ATTACHMENT C 9100E Washer Disinfector Product Specifications.pdf

DOC_PS07-0107_PRODSPEC_9100-SERIES><REV.G><LANG_EN><2021-02-11>

Product Specification Getinge 9100-series

9120E, 9122EW, 9125E, 9127E, 9128E, 9128EW

Washer-disinfector

ATTACHMENT C

36C25626Q1157

Getinge • 9100-series

Contents

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Product Details

Order Information

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Getinge 9100-series

9120E, 9122EW, 9125E, 9127E, 9128E, 9128EW

Washer-disinfector Product Details

Application The 9100-series consists of new models with the designation E. In this document we present the whole range of E-models by using the family name 9100E. The product and registered medical device belongs to the 9100-series.

The Getinge 9100E washer-disinfectors are a series of automatic, large capacity, floor loading hydro-spray mechanical washers. The 9100E is the ideal solution to process large bulky items in a short time with low utility costs. For increased flexibility and back-up in high-volume CSSD departments, the 9100E, equipped with the built-in water docking option, can be used to process surgical instruments loaded on a specified instrument wash cart with integral spray arms.

In addition the 9100E washer-disinfector can be used for Life Science applications such as cleaning of animal racks and cage carts. The items to be processed can be made of stainless steel, aluminum, plastic, rubber and/or silicone.

Intended use The intended use of the 9100E washer-disinfector is to perform cleaning, low or intermediate level disinfection (thermal or chemical) and drying of medical items suited for soaking with water.

Typical types of load for thermal disinfection are: transport trolleys, BUS trolleys, close case carts, equipment from rental centers, including wheelchairs and personal hygiene items, OR tables, hospital beds, containers, bowls, basins, OR shoes and surgical instruments.

Typical types of load for chemical disinfection are: OR shoes, OR tables and hospital beds.

Standards and codes The Getinge 9100E washer-disinfectors comply with:

• MDD 93/42/EEC Medical Devices Directive

• MD 2006/42/EC Machinery Directive (Safety)

• LVD 2014/35/EC Low Voltage Directive

• IEC 61010 part 1 and 2 Safety requirements for electrical equipment

• UL61010-1: 2012 Safety requirements for electrical equipment

• CAN/CSA-C22.2:Safety requirements for electrical equipment

• EMC 2014/30/EC Electromagnetic compatibility Directive

• WEEE 2012/19/EC Waste Electrical and Electronic Equipment Directive

• ROHS2 2011/67/EU Restrictions of Hazardous Substances

• EN1717:2000 Protection against pollution of potable water in water installations and general requirements of devices to prevent pollution back-flow

• EN/ISO 15883 part 1, 2, 5, 6 and 7

• ANSI/AAMI 15883-1

• OSHPD OPM conforms to 2016 CBC. Brackets for seismic anchoring are required.

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Key features

• High volume flow wash – effective for cleaning, rinsing and drying

• Vertically mounted, oscillating spray system in chamber

• Level-walkable flooring

• Efficient drying; integrated dryer with heat exchanger and power floor tilt

• Efficiency tank system reduces consumption and speeds up processes (option)

• Automatic sump cleaning system (option)

• Direct rinse system; low consumption of water and a quick complement for post-rinse (option)

• Adapted wash carts including models with removable spray arms (accessory)

• Instrument wash cart (accessory) for cleaning of surgical instruments

• Full-view, power sliding glass door(s) for loading and unloading

• 10” color touchscreen on both clean and soiled side

Standard design features

View in process (VIP) Glass doors at entry and exit of the chamber allow all personnel to observe the inside of the chamber. The control panel is mounted adjacent to the door, placing the operator in a position to easily see the contents of the chamber when preparing to close the door to start a program.

Compressed gasket seal The power operated doors are separated from the chamber gasket during opening and closing. Air cylinders automatically press the glass door against the chamber gasket, providing a positive seal to air and water leakage. The air cylinders release the door pressure against the chamber gasket before the door slides open.

Pass-through models (double doors) Doors at each end of the chamber promote a convenient and aseptic load flow from the soiled work area to the clean inspection and pack area. Door interlocks assure barrier wall integrity by allowing only one door to be open at the same time.

Automatic threshold plate An automated door threshold remains separated from the chamber floor when the door is moving. When the door is completely opened, the door threshold automatically slides across the door track to provide a smooth transition when loading wheeled carts and racks.

Level chamber floor The chamber is equipped with removable floor sections providing drainage to the sump as well as a level walking and rolling surface to support loading and unloading of carts. Due to the design with three divided floor sections, the floor is easy to disassemble and remove for inspection or maintenance.

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Power floor tilt Tilting the load provides a good water run-off that enables an efficient drying for loads with large flat surfaces. The floor remains in horizontal level during loading and unloading. When the drying starts, the chamber floor on the control panel and service area side, is raised. The floor remains tilted during the drying and is automatically returned to the horizontal level upon completion of the program and before the door is opened.

The power floor tilt button can be customized in two ways to meet local needs. When pressed in it can either activate or deactivate the tilt function.

The power floor tilt function can be programmed within functions 0-3:

0 = No tilt 1 = Tilt during drying only 2 = Tilt during drying and draining

3 = Tilt during the complete program

Chamber guards and guide rails The chamber walls are equipped with bars (removable) to prevent the load from obstructing the oscillating spray system. The height of the bars is adjustable to accommodate various loads.

Guide rails (removable) are mounted on the floor to guide wheeled carts into the chamber and protect the load from accidental moving during floor tilting.

Water filling valves Two air-operated valves are mounted on top of the chamber for connection to the building water supply (HW and CW).

