CSZ ELECTRI-COOL II, 767 Operation And Technical Manual

®
ELECTRI-COOL
II
OPERATION AND TECHNICAL MANUAL
Model 767 Cooling System
Cincinnati, Ohio 45241, U.S.A.
www.cszmedical.com
OPERATION AND TECHNICAL MANUAL ELECTRI-COOL® II, MODEL 767
Electri-Cool® II is a registered trademark of Cincinnati Sub-Zero Products, LLC, Cincinnati, Ohio, USA.
©Copyright 2017, Cincinnati Sub-Zero Products, LLC All rights reserved.
Manual 56269 Rev. Q
ECN: M1802-5455
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OPERATION AND TECHNICAL MANUAL ELECTRI-COOL® II, MODEL 767
40 - 45°F 46 - 50°F 51 - 55°F
5 - 7°C 8 - 10°C 11 -13°C
2°C/36°F
Read Operation
Instructions and Manual
Before Operating
Inspect and Change
Filter Periodically
Low Water Level
Low Water
Temperature
Type B Applied Part
Temperature Settings
Voltage, Alternating
Current
Externally Accessible
Fuse
Potential Equalization
Connection (Grounding)
Risk of Explosion: Do
not use in the presence
of flammable
anesthetics
Power On (Located on
Switch)
Power Off (Located on
Switch)
Separate Disposal for
Electrical Equipment
ELECTRI-COOL® II Symbol Definitions
Page 3 of 34
OPERATION AND TECHNICAL MANUAL ELECTRI-COOL® II, MODEL 767
WARNING
A physician’s order is required for setting temperature and use of equipment. At least every
20 minutes, or as directed by a physician, check the patient’s temperature and skin condition
of areas in contact with the blanket. Also check blanket water temperature. Pediatric, temperature-sensitive patients with vascular disease, surgical patients, diabetics and
patients with Raynaud’s Disease should be checked more frequently. Notify the physician promptly of any change, in order to avoid serious injury.
Observe patient’s skin condition frequently due to individual differences in sensitivity
and susceptibility to injury from cold and/or externally applied chemicals or pressure. Patients at greatest risk are those unconscious, on prolonged therapy, diabetics, children and persons incapacitated or with insensitive skin areas or poor circulation.
Prevent excessive and/or prolonged tissue pressure and shearing forces, especially over
bony prominences to prevent skin damage which may result.
Do not place additional heat or cold sources between the patient and blanket. Skin damage
may occur.
The area between the patient and the blanket should be kept dry to avoid injury to the
patient.
Do not use pins to secure pad or hoses. Do not allow pad or hoses to come in contact with
any sharp object. A water leak could cause a slip hazard.
Do not use the Electri-Cool® II system in the presence of flammable anesthetics. Risk of
explosion can result.
Power interruption will cause the Electri-Cool® II system to revert to the default range of 40°F
- 45°F (5°C - 7°C). Follow instructions for First Time Set-Up/System Test Routine to resume operation. Failure to resume the desired therapy could result in injury.
In order to avoid the risk of electric shock, this equipment must only be connected to a
supply main with protective earth.
Electric shock hazard may be present. Do not remove cover.
Service is to be performed by qualified personnel only.
ELECTRI-COOL® II
OPERATION AND TECHNICAL MANUAL
Cincinnati Sub-Zero Products, LLC, reserves the right to make equipment changes and improvements, which may not be reflected in this manual.
Page 4 of 34
OPERATION AND TECHNICAL MANUAL ELECTRI-COOL® II, MODEL 767
CAUTION
US Federal Law restricts this device to sale by or on the order of a physician.
Use distilled water only. Do not use De-Ionized water. De-Ionized water may cause
corrosion to plumbing system components. Do not use tap water. Minerals and deposits can clog plumbing system components.
 Do not use alcohol. Alcohol may cause blanket and unit deterioration.
Do not overfill. Overfilling may result in overflow when the water in the blanket drains back
into the system when it is turned off.
Use only hospital grade power plug, or electrical shock may result.
Do not operate pump without pad connected or with pad clamps in the “closed” position.
Always check clamps to make sure they are fully open.
Check hose couplings to be certain that they are properly locked together.
Make sure hose and pads are free of kinks which might restrict flow.
Complete folding of pad may restrict flow and reduce therapy to patient.
The pad surface should be checked for damage prior to each application.
To ensure maximum therapy is delivered, it may be necessary to retain the pad on the
patient with straps for adequate contact with the patient.
Follow pad instructions as well as hospital/physician instructions for applying, storing and
disposal of product.
