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Operation / Technical Manual

NORM-O-TEMP

, Model 111W

Page 27 of 82

Electrical System

Electrical Characteristics:

230V, 50Hz, 4.8 Amps

240V, 50Hz, 4.6 Amps

Heater Power:

800 watts

Power Cord:

16/3 Detachable, IEC 320

Leakage Current:

Under 500

a 230/240 VAC

Fuse

5 Amp in IEC 320 connector

Mains Supply Isolation:

Two-Pole Mains Switch

Warranty

1 year parts. Parts and labor if returned to
factory.

Additional Warranty Available

Safety System

Maximum High Control Setting

42°C

Primary Temperature Limit:

43.5°C ± 0.6°C

Secondary Temperature Limit:

44.5°C ± 0.6°C

Independent Mechanical Temperature
Limit:

46°C ± 0.6°C

Environmental Conditions

(during storage and transportation)

Ambient Temperature (transportation

and storage):

-40°C –

50°C

Humidity (transportation and storage):

20% – 95%

UL Electrical Classification

Equipment is Class I.

Equipment is Type BF.

CERTIFICATIONS

Figure 6. NORM-O-TEMP

, Model 111W Features

Medical Electrical Equipment

In Accordance With:

UL 60601-1 2

Ed.

IEC 60601-1-2 3

Ed.

ASTM F-2196-2

Содержание Norm-O-Temp 111W

Страница 1: ...Operation Technical Manual Model 111W Hyperthermia System Cincinnati Sub Zero Products LLC 12011 Mosteller Road Cincinnati Ohio 45241 U S A www cszmedical com...

Страница 2: ...of 82 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 2018 Cincinnati Sub Zero Products LL...

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

Страница 4: ...erature control provided by all hyperthermia units presents the danger of heating body tissues particularly the skin to a point where they are injured Depending on the extent and severity of a burn ve...

Страница 5: ...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...

Страница 6: ...Electrostatic Discharge ESD handling 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...

Страница 7: ...acking 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 3...

Страница 8: ...8 Replacement of the Independent High Limit Safety Thermostat 56 6 9 Calibration of the Independent High Limit Safety Thermostat 57 6 10 Power Interrupt Test 57 6 11 Hi Limit Test 57 6 12 Replacement...

Страница 9: ...NORM O TEMP Model 111W Features 27 Figure 7 NORM O TEMP Maintenance Checklist 39 Figure 8 NORM O TEMP Internal Exploded Front View 70 Figure 9 Front View Parts List 71 Figure 10 NORM O TEMP Internal E...

Страница 10: ...ar 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 fr...

Страница 11: ...and will flash the set point temperature of 37 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 he...

Страница 12: ...lence 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...

Страница 13: ...d 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 characteris...

Страница 14: ...e Norm 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 T...

Страница 15: ...Operation Technical Manual NORM O TEMP Model 111W Page 15 of 82 Figure 1 NORM O TEMP unit Front View...

Страница 16: ...e 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 intern...

Страница 17: ...Operation Technical Manual NORM O TEMP Model 111W Page 17 of 82 Figure 2 NORM O TEMP unit Left Side View...

Страница 18: ...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 o...

Страница 19: ...Operation Technical Manual NORM O TEMP Model 111W Page 19 of 82 Figure 3 NORM O TEMP unit Rear View...

Страница 20: ...external featuresin 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...

Страница 21: ...Operation Technical Manual NORM O TEMP Model 111W Page 21 of 82 Figure 4 NORM O TEMP unit Right Side View...

Страница 22: ...e set point temperature 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 SILENCE ALARM button will...

Страница 23: ...Operation Technical Manual NORM O TEMP Model 111W Page 23 of 82 Figure 5 NORM O TEMP unit Model 111W Top View...

Страница 24: ...ortional to the rate of change in the temperature of the patient 1 5 2 Circulating System The NORM O TEMP 6 quart 5 7 liters capacity dual compartment reservoir is composed of the circulating reservoi...

Страница 25: ...s an additional precaution if the water temperature sensor itself should fail the unit shuts down the alarm sounds and the display will read ERR for error With this safety design the patient is protec...

Страница 26: ...wer Failure Audible and visual Greater than 1 Over Set point Audible and Visual Control System Microprocessor based temperature control system and Alarm indications Controller Range Water Temperature...

Страница 27: ...onal Warranty Available Safety System Maximum High Control Setting 42 C Primary Temperature Limit 43 5 C 0 6 C Secondary Temperature Limit 44 5 C 0 6 C Independent Mechanical Temperature Limit 46 C 0...

Страница 28: ...unpacking process look carefully for signs of shipping damage If any unacceptable damage is found notify the transportation company immediately and file a claim The transportation company is responsib...

