sola_300_instruction_for_use_edition_3_aug_2012.pdf
Page 1
Instructions for use
Sola 300
WARNING
For a full understanding of the performance characteristics of this device,
the user should carefully read these
Instructions for use before use of the
device.
Examination Lights
Page 2
Working with these instructions for use
The title of the main chapter in the header line
helps with quick orientation and navigation.
The instructions for the user combine text and
illustrations, providing a comprehensive overview
of the system. The information is presented as
sequential steps of action, allowing the user to learn
directly how to use the device.
The text provides explanations and instructs the
user step-by-step in the practical use of the product, with short, clear instructions in easy-to-follow
sequence.
1
Consecutive numbers indicate steps of action,
with the numbering restarting with “1” for each
new sequence of actions.
Bullet points indicate individual actions or different options for action.
–
Dashes indicate the listing of data, options or
objects.
(A) Letters in parentheses refer to elements in the
relevant illustration.
The illustrations show the relationship between
the text and the device. Elements mentioned in the
text are highlighted. Unnecessary details are omitted.
A Letters denote elements referred to in the text.
2
Instructions for use Sola 300
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Trademarks
–
Sola®
–
DrägerService®
are trademarks owned by Dräger.
Definition of the safety notes
The safety notes in these instructions for use are
designed and defined as follows:
WARNING
A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in
death or serious injury.
CAUTION
A CAUTION statement provides important information about a potentially hazardous situation
which, if not avoided, may result in minor or moderate injury to the user or patient or in damage to
the equipment or other property.
NOTE
A NOTE provides additional information intended
to avoid inconvenience during operation.
Symbols
For explanations see chapter "Symbols" on
page 12.
Instructions for use Sola 300
3
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Definition of target groups
For this medical product, users, service personnel,
and experts are defined as target groups.
These target groups have received training on the
medical product and have the required training and
knowledge to use, install, reprocess, maintain, or
repair the medical product.
The medical product may only be used, installed,
reprocessed, maintained, or repaired by the
defined target groups.
Users
Users are persons who are permitted to use the
medical product in accordance with its intended
use.
Service personnel
Service personnel are persons who are responsible
to the operator for maintaining the medical product.
Service personnel are persons who are permitted
to install, reprocess, or maintain the medical
product.
Experts
Experts are persons who are permitted to perform
repairs or complex maintenance work on the medical product.
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Instructions for use Sola 300
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Contents
Contents
For Your Safety and that of Your Patients . .
6
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . .
9
Versions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Description . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9
9
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Sola 300 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Sola 300 Mobile . . . . . . . . . . . . . . . . . . . . . . . . 18
Service Work. . . . . . . . . . . . . . . . . . . . . . . . . . 19
Replacing bulbs . . . . . . . . . . . . . . . . . . . . . . . . 19
Adjusting the braking force . . . . . . . . . . . . . . . . 23
Fault – Cause – Remedy . . . . . . . . . . . . . . . . 24
Cleaning and disinfection . . . . . . . . . . . . . . . 25
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Definition of maintenance terms . . . . . . . . . . . .
Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
28
28
29
30
31
Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Safety information. . . . . . . . . . . . . . . . . . . . . . . 32
Disposal of the medical device . . . . . . . . . . . . . 32
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . 33
Accessories List . . . . . . . . . . . . . . . . . . . . . . . 35
Instructions for use Sola 300
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For Your Safety and that of Your Patients
For Your Safety and that of Your Patients
Strictly follow the instructions for use
WARNING
Strictly follow these instructions for use.
Any use of the product requires full
understanding and strict observation of all
portions of these instructions. The device is
only to be used for the purpose specified under
"Intended use" on page 9. Observe all
WARNING and CAUTION statements throughout
these instructions for use and all statements on
device labels. Non-observance of these
instructions constitutes non-authorized use of
the medical device.
Maintenance
WARNING
The device must be inspected and serviced
regularly by experts. Repair of the device may
also only be carried out by experts.
Accessories
WARNING
Only accessories indicated in the list of
accessories have been tested and approved
to be used with the device. We therefore
urgently recommend only using the device in
combination with appropriate accessories.
Otherwise, the correct functioning of the
device may be compromised.
Disconnection of all poles
WARNING
When installing the light system, the operator
must ensure that the disconnection of all
poles is guaranteed for maintenance and
service.
The necessary switching element is not
included in the delivery of Dräger light
systems.
