EER 222420 Salient Characteristics Ameriwater 08.07.2024.pdf

DAYVAMC (Equipment) – Salient Characteristics I. Overview

a. Intent Current dialysis water treatment system is end of life and need to be replaced.

II. Scope of Service

a. Summary of Equipment, Supplies, and Services Requested by Facility

This acquisition is being procured on a brand name basis for the following reasons:

Dialysis water system is life critical systems, as it directly interacts with the patient’s blood during the dialysis process.

Contaminants or impurities in the water can pose serious health risks to patients undergoing hemodialysis. To meet the patient safety requirements of our facility, the systems must have distinguishing features that set them apart from other dialysis water systems machines on the market. Ameriwater MROZ is equipped with several safety features for the benefit of both the user and the patient. They consist of the following:

1. Disinfection using (PAA) disinfecting solution instead of formaldehyde increases safety and avoids health risks associated with formaldehyde. PAA produces no harmful by-products or side effects, thus it is safer for patients.

Using PAA does not require additional ventilation, and disposal is safe and easy. Important information regarding the usage and handling of PAA is listed in Section 5.2, A WORD ABOUT HYDROGEN PEROXIDE/PEROXYACETIC ACID, and in PAA Materials Safety Data Sheet. Please read them carefully.

2. INCOMING TAP WATER, PRODUCT WATER and REJECT WATER TO DRAIN hoses are labeled to prevent incorrect connections.

3. Low pressure shutdown protects the pump if the feed pressure drops below 5 PSI.

4. An audible alarm sounds whenever water quality climbs to an unacceptable level or when feed pressure is too low.

5. Product Water Divert-to-Drain: When the unit goes above the quality set-point, product water is diverted to the drain, preventing poor quality water from reaching the patient.

6. FDA 510K manufacturer of the water system.

8. Manufacturer most provide service for the exchange tanks and must be FDA 510K certified DI tanks.

9. Manufacturer must be current provider for AAMI and LAL testing.

Booster Pump: CME Variable Pressure

(1) 0080190 1½ HP, 208‐230V, 1PH

The variable pressure booster pump provides flow rates up to 25 GPM @ 50 PSI. Single pump design includes:

stainless steel pump, installation plumbing including 3 valve bypass, check valve, outlet pressure gauge, and pressure switch. The control panel requires a 230V, single-phase power source. The controller will transform the 230V single-phase power to the required three-phase power to operate the pump motor.

Pretreatment Headers:

(1) 009591 1" Assembly with Bypass

(1) 0021‐600 1” Assembly with Bypass, Pre‐Filter Header assembly includes isolation and bypass valves, outlet PSI gauge, and sample port.

System Pre‐Filter

(1) 0021015 1", IN/OUT for 20" x 4½" Cartridges The system pre-filter protects the pretreatment equipment from particulate matter that may be present in the source water. The pre-filter is sized for the highest required flow rate in the system. The pre-filter housing is all polypropylene construction with inlet and outlet isolation valves and pressure gauges. The design utilizes dual open-end (DOE) cartridges of 1-5 micron nominal filtration (greater than 80% efficiency). A sump drain and wrench are provided.

System Pre‐Filter Cartridges:

(1) 20‐1056 20" x 4½", 5 Micron, Polybond

Carbon Exchange Tank Headers:

(1) 0011CBN06 6 Tanks, Wall Mount, 1” The header is made with isolation valves for each tank in a worker/polisher arrangement.

This allows for exchange without shutting down the RO unit. The header has sample ports and pressure gauges after the worker and polisher tanks.

Exchange Service Carbons: Requires 16.04 Cubic Feet to Meet 10 Minute EBCT

(6) CA‐111447E 14" x 47", 3 cu ft Carbon tanks are of all non-corrosive inert materials with quick connections which utilize “O” ring seals to prevent leaks. The carbon is 12 x 40 mesh with greater than 1,000 iodine number, acid-washed and fully backwashed to remove carbon fines. The exchange carbon tanks are installed with a header.

Automatic Fleck 2850 SXT Water Softener: Based on 6 Grains Hardness (Subject to change based on actual water hardness)

(1) 0095012 14" x 65", 90,000 Grains A single tank water softener sized to the maximum possible water usage by the RO based on the water hardness and a 30% safety factor is designed to regenerate every night that the center operates. A full flow 1½” valve. The water softener is constructed of all noncorrosive components with a programmable electronic 7-day timer Fleck 2850 control, with the time of regeneration and all cycles fully adjustable. Pretreatment headers are sold separately.

