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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 Cincinnati Sub-Zero Products, LLC, Cincinnati, Ohio USA. ® ® ® ® ® Copyright 2016 Cincinnati Sub-Zero Products, LLC. All rights reserved. Manual 59225 Rev.
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Operation / Technical Manual NORM-O-TEMP, Model 111Z SYMBOLS Caution: Read Fuse Temperature Set Operation Instructions and Manual Before Operating Increasing Silence Alarm Water Temperature Temperature Decreasing Fill to Strainer Temp. Set Point Temperature Indicator Inlet Heat Water Flow Indicator Outlet Risk of Explosion: Do not use in the Power Cord Holder...
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Operation / Technical Manual NORM-O-TEMP, Model 111Z Cincinnati Sub-Zero Products, 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.
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Operation / Technical Manual NORM-O-TEMP, Model 111Z Do not use the NORM-O-TEMP system in the presence of flammable anesthetics. Risk of • ® The warming of transdermal medications (patches) can increase drug delivery, resulting • explosion can result. • • Power interruption will cause the NORM-O-TEMP to revert to Preset Set point Temperature in possible injury to the patient.
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• power source. Unapproved blanket/pad(s) or hoses should never be used. Always use CSZ • No modification of this equipment is allowed without prior, written authorization from CSZ. recommended blankets/pads. • Page 6 of 81...
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 ®...
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Operation / Technical Manual NORM-O-TEMP, Model 111Z 6-0. Introduction ................................. 48 6-1. Access to the Interior ............................49 6-1.1. Removing the Top of the Unit ........................49 6-1.2. Replace / Reinstall the Top of the Unit ....................50 6-1.3. Removing the Three-Sided Enclosure Panel ..................50 6-1.4.
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Operation / Technical Manual NORM-O-TEMP, Model 111Z Figure 1. NORM-O-TEMP unit, Front View ........................14 TABLE OF FIGURES ® Figure 2. NORM-O-TEMP unit, Left Side View ......................16 ® Figure 3. NORM-O-TEMP unit, Rear View ........................18 ® Figure 4. NORM-O-TEMP unit, Right Side View ......................
12011 Mosteller Road 1-513-772-9119 Cincinnati, OH 45241 (U.S.) 24hr Clinical Support 1-513-460-2038 E-Mail csz@genthermcsz.com Visit our Web Site at http://www.cszmedical.com To help us better serve you, please have the serial number of your NORM-O-TEMP unit Before you call for Service..
Operation / Technical Manual NORM-O-TEMP, Model 111Z Read Operation Manual before using this device NORM-O-TEMP Operating Instructions Quick Start Guide ® Refer to Section 5-1.1, 5-1.2, and 5-1.3 for cleaning instructions. First Time Use Cleaning: 1. Check reservoir water level and fill if necessary. Initial Operation: 2.
Operation / Technical Manual NORM-O-TEMP, Model 111Z Section 1. Introduction To provide the patient maximum safety during the use of the NORM-O-TEMP 1-0. General Safety Precautions 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.
Operation / Technical Manual NORM-O-TEMP, Model 111Z The NORM-O-TEMP , Model 111Z hyperthermia System is used to keep a patient NORM-O-TEMP , Model 111Z ® 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.
Operation / Technical Manual NORM-O-TEMP, Model 111Z The external features in Figure 2 of the NORM-O-TEMP unit are described as 1-3.2. External Features and Descriptions – Left Side View follows: ® A. The water flow indicator is a paddle wheel immersed in the path of the circulating water with a window to the outside.
Operation / Technical Manual NORM-O-TEMP, Model 111Z The external features in Figure 3 of the NORM-O-TEMP unit are described as 1-3.3. External Features and Descriptions – Rear View follows: ® A. The specification label outlines the NORM-O-TEMP unit's electrical requirements. ®...
Operation / Technical Manual NORM-O-TEMP, Model 111Z The external features in Figure 4 of the NORM-O-TEMP are described as 1-3.4. External Features and Descriptions – Right Side View ® follows: A. The three sided enclosure panel, secured with eight screws, provides access to the interior.
