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Operation Manual - Central Medical Supplies

1. 51 3 9 OPERATING THE BLANKETROL III SYSTEM IN GRADIENT VARIABLE SMART MODE 54 3 10 OPERATING THE BLANKETROL III SYSTEM IN MONITOR ONLY MODE 56 3 11 CONCLUDINGHYPER HYPOTHERMIA TREATMENT rennen 57 3 12 STATUS DISPLAY MESSAGES beret ee ate eie periere ded 58 SECTION 4 GENERAL MAINTENANCE OF THE BLANKETROL III SYSTEM e eeeceeeetene 65 4 1 INTRODUCTION 35 m npe ingen aint nane cloni iena 65 4 2 MAINTENANCE OF THE WATER RESERVOIR ei 67 4 2 1 Draining the Reservoir iii 69 4 3 MAINTENANCE OF THE WATER FILTER iii 71 4 4 MAINTENANCE OF THE CONDENSER AND GRILL eee 72 4 5 MAINTENANCE OF THE BLANKETROL III EXTERIOR CLEANING INSTRUCTIONS 73 Page 7 of 84 OPERATION MANUAL BLANKETROL III MODEL 233 4 6 MAINTENANCE OF THE HYPER HYPOTHERMIA BLANKETS n 73 4 61 Reusable Blanket oe uc e Mte ibt E dete Eine 73 4 6 2 Disposable Single Patient Use Blankets eese eene eene eren 73 4 7 MAINTENANCE OF REUSABLE THERMISTOR PROBES 74 SECTION 5 SPECIFICATIONS AND CERTIFICATIONS OF THE BLANKETROL III 77 WORLDWIDE ORDER PLACEMENT cscsssssssssssscssssscsscsssnessssnessesssssessssssssssenessssncssessssssssssssossessnessesnesooses 82 FIGURES AND TABLES FIGURE 1 1 BLANKETROL FRONT
2. teo bete ee o ica aaa agi 9 IN WARRANTY REPAIR AND PARTS 9 RECEIVING INSPECTION vitnene NENESE EENEN 9 IMPORTANT SAFETY INFORMATION ocrerrrrerrerere este reziario re statu stas ie nio nin ee nio nin 9 SECTION 1 INTRODUCTION ocrsrrrrrrerrreeezeseezenzeseenenzeseen eee ne 10 1 0 GENERAL SAFETY PRECAUTIONS ie 10 1 1 GENERAL DESCRIPTION OF THIS MANUAL ie 10 1 2 GENERAL DESCRIPTION OF THE BLANKETROL III SYSTEM eene 10 1 3 PHYSICAL DESCRIPTION OF THE BLANKETROL III UNIT eene 12 1 3 External Eeatures s Front View ete ted tede tee P dee iie Pr odere 12 1 3 2 External Features Right Side View 14 1 3 3 External Features Rear VieW iii 16 1 3 4 Description of the Blanketrol III Membrane Control Panel eee 18 1 4 REQUIRED ACCESSORIES np e dee e dede ttes 20 1 5 FUNCTIONAL DESCRIPTION OF THE BLANKETROL III SYSTEM eee 20 12513 Theory of Operation ati 20 La 2 Heating System E te ete ete eta E ee EE 22 123 3 2 Cooling SySIem 55 uh ote iret bt ote EL ha 22 1 5 5 Temperature Safety Control System sse neret treten ene
3. IEC 60601 test level Compliance level Electromagnetic environment guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz 3 Vrms 3 Portable and mobile RF communications equipment should be used no closer to any part of the Blanketrol III Model 233 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 1 2 P 1 21 80 MHz to 800 MHz d 2 3NP 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol 1 NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from Structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcas
4. For Single Patient Use MAXI THERM and MAXI THERM LITE blankets dispose of the blanket per hospital institution policy protocol 3 12 STATUS DISPLAY MESSAGES The Status Display located in the center of the BLANKETROL III unit membrane control panel reports the operating status of the unit or indicates changes the operator must make The Status Display can show different messages to guide the operator The following list defines each message and describes the changes if any the operator must make Note that in the list below the symbol x is used to indicate a numerical digit that can change based on measurements or operator actions and Y is used when C or F would be displayed depending on the temperature scale in use A During normal operation in MANUAL CONTROL MODE the Status Display shows the following messages Status Display Message Function This message is displayed on the left side of the bottom line and indicates MANUAL that the BLANKETROL III is operating in MANUAL CONTROL MODE represents Temperature and Y represents Centigrade or SETPT xx xY Fahrenheit This message is displayed on the right side of the bottom line and indicates the desired current Set Point temperature for the water in the Blanketrol Ill equipment with appropriate temperature scale HEATING WATER This message is displayed on the top line when the BLANKETROL III is heating the circulating water COO
5. Press the MANUAL CONTROL button 1 The microprocessor board beeps Page 33 of 84 OPERATION The preceding BLANKETROL III Model 233 OPERATION MANUAL 2 The LED in the corner of the button illuminates 3 The WATER display shows the temperature of the water in the reservoir 4 The PATIENT display shows the temperature reading of the probe as it is held by the operator if the probe reading is in the range of 10 C 50 C 50 122 5 The Status Display shows either XXXXXX WATER MANUAL SETPT 37 0 C Or Status Display shows WATER QSETPT MANUAL SETPT 37 0 C represents HEATING or COOLING The above depends upon the relationship of the blanket water temperature to the Set Point temperature Note that the Set Point may be displayed in Fahrenheit 6 The pump is activated 7 The heater or compressor may be activated 8 The water flow indicator on the right side panel begins to move step is included to show that the patient display illuminates when the probe is connected and the system is in the MANUAL CONTROL MODE as well as when the system operates in any of the Automatic Modes AG AH AI AJ AK Press TEMP SET button 1 The microprocessor board beeps 2 The LED in the corner of the button illuminates 3 The Status Display returns to set temperature mode To complete this test routine turn the power switch off 1 The membrane control panel goes blank 2 The green light
6. 151 Ibs 68 5kg Cabinet Construction Powder coated steel with plastic top Divided reservoir Bottom air discharge Built in handle Bumper guard Storage Compartment Two 4 conductive 360 swivel type casters and two 4 non conductive 360 swivel type locking casters Ambient Temperature during use 15 C 30 59 F 86 F Maximum Contact Surface Temperature 41 C 105 8 F THERMAL SYSTEM Compressor 1 3 HP Heater 800 Watts NOTE Maximum expected heating capability approximately 3 C 5 4 F per minute Maximum expected cooling capability approximately 5 5 C 9 9 F per minute Time to heat from 20 C to 37 C is approximately 12 minutes with a blanket attached CIRCULATING SYSTEM Divided Compartment Reservoir 2 gallon 7 liters total capacity Error proof quick disconnect couplings ELECTRICAL SYSTEM Electrical Characteristics 115V 10 60Hz 10 2 Amps 230V 10 50Hz 5 2 Amps Power Cord 14 3 SJT 115V Hospital grade plug Standard European Cord 230V Leakage Current Under 300 115 Under 500 ua 230 Circuit Breaker In Power Switch Mains Isolation Two Pole Mains Switch High Limit Safety 44 09 2 00 111 2 F 3 6 High Limit Secondary Back up Safety 44 0 C 2 0 111 2 F 3 6 F Thermostatic Snap Disc 46 0 C 2 0 C 114 8 F 3 6 F Minimum Low Control Setting 4 0 C 39 2 Low Limit Safety 2 0 2 0 C 35 6 F 3 6
7. Biomedical Electronics Technicians or Certified Clinical Engineers can reset the 500 hour counter after preventative maintenance has been performed To reset the PM Required alarm simultaneously press the SILENCE ALARM Decrement and Increment buttons TOTAL HOURS This message displays the total hours of operation To display this message simultaneously press the Increment and Decrement buttons HOURS UNTIL SERVICE This message displays the total number of hours of operation until the next required PM To display this message simultaneously press SILENCE ALARM and TEMP SET buttons Note 1 Maintenance should be performed at least quarterly or when indicated by 500 hour PM notification whichever occurs first 2 Only qualified Medical Equipment Service Technicians Certified Biomedical Electronics Technicians or Certified Clinical Engineers can reset the Hours Until Service hour counter after preventative maintenance has been performed To reset the HOURS UNTIL SERVICE hour counter back to 500 simultaneously press the SILENCE ALARM Decrement and Increment buttons UNDER TEST This message is displayed while the unit is under test during preventative maintenance Page 64 of 84 MAINTENANCE BLANKETROL III Model 233 OPERATION MANUAL SECTION 4 GENERAL MAINTENANCE OF THE BLANKETROL III SYSTEM 4 1 INTRODUCTION This section describes the general requirements maintenance personnel should complete
8. OPERATION MANUAL 4 2 MAINTENANCE OF THE WATER RESERVOIR The dual compartment reservoir holds approximately 2 gallons 7 5 liters of distilled water that remains in the unit between periods of use Quarterly the water reservoir should be drained and replenished The drain hose included in the packaging of the unit is attached and the water is pumped out of the unit When the LOW WATER alarm sounds the remaining water is drained by gravity Distilled sterile distilled water or distilled water bacteriostatic agent preparation is then poured into the reservoir NOTE DO NOT USE DE IONIZED WATER OR ALCOHOL Quarterly at a minimum the FLUID CIRCUIT DISINFECTION DRY STORAGE PROCEDURE listed below should be conducted CAUTION For safe handling and use of chemicals follow manufacturer guidelines Users should not use cleaning or decontamination methods different from those recommended by CSZ without first checking with CSZ that the proposed methods will not damage the equipment Always drain the BLANKETROL III to a sanitary drain because bio contaminants may be present in the unit s water supply Chemical Cleaning Circulation Chart UNIT MODE TEMPERATURE DURATION Blanketrol 233 Heating 38 C 5 Minutes FLUID CIRCUIT DISINFECTION DRY STORAGE PROCEDURE for Circulating Water Units Utilizing Household Bleach The required tools supplies Drain hose s and or hose connector s hous
9. The WATER display shows the temperature of the water in the reservoir The Status Display shows XXXXXX PATIENT AUTO SETPT 37 0 C Or Status Display shows PATIENT SETPT AUTO SETPT 37 0 C AB ou XXXXXX represents HEATING or COOLING The above depends upon the relationship of the blanket water temperature to the Set Point temperature Note that the Set Point may be displayed in Fahrenheit 5 The pump is activated 6 The heater or compressor may be activated 7 The water flow indicator on the right side panel begins to move The water moves from the unit through the blanket and returns to the unit 8 System operates in AUTO CONTROL mode W Press TEMP SET button 1 The microprocessor board beeps 2 The LED in the corner of the button illuminates 3 The Status Display returns to set temperature mode Page 31 of 84 OPERATION BLANKETROL III Model 233 OPERATION MANUAL X Press GRADIENT 10C button The microprocessor board beeps The LED in the corner of the button illuminates The WATER display shows the temperature of the water in the reservoir The Status Display shows XXXXXX PATIENT AUTO SETPT 37 0 C Or Status Display shows PATIENT SETPT AUTO SETPT 37 0 C Pons XXXXXX represents HEATING or COOLING The above depends upon the relationship of the blanket water temperature to the Set Point temperature Note that the Set Point may be displayed in Fahrenheit 5 The pump is activa
10. 107 6 F As in all cases the patient s skin integrity must be closely monitored NOTE SMART MODE can be used while operating in GRADIENT 10C MODE or GRADIENT VARIABLE MODE SMART MODE can be turned on and off at will and is indicated as such by the green LED next to tte SMART MODE button As in all cases the patient s skin integrity must be closely monitored In MONITOR ONLY MODE the BLANKETROL III System can monitor and display the patient s temperature within the following range 10 C 50 0 C 50 F 122 F In order to for this mode to function the operator must insert or attach a 400 Series probe in or to the patient and connect the probe probe connecting cable to the BLANKETROL III unit In this mode the system does not heat cool nor circulate the water NOTE Disposable Temperature Probes amp Associated Probe connecting cables for use with Disposable Temperature Probes can be found on Table 4 2 1 5 2 Heating System The BLANKETROL III heating system consists of an immersion heater water temperature control and three high temperature safety devices Temperature ranges are described in Section 1 5 5 The immersion heater is located in the circulating reservoir The water circulating in the reservoir flows around the immersion heater and is warmed The heating system is operational whenever the control system calls for an increase in the temperature of the water in the Blanketrol III equipment It is important to n
11. 4 GRADIENT VARIABLE MODE 5 GRADIENT VARIABLE SMART MODE The BLANKETROL III System can also be used solely to monitor the temperature of the patient MONITOR ONLY MODE The Blanketrol Ill is intended for use in ambient temperatures of 15 C 30 C 59 F 86 F The maximum contact surface temperature expected is 41 C 105 8 F The recommended blanket s for use are described in Table 4 2 Page 11 of 84 INTRODUCTION BLANKETROL III Model 233 OPERATION MANUAL 1 3 PHYSICAL DESCRIPTION OF THE BLANKETROL III UNIT See Section 5 for specifications and certifications of tte BLANKETROL III 1 3 1 External Features Front View The external features in Figure 1 1 of the BLANKETROL III unit are described as follows A The control panel is composed of pressure sensitive touch switches nine LED indicators a liquid crystal display and two LED displays An expanded description of the membrane control panel is presented in Section 1 3 4 The recessed handle permits the operator to grip the unit when moving it The power switch is a bevel rocker switch labeled I on at the top and O off at the bottom The switch illuminates green when the unit is on A circuit breaker is built into the switch to protect against overload conditions The storage drawer tilts out from the top to provide storage space for items such as probes connecting cables connecting hoses the drain hose and the Operator s M
12. Point temperature in the Status Display changes J Press the GRADIENT VARIABLE button 1 The microprocessor board beeps 2 The LED in the corner of the switch illuminates 3 The PATIENT display shows the patient s actual temperature 4 The WATER display shows the actual temperature of the water in the Blanketrol Ill equipment 5 The Status Display shows XXXXXX PATIENT AUTO SETPT 37 0 C Or Status Display shows PATIENT SETPT AUTO SETPT 37 0 C XXXXXX represents HEATING or COOLING The above depends upon the relationship of the blanket water temperature to the Set Point temperature Note that the Set Point may be displayed in Fahrenheit 6 The pump is activated The heater or compressor may also be activated 7 The Water Flow indicator on the right side panel begins to move 8 The water moves from the unit to the blanket and returns to the unit K Press the SMART key 1 The microprocessor board beeps Page 55 of 84 OPERATION BLANKETROL III Model 233 OPERATION MANUAL 2 The LED on the SMART button illuminates L Check the water flow indicator to confirm that the water is circulating M Touch the hyper hypothermia blanket to confirm that the blanket is heating cooling N To make any changes in the control settings press the TEMP SET button and begin again The BLANKETROL III System is now operating in GRADIENT VARIABLE SMART MODE You should continue to monitor the system and the patient Rev
13. VIEW eee ne cene ene ze 13 FIGURE 1 2 BLANKETROL III RIGHT SIDE VIEW eee cene ne ne ceci 15 FIGURE 1 3 BLANKETROL REAR VIEW iene nananana nane zi ecc eee eene 17 FIGURE 1 4 A BLANKETROL III MEMBRANE CONTROL PANEL 115 VAC UNITS 19 FIGURE 1 4 B BLANKETROL III MEMBRANE CONTROL PANEL 230 VAC UNITS 20 FIGURE 4 1 BLANKETROL III MAINTENANCE CHECKLIST i 66 FIGURE 4 2 BLANKETROL EXPOSED REAR VIEW eee 75 TABLE 4 2 BLANKETROL III SYSTEM ACCESSORIES ei 76 TABLE 5 1 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMMISSIONS hende eiusd RO e Rd i alii li 79 TABLE 5 2 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNIDY hse EREE atat ate aate eat ous 79 TABLE 5 3 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNIEDY ai ie ino NAW sah bia al alnelaland lla eee e les 80 TABLE 5 4 RECOMMENDED SEPARATION DISTANCE BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE BLANKETROL III MODEL 233 81 Page 8 of 84 TECHNICAL HELP BLANKETROL III Model 233 OPERATION MANUAL TECHNICAL HELP United States and Canada Telephone 1 513 772 8810 Cincinnati Sub Zero Products Inc Toll Free 1 800 989 7373 12011 Mosteller Road Fax 1 513 772 9119 Cincinnati OH 45241 www cszmedical com AUT
14. and blankets pads Page 10 of 84 INTRODUCTION BLANKETROL III Model 233 OPERATION MANUAL BLANKETROL III Model 233 The CSZ BLANKETROL III Model 233 Hyper Hypothermia System is used to lower or to raise a patient s temperature and or maintain a desired patient temperature through conductive heat transfer The CSZ BLANKETROL III unit is composed of a heater a compressor a circulating pump and a microprocessor This unit requires no field adjustments or calibrations in order to maintain the precise board measurement of temperature and temperature limits Distilled water is heated or cooled and pumped from the unit to a blanket The blanket rests under and or on top of the patient and is designed so that the water circulates through the blanket and returns to the unit If water that is at a lower temperature than the patient s temperature is circulated through the blanket the desired effect is to reduce the patient s temperature If water that is at a higher temperature than the patient s temperature is circulated through the blanket the desired effect is to elevate the patient s temperature The BLANKETROL III unit can be set so that it operates based on the temperature of the water in the Blanketrol IIl equipment MANUAL CONTROL MODE or it can be set so that it operates based upon the patient s temperature Automatic Modes The five Automatic modes include 1 AUTO CONTROL MODE 2 GRADIENT 10C MODE 3 GRADIENT 10C SMART MODE
15. discontinued The drift may be greater if the patient has been shivering and treatment is abruptly discontinued The operator should continue to monitor the patient s temperature To do so the operator may choose to operate the system in MONITOR ONL Y MODE as described in Section 3 10 To change the mode of operation or to stop the unit the operator must press the TEMP SET button or turn the power switch to the O position The operator can go directly to MONITOR ONLY MODE from any of the control modes by pressing the MONITOR ONLY button When the hyper hypothermia therapy is concluded and the unit is turned off A Permit the blanket s and hose to remain connected to the unit for about ten minutes This allows some of the water to drain back into the unit B Remove the probe from the patient and 1 4 inch receptacle Maintenance of the REUSABLE probe is described in Section 4 7 C Disconnect the power cord from the power source loosely coil it and attach it to the back panel using the nylon strap D Disconnect the connecting hose from the unit and store in the front storage drawer Page 57 of 84 OPERATION BLANKETROL III Model 233 OPERATION MANUAL E Remove the blanket s F For reusable PLASTIPAD blankets loosely coil the hose lengthwise in the center of the blanket Fold the blanket lengthwise into the center 1 3 from the left side and 1 3 from the right side Maintenance of the blanket is described in Section 4 6
