Universal Medical ISOLED XII User manual

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ISOLED XII
OPERATIONAL / SERVICE MANUAL

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ISOLED XII
OPERATING and
SERVICE MANUAL
Document No. OM-1201
Version 2.0
MAY 04, 2012

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TABLE OF CONTENTS
TABLE OF CONTENTS.................................................................................................................3
1. REVISION HISTORY..............................................................................................................4
2. LABEL.....................................................................................................................................4
3. SYMBOLS...............................................................................................................................5
4. Definition of Terms..................................................................................................................7
5. IEC 60601-1 Safety Tests Compliance (Class I, minor surgery) ...............................................8
6. Table of Surgical Luminaires from IEC 60601 - 2- 41.............................................................9
7. Complaince to the requirements of IEC 60601 2-41 and additional safety issues..................10
8. Introduction .............................................................................................................................11
9. Functional Description.............................................................................................................12
10. Theory of Operation ..............................................................................................................16
11. IsoLED XII Performance........................................................................................................16
12. Mechanical Specifications and Options.................................................................................19
13. Head (Lamp) Installation .......................................................................................................23
14. Operating Instructions...........................................................................................................24
15. Cleaning Instructions.............................................................................................................24
16. Care and Maintenance..........................................................................................................25
17. Packing and unpacking .........................................................................................................26
17.1 Transportation Label........................................................................................................26
17.2 Unpacking........................................................................................................................27
18. TROUBLESHOOTING ..........................................................................................................27
19 Disposal of Waste Products ……………………………………………………………………….27

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1. REVISION HISTORY
Version
Release Date
Comments
0.1
03/15/2012
Rough Draft
1.0
04/15/2012
First Draft for Review
2.0
05/04/2012
Final Draft
2. LABEL
LED SURGICAL LAMP class I
MODEL No.: Isoled XII
S/N: XXXXX
INPUT
120 VAC / 60 Hz
38 Watts
OUTPUT
Optical Output: >50 Klux @ 1 m.
Operating Temp.: -10 to 50 C
Storage Temp.: -20 to 85 C
Material: 1. Transparent Gloss Polyester with permanent Acrylic
Adhesive backing.
2. Background color: Transparent.
3 .Lettering and Markings: Black.
4. Size: 3.00” by 1.00”

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Notes:
1. Unit is designed with protection against electric shock as per the requirements of IEC
60601 –1.1, class 1.
2. Equipment is not suitable for use in the presence of a flammable anesthetic mixture with
air or with oxygen or nitrous oxide.
3. SYMBOLS
QPS LISTING MARKING
Caution
Protective Earth Ground
Read accompanying documents

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Temperature Range: Operating
Storage and Transportation
Relative Humidity Range
This Side Up
Keep Dry
Recycle

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4. Definition of Terms
I.E.C.
International Electrotechnical Commission
Medical Electrical Equipment
Electrical equipment intended to diagnose, treat the patient under medical supervision.
Electrical equipment that transfers energy to the patient.
Central Illuminance
Illuminance of light head measured at 1 meter from the light emitting area with no
obstructions. Expressed in Foot-candles or Lux.
Light Field Center
Point of maximum illuminance in lighted area. This is the reference point for light field
size and light distribution measurements.
Light Field Diameter
Diameter of the circle where illuminance reaches 10% of light field center illuminance.
Depth of Illumination
The overall distance from 1 meter where the central Illuminance is reduced to 20%.
Shadow Dilution
Ability of the equipment to minimize the impact of shadows in the working area due to
partial obstruction by an operator or other medical personnel.
Correlated Color Temperature
The color temperature of the light fixture when compared to a blackbody radiator
stated in degrees Kelvin.
Total Irradiance
The total amount of energy imparted to the patient by the lighting system expressed in
Watts/meter squared.
Color Rendering Index (CRI)
A method of how well a light source will render other colors when illuminating them based
upon eight CIE chromaticity coordinates measured with a spectral radiometer.
Handle Sterility
Device when properly sterilized maintains a sterile area in order to handle it under aseptic
conditions when attached to the equipment.
Neutral Conductor
In an AC circuit, the return line for current.

