background image

36

  IRIDEX IQ 577

®

/IQ 532

®

 Laser Systems Operator Manual 

15510-EN Rev G

Laser Warning 

Rear panel of console 

(IQ 577)

Res
po

ns

ib

ilit

y f

or

 V

al

id

at

ion

 a

nd

 F

itness

-o

f-Us

e:

Beca
use

 V

alma
rk 

Ind

ust

rie

s, I

nc.

 ha

no

 c

ont

rol

ove

th

e us
e or
 applicatio

n o

these
 par

ts,

 it i

s t

he s

ol

e re

spo

ns

ibilit
y of

 th

O

EM
 cu

stome

r and/o

r it

s de

signate

ma

nu

fac

tur

er t

tes

t al

l c

ust

om

 part

fo

r fi

tne

ss

-of

-u

se 

and

 v

alidatio

n o

f de

sig

pr

io

r t

o accept

anc

e o

f p

roductio

n uni
ts.

  V

alma
rk I

nd

us

trie

s p

rovide

expe
rtis

e i

th

e la

you

t an

co

nsi

stent

 fab

ricatio
n o
f hig

h q
uali

ty,

 reliabl
e me
mb

ra

ne

 s

witch

cu

st

om

 g

raph

ic

s an

label
ing

 p

roduc
ts.

  V

alma
rk 

an

its 

employee

s d

NO

pur

po

rt t

o b

exper

ts

 in

 th

e en
d-

us

applicatio

n o
f ou

r c

us

tom

er

s, or
 th

en

vir

on

m

ent

s in w
hi

ch t
he

se

 p

roduc
ts

 will

 be

 st

or

ed a
nd

/o

r u

sed
.  

THI
S PR
IN

MUS

T B

APPROVE

D A
N

D

 RETURNE

D

 W
ITH
IN 2

HOU

RS

 IN

 ORDE

R FO

THI

JO

B TO PROC

EE

D WI

TH P
ROD
U

C

TION

. A
CC

EP

TA

N

CE

 OF

 TH

BE

LOW
 AR

SA

MP
LE 

RELE

A

SE

VA

LM
A

RK 

OF

 A

N

Y G
RAPH
IC

S LI

A

BI

LI

TY

 A

FT

ER

 TH

PR

O

DU
CTI

O

RUN

. (1

) V

al

ma
rk

 m

ay,

 a

t i

ts d
isc

reti
on

 u

nless ot

he

rwi

se n
ote

d, 

su

bst

itut

e  an
y m
ateria
ls o

r B

O

co

m

po

nen
ts wi
th

 eq

uiva

len
t o

sim

ila

r m
ateri

als

 an

d/

or

 co
mp
onen
ts 

base
d o
n c
on

tr

ol

 o

f c

os

t or

 

av

ai

labi
lity

RESUBMIT WITH

CORRECTIONS

APPROVED WITH

CORRECTIONS

OK AS IS

APPROVAL

SIGNATURE

DATE

APPROVAL PRINT

F

PN 65888 Rev F

2.450"

4.180"

5.680"

0.222"

0.560"

4.630"

0.730"

1.220"

5.410"

6.630"

0.526"

11.040"

R 0.637"

2X

R 0.125"

ALL CORNERS EXCEPT

WHERE NOTED

0.139"

Conforms to AAMI STD ES60601-1 & IEC STDS 60601-2-22, 60601-1-6, 62304 & 60825-1

Certified to CSA STD C22.2 Nos.  60601-1 & 60601-2-22

ETL CLASSIFIED

.010 8B35

3M468 MP

1

DIE LINE

2

GRAPHICS: WHITE

3

BLACK TEXT WITH PMS YELLOW C FIELD
BACKGROUND: BLACK

5

PMS 285C BLUE LOGO

4

NOTES:

CONSTRUCTION:

BASE MATERIAL

ADHESIVE

GRAPHIC OVERLAY

01/19/17

65888

IRIDEX

REV:

CUSTOMER:

DATE:

DATE:

1 OF 1

1:1

TOLERANCE:

