Sirona SIROInspect Operating Instructions Manual

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Cover page

SIROInspect

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Sirona Dental Systems GmbH

Operating Instructions SIROInspect

Table of Contents

Before you begin ….................................................................................................. 4

1.1 Identification of the danger levels.................................................................. 4

1.2 Formats and symbols used ........................................................................... 5

1.3 Symbol description........................................................................................ 5

1.4 Abbreviations ................................................................................................ 6

Safety information .................................................................................................... 7

Technical description................................................................................................ 8

3.1 Task .............................................................................................................. 8

3.2 Functionality .................................................................................................. 8

3.3 SIROInspect probe design ............................................................................ 9

3.4 Scope of supply............................................................................................. 9

3.5 Technical data............................................................................................... 10

3.6 Service life of Sirona instruments.................................................................. 11

Operation.................................................................................................................. 12

4.1 Connect the power supply unit...................................................................... 12

4.2 Replace and charge the battery .................................................................... 12

4.3 Install attachable filter ................................................................................... 13

4.4 Inserting the light guide ................................................................................. 13

4.5 Align attachable filter..................................................................................... 13

4.6 Switching SIROInspect on/off ....................................................................... 14

4.7 Treatment...................................................................................................... 14

Care and maintenance ............................................................................................. 15

5.1 Dismantling SIROInspect .............................................................................. 15

5.2 Cleaning the outer surface ............................................................................ 15

5.3 Disinfecting the surface................................................................................. 15

5.4 Sterilization instructions ................................................................................ 16

Electromagnetic compatibility................................................................................... 17

6.1 Electromagnetic emission ............................................................................. 17

6.2 Interference immunity.................................................................................... 18

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Sirona Dental Systems GmbH Operating Instructions SIROInspect

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6.3 Working clearances...................................................................................... 19

Storage and transport conditions............................................................................. 21

Disposal................................................................................................................... 22

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1 Before you begin … Sirona Dental Systems GmbH

1.1 Identification of the danger levels Operating Instructions SIROInspect

Before you begin …

Intended use

SIROInspect

SIROInspect aids detection and monitoring of carious tooth substance during excavation of previously opened cavities.

Contraindications Do not use SIROInspect in conjunction with caries detection dyes!

Do not use SIROInspect if you have red-green color blindness or visual impairment.

Target group

Trained dental personnel

This product is intended for use only by trained dental personnel in dental practices and laboratories.

Manufacturer's address

1.1

Identification of the danger levels

Identification of the danger lev els

To prevent personal injury and material damage, please observe the warning and safety instructions provided in this document, which are highlighted as follows:

Tip: Information for simplifying work.

DANGER

Imminent danger that could result in serious bodily injury or death.

WARNING

Potentially dangerous situation that could result in serious bodily injury or death.

CAUTION

Potentially dangerous situation that could result in slight bodily injury.

NOTICE

Potentially harmful situation which could lead to damage of the product or an object in its environment.

IMPORTANT

Instructions for use and other important information.

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Sirona Dental Systems GmbH 1 Before you begin … Operating Instructions SIROInspect 1.2 Formats and symbols used

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1.2

Formats and symbols used

The formats and symbols used in this document have the following meaning:

1.3

Symbol description

RX only Only for the (treating) physician

CE marking pursuant to Council Directive 93/42/EEC. Verifies the compliance of SIROInspect

REF Sirona reference number

LOT yyxx Batch number: yy = week / xx = year

Year of manufacture

Manufacturer

This product only has an electronic operation manual

The disassembled handpiece sleeves and light guides are to be sterilized only in autoclaves with saturated water vapor at minimum sterilization values of 134 °C (273.2 °F), 3 min. holding time and 2.04 bar (29.59 psi) overpressure.

Refers to Directive 2002/96/EC and EN 50419 Do not dispose with domestic waste

✔ Prerequisite

1. First action step

2. Second action step or

➢ Alternative action

 Result

Requests you to do something.

See “Formats and symbols used [ → 5]”

Identifies a reference to another text passage and indicates the relevant page number.

