Lisa MB 17 and MB 22 User Manual Rev 9

RECOMMENDATIONS – SAFETY The purpose of this user manual is to provide you with all the information you need in order to ensure: ព A proper installation and set-up. ព Optimal use. ព A safe and reliable operation. ព A regular and correct servicing requirements.

DECLARATION OF CONFORMITY The Lisa sterilizer MB 17/22 is a Medical device class IIb, in accordance with rule 15 - Appendix IX of the European Directive 93/42/CEE. The sterilizer has been developed, produced and tested in accordance with the new European Norm relative to small water steam sterilizers : EN 13060, and with the applicable safety norms (see appendix 1). You will find enclosed a declaration of conformity and a warranty card specific to your sterilizer.

CONFORM USE: The sterilizer must be used only for the purpose for which it was intended: the steam sterilization of solids, textiles and hollow items unwrapped, single or double wrapped.

This symbol draws attention to the user manual. To disregard the instruction given in this manual, the incorrect use and the unauthorised disassembly of the sterilizer clears the manufacturer, W&H l STERILIZATION of responsibility for warranty and any other claim.

This symbol is visible on the front of the device under the door handle. It recommends attention be paid to the high temperatures associated with the chamber, the door and the area around the door handle.

The documentation and diagrams used in this manual are the property of W&H l STERILIZATION, all rights reserved. The photocopying, even in part, of the text or illustrations is forbidden. We reserve the right to modify the sterilizer in pursuit of our aim to improve our equipment and keep abreast of technology.

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GENERAL RECOMMENDATIONS – SAFETY
The user is responsible for operating and servicing the sterilizer in accordance with the instructions listed in this manual.
The sterilizer has not been designed for the sterilisation of liquids.
The sterilizer has not been designed to operate in the presence of gas or explosive vapours.
The chamber is automatically heated to 110°C as soon as the sterilizer is switched on.
The trays and the load will still be hot at the end of each cycle. Use the tray holder to remove each tray from the chamber.
Comply with the maximum weight specified, having been tested and validated for each load type (see § 4.6.1.) by W&H l STERILIZATION in order to ensure smooth operation and effective sterilization.
Do not remove the instruction plate or any label from the sterilizer.
Do not pour water or any other liquid over the sterilizer.
Unplug the mains lead before inspecting or servicing the machine.
Repairs and maintenance must only be carried out by an approved technician using only original spare parts.
In case of transport, drain both water tanks completely (§ 4.3 and 4.4), allow the sterilization chamber to cool down and preferably use the original packaging.

Compliance with the instructions in this manual ensures safe operation.

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1.

UNPACKING

The sterilizer, the accessories, the user manual and the warranty card are supplied in a sturdy box. Check the condition of the packaging on receipt. Contact the carrier immediately and inform your supplier if the outer packaging is damaged. 1.1.

UNPACKING THE STERILIZER

48

m 0 9 2 5 ,

54

10 m 5 ,0 9 6

64,5 cm 74,5 cm (MB22)

49Kg (MB17) 56 kg (MB22)

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4,25 cm

1.2.  

UNPACKING THE ACCESSORIES

Open the door and remove the accessories from the sterilization chamber. Check the contents:      



5 anodised aluminium trays Reversible rack for 3/5 trays Tray holder Drain tube Mains cable Funnel User manual and warranty card Declaration of conformity

1 2 4

6 3 5

7

Insert the rack into the sterilization chamber and click it into position.

The rack is reversible and can be positioned to take either:

5 trays horizontally / 3 cassettes vertically

CLICK

90°

or

3 trays / cassettes horizontally.

Usable space: This equates to the usable volume of the chamber accommodating the sterilizable load. This volume is equivalent to a parallel pipe with the following dimensions: L: 195 mm, H: 205 mm, W: 300 mm, i.e. 12 litres (MB17) L: 195 mm, H: 205 mm, W: 400 mm, i.e. 16 litres (MB22). This volume is identical for all cycles and all types of load.

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2.

SET-UP

2.1.

