ATTACHMENT A Getinge 9125E Washer Disinfector Salient Characteristics.docx

ATTACHMENT A

36C25626Q1157

Product Specification – Salient Features

Salient Characteristics Getinge 9125E Cart Washer-Disinfector 480V, Double Door, Inclined, Right Hand, Pit Mounted, Performance Dryer, Thermal Disinfection, DI/RO H20 valve, Booster Tank, 3 Chemical Dose Pumps, 3 Detergent Flow Meters, Drain Cooling, USB, Utility Connect Kit for Steam, A/C

Application

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

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 load types 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 solid surgical instruments

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

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 for loading and unloading

· 10” color touchscreen on both clean and soiled side

Unit Size

2500mm Length x 960mm Width x 2000mm Height

Salient 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 stalls completely behind the barrier wall panel.

· 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. Only when the emergency stop is pressed, all doors will be unlocked.

· 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.

· Power floor tilt: Tilting the load provides a good water run-off that enables efficient drying for loads with large flat surfaces. The floor remains in a 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.

· 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 movement 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 options 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, secures an effective drainage and reduces the residuals left in the sump between the phases and programs.

· 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/minute (317 gallons/minute) and sent through the steam/electric heater before energizing the oscillating spray system.

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

· 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.

· 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 in each vertical pipe, from floor to ceiling. When the wash or rinse treatment starts, the 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 complete 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/minute (20 US gallons/minute). The wash and rinse solutions are pumped to a drain-holding tank for handling prior to gravity draining into the building waste water system.

· Non-recirculated ventilated drying system: Fresh air is pulled into the dryer unit by a powerful speed controlled fan motor (maximum capacity 600 m3/hour). The unique brushless motor (without carbon that could contaminate air filters or heating elements) increases the fan lifetime and lowers the maintenance costs. A fan forces heated air out of the chamber through the exhaust ventilation and into the building evacuation system. To reduce the risk of cross-contamination, hot chamber air is not recirculated over the load.

· Performance Dryer: A speed controlled fan forces air through the heat exchanger at high velocity. The drying air is effectively and environmentally friendly heated before entering the chamber by re- using the massive energy in the heated chamber. 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. 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 heating element (performance dryer). 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 droplets are piped to the drain tank and then to the building drain.

· Chemical and detergent dosing control: 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 and 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. Additional pumps and flow meters for detergent monitoring are optional.

· Low-level alarm chemicals: Two low level alarm probes are standard. In case of running out of chemicals, the system will automatically send a low chemical alarm to the touchscreen to alert operators. Extra low chemical alarm probes will be included for each additional chemical dosing pump selected in the optional sections.

Control system features The G1 control system for Getinge washer-disinfectors 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 backup)

· 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) 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), both controlling the soiled side door. The touchscreen includes all necessary functions for an easy operation, including guidelines for the user.

Standard safety 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.

Illuminated chamber The wash chamber is equipped with two LED lights mounted in the ceiling to illuminate the chamber for safe operations.

Emergency stop The control panel on each 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.

Door safety Manual opening of the door The door sealing mechanism is normally open when no power is applied. When the emergency stop is 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 the same 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 programs to be run.

Installation and mounting Pit mounted machine The 9100E sump base is 150 mm (5.9 inches) 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 inches). The unit is to be installed in a current 9100 pit; replacement model must fit in the existing space without any modifications to the existing walls and or size of the existing pit.

Custom 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 access door to the service area are available as accessories.

Must be compatible with Getinge Chemical Dosing Management System.

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