NORM-O-TEMP Model 111W Operation and Technical Manual Rev P Aug 2011

SYMBOLS Caution: Read Operation Instructions and Manual Before Operating

Temperature Set

Fuse

Water Temperature

Increasing Temperature

Silence Alarm

Temp. Set Point Indicator

Decreasing Temperature

Fill to Strainer

Inlet Heat

Water Flow Indicator Outlet

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

I / O On / Off

~ AC Voltage

Power Cord Holder

Danger; Risk of Electric Shock

Type BF Equipment

Seperate collection for electrical and electronic equipment

Protective Earth (Ground)

Earth (Ground)

Equipotentiality

Clean Water Filter Quarterly

Caution

II

Disconnect Power Before Servicing

Low Water Level

High Limit / Over-Temperature Safety Limit

Change Water Monthly

NORM-O-TEMP® MODEL 111W - 230 / 240 Voltage OPERATION & TECHNICAL MANUAL

The operator must read and understand the Operation/Technical Manual in its entirety prior to operating the equipment. This document contains proprietary information and such information that may not be disclosed to others for any purpose or used for manufacturing purposes without written permission from Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, Ohio 45241-1528, Telephone: (513) 772-8810. Cincinnati Sub-Zero Products, Inc., reserves the right to make equipment changes and improvements which may not be reflected in this manual. This document may not be reproduced in whole or in part without written permission from Cincinnati Sub-Zero Products, Inc.

Manual 56430 Rev. P ECN M104-4112 2011-08

III

START UP INSTRUCTIONS: INSERT

When turning ON your Norm-O-Temp, the unit will go through a short diagnostic sequence. The display will read “HE” indicating the heating of the internal water. When the internal water temperature reaches 18°C, the actual internal water temperature will be displayed. If at the end of the three (3) minute sequence the water has not reached an internal temperature of 18°C the display will read “ERR”. If this occurs turn power OFF and then back ON to repeat diagnostic check. If after second diagnostic check “ERR” is still displayed, remove from service. Please call 1-800-989-7373 for CSZ Medical Technical Service.

IV

WARNING 

Read Operation/Technical Manual before operating.



A physician’s order is required for setting temperature and use of equipment. At least every 20 minutes, or as directed by physician, check patient’s temperature and skin condition of areas in contact with blanket; also, check blanket water temperature. Pediatric, temperature-sensitive patients with vascular disease, and operating room patients should be checked more frequently. Notify the physician promptly of any change, or if the patient’s temperature is not responding properly, or does not reach the prescribed temperature in the prescribed time, or there is a change in the prescribed temperature range. Failure to inform the physician of the deviation may result in injury to the patient.



The method of temperature control provided by all hyperthermia units present the danger of heating body tissues, particularly the skin, to a point where they are injured, i.e., burns. Depending on the extent and severity of a burn, very serious and even fatal complications may arise.



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. Skin damage may result.



The area between the patient and the blanket should be kept dry to avoid injury to patient.



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 Setpoint Temperature resulting in inaccurate therapy to the patient. Follow instructions for First Time Set-Up/System Test Routine to resume operation. Failure to resume the desired therapy could result in serious injury or death.



This device is still energized when the power switch is in the off position. To completely disconnect the device from the power source, remove the appliance plug from the back of the unit.



The capacitors inside this unit may remain charged after power is disconnected, discharge before servicing.

V

CAUTION Use distilled water only. Failure to use distilled water may result in poor performance and damage to the Norm-O-Temp. Do not use De-ionized Water. The majority of de-ionizers do not maintain a neutral pH of 7. If the de-ionized water is acidic, it will cause a battery effect, the metal will begin to deteriorate and may cause a leak in the system. 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.

NORM-O-TEMP, MAXI-THERM, MAXI-THERM LITE, TEMP-PAD and PLASTIPAD are Registered Trademarks of Cincinnati Sub-Zero Products, Inc. Copyright© 1986, Cincinnati Sub-Zero Products, Inc.

