Technical Manual
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BLUELINE Ceiling, wall-mounted or mobile surgical light
Technical manual EN
BLUELINE NT 0136201 EN Ed1A
01/08
Ceiling, wall-mounted or mobile mobile surgical surgical lighting light
BLUELINE CONTENTS
QUALITY STANDARDS COMPLIANCE...3 Symbols used in these instructions...4 1
General characteristics...5
2
Cleaning / disinfection / sterilisation...6 2.1 Cleaning and disinfecting the surgical light...6 2.2 Cleaning and sterilising the handles...6
3
General maintenance...8 3.1 Preventive maintenance...8 3.2 First level maintenance...8 3.3 Changing the bulb...11 3.4 Adjusting the balance...15 3.5 Adjusting the top limit stop of the BLUE 80 lighthead 3.6 Adjusting the lighthead brake...17 3.7 Removing and installing the BLUE 30 lighthead...19 3.8 Removing and installing the BLUE 80 lighthead...21 3.9 Checking the BLUE 30/80 HOSPITAL...22
4
Maintenance procedures...24 4.1 BLUE 30...24 4.2 BLUE 80...27
5
Spare parts and maintenance kits...34 5.1 BLUE 30...34 5.2 BLUE 80...36
6
Electrical installation...38 6.1 Suggested electrical installation...38 6.2 Ceiling-mounted BLUE 30 . ...40 6.3 Ceiling-mounted BLUE 80 . ...41 6.4 BLUE 30 MOBILE...42 6.5 BLUE 80 MOBILE...43 6.6 BLUE 30 HOSPITAL...44 6.7 BLUE 80 HOSPITAL...45
7
Diagrams and parts lists...47 7.1 Ceiling-mounted BLUELINE...47 7.2 Wall-mounted BLUELINE...67 7.3 BLUELINE MOBILE...79 7.4 BLUELINE HOSPITAL...87 7.5 Lightheads...99 7.6 Power supply boxes...105
8
2
TROUBLESHOOTING...111
0136201
Technical manual
Ceiling, wall-mounted or mobile surgical light
BLUELINE
Quality standards compliance Certification of MAQUET SA’s quality system LNE/G-MED certifies that the quality system developed by MAQUET SA for design, implementation, sales, installation and after-sales service of surgical lights complies with the requirements of the following international standards: • ISO 9001:2000 • NF EN ISO 13485:2004 Reference standards The BLUE 30/80 surgical light was designed to comply with the following standards: • EN ISO 14971:2000
Medical devices - Application of risk management to medical devices (ISO 14971:2000)
• EN ISO 14971:2000/A1:2003 • EN 60601-1:1990 Medical electrical equipment - Part 1: General requirements for safety Amendment A1:1993 to EN 60601-1:1990 Amendment A2:1995 to EN 60601-1:1990 Amendment A13:1996 to EN 60601-1:1990 • EN 60601-1-2:2001
Medical electrical equipment - Part 1-2: General requirements for safety Collateral standard: Electromagnetic compatibility - Requirements and tests
• EN 60601-1-4:1996
Medical electrical equipment - Part 1-4: General requirements for safety Collateral standard: Programmable electrical medical systems Amendment A1:1999 to EN 60601-1-4:1996
• EN 60601-1-6:2004
Medical electrical equipment - Part 1-6: General requirements for safety Collateral standard: Usability
• EN 60601-2-41:2000
Medical electrical equipment - Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosis
This product has been verified for compliance with the following additional standards: CAN/CSA-C22.2 No. 601.1-M90 (R2005) (includes national differences for Canada), EN 60601-1:1990 + A1:1993 + A2:1995 + A13:1996, UL 60601-1, first edition, 2006-04-26 (includes national differences for the USA). This product only meets FCC/UL requirements when equipped with a MAQUET SA power supply. CE labelling/intended use Compliance with the requirements of Directive 93/42/EEC on medical devices has been assessed and approved by LNE/G-MED. BLUE 30/80 surgical lights belong to Class I as described in Annex IX of Directive 93/42/EEC. This range includes single or dual ceiling-mounted, single wall-mounted and mobile light units with or without battery-backed power supply.
