SCD 700 Operation and Service Manual Nov 2010

TABLE OF CONTENTS Section VI - General Disassembly / Reassembly ...EN-19 Battery Pack (Removal / Installation - see Figure 6) . ... EN-19 Compressor (Removal / Installation - see Figure 8) . ... EN-19 Muffler (Removal / Installation) ... EN-19 Valve Manifold (Removal / Installation) ... EN-19 Power Supply Board (Removal / Installation) . ... EN-20 Fan and Fan Filter (Removal / Installation - see Figure 6) ... EN-20 Main CPU Board and Graphical Display (Removal/Installation - see Figure 6) . ... EN-20 Adjustable Bed Hook (Removal/Installation)... EN-20 Section VII - Parts Listing...EN-21 Section VIII - Specifications...EN-22 Section IX - Schematics ...EN-25 Figure 6 - Parts Assembly Diagram – Exploded view (Page 1 of 2) ... EN-25 Figure 6 - Parts Assembly Diagram (front enclosure)– Exploded view (Page 2 of 2)... EN-26 Figure 7 - Pneumatic & Electrical Schematic... EN-27 Figure 8 - Rear Enclosure View... EN-28 Figure 9 - Front Enclosure View... EN-29

Kendall SCD 700 Series

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 has reached set pressure, 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 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. Circulation enhancement. 2. Deep vein thrombosis prophylaxis. 3. Edema - Acute. 4. Edema - Chronic.

5. Extremity pain incident to trauma or surgery. 6. Leg Ulcers. 7. Venous stasis / venous insufficiency.

If you need further information regarding the Kendall SCD 700 Series Compression System or its clinical benefits, please contact your Covidien 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.

EN-1

Kendall SCD 700 Series

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. Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. 4. Do not operate the controller if the power cord is damaged. WARNING: Do not attempt to repair or replace broken tubing connectors as hazardous inflation of the sleeves may occur.

Kendall SCD 700 Series Explanation of Symbols Used Caution, consult accompanying documents

Controller Serial Number

Type BF Protection Against Electronic Shock

Reorder number for the device located on the carton label

Manufacturing Date Code

Equipotential ground point

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

CE Mark

0123

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

Kendall SCD 700 Series

EN-2

Front Panel Display 1

4

2

5

6 3

7

Item Explanation

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. If required, 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 Bed Foot cover and below the tube set connection points. Board • 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, 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.

EN-3

Kendall SCD 700 Series

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 LED’s 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 LED’s, display screen and the audible alarm 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). 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 or 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 Userselected garment (or the default) configuration, then a Garment Mismatch alarm 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

Kendall SCD 700 Series

EN-4

• 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 E13 alarm. 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 restarting.

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 Covidien’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 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.

EN-5

Kendall SCD 700 Series

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

Express Sleeves

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

Express Tear-Away Sleeves

9529 Knee Length 9530 Thigh Length 9545 Thigh Length 9736 Thigh Length 9780 Thigh Length 9789 Knee Length 9790 Knee Length 73011 Thigh Length 73012 Thigh Length 73013 Thigh Length 73022 Knee Length 73023 Knee Length

9530T 9545T 9780T 73041 73043 73042

Medium Medium Small Medium (sterile) Large Large X-Large Small Medium Large Medium Large

Thigh Length Medium Thigh Length Small Thigh Length Large Thigh Length Small Thigh Length Large Thigh Length Medium

Express Foot Cuff 5897 Regular 5898 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.

Kendall SCD 700 Series

EN-6

Section II - 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 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. The battery Indicator shown below is located in the upper right hand corner of the user interface. See FIGURE 3. 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. FIGURE 3

1

2

3

Battery Status Indicators

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)

EN-7

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

Kendall SCD 700 Series

Unit Powered Off (charging when plugged in) Battery State

Battery Status 1

Battery Status 2

Battery Status 3

0 -100% charge

Off

Off

Off

With 15-40 minutes of battery charge left, an alarm will sound in a sequence of three beeps once every two minutes. Once there is less than 15 minutes of battery charge left, the alarm will sound continuously and the dead battery icon will display as shown in FIGURE 4. FIGURE 4

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. • Charge only with specified chargers according to Covidien’s instructions.

Kendall SCD 700 Series

EN-8

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), displays a fault code, and sounds an audible alarm. If a Garment Mismatch alarm is triggered the user may remedy the problem by pressing the corresponding A and B Button(s). Some alarms 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 alarm and remedies the problem. Alarm Types:

Description

Service Required

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

Manual Reset Required

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

User Resettable

EN-9

This type of alarm 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 alarm, a check mark will be shown indicating what port is the area of concern. A yellow triangle indicates a low concern alarm. If the triangle is red it is indicative of an alarm related to a pressure that is high in an abnormal way. If the alarm persists, then the controller requires service.

