Keeler Spectra Iris User manual

A world without vision loss
Spectra Iris
Indirect Ophthalmoscope
INSTRUCTIONS FOR USE

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SPECTRA IRIS by KEELER
CONTENTS
1. INDICATIONS FOR USE ........................................................................................ 3
2. SAFETY................................................................................................................. 3
2.1 PHOTOTOXICITY ............................................................................................................................3
2.2 WARNINGS AND CAUTIONS..........................................................................................................3
2.3 CONTRAINDICATION.....................................................................................................................5
3. CLEANING AND DISINFECTION INSTRUCTIONS ................................................... 5
4. SETTING UP AND USING THE SPECTRA IRIS......................................................... 6
4.1 FRAME (A), NOSE BRIDGE (B)........................................................................................................6
4.2 APERTURE LEVER (C).....................................................................................................................7
4.3 FILTER SELECTION CONTROL (D)....................................................................................................7
4.4 MIRROR ANGLE CONTROL (E)........................................................................................................8
4.5 INTERPUPILLARY DISTANCE SETTING CONTROL (F)........................................................................8
5. CHARGER – POWER SUPPLY ASSEMBLY ............................................................... 8
5.1 SET PLUG......................................................................................................................................8
6. CHARGER – LITHIUM BATTERY............................................................................. 8
6.1 CHARGING THE BATTERY PACK .....................................................................................................8
6.2 CHARGING TIME ...........................................................................................................................9
6.3 BELT CLIP ......................................................................................................................................9
7. SPECIFICATIONS AND ELECTRICAL RATINGS...................................................... 10
7.1 ELECTROMAGNETIC EMISSIONS..................................................................................................10
7.2 INTERFERENCE IMMUNITY..........................................................................................................10
7.3 ELECTROMAGNETIC IMMUNITY ..................................................................................................11
7.4 RECOMMENDED SAFE DISTANCES ..............................................................................................12
7.5 TECHNICAL SPECIFICATIONS.......................................................................................................13
8. SPARE PARTS AND ACCESSORIES ....................................................................... 14
9. WARRANTY ........................................................................................................ 14
10. PACKAGING AND DISPOSAL INFORMATION....................................................... 15

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Consult instructions for use General warning sign
Date of manufacture Warning: Electricity
Manufacturer’s name and
address Warning: Floor level obstacle
Country of manufacture Warning: Non-ionizing
radiation
Waste Electrical and Electronic
Equipment (WEEE) recycling Warning: Optical radiation
This way up Warning: Hot surface
Keep dry Conformité Européene
Fragile Type B applied part
Do not use if package is
damaged Class II equipment
Temperature limit Atmospheric pressure
limitation
Authorised representative in
the European Community Humidity limitation
Use-by date Serial number
Catalogue number Medical device
Translation
The Keeler Spectra Iris is designed and built in conformity with Directive 93/42/EEC, Regulation (EU) 2017/745 and
ISO 13485 Medical Devices Quality Management Systems.
Classification: CE: Class I
FDA: Class II
The information contained within this manual must not be reproduced in whole or part without the manufacturer’s
prior written approval.As part of our policy for continued product development we the manufacturer reserve the right
to make changes to specifications and other information contained in this document without prior notice.
This IFU is also available on the Keeler UK and Keeler USA websites.
Copyright © Keeler Limited 2021. Published in the UK 2021.