Dräger recommends that a service contract be
obtained with DrägerService and that all
repairs also be carried out by them. Dräger
recommends that only authentic Dräger repair
parts be used for maintenance. Otherwise, the
correct functioning of the device may be
compromised.
Regularly carry out technical safety
inspections on the device, observe chapter
"Maintenance".
6
Instructions for use Sola 300
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For Your Safety and that of Your Patients
Not for use in areas of explosion hazard
General WARNINGS and CAUTIONS
WARNING
This device is neither approved nor certified
for use in areas where combustible or
explosive gas mixtures are likely to occur.
The following WARNING and CAUTION
statements apply to general operation of the
medical device.
Patient safety
The design of the medical device, the
accompanying literature, and the labeling on the
medical device take into consideration that the
purchase and use of the medical device are
restricted to trained professionals, and that certain
inherent characteristics of the medical device are
known to the trained operator. Instructions,
warnings, and caution statements are limited,
therefore, largely to the specifics of the Dräger
design.
WARNINGS and CAUTIONS specific to
subsystems or particular features appear with
those topics in later sections of these instructions
for use or in the instructions for use of any product
being used with this device.
WARNING
The device is intended for use by qualified
medical personnel only.
WARNING
Risk of an electric shock!
Do not open the housing of the device, except
for the light head while replacing the bulb.
These instructions for use exclude references to
various hazards which are obvious to a medical
professional and operator of this medical device, to
the consequences of medical device misuse, and
to potentially adverse effects in patients with
abnormal conditions.
Medical device modification or misuse can be
dangerous.
Instructions for use Sola 300
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For Your Safety and that of Your Patients
Note on EMC/ESD risk for the device
function
WARNING
General information on electromagnetic
compatibility pursuant to EMC/ESD
declaration of the international EMC standard
IEC 60601-1-2:
Electromedical devices are subject to special
precautionary measures concerning
electromagnetic compatibility (EMC) and must
be installed and put into operation in
accordance with the EMC information
included in the technical documentation.
Portable and mobile RF communications
equipment can affect medical electrical
equipment.
8
Instructions for use Sola 300
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Intended Use
Intended Use
Sola 300 (wall light and ceiling light) and
Sola 300 Mobile (mobile light)
This examination light is used in the patient
environment to illuminate the body of the patient
locally as well as support treatment and diagnosis.
In case of failure, the treatment and diagnosis can
be interrupted without any hazard.
It is not intended to be used in operating rooms.
Versions
Sola 300
–
Available as a ceiling-mounted or wall-mounted
version.
Sola 300 Mobile
–
Sola 300 Mobile available as a mobile
examination light.
Description
The Sola 300 examination light is a reflector light.
A halogen bulb projects a light beam onto the
treatment field via a reflector.
Instructions for use Sola 300
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Overview
Overview
Sola 300 wall light
Sola 300 ceiling light
A
A
B
B
C
C
D
001
D
A Wall bearing
E
002
B Swivel arm with spring arm
C Sola 300 light head
D Lateral handle
A Ceiling cover
B Ceiling tube
C Swivel arm with spring arm
D Sola 300 light head
E Lateral handle
10
Instructions for use Sola 300
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Overview
Sola 300 Mobile light
A
B
C
D
E
003
F
A Sola 300 light head
B Lateral handle
C Spring arm
D Tube
E Trolley
F Double castors with parking brakes
Instructions for use Sola 300
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Overview
Symbols
Symbol
Consult
Operating Instructions
Description
A
Follow the instructions for
use/assembly instructions
Follow the instructions for
use/assembly instructions
A
004
Caution!
Caution!
A Sola 300 rating plate
Caution! Hot surface
B
Caution! Risk of tipping
over
B
006
Caution! 5° slope
5°
B Sola 300 Mobile rating plate
Note on disposal according to Directive
2002/96/EEC (WEEE)
Manufacturer
Date of manufacture
004
XXXX
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Instructions for use Sola 300
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Preparation
Preparation
Check for operational readiness before
each use
A
The Sola 300 is ready for operation if the checks
were carried out successfully and without
objections.
008
CAUTION
Before each use, check the condition of the
Sola 300 for:
– Visible damage on the light head and arm
system,
– Present voltage supply,
– Cleaning and disinfection of the Sola 300 in
accordance with the stipulations of the
hospital, see "Cleaning and disinfection" on
page 25.
Fold the spring arm (A) of the Sola 300 Mobile
to the lowest position.