See optional features for additional fill valve for deionized (DiW) final rinse water. An air-gap (compliant with EN1717) prevents backflow (cross contamination) to the building water supply.

Automatic water fill level The water fill level in the chamber is adjusted, based on the load situation, to minimize water usage.

Shallow sump A low profile of the sump tank allows compact installations. Installations can be recessed in a shallow pit or installed on floor with mounted loading ramps.

Low-point drain valve The automatic stainless steel drain valve at the lowest machine point, provides an effective drainage and reduces the residuals left in the sump between the phases and programs.

Note! The valve is standard and a prerequisite for the automatic sump cleaning system (option), described in the section optional features.

Efficient cleaning with high volume of circulating water The solution from the sump is pressurized by a 3.8kW (5.1 HP) pump with a capacity of 1200 L/min (317 gal./min) and sent through the heat exchanger before entering the oscillating spray system.

Water heat exchanger Water from the circulation pump is forced through a powerful heat exchanger for a rapid elevation of the water temperature to the specified set point. The water temperature velocity is approximately 9 °C/min (48 °F/min) for the steam heated version depending on temperature and steam conditions and for the electrical version (60 kW heat elements) approximately 3 °C/min (37.5 °F/min).

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Wash and rinse treatment temperature guarantee The selected wash and/or rinse treatment periods will not begin timing until the recirculated wash and/or rinse treatment solution temperature reaches the desired, programmable set point, assuring a minimum temperature during the entire treatment period.

Coarse debris filters Four coarse debris filter sections are located underneath the floor lids to filter the water entering the sump. The filters are easily removed for cleaning.

External fine debris filter To prevent clogged orifices, the solution from the circulation pump is forced through a canister containing a removable mesh filter, 1 mm (0.039”) with perforations smaller than the jet spray nozzles. Upon completion of the treatment, the flow through the filter is reversed and debris is back-flushed into the effluent drain. The filter assembly is located in the service area, mounted in an ergonomic position for easy operation by one person. It can be easily accessed by removing the sanitary tri-clamp and the cap from the top of the canister, without additional tools.

An optional fine mesh filter, 0.2 mm (0.0078”) is available for delicate loads.

Oscillating spray system The oscillating spray system consists of vertical pipes (8 or more, depending on the chamber model/size), distributed evenly along both sides of the chamber. All pipes are spring-loaded into a motor controlled offset. A total of 96-128 spray nozzles (depending on the chamber model/size) are distributed evenly along each vertical pipe, from floor to ceiling. When the wash or rinse treatment starts, a motor will oscillate all manifold pipes on one side in a back-and-forth sweeping horizontal action, as pressurized solution is sprayed on the load. The oscillating spray system on the opposite wall is moving in the opposing direction.

The sweeping spray assures constant impingement on the surfaces of the load. Each jet spray nozzle is easily removed with a quarter turn, for cleaning or replacement. The vertical manifold pipes are easily removed and interchanged or replaced without additional tools, thanks to a unique and patented spring loaded bayonet design.

Drain pump The 9100E standard model is equipped with a drain pump with a drain capacity of 75-80 L/min (20 US gal./min). The wash and rinse solutions are pumped to a drain holding tank prior to gravity draining into the building waste water system.

Drain tank Hot process solutions from the drain pump and condensate from the heat exchanger(s) are sent to the drain tank for optional treatment, prior to draining into the building waste system.

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Non-recirculated ventilated drying system Fresh air is pulled into the dryer unit by a powerful speed controlled fan motor. The brushless motor (without carbon that could contaminate air filter or heating elements) increases the fan lifetime and lowers the maintenance costs.

Hot air is forced through 20 ports in the wall of the chamber, rapidly reaching all surfaces of the load. Heat and air turbulence interact to dry loads rapidly and to shorten the program time.

The fan forces the air out of the chamber through the exhaust damper and into the building evacuation system. To reduce the risk of cross-contamination, hot chamber air is not recirculated over the load.

Standard dryer Includes the speed control fan motor and the exhaust damper, but no additional forced heating elements or HEPA filters. The pre-heating of the drying air is performed in the drying heat exchanger, as described above.

The exhaust from the machine during the drying phase is 420 m3/h, 247 CFM (ramping up slowly from 0 rpm to allow effective condensation in the heat exchanger).

See section “Optional features” for details about the performance dryer.

Note! In compliance with EN/ISO 15883-6 for cleaning and disinfection of non critical items.

Drying heat exchanger Hot air, leaving the chamber, passes through the heat exchanger in vanes, touching the incoming fresh air. Heat energy is transferred to the colder incoming air, increasing its temperature before it reaches the chamber. Meanwhile, the cool fresh air creates condensation in the moist hot air leaving the heat exchanger. The condensation droplets are piped to the drain tank and then to the building drain.

The condensation in the heat exchanger dries the exhaust air before it enters the building which helps to reduce corrosion in the duct system.

Chemical and detergent dosing Varying soil levels and water conditions are important factors that should be carefully considered when choosing wash detergent and rinse agent chemicals. For the best cleaning efficiency, consult your local Getinge representative for an optimal selection of detergents.

Automatic chemical dispensing By default, two volume controlled peristaltic chemical dosing pumps are used for dispensing the detergent or rinse aid in the wash and rinse phases of the selected programs. The pumps are self-priming and the dosing levels are controlled by program parameters. The pumps are capable of pumping chemicals from a horizontal distance up to 7,5 m (25 ft.).

The dosing pump has a capacity of 10 mL/s (0.24 oz./s). Additional pumps and flow meters for detergent monitoring are optional.

