CSZ Norm-o-Temp 111Z Operation Manual
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CSZ Norm-o-Temp 111Z Operation Manual

Hyperthermia system
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Operation Manual
Model 111Z Hyperthermia System
Cincinnati Sub-Zero Products, LLC • 12011 Mosteller Road • Cincinnati, Ohio 45241, U.S.A.
www.cszmedical.com

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  • Page 1 Operation Manual Model 111Z Hyperthermia System Cincinnati Sub-Zero Products, LLC • 12011 Mosteller Road • Cincinnati, Ohio 45241, U.S.A. www.cszmedical.com...
  • Page 2 Operation 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 59425 Rev. B ECN M510-4952 Page 2 of 50...
  • Page 3 Operation 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 Disconnect Power...
  • Page 4 Operation 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.
  • Page 5 Operation Manual NORM-O-TEMP, Model 111Z WARNING • 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.
  • Page 6 • Unapproved blanket/pad(s) or hoses should never be used. Always use CSZ recommended blankets/pads. • No modification of this equipment is allowed without prior, written authorization from CSZ. Page 6 of 50...

  • Page 7: Table Of Contents

    Operation Manual NORM-O-TEMP, Model 111Z TABLE OF CONTENTS Technical Help ..........................9 Before you call for Service....................... 9 In-Warranty Repair and Parts ......................9 Receiving Inspection ........................9 Important Safety Information ......................9 NORM-O-TEMP System Operating Instructions Quick Start Guide ..........10 ®...
  • Page 8 Operation Manual NORM-O-TEMP, Model 111Z TABLE OF FIGURES ® Figure 1. NORM-O-TEMP unit, Front View ....................13 Figure 2. NORM-O-TEMP ® unit, Left Side View ..................15 Figure 3. NORM-O-TEMP ® unit, Rear View ....................17 ® Figure 4. NORM-O-TEMP unit, Right Side View ..................

  • Page 9: Technical Help

    1-800-989-7373 12011 Mosteller Road 1-513-772-9119 Cincinnati, OH 45241 (U.S.) 24hr Clinical Support 1-513-460-2038 csz@genthermcsz.com E-Mail Visit our Web Site at www.cszmedical.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.

  • Page 10: Norm-O-Temp System Operating Instructions Quick Start Guide

    Operation Manual NORM-O-TEMP, Model 111Z NORM-O-TEMP ® System 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. Fill reservoir with distilled water. 2.

  • Page 11: Section 1. Introduction

    Operation 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.

  • Page 12: Physical Description Of The Norm-O-Temp System

    Operation Manual NORM-O-TEMP ® , Model 111Z 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.

  • Page 13: Figure 1. Norm-O-Temp Unit, Front View

    Operation Manual NORM-O-TEMP ® , Model 111Z Figure 1. NORM-O-TEMP ® unit, Front View Page 13 of 50...

  • Page 14: 1-3.2. External Features And Descriptions - Left Side View

    Operation 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.

  • Page 15: Figure 2. Norm-O-Temp Unit, Left Side View

    Operation Manual NORM-O-TEMP ® , Model 111Z Figure 2. NORM-O-TEMP ® unit, Left Side View Page 15 of 50...

  • Page 16: 1-3.3. External Features And Descriptions - Rear View

    Operation Manual NORM-O-TEMP ® , Model 111Z 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.

  • Page 17: Figure 3. Norm-O-Temp Unit, Rear View

    Operation Manual NORM-O-TEMP ® , Model 111Z Figure 3. NORM-O-TEMP ® unit, Rear View Page 17 of 50...

  • Page 18: 1-3.4. External Features And Descriptions - Right Side View

    Operation Manual NORM-O-TEMP ® , Model 111Z 1-3.4. External Features and Descriptions – Right Side View ® The external features in Figure 4 of the NORM-O-TEMP unit are described as follows: A. The three sided enclosure panel, secured with eight screws, provides access to the interior.

  • Page 19: Figure 4. Norm-O-Temp Unit, Right Side View

    Operation Manual NORM-O-TEMP ® , Model 111Z ® Figure 4. NORM-O-TEMP unit, Right Side View Page 19 of 50...

  • Page 20: 1-3.5. External Features And Descriptions - Top View

    Operation Manual NORM-O-TEMP ® , Model 111Z 1-3.5. External Features and Descriptions – Top View The membrane control panel as shown in Figure 5 is composed of pressure sensitive touch switches and LED displays. The membrane control panel is divided into the following sections: A.

