SCD 700 Operation and Service Manual

TABLE OF CONTENTS Section VI - Test Methods...EN-21 Test Mode Look up Chart...EN-22 Test Mode T1 - Burn-In ...EN-22 Test Mode T2 - General Function Test ...EN-22 Test Mode T3 - Pressure Transducer Calibration...EN-22 Test Mode T4 - Pressure Transducer Calibration Verification...EN-22 Test Mode T5 - Self Test...EN-22 Test Mode T6 - Performance Test...EN-23 Test Mode T7 - Manufacturing Test...EN-23 Test Mode T8 - Feature Menu Mode ...EN-23 Test Mode - Error History...EN-23 Section VII - General Disassembly / Reassembly ...EN-24 Battery Pack (Removal / Installation) ...EN-24 Fan Filter and Exhaust Filter (Removal / Installation) ...EN-24 Adjustable Bed Hook (Removal / Installation)...EN-24 Section VIII - Parts Listing...EN-25 Section IX - Specifications...EN-26 KENDALL SCD 700 Series Compression System...EN-26 Section X - Schematics ...EN-30 Figure 14 - Rear Enclosure View...EN-30 Figure 15 - Front Enclosure View...EN-31 Figure 16 - Rear Device View (Pivot Cover Removed)...EN-32 Figure 17 - Pivot Cover...EN-33

Indications The KENDALL SCD 700 sequential compression system (hereby referenced as “KENDALL SCD 700 series”) 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 cycle, the controller measures the time it takes for the limbs to refill with blood and adjusts the compression frequency to maximize flow rate. The system may be used by all ages of adults and children when indicated to apply intermittent pneumatic compression. The system is intended for use in a clinical setting by health care professionals.

Leg Compression The use of the KENDALL SCD 700 series compression system with leg sleeves is indicated for: 1. Deep vein thrombosis and pulmonary embolism prophylaxis.

Foot Compression The use of the KENDALL SCD 700 series compression system with foot cuffs is indicated for: 1. Deep vein thrombosis prophylaxis. If you need further information regarding the KENDALL SCD 700 series compression system, please contact your Cardinal Health Sales Representative.

Contraindications Leg Compression The KENDALL SCD 700 series 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 KENDALL SCD 700 series 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.

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Cautions and Warnings 1. Federal (USA) 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. Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. 4. No modification of this equipment is allowed. It is acceptable to service and repair the components identified as serviceable in this document. 5. Although training on the use of the device is recommended, no special skills are required. 6. WARNING: Do not operate the controller if the power cord is damaged. 7. WARNING: Do not service while the device is in use with a patient. 8. WARNING: Do not attempt to repair or replace broken tubing connectors as hazardous inflation of the sleeves may occur. 9. WARNING: This device must be connected to a supply main with protective earth ground to avoid the risk of electric shock. 10. WARNING: Do not position the controller so that it is difficult to disconnect the power cord from the AC outlet.

Explanation of Symbols Not made with natural rubber latex

Caution

Federal (USA) law restricts this device to sale by or on the order of a physician.

Consult instructions for use.

Reorder number for the device located on the carton label.

0123 Controller Symbols

Not made with natural rubber latex.

Use By

Use-by

CE Mark

Batch Code

Controller serial number

Manufacturing date code

Keep away from sunlight.

Keep dry. 85%

Type BF applied part

Type BF protection against electric shock.

Humidity limitations 25%

Manufacturer

131°F 55°C -4°F -20°C

Store between these temperatures.

WEEE (Waste from electrical and electronic equipment)

Protection against fluid ingress: spraying water and particulates

Protective earth (ground)

Equipotential ground point

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MEDICAL EQUIPMENT 47DA UL60601-1, CAN/CSA C22.2 NO.601.1.

MEDICAL EQUIPMENT 47DA UL60601-1, ANSI/AAMI ES60601-1:2005, CAN/CSA C22.2 NO.601.1, CAN/CSA C22.2 NO.60601-1 (2008).

MEDICAL EQUIPMENT 47DA UL60601-1, ANSI/AAMI ES60601-1:2005 + AMD 1 (2012), CAN/CSA C22.2 NO.60601-1 (2014).