Sola 300
The Sola 300 versions – suitable for ceiling or wall
installation – are fully assembled and can be
operated immediately.
B
Sola 300 Mobile
CAUTION
Danger of personal injury and equipment
damage!
Only move the Sola 300 Mobile in transport
position (spring arm folded to its lowest position).
Failure to observe may result in the
Sola 300 Mobile tipping over.
Instructions for use Sola 300
009
Moving the Sola 300 Mobile to location of use
To move the Sola 300 Mobile, only use the tube
(B) on the trolley.
The lateral handle on the light head is designed
to be used exclusively to position the light head!
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Preparation
CAUTION
Danger of personal injury and equipment
damage!
CAUTION
Danger of personal injury and equipment
damage!
To move the Sola 300 Mobile, only use the tube
on the trolley!
The light head must always point to the front if the
Sola 300 Mobile is moved downwards on a ramp.
The lateral handle on the light head is designed to
be used exclusively for positioning the light head!
When moving the Sola 300 Mobile light up a
ramp, always pull the Sola 300 Mobile using the
tube on the trolley.
Only move the Sola 300 Mobile at walking
pace.
There is a risk of the Sola 300 Mobile tipping
over at thresholds, uneven surfaces and ramps.
Further reduce the transport speed.
CAUTION
Danger of personal injury and equipment
damage!
Only move the Sola 300 Mobile at walking pace.
010
There is a risk of the Sola 300 Mobile tipping over
at thresholds, uneven surfaces and ramps.
Further reduce the transport speed.
011
The "Warning: risk of tipping over" warning plate is
located on the trolley.
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Instructions for use Sola 300
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Preparation
Sola 300 Mobile at location of use
CAUTION
Danger of personal injury and equipment
damage!
Make sure the power cable is safely routed.
Do not move the double castors of the trolley over
the power cable!
CAUTION
Danger of personal injury and equipment
damage!
A
012
Do not rest on the spring arm!
1
Apply all four parking brakes (A) on the trolley.
CAUTION
Danger of personal injury and equipment
damage!
CAUTION
Danger of personal injury and equipment
damage!
Do not stand on the trolley.
Always apply all four parking brakes on the trolley
of the Sola 300 Mobile at the location of use.
013
B
2
Connect the IEC connector of the power cord
(B) to the trolley.
Connect the power plug to a grounded wall
outlet.
Make sure the power cable is safely routed.
Instructions for use Sola 300
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Preparation
014
5°
The "Warning: 5o slope" warning plate is located on
the trolley.
015
5°
CAUTION
Danger of personal injury and equipment
damage!
Do not tilt the Sola 300 Mobile more than 5o!
Failure to observe this may result in the
Sola 300 Mobile tipping over.
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Instructions for use Sola 300
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Operation
Operation
WARNING
Danger of personal injury and/or equipment
damage!
CAUTION
Danger of personal injury and equipment
damage!
Do not place objects on the light heads or
hang them on the arm system. These objects
can fall down into the treatment field.
When positioning the Sola 300, do not use force
to pull the arm system beyond the end stops.
Do not hang heavy loads (e. g., leaning body
weight) on the arm system. Damage may
result to the mechanism of the arm system, so
that correct positioning of the arm system
may be compromised.
CAUTION
Risk of equipment damage caused by
overheating!
Never cover parts or the entire light head while
using the Sola 300.
CAUTION
Danger of personal injury and equipment
damage!
Do not rest on the spring arm!
Sola 300
016
A
Switch the Sola 300 on or off, using the switch
(A) on the cardan joint.
Instructions for use Sola 300
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Operation
Sola 300 Mobile
016
A
Switch the Sola 300 Mobile on or off, using the
switch (A) on the cardan joint.
CAUTION
Danger of personal injury and equipment
damage!
Do not stand on the trolley.
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Instructions for use Sola 300
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Service Work
Service Work
Service work may only be carried out by experts.
Replacing bulbs
Replacing bulbs
WARNING
Danger of personal injury and/or equipment
damage!
A
Disconnect the Sola 300 from the power
supply before replacing the bulb.
CAUTION
Risk of burns!
017
019
Allow the Sola 300 to cool down.
1
The "Warning: hot surface!" warning plate is
located in the opening of the reflector.
Remove the cover (A) on the upper surface of
the light head.
B
020
018
C
2
Instructions for use Sola 300
Push the fixing clamp (B) forward with your
finger and simultaneously turn it
counterclockwise until the bulb (C) can be
removed.