VI

4-4 MAINTENANCE OF THE WATER CIRCULATING SYSTEM ...32 MAINTENANCE OF THE NORM-O-TEMP EXTERIOR ...34 4-5 4-6. MAINTENANCE OF HYPER-HYPOTHERMIA PADS ...35 PLASTIPAD REUSABLE BLANKET...35 4.6.1 MAXI-THERM, MAXI-THERM LITE AND TEMP-PAD SINGLE-PATIENT USE PADS ...35 4.6.2 SECTION 5.

FIELD REPAIR/SERVICE OF THE NORM-O-TEMP ...36

5-1. INTRODUCTION ...36 5-2. ACCESS TO THE INTERIOR ...37 REMOVING THE TOP OF THE UNIT ...37 5-2.1. REPLACE/REINSTALL THE TOP OF THE UNIT ...38 5-2.2. REMOVING THE THREE SIDED ENCLOSURE PANEL ...38 5-2.3. REPLACE/REINSTALL THE THREE-SIDED ENCLOSURE PANEL ...39 5-2.4. 5-3. REPLACEMENT OF THE HEATER ...39 5-4. REPLACEMENT OF THE PUMP HOUSING ...39 5-5. REPLACEMENT OF THE PUMP MOTOR ...40 5-6. REPLACEMENT OF THE WATER FILTER ASSEMBLY ...41 5-7. REPLACEMENT OF THE WATER TEMPERATURE SENSOR ...42 REPLACEMENT OF THE WATER MANIFOLDS ...43 5.8 OUTLET MANIFOLD ...43 5.8.1 RETURN MANIFOLD ...44 5.8.2 REPLACEMENT OF THE INDEPENDENT HIGH LIMIT THERMOSTAT. ...44 5-9 CALIBRATION OF THE INDEPENDENT HIGH LIMIT SAFETY THERMOSTAT ...45 5-10. 5-11. POWER INTERUPT TEST...46 5-12 HI-LIMIT TEST ...46 REPLACEMENT OR CLEANING OF THE WATER FLOW INDICATOR ASSEMBLY ...46 5-13. REPLACEMENT OF THE POWER SWITCH ...47 5-14. REPLACEMENT OF THE WATER LEVEL SENSOR ASSEMBLY ...48 5-15. REPLACEMENT OF POWER SUPPLY BOARD ...48 5-16 REPLACEMENT OF THE MICROPROCESSOR BOARD AND/OR THE CONTROL PANEL ...49 5-17. ELECTRICAL SAFETY ...50 5-18. GROUND INTEGRITY ...50 5-18.1. LEAKAGE CURRENT ...50 5-18.2. SECTION 6.

TROUBLESHOOTING GUIDE ...51

SECTION 7.

PARTS INFORMATION ...56

7-1. 7-2. 7-3. 7.4 7-5.

INTRODUCTION ...56 ORDERING INFORMATION FOR REPLACEMENT PARTS ...56 RECOMMENDED REPLACEMENT PARTS INVENTORY ...57 RETURNING PARTS UNDER WARRANTY...57 SHIPPING PARTS ...58

ACCESSORIES - PADS ...67 TEMPERATURE PROBES ...67

VIII

LIST OF ILLUSTRATIONS Page No. Figure 1-4.1 Figure 1-4.2 Figure 1-4.3 Figure 1-4.4. Figure 1-5. Figure 1-6. Figure 4-1. Figure 4-2. Figure 4-3. Figure 7-1. Figure 7-2. Figure 7-3. Figure 7-4. Figure 7-5. Figure 7-6. Figure 7-7. Figure 7-8. Figure 7-9.

External Features-Front View...4 External Features-Left Side View...6 External Features-Rear View ...8 NORM-O-TEMP Top View ... 10 Temperature Safety Limits ... 13 NORM-O-TEMP Specifications ... 14 Scheduled Maintenance Requirements ... 27 Recommended Test Equipment... 28 Preventive Maintenance Checklist ... 29 Internal Exploded-Front View ... 61 Parts List A... 62 Internal Exploded Rear View ... 63 Parts List B... 64 Internal Exploded View -Reservoir Assembly... 65 Parts List C ... 66 Electrical Wiring Diagram ... 67 Water Circulation... 68 NORM-O-TEMP Accessories... 69

IX

X

TECHNICAL HELP

Norm-O-Temp Model 111W 230 / 240 V Operation/Technical Manual

TECHNICAL HELP United States and Canada Cincinnati Sub-Zero Products, Inc. 12011 Mosteller Road Cincinnati, OH 45241

Telephone 1-513-772-8810 Toll Free 1-800-989-7373 Fax 1-513-772-9119

AUTHORIZED EUROPEAN REPRESENTATIVE: CEpartner4U 3951DB, 13. NL.

