DIALYSIS MACHINES - SPECIFICATIONS.pdf

ATTACHMENT I

SPECIFICATIONS FOR HEMODIALYSIS MACHINES

MACHINE SPECIFICATIONS:

Standard:

Floor space Approximately 54 cm wide by 63 cm deep Height 149 cm Total weight Approximately 90 kg

Electrical:

Power Supply—Main AC 117 V ±10% 60 Hz ±3 Hz Power Consumption Does not exceed 12.6 amps @ 117VAC

External Connections Isolated RS232 and Ethernet ports;

leakage current isolation per UL 60601-1 between the machine and external computer

Water:

Ingress Rating IPX1 (Vertical drip-proof protection) Back Flow Prevention Integral back flow prevention provided by external vent to atmosphere in water inlet circuit Pressure Min 20 psi; Max 105 psi Temperature Min 50°F (10°C); Max 77°F (25°C) Quality ANSI/AAMI 13959:2014, Water for hemodialysis and related therapies Drain 3 feet maximum height. Must comply with local codes and must maintain a free fall air gap between drain hose and building drain

Rinsing Temperature 37°C. Flow rate 620 mL/min. Time between 10 and 60 minutes (internally selectable)

Blood Circulation:

Blood Pump: Display of blood flow rate Internal diameter of blood pump segment 6–600 mL/min

2.6 to 10 mm (0.1" to 0.4")

Heparin Pump: Type of Syringe Administration Rate 10–12 mL disposable syringe 0 to 9.9 mL/hr

Arterial Pressure Monitor -300 to +500 mmHg Venous Pressure Monitor -80 to +500 mmHg

TMP Monitor +60 to -520 mmHg Level Detector Ultrasonic impulses detect fluid level in the drip chamber Blood Leak Detector Two-color light source transmitter/sensor with a resolution of: minor ≥ 0.35 mL/min of blood (hematocrit = 25%) alarm ≥ 0.45 mL/min of blood (hematocrit = 25%)

Access Flow (Qa) requires OLC Maximum Qa: 2000 mL/min

User Interface:

Language The operating screens may be set to either French

(Canadian), Spanish (Mexico), or English (U.S.)

Blood Pressure Module:

Cuff Inflation Typically 5–10 seconds from 0–250 mmHg Interval Settings Interval times: 5–60 minutes in increments of 5 minutes

Dialyzing Fluid:

Dialysate Flow Adjustment Range Accuracy: ±5%

Sequential (0)/100*/150*/200*/300/400/500/600/700/800 mL/min, selectable in the “Home” screen; Additionally, 1.5X or 2.0X dialysate flow rate based on the Blood Pump rate (Qb):

Qb w/1.5X selected Qb w/2.0X selected Qd

0–165† 0–150† 300 166–215† 151–215† 400 216–315† 216–265† 500 315 and below‡ 265 and below‡ 500 316–415 266–315 600 416–480 316–365 700 481 and above 366 and above 800

Note: All flow rates are approximate. Dialysate flow will not adjust unless the blood pump is adjusted at least 15–20 mL/min.

SLED*: 100/150/200/300 mL/min

* Requires “Allow Slow Flow” Service Mode option † If Auto Flow Minimum 300 Qd is set in Service Mode ‡ If Auto Flow Minimum 500 Qd is set in Service Mode

Concentrate Pressure Max suction height 3 feet

Max supplied pressure 2 psi, 10 psi with bibag kit installed Sodium Adjustment Range 130 to 155 mEq/L Na+ Bicarbonate Adjustment Range 20 to 40 mEq/L Bicarbonate (post-reaction, after mixing with the acid and purified water)

Conductivity Range of Display 10.0 to 17.0 mS/cm at 25°C. Alarm limits will not go below 12.5 or above 16.0 mS/cm.

Dialysate Temperature 35 to 39°C, selectable in 0.1°C steps Sodium Variation System (SVS) Three preset profiles (step, linear, and exponential) Online Clearance (OLC) Dialysate Flow rate: 300–800 mL/min # of Tests: 1–6 during each treatment Ultrafiltration Control:

UF Pump Volume Accuracy ±1% (for Pdi > -500 mbar) where Pdi = dialysate pressure on inlet side of the dialyzer Fluid Removal Rate from Patient 0–4000 mL/hr UF Profiles 8 UF profiles are available for the removal of fluid from the patient 4 are preset and 4 may be defined by the user

Heat Disinfection:

Temperature 83 ± 8°C at NTC 3 Flow Rate 600 mL/min Time Between 10 and 60 minutes (internally selectable)

Chemical Disinfection:

Temperature 37°C (set point applicable) Flow Rate 620 mL/min Time Between 10 and 60 minutes (internally selectable)

REQUIRED SPECIFICATIONS:

Integrated status lights visible 360° Crit-Line® technology Increased visibility with 15" LCD screen and touchscreen navigation Full-scale foldaway keyboard with tactile feedback Ergonomic dialysate connectors Modular design Automatic DIASAFE®plus filter test after chemical disinfect bibag® On-line Dry Bicarbonate Concentrate System Standard 8' extended concentrate lines Protective paint

STANDARD FEATURES INCLUDE:

Additional Default Dialysate Rates 600 and 700 mL/min Additional Dialysate Flow Rate of 150 mL/min Additional Heparin Syringe Selections bibag Conductivity Range CLiC Boundary Lines display Conductivity Alarm Position Lock

Cybersecurity with Service Mode Logins Default Prescription Parameters Screen Independent Conductivity and pH Self-Test Isolated Ultrafiltration (UF) Indication Low-Volume Therapy Machine Remote Protocol Enhancements New Treatment Prescription Warning Plasma NA+ Hide Option Set Time Zone and Date Ultrafiltration (UF) Calculator

ADDITIONAL FEATURES INCLUDE:

Clinical Data eXchange (CDX) offers chairside access to dialysis treatment and Medical Information System (MIS)

Integrated Auto Disinfection (IAD) program Easy software upgrades through integrated USB ports Integrated dialysate sample port on dialysate line