Technical manual
0136201
3
Ceiling, wall-mounted or mobile surgical light
BLUELINE symbols used in the manual Symbol
Meaning Mandatory: may affect patient or user safety
F
Recommendation: risk of damage to device or accessories CE mark: The device complies with the requirements of European Directive 93/42/EEC on Medical Devices. This device complies with Canadian and US safety requirements.
4
0136201
Technical manual
Ceiling, wall-mounted or mobile surgical light
1
BLUELINE
General characteristics
(In accordance with standard IEC 60 601-2-41)
Specifications
Unit
BLUE 30
BLUE 80
Nominal illumination*
lx +/- 10%
35,000
90,000
Nominal voltage
V DC
22.8
22.8
Maximum power
W
40
80
K
4600
4600
>85
>85
Colour temperature
+/-6%
Colour rendering index cm (inch)
175 (69)
140 (67)
Diameter d10
cm (inch) +/- 10%
17 (6.7)
16 (6.3)
Diameter d50
cm (inch) +/- 10%
10 (3.9)
10 (3.9)
With one mask
%
0%
6%
With two masks
%
62%
49 %
At base of tube
%
100 %
100 %
With one mask, at base of tube
%
0%
6%
With two masks, at base of tube
%
62 %
49 %
W/m2
140
360
Shadow dilution
Illumination depth
Irradiance (Ee)* * Values measured during certification:
BLUE 30: 38.400 lx / 139 W/m2 BLUE 80: 85.500 lx / 305 W/m2
Technical manual
0136201
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Ceiling, wall-mounted or mobile surgical light
BLUELINE 2
Cleaning / disinfection / sterilisation
Users must contact their hospital's sanitary specialists. The recommended products and procedures must be applied. Should there be any doubt concerning the compatibility of active agents to be used, contact the local Maquet customer service department.
2.1
F 2.1.1 • • • • • •
Cleaning and disinfecting the surgical light Check that the power is switched off and the light is cool before cleaning. General instructions concerning cleaning, disinfection and safety
Remove the sterilisable handles. Clean the system using a cloth soaked in surface detergent, in line with the manufacturer's recommended dilution, application time and temperature. Use a cloth to rinse the unit with clean water and wipe dry. Disinfect uniformly using a cloth soaked in a disinfectant, in line with the manufacturer’s recommendations. Use a cloth to rinse with clean water in order to remove residues (in particular products containing aldehydes, quaternary ammonium or surfactants). Wipe with a dry cloth.
2.1.2 Examples of recommended products Getinge USA product: TEC-QUAT 256 Anios products: SURFA’SAFE, 0.5% HEXANIOS G + R (ammonium IV, polyhexanide); ANIOSYME P.L.A (quaternary ammonium, enzymes); SALVANIOS pH10 (quaternary ammonium, guanidinium); ANIOS DDSH (quaternary ammonium, guanidinium). Schülke & Mayr products: Antifect Plus (Glyoxal), Terralin (Benzyl-C12-18-alkyldimethyl ammonium, phenoxypropan and phenoxypropanol). 2.1.3
F
Examples of prohibited products 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.
2.2
Cleaning and sterilising the handles
2.2.1
Before cleaning
•
Use a soft cloth immediately after use to wipe away soiling from the handle surface.
•
Store handles in a place that keeps them moist to make further cleaning easier.
•
Take care to store them in such a way that the inside does not get soiled.
2.2.2 Cleaning • Soak the handles in a detergent solution.1 •
Soak for 15 minutes to allow the solution to act, then clean by hand with a soft brush and a lint-free cloth.
•
During cleaning, check regularly that the handles are fully clean and that no soiling remains on the inside or outside. If any soiling remains, repeat cleaning or use an ultrasonic cleaning process. Rinsing: Rinse thoroughly in clean water to completely eliminate the detergent solution. Drying: Wipe with a clean lint-free cloth.
• • • 1
6
Never soak the handles in enzyme-based detergents as they may damage the material used; rinse thoroughly if these detergents are used.
