Huvitz HS-5500 User manual

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SLIT LAMP HS
-
5
5
00
1
Operator’s Manual
SLIT LAMP MICROSCOPE HS
-
5
5
00

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-
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00
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I
MPORTANT NOTICE
!
WARNING
Potential electromagnetic or other interference between medical equipments and other
devices being operated together in the same environmental may expert an adverse
influence on f
unctioning of the medical equipment.
Non
-
medical equipments not in
compliance with the requirements of EN 60601
-
1 and EN 60601
-
1
-
2 should not be
used together in the same environmental as the medical equipments
This equipment has been tested and found t
o comply with the limits for medical devices in
IEC 60601
-
1
-
2:2001.
These limits are designed to provide reasonable protection against
harmful interference in a typical medical installation
Power Cord
For use of equipment in rated voltage less than 125V
ac
, minimum
6A
, Type
SJT or
SVT,
18/3AWG
, 10A
, max 3.0m
long:
One end with Hospital Grade Type, NEMA 5
-
15P
other
end with appliance coupler. For use of equipment in rated voltage less than 250Vac
,
minimum
6A
, Type
SJT or
SVT,
18/3AWG
, 10A
, max 3.0m
long:
O
ne end
terminated
with
blade attachment
plug (
HAR) Type, NEMA 6
-
15P.
This product may malfunction due to electromagnetic waves caused by portable personal
telephones, transceivers, radio
-
controlled toys, etc. Be sure to avoid having objects such as,
which
affect this product, brought near the product.
The information in this publication has been carefully checked and is believed to be entirely
accurate at the time of publication. HUVITZ assumes no responsibility, however, for possible
errors or omissions,
or for any consequences resulting from the use of the ormation
contained herein.

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-
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HUVITZ reserves the right to make changes in its products or product specifications at any
time and without prior notice, and is not required to update this documentation
to reflect such
changes.
©200
9
HUVITZ Co., Ltd.
689
-
3, Geumjeong
-
dong, Gunpo
-
si, Gyeonggi
-
do,
435
-
862, Republic of Korea
All rights are reserved.
Under copyright laws, this manual may not be copied, in whole or in part, without the prior
written c
onsent of HUVITZ Co., Ltd.
Document
Number: 9000ENGJ101
-
A.

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Contents
1.
Introduction
................................
................................
................................
.......
6
2.
Safety Information
................................
................................
..............................
7
3.
Features & Operating Condition
................................
................................
......
14
4.
Standard Components
................................
................................
.....................
16
5.
Accessories
................................
................................
................................
.....
17
6.
Composition
................................
................................
................................
....
18
7.
Installation
................................
................................
................................
.......
23
8.
Trial Operations
................................
................................
...............................
27
9.
Main Features
................................
................................
................................
..
28
10.
Ordinary Maintenance
................................
................................
......................
29
1.
1.
Indication for use
................................
................................
.....................
6.
1.2.
Classification
................................
................................
............................
6
2.1.
Introduction
................................
................................
..............................
7
2.2.
Safety Symbols
................................
................................
........................
8
2.3.
Environment factors
................................
................................
................
10
2.4.
Safety Preca
utions
................................
................................
..................
12
3.1.
Brief Description
................................
................................
.....................
14
3.2.
Operating Condition
................................
................................
................
14
7.1.
Assembling the Instrument
................................
................................
......
23

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11.
EMC Information
................................
................................
..............................
33
12.
Electric Diagram
................................
................................
...............................
42
13.
Technical Specifications
................................
................................
..................
43
14.
Service Information
................................
................................
..........................
45
15. Pa
rti
cular Information
………………
…
…
…………………
………………
..
…
.
…
……
.47
10.1.
Halogen Projection bulb
................................
................................
..........
29
10.2.
Protection fuses replacement
................................
................................
...
30
10.3.
Cleaning & Disinfect
ion
................................
................................
...........
32
11.1.
Guidance and manufacturer’s declaration
–
electromagnetic emissions
......
33
11.2.
Guidance and manufacturer’s declaration
–
electromagnetic immunity
.......
34
11.3.
Guidance and manufacturer’s declaration
–
electromagnetic immunity
.......
36
11.4.
Recommended separation distances between portable and mobile RF
communications equipment and the EUT
................................
..............................
38
11.5.
Immunity
and Compliance Level
................................
..............................
39
11.6.
Guidance and manufacturer’s declaration
–
electromagnetic immunity
.......
40