Operation / Technical Manual NORM-O-TEMP, Model 111Z The membrane control panel as shown in Figure 5 is composed of pressure 1-3.5. External Features and Descriptions – Top View sensitive touch switches and LED displays. The membrane control panel is divided into the following sections: A.
Operation / Technical Manual NORM-O-TEMP, Model 111Z Operation of the NORM-O-TEMP unit requires the use of the blanket/pad(s) designed to 1-4. Required Accessories circulate warm water via a connecting hose with quick-disconnect male and female ® couplings. NORM-O-TEMP System Equipment and accessories are listed in Figure 16. Note: Some reusable blankets/pads come with a permanently attached hose.
Operation / Technical Manual NORM-O-TEMP, Model 111Z In addition, the circulating reservoir contains a low water level sensor which shuts down the unit and sounds an alarm if the water level drops below 1 ½ quarts (1.4 liters). The unit becomes operational after the water level is restored to normal. The NORM-O-TEMP unit is designed to carefully measure and control the 1-5.3.
Operation / Technical Manual NORM-O-TEMP, Model 111Z Section 2. Specifications and Certifications Specifications for the NORM-O-TEMP are presented in Figure 6 and are subject to change without notice. ® Physical Control System Microprocessor-based temperature control 22.86 cm (9 inches) Wide system, and Alarm indications.
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Operation / Technical Manual NORM-O-TEMP, Model 111Z Electrical System Safety System 100V, 50/60Hz, 8.2 Amps 42°C / 107.6°F Electrical Characteristics: Maximum High Control Setting 800 watts 43.5°C ± 0.6°C (110.0°F ± 1.08°F) Heater Power: Primary Temperature Limit: 44.5°C ± 0.6°C (112.0°F ± 1.08°F) Power Cord: Secondary Temperature Limit: 3 Conductor, detachable, 16/18...
Operation / Technical Manual NORM-O-TEMP, Model 111Z Section 3. General Preparation of the NORM-O-TEMP ® System This section describes the procedures to prepare the NORM-O-TEMP unit for general 3-0. Introduction use. This entails unpacking the shipment, arranging all the equipment for the first time, ®...
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Operation / Technical Manual NORM-O-TEMP, Model 111Z OPTION: The NORM-O-TEMP unit can be mounted on an optional Low Profile stand with casters or an optional I.V. Stand. For installation instructions, see ® insert packaged with the stand. B. Visually inspect the NORM-O-TEMP unit to determine that there are no missing parts, dents, or punctures.
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Operation / Technical Manual NORM-O-TEMP, Model 111Z H. Connect the blanket/pad(s) to the NORM-O-TEMP unit by attaching the quick- disconnect female socket of the connecting hose to a male outlet plug (on the ® bottom row) of the unit. Attach the male quick-disconnect plug of the connecting hose to a female return socket (on the top row) of the unit.
Operation / Technical Manual NORM-O-TEMP, Model 111Z After arranging the equipment described in Section 3-2.1, complete this System Test 3-2.2. Completing a System Test Routine Routine which describes what switches to press and the changes to observe. ALARM NOTE: If power is removed from the unit without actuating the power switch (I/O switch) a power fail alarm is activated and the LED located on the front panel of the unit flashes.
Operation / Technical Manual NORM-O-TEMP, Model 111Z E. Press the INCREMENT ▲ button during the five second interval after pressing the TEMP SET button. 1. A beeper sounds each time it is pressed, but does not beep when held down continuously.
Operation / Technical Manual NORM-O-TEMP, Model 111Z 3-4. Patient Preparation and Bedside Care Effective use of the NORM-O-TEMP system must include proper patient care prior to and while using the hyper-hypothermia blanket/pad(s). ® A. A base line recording should be made of vital signs, level of consciousness and responsiveness.
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Operation / Technical Manual NORM-O-TEMP, Model 111Z C. Primary High Temperature Safety Alarm 1. If the circulating water reaches 43.5°C ± 0.6°C (110°F ± 1.08°F), the primary high temperature safety will activate to turn off pump, turn off heater, the HI TEMP LED flashes and the trouble alarm sounds. 2.
