UV-X 2000 User's Manual March 2012 Rev 1

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EC (European Community)-Declaration of Conformity

We IROC AG Stockerstrasse 37 CH-8002 Zürich Switzerland Tel: +41-43-488-38-00

declare in exclusive responsibility that the product

UV-X device for corneal cross linking ---------------------------------------------to which this declaration refers, corresponds with the Council Directive MDD 93/42/EEC Annex I. The UV-X device is an illumination system for medical theraphy (photodynamic therapy) of Class IIa. The manufacturer’s quality management system meets the applicable provisions of the directive 93/42/EEC Annex II.

The CE-seal on the unit proves the accordance.

Zurich,

Dr. Michael Mrochen, General Manager

...20.1.2012.. ...:... Date of issue Name and signature of the authorized person

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Conventions used in this manual Warnings WARNING - A warning alerts the user to potential serious outcomes to the patient or user. Precautions CAUTION - Precautions alert the reader to exercise special care necessary for the safe and effective use of the device. Supplemental Information NOTE - Notes provide helpful or supplementary information to the user.

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Table of Content 1

General Notice to the User

7

2

Device Description / Product lifetime

8

3

Purpose of the Device

8

4

Safety Instructions

9

4.1

Eye protection

10

4.2

Patient safety

11

4.3

Use restrictions

13

4.4

Safety design

14

4.5

Additional safety considerations

15

4.6

Electrical hazards

16

4.7

Fire hazards

16

System Description

17

5.1

System overview

17

5.2

Beam characteristics UV-X 2000

17

5.3

Mechanical stand

18

5.4

Power supply 20

5.5

UV-X Light source overview

21

5.6

Light source – DC in socket

21

5.7

Light source - Beam aperture

22

5.8

Light source - Aperture wheel

23

5.9

Light source – Status display

24

5.10

Light source - Switches

24

5.11

Structure of system processes

25

5.12

UV light meter

26

5.13

Sensor probe with adapter

27

5

6

Functional Description

28

6.1

Important steps before turning on the system

28

6.2

Device setup

29

6.3

Turning on the system

29

6.4

Light test

30

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Treatments

34

7.1

UV- Dose

34

7.2

Select aperture size

35

7.3

Preparation of the device

35

7.4

Preparation of the patient

36

7.5

Pre-alignment of the light source

37

7.6

Start of the treatment

37

7.7

Treatment monitoring

39

7.8

Stopping a treatment

39

7.9

Resume a treatment

40

7.10

End of the treatment

40

8

Problems and Solutions

41

9

Care of Device and Accessories

42

10

Assistance

43

10.1

Technical assistance

43

10.2

Annual calibration of UV light meter

43

10.3

Periodical technical safety inspection

43

10.4

Severe adverse events

43

11

Warranty

44

12

Returning the Device

44

13

Labeling

45

13.1

Labeling of the UV light source

45

13.2

Labeling of the UV light meter

47

13.3

Labeling of the power supply

47

13.4

Labeling of the LED area

47

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14

Technical Data

48

15

Electromagnetic Compatibility

49

15.1

Electromagentic Emissions

50

15.2

Electromagentic Immunity

50

15.3

Recommended Safety Distances

52

16

List of Parts and Accessories

54

17

Forms

55

17.1

Device and Setup Log Form

56

17.2

Instructions Log Form

57

17.3

Technical inspections and repair log form

58

17.4

Incidents, accidents and near accidents log form

59

17.5

Light test log form

60

17.6

Adverse event form

61

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1 General Notice to the User CAUTION – User’s Manual, please read carefully! CAUTION - This system must only be used by specially trained physicians who are well-versed in its therapeutic effects and possible dangers and possess the necessary skills to use it in conformity with the operating instructions contained in this user’s manual. CAUTION – Radio frequency communication devices and installations should not be operated in the vicinity of the device during treatments. CAUTION – Persons with implanted active medical devices should not be present in the vicinity of the device as long as the device is powered on. This user’s manual refers only to operation, maintenance and care of the device. Do NOT drop the equipment; components on the circuit board may become dislodged and optical components might be damaged. Store the equipment in the transportation case in a cool dry area. Avoid touching the surface of the beam aperture. When the device is not used always store it in the original case to keep the beam aperture clean. Should the device require service, please do not attempt to perform service yourself. Servicing or any kind of manipulation of the system by non-authorized personnel will result in the termination of the warranty and a nullification of any liability on the part of IROC AG. Always use transportation case and original packaging for returns. Record all device failures, near incidents, incidents, accidents and adverse events in corresponding log files (Forms provided in this manual).

