Gambro WRO 300, Operator'S Manual

Page 1: ...n action which if taken can cause a potential hazard and result in a serious adverse reaction injury or death A warning may also be used to alert the user operator to take a certain action to avoid th...

Page 2: ...he WRO 300 H will perform as designed only if it is used and maintained in accordance with Gambro s written instructions Any warranties made by Gambro with respect to the WRO 300 H are voided if the e...

Page 3: ...or storage time is more than 15 weeks the environmental data relating to the operation must be followed For the qualified technician the WRO 300 WRO 300 H Service Manual is available The Service Manua...

Page 4: ...rent Protective earth ground Warning consult accompanying documents Off power disconnection from the mains On power connection to the mains Type B applied part Handle with care This way up Keep dry Se...

Page 5: ...ion unit WRO 300 H contains toxic or hazardous substances or elements The figure 25 indicates the corresponding environmental protection use period of the water purification unit WRO 300 H Valid for M...

Page 6: ...mark indicates that the WRO 300 H water purification unit conforms to the requirements related to safety of medical devices for the US and Canada The C and the US adjacent to the CSA mark indicates t...

Page 7: ...acturer Gambro Lundia AB Box 10101 Magistratsv gen 16 SE 220 10 LUND Sweden Phone 46 46 16 90 00 Fax 46 46 16 96 96 www gambro com ULTRASIL is a trademark of Ecolab registered in several countries inc...

Page 8: ...WRO 300 H 8 HCEN12104 Rev 09 2010...

Page 9: ...tart 21 2 2 Stop 22 3 Regular maintenance 23 3 1 Heat disinfection and Low Flow Heat 23 3 1 1 Heat disinfection 24 3 1 2 Low Flow Heat 25 3 2 Chemical disinfection 26 3 2 1 Approved chemical disinfect...

Page 10: ...isinfection and Cleaning 45 4 3 Physical data 46 4 3 1 Materials in contact with product water 46 4 4 Environmental data 47 4 4 1 Electromagnetic environment 47 4 5 Safety 52 5 Troubleshooting 53 5 1...

Page 11: ...hemodialysis equipment used both in hospitals and in home environments in conjunction with appropriate pre and post treatment units as a part of a water treatment system designed to meet applicable re...

Page 12: ...eatures Simple user interface Automated Heat disinfection Chemical disinfection and cleaning modes Auto flush function during Standby periods to minimize stagnant water This manual for WRO 300 H inclu...

Page 13: ...yed Info The WRO continues in the current mode The message text will be displayed Alarm The WRO continues in the current mode The buzzer sounds flashes and the message text will be displayed Stop The...

Page 14: ...e previous run period It may be caused by several reasons such as incipient fouling degrada tion of the RO membrane or change in the feed water quality Conductivity alarm The clinic s predefined maxim...

Page 15: ...ase of a conductivity alarm set alarm and stop limits to the same value If in case of a conductivity alarm the intention is to allow for continued dialysis in order to finish the ongoing dialysis trea...

Page 16: ...r conductivity 100 S cm The limit should be set at least 5 lower than the initial value recorded at installation The Low rejection rate notification will be displayed when the WRO 300 H enters Standby...

Page 17: ...t the selected procedure SELECT or CHEM SELECT Press during the chemical intake procedure to pause Press during dwell period to initiate rinse Press to silence audible alarms Press to unlock the displ...

Page 18: ...disinfection Low Flow Heat or Cleaning is in progress Slow flash The automated Heat disinfection by time channels is activated only in Standby mode Medium flash The disinfection wand connector is ins...

Page 19: ...the user to take certain actions for example exchange cartridge in the pre filter When the reminder time expires the notification message will be displayed Further information of setting the Reminder...

Page 20: ...view will reappear automatically after 15 seconds It is also possible to return to the Main view by using either or to scroll through the alarm list and the operational data until Main view is display...

Page 21: ...ances are present in the feed water carbon filtration is required to remove these substances Severe patient injury may otherwise occur A test for total chlorine of the pretreated water must be per for...

Page 22: ...2 Stop Press until light goes out and the WRO 300 H goes to Standby mode NOTE If power failure occurs during operation mode the procedure contin ues in the same phase as when the power failure occurr...

Page 23: ...to ensure acceptable bacteriological quality of the product water according to the clinic s standards As a guideline Gambro recommends a minimum frequency of weekly Heat disinfection to ensure consis...

Page 24: ...Heat disinfection pro cedure An Active Cooldown is initiated Then the WRO 300 H goes to Standby More information of the settings of Active Cooldown refer to Service Manual NOTE The dialysis machine s...

