OLCR Pachymeter Pachy 01 SL Instruction Manual

Quick reference

Check menu page 25 Position check rod page 31 Slit lamp page 9 Touch screen page 12

Exchange fuse page 32

Mains switch page 13 Printer paper page 13

Short: How to measure Sound

Touch on 'Push to start'

Close to cor"tu tu tu" (low tone) rect position "ti ti ti" Measurement (high tone) unit starts a batch of scans and... "tiuuu"

...ends with successful measurement. New measurement: Touch on result!

Note • Left and right eye are stored separately • Old measurement is deleted when a new one is started! page 2 / 37

4.1

Touch screen

page 12

4.2

Startup

13

4.3

Observer ID

13

4.4

Stand-by / Wake up

13

4.5

Shut down

14

4.6

Overview main screen

14

4.7

Overview More

15

4.8

How to measure Corneal thickness

16

4.9

Print

16

4.10 Change from Corneal to Epithelial

17

4.11 How to measure Epithelial thickness

17

4.12 Right / Left eye

18

4.13 Stop measurement

18

4.14 Patient before measurement

18

4.15 Patient identification

18

4.16 Position on eye

18

4.17 Patient after measurement

19

4.18 Residual Stroma Thickness

19

4.19 Flap thickness

19

4.20 Ablation zone

19

4.21 Spherical equivalent

19

4.22 Calculation of RST

19

4.23 Tonometry

20

4.24 Tonometric IOP

20

4.25 User-set Slope/Zero-Point

21

4.26 Default Slope/Zero-Point

21

4.27 Select user-set Slope/Zero-Point

22

4.28 Observer

23

4.29 n (Cornea)

23

4.30 Statistics

24

4.31 Check

25

4.32 CT-limits (Cornea Thickness)

26

4.33 Measurement mode

26

4.34 Set Date

27

4.35 Set Time

27

4.36 Sound

27

4.37 Stand-by

27

4.38 Aiming beam

27

4.39 Ser(ial) Out

28

4.40 Software version

28

4.41 Polar(isation) Adjust

28

4.42 Ex(ternal) Printer

28

© HAAG-STREIT AG, CH-3098 Koeniz, Switzerland

1500.7200517.02010

Contents Introduction / Purpose of use What this manual describes Quick reference Short: How to measure

page 1 2 2

1

Description of the equipment

4

1.1 1.2 1.3

Standard equipment Accessories Options

5 5 5

2

Operating safety

6

2.1 2.2 2.3 2.4 2.5 2.6

Safety Regulations Transportation, storage and installation Notes on usage Statutory requirements Light emission from instrument Caution

6 6 6 7 7 7

3

Operating

8

3.1 3.2 3.3 3.4 3.5 3.6

Internal Printer Measurement procedure - General Measurement procedure - Central Pachymetry Measurement procedure - Peripheral Pachymetry Measurement conditions Checklist if measurement is difficult

8 9 10 11 11 11

4

Software

12

4.1 4.6 4.8 4.12 4.23 4.28 4.34 4.40

General Overview Main screen / More Measure Cornea / Measure Epithelium Patient data Tonometry Measurement parameters Settings instrument Service

12 14 16 18 20 23 27 28

Appendix A Troubleshooting

28

A.1 A.2

29 30

Software Hardware

Appendix B Equipment maintenance routines

31

B.1 B.2 B.3

31 32 32

Check procedure with check rod Cleaning of the optical parts Exchange of fuse

Appendix C Technical specifications Appendix D Scientific basis and references IOP / RST / Various

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33 35

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1

Description of the equipment

9 10

1 2

A

11 12

3

13

18 4 14

15 16

5 B 6 7 8

17 C

Overview OLCR Pachymeter / Slit lamp BQ 900 ® / Instrument Table HSM 901

page 4 / 37

© HAAG-STREIT AG, CH-3098 Koeniz, Switzerland

1500.7200517.02010

1.1

Standard equipment

1.2

Accessories

1

Connection tube (fixed to headrest)

A

Check rod HS-Part Number 1006164

2

Measurement Head B

3

Slitlamp BQ 900® (could also be: BM 900, BM 900® V or BC 900®)

Fuse for base module HS-Part Number 1006163 (a set of 2 fuses)

C 4

Cable channel

Thermo paper HS-Part Number 1006132 (box containing 5 rolls)

6

OLCR Base Module

7

Legend plate of OLCR system

8

Power connection

9

Measurement head connecting cable

10

Parking station (accepts tonometer or measurement head)