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Protective earth ground
The conductor used to connect the non-current-carrying metal parts of the equipment
to the system grounded conductor, the grounding electrode conductor, or both, of the circuit at
the service equipment or at the source of a separately derived system.
Ft-Lbs
Foot-pounds; the unit of measurement of torque which is caused by an off-center load.
5. IEC 60601-1 Safety Tests Compliance (Class I, minor surgery)
REQUIREMENTS
TEST PARAMETERS
COMPLIANCE
REMARKS
Protective Earthing
40 amps , < 6 volts
compliance, for 2
minutes.
≤ 100 milliohms
Production tests will be done
with an audible continuity
meter.
Dielectric Strength
1.2 KV AC for 1 seconds
No voltage
breakdown
Test will be performed in all
production units.
Figure TBD Protective Earthing Test Set Up

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Figure TBD Typical AC Dielectric Strength Test Set Up
6. Table of Surgical Luminaires from IEC 60601 - 2- 41

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7. Compliance to the requirements of IEC 60601 2-41 and
additional safety issues
REQUIREMENTS
CLAUSE
SURGICAL
REMARKS
Equipment Classification
14.2 a 2)
Class I Minor (treatment)
Sterile Handle
Yes
see Note 1
Central Illuminance (Ec)
50.102.1.1 a
50,140 lux
40 K lux to 160 K lux
Light Field Diameter (d10)
50.102.1.1 b
276 mm
No Limits
Light Distribution:
50.102.1.1 b
Light Field dist. (d50)
139 mm
>50 % of d10
Depth of Illumination
226 cm
L1 + L2; 20% from 1 m
Shadow Dilution
% of Ec with pair of masks
% of Ec with single mask
% of Ec with tube and 2 masks
% of Ec with tube and 1 mask
% of Ec with tube and no
mask
50.102.1.1 c
Yes
91 %
0.06 %
91 %
0.01 %
99 %
see Note 2
Color Temperature
50.102.2.1
3675 º K
3000 º K to 6700 º K
Color Rendering Index (CRI)
50.102.2.1
96
85 to 100
Total Irradiance (Ee) @ 1 m
50.102.3.1
116 watts / m2
< 1000 watts / m2
EMC
No susceptibility nor
interference
see Note 3
Note 1: Sterilization of the fixed handle is accomplished as follows:
Clean with a damp cloth using a 70 % isopropyl alcohol (be sure to cover all surfaces of the
handle) and then wipe clean with a dry clean cloth. This procedure will be used after each use of
the luminaire. The head light body will also be sterilized at the end of the daily use of the
luminaire.
Note 2: Shadow Dilution The IsoLED XII surgical lamp is a single luminaire with 12 LED light
sources, it produces a well defined and homogeneous light spot that when combined with its
mobility and maneuverability with 5 degrees of freedom (2 translational and 3 rotational) will allow
for shadowless operation for minor surgical procedures.
Note 3: The power supply used in the unit is a medical grade unit with EMC certification. The
additional circuitry of the unit does not contain any significant RF sources; additionally the unit is
completely shielded from the outside world by its metal construction.

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8. Introduction
The IsoLED XII is an exam plus minor surgery and procedure lamp using the latest state-of-the-
art LED lighting technology, providing the highest illumination at 1 meter of the industry (55,000
lux typical). Its CRI of 95 rating produces a very high color rendition for accurate diagnosis; and
the life of the LEDs used is kept high by limiting their junction temperature to less than 55 º C for
a better than 50,000 hours of operation; while its meager power consumption of 38 watts
provides for very efficient and eco-friendly lamp.
Furthermore, the use of sharp cutoff optics allows for a well defined spot with a very small “Halo”
effect and good depth of field.
The IsoLED XII lamp has been designed taking into account all of the different disciplines
that makes up for true latest-state-of-the-art LED technologies:
Efficiency
The AC to DC power supply has an efficiency of 91 % and at 40 watts is one of the smallest
available (2” x 3”). The LED driver board uses a buck –p channel design for an efficiency of
91.5 % to produce the 0.72 A drive for the 12 LEDs, the 0.83 watts for the fan and the 5 VDC
for the logic circuitry, for an overall electrical efficiency of 0.82 %.
Power Grid Interface and Energy Star Compliance
Its Power Factor Correction (PFC) of >95 %, its Input current Harmonics of < 20 % and the 66
Lumens / watts ratings of its luminaires (LEDs) provides additional increase in overall
efficiency, surpassing the guidelines of the Energy Star Specifications.
Color Rendition Index
Typical CRI of 95 yields excellent color rendition.
Illumination
The LED optical efficiency plus the optical efficacy of the secondary optics used, provides
> 50,000 lux (candela) at 1 meter from source, for a Figure of Merit of 1496 lux/watt
Thermal
The thermal design has been designed around keeping the Junction temperature of the LEDs
lower than 55 º C (for a 27 º C ambient). This ensures the long life of 50,000 hours (70% of
max.) and the minimum decrease of the lamp’s illuminance vs. time. The fan and heat sink
are positioned for maximum cooling of the MCPCB, additionally the fan’s voltage was reduced
from 12 VDC to 9 VDC to reduce its noise (< 26 dBA).

