Instrumentarium Dental OP-200, OC-200 User Manual

ENGLISH

Orthopantomograph® OP200

Orthoceph® OC200

User Manual & Technical Specifications

5139539-100 rev. 2

Document code: D500318 rev 2

Orthopantomograph

and Orthoceph® are registered trademarks of Instrumentarium Dental. U.S. patents 6,731,717, 6,829,326 and USRE41197. Finnish patents 114383. Windows

is trademark of Microsoft Corporation in the United States of America and other countries. Pentium

Iomega

Jaz® is a registered trademark of Iomega Corp.

is a registered trademark of Intel Corporation.

Documentation, trademark and the software are copyrighted with all rights reserved. Under the copyright laws the documentation may not be copied, photocopied, reproduced, translated, or reduced to any electronic medium or machine readable form in whole or part, without the prior written permission of Instrumentarium Dental.

The original language of this manual is English.

Instrumentarium Dental reserves the right to make changes in specification and features shown herein, or discontinue the product described at any time without notice or obligation. Contact your Instrumentarium Dental representative for the most current information.

Manufactured by Instrumentarium Dental, PaloDEx Group Oy

P.O. Box 20 FI-04301 Tuusula FINLAND Tel. +358 45 7882 2000 Fax. +358 45 7882 2506

For service, contact your local distributor.

Table of Contents

1 Introduction ..............................................................................................1

1.1 General ................................................................................................................. 1

1.2 Markings and graphics symbols............................................................................ 2

1.3 Type and version................................................................................................... 3

1.4 Options, accessories and manuals ....................................................................... 4

1.5 Radiation protection guidelines ............................................................................. 5

1.5.1 Protection by distance ...........................................................................................5

1.5.2 Laser lights ............................................................................................................6

1.5.3 Control from a protected area ...............................................................................6

1.5.4 Emergency Stop Switch ........................................................................................7

1.6 Manufacturer’s liability........................................................................................... 8

1.7 Disposal ................................................................................................................ 8

2 OP200 controls.........................................................................................9

2.1 Main parts ............................................................................................................. 9

2.2 OC200 ceph main parts ......................................................................................11

2.3 Control panel.......................................................................................................14

2.4 Positioning panels ............................................................................................... 17

2.5 Patient positioning accessories........................................................................... 18

2.6 Optional accessories & disposables ...................................................................19

2.7 Changing the fuses .............................................................................................20

3 Equipment preparations........................................................................ 21

3.1 Care Instructions .................................................................................................21

3.2 Cleaning recommendations ................................................................................ 21

3.2.1 Cleaning ..............................................................................................................21

3.2.2 Disinfection and sterilization................................................................................22

3.2.2.1 Autoclave ....................................................................................................... 22

