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.

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Sirona Dental Systems GmbH 3 Technical description Operating Instructions SIROInspect 3.3 SIROInspect probe design

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3.3

SIROInspect probe design

3.4

Scope of supply

Basic equipment, SIROInspect diagnostic set, REF 63 25 174

A SIROInspect charging

station

D SIROInspect battery

B SIROInspect 90° light guide E SIROInspect attachable filter

C SIROInspect base body F SIROInspect power supply unit

SIROInspect

Quantity Designation REF No.

1 SIROInspect base body 63 75 401

2 SIROInspect 90° light guide 63 75 419

1 SIROInspect charging station 63 75 435

1 SIROInspect EU power supply unit 63 75 567

2 SIROInspect battery 63 75 443

2 SIROInspect attachable filter 64 30 057

1 Clinical guidelines 63 75 492

1 SIROInspect operating instructions 63 79 650

1 SIROInspect brief operating instructions 63 90 848

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3 Technical description Sirona Dental Systems GmbH

3.5 Technical data Operating Instructions SIROInspect

Special accessories

3.5

Technical data

LED and diagnosis goggles

Storage battery

Charging station

Electrical protection

Level of protection against the ingress of solid materials and water

Operating conditions

Storage and transport conditions

This product bears the CE marking in accordance with the provisions of Council Directive 93/42/EEC of June 14, 1993 concerning medical devices.

Designation REF No.

Complete SIROInspect probe 63 75 534

SIROInspect 140° light guide 63 75 542

SIROInspect 140° light guide (3 pcs.) 63 75 559

SIROInspect 90° light guide (3 pcs.) 63 75 484

SIROInspect clip-on for magnifying glasses 63 75 583

SIROInspect diagnosis goggles (orange) 63 75 518

SIROInspect diagnosis goggles (yellow) 63 75 450

LED radiation output in mW 60 - 250

LED wavelength in nm approx. 405

Filter of diagnosis goggles in nm > 500

Battery voltage in V 2.4

Battery capacity in mAh 400

Voltage in V 6

Maximum power consumption in VA6

Protection class “Internal power supply”

Type of protection against electric shock

Light guide applied part: Type BF

Charging station IP 20

SIROInspect base body IP 20

Ambient temperature 10° C to 35° C (50° F to 104° F)

Relative humidity in % 30 - 95

Air pressure in hPa 700 - 1060

Ambient temperature: -20° C to +70° C (-4° F to 158° F)

Relative humidity in % 10 - 95

Air pressure in hPa 500 - 1060

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Sirona Dental Systems GmbH 3 Technical description Operating Instructions SIROInspect 3.6 Service life of Sirona instruments

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3.6

Service life of Sirona instruments

Service life 5 + 3 years /3 + 1 1/2 year s

When used as intended:

Additional service life periods_FACE

● The battery has a typical service life of up to 12 months

● The light pens have a typical service life of approx. 2 years or 2000 sterilization cycles

No warranty claim can be inferred here, as wear may occur earlier or later than indicated above depending on use, frequency of sterilization, and frequency of maintenance.

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4 Operation Sirona Dental Systems GmbH

4.1 Connect the power supply unit Operating Instructions SIROInspect

Operation

4.1

Connect the power supply unit

1. Snap the power cable connector into the connecting socket, on the bottom side of the charging station.

2. Lay the cable into the channel adjacent to the connecting socket and clamp the cable in under the holders.

➢ Pull out the plug to disconnect the unit from the power supply.

4.2

Replace and charge the battery

The battery can operate continuously for up to 25 minutes. Once the battery has been completely discharged, a full recharge takes approx. 1 hour. The light pen starts to blink when the battery is running low.

The batteries can be stored for 4 months. Once this period has expired, the battery must be charged. If this is not the case, it may cause the battery to have reduced charging capacity or to fail completely. Sirona recommends storing the battery on the charging station.

As a general rule, the batteries included with the delivery have a service period of up to 12 months. After this period, power decreases accordingly. Please check the usage period based on the LOT number (definition of LOT = week week year year e.g. 0212 for calendar week 2, 2012).