Low level alarm chemicals One adjustable 5-25L (1-6.6 gal.) probe per pump is standard. In case of running out of chemicals the system will automatically send a low chemical alarm to the touchscreen to alert operators. A low chemical alarm probe is included for each additional chemical dosing pump selected in the optional sections.

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Control system features

The G1 control system features:

• Integral process monitoring (key program parameters and integral machine functions)

• Alerts at malfunctions

• Network or USB storage of reports

• Network printing of process reports

• DRAM 256Mbyte RAM CPU processor (no battery replacement required)

• Digital, analogue inputs and outputs for machine control

• RS-232 COM port for serial communication (panel printer)

• Customized program availability

• Copy/renaming functions (programs)

• Supervisor control system for parallel monitoring of critical process parameters (option)

• Ethernet port for Getinge connectivity products:

- Getinge Online (real-time and historical information on machine performance and wash process)

- T-DOC Traceability and management system.

Control panel with CENTRIC 10” touchscreen The machine is controlled and operated from the control panel. The control panel is located to the left or right of the chamber door at a convenient height for the operator. The operator interface is a durable, 10” color touchscreen. A screen saver extends the life of the backlit touchscreen.

Tapping any command button illuminates and reactivates the touchscreen. By default, the touchscreen displays program information during a program. A more detailed view of program parameters can be set by the operator.

Double door pass-through units are provided with two control panels (soiled side and clean side). Each panel controls the door next to which it is located. The touchscreen includes all necessary functions for easy operation, including guidelines for the user.

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Standard safety features

Laminated safety glass doors Four laminated layers of safety tempered glass provide a full-size viewing door on the soiled and clean side of the chamber. Laminated glass provides excellent sound and heat abatement, as well as an extra safety precaution for the operator. The automatic, electrically controlled door slides effortlessly across the chamber opening and stores completely behind the barrier wall panel.

Illuminated chamber The wash chamber is equipped with two LED lights mounted in the ceiling to illuminate the chamber during operation.

Emergency stop Each control panel, mounted on the front panel, alongside the door, is equipped with an emergency stop button.

Emergency stop wire The washer-disinfector chamber is equipped with an emergency stop wire along the entire inside wall. When the wire is pulled, the power to the pumps and motors is immediately interrupted, the door(s) will unlock and the SS door will open partially.

Door safety

Manual opening of the door The door sealing mechanism is normally open when no power is applied. When any of the three (3) emergency stop buttons are activated or at a power interruption, the door sealing mechanism immediately releases the pressure, allowing the door to slide freely in its tracks. The door can be opened by pushing it manually to the side.

Door crush protection

If the moving door comes in contacts with an obstruction while the operator is closing the door, the door motor clutch releases and stops the motor to prevent increased pressure on the obstruction.

Tap the Open Door button to reverse position of the door, remove or clear the obstruction and retry the Close Door operation.

Door safety switch Limit switches mounted at the soiled side and clean side door prevent a program from being started until both doors are fully closed and sealed.

Door interlock The control system will permit only one door to be unsealed and open at a time during normal operations. The alternating door operation helps to maintain barrier wall integrity.

Low level alarm chemicals A low level sensor in the suction tube assembly will automatically send a low chemical alarm to the message screen to alert operators. Chemical containers must be replaced or re-filled before the controller will allow subsequent cycles to be run. The machine can be programmed to overrun a low chemical alarm, to allow running additional cycles to optimize and reduce the remaining chemicals in the containers.

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Optional features

Performance dryer (option)

Additional heating elements (electrical/steam) and HEPA Filter The fan forces air through the additional heating elements at high velocity. Steam heating elements are more efficient than electrical heating elements and rapidly reaches peak temperatures. Drying air is quickly heated to 110 °C (230 °F) and, before entering the chamber, filtered through a H14 HEPA filter.

The exhaust from the machine during the drying phase is 580 m3/h, 341 CFM (ramping up slowly from 0 rpm to allow effective condensation in the heat exchange).

The heat exchanger and the exhaust damper is the same as for the standard dryer, see section “Standard features”.

Note! In compliance with EN/ISO 15883-1 for cleaning and disinfection of surgical instruments.

Deionized water (DiW) valve Select additional top mounted water valve when treated water is used for the final recirculated rinse. Valve, piping and controls are added for connection of a third water source. A 30 L/min (8 gal./min) treated water supply, is recommended, at minimum. When special rinse is selected as a program parameter, the deionized water valve will open in lieu of the hot water valve to fill the sump. It is possible to install a water flow restriction device (accessory) on the DiW valve to reduce the flowrate to a maximum of 38 L/min (10 gal./min), if this is beneficial for the balancing of the water treatment supply system. For more detail, see section Booster tank on next page.

Note! Treated water is purified water, for example Deionized water or RO water.

Built-in water docking option Select this option when wash carts with integral spray arms are used for internal cleaning of loads.

The washer-disinfector is built with a split water circuit that will alternate pressurized flow between the floor manifold and the chamber’s vertical pipe oscillating spray system. Load the wash cart, by placing the wash cart over the floor docking device. When the wash pump starts, the water pressure in the pipe lifts the docking device to engage with the connection on the wash cart. Pressurized solution fills the cart manifold and spray arms, spraying treatment solution onto the load.

The flow control pressurizes the wash cart’s spray arms (for 50 s) and then switches to pressurize the oscillating vertical spray system on the chamber walls (for 20 s). This alternating action continues until the phase times out.

When a wash cart without integral spray arms is placed in the chamber, the system monitors a different pressure than with wash carts including integral spray arms. The docking device then retracts below the floor and the program uses only the vertical spray system to spray the wash cart(s).