Medical- general medical equipment as to electrical shock, fire and mechanical hazards only in accordance with UL60601-1, CAN/CSA C22.2 NO.601.1. Medical- general medical equipment as to electrical shock, fire and mechanical hazards only in accordance with UL60601-1, ANSI/AAMI ES60601-1:2005, CAN/CSA C22.2 NO.601.1, CAN/CSA C22.2 NO.60601-1 (2008). Medical- general medical equipment as to electrical shock, fire and mechanical hazards only in accordance with UL60601-1, ANSI/AAMI ES60601-1:2005 + AMD 1 (2012), CAN/CSA C22.2 NO.60601-1 (2014).

Medical- general medical equipment as to electrical shock, fire and mechanical hazards only in accordance with ANSI/AAMI ES60601-1:2005/A2:2021, CSA-C22.2 No. 60601-1:2014/A2:2022-03.

Sterile Garment Symbols Sterile using ethylene oxide.

Single use device

Do not use if package is opened or damaged.

Tubing Set Symbols Constructed from recyclable materials.

Medical Device

Membrane Panel 1

4

2

5

6 3

7

Item Explanation

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Item Explanation

1

Power On Indicator

5

Battery Status Indicators 1-3

2

Power On/Standby Button

6

Right Arrow Button

3

A - Button

7

B - Button

4

AC Power/Battery Charging Indicator

Section I - General Operating Instructions Set up

• Place the controller on the footboard. This is done by grasping the device handle and the top portion of the pivoting bed hook and squeezing to open the gap. Place it on the foot board so it straddles the foot board and release the bed clamp. See the figure at right. Ensure its security. Alternatively, the device can be placed 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 at the power cord cover and below the Bed tube set connection points. Inhibiting adequate air flow to the vents may cause Foot Board overheating of the controller device. • 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 or patient entanglement in any excess tubing. • If the controller is not secured to the bed or rested on a horizontal surface (i.e. a table) there is a risk for the device falling on onto the patient’s limbs or the user. • Plug the tubes into garment(s) wrapped onto the patient’s limbs. • Match the left and right ports, marked B and A respectively, 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. The blue AC Power Indicator will illuminate. If no AC Power is accessible, the controller can be run using its own internal battery power. • If the controller is being used for the first time or the internal battery has just been replaced, plug the AC power cord in to ensure the battery is able to sufficiently charge. • If compliance monitoring is desired, refer to Section II.

Start-up

• Press the Power On/Standby button to begin normal operation. If using leg sleeves, no further user intervention is required unless there is a fault condition detected or if therapy must be discontinued. • The controller will beep, flash all the LEDs and illuminate the display screen. Quick internal device checks are performed, which may be audible to the user. • The pump will begin to operate as part of the Garment Selection and Verification procedure. • Detection of inoperative LEDs, display screen and the audible error indication function at start-up is the user’s responsibility.

Garment Selection and Verification After startup, the Garment Configuration procedure allows the user to select when foot compression is required at either of the two controller ports: • On the display, the Port A Leg and Port B Leg images blink to indicate the default garment configuration (leg compression). • Pressing either the A or B Button will cause the corresponding port’s leg image to shift to a foot image to signify foot compression. The buttons must be pressed for each port that is connected to a foot cuff to turn on the corresponding foot image(s). Note: Leg sleeve compression is the default configuration when the controller is first powered on. Therefore, the A and B Button(s) do not have to be pressed to begin compression therapy when leg sleeves are being used. The A and B buttons need to be pressed only when foot compression is to be used. NOTE: If a garment is attached anytime after the Garment Detection procedure has started, the system must be restarted to ensure that the proper therapy will be applied to the limb(s).

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Also after startup, the controller immediately begins conducting the Garment Selection and Verification procedure at each port to determine if the garments have been properly attached to the controller: • If necessary, prior to the completion of Garment Selection and Verification, the A and B Button(s) may be pressed again to shift the garment image from the foot to the leg. • During this phase, the compressor and valves are operating and air is delivered out the controller ports to detect the number and type(s) of garment(s) connected [Leg Sleeve(s) and/or Foot Cuff(s)]. • If the controller senses a properly attached garment and the type of garment detected matches the User-selected garment (or the default) configuration, then the corresponding image of a Leg Sleeve or Foot Cuff for both the A and B side will be displayed on the screen. • If the controller senses a properly attached garment but the type of garment detected does not match the User-selected garment (or the default) configuration, then a Garment Mismatch error is triggered. Garment Mismatch errors can be corrected by pushing the corresponding A and B buttons to change the User-selected garment type (Leg or Foot). In the example below, the screen shows Foot Cuffs and indicates the user must press both A and B buttons (FIGURE 1).