1. Remove the discharged battery (B) from SIROInspect (A).

2. Insert the charged battery into SIROInspect until it audibly clicks into place.

3. Position the discharged battery onto the charging station (C) until it audibly clicks into place.

 As soon as the charging light switches on, the battery is fully

charged.

IMPORTANT

Check that the power supply voltage corresponds to the voltage data on the power supply unit before connecting the power supply cable.

IMPORTANT

Position the device at least 1.5 m away from the patient on a stable, horizontal surface. Position the unit so it is easy to disconnect it from the power supply.

SIROInspect

CAUTION

Risk of crushing

When sliding open the battery, the skin on your fingers may become trapped.

➢ Hold the battery as far back as possible.

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Sirona Dental Systems GmbH 4 Operation Operating Instructions SIROInspect 4.3 Install attachable filter

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4.3

Install attachable filter

➢ Slide the attachable filter from the front onto the base body. Press the

silicone ring with the fingers until the attachable filter is firmly in place.

4.4

Inserting the light guide

After 2000 sterilization cycles or 2 years which marks the end of the service period, the light guides will have reached their wear limit.

Please check the usage period based on the LOT number (definition of LOT = week week year year e.g. 0212 for calendar week 2, 2012). Please replace the light pen accordingly. The optical output can be reduced and distinction between red and green fluorescence is therefore not so clearly depicted.

➢ Screw the light pen (90° or 140°) into the base body until it reaches

the end stop.

4.5

Align attachable filter

1. Hold the base body behind the attachable filter.

2. Look through the attachable filter to the light guide.

3. Grasp the attachable filter on the outside edge.

4. Turn the attachable filter into the desired position.

SIROInspect

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4 Operation Sirona Dental Systems GmbH

4.6 Switching SIROInspect on/off Operating Instructions SIROInspect

4.6

Switching SIROInspect on/off

1. Hold the SIROInspect in the patient’s mouth.

2. Align the attachable filter.

3. Operate the rotary switch (A) ("on - off") with your other hand. A 90° rotation is performed. The direction of the rotation is not important here.

 SIROInspect is switched on.

4. If the rotary switch (A) (“on - off”) is operated again, i.e., rotated either backwards or forwards, the SIROInspect is switched off.

4.7

Treatment

SIROInspect assists operators when excavating caries in already open cavities and functions as a visual detection and monitoring tool. It works by highlighting carious tooth material in fluorescent red and healthy tooth material in fluorescent green.

SIROInspect cannot assess initial caries.

Use SIROInspect if an initial diagnosis has been made and a decision has already been made on how the caries is to be treated and if the cavity is open.

The fluorescent results of SIROInspect provide extensive information, which can be used for treatment. The final decision as to whether treatment is performed and how long it should last is made by the user.

Avoid external sources of light to ensure that the distinction between red and green fluorescence is clearly maintained. Turn the OP lights away or switch them off while using SIROInspect.

While excavating a deep caries, the fluorescent light may appear brown near the pulp. The reason for this has not been fully established. In this case in particular, a further detection tool (e.g. probe) can be used to decide on the course of treatment.

After removing carious tooth material, we recommend checking the cavity with SIROInspect before finishing the process.

Clinical guidelines illustrate how to use a treatment process and fluorescence. The red fluorescence alters depending on the degree of treatment.

The clinical guidelines can also be downloaded from the Internet.

SIROInspect

CAUTION

Avoid glare!

If the probe is shone directly into the eyes, it may cause blinding. This is not harmful, but can temporarily impair vision.

➢ Switch SIROInspect on only when it is in the patient’s mouth. ➢ Never shine SIROInspect directly into the eyes.

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Sirona Dental Systems GmbH 5 Care and maintenance Operating Instructions SIROInspect 5.1 Dismantling SIROInspect

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Care and maintenance

5.1

Dismantling SIROInspect

The SIROInspect can be dismantled for cleaning, disinfection or sterilization.