Example E5

E1 A

B

E3 A

B

Kendall SCD 700 Series

Alarm Codes Alarm Code

Alarm Type

Garment Mismatch Error A

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.

User Resettable

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

Check for a loose leg sleeve and adjust fit appropriately. Also check for leaks in the sleeve or the tube connections

User Resettable

Foot Cuff pressure is less than 125 mmHg after 5 consecutive cycles.

Check for a loose foot cuff and adjust fit appropriately. Also check for leaks in the cuff or the tube connections

B

System High Pressure Alarm E1 A

B

High Pressure (Leg Sleeves) E2 A

B

High Pressure (Foot Cuffs) E2 A

B

Low Pressure (Leg Sleeves) E3 A

B

Low Pressure (Foot Cuffs) E3 A

Kendall SCD 700 Series

B

EN-10

Alarm Code

Alarm Type

Low Pressure (Leg Sleeves)

Description

Troubleshooting

User Resettable

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

Check garment application for proper fit. Check for patient interference with the garments, like pressing the foot against the foot board.

User Resettable

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

Check garment application for proper fit. Check for patient interference with the garments, like pressing the foot against the foot board.

Service Required

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

Service Technician only: Verify that the valve assembly wires are properly connected and confirm solenoid actuation.

Service Required

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

Return to Covidien for service

Service Required

If the compressor electrically malfunctions this error will be displayed.

Service Technician only: Verify that the compressor wires are properly connected.

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 A

B

Low Pressure (Foot Cuffs) E4 A

B

Valve Feedback Alarm E5

Software Error E6

Compressor Alarm E7

Vent Alarm E8 A

EN-11

B

Service Technician only: Check for kinked internal tubing.

Kendall SCD 700 Series

Alarm Code

Alarm Type

Temperature Alarm E9

Description

Troubleshooting

Manual reset required

If the internal case temperature of the Controller drops below 5°C (41°F) or exceeds 55°C (131°F).

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: Ensure that an unauthorized battery pack replacement has not been made. Replace pack or return to Covidien 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.

Service Technician Only: Check the transducer tube inside the controller and ensure it is neither kinked or disconnected.

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 Alarm E10

Tubing Disconnect Alarm E12 A

B

Pressure Transducer Alarm E13

Low Battery Alarm

Kendall SCD 700 Series

EN-12

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

Introduction The Kendall SCD 700 Series Controller contains no user serviceable parts. User maintenance is covered in the sections that follow. All other maintenance must be performed by technically qualified service personnel. 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 Covidien 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 an exploded view of the Controller shown in Figure7. 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 Covidien 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. CANADA Covidien Canada 7500 Trans Canada Highway Pointe-Claire, Qc H9R 5H8 877-664-TYCO (8926)

UNITED STATES Covidien 5920 Longbow Drive Boulder CO 80301 1- (800) 255-8522

OUTSIDE U.S. AND CANADA Covidien Service Centre Unit 2 Talisman Business Centre London Road Bicester, England OX26 6HR (+44)1869328065

Service Precautions: • Always unplug the controller from Mains voltage before servicing the controller. • Use proper techniques such as grounding straps and pads to protect printed circuit board assemblies from ESD (Electrostatic Discharge)

EN-13

Kendall SCD 700 Series

Fan Filter and Ventilation CAUTION: Unplug the Controller before accessing the fan filter. The fan filter must be kept clean to ensure continued trouble-free operation. The Controller should never be run without the fan filter in place. Clean or replace the filter when required . See instructions in the General Disassembly/ Reassembly Section. 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 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. Electrical Safety CAUTION: Be sure the Controller is disconnected from the AC power source 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. To facilitate electrical safety testing, the controller has an equipotential lug, located on the back of the device opposite the power cord. There are no other grounded exposed metal parts. Power cord 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.

Suggested Preventative Maintenance Schedule Proposed Maintenance

After Any Repair Once Per Year

Inspect and Clean Fan Filter

X

As Required

Verify Transducer Calibration (Test Modes T3 and T4)

X

X

Electrical Safety Tests

X

X

General Function Test (Test Mode T2)

X

Alarm History The Kendall SCD 700 Series Compression System stores the ten most recent alarm codes for use in troubleshooting devices returned from use. There is a test access mode, discussed later in this manual that describes exactly how to use the feature.