3.2.2.2 Steam sterilization.......................................................................................... 22

3.2.2.3 Ethylene oxide sterilization............................................................................. 23

3.2.3 Other sterilization processes ...............................................................................23

3.2.3.1 Dry heat sterilization....................................................................................... 23

3.2.3.2 Liquid chemical sterilant gases ...................................................................... 23

3.2.3.3 Chemical sterilant gases ................................................................................ 23

3.3 Loading the panoramic cassette ......................................................................... 24

3.4 Cephalostat cassette loading .............................................................................. 26

4 Panoramic procedures .......................................................................... 29

4.1 P1: Standard panoramic exposure...................................................................... 29

4.2 P2: Pediatric panoramic exposure ......................................................................34

4.3 P3: Ortho Zone enhanced panoramic exposure ................................................. 36

4.4 P4: Orthogonal exposure ....................................................................................37

4.5 P5: Wide arch panoramic exposure .................................................................... 38

5 Special imaging procedures ................................................................. 41

5.1 P6: TMJ, Lateral projection .................................................................................41

5.2 P6: Ortho TMJ, axial corrected lateral projection (optional) ................................ 44

5.3 P7: Open - closed TMJ, lateral projection ........................................................... 47

5.4 P8: TMJ, posteroanterior projection .................................................................... 49

5.5 P9: TMJ, lateral & PA projection ......................................................................... 50

5.6 P10: Maxillary sinus view .................................................................................... 51

5139539-100 rev 2 Instrumentarium Dental i

6 Cephalometric procedures (optional) .................................................. 55

6.1 P11: Cephalo lateral projection ........................................................................... 55

6.2 P12: Cephalo posterior-anterior (PA) projection ................................................. 58

6.3 P7: Axial view of the mandible exposure ............................................................59

6.4 P5: Rewerse Towne projection exposure ........................................................... 60

6.5 P5: Waters view exposure .................................................................................. 61

6.6 P7: Carpus View exposure (optional).................................................................. 62

6.7 P13: Ortho Trans mandible exposure (optional) ................................................. 63

6.8 P14: Ortho Trans maxilla exposure (optional)..................................................... 63

7 Imaging technique ................................................................................. 65

7.1 Recommended film & screen combinations........................................................ 65

7.2 Automatic exposure control (AEC)...................................................................... 65

7.3 Exposure technique factors................................................................................. 66

7.4 Manual mode ...................................................................................................... 67

7.5 Test mode ...........................................................................................................69

7.6 Film processing ................................................................................................... 69

7.7 Measurements from the image ........................................................................... 70

8 Special features......................................................................................71

8.1 Quality assurance ............................................................................................... 71

8.2 Exposure counter ................................................................................................ 72

8.3 Preventive maintenance reminder ...................................................................... 73

8.4 Ortho ID film marking .......................................................................................... 73

8.5 OP200 CR model for computerized radiography ................................................ 73

8.6 Free selection of kV and mA ............................................................................... 74

9 Understanding the OP200 radiograph .................................................75

10 Failure diagnostics ................................................................................77

10.1 Failure messages................................................................................................ 77

10.2 kV display............................................................................................................77

10.3 mA display........................................................................................................... 77

10.4 Time display ........................................................................................................78

10.5 Resetting failure ..................................................................................................78

10.6 Multiple failure codes .......................................................................................... 79

11 Diagnosing image quality problems .................................................... 81

11.1 Patient positioning............................................................................................... 81

11.2 Film density and contrast ....................................................................................83

11.3 Artefacts ..............................................................................................................85

11.4 Unit operation......................................................................................................87

12 How to use the user programming mode .......................................... 89

12.1 General ............................................................................................................... 89

12.2 Installation & unit configuration programs .......................................................... 89

12.3 Programs affecting to image quality................................................................... 90

12.4 Other Pr programs .............................................................................................. 90

12.5 How to use the user programming mode ............................................................ 91

13 User program features...........................................................................93

13.1 PR 50 LAY: linear tomography image layer (optional) ........................................ 93

13.2 PR 51 PUS: power up setting ............................................................................. 95

ii Instrumentarium Dental 5139539-100 rev 2

13.3 PR 52 GCO and PR 52 PCO:

constant contrast & density settings.................................................................... 96

13.4 PR 53 NOR: resume normal settings................................................................ 100

13.5 PR 54 ARN: rotating unit autoreturn ................................................................. 101

13.6 PR 55 HUP: cassette holder autolift.................................................................. 101

13.7 PR 56 HLI: cassette holder vertical limit ...........................................................102

13.8 PR 57 HON: Cassette lift side........................................................................... 103

13.9 PR 58 CON: vertebrae shadow compensation ................................................. 104

13.10 PR 59 PSE: preventative maintenance reminder ............................................ 106

13.11 PR 60 BEP: panel beep................................................................................... 106

13.12 PR 61 CLC: clear exposure counter ................................................................107

13.13 PR 62 ERR: last failure code ........................................................................... 107

13.14 Pr 65 doS: dose / time display selection.......................................................... 108

13.15Pr 66 COU: Exposure counters ........................................................................ 109

14 User's statement .................................................................................. 111

15 Technical specifications......................................................................117

15.1 Electromagnetic Compatibility (EMC) tables..................................................... 123

16 Maintenance .........................................................................................127

16.1 Maintenance Schedule...................................................................................... 127

16.2 Monthly Inspection by User............................................................................... 127

16.3 Preventative Maintenance Reminder ................................................................ 127

5139539-100 rev 2 Instrumentarium Dental iii

iv Instrumentarium Dental 5139539-100 rev 2

1 Introduction

NOTE!