1. Pull the battery (D) out of the base body (C).

2. Unscrew the light pen (A or B) from the base body.

3. Slide the attachable filter (E) off the base body.

4. Carry out cleaning, disinfection, and sterilization.

5.2

Cleaning the outer surface

Combining cleaning and disinfection

Manual cleaning must always be combined with disinfection.

Cleaning SIROInspect

The SIROInspect must not be cleaned or disinfected with a machine.

1. Remove the silicone ring from the attachable filter.

2. Clean the light guide, the silicone ring and attachable filter by placing it under running water (< 38 °C, water must be at least drinking water quality).

3. Wipe down the battery and base body with a damp cloth. NOTICE! The battery and base body must not be cleaned under running water.

5.3

Disinfecting the surface

Disinfecting the surfa ce

Immersion in disinfecta nts, SIROInspect

The SIROInspect must not be cleaned or disinfected with a machine.

SIROInspect can be disinfected by wiping it. NOTICE! The battery and base body must not be disinfected by immersion.

SIROInspect

NOTICE

Risk of short circuit

The battery (D) and the base body (C) must not under any circumstances be immersed in liquid. These components can only be disinfected by wiping them down.

SIROInspect

NOTICE

Never clean in an ultrasonic bath!

NOTICE

Never immerse in disinfectants!

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5 Care and maintenance Sirona Dental Systems GmbH

5.4 Sterilization instructions Operating Instructions SIROInspect

Wipe disinfection

✔ The disinfectants that are approved in your country must have proven

bactericidal, fungicidal and virucidal properties.

➢ Disinfect by wiping the parts down according to manufacturer

documentation.

Disinfectants to be used

Please observe the manufacturer's instructions for using instrument disinfectants.

5.4

Sterilization instructions

Sterilization instructio ns

1. Clean and disinfect the components.

2. Sterilize the light guides (A/B) in the autoclave with saturated steam at 134 °C (274 °F) and 3 min. holding time (2.04 bar; 29.59 psi overpressure). NOTICE! Never sterilize the battery (D), attachable filter (E) or the base body (C).

DAC PROFESSIONAL FACE

Steam sterilizers are permitted, but must correspond either to EN 13060 class B (for example, DAC PROFESSIONAL) or to EN 13060 class S and in addition, must be suitable for the sterilization of dental instruments and products.

NOTICE

Use only disinfectants that comply with the requirements of your national authorities and whose bactericidal, fungicidal and virucidal properties have been tested and properly certified.

Sirona recommends using MinuteWipes from Alpro. In the US: Caviwipes

™

Observe the instructions of the disinfectant manufacturers.

SIROInspect

274 3 min

NOTICE

Sterilize the light guides in a packing material suitable for sterilization and storage so as to prevent scratching or chipping the light guides in the autoclave.

Do not exceed a temperature of 140 °C (284 °F) during the drying cycle. Do not abort the drying cycle before it has ended.

Do not try to accelerate the cool-down process by placing the light guides in cold water. This could cause the light guides to crack.

CAUTION

Store all components so that they are protected against contamination.

Sterilize again once the storage period has elapsed.

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Sirona Dental Systems GmbH 6 Electromagnetic compatibility Operating Instructions SIROInspect 6.1 Electromagnetic emission

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Electromagnetic compatibility

Definitions:

Emission (electromagnetic) When electromagnetic energy is emitted by a source.

Interference immunity The ability of a device or system to work without errors even if there is electromagnetic interference.

Immunity level The maximum level of a certain electromagnetic interference that affects a particular device or system, where the device or system remains operative with a certain level of performance.

6.1

Electromagnetic emission

The UNIT is intended for operation in the electromagnetic environment specified below.

The customer or user of the UNIT should make sure that it is used in such an environment.

NOTICE

SIROInspect complies with all requirements for electromagnetic compatibility according to IEC 60601-1-2: 2007.

Emission measurement Conformity Electromagnetic environment – guidance

RF emissions according to CISPR 11 Group 1 The UNIT 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.

RF emissions according to CISPR 11 Class B The UNIT is intended for use in all facilities,

including residential areas and those directly connected to a public power supply, which also provides electricity to buildings used for residential purposes.

