FiberTech Medical Device for laser medicine & endoscopy

The Quality Connection

FiberTech

Medical Device for laser medicine & endoscopy

www.leoni-marine-technologies.com

Our product family FiberTech Our experience in laser medicine

We manufacture multimode and singlemode fibers and fiber bundles with different numerical apertures, coatings and claddings. We produce medical fibers for laser energy transmission and also offer series production of surgical, ophthalmological, urological, dental and endovascular laser probes with biocompatible materials.

Optical technologies and LEONI The Fiber Optics business unit of the LEONI Group is one of the leading providers of optical fibers for communication as well for special applications in industry, sensor technology and analytics, in science and laser medicine. LEONI is offering a unique product range at every stage along the value chain: from the preform, to the fibers, up to fiber optic cables and complet fiber optic systems. Get to know our product families: The LEONI Group, which is market-listed in the German MDAX index, employs about 60,000 people in 33 countries and, with 88 subsidiaries, generated consolidated sales of 2.96 billion in 2010.

Get to know our product families:

FiberConnect
Light Guide Cable Solutions

FiberTech
Special Optical Fiber Technologies

FiberSwitch
Light Switching for Optical Systems

FiberSplit
Light Distribution for Optical Systems

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Medical Device for laser medicine & endoscopy

FiberTech

Medical disciplines and methods

Your business partner for:

Aesthetic Surgery

Endoscopy

Ophthalmology

Children`s Surgery

ENT

Orthopaedics

Dentistry

Gastroenterology

Pneumology

Dermatology

Gynaecology

Urology

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FiberTech

Medical Device for laser medicine & endoscopy

Our product portfolio

SideFiring Fiber Reusable BareFiber Disposable BareFiber Hard Clad BareFiber GlueFree BareFiber CapillaryTip BareFiber BareFiber for dentistry BareFiber, gas/liquide cooled Ophthalmic probes Handpieces and accessories Fiber-bundles Light-guide cones/rods

Note
Versions with customer-specific adaptations such as different colors, diameters and lengths, for example, arepossible for all products and designs.

Services

Development of a customer-oriented product design Fibers for different wavelengths with different numerical apertures (NA) as well as particularly low OH content are available

Series production of surgical, ophthalmological, urological, dentaland endovascular probes with biocompatible materials Manufacturing of medical fibers for laser energy transmission primarily in the wavelength range from 266 nm to 2200 nm

Manufacturing of medical probes for the laser energy transmission of argon, Nd:YAG, excimer, holmium and diode lasers

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Medical Device for laser medicine & endoscopy

FiberTech

It all starts with the development of solutions

ISO 9001 certified ISO 13485 certified FDA Reg. No. 3005128587 approval for CE marking
certifications & approvals

Your systems partner for every application

In-house fiber production

Fiber assemblying under clean room condition

Packaging and sterilisation

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FiberTech

Medical Device for laser medicine & endoscopy

SideFiring BareFiber
Fiber optic probes with lateral radiation and excellent beam quality. TheSideFiring fibers with their special design are characterised by a long service life and are tested and wellregarded in clinics around the world.
Properties

standard length 3 m suitable for UV 532 nm and IR up to 2200 nm capillary 1750 or 2050 m handling aid and capillaries with beam direction marking high-power F-SMA905 connector (free-standing) max. output up to 250 W CW optimisation for customer-specific laser devicespossible

Applications

Urology

resection of prostate

Gynaecology

endometrium ablation

Wavelength UV UV IR IR
* S = sterile, N = non sterile

Core [m] 600 600 600 600

Capillary [m] 1500 2000 1750 2050

Type designation FT UV600/720HCN-3/SL-SF-1500 014011L FT UV600/720HCN-3/SL-SF-2000 014011L FT IR600/720HCN-3/SL-SF-1750 012011L FT IR600/720HCN-3/SL-SF-2050 012011L

Order no.* M280100S M280150S M280200S M280300S

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Medical Device for laser medicine & endoscopy

FiberTech

Reusable BareFiber
High-quality silica/silica fiber with a wide range of application options.
Properties

standard length 3 m, NA = 0.22 also available as a special version for pulsed lasers, such as holmium lasers (note: different order no.) available as a sterile or non-sterile item F-SMA extension sleeve available in various colours, laser inscription possible applicable for UV 532 nm and IR up to 2200 nm standard (SM) or high power (SL) F-SMA905 connectors customer-optimised designs on request various accessories available (strippers, cleavers, etc.)

