 - Corporate
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*User interface designed with warning limits for safer use

Let's drive together to empower your OR

 

 

The new 60 W Coloplast TFL Drive, featuring the latest Thulium Fiber Laser (TFL) technology is here!

 

Our laser combines surgical versatility and optimal clinical performance1 on a graphic interface designed by surgeons for surgeons. This all-in-one solution for lithotripsy, BPH and soft tissue offers full support and customization to truly inspire confidence and innovation in the OR.2

 

1As evidenced through in vitro tests comparing Coloplast TFL Drive to Holmium laser, showing significant increase of ablation volume, finer dust quality and less energy consumption: Coloplast data on file

2Usability tests: Coloplast data on file

For outside of the US Indications for Use please click here


Outside of the US Indications for Use:

The Coloplast TFL Drive laser device and its accessories are intended for use in surgical procedures using open laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and lithotripsy of stones in use in medical specialties including: Urology, Thoracic and Pulmonary, ENT, Neurosurgery, Gastroenterology, Gynecology and General Surgery.

Refer to User Manual and IFUs for Indications, Warnings, Precautions and Potential Complications.  

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Interface assists the laser user when handling this new technology



 

 

  • Coloplast TFL Drive is emerging as a new alternative to Holmium YAG laser, intended for lithotripsy, BPH, soft tissue.

  • Our interface guides users step-by-step to quickly select appropriate parameters for treatment.2

  • Developed to simplify access to the main screen, you can easily go to free mode or your own pre-settings.

  • Coloplast Interventional Urology provides a learning curriculum to support operators along the learning curve period and beyond.

 

2Usability tests: Coloplast data on file

Coloplast Thulium Fiber Laser

Click on the circles and discover Coloplast TFL Drive's features

Graphical User Interface
  • Step-by-step guide to setup fiber/pre-setting combination for specific clinical situations.
  • Dashboard with dial-like design to increase focus on Energy (J).
Double Footswitch
  • Right pedal to change among treatment modes
  • Left pedal for laser firing
Monitor
Touch screen rotates vertically and laterally.
Front Hooks
Front hooks for footswitch hanging.
Back Hooks
Back hooks for footswitch hanging.
Plug
Uses standard wall plug for easy set up and use.
Laser Port
Laser port with light ring indicating generator status.
IR Sensor
IR sensor for hands-free laser hatch opening.
Tower Model
With multi-directional wheels for easy transportability.
Air Cooling System

Coloplast Driving Dashboard - interface specifications

Click on the circles, and discover Coloplast driving dashboard features

Procedure
Save personnal pre-settings
Nominal Value - defined to be safe
Frequency to increase speed
Optimal Zone – Defined for targeting safety and efficacy
Procedure time
Lasering time
Fiber size used
Energy based
Treatment

Important Safety Information

Coloplast TFL Drive Brief Statement for US only

Coloplast TFL Drive

BRIEF STATEMENT FOR US ONLY

Coloplast TFL Drive BRIEF STATEMENT


Indications

The Coloplast TFL Drive laser device and its accessories are intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue with or without an endoscope, in the following indications: Urology, Lithotripsy, Gastroenterological Surgery and Gynecological Surgery.

Contraindications

The use of the laser is contraindicated:

  • In patients whose general medical condition contraindicates surgical intervention.
  • When appropriate anaesthesia is contraindicated by patient history or inability to receive anesthesia.
  • Where tissue (especially tumors) is calcified.
  • For hemostasis of vessels with diameters over approximately two millimeters.
  • Where laser therapy is not considered the treatment of choice.
  • In patients who have recently undergone radiotherapy. Such patients may be at greater risk of tissue perforation or erosion.
  • In patients unable to receive endoscopic treatment.
  • In patient suffering from bleeding disorders and coagulopathy.
  • Diagnosed with acute or chronic prostatitis, prostate cancer, or severe urethral stricture.
  • Diagnosed at the time of treatment with acute or chronic urinary tract infection.
  • Patients with compromised renal function or upper urinary tract obstructive diseases.
  • Patients who still wish to have children.
  • Patients with an ASA classification of physical status 5.
  • Patients with a prostate gland > 120g.

Warnings and Precautions

Clinical studies have shown that patients who have undergone radiation therapy present a greater risk of perforation or tissue erosion. The Coloplast Drive Laser System is a surgical device that should be used only by physicians or surgeons who have been thoroughly trained in laser surgery. Surgeons using Coloplast TFL Drive Laser System must understand the laser’s unique properties prior to using the device.

