NORM-O-TEMP Model 111Z Operation and Technical Manual Rev M

Operation / Technical Manual

NORM-O-TEMP, Model 111Z

NORM-O-TEMP®, MAXI-THERM®, MAXI-THERM® LITE, Gelli-Roll® and PLASTI-PAD® are registered trademarks of Gentherm Medical, LLC, Cincinnati, Ohio USA. © Copyright 2021 Gentherm Medical, LLC. All rights reserved. Manual 57225 Rev. M

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Operation / Technical Manual

NORM-O-TEMP, Model 111Z SYMBOLS

Caution: Read Operation Instructions and Manual Before Operating

Temperature Set

Fuse

Water Temperature

Increasing Temperature

Silence Alarm

Temp. Set Point Indicator

Decreasing Temperature Inlet

Water Flow Indicator

Disconnect Power Before Servicing

~ AC Voltage Separate collection for electrical and electronic equipment

Type BF Equipment

Earth (Ground)

Caution

Heat

Outlet

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

I / O On / Off

Fill to Strainer

Equipotentiality

Low Water Level

High Limit / Over-Temperature Safety Limit Page 3 of 84

Power Cord Holder

Danger; Risk of Electric Shock

Protective Earth (Ground)

Clean Water Filter Quarterly

Change Water Monthly

Operation / Technical Manual

NORM-O-TEMP, Model 111Z

Gentherm Medical, LLC, reserves the right to make changes to the device, which may not be reflected in this manual.

WARNING •

A physician's order is required for the use of the device and setting the temperature of the blanket/pad. At least every 20 minutes, or as directed by physician, check patient's temperature and skin condition of areas in contact with blanket/pad; also, check blanket/pad water temperature. Pediatric patients, temperature-sensitive patients with vascular disease, surgical patients, and diabetic patients are at greater risk for developing tissue injuries, and this should be considered when selecting the temperature, duration of therapy and frequency of skin checks. If patient’s temperature does not reach desired set point or differs drastically from recommended set point, notify physician. Notify the physician promptly of any change in patient status in order to avoid serious injury or death.

1. Pediatrics – Infants’ and children’s body temperatures are often more responsive to surface heating and cooling than adults. Due to their size, the effect of heating or cooling a child is likely more pronounced because of their higher ratio of skin contact area to body mass. 2. Temperature Sensitive Patients – Patients with impaired peripheral blood circulation and patients who are incapacitated may be more sensitive to temperature changes than patients with normal circulation.

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3. Surgical Patients – Patients with poor circulation due to inadequate heart function, loss of blood, or impaired peripheral blood circulation may be more sensitive to temperature changes. The method of temperature control provided by all hyperthermia units presents the danger of heating body tissues, particularly the skin, to a point where they are injured. 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 base on patient age, clinical condition, and current medications. Avoid placing additional heating or cooling sources between the patient and blanket/pad. Depending on the extent and severity of a burn, very serious and even fatal complications may arise. Do not use the NORM-O-TEMP® System distal to arterial cross clamping. Thermal injury may result. Prevent excessive and/or prolonged tissue pressure and shearing forces, especially over bony prominences, to prevent skin damage that may result. Do not place additional heat sources between the patient and blanket/pad. Skin damage may result. The area between the patient and the blanket/pad should be kept dry to avoid injury to patient. Prep solutions have been reported to injure the skin when allowed to remain between patients and a water-circulating heating blanket/pad during prolonged procedures. If using a vinyl blanket/pad, place a dry absorbent sheet between the patient and the blanket/pad to prevent moisture from accumulating.

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Operation / Technical Manual • • •