1.1 GENERAL

INSTRUMENTARIUM DENTAL® Orthopantomograph® OP200 panoramic unit is a software controlled diagnostic panoramic dental xray equipment for producing high quality images of dentition, TM-joints and skull. Anatomical details will be displayed on the film magnified nominally by 30%.

The Orthopantomograph procedures:

• Standard panoramic exposure

• Pediatric panoramic exposure

• Wide arch panoramic exposure

• Ortho Zone enhanced panoramic exposure

• Orthogonal panoramic exposure

• TMJ, lateral projection or

• Ortho TMJ axial corrected lateral projection (optional)

• TMJ, lateral projection jaw closed and open

• TMJ, PA projection

• TMJ, lateral and PA projection

• Maxillary sinus

1 Introduction

OP200 can perform the following

Your Orthopantomograph can be field upgraded at a later time to the Orthoceph

OP200, model OP200 OT or OP200 CR,

OC200 model. With this addition, high quality cephalometric exposures can also be made.

OP200 must be installed according to the OP200 installation & Adjustments manual by a qualified technician. Only trained personnel should be allowed to operate OP200.

In addition to the above mentioned procedures Orthoceph

OC200

can perform the following cephalometric procedures:

• Lateral view

• Postero-anterior and Antero-posterior views

• Oblique projections

• Townes, Waters, Caldwell, SMV, Carpus

Orthopantomograph

OP200 or Orthoceph® OC200 can also be field upgraded to the OP/OC200 OT model. OP200 with the Ortho Trans option can do the following linear tomographic procedures:

• Maxillary imaging in longitudinal and transversal views

• Mandible imaging in longitudinal and transversal views

Digital imaging is possible with OP200 D and OC200 D models or by using phosphor image plates with OP200 CR, OC200 CR, OP200 OT/ CR and OC200 OT/CR models.

5139539-100 rev 2 Instrumentarium Dental 1

1 Introduction

NOTE!

CAUTION!

WARNING!

As the manufacturer we strongly recommend that you read this manual before taking the unit into use.

1.2 MARKINGS AND GRAPHICS SYMBOLS

The following markings are used in this manual:

Contains useful information for the reader about the unit and its use.

Contains important instructions. If these instructions are not observed, malfunction of the unit or damage to the unit or other property may occur.

Contains warnings and instructions about the safety of the unit. If these warnings are not respected, serious risks and injury may be caused to the patient and operator.

The following symbols are used in the OP200.

Radiographic control

Protective earth (ground)

Type B equipment

Dangerous voltage

On (Power)

Off (Power)

Attention, consult accompanying documents

If the unit has CE-marking it is CE-marked according to the Medical Device Directive 93/42/EEC.

2 Instrumentarium Dental 5139539-100 rev 2

1 Introduction

ETL symbol

This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.

1.3 TYPE AND VERSION

The type and version of the OP200 are defined in the main label of the unit. The unit is class I, type B and with IP-20 protection.

Fig 1.1. Location of main label and CE mark

TYPE AND VERSION

OP200

OC200

short form for Orthopantomograph

short form for Orthoceph

OC200

type of the x-ray tube insert which is originally utilized:

OP200

1 = Toshiba D-051S

version number:

1 OP200 models starting from s/n 100 000

indication of a "Special" version, marked only in products which have a non-standard modification

5139539-100 rev 2 Instrumentarium Dental 3

1 Introduction

WARNING!

NOTE!

CAUTION!

For example, OP200-1-1 is:

(OP200) Orthopantomograph

OP200 (-1) with Toshiba D-051S tube (-1) first version of OP200.

1.4 OPTIONS, ACCESSORIES AND MANUALS

The options are listed in the appendices. The accessories are listed in sections 2.5 and 2.6. All standard items and approved accessories are suitable for use within the patient environment.