11

Touch Screen

12

Control panel Legend plate of operating unit on backside

13

Control panel Holder

14

Connection Cable of Control panel

16

Mains switch of OLCR Pachymeter

17

Internal Printer

18

Cable for PC / Laptop connection (RS 232) [OLCR Pachymeter PC Software]

1.3

Options

5

OLCR Base Module - variant: not fixed on table, with longer cable

15

Instrument Table HSM 901

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© HAAG-STREIT AG, CH-3098 Koeniz, Switzerland

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2

Operating safety

2.1

Safety Regulations

The following instructions should be observed to ensure the safety of patients:

• The OLCR Pachymeter should be verified for damage after unpacking. Functional verifications is to be carried out according to Appendix B. • The equipment may only be operated with the listed accessories according to the operating instructions or in accordance with the separate operating instructions supplied with the accessories.

• Only a hospital grade 3-conductor electrical power supply cable must be used. For USA and Canada • Power cord: Only a hospital grade 3-conductor electrical power supply cable must be used. Detachable Power Supply Cord Set, UL Listed, type SJE, SJT or SJO, 3 conductor not smaller than 18 AWG.

2.2

Transportation, storage and installation

• The OLCR Pachymeter may only be exposed to the following environmental/ambient conditions for 1. Shipment (in the packaging): temperatures from -40 °C to +70 °C a relative humidity range from 10 % to 95 % a range of air pressures from 500 hPa to 1060 hPa The equipment should be allowed to adjust to the ambient temperature of the new location for several hours in the packaging, to avoid the forming of condensation. 2. Storage conditions: temperatures from -10 °C to +55 °C a relative humidity range from 10 % to 95 % a range of air pressures from 700 hPa to 1060 hPa 3. Ambient conditions: temperatures from +10 °C to +35 °C a relative humidity range from 30 % to 75 % a range of air pressures from 800 hPa to 1060 hPa • Do not store or use this instrument in damp rooms. Avoid dripping or splashing fluids near the instrument. • Defective equipment should always be transported in the original HAAG-STREIT packaging!

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2.3

Notes on usage

• Only qualified and trained personnel may operate the equipment • The training of the operating personnel is the responsibility of the equipment user • This type of sensitive measuring equipment is to be checked after exposure to external force (e.g. unintentional shocks or being allowed to fall) in accordance with Annex B and if necessary, is to be returned to the works for repair. • Reinstatement routines on, and alterations to, the equipment may only be carried out by authorised service technicians or by other authorised persons • The manufacturers of the equipment will not be liable for any loss or damage resulting from unauthorised intervention in the equipment. All ensuing warranty claims will, in addition be deemed null and void as a result • Cleaning of the OLCR Pachymeter should be carried out by means of a slightly moistened cloth. No fluid should be permitted to penetrate into the equipment (for this purpose soap suds can be employed, but no corrosive agents). No direct spraying! • It is hazardous to operate the equipment in locations where combustible gases or vapors could be present. The use of the equipment in the presence of volatile solvents such as alcohol, benzol or similar chemical products, as well as flammable anaesthetic agents is also hazardous. • The built-in power supply unit is short-circuitproof and does not contain externally accessible fuses. • Electrical hazards to patients and operators are eliminated if the instrument is properly used.

© HAAG-STREIT AG, CH-3098 Koeniz, Switzerland

1500.7200517.02010

• The electrical supply should always be switched off after operating the appliance by switching off at the base unit.

2.4

2.6

Caution

• The safety aspects and information emphasized in the instruction manual are to be observed with special care.

Statutory requirements The pictogram symbol means:

• The OLCR Pachymeter is designated as Class IIa under the EEC Directive 93/42 for medical equipment products. • All statutory accident prevention regulations are to be observed.

CAUTION Strictly observe all warning notices!

CAUTION "Laser"

• National calibrating regulations for measuring equipment are also to be observed. • Classification

"Always disconnect the electrical supply before opening the equipment!"

CE-Regulation 93/42 EEC Class IIa Application part Type B Operation mode - continuous operation

"Danger to the instrument!"

FDA Class II "Laser Class 1 Device" Safety standards EN 60601-1 CAN/CSA-C22.2 No. 601.1-M 90 UL Std. No. 2601

"Type B Product Classification Class 1 Equipment Continuous Operation"

EMC standards EN 60601-1-2; EN 61000-3-2/3

"Alternating current"

Laser safety IEC 60825-1

"Protection earth"

2.5

Light emission from instrument

• The instrument emits light in the visible and infrared spectral regions. It keeps within the limit values specified by DIN EN ISO 15004 "Ophthalmic Instruments Fundamental requirements a) and test methods".

