English instructions

Transcription

Dr. Mach
Soloflex Ceiling, Wall, Stand Model
Lamps and Engineering
Directions for use
SOLOFLEX
Stand lamp – one-handed height adjustment ______ Order No. 1281 3011 00
Stand lamp - swivel arm _______________________ Order No. 1281 3012 00
Wall lamp ___________________________________ Order No. 1281 3021 00
Ceiling lamp for room heights up to 2,50m ________ Order No. 1281 3031 24
Ceiling lamp for room heights between
2,51m and 3,0m ______________________________ Order No. 1281 3031 30
Ceiling lamp - combinations
Dr. Mach GmbH u. Co., Flossmannstrasse 28, D-85560 Ebersberg
Tel.: +49 (0)8092 2093 0, Fax +49 (0)8092 2093 50
Internet: www.dr-mach.com, E-mail: info@dr-mach.de
59070001
Edition 06
04.03.2005 / Bak Page 1/22
Dr. Mach
List of contents
1.
Safety instructions ............................................................................................ Page 3
2.
Operating the lamp Soloflex ............................................................................. Page 4
2.1 ON/OFF switch, light intensity control ........................................................ Page 4
2.2 Positioning.................................................................................................. Page 4
2.3 Light field adjustment (focusing)................................................................. Page 5
3.
Cleaning ........................................................................................................... Page 6
3.1 Sterilizable handle ...................................................................................... Page 6
3.2 Lamp head, splinter protection disk............................................................ Page 8
4.
Maintenance..................................................................................................... Page 9
4.1 Adjustments at the ceiling / wall attachment .............................................. Page 9
4.2 Adjustments at the stand............................................................................ Page 9
4.3 Adjustments at the lamp head.................................................................... Page 10
4.4 Changing of spare parts ............................................................................. Page 11
4.4.1 Changing the halogen bulbs ................................................................. Page 11
4.4.2 Changing the fuses (230V; 120V) ......................................................... Page 12
4.4.3 Changing the filter disk ......................................................................... Page 13
4.4.5 Changing the splinter protection disk .................................................... Page 13
4.4.6 Conversion to sterilizable handle .......................................................... Page 14
5.
Data.................................................................................................................. Page 15
5.1 Technical data ............................................................................................ Page 15
5.2 Environmental conditions ........................................................................... Page 16
6.
Characteristics.................................................................................................. Page 16
6.1 Specification of bulb ................................................................................... Page 16
6.2 Specification of fuse ................................................................................... Page 16
6.3 CE-mark ..................................................................................................... Page 17
7.
Disposal............................................................................................................ Page 17
8.
Spare parts....................................................................................................... Page 18
8.1 Soloflex 230V/120V built in toroid transformer ........................................... Page 18
8.2 Soloflex 22,8V external transformer ........................................................... Page 19
8.3 Short arm (stand model)............................................................................. Page 19
8.4 Swivel arm (stand model)........................................................................... Page 19
9.
Spare part list .................................................................................................. Page 20
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Dr. Mach
Dear customer!
Please read the safety instructions and the directions for use carefully before handling the lamp.
Pay attention to the special mounting instructions for ceiling and wall lights.
1. Safety instructions
Please pay attention to the directions for use when handling the lamp.
Attention:
This device is not suitable for use in hazardous locations.
According to the Medical Device Regulation the lamp is classified under class I.
Repairs to the lamp and special installation work on the reflector or plug-in socket
should only be carried out by ourselves or a company expressly authorised by ourselves.
The manufacturer is only responsible for the safety of the lamp if repairs and alterations have been carried out by themselves or a company who can guarantee that the
safety regulations have been observed.
The manufacturer is not liable for personal or material damages if the lamp is misappropriately or incorrectly operated or misused.
The lamp body may only be dismantled from the swivel arm (in reverse order to its assembly) after the assembly locking device has been inserted and tightened since the
arm is under spring tension.
Make sure that the lamp is in perfect working order before every use.
The lamps Soloflex may not be used without the dielectric filter disk.
The dielectric filter disk (blue) between reflector and splinter protection disk prevents
a damaging heating of the illuminated area.
59070001
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04.03.2005 / Bak Page 3/22
Dr. Mach
2. Operating the lamp Soloflex
All Dr. Mach Soloflex lamps are supplied with focusable light filed size and integrated dielectric filter
disk.
The reflector is adapted to the dielectric filter disk.
The lamps are available as:
• Soloflex 22,8V / external transformer
• Soloflex 120V / integrated toroid transformer
• Soloflex 230V / integrated toroid transformer
2.1 ON/OFF switch,
light intensity control
The rocker switch 1 switches the lamp on and off.
