SCD Express Operation and Service Manual

Operation and Service Manual

English

TABLE OF CONTENTS

Page Section V - Test Methods and Calibration Test Mode Look Up Chart ...14 Test Mode 01 ...14 Test Mode 02 ...14 Test Mode 03 ...15 Test Mode 04 ...15 TTest Mode 05 ...16 TTest Mode 06 ...16 TTest Mode 07 ...16 Section VI - Disassembly and Reassembly Battery Pack ...17 Compressor ...17 Valve Manifold and Bed Hook ...17 Muffler ...17 Power Supply Board ...18 Fan and Screen ...18 Main Controller Board ...18 Section VII - Specifications ...18 Section VIII - Schematics Figure 1 - Parts Assembly Diagram - Exploded View ...20 Figure 2 - Pneumatics & Electrical Schematic ...21 Section IX - Pump Diagrams Diagram 01 ...22 Diagram 02 ...22 Diagram 03 ...23 Diagram 04 ...23

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■ Indications The SCD EXPRESS Compression System is designed to apply intermittent pneumatic compression to increase venous blood flow in at-risk patients in order to help prevent deep vein thrombosis and pulmonary embolism. The System consists of the Controller, the Tubing Sets (provided with the Controller) and single-patient use garments (purchased separately from this Controller). The garments, both leg sleeves and foot cuffs, compress the limbs to enhance venous blood movement. After the compression, the Controller measures the time it takes for the limbs to refill with blood and waits that period of time before the next compression is initiated.

Leg Compression: The use of the SCD EXPRESS Compression System with Leg Sleeves is indicated for: 1. Deep vein thrombosis and pulmonary embolism prophylaxis.

Foot Compression: The use of the SCD EXPRESS Compression System with Foot Cuffs is indicated for: 1. Circulation enhancement. 5. Extremity pain incident to trauma or surgery. 2. Deep vein thrombosis prophylaxis. 6. Leg Ulcers. 3. Edema - Acute. 7. Venous stasis / venous insufficiency. 4. Edema - Chronic. If you need further information regarding the SCD EXPRESS Compression System or its clinical benefits, please contact your TYCO Healthcare / KENDALL Sales Representative.

■ Contraindications Leg Compression: The SCD EXPRESS Compression System may not be recommended for use with Leg Sleeve on patients with the following: 1. Any local leg condition in which the sleeves may interfere, such as: (a) dermatitis, (b) vein ligation [immediate postoperative], (c) gangrene, or (d) recent skin graft. 2. Severe arteriosclerosis or other ischemic vascular disease. 3. Massive edema of the legs or pulmonary edema from congestive heart failure. 4. Extreme deformity of the leg. 5. Suspected pre-existing deep venous thrombosis.

Foot Compression: The SCD EXPRESS Compression System may not be recommended for use with Foot Cuffs on patients with the following: 1. Conditions where an increase of fluid to the heart may be detrimental. 2. Congestive heart failure. 3. Pre-existing deep vein thrombosis, thrombophlebitis or pulmonary embolism. Use with caution on the infected or insensitive extremity.

Cautions 1. Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. 2. Patients with diabetes or vascular disease require frequent skin assessment. 3. Explosion hazard. Do not use in the presence of flammable anesthetics. WARNING: Do not attempt to repair or replace broken tubing connectors as hazardous inflation of the sleeves may occur.

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Kendall’s SCD EXPRESS Compression System is protected by one or more of the following U.S. patents: 5,478,119; 5,876,359; Des.363,988; Des.364,460; Des.369,664; Des.373,192. Other patents pending. Kendall expressly states that no implied license with respect to use of non-Kendall components is granted by the sale or lease of this system. The use of an intermittent pneumatic compression controller to measure venous revill time in a limb, without permission from Tyco Healthcare Group LP, may constitute infringement of Tyco Healthcare’s U.S. Patent No. 6,231,532.

■ Explanation of Symbols Used

SN Controller Serial Number

Refer to Accompanying Documents

number for the device located REF Reorder on the carton label

Type BF Protection Against Electronic Shock

MEDICAL EQUIPMENT

Vascular Refill Detection occurring while illuminated

Manufacturing Date Code

CE Mark 0123

Underwriters Laboratories (UL) Classification mark for Canada and the United States

■ Front Panel Display 4

3

5

2

6

1

7

11 Item Explanation 1 AC Power Indicator 2 Hidden Button #1 3 Port A Status Indicator 4 Vascular Refill Indicator 5 Port B Status Indicator 6 Hidden Button #2

10

9 Item 7 8 9 10 11

8

Explanation Power On/Standby Button Power On Indicator Service Required Error Indicator Test Mode/Error Code Indicators 4-8 Battery Status/Test Mode Indicators 1-3

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■ Section I - General Operating Instructions Set up • Place the Controller on the footboard via the bed hook or place it on a horizontal surface appropriate for the environment, such as on a table, within reasonable proximity to the point of use. Be sure to allow adequate air flow to the vents located on either end of the controller. • The controller can operate with one or two garments attached to the patient. • Plug the tubing set(s) into the back of the controller. Route the tubing toward the patient’s limbs, being careful to leave access ways clear and eliminate tripping hazards. • Plug the tubes into garment(s) wrapped onto the patient’s limbs. • Match the left and right ports with the left and right limbs of the patient. Although the operation of the controller is not affected, troubleshooting can be easier. Check tubing set(s) for kinking and secure attachment at the controller and the garment(s). • Plug the controller power cord into a properly grounded hospital grade receptacle. • Be certain that no flammable anesthetic gases are present.

