Blanketrol III Model 233 Operation and Technical Manual Rev AL

OPERATION AND TECHNICAL MANUAL

BLANKETROL III, Model 233

Symbol Definitions

Read Operation Instructions and Manual Before Operating

V

10C Temperature Set

Gradient 10˚ C

Gradient Variable 5C

INCREMENT (Increase Temperature)

DECREMENT (Decrease Temperature)

Automatic Control

Manual Control

Monitor Only

Test Indicators

Water Temperature

Patient Temperature

Smart Mode

Silence Alarm

Inlet

Water Flow Indicator

Risk of Explosion: Do not use in the Presence of Flammable Anesthetics

ESD Susceptibility

Fill to Strainer

Outlet

Low Water Level

Disconnect Power Before Servicing

Danger; Risk of Electric Shock

Power Failure

Separate Disposal for Electrical / Electronic Equipment

O/I

OFF/ON

OFF / ON Switch

OFF / ON Switch

Equipotential Symbol

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Type BF Equipment

~ AC Voltage

Power Cord Holder

USB Port: Insert Port in This Direction

OPERATION AND TECHNICAL MANUAL

BLANKETROL III, Model 233

BLANKETROL® III OPERATION AND TECHNICAL MANUAL Gentherm Medical, LLC, reserves the right to make equipment changes and improvements, which may not be reflected in this manual

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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 the BLANKETROL III’s water temperature. Pediatric patients, temperature-sensitive patients with vascular disease, surgical patients, diabetics and patients with Raynaud’s Disease are at a greater risk for developing tissue injuries, and this should be considered when selecting the temperature, duration of therapy and frequency of skin checks. Notify the physician promptly of any change in patient status in order to avoid serious injury or death. 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. The clinician is responsible for determining the appropriateness of the temperature limits in dependency to time. Exceeding 40°C water temperature for extended periods can cause tissue damage and burns. Clinical judgment should be used to determine the safe maximum contact periods based on patient age, clinical condition, and current medications. Depending on the extent and severity of a burn, very serious and even fatal complications may arise. Do not use the BLANKETROL III System distal to arterial cross clamping. Thermal injury may result. Thermal injury may occur if heating/cooling therapy is applied to ischemic limbs. The warming of transdermal medications (patches) can increase drug delivery, resulting in possible injury to the patient. Prevent excessive and/or prolonged tissue pressure and shearing forces, especially over bony prominences. Failure to do so may result in tissue injury. Do not place additional heat sources between the patient and blanket. Tissue damage may result. Means to maintain contact between the patient and the blanket during therapy may be required and should not block the fluid pathways of the blanket or connecting hose. Failure to do so may result in inadequate treatment. 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 III 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. 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, or equivalent, probes on GENTHERM equipment (refer to Table (6-8)). Failure to do this will cause incorrect temperature readings and may result in inadequate/inappropriate treatment. Due to static electricity, a 400 Series Probe may not be connected to the BLANKETROL III unit without first discharging one’s body to the frame of the BLANKETROL III unit or another grounded object. Failure to do so may result in damage from electrostatic discharge (ESD). All staff that may touch the 400 Series Probe must be familiar with this warning and basic static electricity or electrostatic discharge (ESD) training.

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OPERATION AND TECHNICAL MANUAL •