1
2
The lamps with integrated toroid transformer are
supplied with an additional rocker switch 2. The
switch 2 adjusts the light intensity from bright to
dark.
At lamps with external transformer, in addition to
the rocker switch 1, a two-pole switch ON/OFF
must be provided by the customer.
After finishing the work, and especially in the evening, both ON/OFF switches must be OFF.
1
2.2 Positioning
Use the handle 3 to position the lamp.
6
5
3
59070001
There are two handle types available:
• Standard handle 3
The standard handle can be removed.
• Sterilizable handle 4
The sterilizable handle can be removed for sterilisation. It is fixed to the handle bar 6 by the
coupling 5.
4
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Dr. Mach
7
2.3 Light field adjustment (focusing)
All Soloflex-lamps have a focusing function. That
means, you can either enlarge the diameter of the
light field or bundle the light to a smaller area, depending on the circumstances.
To activate the function of focusing, turn the control
knob 7 on the upper part of the lamp housing.
59070001
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Dr. Mach
3. Cleaning
3.1 Sterilisable handle
V
The removable handles for Soloflex lamps are
steam-sterilisable and must be cleaned, disinfected
and sterilised before first and subsequent use.
The handle must be removed for sterilisation:
• to remove, press latch 1 and pull down the sterilisable handle 4 while the latch is pressed;
• to attach, push on and slightly twist the handle
until the latch 1 engages securely.
4
Handles often become unsterile during an OP; therefore always keep additional handles available for
exchange.
Cleaning / disinfection and sterilisation
4
59070001
Basics
Efficient cleaning/disinfection is an essential requirement for effective sterilisation of the handle.
Within the scope of responsibility for the sterility of
the products it should be noted that only sufficiently
validated equipment and product specific processes
are used for cleaning/disinfection and that the validated parameters are complied with in every cycle.
In addition, the hospital/clinic hygiene regulations
must be observed.
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Dr. Mach
Cleaning/disinfection
Cleaning and disinfection must be carried out immediately after use.
A mechanised process (disinfector) should be used for cleaning/disinfection. The efficiency of the process
used must be recognised and validated in principle (e.g. listed under disinfectants and disinfection procedures tested and recognised by Robert Koch-Institut/DGHM).
When using other procedures (e.g. a manual procedure), proof of process efficiency in principle must be
provided within the scope of validation.
Proof in principle of the suitability of the handles for efficient cleaning/disinfection was provided using a
cyclic cleaning system (Netsch-Bellmed T-600-IUDT/AN, Programme 2 for Small Parts; Code B).
No cleaning agents/disinfectants must be used, which contain the following substances, as these may
cause changes in the material:
• high-concentration organic and inorganic acids
• chlorinated hydrocarbons
• 2-ethoxyethanol
When cleaning/disinfecting, the following procedures must be followed:
Process
Time (sec.)
Zone 1
Pre-rinse, external, cold, 10 – 15°C
Washing, acidic, external, 35°C
Draining time
Re-rinse, external, ca. 80°C
Draining time
Re-rinse, external, ca. 80°C
Draining time
45
120
10
*10
*15
*15
15
Zone 2
Washing, alkaline, external, 93°C
Draining time
Re-rinse, external, acidic, 90°C
Draining time
Re-rinse, external, 90°C
Draining time
135
10
10
15
15
15
Zone 3
Drying, external, 100 – 120°C
200
Zone 4
Drying, external, 100 – 120°C
200
Door open/close & transport
(sluice discharge)
60
Cycle time overall ca.
290
≈ 5 minutes
* When occupying the disinfection zone (Washing Zone 2), the re-rinse and draining times will depend
on the respective objects being washed therein!
Sterilisation
Only previously cleaned and disinfected handles may be sterilised.
The handles are placed in a suitable sterilisation pack (one-way sterilisation pack, e.g. foil/paper sterilisation bags, single or double pack) in accordance with DIN EN 868/ISO 11607 for steam sterilisation and
are ten sterilised.
Use only the sterilisation procedure listed below for sterilisation. Other sterilisation procedures (e.g. ethylene oxide, formaldehyde and low-temperature plasma sterilisation) are not permissible.
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Dr. Mach
•
Steam sterilisation procedure
Validated in accordance with DIN EN 554/ISO 11134
Maximum sterilisation temperature 134°C
Proof in principle of the handles’ suitability for effective sterilisation was provided using a fractional vacuum process (Euroselectomat 666 by MMM Münchner Medizin Mechanik GmbH, sterilising temperature
134°C, holding time 7 min).
When using other sterilisation procedures, proof of suitability and effectiveness in principle of the process
must be provided within the scope of validation.