A

B

FIGURE 1

• Once the Garment Detection procedure is completed and any garment mismatch errors are addressed, the A and B button(s) will be disabled and normal operation begins by starting the compression therapy. • If only one controller port is connected to a garment for single-limb compression, then the User-selected garment (or the default) configuration setting (Leg or Foot) for the open port will be ignored and both the leg and foot will be grayed out such as the example shown below (FIGURE 2).

A

B

FIGURE 2

• If any garments are not properly detected or if no garments are attached to the controller, the system will trigger an E12 error. See section IV (Fault Conditions and Troubleshooting) in this manual. Check the garment application and tubing connections. In this case, either the system can be turned off and restarted or the corresponding A and B Button(s) can be pressed to confirm problem resolution and operation will continue without having to power the controller down and restart.

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Normal Operation and Pressure Adjustment • Verify that the corresponding garment images match the disposable garment(s) applied to the patient. • The controller automatically begins the process of applying intermittent compression alternating between limbs or to one if only one garment is applied. • On successive cycles, the controller automatically adjusts its operating parameters to maintain set pressure. • The pressure setting depends on the type of garment: 45 mmHg for Leg Sleeves; 130 mmHg for Foot Cuffs.

Vascular Refill Detection • The KENDALL SCD 700 series compression system incorporates CARDINAL HEALTH 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. • Vascular Refill Detection occurs automatically and requires no operator interaction. • Vascular Refill Detection will only occur when the device is operating on AC power. When operating on battery power, the Vascular Refill Time will default to 60 seconds. • The Vascular Refill Detection method is used when first powering on the System after it reaches set pressure and every thirty minutes thereafter. • During the entire time Vascular Refill Detection is in progress, a rotating ring symbol will display in the center of the screen as shown below in Figure 3. This symbol is informative only. No action is required by the user during the Vascular Refill Detection Process. • 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 on the same limb will never be shorter than twenty 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.

FIGURE 3

Shutdown To terminate the operation, press the Power On/Standby button on the device.

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Garment Compatibility The KENDALL SCD 700 series compression system is designed for use with KENDALL SCD garment Reorder Codes: KENDALL SCD Sequential Compression Comfort Sleeves 74010- Thigh Length X-Small 74011 Thigh Length Small 74012- Thigh Length Medium 74013 Thigh Length Large 74021 Knee Length Small 74022 Knee Length Medium 74023 Knee Length Large

KENDALL SCD Sequential Compression Comfort Tear-Away Sleeves 74041 Thigh Length Small 74042 Thigh Length Medium 74043 Thigh Length Large

KENDALL SCD Express Sleeves 9529- Knee Length Medium 9530 Thigh Length Medium 9545- Thigh Length Small 9736 Thigh Length Medium (sterile) 9780- Thigh Length Large 9789- Knee Length Large 9790 Knee Length X-Large 73011 Thigh Length Small 73012 Thigh Length Medium 73013 Thigh Length Large 73022 Knee Length Medium 73023 Knee Length Large KENDALL SCD Express Tear-Away Sleeves 9530T 9545T 9780T 73041 73043 73042

Thigh Length Thigh Length Thigh Length Thigh Length Thigh Length Thigh Length

Medium Small Large Small Large Medium

KENDALL SCD Express Foot Cuff 5897 5898 73032 73033

Regular Large Regular Large

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 Extension Tubing Sets are also available as Reorder Code 9595. It is recommended that the connection between the garment and the controller be no longer than one tube set 9528 and one extension 9595.

EN-7

Section II - Patient Detection and Compliance Meter Compliance Meter The KENDALL SCD 700 series controller has a feature called the Compliance Meter that can be used to monitor the amount of time compression therapy is delivered either by shift, day, or during an entire hospital stay. This feature operates in the background, so that it does not interrupt normal operation. Prior to using the Compliance Meter, confirm the controller has been set up as described in Section I. Time is tracked using a numerator/denominator format. The denominator (bottom number) displays the elapsed time since the Compliance Meter was reset. The elapsed time has an upper bound of the shift selection. The numerator (top number) is the therapy time applied over the last 8, 10, 12, 24 hours or since last reset. • If the Patient Detection feature is active, the numerator will display the amount of time compression therapy was applied to the patient during the elapsed period of time specified in the denominator. • If the Patient Detection feature is disabled, the numerator notes the patient therapy time as the amount of time the unit is operating during the elapsed period of time specified in the denominator. • NOTE: The patient must wear a leg or foot garment for prescribed compression therapy to be delivered and provide intended prophylaxis.