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2 Device Description / Product lifetime UV-X illumination system (the “device”, the “system”) is a portable medical optoelectronic device. Light Emitting Diodes (“LEDs”) of the device create UV-A light at a wavelength of 365 nm. The device is used to illuminate the human cornea during corneal cross linking procedures. The UV-X system delivers a uniform, metered dose of UV-A-light to a targeted treatment area. Product lifetime of the UV-X is limited to 2 years after the date of delivery. The product lifetime is limited by the optical UV-elements used inside the UV-X. After the expiration you are kindly requested to contact IROC or your local IROC representative regarding your options.

3 Purpose of the Device Treatments of corneal tissue with the device are performed after application of the photosensitizer drug riboflavin (Vitamin B2). The photosensitizer increases the cross linking of collagen within the corneal structure. Clinical applications of corneal cross-linking include the treatment of keratoconus, pellucid marginal degeneration and iatrogenic ectasia following surgical procedures. NOTE -The photosensitizer is not a part of the product UV-X Illumination System described in this documentation. The photosensitizer is not part of the Declaration of Conformity for this product.

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4 Safety Instructions National regulations for installation, startup and operation of medical products (respectively medical illumination) have to be considered in addition to the instructions given in this manual. The UV-X device is an active medical device of class IIa according to European Medical device directive 93/42/EEC. Any LED system can cause physical harm if used improperly. Created UV-light leaves the housing of the device at the designated aperture. Protective goggles must be worn in case of peripheral light emission in the treatment room. Always keep the beam aperture covered with the UV-sensor before and after each treatment. System tests should not be started without a properly mounted sensor. Remember that reflective materials can deflect the UV-light in unexpected directions. Special attention must be paid to mirrors and glass surfaces. Except for the therapeutic application, never look directly into the light beam or aperture. If the light beam is deployed for medical purposes, the user is responsible for assuring that all optical devices used for observation or adjustment are outfitted with appropriate protective filters. All system components such as the light source, power supply, DC cable with plug, UV light meter and stand should be checked prior to each treatment. Do not use the UV-X system if any signs of damage of the equipment are observed. The UV light meter has to be calibrated every 12 months by IROC. The system should undergo routine inspection and maintenance per manufacturer’s recommendations and institutional standards.

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Eye protection CAUTION – The UV-X system is a high-power LED product. It is emitting UV-light at 365 nm. CAUTION – Avoid direct exposure to the beam. CAUTION - Never look directly into the UV light beam. Never direct the beam towards a person except for therapeutic purposes. CAUTION - According to the norm IEC 62471 the UV-X system is a risk group 1 UV emitting LED device. Therefore exposure of skin and eyes must be minimized.

Due to the irradiance levels involved, the eye is particularly at risk of injury from direct exposure to the high-power LED beam. The protection concept against LED radiation has two components: •

Proper operation of the LED device by the physician to protect the patient

•

Use of safety goggles to protect involved persons, including the physician, from unintended beam emissions

Protective safety goggles for use with UV-X LED system must meet the following minimum specifications: D 365 nm L1 (according to EN 207:2009) 2-1.2 (according to EN 170:2002) For the purpose of safety verification, the protective goggles must be marked as indicated above.

