Keeler Spectra Iris Instructions For Use Manual

Download

Page 1

Spectra Iris

Indirect Ophthalmoscope

Instructions for use

Page 2

Contents

Page

1. Copyright and trademarks ................................................... 3

2. Introduction ........................................................................... 4

3. Symbols ..................................................................................5

4. Safety ..................................................................................... 6

• Device classification

• Warnings

• Cautions ...........................................................................7

• Safety considerations ...................................................... 8

5. Setting up and using the Spectra Iris .................................. 9

• Description of the product

• Fitting the Spectra Iris to the frame ............................ 10

• Frame adjustments ........................................................ 11

• Aperture Lever .............................................................. 12

• Filter selection control

• Mirror angle control

6. Chargers, battery packs and power supply 14

• Power supply assembly

• Charging the battery pack ........................................... 15

• Charge time / belt clip .................................................. 16

7. Cleaning instructions .......................................................... 17

8. Specifications and electrical ratings .................................. 18

• Electrical specifications

• Transport, storage and operation

9. Annex I – EMC statement and guidelines ......................... 19

10. Spare parts and accessories ................................................ 24

11. Warranty .............................................................................. 25

12. Contact and disposal information ..................................... 26

• Interpupillary distance setting control ........................ 13

Click on the headings above to go directly to that section.

Use the buttons on the right to navigate the document.

Clicking ‘Home’ from any page brings you back to this contents page.

Back

Page 3

1. Copyright and trademarks

The information contained within this manual must not be reproduced in

whole or in part without the manufacturer’s prior written approval.

As part of our policy for continued product development we reserve the

right to make changes to specifications and other information contained

in this document without prior notice.

Spectra Iris is a registered trademark of Keeler Ltd 2012.

Published in the UK 2012.

Home

Back

Page 4

2. Introduction

Thank you for purchasing the Keeler Spectra Iris Indirect

Ophthalmoscope.

We have taken the greatest care in the design,

development and manufacture of

this product to ensure that you get

many years of trouble free service.

However, it is important that you read

the descriptions, installation and operating

instructions carefully prior to installing or

using your new indirect ophthalmoscope.

Please read and follow these instructions carefully.

Home

Back

Page 5

3. Symbols

Keep dry

Material suitable

for recycling

Read user instructions for warnings, cautions and

additional information

The CE mark on this product indicates it has been

tested to and conforms with the provisions noted

within the 93/42/EEC Medical Device Directive

Consult instructions for use

Double insulated

Manufacturer's name and address

This Symbol on the product or on its packaging

and instructions indicates that it was put on the

market place after August 2005 and that this

Follow instructions for use

High voltage

Trip hazard

Optical radiation hazard

Hot surface

Non-ionizing radiation

This way up

Keep dry

product shall not be treated as Household Waste

Type B protections against shock

Mandatory action sign

Fragile

Material suitable

for recycling

Home

Back

Page 6

4. Safety

Device classification

CE Regulation 93/42 EEC: Class I

FDA: Class II

Carefully read this Instruction Section before using your Keeler

product. For your own safety and that of your customers

observe all cautionary information provided in this section. The

following information is intended to highlight potential safety

hazards that can be associated with misuse, or damage.

Warnings and cautions

Warning

• Check your Keeler product for signs of transport / storage

damage prior to use

• Do not use if the product is visibly damaged, and periodically

• 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

• US Federal law restricts this device to sale by or order of a

physician or practitioner

Do not fit mains power adapter into a damaged mains

outlet socket

Route power cords safely to eliminate risk of tripping or

damage to equipment

Bulbs / LED’s can reach high temperatures in use – allow

to cool before handling

inspect for signs of damage

• Do not use in the presence of flammable gases / liquids, or in

an oxygen rich environment

• This product should not be immersed in fluids

• Do not disassemble or modify the battery. There are no

serviceable parts inside

Do not exceed maximum recommended exposure time

After removal of the bulb / LED do not touch the bulb /

LED contacts and the patient

simultaneously

Home

Back

Page 7

4. Safety

Caution

• 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 10

• 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

• For indoor use only (protect from moisture)

• When replacing lithium battery pack, turn indirect off and

attach new pack

• Remove batteries when device may not be used for prolonged

periods

• Ensure battery orientation is correct, or personal injury /

damage to equipment may occur

• Care should be taken when handling halogen bulbs. Halogen

bulbs can shatter if scratched or damaged

• 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

• Dispose of batteries in line with local environmental

regulations

• At product end of life dispose of in accordance with local

environmental guidelines (WEEE)

• 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

Note: Lithium Ion batteries contain no toxic heavy metals

such as mercury, cadmium or lead

Home

Back

Page 8

4. Safety

Safety considerations

It is well established that exposure of the eye to intense light

sources for extended periods of time poses a risk of retinal

photic injury. Many ophthalmic instruments illuminate the eye

with intense light. The decision about the intensity of the light

level to use in any procedure must be made on a case to case

basis. In each case, the clinician must take a risk benefit

judgement about the intensity of light to be used. Use of

insufficient intensity may result in inadequate visualization and

in adverse effects more serious than retinal photic damage.

