KLS Martin diomax User manual

English
Laser Surgical Unit
Instructions for Use
90-336-52-50
Revision 6
Date of Release: 2019-07
Valid for software version V5
.00
hardware re
lease HW 03 and software version SW 04

2 Revision 6
Symbol explanation
Safety alert symbol
CAUTION Indicates a situation which, if not avoided, could result
in minor or moderate injury.
WARNING Indicates a situation which, if not avoided, could result
in death or serious injury.
DANGER Indicates a situation which, if not avoided, will result
in death or serious injury.
Follow instructions for use
Follow instructions for use
Item number (Item no.)
Serial number
Store in a place protected from direct sunlight
Store in a dry place
Information on minimumand maximum temperature for storage and
transportation.
See section 11 “Tecnical Data”, page 67 for valid values.
Information on minimum and maximum atmospheric pressure for
storage and transportation.
See section 11 “Tecnical Data”, page 67 for valid values.
Information on minimum and maximum atmospheric humidity for
storage and transportation.
See section 11 “Tecnical Data”, page 67 for valid values.

Revision 6 3
Fragile, avoid pressure and shock
Arrows pointing up, transport and store upright
Manufacturing date
Manufacturer
Do not use if packaging is damaged
CE mark of conformity
This product may not be disposed of as normal household garbage

Instructions for Use
Laser Surgical Unit diomax®
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Contents
1Product Liability and Warranty ...................................................... 7
1.1 General Information ..............................................................................7
1.2 Scope of Delivery..................................................................................7
1.3 Intended Use........................................................................................8
1.4 Frequently Used Functions .....................................................................9
1.5 Contraindications ..................................................................................9
1.6 Warranty .............................................................................................9
1.7 User’s Inspection ..................................................................................9
1.8 Hotline............................................................................................... 10
2Notices Concerning this Document................................................11
2.1 Validity of this Document ..................................................................... 11
2.2 Symbols Used in this Document............................................................ 12
3Safety Notes..............................................................................13
3.1 General Specifications ......................................................................... 13
3.2 Installation and Initial Commissioning ................................................... 14
3.3 Laser Safety ....................................................................................... 16
3.4 Danger of Explosion and Fire ................................................................ 17
3.5 Protection of the Patient ...................................................................... 17
3.6 Requirements for Treatment Rooms ...................................................... 18
3.7 Safety Requirements for the Laser Device .............................................. 18
3.8 Safety Notes for the Pilot Laser............................................................. 18
3.9 Laser Safety Officer............................................................................. 19
3.10 User .................................................................................................. 19
3.11 Electrical Safety .................................................................................. 19
3.12 Earthing of the Device ......................................................................... 19
3.13 Fuses ................................................................................................20
3.14 Safety Systems of the Device ............................................................... 20
3.15 Usage Restrictions...............................................................................20
3.16 Warning and Information Labels ........................................................... 21
3.17 Fumes ............................................................................................... 22
3.18 Using Laser Fibers............................................................................... 22
4Commissioning ..........................................................................23
4.1 Function ............................................................................................23
4.2 Installation......................................................................................... 23
4.3 Front of Device ...................................................................................24
4.4 Rear of Device ....................................................................................24
4.4.1 Type Plate .....................................................................................................25