• It is mandatory to observe the following safety precautions when operating the Instrument Table HSM-901, type M: Höhenverstellung nur mit aufgesetztem Gerät betätigen Do not use height adjustment without instrument in place Ne pas utiliser le réglage en hauteur quand l'instrument n'est pas en place

• LED / laser exit location a) Axial aiming beam / OLCR measuring beam

Patents: US Pat. 3.685.779 and other countries

HAAG-STREIT BERN SWISS MADE

b)

b) Lower aiming beam

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© HAAG-STREIT AG, CH-3098 Koeniz, Switzerland

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3

Operating the equipment

3.1

Internal Printer

LED

Advance paper button

Advance paper Press button and hold.

No paper left If there is no paper left in the printer: • LED blinks and • Indication on screen

Refill paper 1. Open door

2. Insert new paper roll as shown on picture.

Use thermopaper rolls with dimensions width: 57 mm (+/- 0.5 mm) diameter ø: 31 mm (+/- 0.5 mm)

Make sure that the thermo-sensitive side of the paper is uppermost. Scratch on the paper with your fingernail. The thermo-sensitive side of the paper will show dark traces, the other side not!

3. Close the door. LED flashes: printer is ready to operate. visible scratch on paper: this side up

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© HAAG-STREIT AG, CH-3098 Koeniz, Switzerland

1500.7200517.02010

Accessories Thermo paper HS-Part Number 1006132 Note Inferior quality or cheap thermal paper tends to fade within months. We recommend the use of good quality thermal paper.

No printer Screen indication (after "Prnt" has been pressed) shows: • system without printer, or • internal printer cable not connected (call your local HAAG-STREIT service)

3.2

Measurement procedure - General

Dimension of the measuring spot is approximately 0.1 mm. The measuring location on the cornea is the spot of convergence of the two red aiming beams. Measurements can only be made if the angle allows for perpendicular incidence of the beam on the cornea, with a tolerance of +/- 3 degrees. Two spots on cornea: Distance from slit lamp to patient either too long or too short.

Axial aiming beam

1 One spot:

2

3

Low

er a

imi

ng

bea

m

means both spots convergent, Correct distance!

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© HAAG-STREIT AG, CH-3098 Koeniz, Switzerland

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Measurement procedure

3.3

Central Pachymetry Display / Sound

What's to be done

1

The slit lamp should be perpendicular to the patient's eye. The patient looks straight into the red light (horizontal aiming beam).

2

Start measuring procedure: Touch on 'Push to start'

3

Position the axial (horizontal) aiming beam in the center of the eye

to simplify: second beam not shown here!

4

Move the slit lamp: forward (if slit lamp is too far away from the eye)

or backward (if slit lamp is too close to the eye)

5

... until the two aiming beams focus in one spot!

"tu tu tu" (each "tu" shows: close to measurement position)

if not yet successful continue:

6

Move the slit lamp slightly left and right by using the joystick without changing the distance 1)

"ti ti ti" (each "ti" is a successful thickness scan)

if not yet successful: move slightly up and down

7

... until successful measurement.

1)

"tiuuu" (confirmation and end of successful measurement)

see Appendix D

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© HAAG-STREIT AG, CH-3098 Koeniz, Switzerland

1500.7200517.02010

Measurement procedure

3.4

Peripheral Pachymetry Display / Sound

What's to be done Example 4 mm 225° (7 o'clock)

1

Position on eye needs to be entered in submenu 4.16 (Patient / Position / ... )

2

The slit lamp should be perpendicular to the patient's eye.

Fixation light

The patient looks in direction of the fixation light according to the point to be measured. to simplify: second beam not shown here!

3

Start measuring procedure: Touch on 'Push to start'

4

Position the axial (horizontal) aiming beam perpendicular to the eye (spot to be measured) (same procedure as Central Pachymetry)

then follow description as for Central Pachymetry steps 4 - 7

3.5

Measurement conditions

• Position patient and slit lamp as usual for normal cornea observation.

3.6

Checklist if measurement is difficult

• Continuous mode ON? see 4.33 • Signal level still OK? see 4.41

• Ambient light should be dimmed to a level at which the two pilot laser beams can be clearly seen. However, the ambient light should not be too low, in order to be able to distinguish a dark iris from the pupil.