INSTALLATION

The sterilizer has been calibrated and tested in the factory. It does not require calibration during installation. Working temperature range: Storage temperature range :

10°C to 40°C / Humidity : 0 to 90%. -20°C to 60°C / Humidity : 0 to 90% (Water tanks empty).

Install the sterilizer as outlined below:

ព ព

Install the sterilizer on a flat and level surface.

ព ព ព ព

Leave a gap of 5 cm at the back and 2 cm on each side of the sterilizer to ensure adequate ventilation.

The maximum weight of the sterilizer with the main water tank full and the chamber fully loaded is: 57,0 kg, 129.4 N/m², 140 N/foot (MB17) 66.5 kg, 177.3 N/m², 160 N/foot (MB22)

Do not place the sterilizer near a sink or in a location where it is likely to be splashed. Install the sterilizer in a well ventilated room. Keep away from all sources of heat.

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2.2.

ELECTRICITY SUPPLY

The electrical installation must comply with the current standards in the country. ព The electricity supply must be single phase 230 volts ±10%, 50/60Hz, 10A.

ព ព

Installation category / Mains overload category = II An earth connection is essential.

The sterilizer must be connected to an electrically earthed plug. Use only the mains cable delivered with the sterilizer.

The maximum absorbed power of the sterilizer is 2100 W (9,2A). The installation must include: - an earthed plug. - a 10A differential circuit breaker with a sensitivity of 30mA (2).

2

+

Plug in the mains cable to the back of the sterilizer. Check that the serviceable voltage specified on the name plate located on the back of the sterilizer corresponds to the supplied mains voltage. The overall electrical safety of the sterilizer is only guaranteed if the sterilizer is appropriately earthed. If unclear, have the installation checked by a qualified electrician. Do not plug other equipment into the same socket. Do not bend or twist the mains cable.

W&H l STERILIZATION does not accept any responsibility if these instructions are not complied with.

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2.3.

PRINTER CONNECTION (OPTIONAL)

Attention ! We recommend to use the following printer:

- Custom DP40H. It has been tested and is perfectly compatible with the sterilizer and its software. The use of another printer is undertaken with the full responsability of the user, clearing the manufacturer, W&H l STERILIZATION of responsability for warranty and any other claim.

    

Connect the printer cable to the 25 pin parallel port socket at the back of the sterilizer. Cable length should not exceed 2 metres. Plug in the printer mains cable. Switch ON the printer. Switch ON the sterilizer. Select the printer type (§ 4.5.4.).

All the information needed to document the sterilization cycles is printed: - The name of the Doctor / surgery (§ 4.5.2.). - The serial number of the sterilizer. - The chronological number of the cycle. - The date and time at the beginning and at the end of the cycle. - The cycle selected. - The duration, temperature and pressure of the various phases. - Comments on cycle efficiency.

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3.

DESCRIPTION

3.1.

FRONT VIEW OF THE STERILIZER

Touch screen

Door

Service door

Main switch / circuit breaker * Switch ON/OFF of the sterilizer. Use this switch to interrupt a cycle only in the case of a noted defect.

9 pin serial port For technical department only.

* Replaces the fuses.

Used water tank drain connection

Main water tank drain connection

Bacteriological filter

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3.2.

REAR VIEW OF THE STERILIZER

Condenser ventilation

25 pin printer port

Compliance plate

Mains plug socket

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Connection for external used water drainage

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4.

USE

4.1.

MAIN MENU

Activate the mains switch, the selection screen appears.

Manual stand-by

Cycle selection (§ 4.6.2.)

Access to sub menus (§ 4.5.)

If the sterilizer is not used for a certain period of time, it will automatically go into stand-by mode. Stand-by mode time is programmable (§ 4.5.6.).

When the sterilizer is switched ON, the chamber is automatically heated to 110°C. Pre-heating starts from room temperature and takes approximately 10 minutes. It is nevertheless possible to select and start a cycle before the end of pre-heating.

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4.2.