This product itself complies IEC601-1-1 medical safety standard but in order to the system incorporating also a PC to comply the standard, EITHER the PC has to be a medical PC OR the PC has to be located over 1,5 meters apart from the OP/OC200 unit. The installer and the user of the system shall confirm that at least one of the above requirements is fulfilled. A PC is a medical one if it complies IEC 6011standard and that is indicated in the accompanying documents of the PC.

To maintain safe and correct functioning of OP200, only the approved accessories may be used.

Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.

Following manuals and documents are shipped with the OP200:

• OP200 / OC200 User Manual & Technical Specifications

• OP200 / OC200 Installation & Adjustments Manual

These manuals and future updates are available on request from the manufacturer.

4 Instrumentarium Dental 5139539-100 rev 2

1 Introduction

NOTE!

WARNING!

1.5 RADIATION PROTECTION GUIDELINES

X-ray equipment may cause injury if used improperly. The instructions contained in this manual must be read and followed when operating the Orthopantomograph pertaining to radiation safety must be observed.

For USA: Many provisions of these regulations are based on recommendations of the National Council on Radiation Protection and Measurements. Recommendations for dental x-ray protection are published in NCRP Report #35 available from NCRP Publications, 7910 Woodmont Avenue, Suite 1016, Bethesda, MD 20814.

Personal radiation monitoring and protective devices are available and recommended for staff members. It is also recommended to provide the patient with a protective apron. Consult the physician before taking images of pregnant patients.

OP200. All government and local regulations

Orthopantomograph® OP200 must not be used in rooms where an explosion hazard exists. Equipment not suitable for use in the presence of flammable mixtures.

OP200 with radiation protection in accordance with IEC601-1-3:1994.

1.5.1 Protection by distance

In all examinations the user of the x-ray equipment should wear protective clothing. The operator does not need to be close to the patient during normal use. The protection against stray radiation can be achieved by using the hand switch not less than 2 m (7 ft.) from the focal spot and the x-ray beam. Operator should maintain visible contact with the patient and technique factors. This allows immediate termination of radiation by the release of the exposure button in the event of a malfunction or disturbance.

Fig 1.2. Caution information on Control panel

5139539-100 rev 2 Instrumentarium Dental 5

1 Introduction

1.5.2 Laser lights

1 FH-light

2 Mid-Sagittal light

3 Layer light

Fig 1.3. Laser light (CLASS 1 LASER PRODUCT). Max output 100µW.

1.5.3 Control from a protected area

The operator does not need to be close to the patient during normal use. Control panel hand switch or optional remote hand switch can be used from an area protected from the x-ray beam. The fully extended spiral cable length of the control panel hand switch is approx. 4 m / 13 ft. The cable length of the remote hand switch (part #69961) is approximately 10 m / 32 ft.

6 Instrumentarium Dental 5139539-100 rev 2

1.5.4 Emergency Stop Switch

1 Introduction

In case of malfunction of the exposure button release or other protective devices of the unit, an emergency stop switch is provided on the right side of the unit so that the patient can reach it. If the emergency stop switch is pressed during the exposure, the exposure is terminated immediately and the x-ray unit is completely stopped. The exposure interrupted by emergency stop switch, cannot be continued later, but has to be retaken from the beginning.

5139539-100 rev 2 Instrumentarium Dental 7

1 Introduction

1.6 MANUFACTURER’S LIABILITY

As a manufacturer we can only assume liability of safe and reliable operation of this unit when

• OP200 unit installation was performed according to the OP200

Installation & Adjustments Manual and

• OP200 Unit is used according to the OP200 User Manual

• Maintenance and repairs are performed by a qualified

Orthopantomograph

• Original or authorized spare parts are used

In order to quarantee maximal image quality for entire life time of this high performance imaging system, we suggest that a special image quality assurance procedure (* and test object designed for image quality assurance purposes is used (code 68795). Also we recommend qualified serviceman to check the unit to be in its original condition regarding electrical, radiation and mechanical safety according to our maintenance program described in more details in maintenance manual (code 61049) every year or after 2000 images. For more information please contact your local dealer.