Telephone +31 (0) 6-516.536.26

CEpartner4U BV Esdoorlaan 13, 3951 DB Maarn. The Netherlands

Telephone + 31 (0) 6-516.536.26

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. IN-WARRANTY REPAIR AND PARTS All parts on your Norm-O-Temp unit are covered by a one-year warranty. To return defective parts or units, first obtain a Returned Materials Authorization (RMA) number from our Medical Technical Service department. A Norm-O-Temp shipping carton will be sent to you, if needed.

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 Cincinnati Sub-Zero. 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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INTRODUCTION

SECTION 1. 1-0.

Norm-O-Temp Model 111W Operation/Technical Manual

INTRODUCTION

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, 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, all precautions and warnings prior to use. It is recommended that this manual be reviewed at least semiannually as a refresher to safe operation and application. Failure to read, understand, or follow operating manual could result in serous injury or death.

1-1.

GENERAL DESCRIPTION OF THIS MANUAL

This manual describes the operation, maintenance, and service of the Cincinnati SubZero NORM-O-TEMP total body hyperthermia system. Section One describes the physical and functional characteristics of the NORM-O-TEMP System. Section Two describes how to prepare the NORM-O-TEMP unit for general use. Section Three describes how to operate the unit. Section Four describes the regular maintenance of the NORM-O-TEMP unit. Section Five describes field repair and service of the unit. Section Six is a Troubleshooting Guide and Section Seven outlines parts information as well as wiring schematics and water flow diagrams. This manual is prepared for professional personnel who use the equipment for patient care. It is also intended for technicians and service personnel who are responsible for maintaining the equipment. A selected part of the information of this manual covers the operation of the NORM-OTEMP which should be readily available for reference when operating the unit.

1-2.

GENERAL DESCRIPTION OF THE NORM-O-TEMP SYSTEM

The Cincinnati Sub-Zero NORM-O-TEMP SYSTEM (Model 111W) total body hyperthermia system is used to raise and/or maintain a patient’s temperature through conductive heat transfer. The Cincinnati Sub-Zero NORM-O-TEMP is composed of a heater, circulating pump, fan, safety high limit, microprocessor board, and power supply board. Water is heated and pumped from the unit to a blanket. The blanket (see Section 1-5.) rests under and/or on top of the patient and is designed so that the water circulates 2

INTRODUCTION

Norm-O-Temp Model 111W Operation/Technical Manual

through the blanket and returns to the unit. When warmed water is circulated through the blanket, the desired effect is to elevate the patient’s temperature. The unit is designed to operate based on the temperature of the circulating water.

1-3.

CLINICAL APPLICATIONS

The NORM-O-TEMP unit is used primarily in the Operating, Recovery and Emergency Rooms. The total body hyperthermia system can be used with adult and pediatric patients to produce normothermia by raising a patient’s sub-normal temperature. It can also be utilized to maintain normal body temperature (normothermia) during surgical procedures. 1-4.

PHYSICAL DESCRIPTION OF THE NORM-O-TEMP

See Figure 1-7. 1-4.1. EXTERNAL FEATURES - FRONT VIEW The external features in Figure 1-4.1 are described as follows: A. The control panel is composed of pressure sensitive touch switches and LED display windows. An expanded description of the control panel is presented in Section 1-4.5. 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 l/0. D. The four rubber feet help the unit to mount on the I.V. stand (Catalog #118) or allow the unit to sit on any flat surface. E. The water fill opening is where the operator pours distilled water to fill the reservoir. F. The red LED is the visual indicator when power is disconnected with the switch in its on position. Note: This LED also illuminates as a secondary visual indicator when the water temperature reaches 44.0°C.