Страница 29: ...s steel machine screws provided 2 To mount the NORM O TEMP on the Low Profile Stand i Place the NORM O TEMP unit on the equipment pan so that the threaded holes on the bottom of the unit line up with...

Страница 30: ...lastic return coupling of the connecting hose iii Gently pull on the blanket pad to check that the connection is secure I Assure that the blanket pad is laying flat and that the connecting hose to the...

Страница 31: ...n the operator has five seconds to change the set point temperature by pressing either the INCREMENT or DECREMENT buttons C Press the DECREMENT button during the five second interval after pressing th...

Страница 32: ...distilled water and electricity to operate NOTE Please consult pages 4 6 at the beginning of the manual for a complete list of warnings and cautions related to the NORM O TEMP system 3 4 Patient Prepa...

Страница 33: ...lls below 3 quarts 3 3 liters a low water level alarm will activate the LO WATER LED located on the membrane control panel will flash and the unit will shut down 2 To clear the low water alarm repleni...

Страница 34: ...emperature has been set at least 1 C lower than the actual circulating water temperature the 1 C Over Set point Temperature Alarm will activate to turn off the heater the HI TEMP LED flashes the WATER...

Страница 35: ...the power switch is in the O position unit is off E Check the level of distilled water in the reservoir To do so slide the cover of the water fill opening and check if the water is visibly touching th...

Страница 36: ...heet and or blanket pad Patient 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 powe...

Страница 37: ...water 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...

Страница 38: ...description of each requirement includes the tools the procedures and the precautions necessary to complete the requirements Maintenance repair and or service of the NORM O TEMP unit by qualified main...

Страница 39: ...filter See Section 5 2 9 Refill reservoir with distilled sterile distilled water See Section 5 1 5 10 Check flow rate a Flow rate Minimum of 0 5 GPM b Pressure Maximum of 10 PSI 11 Condition of blank...

Страница 40: ...OR ALCOHOL Chemical Cleaning Circulation Chart UNIT MODE TEMPERATURE DURATION NORM O TEMP 111W Heating 38 C 5 Minutes 5 1 1 Internal Clean using Bleach Dry Storage Procedure For circulating water unit...

Страница 41: ...repeat Steps F H J 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...

Страница 42: ...below chart D Fill the 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...

Страница 43: ...r with the appropriate 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...

Страница 44: ...nto position D Plug the power cord into a properly grounded power outlet E Place the power switch to the I position The water is pumped into the container until there is approximately 1 quarts 1 4 lit...

Страница 45: ...r filter designed to clear the line of any particulate matter as the water is pumped through the system The water filter assembly is a plastic T shaped fitting that intersects the hose from the water...

Страница 46: ...ion the wire mesh O ring and plastic cap H Screw the cap clockwise onto the fitting until it is secure I Replace the three sided enclosure panel J Replenish the water reservoir as described in Section...

Страница 47: ...ne urethane Stains and debris can be wiped away with mild soap and water For cleaning always use conventional hospital approved topical cleaners and disinfectants that do not contain alcohol Avoid alc...

Страница 48: ...Board 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...

Страница 49: ...t or the three sided enclosure panel It is recommended that the reservoir be drained and the power cord disconnected before removing any part of the unit 6 1 1 Removing the Top of the Unit A Remove th...

Страница 50: ...d screws that secure the three sided panel to the unit D Remove the enclosure panel and put aside or discard if it is being replaced 6 1 4 Replace Reinstall the Three Sided Enclosure Panel Re Install...

Страница 51: ...ate the pump housing assembly and the inlet and outlet hose connections at the bottom front of the unit in Figure 9 E Disconnect the hose at the inlet of the pump housing by loosening the screw clamp...

Страница 52: ...nd an 11 32 inch wrench remove the four screws from the bottom of the base while holding the 11 32 inch lock nuts on the pump mounting plate Using a 7 16 inch wrench remove the four bolts and nuts hol...

Страница 53: ...the top points towards the front of the unit I Reinstall the plastic snapper clamp J Secure the three sided enclosure panel as described in Section 6 1 4 K Refill the reservoir as described in Sectio...

Страница 54: ...D Locate the bottom manifold to be replaced which is secured on the left side of the unit shown in Figure 9 The water manifold is connected to the two male quick disconnect couplings and to the hose f...

Страница 55: ...h pliers phillips screwdriver 2 Teflon tape 3 Replacement of the water return manifold B Drain the reservoir as described in Section 5 1 4 C Remove the three sided enclosure panel as described in Sect...

Страница 56: ...r the back of the unit as shown in Figure 13 E Unscrew the two screws which secure the thermostat to its bracket F Disconnect the two wires from the slide on terminals G Loosen the compression fitting...