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Patient safety The UV-X system should only be operated by ophthalmic professionals who have been trained in its use and are capable of ensuring operation in accordance with this manual and regulations. After turning on the UV-X illumination system, carefully review the System Test procedure and note the results in the Test Log. (See chapter 6.4, Light test and 17.5, Light test log form). Pay careful attention to the red, yellow and green status display lights informing the reader about current mode or possible errors of the device. The treatment should take place in a quiet and relaxed atmosphere in order not to distract the attention of the patient. The patient should lay on a bed or patient’s chair. The head should rest comfortably in a headrest. It is imperative that the patient chair or the system are not be moved during the treatment procedure. Treatments with inaccurate UV light dosage may be ineffective or cause significant harm to the patient’s eye. Possible damages may include: •

Irreversible light damage to the retina or other intraocular structures (Causes: No riboflavin and normal UV-light dose)

•

Irreversible endothelium cell damage (Cause: High UV-light dosage with low riboflavin dosage)

•

Reversible corneal edema (Cause: High UV-light dosage)

•

Reversible corneal opacifications after crosslinking treatment

•

Forming of corneal scars

•

Loss in best corrected visual acuity

•

Delayed healing of epithelium

•

Forming of steril infiltrates

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WARNING - Patient’s compliance and the proper operation of UV-X system should always be monitored by an ophthalmic professional during the treatment! WARNING - Treatments without a photosensitizer, such as riboflavin (vitamin B2), may cause significant harm to the patient’s eye! Treatments with UV-X and riboflavin for corneal cross linking has a potential risk of harming the patient’s vision if an under or overdosage of UV-light are applied to the eye! WARNING - Do not move the UV-X system during treatment! WARNING – Sensor probe adapter should always be mounted. Remove the adaptor only for patient treatments! CAUTION - Carefully select the indications for the treatment! CAUTION – Only use photosensitizers that are specific to the treatment. NOTE - Consult your nearest authorized IROC AG dealer if there are any questions regarding the device and its application.

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Use restrictions IROC AG will provide all the accessories and components that will be needed to operate the UV-X in its intended use. Each of these components and accessories have been inspected and approved for use. The components shall not be powered with the use of a multiple or non-fixed outlet. The UV-X system must not be operated in combustible rooms and areas. The UV-X shall only be used in designated medical rooms in accordance with national and international guidelines and standards. The device has been tested for electromagnetic conformity (EMC) according to EN 60601-1-2 and EN 55011 (Class B). Despite adherence to all applicable EMC requirements, malfunctioning cannot be completely ruled-out. The UV-X light source should not be placed directly adjacent to other electric devices during treatment. Other electrical devices (e.g. cellular phones, RF systems, etc.) should only be used according to their EMC classifications. Such systems should only be used within a certain distance from the UV-X light source. If it is necessary to operate the system in close proximity to other devices, the system shall be monitored closely for malfunctioning or unusual behaviour. The UV-X system may only be operated in rooms with room temperatures between 10°C to 40°C and air humidity between 30% and 70% (not condensing). Ask your IROC AG representative if the system was exposed to any type of mechanical shock that could have caused a misalignment of the optical pathway. A safety check is necessary after any type of shock before any further treatments are performed. Misalignment after a mechanical shock exposure could result in unsatisfying treatment results. CAUTION - The UV-X is a medical device. It may, therefore, be operated only in health care facilities or medical areas under the supervision of medically trained personnel.

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Safety design General specifications and standards relevant to design and manufacturing practices and procedures, such as those delineated in standards EN 60601ff were adhered to in the design and manufacture of the UV-X illumination system. The following protective measures are integrated in the system to achieve a high degree of safety and operating comfort. The device is controlled by an internal microprocessor. This processor is checked for proper working functions. In case of processor failure, no UV light will be emitted due to the design of the device. The microprocessor unit controls the electrical current used to drive the UV-LEDs. This design allows the required UV light emission to remain constant and to detect defective LEDs. A red status display light indicates internal errors of the device. UV emission is locked in such cases. The user is actively involved with the testing of the irradiance level and should record the test results. If test results are not within the permitted tolerance levels, treatments must not be performed.

