Service Manual
76 Pages
Preview
Page 1
EQ-5000 ®
EQUATOR Convective Warmer REF EQ-5000 100V REF EQ-5000 115V REF EQ-5000 230V
Service Manual P/N 4533902-GB Rev A
Copyright EQUATOR ® Convective Warmer Part Number: 4533902-GB Rev. A (2005-01) This revision supercedes all previous revisions. Under copyright laws, this manual may not be reproduced in any form, in whole, or in part, without prior written permission of Smiths Medical ASD, Inc. (Smiths Medical ASD). Level 1 and EQUATOR are trademarks of the Smiths Medical family of companies. The symbol ® indicates the trademark is registered in the U. S. Patent and Trademark office and certain other countries. Every effort has been made to ensure that the information in this manual is accurate and details provided are correct at the time of printing. The company, however, reserves the right to improve the equipment shown. Other company and product names mentioned herein are trademarks of their respective companies. Mention of third-party products is for informational purposes only and constitutes neither an endorsement nor a recommendation. Smiths Medical ASD assumes no responsibility with regard to the performance or use of these products. For further information, please call the local Smiths Medical ASD representative or Smiths Medical ASD direct at 1-800-258-5361 or +1-781-878-8011. ©2005 Smiths Medical family of companies. All rights reserved. The products described are covered by one or more of the following U.S. Patent Nos. 5,785,723; 6,143,020; 6,277,144; 6,440,157; other patent(s) pending; foreign patent(s) pending. Manufactured in the U.S.A.
Contents
Contents v vi vi vi vii ix ix ix x x xi 1 1 1 2 3 3 3 4 7 7 9 10 12 12 13 14 16 17 18 18 19 19 20 21 22 22 22 23 25 26 28 30 32 32 34 34 35 36 38
Introduction Abbreviations Used in the Manual Appropriate Use and Service Indications for Use Symbols Service Information Warranty Service Non-Warranty Service Returning the Device for Service Service Contacts Important Safety Information
1 Description
EQUATOR ® Convective Warmer Convective Warming Blankets Control Panel
2 Preventive Maintenance Recommended Schedule Cleaning the Hose and Enclosure Replace the Air Filter
3 Functional Test and Calibration Procedure Functional Test and Calibration Procedure Checklist Instrument Test Setup Preliminary Voltage Checks and Adjustments Functional Tests Test 1: Self-Test Sequence Test 2: Disconnect Indicator Test Test 3: HI Temperature Test Test 4: MED Temperature Test Test 5: LO Temperature Test Test 6: LO OverTemp and UnderTemp Test Test 7: MED OverTemp and UnderTemp Test Test 8: HI OverTemp and UnderTemp Test Test 9: Ambient OverTemp Test Test 10: OverTemp and UnderTemp Readjustment Test 11: Temperature DownStep Alarm Delay Check Test 12: Fire Safety Thermostat Function Test Test Completion Shut Down the Instrument Determine Instrument Disposition
4 Component Removal and Replacement Open the Enclosure Replace the Motor Driver Electronic Assembly Replace the Motor Replace the Impeller Replace the Heater Replace the Hose Microswitch Assembly Replace the Air Outlet Replace the Pole Clamp Replace the Control Panel Replace the Power Supply Assembly
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Contents
A Reference Diagrams B Troubleshooting General Failures Airflow Failures Heat Related Failures Self-Test Does Not Complete Self-Test Completes Thermal Runaway – Device Causes T-Stat to Open Safety Leakage Test
C Specifications D Parts List E Schematic Drawings Maintenance Log
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39 43 43 44 44 45 46 47 47 49 51 55 61
Introduction
Introduction This manual provides qualified hospital facility biomedical technicians and other qualified service facility personnel with procedures to service and make repairs to the EQUATOR ® Convective Warmer – 100V/115V/230V. Only trained, qualified personnel knowledgeable of the good practices for servicing and repairing medical devices should service the device. Perform service and repairs according to the procedures described in this manual. ________________________________________________________________
•
WARNING! Electrocution Hazard. There are no user-serviceable parts inside the enclosure. Only competent personnel knowledgeable in the safety procedures required for servicing live Mains parts shall be allowed to open the enclosure.
