ATTACHMENT D - MTRs.pdf

1. SYSTEM SPECIFIC MINIMUM TECHNICAL REQUIREMENTS (MTR)

a. Central Dialysis Water Purification and Distribution System (In-Center, Purchased)

1) Standards: Shall have FDA clearance as a water purification system for hemodialysis (21CFR876.5665).

2) Heat Disinfection: Shall be capable of fully automated heat disinfection of the entire system including the membranes and distribution loop. Shall not require chemical disinfection to meet AAMI standards.

3) Chemical, Microbial, and Endotoxin Contaminant Control: Shall provide product water to each dialysis station that meets the AAMI standards.

4) Sizing: Contractor shall provide the following sizing options:

a) Central Dialysis Water Purification and Distribution System for dialysis center with 1-12 stations

b) Central Dialysis Water Purification and Distribution System for dialysis center with 13-25 stations

c) Central Dialysis Water Purification and Distribution System for dialysis center with 26-38 stations

d) Central Dialysis Water Purification and Distribution System for dialysis center with 39-51 stations

5) Automation: Shall have full automation and monitoring of system functions and water quality including start, heat disinfection, safety features (divert, drain, shut down), back wash, and flush based on operator defined parameters.

6) Alarms: Shall have automated alarm system with visible and audible alarms in the water treatment room and patient treatment area that notifies operator when quality of water does not meet desired specifications or when system malfunctions.

7) User Interface: Shall have color touch control panel for all components and a remote color touch control panel at the nursing station.

8) Hemodialysis System Integration: Shall be compatible with all FDA 510(k) cleared hemodialysis systems.

9) Emergency Operation: Shall have capability for emergency single pass mode for each reverse osmosis (RO) membrane in the event of membrane or pump failure.

10) Design and Components:

a) Shall be a double (dual) pass stand-alone RO system.

b) Shall include all components for water purification including pre-treatment, purification, and distribution including devices, piping, fittings, and wall boxes to the point of use.

c) Shall have zero dead legs/space and maintain continuous flow throughout the entire system.

d) Piping, housings, and membranes shall be heat tolerant and chemically inert.

e) Shall include seismic restraints (as applicable).

f) Pre-Treatment System:

i. Pressure Gauges: Shall include pressure gauges before and after each component of the pre-treatment system.

ii. Sampling Ports: Shall include sampling ports before the first element in the system and after each element.

iii. Temperature Adjustment: Shall have temperature blending valve and properly sized water heater that meets AAMI specified temperature range for dialysis. Shall have a thermometer that displays output water temperature.

iv. Backflow Prevention: Shall have a backflow preventer valve.

v. Pressurization: Shall have booster pump with pressure switch that automatically turns booster pump on and off based on operator defined parameters.

vi. Grit and Sediment Filter: Shall have sediment filter with automatic backwash and programmable control head. Shall be capable of removing particulate matter to < 10 pounds per square inch (psi). Shall lockout RO when in backwash. Shall have a 7-day timer for display of the backwash cycle.

vii. Water Softener: Shall have automatic regeneration water softeners (2) and a brine tank. Softener shall be before the carbon tanks and have a lockout device to prevent regeneration during treatment. Shall provide softened water for a minimum of 2 days of operation before requiring regeneration. Softener shall have a programmable control head for automated regeneration cycle setup and a 7-day timer for display of the regeneration cycle. Shall include pressure gauges on the water softener inlet and the outlet to measure pressure drops.

i. Carbon Tanks: Shall have automatic backwashing carbon tanks and programable control head. Shall consist of a primary worker tank and a secondary polisher tank aligned in a series and are filled with pre-rinsed granular activated carbon. Tanks shall be sized to provide a minimum total Empty Bed Contact Time (EBCT) of 5 minutes per tank.

