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Operation Manual                                

   NORM-O-TEMP

®

, Model 111Z  

 
 

Page 11 of 50 

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 semi-annually 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. 
 

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). 

 

Summary of Contents for Norm-o-Temp 111Z

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: ...50 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 Al...

Page 3: ...Temperature Decreasing Temperature Disconnect Power Before Servicing Water Flow Indicator Outlet Inlet Silence Alarm Caution Read Operation Instructions and Manual Before Operating Temp Set Point Ind...

Page 4: ...rticularly the skin to a point where they are injured 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 art...

Page 5: ...P SYSTEM TEST ROUTINE in the Operation Technical Manual must always be performed Improper repair and inadequate maintenance can result in damage to the NORM O TEMP system and patient injury Remove the...

Page 6: ...er Electrostatic Discharge ESD practices should be followed during replacement of any electronic board To Discharge the NORM O TEMP system ensure the unit is unplugged and use any metal tool such as a...

Page 7: ...m 26 3 0 Introduction 26 3 1 Unpacking the Shipment 26 3 2 First Time Set Up System Test Routine 26 3 2 1 Inspecting and Arranging the Equipment 26 3 2 2 Completing a System Test Routine 28 3 3 Unit a...

Page 8: ...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 19 Figure 5 NORM O TEMP unit Model 111Z Top View 21 Figure 6 NORM O TEMP Mo...

Page 9: ...vailable 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 departme...

Page 10: ...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...

Page 11: ...vice 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...

Page 12: ...M O TEMP System See Section 2 for specifications and certifications of the NORM O TEMP system 1 3 1 External Features and Descriptions Front View The external features in Figure 1 of the NORM O TEMP u...

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

Page 14: ...ricted 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 c...

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

Page 16: ...ir 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 printe...

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

Page 18: ...nal 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 B The recessed handle is one of tw...

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

Page 20: ...temperature reaches 46 0 C 0 6 C 115 F 1 08 F D When the LO WATER LED is lit it indicates that the unit needs more distilled water to operate The LED will be accompanied by an audible alarm E The SIL...

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

Page 22: ...ters capacity dual compartment reservoir is composed of the circulating reservoir situated under and connected to the replenishing reservoir When the operator fills the reservoir with distilled water...

Page 23: ...t from damage caused by extreme high temperatures Safety Controls for Protection from High Temperature If the circulating water reaches 42 0 C 0 6 C 107 6 F 1 08 F the microprocessor shuts off heater...

Page 24: ...al Greater than 1 Over Set point Audible and Visual Control System Microprocessor based temperature control system and Alarm indications Option to select temperature settings as either C or F Controll...

Page 25: ...itional Warranty Available Safety System Maximum High Control Setting 42 C 107 6 F Primary Temperature Limit 43 5 C 0 6 C 110 0 F 1 08 F Secondary Temperature Limit 44 5 C 0 6 C 112 0 F 1 08 F Indepen...

Page 26: ...found notify the transportation company immediately and file a claim The transportation company is responsible for the shipment after it leaves the factory If problems other than shipping damage are...

Page 27: ...RM O TEMP unit Hand tighten knurled knobs until snug G Slide the lid of the water fill opening and add 340 cc of propylene glycol then gradually pour approximately 6 quarts 5 7 liters of distilled wat...

Page 28: ...level the LO WATER LED is activated and the alarm sounds The unit shuts down and the operator cannot proceed until this is corrected by filling the reservoir A Make sure that the power switch is in th...

Page 29: ...sent a risk of infection to the patient because the water is not sterile If a leak is found the blanket pad should not be used I Check the couplings at the unit and at the blanket pad for positive con...

Page 30: ...the prescribed temperature range B Changes in skin color edema inflammation or indications of pressure especially over bony prominences should be noted and treated as ordered Avoid prolonged tissue pr...

Page 31: ...ical high temperature safety will activate to shut off the power to the pump and heater In addition the HI TEMP LED and Power Fail LED illuminate and the audible alarm sounds 2 If the independent mech...

Page 32: ...fill opening and check if the water is visibly touching the strainer If needed carefully add distilled water Do not use de ionized water Do not overfill If the water falls below a preset level the al...

Page 33: ...nt preparation and bedside care are further described in Section 3 4 NOTE If at anytime power is removed from the unit without actuating the power switch I O switch a power fail alarm will activate an...

Page 34: ...ater to drain back into the unit B Disconnect the power cord from the power source loosely coil it and attach it to the back panel using the nylon straps C Remove the blanket pad s D Loosely coil the...

Page 35: ...cautions necessary to complete the requirements Maintenance repair and or service of NORM O TEMP by qualified maintenance technical personnel will not void the warranty of the unit The following maint...

Page 36: ...ater See Section 5 1 5 10 Check flow rate a Flow rate Minimum of 0 5 GPM check both sets of fittings b Pressure Maximum of 10 PSI check both sets of fittings 11 Condition of blanket pad s hoses and co...

Page 37: ...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 t...

Page 38: ...t step M K If unit is to be returned to service once no bleach is detected add the appropriate amount of U S P Grade Propylene Glycol to the water reservoir per the following chart UNIT U S P Grade Pr...

Page 39: ...reservoir with distilled water E Turn the unit on and circulate per the Chemical Cleaning Circulation Chart above F Drain the unit as instructed in Step A G Rinse the unit with Distilled Water three 3...

Page 40: ...amount of water per the above chart E Turn the unit on and circulate per the Chemical Cleaning Circulation Chart above F Drain the unit as instructed in Step A G Rinse the unit three 3 times as descr...

Page 41: ...r switch to the I position The water is pumped into the container until there is approximately 1 quarts 1 4 liters of water remaining to be drained The LO WATER indicator lights up the status display...

Page 42: ...ped fitting that intersects the hose from the water flow indicator to the reservoir A stainless steel wire mesh screen is located inside the clear plastic cap of the water filter assembly Quarterly or...

Page 43: ...rs and disinfectants that do not contain alcohol Avoid alcohol and other strong undiluted disinfectants These may cause staining of the device s outer skin Thoroughly wipe down device with a damp clot...

Page 44: ...zation or autoclaving for cleaning and disinfecting the blankets pads To drain the water from the reusable blankets pads simply shut off power to the unit and allow the water to drain from the blanket...

Page 45: ...3 Infant Size 12 5 x 18 872 Pediatric 25 x 19 871 Pediatric 25 x 17 25 870 Localized therapy 4 x 25 300 Staff vest PLASTIPAD Reusable Molded Plastic Blanket pad s Polyurethane 196 Adult Size 24 x 60 1...

Page 46: ...l Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors a...

Page 47: ...ration distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference...

Page 48: ...Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0...

Page 49: ...NORM O TEMP Model 111Z Page 49 of 50 THIS PAGE INTENTIONALLY LEFT BLANK...

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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