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.