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WARNING

BLANKETROL III, Model 233

Basic static electricity or ESD training should include an introduction to the physics of electrostatic charge, the voltage levels that can occur in normal practice and the damage that can be done to electronic components if equipment is touched by an operator who is electrostatically charged. Further, an explanation should be given of methods to prevent build-up of electrostatic charge, and how and why to discharge one’s body to the BLANKETROL III unit or another grounded object. Failure to do so may result in damage from electrostatic discharge (ESD). Do not use the BLANKETROL III system in the presence of flammable anesthetics. Risk of explosion can result. 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 temperatures could cause injury of patient or operator. Keep unit, specifically the grill away from curtains or other obstructions. 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 III unit. Working with electronic boards, plugs, and cables requires delicate handling. Proper electrostatic discharge (ESD) procedures should be followed during replacement of any electronic board. Failure to do so may result in damage to the board. 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. Use of accessories other than those specified in Table 6-8 may result in increased electromagnetic emissions or decreased immunity to electromagnetic emissions of the BLANKETROL III unit. This could affect the BLANKETROL III’s compatibility with other electrical equipment. Electromagnetic compatibility refers to electronic devices unintentionally affecting the operation of each other by emitting electromagnetic energy. 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 (230V System). Electrical Hazards may result. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. Risk of electrical shock may occur. Blanket punctures can result in an increased risk of infection or electrical shock. Inspect all blankets for mechanical damage before use. Do not use in proximity to sharp objects. 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 followed including, but not limited to, the preventative maintenance described in this manual. Leaky blankets or hoses should never be used. Water leaks could present a slip hazard and risk of infection and could lead to electric shock. 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. Due to electromagnetic compatibility, the BLANKETROL III unit should not be used adjacent to or stacked with other equipment. Potential electromagnetic interference may result. Other equipment includes ventilators, patient monitors, anesthesia delivery equipment, etc. Electromagnetic interference refers to electronic devices unintentionally affecting the operation of each other by emitting electromagnetic energy. Unit complies with IEC 60601-1-2.

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OPERATION AND TECHNICAL MANUAL •

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WARNING

BLANKETROL III, Model 233

If the BLANKETROL III unit or the other equipment is not operating normally, remove the device from service and have a biomedical or service technician observe the device in operation. Refer to Section 7 for recommended separation distances between other equipment and the BLANKETROL III. Failure to do so may 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. 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. No modification of this equipment is allowed without prior, written authorization from GENTHERM. Failure to do so may result in damage to the BLANKETROL III system and patient injury. Before returning the BLANKETROL III to patient use after repairs, the FIRST TIME SETUP/SYSTEM TEST ROUTINE in Section 2 must always be performed. Improper repair and inadequate maintenance can result in damage to the BLANKETROL III system and patient injury.

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OPERATION AND TECHNICAL MANUAL

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BLANKETROL III, Model 233

CAUTION

Federal law restricts this device to sale by or on the order of a physician. Use Sterile water or water that has been passed through a filter less than or equal to 0.22 microns only. Do Not Use distilled water. Do Not Use De-Ionized water. De-Ionized 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 and unit deterioration. 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. Always drain the BLANKETROL III to a sanitary drain because bio-contaminants may be present in the unit’s water supply. Handling or use of the patient probe may result in damage from electrostatic discharge (ESD) if proper precautions are not taken. All wire-lead, patient-connected transducer assemblies are subject to reading error, local heating, and possible damage from high intensity sources of RF energy. Inadequately grounded electrosurgical equipment represents one such source, since capacitively coupled currents may seek alternate paths to ground through probe cables and associated instruments. Patient burns may result. If possible, remove the probe from patient contact before activating an electrosurgical unit. Do not immerse probes or connecting cables in liquid. Failure to do so may result in damage to the probes. 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 the USB port terminal while the device is also connected to a patient. Do not touch this connector and the patient at the same time. Patient injury may result. Users should not use cleaning or decontamination methods different from those recommended by GENTHERM without first checking with GENTHERM that the proposed methods will not damage the equipment. Working with electronic boards, plugs, and cables requires delicate handling. Proper electrostatic discharge (ESD) procedures should be followed during replacement of any electronic board. Failure to do so may result in damage to the board. If device is set to operate in any Automatic mode, the device will shut down and activate the CHECK PROBE alarm if the patient temperature falls below 30.0°C (86°F). Patient temperature must rise above 30.0°C (86°F) before restarting the device in Automatic mode. The device can be operated in Manual Control mode in order to warm the patient above 30.0°C (86°F). Potential for interruption of therapy. Unapproved blankets or hoses should never be used. Do not use GRADIENT VARIABLE MODE OR GRADIENT 10C MODE without SMART MODE. Unintended therapy could occur.

