Henry Schein Maxima Turbo Bedienungsanleitung

Maxima Turbo - 1

Turb o

Class B Sterilizer

Esterilizador Clase B

Stérilisateur de classe B

570-3362

INSTRUCTIONS FOR USE

INSTRUCCIONES DE USO

DIRECTIVES D’UTILISATION

2 - Maxima Turbo

INDICATIONS FOR USE

The Maxima Turbo is an air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by

means of pressurized steam. It is suitable for the sterilization of dental and medical instruments that are validated to be sterilized by steam. The Max-

ima Turbo has not been designed to sterilize liquid loads, bio-medical waste or materials not compatible with steam sterilization. The processing of

such loads may result in incomplete sterilization and/or damage to the autoclave. Please refer to the table below for program name, load description,

sterilization temperature, exposure time, drying time and maximum load.

MAXIMA TURBO

Program

name

Load description Sterilization

temperature

Sterilization time Drying time maximum

load

Maximum load

134˚C solid objects, small

porous objects, sim-

ple objects recessed,

narrow-clearance items,

dental handpieces, and

textiles; wrapped and

unwrapped

134˚C

(273˚F)

4:00 minutes 3 minutes 0.5 Kg

/1.1 lbs

121°C solid objects, small

porous objects, sim-

ple objects recessed,

narrow-clearance items,

dental handpieces,

textiles, and plastics;

wrapped and unwrapped

121°C

(250˚F)

30 minutes 5:30 minutes 0.5 Kg

/1.1 lbs

134°C

FAST*

solid objects, non-po-

rous objects, simple

instruments (such as

scissors, handles, pliers,

chisels, probes, etc.),

and dental handpieces;

unwrapped

134˚C

(273˚F)

4:00 minutes N/A 0.5 Kg

/1.1 lbs

* - Immediate Use Steam Sterilization cycle

The sterilizer is suitable for use in the vicinity of other powered medical products.

The Maxima Turbo device may not be used to sterilize

liquids, biomedical waste or pharmaceutical products.

The device is intended for professional use by properly trained staff only.

SYMBOLS USED ON THE DEVICE

This symbol is located on the front of the appliance, on top of the drawer front, and advises extreme caution due to the high temperature of

the compartment and its immediate surroundings.

This symbol is located on the unit’s rating plate and identiﬁes its individual serial number.

This symbol is located on the unit’s rating plate and identiﬁes the year the unit was manufactured.

This symbol is located on the equipment rating plate and identiﬁes the equipment manufacturer.

This symbol can be found on the unit’s rating plate and requires the user to read and follow the information in this manual.

Used electrical and electronic equipment must not be placed, thrown away or stored with other waste. Used equipment should be deliv-

ered to a local collection point for used electrical equipment, which is registered with the respective environmental protection ofﬁce and

conducts selective waste collection.

Maxima Turbo - 3

INDICATIONS FOR USE

• Maxima Turbo complies with IEC 60601-1-2:2014 (Edition 4.0)

• Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is

necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Max power cord length is 160 cm.

• Use of accessories and cables other than those speciﬁed or provided by Maxima Turbo could result in increased electromagnetic emissions or

decreased electromagnetic immunity of this equipment and result in improper operation.

• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30

cm (12 inches) to any part of the Maxima Turbo S, including cables speciﬁed by Maxima Turbo. Otherwise, degradation of the performance of this

equipment could result.

• The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a

residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency

communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.

• The user is responsible for the installation, correct operation and maintenance of the device in accordance with instructions provided in this user

manual. If needed, contact the service or the supplier of the device.

• The sterilizer is not intended for sterilizing liquids, biomedical waste or pharmaceutical products.

• The sterilizer must not be used if explosive gases or vapours are present in the air.

• After the cycle is completed, the load is hot. Remove tools or packs from the chamber using appropriate thermal gloves or equipment that prevents

burns.

• Do not remove the rating plate or any other elements of labeling from the device.