________________________________________________________________ Note: Any EQUATOR ® Convective Warmer circuit modifications or electronic assembly component replacements by persons other than those authorized by Smiths Medical ASD are strictly forbidden. Any adjustment or repair of the EQUATOR ® Convective Warmer must be performed at a properly grounded ESD workstation using the procedures presented in this manual. Read and follow instructions and all accompanying documents. Failure to follow instructions could lead to misuse of the device or device malfunction. The manual is divided into the following sections: Section
Contains
Chapter 1
Describes general information about the device
Chapter 2
Procedures to perform scheduled maintenance
Chapter 3
Functional tests used to check the safety functions of the device
Chapter 4
Procedures to replace components of the device
Appendix A
Diagrams for the Mains and Control Electronic Assembly
Appendix B
Causes and solutions for troubleshooting device issues
Appendix C
System specifications
Appendix D
List of parts available to order
Appendix E
Circuit drawings
Maintenance Log
Form to record maintenance tasks
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Introduction
Abbreviations Used in the Manual Abbreviation DVM TA TP LED AMB LO MED HI OT UT
Definition Digital Volt Meter Thermo-Anemometer Test Points Light Emitting Diode Ambient – Room Temperature Low Temperature – 36°C Medium Temperature – 40°C High Temperature – 44°C Over Temperature Under Temperature
Appropriate Use and Service Smiths Medical ASD cannot assume responsibility for performance, safety, and reliability of the device when any of the following situations occur: •
Any adjustments and repairs are performed by unauthorized personnel.
•
The device is not used according to the manufacturer’s recommendations.
•
The procedures described in the EQUATOR ® Convective Warmer Operator’s Manual and in this service manual are not followed.
•
Environmental operating conditions and location recommendations are not followed.
Indications for Use The EQUATOR ® Convective Warmer is intended for thermal regulating of a patient’s temperature by a warm-air-heated blanket system. It is designed to prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures. It is intended for use by appropriately trained healthcare professionals in clinical environments.
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Introduction
Symbols The following symbols are used in the manual, and on the device and disposables.
Symbol
Definition Power ON Button
Power OFF Button Ambient Temperature Setting Button (Start up setting) 36°C Temperature Setting Button
40°C Temperature Setting Button
44°C Temperature Setting Button
Over Temperature Alarm Indicator
Under Temperature Indicator Disconnect LED Elapsed Time Display (h=hour)
Hose End Temperature Type BF Equipment Protected Against Dripping Water
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Introduction
Symbol
Definition Catalog Number Serial Number Part Number Batch Code Authorized Representative in the European Community Manufacturer Date of Manufacture Quantity Protective Earth [Ground] Alternating Current Do Not Reuse Attention, see instructions for use Electrical Shock Hazard Latex Free Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician. Protective earth terminal Temperature limitation Use by
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Introduction
Symbol
Definition Recyclable Product Device has been tested by National Technical Systems, a nationally recognized technical lab, to meet U.S. requirements for safety. CE Mark and Notified Body number (0473 indicates AMTAC) Humidity limitation Sterilized using ethylene oxide Non-sterile
CONTRAINDICATION
CAUTION!
WARNING!
A Contraindication statement alerts the user to conditions when the device should not be used. A Caution statement alerts the user to conditions that may cause damage to the device. A Warning statement alerts the user to conditions that may cause personal injury to the user or patient.
Service Information All service must be performed by Smiths Medical ASD or a Smiths Medical ASD authorized representative. Service by any other person or organization voids the warranty and transfers liability for malfunctions of the device to the servicing organization.
Warranty Service Devices received for repair that have not been obviously abused or impactdamaged and are still under warranty will be promptly repaired and returned at no charge. A no-charge purchase order is requested for tracking. Refer to the EQUATOR ® Convective Warmer Operator’s Manual for the complete text of the limited warranty.
Non-Warranty Service Devices received that have suffered obvious abuse or impact damage and devices no longer under warranty will be promptly inspected and a verbal
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Introduction
estimate of repair cost will be given to you. A purchase order will be required from the hospital consistent with the verbal estimate. A written estimate will be provided upon request.
Returning the Device for Service Before returning the EQUATOR ® Convective Warmer for service, contact Smiths Medical ASD for Returned Goods Authorization. Note: The EQUATOR ® Convective Warmer must be cleaned and disinfected for repair shipment or it will be immediately returned as received.