Automatic sump cleaning system The system automatically cleans the sump floor (underneath the walkable floor), without need of manual assistance. Six separate spray nozzles will efficiently flush to remove the debris and residuals through the low point drain valve and into the building drain system.

The automatic cleaning sequence can be activated for each program or be operated from the control panel as a service program while performing maintenance of the machine.

Docking device is in “stand-by” position. No wash cart detected.

Docking device is in activated position. Wash cart docked.

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Efficiency tanks

Re-use tanks Each program can be set to either save the process water in the re-use tank (for re-use in the wash phase for the next program) or automatically discharge the water to the drain tank/drain. The washer-disinfector can re-use the water upstream (backwards one step and phase in the program) or for the same phase in the next program. Re-using the water shortens the program time and reduces consumption up to 300 L (79 gal.) per program, depending on re-use method selected. One or two re-use tanks can be selected; with 150 L (40 gal.) capacity each.

Note! For a maximum reduction of program time and water usage, two re-use tanks need to be selected.

Booster tank An steam or electrically heated separate pre-heating tank (option) is provided to increase the incoming water temperature and fast filling of the required volume into the chamber for the final rinse. Furthermore the tank is used as a buffer to allow low and moderate flowrate from the high quality water system without affecting the program time. The built in flow restrictor (38 L/min, 10 gal./min) maintains the balancing of the water system for other uses on the same piping system. The filling of the heated water into the chamber is very fast due to the large orifice valve and gravity fill.

This option reduces the program time due to pre-heating and fast filling the chamber. It is highly recommended when program time is of importance.

The booster tank is a 180 L (47 gal.) AISI 316 L stainless steel tank with 40 kW electrical power (or steam elements for steam heated models) and it is located at the opposite side of the drain tank. The tank preheats 150 L (40 gal.) of water to be used for final and/or direct rinse.

Process tank Note! The process tank can not be combined with the re-use tanks.

A process tank (option) reduces the time needed to fill fresh water from the building into the chamber. The tank is pre-filled during the program and ready to be used for the following cleaning or post-rinse phases. The booster tank is fully compatible with the process tank. It is recommended for applications where re-use is not required, but where it is important to keep the program time as short as possible.

Direct rinse system A fast non-recirculating rinse effectively reduces the risk of program residuals to transfer between phases. There is no need to fill the entire volume in the chamber to start rinsing since the separate nozzle system is connected to the booster tank and the additional pump for optimal pressure and flow control.

Note! The booster tank (option) needs to be selected in combination with the direct rinse system option. Direct rinse can be used after wash phase and/or after final rinse phase.

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Monitored drain cooling (option) A temperature probe and an electrically controlled valve are placed on the drain tank outlet. If the drain solution temperature exceeds the value set in the parameter Drain Cool Temperature, the valve closes and water is injected to cool down the solution. The default temperature of the parameter Drain Cool Temperature is 60 °C (140 °F). When the solution has cooled down to the set value, the valve closes and the solution is flushed out to the building drain system.

If Monitored drain cooling is not installed, the drain pump stops when the drain solution temperature exceeds 55 °C (131 °F). The pump starts again when the temperature reaches below 55 °C (131 °F) and the solution is flushed out to the building drain system.

If re-use tanks are used, see section “Re-use tanks” on page 11.

Printer (2”) built into control panel Program performance data is printed during the program and at program complete. The printed program information includes program number, program start date and time, phase transition points, disinfection quality and program alarms that occurred during the program. In case of printer failure during the program, the control system stores the program data and can, on demand, reprint the last program.

Air conditioning unit (AC) An independent AC unit for internal cooling of the electrical cabinet, is embedded in the door. This option prolongs the life time of internal components in the electrical cabinet when the maximum temperature of 25 °C (77 °F) in the service area is not met by the building ventilation system.

Air barrier Note! See separate document with technical data.

Stainless-steel cover plates (option) behind the front standard barrier panels, provide an air separation between the soiled and the clean side in pass-through models. This supports the building ventilation to maintain differential pressures and reduces the risk of cross contamination between departments.

Note! It is recommended to use the front service access door (accessory) to provide the required clearance for the installation of the air barrier package.

The image shows both left and right hand version of the air barrier. Note that the air barrier must only be installed on the clean side.

Utility Installation kit The installation kit consists of manual shut-off valves, pressure gauges and fittings for water and steam building connections, including metric and imperial connections.

Water Steam

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Chemical and water control

One additional volume based injection chemical dosing pump (total of three pumps) One additional peristaltic chemical dosing pump is provided for time/volume based control of dilution in the wash and rinse phases of the selected programs. The pumps are capable of pumping chemicals from a horizontal distance of

7.5 m (25ft.).

Note! Two peristaltic injection dosing pumps for chemicals are standard.

Two additional volume based injection chemical dosing pumps (total of four pumps) Two additional peristaltic chemical dosing pumps are provided for control of dilution in the wash and rinse phases of selected programs. The pumps are capable of pumping chemicals from a horizontal distance of 7.5 m (25 ft.).

Chemical neutralization of drain water (alkaline or acid neutralization) A time-based dosing system is provided to automatically inject user supplied neutralization agent into the sump, to neutralize highly acid or alkaline solutions to a neutral pH, before discharging to the drain to conform to plumbing code requirements. The treatment solution pH is pre-set (acid or alkaline) and a predefined amount of agent is injected to attain a neutral pH value.

Chemical neutralization of drain water (alkaline and acid) A pH monitored, proportional type system can be provided to automatically inject user supplied neutralization agent into the sump, to neutralize highly acidic or alkaline solutions to a neutral pH before discharging to drain to conform to plumbing code requirements. The treatment solution pH is sensed with a probe and a proportional amount of agent is injected to attain a neutral pH value.