UNLESS OTHERWISE SPECIFIED

DIMENSIONS ARE IN INCHES

THIRD ANGLE PROJECTION

SHEET:

SCALE:

TITLE:

APP BY:

DR BY:

Fax (925) 960-0900

Phone (925) 960-9900

www.nidec-vis.com

7900 National Dr. Livermore, CA 94550

PART #:

.XX  ±0.01” 

.XXX  ±0.010” 

TOOLING:

ANGLES

±0.5º

.XX  ±0.02” 

.XXX  ±0.015” 

CUT TO GRAPHICS:

ANGLES

±0.5º

Patent: http://iridex.com/patents.aspx

FCC ID:  UDB65600

      

       

Emergo Europe

Prinsessegracht 20

2514 AP The Hague

The Netherlands

       

LASER RADIATION

AVOID EYE OR SKIN EXPOSURE TO

DIRECT OR SCATTERED RADIATION

CLASS 4 LASER PRODUCT

CLASS 2 LASER PRODUCT

(IEC 60825-1:2007/2014)

RAYONNEMENT LASER

EXPOSITION DANGEREUSE DE

L’OEIL OU DE LA PEAU AU

RAYONNEMENT DIRECT OU DIFFUS

APPAREIL A LASER DE CLASSE 4

APPAREIL A LASER DE CLASSE 2

(CEI 60825-1:2007/2014)

Laser Warning 

Rear panel of console 

(IQ 532)

Re

sp

on

sib

ility

 for 

Va

lid

ation a
nd

 Fi

tnes
s-o

f-U

se

:

Bec

au

se

 V

alma

rk

 In

du

str

ie

s, In

c.

 ha

no

 c

on

tro

lo

ve

the

 u

se

 o

applicati

on o

th

es

pa

rts

, it

 is

 the

 sol

e r

es

po

ns

ibili

ty of

 th

OE

M

 c

us

to

m

er an

d/

or it

s de

sig

nat

ed 

ma

nu

fa

ct

ur

er t

o te

st

 a

ll c

us

tom

 par

ts f

or 

fitn

ess

-o

f-u

se

 an

d v

alidati

on

 o

f d

esi

gn

 

pr

io

r to

 accep

tanc

of p

rod

ucti

on u

nits.

  Va

lm

ark

 In

du

str

ie

s p

rov

id

es 

exp
er

tis

e i

the l

ay

ou

t an
d co

ns

isten

t fa

br

icati
on

 of

 h

ig

h qu
al

ity,

 reliab
le m

em

br

an

e s

w

itc

h, 

cu

sto

m

 g

rap

hic

s an

labe
lin

g p
rod

uc

ts

.  

Va

lm

ark

 an

its

 em

plo

yee

s do

 NO

pu

rpo

rt to

 be
 expe
rts

 in

 th

e en
d-

us

applicati

on

 o

f o

ur

 c

us

tom

ers,

 o

the

 

env

iro

nm

en

ts i

w

hi

ch

 th

es

e pr
od

uct

s w
ill b

e st
or

ed 

and

/o

r u

se

d.  

THI
S PR
IN

MU
ST B

AP

PRO
VE

D

 AN
D R
ETURN

ED

 W
IT

H

IN

 2

HO
URS
 IN

 ORDE

R F

O

R T

H

IS

 J

O

B TO PRO

CE

ED
 W

IT

PR

O

D

UC

TIO
N.

 AC
CE

PT

A

N

CE

 OF THE

 B

EL

OW 

A

RT

 S

A

M

PL

REL

EAS
ES

 

VA

LMAR
K OF 
A

N

GR

AP

H

IC

S L

IA

BIL

IT

Y AF

TE

R T

HE

 P

ROD

UC
TIO

RU
N

. (

1) 