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4.4.2 Mains Connection ...........................................................................................25
4.4.3 Equipotential Grounding Pin.............................................................................25
4.4.4 Foot Switch Connection...................................................................................25
4.4.5 Connection Interlock/Warning..........................................................................26
4.4.6 Accessory Port ...............................................................................................28
4.4.7 Service Interfaces ..........................................................................................28
4.4.8 Option CAN....................................................................................................28
4.4.9 Speakers.......................................................................................................28
4.5 Preparing the Laser System.................................................................. 29
5Operating the Device ..................................................................30
5.1 Control and Display Elements ............................................................... 30
5.1.1 Key Switch ....................................................................................................30
5.1.2 EMERGENCY STOP..........................................................................................31
5.1.3 SMA-X Fiber Connection Socket .......................................................................31
5.1.4 Laser Signal Light...........................................................................................32
5.1.5 Key Field .......................................................................................................33
5.1.6 Display .........................................................................................................34
5.1.7 Rotary Knob with Ring Light ............................................................................35
5.1.8 Laser Status Display .......................................................................................36
5.2 Connecting Laser Fibers ....................................................................... 37
5.3 Checking the Laser Fiber Using the Pilot Laser ........................................ 38
5.4Replacing the Laser Fiber ..................................................................... 39
5.5 Connecting Focusing Handpiece/Applicators ........................................... 39
5.6 Switching on the Device....................................................................... 40
5.7 System Check ....................................................................................40
5.8 Foot Switch ........................................................................................ 41
5.9 Applying the Laser .............................................................................. 42
5.10 Switching off the Device ...................................................................... 43
5.11 Emergency Stop ................................................................................. 43
5.12 Working with Programs........................................................................ 44
5.12.1 Default Program.............................................................................................44
5.12.2 Selecting a Program .......................................................................................45
5.12.3 Program change.............................................................................................47
5.12.4 Laser output ..................................................................................................47
5.12.5 Operating modes............................................................................................47
5.12.6 Times ...........................................................................................................51
5.12.7 Saving the Modified Program ...........................................................................51
5.12.8 Deleting Programs..........................................................................................53
5.13 Log ...................................................................................................54
5.13.1 Edit log entries...............................................................................................54
5.13.2 View logfile....................................................................................................56

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5.14 Pilot Laser.......................................................................................... 57
5.15 Setup ................................................................................................ 58
6Abridged Instructions for Use.......................................................62
7Maintenance ..............................................................................63
7.1 Periodic Maintenance ........................................................................... 63
7.1.1 Maintenance Schedule ....................................................................................63
8Cleaning and Disinfecting ............................................................64
9Troubleshooting .........................................................................65
9.1 Messages on the Display ...................................................................... 65
9.2 Other Malfunctions ..............................................................................65
10 Accessories................................................................................66
10.1 Safety Distances (NOHD) ..................................................................... 66
11 Tecnical Data.............................................................................67
12 Safety Check (SC) ......................................................................69
13 Guidelines and Manufacturer’s Declaration
Regarding Electromagnetic Compatibility (EMC) .............................71
14 Ecological Information ................................................................75
14.1 Disposal of Packing ............................................................................. 75
14.2 Environment-friendly Device Operations ................................................ 75
14.3 Disposal of the Unit .............................................................................75

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1Product Liability and Warranty
1.1 General Information
We thank you for having decided to buy a KLS Martin product. This product carries the
CE mark, which means that it satisfies the essential requirements laid down in the EC Directive
concerning medical devices.
We are the manufacturer of this product:
Gebrüder Martin GmbH & Co. KG
A company of the KLS Martin Group
KLS Martin Platz 1 · D-78532 Tuttlingen · Germany
Postfach 60 · D-78501 Tuttlingen · Germany
Tel. [phone] · Fax [phone]
[e-mail] · www.klsmartin.com
1.2 Scope of Delivery
•Laser surgical unit diomax®
•Power supply cable
•2 keys
•Equipotential bonding cable
•diomax®Instructions for Use
•Interlock connector with bypass
•Footswitch
•2 laser warning signs
•Medical product log