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1. INDICATIONS FOR USE
This device is intended to be used only by suitably trained and authorised healthcare
professionals.
CAUTION: Federal Law restricts this device to sale by or on the order of a
physician or practitioner.
Intended use / purpose of instrument
The Spectra Iris is indicated for examining the fundus; specifically the posterior segment
where a wider field of view is needed in order to aid in the screening and diagnosis of retinal
pathology including, but not limited to, lesions such as choroidal melanomas, papilloedema,
retinopathy of prematurity, glaucomatous disc cupping, diabetic retinopathy, hypertensive
retinopathy, retinal detachments and also help the practitioner to better understand where the
lesion is located on the retina in relation to anatomical features such as the disc.
2. SAFETY
2.1 PHOTOTOXICITY
CAUTION: The light emitted from this instrument is potentially hazardous.
The longer the duration of exposure, the greater the risk of ocular
damage. Exposure to light from this instrument when operated at
maximum intensity will exceed the safety guideline after 3 hours 24
minutes. Testing was completed with a 20D, 55mm diameter Volk lens.
While no acute optical radiation hazards have been identified for slit
lamps, we recommend keeping the intensity of the light reaching the
patient’s retina to the minimum possible for the respective diagnosis.
Children, people with aphakia and people suffering from eye conditions
are most at risk. An increased risk may also occur if the retina is exposed
to the same or a similar device with a visible light source within 24 hours.
This applies, in particular, if the retina has been photographed with a
flashbulb in advance.
Keeler Ltd shall on request, provide the user with a graph showing the
relative spectral output of the instrument.
2.2 WARNINGS AND CAUTIONS
Please note that the proper and safe functioning of our instruments is only guaranteed if
both the instruments and their accessories are exclusively from Keeler Ltd. The use of other
accessories may result in increased electromagnetic emissions or reduced electromagnetic
immunity of the device and may lead to incorrect operation.
Observe the following precautions in order to ensure safe operation of the Spectra Iris.

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WARNINGS
• Do not use if the product if visibly damaged and periodically inspect it for signs of damage
or misuse.
• Check your Keeler product for signs of transport / storage damage prior to use.
• Do not use in the presence of flammable gases / liquids, or in an oxygen rich environment.
• US Federal Law restricts this device to sale by or on the order of a physician or practitioner.
• This device is intended to be used only by suitably trained and authorised healthcare
professionals.
• This product should not be immersed in fluids.
• Do not disassemble or modify the battery. There are no serviceable parts inside.
• Do not dispose of battery in fire, puncture or short circuit.
• Do not use a battery that is deformed, leaking, corroded or visually damaged. Handle a
damaged or leaking battery with care. If you come into contact with electrolyte, wash
exposed area with soap and water. If it contacts the eye, seek medical attention immediately.
• Do not fit mains power adapter into a damaged mains outlet socket.
• Route power cords safely to eliminate risk of tripping or damage to user.
• Do not exceed maximum recommended exposure time.
• LEDs can reach high temperatures in use – allow to cool before handling.
• After removal of the LED do not touch the LED contacts and the patient
simultaneously.
CAUTION
• Refraction stand variants or adaptors should only be used in combination with EN/IEC
60601-1 and EN/IEC 60601-1-2 compliant power supplies and devices.
• Use only genuine Keeler approved parts and accessories or device safety and performance
may be compromised.
• Use only Keeler approved batteries, chargers and power supplies as per the accessories
listed in section 8.
• The product has been designed to function safely when at an ambient temperature
between +10°C and +35°C.
• Keep out of the reach of children.
• To prevent condensation from forming, allow instrument to come to room temperature
before use.

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SPECTRA IRIS by KEELER
• For indoor use only (protect from moisture).
• When replacing lithium battery pack, turn Spectra Iris off and attach new pack.
• Remove battery pack when device may not be used for prolonged periods.
• Do not charge battery in any environment where the temperature may exceed 40˚C or fall
below 0˚C.
• There are no user serviceable parts inside. Contact authorised service representative for
further information.
• Ensure battery orientation is correct, or personal injury / damage to equipment may occur.
• Ensure device is securely held in docking station to minimise risk of injury or damage to
equipment.
• Follow guidance on cleaning / routine maintenance to prevent personal injury / damage to
equipment.
• Switch off the electrical supply and disconnect from the mains electrical supply
before cleaning and inspection.
• At product end of life dispose of in accordance with local environmental
guidelines (WEEE).
• Dispose of batteries in line with local environmental regulations.
Note: Lithium Ion batteries contain no toxic heavy metals such as mercury, cadmium or lead.
2.3 CONTRAINDICATION
There is no restriction to patient population this device can be used with other than those
outlined in the contra-indications stated below.
Whilst BIO using a head mount can be performed through an undiluted pupil, the field of view
and magnification can be greatly compromised; therefore, pupillary dilation using mydriatics
is recommended in practice. Optometrists regularly perform pupil dilation to comprehensively
examine the ocular fundus as part of a comprehensive eye health examination where clinically
indicated. Furthermore, in order to gain a more peripheral view of the retina, scleral indentation
is performed as an adjunct to BIO when using a head mount.
3. CLEANING AND DISINFECTION INSTRUCTIONS
Always disconnect power supply from source before cleaning.
Only manual non-immersion cleaning as described should be used for this instrument. Do not
autoclave or immerse in cleaning fluids.
1. Wipe the external surface with a clean absorbent, non-shedding cloth dampened with
a de-ionised water / detergent solution (2% detergent by volume) or water / isopropyl
alcohol solution (70% IPA by volume). Avoid optical surfaces.