0136201
Technical manual
Ceiling, wall-mounted or mobile surgical light
2.2.3
BLUELINE
Washing and disinfection
Handles may be disinfected by machine (Clean Maquet) and rinsed at a maximum temperature of 93°C. Typical recommended cycles: 2.2.4
Sterilisation
Step
Temperature
Time
Pre-wash
18 - 35°C
60 sec
Wash
46 - 50°C
300 sec
Neutralisation
41 - 43°C
30 sec
Wash 2
24 - 28°C
30 sec
Rinse
92 - 93°C
600 sec
Dry
20 min
After cleaning, the handles must be steam sterilised as set out below: Countries
Sterilisation cycle
Temperature [°C]
Time [min]
Drying [min] 16
USA & Canada
Prevacuum2
132 - 135
10
France
ATNC (Prion) (Prevacuum)
134
18
Other countries
Prevacuum
Comply with national regulations
• •
Check that each handle is clean before continuing the process. Wrap the handles with sterilisation wrapper material (double wrapper or equivalent). Handles may also be placed in paper or plastic sterilisation bags3, for easier identification and reuse. Place the handles on steriliser trays with the opening downwards.4 Package with biological and/or chemical indicators for monitoring the sterilisation process, in accordance with applicable regulations. Run the sterilisation cycle according to the steriliser manufacturer's instructions. To ensure correct sterilisation do not allow any soiling to penetrate inside the handle. Handles are not guaranteed beyond 350 sterilisation cycles with the above sterilisation parameters. Dispose of sterilisable handles in the same way as other hazardous products in a hospital environment.
• • •
F F •
2
This handle is made of a porous material.
3
Possible sterilisation bag suppliers: Medical Action Industries SBW Medical Baxter International
4
For air removal and faster drying.
Technical manual
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Ceiling, wall-mounted or mobile surgical light
BLUELINE 3
General maintenance Isolate the surgical light from all electrical power sources and/or check that it is connected to an isolating transformer at very low voltage. If the spring arm is not disabled when dismantling the lighthead, the arm may spring up abruptly and present a hazard. The first step is therefore to disable the spring arm. The light unit becomes hot during operation. Allow it to cool down before any maintenance or repair work.
3.1
Preventive maintenance
To preserve your surgical light’s original performance and reliability, annual maintenance and inspections should be performed as follows: • By a Maquet technician or Maquet-approved distributor during the guarantee period. • By a Maquet technician or Maquet-approved distributor or by the hospital's technical maintenance department outside the guarantee period (contact your dealer to arrange the required technical training).
3.2 First level maintenance 3.2.1 Daily inspection (user) • Check that the bulbs operate correctly. •
Check that the sterilisable handle locks correctly in place, and replace it if not.
•
Check the arm position.
•
If a backup power supply is installed, check that the light would operate correctly if a power cut were to occur.
•
Check the overall condition of the unit: paintwork in good condition, screws fastened tightly, bezels and covers in position.
3.2.2 Annual inspection (must be performed by an authorised technician) • Check that the limit stops are in place and in good condition. •
Check and tighten the brakes.
•
Check the bulb holder and replace if necessary.
•
Check that the lighthead limit stops are in place and in good condition.
•
For the BLUE HOSPITAL, check the battery autonomy and the backup supply changeover system (see section 5.4).
•
Check that the underside is in good condition and replace it if necessary.
Safety items Check the following points: •
Attachment screws on suspension tube correctly tightened, seals in position.
•
Arm(s) correctly mounted.
•
All covers and caps installed.
Other checks • Nominal illumination: see technical data. •
Earth continuity: 0.1 Ohm maximum.
•
Suspension tube vertical.
•
Balancing system adjusted correctly.
•
Sterilisable handle locking mechanism.
•
Voltage.
8
0136201
Technical manual
Ceiling, wall-mounted or mobile surgical light
BLUELINE
Dismantling certain elements may affect operation and safety. For example: • Servicing the electrical power supply. • Servicing the suspension arm and balance system. • Servicing the optical system of lightheads equipped with filters designed to eliminate radiation not visible to the patient. Surgical lights must never be used without these filters. Contact the authorised Maquet after-sales service department for this type of inspection.