  • Page 21: Figure 5. Norm-O-Temp Unit, Model 111Z Top View

    Operation Manual NORM-O-TEMP ® , Model 111Z ® Figure 5. NORM-O-TEMP unit, Model 111Z Top View. Page 21 of 50...

  • Page 22: Required Accessories

    Operation Manual NORM-O-TEMP ® , Model 111Z 1-4. Required Accessories ® Operation of the NORM-O-TEMP unit requires the use of the blanket/pad(s) designed to 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 8.

  • Page 23: 1-5.3. Temperature Safety Control System

    Operation Manual NORM-O-TEMP ® , Model 111Z 1-5.3. Temperature Safety Control System ® The NORM-O-TEMP unit is designed to carefully measure and control the temperature of the circulating water by heating. The unit is engineered so that when the temperature of the circulating water reaches the desired set point, the heater cycles on and off to maintain that set point temperature.

  • Page 24: Section 2. Specifications And Certifications

    Operation Manual NORM-O-TEMP ® , Model 111Z Section 2. Specifications and Certifications ® Specifications for the NORM-O-TEMP unit are presented in Figure 6 and are subject to change without notice. Physical Control System Dimensions: Microprocessor-based temperature control 22.86 cm (9 inches) Wide system, and Alarm indications.

  • Page 25: Figure 6. Norm-O-Temp , Model 111Z Features

    Operation Manual NORM-O-TEMP ® , Model 111Z Electrical System Safety System Electrical Characteristics: Maximum High Control Setting 100V, 50/60Hz, 8.2 Amps 42°C / 107.6°F Heater Power: Primary Temperature Limit: 800 watts 43.5°C ± 0.6°C (110.0°F ± 1.08°F) Time to Heat: Secondary Temperature Limit: 23°C ±...

  • Page 26: General Preparation Of The Norm-O-Temp

    Operation Manual NORM-O-TEMP ® , Model 111Z ® Section 3. General Preparation of the NORM-O-TEMP System 3-0. Introduction This section describes the procedures to prepare the NORM-O-TEMP ® unit for general use. This entails unpacking the shipment, arranging all the equipment for the first time, and completing a test routine.
  • Page 27 Operation Manual NORM-O-TEMP ® , Model 111Z ® D. Review Section 1-3 to identify the features of the NORM-O-TEMP unit. E. Collect and arrange the following equipment and supplies: 1. Hyper-hypothermia blanket/pad(s) Listed in Figure 8. 2. Connecting hose with quick-disconnect Hansen fittings (if applicable). F.

  • Page 28: 3-2.2. Completing A System Test Routine

    Operation Manual NORM-O-TEMP ® , Model 111Z 2. To attach a blanket/pad to the connecting hose (if necessary): Insert one end of the blanket/pad to the plastic outlet coupling of the connecting hose Insert the other end of the blanket/pad to the plastic return coupling of the connecting hose iii.

  • Page 29: Unit And Patient Related Precautions

    Operation Manual NORM-O-TEMP ® , Model 111Z D. Press the DECREMENT ▼ 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.

  • Page 30: Patient Preparation And Bedside Care

    Operation Manual NORM-O-TEMP ® , Model 111Z 3-4. Patient Preparation and Bedside Care ® Effective use of the NORM-O-TEMP hyperthermia 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.
  • Page 31 Operation 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 the pump and turn off heater. In addition, the HI TEMP LED flashes and the audible alarm sounds.

  • Page 32: Operating The Norm-O-Temp System

    Operation Manual NORM-O-TEMP ® , Model 111Z Operating the NORM-O-TEMP ® System Section 4. 4-0. Introduction This section describes how to operate the NORM-O-TEMP ® system in order to control the blanket/pad water temperature. For proper knowledge and understanding of the unit, in-service training is available upon request.

  • Page 33: System

    Operation Manual NORM-O-TEMP ® , Model 111Z M. The hyper-hypothermia blanket/pad may be pre-warmed before positioning the patient. To do so, operate the unit at desired temperature for about 25 minutes. N. Place the patient on the hyper-hypo thermia blanket/pad. O.

  • Page 34: Concluding The Use Of The Norm-O-Temp System

    Operation 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 ®...

  • Page 35: General Maintenance Of The Norm-O-Temp

    Operation Manual NORM-O-TEMP ® , Model 111Z Section 5. General Maintenance of the NORM-O-TEMP ® System 5-0. Introduction This section describes the general requirements maintenance personnel should complete on a ® regular basis so that the NORM-O-TEMP system continues to operate within the manufacturer’s specifications.

  • Page 36: Figure 7. Norm-O-Temp Maintenance Checklist

    Operation Manual NORM-O-TEMP ® , Model 111Z (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) 4.