The Compliance Meter time is expressed in hours and minutes. When the controller is turned off or when an error condition is present, thus halting normal operation, the therapy time (numerator) will not increment, but the elapsed time will continue to increment. The maximum amount of time that can be displayed is 999 hours. After the controller is off for 40 days continuously, the Compliance Meter will reset to zero. The Compliance Meter features are shown below: Therapy time (top number) (HHH:MM)

Elapsed time (bottom number) (HHH:MM)

Right arrow button

A - button (shift selector)

Patient Detection

B - button (reset button) Shift selections

Selection Indicator

Reset icon

FIGURE 4 - COMPLIANCE SCREEN

The KENDALL SCD 700 series controller with software version 3.00.00 or greater, offers a feature that automatically detects if the compression garments are applied to a patient. Referred to as the Patient Detection feature, it is designed to supplement the Compliance Meter. Compliance time reported accurately communicates therapy delivered to a patient. The system periodically checks for the presence of a patient. If the system is not able to detect a patient, the controller will display a notification and sound an audible alert. When the Patient Not Detected alert is present, the controller will continue to perform compression cycles. However, it is still necessary to resolve the Patient Not Detected alert.

FIGURE 5 - PATIENT NOT DETECTED ALERT SCREENS (LEG SLEEVES)

EN-8

FIGURE 6 – PATIENT NOT DETECTED ALERT SCREENS (FOOT CUFFS)

If the patient not detected alert shown in Fig 5 or Fig 6 is displayed, turn the controller off, confirm the leg or foot garment placement and securement. Then, turn the controller on. The white icon in upper right hand corner indicates that patient is actively being detected by the controller.

On the compliance meter screen, the therapy time is based on the time that therapy is being delivered to the patient. FIGURE 7 - PATIENT DETECTION ACTIVE

If the sleeve is removed, the controller will display the Patient Not Detected Alert and sound an audible alert.

There may be instances in which a patient is present but is not able to be detected by the controller. In this instance, the white icon in the top corner (Figure 7) will turn blue (Figure 8) but the controller will continue to perform compression cycles. After two Patient Not Detected Alerts and subsequent power cycles within one hour, the system will silence the Patient Not Detected Alert. When the icon is blue the Patient Not Detected Alert will be silenced (Off). The controller will continue to attempt to detect the patient in the background, even though the alert is silenced. If a patient is subsequently detected, the icon in the top right corner will turn white meaning the controller is now able to detect the patient (Patient Detection is Active). The blue icon in upper right hand corner indicates that patient is not currently being detected by the controller. No intervention is required when the blue icon is displayed, it is just informational. The controller will continue to perform compression cycles and attempt to detect the patient’s presence.

FIGURE 8 - PATIENT DETECTION INACTIVE

On the compliance meter screen, the therapy time is based on the time that the device is running. If the sleeve is removed, the controller will NOT display the Patient Not Detected Alert and will NOT sound an audible alert.

The Patient Detection feature may be disabled in Test Mode (see Test Mode T8). In this instance, there will be no patient detection icon displayed on the user interface and the unit will not attempt patient detection until the feature is re-enabled. The therapy time will increment while the device is running and delivering therapy.

EN-9

Accessing the Compliance Meter Feature The Compliance Meter can only be accessed when the controller is powered on and is delivering therapy. The controller will sound a “deny” tone, three quick beeps, at any other time such as immediately after turning the system on and garment detection is in progress (garments icon blinking). Note: Use of the Compliance Meter does not halt or otherwise affect the ongoing compression therapy. • Access the Compliance Meter by pressing the right arrow button. A screen similar to the one in Figure 4 will be displayed. Pressing it again will return the user to normal operating mode. If the Compliance Meter is accessed, but no further action is taken, then the system will change the display back to normal operating mode in thirty seconds.

Reading the Compliance Meter • The lower left corner of the screen displays numbers and a symbol representing time durations. Typical nurse shifts are 8, 10, and 12. A full day is 24. The symbol ∑ represents total compliance time since the last reset. • Pressing the A button (shift selector) allows the user to select a time duration of interest. The selection indicator moves with each button press. • Examples: ° To determine the amount of therapy a patient has received over the most recent 8 hours, for example, select the ‘8’ on the shift selector. ° To determine the amount of therapy a patient received over the most recent 24 hours, for example, select the ‘24’ on the shift selector. Note: If the amount of elapsed time has not yet reached the time selected on the shift selector, then the actual elapsed time will display in the bottom number. Note: After 30 seconds of inactivity, the Compliance Meter will return to the normal therapy screen.