• Follow guidelines for preparing tools for sterilization.

• Pouring water or other liquids on the device may cause a short-circuit.

• Prior to inspection, maintenance or servicing, turn off the device and disconnect it from the power source.

• Servicing may only be performed by trained service personnel and using original replacement parts.

• The device is intended for indoor use only.

• Max working high elevation of the device is 2,000 m above sea level.

• Pollution Degree 2: Normally only nonconductive pollution occurs. Temporary conductivity caused by condensation is to be expected.

• Overvoltage Category II.

• If the equipment is used in a manner not speciﬁed by the manufacturer, the protection provided by the equipment may be impaired.

• Use only detachable cord that rated equal or greater to the equipment electrical ratings.

Read this Operating Manual carefully before using this device. Install and operate the device strictly as speciﬁed herein. Comply with all safety

requirements for the device. This will ensure proper and safe operation of this device. Any other application, inconsistent with this manual, may lead

to dangerous accidents. Restrict unauthorised personnel access to the device and train the personnel handling the device. An operator of this device

is any person who, by training, experience and knowledge of applicable reference standards, manuals and occupational health and safety regulations

has been authorised for the essential operation with the device and who is capable of identifying and avoiding the hazards related to operation of this

product.

Always append this Operating Manual with the device if transferred to a new owner. The Operating Manual contains detailed information about

assembly, installation, initial start-up, use, repairs and maintenance of the device. If the device is used as intended, this Manual will provide sufﬁcient

guidance to qualiﬁed personnel. Keep this Operating Manual close to the device and easily accessible at all times. As required by continuous improve-

ment of the product, the manufacturer has the right to amend this Manual or make changes to the device without prior notice. Henry Schein shall not

be liable for damage incurred during the wait for warranty service, any damage to the Customer’s property other than this device, or errors caused by

improper installation and/or improper operation of the device.

Detailed recommendations, coutnerindications and warnings are

described in the relevant sections.

PRODUCT STRUCTURE AND ACCESSORIES

22 in (561 mm) 9.9 in (252 mm)

6.4 in (162 mm)

4 - Maxima Turbo

Hepa ﬁlter

seat

Power socket

WATER IN feed

water inlet

USB socket

Condensate

outlet WATER OUT

Main switch

HEPA Filter Power Cord Water and condensate connection cables, rubber

plugs for water/condensate containers

Operating Manual (PDF, on USB drive) Data viewer software

* The electronic versions of the documents are stored on USB stick.

DEVICE SETUP

Please read these operating instructions carefully before using the Maxima Turbo. During operation, observe the guidelines in these instructions as

well as the applicable local health and safety rules. The Maxima Turbo unit is designed for self-assembly by the user and do not require specialized

installation on site. The user is responsible for proper installation of the unit on site in accordance with these instructions.

HEPA ﬁlter installation.

To protect the component during transport, a HEPA ﬁlter is not installed in the device. It was placed inside the chamber, on a tray. Take it out of the

chamber, take it out of the bag and by yourself, carefully screw it into the slot provided for this purpose (see ﬁg.). The ﬁlter should be screwed in by

hand (approx. 7 turns) until resistance is felt - further screwing in will damage the ﬁlter and immobilize the sterilizer.

Maxima Turbo - 5

Feed water quality

It is unacceptable to use any liquids, solutions, chemicals, additives to the feed water - the device may be powered only with demineralized or distilled

water of appropriate quality.

No chemicals or additives must be added to the sterilization water, even if they are speciﬁcally intended for use in steam generators, steam production

or for use as additives in sterilization, disinfection, cleaning or corrosion protection.

The use of incorrect quality water or solutions other than water reduces the effectiveness of sterilization and leads to damage to the device and loss of

warranty.

The total mineral content of the sterilization water must be less than 10 ppm or, in the case of conductivity measurement, it must be less than 15 μS/

cm - therefore tap water cannot be used as feed water for the device.

