Instruction for Use
36 Pages

Preview
Page 1
##CFG BWOP Manuals##
Astramax® Mobile versions Instruction for Use
IFU-AMAX-MOBILE Issue A1– 03rd June 2015
Contents 1
General ... 3 1.1 Symbols used ...3 1.2 All rights reserved ...4 1.3 Electromagnetic compatibility...4 1.4 Declaration of Conformity ...8 1.5 Disposal Instructions ...8 1.6 Guarantee ...9
2
Safety... 10 2.1 Intended use ... 10 2.2 User Profile ... 10 2.3 Safety Instructions ... 11 2.4 Warnings ... 11
3
Technical data ...12 3.1 Models covered ... 12 3.2 Classification ... 12 3.3 Environmental ... 13 3.4 Technical Information ... 13 3.5 Specification ... 14
4
Electrical Installation ...16
5
Mechanical Assembly...17 5.1 Fitting the Casters ... 17 5.2 Fitting the Column ... 18 5.3 Fitting the Spring Arm ... 20 5.4 Fitting the Lamp head ... 21 5.5 Fitting the sterilisable handle system ... 22
6
Mechanical Adjustment ...23 6.1 Adjusting the Spring Arm balance ... 23 6.2 Adjusting the Brake Screw ... 24
7
Operating Instructions ...25 7.1 Using the controls ... 25 7.2 Transporting the Mobile... 27
8
Settings ... 28 8.1 Entering the Default Setting Mode ... 28 8.2 Changing Power on Behaviour ... 29 8.3 Changing the default intensity at power up ... 29 8.4 Changing the default colour temp at power up ... 30 8.5 Setting the service hour counter ... 30 8.6 Resetting the service hour counter ... 31
9
Routine maintenance & service ... 32 9.1 Adjusting the Spring Arm ... 32 9.2 Adjusting the Yoke Arm ... 33 9.3 Cleaning Instructions... 33 9.4 Maintenance checklist ... 34 9.5 Recommended spares ... 35
Page 2 of 36
1
General
1.1
Symbols used The symbols used in this guide and on the product are explained in the following table.
Caution
Consult instructions for use
CE conformity mark
Disposal
Manufacturer
Date of manufacture
Fragile handle with care
Catalogue number
Serial number
Temperature limit
Humidity limitation
Atmospheric pressure limitation
Table 1
Page 3 of 36
1.2
All rights reserved
© Brandon Medical Company Ltd All rights are reserved. No part of the content may be reproduced, adapted, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise without the prior permission of the Copyright owner. Whilst every effort is made to ensure the accuracy and completeness of this guide, we do not warrant that the content is error free. The brand names or product names mentioned or referred to throughout this guide are fully recognised as the trademark or registered trademark of their respective owners.
1.3
Electromagnetic compatibility
Medical devices manufactured by Brandon Medical Company Ltd conform to EN60601-1-2:2007 (EMC Directive 2004/108/EC) standard for both immunity and emissions.
Nevertheless, special precautions need to be observed: Refer to further guidance below regarding the EMC environment in which
1.3.1
Electromagnetic Emissions Guidelines & Declaration
Brandon Medical Company Ltd Astramax is intended for use in the electromagnetic environment specified below. The customer or the user of this Brandon Medical Astramax should assure that it is used in such environment.
Emissions Test
Compliance
Electromagnetic Environment Guidance
RF emissions CISPR 11
Group 1
The Brandon Medical Company Ltd Astramax uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11
Class B
Harmonic emissions IEC 61000-3-2 Voltage fluctuations/flicker emissions IRC 61000-3-3
Class A
The Brandon Medical Company Ltd Astramax is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Complies
Table 2
The medical devices should not be used adjacent to or stacked with other equipment. In case adjacent or stacked use is necessary, the medical device should be observed to verify normal operation in the configuration in which it will be used.
Page 4 of 36
1.3.2
Electromagnetic Immunity Guidelines & Declaration
Brandon Medical Company Ltd Astramax is intended for operation in an electromagnetic environment such as the one specified below. The user must ensure that it is operated in such an environment.
Immunity Test Electrostatic discharge (ESD) IEC 61000-4-2 Fast transients/ electrical disturbance variables/ bursts (IEC 61000-4-4) Surge IEC 61000-4-5
Voltage dips, short interruptions and voltage variations on power supply IEC 61000-4-11
IEC60601 Test Level ±6 kV contact ±8 kV air
Compliance Level
Electromagnetic environment guidance
±6 kV contact ±8 kV air
Floor should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.