Reverse Osmosis System:

(1) 00MRO4Z402 4 Membrane, up to 8,800 GPD, 208V, 3 Ph The MROZ an open frame RO and a cabinet RO. The pump and membranes are mounted open frame and the controls and hydraulic hardware are mounted in a cabinet with a full-size door for easy access. The entire device conforms to IEC UL standard 61010-1. The tank override feature allows the RO to be turned on even if the storage tank is full so the required 15 minute RO run time before sampling can be done. 4” x 40” thin film composite membranes provide superior contaminant rejection/product flow and the quick connect product manifold facilitates membrane profiling. Disinfection is quick and easy with a simple push of the keypad. The MROZ has a high efficiency quiet submersible pump with integral motor starter and motor protection that keeps the system running smoothly and protects the motor from overload. A microprocessor controller with backlit LCD display shows product and feed water conductivity, product water temperature, operating hours, percent rejection, and a variety of operating status messages. A programmable flush for either storage tank or direct feed keeps RO fresh between uses. The product divert feature diverts water to the drain when the conductivity exceeds the set point for added patient safety. Note: RO flow rates are based on feed water at 77°F, 50 psi feed pressure, and with a maximum loop backpressure of 50 psi.

MRO Bypass and Header Assembly:

(1) 0011RO1 Single MRO Header with RO Bypass Valves, 1" Storage Tank:

(1) 00CT250‐1 250 Gallons The storage tank is made of virgin polyethylene with a cone bottom for complete draining. The top opening is molded into the tank design with a single gasketed screw on lid. The tank comes complete with PVC schedule 80 type I fittings and valves for tank draining and pump feed. The return loop manifold consists of a relief valve, flow meter and sample port, stainless steel pressure gauge, loop drain valve, loop shut off valve and spray nozzle to continuously rinse down the inside of the tank. The storage tank also utilizes a submicron vent filter in a clear filter housing to warn of moisture in the filter and has a rupture disk in case of over pressure or vacuum conditions. The tank has liquid level switches for RO on/off, low-level alarm, and low-level pump shut down.

Product Spray Ball Kits for Storage Tanks

(1) 0111‐0390 Kit, Header, Storage Tank, Inlet with 8 GPM Spray Ball

CRI Dual Distribution Pump: Based on 12.47 GPM @ 75 PSI (Subject to change based on an approved loop design)

EXISTING 0080454 1½ HP, 208V, 3PH

Dual Grundfos stainless steel pump design including inlet/outlet isolation valves, outlet spring check valve, stainless steel pressure gauge. The pump is mounted on vibration isolators secured to FRP unistrut to floor mount.

The pump motor is a TEFC 3-phase motor design. The control panel is NEMA 4x including a single power source disconnect switch, ON/OFF pump isolation switch, pump on light, low water pump disabled light, and motor starter/overload.

Deionizer Exchange Service:

(6) DI‐451447E Ultra‐Pure, 14" x 47", 3.5 cu ft Ultra-pure segregated aseptic exchange deionizer service will be provided in an on-line worker/polisher arrangement with a temperature compensated 1 megohm/cm resistance light monitor with audible alarm between the worker/polisher and a 0-19 megohm/cm temperature compensated digital readout resistance meter with adjustable remote audio and visual alarm. The tanks are regenerated under DA/QS system with batch control of capacity, quality and microbiological (using LAL testing) monitoring. An isolation valve arrangement is provided so tanks can be exchanged without interrupting flow to the water loop.

Alarm Panel with Remote:

(1) 00850253 Good Water, RO Alarm, Storage Tank Low, Conductivity Alarm, Resistivity DI Alarm, Bicarb Low, Remote Located in the main water room the multi-function alarm panel includes a LED display that notifies you visually and audibly of any RO alarm, storage tank low level, conductivity alarm, resistivity DI alarm, and a low level bicarb. The alarm panel includes a disinfection mode to disable the alarms when the distribution loop is being disinfected.

Main NEMA

(1) enclosure is 6¼" x 8¼". Nurses station remote is operated from the main alarm panel located in the water room. 100 feet of multi-wire, low-voltage cable is provided.

Remote enclosure is 4½" x 4½" surface wall mount.

Pre‐Distribution Loop Endotoxin Filter Housing:

(1) 0021006 1" Dual, 20" An ultra-filter for endotoxin is required on system utilizing a storage tank or deionizer tanks. The filter housing assembly is wall mounted on FRP unistrut with CPVC schedule 80 inlet/outlet isolation valves and inlet/outlet stainless steel pressure gauges. The housings are constructed of opaque virgin polypropylene with 222 type cartridge connectors.

Endotoxin Filter Cartridges:

(2) 20‐3046 0.2 Micron, 2.5" x 20", 222, Pall, 10 GPM CMS Water Treatment Label Kit:

(1) 99‐9075 Label Kit Includes color coded directional flow arrows and product identification labels to meet CMS requirements.

Central System Valve Tags and Labels:

(1) 0099‐0001 Central System Valve Tags (100) and Labels PVC Wall Boxes*:

(15) 000‐082‐0050 Water Only White single piece ABS construction with an opening cut out of 14⅝"W x 13⅝"H with a depth of 4¾”.

Pretreatment Water Sample Port Box:

(1) 0082‐0024 Pretreatment Water Sample Port Box

The AmeriWater sample box for pretreatment water is designed to deliver test sample water to a central collection point. This provides easy sampling and draining of the test lines. Single piece ABS construction wall box is recessed to prevent damage to the valves. Water valves are PVC ball type with a lever handle for ease of operation.

Measuring cup makes sure tubing to the sample box is flushed before sample is drawn. Drain connection is 1” PVC pipe.