16. etc B The BLANKETROL III unit is equipped with a circuit breaker in the I O on off power switch to protect against current overload 2 5 PATIENT PREPARATION AND BEDSIDE CARE Effective use of the BLANKETROL III System must include proper patient care prior to and while using the hyper hypothermia blanket s Page 35 of 84 OPERATION BLANKETROL Ill Model 233 OPERATION MANUAL WARNING e A physician s order is required for setting blanket temperature and use of equipment At least every 20 minutes or as directed by physician check patient s temperature and skin integrity of areas in contact with blanket also check the Blanketrol III s water temperature Pediatric patients temperature sensitive patients with vascular disease surgical patients diabetics and patients with Raynaud s Disease should be checked more frequently Notify the physician promptly of any change in patient status in order to avoid serious injury or death e The method of temperature control provided by all hyper hypothermia units presents the danger of heating or cooling body tissues particularly the skin to a point where they are injured i e burns or frostbite respectively Depending on the extent and severity of a burn very serious and even fatal complications may arise e Prevent excessive and or prolonged tissue pressure and shearing forces especially over bony prominences Failure to do so may result in tissue injury e Do not pla
17. heater or compressor may also be activated Page 50 of 84 OPERATION BLANKETROL Ill Model 233 OPERATION MANUAL 7 The water flow indicator on the right side panel begins to move 8 The water moves from the unit to the blanket and returns to the unit Press the SMART key 1 The microprocessor board beeps 2 The LED on the SMART button illuminates J Check the Water Flow indicator to confirm that the water is circulating Touch the hyper hypothermia blanket to confirm that the blanket is heating cooling L To make any changes in the control settings press the TEMP SET button and begin again The BLANKETROL III System is now operating in GRADIENT 10C SMART MODE You should continue to monitor the system and the patient Review the suggestions for patient care described in Section 2 5 If at any time the Status Display shows a message other than the messages described in GRADIENT 10C SMART MODE procedures make the changes indicated by the display and or consult the list of display messages in Section 3 12 If at any time the unit sounds an alarm and the Status Display flashes a message make the changes indicated To turn off the unit or discontinue hyper hypothermia treatment proceed as described in Section 3 11 NOTE IN ORDER TO CHANGE FROM GRADIENT 10C SMART MODE ANOTHER CONTROL MODE FIRST PRESS THE TEMP SET BUTTON AND THEN SELECT THE OPERATING MODE OF CHOICE In order to change from GRADIENT 10C SMA
18. microprocessor board goes through self test 3 The Status Display flashes CHECK SETPT D Press the MONITOR ONLY button Page 56 of 84 OPERATION BLANKETROL III Model 233 OPERATION MANUAL 1 The microprocessor board beeps 2 The LED in the corner of the button illuminates 3 The Patient display shows the patient s temperature 4 The Status Display indicates MONITOR ONLY and the selected temperature scale E To make any changes in the control settings press the TEMP SET button and begin again The BLANKETROL III System is now operating in MONITOR ONLY MODE If at any time the Status Display shows a message other than the messages described in MONITOR ONLY MODE procedures make the changes indicated by the display and or consult the list of display messages in Section 3 12 If at any time the unit sounds an alarm and the Status Display flashes a message make the changes indicated To turn off the unit or discontinue hyper hypothermia treatment proceed as described in Section 3 11 NOTE IN ORDER TO CHANGE FROM MONITOR ONLY MODE TO ANOTHER OPERATING MODE FIRST PRESS THE TEMP SET BUTTON AND THEN SELECT THE OPERATING MODE OF CHOICE 3 11 CONCLUDING HYPER HYPOTHERMIA TREATMENT After the patient temperature reaches the prescribed temperature for the prescribed amount of time discontinue the use of the BLANKETROL III System as ordered Patient s temperature can drift up or down 5 C 1 F after therapy has been
19. of the 400 Series probe in or on the patient B Connect the probe to the 1 4 inch receptacle on the right side of the unit C Press the power switch to the I position 1 The switch illuminates green 2 The microprocessor board goes through self test 3 The Status Display flashes CHECK SETPT D Consult the physician s orders to determine the desired patient Set Point temperature As a safety precaution the desired patient Set Point can only be set between 30 40 C 86 F 104 F to operate in GRADIENT 10C MODE E Use the C F button to choose the desired temperature scale F Press the TEMP SET button 1 The microprocessor board beeps 2 The LED in the corner of the switch illuminates 3 The Status Display shows a temperature Set Point G Press the Up arrow or Down arrow to change the Set Point temperature on the Status Display to the desired patient temperature The display can only be set between 30 C 40 C 86 F 104 F Page 54 of 84 OPERATION BLANKETROL III Model 233 OPERATION MANUAL 1 The microprocessor board beeps 2 The Set Point temperature in the Status Display changes H Press the GRADIENT VARIABLE button 1 The microprocessor board beeps 2 The LED in the corner of the button illuminates 3 The Status Display shows a gradient variable Press the Up arrow or Down arrow to change the gradient variable offset to the desired value 1 The microprocessor board beeps 2 The Set
20. on a regular basis so that the BLANKETROL III System continues to operate within the manufacturers allowable tolerances These requirements include changing and replenishing the water in the reservoir cleaning the water filter the exterior of the unit the front grill the condenser the thermistor probes and the hyper hypothermia blankets The repair of reusable hyper hypothermia blankets is also described Figure 4 1 provides a convenient checklist to record the maintenance history of the unit The description of each requirement includes the tools the procedures and the precautions necessary to complete the requirements Maintenance repair and or service of BLANKETROL III by qualified maintenance technical personnel will not void the warranty of the unit After maintenance has been performed the PM Required HOURS UNTIL SERVICE hour counter should be reset back to 500 by a qualified Medical Equipment Service Technician Certified Biomedical Electronics Technician or Certified Clinical Engineer See Operational and Technical Manual WARNING Before returning the BLANKETROL III to patient use after repairs the FIRST TIME SET UP SYSTEM TEST ROUTINE in Section 2 must always be performed Improper repair and inadequate maintenance can result in damage to the BLANKETROL Ill system and patient injury The following procedures should be performed quarterly or when indicated by 500 hour PM notification whichever occurs
21. solutions DO NOT use gas sterilization or autoclaving for cleaning and disinfecting the blankets To drain the water from the reusable blankets simply shut off power to the unit or shut off the operation of the manual or automatic mode and allow the water to drain from the blanket back into the Blanketrol unit To store PLASTIPAD blankets loosely coil the hose lengthwise into the center of the blanket Fold the blanket lengthwise into the center 1 3 from the left side and 1 3 from the right side Do not fold the blankets width wise as doing so will crimp the tubing Disposal of blankets are done in a means consistent with hospital institution policy protocol for patient contact items 4 6 2 Disposable Single Patient Use Blankets The reusable blanket maintenance procedures do not apply to the disposable single patient use blankets Disposal of blankets are done in a means consistent with hospital institution policy protocol for patient contact items Page 73 of 84 MAINTENANCE BLANKETROL III Model 233 OPERATION MANUAL 4 7 MAINTENANCE OF REUSABLE THERMISTOR PROBES The standard 400 Series probe consists of a thermistor temperature sensing element housed in a probe and attached to a plasticized vinyl jacketed shielded lead wire terminated with a phone plug Refer to the printed material enclosed with each probe regarding temperature specifications cautions maintenance and disposal In general clean with a damp cloth and mil
22. trouble alarm will continue to sound until the unit is turned off using the ON OFF switch or the power cord is disconnected from the power source If the unit is unplugged before turning the ON OFF switch the power fail alarm will activate and the power fail LED will light If the unit is turned back on this message will reappear and the trouble alarm will sound The unit cannot be used again until it is serviced The seven segment displays WATER and PATIENT will both be blank during this condition Contact CSZ Technical Service Page 61 of 84 OPERATION BLANKETROL III Model 233 OPERATION MANUAL LOW LIMIT REMOVE FROM SERVICE This message occurs when the software fails and the water in the Blanketrol IIl equipment has reached the low temperature limit of 2 0 C 2 C 35 6 F 3 6 F activating the independent safety While this message is displayed the trouble alarm will sound and the compressor and pump will turn off The alarm silence key cannot silence this alarm This message will continue to display and the trouble alarm will continue to sound until the unit is turned off using the ON OFF switch or the power cord is disconnected from the power source If the unit is unplugged before turning the ON OFF switch the power fail alarm will activate and the power fail LED will light If the unit is turned back on this message will reappear and the trouble alarm will sound The unit cannot be used again until it is s
23. 0 MHz 800 MHz to 2 5 GHz 1 2 L2NP d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Page 81 of 84 SPECIFICATIONS BLANKETROL III Model 233 OPERATION MANUAL Worldwide Order Placement United States and Canada Telephone 1 513 772 8810 U S Toll Free 1 800 989 7373 1 513 772 9119 Healthlink Europe Centaurusweg 123 5015 TC Tilburg The Netherlands Tel 00 31 13 547 9300 Page 82 of 84 Cincinnati Sub Zero Cincinnati Sub Zero Products Inc 12011 Mosteller Road Cincinnati OH 45241 Telephone 513 772 8810 u Fax 513 772 9119 E Mail csz cszinc com www cszmedical com
24. AFETY INFORMATION Refer to this manual for instructions and operator information Read and understand all WARNINGS CAUTIONS before using prescribing or servicing the BLANKETROL III System Page 9 of 84 INTRODUCTION BLANKETROL III Model 233 OPERATION MANUAL SECTION 1 INTRODUCTION 1 0 GENERAL SAFETY PRECAUTIONS To provide the patient maximum safety during the use of the BLANKETROL III Hyper Hypothermia System a thorough knowledge and understanding of the system and its correct application and operating use are required Each person who is responsible for use or direction of use of the system such as physicians nurses technicians and operators must read and understand this operating manual and all precautions and warnings prior to use It is recommended this manual be read at least semi annually as a refresher for safe operation and application For proper knowledge and understanding in service is available upon request 1 1 GENERAL DESCRIPTION OF THIS MANUAL This manual describes the operation and general maintenance of the CSZ BLANKETROL III Hyper Hypothermia System Section one describes the physical and functional characteristics of the BLANKETROL III System Section two describes how to prepare the BLANKETROL III System for general use Section three describes how to operate the unit in the MANUAL CONTROL MODE AUTO CONTROL MODE GRADIENT 10C MODE GRADIENT 10C SMART MODE GRADIENT VARIABLE MODE GRADIENT VARIABLE SM
25. ART MODE and MONITOR ONLY MODE Section four describes the regular maintenance of the BLANKETROL III unit Section five lists the specifications of the BLANKETROL III This manual is prepared for professional personnel who use the BLANKETROL III for patient care as well as technicians and service personnel who are responsible for maintaining the equipment All personnel who operate or service the unit should be familiar with all parts of this manual However Sections one two and three are primarily intended for personnel who unpack and setup the unit Section three is primarily intended for personnel who operate the unit and Sections three through five are primarily intended for personnel who maintain the unit Section 1 3 describes the external features of the BLANKETROL III and Section 3 12 describes display messages These sections should be consulted if questions arise over the terminology used in this manual Operating modes are described in Section 1 5 1 and are highlighted throughout the manual in italics and capital letters Button names and display messages are shown in all capital letters 1 2 GENERAL DESCRIPTION OF THE BLANKETROL III SYSTEM INDICATIONS FOR USE The Blanketrol IIl Hyper Hypothermia Temperature Management System is used to lower or to raise a patient s temperature and or maintain a desired patient temperature through conductive heat transfer The system is composed of a heater a compressor a circulating pump
26. BLANKETROL II Operation Manual Model 233 Hyper Hypothermia System Cincinnati Sub Zero Cincinnati Sub Zero Products Inc e 12011 Mosteller Road e Cincinnati Ohio 45241 U S A www cszmedical com OPERATION MANUAL BLANKETROL III MODEL 233 BLANKETROL MAXI THERM MAXI THERM LITE and PLASTI PAD are registered trademarks of Cincinnati Sub Zero Products Inc Cincinnati Ohio USA Copyright 2011 Cincinnati Sub Zero Products Inc All rights reserved Manual 57201 Rev P ECN M212 4484 Page 2 of 84 OPERATION MANUAL BLANKETROL III MODEL 233 BLANKETROL Ill Definitions LU i OL OF Read Operation Instructions and Manual Gradient Before Operating Temperature Set Gradient 10 C Variable A V p sc INCREMENT DECREMENT Increase Decrease Automatic Manual Smart Temperature Temperature Control Control Mode 8 Monitor Water Patient Silence Only Test Indicators Temperature Temperature Alarm Inlet ue gt NAAAY AAA Water Flow gt Low Water Indicator Fill to Strainer Outlet Level Risk of Explosion Do not use in the Disconnect Power Before Servicin Danger Risk of Power Failure Presence of Flammable 0 Electio Shock Anesthetics ESD Separate Disposal for Power Cord Susceptibility Electrical Electronic Type BF Holder Equipment Equipment O I xy gt t Equipotential AC Voltage OFF ON Switch Symbol USB Port In
27. Display flashes CHECK SETPT Page 47 of 84 OPERATION BLANKETROL III Model 233 OPERATION MANUAL D Consult the physician s orders to determine the desired patient Set Point temperature As a safety precaution the desired patient Set Point can only be set between 30 C 40 C 86 F 104 F to operate in GRADIENT 10C mode E Use the C F button to choose the desired temperature scale F Press the TEMP SET button 1 The microprocessor board beeps 2 The LED in the corner of the button illuminates 3 The Status Display shows a temperature Set Point G Press the Up arrow or Down arrow to change the Set Point temperature on the Status Display to the desired patient temperature The display can only be set between 30 40 C 86 F 104 F 1 The microprocessor board beeps 2 The Set Point temperature in the Status Display changes H Press the GRADIENT 10C switch 1 The microprocessor board beeps 2 The LED in the corner of the button illuminates 3 The PATIENT display shows the patient s actual temperature 4 The WATER display shows the actual temperature of the water in the Blanketrol Ill equipment 5 The Status Display shows XXXXXX PATIENT AUTO SETPT 37 0 Or Status Display shows PATIENT SETPT AUTO SETPT 37 0 represents HEATING or COOLING The above depends upon the relationship of the blanket water temperature to the Set Point temperature Note that the Set
28. F Low Limit Secondary Back up Safety 2 0 C 2 0 C 35 6 3 6 F Defective or Dislodged Probe Alarm Audible amp Visual Primary amp Secondary High and Secondary Low Limit Failure Alarm Audible amp Visual Low Water Alarm Audible amp Visual Defective Water Temp Sensor Audible amp Visual Water Flow Indicator Visual Low Flow Alarm Audible amp Visual Water Temperature Sensor Fault Alarm Audible amp Visual Page 77 of 84 SPECIFICATIONS BLANKETROL III Model 233 OPERATION MANUAL CONTROL SYSTEM CONTROL SYSTEM cont d Microprocessor controlled Lighted OFF ON Display Type LED power switch Digital LED Read Outs Alarm Indications and Mode Indications Temp Settings Water Temp 0 1 C 0 1 F Controller Range Patient Temp 0 1 C 0 1 F Water Temp 4 C to 42 C Patient Probe 4 inch receptacle One 39 2 F to 107 6 F Probe Type 400 Series Patient Temp 30 C to 40 0 C 86 F to 104 F ENVIROMENTAL CONDITIONS Display Accuracy during storage and transportation Water Temp 0 5 C 1 F measured at 37 C Patient Temp 0 3 C 5 F Ambient Temperature transportation and storage Display Range 40 C 50 C 40 F 122 F Water Temp 0 C 52 C 32 126 F Humidity transporiaton and storage Patient Temp ele io MANUAL CONTROL 10 C 50 0 C WARRANTY 50 F 122 AUTO MODES 30 0 43 5 2 yr parts L
29. HORIZED EUROPEAN REPRESENTATIVE ECIREP Epartner4U BV Telephone 31 0 343 442 524 Esdoornlaan 13 Fax 31 0 343 442 162 3951 DB Maarn The Netherlands www CEpartner4U eu BEFORE YOU CALL FOR SERVICE To help us better serve you please have the serial number of your BLANKETROL III unit ready when you call for parts or service The serial number is located on a specification label attached to the unit s rear panel How to read serial numbers Example 121 3 60000 e 12 indicates a manufacturing date of the year 2012 e 1 indicates the quarter first e 3 means Blanketrol III Model 233 e 60000 indicates that this is the 60 000 unit of a certain model IN WARRANTY REPAIR AND PARTS All parts on your BLANKETROL III unit are covered by a two year 2 warranty Additional third year warranty is available at the time of purchase To return defective parts or units first obtain a Returned Materials Authorization RMA number from our Medical Technical Service department RECEIVING INSPECTION After unpacking the BLANKETROL III System be sure to inspect the system for concealed damage Retain all packing material and carefully describe or photograph any damage Notify the carrier at once and ask for an inspection in writing Failure to do this within 15 days may result in loss of claim Do not return the equipment to Cincinnati Sub Zero Call our Medical Technical Service department for further instructions IMPORTANT S
30. LING WATER This message is displayed on the top line when the BLANKETROL III is cooling the circulating water WATER SETPT This message is displayed on the top line when the water temperature has reached the water temperature Set Point Page 58 of 84 OPERATION BLANKETROL III Model 233 OPERATION MANUAL B During normal operation in the five automatic modes AUTOMATIC CONTROL MODE GRADIENT 10C MODE GRADIENT 10C SMART MODE GRADIENT VARIABLE MODE and GRADIENT VARIABLE SMART MODE the Status Display shows the following messages Status Display Message Function This message is displayed on the left side of the bottom line and indicates AUTO that the BLANKETROL III is operating in one of the five automatic modes represents Temperature and Y represents Centigrade or SETPT Fahrenheit This message is displayed on the right side of the bottom line in the five automatic modes and indicates the desired current Set Point temperature for the patient with appropriate temperature scale HEATING PATIENT This message is displayed on the top line when the BLANKETROL III is heating the patient COOLING PATIENT This message is displayed on the top line when the BLANKETROL III is cooling the patient PATIENT SETPT This message is displayed on the top line when the patient s temperature has reached the Set Point temperature C During normal op