Start-up • Press the Power/Standby button to begin normal operation. No further user intervention is required unless there is a fault condition detected or if therapy must be discontinued. • The Controller will beep and then flash all the LED’s. LED Indicator Sequence: 1. Port A Status, Port B Status, & Vascular Refill 2. Port A Status, Port B Status, & Service Required Error 3. Battery Status/Test Mode 1-3 & Test Mode/Error Code 4-8 4. Battery Status/Test Mode 1-3 & Test Mode/Error Code 4-8

➙ GREEN ➙ RED ➙ GREEN ➙ RED

• An automatic valve and pump test will be quickly performed as the system tests microprocessor function and system memory. • The pump will begin to operate as part of the Automatic Garment Detection procedure. • Detection of inoperative LED’s and the audible alarm function at start-up is the user’s responsibility.

Automatic Garment Detection • Automatic Garment Detection will determine if a disposable garment has been properly connected to the controller. • The controller will automatically detect the number and type(s) of garments connected [Leg Sleeve(s) or Foot Cuff(s)]. • If the controller senses an attached garment, then the corresponding Port Status Indicator (A or B side) on the front display will be lit green. • If no garments are detected, the system will alarm until it is turned off. Check the garment application and tubing connections then restart Controller if necessary. Note: If a garment is attached anytime after the Automatic Garment Detection Procedure has started, the system must be restarted to ensure that the proper therapy will be applied to the limb(s).

Normal Operation • Verify that the corresponding Port Status Indicators are green for each disposable garment attached to the controller. • After garments have been successfully detected, the Controller begins the process of applying intermittent compression alternating from one port to the other if two garments are attached. Otherwise, the controller applies compression to only one port when one garment is attached. • On successive cycles, the controller automatically adjusts its operating parameters to maintain set pressure.

Pressure Settings • The Controller features microprocessor-controlled automatic pressure adjustment. • The pressure setting depends on the type of garment: 45 mmHg for Leg Sleeves; 130 mmHg for Foot Cuffs.

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Vascular Refill Detection • The SCD EXPRESS Compression System incorporates Kendall’s patented “Vascular Refill Detection” method to customize the therapy for each patient’s physiology. This system measures the time it takes for the veins in the limb to refill after having been compressed by the system. The time is then used in subsequent cycles as the time between compressions. • The vascular refill detection method is used when first powering on the System, after it reaches set pressure, and every thirty minutes thereafter. • The hourglass-shaped Vascular Refill Indicator on the front display will be illuminated during a measurement cycle. • The method works best when the patient is still, however it will accommodate movement. • If an error is detected during any measurement or if the compression is not within the System pressure specifications, the refill time measurement will be repeated after the next compression cycle. • The time between compressions will never be shorter than thirty seconds or longer than sixty seconds. • If both Controller ports are being used, then the longer of the two measurements will be used to adjust the time between cycles.

Garment Compatibility The SCD EXPRESS Compression System is designed for use with KENDALL garment Reorder Codes: • 9545 Leg Sleeve (Small Thigh Length) • 9530 Leg Sleeve (Medium Thigh Length) • 9780 Leg Sleeve (Large Thigh Length) • 9529 Leg Sleeve (Medium Knee Length) • 9789 Leg Sleeve (Large Knee Length) • 9736 Leg Sleeve (Sterile Thigh Length)

• 9545T Leg Sleeve (Small Thigh Length Tear-Away) • 9530T Leg Sleeve (Medium Thigh Length Tear-Away) • 9780T Leg Sleeve (Large Thigh Length Tear-Away) • 5897 Foot Cuff (Regular Foot) • 5898 Foot Cuff (Large Foot)

Further instructions for garment application and use are included with the Leg Sleeve and Foot Cuff packaging.

Tubing Set Compatibility The garments connect to the Controller via the Tubing Sets provided with the Controller. Additional or replacement Tubing Sets are available as Reorder Code 9528. The Ambulatory/Extension Tubing Sets are also available as Reorder Code 9595.

Portable Controller Configuration • The SCD EXPRESS Compression System Controller can be configured without the bed hook for easier portability. The System can also be used without the cord cover door so that the power cord can be disconnected at the Controller instead of at the AC power wall outlet. • An optional Shoulder Strap for the SCD EXPRESS Compression System is available as Reorder Code 9527. Note: Removal of the bed hook and the cord cover door is described in Section VI – Disassembly and Reassembly.

■ Section II - Battery Operation The SCD EXPRESS Compression System is designed to operate normally on AC line power or DC battery power without interruption. If the Controller is equipped with the optional battery pack there are three Battery Status Indicator LED’s used to represent the charge level of the battery. Once the Controller is powered on, it may take the system a few seconds to establish communication with the battery and display the charge level. If the Controller is not connected to a battery then the indicator lights will remain off. Note: To prevent a potential shock hazard, the battery compartment should not be left vacant while operating the SCD EXPRESS Compression System. The battery pack, or a dummy pack (if so equipped), must be installed in the controller to prevent the user from having access to the battery’s electrical connection.

