Download Renatron® II Instruction Manual

Renatron® II Service
Maintenance Seminar
Class Schedule
DAY ONE
8:30 AM- Seminar start: Introduction
10:00 AM- Break
12:00 PM- Lunch
2:30 PM - Break
5:00 PM- End of first day
Class Schedule
DAY TWO
8:30 AM- Seminar start
10:00 AM- Break
12:00 PM- Lunch
2:30 PM - Break
3:30 PM- End of Seminar
Cautions
 The Renatron® 100 is intended only
for use with Renalin® 100 Cold Sterilant
 Used only for Hemodialyzers that
have been labeled multiple use.
 Never run the machine without the
uptake tube assembly
 All hoses and lines for the Renatron®
are cut to length and should not be
altered.
Indications
The Renatron® Dialyzer Reprocessing
System is intended for in vitro, rinsing,
cleaning testing, and delivery of
proportioned Renalin® solution to hollow
fiber dialyzers that have been validated to
be reprocessed with the Renatron® II
System and Renalin® sterilant. It is also
indicated for record keeping of these
functions.
Specifications
Electrical Leakage Current
 100 micro amps
 Selectable voltage 100, 120, 230, 240
VAC
 The supply line voltage must not fluctuate
more than 10% of the nominal voltage.
 Fuses 100-120vac, one 4A
 Fuses 220-240vac, two T2A
Environmental Limits
 Operation Ambient
Temperature Range
41-104° F (5-40° C)
Water Requirements
 Water must be filtered to particle
size no larger than 1 micron.
 Inlet Water Must Meet or Exceed
AAMI Guidelines
Water Temperature
 Must be 59 -75°F (15-24° C)
 A maximum temperature of 86° F
is allowable if the dialyzer is stored
immediately after reprocessing in an
area where the temperature is
between 59-75° F. (Must have letter)
Feed Line Flow
 1.725 liters (.46 gallons) per minute average
 Maximum water pressure is 55 PSI static
 Minimum water pressure is 20 PSI dynamic
read in step 4.
 Optimum pressure of 30-35 PSI in Step 4.
Peak Flow Rate
 6 liters (1.6 gallons) per minute
 15-35 seconds in duration
 Occurs at approximately 3 minute
intervals
 3 times per cycle
Drain Requirements
 Must be able to accept 6 liters
(1.6 Gallons) per minute per
Renatron®.
Materials of Construction
 The drain should be constructed of
PVC/CPVC or other Non-corrosive
Material
Renatron II Station
Components
Renatron® II Station
Components
 Renatron® II Dialyzer Reprocessing
Station
 Has a hydraulic side and electronic side.
 1 - 6 ft water supply hose with back flow
preventor.
 1 - 6 ft drain hose.
 1 - 6 ft Renalin® hose.
 1 - 6 ft RS-232 communication cable
Renatron® II Station
Components
 Pressure gauge block/regulator
 70 cc cal cell
 Drip tray-single or dual
 Renalin®100 Uptake tube assembly
Renatron® II Station
Components
Computer
Top of the line computer system
Windows XP
Monitor
 VGA Monitor- CRT or Flat Screen
Renatron® II Station
Components
 Renalog RM Data Management System
 Dedicated label printer
 Dedicated Report Printer

Interface Module
 Multiplexing module that can connect up to 6
Renatrons®.
 Renalog RM – 12 Renatrons per computer
Overview of Dialyzer
Reprocessing
End of Treatment
After treatment is completed, the
dialyzer is brought to the reuse room.
The time interval between the end of the
treatment and reprocessing the dialyzer
should be kept within the time limits
prescribed by the physician
 The suggested maximum time interval
is two hours
Dialyser Cleaning
Many clinics will clean or rinse a
dialyzer before reprocessing.
Blood side flush
RUF
 Renaclear®
Reprocessing
 Attaching a dialyzer
Connect:
Venous blood side
Venous dialysate side
Arterial dialysate side
Arterial blood side
End of Reprocessing Cycle
 Make sure reset is pressed before the dialyzer
is disconnected.
