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Coloplast TFL Drive
Thulium Fiber Laser & Fibers

Power Made Safer*

Experience the power of advanced Thulium Fiber Laser (TFL) technology with the Coloplast TFL Drive. Our all-in-one laser system for lithotripsy, BPH and precise soft tissue treatments was designed by surgeons for surgeons to promote safety. Its intuitive touch screen, surgical versatility and cutting-edge technology provides confidence and support in the OR.

We invite you to try the Coloplast TFL Drive and see for yourself how you can optimize your experience while managing safety.
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*User interface designed with warning limits for safer use

Quick Links:   Safety & support  |   Product features  |   Laser fibers  |   Product specifications  |   Resources  |   Ordering information  |  Important safety information

Take a test drive (kidney stone demo)

See for yourself how easy the Coloplast TFL Drive is to use.

Learn more

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Set for safety

Safety should be simple. That’s why we worked with experienced surgeons to build it right in. Coloplast TFL Drive’s pre-settings, power limits and intuitive interface optimize your experience.

Intuitive interface with Pre-settings

Provide a quick starting point for every case and a flatter learning curve.
Adopt energy, frequency and power values to the size of fiber used.

Power limits

Alerts appear when exceeding pre-defined power limits for each anatomical location.

First peer-reviewed settings supported by clinical practice.1
In

94.1%
of cases, parameters selected by surgeon remained in Coloplast pre-setting safety range.1


1. Choose setting
 

2. Choose treatment area
and treatment type

3. Review energy, power and frequency values before starting procedure

Designed for ease

The Coloplast TFL Drive offers powerful, consistent performance at your fingertips. Add in a flexible, maneuverable design that you can use in any OR and you’ve scored a winning workflow.

Standard plug
Available in any OR suite

Quiet
Uses air-cooling technology (<70dBA)

Lightweight, compact design
Tower model is only 220 lbs.
(vs. >500 lbs. for high power holmium

Less maintenance
Simple internal architecture

Double footswitch
Surgeon can change modes without nurse assistance

High performance2 with less energy consumption

TFL technology is the latest cutting-edge laser technology, bringing highly effective intra-operative performance.

With the Coloplast TFL Drive, do more in less time, using less energy.

Faster and finer dusting
Less stone retropulsion
High stone ablation speed and efficiency
Reduced energy requirements
Greater variety of laser settings
(0.02-6J and up to 2,500 Hz)

Wide offering of laser fibers

The Coloplast TFL Drive operates with a large range of fibers depending on the application, flexibility and settings required.

Available diameters

150, 200, 272, 272 ball tip, 365, 550, 600 (lateral flow), 800 and 1000 μm.

150 μm fiber

For greater scope flexibility, irrigation and visibility.

Single use and Reusable fibers

150, 272 ball tip, and 600 μm fibers only available in single use.

Laser specifications

Laser Classification Class 4
Laser type TFL (Thulium Fiber Laser)
Wavelength 1940 nm ± 20nm
Max pulsed energy 0.02 – 6 J
Repetition rate 1 – 2500 Hz
Max power 60 W (CW and pulsed mode)
Operating mode Pulsed (single or multiple) / CW
Pulse duration 50µs – CW
Aiming Beam Green 532nm (adjustable) < 5mW, class 3R

Technical specifications

Classification of Medical Device Directive Class IIb
Electrical requirements 100–240 Vac; 50/60 Hz; 1000VA
Dimensions 470(W)x810(D)x1156(H) mm
Display standing up
470(W)x810(D)x940(H) mm
Display closed
Weight 100kg
Cooling system Air cooling system
Protection against
electric shock		 Class 1 / Type BF

Ordering information

For ordering information, please call 800-258-3476.

Product Code Description UOM Quantity/Box
TFLD01 Coloplast TFL Drive 60W Thulium Fiber Laser (TFL)

Includes double footswitch, optical blast shield, safety goggles (2), power cord, user manual, and accessory case containing fiber stripper for optical fibers 300 to 1000 µm, Fiber stripper for optical fibers 100 to 400 µm, ceramic fiber cutter with slipcase, interlock connector, optical blast shield, and key for use with Coloplast TFL Drive.
FSI150 Optical Fiber 150 µm Single Use, for use with Coloplast TFL Drive BX 5/box
FSI200 Optical Fiber 200 µm Single Use, for use with Coloplast TFL Drive BX 5/box
FSV200 Optical Fiber 200 µm 5X reusable, for use with Coloplast TFL Drive BX 5/box
FSX200 Optical Fiber 200 µm 10x reusable, for use with Coloplast TFL Drive BX 5/box
FBI272 Optical Fiber 272 µm Ball tip Single Use, for use with Coloplast TFL Drive BX 5/box
FSI272 Optical Fiber 272 µm Single Use, for use with Coloplast TFL Drive BX 5/box
FSV272 Optical Fiber 272 µm 5x Reusable, for use with Coloplast TFL Drive BX 5/box
FSX272 Optical Fiber 272 µm Reusable 10x, for use with Coloplast TFL Drive BX 5/box
FSI365 Optical Fiber 365 µm Single Use, for use with Coloplast TFL Drive BX 5/box
FSV365 Optical Fiber 365 µm Reusable 5x, for use with Coloplast TFL Drive BX 5/box
FSX365 Optical Fiber 365 µm Reusable 10x, for use with Coloplast TFL Drive BX 5/box
FSI550 Optical Fiber 550 µm – Single Use, for use with Coloplast TFL Drive BX 5/box
FSV550 Optical Fiber 550 µm – 5x Reusable, for use with Coloplast TFL Drive BX 5/box
FSX550 Optical Fiber 550 µm – 10x Reusable, for use with Coloplast TFL Drive BX 5/box
FSI800 Optical Fiber 800µm – Single Use, for use with Coloplast TFL Drive BX 5/box
FSV800 Optical Fiber 800 µm – 5x Reusable, for use with Coloplast TFL Drive BX 5/box
FSX800 Optical Fiber 800 µm – 10x Reusable, for use with Coloplast TFL Drive BX 5/box
FSI000 Optical Fiber 1000 µm – Single Use, for use with Coloplast TFL Drive BX 5/box
FSV000 Optical Fiber 1000 µm – 5x Reusable, for use with Coloplast TFL Drive BX 5/box
FSX000 Optical Fiber 1000 µm – 10x Reusable, for use with Coloplast TFL Drive BX 5/box
FLI600 Lateral Fiber – Single Use, for use with Coloplast TFL Drive BX 5/box

