TRUMPF
MARS 2 Operating Table Instruction Manual March 2008
Instruction Manual
72 Pages
Preview
Page 1
MARS 2 Operating Table Instruction Manual
This is a medical product of class I according to Appendix IX of the Medical Product Directive (MDD) 93/42/ EEC of 14 June 1993. The manufacturer declares the satisfaction of the essential requirements indicated in Appendix I, MDD, as well as the performance of a conformity evaluation procedure required for class I products according to Appendix VII, MDD. This is documented by the CE mark.
TRUMPF Medizin Systeme GmbH Postfach 24 44 D-07310 Saalfeld TRUMPF Medizin Systeme GmbH Carl-Zeiss-Straße 5 D-07318 Saalfeld, Germany
Distribution
Technical Customer Service
Telephone
+49 3671 586-0
Fax
+49 3671 586-166
Telephone
+49 3671 586-172 +49 3671 586-176
Fax
+49 3671 586-175
We are constantly developing our products. We therefore reserve the right to make changes to the scope of the delivery with respect to the format, equipment and technology at any time. Reprinting, copying or translating this document, in whole or in part, is forbidden without the express written permission of TRUMPF Medizin Systeme GmbH. All rights under the copyright laws are expressly reserved by TRUMPF Medizin Systeme GmbH. Within the bounds of the legal requirements, the manufacturer is only then responsible for the technical safety characteristics of this apparatus if the maintenance, repairs and modifications to this apparatus are performed by him or by someone appointed by him and in accordance with his instructions. © 03/2008 TRUMPF Medizin Systeme GmbH
This instruction manual applies to the following sales units: Product name
Mat. no.
MARS 2.01 operating table
1 380 094
MARS 2.01 M operating table
1 429 728
MARS 2.01 T operating table
1 429 737
MARS 2.02 operating table
1 380 095
MARS 2.02 M operating table
1 429 729
MARS 2.02 T operating table
1 429 739
MARS 2.03 operating table
1 380 096
MARS 2.03 M operating table
1 429 730
MARS 2.03 T operating table
1 429 740
MARS 2.04 operating table
1 380 097
MARS 2.04 M operating table
1 429 731
MARS 2.04 T operating table
1 429 741
MARS 2.05 operating table
1 380 198
MARS 2.05 M operating table
1 429 732
MARS 2.05 T operating table
1 429 742
MARS 2.06 operating table
1 380 199
MARS 2.06 M operating table
1 429 736
MARS 2.06 T operating table
1 429 733
Cable-based remote control, MARS 2 BM*
1 416 569
Cable-based remote control, MARS 2 BE**
1 411 554
Cable-based remote control, MARS 2 FA***
1 409 407
IR remote control, MARS 2 BM*
1 416 572
IR remote control, MARS 2 BE**
1 411 553
IR remote control, MARS 2 FA**
1 409 406
230 mobile charger
4 544 122
230 wall-mounted charger
4 544 123
24 wall-mounted charger
4 544 139
IR DVE 230 charger
1 314 349
Panelboard-installed charger
1 220 519
* For the MARS 2.01/2.02 operating tables ** For the MARS 2.03/2.05 operating tables *** For the MARS 2.04/2.06 operating tables
Instruction manual, MARS 2 - 1 422 350 - 03/2008
The operating table models differ from each other as follows: Properties Tabletop height, standard
MARS model 2.01 2.01 M 2.01 T
2.02 2.02 M 2.02 T
2.03 2.03 M 2.03 T
2.04 2.04 M 2.04 T
Tabletop height, low
2.02 2.02 M 2.02 T
Tabletop longitudinal displacement Travel mode that can be (mechanically) set by a pedal
2.01 2.01 M 2.01 T
2.05 2.05 M 2.05 T
2.06 2.06 M 2.06 T
2.03 2.03 M 2.03 T
2.04 2.04 M 2.04 T
2.05 2.05 M 2.05 T
2.06 2.06 M 2.06 T
2.03 2.03 M 2.03 T
2.04 2.04 M 2.04 T
2.05 2.05 M 2.05 T
2.06 2.06 M 2.06 T
2.02 2.02 M 2.02 T
Travel mode that can be (electrically) set by a control unit
2.04 2.04 M 2.04 T
Travel mode with an electrical drive
2.06 2.06 M 2.06 T
Standard pad
2.01
2.02
2.03
2.04
2.05
2.06
Prophylactic pad
2.01 M
2.02 M
2.03 M
2.04 M
2.05 M
2.06 M
Prophylactic plus pad
2.01 T
2.02 T
2.03 T
2.04 T
2.05 T
2.06 T
Instruction manual, MARS 2 - 1 422 350 - 03/2008
Contents
Contents 1 1.1 1.2 1.3 1.3.1 1.3.2 1.3.3 1.3.4 1.3.5 1.3.6 1.3.7 1.3.8 1.4