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1.
Introduction
1.1.
Indication for
use (
intended use)
1.2.
Classification
!
CAUTION
The SLIT LAMP, HS
-
5500 is intended for use in eye examination of the ant eye
segments, from the cornea epithelium to the posterior capsule. It is used to aid in the
diagnosis of dise
ases or trauma which
affects
the structural properties of the anterior
eye segment.
-
Protection against electric shock: Class I
-
Applied Parts: Type B applied parts.
-
Protection against harmful ingress of water: Ordinary, IPX0
-
Degree of safet
y in the presence of a flammable anesthetics mixture with air
or with oxygen or with nitrous oxide: Not suitable for use in the presence of a
flammable anesthetics mixture with air or with oxygen or with nitrous oxide.
-
Mode of operation: Continuous
-
Light H
azard protection Classification: Group 2 by ISO15004
-
2:2007
-
Stationary:
Do not try to move this equipment without help.
This microscope is
heavy and should maintain stationary. Always get two persons to help lift this
unit
Federal law restricts this de
vice to sale by or on the order of a physician

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2.
Safety Information
2.1.
Introduction
NOTE
!
WARNING
!
CA
UTION
Safety is everyone
’
s responsibility. The safe use of this equipment is largely dependent
upon the installer, user, operator, and maintainer. It is imperative that personnel
study
and become familiar with this entire manual before attempting to
install
use, clean,
service or adjust this equipment and any associated accessories. It is paramount that
the instructions contained in this manual are fully understood and followed to
enhance
safety to the patient and the user/operator. It is for this reason that the following safety
notices have been placed appropriately within the text of this manual to highlight safety
related information or information requiring special emphasis. Al
l users, operators, and
maintainers must be familiar with and pay particular attention to all Warnings and
Cautions incorporated herein.
“
Warning
”
indicates the presence of a hazard that could result in severe personal injury,
death or substantial prop
erty damage if ignored
.
“
Note
”
describes information for the installation, operation, or maintenance of which is
important but hazard related if ignored.
“
Caution
”
indicates the presence of a hazard that could result in minor injury, or
proper
ty damaged if ignored.

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2.2.
Safety Symbols
Save this instruction
The International
Electro technical
Commission
(IEC) has established a set of symbols
for medical electronic equipment which classify a connection or warn of any potential
hazards. The classifications and symbols are
shown below.
This applies only to the instrument that has the certification symbol printed explicitly on
the product label or sticker.
I and O on power switch represent ON and OFF respectively.
Type B Isolated patient connecti
on.
This symbol identifies a safety note. Ensure you understand
the function of this control before using it. Control on
is
described in the appropriate User’s or Service Manual.
Identifies the point where the system safety ground is
fastened t
o the chassis. Protective earth connected to
conductive parts of
Class I equipment for safety purposes.
Hot surface.

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UL60601
-
1
CAN/CSA C22.2
NO.601.1
MEDICAL EUIPMENT
WITH RESPECT TO ELECTRIC SHOCK
FIRE AND MECHANICAL HAZARDS
ONLY IN ACCORDANC
E WITH UL
60601
-
1,
AND CAN/CSA
C22.2
NO.601.1
Disposal of your old appliance
When this crossed
-
out wheeled bin
symbol is
attached to a
product it
means the
product is covered by the European
Directive 2002/96/EC.
All electrical and electronic products s
hould be disposed of
separately from the municipal waste stream via designated
collection facilities appointed by the government or the local
authorities.
The correct disposal of your old appliance will help prevent
potential negative consequences for the
environment and
human health.
4. For more detailed information about disposal of your old
appliance, please contact your city office, waste disposal
service or the shop where you purchased the product.
Alternating Current

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2.3.
Environment factors
Avoid
the following environments for operation or storage:
Where the equipment is exposed to water vapor.
Don
’
t operate
equipment
with a wet hand.
Where the equipment is exposed to direct sunlight.
Where the temperature changes
extremely
.
Normal operat
ing temperature range is from 10
C to 40
C,
Humidity is from 30% to 75%.
Altitude is from 700 to 1060hpa
Where it is near the heat equipment.
Where the humidity is extremely high or there is a ventilation
problem.
Where t
he equipment is subject to excessive shocks or
vibrations.
°
°