±2 kV for power supply lines
±2 kV for power supply lines
Mains power quality should be that of a typical commercial and/or hospital environment.
±1 kV for input/output lines ±1 kV line to line ±2 kV line to earth <5 % UT (>95 % dip in UT) for 0.5 cycle
±1 kV for input/output lines
40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (95 % dip in UT) for 5 sec.
40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (95 % dip in UT) for 5 sec.
±1 kV line to line ±2 kV line to earth <5 % UT (>95 % dip in UT) for 0.5 cycle
Mains power quality should be that of a typical commercial and/or hospital environment. Mains power quality should be that of a typical commercial and/or hospital environment. If the user of the Astramax requires continued operation during power mains interruption, it is recommended that the Astramax be powered from an uninterruptible power supply or battery.
Power frequency 3 A/m Power frequency magnetic fields should (50/60Hz) be at levels characteristic of a typical magnetic field location in a typical commercial or hospital IEC 61000-4-8 environment. Note: UT is the a.c. mains voltage prior to application of the test level. Table 3
Page 5 of 36
1.3.3
Electromagnetic Immunity Guidelines & Declaration
Brandon Medical Astramax is intended for use in the electromagnetic environment specified below. The customers or the users of this Astramax should assure that it is used in such environment.
Immunity test
IEC 60601 Test level
Compliance level
Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the Brandon Medical Astramax including cables, than the recommended separation distance calculated from the equation appropriate to the frequency of the transmitter.
Conducted RF IEC 61000-4-6
3 Vrms 150 kHz ~ 80 MHz
3 Vrms 150 kHz ~ 80 MHz
3 V/m 80 MHz to 2.5 GHz
3 V/m 80 MHz to 2.5 GHz
Recommend separation distance d = [3.5/V1]√P d = [3.5/V1]√P 80 MHz to 800 MHz d = [3.5/V1]√P 800 MHz to 2.5 GHz
Radiated RF IEC 61000-4-3
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol:
Note1: At 80 MHz and 800 MHz, the higher frequency range applies. Note2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Brandon Medical Astramax is used exceeds the applicable RF compliance level above, the Astramax should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Astramax.
a
b
Over the frequency range 150 kHz to 80MHz, field strengths should be less than 3 V/m. Table 4
Page 6 of 36
1.3.4
Recommended separation distance between portable and mobile RF communications equipment & the Quasar eLite
Brandon Medical Astramax is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customers or the users of these Astramax can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Astramax as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter m Rated maximum output power of transmitter W
150 KHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
d = 1.2 √P
d = 1.2 √P
d = 2.3 √P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
Table 5
Page 7 of 36
1.4
Declaration of Conformity
Brandon Medical Co Ltd hereby declares that this product – Astramax– is in compliance with the EC Directive 93/42/EEC. The Class 1 medical device specified above conforms to the essential requirements listed in the Annex 1 of the EC Directive 93/42/EEC of 14 June 1993. Despite any compliance with EMC standards, the device may emit radiation that interferes with adjacent equipment. If this becomes apparent then increase the distance between the two pieces of equipment.
1.5
Disposal Instructions
Do not dispose of the light with normal refuse. Depending on local regulations, dispose of the light at a recycling centre or return it to a dealer with a disposal service. Equipment must be de-contaminated before disposal or return to dealer.
Page 8 of 36
1.6
Guarantee
1.6.1
Terms of the Guarantee
Subject to the conditions listed below Brandon Medical Company Ltd guarantee to provide for the repair of, or at its option replacement of Brandon Medical equipment, or any component thereof (other than consumables), found to be faulty or below standard, as a result of inferior workmanship or materials. This Guarantee will be passed to the purchaser through the Approved Brandon Medical Distributor where equipment is purchased outside of the United Kingdom.
1.6.2
Conditions of the Guarantee
This Guarantee shall only apply to defects or faults that are notified to Brandon Medical Company Ltd. or its Approved Distributor within 12 months of the delivery date.
This Guarantee covers equipment intended for use in hospitals and healthcare establishments only.
It is a condition of the Guarantee that the equipment is maintained as recommended in the instruction manuals provided.