Important Information... 4 Proper Use of the Equipment... 4 Explanation of symbols... 5 Safety Information... 6 General information... 6 Electricity... 7 High-frequency (HF) Surgery... 8 Pad... 8 Transport/Repositioning... 9 Maintenance/Repair... 10 Protection against infection... 10 Environmental protection... 10 Glossary... 11
2 2.1
Delivery state... 12 Unpacking and setup... 12
3 3.1 3.2
The operating table - An overview... 14 Pad versions... 15 Pictograms... 16
4 4.1 4.1.1 4.1.2 4.2 4.2.1 4.2.2 4.2.3 4.2.4
Control units... 18 Priorities... 18 Column keypad... 19 Overview... 19 Service displays... 20 Cable and IR remote control... 21 Connect the cable remote control... 21 IR remote control standby... 21 Overview... 22 Displays... 24
5 5.1
Charger for the IR remote control... 25 Charge readiness... 25
6 6.1 6.2 6.3 6.4 6.5
Power supply... 26 AP safety... 27 Internal power supply... 27 External (mains) power supply... 28 Ready for use (turning on)... 29 Turning off... 29
7 7.1 7.2 7.3 7.4 7.4.1 7.4.2 7.4.3 7.4.4 7.4.5
Coupling Points... 30 Definition... 30 TRUMPF coupling variants... 31 Tabletop... 32 Un/coupling... 32 Seat for OR adapter... 32 Coupling the double clamp... 33 Uncoupling the double clamp... 33 Coupling a single clamp... 34 Uncoupling a single clamp... 34
Instruction manual, MARS 2 - 1 422 350 - 03/2008
1
Contents 8
Radiolucence...35
9
Patient positioning...35
10 10.1 10.2
10.5
Loading capacity...36 Conditions for using the operating table at loads up to 360 kg...36 Conditions for using the operating table at loads up to 225 kg...37 Option 1...37 Option 2...37 Conditions for using the operating table at loads up to 160 kg...38 Option 1...38 Option 2...38 Option 3...39 Conditions for using the operating table at loads up to 135 kg...39 Option 1...39 Option 2...40 Option 3...40 Option 4...41 Standard rails...41
11 11.1 11.2 11.3 11.4 11.5 11.6 11.7 11.8 11.9 11.10 11.11
Operation...42 Acoustic signals...42 Head positioning...43 Zero position...43 Tilt...44 Anti-/Trendelenburg...45 Lift...46 Longitudinal displacement (not valid for MARS 2.01 (M/T))...47 Back section...48 Back section joints...49 Leg section joint...50 Flex/Reflex...51
12 12.1 12.1.1 12.1.2 12.1.3 12.2 12.2.1
Travel Modes...52 MARS 2.01 (M/T) / 2.02 (M/T)...52 Braking...53 Freewheeling...53 Directional travel...54 MARS 2.03 (M/T) through 2.06 (M/T)...54 Braking...54 Braking (Jacking up)...54 Releasing (jacking down)...55 Emergency release...56 Freewheeling and directional travel (MARS 2.03 (M/T)/2.05 (M/T))...57 Motorised operation, freewheel and directional travel (MARS 2.04 (M/T)/2.06 (M/T))...57 Extending the wheel...57 Retracting the wheel...58 Drive mode...59
10.3
10.4
12.2.2 12.2.3
13
2
Emergency operation...60
Instruction manual, MARS 2 - 1 422 350 - 03/2008
Contents 14
Care, Cleaning and Disinfection... 61
15 15.1 15.2 15.3
Technical Data... 62 Conditions for operation, storage and transport... 62 Operating table... 62 Chargers... 64
16
Troubleshooting... 65
17
Maintenance and Repair... 66
18
Scrap Disposal... 66
Instruction manual, MARS 2 - 1 422 350 - 03/2008
3
Important Information
1
Important Information Products from TRUMPF Medizin Systeme GmbH are manufactured to give a long and trouble-free service life. Development, design and production by TRUMPF Medizin Systeme GmbH have been certified in accordance with DIN EN ISO 13485:2003. This guarantees: • highest quality and a long service life, • easy operation, • functional design and • optimisation for the intended purpose. The products are manufactured in accordance with the requirements of the Medizinproduktegesetz MPG (Medical Products Act) and bear the CE mark. Prior to using the products, read this instruction manual carefully from the beginning to the end in order to familiarise yourself with the product and its diverse functions in a step-by-step manner. Store the instruction manual near the product. This operating table can be used safely. Reference is made to any residual dangers at the appropriate points in the manual. Please observe the following instructions.