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2. Ensure that excess solution does not enter the instrument. Use caution to ensure cloth is
not saturated with solution.
3. Surfaces must be carefully hand-dried using a clean non-shedding cloth.
4. Safely dispose of used cleaning materials.
4. SETTING UP AND USING THE SPECTRA IRIS
4.1 FRAME (A), NOSE BRIDGE (B)
1. The nose bridge is fitted by sliding into
the slot as shown.
2. As the nose bridge slides into the slot
a sprung catch will engage with the
dimples on the nose bridge. This is to
allow a range of adjustment to suit the
users requirements.
3. The prescription lens frame (if required)
is fitted.
4. The prescription lens frame (if required)
and shield are fitted as shown below.
Prescription lens frame in correct position
A
B

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5. Fit the Spectra Iris head unit into the
frame (A) via the pin mounting system.
6. Once the desired position has
been confirmed this can be
locked more securely in position
by gently tightening the screws
circled.
Please note: Care must be taken not to overtighten the screws during this
process, or the equipment may be damaged.
4.2 APERTURE LEVER (C)
By sliding the lever (C) in direction of the
arrows, the size of the aperture can be
adjusted. Slide to the right to increase
aperture size, to the left to decrease. Refer to
the white dots located on the top of the
lever, as per image below.
4.3 FILTER SELECTION CONTROL (D)
By sliding the lever (D) in direction of the arrows, different filters can be selected.
Clear Select the clear with no filter when inspecting a specific pathology and a
brighter, whiter light is desired.
Green Red-free filter reduces the red light, so blood will appear black, silhouetted
against a dark background.
Blue Cobalt blue for fluorescein angioscopy.
C
D
E

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4.4 MIRROR ANGLE CONTROL (E)
The light is positioned vertically into the field of view by rotation of the levers (E) located either
side of the binocular block.
4.5 INTERPUPILLARY DISTANCE SETTING CONTROL (F)
Place an object approximately 40cm from
the face and centre it horizontally in the
light patch. Then, close one eye. Using the
thumb and forefinger of the opposite hand,
slide the P.D.Control (F) of the open eye
(located directly under each eyepiece) so
that your object moves into the centre of
the field, keeping the object in the centre of
the light patch. Repeat for the other eye.
5. CHARGER – POWER SUPPLY ASSEMBLY
5.1 SET PLUG
Replace the blanking plate with the appropriate mains plug adaptor if required, or use IEC
60320 TYPE 7 connector (not supplied).
6. CHARGER – LITHIUM BATTERY
6.1 CHARGING THE BATTERY PACK
Connect plug on cable to power input socket on side of
charger.
Turn the battery pack off. The Green LED shows charging
storage unit is powered.
Place the battery pack into the charging well as shown.
A yellow LED indicates battery pack’s charge state as below:
F

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Charging the battery pack
Green LED Charging storage unit powered
No LED light Battery charged
Flashing yellow LED Top-up charge
Solid yellow LED Rapid charge
The battery pack can be used at any time during the charging cycle and will resume charging
when battery pack is placed back in the charger.
6.2 CHARGING TIME
The battery will take approximately 3 hours to fully charge.The battery will last approximately
4 hours on full power.
Turn the illumination on by rotating the dimmer control knob in an anti-clockwise direction.
A yellow LED indicates battery pack’s charge state as below:
Flashing yellow LED
Battery requires charging
Insert connector in socket as shown. To remove the lead pull in the direction of the arrows on
the connector do not twist or unscrew
6.3 BELT CLIP
The belt clip can be used for those who prefer to carry the unit on a belt.