Shall have sampling ports before and after the worker and polisher tanks. Tanks shall lockout RO when in backwash and shall have a programmable control head for automated backwash cycle setup and a 7-day timer for display of the backwash cycle. Shall have a continuous chlorine meter between the first and second carbon tanks and alarm at the nurse’s station.

ii. Bypass: Shall have bypass options for the temperature blending valve, sediment filter, and water softener tanks. Shall not bypass the carbon tanks.

iii. Particulate Filter: Shall be after the secondary carbon tank and before the feed water inlet to the water purification system. Filter pore size shall be 1 micron.

g) Purification System:

i. Shall heat disinfect the entire water distribution system up to the dialysis station wall boxes (end to end disinfection). Shall have automated heating element control to maintain temperature that meets AAMI standards.

ii. RO Pump and Membranes: Shall have a high-pressure pump made of durable material that is capable of maintaining operating pressures per manufacturer guidelines. Shall have a RO membrane that meets AAMI standards for percentage rejection and conductivity of product water. Shall have built-in monitor to continuously measure percent rejection and conductivity of final product water and shall display in micro-Siemens per 1 cm or by the total dissolved solids in milligrams per liter or PPM. Shall have audible (able to be heard at dialysis unit treatment room(s) and nurses’ station) and visual alarms that notifies operator when quality of water does not meet desired specifications or when system malfunctions.

iii. Endotoxin Filter: Shall have a pore size of <0.05µ

h) Distribution Loop: Direct feed system preferred. Shall be sized to meet dialysis center size.

i) Post-Treatment: Shall include a water sampling port in the post-RO system.

b. Central Dialysis Water Purification and Distribution System Accessories

(Separately Priced) (In-Center, Purchased): Unit price shall include all corrective and preventive maintenance.

1) Emergency Deionization (DI) System: Shall include:

a) Shall provide emergency bypass in the event of RO system failure.

b) Shall include a minimum of two DI tanks connected in series (additional tanks may be requested based on center size) followed by an endotoxin filter system. DI system, couplings, and connecting tubing shall be leak free and meet AAMI standards. The capacity of the DI system shall be disclosed as volume of resin per tank and removal capacity per tank (as grains, CaCO3 equivalents).

c) Shall include a resistivity monitor and audible and visible resistivity meter alarms between the first and second tank including a remote audible alarm at the nurse’s station. Shall have a divert to drain function between the second tank and the distribution system that diverts water to drain in the event it does not meet AAMI standards.

d) DI tanks shall be delivered in a semi-dry state (excess water removed), with inlet and outlet ports sealed with liquid-tight enclosures. Preservatives, germicides, or antifreeze solutions shall not be added. DI inlet and outlet connections shall be clearly labeled. DI tanks shall be labeled with date of regeneration, date of delivery to VA, and whether the tanks contain mixed bed, anion, or cation resin.

e) DI components shall be disinfected at time of resin regeneration. DI resin shall be kept separate from non-potable or non-medical applications. DI media shall be reagent grade (or better), consisting of strong base anion exchange resin and strong acid cation exchange resin. Industrial grade or “process” resin shall not be used.

2) Ultraviolet (UV) Disinfection System: Shall minimize bacterial growth using an approved germicidal radiation method.

3) Dialysis Wall Boxes: Contractor shall provide and install the dialysis wall station boxes (including feed lines to the dialysis machine) that connect the water distribution system to the hemodialysis machine model used by the VA center.

Each box shall have a shut off valve and drain line. Installation shall be recessed into the wall cabinet or chase way. Shall provide the following wall box configuration options:

a) Dialysis wall station box with connections for water, acid, drain, dialysis machine

b) Dialysis wall station box with connections for water, bicarb, acid, drain, dialysis machine

c) Dialysis wall station box with two connections each for water, drain, dialysis machine

4) Temporary Central Water Purification and Distribution System (Monthly Lease with 24/7/365 service): Shall provide temporary product water to enable VA facilities to maintain operation. Shall have the following sizing options:

a) Temporary Dialysis Water Purification and Distribution System for dialysis center with 1-12 stations

b) Temporary Dialysis Water Purification and Distribution System for dialysis center with 13-25 stations

c) Temporary Dialysis Water Purification and Distribution System for dialysis center with 26-38 stations

d) Temporary Dialysis Water Purification and Distribution System for dialysis center with 39-51 stations

5) Chlorine Monitoring System

a) Shall automatically measure chlorine levels of pre-treatment water.

b) Shall be a component of the pre-treatment system and located between the first and second carbon tanks.

c) Shall include audible and visual alarms in the water treatment room and nurse’s station that notify operator when levels do not meet AAMI standards.