31. M GRADIENT VARIABLE MODE TO ANOTHER CONTROL MODE FIRST PRESS THE TEMP SET BUTTON AND THEN SELECT THE OPERATING MODE OF CHOICE In order to change from GRADIENT VARIABLE MODE to MONITOR ONLY MODE simply press the MONITOR ONLY button Page 53 of 84 OPERATION BLANKETROL III Model 233 OPERATION MANUAL 3 9 OPERATING THE BLANKETROL III SYSTEM IN GRADIENT VARIABLE SMART MODE WARNING A physician s order is required for setting blanket temperature and use of equipment At least every 20 minutes or as directed by physician check patient s temperature and skin integrity of areas in contact with blanket also check blanket water temperature Pediatric patients temperature sensitive patients with vascular disease surgical patients diabetics and patients with Raynaud s Disease should be checked more frequently Notify the physician promptly of any change in patient status in order to avoid serious injury or death The BLANKETROL III System can be set to gradually change the patient s temperature according to specific patient s needs by maintaining the water in the Blanketrol IIl equipment at a specified temperature from the patient s body temperature as chosen by the operator The system then increases this temperature difference by 5 C 9 F every 30 minutes until the patient s temperature reaches Set Point After arranging the equipment as described in Section 3 2 proceed as follows A Check the placement
32. NKETROL Ill MEMBRANE CONTROL PANEL 115 VAC UNITS Page 19 of 84 INTRODUCTION BLANKETROL III Model 233 OPERATION MANUAL B 2 Ql c 9 D ai lt T B o a O Cincinnati Sub Zero GRADIENT Smart VARIABLE BLANKETROL Il Hyper Hypothermia N K FIGURE 1 4 B BLANKETROL III MEMBRANE CONTROL PANEL 230 VAC UNITS E 1 4 REQUIRED ACCESSORIES Operation of the BLANKETROL III System requires the use of the blanket s designed to circulate warm or cool distilled water a connecting hose with quick disconnect male and female couplings and if any of the automatic modes are to be utilized a 400 Series thermistor probe BLANKETROL III System Equipment and accessories are listed in Table 4 2 1 5 FUNCTIONAL DESCRIPTION OF THE BLANKETROL III SYSTEM 1 5 1 Theory of Operation The BLANKETROL III unit can be set so that it operates based on the circulating water temperature MANUAL CONTROL MODE or it can be set so that it operates based upon the patient s temperature Automatic Modes The five Automatic modes include Page 20 of 84 INTRODUCTION BLANKETROL III Model 233 OPERATION MANUAL 1 AUTO CONTROL MODE 2 GRADIENT 10C MODE 3 GRADIENT 10C SMART MODE 4 GRADIENT VARIABLE MODE 5 GRADIENT VARIABLE SMART MODE In MANUAL CONTROL MODE the operator specifies the circulating water Set Point temperature The unit heats cools th
33. Point may be displayed in Fahrenheit 6 The pump is activated The heater or compressor may also be activated 7 The Water Flow indicator on the right side panel begins to move 8 The water moves from the unit to the blanket and returns to the unit Check the water flow indicator to confirm that the water is circulating Page 48 of 84 OPERATION BLANKETROL III Model 233 OPERATION MANUAL J Touch the hyper hypothermia blanket to confirm that the blanket is heating cooling K To make any changes in the control settings press the TEMP SET switch and begin again The BLANKETROL III System is now operating in GRADIENT 10C MODE You should continue to monitor the system and the patient Review the suggestions for patient care described in Section 2 5 If at any time the Status Display shows a message other than the messages described in GRADIENT 10C MODE procedures make the changes indicated by the display and or consult the list of display messages in Section 3 12 If at any time the unit sounds an alarm and the Status Display flashes a message make the changes indicated To turn off the unit or discontinue hyper hypothermia treatment proceed as described in Section 3 11 NOTE IN ORDER TO CHANGE FROM GRADIENT 10C MODE TO ANOTHER CONTROL MODE FIRST PRESS THE TEMP SET BUTTON AND THEN SELECT THE OPERATING MODE OF CHOICE In order to change from GRADIENT 10C MODE to MONITOR ONLY MODE simply press the MONITOR ONLY butt
34. RM button 1 The alarm stops 2 The Status Display continues to flash CHECK PROBE The Operator has 5 minutes to correct the problem In an actual situation the operator would check the probe and then continue operation Q Press the TEMP SET button 1 The microprocessor board beeps 2 The LED in the corner of the button illuminates 3 The Status Display returns to set temperature mode Page 30 of 84 OPERATION BLANKETROL III Model 233 OPERATION MANUAL R Press the Up arrow or the Down arrow so that the Set point display shows a number less than 30 C 86 F or greater than 40 C 104 F S Press the AUTO CONTROL button 1 The Set point display goes blank 2 The Status Display flashes CHECK SETPT The display flashes because the Set point temperature is outside the AUTOMATIC CONTROL MODE temperature range of 30 C 40 C 86 F 104 F The unit will not operate in any of the Automatic Modes unless the Set point display shows a number within the range T Press the TEMP SET button 1 The microprocessor board beeps 2 The LED in the corner of the button illuminates 3 The Status Display returns to set temperature mode Press the Up arrow or the Down arrow so that the Set point displays 37 C d 6 F Set the patient probe to a temperature reading between 30 43 5 C 86 F 110 3 F V Press the AUTO CONTROL button The microprocessor board beeps The LED in the corner of the button illuminates
35. RT MODE to MONITOR ONLY MODE simply press the MONITOR ONLY button 3 8 OPERATING THE BLANKETROL III SYSTEM IN GRADIENT VARIABLE MODE WARNING A physician s order is required for setting blanket temperature and use of equipment At least every 20 minutes or as directed by physician check patient s temperature and skin integrity of areas in contact with blanket also check blanket water temperature Pediatric patients temperature sensitive patients with vascular disease surgical patients diabetics and patients with Raynaud s Disease should be checked more frequently Notify the physician promptly of any change in patient status in order to avoid serious injury or death The BLANKETROL III System can be set to gradually change a patient s temperature by maintaining the water in the Blanketrol Ill equipment temperature at a specified temperature difference from the patient s body temperature Page 51 of 84 OPERATION BLANKETROL III Model 233 OPERATION MANUAL After arranging the equipment as described in Section 3 2 proceed as follows A Check the placement of the 400 Series probe in or on the patient B Connect the probe to the 1 4 inch receptacle on the right side of the unit C Press the power switch to I position 1 The switch illuminates green 2 The microprocessor board goes through self test 3 The Status Display flashes CHECK SETPT D Consult the physician s orders to determine the des
36. TROL MODE TO ANOTHER CONTROL MODE FIRST PRESS THE TEMP SET BUTTON AND THEN SELECT THE OPERATING MODE OF CHOICE In order to change from MANUAL CONTROL MODE to MONITOR ONLY MODE simply press the Monitor Only button 3 6 OPERATING THE BLANKETROL III SYSTEM IN GRADIENT 10C MODE WARNING o A physician s order is required for setting blanket temperature and use of equipment At least every 20 minutes or as directed by physician check patient s temperature and skin integrity of areas in contact with blanket also check blanket water temperature Pediatric patients temperature sensitive patients with vascular disease surgical patients diabetics and patients with Raynaud s Disease should be checked more frequently Notify the physician promptly of any change in patient status in order to avoid serious injury or death The BLANKETROL III System can be set to gradually change a patient s temperature by maintaining the water in the Blanketrol III equipment at a maximum temperature 10 C 18 F different from the patient s body temperature After arranging the equipment as described in Section 3 2 proceed as follows A Check the placement of the 400 Series probe in or on the patient B Connect the 400 Series probe to the 1 4 inch receptacle on the right side of the unit C Press the power switch to the I position 1 The switch illuminates green 2 The microprocessor board goes through self test 3 The Status
37. UAL SETPT 37 0 represents HEATING or COOLING The above depends upon the relationship of the blanket water temperature to the Set Point temperature Note that the Set Point may be displayed in Fahrenheit 5 The pump is activated The heater or compressor may be activated 6 The Water Flow indicator on the right side panel begins to move 7 The water moves from the unit through the blanket and returns to the unit G Check the water flow indicator to confirm that the water is circulating H Touch the hyper hypothermia blanket to confirm that the blanket is heating cooling l To make any changes in the control setting press the TEMP SET button and begin again The BLANKETROL III System is now operating in MANUAL CONTROL MODE The operator must continue to monitor the change in the patient s temperature Review the suggestions for patient care described in Section 2 5 Page 45 of 84 OPERATION BLANKETROL Ill Model 233 OPERATION MANUAL When operating in MANUAL CONTROL MODE the system should be turned off when the patient s temperature is within 5 C 1 F higher than the desired patient temperature to avoid complications associated with temperature drift If at any time the Status Display shows a message other than the messages described in MANUAL CONTROL MODE procedures make the changes indicated by the display and or consult the list of display messages in Section 3 12 If at any time th
38. V Nod AA ies NI N BY ZA o v AZT 2 LY mM f 2 G oil oH m Ih al Wi ste LL A TA K ym 4i Lf ff CL C So NS ML FIGURE 4 2 BLANKETROL Ill EXPOSED REAR VIEW Page 75 of 84 SPECIFICATIONS BLANKETROL III Model 233 OPERATION MANUAL TABLE 4 2 BLANKETROL Ill SYSTEM ACCESSORIES Blankets Pads and Hoses Approved for Use with the Blanketrol IIl are listed below MAXI THERM Single Patient Use Blankets 276 Adult or O R Table Size 24 x 60 274 Pediatric Size 22 x 30 273 Infant Size 12 x 18 Contents 5 box 4 boxes case 286 Reusable Connecting Hose for CSZ Unit MAXI THERM LITE Single Patient Use Blankets 879 Adult Size 25 x 64 876 Adult Size 25 x 64 874 Pediatric Size 25 x 33 873 Infant Size 12 5 x 18 872 Pediatric Size 25 x 19 871 Pediatric Size 25 x 16 870 Localized Therapy 25 x 4 300 Staff Vest 801 Patient Vest 800 Patient Vest PLASTIPAD Reusable Molded Plastic Blankets Polyurethane 196 Adult Size 24 x 60 195N Narrow Adult Size 20 x 60 194 Pediatric Size 22 x 30 193 Infant Size 12 x 18 193CPC Infant Size with CPC Connectors 12 x 18 186 9 Blanket Extension Hose with Couplings Head Wrap Single Pati
39. abor if returned to CSZ 86 0 F 110 3 F Additional warranties available at time of MONITOR ONLY 10 C 50 0 purchase Contact CSZ 50 F 122 CLASSIFICATION Equipment is Class 1 Equipment is Type BF The blanket is a means of patient protection CERTIFICATIONS MODEL 233 MEDICAL ELECTRICAL EQUIPMENT WITHRESPECT TO ELECTRIC 2 SHOCK FIRE AND MECHANICAL HAZARDS ONLY C US IN ACCORDANCE WITH UL60601 1 IEC60601 1 16HV IEC60601 2 35 ASTM F2196 02 C IEC60601 1 2 AND 0344 CAN CSA C22 2 No 601 1 Page 78 of 84 SPECIFICATIONS BLANKETROL III Model 233 OPERATION MANUAL BLANKETROL Ill MODEL 233 FEATURES CONT The following tables are presented in fulfillment of the requirements of IEC 60601 1 2 TABLE 5 1 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMMISSIONS The Blanketrol III Model 233 is intended for use in the electromagnetic environment specified below The customer or the user of the Blanketrol III Model 233 should assure that it is used in such an environment Emissions tests Compliance Electromagnetic environment guidance ies The Blanketrol III Model 233 uses RF energy only for its internal RF emissions 4 Ts Group 1 function Therefore its RF emissions are very low and are not CISPR 11 likely to cause any interference in nearby electronic equipment RF emissions The Blanketrol III Model 233 is suitable fo
40. ain even though the SILENCE ALARM button has been previously pressed LOW FLOW This message is displayed when the flow out of the unit to a blanket is reduced below 6 3 GPH after an acceptable flow has been previously detected Along with this message a trouble alarm will sound The operator can silence this alarm using the SILENCE ALARM button The operator has 5 minutes to fix the condition If after that time the condition has not been cleared the system will trouble alarm again even though the SILENCE ALARM button has been previously pressed The condition can also be satisfied if the flow increases above 6 3 GPH BAD FLOW SWITCH This message will be displayed after the indicators are tested if the flow switch is closed upon initial power up of the unit This indication results from a stuck flow switch The audible alarm shall sound continuously for 30 seconds After 30 seconds the message will clear and the alarm will stop sounding Pressing the SILENCE ALARM key while the alarm is sounding shall silence the alarm and clear the message A unit with a bad flow switch is still operable however a LOW FLOW alarm will not sound when flow through the blanket is blocked PM REQUIRED This message will be displayed after 500 hours of operation past the last time the 500 hour counter was reset The message will only be displayed for 5 seconds at power up Note Only qualified Medical Equipment Service Technicians Certified
41. anket Water temperature After arranging the equipment as described in Section 3 2 proceed as follows A Check the placement of the 400 Series probe in or on the patient B Connect the 400 Series probe to the 1 4 inch receptacle on the right side of the unit C Follow Steps A 1 as described in Section 3 4 In addition to the Blanket Water display showing actual water temperature the Patient display shows the actual patient temperature The BLANKETROL III System is now operating in MANUAL CONTROL MODE while monitoring the patient s temperature However you must also monitor the patient s temperature Review the suggestions for patient care described in Section 2 5 Page 46 of 84 OPERATION BLANKETROL III Model 233 OPERATION MANUAL When operating in MANUAL CONTROL MODE the unit should be turned off when the patient s temperature is 5 C 1 F above the desired patient temperature to avoid complications associated with temperature drift If at any time the Status Display shows a message other than the messages described in MANUAL CONTROL MODE procedures make the changes indicated by the display and or consult the list of display messages in Section 3 12 If at any time the unit sounds an alarm and the Status Display flashes a message make the changes as indicated To turn off the unit or discontinue hyper hypothermia treatment proceed as described in Section 3 11 NOTE IN ORDER TO CHANGE FROM AUTOMATIC CON
42. anual The grill permits air to be drawn into the unit and pass over the condenser The air is then discharged through the bottom of the unit The grill and compressor should be kept clear from blockage and cleaned regularly as described in Section 4 4 The protective bumper guard surrounds the lower edge of the unit and protects the unit as well as the walls Four swivel casters are specially designed to permit the unit to move easily and to prevent it from tipping The unit is equipped with two locking casters to prevent unintended movement during operation Page 12 of 84 INTRODUCTION BLANKETROL III Model 233 OPERATION MANUAL GY SWIVEL CASTERS FIGURE 1 1 BLANKETROL Ill FRONT VIEW Page 13 of 84 INTRODUCTION BLANKETROL III Model 233 OPERATION MANUAL 1 3 2 External Features Right Side View The external features in Figure 1 2 of the BLANKETROL III unit are described as follows A The water flow indicator is a paddle wheel immersed in the path of the circulating water with a window to the outside As water is circulated through the system it passes over the paddle wheel causing it to spin like a pinwheel The water flow indicator provides a visual display of the general rate at which the water is circulating For example if the unit is circulating water but the connecting hose is pinched the circulation of the water is restricted The restriction in water flow decreases the speed of the paddle whee
43. ater per the above chart Turn the unit on and circulate per the Chemical Cleaning Circulation Chart above Drain the unit as instructed in Step 1 Rinse the unit with distilled water three 3 times as described in Steps 4 6 Be sure to omit the Maranon H After the third rinse drain the unit and fill the reservoir with distilled water and circulate Check the water with PH strips or other appropriate test method for Maranon H detection If Maranon H is detected repeat Steps 4 6 If unit is to be returned to service replenish reservoir s with the appropriate volume of distilled water If unit is being placed in dry storage continue with procedure When all fluid has been removed from the unit disconnect the drain hose s and wipe unit clean Unit is now ready for storage Document unit maintenance 4 2 1 Draining the Reservoir CAUTION Always drain the BLANKETROL III to a sanitary drain because bio contaminants may be present in the unit s water supply A Collect these items 1 An empty container to drain the water into that can hold at least 3 gallons 11 4 liters 2 The drain hose with a female quick disconnect coupling usually found in the storage drawer of the unit 3 2 gallons 7 6 liters distilled sterile water to replenish the reservoir Insert the drain end of the hose into the 3 gallon 11 4 liters container Set the container on the floor so the hose drains do
44. atus Display indicates LOW LIMIT REMOVE FROM SERVICE and the trouble alarm sounds 1 5 6 USB Port Operation Refer to CSZ manual 57059 for instructions and usage of the Blanketrol Ill Data Export Software CAUTION Do not make any connection to this terminal while the device is also connected to a patient Do not touch this connector and the patient at the same time WARNING The USB connection on the Blanketrol III unit is intended for data transfer to a computer Any other uses connections may result in damage to the Blanketrol Ill unit Page 24 of 84 OPERATION BLANKETROL III Model 233 OPERATION MANUAL SECTION 2 GENERAL PREPARATION OF THE BLANKETROL III SYSTEM 2 1 INTRODUCTION This section describes the procedures to prepare the BLANKETROL III System for general use This entails unpacking the shipment arranging all the equipment for the first time and completing a test routine This section also outlines the bactericidal agent preparations standard safety precautions and patient preparation bedside care when using the hyper hypothermia blanket s Technical support is available upon request 2 2 UNPACKING THE SHIPMENT WARNING Remove the BLANKETROL III from service if the outer casing or membrane control panel is cracked or internal components are exposed Contact with internal components could result in electric shock to the patient or operator Cut the ban
45. ce additional heat sources between the patient and blanket Tissue damage may result e Means to maintain contact between the patient and the blanket during therapy may be required Failure to do so may result in inadequate treatment e Proper sanitation procedures must be practiced and hygienic safety must be maintained to prevent contamination Contamination can affect patient s health i e skin irritation rash may result Use only YSI 400 Series probes on CSZ equipment refer to Table 6 8 Failure to do this will cause incorrect temperature readings and may result in inadequate inappropriate treatment Do not use the BLANKETROL III system in the presence of flammable anesthetics Risk of explosion can result Power interruption will cause the BLANKETROL III to revert to CHECK SET POINT resulting in no therapy to the patient Follow instructions for desired mode to resume operation Failure to resume therapy could result in serious injury or death Do not by pass ground lug Electrical Hazards may result To avoid the risk of electric shock this equipment must only be connected to a supply mains with protective earth Inspect all blankets for mechanical damage before use Do not use in proximity to sharp objects Blanket punctures can result in an increased risk of infection or electrical shock Any time water is found leaking into or around the unit connecting hose and or blan
