Instruction Guide for Cleaning, Testing, and Packaging Kendall SCD
Contents
1. Durable Medical Equipment DME Instruction Guide for COVIDIEN Instruction Guide for Cleaning Testing and Packaging Kendall SCD 700 Sequential Compression System Controller and Tubing Set TABLE OF CONTENTS Section 1 Instructions for UNUSED Units Confirm Kit Materials Apply DME Label to Kendall SCD 700 Controller Packaging Instructions Section 2 Instructions for Customer Returned Units Reference Documents Equipment List Preparation Tubing Set Visual Inspection Cleaning Leak Test Kendall SCD 700 Controller Visual Inspection Cleaning General Function Test Re Packaging Procedure Kit Materials Packaging Instructions Attachment A Instructions for Returning Damaged Controllers N N N NOAOA AOA 10 10 11 11 11 13 Section 1 Instructions for UNUSED Units CONFIRM KIT MATERIALS e Verify that all the following materials are available Part Description Quantity ae l Contact Info New Kendall SCD 700 compression system a H29525 1 800 962 9888 www com E 800 9888 Kendall SCD 700 controller QuickStart Guide n 1066981 1 800 962 9888 www covidien com Kendall SCD 700 controller Printed IFU 1066980 1 800 962 9888 www covidien com APPLY DME LABEL TO KENDALL SCD 700 CONTROLLER e Remove home controller from the packaging and take out of the polybag and AIR PAQ inflatable packaging e Create a label that provides the DME supplier contact informa2. controller Place the controller into the polybag and use a twist tie to secure o Place the Kendall SCD 700 controller in the AIR PAQ inflatable packaging and close the AIR PAQ inflatable packaging o Place the QuickStart Guide on top of the AIR PAQ inflatable packaging as shown a oh Ma o Seal the top of the box and assemble the following labels on the outside of the shipping box as shown below Vv Pre printed shipping label on the front wrapping on the left side v Return label to the right of the shipper label RETURN PRE PRINTED ABEL SHIPPING LABEL 12 ATTACHMENT A Instructions for Returning Damaged Controllers To obtain service on your Covidien Kendall SCD 700 controller you must contact the service department and request a Return Material Authorization Number RMA Please contact the service department by 1 Phone 1 800 962 9888 opt 1 opt 1 2 Email SWM customerservice covidien com 3 CovidienConnect https www covidienconnect com Please have the following available when contacting the service department e Account Bill To e Account Ship To e Device Serial Number e Reason for service return e Contact information for Estimate approval if applicable Name Phone Number amp Email address Repackage the Kendall SCD 700 controller carefully in its original box List the RMA number on the shipping label or exterior of the box Equipment returned without RMA number will
3. ERENCE DOCUMENTS e Kendall SCD 700 system Operation and Service Manual EQUIPMENT LIST e Regulated air source i e compressor or factory air e Tubing set Leak Test Fixture provided by Covidien e Known good tubing set PREPARATION e TUBING SET LEAK TEST FIXTURE SETUP NOTE This is to be performed upon receipt of the fixture to confirm acceptable fixture functionality o Confirm the tubing set Leak Test Fixture s certification from the fixture manufacturer o Confirm pressure gauge is calibrated If not send out for re calibration o Conduct the leak test with the known good tubing set as follows Ensure that the Leak Test Fixture see sketch below is connected to a regulated air source The input air should be at pressure between 3 psi and 4 psi CONNECT TO AIR Connect the tubing set to the connectors on the test fixture See pictures below Section 2 Instructions for Customer Returned Units continued PREPARATION continued e TUBING SET LEAK TEST continued Turn ball valve to open position so that the knob position is in line with valve body see picture below Adjust the input air pressure so that a pressure of between 125mmHg 2 4 psi and 135mmHg 2 6 psi is indicated on the fixture s pressure gauge and allow to hold for approximately 2 seconds Close ball valve so that the knob position is perpendicular to valve body see picture below Activate the stopwatch Wai