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9. Functional Description
.
The unit’s functional diagram is depicted in Figure 2.1
All of the electronics and optics are housed in the head; the head enclosure is an Aluminum
cylinder 5” in diameter by 7.625” long containing four sub-assemblies: the power supply, the LED
Driver board, the Control board and the Light Engine.
The unit’s three controls are located at the round panel at the back end of the head. (see figure
2.X). The three membrane switches are momentary SPST switches with a common ground.
The 2” x 3” AC to DC power supply board is a vendor’s item with the following safety approvals:
EN60601-1, UL60601-1, IEC60601-1, EN60950-1, UL60950 and IEC60950-1 (see attached
specifications, Figures 2.2 and 2.3); it provides 30 VDC to supply the rest of the electronics.
The AC to DC power supply is grounded internally to the Lamp’s Head Aluminum enclosure; the
same ground point is used to connect the 3rd (earth) conductor to the chassis.
The 2” x 3.5” LED Driver Board provides the 0.72 A to drive the IsoLED XII 12 LEDs and the 9
VDC needed to drive the unit’s cooling fan (for lower audible noise). It also generates the 5 VDC
for the logic circuitry of the Control Bd.
The 2” x 3.5” Control board provides all of the control signals needed by the system and the
interface between the membrane switch assembly and it. The dimming DC signal used by the 3A
LED Driver is also provided by this sub-assembly.
The Light Engine contains the unit’s 12 LEDs and optics, mounted on a MCPCB, plus a 10 K
thermistor to measure the junction temperature of the LEDs. It also has the heat sink together
with the cooling fan to dissipate the heat produced by the LEDs and additional unit’s circuitry.
The mobile stand has a 3-male-pins AC receptacle that accepts a 3 –18 AWG, 8 ft. power cord.
Additionally, the stand has a 3-conductor rotary joint to allow for 3 dimensional movements of the
head.

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Membrane
Switch
Assembly
AC INPUT
4
3
2
1
1
2
3
V ctr
Rtn.
Enable 2
1
3
4
3
2
1
1 2 3 4
+ 5 VDC
+ 5 VDC Rtn.
+ 30 VDC
+ 30 VDC
+ 30 VDC Rtn. + 30 VDC Rtn.
HOT
NEUTRAL
4
3
2
1
Common
Pwr On / Off
Down
Up CONTROL
BOARD
LED DRIVER
BOARD
AC to DC
CONVERTER
ISOLED XII
LIGHT ENGINE
ASSEMBLY
Figure 2.1 IsoLED XII INTERCONNECT DIAGRAM
TH 1
TH 2
Vo
Vo Rtn.
1
21 2
1
2
1
2FAN
5 VDC
5 VDC R
9 VDC
9 VDC R
J2
J3
J4
J5
J6
J1
(A1) (A3)
(A2)
(A4)
P1
J2 J3
1
2J1
J2
P1
P3 P2
P1
P2
P3
P4
P6
P5
J1
GROUND E

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Figure 2.2 40 watts AC to DC Power Supply Specifications
91 %

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Figure 2.3 Alternative 40 watts Power Supply Specifications