46. cessary Note If the CHECK SETPT display flashes for five minutes the alarm will sound until the operator proceeds to the next step This alarm will also notify the operator if there has been an interruption in power SET TEMPERATURE SETPT xxx xY represents Temperature and Y represents Centigrade or Fahrenheit This message occurs when the TEMP SET button is pressed The Status Display can now be changed by pressing the Up or Down arrow or verify the preset temperature of 37 C 98 6 on power up GRADIENT VARIABLE OFFSET xxY xx represents Temperature and Y represents Centigrade or Fahrenheit This is displayed after the first press of the GRADIENT VARIABLE button when the user is setting the BLANKETROL in GRADIENT VARIABLE MODE When this display is shown the user can adjust the gradient variable offset HIGH LIMIT REMOVE FROM SERVICE This message occurs when the high limit is triggered because the water in the Blanketrol Ill equipment has reached the high temperature of 44 0 C 2 C 111 2 F 3 6 F While this message is displayed the trouble alarm will sound and the heater and pump will turn off The alarm silence key cannot silence this alarm This message will continue to display and the trouble alarm will continue to sound until the unit is turned off using the ON OFF switch or the power cord is disconnected from the power source If the unit is unplugged b
47. ckwise The cap may contain a small amount of water E Remove the wire mesh F Clean the wire mesh and the plastic cap Be careful not to lose the black O ring in the rim of the plastic cap G Replace the wire mesh in the plastic cap and position the wire mesh O ring and plastic cap H Screw the cap clockwise onto the fitting until it is secure l Replace the rear enclosure panel J Replenish the water reservoir as described in Section 4 2 2 4 4 MAINTENANCE OF THE CONDENSER AND GRILL Quarterly the grill and the fins of the condenser should be cleaned to remove any accumulated dust and lint To clean the condenser and grill WARNING The repair calibration and servicing of the BLANKETROL III should be performed by qualified Medical Equipment Service Technicians Certified Biomedical Electronics Technicians or Certified Clinical Engineers familiar with good repair practices for servicing medical devices and in accordance with instructions contained in this manual Improper repair can result in damage to the BLANKETROL III system and patient injury Always unplug the unit before accessing internal components during service Failure to unplug the unit could result in electric shock Page 72 of 84 MAINTENANCE BLANKETROL III Model 233 OPERATION MANUAL A Remove the grill B Using a brush or a vacuum dust both sides of the front panel grill C Next brush or vacuum the fins of the
48. condenser Be careful not to bend any of the fins D Replace the grill 4 5 MAINTENANCE OF THE BLANKETROL III EXTERIOR CLEANING INSTRUCTIONS The BLANKETROL III unit is constructed of powder coated steel with a plastic top that should be cleaned quarterly with water and mild detergent solution For cleaning and disinfecting always use conventional hospital approved topical equipment cleaners and disinfectants that do not contain alcohol Avoid alcohol and other strong undiluted disinfectants These may cause staining of the device s outer skin Thoroughly wipe down device with a damp cloth to remove any residue from cleaning solutions 4 6 MAINTENANCE OF THE HYPER HYPOTHERMIA BLANKETS This section describes the general maintenance and repair procedures for the reusable and disposable blankets General maintenance tasks include cleaning draining and storing the blankets Repair procedures are included for the reusable blankets 4 6 1 Reusable Blanket Cincinnati Sub Zero reusable blankets are constructed from biocompatible polyurethane urethane Stains and debris can be wiped away with mild soap and water For cleaning and disinfecting always use conventional hospital approved topical cleaners and disinfectants that do not contain alcohol Avoid alcohol and other strong undiluted disinfectants These may cause staining of the device s outer skin Thoroughly rinse product with clear water to remove any residue from cleaning
49. condenser could result in the unit overheating which could render the unit unable to provide adequate therapy and excessive surface temperatures could cause injury of patient or operator Keep unit specifically the grill away from curtains or other obstructions e Use proper precautions when handling or using the patient probe Failure to do so may result in damage from electrostatic discharge ESD The USB connection on the Blanketrol III unit is intended for data transfer to a computer Any other uses connections may result in damage to the Blanketrol Ill unit e Working with electronic boards plugs and cables requires delicate handling Proper Electrostatic Discharge procedure should be followed during replacement of any electronic board Failure to do so may result in damage to the board e The warming of transdermal medications patches can increase drug delivery resulting in possible injury to the patient e If unit requires repair do not attempt to fix unit on your own Only qualified personnel should perform repairs Damage to the unit or malfunction may otherwise result Page 37 of 84 OPERATION BLANKETROL Ill Model 233 OPERATION MANUAL CAUTION Federal law restricts this device to sale by or on the order of a physician e Use distilled water only Do Not Use De lonized water De lonized water may cause corrosion to plumbing system components Do Not Use Tap Water Minerals and depos
50. ct the BLANKETROL III System to determine that there are no missing parts unusual dents or punctures C Examine the power cord for cuts or exposed wires and the power plug for bent or missing prongs D Review Section 1 3 to identify the features of the BLANKETROL III System E Collect and arrange the following equipment and supplies 1 Hyper hypothermia blanket s described in Section 1 4 and listed in Table 4 2 2 Connecting hose with quick disconnect fittings if using disposable blanket s 3 400 Series Thermistor Probes connecting cables described in Section 1 4 and listed in Table 4 2 CAUTION Use distilled water only Do Not Use De lonized water De lonized water may cause corrosion to plumbing system components Do Not Use Tap Water Minerals and deposits can clog plumbing system components Do not use alcohol Alcohol may cause blanket deterioration Do not overfill Overfilling may result in overflow when the water in the blanket drains back into the system when the system is turned off F Liftthe lid of the water fill opening and gradually pour approximately 2 gallons 7 6 liters of distilled water into the reservoir Stop pouring when the water reaches the strainer visible at the bottom of the water fill opening G The Blanketrol Ill and the blanket applied part are BF rated as a system Contact with other parts i e the quick disconnect couplings at the same
51. d detergent When not in use the probes should be loosely coiled and stored at room temperature Never boil or autoclave the vinyl jacketed leadwire Avoid contact with strong aromatic chlorinated ketone ether or ester solvents CAUTION Do not immerse probes or connecting cables in liquid When cleaning or sterilizing the probe should be handled gently Excessive pressure can stretch the covering and or break the internal wires At high temperatures the vinyl softens and can be deformed by pressure and stress DO NOT AUTOCLAVE Similar to the blankets disposal of probes are done in a means consistent with hospital institution policy protocol for patient contact items 4 8 BLANKTROL INTERIOR COMPONENTS Figure 4 2 highlights the interior components of the BLANKETROL III unit The internal components referenced in figure 4 1 are as follows Upper manifold return Water temperature sensor Lower manifold outlet Pump housing assembly Transformer Compressor Compressor electrical box Filter drier Refrigeration solenoid valve Starting capacitor Condenser fan blade Hot gas by pass valve Terminal Block Water filter assembly Heater Thermal disc Reservoir oQvozermce rommoog9 Page 74 of 84 MAINTENANCE BLANKETROL III Model 233 OPERATION MANUAL KCN NU Pet TN DI I 7 N 2 u S
52. d under and connected to the replenishing reservoir When the operator fills the reservoir with distilled water the circulating reservoir fills first and holds approximately 1 2 gallon 1 9 liters of water The remaining 1 gallons 5 6 liters are held in the replenishing reservoir The water moves from the replenishing reservoir to the circulating reservoir as needed The circulating water flows over and around the heating cooling element located in the circulating reservoir The heated or cooled water then flows out of the reservoir to the circulating pump through connecting hoses over a water temperature sensor to the hyper hypothermia blanket s The water circulates through the blanket s and returns to the unit The water then passes through the water flow indicator through the water filter and returns to the circulating reservoir to be reheated or re cooled and then recycled An internal by pass inside the BLANKETROL III by passes the Hansen fittings the flow indicator and the flow switch for water circulation during preconditioning of the water The circulating water system contains a flow switch to alert the operator when an occlusion prevents water flow through the blanket s The flow switch will only activate an alarm when flow is interrupted after normal flow has been detected Therefore the operator should check the flow indicator for proper flow when operation is first begun In addition the replenishing reservoir contains a
53. de plug or electric shock may result Do not overfill Overfilling may result in overflow when the water in the blanket drains back into the system when the system is turned off e Always drain the BLANKETROL III to a sanitary drain because bio contaminants may be present in the unit s water supply e If possible remove the probe from patient contact before activating an electrosurgical unit ESU Do not immerse probes or connecting cables in liquid If the unit was shipped on its side permit the unit to rest in an upright position for twelve 12 hours before operating due to refrigeration oil displacement For safe handling and use of chemicals follow manufacturer guidelines Do not make any connection to this terminal while the device is also connected to a patient Do not touch this connector and the patient at the same time e Users should not use cleaning or decontamination methods different from those recommended by CSZ without first checking with CSZ that the proposed methods will not damage the equipment Page 6 of 84 OPERATION MANUAL BLANKETROL III MODEL 233 TABLE OF CONTENTS TECHNICAL HELP zio nin io nio nin io nio riore nio nin ie nio nin EEES nio nin io nio nin io EES EENE EEEE 9 AUTHORIZED EUROPEAN REPRESENTATIVE csssssssssssssssessessrsesscssesessessrsessessssessessesessessssessssessessssessesers 9 BEFORE YOU GAEL FOR SER VICE
54. ds at the bottom of the carton Lift off the cardboard box and lift the unit from the cardboard insert Locate and remove the envelope containing the manual During the unpacking process look carefully for signs of shipping damage If any unacceptable damage is found notify the transportation company immediately and file a claim The transportation company is responsible for the shipment after it leaves the factory If problems other than shipping damage are found notify your Cincinnati Sub Zero representative or the Factory 2 3 FIRST TIME SET UP SYSTEM TEST ROUTINE CAUTION o If the unit was shipped on its side permit the unit to rest in an upright position for twelve 12 hours before operating due to refrigeration oil displacement This section describes the tasks necessary to inspect and arrange the equipment for the first time after unpacking and describes a System Test Routine to check out the membrane control panel The System Test Routine can also be used to teach operators unfamiliar with the equipment how to use the unit Page 25 of 84 OPERATION BLANKETROL III Model 233 OPERATION MANUAL 2 3 1 Inspecting and Arranging the Equipment A Place the BLANKETROL III System in an uncluttered work space that is accessible to the correct power source with an ambient temperature between 15 C 30 C 59 F 86 F Position the unit so that the membrane control panel faces the operator B Visually inspe
55. e Status Display flashes CHECK SETPT D Consult the physician s orders to determine the desired patient Set Point temperature As a safety precaution the desired patient Set Point can only be set between 30 C 40 C 86 F 104 F to operate in GRADIENT 10C MODE E 115V only Use the C F button to choose the desired temperature scale F Press the TEMP SET button 1 The microprocessor board beeps 2 The LED in the corner of the button illuminates 3 The Status Display shows a temperature Set Point G Press the Up arrow or Down arrow to change the Set Point temperature on the Status Display to the desired patient temperature The display can only be set between 30 C 40 C 86 F 104 F 1 The microprocessor board beeps 2 The Set Point temperature in the Status Display changes H Press the GRADIENT 10C button 1 The microprocessor board beeps 2 The LED in the corner of the button illuminates 3 The PATIENT display shows the patient s actual temperature 4 The WATER display shows the actual temperature of the water in the Blanketrol Ill equipment 5 The Status Display shows XXXXXX PATIENT AUTO SETPT 37 0 C Or Status Display shows PATIENT SETPT AUTO SETPT 37 0 C XXXXXX represents HEATING or COOLING The above depends upon the relationship of the blanket water temperature to the Set Point temperature Note that the Set Point may be displayed in Fahrenheit 6 The pump is activated The
56. e appropriate controls AUTOMATIC CONTROL MODE MANUAL CONTROL MODE GRADIENT 10C MODE GRADIENT 10C SMART MODE GRADIENT VARIABLE MODE GRADIENT VARIABLE SMART MODE or MONITOR ONLY MODE For proper knowledge and understanding of the unit in service is available upon request 3 2 ARRANGING THE SYSTEM COMPONENTS A Collect all supplies and equipment 1 BLANKETROL III unit 2 Hyper hypothermia blanket s 3 Dry sheet or bath blanket 4 Connecting hose if using MAXI THERM or MAXI THERM LITE Disposable Blanket s 5 400 Series probe refer to Table 4 2 6 Connecting cable if using disposable probes 7 Distilled water B Place the BLANKETROL III unit in the patient area accessible to the correct power source and in an ambient environment of 15 C 30 C 59 F 86 F C Review Section 1 3 that outlines the features of the unit and membrane control panel CAUTION Use distilled water only Do Not Use De lonized water De lonized water may cause corrosion to plumbing system components Do Not Use Tap Water Minerals and deposits can clog plumbing system components Do not use alcohol Alcohol may cause blanket deterioration Do not overfill Overfilling may result in overflow when the water in the blanket drains back into the system when the system is turned off Page 39 of 84 OPERATION BLANKETROL III Model 233 OPERATION MANUAL D Check the level of distilled water in t
57. e condition has not been cleared the system will trouble alarm again even though the SILENCE ALARM button has been previously pressed In MONITOR ONLY MODE CHECK PROBE is displayed if 1 The temperature goes out of the range 10 0 C 50 0 C 50 F 122 0 F The trouble alarm sounds and cannot be silenced The patient display is blank If the temperature comes back into range the unit should resume operation in MONITOR ONLY MODE In MANUAL CONTROL MODE a probe out of range should result in the PATIENT display going blank but the unit continuing operation with no error message lf the temperature comes back into range the PATIENT display should come back on BAD PROBE While in any of the five automatic modes if the patient probe indicates only a direct short in the probe circuit this message occurs As this message is displayed the trouble alarm sounds and the unit shuts down This alarm can be silenced using the SILENCE ALARM button The operator than has 5 minutes to fix the probe If after that time the condition has not been fixed the system will trouble alarm again even though the SILENCE ALARM button has been previously pressed During this condition the seven segment displays will both be blank While operating in MANUAL CONTROL mode if a bad patient probe develops the heating cooling system remains on but the seven segment PATIENT display blanks While operating in the MONITOR ONLY mode if a bad pa
58. e relationship of the blanket water temperature to the Set Point temperature Note that the Set Point may be displayed in Fahrenheit 5 The pump is activated Page 28 of 84 OPERATION BLANKETROL III Model 233 OPERATION MANUAL 6 The heater or compressor may be activated 7 The water flow indicator on the right side panel begins to move The water moves from the unit through the blanket and returns to the unit If at any time the water falls below a preset limit the Low Water sensor is activated and the Status Display flashes LOW WATER and the alarm sounds The unit shuts down and the operator cannot proceed until this is corrected Use distilled water only CAUTION Use distilled water only Do Not Use De lonized water De lonized water may cause corrosion to plumbing system components Do Not Use Tap Water Minerals and deposits can clog plumbing system components WARNING Proper sanitation procedures should be followed including but not limited to the preventative maintenance described in this manual Leaky blankets or hoses as well as unapproved blankets or hoses should never be used Water leaks present a risk of infection and should be handled accordingly Any time water is found leaking into or around the unit connecting hose and or blanket turn the unit off disconnect the power cord from its power source and correct the problem before proceeding Proper maintenance procedures should be follo
59. e type of BF rating Page 14 of 84 INTRODUCTION BLANKETROL III Model 233 OPERATION MANUAL LOCKING CASTERS SWIVEL CASTER FIGURE 1 2 BLANKETROL Ill RIGHT SIDE VIEW Page 15 of 84 INTRODUCTION BLANKETROL III Model 233 OPERATION MANUAL 1 3 3 External Features Rear View The external features in Figure 1 3 of the BLANKETROL III unit are described as follows A B The specification label outlines the BLANKETROL III unit s electrical requirements The maintenance label outlines the periodic checks for the BLANKETROL III unit The air vents on both the right and left side of the unit provide air circulation for the microprocessor The nylon strap is used to secure and store the coiled power cord when not in use The rear enclosure panel secured with four screws provides access to the interior The panel is removed to perform maintenance repair or replacement of components The water fill opening is where the operator pours distilled water into the unit to fill the reservoir The operating instructions are printed directly on the back lid of the unit This allows the operator to clearly see the directions and efficiently use the unit The USB port for future data reporting functions Page 16 of 84 INTRODUCTION BLANKETROL III Model 233 OPERATION MANUAL FIGURE 1 3 BLANKETROL Ill REAR VIEW Page 17 of 84 INTRODUCTION BLANKETROL III Model 233 OPERATION MANUAL 1 3 4 Descript
