sprayvit / c8 / e / l / m - Sirona

sprayvit / c8 / e / l / m - Sirona

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Operating instructions

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Table of Contents Sirona Dental Systems GmbH

Operating Instructions SPRAYVIT / C8 / E / L / M

Table of Contents

1

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

4

1.1

Structure of the document.............................................................................

1.1.1

Labeling of information.....................................................................

1.1.2

Formats and symbols.......................................................................

1.2

Service life of Sirona instruments..................................................................

4

4

5

5

2

Safety information ....................................................................................................

6

3

Technical description................................................................................................

7

3.1

Task ..............................................................................................................

3.2

SPRAYVIT / C8 / E / L / M design.................................................................

7

7

3.3

Technical data...............................................................................................

7

4

Preparation...............................................................................................................

9

4.1

Initial start-up and longer breaks in use ........................................................

4.2

Prior to starting the work day ........................................................................

9

9

4.3

Before each patient .......................................................................................

9

5

Operation..................................................................................................................

10

5.1

Connect the multifunctional syringe to the supply hose ................................

10

5.2

Attach/remove the handle sleeve and nozzle ...............................................

10

5.3

Vent supply lines ...........................................................................................

11

5.4

Applying air, water, or spray..........................................................................

11

6

Follow-up..................................................................................................................

12

6.1

After each treatment session ........................................................................

12

7

Conditioning .............................................................................................................

13

7.1

Conduct pre-disinfection ...............................................................................

13

7.2

Automated cleaning and disinfecting ... ........................................................

13

7.2.1

... with cleaning and disinfection equipment.....................................

13

7.3

Manual cleaning and disinfection ..................................................................

13

7.3.1

Cleaning the nozzle..........................................................................

14

7.4

Sterilizing.......................................................................................................

14

8

Maintenance.............................................................................................................

15

8.1

Replacing O-rings .........................................................................................

15

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Operating Instructions SPRAYVIT / C8 / E / L / M

Table of Contents

8.2

Replacing lamps...........................................................................................

15

8.3

Cleaning heating cartridges..........................................................................

15

8.4

Replacing the heating cartridges..................................................................

16

9

Spare parts and consumables.................................................................................

17

10

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

19

11

Disposal...................................................................................................................

20

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4

1 Before you begin …

1.1 Structure of the document

Intended Use

Contraindications

Target group

Warnings

Instructions for use

Sirona Dental Systems GmbH

Operating Instructions SPRAYVIT / C8 / E / L / M

1

Before you begin …

SPRAYVIT / C8 / E / L / M complies with state-of-the-art technical regulations.

1. Read the operating instructions prior to using SPRAYVIT / C8 / E / L

/ M.

2. Only use SPRAYVIT / C8 / E / L / M for the applications described in the operating instructions.

3. Observe the applicable hygiene standards, occupational safety regulations and accident prevention measures for SPRAYVIT / C8 /

E / L / M.

SPRAYVIT M: multifunctional syringe for dental treatment with unheated air and heated water and to illuminate the preparation field.

SPRAYVIT E: multifunctional syringe for dental treatment with unheated air and unheated water and to illuminate the preparation field.

SPRAYVIT C8: multifunctional syringe for dental treatment with unheated air and heated water.

SPRAYVIT L: multifunctional syringe for dental treatment with heated air and heated water and to illuminate the preparation field.

SPRAYVIT: multifunctional syringe for dental treatment with heated air and heated water.

None

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

1.1

Structure of the document

1.1.1

Labeling of information

➢ To prevent injuries, please observe all warnings.

Warnings are labeled as follows:

DANGER! indicates a danger leading to death or serious injury if not avoided.

WARNING! indicates a danger that may lead to death or serious injury if not avoided.

CAUTION! indicates a danger that may lead to injury if not avoided.

➢ To prevent material damage and additional expenses, please observe all instructions for use.

Instructions for use are labeled as follows:

NOTICE! indicates measures for the prevention of material damage.

IMPORTANT: indicates information on the avoidance of additional expenses and other important information.

Tip: indicates information for facilitating work.

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Operating Instructions SPRAYVIT / C8 / E / L / M

1 Before you begin …

1.2 Service life of Sirona instruments

1.1.2

Formats and symbols

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

Prerequisite

1. First action step

2. Second action step or

➢ Alternative action

Requests you to do something.

Result

➢ Individual action step

Use of formats and symbols [ → 5]. Identifies a reference to another

text passage and specifies its page number.

● List Identifies a list.