 Disconnect the dialyzer in the reverse order
that it was 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
Dialyzer Storage
 Storage Area
 Well ventilated
 Temp. range 59-75°F
 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 Testing before
Treatment
The dialyzer must be tested for Renalin® 100
content after proper storage time- Perrassay Test
Strip
The dialyzer is rinsed on the dialysis machine
and a Residual Test Strip is used to verify that
the Renalin® 100 content has been rinsed to
acceptable levels
Recirculate until treatment is started to
prevent rebound
®
RENATRON
II
SYSTEM
OPERATION
Power Up Sequence
 Power on sequence





Printers
Monitor
Computer
Interface module
Renatron® II
 All at once if using the power strip
Renalog® RM Start Up
 Log in
 User ID
 Password
 Mode
 Change Time- Activation key needed
 Start Up Screens







Renalin Verifications
Service Rinse
Sanitize Renatrons
Calibration
Water Verifications- 20 psi to 55 psi
Water Cultures
Dialyzer Verifications- Precleaned, Expired, and not Processed
Renatron® II 100 Startup
Renalog® RM Startup
Renalin® 100 is connected
The Renatron® II 100 is sanitized
The Renatron® II 100 is calibrated
Static and dynamic water pressure readings
Renatron® II 100 Startup
Calibration verification
Scan barcodes- Authentication label, Renatron, and
Dialyzer
The Renatron® II 100 runs to step 57
Calibration information is stored in the computer and a
calibration report can be generated.
Modes of Operation
Program Mode
 Low flux dialyzers (00) kuf <8. Program
time = 8 minutes.
 High efficiency dialyzers (CH) kuf 8-15.
Program time= 10 minutes.
 High flux dialyzers (HF) kuf 15+. Program
time = 10 minutes.
Automatic Reprocessing
 Scan Authentication label, dialyzer barcode
label, and Renatron® barcode.
 Minimum Volume
 Program Mode
 When reset is pressed in step 57, labels are
printed and the database is updated.
Semi-Automatic
 Click on F6 to display Patient list
 Select patient’s dialyzer
 Select type of reprocessing
 Preclean
 Reprocess without a use
 Reprocess after use
 Sets the Renatron® II 100 to the
proper settings for that dialyzer
Manual Reprocessing
With Computer
Process dialyzer on Renatron® II 100
Set Hold to Set volume to dialyzer minimum volume setting
 Press mute and reset button to select program setting
 At end of cycle, enter information into computer
Preprocess
Reprocess without use
Reprocess after use
Renatron number
Container number
Current Volume
Did the dialyzer fail?
Manual Reprocessing
with Renatron® II 100 only
Process dialyzer on Renatron® II 100
Set Hold to Set volume to dialyzer minimum volume
 Press mute and reset button to select program setting
 At end of cycle, hand write label
Preclean Mode
Pre-clean Mode
Pre-cleaning a dialyzer will help breakdown
residual blood in the dialyzer.
Pre-clean program works for all types of
dialyzers. Program time  4 minutes.
Recommended contact time for pre-cleaned
dialyzers is 10 minutes to two hours.
Caution
 Pressure buildup may occur in
dialyzers left on the Renatron®
 Take care when removing the
dialyzer
 Pressure buildup may cause fluid to
spray
Barcode labels
User Authentication Label
Information Label
Dialyzer Barcode Label
Pre-Cleaned Label
Calibration Cell Label
Failed Label
Sanitize Program
Daily Sanitize
 The Renatron needs to be sanitized once a day.
 The machine must be connected in sanitize
configuration. “SEL” must be in the top display
and any of the programs “00”, “CH” or “HF” in
the bottom display before “Start Sanitize” is
pressed
 The machine will display “sanitize complete” and
a 3 second tone will sound at the end of step 83.
 Turn off the Renatron and the water supply to the
Renatron.
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 days before it needs to be
resanitized.
10 Minute Sanitize Cycle
 Press start process at the end of step 83, after a 10
minute hold in step 84, the machine will run to
step 97, and signal sanitize complete. All fluid will
be removed from the machine.
 This cycle is to be used after a 409® procedure,
when maintenance is performed on the machine,
or when the machine is being returned for
maintenance.