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10. Theory of Operation
The membrane switch assembly controls the complete unit. It consists of three momentary SPST
switches: The Power ON switch, the down switch and the up switch; their outputs go to the Control
Board to be conditioned and processed. By depressing once the power ON switch (momentary
connection to ground), the signal goes to a delay circuit comprised of one-shot U12 and set –reset
flip flop U11. The resulting signal (LED Driver Enable) is sent to the LED Driver Board to turn on
various DC voltages on the board.
The Control Board takes the output of the two remaining membrane switches (down and up) and
converts the duration that they are pressed into a digital value produced by an 8 bit up/down
counter comprised of U1 and U2, the counter drives an 8 bit D/A converter (U7) whose output,
after being conditioned by U13a, feeds the Led Driver Board as the V control signal which controls
the light intensity of the system; this set intensity value is stored in memory while unit is operating,
eliminating any set ability drift.
The LED Driver Board provides the + 5 VDC needed by the Control Board, and when the Enable
signal is high, it turns on the switched + 9 VDC for the fan and the constant current (0.72 A) drive
to the 12 LEDs on the Light Engine. It also takes the 0 to 1.25 volts Control signal to provide the
dimming of the 12 LEDs (1.25 VDC equal maximum intensity).
The AC to DC power supply takes the universal AC input power and converts it to 30 VDC to
supply the LED Driver Board to generate all of the dc voltages required by the system.
11. Isolux XII Performance
The unit’s performance is depicted in Figure 4.1: IsoLED XII Specifications and Figure 4.2:
Efficiency Calculations.

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Figure 4.1 ISOLED XII SPECIFICATIONS
Typical Optical Power @ 0.5 meters
> 110,000 lux
Typical Optical Power @ 1 meter
> 50,000 lux
Spot Size
13 cm
Color temperature
4000 º K Typical
CRI (Color Rendition Index)
95 typical
LED Life
> 50,000 hours
Power Consumption
32 watts
Dimming Range
3 to 100 %
Audible Noise
< 26 dBA
Safety Standards
CAN/CSA C22.2 No. 601.1-M90,
UL60601-1, IEC 60601-2-41
Energy Star
The unit’s design complies and
surpasses Energy Star requirements.
Operating Temperature Range
- 10 º C to + 50 º
Storage Temperature Range
- 10 º C to + 70 º
Operating Humidity
10 to 90 % RH, non-condensing
Head Rotation
Vertical ± 40º, Horizontal 345º, Head
360º
AC Input Voltage Range
Universal: 100 to 240 VAC
Input Frequency
47 to 63 Hz.
Head Assembly Dimensions
5” diameter by 7.625” long
Head Assembly Weight
4.28 pounds

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Figure 4.2 Efficiency Calculations
1.44 A @ 20.52 VDC
LEDs Drive
Fan Drive
9 VDC @ 0.092 A
Logic Supply
5 VDC @ 0.05 A
3 A LED
DRIVER
40 WATTS
POWER SUPPLY
UNIVERSAL
AC POWER
Efficiency : 91%
29.84 VDC
@ 1.121 A
33.45 W
29.55 W
0.83 W
0.25 W
36.75 W
TOTAL LOAD: P Led + P fan + P logic = 30.63 Watts
Efficiency : 91.5%
The total electrical efficiency is = 0.9x 0.91 = 0.82 %
The typical illumination at 1 meter was measured at 55,000 lux
The overall efficiency of the system is equal to: 55,000 lux / 36.75 watts = 1496 lux / watt

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12. Mechanical Specifications and Options
The general mechanical specifications for the Ondal’s Acrobat Swing arm are shown in Figure
5.1 and the three mounting options are depicted in Figure 5.2.
The complete Head assembly and its components (sub-assemblies) are depicted in Figure 5.3
and the Switch assembly is depicted in Figure 5.4.
Figure 5.1 ACROBAT Swing Technical Data
Models
Ceiling mounted
Wall mounted
Mobile floor unit
Maximum load capacity
of spring-balanced arm:
3 kg - 720 mm
6 kg - 550 mm length
Load ranges: 1-2, 2-3, 3-6 kg
Extension arm: 800 mm
Features: comfortable load adjustment
Safety factor: 4-times pay load towards the
yield strength according to EN 60601
Electricity -
non-stop 3-pole rotating commutator:
230 V, 16 Amp., 1.5 mm2
Initiating Force at: 2N
Color: RAL 9010 (pure white)
Approvals: VDE, CE, UL

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Ceiling unit
Figure 5.2 ISOLED XII Mounting Options
Mobile Floor unit