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1.3 Intended Use
The diomax®is a laser surgical device operating on a diode laser. It is intended for treating
biological tissue by way of:
•hyperthermia
•cutting
•coagulation
•vaporization
To this end, the electric energy provided by the power supply network is converted into
infrared laser light enabling the surgical applications specified above.
Safe laser surgery presupposes that the user is fully familiar with the surgical technique and its
various forms of application.
Prior to using the laser unit, be sure to read and understand the
information contained herein!
This user manual describes how to handle the unit properly. Please note that
improper use of the laser or its accessories releases the manufacturer from any
liability for damage, irrespective of whether such damage is caused within or
after the period of warranty!
The laser surgery device may be used only in rooms intended for medical purposes that are
marked as laser rooms!
The operator may operate the device only if an on-site functional test has previously been
performed by Gebrüder Martin or a person authorized by Gebrüder Martin. In addition, a
responsible person designated by the operator must have been instructed in the proper
handling, application and operation of the unit, as well as in its permissible combination with
other medical devices, objects and accessories. This duly instructed officer shall subsequently
be responsible for familiarizing the operator’s staff with the unit as the need arises. We
recommend documenting all user instructions in a medical device logbook. A copy of the
logbook is available from Gebrüder Martin.
The operating safety of the device must be checked in regular intervals, see section 7
“Maintenance”, page 63 and section 12 “Safety Check (SC)”, page 69.
If the device is not functionally reliable and / or safe to operate, it must be marked as such
and withdrawn from service. A technical check is mandatory in any such case.

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1.4 Frequently Used Functions
Section 5 “Operating the Device”, page 30 describes applications that explain frequently used
functions of the laser in form of saved programs.
1.5 Contraindications
There are currently no known contraindications for the application.
1.6 Warranty
Our Standard Terms and Conditions of Sale effective at the time shall apply. Agreements di-
verging from these Standard Terms and Conditions do not restrict the legal rights of the buyer.
Any warranty exceeding the above provisions shall require a contractual form and shall exclude
component-related vandalism, software updates and consumables.
Important Notices
The product may only be repaired by Gebrüder Martin or a qualified person or firm expressly
authorized by Gebrüder Martin to perform such work.
If the repair is carried out by a person or firm specially authorized by Gebrüder Martin, the
operator of the product is required to obtain from the repairer a certificate with details about
the nature and scope of the repair work done. This certificate must show the date of the repair
and the details of the person or firm carrying out the work and must be signed.
In all cases where a party other than the product manufacturer performed the work, repaired
products must be additionally marked with the repairer’s ID label.
Improper interventions or alterations performed by third parties during the period of limitation
shall void any and all warranty claims. Unauthorized actions performed on the product shall
invalidate any liability claims against Gebrüder Martin.
1.7 User’s Inspection
Immediately upon receipt, the goods must be checked for completeness and potential damage
in transit. Notice of any such damage must be given immediately.

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1.8 Hotline
•Should you have any questions on how to handle the product or use it for clinical
applications, please do not hesitate to contact the Product Management:
Tel: [phone]
Fax: [phone]
•Should you have any technical questions, please do not hesitate to turn to our
Martin Service Center:
Tel: [phone]
Fax: [phone]
E-Mail: [e-mail]
•Should you have any questions concerning maintenance contracts or training courses,
please contact our Technical Service Manager:
Tel: [phone]
E-Mail: [e-mail]
NOTICE
To answer your technical questions as efficiently as possible, our service technicians require
the serial number of the prod
uct. Therefore, please have this number at hand when
contacting our hotline. It is part of the information provided on the rating plate; see
section 4.4.1 “Type Plate”, page 25).

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2Notices Concerning this Document
Non
-observance of this document can lead to serious or even lethal patient injury!
Improper handling and care as well as non
-intended use can lead to premature wear and/or
pose a risk to patients and users!
Be sure to read, understand and follow the instructions given below!
•Every user is required to read this document completely and follow them carefully.
•In particular, be sure to heed all cautions, warnings and danger notices.
•Keep this document accessible to users at all times.
2.1 Validity of this Document
These instructions for use are valid for software version V5.00 or higher hardware release
HW 03and software version SW 04.
The software version currently installed in your diomax®is indicated on the initial screen (see
section 5.7 “System Check”, page 40). If older hardware and software versions are used, it
may be that newer functions described in this document are not available. On the startup
screen, the diomax®software indicates which version of this document matches the software
version currently implemented, see section 5.7 “System Check”, page 40. This ensures that it
is always clear which software versions are covered by this document. If the software version
of the unit does not match the version in the Instructions of Use, the appropriate
documentation can be obtained from the Martin Service Center.