Applications

Urology

resection of prostate lithotripsy of urinary calculi partial nephrectomy septum dissection adhesiolysis exision of tumors tonsillectomy chondroplasty removal of multiple lung metastases diskectomy menisectomy chondroplasty

Gynaecology

ENT

Pneumology

Orthopaedics

Core [m]

Clad [m]

Fiber [m]

Type designation

Order no.*

200 272 365 400 550 600 800 1000

Core [m] approx.

220 300 400 440 605 660 880 1100

Core [m] dist.

420 600 700 750 900 1000 1350 1500

Fiber [m]

FT IR200/220ST-3/SL-F 1500K3L FT IR272/300ST-3/SL-F 1500K3L FT IR365/400ST-3/SL-F 1500K3L FT IR400/440ST-3/SL-F 1500K3L FT IR550/605ST-3/SL-F 1500K3L FT IR600/660ST-3/SL-F 1500K3L FT IR800/880ST-3/SL-F 1500K3L FT IR1000/1100ST-3/SL-F 1500K3L
Type designation

M220100S M220200S M220300S M220900S M220500S M220600S M220700S M220800S

Order no.*

400 400
* S = sterile, N = non sterile

200 300

420 650

FT IR400/200ST-3/SL-F-ST 1100K3L FT IR400/300ST-3/SL-F-ST 1100K3L

M230106S M230205S

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FiberTech

Medical Device for laser medicine & endoscopy

Disposable BareFiber
High-quality silica/silica fiber with a wide range of application options.
Properties

standard length 3m, NA = 0.22 also available as a special version for pulsed lasers, such as holmium lasers (note: different order no.) available as a sterile disposable item F-SMA extension sleeve available in various colors, laser inscription possible applicable for UV 532 nm and IR up to 2200 nm standard (SM) or high power (SL) F-SMA905 connectors customer-optimised designs on request

Applications

Urology

resection of prostate opening of ureteral strictures partial nephrectomy septum dissection adhesiolysis exision of tumors tonsillectomy chondroplasty removal of multiple lung metastases diskectomy menisectomy chondroplasty

Gynaecology

ENT

Pneumology

Orthopaedics

Core [m] 200 272 365 400 550 600 800 1000
* S = sterile, N = non sterile

Clad [m] 220 300 400 440 605 660 880 1100

Fiber [m] 420 600 700 750 900 1000 1350 1500

Type designation FT IR200/220ST-3/SL-F 120011L FT IR272/300ST-3/SL-F 120011L FT IR365/400ST-3/SL-F 120011L FT IR400/440ST-3/SL-F 120011L FT IR550/605ST-3/SL-F 120011L FT IR600/660ST-3/SL-F 120011L FT IR800/880ST-3/SL-F 120011L FT IR1000/1100ST-3/SL-F 120011L

Order no.* M210100S M210200S M210300S M210900S M210500S M210600S M210700S M210800S

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Medical Device for laser medicine & endoscopy

FiberTech

Disposable BareFiber Slim Version

High quality silica/silica fiber with increased NA for power applications
Properties

also available as a special version for pulsed lasers, such as holmium lasers (note: different order no.) available as a sterile disposable item F-SMA extension sleeve available in various colors, laser inscription possible applicable for UV 532 nm and IR up to 2200 nm standard (SM) or high-power (SL) F-SMA905 connectors customer-optimised designs on request standard length 3 m, NA = 0.32

Applications

Urology

resection of prostate opening of ureteral strictures partial nephrectomy septum dissection adhesiolysis exision of tumors tonsillectomy chondroplasty removal of multiple lung metastases diskectomy menisectomy chondroplasty

Gynaecology

ENT

Pneumology

Orthopaedics

Core [m] 200 272 365 400 550 600 800 1000
* S = sterile, N = non sterile

Clad [m] 220 300 400 440 605 660 880 1100

Fiber [m] 400 450 580 650 780 880 1200 1400

Type designation FT IR200/220HCT-3/SL-F 130011L FT IR272/300HCT-3/SL-F 130011L FT IR365/400HCT-3/SL-F 130011L FT IR400/440HCT-3/SL-F 130011L FT IR550/605HCT-3/SL-F 130011L FT IR600/660HCT-3/SL-F 130011L FT IR800/880HCT-3/SL-F 130011L FT IR1000/1100HCT-3/SL-F 130011L