1.1
Proper Use of the Equipment The devices described in this manual are for human medical use only. The MARS 2 operating table in conjunction with the TRUMPF operating table components and accessories are intended for the following uses: • Holding patients during the operation: - Induction of anaesthesia - Operation - Recovery from anaesthesia • Transporting the patient on the operating tabletop: - from a patient transfer system to the operating theatre - from the operating theatre to the patient transfer system. The rails* located beneath the back section on the inside of the arms are for securing the X-ray cassettes (14 inch in size). The operating table must be covered with a sterile material before use and must be used and operated in a controlled and responsible manner by duly instructed medical professionals only.
* optional
4
Instruction manual, MARS 2 - 1 422 350 - 03/2008
Important Information Proper use of the tabletop includes following the instructions in this manual. Any other use of the operating table is regarded as improper usage. The supplier/manufacturer is not liable for damage to property or injury to persons resulting from incorrect operation of the table or putting it to an improper use.
1.2
Explanation of symbols Important information in this instruction manual is marked with symbols and keywords. Key words such as DANGER, WARNING or CAUTIONindicate the level of danger involved. The symbols emphasise the message visually. Additional symbols can indicate injury hazards or danger to life and limb. The measures to prevent dangers arising must be implemented without fail. DANGER Danger to life and limb (for example electric shock)! Refers to a directly imminent danger that will result in death or serious injuries if the appropriate precautionary measures are not taken. WARNING Danger to life and limb! Refers to a directly imminent danger that can result in death or serious injuries if the appropriate precautionary measures are not taken. CAUTION Danger of injury (such as crushing)! Refers to a possible danger that can lead to slight or moderate injury or material damage if the appropriate precautionary measures are not taken. CAUTION Risk of material damage! Refers to a possible danger that can lead to material damage if the appropriate precautionary measures are not taken. NOTE Additional useful information and tips.
Instruction manual, MARS 2 - 1 422 350 - 03/2008
5
Important Information 1.3
Safety Information Safety information and measures to protect the user and patients from hazards that can result from use of the operating table. During an operation, changing the patient's position by moving the operating table (to the zero position, Trendelenburg) may be necessary to enable life-saving measures in critical situations. WARNING Hazard to the patient! Functional failure of the operating table cannot be completely excluded given state-of-the-art technology available on the market today. Should this rare event occur, motor-driven operating table functions will no longer be available during the operation. If the electrical operating table functions fail, the patient can only be moved with suitable aids (e.g., by placing a pad underneath the patient) or by manually moving the patient from the operating table.
1.3.1
General information • Risk of material damage to electrical equipment through condensation! Do not immediately turn on the operating table. When moving the operating table from a cold to a warm environment or vice versa, condensation can occur on the inside of the operating tabletop. Before turning on the operating table, store the table in a room with the prescribed ambient temperature and humidity (See chapter 15.1 “Conditions for operation, storage and transport” on page 62) (for at least 12 hours) and allow it to heat up/cool down. The batteries must be completely recharged after a significant change in temperature or humidity. • Check that all electrical and mechanical functions/parts of the operating table, including accessories, are undamaged and in good working order before using them. Defective or damaged products may not be used. • The knobs are loosened by turning counter-clockwise and tightened by turning clockwise, like a standard screw. • Spontaneous movement of released elements may occur. Check that all fastening elements are seated properly and tight. • Danger of crushing by moving parts! Familiarise yourself with its operating functions before use. • Pay attention to the pictograms on the product. All pictograms (adhesive labels) on the product must be complete and legible. Replace damaged or loose adhesive labels. • Read the relevant instruction manuals for the proper and safe use of the additional equipment.