Harmonics according to IEC 61000-3-2

Class A

Voltage fluctuations/flicker according to IEC 61000-3-3

Complies

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6 Electromagnetic compatibility Sirona Dental Systems GmbH

6.2 Interference immunity Operating Instructions SIROInspect

6.2

Interference immunity

The UNIT is intended for operation in the electromagnetic environment specified below.

The customer or user of the UNIT should make sure that it is used in such an environment.

Interference immunity tests

IEC 60601-1-2 test level

Conformance level Electromagnetic environment –

guidance

Electrostatic discharge (ESD) according to IEC 61000-4-2

± 6 kV contact discharge

± 8 kV air discharge

± 6 kV contact discharge

± 8 kV air discharge

Floors should be made of wood or concrete or finished with ceramic tiling. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/ burst according to IEC 61000-4-4

± 1 kV for input and output lines

± 2 kV for power supply lines

± 1kV for input and output lines

± 2 kV for power supply lines

The quality of the power supply should be that of a typical commercial or hospital environment.

Surge voltages according to IEC 610004-5

± 1 kV differential mode

± 2 kV common mode voltage

± 1 kV differential mode

± 2 kV common mode voltage

The quality of the line power supply should be that of a typical commercial or hospital environment.

Voltage drops, short interruptions and fluctuations of the power supply according to IEC 610004-11

<5% U

for ½ period

(>95% drop of U

)

40% U

for 5 periods

(60% drop of U

)

70% U

for 25 periods

(30% drop of U

)

<5% U

for 5 sec.

(>95% drop of U

)

<5% U

for ½ period

(>95% drop of U

)

40% U

for 5 periods

(60% drop of U

)

70% U

for 25 periods

(30% drop of U

)

<5% U

for 5 sec.

(>95% drop of U

)

The quality of the line power supply should be that of a typical commercial or hospital environment.

If the user of the UNIT requires it to continue functioning following interruptions of the power supply, it is recommended to have the UNIT powered by an uninterruptible power supply.

Magnetic field of power frequencies (50/60 Hz) according to IEC 610004-8

3 A/m 3 A/m Power frequency magnetic fields

should at levels characteristic of those found in the business and hospital environment.

Remark: U

is the alternating supply voltage prior to application of the test level.

Portable and mobile radio equipment are not used at a smaller distance to the UNIT and cables that is lower than the recommended working clearance, which is calculated according to the equation suitable for the transmission frequency.

Recommended working clearance:

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Sirona Dental Systems GmbH 6 Electromagnetic compatibility Operating Instructions SIROInspect 6.3 Working clearances

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1. The higher frequency range applies at 80 MHz and 800 MHz.

2. Field strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile services, amateur radio stations, and AM and FM radio and TV stations, cannot be predicted beforehand with accuracy. An investigation of the location is recommended to determine the electromagnetic environment resulting from stationary HF transmitters. If the measured field strength in the location in which the UNIT is used exceeds the applicable RF compliance level specified above, the UNIT should be observed to verify normal operation. If unusual performance characteristics are observed, it may be necessary to take additional measures, such as a reorientation or repositioning of the UNIT.

3. Over the frequency range of 150 kHz to 80 MHz, the field strength is less than 3 V/m.

6.3

Working clearances

Recommended working clearances between portable and mobile RF communication devices and the UNIT

The UNIT is intended for operation in an electromagnetic environment, where radiated RF interference is checked. The customer or the user of the UNIT can help prevent electromagnetic interference by duly observing the minimum distances between portable and mobile HF communication devices (transmitters) and the UNIT. These values may vary according to the maximum output power of the communication device as specified below.

Conducted RF interference IEC 61000-4-6

3 V

eff

150 kHz to 80 MHz

3 V

eff

d= [1.2] √P

Radiated RF interference IEC 61000-4-3

3 V/m 80 MHz to 800 MHz

3 V/m 800 MHz to 2.5 GHz

3 V

eff

3 V

eff

d= [1.2] √P

at 80 MHz to 800 MHz

d= [2.3] √P

at 800 MHz to 2.5 MHz

where P is the nominal transmitter output in watts (W) specified by the

transmitter manufacturer and d is t he recommended working clearance in

meters (m).