Conductivity controlled final rinse Conductivity controlled final rinse monitors and runs automatically multiple rinse cycles (if needed) and alarms if the conductivity of the final rinse water exceeds the alarm settings.

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Installation and mounting

Note! See separate document with technical data or installation manual for more details.

Pit mounted machine The 9100E sump base is 150 mm (5.9“) below the door threshold and is best utilized when installed in a pit for level floor loading and unloading operations. The lowest point of the machine is the low point drain valve located at 185 mm (7.25”).

If the unit is to be installed in a current 9100 PIT <190 mm (7.5”), there is an extension pipe available (accessories) to move the low point drain valve closer to the building drain - at 170 mm (6.7”).

Floor mounted machine When a pit is not possible, the 9100E can be mounted directly on the floor with 190 mm (7.5”) high ramps for loading and unloading. Specify and select the full size ramp or two independent ramps for loading of carts. Both are 1500 mm (59”) in length.

Barrier wall panels The soiled side and clean side of the 9100E are provided with stainless steel finishing panels to conceal the rough opening when installed between two walls. Extension panels, with a front access service door, are available as accessories.

Seismic anchoring kit The kit consists of bracket for seismic anchoring of the machine.

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Program description and operation

Note! The Getinge 9100E washer-disinfector is specifically designed to process only load outlined in the intended use. If there is any doubt regarding the processing of a specific material or product in the 9100E, contact the manufacturer of the product to be reprocessed for recommended mechanical cleaning techniques and processes.

Note! The total process time is affected by several factors: heating methods, water and steam supply line (pressure, flow and temperature) etc.

Program group - Thermal disinfection with instrument program

Program name Default process Typical load Total program time

Fast Clean T Wash 55 °C (131 °F) 1 min Disinfection Drying 3 min

Almost visually clean load, no blood 10-30 min

Short Clean T Wash 60 °C (140 °F) 2 min Disinfection Drying 5 min

Slightly soiled load, no blood 14-35 min

Normal Clean T Pre-rinse CW 1 min Wash 60 °C (140 °F) 3 min Disinfection Drying 5 min

Soiled load 21-40 min

Long Clean T

Pre-rinse CW 1 min Wash 60 °C (140 °F) 3 min Post-rinse HW 1 min Disinfection Drying 5 min

Very soiled load 26-45 min

Instrument Clean T 1

Pre rinse CW 5 min x 2 Wash 60 °C (140 °F) 15 min Post-rinse 5 min x 2 Disinfection Drying 16 min

Medical surgical Instruments 80-100 min

Instrument Clean T Dual 2

Pre rinse CW 2 min Wash 54 °C (129 °F) 10 min Wash 60 °C (140 °F) 10 min Post-rinse 1 min Disinfection Drying 16 min

Medical surgical Instruments 60-80 min

1 The Instrument program needs to be selected

2 The Instrument program group needs to be selected

Note! Prior to using the machine, a technician needs to review the factory programmed settings for compatibility with materials and products to be cleaned and disinfected. When necessary, the pre-programmed process times, temperatures and chemical dosage of selected programs can be adjusted. The disinfection is default A0=60 for all thermal disinfection programs intended for non-critical medical devices, except for the instrument programs A0=600. The time, temperature and A0 value can be individually adjusted to meet local requirements.

Placing load in chamber Place utensils, containers, etc. on an appropriate wash cart. Open wire carts such as storage carts can be placed directly into the chamber. Doors of closed case carts must be opened and secured from re-closing during processing.

Open the chamber door and place the load in position inside the chamber. If multiple loads are intended, arrange loads in a way that they do not extend beyond the side guide rails and do not interfere with the closing of the door.

Note: Case cart openings need to be positioned facing away from the service side of the chamber, to allow proper drainage of the wash cart, when the floor is tilted, during a wash cycle.

Closing soiled side door Exit the chamber. On the touchscreen, tap the Close Door button. The door closes completely and seals against the door gasket. The door must be sealed to start a program.

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Start of program Select the required program and tap the Start Program button.

The sequence of program phases varies depending on the intended use of the program or on the pre-programmed intent of the program. The individual phases and program steps are described in the following sections.

Pre-rinse The sump is filled with water which is recirculated through the jet spray system under pump pressure. The phase time and temperature is user programmable: 60-180 s and 0-60 °C (32-140 °F).

Wash Water from the building supply fills the sump for the first phase of the program. Once full, the circulation pump starts and pressurized cleaning solution is forced through a steam or electrical heat exchanger, into the oscillating spray nozzles and onto the load. A peristaltic dosing pump automatically adds a programmed amount of chemical cleaning agent.

The motorized manifold oscillates the 96-128 nozzles (depending on chamber size) at 110 degrees to constantly sweep across the load. Load surfaces are always under impingement pressure. The spray manifolds, along each chamber side wall sweeps, in the opposite direction. Cleaning continues until the wash solution reaches programmed set point. Wash temperature is factory set for different standard wash programs, and can be adjusted: 20–93 °C (68–199 °F).

Once set point temperature has been achieved, the controller times the wash for the pre-set time (adjustable; 60-360 s) and then terminates the wash phase.

Post rinse Upon completion of the drain phase, fresh hot water (or water from the re-use tank) fills the sump. Once completed, the circulation pump is energized and rinse water is forced through, either the steam or electrically heated sump heat exchanger, into the oscillating spray nozzles and onto the load. Phase time is user programmable; 60–1800 s. In addition the direct rinse (option) can be used as an alternative or complement for the post rinse.

