Operating Manual
82 Pages
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CUSTOMER OPERATING MANUAL - EN
ROLITE
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Copyright All rights reserved. This document may not be copied, adapted or translated without prior written permission, except as permitted under copyright law. © Copyright Maquet SAS Subject to technical changes. The illustrations and technical specifications provided in this user manual may, on account of future product developments, differ slightly from the actual product supplied. 1 July 2014 | Ed2B
ROLITE AXL | Customer operating manual | EN | 0165102 | 2B |
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CONTENTS
1 1.1 1.2 2 3 4 5 6 6.1 7 7.1 8 9 9.1 9.2 9.3 9.4 9.5 9.6 9.7 9.8 9.9 9.10 9.11 9.12 9.13 10 11 11.1 11.2 11.3 11.4 11.5 11.6 11.7 11.8 11.9 11.10 11.11 11.12 11.13
Standards and regulations Certification of MAQUET SAS’s quality system Ec marking Warnings Symbols used in these instructions Symbols used on the device Introduction Description of equipment Description Characteristics Outline drawing Installation / assembly Use Turning on Basic model: without batteries Battery-powered model: with batteries Turning off Moving and positioning the light To move the device easily Locking and releasing the casters Using and charging the batteries (option) Positioning the mobile light Example positions Using the sterilisable handle Disassembling rolite Cleaning and disinfection EMC declaration Maintenance Preventive maintenance Basic maintenance Replacing the control keypad Replacing the power supply unit Power supply unit: description Features Power supply unit dimensions Specifications Replacing the battery packs or adding new packs Servicing and storing the batteries Battery disposal Replacing the bulbs Replacing the fuses
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4 4 4 5 8 9 11 13 13 14 16 17 21 23 24 25 27 28 28 29 30 32 33 33 33 34 35 39 39 39 41 42 43 43 43 44 45 45 45 46 47
ROLITE AXL | Customer operating manual | EN | 0165102 | 2B |
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11.14 11.15 11.16 11.17 11.18 12 13 14 15
Replacing the power cable (mains) Adjustments Repair kits and subassemblies Recommended spare parts and consumables Maintenance tools (OPM) Servicing checklist Parts lists and drawings Inspection sheet Troubleshooting
1
STANDARDS AND REGULATIONS
1.1
CERTIFICATION OF MAQUET SAS’S QUALITY SYSTEM
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47 48 49 50 50 51 53 75 79
LNE/G-MED certifies that the quality system developed by MAQUET SAS for design, implementation, sales, installation and after-sales service of surgical lights complies with the requirements of the following international standards: ISO 9001:2008 EN ISO 13485:2004
1.2
EC MARKING Compliance with the requirements of European Directive 93/42/EEC of 14 June 1993 concerning medical devices has been assessed in accordance with Annex VII of the Directive. ROLITE mobile surgical lights belong to Class I as described in Annex IX of Directive 93/42/EEC.
ROLITE AXL | Customer operating manual | EN | 0165102 | 2B |
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2
WARNINGS
!
WARNING Changes or modifications not expressly approved by MAQUET SAS could void the user’s authority to operate the equipement.
!
WARNING To avoid damaging the medical devices, do not use this equipment for purposes other than those described in this document.
!
WARNING To maintain our products in full working order, please follow the instructions for use.
!
WARNING The instructions given in this document must be followed to the letter. Failure to do so may endanger the safety of the installers or users. More specifically, the equipment must be assembled in full, adjusted, and checked before being used for the first time.
!
WARNING The warranty clauses as well as specific information on operating the entire product and conducting preventive maintenance on it are provided in the user manual. For futher information, please contact our sales network or our local network.
!
WARNING In order to ensure that this device continues to operate at optimal levels, always inform MAQUET SAS if it is used in an environment or for a purpose other than those described in this manual.
!
WARNING Ensure that other equipment used is compatible with this device.
!
WARNING Check that the sterilisable/disposable handle is compatible with the product.
!
WARNING Before reusing the handle after it has been sterilised, always: Check for cracks. Check that the handle clicks (x2) into place correctly in the surgical light.