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OPERATION AND TECHNICAL MANUAL

BLANKETROL III, Model 233

Table of Contents TECHNICAL HELP ... 10 AUTHORIZED EUROPEAN REPRESENTATIVE: ... 10 BEFORE YOU CALL FOR SERVICE... ... 10 IN-WARRANTY REPAIR AND PARTS ... 10 RECEIVING INSPECTION ... 10 IMPORTANT SAFETY INFORMATION ... 10 SECTION 1. INTRODUCTION... 11 1-0. GENERAL SAFETY PRECAUTIONS ... 11 1-1. GENERAL DESCRIPTION OF THIS MANUAL ... 11 1-2. GENERAL DESCRIPTION OF THE BLANKETROL III SYSTEM ... 12 1-3. PHYSICAL DESCRIPTION OF THE BLANKETROL III UNIT ... 13 1-3.1. External Features - Front View ... 13 1-3.2. External Features – Right Side View ... 15 1-3.3. External Features – Rear View ... 17 1-3.4. Description of the BLANKETROL III Membrane Control Panel ... 19 1-4. REQUIRED ACCESSORIES ... 21 1-5. FUNCTIONAL DESCRIPTION OF THE BLANKETROL III SYSTEM ... 21 1-5.1. Theory of Operation ... 21 1-5.2. Heating System ... 24 1-5.3. Cooling System ... 24 1-5.4. Circulating System ... 24 1-5.5. Temperature Safety Control System ... 25 1-5.6. USB Port Operation ... 26 SECTION 2. GENERAL PREPARATION OF THE BLANKETROL III SYSTEM ... 27 2-1. INTRODUCTION ... 27 2-2. UNPACKING THE SHIPMENT... 27 2-3. FIRST TIME SET-UP/SYSTEM TEST ROUTINE ... 27 2-3.1. Inspecting and Arranging the Equipment ... 27 2-3.2. Completing a System Test Routine ... 29 2-4. UNIT AND PATIENT RELATED PRECAUTIONS ... 36 2-5. PATIENT PREPARATION AND BEDSIDE CARE ... 36 SECTION 3. OPERATING THE BLANKETROL III SYSTEM ... 41 3-1. INTRODUCTION ... 41 3-2. ARRANGING THE SYSTEM COMPONENTS... 41 3-3. OPERATING THE BLANKETROL III SYSTEM IN AUTO CONTROL MODE ... 44 3-4. OPERATING THE BLANKETROL III SYSTEM IN MANUAL CONTROL MODE ... 47 3-5. OPERATING THE BLANKETROL III SYSTEM IN MANUAL CONTROL MODE WITH THE ADDITION OF THE PATIENT PROBE... 49 3-6. OPERATING THE BLANKETROL III UNIT IN GRADIENT 10C SMART MODE ... 51 3-7. OPERATING THE BLANKETROL III SYSTEM IN GRADIENT VARIABLE SMART MODE ... 54 3-8. OPERATING THE BLANKETROL III SYSTEM IN MONITOR ONLY MODE ... 57 3-9. CONCLUDING HYPER-HYPOTHERMIA TREATMENT ... 58 3-10. STATUS DISPLAY MESSAGES ... 59 SECTION 4. GENERAL MAINTENANCE OF THE BLANKETROL III SYSTEM ... 66 4-1. INTRODUCTION ... 66 4-1.1. TEST EQUIPMENT REQUIRED ... 67 4-2. MAINTENANCE OF THE WATER RESERVOIR ... 69 4-2.1. Draining the Reservoir ... 72 4-2.2. Replenishing the Reservoir ... 73