Inspection/durability
The handles should be inspected for damage and changed before re-use, if required.
The handles may be cleaned/disinfected, sterilised and re-used for a maximum of 1000 times. If respiration hoses are re-used more than 1000 times, then this will be the responsibility of the hospital/clinic.
3.2 Lamp head,
splinter protection disk
The lamp has a high quality surface, which can be
cleaned with conventional cleaning agents.
The splinter protection disk 8 is made of a highquality plastic. Pay attention to the following during
cleaning:
Wipe over the splinter protection disk 8 with a
wet cloth (never use a dry cloth!).
Only use disinfectant with less than 20% alcohol.
8
Wipe the splinter protection disk 8 after cleaning
with an antistatic, non-fluffy cloth.
Alc. ≤ 20 %
59070001
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Dr. Mach
4. Maintenance
The lamp has been designed and built so that regular maintenance intervals are not necessary.
In order to keep the system easy running throughout its life span we recommend that the hinges be
greased once a year with an acid-free grease.
4.1 Adjustments at the ceiling /
wall attachment
Hole 1
♦ Adjusting the spring arm
Note:
Maximum additional load at spring arms: Spring
arms are equipped with different springs to compensate the lamp / device weight.
To adjust the spring force make sure that the spring
arm with the lamp / device can come to rest in any
desired position.
•
•
•
2
A hole 1 is located at the position marked by
detail X.
Position the spring arm 2 with the lamp / device
approximately 10° above horizontal.
Insert Allan key (width 5, included in the scope of
supply) into the hole 1.
If the spring arm drops, the spring force is too low:
Rotate the adjustment screw to the left (counter
clockwise) in the + direction.
-
10°
X
If the spring arm rises, the spring force is too high:
Rotate the adjustment screw to the right (clockwise) in the - direction.
-
1
-
+
If the spring arm with the lamp / device cannot
come to rest in any desired position after the
spring force has been adjusted, the springs must
be replaced by a service technician.
Width 5
10
4.2 Adjustments at the stand
♦ Swivel arm
11
59070001
You can fasten the move of the swivel arm 10 by
adjusting lever 11.
Edition 06
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Dr. Mach
♦ Adjusting the brake pins
G
13
Push the sliding sleeve 12 backwards as shown in
the figure, by pressing the element G upwards with a
screwdriver.
Tighten the brake pins 13 M4 using a screwdriver
(turn clockwise).
12
♦ One-handed height adjustment
It is usually not necessary to adjust the spring force
at stands with one-handed height adjustment.
Stand for Mach 120 / 120F, Mach 115 and
Makrolux (∅ 13,8mm)
An adjustment of the spring force is not possible.
II
Stand for Mach 130 / 130F and Soloflex –
design with short arm (∅ 22,8mm)
AR
• Push the extension tube AR into the stand tube
SR to the stop (I).
• Insert a screwdriver into the extension tube AR
(II).
• Turn the screw inside the extension tube AR very
carefully.
A slight turn of the screw may change the
height adjustment.
I
SR
4.3 Adjustments at the lamp head
14
♦ Manipulating the lamp
The lamp bow 14 enables a perfect movability and
positioning of the Soloflex lamps.
The brake force in the axis 15 is set. It is usually not
necessary to adjust it.
15
59070001
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Dr. Mach
4.4. Changing of spare parts
4.4.1 Changing the halogen bulb
Dr. Mach uses special halogen bulbs as illuminants.
Only original Dr. Mach replacement bulbs should be
used.
The use of other bulbs can lead to a considerable
reduction of the light power and increase in the
thermal load.
17
19
X
16
To change the halogen bulb proceed as follows:
• Loosen the knurled screw 16 on the side of the
upper part of the lamp housing 17.
• Remove the lower part of the lamp housing 18.
• Draw halogen bulb 19 (22,8-24V/ 40W) carefully off its socket.
• Put in the new halogen bulb.
• Fix the lower part of the lamp housing 18 to the
upper part of the lamp housing 17 using knurled
screw 16.
Do not touch the halogen bulb with naked
hands.
Remove stains with a clean cloth and alcohol since
otherwise these can burn into the glass and lead to
early failures.
Remark:
18
The halogen bulbs have a service life of approx. 1200 hours without any deterioration in
their luminosity.
Einzelheit X
16
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Dr. Mach
4.4.2 Changing the fuses
The fuses in the lamp housing (models with built in
transformer only) prevent the transformer burning
through in the event of a short circuit.
Vsible type 5x20/0,63A/250V/t for 230V
Visible type 5x20/1,25A/250V/t for 120V
If the bulb is no longer on, check the bulb first, then
the fuses.