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Instruction manual, MARS 2 - 1 422 350 - 03/2008
Important Information 1.3.2
Electricity • Get a qualified electrician to check the electrical safety of the operating table and the power supply every year. We recommend an annual general safety check by TRUMPF Medizin Systeme GmbH customer service. • The anti-static properties of the operating tabletop comply with legal requirements if the standard and Prophylactic plus pads supplied are used and properly secured. • Always keep rechargeable batteries ready for service (i.e., charged) so they may be immediately used in the event of a loss of power. • Power and potential equalisation cables: - Do not crush or roll over with table. - Do not continue to use any damaged cables. - Remove cables before moving table. If you have any concern about the safety of the power and potential equalisation cables, work with the internal (rechargeable) power supply only until you have replaced the cable in question. • Only the use of the operating table when an equipotential bonding conductor is connected to an electrically conductive floor. • Connection points for the the equipotential bonding conductor on the operating table comply with DIN EN 60601-1 (VDE 0750-1).
Instruction manual, MARS 2 - 1 422 350 - 03/2008
7
Important Information 1.3.3
High-frequency (HF) Surgery Note DIN EN 60601 and the instruction manual from the HF surgical device manufacturer. TRUMPF operating tables are electrically conductive according to the currently valid DIN EN 60601 regulations. When highfrequency devices (defibrillators, defibrillator monitors, etc.) are used, the patient runs the risk of electrical shocks or burns if no safety precautions are taken. • Risk of burns to patient! Position patient on the operating table to be isolated from metal parts (operating table, accessories) and conductive pads or tubes. • Make sure patient does not come into contact with damp towels or pads. Only use dry materials. • The use of HF surgical devices can lead to interruptions of electric motor-driven functions during use.
1.3.4
Pad • The pads and cover retain the patient's body heat, thereby preventing the body temperature from falling due to heat diffusion. • Use appropriate pads only (manufactured by TRUMPF Medizin Systeme GmbH). Do not lay the patient on the operating table without a pad. The pad edges are flush if the operating table components have been properly affixed. • Lift the patient into the desired position. Do not pull the patient across the pads. After each change of position, lift the patient's appropriate body parts. Any wrinkles or shearing forces that have developed will be eliminated. • Do not place any sharp-edged objects on the pad or stick them into the pad. Do not attach any adhesive foil. • Note the different properties of the pad versions. Always use only ONE pad version for the patient positioning area (tabletop including components and accessories).
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Instruction manual, MARS 2 - 1 422 350 - 03/2008
Important Information 1.3.5
Transport/Repositioning • Hazard to the patient due to improper attachment! Check that the section segments and accessories are securely fastened to the operating table before each use. Loosen controls for adjustment purposes only. Clamp them down immediately thereafter. • Secure the patient before adjusting the operating table and support the patient actively during adjustments. • Observe all electrically assisted functions and system movements near the operating table to prevent - there is a hazard to the patient - there is damage to property or equipment, the operating tabletop or the furnishings. • Perform all manual patient repositioning in a controlled and responsible manner. Watch the movements of electrically powered operating table adjustments carefully until the end position has been reached. • Pay particular attention during downward movement, as the tabletop may collide with operating accessories lying below it, or it may even contact the floor if it is in an extreme position. In some circumstances, there is a risk of crushing injuries to persons. • When the zero position is approached, inclined patient positions may become steeper than they were before the movement commenced. Select the ZERO POSITION function only if there is no possibility of collisions. Closely watch the table as it moves from the zero position to the end position. • Risk of tipping over! Before moving the operating table: - Lower the operating tabletop until the pictogram on the column covers is obscured. - Return any tilted position to a horizontal position. - Shut or disassemble any accessories. • Danger of collision! Be especially careful when transporting the operating table. Be careful to avoid collisions with nearby persons or furniture to prevent damage to the table. • For accessories with removable pads, do not carry the accessories by the pad. The accessory will slip out of the pad and fall onto the floor.