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Where equipment is exposed to chemical material or
explosive gas.
Be careful not to be inserted dust, especially, metal.
Don
’
t disassemble the product or open. We aren
’
t
responsible for
it for nothing.
Be careful not to close the fan located on the lateral or back
side of the equipment.
Don
’
t plug the AC power cord into the outlet before the
connection between devices of the equipment is completed.
This can generate the defect.
P
ull out the power cord with holding the plug, not the cord.
Avoid places where the ambient temperature falls below 10
or exceeds 40
for
normal operation, or below
-
10
or exceeds 40
(14
-
104
) for transportation and
storage. Humidity should be maint
ained between 30 and 75% for normal operation,
transportation and storage. The
atmospheric pressure in
operation, transportation and
storage
is from
700
to
1060hp
a
.
℃
℃
℃
℃
℉
℉

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2.4.
Safety Precautions
This equipment
has been developed and tested according to safety stand
ards as well
as national and international standards. This guarantees a very high degree of safety
for this device. The legislator expects us to inform the user expressively about the
safety aspects in dealing with the device. The correct handling of this
equipment
is
imperative for its safe operation. Therefore, please read carefully all instructions before
switching on this device. For more detailed informatio please contact our Customer
Service Department or one of our authorized representa ves.
1.
This
equipment
must not be used (a) in an area that is in danger of explosions
and (b) in the presence of flammable, explosive, or vo tile solvent such as
alcohol, benzene or similar chemicals.
2.
Do not put or use this device in humid rooms. Humidity should be
maintained
between 30 and 75% for normal operation. Do not expose the device to water
splashes, dripping water, or sprayed water. Do not place containers containing
fluids, liquids, or gases on top of any electrical equipment or devices.
3.
The equipment mu
st be operated only by, or under direct supervision of a
properly trained and qualified person.
4.
Modifications of this equipment
may only be carried out by Huvitz
’
s service
technicians or other authorized persons.
5.
Customer maintenance of this equipment
ma
y only be performed as stated in
the User
’
s Manual and Service Manual. Any additional maintenance may only
be performed by Huvitz
’
s service technicians or other authorized persons.
6.
The manufacturer is only responsible for effects on safety, reliability, a
nd
performance of this equipment when the following requirements are fulfilled: (1)
The electrical installation in the respective room corresponds to the
specifications stated in this manual and (2) This equipment is used, operated,
And
maintained accordi
ng to this manual and Service Manual.

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7.
The manufacturer is not liable for damage caused by unauthorized tampering with
the device(s). Such tampering will forfeit any rights to claim under warranty.
8.
This equipment
may only be used together with accesso
ries supplied by Huvitz
’
s.
If the customer makes use of other accessories, use them only if their safe
usability under technical safety aspects has been proved and confirmed by Huvitz
or the manufacturer of the accessory.
9.
Only persons who have undergone p
roper training and instructions are authorized
to install, use, operate, and maintain this equipment.
10.
Keep the User
’
s Manual and Service Manual in a place easily accessible at all
times for persons operating and maintaining the equipm t.
11.
Do not force ca
ble connections. If a cable does not connect easily, be sure that the
connector (plug) is appropriate for the
receptacle
(socket). If you cause any
damage to a cable connector(s) or receptacle(s), let the damage(s) be repaired by
an authorized service tech
nician.
12.
Please do not pull on any cable. Always hold on to the plug when disconnecting
cables.
13.
Before every operation, visually check the equipment for exterior mechanical
damage(s) and for proper function.
14.
Do not cover any ventilation grids or slits.
15.
Immediately turn off and unplug any equipment that gives off smoke, sparks,
strange noises, or odors.
16.
Power Supply Cord set (international)
-
(Detachable) Rated 10 A, 250 V. Plug type
CEE 7/VII, Connector type IEC 60320/C13, and Cord type H05VV
-
F3G, min.
0.75
mm2, 3
-
conductor terminating in molded
-
on grounding type attachment plug.
<HAR> marked on the cord. Maximum4.0 m long
.

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3.
Features & Operating Condition
3.1.
Brief Description
3.2.
Operating Condition
The
device works like all slit lamps:
Stereomicroscopic
examination of the ey
e under the slit light.
Microscopic
examination of the ocular fundus and posterior vitreou body (using
h
r
uby
’
s lens).
These devices are designed for use by ophthalmologists and
optometrists (
within the
realms of their respective professions) for specific
diagnostic
procedures (
bio
-
microscopic examination of the eye)
As long as the slit lamp is in its original package it can be exposed to the
following environmental conditions for up to 15 weeks shipping and storage
without risk
of damage:
-
Temperature
range:
from
–
10
C to +40
C;
-
Relative humidity range: from 30% to75%;
The device is made to operate under the following environmental conditions:
-
Temperature
range:
from +1
0
C to +
4
0
C;
-
Relative humidity range: from 30%
to
75%;
The device
neither
generates nor receiv
es electromagnetic interference when used
near other equipment. Therefore, no preventive or corrective measures are required
-
-
l
l
˚
˚
˚
˚