Resetting the Compliance Meter 1. Press the B button to reset the Compliance Meter. The confirmation screen will display as shown in Fig 9. 2. To confirm the reset, press the A button. A check mark icon displays to confirm your selection. 3. To decline the reset, press the B button. An X icon displays to confirm your selection. 4. After either A or B is pressed, the screen will revert to the Compliance Meter Screen. Reset icon

Confirm reset Deny reset FIGURE 9 - COMPLIANCE RESET SCREEN

5. When the Compliance Meter is reset, the therapy and elapsed time are reset to zero. 6. The compliance Meter continues its operation until it is reset. That is, the therapy time and elapsed time continue counting until the meter is reset. This may result in inaccurate compliance information for the patient. However, it is not recommended to reset the meter until it is assigned to a new patient.

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EN-11

Elapsed Time (hours)

Device is reset

2:30

2:30 2:30

0:00 0:00

0:00

Patient is compliant for 2 1/2 hours

3:30

Patient goes to 1 hour test

2:30 3:30

6:30

5:30 6:30

Patient is compliant for an additonal 3 hours

7:00

Patient turns device off for half an hour

5:30 7:00

8:00

6:30 8:00

Nurse reapplies system to patient for 1 more hour

18:00

16:30 18:00

8:00 8:00

Patient sleeps for 10 hours with device on.

The example below shows a timeline of Compliance for a hypothetical patient. The 8 hour shift selection is active in this example:

Nurse selects “Σ” on the shift selector. This indicates how much therapy since the last system reset.

Section III - Battery Operation The KENDALL SCD 700 series compression system is designed to operate normally on AC line power or DC battery power without interruption. There are three Battery Status Indicator LEDs 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. The battery Indicator shown below is located in the upper right hand corner of the user interface. See FIGURE 10. WARNING: If the ground integrity of the mains power cable is in question, the device should be operated on battery power until the ground integrity can be insured.

1

2

3

Battery Status Indicators FIGURE 10

Unit plugged in and 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

15-40 minutes left*

Amber (Flashing)

Off

Off

< 15 minutes left*

Red (Flashing)

Off

Off

Unit Powered Off (charging when plugged in) Battery State

Battery Status 1

Battery Status 2

Battery Status 3

0 -100% charge

Off

Off

Off

EN-12

*With 15-40 minutes of battery charge left, an audible error indicator will sound in a sequence of three beeps once every two minutes. Once there is less than 15 minutes of battery charge left, the audible error indicator will sound continuously and the dead battery icon will display as shown in FIGURE 11.

FIGURE 11

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: If the operation time on battery power is extremely short the battery should be returned for service or replacement. Note: The battery performance may be reduced 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.

Battery Warnings The KENDALL SCD 700 series compression system battery pack contains Lithium Ion (Li-Ion) battery cells and must be used properly for safety and to maintain optimal performance. • Store spare battery packs 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.

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Section IV - 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), displays a fault code, and sounds an audible error indicator. If a Garment Mismatch error is triggered the user may remedy the problem by pressing the corresponding A and B Button(s). Some errors will remain active until the controller is turned off, or the battery runs out of charge (if operating on battery power). Others can be reset once the user confirms the cause of the error and remedies the problem. Error Types:

Description

Service Required

Error code is present because of a failed internal component. It can not be addressed by the user.

Manual Reset Required

Error that can be troubleshot and corrected by the user but requires the device to be powered off and on. If the error persists, then the controller requires service.

User Resettable

This type of error allows the user to remedy the issue and resume operation by pressing the A and B button(s) corresponding with the port affected without powering the unit down. For this type of error, a check mark will be shown indicating what port is the area of concern. A yellow triangle indicates a low concern error. If the triangle is red it is indicative of an error related to a pressure that is high in an abnormal way. If the error persists, then the controller requires service.

Example E5

E1 A

B

E2 A

B

For information on Patient Not Detected Notification, see Section II - Patient Detection and Compliance Meter.

EN-14

Error Codes Error Code

Error Type

Description

Troubleshooting

User Resettable

The Garment Detection procedure has detected a garment configuration (Leg or Foot flashing green) that does not match the User-selected configuration (Leg or Foot red).