OP200 Dealer and

*) According EN61223-3-4 and DIN 6868-151

If service on the unit is performed, a work order describing the type and extent of repair must be provided by the service technician. This must contain information of changes of nominal data or work range performed. The work order must furthermore indicate the date of repair, the name of the company concerned and a valid signature. User should keep this work order for future references.

1.7 DISPOSAL

Follow the local regulations on disposal of waste parts. OP200 has at least the following parts that should be regarded as non-environmental friendly waste products:

– X-ray source assembly – All electronic circuits – Column counter weight (Pb)

8 Instrumentarium Dental 5139539-100 rev 2

2 OP200 controls

Optional Cephalostat

2.1 MAIN PARTS

2 OP200 controls

1 Cassette holder

2 Main support

3 Film cassette

4 Rotating unit

5 Head and Temple support

6 Primary collimator

7 Bite fork with rod

8Chin rest

9 Handles

10 Patient positioning panel

11 Control panel

12 Exposure indicator lights

13 FH light height adjustment

14 Mirror

15 Base plate (optional)

5139539-100 rev 2 Instrumentarium Dental 9

2 OP200 controls

16 Exposure Button with cable and holder (optional in some

markets)

21) Main label

22) Power ON / OFF switch with an indicator

23) Main fuses with label

24) Connector for Control panel

25) Connector for Ortho ID (optional)

Fig 2.1. Unit main label and Power switch

10 Instrumentarium Dental 5139539-100 rev 2

2.2 OC200 CEPH MAIN PARTS

Fig 2.3. Head positioner, ear holde

cassette holder

Fig 2.4. Lock for axial rotation

Fig 2.5. Soft tissue scale display

Fig 2.2. OC200 LL: Cephalostat mounted on the left side

2 OP200 controls

Cephalostat arm

1 Cephalostat head

2 Cassette holder

3 Cassette retainer

4 Film cassette sizes:

18 x 24 cm and 24 x 30 cm or 8” x 10” and 10” x 12”

5 Guides for optional grid

6 Lock for axial rotation

(see Fig 2.5)

7Ear rods

8 Nasion support

9 Soft tissue scale display

10 Magnification scale

11 Ear holder brake

5139539-100 rev 2 Instrumentarium Dental 11

2 OP200 controls

Fig 2.6. Cassette (4) and grooves (5) for optional grid

Fig 2.7. Panoramic cassette holder lifted to allow cephalostat procedure

Fig 2.8. Tubehead

12 Instrumentarium Dental 5139539-100 rev 2

2 OP200 controls

NOTE!

Tube head

1 Soft tissue filter scale & slider

2 Quality Assurance collimator "QA"

3 Pediatric collimator

4 Panoramic collimator "PAN"

5 Ortho Trans Collimator

6 Cephalometric collimator alternatives: Lateral view: Europe 18 x

24 cm AH, 18 x 24 cm AV, other markets 8” x 10” AV, 10” x 8” AH, 10” x 12” AV

7 Cephalometric collimator: Symmetrical view: Europe 18 x 24 cm

SV, other markets 8” x 10” SV

8 Collimator selection lever

5-7: Cassette orientation markings: AV = Asymmetric vertical, AH = Asymmetric horizontal, SV = Symmetrical vertical (for facial / PA views).

Pediatric collimator is available when the lever on the PAN position is lifted up for one step. QA collimator is available when the lever on the PAN position is lifted up for two steps.

The collimator selection and film sizes are usually connected to the used systems in the counter so that you can select the cm or inch sizes, but not mixed.

5139539-100 rev 2 Instrumentarium Dental 13

2 OP200 controls

NOTE!

2.3 CONTROL PANEL

Exposure Control

1 Exposure Button

2 Exposure Indicator Light

3 "Ready" Indicator Light

Sections

1 Anterior

2Premolar

3Molar

4Jaw joint

Sections 2 and 3 are combined as one section in panoramic programs.