Special precautions regarding electromagnetic compatibility are required and the Electri-
Cool® II needs to be installed and put into service according to the electromagnetic
compatibility information provided. Electromagnetic compatibility refers to electronic devices unintentionally affecting the operation of each other by emitting electromagnetic energy.
Due to electromagnetic compatibility, other equipment can affect the Electri-Cool® II system.
The Electri-Cool® II should not be used adjacent to or stacked with other equipment. Other equipment includes ventilators, patient monitors, anesthesia delivery equipment, etc. If adjacent placement or stacking is necessary, the Electri-Cool® II and the other equipment should be observed to verify that it is operating normally in the mode that is set.
If the Electri-Cool® II system or other equipment is not operating normally, remove the device
from service and have a biomedical or service technician observe the device in operation. Refer to the specifications section for recommended separation distances between other equipment and the Electri-Cool® II system.
For safe handling and use of chemicals, follow manufacturer guidelines for cleaning.
Always drain the Electri-Cool® II to a sanitary drain because bio-contaminants may be
present in the unit’s water supply.
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OPERATION AND TECHNICAL MANUAL ELECTRI-COOL® II, MODEL 767
Table of Contents
TECHNICAL HELP..................................................................................................................... 8
BEFORE YOU CALL FOR SERVICE ........................................................................................ 8
IN-WARRANTY REPAIR AND PARTS ...................................................................................... 8
IMPORTANT SAFETY INFORMATION ..................................................................................... 8
1) RECEIVING AND INSPECTION ............................................................................................ 9
2) INTRODUCTION .................................................................................................................... 9
a) General Safety Precautions ............................................................................................. 9
b) General Product Description ............................................................................................ 9
c) Intended Use .................................................................................................................... 9
d) Contraindications ............................................................................................................. 9
e) Transporting and Shipping ............................................................................................. 10
3) SET-UP/OPERATION/CLEANING & STORAGE ................................................................ 11
a) Equipment Set-Up .......................................................................................................... 11
b) Filling Instructions .......................................................................................................... 12
c) Startup Instructions ........................................................................................................ 12
d) Setting Temperature ...................................................................................................... 12
e) Accessories .................................................................................................................... 14
f) Pad Instructions .............................................................................................................. 15
g) Disposal ......................................................................................................................... 15
h) Cleaning (External) ........................................................................................................ 15
i) Storage............................................................................................................................ 15
4) TROUBLESHOOTING GUIDE ............................................................................................. 19
a) General .......................................................................................................................... 19
b) Indicator Specifics ................................ ................................ ................................ .......... 19
5) GENERAL MAINTENANCE AND CHECKOUT PROCEDURE ........................................... 20
a) Exterior Physical Inspection ........................................................................................... 20
b) Air Filter Inspection ........................................................................................................ 20
c) Flow Test ........................................................................................................................ 20
d) Temperature Test .......................................................................................................... 21
e) Low Water Switch/Indicator Test .................................................................................... 21
f) Leakage Current Test ..................................................................................................... 21
g) Ground Continuity Test .................................................................................................. 21
h) Water Temperature Low-Limit Thermistor Test .............................................................. 22
i) Internal Physical Inspection ............................................................................................. 22
6) SPECIFICATIONS................................................................................................................ 24
7) APPROVALS ....................................................................................................................... 25
8) SERVICE .............................................................................................................................. 25
a) Replacement Parts ........................................................................................................ 25
b) Parts List ........................................................................................................................ 26
9) FLUID CIRCUIT DISINFECTION/DRY STORAGE PROCEDURE ...................................... 29
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OPERATION AND TECHNICAL MANUAL ELECTRI-COOL® II, MODEL 767
List of Figures
Figure 1 - Electri-Cool® II Front View ................................................................................................... 10
Figure 2 - Electri-Cool® II Left-side View ............................................................................................. 10
Figure 3 - Mounting the Electri-Cool® II to the Bed Bracket ............................................................. 11
Figure 4 - Electri-Cool® II Membrane Control Panel ......................................................................... 13
Figure 5 - Electri-Cool® II Filter View ................................................................................................... 20
Figure 6 - Electri-Cool® II Exploded View ........................................................................................... 27
Figure 7 - Electri-Cool® II Wiring Schematic ....................................................................................... 28
List of Tables
Table 1 - Tables Presented in Fulfillment of IEC 60601-1-2 ............................................................ 16
Table 2: Preventive Maintenance Inspection Sheet .......................................................................... 23
Page 7 of 34
OPERATION AND TECHNICAL MANUAL ELECTRI-COOL® II, MODEL 767
TECHNICAL HELP:
United States and Canada Cincinnati Sub-Zero Products, LLC Toll Free 1-800-989-7373 12011 Mosteller Road (U.S.) 24hr Clinical Support 1-513-460-2038 Medical Tech Service 1-888-437-5608 Cincinnati, OH, 45241 Fax 1-513-772-9119 www.cszmedical.com
BEFORE YOU CALL FOR SERVICE....