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The battery pack for the SCD EXPRESS Compression System is optional. To order a new or replacement battery please contact Kendall Customer Service.

Battery Indicators Status::

1

2

3

Unit plugged in and On Standby or Powered On (Charging) Battery State

Battery Status 1

Battery Status 2

Battery Status 3

100% charge

Green

Green

Green

67-99% charge

Green

Green

Green (Pulsing)

34-66% charge

Green

Green (Pulsing)

Off

0-33% charge

Green (Pulsing)

Off

Off

Unit not plugged in and Powered On (Operating on Battery) Battery State

Battery Status 1

Battery Status 2

Battery Status 3

67-100% charge

Green

Green

Green

34-66% charge

Green

Green

Off

< 34% charge

Green

Off

Off

10-30 minutes left*

Amber (Flashing)

Off

Off

< 10 minutes left*

Red (Flashing)

Off

Off

* With 10-30 minutes of battery charge left, an alarm will sound in a sequence of three beeps once every two minutes. Once there is less than 10 minutes of battery charge left, the alarm will sound continuously.

Unit not plugged in and on standby Battery State

Battery Status 1

Battery Status 2

Battery Status 3

0-100% charge

Off

Off

Off

Charging the Battery The battery will begin charging as soon as the unit is plugged into an AC power source. The amount of time required to charge the battery will vary depending on the battery’s overall condition, age, and the controller’s state during charging. For example, charging a new, fully drained battery will take approximately 4 hours with the controller on standby and 8 hours with the controller powered on. The Battery Status indicators should always be used to determine the state of charge for the battery. A fully charged battery will typically provide 6-8 hours of operation time depending on the sleeve configuration, sleeve application, and the battery condition. Note: The battery may sustain permanent damage and become unrecoverable if it is left unused for extended periods of time. It is recommended that the battery pack be stored with a minimum charge of 50% and kept near 25° C (77°F) if prolonged storage is necessary.

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Battery Warnings The SCD EXPRESS Compression System battery pack contains Lithium Ion (Li-Ion) battery cells and must be used properly for safety and to maintain optimal performance. • Store only between –20° C (-4° F) and 60° C (140° F). • Do not drop, impact, or immerse in water. • Do not touch or ingest any leaking electrolyte. If contact occurs, rinse skin and/or eyes immediately and seek medical attention if irritation develops. If ingested, contact local poison control center. • Do not open battery, dispose of in fire, or short circuit. Doing so may cause the battery to ignite, explode, leak, or become hot and cause personal injury. • Dispose of improperly working or damaged battery packs according to local regulations. • Charge only with specified chargers according to Kendall’s instructions.

■ Section III - Fault Conditions and Troubleshooting When the microprocessor detects a fault condition, it interrupts the normal operation of the Controller, deactivates all valves to vent the air from the garment(s), dispalys a fault code, and sounds an audible alarm. This alarm will remain active until the Controller is turned off, or the battery runs out of charge (if operating on battery power). • The most common Controller alarm is the Garment Pressure alarm, indicated by flashing red Port Status Indicator(s). Garment Pressure alarms can usually be remedied by checking the disposable garment(s) for proper application and tubing set connection(s) for any leaks or kinks, and then restarting the System. However, if the alarm condition persists or if the Service Required Error Indicator is illuminated then the Controller should be returned for service.

Alarm Code

Fault Type

Description

Garment Pressure

B

A

Troubleshooting • Check tubing set for any kinks.

• System High

• System pressure has exceeded 90 mmHg (Leg Sleeve) or 180 mmHg (Foot Cuff)

• Check garment application (too loose or tight).

• High Pressure

• Leg Sleeve pressure is greater • Check tubing connections. than 47 mmHg after 5 consecutive cycles; Foot Cuff • Check for leaks in garment(s) pressure is greater than 135 and the tubing sets. If suspect, mmHg after 5 consecutive cycles. substitute a new tubing set or garment(s).

• Low Pressure

• Leg Sleeve pressure is less than 43 mmHg after 5 consecutive cycles; Foot Cuff pressure is less than 125 mmHg after 5 consecutive cycles.

• Turn the Controller off and restart. • Have the Controller serviced by a professional.

This alarm will also be triggered when no garments are detected at either Controller port (A or B) during startup.

4

System Pressure

Leg Sleeve pressure is not between 35 and 55 mmHg for 12 consecutive cycles; Foot Cuff pressure is not between 110 and 150 mmHg for 12 consecutive cycles.

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• Check garment application (too loose or tight). • Turn the Controller off and restart.

SCD EXPRESS R RESS ™

English Alarm Code

Fault Type

Description

Troubleshooting

5

Valve Error

If a valve electrically malfunctions, this error will be displayed.

• Verify that the valve assembly is properly connected. • Turn the Controller off and restart. • Have the Controller serviced by a professional.

6

Software Error

Upon startup, the microprocessor • Turn the Controller off and restart. performs diagnostic tests. If the Controller fails to pass these tests, • Have the Controller serviced by a this error will be displayed. professional.

7

Pump Error

If the pump electrically malfunctions, this error will be displayed.