Technical manual
0136201
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Ceiling, wall-mounted or mobile surgical light
BLUELINE BLUE 30 2
1
Figure 2
Figure 1
3
4
Figure 3
Figure 4
Figure 5
Figure 6
Figure 7
10
0136201
Technical manual
Ceiling, wall-mounted or mobile surgical light
3.3
BLUELINE
Changing the bulb
BLUE 30 lighthead When changing a blown bulb: • Switch off the power supply and leave the lighthead to cool for 25 minutes. • Only use MAQUET bulbs. • Handle bulbs carefully through a cloth or wearing gloves. • Never touch bulbs with bare hands. Grease on bulbs can shorten their life. Do not change bulbs during an operation.
The unit is designed to operate with the cover closed. When conducting maintenance, take precautions to avoid touching surfaces marked as hot with the following symbol:
F
To avoid failures during operations, we recommend changing the bulbs on a preventive basis every 600 hours.
Figures 1 and 2 •
Press the locking tab (1) and raise the casing of the failed bulb (2).
Figure 3 •
Remove the bulb holder (3), taking care not to knock the hot bulb against any surfaces.
Figure 4 •
Take the failed bulb (4) and remove it from the holder.
•
Take the new bulb and remove it from its packaging.
Figure 5 •
Insert the bulb pins into the bulb holder as far as they can go.
•
Check that the bulb is correctly seated.
F
If the bulb cannot be inserted fully, do not force it beyond the limit stop.
Figure 6 •
Replace the bulb holder (3) and check that the locking tab clicks audibly into place.
Figure 7 •
Close the cover and check that the locking tab clicks audibly into place.
F
Check that the cover is correctly in place.
Technical manual
0136201
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Ceiling, wall-mounted or mobile surgical light
BLUELINE BLUE 80
1
1
Figure 1
Figure 2
1
4
3
Spare bulb
Main bulb
Figure 3
2
Figure 4
5
Figure 5
Figure 6
1
2 1
Figure 8
Figure 7
12
0136201
Technical manual
Ceiling, wall-mounted or mobile surgical light
BLUELINE
BLUE 80 lighthead When changing a blown bulb: • Switch off the power supply and leave the lighthead to cool for 20 minutes. • Only use MAQUET bulbs. • Handle bulbs carefully through a cloth or wearing gloves. • Never touch bulbs with bare hands. Grease on bulbs can shorten their life. Do not change bulbs during an operation.
The unit is designed to operate with the cover closed. When conducting maintenance, take precautions to avoid touching surfaces marked as hot with the following symbol:
F
To avoid failures during operations, we recommend changing the main and spare bulbs on a preventive basis every 750 hours. The yellow indicator on the underside of the BLUE 80 lighthead is lit if the spare bulb is activated. To avoid a total failure of the surgical light, change the main bulb as soon as possible. We recommended changing the spare bulb at the same time.
Figures 1 and 2 •
Push the cover in slightly (1) and slide it sideways.
Figures 3 and 4 •
First remove the main bulb holder (3), then the spare bulb holder (4), taking care not to knock the hot bulb against any surfaces.
Figure 5 •
Take the failed bulb (5) and remove it from the holder.
•
Take the new bulb and remove it from its packaging.
•
Insert the bulb pins into the bulb holder as far as they can go.
F
If the bulb cannot be inserted fully, do not force it beyond the limit stop.
Figure 6 •
Check that the bulb is correctly seated.
Figure 7 •
Replace the spare bulb holder first, then the main bulb holder, checking that the locking tab clicks audibly into place in each case.
Figure 8 •
Close the cover (1) and check that it is correctly in place.
Technical manual
0136201
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Ceiling, wall-mounted or mobile surgical light
BLUELINE
2
1
3
Figure 33 1
Bezel on mobile arm of spring arm
2
Bezel on fixed arm of spring arm
3
Adjustment nut
1
2
Figure 34 1
Bezel on mobile arm of spring arm
2
Set screw
14
0136201
Technical manual
Ceiling, wall-mounted or mobile surgical light
3.4
BLUELINE
Adjusting the balance
Figure 33
F
If the spring arm does not remain steady in all positions, the force of the spring in the arm can be increased or decreased.
•
Remove the bezel from the mobile arm of the spring arm (1) and, for the BLUE 80, the bezel from the fixed arm (2).