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BLANKETROL III, Model 233

4-3. MAINTENANCE OF THE WATER FILTER ... 73 4-4. MAINTENANCE OF THE CONDENSER AND GRILL ... 75 4-5. MAINTENANCE OF THE BLANKETROL III EXTERIOR – CLEANING INSTRUCTIONS ... 75 4-6. MAINTENANCE OF THE HYPER-HYPOTHERMIA BLANKETS ... 75 4.6.1 Reusable Blanket... 75 4-6.2. Disposable, Single-Patient Use Blankets ... 76 4-7. MAINTENANCE OF REUSABLE THERMISTOR PROBES ... 76 4-8. LOW LIMIT SAFETIES CHECK ... 77 4-9. HIGH LIMIT SAFETIES CHECK ... 78 4-10. TEMPERATURE ACCURACY CHECK ... 79 SECTION 5. FIELD REPAIR/SERVICE OF THE BLANKETROL III UNIT ... 80 5-1. INTRODUCTION ... 80 5-2. ACCESS TO THE INTERIOR OF THE BLANKETROL III UNIT... 83 5-2.1. Removing the Rear Enclosure Panel... 83 5-2.2. Removing the Top of the Unit ... 83 5-2.3. Removing the Left Side Enclosure Panel ... 84 5-2.4. Disconnecting the Cables from the Microprocessor Board ... 84 5-2.5. Extending the Front Storage Drawer ... 85 5-2.6. Repositioning the Front Storage Drawer ... 85 5-3. REPLACEMENT OF THE HEATER ... 86 5-4. REPLACEMENT OF THE WATER FILTER ASSEMBLY ... 86 5-5. REPLACEMENT OF THE PUMP HOUSING... 87 5-6. REPLACEMENT OF THE PUMP MOTOR ... 88 5-7. REPLACEMENT OF THE FLOW SWITCH ... 89 5-8. REPLACEMENT OF THE WATER TEMPERATURE SENSOR ... 90 5-9. REPLACEMENT OF THE UPPER AND/OR LOWER WATER MANIFOLDS ... 91 5-10. REPLACEMENT OF THE COMPRESSOR STARTING CAPACITOR, THE OVERLOAD PROTECTOR, AND/OR THE COMPRESSOR RELAY... 93 5-11. REPLACEMENT OF THE THERMAL DISC OVER TEMPERATURE DEVICE ... 93 5-12. REPLACEMENT OR CLEANING OF THE WATER FLOW INDICATOR ASSEMBLY ... 94 5-13. REPLACEMENT OF THE I/O POWER SWITCH ... 95 5-14. REPLACEMENT OF THE WATER LEVEL SENSOR ASSEMBLY... 96 5-15. REPLACEMENT OF THE MICROPROCESSOR BOARD AND/OR THE MEMBRANE CONTROL PANEL 97 5-16. REPLACEMENT OF THE BEEPER ASSEMBLY ... 98 5-17. REPLACEMENT OF THE POWER CORD ... 98 5-18. LEAKAGE CURRENT ... 99 5-18.1. Arranging the Equipment ... 99 5-18.2. Taking Measurements in Normal Polarity ... 99 5-18.3. Taking Measurements in Reverse Polarity ... 100 5-19. REFRIGERANT CHECK ... 100 5-20. TROUBLESHOOTING GUIDE ... 101 SECTION 6. PARTS INFORMATION ... 110 6-1. 6-2. 6-3. 6-4. 6-5.

INTRODUCTION ... 110 ORDERING INFORMATION FOR REPLACEMENT PARTS ... 110 RECOMMENDED REPLACEMENT PARTS INVENTORY ... 110 RETURNING PARTS UNDER WARRANTY ... 111 SHIPPING PARTS ... 111

SECTION 7. SPECIFICATIONS AND CERTIFICATIONS OF THE BLANKETROL III ... 122 WORLDWIDE ORDER PLACEMENT ... 126

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OPERATION AND TECHNICAL MANUAL

