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Instruction Manual

WARNING

THE  PROPORTIONED  RENALIN

®

 

  100  SOLUTION  CONTAINED  IN  THE 

REPROCESSED DIALYZER MUST BE ADEQUATELY AND THOROUGHLY RINSED 

OUT OF THE DIALYZER PRIOR TO ITS CLINICAL USE. THIS SHOULD BE DONE 

IN ACCORDANCE WITH THE INSTRUCTIONS SET FORTH IN THE RENALIN 100 

COLD STERILANT INSTRUCTIONS FOR USE (PART #50090-679).

B. 

Start Up

1.   Prior to the first use of day, 

wipe off the front panel of the RENATRON

®

 

 II 100 Series station

 with a  

  disposable wipe saturated with fresh 1% RENALIN 100 Solution or full strength ACTRIL

® 

Cold Sterilant.  

  Discard the used wipe.

2.  

Verify that the Calibration Cell is attached to the RENATRON II 100 Series Station

.

3.  

Turn on the water supply and check static water pressure reading

 (should be between 20-55 psi).

4.  

Verify that there is sufficient RENALIN 100 in the container

 to reprocess the dialyzer that will be 

installed on the RENATRON II 100 Series station in step D, below and that the RENALIN 100 Cold 

Sterilant is not expired. Approximately 1" of RENALIN 100 Cold Sterilant is required. Verify that the 

uptake hose is connected to the container.

5.  

Touch the "ON" switch and select program mode "00". 

a.   To change the program mode, simultaneously press 

"MUTE/ALARM" 

and

 "RESET".

b. 

"START PROCESS" 

will not initiate if "SEL" is displayed in the upper window. To clear, press 

"HOLD TO SET" 

and turn "SET" knob to 67.

6.   

Check dynamic water pressure

. In step 

4

, the dynamic pressure should optimally be between 30-35 psi.

7.  

Verify that the Calibration Cell volume displayed is within ± 3 ml of the recorded reference volume

.

8.  

Remove the Calibration Cell

.

9. 

Press "RESET."

Note – When calibrating the RENATRON II 100 using the RENALOG RM Dialyzer Reprocessing 

Management System, follow the calibration procedure outlined in the RENALOG RM User Guide (PN 

50090-859).

C. 

Remove the Dialyzer from the Extracorporeal Blood Circuit

 using standard facility protocols.

Note – Prior to removing the dialyzer from the extracorporeal circuit, the operator must ensure that all 

identification and information on the dialyzer is legible and current before proceeding.

WARNING

THE OPERATOR SHOULD WEAR PROTECTIVE EYEWEAR, GLOVES, AND OTHER 

PROTECTIVE CLOTHING. FOLLOW UNIVERSAL SAFETY PRECAUTIONS FOR 

DEALING WITH BLOOD CONTAMINATED DEVICES.

 

CAUTION

 – THE TIME INTERVAL BETWEEN REMOVING THE  DIALYZER FROM THE EXTRACORPOREAL 

CIRCUIT AND REPROCESSING IT SHOULD BE KEPT WITHIN THE LIMITS PRESCRIBED BY THE PHYSICIAN. 

THE SUGGESTED MAXIMUM TIME INTERVAL IS TWO (2) HOURS.

D. 

Installation of the Dialyzer on the RENATRON II 100 Series station

.

1.  Remove the blood port cap from the venous blood port of the dialyzer.

2.   Wipe the venous blood port with a wipe saturated with 1% RENALIN 100 Cold Sterilant Solution or full 

strength Actril Cold Sterilant and attach a disinfected reprocessing connector.

3.   Attach the RENATRON II 100 venous outlet line to the reprocessing connector attached to the venous port of 

the dialyzer. 

4.  Connect the dialyzer dialysate inlet to the RENATRON II 100 dialysate inlet.

5.  Connect the dialyzer dialysate outlet to the RENATRON II 100 dialysate outlet/sanitize interlock.

6.  Remove the blood port cap from the arterial blood port.

7.  Wipe the arterial blood port with a wipe saturated in 1% RENALIN 100 Cold Sterilant Solution or full strength 

Actril Cold Sterilant and attach a disinfected reprocessing connector.