Operation / Technical Manual NORM-O-TEMP, Model 111Z Operating the NORM-O-TEMP System Section 4. ® This section describes how to operate the NORM-O-TEMP system in order to control 4-0. Introduction the blanket/pad water temperature. ® For proper knowledge and understanding of the unit, in-service training is available upon request.
Operation / Technical Manual NORM-O-TEMP, Model 111Z L. If a single-patient use hyper-hypothermia blanket/pad is used, connect the couplings of the connecting hose to the blanket/pad as described in the instructions packaged with each blanket/pad. M. The hyper-hypothermia blanket/pad may be pre-warmed before positioning the patient.
Operation / Technical Manual NORM-O-TEMP, Model 111Z 4-3. Concluding the Use of the NORM-O-TEMP System ® NOTE: It is important to drain the unit before placing in dry storage. After the patient temperature reaches the prescribed temperature for the prescribed amount of time, discontinue the use of the NORM-O-TEMP unit as ordered.
Operation / Technical Manual NORM-O-TEMP, Model 111Z Section 5. General Maintenance of the NORM-O-TEMP System ® This section describes the general requirements maintenance personnel should complete 5-0. Introduction on a regular basis so that the NORM-O-TEMP system continues to operate within the manufacturer’s specifications.
Operation / Technical Manual NORM-O-TEMP, Model 111Z Required Preventative Maintenance Checklist (Quarterly Hospital Control No. Serial Number Check When Completed 1. External cabinet in good condition. (No unusual dents or missing parts.) 2. All labels properly affixed. 3. Clean the unit’s exterior and vents. (See Section 5-3) ...
Operation / Technical Manual NORM-O-TEMP, Model 111Z The dual compartment reservoir holds approximately 1½ gallons (5.7 liters) of distilled 5-1. Maintenance of Water Reservoir water that remains in the unit between periods of use. Once a month the water reservoir should be drained and replenished. The drain hose, included in the packaging of the unit, is attached and the water is pumped out of the unit.
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Operation / Technical Manual NORM-O-TEMP, Model 111Z C. Fill the reservoir with the appropriate amount of household bleach per chart below. UNIT BLEACH WATER NORM-O-TEMP , 111Z 168 Milliliters 5.4 Liters ® D. Fill the reservoir with warm distilled water. E.
Operation / Technical Manual NORM-O-TEMP, Model 111Z For Circulating Water Units Utilizing CE Approved Gigasept FF (Product of Schulke 5-1.2. Internal Cleaning & Disinfection Using Gigasept FF / Dry Storage Procedure & Mayr) (Contact your local Cleaning Supplier). Gigasept FF Is Not Available In the United States.
Operation / Technical Manual NORM-O-TEMP, Model 111Z For circulating water units utilizing CE approved Maranon H (Product of Ecolab). 5-1.3. Internal Cleaning & Disinfection Using Maranon H / Dry Storage Procedure Maranon H is not available in the United States. The following procedure disinfects the fluid circuit in these products.
Operation / Technical Manual NORM-O-TEMP, Model 111Z CAUTION Always drain the NORM-O-TEMP to a sanitary drain because bacteria may be present in the unit’s water supply. • ® A. Collect these items: 5-1.4. Draining the Reservoir 1. An empty container to drain the water into that can hold at least 3 gallons (11.4 liters).
Operation / Technical Manual NORM-O-TEMP, Model 111Z CAUTION Do not use alcohol. Alcohol may cause blanket/pad and unit deterioration. Use distilled water only. Do Not Use De-Ionized water. • Do not overfill. Overfilling may result in overflow when the water in the blanket/pad •...
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Operation / Technical Manual NORM-O-TEMP, Model 111Z WARNING The repair, calibration, and servicing of the NORM-O-TEMP 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.
Operation / Technical Manual NORM-O-TEMP, Model 111Z The NORM-O-TEMP unit is constructed of powder coated steel with a plastic top that 5-3. Maintenance of the NORM-O-TEMP Exterior & Vents – Cleaning Instructions ® should be cleaned quarterly with water and mild detergent solution. For cleaning and ®...