1.2

Service life of Sirona instruments

● Non-moving parts of Sirona instruments have a typical service life of approx. 5 years

● Moving parts of Sirona instruments have a typical service life of approx. 3 years

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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6

2 Safety information Sirona Dental Systems GmbH

Operating Instructions SPRAYVIT / C8 / E / L / M

Obligations of the user

Risk of scalding

Malfunction or damage

2

Safety information

● Use only fault-free materials that do not deviate from the specified data [ → 7].

Preventing the spread of infections and cross contamination

● Protect yourself, patients, and others against any foreseeable dangers. To do this, follow the safety information.

● Comply with the Intended use of the equipment.

● You should always keep these operating instructions within reach for further reference.

Prevent the spread of infections and cross contamination between patients, users, and third parties. Sterilize equipment after each patient.

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

Test the required media flow amounts [ → 7] before use and conduct a

flow rate check [ → 9].

Discontinue use immediately in case of malfunction, unusual or different sounds or damage. Damaged instruments may cause injury. Notify the dental depot or the manufacturer.

Potential explosion hazard

Repair

Spare and accessory parts Use only original Sirona parts or parts approved by Sirona. Safe operation is not guaranteed for parts that have not been approved by

Sirona.

Disposable nozzles with an external adapter are not SPRAYVIT / C8 / E

/ L / M components and may not be used.

First aid _ US

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

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Operating Instructions SPRAYVIT / C8 / E / L / M

3 Technical description

3.1 Task

3

Technical description

3.1

Task

The SPRAYVIT / C8 / E / L / M multifunctional syringe is used for media supply and illumination during dental treatment.

3.2

SPRAYVIT / C8 / E / L / M design

A

B

C

D

E

F

G

Media lever

SN xxxxx

Serial number

20xx

Year of manufacture

Valve body

Handle sleeve

Keypad

Nozzle

Light emission (only for SPRAYVIT E / L / M)

3.3

Technical data

SPRAYVIT

Multifunctional syringe

SPRAYVIT

Available position of the water button right left

Spray water, heated

Spray air, heated

Light function

Halogen lamp

LED

Available nozzle version

Long, with light -

Long, without light

Short, with light

Short, without light x

Available for use in the US -

x

-

x x

x

-

-

SPRAYVIT C8 SPRAYVIT E SPRAYVIT L

x x

x

-

x x x

x

x

-

x x

x x

-

-

x x x x x

x

SPRAYVIT M

x

x x x x

x

x

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8

3 Technical description

3.3 Technical data

Sirona Dental Systems GmbH

Operating Instructions SPRAYVIT / C8 / E / L / M

Electronic supply (if required)

Water heating power in W

Air heating power in W

Heating cartridge, electrical resistance in Ω

Lamp voltage in V

LED current in mA

60 - 120 (max. 22 V)

~ 15 (max. 8 V)

4.2 ± 0.21

3.4 ± 0.1

100 ± 5

Media supply

SPRAYVIT SPRAYVIT C8 SPRAYVIT E SPRAYVIT L SPRAYVIT M

At the supply hose inlet, unit end:

18 ± 3 max. 38 max. 38 18 ± 3 18 ± 3 Temperature of input medium in °C

Water pressure in bar

(flowing)

Water flow rate in ml/min

2 ± 0.1

≥ 130

Air pressure in bar (flowing) 3.2 ± 0.1

Air flow rate in Nl/min ≥ 13

2 ± 0.1

≥ 130

3.2 ± 0.1

≥ 13

2 ± 0.1

≥ 130

3.2 ± 0.1

≥ 13

2 ± 0.1

≥ 130

3.2 ± 0.1

≥ 13

2 ± 0.1

≥ 130

3.2 ± 0.1

≥ 13

Operating conditions

Ambient temperature

Relative humidity in %

Air pressure in hPa

10°C - 40°C, (50°F - 104°F)

30 - 85

700 - 1060

Year of manufacture On the valve body.

This product bears the CE marking in accordance with the provisions of

Council Directive 93/42/EEC of June 14, 1993 concerning medical devices.

0123

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Operating Instructions SPRAYVIT / C8 / E / L / M

100 ml max. 45 sec

4 Preparation

4.1 Initial start-up and longer breaks in use

4

Preparation

4.1

Initial start-up and longer breaks in use

➢ Sterilize the multifunctional syringe and accessory parts prior to startup.

➢ Clean and maintain the multifunctional syringe after longer breaks in use.

➢ Vent the lines before starting up or if the supply hose was separated from the treatment center [ → 11].

4.2

Prior to starting the work day

➢ Purge the water and air channels for 20-30 seconds.