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NORM-O-TEMP, Model 111Z

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. Do not use the NORM-O-TEMP® system in the presence of flammable anesthetics. Risk of explosion can result. Power interruption will cause the NORM-O-TEMP® to revert to Preset Set point Temperature resulting in possible inaccurate therapy to the patient. Follow instructions for First Time SetUp/System Test Routine to resume operation. Failure to resume therapy could result in serious injury or death. Do not by-pass ground lug. Electrical Hazards may result. Any time water is found leaking into or around the unit, connecting hose, and/or blanket/pad, turn the unit off, disconnect the power cord from its power source, and correct the problem before proceeding. Water leaks could lead to electric shock. Water leaks could also present a slip hazard. Water leaks present a risk of infection and should be handled accordingly. Proper sanitation procedures should be followed including, but not limited to, the preventative maintenance described in this manual. Leaky blanket/pad(s) or hoses should never be used. Exercise extreme caution if the unit is used for patients who are electrically susceptible (probe, catheter, or electrodes connected to the heart). Do not position unit near any objects that can generate a strong electrical/magnetic field. Potential electromagnetic interference may result. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. 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 NORM-O-TEMP® should be performed by qualified Medical Equipment Service Technicians, Certified Biomedical Engineering Technicians, or Certified Clinical Engineers familiar with good repair practices for servicing medical devices, and in accordance with instructions contained in the Operation / Technical Manual. Improper repair could result in damage to the NORM-O-TEMP® system and possible patient injury. Before returning the NORM-O-TEMP® to patient use after repairs, the FIRST TIME SETUP/SYSTEM TEST ROUTINE in Section (3-2.) must always be performed. Improper repair and inadequate maintenance can result in damage to the NORM-O-TEMP® system and patient injury. Remove the NORM-O-TEMP® 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 the vents clean and free of debris and obstruction. Blockage of the vents could result in the unit overheating which could render the unit unable to provide adequate therapy; excessive surface temperatures could cause injury of patient or operator. Keep unit, specifically the vents away from curtains or other obstructions. The warming of transdermal medications (patches) can increase drug delivery, resulting in possible injury to the patient. Thermal injury may occur if heating/cooling therapy is applied to ischemic limbs.

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Operation / Technical Manual •

NORM-O-TEMP, Model 111Z

Use only hospital grade plug or electric shock may result.

CAUTION • • • • • • • • •

Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. Use sterile water or water that has been passed through a filter less than or equal to 0.22 microns only. Do Not Use De-Ionized water or Distilled water. Do not use alcohol. Alcohol may cause blanket/pad and unit deterioration. Do not overfill. Overfilling may result in overflow when the water in the blanket/pad drains back into the system when the system is turned off. Always drain the NORM-O-TEMP® to a sanitary drain because bacteria may be present in the unit’s water supply. Working with electronic boards, plugs, and cables requires careful handling. Proper Electrostatic Discharge (ESD) practices should be followed during replacement of any electronic board. To Discharge the NORM-O-TEMP®, ensure the unit is unplugged and use any metal tool, such as a screwdriver, with an insulated handle to simultaneously touch both pins on the power cord. Unapproved blanket/pad(s) or hoses should never be used. Always use GENTHERM recommended blankets/pads. No modification of this equipment is allowed without prior, written authorization from GENTHERM.

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Operation / Technical Manual