External Disinfection
(Daily)
 1 % Renalin® solution is used to
wipe down external surfaces of the
Renatron® station
 Actril® undiluted is also acceptable
Formula 409 Cleaning
409® Cleaning
 Institutional Formula 409®
 Institutional Formula 409® Cleaner
Degreaser only
 Must say NQF
 Do not use any other solutions
 Internal fluid pathways must be
cleaned periodically ( typically once
every two weeks )
 This should be performed on
Saturday a long dwell time is preferred
409® Cleaning
 Institutional Formula 409® is free
when Renalin® 100 is ordered in
proper quantities
Dialyzer Reprocessing Cycle
Cleaning Cycle
Step 8 to 24
 Chemical Draw- Step 9
 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
 Flush Blood Circuit (Venous to Arterial)-Step 25
Test- Step 25 to 40
Blood Compartment Volume Measurement
Step 25 to 35
 Fill Blood Compartment from venous to arterial- Step 25
 Sweep Blood Compartment- Steps 29, 31 and 33
Measure Mass- Step 35
 Repeatability ± 5%
Test- Step 25 to 40
Pressure Leak Test- Steps 36 to 39
Draw vacuum- Steps 36 and 38
Measure bleed off rate- Step 39
Dialysate compartment is at -250 mmHg or less
 Blood compartment atmospheric pressure
 Leakage rate of .83mmHg per second fails ± 10
% for 00, CH mode
 Leakage rate of 1.25mmHg per second fails ±
10% for HF program
Disinfect- Steps 41 to 57
 Draw Renalin® - Step 45
Verify Renalin® Draw- Steps 46 and 47
 Proportion Renalin® solution- Step 48
 Flush Blood Compartment- Step 50
Flush Dialysate Compartment- Step 51
 Draw Renalin® Solution to Dialysate
Compartment- Step 53
 Draw Renalin® Solution to Blood
Compartment- Step 54
Interface Module/Scanner
Operation
Interface Module
 Yellow power indicator light.
 Green On Line light- Indicates that the computer
is in communication mode. This light will only be
on in the Automatic Reprocessing, Automatic
Calibrations, or Renalin Connection screens.
 On/Off switch and fuse at power entry module.
 Older version of scanner will beep twice when
scanning.
 The newer version of the scanner will beep once
when scanning.
Scanner
 For best operation of Scan Team 3000 and 3400
models, hold the scanner so it is touching the
barcode and press the trigger. Continue to press
the trigger while moving the scanner away form
the barcode until the scanner beeps.
 Scan Team 3800 models, hold the scanner 3-9
inches from the barcode.
 Make sure scanner lens is clean.
 Clean the scanner with a nonabrasive cloth. Do
not use a cleaner that contains alcohol.
Renalog® RM Label Printer
Label Printer
Should be connected to the computer with a Parallel
Printer Cable.
If printing is not aligned on label, perform the Calibration
Procedure.
Turn power switch to Off
Hold Green Button down
Turn Power switch to On
Let go of Green Button when the red light flashes
Press Green Button to get “out of dump” label
Red light means that:
 Cover is not completely closed
 Ribbon is not advancing
 Labels are not advancing
Renatron® II 100 Controls and
Indicators
Description of Controls
 On
 Off
 Hold to Set
Set Knob
 Start Process
 Start Sanitize
 Mute
 Reset
 Display
Indicators
 Volume Display
 Program Step
 Clean
 Test
 Disinfect
 Process Complete
 Sanitize Complete
Error Messages
 Volume Fail- Step 35
 Pressure Fail- Steps 36, 38, or 39
 Add Chemical- Steps 9, 45, 67, or 77
 Tank Volume- Many steps throughout the program
 Alarm
 Interlock
Safety Features
 Tracks Preclean Dialyzers
 Tracks Maximum storage time
 Tracks Dialyzers that have not been
processed- Preprocessed and Dry Packs
 Information stored on hard drive
 Precautions for similar name patients
 Patient data and program settings are
password protected
Renatron® Storage
 Long term storage
 run machine through step 97 to
ensure fluid pathways are drained
 Box in Renatron® box
 Keep in low traffic area
Technical Service
 Telephone Support
24 hours a day 7 days a week
 1-800-328-3324
Press “2” for “Medical Equipment
Emergency” to get a live person
 Service
 Loaners available upon request
 Board exchanges for $200
 RMA’s must accompany all returns
Warranty / Promotions
 Warranty
 1 year warranty from date of install
 90 days for service warranty
 90 days for parts orders
 Promotions
 PM contracts
 Service contracts
Renalin® 100
Warnings




Corrosive.
Use universal precautions.
Can cause eye damage and skin irritation.
When handling Renalin®100, wear eye
protection, rubber gloves and protective
clothing.
 Do not mix Renalin®100 with alkaline
substances such as bleach.
Indications
Renalin® 100 Cold Sterilant is indicated for
the in vitro cleaning and sterilizing of hollow
fiber dialyzers with the RS8300 and RS8330
models of the Renatron® Dialyzer
Reprocessing System labeled for use with
Renalin®100. Renalin®100 Cold Sterilant also
may be used for disinfecting dialysis
equipment (e.g. kidney machines) and
supplies (e.g. port caps).
