Renatron® PA/II (100)

Training Seminar
Introduction Renatron
PA / II 100 System
 Renatron® PA/II Station
Components
 Renatron® PA/II Dialyzer Reprocessing Station
 Has a hydraulic side and electronic side.
 1 - 6 ft water supply hose with back flow preventer.
 1 - 6 ft drain hose.
 1 - 6 ft Renalin® hose.
 70 cc cal cell
 Renalin®100 Uptake tube assembly
 Renatron® PA/II Station
Components
1 - 6 ft RS-232 communication cable
( Renatron II only)
Pressure gauge block/regulator(option)
Drip tray-single or dual (option)
 Cautions

All hoses and lines for the Renatron® are

cut to length and should not be altered.
 Description of Operation
The Renatron® PA/II Dialyzer Reprocessing
System will Rinse, Clean and, Test for TCV,
Test fiber integrity, and Pack the dialyzer with
Renalin®.
 Cautions
1)The Renatron® is intended only for use with
Renalin® Cold Sterilant

2)Used only for Hemodialyzers that have been

validated with the Renatron®

3)Operator should be familiar with the

Renatron® and Renalin® instructions for use
 Warning
1)Renalin® can cause eye damage and skin
irritation.

2)Always wear personal protective

equipment (PPE) when operating the
Renatron® station

3)Do not allow Renalin® Cold Sterilant to

mix with alkaline substances such as bleach.
Specifications
 Electrical
1)leakage current 100 micro amps (IEC61010-1)

2)Selectable voltage 100, 120, 230, 240 VAC

3)The supply line voltage must not fluctuate more

than 10% of the nominal voltage.

4) Fuses 100-120vac, one 4A

Fuses 220-240vac, two T2A
 Environmental
Operation Ambient
Temperature Range
41-104° F (5-40° C)
Relative Humidity
Maximum relative humidity of 80% at
31° C, decreasing linearly to 50% at
40° C and altitudes up to 6500 feet.
Water and Drain
Requirements
 Materials of Construction

Acrylic, PVC, ABS, Polypropylene, Delrin,

Ethylene Propylene, Viton Rubber, Stainless
Steel, other Non-corrosive material
 Water Requirements
Water supplied to the Renatron® must meet
AAMI specifications (R O Water) .
 Feed Line Peak Flow

 6 liters (1.6 gallons) per minute

 Average pressure of 20-55 PSI
 Optimum pressure of 30-35 PSI in Step 4.
 Water Temperature
 Must be 59 -75°F (15-24° C)

 A maximum temperature of 86° F (30oC)

is allowable if the dialyzer is stored
immediately after reprocessing in an area
where the temperature is between 59-75° F.
(15-24° C)
 Drain Requirements

 Must be able to accept 6 liters (1.6 Gallons)

per minute per Renatron®.
Renatron Controls and
Indicators
 Description of Controls
 On
 Off
 Hold to Set ( to set min. volume)
 Set Knob
 Start Process
 Start Sanitize
 Mute
 Reset
 Display
 Indicators
 Volume Display
 Clean
 Test
 Disinfect
 Process Complete
 Sanitize Complete
 Program Mode and Step Display
 Error Messages
Volume Fail
Pressure Fail
Add Chemical
Tank Volume
Interlock
Operation
 Proper Connection of
Dialyzers to Renatron®
 Attaching a dialyzer :

• Venous blood side

• Venous dialysate side
• Arterial dialysate side
• Arterial blood side
 Manual Reprocessing
with Renatron® only
 Process dialyzer on Renatron
• Set Hold to Set volume to dialyzer minimum volume
• Press mute and reset button to select program Modes
• Press “Start Process” to start the reprocessing
• At end of cycle, record information on label
 Dialyzer Removal
 Disconnect the dialyzer in the reverse order
that they were connected. Cap each port as
soon as it is disconnected from the Renatron®.
 Aseptic technique must be followed while
removing the reprocessed dialyzer from the
Renatron® station to prevent contamination of
the dialyzer blood pathway
 Caution
 Pressure Buildup may occur in dialyzers
left on the Renatron®
 Take care when removing the dialyzer
 Pressure buildup may cause fluid to spray
 Dialyzer Storage
 Storage Area
• Well ventilated
• Temp. range 59-75°F (15-24° C)
• Out of direct Sun light
 Dialyzer Storage
• Minimum storage time is 11 hours
• Maximum storage time ?
• Temperature differences may cause
pressure buildup in dialyzer
 Dialyzer Storage
• AAMI standards state a maximum of 30 days
storage regardless of the disinfectant (Renalin,
formaldehyde...).
• Because the conditions will vary from clinic to
clinic.
• Dialyzer with blood will probably not test positive
at 30 days so most clinics in the US will have a
storage time of 7 to 14 days.
• The important consideration for the clinic is they
need to verify that their dialyzers will test positive
after the maximum storage time.
Dialyzer Reprocessing
Program
 Program Mode
(00)
 Calibration verification
 Daily Sanitize
 Low flux dialyzers kuf <8. Program time = 8 minutes.
 (CH)
High efficiency dialyzers kuf 8-15. Program time
= 10 minutes.
 (HF)
High flux dialyzers kuf 15+. Program time
= 10 minutes.
 Machine Self Test
Step 2 to 9

 Drain water from the Tank – Step 2

 Fill water to the Tank – Step 3
 Draw Chemical to the Tank - Step 9
 Cleaning Step
Step 12 to 24
 Flush Blood Circuit Arterial to Venous-Step 14
 Reverse Ultrafiltration- Steps 16 and 18
 Flush Dialysate Compartment- Step 20
 Flush Blood Circuit (Arterial to Venous)-Step 21
 Testing- Step 25 to 39
Blood Compartment Volume Measurement
Step 25 to 35

 Fill Blood Compartment from venous to arterial -

Step 25

 Draw Blood Compartment- Steps 29, 31 and 33

 Measure Mass- Step 35

 Testing- Step 25 to 39
Pressure Leak Test- Steps 36 to 39
 Steps 36 - Draw vacuum dialysate compartment
to -200 mmHg or less
 Steps 37 - Check the leak
 Steps 38 - Draw vacuum dialysate compartment
to -250 mmHg or less
 Steps 39 - Check the leak
 Alarm if pressure changes by more than
50 mmHg
 Disinfect- Step 41 to 57
 Draw Renalin® - Step 45
 Proportion Renalin® solution- Step 48
 Draw proportion Renalin® Solution to
Dialysate Compartment- Step 53
 Draw Renalin® Solution to Blood
Compartment- Step 54
 Process Complete- Step 57
Sanitize Program
 Daily Sanitize
Step 60 -83
 The Renatron needs to be sanitized once a day.

 The machine will display “sanitize complete” and

a 3 second tone will sound at the end of step 83.
 Minimum Sanitize Time
The Renatron must sit for a minimum of 6
hours before it can be used.
Maximum Sanitize Time
The Renatron® can sit for a maximum
of seven (7) days before it needs to be
resanitized.
 External Disinfection
(Daily)

1 % Renalin® solution is used to wipe down

external surfaces of the Renatron® station
 409® Cleaning

 Internal fluid pathways must be clean every two weeks

(This should be performed on Saturday for a long dwell time)

 Port cap Disinfection
Blood and Dialysate port caps

 1% Renalin® for a minimum of 30 minutes

 See Renatron® II Instruction Manual- Page 20

 Renatron® Storage
 Long term storage or Transportations

Run machine through step 97 to ensure fluid

pathways are drained
Thank You