NORM-O-TEMP, Model 111Z

TABLE OF CONTENTS

Technical Help ...10 Before you call for Service... ...10 In-Warranty Repair and Parts ...10 Receiving Inspection ...10 Important Safety Information ...10 NORM-O-TEMP® Operating Instructions Quick Start Guide...11 Section 1. Introduction ... 13 1-0. General Safety Precautions...13 1-1. General Description of this Manual...13 1-2. Description of the NORM-O-TEMP® Hyperthermia System ...14 1-3. Physical Description of the NORM-O-TEMP® System ...14 1-3.1. External Features and Descriptions – Front View ...14 1-3.2. External Features and Descriptions – Left Side View ...17 1-3.3. External Features and Descriptions – Rear View ...19 1-3.4. External Features and Descriptions – Right Side View ...21 1-3.5. External Features and Descriptions – Top View ...22 1-4. Required Accessories ...24 1-5. Functional Description of the NORM-O-TEMP® System ...24 1-5.1. Heating System ...24 1-5.2. Circulating System ...24 1-5.3. Temperature Safety Control System...25 Section 2. Specifications and Certifications ... 26 Section 3. General Preparation of the NORM-O-TEMP® System ... 28 3-0. Introduction...28 3-1. Unpacking the Shipment ...28 3-2. First Time Set-Up / System Test Routine ...28 3-2.1. Inspecting and Arranging the Equipment ...28 3-2.2. Completing a System Test Routine...30 3-3. Unit and Patient Related Precautions ...32 3-4. Patient Preparation and Bedside Care...32 3-5. Alarms and Error Displays ...33 Section 4. Operating the NORM-O-TEMP® System ... 35 4-0. Introduction...35 4-1. Arranging the System Components ...35 4-2. Operating the NORM-O-TEMP® System...36 4-3. Concluding the Use of the NORM-O-TEMP® System...37 Section 5. General Maintenance of the NORM-O-TEMP® System ... 38 5-0. Introduction...38 5-1. Maintenance of Water Reservoir ...41 5-1.1. Internal Clean using Bleach / Dry Storage Procedure ...41 5-1.2. Internal Cleaning and Disinfecton Using Gigasept FF / Dry Storage Procedure ...42 5-1.3. Internal Cleaning and Disinfection Using Maranon H / Dry Storage Procedure ...44 5-1.4. Draining the Reservoir ...45 5-1.5. Replenishing the Reservoir / Fixing a Low Water Alarm ...46 5-2. Maintenance of the Water Filter ...46 5-3. Maintenance of the NORM-O-TEMP® Exterior – Cleaning Instructions ...47 5-4. Maintenance of the Hyper-Hypothermia Blanket / Pad(s) ...48 5-4.1. Cleaning / Maintenance of Reusable Blanket / Pad(s) ...48 5-4.2. Cleaning / Maintenance of Disposable, Single-Patient Use Blanket / Pad(s) ...48 Section 6. Field Repair / Service of the NORM-O-TEMP®... 49

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Operation / Technical Manual

NORM-O-TEMP, Model 111Z

6-0. Introduction...49 6-1. Access to the Interior ...50 6-1.1. Removing the Top of the Unit...50 6-1.2. Replace / Reinstall the Top of the Unit ...51 6-1.3. Removing the Three-Sided Enclosure Panel ...51 6-1.4. Replace / Reinstall the Three-Sided Enclosure Panel ...51 6-2. Replacement of the Heater ...51 6-3. Replacement of the Pump Housing ...52 6-4. Replacement of the Pump Motor ...53 6-5. Replacement of the Water Filter Assembly. ...54 6-6. Replacement of the Water Temperature Sensor. ...54 6-7. Replacement of the Water Manifolds ...55 6-7.1. Outlet Manifold ...55 6-7.2. Return Manifold ...56 6-8. Replacement of the Independent High Limit Safety Thermostat ...57 6-9. Calibration of the Independent High Limit Safety Thermostat ...58 6-10. Power Interrupt Test ...58 6-11. Hi-Limit Test...58 6-12. Replacement or Cleaning of the Water Flow Indicator Assembly...59 6-13. Replacement of the Power Switch ...60 6-14. Replacement of the Water Level Sensor Assembly ...61 6-15. Replacement of the Power Supply Board ...61 6-16. Replacement of the Microprocessor Board and/or the Control Panel...62 6-17. Electrical Safety ...63 6-17.1. Ground Integrity...63 6-17.2. Leakage Current ...63 Section 7. Troubleshooting Guide ... 65 Section 8. Parts Information ... 69 8-0. Introduction...70 8-1. Ordering Information for Replacement Parts ...70 8-2. Recommended Replacement Parts Inventory ...70 8-3. Returning Parts Under Warranty ...71 8-4. Shipping Parts ...71

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Operation / Technical Manual

NORM-O-TEMP, Model 111Z

TABLE OF FIGURES Figure 1. NORM-O-TEMP® unit, Front View ... 16 Figure 2. NORM-O-TEMP® unit, Left Side View ... 18 Figure 3. NORM-O-TEMP® unit, Rear View ... 20 Figure 4. NORM-O-TEMP® unit, Right Side View ... 21 Figure 5. NORM-O-TEMP® unit, Model 111Z Top View. ... 23 Figure 6. NORM-O-TEMP®, Model 111Z Features ... 27 Figure 7. NORM-O-TEMP® Maintenance Checklist ... 40 Figure 8. NORM-O-TEMP® Internal Exploded – Front View ... 72 Figure 9. Front View Parts List ... 73 Figure 10. NORM-O-TEMP® Internal Exploded – Rear View ... 74 Figure 11. Rear View Parts List ... 75 Figure 12. NORM-O-TEMP® Internal Exploded Reservoir Assembly ... 76 Figure 13. Reservoir Assembly Parts List... 77 Figure 14. NORM-O-TEMP® Electrical Wiring Diagram... 78 Figure 15. NORM-O-TEMP® Water Circulation Diagram... 79 Figure 16. NORM-O-TEMP® System Accessories... 80