• Verify that the pump is properly connected. • Turn the Controller off and restart. • Have the Controller serviced by a professional.

8

Vent Error

The pressure in a garment is greater than 10 mmHg at the end of any vent period. The pressure detected during an inflation cycle does not rise above 5 mmHg.

• Check tubing for kinks. • Check garment application (too loose or tight). • Check to make sure there are no kinks in the internal tubing. • Turn the Controller off and restart. • Have the Controller serviced by a professional.

9

Low Battery Alarm

(Error Indicator 1)

10

(Error Indicators 1, 2, & 3)

Battery Error

There is less than 10 minutes of battery charge remaining. The pump and valves will continue to operate for as long as there is enough power.

• Plug the Controller into an AC power outlet. • If the problem persists, replace the battery pack.

If a battery calibration error or • Turn the Controller off and restart. battery cell failure is detected, this error will be displayed. • If the problem persists, replace the battery pack.

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English

Fault Type

Description

Troubleshooting

Temperature Error

If the internal case temperature of the Controller drops below 5ºC (41ºF) or exceeds 55ºC (131ºF).

• Make sure the Controller is not covered and that the fan port is not obstructed.

(Error Indicators 5 & 7)

• Turn the Controller off, allow it to cool, and restart. • Verify that the cooling fan is properly connected. • Have the Controller serviced by a professional if the problem persists.

Watchdog Circuit • If the microprocessor cannot continue normal function, the watchdog circuit will trip. This causes the Controller to go into reset and restart normal operation. • If the cause of the disruption is still present, the unit will continue to attempt to reset, which will cause the alarm to sound once every second. • If the cause of the disruption was transient, such as a high energy RF pulse, the Controller will restart and continue normal operation.

■ Section IVV - Service and Maintenance This service manual is intended for use as a guide to technically-qualified personnel when evaluating System malfunctions. It must is not to be construed as authorization to perform warranty repairs. Unauthorized service will void the warranty.

Introduction The SCD EXPRESS Controller contains no user serviceable parts. User maintenance is covered in the sections that follow. All other maintenance must be performed by appropriately qualified service technical personnel. Service technicians should be familiar with the operator’s portion of this manual and the operating principles of the SCD EXPRESS Compression System. If a Controller is to be returned to Kendall for service, a description of the operating conditions and the fault code displayed should accompany the unit. The fault codes displayed by the Controller are useful in diagnosing service problems. This manual describes service procedures to the board level, with an exploded view of the Controller shown in Figure1. If a component failure on a circuit board is suspected, the unit should be returned for service. It is recommended that the system be returned with the circuit board in place, as removal of the board(s) involves additional risk of mechanical damage and damage from electrostatic discharge (ESD).

Warranty and Factory Service Tyco Healthcare Group LP warrants that your SCD EXPRESS Compression System is free from defective material and workmanship. Our obligation under this warranty is limited to the repair of Controllers returned to a service center, transportation charges prepaid, within one year of delivery to the original purchaser. Specifically, we agree to service and/or adjust any Controller as required if returned for that purpose, and to replace and repair any part which, upon our examination, is proven to have been defective. This warranty does not apply to the Tubing Set or the disposable garments, or to equipment damaged through shipping, tampering, negligence, or misuse, including liquid immersion, autoclaving, EtO sterilization, or the use of unapproved cleaning solutions. To the extent permitted by applicable law, this limited warranty does not cover, and is intended to exclude, any and all liability on the part of the Company, whether under this limited warranty or any warranty implied by law, for any indirect or consequential damages for breach hereof or thereof. Except as expressly provided above in the limited warranty, to the extent - 11 -

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permitted by applicable law, the Company hereby negates and disclaims all express and to the extent permitted by applicable law, implied warranties, including the warranties or merchantability and fitness for a particular purpose. Controllers requiring repairs should be sent to a service center. Call one of the service centers listed below. Obtain a return material authorization number and ship the controller, prepaid and insured in the original carton.

UNITED STATES

CANADA

Tyco Healthcare Group LP 98.6 Faichney Drive Watertown, NY 13601 (800) 448-0190 or (315) 788-5246

Tyco Healthcare Group Canada 7500 Trans Canada Highway Pointe-Claire, Qc H9R 5H8 877-664-TYCO (8926)

Outside U.S. and Canada

Tyco Healthcare Group LP 20 Garryduff Road Ballymoney, BT53 7AP 00-44-(0)-2827-661719 Service Center. 00-44-(0)-1329-224226 Customer Care

Suggested Preventative Maintenance Schedule After Any Repair Inspect and Clean Fan Screen

Once Per Year As Required

Verify Transducer Calibration (Test Modes 03 and 04)

X

X

Electrical Safety Tests

X

X

Leak Test (Test Mode 06)

X

General Function Test (Test Mode 07)

X

Fan Screen and Ventilation CAUTION: Unplug the Controller and remove the battery pack (see Section VI) before fan screen maintenance. It is very important that the fan screen be cleaned as required to ensure continued trouble-free operation. The Controller should never be run without the fan screen in place. To clean the fan screen, follow the instructions later in this manual in the “Fan and Screen (Removal/Installation)” Section to first remove the fan screen. Brush any loose dirt and lint from the surface of the screen. Reinstall the fan and screen, making sure the gasket material is oriented so as to prevent the screen from touching the fan directly. During system use, obstruction of the fan cover and vents should be avoided. Free flow of air is necessary to prevent overheating and premature component failure.