Order no.* M240100S M240200S M240300S M240900S M240500S M240600S M240700S M240800S

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Medical Device for laser medicine & endoscopy

HardClad BareFiber
Fiber optic probes with increased NA (NA=0.37) and excellent beam quality. A disposable product high quality and economical.
Properties

ETO-sterilised, double packed (pouch in pouch) length marking on the fiber for optimum treatment control available male/female LuerLock for catheter connection available (with L in the product code)

F-SMA extension sleeve available in various colors, laser inscription possible IR fibers, low OH F-SMA905-connectors, customer-specific connectors can be assembled cost-efficient standard length 3 m, NA = 0.37

Applications

Aestetic surgery

laser lipolysis angiodyplasia and hemangioma removal of leg veins paradontal treatment preparation of root chanels oral surgery

Dentistry

Core [m] 200 300 400 600 600 800

* S = sterile, N = non sterile

Fiber [m] 500 520 730 800 950 1000

Type designation FT IR200T-3/SM-F 000011L FT IR300T-3/SM-F 000011L FT IR400T-3/SM-F 000011L FT IR600T-3/SM-F-SLIM 000011L FT IR600T-3/SM-F 000011L FT IR800T-3/SM-F 000011L

Order no.* M200200S M200300S M200400S M200600S M200800S M201000S

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Medical Device for laser medicine & endoscopy

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FiberTech

GlueFree HardClad BareFiber

Laser probe with increased NA (NA=0.37), excellent beam quality and adhesive-free connector. The cost-effective alternative.
Properties

ETO-sterilised, double packed (pouch in pouch) Length marking on the fiber for optimum treatment control available male/female LuerLock for catheter connection available (with L in the type designation) extension sleeve available in various colors, laser inscription possible IR fibers, low OH F-SMA905 compatible connector Tefzel coated standard length 3 m, NA = 0.37

Applications

Aestetic surgery

laser lipolysis, angiodyplasia and hemangioma,removal of leg veins, endovenous laser therapy paradontal treatment oral surgery

Dentistry

Core [m] 400 600 600

* S = sterile, N = non sterile

Fiber [m] 730 800 950

Type designation FT IR400T-3/SM-F-GF 000031L FT IR600T-3/SM-F-GF-SLIM 000041L FT IR600T-3/SM-F-GF 000021L

Order no.* M290400S M290600S M290800S

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FiberTech

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Medical Device for laser medicine & endoscopy

CapillaryTip BareFiber
The atraumatic tip construction enables treatments without the otherwise usual catheters and at the same time displays an enhanced energy profile.
Properties

ETO-sterilised, double packed (pouch in pouch) enhanced emission pattern compared to FlatTip through lens-shaped tip design. length marking on the fiber for optimum treatment control available male/female LuerLock available F-SMA extension sleeve available in various colors, laser inscription possible IR fibers, low OH standard length 3 m, NA = 0.37

Applications

Aestetic surgery

laser lipolysis, removal of leg veins

Core [m] 600

Fiber [m] 950**

Type designation FT IR600T-3/SM-F-CT 000011L

Order no.* M320600S

* S = sterile, N = non sterile ** recommended cannula 16 Gauge, ID > 1200 m

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FiberTech

Laser probes with polyimide fibers for dental medicine

The polyimide fibers guarantee very high mechanical stability withthesmallest outer diameter.
Properties

F-SMA905 connectors, customer-specific connectors can be assembled IR fibers, low OH available with germanium-doped silica/silica fibers (NA=0.37/0.40) sterilisable, autoclavable polyimide coating biocompatible protection tube with 2.0 mm outer diameter distal 10 cm of fibers free-standing laser-inscribed handpieces available standard length 3 m, NA = 0.22 autoclavable connection for Luer cannulae single-part fiber clamping system

Accessories

Dental handpiece HPD1

Applications

Dentistry

paradontal treatment preparation of root chanels oral surgery

Dental handpiece

Core [m] 200 320 400 600 Dental handpiece

* S = sterile, N = non sterile

Fiber [m] 265 410 465 685

Tube [m] 2000 2000 2000 2000

Type designation FT IR200/240PI-3/SM-F 500110L FT IR320/385PI-3/SM-F 500110L FT IR400/440PI-3/SM-F 500210L FT IR600/660PI-3/SM-F 500210L HPD1