As with conventional endoscopic surgery, the possibility of complications and adverse events (such as chills, fever, edema, hemorrhage, inflammation, tissue necrosis or infection) may occur following treatment. In extreme cases, death may occur due to procedural complications or concurrent illness. The laser may not be effective for coagulation in massive haemorrhage situations. The surgeon must be prepared to control haemorrhages with alternative non-laser techniques, such as ligature or cautery. The risk of infection and scarring associated with any surgical procedure has to be taken into account.  Tissue perforation may result if excessive laser energy is applied. This could occur through the use of excessive laser power or the application of a correct power for excessive periods, particularly in diseased tissue. The use of mechanical pressure on the Single-Use and Reusable Optical Fiber devices does not increase its cutting or vaporization effects but may induce bleeding, thermal damage and fiber destruction.

The manufacturer has no clinical information or experience concerning the use of the Laser System on pregnant women or nursing mothers. There is no guarantee that treatment with the Laser System will entirely eliminate the disease. Repeated treatment or alternative therapies may subsequently be required.

Potential Complications

Complications and risks are the same of the conventional laser surgery. Acute pain may occur immediately following laser therapy and may persist for as long as 48 hours. Immediately following laser therapy, the patient may experience fever and leucocytosis, which are commonly associated with tissue destruction. These generally resolve without treatment. Laser ablated tissue may become necrotic or infected after treatment. In case of concerns about any possible infection, appropriate treatment should be carried out.

Acute complications and non-thermal risks include induced hemorrhage, ulceration, perforation, edema, pain, fever, leukocytosis, and chills. Critical complications and thermal risks include healing delay, perforation, stenosis, delayed hemorrhage, sepsis, and embolism.

The following complications could be serious and could result in death:

  • Patients may experience bleeding at the site of laser therapy. Haematocrit analysis after treatment is recommended to identify this potential complication.
  • Sepsis can result from performing any surgical procedure. In case of concerns about any possible sepsis, appropriate evaluations should be made.
  • Perforation may occur as a result of laser treatment. In order to diagnose perforations, patients must be carefully followed post-operatively with appropriate tests.

The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company website at www.coloplast.com.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

 

Minneapolis, MN

6/27/2022 PM- 21981

 

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Coloplast TFL Drive Laser Fibers Brief Statement for US only

Coloplast TFL Drive Laser Fibers

BRIEF STATEMENT FOR US ONLY

Indications – Single Use Lateral and 150μm Optical Fibers

Single Use Lateral and 150μm Optical Fibers are intended to be used to deliver the laser radiation to the target tissue when used with any cleared/certified surgical laser with operational wavelengths between 532 nm – 2200 nm equipped with SMA 905 or SMA 906 or compatible connector, as per the indications of the laser device used with.

Indications – Single Use and Reusable Optical Fibers

Single Use and Reusable Optical Fibers are intended to be used in conjunction with any cleared surgical laser distributed by Coloplast equipped with SMA 905 or SMA 906 or compatible connector for use in general surgical applications (incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in contact or non-contact mode). Optical Fibers are also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated.

The Optical Fibers are indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT/otolaryngology, endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis. Optical Fibers are also intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue, and for use in lithotripsy.

Optical Fibers are indicated for use with laser devices emitting radiation from 532 nm to 2100 nm, with pulsed and continuous wave (CW) emission mode, and, but not limited, for use with Diode laser, Argon, KTP/532, Ho:YAG, Nd:YAG, Tm:YAG pulsed and continuous wave CW laser devices.

Optical Fibers may be used in surgical specialties or procedures for which compatible lasers have received regulatory clearance: for a complete information about applications, contraindications, precautions and warnings when using Optical Fibers it is necessary to refer to the applicable laser device User Manual.

Warnings and Precautions - Single Use, Single Use 150μm and Reusable Optical Fibers

Optical Fibers shall be used by trained and qualified users only. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to a device failure which, in turn, may result in patient injury, illness or death (For Single Use Fibers Only). On patients with confirmed or suspected Transmissible spongiform encephalopathies (TSEs), also known as prion disease, use only Single-use Sterile Optical fibers.

Potential Complications - Single Use, Single Use 150μm and Reusable Optical Fibers

Complications that could occur during laser treatments include local and/or systemic infection, thermal changes to the surrounding structures, local hematoma, dissection and perforation, tissue adhesion, distal tip detachment, and discomfort during and/or after (laser) energy application. In the unlikely event of a detached tip, it may be visually located through an appropriate scope and removed using forceps. Irrigate the area thoroughly to remove any traces of the tip.

The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company website at www.coloplast.com.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Minneapolis, MN

7/14/2022 PM-21989

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