ROCAMED MH01 Laser 30W Instructions for Use Rev 02

PRODUCTS: DOCUMENT:

LASER MH01 INSTRUCTION FOR USE

REF: NOTE-MH01 REV: 02

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For an optimal functioning of the equipment, and to ensure the maximum safety of operators and patients:

•

Verify that the treatment room temperature does not exceed 30 °C (86 F)

•

Keep the equipment away from walls, especially where fans are positioned, ensuring the right ventilation

•

Use protective goggles, ALWAYS

•

Protect the patient from hazardous optical radiation

•

Protect any operator, using personal protection means and environment protection barriers

•

Please consult, in advance, the “Safety” session of this manual

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CONTENTS:

1

2

3

GENERAL INFORMATION ... 9 1.1

Introduction... 9

1.2

Purpose of the manual ... 9

1.3

Safety instruction ... 10

1.4

Symbols and Abbreviations used in this manual ... 11

1.5

Distributor and Manufacturer ... 13

1.6

Device Identification... 14

1.7

Combinations ... 15

LASER SAFETY ...16 2.1

General Safety ... 16

2.2

Classification ... 16

2.3

Training of the medical staff... 16

2.4

Nominal Ocular Hazard Distance ... 17

2.5

Working Area... 20

2.6

Eye and skin exposure ... 20

2.7

Fire hazard ... 21

2.8

Emission of plume ... 22

2.9

Safety Measures for the electromagnetic compatibility (EMC) ... 22

2.10

Emission of toxic gas or vapour ... 22

2.11

Warning and instructions for the device disposal ... 22

2.12

Labelling plan ... 23

DEVICE DESCRIPTION ...28 3.1

Introduction... 29

3.2

General description of the device ... 29

3.2.1

Device frontal view ... 29

3.2.2

Device Back view ... 30

3.2.3

Device Lateral view... 31

3.2.4

Laser and electric system ... 32

3.2.5

Electrical control ... 32

3.3

Accessories ... 33

3.3.1 4

Optical fiber ... 33

ENVIRONMENTAL CONDITIONS AND INSTALLATION ...34 4.1

Environmental condition ... 34

4.1.1

Working area ... 34

4.1.2

Electrical connection requirements ... 34 Page 5 of 85

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4.1.3

Temperature and humidity ... 34

4.1.4

Minimum space requirements ... 34

4.2

5

LASER MH01 INSTRUCTION FOR USE

Device installation ... 35

4.2.1

Transportation ... 35

4.2.2

Packaging ... 35

4.2.3

Inspection ... 35

4.2.4

Labelling check ... 36

4.2.5

Installation procedure ... 36

4.2.6

Main device connection. ... 37

4.2.7

Remote interlock connection ... 38

4.2.8

Footswitch connections... 39

4.2.9

Optical fiber connection ... 39

4.2.10

Optical fiber check ... 40

4.2.11

Hydraulic system filling... 40

4.2.12

Emptying the hydraulic circuit... 41

INSTRUCTION FOR USE ...42 5.1

Start-up procedure ... 42

5.1.1 5.2

RFID Fiber connection ... 43

Operating instruction ... 44

5.2.1

Main display screen ... 44

5.2.2

Mode ... 45

5.2.3

Frequency ... 48

5.2.4

Energy ... 48

5.2.5

Fiber INFO ... 49

5.2.6

Pilot laser ... Erreur ! Signet non défini.