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Operation / Technical Manual Technical Help United States and Canada Gentherm Medical, LLC 12011 Mosteller Road Cincinnati, OH 45241

NORM-O-TEMP, Model 111Z

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

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

Visit our Web Site at http://www.gentherm.com Before you call for Service... To help us better serve you, please have the serial number of your NORM-O-TEMP® unit ready when you call for parts or service. The serial number is located on a specification label on the back of the unit. In-Warranty Repair and Parts All parts on your NORM-O-TEMP® unit are covered by a one-year (1) warranty. Additional warranties are available at the time of purchase or during the warranty period. 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 NORM-O-TEMP® 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 caregiver information. Read and understand all precautionary information before using, prescribing, or servicing the NORM-O-TEMP® unit.

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Operation / Technical Manual

NORM-O-TEMP, Model 111Z

NORM-O-TEMP® Operating Instructions Quick Start Guide Read Operation Manual before using this device First Time Use Cleaning: Refer to Section 5-1.1, 5-1.2, and 5-1.3 for cleaning instructions. Initial Operation: 1. Check reservoir water level and fill if necessary 2. Insert power cord plug into hospital grade outlet 3. Connect hyperthermia blanket or pad 4. Turn power switch “ON” Unit will go through an 8-10 second calibration cycle to test all indicators and will flash the set point temperature of 42°C. Observe Water Flow Indicator on the side of the unit to verify that the pump is circulating water when blanket/pad is connected. The unit will start heating to a preset temperature of 42°C/107°F. To change the desired set point temperature, proceed to step 5 below. 5. Depress the”TEMP SET” button. The display will flash the previous set point temperature or the default temperature of 42°C/107°F if the unit has been turned OFF, and then back ON. NOTE: You have five seconds to depress one of the arrows or the temperature readout will return to the actual reservoir water temperature. 6. Depress the “UP” ▲ or “DOWN” ▼ arrow to raise or lower the set point temperature to the desired setting. 7. Select the desired temperature scale using the “C/F” button (Celsius or Fahrenheit)

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Operation / Technical Manual

NORM-O-TEMP, Model 111Z

Draining Instructions: 1. Turn “OFF” power switch. 2. Connect drain hose to one of the outlet fittings and allow to gravity drain. Alarm Conditions: • If an alarm sounds, check indicator lights or display for problem and take corrective action. • Alarm may be silenced temporarily for five minutes by depressing the “Silence Alarm” button • The “Silence Alarm” button will not silence the alarm when “ERR” appears on the display or “HIGH TEMP” indicator light comes on and does not flash. Power cord should be removed from outlet and the unit sent to Biomedical Engineering for repair. CAUTION: • This device should be operated only by trained personnel, under the direction of a physician. • Patients vary in degree of sensitivity to cold, heat, and pressure • The patient’s temperature and skin conditions should be checked at least every 20 minutes, or as directed by a physician, while on a thermal blanket.

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Operation / Technical Manual

NORM-O-TEMP, Model 111Z

Section 1. Introduction 1-0. General Safety Precautions To provide the patient maximum safety during the use of the NORM-O-TEMP® hyperthermia system, a thorough knowledge and understanding of the system, and the 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 reviewed at least semiannually as a refresher to safe operation and application. For proper knowledge and understanding, in-service training is available upon request. Failure to read, understand, or follow operating manual could result in serious injury or death. 1-1. General Description of this Manual This manual describes the operation, maintenance, and service of the NORM-O-TEMP® hyperthermia system. This manual is prepared for professional personnel who use the NORM-O-TEMP® hyperthermia system 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. Physical and functional characteristics are described in Sections 1-3 and 1-5. 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

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Operation / Technical Manual

