KLS Martin group Laser Surgical Unit diomax 1550 User manual

English
L
aser Surgical Unit diomax®1550
Instructions for Use
90-458-52-20
Revision 2
Date of Release: 2014-03
Valid f
rom software version V1.00,
hardware
release HW 02 and software version SW 01

2 Revision 2
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.
Observe 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 minimum and maximum temperature for storage and
transportation.
See section 11 “Technical Data”, page 66 for valid values.
Information on minimum and maximum atmospheric pressure for
storage and transportation.
See section 11 “Technical Data”, page 66 for valid values.
Information on minimum and maximum atmospheric humidity for
storage and transportation.
See section 11 “Technical Data”, page 66 for valid values.
Fragile, avoid pressure and shock

Revision 2 3
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®1550
4 Revision 2
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

Instructions for Use
Laser Surgical Unit diomax®1550
Revision 2 5
4.4 Rear of Device ....................................................................................24
4.4.1 Type Plate .....................................................................................................25
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
4.4.8Option 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 ....................................................................................................31
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
5.4 Replacing the Laser Fiber ..................................................................... 39
5.5 Connecting Focusing Handpiece/Applicators ........................................... 39
5.6 Switching on the Device....................................................................... 39
5.7 System Check ....................................................................................40
5.8 Foot Switch ........................................................................................ 40
5.9 Applying the Laser ..............................................................................41
5.10 Switching off the Device ...................................................................... 42
5.11 Emergency Stop ................................................................................. 42
5.12 Working with Programs........................................................................ 43
5.12.1 Standard Program ..........................................................................................43
5.12.2 Selecting a Program .......................................................................................44
5.12.3 Program change.............................................................................................46
5.12.4 Laser output ..................................................................................................46
5.12.5 Operating modes............................................................................................46
5.12.6 Times ...........................................................................................................50
5.12.7 Saving the Modified Program ...........................................................................50
5.12.8 Deleting Programs..........................................................................................52

Instructions for Use
Laser Surgical Unit diomax®1550
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5.13 Log ...................................................................................................53
5.13.1 Edit log entries...............................................................................................53
5.13.2 View logfile....................................................................................................55
5.14 Pilot Laser..........................................................................................56
5.15 Setup ................................................................................................ 56
6Abridged Instructions for Use.......................................................60
7Maintenance ..............................................................................61
7.1 Periodic Maintenance ........................................................................... 61
7.1.1Maintenance Schedule ....................................................................................61
8Cleaning and Disinfecting ............................................................62
9Troubleshooting .........................................................................63
9.1 Information Displayed ......................................................................... 63
9.2 Other Malfunctions ..............................................................................63
10 Accessories................................................................................64
10.1 Safety Distances (NOHD) ..................................................................... 65
11 Technical Data ...........................................................................66
12 Safety Check (SC) ......................................................................68
13 Guidelines and Manufacturer’s Declaration
Regarding Electromagnetic Compatibility (EMC) .............................70
14 Ecological Information ................................................................74
14.1 Disposal of Packing .............................................................................74
14.2 Environment-friendly Device Operations ................................................ 74
14.3 Disposal of the Unit .............................................................................74

Instructions for Use
Laser Surgical Unit diomax®1550
Revision 2 7
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®1550
•Power supply cable
•2 keys
•Equipotential bonding cable
•2 laser warning signs
•diomax®1550 Instructions for Use
•Interlock connector with bypass
•Footswitch

Instructions for Use
Laser Surgical Unit diomax®1550
8 Revision 2
1.3 Intended Use
The diomax®1550 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 document 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 61 and section 12 “Safety Check (SC)”, page 68.
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.

Instructions for Use
Laser Surgical Unit diomax®1550
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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.

Instructions for Use
Laser Surgical Unit diomax®1550
10 Revision 2
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]
To answer your technical
questions as efficiently as possible, our service technicians require
the serial number of the product. 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.
NOTICE