5.3

MENU ... 49

5.3.1

Fiber... 49

5.3.2

Pilot laser ... 50

5.3.3

Device Parameters ... 50

5.3.4

User Manual ... 50

5.4

DEVICE PARAMETERS ... 51

5.4.1

Service (Only for Technical Service) ... 51

5.4.2

Display ... 52

5.4.3

Audio ... 53

5.4.4

Device Info ... 53

5.4.5

Language ... 54

5.5

Laser emission ... 54

5.5.1

Ready / Standby ... 55 Page 6 of 85

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5.5.2

Ready Mode ... 56

5.5.3

Mode of Emission ... 56

5.5.4

Power output settings ... 57

5.5.5

Emission... 57

5.5.6

Laser Parameters ... 59

5.6

Alarms and warning description... 61

5.7

Shutdown procedure and protection against unauthorized use ... 61

CLINICAL APPLICATION ...62 6.1

Intended use ... 62

6.2

General Warnings, Precautions, and Complications to consider when using the Holmium wavelength ... 63

6.2.1

General Laser Warnings ... 63

6.2.2

General Laser Precautions ... 63

6.2.3

General laser Complications ... 64

6.3

Urology Indications... 64

6.3.1

Urology Contraindications ... 65

6.3.2

Urology Warnings ... 65

6.3.3

Urology Precautions ... 65

6.3.4

Urology Complications ... 65

6.3.5

Urology Clinical Parameters ... 66

6.4

Urinary Lithotripsy Indications ... 66

6.4.1

Urinary Lithotripsy Contraindications ... 66

6.4.2

Urinary Lithotripsy Warnings ... 67

6.4.3

Urinary Lithotripsy Precautions ... 68

6.4.4

Urinary Lithotripsy Complications ... 68

6.4.5

Urinary Lithotripsy Clinical Parameters ... 69

6.5

ENT – Gynaecology – General Surgery – Gastroenterology – Arthroscopy ... 70

6.5.1

Specific Contraindications ... 70

6.5.2

Specific laser complications ... 71

MAINTENANCE, CLEANING AND STERILIZATION...72 7.1

Device cleaning ... 72

7.2

Laser Maintenance and technical check ... 72

7.3

Safety labelling check ... 72

7.4

Water cooling system ... 73

7.5

Check of the line cable ... 73

7.6

Optical fiber maintenance ... 73

7.6.1

Check the optical fiber before operation ... 75

7.7

Use, Cleaning, disinfection, sterilization of optical fibers ... 75

7.8

Blast shield replacement ... 76 Page 7 of 85

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8

TROUBLESHOOTING ...77

9

CUSTOMER SERVICE ...78 9.1

Manufacturer warranty and responsibility ... 78

9.2

Repair and modifications of the device ... 79

9.3

Service department contacts ... 79

10

TECHNICAL SPECIFICATIONS ...80

10.1

General specification ... 80

10.2

Laser source specification ... 80

11

ACCESSORIES ...81

12

Tables (EMC) ...82

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1 GENERAL INFORMATION 1.1

Introduction Medical Device Rocamed MH01 is a 30W Holmium Yag Laser with 2100nm wavelength which is used by physician as a tool in surgical procedure. The laser Rocamed MH01 is the result of a long experience of ROCAMED in the field of medical laser equipment This manual contains important information regarding the safe use of medical device Rocamed MH01. The manual describes the instrument, surgical procedures, a description of the various inspections, routine maintenance and operator information for the use and care of optical fibers used for the release of the laser radiation to the patient. Medical people using the medical device Rocamed MH01 must read this manual carefully. Professional information regarding specific surgical specialties can be found in Chapter 6, "Clinical Applications". Like all surgical instruments, for a responsible and proper use is necessary practice. This manual should be read and understood thoroughly before first use! For more information regarding the installation, clinical applications, or other problems you may encounter, please contact the company ROCAMED.

1.2

Purpose of the manual This manual contains essential information necessary for the installation, operation and maintenance of the medical device Rocamed MH01. The manual is intended to be used as a guide. This manual contains instructions for operation and maintenance. These instructions were written specifically for staff who are fully trained in laser and conventional surgery. This manual contains information on the optional accessories supplied with the medical device Rocamed MH01, their cleaning and sterilization (Chapter 7, "Maintenance and cleaning"). This manual is not used as an alternative to surgical preparation. In addition, this manual does not provide specific technical information regarding operations of the medical device Rocamed MH01 assistance. For any information regarding the technical assistance contact the company ROCAMED.