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2.2 Symbols Used in this Document
Throughout this document, important information (such as general or safety-related notices) is
marked with the following symbols and signal words:
WARNING
Danger of death or serious injury!
Indicates a situation which, if not avoi
ded, could result in death or serious injury!
CAUTION
Danger of minor injury!
Indicates a situation which, if not avoided, could result in minor or moderate injury!
NOTICE
Risk of material damage!
Indicates a situation which, if not avoided,
could lead to material damage (loss of time, data
loss, device/machine failure, etc.)!

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3Safety Notes
3.1 General Specifications
The following standards, laws, directives and regulations were observed in the design and
manufacture of this product:
Standard Title
MPG (MDA) Medical Devices Act
93/42/EEC (MDD) EU Directive 93/42/EEC concerning medical devices
IEC 60825-1:2003-10 Safety of laser products – Part 1: Equipment classification and
requirements
IEC 60601-1:1996-03 Medical electrical equipment – General requirements
IEC 60601-1-1:2002-08 Medical electrical equipment – General requirements for safety
IEC 60601-1-2: 2016-05 Medical electrical equipment – Electromagnetic disturbances –
Requirements and tests
IEC 60601-2-22:1996-12 Medical electrical equipment – Particular requirements for the
safety of diagnostic and therapeutic laser equipment
IEC 60601-1-4:2001-04 4. Collateral standard: Programmable electrical medical systems
IEC 60601-1-6:2010-10 Usability
IEC 62304:2007-03 Medical device software – Software life-cycle processes
IEC 62353:2008-08 Medical electrical equipment – Recurrent test and test after repair
of medical electrical equipment
IEC 15223-1:2012-10
Medical devices – Symbols to be used with medical device labels,
labelling and information to be supplied – Part 1: General
requirements
BGI 832 Operation of laser devices – (Application of the accident prevention
regulation concerning laser radiation (BGV B2))
NOTICE
Comply with national safety regulations!
MPG and BGV are applicable law in Germany. Compliance w
ith all national laws, regulations
and rules is likewise required!

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3.2 Installation and Initial Commissioning
Installation and initial commissioning may be performed only by Gebrüder Martin or authorized
service partners.
CAUTION
Danger of physical injury!
Any person that handles the device in any way must have fully read and understood the
contents of this document. Improper handling that does not comply with these instructions
can
lead to injury or to damage to the device.
Before commissioning, the operator must ensure that the following points are complied with:
•Acceptance by a medical technician of the customer.
•Written appointment of a laser safety officer by the operator (see § 6 BGV B2).
•Training of a person responsible for the device and the personnel.
•Medical product log created.
•Registration of the device with the trade association and with the authority responsible for
occupational safety.
•Handover of the fully operational device and training of the personnel by Gebrüder Martin
or an authorized representative.
•Compliance with all safety notes.
•Observance of all notes regarding electromagnetic compatibility. See also section 13
“Guidelines and Manufacturer’s Declaration Regarding Electromagnetic Compatibility
(EMC)”, page 71.
•Knowledge of the operational procedures and measures in case of faults and malfunctions.
The accident prevention directive (BGV B2) for the protection of medical personnel must be
complied with during the medical application of the device. Medical applications include
diagnostic, surgical or therapeutic applications with laser light in the broadest sense. The
operator and the security officers (e. g. laser safety officer) are responsible for the
implementation of all safety measures to protect the patient, the attending physician and
other persons present during laser operation.