Operation / Technical Manual NORM-O-TEMP, Model 111Z The reusable blanket/pad maintenance procedures do not apply to the 5-4.2. Cleaning / Maintenance of Disposable, Single-Patient Use Blanket / Pad(s) disposable, single-patient use blankets/pads. Disposal of blankets/pads are done in a means consistent with hospital policy protocol for patient contact items.
Operation / Technical Manual NORM-O-TEMP, Model 111Z Section 6. Field Repair / Service of the NORM-O-TEMP ® This section describes the repair and service that qualified maintenance personnel can 6-0. Introduction complete in the field if a problem should occur. Only qualified personnel should undertake repairs and service.
Operation / Technical Manual NORM-O-TEMP, Model 111Z WARNING The repair, calibration, and servicing of the NORM-O-TEMP® should be performed by a 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.
Operation / Technical Manual NORM-O-TEMP, Model 111Z A. Re-Install top as it was removed in Section 6-1.1. 6-1.2. Replace / Reinstall the Top of the Unit NOTE: When securing top, be sure the fill spout gasket inner lip on aluminum cover top is in the up position and fill spout goes directly into it. A.
Operation / Technical Manual NORM-O-TEMP, Model 111Z A. Obtain a replacement pump housing. 6-3. Replacement of the Pump Housing B. Drain the reservoir and disconnect the power cord as described in Section 5-1.4. C. Remove the three-sided enclosure panel as described in Section 6-1.3. D.
Operation / Technical Manual NORM-O-TEMP, Model 111Z A. Obtain a replacement pump motor. 6-4. Replacement of the Pump Motor B. Drain the reservoir and disconnect the power cord as described in Section 5-1.4. C. Remove the three-sided enclosure panel as described in Section 6-1.3. D.
Operation / Technical Manual NORM-O-TEMP, Model 111Z A. Obtain a replacement water filter assembly. 6-5. Replacement of the Water Filter Assembly. B. Drain the reservoir and disconnect the power cord as described in Section 5-1.4. C. Remove the three-sided enclosure panel as described in Section 6-1.3. D.
Operation / Technical Manual NORM-O-TEMP, Model 111Z 6-7. Replacement of the Water Manifolds A. Obtain replacement water outlet manifold. 6-7.1. Outlet Manifold B. Drain reservoir and disconnect power cord as described in Section 5-1.4. C. Remove the three-sided enclosure panel as described in Section 6-1.3. D.
Operation / Technical Manual NORM-O-TEMP, Model 111Z A. Obtain replacement water return manifold. 6-7.2. Return Manifold B. Drain reservoir and disconnect power cord as described in Section 5-1.4. C. Remove the three-sided enclosure panel as described in Section 6-1.3. D. Locate the (top) manifold to be replaced which is secured to the left side of the unit behind the water pump, shown in Figure 8.
Operation / Technical Manual NORM-O-TEMP, Model 111Z F. Disconnect the two wires from the slide-on terminals. G. Loosen the compression fitting on the back of the reservoir and remove the copper sensing bulb. Be sure to remove the compression fitting cap, washer, and rubber “O”...
Operation / Technical Manual NORM-O-TEMP, Model 111Z A. Leaving the power switch on, disconnect the power cord from its source. The Power Interrupt Test audible and visual alarm must indicate for at least 10 minutes. A. Raise the top of the unit and move both jumpers on the power supply board to 6-10.
Operation / Technical Manual NORM-O-TEMP, Model 111Z A. Obtain a replacement water flow indicator. 6-11. Replacement or Cleaning of the Water Flow Indicator Assembly B. Drain reservoir and disconnect power cord as described in Section 5-1.4. C. Remove the three sided enclosure panel as described in Section 6-1.3. D.
Operation / Technical Manual NORM-O-TEMP, Model 111Z A. Obtain the replacement power switch. 6-12. Replacement of the Power Switch B. Drain reservoir and disconnect power cord as described in Section 5-1.4. C. Remove the three-sided enclosure panel as described in Section 6-1.3. D.