● List Identifies a list item.

"Command / menu item" Identifies commands / menu items

or a quote.

20XX

134°C

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1 Before you begin … Sirona Dental Systems GmbH

1.4 Abbreviations Operating Instructions SIROInspect

1.4

Abbreviations

LED Light-emitting diode

VVolt

mAh Milliampere hour

mW Milliwatt

m Meter

nm Nanometer

°C Degree Celsius

°F Degree Fahrenheit

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Sirona Dental Systems GmbH 2 Safety information Operating Instructions SIROInspect

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Safety information

Obligations of the user ➢ Use only fault-free materials that do not deviate from the specified

data [ → 10].

➢ Protect yourself, patients, and others against hazards. To do this,

follow the safety instructions. ➢ Use the equipment as intended. ➢ You should always keep these operating instructions within reach for

further reference.

Cross contamination and spreading of infection

Prevention of the spread of infection and cross contamination

Prevent the spread of infections and cross contamination among patients, users, and others; sterilize after every patient.

Take the appropriate hygiene measures, e.g. wear protective gloves.

Before startup _ FACE

Before startup Sterilize the new light guide prior to initial start-up.

Periods of non-use _ SIR OInspect

Periods of non-use In the event of prolonged non-use, SIROInspect must be cleaned and

disinfected in accordance with the instructions. Sterilize the light guide. Observe the instructions for storing the battery [ → 12].

SIROInspect safety instructions

Normalization phase An adequate period of normalization must be maintained following

transport and initial operation.

Blinding Do not shine directly into the eyes.

Only switch the SIROInspect on once it is in the patient’s mouth to avoid glare. The glare is not harmful, but may temporarily impair vision.

UV radiation LED product of risk class 0. SIROInspect emits UV light. Prevent the oral

mucosa from being unnecessarily exposed to radiation from UV rays.

Light guide Make sure the SIROInspect is in good condition and that the light guide

fits tightly prior to every use.

If the glass in the light guide has shattered or has sharp edges, there is a risk of cutting injuries. By not using a damaged light guide, you can prevent cutting injuries.

The light guide or SIROInspect must not be dropped or knocked. Should this occur, inspect the light guide or SIROInspect for damage.

Temperature rise during contin uous operation, SIROInsp ect

Temperature rise The maximum operating period is 3 minutes. In this time, SIROInspect

can heat up to 48 °C. Afterwards, the cool-down time is 12 minutes.

Malfunction / Damage _ Instruments

Malfunction or damage Immediately discontinue use in the case of malfunction or damage.

Damaged instruments may cause injury. Notify the dental depot or the manufacturer.

Accessory parts

Spare and accessory parts Use only Sirona original or approved parts. Safe operation is not

guaranteed for parts that have not been approved by Sirona.

Power supply unit _ SIROIn spect

Only the power supply unit provided may be used.

No unauthorized changes may be made. Position SIROInspect so it is easy to disconnect it from the power line.

If you have any questions, please contact your dental depot or the manufacturer.

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3 Technical description Sirona Dental Systems GmbH

3.1 Task Operating Instructions SIROInspect

Technical description

3.1

Task

SIROInspect

FACE ® (Fluorescence aided caries excavation) is a method which enables the practitioner to remove infected tooth material in a targeted manner, based on the special fluorescent properties of the decomposition products resulting from caries-causing bacteria.

3.2

Functionality

FACE

As shown in the illustration below, the tooth is illuminated with an violet light during the excavation. Carious tooth material and healthy dentin is excited to fluorescence. The operator views the cavity through a filter. Shorter wavelengths are thereby filtered out, in particular the violet excitation light. Light with higher wavelengths remains visible through the filter, so that the red-fluorescent sections of a caries can be precisely detected. The red-fluorescent carious tooth material can be easily detected and compared to neighboring green-fluorescent, normal tooth material. The carious tooth material can therefore be precisely removed with a bud bur or scraper.

+ 16 hidden pages

Sirona SIROInspect Operating Instructions Manual

Specifications and Main Features

Frequently Asked Questions

User Manual