Cleaning CONTROLLER CLEANING The Controller enclosure can be cleaned with a soft cloth dampened with water or a mild detergent. To sanitize the device, apply cleaning agents with a cloth or wipe. Avoid excessive spraying, especially in the areas of the connection ports on the back of the device. If any liquid enters the ports, then internal component damage will likely result. The table at right provides optional cleaners and their chemical components.

Kendall SCD 700 Series

700 SERIES CONTROLLER CLEANERS Chemical component (with approximate concentrations)

Commercial Example

0.5% bleach solution

Dispatch™*

70% Isopropanol alcohol

Generic

0.37% o-Phenylophenol

Precise™*

0.15% dimethyl benzyl Ammonium Chloride, 0.15% dimethyl ethylbenzyl Ammonium Chloride

Spray Nine™*

7.35% Hydrogen Peroxide, .023% Peracetic Acid

Sporgon™*

3.4% Glutaraldehyde

Cidex™*

Dodecylbenzene Sulfonate, Coconut Diethanolamide diluted per instructions

Manu-klenz™*

EN-14

The SCD 700 Series Compression System cannot be effectively sterilized by liquid immersion, autoclaving, or ETO sterilization, as irreparable damage to the System will occur. TUBE SET CLEANING The tube sets can be cleaned with a soft cloth dampened with water or a mild detergent. Do not immerse. The table at right provides optional cleaners and their chemical components.

Chemical component (with approximate concentrations)

Commercial Example

0.5% bleach solution

Dispatch™*

70% Isopropanol alcohol

Generic

Electrical/Electronics Description

7.35% Hydrogen Peroxide, .023% Peracetic Acid

Sporgon™*

TUBE SET CLEANERS

Manu-klenz™* Line voltage is fed into the controller through the power cord to the power supply mounted 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 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. Covidien 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. Dodecylbenzene Sulfonate, Coconut Diethanolamide diluted per instructions

Pneumatic Operation Description When the controller is turned on, the compressor operates and the valves are cycled to verify the garment type selected by the user. After garment selection and verification 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.

Section V - Test Methods and Calibration The Kendall SCD 700 Series 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 T2 T3 T4 T5 T6 T7 follow these steps for entering “Test Access Mode”. FIGURE 5 shows the user interface features used in Test Access Mode. • Plug the controller into an outlet supplying the appropriate line voltage. Do not activate the test modes while operating on battery power. FIGURE 5 • Press the B Button at the same time while turning the controller on. Hold thet B button for a moment until test mode access can be confirmed visually • The buzzer will beep and T1 will be underscored and will illuminate signifying “Test Mode T1”. • The user can cycle through the test modes by pressing the Right Arrow button. Each test mode is indicated by the slider under the corresponding test modeand the selected test mode is shown at the bottom of the screen for clarity. Pressing the Right Arrow Button with the last test mode number illuminated alarm history will cycle the test mode back to Test Mode T1.

T5

EN-15

Kendall SCD 700 Series

• After selecting the desired test mode, the B Button can be pressed to initiate the test. • If test access is entered but no test mode is selected within 2 minutes, it is assumed that the test access mode was entered inadvertently and a Low Pressure alarm will be triggered. • If a test mode is entered and left idle for 5 minutes the unit will revert back to test access mode selection. • To exit Test Access Mode, turn the controller off.

Test Mode Look up Chart T1 – Burn-In Feature T2 – General Function Test T3 – Pressure Transducer Calibration T4 – Pressure Transducer Calibration Verification T5 – Self Test T6 – Performance Test T7 – Manufacturing Test Alarm History Mode

Test Mode T1 - Burn-In Note: Burn-In mode is used in manufacturing to ensure proper assembly, to identify premature failures. This mode is not generally used outside of the manufacturing environment. • Verify nothing is plugged into the ports on the back of the controller and enter test access mode. Select Test Access Mode 01. • Press the B Button 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). • The battery will be discharged then charged to approximately 70% charge level. • When 16 hours of Burn-In is completed the controller will go into alarm mode, blinking Test Access Mode T1. The buzzer will not pip during this alarm.

Test Mode T2 - General Function Test • With nothing plugged into the ports on the back of the controller, enter test access mode. Select Test Access Mode T2. • Press the B Button to begin the test. • Pressing the A Button during this test will cause each one of the LED’s to illuminate one at a time in succession and the alarm to pip. • Pressing and holding the B Button will increase the pump speed to its maximum in 4-5 seconds. • Releasing the B Button will allow the pump to decrease its speed. • The valves will actuate in succession (valve #1 through valve #6) for two seconds each.

