-4-
Instruction Manual
Read this Manual and the
RENALIN
®
100 Cold Sterilant Instructions for Use prior to
using the RENATRON
®
II 100 Series Dialyzer Reprocessing System. Failure to follow the
instructions for use may result in injury.
Retain this manual for future reference.
CAUTION
- ONLY HOLLOW FIBER DIALYZERS SHOULD BE PROCESSED AS SPECIFIED IN THIS
MANUAL.
CAUTION
– U.S.A. FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON ORDER OF A
PHYSICIAN.
WARNING
THE RENATRON II 100 SERIES
SYSTEM IS INTENDED EXCLUSIVELY FOR IN
VITRO CLEANING, TESTING, AND DELIVERY OF PROPORTIONED RENALIN
®
100
SOLUTION TO THE DIALYZER AND RECORD KEEPING FOR THESE FUNCTIONS.
ANY SUBSEQUENT CLINICAL APPLICATION OR USE OF A HOLLOW FIBER
DIALYZER THAT HAS BEEN PROCESSED BY THE MACHINE IS THE SOLE
RESPONSIBILITY OF THE ATTENDING PHYSICIAN.
WARNING
A HOLLOW FIBER DIALYZER THAT IS PROCESSED ON THIS MACHINE IS
FILLED WITH A PROPORTIONED RENALIN 100 COLD STERILANT SOLUTION.
THE PROPORTIONED RENALIN
100 COLD STERILANT SOLUTION MUST BE
ADEQUATELY AND THOROUGHLY RINSED OUT OF THE DIALYZER PRIOR TO
CLINICAL USE.
The RENATRON II 100 Series Dialyzer Reprocessing System is indicated for the in vitro rinsing, cleaning, testing,
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 for use only with RENALIN
100 Cold Sterilant solution.
This device is not designed, sold, or intended for use except as indicated.
ADDITIONAL WARNINGS AND PRECAUTIONS THAT APPLY TO SPECIFIC PROCEDURES ARE FOUND IN
APPROPRIATE PLACES THROUGHOUT THIS MANUAL.
DANGER
—
EXPLOSION HAZARD
- DO NOT USE IN THE PRESENCE OF FLAMMABLE ANESTHETICS.
RISQUE D’EXPLOSION
– NE PAS EMPLOYER EN PRESENCE D’ANESTHESIQUES INFLAMMABLES.
FAILURE TO FOLLOW INSTRUCTIONS IN THIS MANUAL MAY RESULT IN PATIENT OR USER INJURY.
CAUTION
– DISCONNECT POWER SUPPLY CORD BEFORE SERVICING.
ATTENTION
: DEBRANCHER LE CORDON D’ALIMENTATION AVANT DE FAIRE LE DEPANNAGE
WARNING
GROUNDING RELIABILITY CAN ONLY BE ACHIEVED WHEN THIS DEVICE
IS CONNECTED TO A RECEPTACLE MARKED "HOSPITAL GRADE" OR
EQUIVALENT.
CAUTION
– IF THE DEVICE IS USED IN A MANNER NOT SPECIFIED BY THE MANUFACTURER, THE
PROTECTION PROVIDED BY THE DEVICE MAY BE IMPAIRED.
CAUTION
–
DO NOT
USE CHEMICALS OTHER THAN RENALIN 100 COLD STERILANT WITH THIS
MACHINE.
CAUTION
– WATER SUPPLIED TO THIS SYSTEM MUST MEET THE REQUIREMENTS LISTED IN
SECTION
5
SPECIFICATIONS. THE RS-8335 AND RS-8330 100 SERIES
DOES NOT
PERFORM WATER TREATMENT.
Indications
Contraindications
Warnings and
Precautions
