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Gentherm BLANKETROL III Operation Manual

Hyper-hypothermia system
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Operation Manual
Model 233 Hyper-Hypothermia System
Gentherm Medical, LLC • 12011 Mosteller Road • Cincinnati, Ohio 45241, U.S.A.
www.gentherm.com
®
BLANKETROL
is a registered trademark of Gentherm Medical, LLC, Cincinnati, Ohio USA
Copyright 2025, Gentherm Medical, LLC All rights reserved.
Manual 57201 Rev. AE

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Summary of Contents for Gentherm BLANKETROL III

  • Page 1 Operation Manual Model 233 Hyper-Hypothermia System Gentherm Medical, LLC • 12011 Mosteller Road • Cincinnati, Ohio 45241, U.S.A. www.gentherm.com ® BLANKETROL is a registered trademark of Gentherm Medical, LLC, Cincinnati, Ohio USA Copyright 2025, Gentherm Medical, LLC All rights reserved.

  • Page 2: Technical Help

    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.

  • Page 3: Table Of Contents

    OPERATING THE BLANKETROL III SYSTEM IN MANUAL CONTROL MODE WITH THE ADDITION OF THE PATIENT PROBE ......................... 25 3-6. OPERATING THE BLANKETROL III UNIT IN GRADIENT 10C SMART MODE ........ 26 3-7. OPERATING THE BLANKETROL III SYSTEM IN GRADIENT VARIABLE SMART MODE ....28 3-8.
  • Page 4 FIGURES AND TABLES FIGURE 1-1. BLANKETROL III – FRONT VIEW ........................ 10 FIGURE 1-2. BLANKETROL III – RIGHT SIDE VIEW ......................11 FIGURE 1-3. BLANKETROL III – REAR VIEW ........................12 FIGURE 1-4.A. BLANKETROL III – MEMBRANE CONTROL PANEL (E ) ..............
  • Page 5 OPERATION MANUAL BLANKETROL III, Model 233  Symbol Definitions Read Operation Instructions and Manual Gradient Gradient 10˚ C Temperature Set Variable Before Operating INCREMENT DECREMENT Automatic Manual (Decrease (Increase Smart Control Control Temperature) Temperature) Mode Monitor Water Patient Silence Test Indicators...

  • Page 6: Operation Manual

    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).
  • Page 7 Unit complies with IEC 60601-1-2. • 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 5 for recommended separation distances between other equipment and the BLANKETROL III.
  • Page 8 • 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.

  • Page 9: Section 1. Introduction

    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).

  • Page 10: 1-2.1. External Features - Front View

    BLANKETROL III, Model 233 1-2.1. External Features - Front View The external features in Figure (1-1) of the BLANKETROL III unit are described as follows: The control panel is composed of pressure sensitive touch switches, nine LED indicators, a liquid crystal display, and two LED displays.

  • Page 11: 1-2.2. External Features - Right Side View

    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 the type of BF rating.

  • Page 12: 1-2.3. External Features - Rear View

    1-2.3. External Features – Rear View The external features in Figure (1-3.) of the BLANKETROL III unit are described as follows: The specification label outlines the BLANKETROL III unit's electrical requirements and displays the serial and model numbers of the unit.

  • Page 13: 1-2.4. Description Of The Blanketrol Iii Membrane Control Panel

    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. The center display reports the status of the unit, displays the Set Point, and/or indicates changes the operator should make.

  • Page 14: Required Accessories

    REQUIRED ACCESSORIES Operation of the BLANKETROL III System requires the use of the blanket(s) designed to circulate warm or cool Sterile water or water that has been passed through a filter less than or equal to 0.22 microns, 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.

  • Page 15: 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 water temperature (MANUAL CONTROL), or it can be set to operate based on the patient’s temperature (AUTOMATIC CONTROL) using servo control. The three...
  • Page 16 The Blanketrol III will not alarm or indicate when the patient’s temperature is outside of the selected Patient Set Temperature. It is recommended to use an additional temperature monitoring system to set alarm parameters to alert the operator if the patient temperature falls outside of the acceptable range.
  • Page 17 OPERATION MANUAL BLANKETROL III, Model 233 Patient temperature and skin integrity should be closely monitored. Exceeding 40°C 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.

  • Page 18: Section 2. General Preparation Of The Blanketrol Iii

    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 the type BF rating.