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INTRODUCTION

Norm-O-Temp Model 111W Operation/Technical Manual

Figure 1-4.1. NORM-O-TEMP SYSTEM - Front View

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INTRODUCTION

Norm-O-Temp Model 111W Operation/Technical Manual

1-4.2. EXTERNAL FEATURES - LEFT SIDE VIEW The external features in Figure 1-4.2 of the NORM-O-TEMP 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. The water flow indicator provides a visual display of the general rate at which the water is circulating. B. Two screws on the left and right side of the unit secure the top to the base. C. Two 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. D. Two 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. 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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INTRODUCTION

6

Norm-O-Temp Model 111W Operation/Technical Manual

INTRODUCTION

Norm-O-Temp Model 111W Operation/Technical Manual

1-4.3. EXTERNAL FEATURES - REAR VIEW The external features in Figure 1-4.3 of the NORM-O-TEMP are described as follows: A. The specification label outlines the NORM-O-TEMP’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 is permanently attached 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 grade specified by local codes and practices. Electrical specifications are described in Section 1.7.

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INTRODUCTION

8

Norm-O-Temp Model 111W Operation/Technical Manual

INTRODUCTION

Norm-O-Temp Model 111W Operation/Technical Manual

1-4.4. EXTERNAL FEATURES - RIGHT SIDE VIEW The external features in Figure 1-4.4 of the NORM-O-TEMP are described as follows: A. The three sided enclosure panel, secured with eight screws, provides access to the interior. B. The recessed handle is one of two provided to assist in lifting the unit. C. Two screws on the right and left side of the unit secure the top to the base. 1-4.5. TOP VIEW DESCRIPTION The control panel is described as follows: A. The green four digit LED display shows the actual water temperature and setpoint temperature. B. The Heat LED indicates that the water is being heated. C. The alarm indicator light, will illuminate and the audible alarm sound when the water temperature reaches 44° C D. The Low Water LED indicates that the unit needs more distilled water to operate. The LED will be accompanied by an audible alarm. E. The Silence Alarm switch will silence the audible alarm for five minutes and if the problem is not solved, the alarm will sound again until the switch is pressed or the problem is solved. F. The Temp Set switch is used to display the desired water temperature. When this switch is pressed, the display will flash the setpoint temperature for five seconds. G. The UP and DOWN arrow switches are used to raise or lower the setpoint temperature. There is a five second interval to set the temperature up or down after pressing the Temp Set switch. H. The fill reservoir lid slides to the left to open and to the right to close.

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INTRODUCTION

Norm-O-Temp Model 111W Operation/Technical Manual

H

Figure 1-4.4. NORM-O-TEMP SYSTEM - Top View

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INTRODUCTION

1-5.

Norm-O-Temp Model 111W Operation/Technical Manual

REQUIRED ACCESSORIES

Operation of the NORM-O-TEMP unit requires the use of a pad through which warm water circulates via a connecting hose with quick-disconnect male and female couplings. NORM-O-TEMP System Equipment and accessories are listed in Figure 7-10. Cincinnati Sub-Zero offers the widest selection of hyper-hypothermia blankets to serve your needs, providing both reusable and single-patient use pads. The reusable pads, the lightweight PLASTIPAD, come with an integral three meter connecting hose with quick-disconnect, error proof male and female couplings. Single-patient use pads, MAXI-THERM, MAXI-THERM LITE, TEMP-PAD and a reusable connecting hose are also available All Cincinnati Sub-Zero blankets offer significantly higher thermal transfer capability than any other brand of hyper-hypothermia blankets. Operation of the NORM-O-TEMP unit requires the use of distilled water. Draining the NORM-O-TEMP unit requires the use of a drain hose with a female coupling. This hose is included with the unit.

1-6.

FUNCTIONAL DESCRIPTION OF THE NORM-O-TEMP

The unit heats the water to reach a preset setpoint temperature of 37°C. The water circulates through the pad(s) which raises and/or maintains the temperature of the patient. There is not a constant relationship between the temperature of the water and the patient’s temperature. 1-6.1. HEATING SYSTEM

The NORM-O-TEMP heating system consists of an immersion heater and water temperature control. The temperature ranges are described in Section 1-7. The immersion heater is located in the circulating reservoir. The water circulating in the reservoir flows around the immersion heater and is warmed. 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 temperature of the patient.

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