BLANKETROL III, Model 233

FIGURES AND TABLES FIGURE 1-1. BLANKETROL III - FRONT VIEW ... 14 FIGURE 1-2. BLANKETROL III - RIGHT SIDE ... 16 FIGURE 1-3. BLANKETROL III - REAR VIEW ... 18 FIGURE 1-4.A. BLANKETROL III - MEMBRANE CONTROL PANEL (ENGLISH) ... 20 FIGURE 1-4.B. BLANKETROL III - MEMBRANE CONTROL PANEL (SYMBOLS) ... 20 FIGURE 4-1. BLANKETROL III MAINTENANCE CHECKLIST ... 68 FIGURE 5-1. BLANKETROL III - EXPOSED REAR VIEW ... 82 FIGURE 6-1. PARTS LIST A ... 112 FIGURE 6-2. BLANKETROL III - INTERNAL EXPLODED - FRONT VIEW ... 113 FIGURE 6-3. PARTS LIST B ... 114 FIGURE 6-4. BLANKETROL III - INTERNAL EXPLODED - REAR VIEW ... 115 FIGURE 6-5.A. BLANKETROL III - ELECTRICAL WIRING DIAGRAM - 115 VOLT ... 116 FIGURE 6-5.B. BLANKETROL III - ELECTRICAL WIRING DIAGRAM - 230 VOLT ... 117 FIGURE 6-6. BLANKETROL III - WATER CIRCULATION DIAGRAM ... 118 FIGURE 6-7. BLANKETROL III - REFRIGERATION FLOW DIAGRAM... 119 TABLE 6-8. BLANKETROL III SYSTEM ACCESSORIES ... 120 TABLE 7-1. GUIDANCE AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC EMISSIONS ... 124 TABLE 7-2. GUIDANCE AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC IMMUNITY ... 124 TABLE 7-3. GUIDANCE AND MANUFACTUERER'S DECLARATION - ELECTROMAGNETIC IMMUNITY ... 125 TABLE 7-4. RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE BLANKETROL III, MODEL 233 ... 126

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TECHNICAL HELP

BLANKETROL III, Model 233 OPERATION AND TECHNICAL MANUAL

TECHNICAL HELP United States and Canada Gentherm Medical, LLC 12011 Mosteller Road Cincinnati, OH 45241 www.gentherm.com

Telephone (U.S.) Toll Free (U.S.) 24hr Clinical Support Fax

1-513-772-8810 1-800-989-7373 1-513-460-2038 1-513-772-9119

Authorized European Representative: CEpartner4U, BV Esdoornlaan 13 3951 DB Maarn The Netherlands www.CEpartner4U.com 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 • 12 indicates a manufacturing date of the year 2012 • 1 indicates the quarter (first) • -3- means BLANKETROL III, Model 233 • 60000 indicates that this is the 60,000th 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. All returns should be made using GENTHERM-issued shipping cartons. 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 Gentherm. Call our Medical Technical Service department for further instructions. IMPORTANT SAFETY 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.

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OPERATION

BLANKETROL III, Model 233 OPERATION AND TECHNICAL MANUAL

SECTION 1. INTRODUCTION 1-0.

GENERAL SAFETY PRECAUTIONS

To provide the patient maximum safety during the use of the BLANKETROL III 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 semiannually as a refresher for safe operation and application. For proper knowledge and understanding, in-service is available upon request.

Maintenance and service activities will sometimes overlap. In general, maintenance refers to any activity that does not require a certified technician. Maintenance may be performed by healthcare personnel or by other trained persons. The following actions are considered maintenance: 1. Inspecting, cleaning, and disinfecting the exterior 2. Adding or replacing water 3. Replacing hoses 4. Cleaning hoses, blankets 5. Draining reservoirs

Service refers to any activity that requires a Medical Equipment Service Technician, Certified Biomedical Electronics Technician, or a Certified Clinical Engineer. The following actions are considered service: 1. Equipment or parts replacement 2. Repairs 3. System testing 4. Cleaning & disinfecting water reservoirs 5. Replacing hoses (air, water), cords, and other accessories 1-1.

GENERAL DESCRIPTION OF THIS MANUAL

This manual describes the operation, maintenance, and service of the GENTHERM BLANKETROL III 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 SMART MODE, GRADIENT VARIABLE SMART MODE, and MONITOR ONLY MODE. Section four describes the regular maintenance of the BLANKETROL III unit. Section five describes Field Repair and Service of the BLANKETROL III unit and contains a troubleshooting guide. Section six outlines parts information and section seven 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 six are primarily intended for personnel who service and repair the unit. Section (1-3.) describes the

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OPERATION

BLANKETROL III, Model 233 OPERATION AND TECHNICAL MANUAL

external features of the BLANKETROL III and Section (3-10.) 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 III 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 and blankets/pads.