DESCRIPTION OF THE WATER TANK

The sterilizer is equipped with 2 independent water tanks of equal volume - 3.5 litres (MB17) or 4,5 litres (MB22). The left tank also called the "main tank" contains the distilled or demineralized water required for each cycle. It is fitted with 2 level sensors, minimum (0.5 l) and maximum (3.5 l on MB17 or 4.5 l on MB22). The right tank called the "used water tank" contains the used water collected at the end of each cycles. It is fitted with a maximum level sensor (3.5 l on MB17 or 4.5 l on MB22). The 2 tanks are connected to drain connections located behind the service door.

Used water tank

Main water tank

Used water tank drain connection

Main water tank drain connection

The water consumption per cycle varies depending on the type and mass of the sterilized load.

The sterilizer will run for at least 8 cycles before the main tank needs refilling. The following message is displayed on the screen when the minimum water level is reached in the main tank:

FILL THE WATE R TAN K

While the message is displayed, it is impossible to run another cycle. The selection button has disappeared !

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4.3.

FILLING OF THE MAIN WATER TANK Attention ! Use only high quality distilled or demineralized water (see Annex 7).

Remove the main water tank cap located on the top of the sterilizer …

…Fill the tank with approx. 3 litres on MB17 (or 4 litres on MB22) of water...

…Once the tank is almost full, an audible tone will be heard.

When you hear the tone proceed carefully. You must stop filling as soon as the water level reaches the lower edge of the opening to the water tank.

The water from the main tank (3 litres on MB17 or 4 litres on MB22) has been used for a series of cycles. This water has been drained off and stored in the used water tank which will be full. While the main tank is re-filled, the used water tank must be drained in the meantime (see § 4.4.).

If the sterilizer is not used for more than 3 days, both water tanks must be completely drained in order to avoid alga growth or any other deposits.

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4.4.

DRAINING OF THE USED WATER TANK

When the used water tank is full, it is impossible to run another cycle. The following message appears:

DRAIN THE U S E D W AT E R TA N K

♦ Open the service door. ♦ Insert the drain tube into the quick coupling drain connection of the used water tank (right) as shown in the diagram. ♦ Allow the entire contents of the tank to empty and discard the used water.

NEVER RE-USE THE USED WATER !

Disconnect the drain tube by pressing the push button on the drain connection.

In the meantime, while the used water tank is drained, the main tank can be re-filled.

If the sterilizer is not used for more than 3 days, both water tanks must be completely drained in order to avoid alga growth or any other deposits.

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4.5.

PROGRAMMING

Press the "M" key on the selection screen…

…The program menu is displayed…

To exit the program menu Cursor UP

Consult: § 4.5.1. ➔ § 4.5.2. ➔ § 4.5.3. ➔ § 4.5.4. ➔ § 4.5.5. ➔ § 4.5.6. ➔ § 4.5.7. ➔ § 4.5.8. ➔

LANGUAGE USER NAME D AT E / C L O C K PR I N T E R TOUCH SCREEN S TA N D - B Y MAINTENANCE SERVICE

Cursor DOWN

Access to sub-menu

… Place the cursor ">" in front of the desired sub-menu using the "UP" and "DOWN" keys. Confirm the selection by pressing the sub-menu access key. Refer to the relevant chapter for the sub-menu selected.

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4.5.1. SELECTING THE LANGUAGE

To exit the sub-menu

Cursor UP

Cursor DOWN

Selection confirmation

4.5.2. PROGRAMMING THE NAME OF THE DOCTOR / SURGERY

Confirmation, exit of the sub-menu Alphabet scrolling +

Alphabet scrolling -

Letter selection cursor to the right

Letter selection cursor to the left

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4.5.3. PROGRAMMING THE DATE AND TIME It is essential to adjust the date and time especially if the sterilizer is connected to a printer. These parameters are systematically printed at the beginning and at the end of the cycle report. Place the selection cursors under the data that is to be adjusted. Increase or decrease its value, move the cursors under the next value and repeat operation. Confirm the adjustment by pressing the "Ok" key.