According to an electromagnetic onsite survey,

the field strength of fixed radio transmitters is less than the compliance level in each frequency

range.

Interference is possible in the vicinity of equipment bearing the following

symbol.

Interference immunity tests

IEC 60601-1-2 test level

Conformance level Electromagnetic environment –

guidance

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6 Electromagnetic compatibility Sirona Dental Systems GmbH

6.3 Working clearances Operating Instructions SIROInspect

For transmitters whose maximum nominal output is not specified in the above table, the recommended working clearance d in meters (m) can be

determined using the equation in the corresponding column, where P is the maximum nominal output of the transmitter in watts (W) specified by

the manufacturer of the.

Remark 1

The higher frequency range applies at 80 MHz and 800 MHz.

Remark 2

These guidelines may not be applicable in all cases. The propagation of electromagnetic waves is influenced by their absorption and reflection by buildings, objects and persons.

Rated maximum output power of transmitter [W]

Working clearance according to transmission frequency [m]

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

d= [1.2] √P d= [1.2] √P d= [2.3] √P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

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Sirona Dental Systems GmbH 7 Storage and transport conditions Operating Instructions SIROInspect

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Storage and transport conditions

Storage and transport c onditions

Dispatch Clean and disinfect the instrument or accessory used on the patient

before sending it in.

Protect against moisture

Sensitive contents

Relative humidity Air pressure

Temperature After a severe change in

temperature, allow sufficient time for acclimatization.

kPa

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8 Disposal Sirona Dental Systems GmbH

Operating Instructions SIROInspect

Disposal

To the best of our knowledge, apart from the battery, SIROInspectdoes not contain any environmentally hazardous substances.

Disinfected

● Disinfect the product prior to disposal.

● Please observe the disposal regulations applicable in your country.

Disposing of batteries and charging stations

Batteries must be disposed of according to disposal regulations and statutory provisions in your country.

Remove the battery from the base body of the SIROInspect probe before disposal.

Your product is marked with the adjacent symbol. Within the European Economic Area, this product is subject to Directive 2002/96/EC as well as the corresponding national laws. This directive requires environmentally sound recycling/disposal of the product. The product must not be disposed of as domestic refuse!

Please observe the disposal regulations applicable in your country.

Disposal procedure

Please note that this product is subject to the stipulations in EC Directive 2002/96 governing waste electrical and electronic equipment and must be disposed of in line with these special requirements within the European Union (EU).

Prior to disassembly / disposal of the product, it must be fully prepared (cleaned / disinfected / sterilized).

When disposing of equipment permanently, please proceed as follows:

In Germany:

To initiate return of the electrical device, please send a disposal order to "enretec GmbH".

1. You can find a form for placing a disposal order on the company's homepage (www.enretec.de) under the menu item "Entsorgung elektrischer und elektronischer Geräte" (Disposal of electric and electronic devices). The form can either be downloaded or completed online.

2. Fill the form out with the relevant information and send it as an online order or fax it to enretec GmbH at +49 (0)3304 3919 590. Alternatively, for initiating a waste disposal order or for questions, the following contact options are available: Telephone: +49(0)3304 3919 500; E-mail: pickup@eomRECYCLING.com ; Mailing address: enretec GmbH, Geschäftsbereich eomRECYCLING Kanalstraße 17, 16727 Velten

 Any nonpermanently installed equipment will be picked up at its

installation site in the practice. Permanently installed equipment will be picked up curbside at your address by appointment.

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63 82 936 D3584 D3584.201.01.03.02 02.2013

Sirona Dental Systems GmbH 8 Disposal Operating Instructions SIROInspect

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All disassembly, transport and packaging costs are to be borne by the owner / operator of the equipment. The disposal itself is free of charge.

Worldwide (outside Germany):

Please contact your local dental equipment specialist for country-specific information on disposal.

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