8.  Attach the RENATRON II 100 Series station arterial inlet line to the reprocessing connector attached to the 

arterial blood port of the dialyzer. Dialyzer placement should be vertical to the RENATRON II 100 Series 

station.

Summary of Contents for MEDIVATORS renatron II 100 Series

Page 1: ...100 Series Dialyzer Reprocessing System INSTRUCTION MANUAL MODEL RS 8330 RS 8335 100 Series...

Page 2: ...IN PERASSAY ACTRIL and ON DEMAND are registered trademarks of Medivators Inc Formula 409 is a registered trademark of the Clorox Company 50096 725 Rev D 2015 Medivators Inc Printed and Assembled in th...

Page 3: ...tions 12 8 Computer Installation Instructions 16 9 Daily Machine Sanitize Procedure 17 10 Operating Procedures 17 11 Bar Code Scanner Procedures 23 12 Storage and Handling for Reprocessed Dialyzers 24...

Page 4: ...and delivery of proportioned RENALIN 100 Cold Sterilant solution to hollow fiber dialyzers It is also indicated for record keeping of these functions The RENATRON II 100 Series system is indicated fo...

Page 5: ...TION THE OPERATOR SHOULD BE FAMILIAR WITH THE SAFE HANDLING TECHNIQUES FOR THE MACHINE AND THE RENALIN 100 COLD STERILANT AND WITH THE RECOMMENDED FIRSTAID PROCEDURES IN CASE OF CONTACT WITH OR EXPOSU...

Page 6: ...tem for rinsing cleaning and testing of hollow fiber dialyzers and for delivery of Proportioned RENALIN 100 Cold Sterilant solution to the dialyzers The RENATRON II 100 Series System can also perform...

Page 7: ...dialyzer measured priming volume may differ from advertised volume by as much as 20 It is recommended that the operator measure new dialyzer volume with a known calibrated RENATRONII 100 Series to det...

Page 8: ...nstruction Acrylic PVC ABS Polypropylene Delrin Ethylene Propylene Viton Rubber Stainless Steel B Electrical Leakage Current risk current Each RENATRON II 100 Series is allowed a leakage current less...

Page 9: ...3 cm Weight 3 2 lbs 1 5 kg 4 Report Printer approximately Width 17 7 inches 50 cm Depth 14 6 inches 37 cm Height 5 7 inches 15 cm Weight 11 7 lbs 5 3 kg 5 Monitor LCD approximately Width 14 8 inches 3...

Page 10: ...e RENATRON station will perform a header leak test between program Step 2 and 3 If a Pressure Fail message appears in Step H 2 verify that the blood port connections are secure and that the dialyzer h...

Page 11: ...display to SEL Reset must be used at the end of a cycle or in an alarm state locked out or disabled at all other times to guarantee automatic transfer of reprocessing data to the computer 7 DISPLAY sw...

Page 12: ...er to the respective manuals for detailed information about the computer monitor and printer controls and indicators IMPORTANT TO ISOLATE THE STATION FROM THE ELECTRICAL SUPPLY YOU MUST DISCONNECT THE...

Page 13: ...13 Instruction Manual Figure 1 RS 8335...

Page 14: ...14 Instruction Manual Figure 2 RS 8330...

Page 15: ...he water pressure gauge block to the back of the drip tray using the screws provided Be absolutely certain that no water leaks exist and all connections are secure G Connect the dialysate line quick d...

Page 16: ...the computer manufacturer s manual for instructions for connecting the monitor keyboard and mouse G Power on sequence of computer system 1 Printer s 2 Monitor 3 Computer 4 Interface module 5 RENATRON...

Page 17: ...UP THE RENALOG RM PROGRAM BEFORE NORMAL ONLINE USE OF THE SYSTEM IS ATTEMPTED THERE IS A SEPARATE RENALOG RM INSTRUCTION MANUAL P N 50090 859 A General Considerations and Cautions CAUTION MEDIVATORS S...