Service Contacts Contact Smiths Medical ASD Technical Service Department or Smiths Medical ASD distributor at: USA/Canada Smiths Medical ASD, Inc. Anesthesia and Safety Devices Division 160 Weymouth Street Rockland, MA 02370 USA USA/Canada 1-800-258-5361 International 1-781-878-8011 European Representative Smiths Medical International Ltd Watford, Herts, WD24 4LG, UK Tel +44 (0) 1923 246434 Fax +44 (0) 1923 240273 Australian Representative Smiths Medical Australasia Pty. Ltd. 61 Brandl Street, Brisbane Technology Park Eight Mile Plains, QLD 4113, Australia Tel +61 (0) 7 3340 1300 Fax +61 (0) 7 3340 1399
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Introduction
Important Safety Information
• •
CONTRAINDICATIONS Thermal injury may occur if convective warming therapy is applied to lower extremities during aortic cross-clamping procedures. Thermal injury may occur if convective warming therapy is applied to ischemic limbs.
WARNING! Death or serious injury may occur if these warnings are not followed: •
Read and follow all instructions and accompanying documents. Failure to follow instructions could lead to misuse of the device or device malfunction.
•
Electrocution Hazard. There are no user-serviceable parts inside the enclosure. Only competent personnel knowledgeable in the safety procedures required for servicing live Mains parts shall be allowed to open the enclosure.
•
Blankets are for single use only. To reduce the risk of cross contamination, do not reuse blankets.
•
Cover all open wounds under the warming blanket to prevent airborne contamination.
•
Grounding reliability can only be achieved when the Mains power cord is connected to a properly grounded receptacle. Risk of electrical shock exists if the equipment is not connected to a properly grounded receptacle resulting in death or serious injury to the patient or user.
•
Exposed conductors on the Mains power cord can cause an electrocution hazard. Remove the device from service if the Mains power cord has exposed wires.
•
The EQUATOR ® Convective Warmer must be calibrated by Smiths Medical ASD or Smiths Medical ASD authorized personnel.
•
Do not use the EQUATOR ® Convective Warmer in high-energy fields such as: Cauterizers, MRI, X-RAY, portable and mobile RF communications equipment, and other such devices. The EQUATOR ® Convective Warmer may act as a projectile in a strong magnetic field, cause image artifacts, or not function as intended.
•
Do not use the EQUATOR ® Convective Warmer in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. The risk
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Introduction
of explosion exists if the device is operated in a potentially explosive environment. •
To prevent fire hazard and possible damage to the EQUATOR ® Convective Warmer, use only fuses specified. Only competent personnel knowledgeable in the safety procedures required for servicing live Mains parts shall be allowed to open the enclosure.
CAUTION! Thermal injury may occur if these cautions are not followed: •
If Over Temperature audible alarm sounds and/or red Over Temperature alarm indicator illuminates, discontinue use of the convective warmer and remove from service. Contact Smiths Medical ASD or an authorized representative for service.
•
If the EQUATOR ® Convective Warmer does not perform its self-test properly, fails to operate, or stops while running, discontinue use of the convective warmer and remove it from service. Contact Smiths Medical ASD or an authorized representative for service.
•
Hose Nozzle MUST be connected to a compatible Forced Air Blanket.
•
Monitor the temperature of the patient at regular intervals.
•
Periodically observe cutaneous response under blanket. If erythema is evident, decrease the temperature setting or discontinue use of convective warming therapy.
•
Do not place objects onto the blanket that will obstruct airflow.
•
If equipment malfunction is evident, discontinue use of the EQUATOR ® Convective Warmer and remove it from service. Contact Smiths Medical ASD or an authorized representative for service.
•
Use only blankets manufactured and/or approved by Smiths Medical ASD.
•
Warming unit must be calibrated by competent personnel authorized by Smiths Medical ASD.
•
Federal law (USA) restricts this device to sale by or on the order of a physician.
Physical injury to the user and/or patient may occur if these cautions are not followed: •
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Ensure that the EQUATOR ® Convective Warmer IV pole mounting clamp is properly tightened before each use.
EQUATOR ® Convective Warmer Service Manual
Introduction
•
Do not mount the EQUATOR ® Convective Warmer higher than 46” (1.17m) on the IV pole. For convenience, 46” (1.17m) is indicated by a black mark on the EQ-5000 power cord. Mounting the device above 46” (1.17m) may result in instability of the pole and tipping.
•
Do not change filter while unit is operating.