Order no.* M250200N M250300N M250400N M250600N MHPD1

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FiberTech

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Medical Device for laser medicine & endoscopy

BareFiber for orthopaedics

The polyimide fibers guarantee very high mechanical stability withthesmallest outer diameter.
Properties

F-SMA905 connectors, customer-specific connectors can be assembled IR fibers, low OH EtO-sterilised, double packed (pouch in pouch) sterilisable, autoclavable polyimide coating C-Flex or silicone tube with 2.00 mm outerdiameter distal 10 cm of fibers free-standing laser-inscribed handpieces available standard length 3 m, NA = 0.22

Applications

Orthopaedics

diskectomy menisectomy chondroplasty

Core [m] 200 320 400 600

* S = sterile, N = non sterile

Fiber [m] 265 410 465 685

Tube- [m] 2000 2000 2000 2000

Type designation FT IR200/240PI-3/SM-F 500111L FT IR320/385PI-3/SM-F 500111L FT IR400/440PI-3/SM-F 500211L FT IR600/660PI-3/SM-F 500211L

Order no.* M330200S M330300S M330400S M330600S

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Medical Device for laser medicine & endoscopy

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FiberTech

BareFiber, gas/liquide cooled

Especially interesting for the gastroenterological discipline.
Properties

F-SMA905 connectors, customer-specific connectors can be assembled IR fibers, low OH, NA = 0.37 ETO-sterilised, double packed (pouch in pouch) Luer adapters for rinsing medium F-SMA extension sleeve available invariouscolors Laser inscription possible also available: silica/silica fiber, NA = 0.32

Applications

Gastroenteology

recanalization of oesophagus carcinoma recanalization in tracheal carcinoma tissue ablation

Pneumology

Core [m] 400 600 400** 600**

* S = sterile, N = non sterile ** NA = 0.32

Fiber [m] 730 950 750 1000

Outer [m] 1800 2100 1800 2100

Type designation FT IR400T-3/SM-GLC-1800 000A11L FT IR600T-3/SM-GLC-2100 000B11L FT IR400/440HCT-3/SM-GLC-1800 000A11L FT IR600/660HCT-3/SM-GLC-2100 000B11L

Order no.* M260100S M260200S M260300S M260400S

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FiberTech

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Medical Device for laser medicine & endoscopy

Ophthalmic probes
The probes are characterised by their high-quality, ergonomicaldesignand have an anodised metal handpiece.
Properties

excellent mechanical and optical quality fibers centric in the cannula, minimaladhesivegap ETO-sterilised, double packed (pouch in pouch) available low NA = 0.11** Many connector types available (F-SMA, FC/PC, ceramic ferrules, etc.) available with core diameter of 100 m laser inscription possible (handpiece and/orextension sleeve) endoprobes available in 20, 23, 25 gauge cycloprobe with ball made from fiber material, 900 m retinopexy probe with laterally decoupling laser beam straight (S), curved (C), retractable (R) versions available

Application

Ophthalmology

vitrectomy

Type Endo 20G straight Endo 20G curved Endo 23G straight Endo 23G curved Endo 23G straight** Endo 23G curved** Endo 25G straight Endo 25G curved Illum. EP 20G straight Illum. EP 20G curved Endo 23R retractable Cyclo 900 Retinopexi
* S = sterile, N = non sterile ** NA = 0.11

Core [m] 210 210 210 210 100 100 210 210 210 210 210 600 600

Type designation FT IR210/220A-2.5/SM-ES20 000311L FT IR210/220A-2.5/SM-EC20 000311L FT IR210/220A-2.5/SM-ES23 000311L FT IR210/220A-2.5/SM-EC23 000311L FT IR100/240A-2.5/SM-ES23-LNA 000311L FT IR100/240A-2.5/SM-EC23-LNA 000311L FT IR210/220A-2.5/SM-ES25 000311L FT IR210/220A-2.5/SM-EC25 000311L FT IR210/220A-2.5/SM-EIS20 000311L FT IR210/220A-2.5/SM-EIC20 000311L FT IR210/220A-2.5/SM-ER23 000311L FT IR600/900AN-2.5/SM-CS 000411L FT IR600/630A-2.5/SM-ER 000411L