BLANKETROL III Model 233

This unit requires no field adjustments or calibrations to maintain the precise board measurement of temperature and temperature limits. Sterile water or water that has been passed through a filter less than or equal to 0.22 microns 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 III equipment (MANUAL CONTROL MODE) or it can be set so that it operates based upon the patient’s temperature (Automatic Modes). The three Automatic modes include: 1) AUTO CONTROL MODE 2) GRADIENT 10C SMART MODE 3) 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 III is intended for use in ambient temperatures of 15°C – 30°C (59°F – 86°F). The maximum contact surface temperature is 41°C (105.8°F). * The recommended blanket(s) for use are described in Table 6-8.

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OPERATION 1-3.

BLANKETROL III, Model 233 OPERATION AND TECHNICAL MANUAL

PHYSICAL DESCRIPTION OF THE BLANKETROL III UNIT

See Section (7.) for specifications and certifications of the 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.).

B.

The recessed handle permits the operator to grip the unit when moving it.

C.

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.

D.

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 Manual.

E.

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.).

F.

The protective bumper guard surrounds the lower edge of the unit and protects the unit as well as the walls.

G.

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.

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BLANKETROL III, Model 233 OPERATION AND TECHNICAL MANUAL

FIGURE 1-1. BLANKETROL III - FRONT VIEW

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BLANKETROL III, Model 233 OPERATION AND TECHNICAL 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 wheel. 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.

B.

The air vents, on both the right and left side of the unit, provide air circulation for the microprocessor.

C.

The four capped screws on the right and left side of the unit secure the top to the base.

D.

The patient 1/4-inch receptacle is where the 400 Series probe (refer to Table 6-8 for a list of temperature probes) is connected to the unit. Only one patient probe can be connected at a time.

E.

Three female, quick-disconnect return fittings on the top row are designed for water to flow in when the male coupling of the connecting hose is attached.

F.

The three male quick-disconnect outlet fittings on the bottom row are designed for water to flow out when the female coupling of the connecting hose is attached.

G.

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 (7.).

H.

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 fittings) at the same time as contacting the patient will negate the type of BF rating.

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BLANKETROL III, Model 233 OPERATION AND TECHNICAL MANUAL

FIGURE 1-2. BLANKETROL III - RIGHT SIDE

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BLANKETROL III, Model 233 OPERATION AND TECHNICAL 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.

The specification label outlines the BLANKETROL III unit's electrical requirements and displays the serial and model numbers of the unit.

B.

The air vents, on both the right and left side of the unit, provide air circulation for the microprocessor.

C.

The nylon strap is used to secure and store the coiled power cord when not in use.

D.

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.

E.

The water fill opening is where the operator pours sterile water or water that has been passed through a filter less than or equal to 0.22 microns into the unit to fill the reservoir.

F.

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.

G.

The USB port for data reporting functions.

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BLANKETROL III, Model 233 OPERATION AND TECHNICAL MANUAL

FIGURE 1-3. BLANKETROL III - REAR VIEW

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OPERATION

BLANKETROL III, Model 233 OPERATION AND TECHNICAL MANUAL

1-3.4. Description of the BLANKETROL III Membrane Control Panel The membrane control panel as shown in Figure (1-4. A.) for English and (1-4.B.) for Symbols 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 III equipment.

B.

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 III equipment relative to the desired Set Point temperature.

C.

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 (3-10.).

D.

The TEMP SET button and the Up and Down arrow buttons are used to adjust the Set Point as shown on the LCD display.

E.

The green LED display, labeled PATIENT, shows the patient’s temperature reading.

F.

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.

G.

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 Set Point temperature.

H.

The GRADIENT VARIABLE button is used to activate the unit GRADIENT VARIABLE MODE. In this mode, the operation is based on the patient’s temperature relative to the desired Set Point temperature.

I.

The SMART button is used to activate the SMART function in the appropriate modes.

J.

The MONITOR ONLY button is used to monitor the patient’s temperature without heating, cooling or circulating the water.

K.

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.

L.

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.

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 (3-10-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 units with an English membrane.

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OPERATION

BLANKETROL III, Model 233 OPERATION AND TECHNICAL MANUAL

FIGURE 1-4. A. BLANKETROL III - MEMBRANE CONTROL PANEL (English)

FIGURE 1-4. B. BLANKETROL III - MEMBRANE CONTROL PANEL (Symbols)

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