Instruction manual, MARS 2 - 1 422 350 - 03/2008
9
Important Information 1.3.6
Maintenance/Repair • Keep a log book for medical apparatus! All services, inspections and repairs are to be documented in this book. • All repairs must be performed in accordance with the safety regulations as per DIN VDE 0750-1/IEC 601-1! • Within the bounds of the legal requirements, the manufacturer is only then responsible for the technical safety characteristics of this apparatus if the maintenance, repairs and modifications to this apparatus are performed by him or by someone appointed by him and in accordance with his instructions. • TRUMPF Medizin Systeme GmbH shall not liable for damage of any kind arising from the failure to perform inspections or as a result of inadequate repairs or maintenance, or modifications to the product.
1.3.7
Protection against infection • Comply with all the stipulations concerning cleaning/ disinfection. Follow the instructions in this manual concerning cleaning and disinfection procedures and the substances to be used thereof. • Devices and fitments must be cleaned and disinfected before being handed over to service technicians for maintenance and repair work. • Replace pads that no longer meet hygiene and infection requirements.
1.3.8
Environmental protection • Dispose of all left over cleaning and disinfection materials and any residues thereof in a safe manner which does not harm the environment. • If possible, please recycle any rechargeable batteries you can no longer use. • Observe the information in this document concerning enivornmentally-friendly disposal methods.
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Instruction manual, MARS 2 - 1 422 350 - 03/2008
Important Information 1.4
Glossary The following terms and distinctions are used in this instruction manual: ITALICISED... Designation of keys, functions, text displays or device parts Numbers in... Number code for illustrations brackets [50] (referencing text to graphics) Operating table... Operating table plus running gear Column keypad... Operating keypad on the column Standard rail... Fixing rails for accessories Section segment... Tabletop components (such as leg/head sections) to enlarge the patient positioning area Enclosed section... One-piece section segment with two segment clamps, the width of the operating tabletop AP... Denotation used for class AP devices applied in areas with combustible materials and at risk of explosions as per DIN VDE 0100-710 Two-key... Pressing two keys simultaneously to select operation a function on the column keypad + corresponding function key ON
* (asterisk)... Sections marked with * (asterisk) are available optionally!
Instruction manual, MARS 2 - 1 422 350 - 03/2008
11
Delivery state
2
Delivery state The MARS 2 operating table comes delivered in cardboard packaging and on a pallet. Any section segments/accessories you have ordered are individually packaged and also on the pallet. Package dimensions: Length Width Height
1,940 mm 800 mm 1,250 mm
Weight:
approx. 300 kg (order-dependent)
CAUTION Risk of material damage! The packaging is not weatherproof. Store in accordance with the instructions in the technical data.
2.1
Unpacking and setup Unpack the operating table in an open area with a level floor and with sufficient free space for the apparatus to be rolled off the pallet. Unpack in the following sequence:
1,5 m
5m
12
1.
Place the pallet in a position where there is a free space of about 1.5 m x 5 m available.
2.
Open the top of the carton.
3.
Pull the two-part ramp out in an upward direction and place it at the front end of the pallet.
4.
Free the bottom of the carton from the pallet.
5.
Pull the carton off in an upward direction.
6.
Remove the delivered parts.
7.
Take off the tension belts.
8.
Remove the wooden chocks.
Instruction manual, MARS 2 - 1 422 350 - 03/2008
Delivery state 9.
CAUTION Risk of material damage to electrical equipment through condensation! Do not immediately turn on the operating table. When moving the operating table from a cold to a warm environment or vice versa, condensation can occur on the inside of the operating tabletop. Before turning on the operating table, store the table in a room with the prescribed ambient temperature and humidity (See chapter 15.1 “Conditions for operation, storage and transport” on page 62) (for at least 12 hours) and allow it to heat up/ cool down. The batteries must be completely recharged after a significant change in temperature or humidity.
1.
MARS 2.01 (M/T) and 2.02 (M/T) operating tables Move the TRAVEL MODE pedal located on the running gear upwards to the DIRECTIONAL TRAVEL position. Follow the pictogram. MARS 2.03 (M/T) through 2.06 (M/T) operating tables Turn the operating table via the column keypad (green ON button), and press and hold the UNLOCK button for at least 1 second. The operating table is lowered.
2.
10.