31
To change the fuses proceed as follows:
• Turn the black fuse holder 31 ¼ of a rotation
anticlockwise with a screwdriver and remove.
• Change the fuses.
• Insert the fuse holder 31 under light pressure
and rotate in a clockwise direction (bayonet
catch).
In case of designs with external transformer or the
lamp is connected to the 24V network, the fuses are
provided by the customer.
Pay attention to the instructions from the local installer.
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Dr. Mach
4.4.3 Changing the filter disk
The dielectric filter disk (blue) between reflector and
splinter protection disk prevents a damaging heating of the illuminated area.
The lamp may not be used without this filter.
17
20
21
22a
Y
23
22b
Only use filter disks that have been cleaned
properly.
24
4.4.4 Changing the splinter protection disk
16
In case you notice a reduced light quality because
of a dull splinter protection disk, it may be necessary to change the disk.
X
18
Detail X
16
Detail Y
To change the filter disk proceed as follows:
• Loosen the knurled screw 16 on the side of the
upper part of the lamp housing 17.
• Remove the lower part of the lamp housing 18.
• Loosen the three plastic nuts 20 on the lower
part of the lamp housing 18. You can remove
the filter disk 21 now.
• Change the filter disk 21.
• Replace nuts 20 according to the figure and
tighten carefully by hand, so the filter disk 21 is
not completely fixed.
• Fix the lower part of the lamp housing to the
upper part of the lamp housing using knurled
screw 16.
20
21
22a
To change the splinter protection disk proceed as
follows:
• Remove the lower part of the lamp housing 18
as described at chapter 4.4.3.
• Remove filter disk 21 as described at chapter
4.4.3.
• Lift the first spacer ring 22a and remove it.
• Remove the three tubular rivets 23.
• Lift the second spacer ring 22b and remove it.
• Change splinter protection disk 24.
• Replace tubular rivets 23 and spacer rings 22a
and 22b in reverse order according to the figure.
• Replace filter disk 21 as described at chapter
4.4.3.
• Fix the lower part of the lamp housing 18 as
described at chapter 4.4.3.
Only use splinter protection disks that have
been cleaned properly.
23
22b
24
59070001
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Dr. Mach
27
26
25
Kabel
4.4.5 Conversion to sterilizable handle
For mounting the sterilizable handle proceed as
follows:
• Turn off the lamp.
• Remove the standard handle:
Loosen stop screw 25 and remove.
Loosen wing nut 26 M10 and remove.
Remove lamp bow 27.
Caution: The inside cable keeps the lamp
bow connected to the lamp housing. Notice
the winding direction of the cable.
Loosen two screws 28 M3x12 and remove.
You can remove the standard handle 29 now.
•
28
27
Mount the handle bar and coupling for the sterilizable handle:
Extent of supply:
handle bar for sterilisable handle, completely pre-mounted
two screws M3x12
-
Put the handle bar 30 for sterilisable handle in
the fixing boreholes on the lamp housing.
Fix the handle bar with two screws 28 M3x12
(standard accessory).
Replace the lamp bow 27.
Caution: Insert the cable with the correct
winding direction.
29
Tighten wing nut 26 M10.
Replace stop screw 25 and tighten.
27
30
27
25
26
59070001
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Dr. Mach
5. Data
5.1 Technical data
Design with 230 Volt
~ Wechselstrom
Pr Primärseitig
Sek Sekundärseitig
Hz Hertz-Frequenz
Sicherung
Schutzgrad
alternating current
primary side
secondary side
frequency Hertz
fuse
class of protection
230V / 0,21A
22,8V / 2,08A
50 / 60Hz
Typ „B“
~ Wechselstrom
Pr Primärseitig
Sek Sekundärseitig
Hz Hertz-Frequenz
Sicherung
Schutzgrad
alternating current
primary side
secondary side
frequency Hertz
fuse
class of protection
120V / 0,42A
22,8V / 2,08A
50 / 60Hz
Typ „B“
Design with 22,8 Volt (external transformer)
~ Wechselstrom
Nennspannung
Nennstrom
Hz Hertz-Frequenz
Schutzgrad
59070001
alternating current
rated voltage
rated current
frequency Hertz
class of protection
22,8V
2,08A
50 / 60Hz
Typ „B“
Edition 06
04.03.2005 / Bak Page 15/22
Dr. Mach
5.2 Environmental conditions
Operation
Temperature
Relative atmospheric humidity
Air pressure
Min.
Max.
+10°C
30%
700 hPa
+40°C
75%
1060 hPa
Transport / Storage
Temperature
Relative atmospheric humidity
Air pressure
Min.