Imaging Procedures P1-P14 with Indicator lights

Standard Panoramic (P1)

Pediatric Panoramic (P2)

Ortho Zone enhanced panoramic exposure (P3)

Orthogonal exposure (P4)

Wide arch panoramic exposure (P5)

TMJ, lateral projection (P6) or Ortho TMJ, axial corrected lateral projection (P6 optional)

Open-closed TMJ, lateral projection on one film (P7)

14 Instrumentarium Dental 5139539-100 rev 2

2 OP200 controls

TMJ, posterior-anterior projection (P8)

TMJ lateral and TMJ PA projection on one film (P9)

Maxillary sinus view (P10)

Cephalo lateral projection (P11)

Cephalo PA projection and other special projections (P12)

Ortho Trans mandible (P13 optional)

Ortho Trans maxilla (P14 optional)

Exposure Modes with Indicator lights

Automatic Exposure Control

Test Mode

Manual Exposure Control

Automatic Exposure Density Scale (nine steps)

Default

One and half steps lighter

Half step darker

Two steps darker

5139539-100 rev 2 Instrumentarium Dental 15

2 OP200 controls

NOTE!

Child

Juvenile

Adult

Large adult

Control panel displays

kV display

mA display

Exposure time display / Exposure counter value display

Icons for Pre-programmed Technique Factors with Indicator lights

Function Selection buttons

Move the flashing indicator left or right Decrease or increase the value on display

Move the flashing indicator up or down to the next selection row

P1-P12: Show Exposure counter value or reset user error (Ch)

In the programming mode:

• Enter & Exit Program Mode

• Accept the displayed choice

OK button has special functions in the user and service programming mode. See User Program Chapter in the User Manual for details.

Radiation warning

16 Instrumentarium Dental 5139539-100 rev 2

2.4 POSITIONING PANELS

23 22

Fig 2.9. Positioning panel, right side

(on left side just the buttons 25 and 26 are flipped)

Positioning Panel button meaning in each mode

2 OP200 controls

Key Panoramic

(P1-P5)

Cephalostat (P11-P12)

TMJ (P6-P9)

20 Carriage vertical movement up / down

21 moves the

image layer 3 mm anterior

moves image layer

anterior during exposure

22 normal

occlusion /

reset to

middle reset position

23 moves the

image layer 3 mm posterior

moves

image

layer

posterior during exposure

24 Positioning

Positioning lights on / off lights on / off

Maxillary Sinus (P10)

moves the image layer 10 mm anterior from nominal position during exposure

nominal position

moves the image layer 10 mm posterior from nominal position during exposure

25 Rotating unit movement: Start position

26 Cassette holder down

27 Cassette holder up

28 Rotating unit movement: Patient positioning

5139539-100 rev 2 Instrumentarium Dental 17

2 OP200 controls

50076

62895

62875

6722

62942 62965

62985

62988

2.5 PATIENT POSITIONING ACCESSORIES

Fig 2.10. Panoramic patient positioning accessories

Fig 2.11. TMJ patient positioning accessories

Part code:

Part description: Part

code:

Part description:

62875 Chin rest 62904* Nose support, long

62895 Sinus rest 62906* Nose support, short

62942* Bite block 10 pcs 60477 TMJ pointer

62985* Bite fork, short 56 mm 64665 TMJ angle indicator

(Ortho TMJ option)

62988* Bite fork 71 mm 62943 TMJ chin rest

(Ortho TMJ option)

62958* Bite fork, long 80 mm,

optional (not shown)

64694 TMJ pointer (for

Ortho Trans units)

50076 Child adaptor

6722 Chin support

62965 Edentulous bite

positioned, optional

18 Instrumentarium Dental 5139539-100 rev 2

2 OP200 controls

NOTE!

8915

7453

6644

7451

7452

The parts marked with * are autoclavable.

Convenient bins for small accessories and disposables are located on the both sides of the vertical carriage.

Fig 2.12. Left and right cabins.