ROLITE AXL | Customer operating manual | EN | 0165102 | 2B |
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!
WARNING The sterilisable handle can be sterilized up to 50 times.
!
WARNING To avoid all risk of asepsis, only the medical team may touch the handle during procedures.
!
WARNING Do not use the unit in the presence of inflammable anaesthetic gases.
!
WARNING Solutions containing glutaraldehyde, phenol, iodine, bleach, alcohol or chloride ions must not be used. Fumigation methods are unsuitable for disinfecting the unit and must not be used.
!
WARNING Dismantling certain elements may affect operation and safety. For example: When servicing the electrical power supply. When intervening on the spring arm and the balancing system. Contact the authorised Maquet after-sales service department for this type of inspection.
!
WARNING Any damaged paintwork should be touched up immediately. Consult MAQUET SAS if necessary for further information regarding repairs.
!
WARNING Customers must consult applicable environmental standards regarding the recycling and disposal of the product.
!
WARNING Do not use in an MRI environment.
!
WARNING Light is a form of energy that can dry out tissue, particularly if light beams from more than one lighthead are superimposed. Users must be vigilant and set appropriate illumination levels for each operation and patient, in particular for long operations.
ROLITE AXL | Customer operating manual | EN | 0165102 | 2B |
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!
WARNING Light is a form of energy that, on account of certain wavelengths emitted, may not be suitable for certain pathologies.
!
WARNING The light source is a high-intensity light source. Do not look directly into it.
!
WARNING In the event of a power cut, only lightheads connected to a backup power supply will remain on.
!
WARNING Do not allow the surgical light to touch patients.
!
WARNING To protect against the risk of electrical shock, this device must be connected to a power source with a protective earth contact.
!
WARNING Two people are required to install the equipment.
!
WARNING To prevent the device tipping over, make sure that the batteries or counterweights are correctly in place and that the legs on the base are fully opened before installing the lighthead.
!
WARNING Never fold the legs on the base when using or moving the mobile light with the lighthead installed.
!
WARNING During installation, check that symbols
!
on legs base are opposite each other.
WARNING The spring arm is delivered with two rings. Use the LARGER one to fit the AXCEL lighthead.
ROLITE AXL | Customer operating manual | EN | 0165102 | 2B |
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!
WARNING The connection to the electrical outlet must remain accessible.
!
WARNING Do not touch the patient and non-sterile parts of the system at the same time.
3
SYMBOLS USED IN THESE INSTRUCTIONS Symbol
Meaning Mandatory May affect patient or user safety
F
Recommendation Risk of damage to device or accessories
ROLITE AXL | Customer operating manual | EN | 0165102 | 2B |
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4
SYMBOLS USED ON THE DEVICE Symbol
Meaning Caution Follow the instructions for use Read the documents supplied with unit carefully
Manufacturer Direct current
~ Main Fuse
REF. SN.
S
Alternating current Device fitted with equipotential grounding connector.
2 x fuse type: 6.3 A - 250 VAC Technical designation and serial numbers.
Comply with the applicable handling precautions for products that are sensitive to electrostatic discharges. CE label The device complies with the requirements of European directive 93/42/EEC relating to medical devices.
This device complies with Canadian and US safety requirements. This equipment must not be disposed of with household waste as it is subject to separate collection for value enhancement, reuse or recycling.
ROLITE AXL | Customer operating manual | EN | 0165102 | 2B |
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SYMBOLS USED ON THE PRODUCT Symbol
Meaning Do not lean on the Rolite mobile light.
Push the Rolite mobile light to move it. Do not pull it behind you.
The lighthead arm must be be folded before moving the Rolite mobile light. Place yourself on the lighthead side when moving the light on sloped surfaces. Only pull the cart behind you when moving it on sloped surfaces.
The batteries must be placed facing the direction of the bottom of the slope. This device meets the requirements the Code of Federal Regulations, Title 47 (47 CFR), Part 15 (USA only).