  • Page 19: 2-3.2. Complete A System Test Routine

    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, etc. The BLANKETROL III unit is equipped with a circuit breaker in the I/O (on/off) power switch to protect against current overload.

  • Page 20: 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 the appropriate controls: •...
  • Page 21 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°C (86°F). It is important that the 400 Series probe be inserted in or attached to the patient at least three minutes before pressing a control mode button.

  • Page 22: Operating The Blanketrol Iii System In Auto Control Mode

    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).
  • Page 23 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.)).

  • Page 24: Operating The Blanketrol Iii System In Manual Control Mode

    The BLANKETROL III System can be set so that it operates based upon the actual temperature of the water in the BLANKETROL III equipment relative to the Set Point temperature.

  • Page 25: Operating The Blanketrol Iii System In Manual Control Mode With The Addition Of The Patient Probe

    Failure to do so may result in damage from electrostatic discharge (ESD). 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 III equipment relative to the desired Blanket/Water temperature.

  • Page 26: Operating The Blanketrol Iii Unit In Gradient 10C Smart Mode

    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).
  • Page 27 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.)).

  • Page 28: Operating The Blanketrol Iii System In Gradient Variable Smart Mode

    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).
  • Page 29 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. (Review the suggestions for patient care described in Section (2-5.).

  • Page 30: Operating The Blanketrol Iii System In Monitor Only Mode

    Failure to do so may result in damage from electrostatic discharge (ESD). 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.).

  • Page 31: 3-10. Status Display Messages

    3-10. 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.
  • Page 32 GRADIENT VARIABLE button, when the user is setting OFFSET xxY * the BLANKETROL III in GRADIENT VARIABLE MODE. When this display is shown, the user can adjust the gradient variable offset. This message occurs when the high limit is triggered because the water in the BLANKETROL III equipment has reached the high temperature of 44.0°C ...
  • Page 33 The seven-segment displays (“WATER” and ”PATIENT”) will both be blank during this condition. Contact GENTHERM Technical Service. This message occurs when the software fails and the water in the BLANKETROL III equipment has reached the low temperature limit of 2.0°C  2°C (35.6°F  3.6°F), activating the independent safety.
  • Page 34 OPERATION MANUAL BLANKETROL III, Model 233 operator then 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.

  • Page 35: Section 4. General Maintenance Of The Blanketrol Iii System

    MAINTENANCE OF THE BLANKETROL III EXTERIOR – CLEANING INSTRUCTIONS 4-2. 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.
  • Page 36 MAINTENANCE BLANKETROL III, Model 233 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), household bleach, sterile water or water that has been passed through a filter less than or equal to 0.22 microns, and the appropriate AC electrical power The following procedure disinfects the fluid circuit in these products.

  • Page 37: 4-3.1. Draining The Reservoir

    MAINTENANCE BLANKETROL III, Model 233 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, sterile water or water that has been passed through a filter less than or equal to 0.22 microns, and the appropriate AC electrical power...

  • Page 38: 4-3.2. Replenishing The Reservoir

    4-4.1 Reusable Blankets Gentherm 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.

  • Page 39: Section 5. Specifications And Certifications Of The Blanketrol Iii

    SPECIFICATIONS BLANKETROL III, Model SECTION 5. SPECIFICATIONS AND CERTIFICATIONS OF THE BLANKETROL III BLANKETROL III MODEL 233 FEATURES PHYSICAL SAFETY SYSTEM Dimensions: 17"W x 17"D x 37.5"H (43.18cm. W x 43.18 cm. D x 95.25cm. H) Maximum High Control Setting: Weight: Empty -131 lbs.
  • Page 40 MONITOR ONLY: (50°F - 122°F) Service Life The expected service life/ lifetime of the Blanketrol III, Model 233 unit is twelve (12) years from the date of manufacture provided the product is not subject to misuse, negligence, accident or abuse and under the conditions that the device is properly used as intended, and serviced and maintained according to the Operation /Technical Manual provided with the device.
  • Page 41 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.
  • Page 42 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.

  • Page 43: Worldwide Order Placement

    COMMUNICATIONS EQUIPMENT AND THE BLANKETROL III, 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.
  • Page 44 Gentherm Medical, LLC 12011 Mosteller Road Cincinnati, OH 45241 Toll Free: 1-800-989-7373 Fax: (513) 772-9119 www.gentherm.com...

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