60. e unit sounds an alarm and the Status Display flashes a message make the changes as indicated To turn off the unit or discontinue hyper hypothermia treatment proceed as described in Section 3 11 NOTE IN ORDER TO CHANGE FROM MANUAL CONTROL MODE TO ANOTHER CONTROL MODE FIRST PRESS THE TEMP SET BUTTON AND THEN SELECT THE OPERATING MODE OF CHOICE In order to change from MANUAL CONTROL MODE to MONITOR ONLY MODE simply press the MONITOR ONLY button 3 5 OPERATING THE BLANKETROL III SYSTEM IN MANUAL CONTROL MODE WITH THE ADDITION OF THE PATIENT PROBE WARNING A physician s order is required for setting blanket temperature and use of equipment At least every 20 minutes or as directed by physician check patient s temperature and skin integrity of areas in contact with blanket also check blanket water temperature Pediatric patients temperature sensitive patients with vascular disease surgical patients diabetics and patients with Raynaud s Disease should be checked more frequently Notify the physician promptly of any change in patient status in order to avoid serious injury or death When the BLANKETROL III System is set to operate in MANUAL CONTROL MODE the patient probe can be connected to the unit to monitor the patient s temperature without affecting the operation The system continues to operate based upon the temperature of the water in the Blanketrol Ill equipment relative to the desired Bl
61. e water in the Blanketrol III equipment to reach this temperature The water circulates through the blanket and raises lowers the patient s temperature NOTE In MANUAL CONTROL MODE the Blanketrol Ill System does not read the patient s temperature Because of this special care must be taken to monitor the patient s temperature As in all cases the patient s skin integrity must be closely monitored In AUTO CONTROL MODE the operator specifies the patient s Set Point temperature In order to for this mode to function the operator must first insert or attach a 400 Series probe in or to the patient and connect the probe probe connecting cable to the BLANKETROL III unit The probe measures the patient s temperature and unit s microprocessor compares the patient s temperature reading to the specified Set Point If the patient s temperature reading measures below Set Point the BLANKETROL Ill System heats the water in the Blanketrol Ill equipment to the highest allowable water temperature 42 C 107 6 F to raise the patient s temperature NOTE The water in the Blanketrol Ill equipment will remain at 42 C 107 6 F until the patient s temperature reading is raised to Set Point If the patient s temperature reading measures above Set Point the BLANKETROL III System cools the water in the Blanketrol III equipment to the lowest allowable water temperature 4 C 39 2 F until the patient s temperature is lowered to Set Point When the patient s temp
62. efore turning the ON OFF switch the power fail alarm will activate and the power fail LED will light If the unit is turned back on this message will reappear and the trouble alarm will sound The unit cannot be used again until it is serviced The seven segment displays WATER and PATIENT will both be blank during this condition Contact CSZ Technical Service Page 60 of 84 OPERATION BLANKETROL III Model 233 OPERATION MANUAL This message occurs when the software fails and the water in the Blanketrol IIl equipment has reached the high temperature limit of 44 0 C t 2 C 111 2 F 3 6 F activating the independent safety While this message is displayed the trouble alarm will sound and the heater and pump will turn off The alarm silence key cannot silence this alarm This message will continue to display and the trouble alarm will continue to HIGH LIMIT sound until the unit is turned off using the ON OFF switch or the power REMOVE FROM SERVICE cord is disconnected from the power source If the unit is unplugged before turning the ON OFF switch the power fail alarm will activate and the power fail LED will light If the unit is turned back on this message will reappear and the trouble alarm will sound The unit cannot be used again until it is serviced The seven segment displays WATER and PATIENT will both be blank during this condition Contact CSZ Technical Service SNAP DISC REMOVE FROM SERVICE Thi
63. ehold bleach distilled water U S P Grade Propylene Glycol and the appropriate AC electrical power The following procedure disinfects the fluid circuit in these products PROCEDURE Drain the water from the reservoir as described in Section 4 2 1 Turn unit off O position Fill the reservoir with the appropriate amount of household bleach per the below chart UNIT BLEACH WATER Blanketrol 233 227 Milliliters 7 6 Liters Fill the reservoir with warm distilled water Turn the unit on and circulate per the Chemical Cleaning Circulation Chart above Drain the unit as instructed in Step 1 Rinse the unit three 3 times as described in Steps 4 6 Be sure to omit the household bleach sodium hypochlorite After the third rinse drain the unit and fill the reservoir with distilled water and circulate Page 67 of 84 eo m Doo MAINTENANCE BLANKETROL III Model 233 11 12 13 14 15 OPERATION MANUAL Check the water with pH strips or other appropriate test method for detecting bleach If bleach is detected repeat Steps 4 6 If unit is to be returned to service once no bleach is detected add the appropriate amount of U S P Grade Propylene Glycol to the water reservoir per the following chart UNIT U S P Grade Propylene Glycol Per Unit Blanketrol 233 16 ounces 500cc Continue to fill the water reservoir with distilled water If unit is being placed in dr
64. ent Use Pad 600 Adult Head Wrap KOOL KIT Single Patient Use Convenience Kits 900 Kool Kit Adult Head Wrap Patient Vest and Lower Body Pad 910 Head Wrap Kit Adult Head Wrap and Lower Body Pad 920 Patient Vest Kit Patient Vest and Lower Body Pad 930 Bariatric Kool Kit Adult Head Wrap Patient Vest and Lower Body Pad 950 Kool Kit Neonate Pediatric Pad and Esophageal Rectal Temperature Probe Gelli Roll Reusable Blankets 195P Adult Size 73 5 x 21 5 194P Pediatric Size 31 25 x 23 75 193P Infant Size 20 x 13 Miscellaneous USB 127 Data Export Software TFRW Tri matic Tester TEMPERATURE PROBES 400 Series Reusable Probes 401 Adult Esophageal or Rectal 402 Infant Esophageal or Rectal 408 Banjo Surface Temperature 409 Attachable Surface Temperature Tape on Skin 440 Probe Extension Cord 10 Length Disposable Temperature Probes and Associated Probe Connecting Cable For Use With Disposable Temperature Probes Foley Catheters and Associated Connecting Cables For Use With Disposable Catheters Contact CSZ Customer Service about product line Page 76 of 84 SPECIFICATIONS BLANKETROL III Model 233 OPERATION MANUAL SECTION 5 SPECIFICATIONS AND CERTIFICATIONS OF THE SAFETY SYSTEM Maximum High Control Setting 42 0 107 6 F BLANKETROL III BLANKETROL III MODEL 233 FEATURES PHYSICAL Dimensions 17 W x 17 D x 37 5 H 43 18cm W x 43 18 cm D x 95 25cm H Weight Empty 131 lbs 59 5kg Shipping
65. eration in MONITOR ONLY MODE the Status Display shows the following messages Status Display Message Function MONITOR ONLY CELSIUS This message is displayed when the temperature scale is set to Celsius in MONITOR ONLY MODE MONITOR ONLY FAHRENHEIT This message is displayed when the temperature scale is set to Fahrenheit in MONITOR ONLY MODE Page 59 of 84 OPERATION BLANKETROL III Model 233 OPERATION MANUAL D The following messages are warnings and indications shown in the Status Display Indication Warning Message Function CHECK SETPT This message occurs for the following three possible reasons followed by their remedial actions 1 During start up when the operator turns the unit ON a Proceed by pressing the TEMP SET button to enter the Set Point temperature 2 During start up when the operator attempts to begin one of the five Automatic Control modes with a Patient Set Point temperature selected outside the range of 30 C 40 C 86 F 104 F The unit will not permit the operator to proceed to the Automatic Control modes until the Patient Set Point temperature setting is corrected a Proceed by pressing the TEMP SET button and change the SET POINT temperature to bring it within the allowable range 3 During operation a low water condition could cause CHECK SETPT to indicate a Check the water level in the reservoir and fill the unit with water as ne
66. erature reading reaches Set Point the system continues circulating the water through the system but stops heating cooling it If the patient s temperature reading deviates from Set Point the system heats cools the circulating water again until the patient s temperature reading reaches Set Point As in all cases the patient s skin integrity must be closely monitored In GRADIENT 10C MODE the operator specifies the patient s Set Point temperature and the BLANKETROL III System operates as in AUTO CONTROL MODE except for the following The system monitors the patient s temperature and maintains the temperature of the water in the Blanketrol Ill at a maximum of 10 C 18 F from the patient s temperature reading This will gradually raise lower the patient s temperature to Set Point When the patient s temperature reading reaches Set Point the system continues circulating the water through the system but stops heating cooling it If the patient s temperature reading deviates from Set Point the unit will automatically resume full operation in GRADIENT 10C MODE until the patient s temperature again reaches Set Point As in all cases the patient s skin integrity must be closely monitored In GRADIENT VARIABLE MODE the operator specifies the patient s Set Point temperature and the BLANKETROL 1 System operates as in AUTO CONTROL MODE except for the following The system monitors the patient s temperature and maintains the temperature of the water
67. erviced The seven segment displays WATER and PATIENT will both be blank during this condition Contact CSZ Technical Service EEO1 REMOVE FROM SERVICE This message occurs when EE01 appears in the PATIENT temperature display Both messages appear when the backup processor does not agree with the primary processor While both messages are displayed the trouble alarm will sound and the heater compressor and pump will turn off The alarm silence key cannot silence this alarm Both messages will continue to display and the trouble alarm will continue to sound until the unit is turned off using the ON OFF switch or the power cord is disconnected from the power source If the unit is unplugged before turning the ON OFF Switch the power fail alarm will activate and the power fail LED will light If the unit is turned back on only EE01 REMOVE FROM SERVICE will reappear in the Status Display and the trouble alarm will sound The unit cannot be used again until it is serviced Contact CSZ Technical Service SENSOR FAULT REMOVE FROM SERVICE This message will be displayed if the water temperature sensor is open or shorted The trouble alarm will sound and this message will continue to display until the power cord is disconnected from the power source The unit cannot be used again until it is serviced While this message is displayed the trouble alarm will sound and the heat compressor and pump will be off The alarm s
68. es with IEC 60601 1 2 e Always unplug the unit before accessing internal components during service Failure to unplug the unit could result in electric shock e The repair calibration and servicing of the BLANKETROL III should be performed by qualified Medical Equipment Service Technicians Certified Biomedical Electronics Technicians or Certified Clinical Engineers familiar with good repair practices for servicing medical devices and in accordance with instructions contained in this manual Improper repair can result in damage to the BLANKETROL Ill system and patient injury e No modification of this equipment is allowed without prior written authorization from CSZ Before returning the BLANKETROL III to patient use after repairs the FIRST TIME SET UP SYSTEM TEST ROUTINE in Section 2 must always be performed Improper repair and inadequate maintenance can result in damage to the BLANKETROL Ill system and patient injury e Remove the BLANKETROL III from service if the outer casing or membrane control panel is cracked or internal components are exposed Contact with internal components could result in electric shock or thermal injury to the patient or operator and exposure to sharp edges Keep grill and condenser clean and free of debris and obstruction Blockage of the grill and condenser could result in the unit overheating which could render the unit unable to provide adequate therapy and excessive surface tempe
69. first Draining Replenishing the Reservoir Cleaning the Condenser and Grill Maintenance Checklist Cleaning the Water Filter Cleaning Water System Cleaning the Exterior of the Unit Cleaning Hyper Hypothermia Blankets Cleaning Thermistor Probes Check Leakage Current Cleaning the Water Flow Indicator Assembly Test low and high temperature protection Page 65 of 84 MAINTENANCE BLANKETROL III Model 233 OPERATION MANUAL Check temperature accuracy FIGURE 4 1 BLANKETROL Ill MAINTENANCE CHECKLIST REQUIRED PREVENTIVE MAINTENANCE CHECKLIST Quarterly or when indicated by 500 hour PM notification BLANKETROL III Model 233 Hospital Control No Serial Number Check When Completed 1 External cabinet in good condition No unusual dents or missing parts Ul 2 All labels properly affixed Ll 3 Quick disconnect couplings are tight straight and not leaking Ll 4 Power cord no cuts or exposed wire and plug no bent or missing prongs Ll 5 Indicator lights are operative E 6 Drain and clean reservoir See Section 4 2 L a Check circulation through each male coupling with drain hose Ll 7 Clean water filter See Section 4 3 E Refill reservoir with distilled sterile distilled water See Section 4 2 2 E 9 Condition of blankets hoses and couplings check for leaks Ll 10 Connecting hoses are tight and not leaking Ll Signature of Inspector Date of Inspection Page 66 of 84 MAINTENANCE BLANKETROL III Model 233
70. he clear plastic cap of the water filter assembly Quarterly or more often if deemed necessary the water filter should be disassembled and cleaned To do so the reservoir must first be drained and the rear enclosure panel removed The cap of the water filter assembly is unscrewed The wire mesh and the plastic cap are cleaned The parts are then reassembled CAUTION Always drain the BLANKETROL III to a sanitary drain because bio contaminants may be present in the unit s water supply After draining the reservoir as described in Section 4 2 1 A Disconnect the unit from its power source Page 71 of 84 MAINTENANCE BLANKETROL III Model 233 OPERATION MANUAL WARNING The repair calibration and servicing of the BLANKETROL III should be performed by qualified Medical Equipment Service Technicians Certified Biomedical Electronics Technicians or Certified Clinical Engineers familiar with good repair practices for servicing medical devices and in accordance with instructions contained in this manual Improper repair can result in damage to the BLANKETROL Ill system and patient injury Always unplug the unit before accessing internal components during service Failure to unplug the unit could result in electric shock B Remove the back panel Locate the water filter assembly as shown in Figure 4 2 D Firmly grasp the notched rim of the cap of the assembly and turn it counterclo
71. he reservoir To do so lift the cover of the water fill opening and check if the water is visibly touching the strainer If needed carefully add distilled water In addition if the water falls below a preset level the alarm sounds and the Status Display flashes LOW WATER The operator cannot proceed until this is corrected as described in Sections 3 12 D and 4 2 2 E Check that the power switch is in the O position unit is off E Inspect the power plug for bent or missing prongs WARNING Do not by pass ground lug 230V System Electrical hazards may result G Insert the plug into a properly grounded hospital grade receptacle H Lay the hyper hypothermia blanket flat with the hose routed without kinks towards the unit If the blanket is already filled check that there are no leaks WARNING Proper sanitation procedures should be followed including but not limited to the preventative maintenance described in this manual Leaky blankets or hoses as well as unapproved blankets or hoses should never be used Water leaks present a risk of infection and should be handled accordingly J Cover the blanket with a dry sheet or bath blanket if using PASTI PAD or MAXI THERM Blanket K Connect the blanket to the BLANKETROL III unit as described in Section 2 3 1 Step G L If a MAXI THERM or MAXI THERM LITE single patient use hyper hypothermia blanket is used connect the color coded c
72. hird rinse drain the unit and fill the reservoir with distilled water and circulate 9 Check the water with PH strips or other appropriate test method for Gigasept FF detection If Gigasept FF is detected repeat Steps 4 6 10 If unit is to be returned to service replenish reservoir s with the appropriate volume of distilled water 11 If unit is being placed in dry storage continue with procedure 12 When all fluid has been removed from the unit disconnect the drain hose s and wipe unit clean 13 Unit is now ready for storage 14 Document unit maintenance Page 68 of 84 MAINTENANCE BLANKETROL III Model 233 OPERATION MANUAL FLUID CIRCUIT DISINFECTION DRY STORAGE PROCEDURE for Circulating Water Units Utilizing CE Approved Maranon H Product of Ecolab Contact your local Cleaning Supplier Maranon H Is Not Available In the United States The following procedure disinfects the fluid circuit in these products The required tools supplies are appropriate drain hose s and or hose connector s Maranon H distilled water and the appropriate AC electrical power DI Oy ee 10 11 12 13 14 PROCEDURE Drain the water from the reservoir as described in Section 4 2 1 Turn unit off O position Fill the reservoir with the appropriate amount of Maranon H per the below chart UNIT MARANON H WATER Blanketrol 233 227 Milliliters 7 6 Liters Fill the reservoir with the appropriate amount of w
73. iew the suggestions for patient care described in Section 2 5 If at any time the Status Display shows a message other than the messages described in GRADIENT VARIABLE SMART MODE procedures make the changes indicated by the display and or consult the list of display messages in Section 3 12 If at any time the unit sounds an alarm and the Status Display flashes a message make the changes indicated To turn off the unit or discontinue hyper hypothermia treatment proceed as described in Section 3 11 NOTE IN ORDER TO CHANGE FROM GRADIENT VARIABLE SMART MODE TO ANOTHER CONTROL MODE FIRST PRESS THE TEMP SET BUTTON AND THEN SELECT THE OPERATING MODE OF CHOICE In order to change from GRADIENT VARIABLE SMART MODE to MONITOR ONLY MODE simply press the MONITOR ONLY button 3 10 OPERATING THE BLANKETROL III SYSTEM IN MONITOR ONLY MODE The BLANKETROL III System can be set so it displays the patient s temperature but does not heat cool or circulate the water In this operating mode the patient may or may not already be positioned on a hyper hypothermia blanket but the unit and the 400 Series probe must be arranged as described in Section 3 2 After arranging the equipment proceed as follows A Check the placement of the 400 Series probe in or on the patient B Connect the probe to the 1 4 inch receptacle on the right side of the unit C Press the power switch to I position 1 The switch illuminates green 2 The