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Furthermore, the following additional requirements must be observed:
•The device may be commissioned by authorized users only. The users must be familiar
with the laser device and know the applicable safety precautions. The persons authorized
to use the device must be listed in the medical product log.
•The training of the personnel is to be repeated annually and must be documented by the
users in written form.
•When the device is not in use, it must be protected against unauthorized use.
—Remove key and store it in a safe location.
•Operation, maintenance and regular safety-related checks must be performed as described
in this document.
The operator must ensure that the following documents are always accessible and updated
regularly:
•Medical product log or device card, respectively.
•Instructions of use for device and accessory equipment.
Accident and damage reports for cases of personal injury must be submitted to the relevant
authorities immediately.

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3.3 Laser Safety
The laser surgery device diomax®
•is a class IIb device acc. to MPG (Medical Devices Act),
•is a class 4 laser device (acc. to IEC 60825-1),
•has the CE label acc. to directive 93/42/EEC.
WARNING
Danger of injury to eyes, skin and other organs!
The device emits light in th
e invisible spectral range of 980 nm which can cause irreversible
damage to eyes, skin and other organs!
Both the direct laser beam of a class
4 laser device itself and the laser light that is reflected
diffusely from surfaces can be harmful!
Wear protective
goggles!
Required safety goggles:
D 980 nm L4 / LB4
The laser range is the range in which the values for the permitted maximum radiation can be
exceeded. However, be aware that the laser beam may be deflected unintentionally.
Therefore, the following safety precautions must be strictly complied with:
•All accesses to the laser areas must be marked with warning lamps.
•Persons working in the laser area must be informed about safety regulations and
precautions and instructed in the operation of the device at least once per year. This
training must be documented in written form including a list of all participants.
•All persons present in the laser area during laser operation must – without exception –
wear protective goggles when the mode is switched from STANDBY to LASER READY:
Laser protection goggles according to EN 207 for diode laser radiation with a
protection class of D 980 nm L4 / LB4 or higher.
•The patient's eyes must be protected.
•The operator is responsible for provision of appropriate protective equipment.
•Do not directly look into the red pilot laser light! The protective goggles mentioned above
do not protect from the red pilot laser light.

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3.4 Danger of Explosion and Fire
WARNING
Fire hazard!
Class
4 lasers (IEC 60825-1) can cause fires due to the heating of tissue or fiber ends.
Therefore, comply with the following requirements to prevent laser
-induced fires and
explosions when using the device:
•
The device must not be activated near flammable anesthetics or highly volatile mixtures
such as alcohol or gasoline.
•
There is risk of fire or explosion if the laser light is used in the presence of flammable
materials, solutions or gases or in an oxygen-enriched environment.
•
The operation area is to be prepared in such a way that even if the laser beam is
activated unintentionally the patient or personnel cannot be endangered, and highly
flammable materials cannot ignite. Therefore, oxygen must not be used as flushing
medium in endoscopic applications.
•
When laser light is used in areas of organs, body cavities and tubi that may contain
flammable gases or vapors, protective measures against fire and explosion must be
taken.
3.5 Protection of the Patient
The patient must under all circumstances be protected from injury by improper handling of the
laser. This applies to the following in particular:
•Protection of the eyes by appropriate protective goggles or a light-proof/radiation-proof
cover.
•Protection of the organs and tissue regions in the operation area that must not come into
contact with laser light by covering them with materials that reflect laser light diffusely or
with light-absorbing materials, such as damp cloths or compresses.
•Prevention of laser-induced fires, especially during endolaryngeal operations.
•Prevention of ignition of intestinal gases and tissue in case of respiration methods using
oxidizing gases.