Test Mode T3 - Pressure Transducer Calibration Note: The transducer used in the Kendall SCD 700 Series 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 T4 before test T3 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. • With nothing plugged into the ports on the back of the controller, enter test access mode. Select Test Access Mode 03. • Press the B Button to begin the test. • The T3 will blink on the display screen until the calibration procedure is completed or an error condition occurs. • 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 Kendall SCD 700 Series

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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 left-most fitting within Port A (as viewed from the back of the Controller). • The controller will prompt the user to apply the pressure to the controller by displaying the required pressure on the screen. Once the applied pressure is confirmed and stable, the B Button is pressed to proceed to the next pressure. The controller requires a multipoint calibration at 0, 18, 45 and 130 mmHg. • It is required that the pressure source be accurate to +/- 0.1 mmHg and that it is stable. • The controller will start calibration by displaying “0 mmHg”. Each time the B Button is pressed the display will advance to the next pressure in succession. After the last calibration step, press B again to reenter Test Access Mode. • Upon completion, the new calibration values are recorded into memory and the unit beeps and reverts back to Test Access Mode. • If the calibration test mode is exited before the process is completed, the previous calibration values remain unchanged. • If a pressure outside of an expected range is sensed during any of the calibration steps an alarm will be activated.

Test Mode T4 - Pressure Transducer Calibration Verification Note: The transducer used in the Kendall SCD 700 Series 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 T4 before test T3 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. • With nothing plugged into the ports on the back of the controller, enter test access mode. Select Test Access Mode T4. • Press the B Button to begin the test. • The T4 will blink on the display screen until the calibration verification procedure is completed or an error condition occurs. • 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). • The controller will prompt the user to apply the pressure to the controller by displaying the required pressure on the screen. Once the applied pressure is confirmed and stable, the B Button is pressed to proceed to the next pressure. The controller requires a multipoint calibration at 0, 18, 45 and 130 mmHg. • It is required that the pressure source be accurate to +/- 0.1 mmHg and that it is stable. • The controller will start calibration verification by displaying “0 mmHg”. Each time the B Button is pressed the display will advance to the next pressure in succession. After the last step, press B again to reenter Test Access Mode. • For each of the calibration verification steps, the target pressure will be shown on the screen. If the system reads pressure applied to the controller outside the correct range, then the pressure value will be shown in red with either a less than symbol “<” or greater than “>” symbol to indicate the direction of the error. If the pressure read is within the calibration range, then the target value will be shown in green • Calibration Verification mode does not change calibration values.

Test Mode T5 - Self Test • Enter Test Access Mode and select Test Access Mode 05. • Press the B Button to begin the self test. • The T5 will blink on the display screen until the test is completed. • The alarm will pip and the unit will perform the full array of tests performed during Start-up.

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Kendall SCD 700 Series

Test Mode T6 - 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 s. 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 to verify system performance. • Attach a tubing set connected to leg sleeves wrapped around appropriately sized leg forms. • Enter Test Access Mode and select Test Access Mode T6. • Press the B Button to begin the Performance Test. • The T6 will blink on the display screen until the test is completed. • After initiating the performance test, the A Leg icon will flash in sync with an audible alarm. • After the B Button is pressed the A Leg icon will stop flashing, the alarm will stop, and the controller will then go through a normal inflation cycle on port A with the pump operating at a low speed throughout the cycle. • Next, the B Leg icon will flash green in sync with an audible alarm. • After the B Button is pressed, the B Leg icon will stop flashing, the alarm will stop, and the controller will then go through a normal inflation cycle at B with the pump operating at a high speed throughout the cycle. • Upon completion the unit beeps and reverts back to Test Access Mode.

Test Mode T7 - Manufacturing Test Manufacturing Test mode is used in manufacturing with specialized test equipment to ensure proper assembly and performance. This mode is not intended for use outside of the manufacturing environment.

Test Mode – Alarm History Alarm History test mode allows the user to access the recent alarm history of a device. It stores the ten most recent alarms in reverse chronological order. This feature makes diagnosing device problems easy. To view the Alarm History, enter test access mode and select the Alarm History icon after T7. The Alarm History is shown starting with the most recent alarm numbered 1. The alarm icon associated with the alarm will be displayed. Each time the Right Arrow Button is pressed the display will show the next alarm in the reverse chronological order up to 10 alarms Pressing the button again after the 10th alarm will return the user to the first alarm. If the A or B Button is pressed the controller will return to Test Access Mode.

Kendall SCD 700 Series

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