2.6 OPTIONAL ACCESSORIES & DISPOSABLES

The following optional accessories, disposables and tools are available for the equipment:

Fig 2.13. Consumer accessories

Part

Part description:

code:

6644 Bite fork coat,

200 pcs

7451 Chin rest coat,

200 pcs

5139539-100 rev 2 Instrumentarium Dental 19

2 OP200 controls

Part code:

7452 Temple support coat,

7453 Nose support coat,

8915 Ear holder coat,

Part description:

200 pcs

20 pcs

2.7 CHANGING THE FUSES

Push inward on the fuse base and twist it counter-clockwise with a screwdriwer. The fuse with the base will come out.

Remove the fuse from the base and replace it with the new one. Repeat this with each blown fuse.

Fasten both fuses by pushing the base in and twisting it clockwise with a screwdriver.

Use only appropriate fuses:

326 Littelfuse 10A (slow blow) 230 VAC line voltage

MDA-15 Cooper Bussman 15A (time delay) 115 VAC line voltage

20 Instrumentarium Dental 5139539-100 rev 2

3 Equipment preparations

NOTE!

CAUTION!

WARNING!

CAUTION!

3.1 CARE INSTRUCTIONS

X-ray devices are sophisticated electronic products including advanced technologies. As such, they have to be handled with a high degree of care. This document gives the care instructions applicable to the Orthopantomograph

It is strictly mandatory to follow these Care Instructions in order to not void the warranty of the product.

As a standard recommendation, clean the unit regularly using nonagressive, mild, commercially available cleaning agents.

panoramic and cephalostat units.

3 Equipment preparations

3.2 CLEANING RECOMMENDATIONS

The unit should be cleaned after every usage between the patients. Items and surfaces that are not given special instructions for cleaning, disinfecting and sterilizing, can be cleaned with soft cloth moistured with disinfective after every usage.

Always disconnect OP200 from mains or switch off the power prior to cleaning or disinfecting the unit.

Do not allow water or other cleaning liquids to enter the unit interior since these may cause short-circuits or corrosion.

3.2.1 Cleaning

The purpose of cleaning and rinsing is to remove all adherent visible soil (eg. blood, protein substances and other debris), to reduce the number of particulate and micro-organisms, and to reduce the amount of pyrogenic and antigenic material.

Use a cloth moistened in cool-to-lukewarm, soapy water to clean the unit, and prevent coagulation and thus faciliate the removal of protein substances. Then wipe with a cloth moistened in clear water. Mild detergent solution can be used. Use cleaners or solvents, which are listed as allowed cleaning agents below. If you are uncertain of the nature of cleaning agent, do not use it.

5139539-100 rev 2 Instrumentarium Dental 21

3 Equipment preparations

NOTE!

WARNING!

Examples of cleaning agents that are allowed or prohibited when cleaning the unit panels:

Allowed: Methanol (metyl alcohol), Soap, Isopropyl alcohol, distilled water.

Not allowed: Bentzene, Chlorine bentzene, Acetone, Acetic ether, agents containing phenol, paracetic acid, peroxide and other oxygencleaving agents, sodium hypochlorite and iodine-cleaving agents.

3.2.2 Disinfection and sterilization

The disinfection and sterilization concerns the parts of the equipment like bite block, chin support and accessories. Wipe manually with clean cloth moistured in disinfectant solution. Never use corrosive or solvent disinfectants. All items and surfaces should be dried before next usage.

Wear gloves and other protective equipment during decontamination process.

Do not use any disinfecting sprays since the vapor could ignite causing injury.

Disinfecting techniques for both the unit and the room must comply with all laws and regulations that have jurisdiction of law within the jurisdiction on which the unit is.

3.2.2.1 Autoclave

Some removable parts in touch with the patient are sterilizable in autoclave. Such parts are:

Bite forks (62985, 62988, 62958), Bite block (62942) and Nose supports (62906, 62904).

If autoclaving is performed for these items, disinfection by immersing in disinfectant solution for 10 minutes is not needed.

3.2.2.2 Steam sterilization

Recommended parameters for sterilizable parts are:

Gravity-displacement steam sterilization "Flash" sterilization:

Temperature: 270 F (132°C) Exposure time: 3 minutes

Prevacuum steam sterilization "Flash" sterilization:

22 Instrumentarium Dental 5139539-100 rev 2

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