Page 18: ...100 SERIES COMM PORT 2 RENATRON II 100 SERIES COMM PORT 5 RENATRON II 100 SERIES COMM PORT 3 RENATRON II 100 SERIES COMM PORT 6 RENATRON II 100 SERIES COMM PORT Port 6 Port 5 Port 4 SCANNER Port 3 Por...

Page 19: ...rocessing Management System follow the calibration procedure outlined in the RENALOG RM User Guide PN 50090 859 C Remove the Dialyzer from the Extracorporeal Blood Circuit using standard facility prot...

Page 20: ...screen of the RENALOG RM Program when the green light is illuminated on interface module scan the bar code label on the dialyzer to be reprocessed scan the bar code label on the RENATRON II 100 Serie...

Page 21: ...e a supply of disinfected port caps Disinfection of the dialysate port caps blood port caps and the reprocessing connectors from the dialyzer can be achieved by one of the following ways a Place the c...

Page 22: ...ble waterproof or permanent ink or other indelible marking systems to label the dialyzer is recommended when the RENATRON II 100 Series station is operated without RENALOG RM In the automaticmode thei...

Page 23: ...bar code and the gun should be held 6 to 9 inches from the bar code 2 With a straight vertical motion move the scanner down over the label so that the red beam passes over the bar code The illustratio...

Page 24: ...TION EXPOSING DIALYZERS TO CYCLIC TEMPERATURE DIFFERENCES DURING ANY PART OF THE REUSE PROCEDURE MAY RESULT IN INCREASING OR INITIATING PRESSURE BUILDUP IN THE DIALYZER DURING STORAGE IN THESE CONDITI...

Page 25: ...ss ON switch SEL and will be displayed 4 Press and hold the SETUP switch S3 on the microprocessor board for 4 seconds until you hear the second chirp The PROGRAM STEP will display c1 and CAL will be d...

Page 26: ...inue operating until it enters PROGRAM STEP 14 23 Press the OFF switch 24 Verify that the liquid level in the tank is at the 507 reference line upper tank scribe line 25 If the liquid level is above o...

Page 27: ...TS DO NOT USE BLEACH C Formula 409 Service Cleaning Procedure The internal fluid pathways must be cleaned periodically typically once every two weeks or as required as outlined below RENATRONII100Seri...

Page 28: ...ess the OFF switch and turn the water supply to the machine off Leave the machine overnight Wait at least 8 hours 14 Remove the uptake tube from the container of Formula 409 and make sure any excess F...

Page 29: ...e hose and replaces it with Formula 409 9 Press ON select program 00 press the START SANITIZE switch Allow the machine to continue operating to the SANITIZE COMPLETE message in PROGRAM STEP 83 10 Pres...

Page 30: ...t a sample from the calibration cell for a culture of water from the RENATRON station b After the sample has been collected press the RESET switch The RENATRON II 100 Series Station is now ready for c...

Page 31: ...ATORS Renal Technical Support for the appropriate packing and shipping instructions Do not ship any part of the RENATRON II 100 Series system to MEDIVATORS without first notifying the Renal Technical...

Page 32: ...Inspect Reprocessing Connections X X X X Inspect RENALIN 100 Uptake X X Tubing Assembly Inspect valve Assembly Large Small X V15 Inspect Hydraulic Compartment for X any signs of fluid leakage Test Jet...

Page 33: ...ive Products or any parts it deems defective or ii a refund of the purchase price This will be customer s exclusive remedy for a covered defect In order to recover under the warranty the customer must...

Page 34: ...Fuse Location Note Parts service and a service manual with drawings parts lists circuit diagrams are available on request from MEDIVATORS Renal Technical Support Explanation for Symbols Technical Supp...

Page 35: ...ing Management Software 78398 192 RENALIN Residual Test Strips 78198 000 PERASSAY 500 Peracetic Acid Test Strips 78378 000 Dialyzer Dialysate Port Caps Red 78196 010 100 Ventable Dialyzer Dialysate Po...

Page 36: ...729 Medivators BV Sourethweg 11 6422PC Heerlen The Netherlands Tel 31 45 5 471 471 Cantel Medical Asia Pacific Pte Ltd 1A International Business Park 05 01 Singapore 609933 Tel 65 6227 9698 Cantel Med...

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