Page 25: ...gether with Gambro Dialysis machines please refer to separate instructions for Low Flow Heat Procedure Follow the procedure Heat disinfection on page 24 In step 3 select LOW FLOW HEAT in the SELECT me...

Page 26: ...ml per disinfection cycle will be diluted to 3 solution of DIALOX disinfectant by the WRO 300 H MINNCARE Cold Sterilant Required amount 50 ml of concentrated disinfectant Example of test kit STERICHE...

Page 27: ...fection is in progress and what type of disinfectant is being used NOTE If power failure occurs during Chemical disinfection 404 RINSE REQUIRED is displayed when the WRO 300 H restarts also 401 REMOV...

Page 28: ...e open end of the disinfection wand into a container with sufficient amount of disinfectant refer to Approved chemical disinfectants on page 26 Check that the open end of the intake wand is below the...

Page 29: ...ore the intake phase is finished CAUTION The Chemical disinfection has to be restarted if alarm 406 INSUF FICIENT INTAKE has appeared Action Pause of chemical intake phase Press until light flashes To...

Page 30: ...aining time to complete the Chemical disinfection procedure is also displayed 14 When the Chemical disinfection program is completed the display will show PERFORM RESIDUAL TEST The indi cation will re...

Page 31: ...ips or methods 4 Confirm by pressing until light goes out Indication remains steady lit 5 Remove any tag indicating storage with disinfectant If detecting residuals If residuals are detected after sta...

Page 32: ...ution is fed into a device other than Gambro dialysis machines it is the user s responsibility to ensure that the connected device is compatible with Peracetic acid disinfectants and to establish the...

Page 33: ...200 ml of product water from the WRO 300 H This will result in a 2 solution in the WRO 300 H For procedure refer to Cleaning procedure on page 34 3 3 2 Alkaline cleaning Alkaline cleaning should be p...

Page 34: ...he WRO 300 H Indication will be steady lit and will flash 2 Collect a water sample from the product water line 3 The absence of cleaning chemical in the product water is confirmed if the pH is within...

Page 35: ...disconnected Preservation agents Use MEMSTOR and dissolve 100 ml in two liters of potable tap water Warm water 35 40 C speeds up dissolution Procedure 1 Follow the Chemical disinfection procedure refe...

Page 36: ...Check for complete rinse out The required rinse program in the WRO has been designed and validated to ensure complete rinse out of the preservation 1 Press until light goes on to start the WRO Indica...

Page 37: ...AL FLUSH will be displayed and will be lit 3 5 2 Auto flush During Standby Auto flush is regularly performed to exchange water in the WRO if enabled in preset Within specified inter vals the water cir...

Page 38: ...WRO 300 H 38 Regular maintenance HCEN12104 Rev 09 2010...

Page 39: ...insulated under the following conditions by Gambro recommended insulation shall be used the minimum feed water temperature is 10 C the minimum ambient temperature is 18 C Product water pressure 0 12...

Page 40: ...or order no W522001001 should be installed Feed Water Temperature 5 to 30 C Feed Water Quality Potable water should be used Particle filtration shall be used 5 m Carbon filtration shall be used if wat...

Page 41: ...OTE Air will move back and forth in this line because of the variation of the level in the tank Chemical intake The machine is designed to bring in disinfectant cleaning agent through the chemical int...

Page 42: ...CEN12104 Rev 09 2010 Temperature measurement Operating range 0 to 105 C Accuracy 4 C Reverse osmo sis module Membrane material Polyamide thin film composite Membrane configuration Spiral wound Membran...

Page 43: ...minimum 1 mm 220 240 V AC AWG 16 at 100 and 115 V AC Mains plug Continental Europe 230 V AC mains plug CEE 7 VII United Kingdom 230 V AC mains plug BS 1363 A Australia 240 V AC mains plug AS NZS 3112...

Page 44: ...h level min output voltage 5 0 V DC Low level max output voltage 5 0 V DC Max Current 5 mA DC External connector 8 pins REDEL green External equipment Accessory equipment connected to the WRO 300 H sh...

Page 45: ...s for Use for the specific disinfectant Cleaning agents The following cleaning agents may be administered via the chemical intake Citric acid P3 Ultralsil 10 Minnclean AC Minnclean TF Acetic Acid 5 Ot...

Page 46: ...h Max 205 mm Footprint 185 mm Internal fluid volume Approximately 3 5 litres excluding the product water loop Type Material Polymers PA Polyamide PEEK Polyetheretherketone PEI Polyetherimide PE Polyet...

Page 47: ...packing If transportation or storage time is more than 15 weeks the environmental data relat ing to the operation must be followed If condensation occurs when moving the equipment between locations wi...