4.3

Before each patient

2. Connect the multifunctional syringe.

3. Adjust the media supply at the unit end.

CAUTION! The water may be hot. Risk of scalding! Set the required media flow rate.

4. Ensure that there is perceptible air flow.

5. Check the water flow rate. It must be at least 130 ml/min.

6. Use filtered water only (< 50 µm).

7. Check the nozzles for blockages and lime deposits, for example, and

clean the nozzles if necessary [ → 14].

Tip: Conduct a flow rate test to check the water flow quantity and avoid endangering patients:

Flow rate check

➢ Measuring the time required to fill a measuring cup up to the 100 ml mark with the water button fully actuated.

The maximum filling time is 45 seconds.

If the filling time is not 45 seconds maximum:

CAUTION! Stop using it immediately until the required flow rate is restored.

➢ Clean the nozzles [ → 14] and clean the heating cartridges as well [ → 15], if any.

or

Have the treatment center checked by a service technician.

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5 Operation

5.1 Connect the multifunctional syringe to the supply hose

B

20xx

SN xxxxx xxx

REF

A

Sirona Dental Systems GmbH

Operating Instructions SPRAYVIT / C8 / E / L / M

5

Operation

CAUTION! Too little media supply leads to overheating the water. Risk of

scalding! Set the required media flow rate [ → 7].

WARNING! A small metal tube protrudes at the tip of the nozzle. Risk of injury and contamination! Avoid contact with the tip of the nozzle. Do not attempt to handle with the nozzle attached. Remove the nozzle after every patient and sterilize.

IMPORTANT: Air and water flow from the nozzle must be unimpeded. Do not place the nozzle against a tooth or other object. Do not press the nozzle into the impression material.

CAUTION! There may be exposed voltage! Do not operate the media lever when the handle is detached! Risk of burns and electric shock!

5.1

Connect the multifunctional syringe to the supply hose

SPRAYVIT L

Connect SPRAYVIT / E / L / M to the supply hose

CAUTION! There may be exposed voltage! Do not operate the media lever when the handle is detached! Risk of burns and electric shock!

1. Attach the valve body (A) to the supply hose, observing the various tube diameters. The valve body may also remain in the handle sleeve.

2. Screw the cap nut (B) onto the valve body and tighten it.

Attach SPRAYVIT L hose

Connect SPRAYVIT C8 to the supply hose

1. Attach the water hose and air hose to the SPRAYVIT C8, ensuring the correct position of the hoses (C: blue, D: green).

2. Screw the cap nut (B) onto the valve body and tighten it.

A

B

5.2

Attach/remove the handle sleeve and nozzle

Attachment

1. Align knob (A) and recess (B) so they face each other.

2. Insert the handle sleeve until it snaps into place.

3. Twist the nozzle onto the handle sleeve.

4. Check to make sure the nozzle is firmly attached.

CAUTION! If the nozzle is not locked in place, it can come loose when the multifunctional syringe is operated and fall into the patient's throat.

10

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Operating Instructions SPRAYVIT / C8 / E / L / M

5 Operation

5.3 Vent supply lines

Removal

1. Twist the nozzle to detach it from the handle sleeve.

2. Press the lock knob and pull the valve body out of the handle sleeve at the cap nut. Do not hold or pull on the supply hose!

5.3

Vent supply lines

Because of the automatic air discharge in Sirona treatment centers for the

SPRAYVIT product family, the media can be cold at the start of treatment even if SPRAYVIT is heated.

5.4

Applying air, water, or spray

IMPORTANT: Regulate heating and lighting from the treatment center.

➢ Press the button to release air or water.

➢ Press both buttons simultaneously for good spray production.

➢ Twist the nozzle to reach the desired direction of spray.

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6 Follow-up

6.1 After each treatment session

Sirona Dental Systems GmbH

Operating Instructions SPRAYVIT / C8 / E / L / M

6

Follow-up

6.1

After each treatment session

Wear appropriate protective clothing.

1. Remove any residue, e.g. from impression material or caustic chemicals immediately.

2. Purge the water and air channels on the treatment center for 30 seconds.

3. Pre-disinfect directly at the treatment center [ → 13].

4. Detach the nozzle and the handle sleeve [ → 10].

5. Transport the nozzle and handle sleeve to the hygiene room in a suitable transport container.

6. Conduct automatic conditioning [ → 13]. Manual conditioning [ → 13]

is possible in exceptional cases if the national/local regulations are followed.