4. able If any marks are present that obscure or interfere with the display of the icons or the clear membrane on the control panel send the controller to the Covidien service center for repair Attachment A e Inspect the controller for missing broken or cracked components If any components are missing broken or cracked send the controller to the Covidien service center for repair Attachment A e Inspect the controller for the presence of the serial label on the bottom of the device It the serial label is not present or if it is illegible or damaged send the controller to the Covidien service center for repair Attachment A Section 2 Instructions for Customer Returned Units continued KENDALL SCD 700 CONTROLLER continued CLEANING e Unplug the controller from Mains voltage before cleaning e Clean the customer returned Kendall SCD 700 controller as per the Kendall SCD 700 system Operation and Service Manual GENERAL FUNCTION TEST e With no tubing set connected to the SCD 700 controller connect the controller to AC power Verify that the power source light power on indicator turns on Note Controller must be connected to AC power to enter test mode e See front panel display below Ey covipien KendallSCD 700Series o m Item Explanation Item Explanation 1 Power On Indicator 5 Battery Status Indicators 1 3 2 PowerOn Standby Button 6 Right Arrow Button 3 A Button 7 B Button 4 AC Power Ba
5. not be serviced Mail Device to Covidien 5290 Longbow Drive Building 4 Service Dock Boulder Co 80301 COVIDIEN COVIDIEN with logo and Covidien logo are U S and internationally registered trademarks of Covidien AG Trademark of its respective owner Other brands are trademarks of a Covidien company Covidien llc 15 Hampshire Street Mansfield MA 02048 USA www covidien com 2014 Covidien 14MANO0014 07 14 13
6. stem AIR PAQ inflatable 1031823 1 800 962 9888 packaging www covidien com Polybag for Kendall SCD 700 controller 1033373 1 800 962 9888 www covidien com Polybag for tubing set F123450 1 800 962 9888 www covidien com Twist Ties Blue Plastic Ee F150023 1 800 962 9885 www covidien com Kendall SCD 700 controller QuickStart Guide Ee 1066981 1 800 962 9888 www covidien com Kendall SCD 700 controller Printed IFU po 1066980 1 800 962 9888 www covidien com PACKAGING INSTRUCTIONS o Using regulated air source set at 9 10 psi of pressure inflate the AIR PAQ inflatable packaging If an air source is not available to inflate AIR PAQ inflatable packaging you should not ship the device Hand delivery of the kit is recommended in this situation o Tape the bottom surface of the shipping box o Place the Chip Board in the box on the bottom surface Place the Printed IFU in the shipping box on top of the Chip Board o Place the AIR PAQ inflatable packaging into the shipping box on top of the printed IFU Place a tubing set on either side of the AIR PAQ inflatable packaging as shown below AIR PAQ INFLATABLE TUBING SET eens TUBING SET 11 Section 2 Instructions for Customer Returned Units continued KENDALL SCD 700 CONTROLLER continued RE PACKAGING PROCEDURE continued PACKAGING INSTRUCTIONS continued o Verify that the DME supplier contact information label is on the Kendall SCD 700
7. t 15 seconds and observe the pressure gauge Because the test was conducted with known good tubing set the pressure should not fall below 89mmHg 1 72 psi If pressure falls below 89mmHg contact your sales rep for replacement tubing set Leak Test Fixture Section 2 Instructions for Customer Returned Units continued TUBING SET VISUAL INSPECTION e Inspect the tubing sets for missing broken or cracked components If any components are missing broken or cracked discard the tubing set e Inspect the tubing set for condensation in the tubing If condensation is present in the tubing discard the tubing set e Inspect the printing on the tubing set connectors If any connectors contain incomplete characters discard the tubing set CLEANING e Clean the customer returned tube set as per the Kendall SCD 700 system Operation and Service Manual e All visible extraneous markings or materials should be removed by the cleaning step If extraneous markings or materials are not removed discard the tubing set LEAK TEST e Inspect the Leak Test Fixture to ensure that it is in working order and that the pressure gauge has a valid calibration date e Ensure that the Leak Test Fixture is connected to a regulated air source The input air should be at pressure between 3 psi and 4 psi See sketch below CONNECT TO AIR Section 2 Instructions for Customer Returned Units continued TUBING SET continued LEAK TEST con