Fuses CAUTION: Unplug the Controller and remove the battery pack (see Section VI) before replacing the fuse(s). Blown fuses should only be replaced by those indicated on the power supply board near the location of the fuses at the AC inlet. Use only 1.6 A, 250 VAC, 5x20mm Slo Blo fuses. The use of fuses that have the Semko and/or VDE marking is preferred. If a fuse blows a second time, it should be presumed that the Controller is defective and requires further service. Please contact your service center. Fuses are not accessible from the outside of the controller. Refer to the Disassembly/Reassembly procedures later in the manual. The fuses are located on the power supply board as part of the power inlet module under the fuse cover.

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Electrical Safety CAUTION: Be sure the Controller is disconnected from the power source (AC line power and DC battery power) before any disassembly. A potential SHOCK HAZARD exists when the front cover is removed even with the unit turned off. Note: The power supply cord/plug serves as the electrical supply mains disconnect device. The system should be periodically inspected to ensure its electrical safety. Check the resistance of the power cord ground from the plug to the IEC 60320 connector. This resistance should not exceed 0.1 ohm. If ground resistance exceeds this value or the insulation integrity of the unit has been compromised through mechanical damage, the Controller should be returned to a service center for testing and repair.

Cleaning The Controller cabinet can be cleaned with a soft cloth dampened with water. If necessary, a mild disinfectant and/or detergent can be used; excess fluid should be avoided. The Controller should be wiped with a clean, dry cloth afterward. Do not immerse in any liquid. Do not use products containing ammonium chloride, acetone or other aromatic solvents, as those chemicals will degrade the integrity of the case and cause it to become embrittled and possibly crack. The SCD EXPRESS Compression System cannot be effectively sterilized by liquid immersion, autoclaving, or ETO sterilization, as irreparable damage to the System will occur.

Electrical/Electronics Description Line voltage is fed into the controller through the power cord to the power supply mounted on the Power Supply PC Board in the rear case of the controller. It is important to disconnect the power cord at the outlet before opening the controller case. Exposure to high voltage on the Power Supply PC Board is likely to occur if it is electrically live. The power supply converts AC line voltage, 100 to 240 VAC, to DC voltage to power the controller components, including the main Controller PC Board that is mounted onto the front case. Alternately, the main Controller PC Board may be directly powered by the optional battery pack. The Controller PC Board controls all functionality of the system and includes the transducer and buzzer. It does not contain any high voltage. The buttons and indicator LED’s on the front display of the controller are integrated into the membrane panel which connects to the Controller PC Board. Kendall does not recommend any attempt to repair printed circuit boards. In manufacturing, extensive testing is performed that cannot be duplicated in the field without specialized equipment. Improper repair could result in patient or user hazards.

Pneumatic Operation Description When the controller is turned on, the compressor operates and the valves are cycled to determine which type of garment is connected. After garment detection has completed, an inflation cycle is initiated, releasing air through the set of valves, mounted to a manifold. A transducer monitors the pressure in the garments. The reading from the transducer assists the controller in adjusting the pump’s motor speed to deliver the proper pressure to the garments in the appropriate amount of time.

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■ Section V - Test Methods and Calibration The SCD EXPRESS Compression System has various test modes that can be accessed by the service technician. They are intended for use by qualified personnel. To activate the test modes follow these steps for entering “Test Process Mode”. 1. Plug the controller into an outlet supplying the appropriate line voltage. Do not activate the test modes while operating on battery power. 2. There are two hidden buttons located next to the Port A and Port B Status Indicators (the locations are shown in “Front Panel Display” section). 3. Press both hidden buttons at the same time while turning the controller on. 4. The buzzer will beep and the first bar on the battery status indicator will illuminate signifying “Test Mode 01”. Note: The Battery Status Indicators 1-3 double as Test Mode Indicators 1-3. For example, illuminating the first bar of the Battery Status Indicators represents “Test Mode 01”. 5. The user can cycle through the test modes by pressing hidden button #1. Each test mode is indicated by the illumination of the corresponding test mode indicator number. Pressing hidden button #1 with the last test mode number illuminated (Test Mode 07) will cycle the test mode back to Test Mode 01. 6. After selecting the desired test mode, hidden button #2 can be pressed to initiate the test. 7. If test access is entered but no test mode is selected within 2 minutes, it is assumed that the test mode was entered inadvertently and a Low Pressure alarm will be triggered. 8. If a test mode is entered and left idle for 5 minutes the unit will revert back to test mode selection. 9. To exit Test Access Mode, turn the controller off.

Test Mode Look up Chart 01 – Burn-In Feature 02 – Functional Test 03 – Pressure Transducer Calibration 04 – Pressure Transducer Calibration Verification

05 – Self Test 06 – Leak Test 07 – Performance Test

Test Mode 01 - Burn-In Note: Burn-In mode is used in manufacturing to ensure proper assembly, to identify premature failures and to calibrate the battery pack. This mode is not generally used outside of the manufacturing environment. 1. Verify nothing is plugged into the ports on the back of the controller and enter test access mode. Select Test Access Mode 01. 2. Press hidden button #2 to begin Burn-In. The compressor will operate and the valves will actuate, releasing air out of the ports. The process repeats continuously until the Burn-In period is complete (approximately 16 hours). 3. The battery, if equipped, will be discharged then charged for calibration during Burn-in. 4. When 16 hours of Burn-In is completed the controller will go into alarm mode, flashing Test Access Mode 01, Sleeve A, and Sleeve B indicators green. The buzzer will not pip during this alarm.