74. ilence key cannot silence this alarm The seven segment displays WATER and PATIENT will both be blank during this condition This message will also be displayed if the WATER temperature is out of the range 0 C 52 0 C 32 F 125 6 F of the available temperature readout Contact CSZ Technical Service Page 62 of 84 OPERATION BLANKETROL III Model 233 OPERATION MANUAL CHECK PROBE This message is displayed to alert the operator when the probe needs to be checked For instance 1 If the probe is operating outside of the normal operating range of 30 0 C 43 5 86 F to 110 3 F during any automatic mode this message will be displayed If the probe is not connected to the 1 4 inch receptacle prior to pressing any of the automatic modes button If the probe is dislodged from the patient If the PATIENT temperature falls below 30 C 86 F If the PATIENT temperature is greater than 43 5 C 110 3 F If the probe is defective or open If other than a 400 Series probe was connected to the 1 4 inch receptacle m DX DT de Co As this message is displayed the trouble alarm sounds and the unit shuts down The operator can silence the alarm by pressing the SILENCE ALARM button After silencing the alarm and checking the probe the operator must press the TEMP SET button to proceed otherwise STATUS will continue to display CHECK PROBE The operator has 5 minutes to fix the probe If after that time th
75. in the Blanketrol Ill equipment at a programmable temperature difference from the patient s temperature reading NOTE This temperature difference is set by the operator This will gradually bring the patient s temperature to Set Point according to the specific needs of the patient determined by the caregiver When the patient s temperature reading reaches Set Point the system continues circulating the water through the system but stops heating cooling it If the patient s temperature reading deviates from Set Point the system will automatically resume full operation in GRADIENT VARIABLE MODE until the patient s temperature again reaches Set Point As in all cases the patient s skin integrity must be closely monitored Page 21 of 84 INTRODUCTION BLANKETROL III Model 233 OPERATION MANUAL In SMART MODE the BLANKETROL III System compares the patient s temperature to the Set Point temperature selected by the operator Every 30 minutes the system adjusts the water temperature in the Blanketrol Ill equipment or 5 0 C as appropriate Once the patient reaches Set Point the SMART MODE becomes temporarily inactive and the unit simply maintains the patient s temperature If the patient s temperature deviates from Set Point the unit automatically switches to SMART MODE until the patient s temperature again reaches Set Point NOTE the lowest allowable water temperature is 4 C 39 2 F and the highest allowable water temperature is 42 C
76. ion of the Blanketrol III Membrane Control Panel The membrane control panel as shown in Figure 1 4 A for 115 Volt and 1 4 B for 230 Volt is composed of pressure sensitive touch switches and LED displays The membrane control panel is divided into the following sections A The green LED display labeled WATER shows the water temperature in the Blanketrol Ill equipment The MANUAL CONTROL button is used to activate the MANUAL CONTROL MODE This mode s operation is based on the water temperature within the Blanketrol Ill equipment relative to the desired Set Point temperature The green LCD display reports the status of the unit displays the Set Point and or indicates changes the operator should make It is referred to as the Status Display The possible Status Displays are listed in Section 3 12 The TEMP SET button and the Up and Down arrow buttons are used to adjust the Set Point as shown on the LCD display The green LED display labeled PATIENT shows the patient s temperature reading The AUTO CONTROL button is used to activate the AUTO CONTROL MODE In this mode the operation is based on the patient s temperature relative to the desired Set Point temperature The GRADIENT 10C button is used to activate the GRADIENT 10C MODE In this mode the operation is based on the patient s temperature relative to the desired Set Point temperature The GRADIENT VARIABLE button is used to activate the unit GRADIENT VARIABLE MODE I
77. ired patient Set Point temperature As a safety precaution the desired patient Set Point can only be set between 30 C 40 C 86 F 104 F to operate in GRADIENT VARIABLE MODE E Use the C F button to choose the desired temperature scale F Press the TEMP SET button 1 The microprocessor board beeps 2 The LED in the corner of the button illuminates 3 The Status Display shows a temperature Set Point G Press the Up arrow or Down arrow to change the Set Point temperature on the Status Display to the desired patient temperature The display can only be set between 30 C 40 C 86 F 104 F 1 The microprocessor board beeps 2 The Set Point temperature in the Status Display changes H Press the GRADIENT VARIABLE button 1 The microprocessor board beeps 2 The LED in the corner of the button illuminates 3 The Status Display shows a gradient variable Press the Up arrow or Down arrow to change the gradient variable offset to the desired value 1 The microprocessor board beeps 2 The Set Point temperature in the Status Display changes J Press the GRADIENT VARIABLE button Page 52 of 84 OPERATION BLANKETROL III Model 233 OPERATION MANUAL 1 The microprocessor board beeps 2 The LED in the corner of the button illuminates 3 The PATIENT display shows the patient s actual temperature 4 The WATER display shows the actual temperature of the water in the Blanketrol Ill equipment The Status Disp
78. it near any objects that can generate a strong electrical magnetic field Potential electromagnetic interference may result Unit complies with IEC 60601 1 2 Always unplug the unit before accessing internal components during service Failure to unplug the unit could result in electric shock e The repair calibration and servicing of the BLANKETROL III should be performed by qualified Medical Equipment Service Technicians Certified Biomedical Electronics Technicians or Certified Clinical Engineers familiar with good repair practices for servicing medical devices and in accordance with instructions contained in this manual Improper repair can result in damage to the BLANKETROL Ill system and patient injury e No modification of this equipment is allowed without prior written authorization from CSZ Before returning the BLANKETROL III to patient use after repairs the FIRST TIME SET UP SYSTEM TEST ROUTINE in Section 2 must always be performed Improper repair and inadequate maintenance can result in damage to the BLANKETROL Ill system and patient injury e Remove the BLANKETROL III from service if the outer casing or membrane control panel is cracked or internal components are exposed Contact with internal components could result in electric shock or thermal injury to the patient or operator and exposure to sharp edges Keep grill and condenser clean and free of debris and obstruction Blockage of the grill and
79. its can clog plumbing system components Do not use alcohol Alcohol may cause blanket and unit deterioration e Use only hospital grade plug or electric shock may result Do not overfill Overfilling may result in overflow when the water in the blanket drains back into the system when the system is turned off e Always drain the BLANKETROL III to a sanitary drain because bio contaminants may be present in the unit s water supply e If possible remove the probe from patient contact before activating an electrosurgical unit ESU Do not immerse probes or connecting cables in liquid If the unit was shipped on its side permit the unit to rest in an upright position for twelve 12 hours before operating due to refrigeration oil displacement e For safe handling and use of chemicals follow manufacturer guidelines Do not make any connection to this terminal while the device is also connected to a patient Do not touch this connector and the patient at the same time e Users should not use cleaning or decontamination methods different from those recommended by CSZ without first checking with CSZ that the proposed methods will not damage the equipment A dry sheet should be placed between the hyper hypothermia blanket and the patient when using PLASTI PAD or MAXI THERM Blankets The MAXI THERM LITE Blanket does not require an interposed sheet While using a hyper hypothermia blan
80. ket turn the unit off disconnect the power cord from its power source and correct the problem before proceeding Proper maintenance procedures should be followed including but not limited to the preventative maintenance describe in this manual Leaky blankets or hoses should never be used Water leaks present a risk of electrocution Proper sanitation procedures should be followed including but not limited to the preventative maintenance described in this manual Leaky blankets or hoses as well as unapproved blankets or hoses should never be used Water leaks present a risk of infection and should be handled accordingly Page 36 of 84 OPERATION BLANKETROL Ill Model 233 OPERATION MANUAL WARNING Prep solutions have been reported to injure the skin when allowed to remain between patients and a water circulating heating blanket during prolonged procedures Use of materials of good thermal conductivity such as water gel and similar substances with the Blanketrol Ill not switched ON may decrease the temperature of the patient The area between the patient and the blanket should be kept dry to avoid injury to patient Exercise extreme caution if the BLANKETROL III System is used on patients with cardiac issues for example patients with pacemakers or when a probe is inserted in or attached to the patient Failure to properly monitor patient may result in serious injury or death e Do not position un
81. ket include the following tasks A Patient core temperature and the condition of the skin in contact with the blanket and blanket water temperature should be checked every twenty minutes or per hospital institution policy protocol Surgical patients temperature sensitive and pediatric patients should be checked more frequently Notify the physician if the patient s core temperature does not reach the prescribed temperature in the time prescribed or deviates from the prescribed temperature range B The position and the placement of the 400 Series probe should be inspected regularly Also the BLANKETROL III System activates an alarm the automatic modes when the patient probe registers outside the range of 30 C 43 5 86 F 110 3 F C Changes in skin color edema inflammation or indications of pressure especially over bony prominences should be noted and treated promptly as ordered Avoid prolonged tissue pressure and shearing forces over bony prominences Page 38 of 84 OPERATION BLANKETROL III Model 233 OPERATION MANUAL D The patient should be turned and properly re positioned according to hospital institution policy protocol SECTION 3 OPERATING THE BLANKETROL III SYSTEM 3 1 INTRODUCTION This section describes how to operate the BLANKETROL III System in order to control a patient s temperature First collect the equipment and prepare the patient Second decide which mode of operation to use Third set th
82. l The water flow indicator only spins when a blanket or by pass hose is connected to the unit It will not spin while the water is being circulated internally to pre condition the water to the preset water temperature chosen by the operator A total obstruction of the water path will cause the paddle wheel to stop completely The air vents on both the right and left side of the unit provide air circulation for the microprocessor The four capped screws on the right and left side of the unit secure the top to the base The patient 1 4 inch receptacle is where the 400 Series probe refer to Table 4 2 for a list of temperature probes is connected to the unit Only one patient probe can be connected at a time Three female quick disconnect return couplings on the top row are designed for water to flow in when the male coupling of the connecting hose is attached The three male quick disconnect outlet couplings on the bottom row are designed for water to flow out when the female coupling of the connecting hose is attached The power cord with a hospital grade plug should only be plugged into a properly grounded hospital grade receptacle Electrical Specifications are described in Section 5 The isolation label indicates that the Blanketrol III and the blanket applied part are BF rated as a system Contact with other parts i e the quick disconnect couplings at the same time as contacting the patient will negate th
83. l activate and the Power fail symbol LED located on the Page 41 of 84 OPERATION BLANKETROL III Model 233 3 3 OPERATION MANUAL membrane control panel will flash To stop the alarm restore power or push the SILENCE ALARM button In the case that the unit is powered off for 5 seconds or less the unit will resume the previous operation mode However if power is off longer than 5 seconds the unit will go into power fail alarm mode OPERATING THE BLANKETROL III SYSTEM IN AUTO CONTROL MODE WARNING A physician s order is required for setting blanket temperature and use of equipment At least every 20 minutes or as directed by physician check patient s temperature and skin integrity of areas in contact with blanket also check blanket water temperature Pediatric patients temperature sensitive patients with vascular disease surgical patients diabetics and patients with Raynaud s Disease should be checked more frequently Notify the physician promptly of any change in patient status in order to avoid serious injury or death In AUTO CONTROL MODE the BLANKETROL III System can monitor the patient s temperature and deliver the maximum heating or cooling therapy in order to bring the patient s temperature to a Set Point chosen by the operator After arranging the equipment as described in Section 3 2 proceed as follows A Check the placement of the 400 Series probe in or on the patient B Connect the 400 Se
84. lay shows either XXXXXX PATIENT AUTO SETPT 37 0 C Or Status Display shows PATIENT SETPT AUTO SETPT 37 0 C XXXXXX represents HEATING or COOLING The above depends upon the relationship of the blanket water temperature to the Set Point temperature Note that the Set Point may be displayed in Fahrenheit 6 The pump is activated The heater or compressor may also be activated 7 The water flow indicator on the right side panel begins to move 8 The water moves from the unit to the blanket and returns to the unit K Check the water flow indicator to confirm that the water is circulating L Touch the hyper hypothermia blanket to confirm that the blanket is heating cooling M To make any changes in the control settings press the TEMP SET button and begin again The BLANKETROL III System is now operating in GRADIENT VARIABLE MODE You should continue to monitor the system and the patient Review the suggestions for patient care described in Section 2 5 If at any time the Status Display shows a message other than the messages described in GRADIENT VARIABLE MODE procedures make the changes indicated by the display and or consult the list of display messages in Section 3 12 If at any time the unit sounds an alarm and the Status Display flashes a message make the changes indicated To turn off the unit or discontinue hyper hypothermia treatment proceed as described in Section 3 11 NOTE IN ORDER TO CHANGE FRO
85. ll cases the patient s skin integrity must be closely monitored After arranging the equipment as described in Section 3 2 proceed as follows A Press the power switch to the I position 1 The switch illuminates green 2 The microprocessor board goes through self test 3 The Status Display flashes CHECK SETPT B Consult the physician s orders to determine the desired patient Set Point temperature and the desired water temperature setting C Press the TEMP SET Switch 1 The microprocessor board beeps 2 The LED in the corner of the button illuminates 3 The SET POINT display shows a temperature reading Page 44 of 84 OPERATION BLANKETROL III Model 233 OPERATION MANUAL 4 The Status Display shows SET TEMP D Use the C F button to choose the desired temperature scale E Press the Up arrow or Down arrow to change the SETPOINT display to the desired water Set Point temperature As a safety precaution the water temperature in the Blanketrol Ill equipment can only be set between 4 C 42 C 39 2 F 107 6 F 1 The microprocessor board beeps 2 The Status Display changes F Press the MANUAL CONTROL switch 1 The microprocessor board beeps 2 The LED in the corner of the button illuminates 3 The BLANKET WATER display shows the actual temperature of the water in the Blanketrol Ill equipment 4 The Status Display shows XXXXXX WATER MANUAL SETPT 37 0 Or Status Display shows WATER SETPT MAN
86. low water level sensor which shuts down the unit and sounds the alarm if the water level drops below a preset amount The unit becomes operational only after the water level is restored to normal After the unit is refilled with water the system must be returned to the previous operational settings 1 5 5 Temperature Safety Control System The BLANKETROL III System is designed to carefully measure and control the temperature of the water in the Blanketrol Ill equipment The system is engineered so that when the temperature of the water in the Blanketrol III equipment reaches the desired Set Point temperature the unit cycles between heating and cooling the water in order to maintain the Set Point temperature The unit is designed not to exceed or fall below the desired temperature As a Safety precaution the BLANKETROL III System has three high temperature safety devices and two low temperature safety devices Each safety device continuously monitors the temperature of the water in the Blanketrol III equipment As an additional precaution if the water temperature sensor itself should fail the unit shuts down and indicates SENSOR FAULT REMOVE FROM SERVICE With this safety design both the patient and the unit are protected from injury or damage caused by extreme temperatures Page 23 of 84 INTRODUCTION BLANKETROL III Model 233 OPERATION MANUAL The operator must regularly monitor the patient according to hospital institution policy pr
87. maintenance procedures should be followed including but not limited to the preventative maintenance describe in this manual Leaky blankets or hoses should never be used Water leaks present a risk of electrocution Proper sanitation procedures should be followed including but not limited to the preventative maintenance described in this manual Leaky blankets or hoses as well as unapproved blankets or hoses should never be used Water leaks present a risk of infection and should be handled accordingly Page 4 of 84 OPERATION MANUAL BLANKETROL III MODEL 233 WARNING Prep solutions have been reported to injure the skin when allowed to remain between patients and a water circulating heating blanket during prolonged procedures Use of materials of good thermal conductivity such as water gel and similar substances with the Blanketrol Ill not switched ON may decrease the temperature of the patient The area between the patient and the blanket should be kept dry to avoid injury to patient Exercise extreme caution if the BLANKETROL III System is used on patients with cardiac issues for example patients with pacemakers or when a probe is inserted in or attached to the patient Failure to properly monitor patient may result in serious injury or death e Do not position unit near any objects that can generate a strong electrical magnetic field Potential electromagnetic interference may result Unit compli