•
Turn the adjustment nut (3) by no more than half a turn, holding the hexagon socket screw on the opposite side in position for the BLUE 80. • If the lighthead goes down, turn to the right. • If the lighthead goes up, turn to the left.
•
Check that the spring arm remains steady in each position.
•
Replace the bezel(s).
3.5
Adjusting the lighthead top limit stop BLUE 80
Figure 34
F
BLUE 80 lightheads can be adjusted so that the travel cannot exceed the ceiling height.
•
Carefully remove the bezel from the mobile arm of the spring arm (1).
•
Position the lighthead at the maximum desired height. The spring arm may be damaged if the socket screws are not tightened evenly. Tighten the socket screws uniformly.
•
Tighten the two socket screws (2) until resistance is felt.
Technical manual
0136201
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Ceiling, wall-mounted or mobile surgical light
BLUELINE BLUE 30
1 2 3
Figure 35 1
Locking tab
2
Brake screw
3
Retaining screw (do not loosen)
BLUE 80
1
2
Figure 36 1
Brake screw
2
Lighthead fork
16
0136201
Technical manual
Ceiling, wall-mounted or mobile surgical light
3.6
BLUELINE
Adjusting the lighthead brake The lighthead brakes are adjusted during installation. Brakes, like all mechanical parts, are subject to wear. If the lighthead no longer remains steady in all positions the brake must be readjusted. The light unit becomes hot during operation. Allow it to cool down before adjusting the brake.
BLUE 30 lighthead Figure 35 •
Turn off the BLUE 30 lighthead and allow it to cool down.
•
Press the locking tab (1) to remove the bezel.
•
Adjust the lighthead braking by tightening or loosening the brake screw (2). The retaining screw (3) holds the lighthead in place and must not be loosened.
•
Close the cover and check that the locking tab clicks audibly into place.
•
Check that the cover is correctly in place.
BLUE 80 lighthead Figure 36 •
Turn off the BLUE 80 lighthead and allow it to cool down.
•
Adjust the lighthead braking by tightening or loosening the brake screw (1) above the lighthead fork (2).
Technical manual
0136201
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Ceiling, wall-mounted or mobile surgical light
BLUELINE
2
3
1
Figure 4
4
2
5
6
7
Figure 5
18
0136201
Technical manual
Ceiling, wall-mounted or mobile surgical light
3.7
BLUELINE
Removing and installing the BLUE 80 lighthead If the spring arm is not disabled when removing the lighthead, the arm may spring up abruptly and present a hazard. • Lower the spring arm and lock it in a safe position when installing the lighthead. • Assemble in the correct order: first install the lighthead then enable the arm. • Place the arm in the topmost position when removing the lighthead. • Keep clear of the spring arm when enabling it.
Removing the BLUE 30 lighthead Figure 4 •
Place the spring arm (2) in the top position.
•
Remove the two taper-head hex socket screws (1) to disable the spring arm.
Figure 5
F
The hex socket screw (5) is a safety screw* that must be replaced each time the unit is reassembled.
•
Unscrew the hexagon socket screw (5).
•
Unscrew the brake screw (7).
•
Remove the fork (6) from the spring arm and separate the connectors (4).
Reinstalling the BLUE 30 lighthead Figure 4
F •
The spring arm must be disabled before installing the BLUE 30 lighthead.
To disable the spring arm, unscrew the two taper-head hex socket screws (1).
Figure 5 •
Secure the connectors (4).
F
The hex socket screw (5) is a safety screw that must be replaced each time the unit is reassembled.
•
Insert the fork (6) in the spring arm (2) such that the hole in the spring arm lines up with the hole in the fork.
•
Lock the fork in place with the hex socket safety screw (5).
•
Use a flat screwdriver to tighten the brake screw (7).
Figure 4 •
To enable the spring arm, tilt the lighthead and spring arm (2) upwards until the holes (3) line up with the tappings (3).
•
Install the two taper-head hex socket screws (1).
*
Safety screws are available in packs of 5 (3 690 51 555).
Technical manual
0136201
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Ceiling, wall-mounted or mobile surgical light
BLUELINE
1
2
4
3
Figure 9
8
2
5
6
7
Figure 10
20
0136201
Technical manual