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3.6 Requirements for Treatment Rooms
•Rooms in which the device is to be operated must be marked with a laser warning sign
(included in the delivery) at all accesses.
•All access doors to the laser area must be equipped with a warning lamp. When the
warning lamp is activated, the laser area may be accessed only by authorized persons
wearing the required laser protection goggles.
•The doors to the laser area must be kept closed during laser application.
•Avoid surfaces in the laser area that may reflect laser radiation, or cover them
appropriately.
3.7 Safety Requirements for the Laser Device
•The instruments to be used must have a shape and surface finish to eliminate dangerous
reflections as far as possible.
•Optical systems for observation of the operation area must be designed for laser
applications. They may be used only with suitable attachment filters that meet the
requirements for laser protection goggles.
•If any defects on the laser device are noted, the device may no longer be operated! The
defects must be recorded in the medical product log and reported to the laser safety
officer. Immediately contact Gebrüder Martin or an authorized service technician.
3.8 Safety Notes for the Pilot Laser
CAUTION
Possible distraction caused by pilot laser light!
Direct or reflected light of the pilot laser can blind the
user and temporarily impair
his/
her working ability.
The laser protection goggles D
980 nm L4 / LB4 are used to protect the eyes from infrared
laser light but not from the pilot laser light!
•
Do not directly look into the pilot laser light!

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3.9 Laser Safety Officer
According to the German accident prevention directive BGV B2 (laser radiation), the operator
must appoint a laser safety officer in writing. The laser safety officer is responsible for the
following:
•Implementation of safety measures
•Instruction of all persons working with the device in the safety measures and operation of
the device
•Marking of the laser area with signs
•Check of the warning signals
•Availability of the laser protection goggles
•Safe storage of the keys
•Correct connection of the device in case of relocation
•Keeping of the medical product log
3.10 User
The user is responsible for safe and proper use of the medical laser system. He or she must
ensure that all safety precautions are complied with, and be familiar with the laser-specific
surgical technique.
3.11 Electrical Safety
The device conforms to protection class 1 (IEC 60601), which means that it must be connected
to a properly earthed mains according to its technical data (see section 11 “Tecnical Data”,
page 67).
•Use only the mains cable included in the delivery.
•Mains cable and plugs must not show any signs of damage.
•The laser system must never be activated if any part of the casing is not attached
correctly. If the casing is not properly closed, laser radiation may escape uncontrollably,
and dangerous electrical voltages or currents may be exposed.
3.12 Earthing of the Device
The device is earthed via the earthing conductor in the mains cable. This is an indispensable
prerequisite for safe operation of the device. Proper earthing is ensured if the mains cable is
connected according to the VDE regulations.
The equipotential bonding required for use of the device in certain operation areas (e. g.
during intracardiac operations) can be established via the green-yellow equipotential bonding
cable.

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3.13 Fuses
Fuses may be replaced only by authorized and qualified personnel.
At the rear of the device there are the fuses of the mains input socket whose fuse rating is
printed on the rear of the device (see section 4.4 “Rear of Device”, page 24).
3.14 Safety Systems of the Device
The device was designed taking into account the strictest standards of personal safety. The
safety measures built into the system make incorrect operation impossible:
•Upon activation or re-activation of the device after a power failure, the device switches into
STANDBY mode – the laser beam cannot be activated.
•The laser beam cannot be activated either as long as the laser fiber is not connected.
•Regarding the duration of laser activation, for safety reasons the foot switch has absolute
priority over the set pulse times, i. e. when the foot switch is not pressed any longer, the
emission of laser light is stopped immediately even if the preset pulse time has not ended
yet.
•The foot switch has two switches, one for accessory devices and one for the laser
activation itself. Laser light can be emitted only while both switches are activated.
•When the foot switch is activated, all buttons and the rotary knob are blocked to avoid
unintentional changing of the radiation parameters during the operation.
•The laser power is continuously monitored during the emission of laser light.
•The coding of the SMA-X fiber connection socket ensures that only appropriate laser fibers
can be connected to the device.
•Using the EMERGENCY-STOP switch, the device can immediately be separated from the
electric circuit in case of emergencies.
3.15 Usage Restrictions
Youths below the age of 16 must not work with lasers or in laser areas (applies to laser classes
3R, 3B and 4, see BGV B2 §11). Youths below the age of 16 may work with lasers or in laser
areas under supervision and if safety is ensured by a qualified person, and if such work is
required in the context of training.