Test Mode 02 - General Function Test 1. With nothing plugged into the ports on the back of the controller, enter test access mode. Select Test Access Mode 02. 2. Press the hidden button #2 to begin the test. 3. Pressing hidden button during this test will cause each one the of the LED’s to illuminate one at a time in succession and the alarm to pip. 4. Pressing and holding hidden button #2 will increase the pump speed to its maximum in 4-5 seconds. 5. Releasing hidden button #2 will allow the pump to decrease its speed at the same rate until it stops. 6. The valves will actuate in succession (valve #1 through valve #6) for two seconds each.

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Test Mode 03 - Pressure Transducer Calibration Note: The transducer used in the SCD EXPRESS Compression System is a state-of -the-art, highly precise and virtually drift free device. Factory calibration certification is void if the case is opened. Recalibration is rarely required and should be done only when necessary. Always perform test 04 before test 03 to verify the pressure transducer calibration. Required Equipment: A regulated, precision air source accurate to ±0.1mmHg over a range of 0 to 130 mmHg. 1. With nothing plugged into the ports on the back of the controller, enter test access mode. Select Test Access Mode 03. 2. Press the hidden button #2 to begin the test. 3. Test Access Mode 03 indicator will flash green until the calibration procedure is completed or an error condition occurs. 4. Valve #1 will be energized throughout the procedure, so that the user can verify the calibration of the pressure transducer with the controller case open or closed. The pressure standard can either be directly connected to the transducer with the case open, or it can be attached to the Bladder #1 location at Port A with the case closed. The Bladder #1 location is the leftmost fitting within Port A (as viewed from the back of the Controller). 5. Test Access Mode 04 indicator is lit green to signal that the unit is ready for the 0 mmHg calibration. After all air pressure is disconnected to zero the transducer, press hidden button #2 to complete calibration for this range. 6. Test Access Mode 05 indicator is lit green to indicate that the unit is ready for the 18 mmHg calibration. After 18 mmHg (± 0.1 mmHg) of air pressure is applied to the transducer, press hidden button #2 to complete the calibration for this range. 7. Test Access Mode 06 indicator is lit green to indicate that the unit is ready for the 45 mmHg calibration. After 45 mmHg (± 0.1 mmHg) of air pressure is applied to the transducer, press hidden button #2 to complete the calibration for this range. 8. Test Mode 07 indicator is lit green to indicate that the unit is ready for the 130 mmHg calibration. After 130 mmHg (± 0.1 mmHg) of air pressure is applied to the transducer, press hidden button #2 to complete the calibration for this range. 9. Upon completion, the new calibration values are recorded into memory and the unit beeps and reverts back to Test Access Mode. 10. If the calibration test mode is exited before the process is completed, the previous calibration values remain unchanged.

Test Mode 04 - Pressure Transducer Calibration Verification Note: The transducer used in the SCD EXPRESS Compression System is a state-of-the-art, highly precise and virtually drift free device. Factory calibration certification is void if the case is opened. Recalibration is rarely required and should be done only when necessary. Always perform test 04 before test 03 to verify the pressure transducer calbration. Required Equipment: A regulated, precision air source accurate to ±0.1mmHg over a range of 0 to 130 mmHg. 1. With nothing plugged into the ports on the back of the controller, enter test access mode. Select Test Access Mode 04. 2. Press the hidden button #2 to begin the test. 3. Test mode 04 indicator will flash green until the calibration procedure is completed or an error condition occurs. 4. Valve #1 will be energized throughout the procedure, so that the user can verify the calibration of the pressure transducer with the controller case closed. The pressure standard can be directly connected to the Bladder #1 location at Port A with the case closed. The Bladder #1 location is the left-most fitting within Port A (as viewed from the back of the Controller). Note: For each of the calibration verification ranges, if the supplied pressure is less than the specific calibration range then the Port A indicator will light red. If the supplied pressure is greater than the specific calibration range then the Port B indicator will light red. When the supplied pressure is within the calibration range, then both the Port A and Port B indicators will light green. 5. Test Access Mode 05 indicator is lit green to indicate that the unit is ready for the 0 mmHg calibration verification. Press hidden Button #2 to complete the verification for this range. 6. Test Access Mode 06 indicator is lit green to indicate that the unit is ready for the 18 mmHg calibration verification. Apply 18 mmHg (± 0.1 mmHg) then press hidden button #2 to complete the verification for this range. 7. Test Access Mode 07 indicator is lit green to indicate that the unit is ready for the 45 mmHg calibration verification. Apply 45 mmHg (± 0.1 mmHg) then press hidden button #2 to complete the verification for this range. 8. Test Access Mode 08 indicator is lit green to indicate that the unit is ready for the 130 mmHg calibration verification. Apply 130 mmHg (± 0.1 mmHg) then press hidden button #2 to complete the verification for this range 9. Upon completion the unit beeps and reverts back to Test Access Mode.