Страница 57: ...imit turn the adjustment screw clockwise E Drain some of the water as described in Section 5 1 4 and then replenish Allow the unit to heat up again to make sure the Independent High Limit Safety Therm...

Страница 58: ...ow indicator to the manifold pan on the outside left wall F Remove the two screws securing the water flow indicator to the back up manifold bracket under the rear of the reservoir G Disconnect the hos...

Страница 59: ...switch Note which wire goes to which terminal Remove and discard the old power switch G Position the replacement power switch into the unit in the same manner and position as the one you removed Reco...

Страница 60: ...place using the same screws removed in step D F Reinstall all of the wires removed in step C G Secure the top of the unit as described in Section 6 1 2 6 16 Replacement of the Microprocessor Board an...

Страница 61: ...l panel aside I Position the replacement control panel from the face side of the top assembly so that the screw posts align with the holes the writing on the control panel is right side up and the cle...

Страница 62: ...ower ON polarity normal and reverse measure when the NORM O TEMP unit is heating and circulating water both the heater and pump are ON When measuring power OFF normal and reverse polarity measure whil...

Страница 63: ...6 13 Check the circuit breaker for the outlet Check for possible open in electrical system B Each time the power switch is pressed to the ON position it snaps back to the OFF position The fuses are d...

Страница 64: ...e clear strip cable leading from the membrane control panel to the microprocessor control board is disconnected Membrane control panel is defective See Section 6 16 Reconnect the 7 pin clear stripe ca...

Страница 65: ...terruption A loose connection of the power cord Check line voltage and proceed with operation Check line voltage and proceed with operation I The unit is operating and it will not heat or pump water T...

Страница 66: ...lating Disengaged quick disconnect couplings Clogged water line Clogged water filter Kink in connecting hose and or blanket Clogged pad Pump not running Defective microprocessor board Defective power...

Страница 67: ...not heat Water not circulating Defective heater Defective power supply board See observation N Replace heater See Section 6 2 Replace power supply board See Section 6 15 N Unit is set to operate Wate...

Страница 68: ...EMP dealer When ordering parts specify the replacement part number listed in the second column of Figure 9 Figure 11 and Figure 13 as well as the serial number of your unit located on the specificatio...

Страница 69: ...Cincinnati Sub Zero To replace parts during the warranty period ship the part to Cincinnati Sub Zero Products LLC 12011 Mosteller Road Cincinnati OH 45241 1528 Telephone 513 772 8810 Fax 513 772 9119...

Страница 70: ...Operation Technical Manual NORM O TEMP Model 111W Page 70 of 82 Figure 8 NORM O TEMP Internal Exploded Front View...

Страница 71: ...06442 Cabinet Base 22 51577 Outlet Pump Elbow Fitting 23 06443 Back Up Manifold Bracket 24 56538 Grounding Point Label 25 60201 6 8 32 S S Phillips Screws 26 not shown 03005 Water Return top Manifold...

Страница 72: ...Operation Technical Manual NORM O TEMP Model 111W Page 72 of 82 Figure 10 NORM O TEMP Internal Exploded Rear View...

Страница 73: ...07000 1 8 Hansen Socket Coupling 5 06002 1 8 Hansen Plug Coupling 6 56907 Flow Indicator Label International 7 91715 Water Flow Indicator Assembly 12 56908 Outlet and Return Label 13 56541 Specificat...

Страница 74: ...Operation Technical Manual NORM O TEMP Model 111W Page 74 of 82 Figure 12 NORM O TEMP Internal Exploded Reservoir Assembly...

Страница 75: ...6 51014 Bulkhead Fitting 3 8 7 51060 Elbow 1 2 Hose barb 8 51033 Bulkhead Fitting 1 2 9 91735 800 Watt Heater Assembly 10 51001 Tank Fitting 11 50315 Plastic Hose Barb 12 50211 Plastic Hose Barb 13 52...

Страница 76: ...Operation Technical Manual NORM O TEMP Model 111W Page 76 of 82 Figure 14 NORM O TEMP Electrical Wiring Diagram...

Страница 77: ...Operation Technical Manual NORM O TEMP Model 111W Page 77 of 82 Figure 15 NORM O TEMP Water Circulation Diagram...

Страница 78: ...CSZ Unit MAXI THERM LITE Single Patient Use Blanket pad s 876 Adult Size 25 x 64 874 Pediatric Size 25 x 33 873 Infant Size 12 5 x 18 872 Pediatric 25 x 19 871 Pediatric 25 x 17 25 870 Localized ther...

Страница 79: ...etic 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 are covered with synthetic mate...

Страница 80: ...eld 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 may occur in the vicinity of...

Страница 81: ...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 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum ou...

Страница 82: ...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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