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PM-27630

Coloplast TFL Drive Laser Fibers BRIEF STATEMENT

Indications
Optical Fibers are indicated for use in general surgical applications such as: incision, excision, vaporization, ablation, hemostasis, coagulation of soft tissue and stone treatment in a contact semicontact or non-contact mode. Applications are defined by the intended use of the surgical laser device, while optical fibers cannot be associated to any specific application. Laser techniques are most commonly applied in surgical fields such as Urology, Gastroenterology, Arthroscopy, Spine surgery, Gynecology, ENT, and General Surgery. Indications are the ones that the laser claims, while fibers cannot be associated to any specific indication.

Contraindications
For warnings, cautions, contraindications, and clinical use of the fiber refer to the medical laser device User Manual. Optical Fibers are contraindicated for treatment of patients for whom endoscopic procedures are contraindicated. Medical opinion is critical to determine if a patient can withstand a laser treatment, considering also the contraindications related to the specific clinical applications.

Warnings & Precautions
This product shall be used by trained and qualified users only. Indications involving heart or central circulatory system, or the central nervous system are excluded from optical fibers intended use. Reusable Optical Fibers should not be used on patients with confirmed or suspected Transmissible Spongiform Encephalopathies (TSEs). For Single-use Optical Fibers Only: Reuse, re-processing, or re-sterilization may compromise the structural integrity of the device and/or lead to a device failure or create risk of contamination. This may result in patient injury, illness or death, or in transmission of infectious disease from one patient to another.

Potential Complications
Refer to the laser system User Manual for specific instructions concerning warnings, cautions, contraindications, and clinical use of the laser. Complications that could occur during laser treatments include: • local and/or systemic infection • thermal damage • local hematoma • dissection and perforation • tissue adhesion • Pain.
Note: It is possible that the optical fiber tip breaks off during use.

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.

PM-21989, July 2024

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.

Other considerations requiring physician’s clinical judgement:

  • 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
3/27/2023
PM-21981

References

  1. Catalina Solano, Luigi Candela, Frederic Panthier, Mariela Corrales and Olivier Traxer World J Urol. 2023 Dec;41(12):3765-3771.
  2. As evidenced through in vitro test comparing Coloplast TFL Drive to holmium laser, showing significant increase in ablation volume, finer dust quality and less energy consumption.
  3. Martov A., Ergakov D., Guseynov M., Andronov A., Plekhanova O.A. Clinical Comparison of Super Pulse Thulium Fiber Laser and High-Power Holmium Laser for Ureteral Stone Management. J. Endourol. 2020:795-800. doi: 10.1089/end.2020.0581.
  4. Gupta, A., Ganpule, A. P., Puri, A., Singh, A. G., Sabnis, R. B., & Desai, M. R. (2023). Comparative study of thulium fiber laser versus holmium laser for ureteric stone management with semi-rigid ureteroscopy: A prospective, single-center study. Asian Journal of Urology.
  5. Chandramohan, Vaddi; Swamy, P M Siddalinga; Ramakrishna, Paidakula; Ganesan, Soundarya; Babu, Manas; Anandan, Hemnath; Panda, Rakesh. Ureteroscopic lithotripsy by thulium fiber laser versus holmium laser: A single-center prospective randomized study. Urology Annals 15(3):p 285-288, Jul–Sep 2023.
  6. Para, S. A., Wani, M. S., Hamid, A., Malik, S. A., Khawaja, A. R., & Mehdi, S. (2023). Incidence of Ureteric strictures Following Ureteroscopic Laser Lithotripsy: Holmium: YAG Versus Thulium Fiber Laser. Urology Research & Practice, 49(3).
  7. Taratkin, Mark, Camilla Azilgareeva, Vladislav Petov, Andrey Morozov, Stanislav Ali, Diana Babaevskaya, Vincent De Coninck et al. “Thulium fiber laser vs Ho: YAG in RIRS: a prospective randomized clinical trial assessing the efficacy of lasers and different fiber diameters (150 μm and 200 μm).” World Journal of Urology 41, no. 12 (2023): 3705-3711.
  8. Pratsinis, Manolis, Ahmet C. Tekin, Valentin Zumstein, Sabine Gusewell, Hans-Peter Schmid, Dominik Abt, Patrick Betschart, and Ahmet Cevdet Tekin. “Urinary Stone Location with Ureteral Stents in Place: Always on the Move, and not Where you Would Expect.” Urology Journal 17, no. 6 (2020).

Coloplast Corp
1601 West River Road North
Minneapolis MN 55411 USA
1-800-258-3476

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