Page 48: ...8 kV Air 6 kV contact 8 kV Air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Surge IEC 61000 4 5 1 kV for dif...

Page 49: ...kHz to 80 MHz 3 V Portable and mobile RF communi cations equipment should be used no closer to any part of the WRO 300 H including cables than the recommended separation distance calculated from the e...

Page 50: ...e phones 30 V m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey d should be less than the compli ance level in each frequency rangee Interference may occur i...

Page 51: ...transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz f 800 MHz to 3 GHz 0 01 0 11 0 11 0 23 0 1 0 37 0 37 0 74 1 1 2 1 2 2 3 10 3 7 3 7 7 4 100 12 12 23 Rated maxi mum output power of mobile phone 2W GS...

Page 52: ...field strength in the location in which the WRO 300 H is used exceeds the applicable RF compliance level above the WRO 300 H should be observed to verify normal operation If abnormal performance is ob...

Page 53: ...ifications Definition 101 CONDUCTIVITY SENSOR FAIL URE WRO 300 H Buzzer sounds with Alarm sound flashes message text is displayed Reason The initial conductivity system check failed Action 1 Press or...

Page 54: ...RO 300 H WRO 300 H stops buzzer sounds with Alarm sound flashes message text is displayed Reason Failure of level sensors in tank Action 1 Press or to silence buzzer 2 Check that no water has flooded...

Page 55: ...run period Action 1 Press or to silence buzzer 2 Perform cleaning according to local pro cedures 3 If problem persists notify technical per sonnel 202 CONDUCTIVITY ALARM WRO 300 H Buzzer sounds with A...

Page 56: ...f the problem persist 4 If problem persists discontinue dialysis 5 Notify technical personnel 204 INSUFFICIENT WATER SUPPLY WRO 300 H WRO 300 H stops flashes fast mes sage text is displayed Reason Lac...

Page 57: ...cation sound flashes message text is displayed Reason The product water flow is below the preset notification limit which indicates that the per formance of the membrane is reduced Action 1 Press or t...

Page 58: ...wer failure Action 1 Press or to silence buzzer 2 Press until light goes on The WRO 300 H either goes to Standby or an Active Cooldown 302 INSUFFICIENT WATER SUPPLY WRO 300 H WRO 300 H stops buzzer so...

Page 59: ...to silence buzzer 2 Activate Heat disinfection procedure manually Refer to Heat disinfection and Low Flow Heat on page 23 304 INCORRECT WATER LEVEL WRO 300 H WRO 300 H stops buzzer sounds with Alarm...

Page 60: ...O 300 H WRO 300 H stops buzzer sounds with Alarm sound flashes message text is displayed Reason Lack of feed water Action 1 Press or to silence buzzer 2 Check the feed water supply 3 Check for leakage...

Page 61: ...buzzer 2 Perform rinse by pressing until rinse starts 405 INCORRECT WATER LEVEL WRO 300 H WRO 300 H stops buzzer sounds with Alarm sound and flashes message text is displayed Reason Water level in tan...

Page 62: ...407 INSUFFICIENT TEMPERATURE WRO 300 H Buzzer sounds with Alarm sound flashes message text is displayed Reason The temperature during Warm acid cleaning has not reached above the presetted limit Actio...

Page 63: ...3 5 2 Boot loader This alarm indicate that the software is corrupt No Alarm and notifications Definition LOAD APPLICA TION FAILED WRO 300 H LOAD APPLICATION FAILED is shown on the display Reason Softw...

Page 64: ...WRO 300 H 64 Troubleshooting HCEN12104 Rev 09 2010...

Page 65: ...010 Check list 65 6 Check list Serial no Check conductivity with separate instrument Feed water Product water Reject Date Hours in operation Conductivity S cm Temp C Conductivity S cm Flow l min Flow...

Page 66: ...WRO 300 H 66 Check list HCEN12104 Rev 09 2010 Feed water Product water Reject Date Hours in operation Conductivity S cm Temp C Conductivity S cm Flow l min Flow l min Rejection rate Remarks...

Page 67: ...Central Chem 32 Cleaning 33 60 Acid 33 Alkaline 33 Complete rinse out 36 Conductivity Alarm 14 Monitoring 14 Notification 14 Stop 15 E Exterior cleaning 37 F Flash indications 18 H Heat disinfection 2...

Page 68: ...2104 Rev 09 2010 Rinse Preservation 36 T Technical data 39 Chemical disinfection and Cleaning 45 Environmental data 47 Performance and specification 39 Physical data 46 Safety 51 Troubleshooting 53 W...