6) Digital Dialysate Conductivity Handheld Meter

a) Shall measure dialysate quality (conductivity, pH, and temperature) and water quality (conductivity, resistivity, temperature, pH, chlorine). Shall not require use of test strips.

b) Shall include carry case.

7) Point of Use Endotoxin Meter

a) Shall be a hand-held meter that provides real-time measurement of endotoxins to a sensitivity of at least 0.01 endotoxin units per mL.

c. Dialysate Delivery Systems (Separately Priced) (In-Center, Purchased)

1) Acid Distribution System: Shall have a tap to allow for manual drainage or filling acid jugs from the tank. Tubing shall be installed for each station. All system components and valves shall be permanently labeled with identification tags.

Shall have the following sizing options:

a) Acid Distribution System for dialysis center with 1-12 stations

b) Acid Distribution System for dialysis center with 13-25 stations

c) Acid Distribution System for dialysis center with 26-38 stations

d) Acid Distribution System for dialysis center with 39-51 stations

2) Bicarbonate Mixing and Distribution System: Shall include bicarbonate sampling port. Shall have the following sizing options:

a) Bicarbonate Mixing and Distribution System for dialysis center, 1-12 stations

b) Bicarbonate Mixing and Distribution System for dialysis center, 13-25 stations

c) Bicarbonate Mixing and Distribution System for dialysis center, 26-38 stations

d) Bicarbonate Mixing and Distribution System for dialysis center, 39-51 stations

d. Portable Dialysis Water Purification and Distribution System (In-Center,

1) Standards: Shall have FDA clearance as a water purification system for hemodialysis and clearance for inpatient acute dialysis.

2) Heat Disinfection: Shall be capable of fully automated heat disinfection up to the hemodialysis system. Shall NOT require chemical disinfection to meet AAMI standards.

3) Chemical, Microbial and Endotoxin Contaminant Control: Shall provide product water that meets AAMI standards.

4) Automation: Shall have full automation and built-in monitoring of system functions based on operator defined parameters.

5) Alarms: Shall have automated alarm system with visible and audible alarms that notifies operator when quality of water does not meet desired specifications or

6) Hemodialysis System Integration: Shall be compatible with all models of FDA cleared hemodialysis systems.

7) Design: Shall be compact portable unit that includes all components for water purification and provides continuous flow throughout the system. Shall be mobile or include a medical grade cart.

8) User Interface: Shall include a touchscreen control panel.

e. Portable Integrated Water Purification and Dialysate Production System (In- Center, Purchased)

1) Standards: Shall have FDA clearance as a high permeability hemodialysis system (21CFR876.5860).

2) Therapies: Shall be capable of providing hemodialysis, sustained low efficiency dialysis (SLED), and ultrafiltration. Shall be capable of providing up to 24 hours of continuous therapy.

3) Dialysate Production: Shall be capable of producing dialysate from Environmental Protection Agency (EPA) quality potable water (i.e. tap water) that meets AAMI standards for dialysis.

4) Chemical, Microbial, and Endotoxin Contaminant Control: Shall produce product water and dialysate that meets AAMI requirements.

5) Automation: Shall have full automation of set-up, treatment management, and maintenance based on operator defined parameters.