Final rinse/thermal disinfection Upon completion of the drain phase, hot water fills the sump. If the machine is programmed to use any of the peristaltic dosing pumps, a set amount of rinse agent is automatically added to the sump. Once full, the circulation pump is energized and rinse water is forced through, either the steam or electrically heated sump heat exchanger, into the oscillating spray nozzles and onto the load. The rinsing continues until the disinfection value is reached. The final rinse, thermal disinfection temperature is adjustable; 75-95 °C (167-203 °F).

The disinfection parameters can be pre-set; temperature and time (1-3600 s), or automatically calculated to achieve the selected value; A0 60, A0 600 or A0 3000, all in accordance with EN/ISO 15883. The default setting for programs intended for non-critical items is A0 60, and for critical items (surgical) the temperature is set to 90 °C (194 °F) for 1 min.

Drain When the wash or rinse phases are completed, the drain pump transports the drain solution to the drain tank. If Drain cooling (option) is selected see section “Monitored drain cooling (option)” on page 12.

Re-use of water If activated in the selected program, the water is, partly or completely (adjustable parameter; 0-100%), saved in the sump or re-use tanks, and can be used for the next phase or program. If the water is not re-used it will be pumped to the drain tank and drained to the building drain system.

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Drying

Note! Forced heating elements are only applicable for the performance dryer (option).

Drying starts upon completion of the final rinse. The built-in exhaust damper will automatically open to allow exhaust to exit. Is has remained closed during the other phases to reduce the energy losses and to speed up the program. A speed controlled fan forces clean air over steam or electric heating elements at high velocity. The speed control fan allows the heat exchanger to improve the condensation of the initial outgoing air. Drying air is quickly heated to 110 °C (230 °F) before entering the chamber.

Hot air is forced through 20 ports in the wall of the chamber, rapidly reaching all surfaces of the load. Heat and turbulence combine to dry loads faster and shorten program times.

Dryer blower forces moist heat from the chamber and sends it through the heat exchanger and into the building exhaust system. To reduce risk of cross-contamination, hot chamber air is not recirculated over the load. Hot air leaving the chamber passes through the heat exchanger in vanes touching the incoming fresh air. Heat energy is transferred to the colder incoming air and increasing its temperature. If the floor tilt has been activated in the selected program, the floor will automatically raise and tilt the load, promoting water runoff. Pre-heated fresh air reduces the energy required to achieve maximum temperature. Meanwhile, the cool fresh air creates condensation in the moist hot air leaving the heat exchanger. The condensation water is piped to the drain tank and then to the building drain. Water is continuously removed from the exhaust during the drying phase.

Program complete is displayed on the touchscreens (potentially free contact output is available for the remote alarm device).

Unloading the chamber When the program is complete; on the clean side touchscreen, tap the Open Door button. The door unseals and automatically slides open. Remove the load from the chamber.

Closing the clean side door When the chamber is unloaded; on the clean side touchscreen, tap the Close Door button. The door closes completely and seals against the door gasket. The chamber is now ready for the operator on the soiled side to process another load.

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Alternative program features

Note! See separate installation drawings and installation manual for more details.

Water filling There are several options for filling the washer-disinfector with water:

Filling water to chamber directly from inlet:

• CW (cold water) valve

• HW (hot water) valve

• CW+HW valves

• DiW valve

Machine accessories

Front trim panels Note! See technical data or installation manual for more details.

Front trim panels, with hinged service access doors provide a panel and a service door attached to the standard machine barrier panels.

The door is adapted for all models LH and RH, and will be equipped with a key lock for each set.

Note! Order the amount needed for the complete installation; if, for instance, both sides are going to be covered (for a pass-through double door model) 2 front trim service panels need to be ordered.

Filling water to chamber from efficiency tanks:

• Booster tank

• Process tank

• Re-use tank 1

• Re-use tank 2

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Stands for Containers for Universal Manifold Wash Carts Measure: 181×157×60 mm Measure: 235×156×60 mm

Wash carts

For more information about the available accessories for the machine and wash carts (part No’s, descriptions etc.), see the tables in section “Accessories” on page 31.

A full range of ergonomic and easy to use wash carts, adapted for different loads and capacities, are available in three different lengths; 700 mm (27”), 1300 mm (51”) and 2000 mm (78.7”), see pictures below. All wash carts are the same width and height and are equipped with ergonomic handles coated with Rilsan.

Wash cart accessories

Length:

1300 mm (51.0”)

Length:

700 mm (27.0”)

Length:

2000 mm (78.7”)

Edge protection A silicone edge protection (for the universal wash cart) is available for shelves. The protection reduces the noise level and the risk of damage to the load when loading and operating the wash cart.

Instrument holder (Holder, silicone hoses) When connection points are needed for lumen instruments, the holder with hoses can be connected to the instrument wash cart’s water manifold.

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Wash cart dimensions

334 mm

(13.1”)

328 mm

(12.8”)

328 mm

(12.9”)

328 mm

(12.9”)

471 mm

(18.5”)

471 mm

(18.5”)

471 mm

(18.5”)

Universal manifold wash cart with spray arms, 3-levels

Universal manifold wash cart with spray arms, 4-levels

L 950 mm (37.4”)

700 mm / 1300 mm / 2000 mm (27.0” / 51.0“ / 78.7”)

1985 mm (78.1”)

Wash cart specifications

Wash cart models Article No No of shelves/ levels

Length mm (in.)

Width mm (in.)

Height mm (in.)

Weight empty kg (lb.)

Weight maximum load kg

(lb.)