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Safety instruction The safety instructions in this manual are intended to prevent possible injuries, material damage and operational faults. The fact that, before operating the laser for the first time, you should read through this manual carefully and keep it for future reference, is also considered to be part of the safe operation of this product. In this manual a distinction is made between the safety instructions used to warn of possible injury (DANGER) and instructions warning against operational faults (WARNING):

Risk of injury! This instruction concerns the safety of patients, operators and other persons, who are in the room, in which the laser is being operated or maintained. In this manual the following symbol is used to warn of the risk of injury from laser radiation (Fig. 1): DANGER :

Fig. 1: Symbol for Danger

Danger of operational fault! Failure to follow this instruction can lead to damage to the laser system, the applicator or the laser fiber. In this manual the following symbol is used to indicate a possible operational fault and the damage to the laser system, which might result from it (Fig. 2). WARNING :

Fig. 2: Symbol for Warning

“Caution: Federal law restricts this device to sale by or on the order of a physician/surgeon”

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Symbols and Abbreviations used in this manual

Symbol

Description

Read the enclosed documentation label

CE label

Symbol of applied part type BF According to standard 60601-1 2° ED

Symbol indicating that the device cannot be disposed of as municipal waste, but must be separated in accordance with the WEEE (Waste Electrical and Electronic Equipment)

Manufacturing date

Serial Number

Manufacturer NOHD NOHZ MPE µm s mrad w J J/cm2 cm

Nominal Ocular Hazard Distance Nominal Ocular Hazard Zone Maximum permissible exposure Units, micro meter Units, Second Units, milliradiant Units, watt Units, Joule Units, Joule for centimetre square Units, centimetre Page 11 of 85

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OD D L KV A/m Vrms KHz GHz WEEE CW Vac A T I nm mm EO Ø SMA mW T on T off Bar °C Kg %

REF: NOTE-MH01 REV: 02

Optical Density Continuous laser according to EN207 Glasses protection degree Units, Kilovolt Units, Ampere for metro Effective supply voltage Units, Kilo Hertz Units, Giga Hertz Waste Electrical and Electronic Equipment Continuous laser pulses Volt AC Units, Ampere Slow blow fuse Electrical Protection Class Units, Nanometre Units, millimetre Sterilization Method diameter Optical Fiber connector type Units, milli Watt Pulse duration laser on Pulse duration laser off Units, Pressure Units, Celsius degree Units, Kilogram Percentage A label that indicates the key switch off

A label that indicates the key switch on

Pushing Prohibited

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Distributor and Manufacturer

Distributed by:

Manufactured by:

ROCAMED S.A.M. Address

9 Avenue Albert II 98000 MONACO

Email

[email protected]

Tel.

+377 97 98 42 43

WebSite

www.rocamed.eu

ROCAMED France Address

ZI de Signes Allée de Sotckholm 83870 Signes FRANCE

Email

[email protected]

Tel.

+33 4 94 90 54 00

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Device Identification

This Laser Device has the following classification: Type Product category

MH01 Surgical laser for medical use

Classification according Medical Device Directive 93/42/EEC Laser Classification according IEC / EN 60825-1:2007 Aiming beam classification according IEC / EN 60825-1:2007 Mains Type of protection against electric shock Degree of protection against the ingress of liquid Degree of protection against electric shock Mode of operation Dimension Weight Operative temperature Storage temperature Transport temperature (without water) Humidity Pressure Cooling system

Class IIb Class 4 (IEC/EN 60825-1:2007) Class 3R 100-120 Vac: 50/60 Hz; 16A 200-240 Vac; 50/60 Hz; 10A Class I IP 20 (Not protected) Type BF Continuous 332 (W) X 967 (D) X 938 (H) mm 60 kg 10°- 30° C Min 10° C / max. 40° C min -5° C / max 70° C 30% - 85% from 800 hPa to 1060 hPa Integrated water cooling system with water/air heat exchanger