Battery
No battery
Swivel legs locked into position for use This symbol serves to warn the user that uninsulated voltage inside the device may be high enough to result in electrical shock. Touching any parts inside the device is therefore hazardous.
ROLITE AXL | Customer operating manual | EN | 0165102 | 2B |
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5
INTRODUCTION
5.1
INTENDED USE This mobile surgical light is designed to ensure the best operating conditions for medical teams and provide optimum safety conditions for patients. It is intended for use by all members of surgical teams.
5.2
INAPPROPRIATE USE
5.3
INTENTED USERS
The unit is intended only for use as mentioned in the user manual and is suitable only for such use. Any other use may result in danger to users and/or damage to the device or its environment. For safety reasons, do not alter or adapt the device in any way without Maquet's approval.
This device may only be used by trained medical staff. he device must be cleaned by specialised personnel. T
5.4
ENVIRONMENTAL REQUIREMENTS TRANSPORT AND STORAGE Ambient temperature: -10°C to +60°C Relative humidity: 20 to 75% Atmospheric pressure: 500 to 1060 hPa OPERATION Ambient temperature: +10°C to +40°C Relative humidity: 30 to 75% Atmospheric pressure: 700 to 1060 hPa The device must be installed and commissioned in accordance with the EMC information provided. Portable and mobile RF communication devices may affect the correct operation of the device.
5.5
MAINTENANCE MAQUET's warranty and the safety and integrity of the operation of the product are guaranteed only if: All inspection, maintenance and repair operations are performed by a MAQUET engineer or a trained and authorised technical support technician. Only original accessories, consumables and spare parts are used. Maintenance operations and checks are performed and documented at least once a year as specified by the preventive maintenance programme.
ROLITE AXL | Customer operating manual | EN | 0165102 | 2B |
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5.6
USER MANUAL This user manual is an integral component of the equipment. It must be kept near the equipment for future reference. It must be read in full before attempting to use the equipment.
5.7
FCC PART 15 (USA ONLY) This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference, in which case the user will be required to correct the interference at its own expense.
5.8
MANUFACTURED BY MAQUET SAS Parc de Limère Avenue de la Pomme de Pin CS 10008 ARDON 45074 ORLÉANS CEDEX 2 FRANCE Telephone: +33 (0) 2 38 25 88 88 Fax: +33 (0) 2 38 25 88 00 www.maquet.com
ROLITE AXL | Customer operating manual | EN | 0165102 | 2B |
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6
DESCRIPTION OF EQUIPMENT
F
RECOMMENDATION Refer to the operating manual for your lighthead.
This mobile surgical light comes in 2 versions: a basic version to be connected to a mains supply a battery-powered version (optional battery pack) It can be equipped with an AXCEL lighthead, containing patented high-tech dichroic mirrors. The AXCEL lighthead product line provides a wide range of features: large illumination area cool, comfortable lighting accurate rendition of color a cross-shaped design
6.1
DESCRIPTION
2 3 1
4 5 10 6 9
7
8
1 - AXCEL lighthead 2 - Spring arm subassembly 3 - Top pole 4 - Bottom pole 5 - Battery or counter-weight 6 - Swivel casters 7 - Rolling base 8 - Cable reel 9 - Lock/release pin 10 - Caster brake pedal
ROLITE AXL | Customer operating manual | EN | 0165102 | 2B |
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7
CHARACTERISTICS LIGHTHEAD Unit
AXCEL
Nominal illumination (Ec)
lx
100 000 ± 15%
Diameter d10
cm (inch)
22 (8.7) ± 10%
Diameter d50
cm (inch)
12,5 (4.9) ± 10%
Illumination depth at 20%
cm (inches)
101 (39.8) ± 10%
Illumination depth at 60%
cm (inches)
50 (19.7) ± 10 %
Colour temperature (Ra)
K
3 500 ± 10%
Colour rendering index
NA
95 ±5
R9 specific index
N/A
50 ± 5
With one mask
%
47
With two masks
%
49
At base of tube
%
100
With one mask, at base of tube
%
47
With two masks, at base of tube
%
49
Radiant energy
mW.m-2.lx-1
≤ 4,4
Irradiance (Ee)
W/m2
≤ 500
Shadow dilution
Specifications
Other characteristics
F
Degree of protection against harmful ingress of water
N/A
Ordinary
Methods of sterilization or disinfection
N/A
See chapter 8
Mode of operation
N/A
Continuous operation
REMARQUE The toleranced values are those values which are guaranted on purchase of the product. The non-toleranced values are those values measured by a certified organization on a production sample.