NORM-O-TEMP, Model 111Z

1-2. Description of the NORM-O-TEMP® Hyperthermia System Intended Use The NORM-O-TEMP® Model 111Z hyperthermia system is intended to prevent hypothermia during surgical procedures and to reduce cold discomfort before, during, and after a surgical procedure. The thermal regulating system is used to keep a patient comfortable by maintaining blanket/pad water temperature through conductive heat transfer. The water heated blankets transfer the thermal energy to adult, pediatric, and infant (includes neonates) patients to keep a patient at a comfortable temperature. The NORM-O-TEMP® system is composed of a heater, circulating pump, and blankets/pads. It is intended for use by appropriately trained healthcare professionals in clinical environments. Intended Environment The NORM-O-TEMP® hyperthermia system is used in the Operating room, Post Anesthesia Care Units, Recovery rooms, Intensive Care Units and Emergency Rooms. The NORM-O-TEMP® hyperthermia system 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). NORM-O-TEMP®, Model 111Z The NORM-O-TEMP®, Model 111Z hyperthermia System is used to keep a patient comfortable by maintaining blanket/pad water temperature through conductive heat transfer. The NORM-O-TEMP® hyperthermia system is composed of a heater, circulating pump, safety high limit, and microprocessor board. Sterile water or water that has been passed through a filter less than or equal to 0.22 microns is heated and pumped from the unit to a blanket/pad. The blanket/pad rests under, around, and/or on top of the patient. The water circulates through the blanket/pad and returns to the unit. When warmed water is circulated through the blanket/pad, the patient is warmed. The unit is designed to operate based on the temperature of the circulating water. The recommended blankets/pads for use are listed in Figure 16 Accessories. 1-3. Physical Description of the NORM-O-TEMP® System See Section 2 for specifications and certifications of the NORM-O-TEMP®. 1-3.1. External Features and Descriptions – Front View The external features in Figure 1 of the NORM-O-TEMP® unit are described as follows:

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NORM-O-TEMP, Model 111Z

A. The control panel is composed of pressure sensitive touch switches and an LED display. An expanded description of the membrane control panel is presented in Section 1-3.5. B. The operating instructions printed below the control panel describe the necessary steps to operate the unit. C. The power switch is a bevel rocker switch labeled “I” (on) at the top and “O” (off) at the bottom. D. The four rubber feet help the unit to mount on the IV stand (Catalog #118), the low profile stand (Catalog #119) or allow the unit to sit on any flat surface. 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 to fill the reservoir. F. The red, Power Fail LED is the visual indicator when power is disconnected with the switch still in its on position or when the independent mechanical (High Limit) safety is activated.

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NORM-O-TEMP, Model 111Z

Figure 1. NORM-O-TEMP® unit, Front View

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Operation / Technical Manual

NORM-O-TEMP, Model 111Z

1-3.2. External Features and Descriptions – Left Side View The external features in Figure 2 of the NORM-O-TEMP® 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 must pass 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 change in water flow decreases the speed of the paddle wheel. The water flow indicator only spins when a blanket/pad or by-pass hose is connected to the unit. It will not spin when water is circulated internally to precondition the water. A total obstruction of the water path will cause the paddle wheel to stop completely. B. Two screws on the left and right side of the unit secures the top to the base. C. Two female fittings, 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. D. Two male fittings, 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. E. The recessed handle, one on each side, is provided to assist in lifting the unit on and off the I.V. stand or when carrying the unit.

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Operation / Technical Manual

NORM-O-TEMP, Model 111Z

Figure 2. NORM-O-TEMP® unit, Left Side View

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Operation / Technical Manual

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1-3.3. External Features and Descriptions – Rear View The external features in Figure 3 of the NORM-O-TEMP® unit are described as follows: A. The specification label outlines the NORM-O-TEMP® unit's electrical requirements. B. Sets of air vents provide air circulation for the internal components. C. The nylon straps are used to secure and store the coiled power cord and/or the connecting hose when not in use. D. The serial number printed on the Spec Label and located just above the power cord. E. Units have a disconnectable power cord and should only be inserted into a properly grounded mating receptacle of a hospital grade specified by local codes and practices. Electrical specifications are described in Section 3.

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Figure 3. NORM-O-TEMP® unit, Rear View

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