Confirmation, exit of the sub-menu

Increase

Cursors

Decrease

Control of selection cursors

4.5.4. PROGRAMMING THE PRINTER

To exit the sub-menu Cursor UP

Cursor DOWN

Confirmation of the selection

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4.5.5. PROGRAMMING THE BRIGHTNESS OF THE TOUCH SCREEN

Darker

Lighter

Confirmation, exit from the sub-menu

4.5.6. PROGRAMMING THE STAND-BY MODE

Exit from the sub-menu Cursor UP

Cursor DOWN

Confirmation of the selection

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4.5.7. MAINTENANCE PROGRAM This screen shows the number of cycles remaining before replacement of the bacteriological filter (400), the door seal (1000) as well as when general servicing (4000) is required. The three counters are decreased in value after each cycle. When one of the counters reaches 0 a corresponding message appears at the bottom of the selection screen. It is not possible to run a new cycle (the selection button will disappear) unless the reading of the message has been confirmed by pushing the Ok icon. The counter is then automatically reset. If one of the three operations is completed before the respective counter has reached 0 it is necessary to reset the counter manually. Place the cursor in front of the operation with the icons UP and DOWN and reset it by pushing the Ok icon. Exit from the sub-menu Cursor UP

Cursor DOWN Reset of the selected counter

4.5.8. SERVICE PROGRAM In this sub-menu it is possible to select and run the Bowie & Dick, Helix and air leakage/vacuum test cycles. The diagnostic function is reserved for technical service personnel and requires an access code.

Exit from the sub-menu

Cursor UP

Cursor DOWN Confirmation of the selection

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4.6.

CYCLE SELECTION

4.6.1. CYCLE TABLE STERILIZATION CYCLES B CYCLE B CYCLE B CYCLE B-STANDARD B-PRION B-STANDARD 134 134 121

TYPE OF CYCLE

TEST CYCLES B&D/ HELIX TEST

VACUUM TEST

Temperature

135.5°C

135.5°C

122.5°C

135.5°C

--

Pressure

2.16 bar

2.16 bar

1.16 bar

2.16 bar

-0.85 bar

4'

18'

15'

3'20

16'

Duration of the plateau

15'

15'

20'

4'

--

Total duration empty – full load

30' - 40’ (MB17) 32' - 52’ (MB22)

44' – 54' (MB17) 46' - 66’ (MB22)

50' – 60' (MB17) 48' - 68’ (MB22)

23' (MB17) 26' (MB22)

24' (MB17) 25' (MB22)

Full solid (Probes, tweezers, burs,…)

YES

YES

YES

Small porous items (gauze, cotton,…)

YES

YES

YES

Full porous : 80% of the usable space.

YES

YES

YES

TYPE OF LOAD

Duration of the drying phase

Hollow A (handpieces, forceps, scissors,)

YES

YES

YES

Hollow B (vacuum tips,…)

YES

YES

YES

Unwr., bagged, single/double wrapped

YES

YES

YES

Max mass of the load : Solid / Porous

4.5 / 1.5 kg (MB17) 6.0 / 2.0 kg (MB22)

4.5 / 1.5 kg (MB17) 6.0 / 2.0 kg (MB22)

4.5 / 1.5 kg (MB17) 6.0 / 2.0 kg (MB22)

Empty

Load: The 3 Class B cycles can sterilize and dry all type of loads: full solid, porous, hollow A, hollow B, plastics, rubber, etc. unwrapped, bagged, single and double wrapped, but :
Instructions given by the respective manufacturers must be followed in each case.
For guaranteed sterilization, never exceed the maximum load weight validated by the manufacturer.

Test cycles See annex 4, 5 & 6

All the cycles have the same profile: Only the duration of the plateau time, the drying time and the temperature (121°) vary. Pressure (bar)

Duration

D2

D1 PV1

PV2

PV3 PV4

PP1 PP2

PP3 PP4

PV5

PV6

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PR

PP5

Fractionated pre-vacuum Legend: PV1..6 : Vacuum pulse PR : Process

PPh

D4

D3

D6

D5

D8

D7

D9

DVs

Plateau time

End

D10

VEN LEV DVe

Pulsed vacuum drying

PP1..5 : Pressure pulse DV : Vacuum drying 20

PPh : Pressure pulse and heating VEN : Ventilation LEV : Levelling