  • Page 37: 5-1. Maintenance Of Water Reservoir

    Chemical Cleaning Circulation Chart UNIT MODE TEMPERATURE DURATION NORM-O-TEMP 111Z Heating 38°C 5 Minutes 5-1.1. Internal Cleaning using Bleach / Dry Storage Procedure For circulating water units utilizing household bleach. The following procedure cleans the fluid circuit in these products. The required tools/supplies are appropriate drain hose(s) and/or hose connector(s), household bleach, distilled water, U.S.P.
  • Page 38 Operation Manual NORM-O-TEMP ® , Model 111Z G. Rinse the unit three (3) times as described in Steps D-F. Be sure to omit the household bleach (sodium hypochlorite). H. After the third rinse, drain the unit and fill the reservoir with distilled water and circulate. Check the water with pH strips or other appropriate test method for detecting bleach.

  • Page 39: 5-1.2. Internal Cleaning And Disinfection Using Gigasept Ff / Dry Storage Procedure

    Operation Manual NORM-O-TEMP ® , Model 111Z 5-1.2. Internal Cleaning and Disinfection Using Gigasept FF / Dry Storage Procedure For Circulating Water Units Utilizing CE Approved Gigasept FF (Product of Schulke & Mayr) (Contact your local Cleaning Supplier). Gigasept FF Is Not Available In the United States.

  • Page 40: 5-1.3. Internal Cleaning And Disinfection Using Maranon H / Dry Storage Procedure

    Operation Manual NORM-O-TEMP ® , Model 111Z 5-1.3. Internal Cleaning and Disinfection Using Maranon H / Dry Storage Procedure For circulating water units utilizing CE approved Maranon H (Product of Ecolab). Maranon H is not available in the United States. The following procedure disinfects the fluid circuit in these products.

  • Page 41: 5-1.4. Draining The Reservoir

    Operation Manual NORM-O-TEMP ® , Model 111Z 5-1.4. Draining the Reservoir 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: 1. An empty container to drain the water into that can hold at least 3 gallons (11.4 liters). 2.

  • Page 42: 5-1.5. Replenishing The Reservoir / Fixing A Low Water Alarm

    Operation Manual NORM-O-TEMP ® , Model 111Z 5-1.5. Replenishing the Reservoir / Fixing a Low Water Alarm A. Check that the drain hose is disconnected. CAUTION • Use distilled water only. Do Not Use De-Ionized water. • Do not use alcohol. Alcohol may cause blanket/pad and unit deterioration. •...

  • Page 43: Maintenance Of The Norm-O-Temp® Exterior - Cleaning Instructions

    Operation 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.

  • Page 44: Maintenance Of The Hyper-Hypothermia Blanket / Pad(S)

    ® , Model 111Z 5-4. Maintenance of the Hyper-Hypothermia Blanket / Pad(s) This section describes the general maintenance for the CSZ reusable and disposable blankets/pads. General maintenance tasks include cleaning, draining, and storing the reusable blankets/pads. 5-4.1. Cleaning / Maintenance of Reusable Blanket / Pad(s) Cincinnati Sub-Zero reusable blankets/pads are constructed from biocompatible polyurethane/urethane.

  • Page 45: Figure 8. Norm-O-Temp System Accessories

    Adult or O.R. Table Size (24" x 60") Pediatric Size (22" x 30") Infant Size (12" x 18") Contents: 5/box, 4 boxes/case Reusable Connecting Hose (for CSZ Unit) MAXI-THERM LITE Single-Patient Use Blanket/pad(s) Adult Size (25” x 64”) Pediatric Size (25” x 33”) Infant Size (12.5”...
  • Page 46 Operation 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 ®...
  • Page 47 Operation Manual NORM-O-TEMP ® , Model 111Z Note: U is the a.c. mains voltage prior to application of the test level. 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 ®...
  • Page 48 Operation Manual NORM-O-TEMP ® , Model 111Z Recommended separation distances between portable and mobile RF communications ® equipment and the NORM-O-TEMP , Model 111Z ® The NORM-O-TEMP , Model 111Z is intended for use in an electromagnetic environment in which ®...
  • Page 49 NORM-O-TEMP ® , Model 111Z THIS PAGE INTENTIONALLY LEFT BLANK Page 49 of 50...
  • Page 50 Cincinnati Sub-Zero Products, LLC 12011 Mosteller Road Cincinnati, OH 45241 Telephone: 1-800-989-7373 or (513)772-8810 Fax: (513)772-9119 E-Mail: csz@genthermcsz.com...

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