7. Sterilize the nozzle and handle sleeve and accessories [ → 14].

12

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Operating Instructions SPRAYVIT / C8 / E / L / M

7 Conditioning

7.1 Conduct pre-disinfection

7

Conditioning

7.1

Conduct pre-disinfection

Wear appropriate protective clothing.

All disinfectants must be approved in your country and have proven bactericidal, fungicidal and virucidal properties. Only use disinfectants with no protein-fixing properties.

1. Spray the surface with disinfectant.

2. Wipe the disinfectant away with a cloth.

For further processing, SPRAYVIT / C8 / E / L / M should be dry and free of residue.

● CAVICIDE

®

● CAVIWIPES

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

7.2

Automated cleaning and disinfecting ...

7.2.1

... with cleaning and disinfection equipment

NOTICE! SPRAYVIT / C8 / E / L / M is not suitable for use with a cleaning and disinfection device.

7.3

Manual cleaning and disinfection

NOTICE! Never clean in an ultrasound bath!

NOTICE! Never immerse in disinfectants!

Wear appropriate protective clothing.

All disinfectants must be approved in your country and have proven bactericidal, fungicidal and virucidal properties. Only use disinfectants with no protein-fixing properties.

1. Brush SPRAYVIT / C8 / E / L / M under running water (< 38 °C,

< 100 °F, at least drinking water quality) and good lighting (min. 500 lux) and color rendering index (min. 80 Ra) until no more dirt can be seen, for at least 10 seconds.

2. Conduct thermal disinfection or unwrapped steam sterilization.

3. Pack SPRAYVIT / C8 / E / L / M in packaging material suitable for sterilization and storage. e.g. paper/plastic composite packaging.

4. Sterilize the adapter [ → 14].

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7 Conditioning

7.4 Sterilizing

Sirona Dental Systems GmbH

Operating Instructions SPRAYVIT / C8 / E / L / M

7.3.1

Cleaning the nozzle

CAUTION! The media temperatures may become too high if the water line in the nozzle is clogged. Risk of scalding! Clean the water line (A) regularly.

The nozzle is removed.

➢ Insert the cleaning wire provided through the water line in the nozzle to clean it.

7.4

Sterilizing

Interval _ US

Intervals:

● Prior to initial operation

● Prior to every other use

Process

The multifunctional syringe is cleaned and disinfected.

If necessary, the multifunctional syringe can be packed in packaging suitable for sterilization and storage, e.g. paper/plastic composite packaging or container.

➢ Sterilize the multifunctional syringe in the steam sterilizer with saturated water vapor.

Unit pressure in bar and psi_US Temperature:

Overpressure:

Holding time:

Drying time:

135 °C (275 °F)

2.13bar (30.89psi)

3 min min. 20 minutes

Dynamic air removal sterilizers or autoclaves with fractional vacuum are permitted.

NOTICE! Do not exceed 140°C (284°F), even during the drying phase.

After sterilizing - heading After sterilizing

1. Remove the nozzle and handle sleeve from the steam sterilizer immediately.

CAUTION! The parts are hot. This may cause burns!

NOTICE! Do not accelerate the cooling process by immersing the parts in cold water. This can damage the parts.

2. Store all components so that they are protected against contamination.

3. Sterilize again once the storage period has elapsed.

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Operating Instructions SPRAYVIT / C8 / E / L / M

B

A

A

8 Maintenance

8.1 Replacing O-rings

8

Maintenance

Elastomers, e.g. O-rings, must be replaced depending on their degree of wear.

8.1

Replacing O-rings

C

1. Unscrew ring (A) from the nozzle.

2. Remove O-rings (B) with a hook probe.

3. Slide tool (C), with the new O-ring [ → 17] attached, up to just in front

of the corresponding groove.

4. Insert the O-ring. Do not use any sharp objects.

5. Repeat steps 3-4.

6. Screw ring (A) tightly onto the nozzle.

8.2

Replacing lamps

IMPORTANT: Only SPRAYVIT E / L / M have lamps.

CAUTION! The lamp can be hot. Risk of burns! Allow the lamp to cool down.

1. Switch the treatment center off at the main switch.

2. Detach the handle sleeve from the valve body [ → 10].

3. Use a probe or the like to pry the lamp out of the socket from the button side.

4. Insert the new lamp, observing the contact surface.

For an LED, the Sirona logo (A) must face upward and must be legible after it is inserted into the valve body.

Tip: Insert a probe into the hole on the LED and pull the LED into the valve body until it clicks in place.

8.3

Cleaning heating cartridges

The heating cartridges are contaminated or plugged.

1. Clean the heating cartridges with an interdental brush with a diameter of 0.5 mm.

2. Check the flow rate.

The flow rate check was successful.