Max.
-10°C
20%
700 hPa
+50°C
90%
1060 hPa
6. Characteristics
Protective conductor
„ON/OFF“ switch
6.1 Specification of bulb
Voltage, power
Socket
Mode of operation
6.2 Specification of fuse
Visible fuse 5x20
Delay action 0,63A
Visible fuse 5x20
Delay action 1,25A
59070001
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Dr. Mach
Design with 22,8 Volt
The Soloflex lamps with external transformer do not have any fuses in the lamp housing.
6.3 CE-mark
The products Soloflex comply with the standard 93/42/EEC for medical products of the
European Community’s Council.
7. Disposal
The lamp does not contain any danger goods.
The components of the lamp should be properly disposed at the end of its shelf-life.
Make sure, that the materials are carefully separated.
For disposal proceed as follows:
• The lamp housing should be submitted to thermal disposal.
• The components should be disposed according to the contained materials.
59070001
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Dr. Mach
8. Spare parts
8.1 Soloflex design with 230V;120V
built in toroid transformer
4
16
1
5,6,7
10
3
9
38,39
25,26
12
13,14
35,36,37
30
20
27,28
2
31
45
48
47
49
47
32
50
46
44
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Dr. Mach
8.2 Soloflex design with 22,8V
external transformer
Remark: For spare parts see lamp Soloflex design with 230V, except the toroid transformer, the fuses
and the fuse holders.
8.3 Short arm (stand model)
52
51
53
8.4 Swivel arm (stand model)
54
55 56
61
57
58
59
62
66
60
64,65
63
67,68
69
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Dr. Mach
9. Spare part list
Item
Qty.
Name
EDVNO
1
1
1
1
1
1
1
Toggle joint complete
Sliding contact (connector)
Wing nut
Washer
Spring washer
07100001
07100003
07100002
07102001
07011004
07011204
65542002
1
1
Handle
Handle bar with coupling
07013001
07013002
1
1
1
Handle sleeve, sterilisable
Lamp housing with toroid transformer
Lamp housing without toroid transformer
22150001
07011001
07011008
1
Control knob with cover
74502001
1
Reflector complete (metal sheet reflector)
07052001
1
1
1
1
Focusing with toroid transformer
Focusing without toroid transformer
Lamp holder
Halogen bulb 22,8V/50W
07050001
07050002
67320001
67100201
01
02
03
04
05
06
07
08
09
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
1
1
1
Two-pole switch, illuminated ON/OFF
Change-over switch STRONG/WEAK
Single-pole switch ON/OFF
67340002
67340001
67340004
2
2
2
1
67370001
67370003
67370004
07054001
39
1
Fuse holder
Visible fuse 5x20/0,63A/250V/t
Visible fuse 5x20/1,25A/250V/t
Toroid transformer 60VA/prim. 220/240V AC/
sec. 22/24V AC
Toroid transformer 60VA/prim. 110/127V AC/
sec. 22/24V AC
40
41
42
43
44
45
46
1
6
1
Lower part of lamp housing
Nut
Knurled screw ∅6
07012001
07012201
07000201
59070001
Edition 06
Remark
alternate
alternate (2350)
only Pos. 2
220/240V AC
110/127V AC
67010104
04.03.2005 / Bak Page 20/22
Dr. Mach
Spare part list - continuation
Item
Qty.
47
48
49
50
51
52
53
54
2
1
3
1
1
1
1
1
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
2
1
1
1
1
1
1
1
1
1
1
1
1
1
2
59070001
Name
EDVNO
Spacer ring
Filter disk
Tubular rivet
Splinter protection disk
Cover
Housing
Handle coupling
Raised countersunk screw
DIN 7985 HM4x10 –4,8Ni
Lock washer A4,3 DIN 6797 –Zn
Brake bushing
Semi-circular spring
Countersunk screw DIN 966 HM3x12 –4,8Zn
Housing
Block transformer 60VA
Sliding bushing
Sliding contact (pin)
Sliding contact (plug)
Washer A8,4 DIN 125 –Zn
Adjusting lever
Thread pin DIN 551 M4x14 14H
Change-over switch
ON/OFF switch (illuminated)
Fuse holder
Edition 06
Remark
07012202
07250201
65702003
07200201
07103001
07102005
10160203
65152010
65582004
07100202
74011001
65112009
53070202
67010201
53070208
67330001
67330002
65512008
74503002
65212002
67340001
67340002
67370001
04.03.2005 / Bak Page 21/22
Dr. Mach
59070001
Edition 06
04.03.2005 / Bak Page 22/22

English instructions

Transcription

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