Operation / Technical Manual NORM-O-TEMP, Model 111Z CAUTION Working with electronic boards, plugs, and cables requires delicate handling. Proper • Electrostatic Discharge (ESD) practices should be followed during replacement of any electronic board. A. Obtain a replacement power supply board. 6-14.
Operation / Technical Manual NORM-O-TEMP, Model 111Z CAUTION Working with electronic boards, plugs, and cables requires delicate handling. Proper • Electrostatic Discharge (ESD) practices should be followed during replacement of any electronic board. Access to the control panel first requires removing the microprocessor board. 6-15.
Operation / Technical Manual NORM-O-TEMP, Model 111Z The NORM-O-TEMP unit should be checked quarterly for electrical safety. 6-16. Electrical Safety It is appropriate to perform such inspection upon receipt of a new unit prior to ® acceptance, following repair and/or service of the unit, and then again during each periodic inspection.
Operation / Technical Manual NORM-O-TEMP, Model 111Z Section 7. Troubleshooting Guide CAUTION 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 power cord plug •...
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Operation / Technical Manual NORM-O-TEMP, Model 111Z Observation Possible Problem Action To Be Taken C. The power switch is Power supply board is Replace the power supply pressed to the ON position. defective. board. See Section 6-14. It lights up green but the control panel is blank/ The cable(s) that connect(s) Reconnect the 12-pin and 9-...
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Operation / Technical Manual NORM-O-TEMP, Model 111Z Observation Possible Problem Action To Be Taken G. Unit is set to operate. Microprocessor control Replace the microprocessor When the unit goes through board malfunctioned. control board. See Section its test indicator cycle, the 6-15.
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Operation / Technical Manual NORM-O-TEMP, Model 111Z Observation Possible Problem Action To Be Taken K. The unit sounds an alarm. The 2-pin connection cable Reconnect the 2-pin The LO WATER indicator from the LOW WATER float connector. light is on. The water level is switch is disconnected.
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Operation / Technical Manual NORM-O-TEMP, Model 111Z Observation Possible Problem Action To Be Taken M. Unit is set to operate Water not circulating. See observation N. but fluid does not heat. Defective heater Replace heater. See Section 6-2. Defective power supply Replace power supply board.
Operation / Technical Manual NORM-O-TEMP, Model 111Z Section 8. Parts Information This section outlines information for ordering, shipping and replacing parts. 8-0. Introduction Identification of parts and components are shown in Figures 8, 10, and 12. The numbers in Figures 8, 10, and 12 correspond to the numbers in the left column of the accompanying parts lists in Figures 9, 11, and 13.
3. Serial Number. 4. Date of installation or purchase of the unit. 5. Return Material Authorization (RMA) Number. (You must call CSZ first to obtain the RMA Number.) Parts to be returned to the factory should be carefully packaged, especially the micro- 8-4.
MAXI-THERM Single-Patient Use Blankets/pads Pediatric Size (22" x 30") Infant Size (12" x 18") Contents: 5/box, 4 boxes/case Reusable Connecting Hose (for CSZ Unit) Adult Size (25” x 64”) MAXI-THERM LITE Single-Patient Use Blanket/pad(s) Pediatric Size (25” x 33”) Infant Size (12.5” x 18”) Pediatric (25”...
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Operation / Technical Manual NORM-O-TEMP, Model 111Z The following tables are presented in fulfillment of the requirements of IEC 60601-1-2 Guidance and manufacturer’s declaration – electromagnetic emissions The NORM-O-TEMP , Model 111Z is intended for use in the electromagnetic environment specified below. The customer or the user of the NORM-O-TEMP , Model 111Z should assure that it is used in such an environment.
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Operation / Technical Manual NORM-O-TEMP, Model 111Z Guidance and manufacturer’s declaration – electromagnetic immunity The NORM-O-TEMP , Model 111Z is intended for use in the electromagnetic environment specified below. The customer or the user of the NORM-O-TEMP , Model 111Z should assure that it is used in such an environment. ®...
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Operation / Technical Manual NORM-O-TEMP, Model 111Z Recommended separation distances between portable and mobile RF communications equipment and The NORM-O-TEMP , Model 111Z is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. the NORM-O-TEMP , Model 111Z ®...
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