CAUTION Risk of personal injury! Risk of tipping over! Do not go over the edge of the pallet! Run the operating table down off the pallet under the control of at least two persons. Carefully transport the operating table from the pallet, via a ramp, to the intended place of operation.
11. MARS 2.01 (M/T) and 2.02 (M/T) operating tables Move the TRAVEL MODE pedal located on the running gear downwards to the BRAKE position. MARS 2.03 (M/T) through 2.06 (M/T) operating tables Press and hold the LOCK button on the column keypad depressed for at least 1 second. The operating table is jacked up. 12. Dispose of the pallet, ramp and packing material in a way that safeguards the environment.
Instruction manual, MARS 2 - 1 422 350 - 03/2008
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The operating table - An overview
3
The operating table - An overview 4 ad He
9
10
d en
23
7
5 d en ot Fo
6
Foot end
17
18
2 13
Head end
8 B
1
14
11
22
12
20 21
3 16
A
15 19
B
20
A [1] [2] [3] [4] [5] [6] [7] [8]
Column keypad Remote control Remote control for recharging device Back section, lower Motorised joint for leg section, plus standard rail: Coupling point for wide double rail Standard rail for seat section Motorised joint for seat section Standard rail, lower back section
MARS 2.02 (M/T) through 2.06 (M/T) [17] [18]
OR seat Bayonet locking mechanism
MARS 2.01 (M/T) and 2.02 (M/T) [19] TRAVEL MODE pedal
[9] [10] [11] [12] [13] [14] [15] [16] [23]
Mechanical joint for back section: Coupling point for narrow double rail Connector socket for the CONTROL UNIT Cover for rechargeable battery area Running gear Connector pin for potential equalisation Connector socket for the MAINS CABLE Foot plate Wheels Seat section
MARS 2.01 (M/T)/2.02 (M/T)/2.03 (M/T)/ 2.05 (M/T) [21] Wheel for directional travel
MARS 2.03 (M/T) through 2.06 (M/T) [22] Emergency release lever for running gear
MARS 2.04 (M/T) and 2.06 (M/T) [20] Wheel for directional travel and drive
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Instruction manual, MARS 2 - 1 422 350 - 03/2008
The operating table - An overview 3.1
Pad versions Operating table
Padding options (as delivered)
MARS 2.01 - 2.06
Standard
MARS 2.01 M - 2.06 M
Prophylactic (M)
MARS 2.01 T - 2.06 T
Prophylactic plus (T)
Standard pad: The pads specially developed by TRUMPF enable the patient to be positioned in such a way that impedes the development of pressure necroses. Trained personnel have to eliminate the residual risk by active decubitus prophylaxis while the patient is in position. The anti-static properties comply with the legal requirements if the pads supplied are used and properly secured. The standard pads are electrically conductive and guarantee AP safety with respect to the regulations. Prophylactic pad: The pads are used for active decubitus prophylaxis due to their foam plastic core. The prophylactic pads are not electrically conductive and do not provide any AP safety (use in potentially explosive areas is not permitted). The use of prophylactic pads is not permitted in conjunction with flammable anaesthetic gases, cleansers or disinfectants. Prophylactic plus pads: The pads are used for active decubitus prophylaxis due to their foam plastic core. The anti-static properties comply with the legal requirements if the pads supplied are used and properly secured. The Prophylactic plus pads are electrically conductive and guarantee AP safety with respect to the regulations.
Instruction manual, MARS 2 - 1 422 350 - 03/2008
15
The operating table - An overview 3.2
Pictograms
Head end
Foot end
IR 3D2
2x2,5 AT
The following pictograms are found on the MARS 2 operating tables: Pictogram
Meaning
Location
Rating plate
Running gear, foot end
Label for the operating table
On the energy cover plate (on both sides)
Connecting pin for potential equalisation cable
Running gear, foot end
IR number
Running gear, foot end
Limited AP safety Read the instruction manual.
Running gear, foot end
IR 3D2
Denotation used for class AP devices applied in areas with combustible materials and at risk of explosions as per IEC 601-1
16
Connector socket for power supply
Running gear, foot end
Fuses
Running gear, foot end
Connector socket for remote control cables
Beneath seat section, at top of column (on both sides)
Instruction manual, MARS 2 - 1 422 350 - 03/2008