Va

lmark

 ma
y,

 a

t its

 d

isc

ret

io

n u
nl

ess

 o

th

er

wi

se

 n

ote

d, 

su

bst

itu

te 

 an
y m
ate

rial

or 

BOM
 co
mp
one

nt

s wi
th

 e

qui
va

le

nt 

or

 

sim

ila

r m

at

er

ials

 a

nd/
or co
mp
one

nts

 b

as

ed

 on
 c

ontr
ol

 of

 c

os

t or

 

av

ai

lab

ility

RESUBMIT WITH

CORRECTIONS

APPROVED WITH

CORRECTIONS

OK AS IS

APPROVAL

SIGNATURE

DATE

APPROVAL PRINT

E

PN 65893 Rev E

0.526"

0.139"

4.180"

6.630"

5.410"

1.220"

2.450"

11.040"

0.560"

0.222"

R 0.637"

2X

R 0.125"

ALL CORNERS

EXCEPT WHERE NOTED

.010 8B35

3M468 MP

1

CUT THROUGH AREAS (8X)

2

GRAPHICS: WHITE

3

BLACK TEXT WITH PMS YELLOW C FIELD
BACKGROUND: BLACK

5

PMS 285C BLUE LOGO

4

NOTES:

CONSTRUCTION:

BASE MATERIAL

ADHESIVE

GRAPHIC OVERLAY

01/19/17

65893

IRIDEX

REV:

CUSTOMER:

DATE:

DATE:

1 OF 1

1:1

TOLERANCE:

UNLESS OTHERWISE SPECIFIED

DIMENSIONS ARE IN INCHES

THIRD ANGLE PROJECTION

SHEET:

SCALE:

TITLE:

APP BY:

DR BY:

Fax (925) 960-0900

Phone (925) 960-9900

www.nidec-vis.com

7900 National Dr. Livermore, CA 94550

PART #:

.XX  ±0.01” 

.XXX  ±0.010” 

TOOLING:

ANGLES

±0.5º

.XX  ±0.02” 

.XXX  ±0.015” 

CUT TO GRAPHICS:

ANGLES

±0.5º

Conforms To AAMI STD ES60601-1, IEC STDS 60601-2-22, 

60601-1-6, 60825-1, 62304

Certified To CSA STD C22.2 Nos 60601-1 & 60601-2-22

Patent: http://iridex.com/patents.aspx

FCC ID:  UDB65600

ETL CLASSIFIED

       

       

Emergo Europe

Prinsessegracht 20

2514 AP The Hague

The Netherlands

       

LASER RADIATION

AVOID EYE OR SKIN EXPOSURE TO

DIRECT OR SCATTERED RADIATION

CLASS 4 LASER PRODUCT

CLASS 2 LASER PRODUCT

(IEC 60825-1:2007/2014)

RAYONNEMENT LASER 

EXPOSITION DANGEREUSE DE

L’OEIL OU DE LA PEAU AU

RAYONNEMENT DIRECT OU DIFFUS

APPAREIL A LASER DE CLASSE 4

APPAREIL A LASER DE CLASSE 2

(CEI 60825-1:2007/2014)

Summary of Contents for IQ 532

Page 1: ...IRIDEX IQ 577 IQ 532 Laser Systems Operator Manual...

Page 2: ...OcuLight EndoProbe and SmartKey are registered trademarks BriteLight CW Pulse DioPexy EasyFit EasyView FiberCheck FlexFiber G Probe IQ 532 IQ 577 IQ 810 LongPulse MicroPulse MilliPulse OtoProbe Power...

Page 3: ...Using the Laser System 17 4 Troubleshooting 24 General Problems 24 Error Messages 26 5 Maintenance 29 Inspecting and Cleaning the Laser 29 Inspecting and Cleaning the Footswitch 29 Verifying the Power...

Page 4: ...Contents iv 15510 EN Rev G...

Page 5: ...ry devices are compatible with the IQ 577 and IQ 532 laser systems TxCell Scanning Laser Delivery System EndoProbe handpiece Slit Lamp Adapters SLA Laser Indirect Ophthalmoscopes LIO ENT Delivery Devi...

Page 6: ...changes because MicroPulse laser delivery is being used instead of CW and The total laser energy of such doses is only a percentage often chosen by clinicians to be 20 70 of that energy needed to prod...