Laser characteristics Laser type

Solid state laser Ho:YAG

Wavelength

2100 nm

Maximum power

30 W

Pulse Energy

0.2 - 4 J

Operating mode

Pulsed (single or multiple)

Pulse duration

150-850 μs

Repetition rate

3-25 Hz

Beam transmission Aiming Beam Fuse

Optical fiber system Laser Diode, green 532nm(adjustable) <5mW) Overcurrent protection, self-resetting

Note 1: During the lifetime of the device the energy laser values can diverge from the declared ones of maximum 5%. Note 2: The device has provided of internal measuring system to control the actual emission of the laser energy. The device is not requiring calibration.

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WARNING! Equipment not suitable for use in the presence of flammable mixtures

!

IMPORTANT For shipment and storage below +5°C, the cooling system must be emptied.

NOTE! To prevent damage during transport or shipment of the products we recommend using the original packaging material.

1.7

Combinations

We recommend to use ROCAMED Fibres in conjunction with the MH01 Laser System. CAUTION! Products may be incorrectly combined! Injury of the patient, user or others as well as damage to the product are possible. The different products may only be applied jointly if the intended use and the relevant technical data, such as working length, diameter, peak voltage, etc. are suitable. Follow the instruction manuals of the products used in combination with this product.

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2 LASER SAFETY 2.1

General Safety • • • • • • • •

For safety use of this device, it’s necessary to know all the safety standards. This manual contains important information about safety use of the device All people who works with this device must know the operation and safety instructions in this manual. Only trained personnel with appropriate safety guidelines can work with this device. The laser must be closed. Only authorized personnel can open the external cover. Only the service staff can work on the electrical section of the device. This User Guide should be available in the operation area of the laser device. All warning labels must always be in good condition. CAUTION! Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure

2.2

Classification This device is a Medical Laser classified as Class 4 according to IEC EN 60825-1: 2007.

2.3

Training of the medical staff The use of the laser device is restricted only to the specialist medical staff*: that, depending on their experience and expertise, can make choices appropriate to achieve the desired therapeutic effects. It is recommended that all operators and support personnel are adequately trained on laser safety standards. *(This device must only be used by adequately qualified and trained medical personnel with experience in Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery)

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Nominal Ocular Hazard Distance Following the Standard IEC / EN 60825-1: 2007, the MPE (Maximum Permissible Exposure), NOHD (Nominal Ocular Hazard Distance) and OD (Optical Density) are calculated. The formulas and the numerical coefficients are specified in sect. 3, chap. 13, tab. 6, fig. 1, 2, 5, 6, 7, 8 of EN 60825-1:2007 standard.

At first we calculate the MPE that is the Maximum Permissible Exposure. This is the level of radiation to which, under normal circumstances, persons may be exposed without suffering adverse effects. The MPE level represents the maximum level to which the eye or skin can be exposed without consequential injury immediately or after a long time and are related to the wavelength of the radiation, the pulse duration or exposure time, the tissue at risk and, for visible and near infrared radiation in the range 1800 nm to 2600 nm, the size of the retinal image.

Then, we evaluate the NOHD, Nominal Ocular Hazard Distance. It is the distance at which the beam irradiance or radiant exposure equals the appropriate corneal maximum permissible exposure. NOHD is:

NOHD =

4 P0 −a πMPE

φ

[m]

Where P0 is the peak power of the laser pulse, a is the output beam diameter and φ is the beam divergence.