This Guarantee does not cover – and is invalidated by – faults or defects caused by accident, misuse, fair wear and tear, neglect, tampering with the equipment, or any attempt at adjustment or repair other than by Brandon Medical approved Service Technicians.
In the unlikely event of the equipment requiring repair, please contact the Dealer or Supplier from whom it was purchased. Where this is not possible or where the equipment was purchased direct from Brandon Medical Company Ltd., please contact us directly:
Tel: +44 (0)113 277 7393
Fax:+44(0)113 272 8844
E-mail: [email protected]
The cost of any carriage to and from the Dealer, Supplier, Brandon Medical Company Ltd or approved Service Agent shall be borne by the Purchaser.
This Guarantee cannot be varied except by written notification by Brandon Medical Company Ltd authorised by a Company Director.
Under no circumstances whatsoever shall Brandon Medical Company Ltd. be liable in respect of consequential loss.
The Guarantee is subject to the equipment in question having been paid for in full.
This Guarantee is offered as an additional benefit to the Purchaser’s statutory rights and does not affect these rights in any way.
Page 9 of 36
2
Safety
2.1
Intended use
The Surgical Luminaire Astramax is intended to illuminate a surgical treatment site to support treatment and diagnosis. The luminaire is to be used as a minor surgical luminaire (Treament Luminaire definition from IEC 60601-2-41) for treatment. The luminaire is not fail safe compliant and should not be used as a major surgical luminare which requires fail safe compliance when an interruption of the illumination would be a hazardous condition.
(Reference: - IEC60601-2-41)
2.2
User Profile
Medical professional A medical professional is any person with medical training who work within their field in which they were trained. Cleaning professional A person with knowledge and training with national and workplace hygiene requirements. Electrician An electrician is trained in the fields of electronics and electrical engineering and is familiar with the relevant standards and regulations. Qualified professional A qualified professional who is capable of mounting and dismounting of the luminaire with professional training, knowledge and experience of the equipment and knowledge of the local regulations.
2.3
Safety Instructions
Please note that certain duties must only be carried out by people with the appropriate training and knowledge of the equipment. This installation guide is for use on Brandon Medical Equipment Only. If there is any other equipment mounted or connected to the system that is not part of Brandon Medical’s remit then the corresponding instruction manual should be consulted. The luminaire is class l protection and must be connected to the protective earth, if this is not done then there is a potential for electric shock. These instructions for use only become applicable after the proper installation and assembly of the equipment in accordance with the installation guide provided. Only persons with medical training are permitted to operate the equipment. Only trained cleaning personnel are permitted to clean the equipment. Please carefully read these instructions for use before using the equipment. If problems are encountered that has not been addressed in these instructions for use, please contact your supplier in the interest of your own safety. The instructions for use should be made available to all users of the equipment. Any work carried out on the luminaire must be done so by a qualified person. Never place any additional loads on the lamp head; this may cause damage to the supporting arms. Never look directly into the light source there is a danger of eye damage. Modifications should never to be made for any reason. Any modifications made to the system will void the warranty. The contents of the instructions for use are subjected to change without notice. Do not use in oxygen-enriched atmospheres.
2.4
Warnings No Modification of the equipment is allowed! Do not modify the equipment without authorisation of the manufacturer! If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of the equipment!
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3
Technical data
3.1
Models covered
Model
Approx. weight
Astramax Mobile model
20 kg Table 6
3.2
Classification
The classifications are explained in the following table. Classification
Description
Electrical classification
Class 1
Classification according to EU Medical Device Directive 93/42/EEC
Class 1
Lamp head degree of protection from ingress of dust and water
IPX0
Degree of protection against the presence of flammable anaesthetic mixtures
Not for use in a flammable atmosphere
Oxygen-enriched atmospheres
Do not use in oxygen-enriched atmospheres.
Table 7
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3.3
Environmental
The environmental conditions relating to transportation and storage.
-40oC to 70oC
10% to 95% non-condensing
500hPa to 1060hPa
Table 8
The environmental conditions relating to operating are explained in the following table.
15oC to 30oC
10% to 80% non-condensing
700hPa to 1060hPa
Table 9
3.4
Technical Information
On request circuit diagrams, component part lists and drawings will be made available to suitably tanned service personnel to assist will the maintenance of the equipment.