The table below shows recommended water hardness and conductivity parameters. Permissible parameters of water used for sterilization

• Hardness <0.02 mmol / l

• Conductivity (at 20 ° C) <15 μS / cm

• PH - from 5 to 7.5

6 - Maxima Turbo

• Chemical additives - none

Water Filter & Water Quality Indicator

To ensure the proper feed water quality a water ﬁlter and water quality indicator has been attached to the inlet line. Any usage of improper water will

begin to discolor the indicator. Check the indicator frequently to ensure proper water is being used. The use of incorrect quality water or solutions

other than water reduces the effectiveness of sterilization and leads to damage to the device and a loss of warranty.

If the indicator is completely discolored the unit will need to be serviced and the inlet line will need to be replaced.

New Indicator Needs to be replaced

Connecting the WATER IN feed water

• Connect the blue connection hose to the blue feedwater connection, which is marked on the rear panel of the WATER IN device. The tubing should

be inserted into the connector, to the depth of the black line (placed on the tubing).

• The other end of the blue tube should be immersed in the tank with the feed water. The device is equipped with a water suction pump, so it is not

necessary to place the water tank above or on the same level as the device.

• To secure and immobilize the water supply hose to the machine, use the plug supplied with the hose and insert the plug into the opening of the

water supply tank. An unsecured tubing may jump out of the water and cause sterilization errors.

• To prevent the hose from coiling in the water tank, install the included weight with a rubber ring at 2 cm from the end of the hose (ﬁg.)

• The minimum water load in the tank is 300 ml.

• Remember and check that the blue tube is always immersed in the water.

• Check the water level in the tank on a regular basis, depending on the frequency of the processes

WATER OUT Wastewater connection

• Connect the red wastewater hose to the orange wastewater connector that is marked on the rear panel of the WATER OUT device. The tubing

should be inserted into the connector, to the depth of the black line (placed on the tubing).

• Wastewater should be discharged directly to the water and sewage system or to a special wastewater tank. If a tank is used, the other end of the

red tube should be placed in the wastewater tank. To secure and immobilize the water drain hose from the machine, use the plug provided with the

hose and insert the plug into the opening of the wastewater tank. The unsecured tubing may jump out of the tank and ﬂood the room.

• Make sure that the red tube is never immersed in water, otherwise the water will not drain properly, causing sterilization errors.

• The wastewater tank or drainage outlet must always be located below the unit.

• When using wastewater tanks, we recommend that you use tanks with the same capacity as the feed water tank. Their simultaneous replacement

will protect against the possibility of wastewater overﬂow.

• The water level in the tank should be checked on a regular basis, depending on the frequency of the processes.

Maxima Turbo - 7

0.4 in

2 in

Setting up the device

• The unit should be placed on a ﬂat, level surface. Do not use the unit if it is at an angle.

• Only demineralized or distilled water should be used in the devices. The use of incorrectly speciﬁed water (see “Supply water quality”) reduces the

sterilization efﬁciency and leads to loss of warranty due to damage to the device.

• Leave a space of 5 cm (2 in) at the rear of the appliance and at least 1 cm (0.4 in) at the sides of the appliance from walls or other elements for

proper ventilation and fresh air access.

• The unit should be located to provide easy access to the main switch located on the rear panel of the unit.

• Do not place the unit near a sink with water or other places where the unit could be ﬂooded - danger of short circuit.

• The device should be installed in a well-ventilated room, far from heat sources and rooms where mixtures of gases or liquids or other dangerous

factors may arise.

The following conditions must be ensured for safe and efﬁcient operation of the device:

• Ambient temperature from + 5 ° C (41°F) to + 25 ° C(77°F),

• Relative humidity from 0 to 90%,

• Storage temperature from -20 ° C (-4°F) to + 60 ° C (140°F),

• 0 to 90% relative humidity.