To help us better serve you, please have the serial number of your Electri-Cool® II unit ready when you call for parts or service. The serial number is located on the unit’s rear panel.
IN-WARRANTY REPAIR AND PARTS:
All parts on your Electri-Cool® II unit are covered by a one-year (1) warranty. Additional three year warranty is available at the time of purchase. To return defective parts or units, first obtain a Returned Materials Authorization (RMA) number from our medical Technical Service department.
IMPORTANT SAFETY INFORMATION:
Refer to this manual for instructions and operator information. Read and understand all WARNINGS and CAUTIONS before using, prescribing or servicing the Electri-Cool® II system.
Page 8 of 34
OPERATION AND TECHNICAL MANUAL ELECTRI-COOL® II, MODEL 767
1) RECEIVING AND INSPECTION/ IMPORTANT SAFETY INFORMATION
After unpacking the Electri-Cool® II, inspect the system for concealed damage. Retain all packing material and carefully record 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 instruction.
2) INTRODUCTION
a) General Safety Precautions
To provide the patient with maximum safety during the use of the Electri-Cool® II Cold Therapy system, a thorough knowledge and understanding of the system, and 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 operation and technical manual as well as all precautions and warnings prior to use. It is recommended that this manual be read at least semi-annually as a refresher for safe operation and application. For proper knowledge and understanding, in-service is
available upon request.
b) General Product Description
The Electri-Cool® II system has been designed to provide maximum thermal transfer efficiency at optimum safety. The Electri-Cool® II consists of a plastic reservoir for holding distilled water; a float switch to sense water level; a pump for circulating water through an external pad; a thermoelectric (TE) module to cool the water; a microprocessor-based electronic control to regulate water temperature; and a fan to transfer absorbed heat to the ambient air. The user can select among three pre-set temperature ranges: 51°F - 55°F (11°C - 13°C); 46°F - 50°F (8°C - 10°C); and 40°F - 45°F (5°C - 7°C). In addition to the aforementioned features, this model includes audible and visual indicators for low temperature and low water levels. The unit also shuts down entirely in the event of an internal component over-temperature condition.
c) Intended Use
The Electri-Cool® II, Model 767 Portable Cold Therapy Unit is used to provide cold therapy immediately following the surgical procedure at the wound site. The system is composed of a water reservoir, a thermoelectric sub-assembly, a circulating pump, a micro-processor control board, a fan and a local therapy pad.
d) Contraindications
There are currently no known contraindications.
Page 9 of 34
OPERATION AND TECHNICAL MANUAL ELECTRI-COOL® II, MODEL 767
Figure 1 - Electri-Cool® II Front View
Figure 2 - Electri-Cool® II Left-side View
e) Transporting and Shipping
Drain all water from the reservoir before shipment or storage. The Electri-Cool® II can be transported through normal shipping methods via ground, air, or water when packaged in its approved packaging material. During transportation and storage, packaging should not be exposed to conditions that fall out of the ranges below:
I. Temperature: -40°C to 70°C (–40°F to 158°F)
II. Humidity: 10% to 100%
III. Atmospheric Pressure: 500 to 1060hPa (7.25 to 15.37 PSIA)
Page 10 of 34
OPERATION AND TECHNICAL MANUAL ELECTRI-COOL® II, MODEL 767
CAUTION
Use distilled water only. Do not use De-Ionized water. De-Ionized water may cause corrosion
to plumbing system components. Do not use tap water. Minerals and deposits can clog plumbing system components.
3) SET-UP/OPERATION/CLEANING & STORAGE
a) Equipment Set-Up
I. Before use, check the air filter for accumulated dust. If filter is dirty, replace it with a new one.
Refer to, “General Maintenance and Checkout Procedures”, for filter replacement instructions.
II. Check to ensure that the water level in the reservoir is at its maximum level. The maximum level
is at the lowest level of the fill spout (or threaded neck). Refer to “Filling Instructions”.
III. The Electri-Cool® II should be placed on a secure, flat surface at least 61cm (2 feet) from any
wall or object that may restrict airflow to the unit. A bed bracket or universal stand as listed in “Accessories” section can also be used within proximity of the patient such that the attached hoses will reach the desired therapy site.
Figure 3 - Mounting the Electri-Cool® II to the Bed Bracket
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