88. n the corner of the button illuminates 3 The Status Display shows SET TEMPERATURE SETPT 37 0 C D 115V ONLY Press the C F button 1 The SETPT temperature displayed in the Status Display changes from 37 C to 98 6 F E Press the MONITOR ONLY button 1 The LED in the corner of the MONITOR ONLY switch illuminates 2 An alarm sounds 3 The Status Displays CHECK PROBE because no probe is attached F Press the TEMP SET switch 1 The microprocessor board beeps once and the alarm stops sounding 2 The LED in the corner of the button illuminates 3 The Status Display shows SET TEMPERATURE SETPT 37 0 C NOTE Set point may be displayed in Fahrenheit INORDER TO CHANGE FROM ONE MODE TO ANOTHER THE TEMP SET BUTTON MUST BE PRESSED BEFORE THE NEXT MODE CAN BE SET For example to change from MONITOR ONLY MODE to MANUAL CONTROL MODE the TEMP SET button must be pressed first before the MANUAL CONTROL MODE button can be pressed However it is possible to move to MONITOR ONLY MODE from any other mode without pressing TEMP SET G Press the MANUAL CONTROL switch The microprocessor board beeps The LED in the corner of the button illuminates The WATER display shows the temperature of the water in the reservoir The Status Display shows XXXXXX WATER MANUAL SETPT 37 0 C Or Status Display shows WATER SETPT MANUAL SETPT 37 0 C Fons represents HEATING or COOLING The above depends upon th
89. n this mode the operation is based on the patient s temperature relative to the desired Set Point temperature The SMART button is used to activate the SMART function in the appropriate modes The MONITOR ONLY button is used to monitor the patient s temperature without heating cooling or circulating the water The two switches labeled TEST INDICATORS and SILENCE ALARM are used to confirm that all the indicators on the membrane control panel are working and to silence the alarm in certain conditions The POWER FAILURE symbol flashes the red LED to the left of the symbol and sounds an audible alarm when the unit loses power or when power has been interrupted restored and the unit does not resume previous operation Page 18 of 84 INTRODUCTION BLANKETROL III Model 233 OPERATION MANUAL M The LOW WATER symbol indicates the unit is low on water The unit flashes the red LED to the left of the symbol sounds an audible alarm and displays LOW WATER in the Status Display Refer to Section 3 12 D Low Water N The C F Button allows the operator to select the measurement scale Celsius or Fahrenheit by which the unit functions This feature is only available on 115 Volt BLANKETROL III Systems B eee oF MANUAL CONTROL ci ci COS ENT ED Vi Dd o Q e NITOR D Cincinnoti Sub Zero VARIABLE BLANKETROL Hl 56e Y FIGURE 1 4 A BLA
90. nterruptions and voltage variations on power supply input lines IEC 61000 4 11 lt 5 295 dip in for 0 5 cycle 40 60 dip in Ur for 5 cycles 70 30 dip in Ur for 25 cycles lt 5 295 dip Ur for 5 lt 5 295 dip Ur for 0 5 cycle 40 60 dip in for 5 cycles 70 30 dip in U1 for 25 cycles 596 295 dip Ur for 5 Mains power quality should be that of a typical commercial or hospital environment If the user of the Blanketrol III Model 233 requires continued operation during power mains interruptions it is recommended that the Blanketrol III Model 233 be powered from an uninterruptible power supply or a battery Page 79 of 84 SPECIFICATIONS BLANKETROL III Model 233 OPERATION MANUAL Power frequency 3 A m 3 A m Power frequency magnetic fields should be at levels 50 60 Hz magnetic field IEC 61000 4 8 characteristic of a typical location in a typical commercial or hospital environment Note U7 is the a c mains voltage prior to application of the test level TABLE 5 3 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY The Blanketrol III Model 233 is intended for use in the electromagnetic environment specified below The customer or the user of the Blanketrol III Model 233 should assure that it is used in such an environment Immunity test
91. o a properly grounded hospital grade receptacle 2 3 2 Completing a System Test Routing After arranging the equipment described in Section 2 3 1 complete this System Test Routine which describes what switches to press and the changes to observe NOTE If power is removed from the unit without actuating the power switch VO switch a power fail alarm is activated and the Power fail symbol LED located on the membrane control panel flashes To stop alarm restore power to the unit and push the SILENCE ALARM button A sure that the power switch is in the I position unit is turned on 1 The switch illuminates green 2 The microprocessor board goes through self test 3 The Status Display in the center of the membrane control panel flashes CHECK SETPT If the above are observed continue with the test routine if not remove unit from service B Press and hold the TEST INDICATOR button 1 The alarm produces a beep 2 The LED s in the corner of the buttons and the low water and power interruption LED s flash on and then off 3 All the displays flash The operator should note that all the displays and indicators illuminate If they illuminate continue with the test routine if not remove unit from service The Status Display continues to flash CHECK SETPT Page 27 of 84 OPERATION BLANKETROL III Model 233 OPERATION MANUAL C Press the TEMP SET button The microprocessor board beeps 2 The LED i
92. of the power switch goes out Remove the 400 Series probe from the 1 4 inch receptacle on the right side of the unit Disconnect the power cord from the power source loosely coil it and attach it to the back panel using the nylon strap For reusable PLASTIPAD blankets disconnect the connecting hose from the unit Loosely coil the hose lengthwise in the center of the blanket Fold the blanket lengthwise into the center 1 3 from the left side and 1 3 from the right side To drain the water from the reusable blanket simply shut off power to the unit or shut off the operation of the manual or automatic mode and allow the water to drain from the blanket back into the Blanketrol unit For single use blankets i e MAXI THERM and MAXI THERM LITE blankets follow the instructions packaged with the blanket The water should be changed quarterly as described in Section 4 2 Page 34 of 84 OPERATION BLANKETROL III Model 233 OPERATION MANUAL The BLANKETROL III unit connecting hose blanket s and probe are now ready for patient use 2 4 UNIT AND PATIENT RELATED PRECAUTIONS This unit requires both water and electricity to operate Please consult page IV and V at the beginning of the manual for a complete list of warnings and cautions related to the BLANKETROL III A Anytime the unit sounds an alarm the operator should immediately check the Status Display and act accordingly e g add water remove from service check the probe
93. on 3 7 OPERATING THE BLANKETROL III UNIT IN GRADIENT 10C SMART MODE WARNING A physician s order is required for setting blanket temperature and use of equipment At least every 20 minutes or as directed by physician check patient s temperature and skin integrity of areas in contact with blanket also check blanket water temperature Pediatric patients temperature sensitive patients with vascular disease surgical patients diabetics and patients with Raynaud s Disease should be checked more frequently Notify the physician promptly of any change in patient status in order to avoid serious injury or death The BLANKETROL III System can be set to gradually change a patient s temperature by maintaining the water in the Blanketrol Ill equipment at a maximum temperature 10 C 18 F different from the patient s body temperature and then increasing the gradient offset temperature difference between the patient s temperature and the water temperature by 5 C 9 F every 30 minutes After arranging the equipment as described in Section 3 2 proceed as follows A Check the placement of the 400 Series probe in or on the patient B Connect the probe to the 1 4 inch receptacle on the right side of the unit C Press the power switch to I position Page 49 of 84 OPERATION BLANKETROL III Model 233 OPERATION MANUAL 1 The switch illuminates green 2 The microprocessor board goes through self test 3 Th
94. or attached to the patient at least one minute before pressing a control mode button This will prevent the accidental triggering of the CHECK PROBE status message 4 The probe connecting cable is used to connect the BLANKETROL III System to disposable temperature probes 5 The catheter connecting cable is used to connect the BLANKETROL III System to disposable temperature probe catheters Q If an upper hyper hypothermia blanket is to be used follow instructions in step J R Connect the top blanket to the unit following the procedure described in Section 2 3 1 Step G S If no top hyper hypothermia blanket is used cover the patient with a top sheet and or blanket Patient preparation and bedside care are further described in Section 2 5 T Choose which operating mode to use Operating in AUTO CONTROL MODE is described in Section 3 3 Operating in MANUAL CONTROL MODE is described in Sections 3 4 and 3 5 Operating in GRADIENT 10C MODE is described in section 3 6 Operating in GRADIENT 10C SMART MODE is described in Section 8 7 Operating in GRADIENT VARIABLE MODE is described in Section 3 8 Operating in GRADIENT VARIABLE SMART MODE is described in Section 3 9 Operating in MONITOR ONLY MODE is described in Section 3 10 NOTE The maximum contact surface temperature is 41 C NOTE If at anytime power is removed from the unit without actuating the power switch I O switch a power fail alarm wil
95. ote that the rate of change in the temperature of the water in the Blanketrol III equipment is not directly proportional to the rate of change in the patient s temperature 1 5 3 Cooling System The BLANKETROL III cooling system is composed of a compressor condenser condenser fan an evaporator coil water temperature control solenoid valve hot gas by pass valve and two low temperature safety devices Temperature ranges are described in Section 1 5 5 The refrigerant of the cooling system flows through the evaporator coil located in the circulating reservoir The water circulating in the reservoir flows over the evaporator coil and is cooled The cooling system is operational whenever the control system calls for a decrease in the temperature of the water in the Blanketrol Ill equipment It is important to note that the rate of change in the circulating water temperature is not directly proportional to the rate of change in the patient s temperature Page 22 of 84 INTRODUCTION BLANKETROL III Model 233 OPERATION MANUAL 1 5 4 Circulating System The BLANKETROL III circulating water system is composed of a magnetically driven circulating pump a dual compartment reservoir a water filter quick disconnect fittings connecting hose an internal by pass a flow switch a flow indicator and hyper hypothermia blanket s The 2 gallon 7 6 liters capacity dual compartment reservoir is composed of the circulating reservoir situate
96. otocol whenever hyper hypothermia therapy is used SAFETY CONTROLS FOR PROTECTION FROM HIGH TEMPERATURE The microprocessor controls the temperature when the water in the Blanketrol III equipment reaches 42 0 0 5 C 107 6 1 0 F If the water in the Blanketrol Ill equipment reaches 44 0 C 2 0 C 111 2 F 3 6 safety device shuts off the unit Status Display flashes HIGH LIMIT REMOVE FROM SERVICE and the trouble alarm sounds If software fails and circulating water reaches 44 0 C 2 C 111 2 F 3 6 F the back up safety device shuts off the unit the Status Display flashes HIGH LIMIT REMOVE FROM SERVICE and the trouble alarm sounds If the reservoir water temperature reaches 46 C 2 C 114 8 3 6 F the thermostatic snap disc shuts down the unit Status Display flashes SNAP DISC REMOVE FROM SERVICE the patient display indicates EE02 and the trouble alarm sounds SAFETY CONTROLS FOR PROTECTION FROM LOW TEMPERATURE The microprocessor controls the temperature when the water in the Blanketrol III equipment reaches 4 0 C 0 5 39 2 F 1 0 F If the water in the Blanketrol Ill equipment reaches 2 0 C 2 0 35 6 F 3 6 F the safety device shuts off the unit the Status Display indicates LOW LIMIT REMOVE FROM SERVICE and the trouble alarm sounds If software fails and water in the Blanketrol Ill equipment reaches 2 0 C 2 C 35 6 F 3 6 F back up safety device shuts off the unit the St
97. ouplings of the connecting hose to the blanket as described in the instructions packaged with each blanket M Check that the blanket is flat and the connecting hose is not twisted or pinched N The hyper hypothermia blanket may be pre cooled or pre warmed before positioning the patient To do so operate the system in MANUAL CONTROL MODE for a few minutes O Place the patient on the hyper hypothermia blanket WARNING Use proper precautions when handling or using the patient probe Failure to do so may result in damage from electrostatic discharge ESD Page 40 of 84 OPERATION BLANKETROL III Model 233 OPERATION MANUAL If the patient s temperature is to be monitored as required in an automatic control mode or MONITOR ONLY MODE insert or attach a 400 Series probe in or on the patient 1 A rectal probe is inserted into the rectum and secured with tape to the leg of the patient 2 The diaphragm of a skin probe is taped to the patient usually under the patient s arm or on the chest 3 The esophageal probe is inserted in the patient It is often preferred that the patient is comatose or under anesthesia when the probe is placed in the esophagus The 400 Series probe should be inspected periodically to insure that it is not dislodged or impacted The BLANKETROL III System sounds an alarm when the reading from the probe falls below 30 86 F It is important that the 400 Series probe be inserted in
98. r e nennen 23 125 6 USB Port Operation et ate t ae te e etl eos 24 SECTION 2 GENERAL PREPARATION OF THE BLANKETROL III SYSTEM 25 2 1 INTRODUCTION 2 eint align abe ber et ri ee bestem pente De 25 2 2 UNPACKING THE SHIPMENT 2 2 ptr P atr uper e nee beste er item eerte Po tute 25 2 3 FIRST TIME SET UP SYSTEM TEST ROUTINE ie 25 2 3 1 Inspecting and Arranging the 26 2 3 2 Completing a System Test iii 27 2 4 UNIT AND PATIENT RELATED PRECAUTIONS ii 35 2 5 PATIENT PREPARATION AND BEDSIDE CARE i 35 SECTION 3 OPERATING THE BLANKETROL III SYSTEM 4 ereeeeen rice sere eee sere eee se statuo 39 3 1 INTRODUGCTION 5 2 REIR aee e Pare e ee ee ia anni 39 3 2 ARRANGING THE SYSTEM COMPONENTS 39 3 3 OPERATING THE BLANKETROL III SYSTEM IN AUTO CONTROL MODE eee 42 3 4 OPERATING THE BLANKETROL III SYSTEM IN MANUAL CONTROL MODE 44 3 5 OPERATING THE BLANKETROL III SYSTEM IN MANUAL CONTROL MODE WITH THE ADDITION OF THE PATIENT PROBBE 1 ein 46 3 6 OPERATING THE BLANKETROL III SYSTEM IN GRADIENT 10C MODE ee 47 3 7 OPERATING THE BLANKETROL III UNIT IN GRADIENT 10C SMARTMODE iii 49 3 8 OPERATING THE BLANKETROL III SYSTEM IN GRADIENT VARIABLE
99. r use in all Class A establishments other than domestic and those directly connected to CISPR 11 gt E ED the public low voltage power supply network that supplies buildings armonic emissions i Class A used for domestic purposes IEC 61000 3 2 Voltage fluctuations flicker emissions Complies IEC 61000 3 3 TABLE 5 2 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY The Blanketrol III Model 233 is intended for use in the electromagnetic environment specified below The customer or the user of the Blanketrol III Model 233 should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 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 Electrical fast 2 kV for power supply 2 kV for power Mains power quality should be that of a typical transient burst lines supply lines commercial or hospital environment IEC 61000 4 4 1 kV for input output 1 kV for input output lines lines Surge 1 kV differential mode 1 kV differential Mains power quality should be that of a typical mode commercial or hospital environment IEC 61000 4 5 2 kV common mode 2 kV common mode Voltage dips short i
100. ratures could cause injury of patient or operator Keep unit specifically the grill away from curtains or other obstructions e Use proper precautions when handling or using the patient probe Failure to do so may result in damage from electrostatic discharge ESD The USB connection on the Blanketrol Ill unit is intended for data transfer to a computer Any other uses connections may result in damage to the Blanketrol III unit e Working with electronic boards plugs and cables requires delicate handling Proper Electrostatic Discharge procedure should be followed during replacement of any electronic board Failure to do so may result in damage to the board e The warming of transdermal medications patches can increase drug delivery resulting in possible injury to the patient e If unit requires repair do not attempt to fix unit on your own Only qualified personnel should perform repairs Damage to the unit or malfunction may otherwise result Page 5 of 84 OPERATION MANUAL BLANKETROL III MODEL 233 CAUTION Federal law restricts this device to sale by or on the order of physician o Use distilled water only Do Not Use De lonized water De lonized water may cause corrosion to plumbing system components Do Not Use Tap Water Minerals and deposits can clog plumbing system components e Do not use alcohol Alcohol may cause blanket and unit deterioration e Use only hospital gra
101. ries probe to the 1 4 inch receptacle on the right side of the unit If using a disposable probe a connecting cable is needed to connect the probe to the BIII C Press the power switch to the I position 1 The switch illuminates green 2 The microprocessor board goes through self test 3 The Status Display flashes CHECK SETPT D Consult the physician s orders to determine the desired patient Set Point temperature As a safety precaution the SET POINT display can only be set between 30 40 C 86 F 104 F to operate in AUTOMATIC CONTROL MODE E Use the C F button to choose the desired temperature scale 115 Volt only F Press the TEMP SET button 1 The microprocessor board beeps 2 The LED in the corner of the button illuminates 3 The SET POINT display shows a temperature reading Page 42 of 84 OPERATION BLANKETROL III Model 233 OPERATION MANUAL 4 The Status Display shows SET TEMP G Press the Up arrow or Down arrow to change the SET POINT display to the desired patient temperature The display can only be set between 30 C 40 C 86 F 104 or else the system will not operate in AUTOMATIC CONTROL MODE 1 The microprocessor board beeps 2 The Set Point on the Status Display changes H Press the AUTO CONTROL button 1 The microprocessor board beeps 2 The LED in the corner of the button illuminates 3 The Patient display shows the patient s actual temperature 4 The WATER display shows
102. s message occurs when the thermostatic snap disc has opened or is disconnected or when the reservoir temperature has exceeded 46 C 2 C 114 8 3 6 F causing the thermostatic disc to shut off heating While this message is displayed EE02 will display in the PATIENT temperature display the trouble alarm will sound and the heater compressor and pump will turn off The alarm silence key cannot silence this alarm This message will continue to display and the trouble alarm will continue to sound until the unit is turned off using the ON OFF switch or the power cord is disconnected from the power source If the unit is unplugged before turning the ON OFF switch the power fail alarm will activate and the power fail LED will light If the unit is turned back on only SNAP DISC HEMOVE FROM SERVICE will reappear and the trouble alarm will sound even if disc has reset The unit cannot be used again until it is serviced Contact CSZ Technical Service EEO2 appears when the thermostatic snap disc has opened or is disconnected LOW LIMIT REMOVE FROM SERVICE This message occurs when the low limit is triggered because the water in the Blanketrol Ill equipment has reached the low temperature limit of 2 0 C t 2 C 35 6 F 3 6 F While this message is displayed the trouble alarm will sound and the compressor and pump will turn off The alarm silence key cannot silence this alarm This message will continue to display and the