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7. SPECIFICATIONS AND ELECTRICAL RATINGS
The Keeler Spectra Iris is a medical electrical instrument. The instrument requires special care
concerning electromagnetic compatibility (EMC). This Section describes its suitability in terms
of electromagnetic compatibility of this instrument. When installing or using this instrument,
please read carefully and observe what is described here.
Portable or mobile-type radio frequency communication units may have an adverse effect on
these instruments, resulting in malfunctioning.
Keeler Spectra Iris and K-LED are designed with similar electrical systems and therefore share
EMC characteristics and cautions.
7.1 ELECTROMAGNETIC EMISSIONS
Guidance and manufacturer’s declaration – electromagnetic emissions
The Keeler Spectra Iris is intended for use in the electromagnetic environment specified below.
The customer or user should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
K-LED/
Spectra Only
RF emissions
CISPR 11
Group 1 The Keeler Spectra Iris and K-LED use RF energy only for
its internal function. Therefore, its RF emissions are very
low and are not likely to cause any interference in nearby
electronic equipment.
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Class A The Keeler Spectra Iris and K-LED are suitable for use in
all establishments, including domestic establishments
and those directly connected to the public low- voltage
power supply network that supplies buildings used for
domestic purposes.
Voltage fluctuations / flicker
emissions IEC 61000-3-3
Complies
Charger only RF emissions
CISPR 14-1
Complies The Keeler Spectra Iris and K-LED is not suitable for
interconnection with other equipment.
7.2 ELECTROMAGNETIC IMMUNITY
Guidance and manufacturer’s declaration – electromagnetic immunity
The Keeler Spectra Iris is intended for use in the electromagnetic environment specified below.
The customer or the user should assure that it is used in such an environment
Immunity test IEC 55015 Test
level
Compliance
level
Electromagnetic
environment – guidance
K-LED/Spectra Only
Electrostatic
discharge (ESD).
IEC 61000-4-2
± 8 kV contact
± 15 kV air
± 8 kV contact
± 15 kV air
Floors should be wood, concrete
or ceramic tile.
If floors are covered with synthetic
material, the relative humidity
should be at least 30%.

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Immunity test IEC 55015 Test
level
Compliance
level
Electromagnetic
environment – guidance
Power frequency
(50/60 Hz)
magnetic field.
IEC 61000-4-8
30 A/m 30 A/m Power frequency magnetic fields
should be at a level characteristic
of a typical location in a typical
commercial or hospital environment.
Charger only
Electrical fast
transient/burst.
IEC 61000-4-4
± 1 kV for power
supply lines
± 1 kV for input/
output lines
± 1 kV for power
supply lines
N/A
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge.
IEC 61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines.
IEC 61000-4-11
<5% UT
(> 95% dip in UT) for
0.5 cycles
40% UT
(60% dip in UT) for
10 cycles
70% UT
(30% dip in UT) for
25 cycles
<5% UT
(> 95% dip in UT) for
0.5 cycles
40% UT
(60% dip in UT) for
10 cycles
70% UT
(30% dip in UT) for
25 cycles
Mains power quality should be
that of a typical commercial or
hospital environment.
If the user of the Keeler Spectra
Iris requires continued operation
during power mains interruptions,
it is recommended that the
charger be powered from an
uninterruptible power supply.
Note: UTis the a. c. mains voltage prior to application of the test level.
Immunity
test
IEC 60601
Test level
Compliance
level
Electromagnetic environment
– guidance
Charger only Portable and mobile RF communications equipment
should be used no closer to any part of the Keeler
Spectra Iris, including cables, than the recommended
separation distances calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
d = 1.2 √ p
d = 1.2 √ p 80MHz to 800MHz
d = 2.3 √ p 800MHz to 2.7GHz
Where p is the maximum output power rating of the
transmitter in watts(W) according to the transmitter
manufacturer and d is the recommended separation
distance in metres(m).
Conducted
RF IEC
61000-4-6
3 Vrms
150 kHz to
230 MHz
3 V
Spectra/K-LED only
Radiated
RF IEC
61000-4-3
10V/m
80MHz to
2.7GHz
10 V/m