Contraindications
Renalin® 100 Cold Sterilant is not designed,
sold, or intended for use except as indicated.
Patients with known hypersensitivity to
hydrogen peroxide and/or peroxyacetic acid
should not be treated using dialyzers
reprocessed with Renalin® 100 Cold Sterilant.
Water Requirements
 AAMI quality water filtered to particle
size no larger than 1 micron
 Water temperature should be between
59-75° F
 Water Temperature may be up to 86° F if
the dialyzers are stored at the proper
temperature
Renalin®100 Storage
 Renalin®100 Storage
Upright
Never in direct sunlight
At temperatures between 32-75° F
Do not freeze
 Never tamper with the cap
 Never replace the vented cap with a
nonvented cap
Renalin® can be removed from the shipping
carton if it is not stored in direct sunlight
Renalin® 100
 Renalin® 100 replaces
Formaldehyde
Bleach and/or hydrogen peroxide
 Active ingredients
Hydrogen peroxide
Peroxyacetic acid
Acetic acid
 Renalin® 100 degrades quickly and will not harm
the environment. It breaks down into ; oxygen,
water, and acetic acid.
Renalin 100®
 Renalin® 100 is supplied in three different
volumes:
Quart bottles
2.5 gallon bottles that contain 2 liters of
Renalin® concentrate
1 gallon bottles containing 3 liters of Renalin®
100
Renalin® Nomenclature
Renalin® 100 Cold Sterilant is a 100%
Renalin® Solution.
Proportioned Renalin® - A 3.25% or 3.5%
Renalin® solution that is used to sterilize the
reprocessed dialyzer.
1% Renalin® solution- A solution made from
1 part Renalin® concentrate and 99 parts
AAMI quality water.
Renalin® Nomenclature
4% Renalin® solution is used to sanitize the
Renatron®
 2% Renalin® solution is used during the
preclean program
Auto
Dilutor
The On Demand™ Auto Dilution System
proportions Renalin® 100 Cold Sterilant
and dispenses a continuous supply of 1%
Renalin solution.
Shelf Life
Renalin® 100 has a shelf life of 1 year from
date of manufacture when properly stored.
Following dilution, Renalin® 100 exhibits a
gradual loss of potency at a rate such that
50% of the active ingredients remain after a
seven day period
Shelf Life
When diluting Renalin® Cold Sterilant to a
1% solution (e.g. port cap disinfection)
fresh Renalin® Cold Sterilant should be
used each time. Do not allow 1% Renalin®
solution to sit for longer than 24 hours.
Test Strips
 Perassay Test Strip
Simple go/no go test
Indicates a 1% Renalin® solution
Green stick for identification
Do not need to be refrigerated
Test Strips
 Residual Test Strip
 Color chart for interpreting test results
Do not need to be refrigerated
Verifies the proportioned Renalin® solution has
been properly rinsed from the dialyzer prior to
clinical use
Renalin® 100 Presence Test
(Perassay)
 Remove 1 ml of solution from the dialysate
port of the dialyzer
 Immerse the entire reaction pad of the Perassay
strip in the solution
 Shake off excess solution
 Read the reaction pad after 2-5 seconds. The
test strip should turn a blue/gray or blue/black
color. This will indicate 500 PPM of peracetic
acid 1% Renalin® solution.
Renalin® 100 Residual Test
Strips
 Turn off the blood pump and clamp the arterial
and venous blood lines adjacent to the access ends.
Separate the blood lines where the access ends are
joined and unclamp the venous blood line.
 Allow a few drops of saline to drip from the
venous line onto the residual test strip.
 After 5 seconds, shake the excess liquid from the
reaction zone and compare with the color scale on
the container.
 Per AAMI standards, a reading of less than 3 PPM
is acceptable
Handling and Storage of
Reprocessed Dialyzers
 If a dialyzer is foaming after being reprocessed it should
be reprocessed again without a use
 Store a reprocessed dialyzer in a cool, well ventilated
area that is shielded from any direct sunlight.
Recommended temperature range is 59-75° F
 A reprocessed dialyzer should not be used until a
minimum of 11 hours has elapsed
 After storage and before rinsing, both headers of the
dialyzers must be at least 2/3 full
Renalin® Spill
 Flush spill with large quantities of water
and also consult the handout “What to do if
Renalin® spills”
 After hours, contact Chemtrec for
emergency spill information at
800-424-9300 (202-483-7616 in the
Washington D.C. area)
Questions