If the flow rate check was not successful, have the treatment center checked by a service technician.

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8 Maintenance

8.4 Replacing the heating cartridges

Sirona Dental Systems GmbH

Operating Instructions SPRAYVIT / C8 / E / L / M

8.4

Replacing the heating cartridges

IMPORTANT: Only SPRAYVIT / L / M has heating cartridges. SPRAYVIT

M has only a water heater.

If heated media no longer heat up, the heating cartridges in the valve body may be burned out. Replace the defective heating cartridge. The procedure is identical for both heating cartridges depending on the side.

1. Switch the treatment center off at the main switch.

2. Detach the handle sleeve from the valve body [ → 10].

3. Swing the heating cartridge (A) to the side away from the valve body.

4. Hold the cartridge hose firmly and twist the cartridge to remove it.

5. Insert the new cartridge in reverse order.

16

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Operating Instructions SPRAYVIT / C8 / E / L / M

9 Spare parts and consumables

9

Spare parts and consumables

SPRAYVIT kombi

SPRAYVIT

SPRAYVIT nozzle G, long, curved, without fiber optic

SPRAYVIT nozzle, short, straight, without fiber optic

Casing, right water line

Touch button

Small cleaning wires

REF

59 92 206

59 92 198

60 02 179

63 21 728

24 00 232

SPRAYVIT C8

O-ring 1.5 x 1 for heating cartridge

O-ring set SPRAYVIT nozzle

● 1 attachment tool

● 10 O-rings 5.5 x 1.03

Heating cartridge

REF

70 41 734

41 76 751

33 27 132

SPRAYVIT nozzle G, long, curved, without fiber optic

SPRAYVIT nozzle, short, straight, without fiber optic

Casing, right water line

Casing, left water line

Touch button

REF

59 92 206

59 92 198

60 02 179

60 02 187

63 21 728

SPRAYVIT E

O-ring set SPRAYVIT nozzle

● 1 attachment tool

● 10 O-rings 5.5 x 1.03

Small cleaning wires

SPRAYVIT nozzle G, long, curved, with fiber optic

SPRAYVIT nozzle, short, straight, with fiber optic

Casing, right water line

Casing, left water line

Touch button

Small cleaning wires

REF

59 92 180

41 77 783

60 02 179

60 02 187

63 21 728

24 00 232

Heating cartridge

O-ring 1.5 x 1 for heating cartridge

O-ring set SPRAYVIT nozzle

● 1 attachment tool

● 10 O-rings 5.5 x 1.03

LED

REF

41 76 751

24 00 232

REF

33 27 132

70 41 734

41 76 751

63 22 007

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9 Spare parts and consumables Sirona Dental Systems GmbH

Operating Instructions SPRAYVIT / C8 / E / L / M

SPRAYVIT L

SPRAYVIT nozzle G, long, curved, with fiber optic

SPRAYVIT nozzle, short, straight, with fiber optic

Casing, right water line

Casing, left water line

Touch button

Small cleaning wires

REF

59 92 180

41 77 783

60 02 179

60 02 187

63 21 728

24 00 232

SPRAYVIT M

Heating cartridge

REF

33 27 132

O-ring 1.5 x 1 for heating cartridge 70 41 734

O-ring set SPRAYVIT nozzle

● 1 attachment tool

● 10 O-rings 5.5 x 1.03

Halogen lamp, brown

41 76 751

59 40 291

SPRAYVIT nozzle G, long, curved, with fiber optic

SPRAYVIT nozzle, short, straight, with fiber optic

Casing, right water line

Casing, left water line

Touch button

Small cleaning wires

REF

59 92 180

41 77 783

60 02 179

60 02 187

63 21 728

24 00 232

Heating cartridge

O-ring 1.5 x 1 for heating cartridge

O-ring set SPRAYVIT nozzle

● 1 attachment tool

● 10 O-rings 5.5 x 1.03

LED

REF

33 27 132

70 41 734

41 76 751

63 22 007

18

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Sirona Dental Systems GmbH

Operating Instructions SPRAYVIT / C8 / E / L / M

10 Storage and transport conditions

10

Storage and transport conditions

Protect from moisture

Sensitive contents

Relative humidity

Temperature

Air pressure kPa

After a severe change in temperature, allow sufficient time for acclimatization.

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11 Disposal Sirona Dental Systems GmbH

Operating Instructions SPRAYVIT / C8 / E / L / M

11

Disposal

● According to current information, the product does not contain any substances that are hazardous to the environment.

● Observe the applicable disposal regulations for your area.

20

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