Page 7: ...inclusive and is not intended to replace surgeon training or experience The regulatory information provided is applicable only in the United States If you use the laser for indications not included he...

Page 8: ...detachment Specific to laser trabeculoplasty IOP spike and disruption of the corneal epithelium Specific Warnings and Precautions It is essential that the surgeon and attending staff be trained in al...

Page 9: ...cations for Use IQ 532 Models This section provides information on the use of the laser in clinical specialties Information is provided by specialty and includes procedural recommendations along with...

Page 10: ...tinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroids including Proliferative and nonproliferative diabetic retinopathy Choro...

Page 11: ...n Ignition or perforation of endotracheal tubes by the laser beam could result in serious or fatal patient complications Use the lowest possible oxygen concentration to support the patient Use the ven...

Page 12: ...the patient s medical and wound healing history If uncertain of expected clinical response always start with a conservative setting and increase the setting in small steps 532 nm Typical Laser Treatm...

Page 13: ...1000 2500 20 100 Control of Bleeding N A 200 2500 20 100 Spot size at target is dependent on many parameters including fiber core diameter and working distance Laryngology Treatment Delivery Device Sp...

Page 14: ...ht reflective surfaces Avoid directing the treatment beam at highly reflective surfaces such as metal instruments Ensure that all personnel in the treatment room are wearing the appropriate laser safe...

Page 15: ...blems with materials or workmanship This warranty is void if service is attempted by anyone other than certified IRIDEX service personnel WARNING Use only IRIDEX delivery devices with the IRIDEX laser...

Page 16: ...IRIDEX Customer Service Representative if there are problems with your order Appearance and type of components may vary based on the system ordered Laser also Console Operator Manual not shown Power...

Page 17: ...cord included in the packaging is appropriate for your location Always use an approved three wire grounding cord set Do not alter the power inlet To ensure proper grounding follow local electrical co...

Page 18: ...PPROVAL PRINT E PN 65893 Rev E 010 8B35 3M468 MP CUT THROUGH AREAS 8X GRAPHICS WHITE BLACK TEXT WITH PMS YELLOW C FIELD BACKGROUND BLACK PMS 285C BLUE LOGO OTES CONSTRUCTION BASE MATERIAL ADHESIVE GRA...

Page 19: ...position To turn the laser off turn the key to the Off position Remove and store the key to prevent unauthorized use NOTE The key can be removed in the Off position only In an emergency press the red...

Page 20: ...llary personnel in the treatment room are wearing the appropriate laser safety eyewear 7 Select Treat mode 8 Position the aiming beam on the treatment site 9 Focus or adjust the delivery device as app...

Page 21: ...Interface A Touchscreen Interface Displays current parameter and functions and acts as the interface to select screens or parameters B Control knobs Used to adjust parameters on the screen C Laser bu...

Page 22: ...l fire when footswitch is pressed Standby Laser is disengaged Treat Laser is firing footswitch pressed H Aiming Beam and LIO adjustments I Displays pulse duration Adjust with control knob J Displays p...

Page 23: ...een MicroPulse Settings Optional A Turn MicroPulse ON or OFF B Select preset values for Duty Cycle MicroPulse duration and Interval parameters update automatically C Displays MicroPulse duration and i...

Page 24: ...the Preset Menu at the Standby screen touch PRESETS A Programmable presets B Selection button to load highlighted preset and go to Standby screen C Cancel loading preset selection and return to Stand...

Page 25: ...Pulse settings C Use control knobs to select pulse duration power and interval D Displays Preset name Press to enter Keyboard mode E Save changes and return to Treat screen F Discard changes and retur...

Page 26: ...rs 0 to 9 Do NOT use any symbols Symbols may generate a warning message Aux Device Required when a TxCell Scanning Laser Delivery System is subsequently connected to the laser console If this error oc...

Page 27: ...h laser settings C Set voice prompt Female Male OFF Use only when adjusting power with footswitch D Set Auxiliary ON in Standby or ON in Treat Operate a warning light or auditory signal outside the tr...