6) Monitoring Treatment and Alarms: Shall have automated alarm system with visible and audible alarms that notifies operator when the system does not meet desired specifications or when system malfunctions. Alarms shall include a message and action required to correct condition. Shall automatically perform inviolable machine safety checks before each treatment. Shall have built-in sensors and alarms that monitor blood flow (arterial and venous pressure, air detection, blood leaks, blood clots), fluid removal, ultrafiltration rate, water and dialysate quality (water pressure, temperature, conductivity, pH), supply and concentrate levels, and maintenance requirements.

7) Design: Shall include all components for water purification and dialysate delivery in one device. Shall be portable with lockable wheels.

8) User Interface: Shall include including a touchscreen control panel.

f. Hemodialysis System (In-Center, Purchased)

2) Therapies: Shall be capable of providing hemodialysis and ultrafiltration.

3) Chemical, Microbial, and Endotoxin Contaminant Control: Shall produce dialysate that meets AAMI requirements.

4) Dialysate Production and Delivery: Shall have options for use of dry bicarbonate powder or premixed liquid bicarbonate solution to make dialysate.

5) Automation: Shall have full automation of set-up, treatment management, and maintenance based on operator defined parameters including safety checks, auto start, auto prime, and auto heat disinfection.

6) Patient-Specific Treatment Parameters: Shall allow operator to set patient-specific treatment parameters including dialysate flow, UF goal, sodium profile, heparin dosing, blood pressure, blood pump speed.

7) Monitoring Treatment and Alarms: Shall have automated alarm system with desired specifications or when system malfunctions. Alarms shall include a message and action required to correct condition. Shall automatically perform inviolable machine safety checks before each treatment. Shall have built-in sensors and alarms that monitor blood flow (arterial pressure, venous pressure, transmembrane pressure, venous needle dislodgement, air detection, blood leaks, blood clots, blood temperature, blood volume), fluid removal, ultrafiltration rate, access flow rate, water and dialysate quality (water pressure, temperature, conductivity, pH), supply and concentrate levels, and maintenance requirements.

8) Design: Shall include all components of the hemodialysis system in one portable device including blood pump and tubing, heparin pump and syringe infusion port/ holder, blood pressure sensors, blood pressure cuff, dialysate pump, bicarbonate connector, membrane, lockable wheels, manual hand crank.

9) User Interface: Shall include including a touchscreen control panel.

10) Water Connection: Shall be compatible with all FDA cleared water purification systems for hemodialysis. Shall include all hoses and connectors to enable connection of the hemodialysis system to the wall box. Shall have timers for auto start for integrated heat disinfection with the water purification system.

g. Hemodialysis System Accessories (Separately Priced):

1) Electronic Motorized Cart (In-Center, Purchased)

2) Monitors for real-time measurement of hematocrit, oxygen saturation, and/or fluid management (In-Center, Purchased)

3) Centrifuge Machine (Home Use, Rental)

h. Continuous Renal Replacement Therapy (CRRT) System (In-Center,

2) Therapies: Shall be capable of providing CRRT.

3) Automation: Shall have full automation of set-up, treatment management, and maintenance based on operator defined parameters including safety checks.

4) Patient-Specific Treatment Parameters: Shall allow operator to set patient-specific treatment parameters including dialysate flow, blood flow rate, pre and post filter solution flow rate, UF goal, heparin dosing, blood pump speed.

5) Monitoring Treatment and Alarms: Shall have automated alarm system with desired specifications or when system malfunctions. Alarms shall include a message and action required to correct condition. Shall automatically perform inviolable machine safety checks before each treatment. Shall have built-in sensors and alarms that monitor blood flow (arterial pressure, venous pressure, transmembrane pressure, venous needle dislodgement, air detection, blood leaks, blood clots, blood temperature, blood volume), fluid removal, ultrafiltration rate, access flow rate, supply and concentrate levels, and maintenance requirements.

6) Design: Shall include all components in one portable device including blood pump and tubing, heparin pump and syringe holder, blood pressure sensors, dialysate pump and dialyzer, membrane, lockable wheels, manual blood return, blood warmer.