• Position on eye must be correct: central or peripheral? see 4.16 • Reduce number of scans? see 4.30

• Slit lamp illumination is not essential for pachymetry.

• Aiming beam needs better visibility? see 4.38

• Magnification: low! Otherwise orientation is too difficult.

• Does the patient wear contact lenses? • Patient in normal position, perpendicular to the slit lamp, looking into the axial (horizontal) beam?

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© HAAG-STREIT AG, CH-3098 Koeniz, Switzerland

page 11 / 37

General

4

Software

4.1

Touch screen

Careful use of touch screen recommended!

CAUTION Do not touch on the screen with metallic or pointed things - to avoid damage on the screen. It has been designed to react to fingertips!

All rectangled areas on the screen can be considered as keys and react to finger touch. Note If an area is touched too long, it happens sometimes, that the next display shows a black rectangle. This phenomen is caused by the display's technology and can't be changed. Continue: simply touch on display!

These keys have consistent functionality in all displays EXIT

Leads back to Main screen

MORE

One step ahead (to more options, to next screen)

BACK

One step backwards

DELETE

Clears sign at left

OK

Confirms and goes to next step/option

PRINT

Through internal printer

DEFAULT

Values set at works. They can only be changed by HAAG-STREIT Bern.

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© HAAG-STREIT AG, CH-3098 Koeniz, Switzerland

1500.7200517.02010

General

4.2

Startup

After mains switch is turned ON...

turn on mains switch

...the "HS" logo-appears.

Automatic Test and Initialisation routines take about 10 seconds. If OK the screen switches automatically to main screen.

4.3

Observer ID

Enter OBSERVER ID number (up to 15 digits). Note • This is not a code, it's a simple means to identify the observing person in case of several observers. The number is reported eg on printout. • Observer (ID) need not be entered. Continue with OK. System ready to measure. • How to measure CORNEAL thickness: see 4.8 • How to measure EPITHELIAL thickness: see 4.11

4.4

Stand-by / Wake up

After not being used for 4 - 30 minutes (can be changed by user, see 4.37), the pachymeter automatically goes into Stand-by mode. To wake it up: simply touch on CONTINUE

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© HAAG-STREIT AG, CH-3098 Koeniz, Switzerland

page 13 / 37

Overview Main screen

4.5

Shut down

After last measurement: wait at least 10 seconds...

wait at least 10 seconds

... before turning off the mains switch!

turn off mains switch

Note The system should be shut down if not used for a longer period (such as lunchtime). There is no automatic shut down! Automatic stand-by see 4.37

4.6

page 27

Overview main screen

page 27 page 16 / 17

4.8 4.12 4.13 4.7 4.23 4.14

How to measure corneal thickness Right / Left eye Stop measurement More (details / submenues) Tonometry Patient

page 18

page 16

page 18

page 18 / 19 page 20 / 21 / 22 4.9

page 23

Print

page 16 / 17

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© HAAG-STREIT AG, CH-3098 Koeniz, Switzerland

1500.7200517.02010

Overview More (submenues)

4.7

Overview More

Touch MORE on main screen

Can be either before or after measurement Information on measurement

page 18

4.11 Change to Epithelial thickness meas.

page 23 page 26 page 26 page 24 page 24 page 17

Measurement parameters 4.28 4.29 4.30 4.31 4.32 4.33

Observer n(Cornea) Statistics Check CT-limits (Cornea Thickness) Measurement mode

Instrument settings 4.34 4.35 4.36 4.37 4.38 4.39

page 23

Set Date Set Time Sound Stand-by Aiming beam Ser(ial) Out

Service

page 24 page 26

page 27

page 23

page 25 page 26

page 27

page 27

page 27

page 27

page 28

page 28

page 28

4.40 Software version 4.41 Polar(isation) Adjust 4.42 Ex(ternal) Printer

page 28

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© HAAG-STREIT AG, CH-3098 Koeniz, Switzerland

page 15 / 37

Measure Cornea

4.8

How to measure Corneal thickness

With AUTO RELEASE method (see 4.33) Touch on PUSH TO START.

"tu tu tu" (low tone)

With USER CONTROL method (see 4.33): System checks if conditions are stable and goes automatically to next screen, then: Touch on PUSH TO MEASURE.

"ti ti ti" (high tone)

Measurement unit starts a batch of scans and...