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Immunity
test
IEC 60601
Test level
Compliance
level
Electromagnetic environment
– guidance
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey¹,
should be less than the compliance level in each
frequency range².
Interference may occur in the vicinity of
equipment marked with the this symbol.
Note 1: At 80MHz and 800MHz, the higher frequency range applies.
Note 2: These guide lines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people
1Field strengths from fixed transmitters, such as base stations ( cellular / cordless) telephones and land mobile
radios, amateur radio,AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy.To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the Keeler Spectra Iris is used exceeds
the applicable RF compliance level above, the Keeler Spectra Iris should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orientating or relocating the
Keeler Spectra Iris.
2Over the frequency range 150kHz to 230 MHz, field strengths should be less than 3 V/m.
7.3 RECOMMENDED SAFE DISTANCES
Recommended separation distances between portable and mobile RF communications
equipment and the Keeler Spectra Irisr.
The Keeler Spectra Iris is intended for the use in an electromagnetic environment in which
radiated RF disturbances are controlled.The customer or the user of the Keeler Spectra Iris
can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the Keeler Spectra Iris
as recommended below, according to the maximum output power of the communications
equipment.
Rated maximum output
power of transmitter (W)
Separation distance according to frequency of
transmitter (m)
150 kHz to 230MHz
d = 1.2√ p
80MHz to 800MHz
d = 1.2√ p
800MHz to 2.7GHz
d = 2.3√ p
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23

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For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in metres (m) can be determined using the equation applicable to the
frequency of the transmitter, where p is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.
Note: 1 At 80MHz and 800MHz, the higher frequency range applies.
Note 2: These guide lines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
7.4 TECHNICAL SPECIFICATIONS
Power Supply
Input mains data: 100-240V – 50/60Hz
Power supply rating: 12V : 2.5amps
Operation: Continuous
Classification: Class II equipment
Type B applied part
Environmental Conditions:
USE
35°C
10°C
90%
30%
1060 hPa
800 hPa
Shock (without packing) 10 g, duration 6 ms
STORAGE CONDITIONS
55°C
-10°C
95%
10%
1060 hPa
700 hPa
TRANSPORT CONDITIONS
70°C
-40°C
95%
10%
1060 hPa
500 hPa
Vibration, sinusoidal 10 Hz to 500 Hz: 0.5g
Shock 30 g, duration 6 ms
Bump 10 g, duration 6 ms

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8. SPARE PARTS AND ACCESSORIES
Item Part Number
Teaching Mirror 1202-P-7205
Battery pack 1919-P-5282
Charger 1941-P-5414
Volk 20D Black Condensing Lens 2105-K-1159
Lens Cloth 2199-P-7136
Neck cord 2199-P-7582
Spectra Iris Carry Case 3412-P-5354
9. WARRANTY
No user serviceable parts – all preventative maintenance and servicing must only be performed
by authorised Keeler representatives.
Your Keeler product is guaranteed for 3 years and will be replaced, or repaired free of charge
subject to the following:
• Any fault due to faulty manufacture
• The instrument and accessories have been used in compliance with these instructions
• Proof of purchase accompanies any claim
Please note:
Batteries are covered by this warranty statement for 1 year only.

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10. PACKAGING AND DISPOSAL INFORMATION
Disposal of old electrical and electronic equipment
This symbol on the product or on its packaging and instructions indicates
that this product shall not be treated as household waste.
To reduce the environmental impact of WEEE (Waste Electrical Electronic
Equipment) and minimise the volume of WEEE entering landfills we
encourage at product end of life that this equipment is recycled and reused.
If you need more information on the collection reuse and recycling then please
contact B2B Compliance on 01691 676124 ([phone]). (UK only).
Any serious incident that has occurred in relation to the device must be reported to
the manufacturer and the competent authority of your Member State.

A world without vision loss
Contact
Manufacturer
Keeler Limited
Clewer Hill Road
Windsor
Berkshire
SL4 4AA UK
Freephone 0800 521251
Tel [phone]
Fax[phone]
EP59-19156 Issue E Date of Issue 12/05/2021
USA Sales Office
Keeler USA
3222 Phoenixville Pike
Building #50
Malvern, PA 19355 USA
Toll Free 1 800 523 5620
Tel [phone]
Fax [phone]
India Office
Keeler India
Halma India Pvt. Ltd.
Plot No. A0147, Road No. 24
Wagle Industrial Estate
Thane West – 400604,
Maharashtra
INDIA
Tel [phone]
China Office
Halma China Group
名称：沃迈（上海）机电有
限公司
地址：上海市闵行区金都路
1165弄123号23幢一号厂房
三层B座
电话：[phone]
Visiometrics, S. L., Vinyals, 131
08221 Terrassa, Spain