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!
CAUTION
Because prolonged intense light exposure can damage the retina, the use of the device
for ocular examination should not be unne
cessarily prolonged, and the brightness
setting should not exceed what is needed to provide cl visualization of the target
structures. This device should be used with filters that eliminate UV
radiation
(
<400nm
) and
, whene ver possible, filters that elim
inate short
-
wavelength blue
light
(
<420nm).
The retinal exposure dose for a photochemical hazard is a product of the radiance and
the exposure time. If the value of radiance were reduc in half, twice the time would
be needed to reach the maximum exposure
limit.
While no acute optical radiation hazards have been identified for slit lamps, it is
recommended that the intensity of light directed into patient
’
s eye be limited to the
minimum level which is necessary for diagnosis. Infants, aphakes and perso
ns with
diseased eyes will be at greater risk. The risk may also increased of the person being
examined has had any exposure with the same instrument or any other ophthalmic
instrument using a visible light source during the previous 24 hours. This will ap
ply
particularly if the eye has been exposed to retinal photography

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4.
Standard Components
The instrument is delivered in package. Taking it out the package, make sure that
none of the following parts is missing.
A table top(N.B. the table top isn
’
t
supplied with the slit lamp for twin table) on
which are placed: A SMPS box(15) including the main switch & a warning
light (13), Two sliding guides for the base with orthogonal movements(17), A
sliding plate for the position device(
19
), A drawer(16);
A
base with orthogonal movements.
A microscope with either dual magnification or a
system (
31) including
eyepieces.
An optical group of the slit projector.
A head rest
module (
59).
A
microscope
arm (
45).
This manual.
A set of accessories including; two
wheels for the sliding guides(18); a setting
rod(43); a protective cover(46); a spare bulb 12V 30W ogen bulb(53); two
protection fuses(48); a breath screen(
5
); a chin
-
rest paper(47);a hole
cover(45); a power cable; two patient
’
s handles(50)
l
l
l
l
l
l
l
l

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5.
Accessorie
s
The following standard accessories are provided with the instrument;
protection cover(46)
a setting rod(43)
spare bulbs
12V 30W Halogen
bulb (
53)
chin
-
rest paper(47)
spare fuses 250Vac T2.0AL
a breath screen(
5
)
power cable
l
l
l
l
l
l
l
[ Figure 1. Accessories ]

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6.
Composition
1)
F
ixation point
2)
Control lever for changing enlargement
3)
Removable eye
-
pieces
4)
Knob for clamping the breath screen
5)
Breath screen
6)
Knobs to change the slit
length
7)
Connecting plug of the projector lamp
8)
Knurled ring for filters insertion
9)
Joystick for lateral, longi
tudinal and vertical movements(x y z)
10)
Base with orthogonal movements
11)
Shaped tabletop
12)
Warning light indicating the ignition of the SMPS is on
13)
Main switch
& Warning light
14)
Luminosity selector
15)
SMPS box
16)
Drawer
17)
Toothed guides
18)
Wheel protection crankcases
19)
Sliding
plate
20)
Knob to lock the projector
21)
Scale for the projector position
22)
Knob to lock the arm of the microscope
23)
Hole cover
24)
Cover
holder
screw
25)
Control handle
for the vertical setting of the chin
-
rest

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26)
Locking pins for chin rest paper
27)
Chin rest
28)
Knobs to change the
slit width
29)
Pointer for the eye positioning
30)
Foreh
ead
R
est
31)
Microscope
32)
33)
Knob to lock the base of the instrument
34)
Knob to lock the microscope
35)
Control handle for horizontal tilting
36)
Control handle for
vertical
tilting
37)
Microscope position stop
38)
Knobs to
change the slit
rotation 90
-
0
-
90
39)
Lamp cover
40)
fuse slots
41)
Connecting plug
42)
Fixation point connector
43)
Setting rod
44)
Microscope separation knob
45)
Microscope arm
46)
Protection cover
47)
Chin rest papers
48)
Guide screw
49)
An optical group of the slit projector
50)
Patient
’
s handle
51)
Hea
d
rest fastening screw
52)
Wheel
53)
Halogen bulb 12V 30W
Lamp socket

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54)
Screw hole cover
55)
Prism
56)
Capture connector ( For the image system)
57)
Capture switch
58)
Luminosity selector connector ( Connect the Luminosity selector to the
SMPS)
59)
Head rest module
60)
Diffuser