Order no.* M270100S M270150S M270200S M270250S M270300S M270350S M270400S M270450S M270500S M270550S M270600S M270800S M270900S

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Medical Device for laser medicine & endoscopy

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FiberTech

Handpieces for medical fibers

Handpieces with cannulae made from stainless steel.
Properties

autoclavable single-part fiber clamping system various needle shapes/lengths/diameters available handpieces for ENT

Surgical handpieces

Length [mm]

Type designation / Order no. for core 400 m for core 600 m MHPS1-20-600 MHPS1-40-600 MHPS1-60-600 MHPS2-60-600 MHPS2-80-600 MHPS2-100-600 MHPS2-120-600 MHPS3-50-600 MHPS3-75-600 MHPS3-100-600 MHPS3-125-600 MHPS4-20-600 MHPS4-40-600 MHPS4-60-600 MHPS4-80-600 MHPS4-100-600 MHPS4-120-600 MHPS4-140-600 MHPS4-160-600 MHPS4-180-600 MHPS4-200-600

short curved (45)

20 40 60 60 80 100 120 50 75 100 125 20 40 60 80

MHPS1-20-400 MHPS1-40-400 MHPS1-60-400 MHPS2-60-400 MHPS2-80-400 MHPS2-100-400 M-HPS2-120-400 MHPS3-50-400 MHPS3-75-400 MHPS3-100-400 MHPS3-125-400 MHPS4-20-400 MHPS4-40-400 MHPS4-60-400 MHPS4-80-400 MHPS4-100-400 MHPS4-120-400 MHPS4-140-400 MHPS4-160-400 MHPS4-180-400 MHPS4-200-400

offset (ENT)

curved

straight

curved

offset (ENT)

short curved (45)

straight

100 120 140 160 180 200

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Medical Device for laser medicine & endoscopy

Optical handpieces & accessories

Handpieces for dermatology and dental medicine
Properties

handpieces with variable spot diameter (1x to 3x fiber core diameter) dermatological handpieces with spacers (30and 50 mm focal distance) handpieces with connected assembled fiber ina protective tube bleaching handpieces

focusing handpiece, 30mm and 50 mm

focusing handpiece, manually adjustable

Designation Focusing handpiece, 30 mm, with 600 m fibers, length 3 m and SMA905 connector Focusing handpiece, 50 mm, with 600 m fibers, length 3 m and SMA905 connector Bleaching handpiece with 600 m fibers, length3m and SMA905 connector

Order no. HPD-D30-600

HPD-D50-600

bleaching handpiece

HPD-B-600

scissors

Accessories
Designation Ceramic scissor cleave tool Ceramic blade cleave tool SMA-Fiber checktool SMA-Fiber microscope Fiber stripper 0.12 to 0.40 mm fiber stripper Fiber stripper 0.30 to 1.00 mm Fiber stripper reusable Preparation set for reusable BareFiber Product code CS1 CB1 FC1 MS1 FS1 FS2 fiber specific SET RUS Order no. M310050 M310100 M310200 M310300 M310400 M310450 M3105xx M310600

SMA fiber checktool

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Medical Device for laser medicine & endoscopy

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FiberTech

Type designations for medical fibers

FT IR 600 /660 S T - 3.5 / S L - F - C2 123456A (example)

Manufacturer FiberTech
LEONI Fiber Optics Gmbh, as per MDA (German Medical Devices Act)

FT

Fiber type high OH low OH low OH NA = 0.38/0.40 Core diameter Cladding diameter Coating Acrylate Silicone Polyimide HardClad Buffer/jacket Teflon Nylon Product length [m] Connector type F-SMA905 FC/PC DIN BST special connector Connector design standard high power programmable Distal Tip flat tapered ball orb spherical sidefire gas/liquid cooled Special designs CapillaryTip GlueFree connector Protective tube C-Flex OD 2 mm Design versions

UV IR GE e.g. 600 e.g. 660 A S PI HC T N e.g. 3.5 S F F B X M L P F T B O S SF GLC CT GF C2 123456A

proximal end

distal tip

protection cap

SMA connector

bend protection

fiber

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Medical Device for laser medicine & endoscopy