Finally we calculate the OD Optical Density of the glosses to be worn. It is defined as OD=log10 (H0/MPE)

H0 is the expected unprotected eye exposure level. In this case this value has been calculated as the radiant exposure (J/m2) averaged over a circular spot of 7 mm diameter according to the limiting aperture applicable to the eyes

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2100 nm

Beam Diameter

Pulse Duration

Divergence Full angle (rad)

Peak Power P0

Maximum Permissible Exposure - EMP

Nominal Ocular Hazard Distance NOHD

Optical Density – OD

200 µm

800µs

0.44

2J@10Hz

100 J/m2

0.44 m

1.23

2

0.44 m

1.23

272 µm

800µs

0.44

3J@10Hz

100 J/m

365 µm

800µs

0.44

3J@10Hz

100 J/m2

0.44 m

1.23

3J@10Hz

100 J/m

2

0.44 m

1.23

2

0.44 m

1.23

550 µm

800µs

0.44

800 µm

800µs

0.44

3J@10Hz

100 J/m

1000 µm

800µs

0.44

3J@10Hz

100 J/m2

0.44 m

1.23

2

0.34 m

1

200 µm

800µs

0.44

2J@5Hz

200 J/m

272 µm

800µs

0.44

3.5J@5Hz

200 J/m2

0.34 m

1

2

0.34 m

1

365 µm

800µs

0.44

4J@5Hz

200 J/m

550 µm

800µs

0.44

4J@5Hz

200 J/m2

0.34 m

1

2

0.34 m

1

800 µm

800µs

0.44

4J@5Hz

200 J/m

1000 µm

800µs

0.44

4J@5Hz

200 J/m2

0.34 m

1

2

0.44 m

1.23

200 µm

800µs

0.44

1.5J@20Hz

50 J/m

272 µm

800µs

0.44

1.5J@20Hz

50 J/m2

0.44 m

1.23

2

0.44 m

1.23

365 µm

800µs

0.44

1.5J@20Hz

50 J/m

550 µm

800µs

0.44

1.5J@20Hz

50 J/m2

0.44 m

1.22

1.5J@20Hz

50 J/m

2

0.44 m

1.22

50 J/m

2

0.44 m

1.22

800 µm 1000 µm

800µs 800µs

0.44 0.44

1.5J@20Hz

From NOHD values we deduce that the laser system has to be used in an enclosed area that does not allow the escape of laser radiation direct, reflected or transmitted. CAUTION! Openings inside installation area that are transparent to laser radiation must be properly darkened. Doors equipped with a special interlocking system have to made by a laser non-transparent material (glass, plastic, curtains, etc.) and windows have to be darkened by using appropriate laser non-trasmittive systems.

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Working Area This device is a laser of Class 4 and must be used in a specific working area defined and delimited following the international standards IEC / EN 60825-1: 2007. IMPORTANT! This device is certified to be used in the operating room. RULES OF ACCESS TO THE RESTRICTED AREA OF WORK External staff and visitors should also: • Be guided by staff • Always wear laser goggles in the working area when the laser is switched on • Be briefed by staff on the laser, electrical hazards and other risks associated with the operation of the laser within the working area (the laser radiation, electric shock, etc.) Admission is strictly prohibited if there is no operator in the working area.

2.6

Eye and skin exposure The laser beam emitted by the Rocamed MH01 can cause sight loss. The laser operates at different wavelengths, visible and invisible. Any energy transmitted by the laser system that enters the eye will be focused directly on the retina. Direct absorption of laser energy by the retina can result in temporary clouded vision, retina lesion, long term scotoma and long term photophobia. A danger exists in any case of: • Direct laser radiation • Reflected laser radiation • Diffused laser radiation WARNING! All the personnel present in the laser working area must wear all the protective devices. Use protective goggles with the following specifications according national standard:

2100 I LB2 for laser source Ho:YAG at 2100 nm In addition, even if you wear goggles, never look directly into the laser beam

!

IMPORTANT Within the range of the laser, every person must wear laser goggles. Check the laser goggles for perfect condition before each use. The goggles must not be mechanically damaged in any way. Page 20 of 85