Universal wash cart 2000 with integral spray arms

6001699301 4 2000 (78.7) 950 (37.4) 1985 (78.1) 120 (264.6) 300 (661.4)

Universal wash cart 2000 with integral spray arms

6001706701 3 2000 (78.7) 950 (37.4) 1985 (78.1) 102 (224.9) 237 (522.5)

Universal wash cart 1300 with integral spray arms

6001767801 4 1300 (51.0) 950 (37.4) 1985 (78.1) 96 (211.6) 276 (608.5)

Universal wash cart 1300 with integral spray arms

6001767901 3 1300 (51.0) 950 (37.4) 1985 (78.1) 83 (183.0) 218 (480.6)

Instrument wash cart 1300 with integral spray arms

6002116701 5 1300 (51.0) 950 (37.4) 1985 (78.1) 106 (233.7) 256 (564.4)

Container/utensils wash cart

6001712501 4 1300 (51.0) 950 (37.4) 1985 (78.1) 106 (233.7) 286 (630.5)

Container/utensils wash cart

6001725901 4 700 (27.0) 950 (37.4) 1985 (78.1) 78 (172.0) 258 (868.8)

OR shoes wash cart 1300 6001712701 8 1300 (51.0) 950 (37.4) 1985 (78.1) 75 (165.3) -

OR shoes wash cart 700 6001726701 8 700 (27.0) 950 (37.4) 1985 (78.1) 55 (121.2) -

183 mm (7,2”)

183 mm (7,2”)

183 mm (7,2”)

183 mm (7,2”)

Instrument manifold wash cart with spray arms, 5-levels

1297,5 mm (51,5”) mm (78.1”)

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Wash cart capacities (maximum load on wash cart)

Wash cart models

A rt ic le

N o

Re qu ir es b ui lt-in w at er do ck in g op ti on

D

IN

c on ta in er s

5x

5x m m

(2 3.

4x

.6 x1

1.

4”

D

IN

tr ay s

0x

0x m m

(1 8.

9x 9.

8x 2”

SP

RI

tr ay s

0x

0x m m

(1 7.

7x

.4 x2

.8

U S tr ay s

8x

7x m m

(2 0x

.5 x3 .5

O R sh oe s ( pa ir s)

In so le s f or O

R sh oe s

(p ai rs

Universal wash cart 2000 with integral spray arms

6001699301 Yes 27 - - - - -

Universal wash cart 2000 with integral spray arms

6001706701 Yes 18 - - - - -

Universal wash cart 1300 with integral spray arms

6001767801 Yes 18 - - - - -

Universal wash cart 1300 with integral spray arms

6001767901 Yes 12 - - - - -

Instrument wash cart 1300 with integral spray arms

6002116701 Yes - 30 30 30 - -

Container/utensils wash cart

6001712501 No 12 - - - - -

Container/utensils wash cart

6001725901 No 6 - - - - -

OR shoes wash cart 1300 6001712701 No - - - - 48 16

OR shoes wash cart 700 6001726701 No - - - - 24 8

Chamber capacity (number of wash carts in the chamber during the same program)

Washer-disinfector sizes Requires docking for

WD

Maximum load in chamber/wash cart combinations

9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW Yes 1 x Universal wash cart 2000 with integral spray arms

9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW Yes 1 x Universal wash cart or instrument wash cart 1300 with integral spray arms

9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW No 1 x Container/utensils/OR shoes wash cart 1300

9127E, 9128E, 9128EW No 2 x Container/utensils/OR shoes wash cart 1300

9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW No 1 x Container/utensils/OR shoes wash cart 1300 1 x Container/utensils/OR shoes wash cart 700

9127E, 9128E, 9128EW No 1 x Container/utensils/OR shoes wash cart 1300 2 x Container/utensils/OR shoes wash cart 700

9128E, 9128EW No 4 x Container/utensils/OR shoes wash cart 700

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Overview of the 9100E washer-disinfector

Exterior view (right service)

1. Door, clean side

2. Control panel, clean side

3. Booster tank

4. Electrical cabinet

5. Detergent system

6. Service area

7. Micro filter

8. Re-use tanks

9. Control panel, soiled side

10. Door, soiled side

Chamber sizes

Chamber model Length mm (in.)

Width mm (in.)

Height mm (in.)

Effective volume m3

(ft.3)

9120E 2000 (78.7) 960 (37.8) 2000 (78.7) 3,84 (135.6)

9125E 2500 (98.4) 960 (37.8) 2000 (78.7) 4,80 (169.5)

9127E 2700 (106.3) 960 (37.8) 2000 (78.7) 5,18 (182.9)

9128E 2850 (112.2) 960 (37.8) 2000 (78.7) 5,47 (193.2)

9122EW 2200 (86.6) 1170 (46.1) 2200 (86.6) 5,66 (199.8)

9128EW 2850 (112.2) 1170 (46.1) 2000 (78.7) 6,67 (235.5)

Materials The wash chamber consists of three modules, a central core and two extension gables fitted to the core to provide the optional load lengths. The interior walls are made of AISI 316L stainless steel, with a Ra 0.45–0.7 finish for long-lasting durability. Exterior panels are made of AISI 304 stainless steel with a Ra 0.45–0.7 finish.

The door is constructed of four sheets of temper-hardened glass, laminated with an air gap in the center and wrapped in an AISI 304 stainless steel edge. Front SS barrier panels and separate optional SS air barrier panels are made of polished AISI 304. Dryer and ducting are all made of AISI 304 stainless steel. Drain tank/re-use tanks and booster tank are made of AISI 316L stainless steel. Process piping, valves, in-line heat exchanger, steam coils, oscillating spray pipes , sump base, removable filter screens and chamber floor are made of AISI 316 stainless steel.