Page 13 of 36
3.5
Specification
Number of light sources Type of light source Colour Rendition Ra (Av R1-R8) Colour Rendition R9 (red) Colour Temperature LED Life Adjustable Colour (Red Balance) Light Intensity Radiant Energy Solid State Focusing Power Consumption at full power Field Size D10 @ 1 meter Normal Working Distance Shadow-less Light Technique On/Off Switch Intensity Control
Lighting Details 13 High Definition LED (HD-LED) 95 98 4,300 >40,000 hours 3500º to 5000º Kelvin 140,000 Lux @ 1 meter 3.31 W/m2 /Klux Via Central Sterilised Handle <50 Watts 310 to 140mm (variable) 600mm - 1,400mm Multiple LED elements Control Module on Lamp arm Control Module on Lamp arm Table 10
Supply Voltage Power Electrical Classification EU Conformance CE Safety Approval
Electrical Details 100-240VAC Fused Via 5A Type T < 49 VA I 93/42/EEC BS EN 60601-1 Table 11
Page 14 of 36
Fig 1
Mechanical Details Light sources mounted in a self-coloured polycarbonate pod assembly. Fixed to a ceiling mounted suspension system. Nominal working distance 1 metre from light head Rotational about column spindle Unlimited 30° either side of centreline Lamp head roll rotation Unlimited 360° Lamp head pitch rotation 290 Height Adjustment Up from Horizontal 747mm / 45 Height Adjustment Down from Horizontal 691mm / 45 Removable Sterilisable Handles Sterilisable at 134C Weight of fitting 20 Kg Total Arm Radius (Reach) 1017mm Colour of Suspension Arms White RAL 9010 Table 12
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4
Electrical Installation
Note, assembly should only be carried out by a suitably qualified general electrician.
This model comes pre-wired with a mains plug.
Page 16 of 36
5
Mechanical Assembly
Unpack the boxes and check that all the parts listed in the following table are present. Box
Quantity
Contents/Quantity
Lamp Head box
1 1
Lamp head with yoke arm Handle assembly
Column and Spring Arm box
1 1
Column Spring arm
Base box
1 2 2 1
Base Brake Casters Standard Casters Handle assembly Table 13
Examine all the parts carefully for any damage in transit. Report any damaged or missing items to the supplier within 5 working days.
5.1
Fitting the Casters
Fit the two casters with brakes into the front legs of the base.
Fit the remaining casters into the rear legs of the base. Ensure all the casters are fully inserted.
Brake Caster
Fig 2
Page 17 of 36
5.2
Fitting the Column
Unscrew and remove the switch nut.
Remove the fuse holder by pushing down the tab and withdrawing.
Unscrew 4 retaining screws from the underside of the base using the Allen key provided and carefully lift the cover clear. Switch Nut Cover
Retaining Screw Push Down
4 Places
& Withdraw
Fig 3
Cover
M3 Locating Screw
Fig 4
On the column, remove and retain the M3 Locating Screw using the Allen key provided.
Slide on the cover past the M3 screw hole then refit the screw trapping the cover at the top of the column.
Using needle nose pliers, pull the connector and approximately one inch of cable through the oval slot at the bottom of the column.
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Attachment bar
M8 Socket Screws & Washers
Fig 5
Fig 6
Remove the two M8 Socket screws & Attachment Bar from the base using the Allen Key provided.
Insert the column into the base boss with oval slot facing forward.
Fig 7
Fig 8
Push the Attachment Bar through the side slots in the column and then align it with the two holes. See fig 7
Refit the two M8 Allen screws and washers then tighten until secure.
M3 Allen Screw
Fig 9
Remove the two screws and separate the parts of the handle.
Position the small part of the handle on the post with the hole placed over the M3 Allen screw. Ensure the curved portion faces up, and the hole is placed over the M3 Allen screw.
Align the large part with the small part and fit together using the two screws provided.
Note: do not over tighten. A small gap between the two parts should be visible.
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5.3
Fitting the Spring Arm
The spring arm comes as a separate part within the column box. Remove the spring arm from the packaging. Cover
Circlip Flat Washer
M4 Allen Screw
Fig 10
Fig 11
Remove the two halves of the cover by gently prying apart.
Remove the M4 Allen screw and lock washer ensuring that the flat washer stays in position.
Offer up the spring arm to the column then join the spring arm connector to the Column connector by pushing firmly together.
M4 Allen Screw & Lock Washer
Fig 12
Insert the spring arm shaft into the Column, turn until the hole is visible then Refit the M4 Allen screw and lock washer.
Refit the cover halves; one at a time.
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