8 - Maxima Turbo

Correct connection of the hoses to

the feed and wastewater connec-

tions

Correct installation of the weight

with the securing ring

Correct positioning of the

hoses in the water tank

Maxima Turbo - 9

PREPARATION AND LOADING OF INSTRUMENTS

The devices are suitable for sterilization of loads for which steam sterilization is stipulated. The instruments must be sterilized only if they are clean

and dry. Therefore they must be washed and disinfected before being loaded onto the tray in accordance with applicable regulations. Residues of used

chemicals or other solid particles may render the sterilization process impossible or even damage the device. In addition, sterilization of instruments

that have not been previously cleaned and disinfected is a biological hazard and can lead to damage (both to the instruments and to the sterilizer). For

instruments that must be lubricated, use steam sterilization lubricants. Excess lubricant must also always be removed.

• The 134 ° C (273°F) FAST program is intended only for sterilization of unwrapped instruments.

• After sterilization with 134°C (273°F) FAST the instruments are moist - it is recommended to leave the door open for a few minutes to evaporate

excess moisture.

• After sterilization of unpackaged loads, they are intended for immediate use.

Preparation of packages

It is recommended to use sterilization packaging that meets the requirements of EN ISO 11607-1: 2020 and EN 868-2: 2017. Appropriate packaging

should:

• Ensure good penetration of the sterilizing agent into the inside of the package.

• Provide resistance to damage during the sterilization process.

• Ensure tight and durable sealing of contents and safe removal for use.

• Provide a barrier to microorganisms and unwanted substances and contaminants.

• Use disposable sterilization sleeves (intended for steam sterilization) as recommended by their manufacturer.

• Sleeves should only be ﬁlled to about 3/4 full to allow for proper sealing and minimize the risk of damage to the package.

• A distance of at least 30 mm should be maintained between the seals and the sterilized load.

• The sharp edges of the load should be protected to avoid damaging the packaging.

• The packaging material must not be placed too loosely or be tightly stretched so as not to affect pressure variations during sterilization.

• a label with information about the contents of the package, the code of the packer, date of sterilization and use-by date as well as parameters of the

sterilization process should be placed on the package.

Arranging packages on the sterilizer tray (sterilization of packed items)

• Packets on the tray should be placed so that the paper side touches the paper side, because penetration of the sterilizing agent and air exchange

can only take place through the paper.

• The packages should be placed on the tray in such a way as to eliminate the contact of the package with the door seal and the phase of the steril-

ization chamber - failure to comply with this rule may cause the chamber to become unsealed and the sterilization cycle incorrectly carried out

• The edges of the packs must not protrude beyond the sterilizer tray, as this would cause the chamber to leak and the sterilization cycle to fail

• If the sterilizer chamber is heavily loaded, the ﬁrst packs must face the foil side towards the bottom of the tray (this ensures faster and more efﬁ-

cient drying of the packs).

Arranging tools on the sterilizer tray (sterilization of loads without packaging)

• In the case of sterilization without packages - the instruments must be placed in such a way that they do not have direct contact with each other, no

element of them falls into the openings of the tray, and does not rest against the edge of the tray or protrude beyond its outline.

• Failure to follow the above recommendations may cause permanent and irreversible damage to the sterilization chamber phase, which will result in

the lack of tightness of the sterilizer and loss of warranty.

Do not exceed the maximum load weight: 500 g for the Maxima Turbo device. In order to verify the correctness of the performed

sterilization, it is recommended to place a sterilization chemical indicator in the chamber for each process, which discoloration

during properly conducted sterilization.

10 - Maxima Turbo

Sample placing of sterilization packages.

Plastic

Paper

Plastic

Paper

Plastic

Example of solid load.

OPERATING THE DEVICE

First run

Turn on the device using the main switch located on the rear panel of the device. Make sure that the supply and wastewater hoses are connected

correctly, and that there is water in the supply tank and the wastewater tank is empty. Place the load on the tray, slide the drawer in and lock it, i.e.