7) User Interface: Shall include including a touchscreen control panel.

i. Peritoneal Dialysis System (Home Use, Rental)

1) Standards: Shall have FDA clearance as a medical device for home dialysis.

2) Therapies: Shall be capable of providing continuous cycling peritoneal dialysis (CCPD), intermittent peritoneal dialysis (IPD), peritoneal dialysis plus (PD+), and tidal peritoneal dialysis (TPD).

3) Automation: Shall have full automation of set-up and treatment management based on operator defined parameters including an automated cycler.

specific treatment parameters including therapy type, treatment settings, drain options, and alarms.

desired specifications or when system malfunctions. Alarms shall include a message and action required to correct condition. Shall automatically perform inviolable machine safety checks before each treatment. Shall have built-in sensors and alarms that monitor solution temperature, sensor functionality, battery life, safety connections, leaks, air pressure and leaks, treatment data, fluid pressure, pneumatic pressure, connectivity, software functionality.

6) Design: Shall be light weight, portable, compact design for tabletop operation and include all components including the cassette, dialysate warmer, solution scale, safety connections, pump and tubing, and drain line. Shall include a carrying case.

7) User Interface: Shall include a touchscreen control panel, on-screen instructions, and simplified patient data entry.

j. Home Hemodialysis System (Home Use, Rental)

2) Therapies: Shall be capable of providing hemodialysis (daytime and nocturnal).

based on operator defined parameters.

specific treatment parameters including therapy type, treatment schedule, dialysis prescription, and alarms.

desired specifications or when system malfunctions. Alarms shall include a message and action required to correct condition. Shall automatically perform inviolable machine safety checks before each treatment. Shall have built-in sensors and alarms that monitor blood flow (arterial pressure, transmembrane pressure, air detection, blood leaks, blood clots, blood temperature, blood volume), fluid removal, ultrafiltration rate, access flow rate, water and dialysate quality (water pressure, temperature, conductivity, pH), supply and concentrate levels, and maintenance requirements.

6) Design: Shall be lightweight, portable, compact, design and include all system components. Shall include a cart for system transport and a carrying case.

k. Portable Dialysis Water Purification and Distribution System (Home Use, Rental)

2) Heat Disinfection: Shall be capable of fully automated heat disinfection up to the hemodialysis system. Shall NOT require chemical disinfection to meet AAMI standards.

3) Chemical, Microbial and Endotoxin Contaminant Control: Shall provide product water that meets AAMI standards.

4) Automation: Shall have full automation and built-in monitoring of system functions based on operator defined parameters.

5) Alarms: Shall have automated alarm system with visible and audible alarms that notifies operator when quality of water does not meet desired specifications or

6) Hemodialysis System Integration: Shall be compatible with all models of FDA cleared home hemodialysis systems.

7) Design: Shall be compact portable unit that includes all components for water purification and provides continuous flow throughout the system. Shall be mobile or include a medical grade cart.

8) User Interface: Shall include a touchscreen control panel.

l. Home Hemodialysis and Integrated Water Purification System (Home Use, Rental)

2) Therapies: Shall be capable of providing hemodialysis (daytime and nocturnal).

based on operator defined parameters.

specific treatment parameters including therapy type, treatment schedule, dialysis prescription, and alarms.

desired specifications or when system malfunctions. Alarms shall include a message and action required to correct condition. Shall automatically perform inviolable machine safety checks before each treatment. Shall have built-in sensors and alarms that monitor blood flow (arterial pressure, venous pressure, transmembrane pressure, venous needle dislodgement, air detection, blood leaks, blood clots, blood temperature, blood volume), fluid removal, ultrafiltration rate, access flow rate, water and dialysate quality (water pressure, temperature, conductivity, pH), supply and concentrate levels, and maintenance requirements.

6) Design: Shall be lightweight, portable, compact, design and include all components including the cassette, dialysate warmer, solution scale, safety connections, pump and tubing, and drain line. Shall include a cart for system transport and a carrying case.