Page 28: ...e No treatment beam Verify that the remote interlock has not been activated Verify that the aiming beam is visible Verify that the fiber switch is in the correct position for the laser system and wave...

Page 29: ...e response threshold for consistent response Increase the laser power and or exposure duration or select a different lens Does not fit on the mounting plate OMA only Inspect and clean the mounting pla...

Page 30: ...essed Turn key off for 5 seconds then on E00701 System controller watchdog failure E01003 E01009 System needs calibration E03002 E03003 Invalid sensor reading E03010 E03020 E03040 Laser temperature in...

Page 31: ...e If installed on a room door close door to proceed E05035 Laser safety eye filter not in position System detected out of position filter while attempting to treat Verify that SmartKey is connected If...

Page 32: ...03 Missing Pulse error System unable to deliver laser pulse when it was expected Check connections and turn laser key OFF for 5 seconds then back ON W0001 Verify a 577 nm eye safety filter is in place...

Page 33: ...ay laser light to transmit WARNING Do not remove covers Removing covers and shields may result in exposure to dangerous optical radiation levels and electrical voltages Only IRIDEX trained personnel m...

Page 34: ...mage the power meter sensor 4 Set the laser Duration to 3000 ms and the Interval to Single Pulse when a CW delivery device is connected Set the Duration to 3000 ms MicroPulse Duration to 1 0 ms and Mi...

Page 35: ...del and Serial Number _______________ Calibrated by _______________ Power Measurements using a MicroPulse Delivery Device Exposure Duration ms MicroPulse Duration ms MicroPulse Interval ms Indicated P...

Page 36: ...ions not expressly approved by the party responsible for compliance could void the user s authority to operate the equipment Protection for the Physician Eye safety filters protect the physician from...

Page 37: ...resulting in unique NOHD values for each delivery device NOTE Not all delivery devices are available for all laser models IQ 577 IQ 532 NOHD Values for Various Delivery Devices Delivery Device MPE W...

Page 38: ...Standby light provides a visible warning that laser radiation is accessible When Treat mode is selected a three second delay prevents unintentional laser exposure The console delivers laser energy onl...

Page 39: ...MALS GRAPHICS ANGLES 3M 468 010 8B35 BASE MATERIAL ADHESIVE Wireless Receiver PRINT MUST BE APPROVED AND RETURNED WITHIN 24 RS IN ORDER FOR THIS JOB TO PROCEED WITH DUCTION ACCEPTANCE OF THE BELOW ART...

Page 40: ...514 AP The Hague The Netherlands LASER RADIATION AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION CLASS 4 LASER PRODUCT CLASS 2 LASER PRODUCT IEC 60825 1 2007 2014 RAYONNEMENT LASER EXPOSIT...

Page 41: ...witch Footswitch In Footswitch Out Fuse Gauge Protective Earth Ground Illuminating Probe Decrease Increase Interval Interval with MicroPulse Laser Aperture at End of Fiber Laser Warning Illumination L...

Page 42: ...aser Firing Laser Preparing Speaker Screen System Brightness Latex Free Prescription Warning Replace with fuses as indicated Specifications Specification Description Treatment wavelength IQ 577 577 nm...

Page 43: ...al 100 240 VAC 50 60 Hz 3 A Cooling Air cooled Operating temperature range 10 C to 35 C 50 F to 95 F Storage temperature range 20 C to 60 C 4 F to 140 F Relative humidity 20 to 80 non condensing Dimen...

Page 44: ...y linked and will not work with other IRIDEX footswitches or similar components Clearly identify each pair to prevent separation of the linked components NOTE The footswitch is designed to operate wit...

Page 45: ...ission frequency range The wireless footswitch has been tested and found to comply with the limits for a Class B digital device pursuant to Part 15 of the FCC Rules These limits are designed to provid...

Page 46: ...ronment Emissions Test Compliance RF emissions CISPR 11 Group 1 The laser system uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any i...

Page 47: ...1000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interrupt...

Page 48: ...eters m a Fields strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range b Interference may occur in the v...

Page 49: ...mum Output Power of Transmitter W Separation Distance According to Frequency of Transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 3...

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