8. tinued e Turn ball valve to open position so that the knob position is in line with valve body see picture below e Adjust the input air pressure so that a pressure of between 125mmbHg 2 4 psi and 135mmHg 2 6 psi is indicated on the fixture s pressure gauge and allow to hold for approximately 2 seconds e Close ball valve so that the knob position is perpendicular to valve body see picture below Activate the stopwatch G i e Wait 15 seconds and observe pressure gauge Pressure should not fall below 89mmHg 1 72 psi If pressure falls below 89mmHg the tubing set has a leak Discard the tubing set NOTE If tubing set inspection and cleaning is not completed as per the steps above discard the tubing sets and provide new tubing sets in the package Section 2 Instructions for Customer Returned Units continued KENDALL SCD 700 SYSTEM CONTROLLER VISUAL INSPECTION e Inspect the DME supplier contact information label If the DME supplier contact information label is torn ripped or illegible replace with a new label see sketch below PLACE LABEL WITHIN THE BOXED AREA e Inspect the power cord for damage If power cord is frayed or damaged send the controller to the Covidien service center for repair Reference Attachment A e Inspect the controller for marks scuffs and scratches especially on the control panel see below CONTROL PANEL e Minor surface scratches or scuffs are accept
9. tion At a minimum the information should contain the following Company name Company address Company telephone number e Apply DME supplier contact information label on the front of the controller approximately centered in the area indicated by the box in the sketch below on the front of the controller below the control panel PLACE LABEL WITHIN THE BOXED AREA e Place home controller back into the polybag and AIR PAQ inflatable packaging e Place the printed IFU into the shipping box Section 1 Instructions for UNUSED Units continued PACKAGING INSTRUCTIONS e Re package the home controller in the polybag and AIR PAQ inflatable packaging Place the tubing sets into the original package the way it was received see picture below AIR PAQ INFLATABLE PACKAGING TUBING SET TUBING SET e Place the QuickStart Guide on top of the AIR PAQ inflatable packaging as shown below kl Section 1 Instructions for UNUSED Units continued PACKAGING INSTRUCTIONS continued e Seal the top of the box and confirm all labels are visible on the outside of the shipping box as shown below o Serial label on the top of the shipping box o Shipping label on the front wrapping on the left side o Return label to the right of the shipper label and beneath the serial label SERIAL LABEL SHIPPING LABEL RETURN LABEL Section 2 Instructions for Customer Returned Units REF
10. ttery Charging Indicator e Enter Test Access Mode and conduct the general function test test mode T2 as per the Kendall SCD 700 system Operation and Service Manual e Verify battery status o Turn off the controller o Disconnect the controller from AC Power and activate again o Confirm that battery charge level is at least 2 3 i e 2 or 3 green battery status indicators o If battery charge level is less than 2 3 connect the controller to AC power and leave connected to AC power until battery reaches at least 2 3 level e f operation of the SCD 700 controller is not correct as per the above tests send the controller to the Covidien service center for repair Attachment A 10 Section 2 Instructions for Customer Returned Units continued KENDALL SCD 700 CONTROLLER continued RE PACKAGING PROCEDURE KIT MATERIALS o Verify that all materials are available referencing the batch record o List of materials required to re package the kit is as follows Part Description Quantity ee ee Contactinfo Info Kendall SCD 700 system corrugate case po 1029053 oe Robey cages www covidien com Kendall SCD 700 system tubing sets for 9508 1 800 962 9888 replacements www covidien com Kendall SCD 700 system hospital DME shipping 1077455 aidien 1 800 962 9888 label www covidien com N A N Chip Board AIR PAQ Protector 1059428 1 800 962 9888 www covidien com TM Kendall SCD 700 sy
Download Pdf Manuals
Related Search