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English Test Mode 05 - Self Test

1. Attach a tubing set connected to leg or foot sleeves. 2. Enter Test Access Mode and press the hidden button #1 until Test Access Mode 05 is selected. 3. Press the hidden button #2 to begin the self test. 4. The Test Access Mode 05 indicator will flash until the test is completed. 5. The alarm will pip and the unit will perform the full array of tests performed during Start-up.

Test Mode 06 - Leak Test The pressure decay leak test will determine if there are any significant leaks in the system (including the pneumatic circuitry inside the controller and the connections with the tubing set). 1. Attach a tubing set connected to leg sleeves or foot cuffs. 2. Enter Test Access Mode and press the hidden button #1 until Test Access Mode 06 is selected. 3. Press hidden button #2 to begin the Leak Test. 4. The Test Access Mode 06 indicator will flash until the test is completed. 5. The controller will inflate all the bladders for port A (Valves #1-3) at the same time to 45mmHg and then vent down to 5-7 mmHg. 6. The unit will then hold the pressure for 40 seconds, while reading the pressure at 20 seconds and 40 seconds. (The alarm will pip at the start of the leak test and at the 20-second and 40-second intervals.) 7. If there is a significant pressure drop over that 20-second time period, a Low Pressure alarm will be triggered. 8. If no leak is detected, the unit will repeat the leak test for port B (Valves #4-6). 9. If no leaks are detected at either port then the system will simply beep and return to Test Access Mode.

Test Mode 07 - Performance Test When in this mode, the user can verify the pump and valve performance, pressure delivery, and the airflow through the pneumatic circuit. In manufacturing, this test is conducted with known volumes connected to the sleeve ports. Then the inflation cycles run during the test at the low and high pump speeds create backpressures in the volumes that are measured and used as a performance specification. 1. Attach a tubing set connected to leg sleeves. 2. Enter Test Access Access Mode and press the hidden button #1 until Test Access Mode 07 is selected. 3. Press hidden button #2 to begin the Performance Test. 4. The Test Access Mode 07 indicator will flash until the test is completed. 5. After initiating the performance test, the Port A indicator will flash green in sync with an audible alarm. 6. After hidden button #2 is pressed the Port A indicator will be lit green, the alarm will stop, and the controller will then go through a normal inflation cycle at Port A with the pump operating at its lowest speed throughout the cycle. 7. Next, the Port B indicator will flash green in sync with an audible alarm. 8. After hidden button #2 is pressed, the Port B indicator will be lit green, the alarm will stop, and the controller will then go through a normal inflation cycle at Port B with the pump operating at its highest speed throughout the cycle. 9. Upon completion the unit beeps and reverts back to Test Access Mode.

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■ Section VI - General Disassembly / Reassembly Warning: Always make sure the power cord is unplugged and the battery is removed before attempting to perform any installation or removal procedures. • • • • • •

Follow ESD (Electrostatic Discharge) safety procedures to protect the electronics located within the controller. Remove the power cord cover by first removing the retaining screw on the cord cover door. Slide the cord cover door off by pressing the door to the right. Remove the power cord by rocking back and forth until the cord is loose. Remove the five (5) screws that hold the front cover to the rear cover with a Phillips head screwdriver. The front cover may now be carefully pulled away. To separate the front and rear covers, reach in and remove the transducer tube from the transducer on the front cover. (Diagram 01) • Observe and note the locations of all tubing and wiring harnesses for ease in reassembly. • If required, disconnect the electrical connectors and tubes so the two case halves can be separated completely. • Reassembly is the reverse of disassembly.

Battery Pack (Removal / Installation) • Remove the battery pack screw located on the bottom center of the rear case of the controller. • Slide the battery pack out by pulling on the tab on the bottom, right side of the unit. • Installation is the reverse of removal.

Compressor (Removal / Installation) • The compressor is not a user serviceable component. Do not dissassemble. Do not oil. The compressor is mounted to its own separate bracket that, in turn, mounts through the inside of the battery compartment in the rear case of the controller. • Disconnect the pump wiring harness from the Controller Board on the front case. • Disconnect the compressor output tube at the check valve. (Diagram 02) • Remove the compressor intake tubing from the muffler port. (Diagram 02) • Remove the two (2) screws from the compressor mounting bracket. (Screws are accessible through the right side battery compartment once the battery pack is removed.) (Diagram 01) • Slide the entire compressor assembly out of the rear case housing. • Installation is the reverse of removal.

Valve Manifold and Bed Hook (Removal / Installation) • The valve manifold is located in the center of the controller on the rear case. It is a plastic manifold block with six solenoid valves. No attempt should be made to repair a damaged manifold or valve. Return the entire assembly for repair or replacement. • Inspect tubes that lead to the manifold for kinks and proper attachment before performing any work. Detach all tubing from the manifold fittings. Note the location of connections and the tubing routing for ease of reassembly. • Disconnect the valve wiring harness from the Controller Board on the front case. • Remove the two side screws from the valve manifold assembly and then pull the bed hook away from the rear case. (Diagram 03) • Remove the center screw from the manifold assembly and remove the valve manifold. • Some wires may be secured to the manifold with wire ties. Be prepared to reattach these wires after reinstalling the assembly. New wire ties will be required. • Installation is the reverse of removal.