ROLITE AXL | Customer operating manual | EN | 0165102 | 2B |
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ROLITE ASSEMBLY Description Supply voltage
Specifications 100 V - 240 V / 50-60 Hz
Max. power of supply and lighthead
400 VA
Weight
89 kg
Length of mains power cable
3m
2 antistatic swivel casters
Ø 125 mm
2 swivel casters
Ø 125 mm
Battery type
Gel lead-acid
Min. battery life (with lighthead)
3 hours
Horizontal rotation of spring arm
+15°/-15°
Vertical reach of spring arm
+15°/-40°
Fuse
6.3A - 250VAC
ROLITE AXL | Customer operating manual | EN | 0165102 | 2B |
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7.1
OUTLINE DRAWING 1249 1115
15°
1051
41
214
284
2000
maxi: 1945 1674 mini: 994
40°
777
564 847
15°
1991
15°
ROLITE AXL | Customer operating manual | EN | 0165102 | 2B |
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8
INSTALLATION / ASSEMBLY
F
RECOMMENDATION Refer to the installation manual for your lighthead.
!
WARNING Two people are required to install the device.
!
WARNING Dismantling certain elements may affect operation and safety. For example: When servicing the electrical Control box. When intervening on the spring arm and the balancing system. Contact the authorised Maquet after-sales service department for this type of inspection.
!
WARNING To prevent the device tipping over, make sure that the batteries or counterweights are correctly in place and that the legs on the base are fully opened before installing the lighthead.
!
WARNING Never fold the legs on the base when using or moving the mobile light with the lighthead installed.
!
WARNING Threaded parts (e.g. mast mounting areas) may be sharp. Avoid touching them with bare hands due to the risk of cuts.
!
WARNING Only authorised MAQUET SAS technician's may install the device.
!
WARNING This device may not be altered without the manufacturer's authorisation.
ROLITE AXL | Customer operating manual | EN | 0165102 | 2B |
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Place the mobile light on the floor.
A
To fold out the 4 legs on the base : Raise the lock/release pin (A) on each leg
Fold out the four legs at the same time. During installation, check that symbols on legs base are opposite each other.
A
ROLITE AXL | Customer operating manual | EN | 0165102 | 2B |
Release the lock/release pin (A) and turn the leg until it clicks into its correct position (symbols on legs base are opposite each other).
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Lock the swivel casters into place by pressing on the brake pedals (B) on the rear casters. Slide the battery packs or the counterweigts along the rails until they click into place (battery lock/release pin (C)). B
C
!
IMPORTANT Insert the pins (G) in the alignment holes when assembling the poles.
Using the alignment hole and pin (G) as a guide, insert the bottom pole into the base and lock it in place with the clamping nut (D).
F
Insert the top pole into the bottom pole and lock it in place with the clamping nut (E). E
G
Insert the spring arm into the top pole and lock it in place with the clamping nut (F).
D
ROLITE AXL | Customer operating manual | EN | 0165102 | 2B |
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FITTING THE LIGHTHEAD
!
IMPORTANT The spring arm is delivered with two rings. Use the LARGER one to fit the AXCEL lighthead.
90°
Remove the brake screw.
urn the cover 90° and T remove the first attachment screw.
Insert the lighthead hub in the spring arm.
Insert the brake screw.
ROLITE AXL | Customer operating manual | EN | 0165102 | 2B |
180°
urn the cover 180° and T remove the second attachment screw.
urn the cover 90° and T insert the first attachment screw. Turn the cover 180° and insert the second attachment screw.