Press the port configuration button(s) to turn the foot selection on/off depending on what type of garment(s) is connected to the controller. If the proper garment is selected and the problem persists have the controller serviced by a professional.

Manual Reset required

System pressure has exceeded 90 mmHg (Leg sleeve) or 180 mmHg (Foot Cuff).

Check for kinked tubes or patient interference with the garments, like pressing foot against foot board.

User Resettable

Leg Sleeve pressure is greater than 47 mmHg for 10 consecutive cycles; or pressure is above 65 mmHg for 5 consecutive cycles.

Check for a tight leg sleeve and adjust fit appropriately. Also check for a partially occluded tube.

User Resettable

Foot Cuff pressure is greater than 135 mmHg for 10 consecutive cycles or pressure is above 160 mmHg for 5 consecutive cycles.

Check for a tight foot cuff and adjust fit appropriately. Also check for a partially occluded tube.

Low Pressure (Leg Sleeves)

User Resettable

Leg Sleeve pressure is less than 43 mmHg for 10 consecutive cycles.

Check for leaks in the sleeve or the tube connections.

Low Pressure (Foot Cuffs)

User Resettable

Foot Cuff pressure is less than 125 mmHg after 10 consecutive cycles.

Check for leaks in the cuff or the tube connections.

Garment Mismatch Error A

B

System High Pressure Error E1 A

B

High Pressure (Leg Sleeves) E2 A

B

High Pressure (Foot Cuffs) E2 A

EN-15

B

Error Code

Error Type

Description

Troubleshooting

Low Pressure (Leg Sleeves)

User Resettable

Leg Sleeve pressure is not between 35 and 55 mmHg for 12 consecutive cycles.

Check for leaks in the sleeve or the tube connections.

Low Pressure (Foot Cuffs)

User Resettable

Foot Cuff pressure is not between 110 and 150 mmHg for 12 consecutive cycles.

Check for leaks in the cuff or the tube connections.

Service Required

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

Return to Cardinal Health for service.

Service Required

Upon startup, and periodically during operation the microprocessor performs diagnostic tests. If a software error is detected, this Error Indicator will be triggered.

Return to Cardinal Health for service.

Service Required

If the compressor electrically malfunctions this error will be displayed.

Return to Cardinal Health for service.

User Resettable

The pressure in a garment is greater than 20 mmHg at the end of any vent period.

Check tubing for kink or occlusion. Check garment application (too loose or tight).

E4

Valve Feedback Error E5

Software Error E6

Compressor Error E7

Vent Error E8 A

B

EN-16

Error Code Temperature Error E9

Error Type

Description

Troubleshooting

Manual reset required

If the internal case temperature of the controller is outside temperature limits.

High temperature: Make sure the controller is not covered by bedding and that the fan port, located near the power cord is not obstructed. Low Temperature: Allow the system to warm to room temperature.

Service Required

Safe battery operation of the controller can not be ensured.

Service Technician Only: Replace pack or return to Cardinal Health for service.

User Resettable

Pressure measured in the inflatable garment is below 10 mmHg for 10 consecutive cycles or no garments are detected during startup.

Check for disconnected tube sets or garments and reconnect.

Service Required

The system could not sense a pressure rise of more than 5 mmHg during an inflation cycle or during start up.

Return to Cardinal Health for service.

Recharge Battery

There is less than 15 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.

E9

Battery Error E10

Tubing Disconnect Error E12 A

B

Pressure Transducer Error E13

Low Battery Error

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

Introduction WARNING: Do not service while the device is in use with a patient. The KENDALL SCD 700 series controller contains no user serviceable parts. User maintenance is covered in the sections that follow. All other maintenance/repairs not captured in this IFU must be performed by technically qualified service personnel.

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Service technicians should be familiar with the operator’s portion of this manual and the operating principles of the KENDALL SCD 700 series compression system. If a controller is to be returned to Cardinal Health 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 circuit board level, with views of the controller shown in Figures “14,15, and 16”. 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 Cardinal Health warrants that your KENDALL SCD 700 series 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 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. Obtain a return material authorization number and ship the controller, prepaid and insured in the original carton. UNITED STATES 1-800-964-5227

CANADA 1-800-268-7916

LATIN AMERICA [email protected]

EMEA +353 (1) 5680000

APAC +65 6230 2388

All Others Contact your local sales representative

PUERTO RICO 787-625-4230

Disposal If the controller, tubing assembly and/or garment(s) is to be disposed of, follow the local country regulations taking environmental factors into consideration.

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