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Chapter 1 Description
1 Description EQUATOR ® Convective Warmer The EQUATOR ® Convective Warmer is used to reduce hypothermia and patient discomfort before, during and after surgical procedures. The system consists of a high-flow warming device with hose-end temperature control and a single-use blanket. The EQUATOR ® Convective Warmer draws ambient-temperature air through a particulate air filter. The filtered air is warmed to a selected temperature. The warmed air enters the blanket through the hose and is distributed through delivery channels to the patient. Perforations on the patient side of the air delivery channels in the blanket gently disperse warm air over the patient, thereby maintaining patient temperature. The warming device has three outlet temperature settings that provide flexibility in patient treatment: 36°C, 40°C, and 44°C. These three temperature settings are servo-controlled by thermistors placed at the hose end that connects to the blanket. A fourth temperature setting delivers ambient-temperature air. The temperature indicated on the display of the warming device is the temperature of the air being delivered to the blanket at the end of the hose. An over-temperature system monitors the air temperature at the end of the hose that connects to the blanket. A control thermistor adjusts the power applied to the heater in the warming device to maintain the selected temperature. This enables the system to maintain the selected temperature under variations in ambient temperature. A safety thermistor provides a signal to a separate high temperature comparison circuit. The safety thermistor activates and alarms if the temperature exceeds the set point. The safety circuit provides an independent means of shutoff, which discontinues power to the heater and blower. This prevents patient exposure to excessive temperatures in a single fault failure of the temperature controller.
Convective Warming Blankets The blanket consists of two layers of non-woven polypropylene fabric coated with a layer of polyethylene. The layers are bonded together to form a distribution network of air delivery channels. The warm air is distributed around the blanket through the delivery channels and exits the blanket through a specially designed series of perforations in the patient side of the blanket. The distribution of air is designed to minimize temperature differences throughout the blanket.
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Chapter 1 Description
Control Panel Figure 1-1 identifies the controls and indicators seen on the control panel.
Symbol
Definition Power ON Button Power OFF Button
Ambient Temperature Setting Button (Start up setting)
36°C Temperature Setting Button
40°C Temperature Setting Button
44°C Temperature Setting Button
Over Temperature Alarm Indicator Under Temperature Indicator Disconnect LED Attention, consult accompanying documents Elapsed Time Display (h=hour) Hose End Temperature
Figure 1-1 Controls and Indicators
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Chapter 2 Preventive Maintenance
2 Preventive Maintenance The EQUATOR ® Convective Warmer (device) requires only minimal preventive maintenance to maintain its appearance and assure normal operation over the life of the instrument.
Recommended Schedule •
Enclosure cleaning: semi-annually, or as required to preserve the enclosure’s appearance.
•
Hose cleaning: as necessary.
•
Replacement of the air filter: annually, or as required to assure unrestricted airflow.
Tools and Equipment The following tools, equipment, and cleaning agents are necessary to perform the maintenance procedures explained in this chapter: •
For enclosure and hose cleaning: a mild, non-abrasive detergent diluted in warm water.
•
For air filter replacement: Phillips-head screwdriver.
Cleaning the Hose and Enclosure 1. Disconnect the power cord from both the electrical outlet and from the rear of the device. 2. If a chassis-ground cable is connected to the grounding stud (located below the power cable connector) at the rear of the device, disconnect the cable. 3. Remove the hose from the device: a. Disconnect the hose thermistor cable from the rear of the device by turning the knurled knob on the thermistor receptacle counterclockwise, until the cable can be unplugged and removed from the device. b. Grasp the hose connector, twist, and pull it straight out from the air outlet at the rear panel. 4. Remove the device from the pole if pole mounted.
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Chapter 2 Preventive Maintenance
5. Using a dampened cloth or sponge, wipe down the enclosure and hose as needed. Note: Do not use alcohol or other strong solvents to clean the hose or exterior surfaces of the device. These solutions may damage the label and other parts. Note: Do not use a soaking wet cloth to clean the hose or exterior surfaces of the device. Water may drip or seep into the electrical connectors and components at the rear of the device and into the air intake opening at the bottom of the enclosure. Electrical components and the air filter could be damaged if they become wet. 6. Wipe the entire enclosure and hose dry using a soft, dry cloth. 7. Record the task on the maintenance log.
Replace the Air Filter ________________________________________________________________
•
CAUTION! Do not change the air filter while the device is operating.
________________________________________________________________ 1. Disconnect the power cord from both the electrical outlet and from the rear of the device. 2. Remove the device from the pole if pole mounted. Lay device on its side. 3. Remove the four small Philips screws on bottom securing the filter in place. Refer to Figure 2-1.
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Chapter 2 Preventive Maintenance
Bottom of Device
Filter Assembly
Figure 2-1 Air Filter Replacement 4. Discard the old filter assembly. 5. Inspect the new filter gasket assembly to be sure it is clean and unmarked. 6. Install new filter assembly using the original screws. 7. Record the task on the maintenance log.
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Chapter 2 Preventive Maintenance
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