"tiuuu"

...shows the RESULT (= average value)! SD: 0.1 µm = Standard Deviation of measurement New measurement: touch on result or R/L

4.9

Print

With internal printer patients data can immediately be printed. Each touch on Prnt prints on internal printer. HAAG-STREIT INTERNATIONAL

Date: 2/3/2003 Time: 09:50 Pat ID: 1234 Obs ID: 8

CAUTION All data of the right and the left eye are stored separately. The data of an eye remain stored (in other words the 'Prnt' button is visible) until: • a print-out on the internal printer is made. • this eye is measured again. • a measurement parameter is changed.

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Pachymeter

Right Eye Corneal Thickness: SD = 0.1 µm 5/3

552.5 µm

Position: Central n(cornea): 1.330 CT-Limits: 50, 900 Measure Mode: Auto Release

© HAAG-STREIT AG, CH-3098 Koeniz, Switzerland

1500.7200517.02010

Measure Epithelium

Epithelium measurement is not yet approved by the FDA, therefore this function is not available in the USA.

4.10 Change from Corneal to Epithelial (thickness measurement procedure) Touch on MORE (also possible)

Then touch on EPIT(helial)

Indication on Epithelial Thickness measurement

4.11 How to measure Epithelial thickness It is recommended to start from a successful corneal thickness measurement.

Measuring procedure same as Corneal measurement, either with AUTO RELEASE see 4.33 or USER CONTROL see 4.33 (reconfirm: PUSH TO MEAS.) USER CONTROL can be useful, because when measuring the epithelium sensitivity is automatically doubled.

Result is displayed and can be printed.

HAAG-STREIT INTERNATIONAL

Pachymeter

Date: 2/13/2003 Time: 15:39 Pat ID: 1234 Obs ID: 8

Right Eye Epithel Thickness: SD = 0.2 µm 5/3

66.9 µm

Position: Central n(cornea): 1.330 CT-Limits: 20, 100, Epithel Measure Mode: Auto Release

Note No parameter concerning epithelial thickness can be changed (such as eg CT Limits).

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change to Corneal thickness

© HAAG-STREIT AG, CH-3098 Koeniz, Switzerland

page 17 / 37

Patient data

4.12 Right / Left eye Touch on R/L area changes from Right eye R to Left eye L and back again. Instant indication which is selected, mentioned on all information screens and printouts (4.9).

4.13 Stop measurement Touch STOP stops measuring procedure at any time.

4.14 Patient before measurement Touch on PAT(ient) before measurement (1 submenu less is displayed than after measurement, see 4.17)

4.15 Patient identification Enter an up to 15 digits number for patients identification (not obligatory - but helpful!).

4.16 Position on eye Cen Sup Nas Inf Tmp

central superior nasal inferior temporal

1mm distance from center (or 2mm or 4mm)

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© HAAG-STREIT AG, CH-3098 Koeniz, Switzerland

1500.7200517.02010

Patient data

4.17 Patient after measurement

Touch on PAT(ient) after corneal thickness measurement (1 submenu more is displayed)

PATIENT IDENTIFICATION POSITION on eye

see 4.15 see 4.16

4.18 Residual Stroma Thickness Note For scientific basis and references IOP / RST: see Appendix D

4.19 Flap thickness

4.20 Ablation zone

4.21 Spherical equivalent

4.22 Calculation of RST RST = Residual Stroma Thickness Calculation of Residual Stroma Thickness must be used only when eye is in central position! Change position of measurement see 4.16

Note The RST data are part of the patients data which can be printed on the internal printer.

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Res Stromal Thickn:

289 µm

Flap Thickness : 160 µm Ablation Zone : 6.5 mm Correction (sph eq) : -7.25 D

© HAAG-STREIT AG, CH-3098 Koeniz, Switzerland

page 19 / 37

Tonometry

4.23 Tonometry

Touch TONO

Tonometry-relevant information at your fingertips

4.24 Tonometric IOP Enter Tonometric value of Right (example) / Left eye

IOP appears on screen

Go Back to measurement screen

After measurement touch on TONO

Tonofit is the corrected IOP according to measured thickness, based on the preselected Slope / Zero-Point

Notes • IOP can be entered before measurement of corneal thickness, as described above. Or it can be entered after measurement! • The tonometric data are part of the patients data which can be printed on the internal printer. • The Tono value remains active until a new value is entered.

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Position: Central n(cornea): 1.330 CT-Limits: 50, 900 Measure Mode: Auto Release

Tono: 22.5 mmHg Tonofit: 19.7 mmHg Slope [mmHg/10µm]: 0.30 Zero-Point [µm] : 520

© HAAG-STREIT AG, CH-3098 Koeniz, Switzerland

1500.7200517.02010