WARNING - System must be mounted and aligned to the patient eye by the user. Unsafe mounting or fixation of the system may cause physical harm to the patient!

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Additional safety considerations Except during actual treatment, the device must always be switched off. Only the user directing the aim of the UV beam should have access to the UV-X illumination system. UV irradiance of the UV-X System is preset by the manufacturer. Any modification of the system’s external light beam by means of optical elements is strictly prohibited. Plastic instrumentation such as speculums or eye shields may be damaged if they come in contact with the UV beam, possibly resulting in chemical burns or noxious gases. Therefore, only stainless steel surgical instruments should be used. Smooth metallic surfaces can reflect despite the effort to blacken them. Therefore, only laser grade instruments should be used. The UV-X system is intended solely for physicians trained in the use of this instrument. Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous UV radiation exposure. Operate the UV-X device only from properly installed main outlet sockets.

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Electrical hazards Never open the protective covers of the light source or power supply. Opening the cover will expose the user to electrical components, the UV light source, and possible UV radiation. Only IROC-certified service engineers shall work inside components. Power supply types other than the one specified in this manual and on the device nameplate must not be used with the UV-X system. The area around the device should be kept dry. Do not operate the system if any of the cords are faulty or frayed. Unplug power supply from main socket before cleaning or maintaining the system.

4.7

Fire hazards Do not use this device in the presence of flammables or explosives such as volatile anaesthetics, alcohol, certain surgical preparation solutions, and similar substances. An explosion and/or fire could result.

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5 System Description 5.1

System overview Power Supply

Stand Rods C-Clamp

UV Light Meter

Light Meter Sensor Probe with Adapter

Cross Clamp Safety Goggles Light Source Figure 1: UV-X Illumination system

5.2

Beam characteristics UV-X 2000

The optimized beam profile of the UV-X 2000 is designed to compensate the shape of the cornea. The beam shape is only defined in the treatment plane. How to find the treatment plane is described in chapter 7.6.

Figure 2: Beam characteristics UV-X 2000

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Mechanical stand The delivered stand has to be used to mount the UV-X light source on a stable table. Adjustable joints allow treatments on patients in supine or upright position.

Figure 3: Mechanical stand components

The stand is delivered in separate parts and must be mounted before use: 1.

Mount C-clamp to the vertical stand rod (not flattened end). Use attached hexagon screw (metric M6 x 16) and hexagon wrench (metric size 4). Mount tight.

2.

Guide other end of this stand rod thorugh one of the bores of the Cross Clamp. Tighten with winged screw.

3.

Guide the horizontal stand rod through the other bore in the Cross Clamp and tighten with adjacent winged screw.

4.

Plug the light source on the beveled end of the vertical stand rod and secure with winged screw to the mechanical stand.

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Figure 4: Light source mount

WARNING - Ensure all parts of the stand are safely clamped and screwed tightly. Loose parts of the mechanical stand may harm the patient during the treatment and/or cause damage to the device! NOTE - A hexagon wrench of metric size 4 is required for mounting the mechanical stand. This wrench is included with the system. Replacement wrenches can be purchased at tool or hardware shops.

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Power supply The UV-X system is powered by a wall power supply. Low voltage is delivered to the light source with the DC cord. Before plugging the power supply into a main outlet, verify that the power supply and its DC-cable are not damaged.

Figure 5: Wall Power Supply and Nameplate

CAUTION - A medical power supply with EN 60601 Conformity is an essential part of the UV-X System. The device is approved with Power Supply , Article Number 1100-200200 (Type: GlobTek GTM21089-1509-W2E) and 1100-2003-01 (Type: GlobTek GTM21089-1509-T3). Use of this type of power supply is mandatory.

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