103. sert Port in This Direction Page 3 of 84 OPERATION MANUAL BLANKETROL III MODEL 233 BLANKETROL III OPERATION MANUAL Cincinnati Sub Zero Products Inc reserves the right to make equipment changes and improvements which may not be reflected in this manual WARNING e A physician s order is required for setting blanket temperature and use of equipment At least every 20 minutes or as directed by physician check patient s temperature and skin integrity of areas in contact with blanket also check the Blanketrol III s water temperature Pediatric patients temperature sensitive patients with vascular disease surgical patients diabetics and patients with Raynaud s Disease should be checked more frequently Notify the physician promptly of any change in patient status in order to avoid serious injury or death e The method of temperature control provided by all hyper hypothermia units presents the danger of heating or cooling body tissues particularly the skin to a point where they are injured i e burns or frostbite respectively Depending on the extent and severity of a burn very serious and even fatal complications may arise e Prevent excessive and or prolonged tissue pressure and shearing forces especially over bony prominences Failure to do so may result in tissue injury e Do not place additional heat sources between the patient and blanket Tissue damage may result e Means to maintain contact bet
104. servoir Page 70 of 84 MAINTENANCE BLANKETROL III Model 233 OPERATION MANUAL 4 2 2 Replenishing the Reservoir A Check that the drain hose is disconnected CAUTION Use distilled water only Do Not Use De lonized water De lonized water may cause corrosion to plumbing system components Do Not Use Tap Water Minerals and deposits can clog plumbing system components Do not use alcohol Alcohol may cause blanket deterioration Do not overfill Overfilling may result in overflow when the water in the blanket drains back into the system when the system is turned off B Lift the water fill opening lid and gradually pour approximately 2 gallons 7 5 liters of distilled water or the distilled water bacteriostatic preparation described in Section 4 2 into the reservoir DO NOT USE ALCOHOL TAP WATER OR DE IONIZED WATER C Stop pouring when the water reaches the strainer visible at the bottom of the water fill opening D Proceed with normal operations always check the water level before starting 4 3 MAINTENANCE OF THE WATER FILTER The BLANKETROL III circulating system includes a water filter designed to clear the line of any particulate matter as the water is pumped through the system As shown in Figure 4 2 the water filter assembly is a plastic T shaped fitting that intersects the hose from the water flow indicator to the reservoir A stainless steel wire mesh screen is located inside t
105. t cannot be predicated theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measure field strength in the location in which the Blanketrol III Model 233 is used exceeds the applicable RF compliance level above the Blanketrol III Model 233 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the Blanketrol III Model 233 Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Page 80 of 84 SPECIFICATIONS BLANKETROL III Model 233 OPERATION MANUAL TABLE 5 4 RECOMMENDED SEPARATION DISTANCE BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE BLANKETROL Ill MODEL 233 The Blanketrol III Model 233 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Blanketrol III Model 233 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Blanketrol III Model 233 as recommended below according to the maximum output power of the communications equipment 3 Separation distance according to frequency of transmitter Rated maximum output m power of transmitter 150 kHz to 80 MHz 80 MHz to 80
106. ted 6 The heater or compressor may be activated 7 The water flow indicator on the right side panel begins to move The water moves from the unit through the blanket and returns to the unit 8 System operates in GRADIENT 10C mode Y Press TEMP SET button 1 The microprocessor board beeps 2 The LED in the corner of the button illuminates 3 The Status Display returns to set temperature mode Z Press GRADIENT 10C button and then SMART button The microprocessor board beeps The LED s in the corner of the buttons illuminate The WATER display shows the temperature of the water in the reservoir The Status Display shows XXXXXX PATIENT AUTO SETPT 37 0 C Or Status Display shows PATIENT SETPT AUTO SETPT 37 0 C Pi m XXXXXX represents HEATING or COOLING The above depends upon the relationship of the blanket water temperature to the Set Point temperature Note that the Set Point may be displayed in Fahrenheit The pump is activated The heater or compressor may be activated The water flow indicator on the right side panel begins to move The water moves from the unit through the blanket and returns to the unit 8 Wait 30 minutes for SMART MODE to occur 9 System operates in GRADIENT 10C SMART mode Press TEMP SET button Page 32 of 84 OPERATION AB AC AD AE AF BLANKETROL III Model 233 OPERATION MANUAL 1 The microprocessor board beeps 2 The LED in the corner of
107. the Up arrow next to the TEMP SET button 1 The microprocessor board beeps each time it is pressed 2 The Set Point display changes the numbers move up the scale The longer the button is pressed the faster the digits change When the button is released and repressed the digits once again change slowly and then increase in speed The highest setting is 42 C or 107 6 F L Press the Down arrow next to the TEMP SET button The microprocessor board beeps each time it is pressed 2 The Set Point display changes the numbers move down the scale The longer the button is pressed the faster the digits change When the button is released and repressed the digits once again change slowly and then increase in speed The lowest setting is 4 C or 39 2 F M Press the Up arrow or Down arrow so that the SET POINT display shows a number between 30 C 40 C 86 F 104 F For example set the display to show 32 3 C or 90 N Connect a 400 Series probe to the 1 4 inch receptacle on the right side of the unit O Press the AUTO CONTROL button 1 The alarm sounds 2 The Status Display flashes CHECK PROBE The alarm sounds because the patient probe as held by the operator in the open air for this test routine detects a reading below 30 C 86 F The unit will not operate in the AUTO CONTROL MODE unless the probe is properly placed on a patient and reading between 30 43 5 C 86 F 110 3 F P Press the SILENCE ALA
108. the actual temperature of the water in the Blanketrol Ill equipment 5 The Status Display indicates XXXXXX PATIENT AUTO SETPT 37 0 C Or Status Display shows PATIENT SETPT AUTO SETPT 37 0 C XXXXXX represents HEATING or COOLING The above depends upon the relationship of the blanket water temperature to the Set Point temperature Note that the Set Point may be displayed in Fahrenheit 6 The pump is activated The heater or compressor may also be activated 7 The water flow indicator on the right side panel begins to move 8 The water moves from the unit to the blanket and returns to the unit l Check the water flow indicator to confirm that the water is circulating J Touch the hyper hypothermia blanket to confirm that the blanket is heating cooling K To make any changes in the control settings press the TEMP SET button and begin again The BLANKETROL III System is now operating in AUTOMATIC CONTROL MODE You should continue to monitor the system and the patient Review the suggestions for patient care described in Section 2 5 If at any time the Status Display shows a message other than the messages described in AUTOMATIC CONTROL MODE procedures make the changes indicated by the display and or Page 43 of 84 OPERATION BLANKETROL III Model 233 OPERATION MANUAL consult the list of display messages in Section 3 12 If at any time the unit sounds an alarm and the Status Display flashes a message make
109. the button illuminates 3 The Status Display returns to set temperature mode Press the GRADIENT VARIABLE button 1 The microprocessor board beeps 2 The LED in the corner of the button illuminates 3 The Status Display shows VARIABLE GRADIENT OFFSET OC Press the Up arrow or Down arrow to change the gradient variable offset to the desired value 1 The microprocessor board beeps 2 The offset in the Status Display changes Press the GRADIENT VARIABLE button 1 The microprocessor board beeps 2 The LED in the corner of the button illuminates 3 The PATIENT display shows the patient s actual temperature 4 The WATER display shows the temperature in the water reservoir 5 The Status Display shows either XXXXXX PATIENT AUTO SETPT 37 0 C Or Status Display shows PATIENT SETPT AUTO SETPT 37 0 C XXXXXX represents HEATING or COOLING The above depends upon the relationship of the blanket water temperature to the Set Point temperature Note that the Set Point may be displayed in Fahrenheit 6 The pump is activated 7 The heater or compressor may also be activated 8 The water flow indicator on the right side panel begins to move The water moves from the unit to the blanket and returns to the unit 9 System operates in GRADIENT VARIABLE mode Press TEMP SET button 1 The microprocessor board beeps 2 The LED in the corner of the button illuminates 3 The Status Display returns to set temperature mode
110. the changes indicated To turn off the unit or discontinue hyper hypothermia treatment proceed as described in Section 3 11 NOTE IN ORDER TO CHANGE FROM ANY CONTROL MODE TO ANOTHER CONTROL MODE FIRST PRESS THE TEMP SET BUTTON AND THEN SELECT THE OPERATING MODE OF CHOICE In order to change from AUTOMATIC CONTROL MODE to MONITOR ONLY MODE press the MONITOR ONLY button 3 4 OPERATING THE BLANKETROL III SYSTEM IN MANUAL CONTROL MODE WARNING o A physician s order is required for setting blanket temperature and use of equipment At least every 20 minutes or as directed by physician check patient s temperature and skin integrity of areas in contact with blanket also check blanket water temperature Pediatric patients temperature sensitive patients with vascular disease surgical patients diabetics and patients with Raynaud s Disease should be checked more frequently Notify the physician promptly of any change in patient status in order to avoid serious injury or death The BLANKETROL III System can be set so that it operates based upon the actual temperature of the water in the Blanketrol IIl equipment relative to the Set Point temperature In MANUAL CONTROL MODE the Blanketrol IIl System does not read the patient s temperature so the unit will not adjust the water temperature in the Blanketrol Ill equipment accordingly Because of this special care must be taken to monitor the patient s temperature And as in a
111. tient probe develops the BAD PROBE message displays the audible alarm sounds and the PATIENT temperature display blanks The audible alarm can be silenced using the SILENCE ALARM button The operator than has 5 minutes to fix the probe If after that time the condition has not been fixed the system will trouble alarm again even though the SILENCE ALARM button has been previously pressed Connecting a working probe in range should clear the error message and return the unit to normal operation in MONITOR ONLY mode Page 63 of 84 OPERATION BLANKETROL III Model 233 OPERATION MANUAL LOW WATER This message occurs when the float switch senses that the water in the reservoir is below a preset level or the float switch is defective The trouble alarm sounds the seven segment displays will be blank the low water symbol LED will flash and the heater compressor and pump will turn off The operator can silence this alarm using the SILENCE ALARM button The condition can also be satisfied when the operator pours the water in and it reaches the proper level Once the LOW WATER condition is satisfied the Status Display changes to show CHECK SETPT The trouble alarm should still sound In order to proceed the operator must once again go through the operating mode button sequence If the alarm is silenced the operator has 5 minutes to add water If after that time the condition has not been cleared the system will trouble alarm ag
112. time as contacting the patient will negate the type BF rating H Connect the blanket s to the unit by attaching the quick disconnect female coupling of the connecting hose to a male outlet coupling on the bottom row of the unit Attach the male quick disconnect coupling of the connecting hose to a female return coupling on the top row of the unit Each blanket must be connected to one outlet and one return Page 26 of 84 OPERATION BLANKETROL III Model 233 OPERATION MANUAL To attach the couplings Grasp the female coupling of the connecting hose Slide the collar back towards the hose Push the female coupling over a male coupling of the unit Allow the collar to SNAP into place and return to its original position Gently pull on the connecting hose to assure a positive connection Next push back the collar of a female return hose on the unit with one hand With the other hand insert the male coupling of the connecting hose Release the collar of the female return coupling Push the male coupling until it SNAPS into position 0 Gently pull the connecting hose to assure a positive connection gt CONDOR Check that the blanket is laying flat and that the connecting hose to the unit is not twisted or pinched J Check that the power switch of the unit is in O position unit is off WARNING Do not by pass ground lug 230V systems Electrical hazards may result Connect the plug t
113. wed including but not limited to the preventative maintenance describe in this manual Leaky blankets or hoses should never be used Water leaks present a risk of electrocution WARNING Prep solutions have been reported to injure the skin when allowed to remain between patients and a water circulating heating blanket during prolonged procedures Use of materials of good thermal conductivity such as water gel and similar substances with the Blanketrol Ill not switched ON may decrease the temperature of the patient The area between the patient and the blanket should be kept dry to avoid injury to patient H Check the blanket for leaks If a leak is found the blanket cannot be used l Check the couplings at the unit and at the blanket for positive connection J Press the TEMP SET switch The microprocessor board beeps The LED in the corner of the switch illuminates The indicator light left of the Set point display goes out The Blanket Water display goes blank The Status Display shows SET TEMPERATURE SETPT 37 0 C NOTE Set point may be displayed in Fahrenheit Page 29 of 84 OPERATION BLANKETROL Ill Model 233 OPERATION MANUAL 6 The pump shuts down the heating cooling stops When the TEMP SET button is pressed the operating mode e g MANUAL CONTROL MODE or any of the Automatic Modes is cancelled The operator is once again at the beginning of the mode selection procedure K Press
114. ween the patient and the blanket during therapy may be required Failure to do so may result in inadequate treatment e Proper sanitation procedures must be practiced and hygienic safety must be maintained to prevent contamination Contamination can affect patient s health i e skin irritation rash may result Use only YSI 400 Series probes on CSZ equipment refer to Table 6 8 Failure to do this will cause incorrect temperature readings and may result in inadequate inappropriate treatment Do not use the BLANKETROL III system in the presence of flammable anesthetics Risk of explosion can result Power interruption will cause the BLANKETROL III to revert to CHECK SET POINT resulting in no therapy to the patient Follow instructions for desired mode to resume operation Failure to resume therapy could result in serious injury or death Do not by pass ground lug Electrical Hazards may result To avoid the risk of electric shock this equipment must only be connected to a supply mains with protective earth e Inspect all blankets for mechanical damage before use Do not use in proximity to sharp objects Blanket punctures can result in an increased risk of infection or electrical shock Any time water is found leaking into or around the unit connecting hose and or blanket turn the unit off disconnect the power cord from its power source and correct the problem before proceeding Proper
115. wnward Page 69 of 84 MAINTENANCE BLANKETROL III Model 233 OPERATION MANUAL C Attach the female coupling of the drain hose to any one of the male outlet couplings on the right side of the unit 1 Slide back the collar of the female coupling 2 Insert the female coupling over the male coupling 3 Release the collar so the coupling Snaps into position WARNING Do not by pass ground lug Electrical Hazards may result D Plug the power cord into a properly grounded power outlet Place the power switch to the I position E Press the TEMP SET button G Press the MANUAL CONTROL button The water is pumped into the container until there is approximately 1 2 gallon 1 9 liters of water remaining to be drained The Status Display flashes LOW WATER and the alarm sounds The unit shuts down but the water continues to drain into the container because of gravitational pull H Press the SILENCE ALARM button l Press the power switch to the O position J Disconnect the power cord from the power source K After all the water has drained from the unit disconnect the drain hose wipe clean and store in a dry environment without disinfecting Refer to Section 5 specifications for storage conditions L Discard the water drained from the unit M If any other maintenance repair is to be completed go to the appropriate section e g cleaning the water filter If not go to Section 4 2 2 to replenish the re
116. y storage continue with procedure When all fluid has been removed from the unit disconnect the drain hose s and wipe unit clean Unit is now ready for storage Document unit maintenance When you are ready to return unit to service replenish the reservoir s with distilled water Perform all the checks as described in the respective Manual FLUID CIRCUIT DISINFECTION DRY STORAGE PROCEDURE for Circulating Water Units Utilizing CE Approved Gigasept FF Product of Schulke amp Mayr Contact your local Cleaning Supplier Gigasept FF Is Not Available In the United States The following procedure disinfects the fluid circuit in these products The required tools supplies are appropriate drain hose s and or hose connector s Gigasept FF distilled water and the appropriate AC electrical power PROCEDURE 1 Drain the water from the reservoir as described in Section 4 2 1 2 Turn unit off O position 3 Fill the reservoir with the appropriate amount of Gigasept FF per the below chart UNIT Gigasept FF WATER DURATION Blanketrol 233 800 Milliliters 7 6 Liters 15 Minutes 4 Fill the reservoir with the appropriate amount of water per the above chart Turn the unit on and circulate in Heating 38 for 15 minutes 6 Drain the unit as instructed in Step 1 7 Rinse the unit with Distilled Water three 3 times as described in Steps 4 6 Be sure to omit Gigasept FF 8 After the t

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