Muffler (Removal / Installation) • The muffler is a custom plastic part used to keep the Kendall SCD EXPRESS Compression System running quietly. • To remove the muffler detach the compressor intake tubing and slide the muffler out from under the power board. • For reinsertion of the muffler be sure to route the intake tubing properly. (Diagram 02) Tubing must be run between the muffler and the right side of the rear case to avoid kinking.

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English Power Supply Board (Removal / Installation) CAUTION: Use a grounded strap when handling any electronic components.

• The power supply has no user serviceable parts except for the fuses. No attempt should be made to repair a damaged supply. Return to the factory for repair or replacement. • Disconnect the 4-pin controller board wiring harness from the power board. • Remove the muffler as described in “Muffler (Removal/Installation).” • The power supply board is held in place by channels on the side of the rear case as well as retaining brackets on the front case. • To remove the power board slide the board out from the rear case. • Installation is the reverse of removal.

Fan and Screen (Removal / Installation) • • • •

Disconnect the 2-pin fan connector from the power board. Observe the angle and orientation of the fan and screen prior to removal to ease reassembly. (Diagram 04) Slide the fan and screen out of the case by pulling straight out. Installation is the reverse of removal. For optimum cooling and quietness, use only Kendall replacement fans.

Main Controller Board (Removal/Installation) CAUTION: Use a grounded strap when handling any electronic components. • The main CPU board has no user serviceable parts. No attempt should be made to repair a damaged board. Return to the factory for repair or replacement. • Disconnect the 4 pin controller board wiring harness from the power board. • The main CPU board is located on the front cover and is held in place with two screws. • Disconnect the two membrane ribbon cables by sliding them out of the connectors on the controller board. • Remove the controller board. • Installation is the reverse of the removal.

■ Section VII - Specifications SCD EXPRESS Compression System Safety Standards

Built to UL60601-1, CSA-C22.2 No. 601.1-M90, EN60601-1, and IEC 60601-1-2 Standards UL Classified File # E189131

UL Device Classification

Class I Equipment Internally Powered, Portable Type BF Applied Parts Not AP or APG Equipments

Mode of Operation

Continuous

Ingress of Water Protection

Ordinary, IPX0 (IEC 529)

Compression Type

Leg Sleeves: Sequential, Gradient Foot Cuffs: Uniform

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Compression Cycle

Leg Sleeves: 11 Seconds Compression Foot Cuffs: 5 Seconds Compression Decompression time based upon Vascular Refill Detection measurement

Set Pressure

Leg Sleeves: 45 mmHg Foot Cuffs: 130 mmHg

Bed Hook

Yes (Optional)

Power Cord Storage

Yes

Audible/Visual Alarms

Low Pressure, High Pressure, Internal Electronics Malfunction

Power Cord

Hospital Grade Plug

Controller Dimensions:

Height: 6.2 inches (15.8 cm) Width: 7.0 inches (17.8 cm) Depth: 4.5 inches (11.4 cm)

Controller Weight

3.5 lbs. (1.6 kg)

Power Requirements

100-240 VAC, 50VA, 50/60 Hz

Battery

16.4 V, 2000mAhr, Lithium Ion (Optional) Run Time: 6-8 hours Charge Time: 4 hours (charging only)

Shoulder Strap

Yes (Optional)

Shipping Unit

Each

Shipping Case Dimensions

Height: 11.6 inches (29.4 cm) Width: 9.0 inches (22.8 cm) Depth: 11.4 inches (28.9 cm)

Shipping Weight

7 lbs. 6 oz. (3.45 kg)

Tubing Set

Included, set of two individual assemblies

Operation & Service Manual

Included

Transport & Storage

0°C (32°F) to 50° C (122°F) If the user suspects that the environment conditions for transport and storage have been exceeded, return the unit for service.

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■ Section VIII - Schematics Figure 1 - Parts Assembly Diagram - Exploded View

Controller Parts List 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17.

Front Membrane Panel Front Enclosure Main Controller Board Valve/Manifold Assembly Wire Barrier Compressor Assembly Power Supply Board Fuses (Set of 2) Muffler Fan Fan Screen Rear Enclosure Rubber Feet (Set of 2) Battery Pack Power Cord Cord Capture Door Bed Hook

3

15 16 17 12

4

5 6

10

1

7 8

2

9

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11

14

FAN

J6

J1

J5

POWER SUPPLY BOARD

POWER

J6

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CPU BOARD

FRONT PANEL

AC INLET FUSES

MAINS VOLTAGE INPUT 110-240 VAC 50-60 Hz

TO J2 & J9

PRESSURE TRANSDUCER

(CPU)

TO J6

BATTERY CONTACTS (BATTERY NOT SHOWN)

(CPU)

TO J5

COMPRESSOR

VALVE ASSEMBLY

PORT A

PORT B

MUFFLER

FLOW DIRECTION

CHECK VALVE

AIR INLET

PRESSURE RELIEF (NO CONNECTION)

Operation and Service Manual

English

■ Section VIII - Schematics

Figure 2 - Pneumatic & Electrical Schematic