Clean In Place:

(1) 00CIP2 MRO3, MRO4, MROX, MROZ

An economical way to keep your membranes scale free for improved performance.

Includes cleaning drum, hose and fittings for quick connection, and recirculation pump.

Use AmeriClean A & B (cleaning agent not included).

Installation Kits:

(1) 001‐014‐0005 Complete Water System Install Kit, 1.0” Pretreatment Manifolds

(1) 001‐142‐0002 Central System Drain to Waste Manifold 2”

PACKAGING:

Packaging: Central Systems

(1) PKG14‐25 14 to 25 Stations

VALIDATION LAB TESTING:

Validation Lab Testing

(12) 00LAL Endotoxin (LAL) AAMI Contaminant Analysis Test

(12) 00MICRO Microbial AAMI Contaminant Analysis Test

(2) 00AAMI AAMI Chemical Contaminant Analysis Test Validation lab testing is included for the following requirements: AAMI Chemical Contaminant Analysis for source water and product water baseline. AAMI Microbial and endotoxin contaminant analysis for product water, post endotoxin filter, and end of distribution loop (weekly for four weeks).

1. Technical Specifications – see following page:

Salient Characteristics for the dialysis water purification system

Reverse Osmosis Systems for Central Dialysis (MROZ Series)

DESCRIPTION:

The MROZ, an open frame Revers Osmosis (RO) and a cabinet RO. The pump and membranes are mounted on a corrosion resistant, powder coated open frame providing superior serviceability. The controls and hydraulic hardware are mounted in a low-profile cabinet with full size door for easy access.

FEATURES:

-4” x 40” thin film composite membranes provide maximum contaminant rejection while achieving high product flow and low energy use.

-High-pressure stainless-steel membrane housings with quick connects enable fast and efficient membrane replacement.

-Disinfection is quick and easy with a simple push of the keypad, the MROZ can be disinfected with PAA and rinsed in 2 hours.

-High efficiency quiet submersible pump with integral motor starter and motor protection keeps system running smoothly and protects the motor from overload.

-Microprocessor controller with backlit LCD display shows product and feed water conductivity, product water temperature, operating hours, percent rejection, and a variety of operating status messages -Programmable flush for storage tank or direct feed keeps RO fresh between uses.

-Product divert feature diverts water to the drain when the conductivity exceeds the set point for added patient safety.

STANDARDS:

– Entire device conforms to IEC UL standard 61010-1

– FDA 510K / ISO 13485 Registered Medical Device

– ANSI/AAMI 13959 and 26722 compliant

Heat Disinfect Reverse Osmosis Systems

The MediQA system uses proven reverse osmosis technology combined with heat disinfection to provide a unique combination of performance, reliability, and functionality. This fully integrated water purification solution when coupled with pre-treatment and heat compatible distribution pipework makes a complete system.

FEATURES:

-Single and dual pass membrane configurations provide maximum flexibility in water quality

-High recovery mode uses up to 40% less water during operation and results in 100% recirculation

-Emergency single pass mode (ESPM) allows MDP systems to automatically transition to single pass operation in the event of a pump failure.

-High flow model available for facilities requiring larger flow requirements.

-Automated heat disinfection of RO membranes.

- Provides system efficiency and labor savings.

- Ensures that any potential for bacterial growth on membrane surfaces is minimized.

-Full color touch screen display with comprehensive menu navigation, including full schematics.

-Advanced data logging technology with password protection.

-Information available via an integrated touch screen display or download to Excel.

- Stored data includes active status indicators, alarm conditions and performance logs.

-8” TFC heat disinfectable membranes in FRP vessels for durability.

-Powder coated aluminum skid mounted package on castors for maximum maneuverability.

STANDARDS:

– Entire device conforms to IEC UL standard 61010-1

– FDA 510K / ISO 13485 Registered Medical Device

– Health Canada Medical Device License 90626

Heat Disinfection System for the Distribution Loop

The Heatsan is an integrated heat disinfection system for disinfecting the distribution loop and providing hot water to the dialysis machines with the ability to adjust for each day of the week, heating intervals, holding times and disinfection temperatures.

FEATURES:

-Provides up to 100 gallons of 185°F hot water.

-PLC controller, dual color touch screen displaying alarms, system status, tank level, disinfection temperatures and event log.

-Easy step through programming (7 day program).

-Program syncs dialysis machines with the Heatsan.

-Intelligent monitoring routines, leak detection, and overuse.

-Heat disinfect will abort if leak is detected.

-Four levels of password protection.

-Event log holds up to 12 months of data including AAMI standards required end of loop history.

-USB download to Excel -Stainless steel skid complete with insulated stainless-steel storage tank with sloping base fitted with three heating elements to minimize electrical consumption, level transmitter and temperature monitor.

-Stainless steel recirculation pump, stainless steel solenoid valves.

-The isolation of the RO system is accomplished with three-way motorized ball valves that are controlled by the Heatsan.

STANDARDS:

– Entire device conforms to IEC UL standard 61010-1

– FDA 510K / ISO 13485 Registered Medical Device

– Health Canada Medical Device License 90864