Endoscopy

Fiber bundles optical fibers with endo-optics

Single-branched and multi-branched optical fibers with endooptics such as lenses, tilted mirrors, homogenisers or prisms so that the light beam can be tailored to the customer's requirements. Spectrometry, analytical technology, sensor
Application

technology. With glass or plastic optical fibers also forlighting and decoration. Individual fibers made from optical glass (whentransmitting visible light) or silica (whentransmitting UV/IR light)

Composition

Protective tubes, receptacles and adhesives as appropriate to temperature and ambient conditions

Length

Up to 100 m

Light-guide cones
Light-guide rod with differently sized cross-sectional areas at both ends changing the aperture of a light beam. Cones bunch light from an optical waveguide with a large cross section into an optical waveguide with a small cross section.

Application

Endoscopy Mono or fiber cones possible

mono cone with core and cladding fiber cone consisting of several hundredindividual fibers enlarging orreducing photographic-grade line possible

Composition

Diameter Receptacles

0.1 mm to 10 mm Stainless steel housing, as per medical standard

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FiberTech

Dentistry and illumination

Light-guide rods
Optical fiber made from silica, optical glass or plastic with large cross-sectional area as well as a core and cladding. For applications with high light transmission where the optical waveguide does not have to be flexible.
Application

Light-guide rods are frequently also used attheends of optical waveguides consisting offiber bundles in order to homogenise theemitted light.

Diameter

0.1 mm to 10 mm Customer-specific: also tapered if required (tapering across specific areas of the cross-sectional area of the light-guide rod)

Receptacles

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Medical Device for laser medicine & endoscopy

Quality checks and materials Production conditions

Bio compatibility
All of our medical devices meet the applicable requirements of EN ISO 10993 and USP Class VI standards for biological assessment of medical devices. The biocompatibility of the materials used was demonstrated by NAMSA under tests, which included:

Cytotoxicity Study ASTM Hemolysis Systemic Toxicity Study Maximation Sensitization Study Intracutaneous Study

Our medical devices are produced in clean rooms of ISO Class 8. The clean rooms and our products are subject to regular hygiene monitoring to ensure a defined environment condition and safety of sterilization.

Sterilization
Products for single use are sterilized using the EO method and are delivered sterile. Upon request, our reusable products can also be supplied sterile. For the treatment of our products for reuse a successful steam sterilization in the autoclave was verified as part of an efficiency validation and the influence of the materials used in relation to their performance and the preservation of their biocompatibility was examined.

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FiberTech

More services and products

LEONI`s Business Unit Healthcare offers an integrated range of products and services. As a partner we design and manufacture special cables, cable systems and sub-systems for equipment medicine. For more informations please visit www.leoni-healthcare.com

Copyright photo by kind permission of Siemens AG

LEONIs Business Unit Fiber Optics uses the experience and know-how of the laser medicine company FiberTech, which since four years is part of LEONI Fiber Optics. For fiber-optic solutions in medical devices and medical technics please visit www.leoni-fiber-optics.com

LEONI Fiber Optics GmbH, January 2012 The contents of this brochure are protected by copyright. They may only be used for private purposes. Any reproduction, presentation or transmission of the contents for commercial purposes is prohibited without the agreement of the copyright holder and is only permitted following prior approval. All rights reserved. We reserve the right to make technical modifications, typographical errors and mistakes. Note: LEONI guarantees that the delivery items contained in this brochure exhibit the agreed quality upon the transfer of risk. This is measured exclusively according to the concrete agreements relating to the properties, features and performance characteristics of the respective delivery item concluded in writing between LEONI and the orderer. Illustrations and specifications in catalogues, price lists and other information material provided to the orderer by LEONI as well as product descriptions are only legally binding if they are explicitly identified as binding specifications. Under no circumstances should specifications of this type be taken as guarantees of the delivery item corresponding to a particular quality. Guarantees of quality of this type must be explicitly agreed in writing. LEONI reserves the right to modify the brochure contents at any time.

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Business Unit Fiber Optics www.leoni-fiber-optics.com

LEONI Fiber Optics GmbH Nalepastrasse 170171 12459 Berlin Germany Phone +49 (0)30 5300-58-0 Fax +49 (0)30 5300-58-58 E-mail medicaldevices@leoni.com