Further, despite all efforts taken to minimise the risk of retinal

damage, damage may still occur. Retinal photic injury is a

possible complication of the need to use bright light clearly

visualize ocular structure during delicate ophthalmic surgical

procedure.

While no visible retinal lesions have been identified for

ophthalmic instruments, it is recommended that illumination

levels be set to the minimum level necessary to perform the

diagnostic function. Young children and persons with diseased

eyes may be at a higher risk. The risk may also be increased if

the person being examined has had any exposure with the same

instrument or any other ophthalmic instrument using an intense

visible light source during the previous 24 hours. This will apply

particularly if the eye has been exposed to retinal photography.

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 guidelines

after 27 minutes.

Home

Back

Page 9

5. Setting up and using the Spectra Iris

Description of the Product

A Frame

B Hinge

C Aperture Lever

D Filter Selector

E Mirror Angle

F Interpupillary Distance Control

G Mounting Holes

Home

Back

Page 10

5. Setting up and using the Spectra Iris

Frame (A)

1. Fit the Spectra Iris head unit into the frame (A)

via the pin mounting system as shown.

2. The prescription lens frame (if required)

is fitted as shown.

Prescription lens frame in correct position

Home

Back

Page 11

5. Setting up and using the Spectra Iris

Frame (A)

3. The nose bridge is fitted by sliding into the slot as shown.

4. 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.

Please note: Care must be taken not to overtighten

the screws during this process, or the equipment

may be damaged.

5. Once the desired position has been

confirmed this can be locked more

securely in position by gently

tightening the screws circled.

Home

Back

Page 12

5. Setting up and using the Spectra Iris

Filter selection control (D)

By sliding the lever (D) in direction of the arrows, different filters

may 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.

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.

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 right.

Home

Back

Page 13

5. Setting up and using the Spectra Iris

Interpupillary Distance Setting Control (F)

Because the eyes are dissociated, particular care must

be taken to ensure the optics (eyepieces) are set properly

in front of each eye.

Place an object, perhaps the thumb, 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.

Home

Back

Page 14

6. Charger – power supply assembly

Set Plug

Replace the blanking plate with the appropriate mains plug

adaptor if required, or use IEC 60320 TYPE 7 connector

(not supplied).

IEC 60320 TYPE 7 connector

Home

Back

Page 15

6. Charger – lithium battery

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 below.

A yellow LED indicates battery pack’s charge state as below:

Green LED Charging storage unit powered

No yellow LED 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.

Home

Back

Page 16

6. Charger – lithium battery

Charge 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 into

socket as shown.

Belt Clip

The belt clip can be used

for those who prefer to

carry the unit on a belt.

Home

Back

Page 17

7. Cleaning

• Only manual non-immersion cleaning as described should be

used for this instrument

• Do not autoclave or immerse in cleaning fluids

Always disconnect power supply from source

before cleaning

a Wipe the external surface with a clean absorbent, non-

shedding cloth dampened with a water / detergent solution

(2% detergent by volume) or water / isopropyl alcohol

solution (70% IPA by volume). Avoid optical surfaces

b Ensure that excess solution does not enter the instrument. Use

caution to ensure cloth is not saturated with solution

c Surfaces must be carefully hand-dried using a clean non-

shedding cloth

d Safely dispose of used cleaning materials

Home

Back

Page 18

8. Specifications and electrical ratings

Input mains data: 100-240V – 50/60Hz

Power supply rating: 12V : 2.5amps

Operation: Continuous

Classification: Class II equipment

Type B protection against shock

Transport, storage and operating conditions

Transport Storage Operation

Temperature

range

Relative

humidity

-40°C

to +70°C

10% to 95% 10% to 95% 30% to 75%

-10°C

to +35°C

+10°C

to +35°C

Home

Back

Page 19

9. Annex I – EMC statement and guidelines

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 this instrument, resulting in malfunctioning.