AISI 316L stainless steel sanitary tri-clamp fittings are used for easy removal of key process components. Gaskets and hoses are made of EPDM, PTFE or Silicone. The interior of the double sheathed chamber ceiling and wall panels are insulated with 50 mm (2”) thick, rigid foam sheets to reduce heat loss.

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Standard features (no selection needed)

• Control panel with a 10” color touchscreen, with mechanical protection against external damage

• Front panels are openable with hinge for easy access of components for service

• Dryer with heat exchanger

• Automatic damper for ventilation exhaust

• Debris filter in chamber floor, 2.0 mm (0.078”) mesh size

• Debris filter assembly in water circulation, 1 mm (0.039”) mesh size

• Drain tank

• Air-gap according to EN1717

• Low point drain valve

• Floor tilt for improved water drip-off for load with horizontal surfaces

• 2 x detergent dosing pumps

• 2 x suction lance adjustable for 5-25L (1-6.6 gal.) detergent containers

• CW and HW inlet connections

• Single door with horizontal door rail

• Tempered glass door with safe Vision In Process

• Oscillating nozzles (96 to 128 pcs depending on chamber size) with simultaneously optimum water coverage for superior cleaning performance

• Efficient heating insulation for chamber, pipes and heating system

• Automatic water level control, with optimal filling of water each time

• Guide rails in floor for safe and easy control of wash carts while loading

• Adjustable protection bars (4 pcs) to prevent damages of cleaning nozzles while loading

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References

Documentation The following documentation is available for the machine and can be downloaded from Getinge Extranet.

Documentation Contents Paper Electronic media Available languages

User manual Instructions for daily use. Local EU-language.

Installation manual Instructions for assembly, installation and commissioning.

English, German, French or Swedish.

Quick Guide Simple instructions for frequently performed tasks. Should be accessible and visible in the working area.

Local EU-language.

Declaration of Conformity Collection of ISO-certificates. - English

Electrical diagrams Collection of circuit diagrams. - English

Service manual Instructions for service and preventive maintenance. - - English, German, French or

Swedish.

Spare Parts List of available spare parts. - - English.

Wash cart user manual Includes unpacking, accessories and spare parts. N/A N/A Not included. Delivered with separately ordered wash carts.

- = Not included in the machine delivery = Included in the machine delivery

Languages available for the Control panel

Bulgarian (bg) Japanese (ja)

Chinese (zh) Latvian (lv)

Croatian (hr) Lithuanian (lt)

Czech (cs) Norwegian (no)

Danish (da) Polish (pl)

Dutch (nl) Portuguese-Brazil (pt-BR)

English (en ) Portuguese (pt)

Estonian (et) Romanian (ro)

Finnish (fi) Russian (ru)

French (fr) Serbian (sr)

German (de) Slovak (sk)

Greek (el) Slovenian (sl)

Hungarian (hu) Spanish (es)

Icelandic (is) Swedish (sv)

Italian (it) Turkish (tr)

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About this form This part of the document is an order form. Mark your selections.

Standard selection (included in base price)

Optional selection (not included in base price, additional cost)

Customer reference State project name, project No, customer name etc.

Documentation State country for correct language in the enclosed manuals.

Language/control panel Select language, for the touchscreen, from the table on the previous page.

Models Select the model and size of the chamber.

9120E 9125E 9127E 9128E 9128EW 9122EW

Getinge 9100-series

9120E, 9122EW, 9125E, 9127E, 9128E, 9128EW

Washer-disinfector Order Information

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Location of service area and control panel Select location looking at the unit from the soiled side.

Right-hand location of the service area and control panel

Left-hand location of the service area and control panel

Machine installation Pit mounted (loading in level with the floor - PIT required)

Floor mounted (loading above floor level, loading ramp required)

Door and rail configuration Pass-through models (double doors) are equipped with interlock door function and one extra control panel with a 10” touchscreen, placed at the clean side (CS).

Note! Narrow pit installations; 1880-2390 mm (74-94”) need rail(s) with inclined door movement.

Single door, with horizontal door movements

Double doors (pass-through), with horizontal door movements

Single door, with inclined door movement, for narrow pit installation

Double doors (pass-through), with inclined door movements, for narrow pit installation

Loading ramp Note! Only applicable for floor mounted installation.

No loading ramp (ramp or arrangements need to be locally adapted)

Loading ramp divided in two pieces (walk between ramps when loading/unloading)

Full size loading ramp (walk on ramp when loading/unloading)

Drying system Standard dryer with heat exchanger, without additional heating elements or HEPA filter.

Performance drying system; with heat exchanger, HEPA filter and additional forced heating elements (electric or steam).

Note! Performance drying system is in compliance with EN/ISO 15883-1 for cleaning and disinfection of surgical instruments.

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Heating and main power supply Note! Only one selection for steam or electric heated unit is possible.

Steam heated unit Electrically heated unit * 400V, 3N+PE, 50Hz 220V, 3+PE, 60Hz 380V, 3+PE, 60Hz 400V, 3N+PE, 50Hz

400V, 3N+PE, 60Hz 230V, 3+PE, 50Hz 415V, 3N+PE, 50Hz 400V, 3N+PE, 60Hz

200V, 3+PE, 50Hz 240V, 3+PE, 50Hz 480V, 3+PE, 60Hz 380V, 3N+PE, 50Hz

200V, 3+PE, 60Hz 240V, 3+PE, 60Hz 600V, 3+PE, 60Hz 380V, 3N+PE, 60Hz

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