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Page 20
Service Work
A
021
B
1
Hold the bulb socket (A) on the edge and pull it
out of the reflector opening until both flat plugs
are accessible.
2
Disconnect both flat plugs (B) from the
connection cable.
CAUTION
Risk of personal injury and/or equipment
malfunction!
Check the connection cable for scorch marks.
Call DrägerService if scorch marks are found.
20
Instructions for use Sola 300
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Service Work
Installing the bulb
1
Remove the bulb from its packaging. Only touch
the bulb socket (ceramic socket).
The glass body of the halogen bulb must not be
touched.
B
CAUTION
The technical characteristics of the new halogen
bulb may be affected.
Do not touch the glass body of the new halogen
bulb with your bare hands!
C
Bulb (halogen bulb with bulb
socket)
Order
number
12 V/50 W (1 piece)
G97780
023
Only use original Dräger bulbs.
3
Insert the bulb (B) into the opening of the
reflector and push both connection cables (C)
under the light head.
The glass body of the halogen bulb must not
touch the opening of the reflector.
CAUTION
Risk of breakage of the glass body!
A
022
The glass body of the halogen bulb must not
touch the reflector.
2
Attach both flat plugs (A) of the new bulb onto
the connectors of the connection cable.
The order of plugs is not important.
Instructions for use Sola 300
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Service Work
C
1
Position the bulb (A) in such a manner that the
engaged fixing clamp cannot cut across or bend
the connecting leads.
026
024
A
3
Reattach the cover (C) on the upper surface of
the light head.
Switch on the Sola 300, the halogen bulb must
light up.
NOTE
The engaged fixing clamp must not cut across or
bend the connecting leads.
025
B
2
At the marked position, push the fixing clamp
(B) forward with your finger and simultaneously
turn it clockwise toward the inside.
The fixing clamp must engage.
22
Instructions for use Sola 300
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Service Work
Adjusting the braking force
Adjust the movability of the cardan joint in such a
manner that the Sola 300 is held in the desired
position.
If this is not the case, the friction (braking force)
must be increased/reduced on the cardan joint of
the Sola 300.
B
028
Adjusting the cardan joint
1
The adjustment of the cardan joint is correct if the
Sola 300 can be positioned in any direction.
Adjust the friction of the joint with the setscrew
(B). Use a slot screwdriver (width 6 mm).
To increase the friction – turn the setscrew (B)
clockwise.
A
027
To reduce the friction – turn the setscrew (B)
counterclockwise.
The friction can be adjusted on the joint (A).
Instructions for use Sola 300
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Fault – Cause – Remedy
Fault – Cause – Remedy
Fault
Cause
Sola 300 cannot be switched on. Bulb defective.
Sola 300 Mobile: no mains
connection.
24
Remedy
Replace bulb, see "Service Work"
on page 19.
Establish the mains connection.
Instructions for use Sola 300
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Cleaning and disinfection
Cleaning and disinfection
Safety information on reprocessing
WARNING
Always follow the hygiene instructions of the
hospital when handling devices that are
contaminated with body fluids.
WARNING
Risk of device damage or injury
Always follow validated procedures when
cleaning and disinfecting the device and
accessories.
Strictly observe and always follow the disinfectant
manufacturer's instructions for use and take the
specifications of the manufacturer into account
when selecting the preparations.
Reprocessing
Classification of medical devices
For reprocessing, medical devices are classified
according to type of application and the risk
resulting from it:
–
CAUTION
Clean and disinfect lights and accessories as
described in the respective instructions for use.
Some components consist of materials that are
sensitive to certain disinfectants. Observe the
recommendations in this chapter.
NOTE
To minimize the risk of infection for hospital staff
and patients, clean and disinfect the device after
each use.
Uncritical medical devices: User-accessible
surfaces, e.g., device surface of the Sola 300.
The following materials are used for the Sola 300:
Component
Material
Light head
Aluminum
Cover
Silicone
Seals
Silicone
Bottom glass
Safety glass
Bottom glass ring
Aluminum
Lateral handle
PUR
NOTE
The surface disinfectant Terralin® (manufacturer:
Schülke & Mayr GmbH, Germany) was tested by
Dräger. The test results showed that it may
damage the material.
The surface disinfectant Terralin® is therefore not
permitted for disinfection of the entire system.
NOTE
Strictly follow the disinfectant manufacturer's
instructions for use.
Instructions for use Sola 300
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