Home

Back

Page 20

9. Annex I – EMC statement and guidelines

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 60601 Test level Compliance level Electromagnetic environment - guidance

Electrostatic discharge (ESD). IEC 61000-4-2

Electrical fast transient/burst. IEC 61000-4-4

Surge. IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines. IEC 61000-4-11

Power frequency (50/60 Hz) magnetic field. IEC 61000-4-8

± 6 kV contact ± 8 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%.

± 2 kV for power supply lines ± 1 kV for input/output lines

± 1 kV line(s) to line(s) ± 2 kV line(s) to earth

<5% U (> 95% dip in U

40% U

) for 0.5 cycles

(60% dip in UT ) for 5 cycles

70% U (30% dip in U

<5% U

) for 25 cycles

(>95% dip in UT) for 5 s

± 2 kV for power supply lines N/A

± 1 kV line(s) to line(s) N/A

<5% U (> 95% dip in U

40% U

) for 0.5 cycles

(60% dip in UT ) for 5 cycles

70% U (30% dip in U

<5% U

) for 25 cycles

(>95% dip in UT) for 5 s

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.

3 A/m 3 A/m Power frequency magnetic fields should be at a level

characteristic of a typical location in a typical commercial or hospital environment.

Note UT is the a. c. mains voltage prior to application of the test level.

Home

Back

Page 21

9. Annex I – EMC statement and guidelines

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

Charger only

Harmonic emissions IEC 61000-3-2

Voltage fluctuations / flicker emissions IEC 61000-3-3

Indirect Ophthalmoscope only

RF emissions CISPR 11

RF emissions CISPR 15

Group 1 The Keeler Spectra Iris uses 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.

Class B The Keeler Spectra Iris is suitable for use in all establishments, including

domestic establishments and those directly connected to the public low-

Class A

Complies

Complies The Keeler Spectra Iris is not suitable for interconnection with other

voltage power supply network that supplies buildings used for domestic purposes.

equipment.

Home

Back

Page 22

9. Annex I – EMC statement and guidelines

Guidance and manufacturer’s declaration – electromagnetic immunity

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.

Immunity test IEC 60601 Test level Compliance level Electromagnetic environment - guidance

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.

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

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. ¹ Field 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. ² Over the frequency range 150kHz to 80 MHz, field strengths should be less than 3 V/m.

3 Vrms 150 kHz to 80 MHz

3 V/m 80MHz to 2.5GHz

3 V

3 V/m

Recommended separation distance

d = 1.2 √ p

d = 1.2 √ p 80MHz to 800 MHz d = 2.3 √ p 800MHz to 2.5GHz

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).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey¹, should be less than the compliance level in each frequency range.²

Interference may occur in the vicinity of equipment marked with the following symbol:

Home

Back

Page 23

9. Annex I – EMC statement and guidelines

Recommended separation distances between portable and mobile RF communications equipment and the Keeler Spectra Iris

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

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.2 1.2 2.3

10 3.7 3.7 7.4

100 12 12 23

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.

objects and people.

150 kHz to 80MHz d = 1.2√ p

Separation distance according to frequency of transmitter

80MHz to 800MHz d = 1.2√ p

800MHz to 2.5GHz d = 2.3√ p

Home

Back

Page 24

10. Spare parts and accessories

The following accessories are supplied with the product:

Part Number Description

1919-P-5215 Lithium battery pack

1941-P-5385

2199-P-7136 Lens cloth 2199-P-7582 Neck cord 2415-P-7001 Instructions for Use CD

The following accessories are available from the distributor:

Part Number Description

Single lithium charger (includes EP29-32777 power supply)

1201-P-6067

1201-P-6075

1205-P-7000 Spectra teaching mirror 1941-P-5350 KLED / Spectra double charger 3412-P-7002 Spectra carrying case

Contact Keeler, who can supply a choice of Volk Lenses

depending on magnification and field of view.

Large thimble depressor for Scleral Indentation

Small thimble depressor for Scleral Indentation

Home

Back

Page 25

11. 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 that batteries are covered by this warranty statement

for 1 year only.

Home

Back

Page 26

12. Contact and disposal information

Keeler Limited Clewer Hill Road Windsor Berkshire SL4 4AA England

Freephone: 0800 521 251 Tel: +44 (0)1753 857177 Fax: +44 (0)1753 827145

Keeler Instruments Inc 3222 Phoenixville Pike Building #50 Malvern, PA 19355 USA

Toll Free: 1 800 523 5620 Tel: 610 353 4350 Fax: 610 353 7814

Disposal of old Electrical and Electronic Equipment

(Applicable in the European Union and other European Countries with

separate Collection Systems).

This symbol on the product or on its packaging and instructions

indicates that it was put on the market place after August 2005 and

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 (+44 1691 676124).

EP59-19156 Issue C

Home

Back