Service Manual
374 Pages
Preview
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*smith&nephew RENASYS™ GO Negative Pressure Wound Therapy
300ml 200ml 100ml 50ml
Service Manual REF 66801244 and 66801496
EN
RENASYS GO Service Manual REF 66801244 and 668001496
Table of Contents Purpose
4
Service and maintenance performed annually 12
Scope
4
• Electrical safety check
12
Responsibilities
4
• Device pressure check
13
Training
4
Preparation for return to clinical use
13
Equipment and materials required
4
Service and maintenance sample checklist
15
RENASYS GO features
5
Repair and returning device
19
Service and maintenance performed after each patient use
6
Limited warranty
19
• Device cleaning and single-use component removal
Global customer assistance
20
6
Replacement parts and accessories
22
• Single-use component replacement
7
Glossary of symbols
23
• Device physical appearance check
7
Specifications
24
• Functionality check
8
Electromagnetic compatibility
26
• Alarm indicator check
10
Purpose
6. RENASYS inlet O-ring (REF 66800603)
This service manual is to provide guidance on regular service and maintenance checks to be conducted by trained personnel on RENASYS™ GO devices (REF 66801244, 66801496).
7. RENASYS odor filter replacement (REF 66800061) 8. Plastic O-ring removal tool [e.g., Perlast O-ring
removal tool Manufactured by Precision Polymer Engineering (www.prepol.com/product-range/ product-subpages/o-ring-removal-tool)].
Note: Service and maintenance checks intended at a facility level do not require opening the device. Opening or attempting to open the device housing will void all warranties and render the user responsible for all subsequent liabilities associated with the device. Contact your local Smith & Nephew global customer assistance or sales representative to resolve device issues.
9. Plastic tweezers (odor filter removal tool) 10. Suction cup (optional) 11. Electrical safety analyzer capable of performing tests according to IEC 62353 (e.g., Rigel® 288 Hand-Held Safety Analyzer, Fluke® ESA615 or equivalent)
Scope
12. Calibrated pressure gauge with minimum range of
This service manual is only applicable to RENASYS GO devices (REF 66801244, 66801496) manufactured by Smith & Nephew.
up to 250 mmHg vacuum (e.g., Extech® HD750, 406800 or 407910, Digitron® 2000P series, Dwyer® Series 475 or equivalent)
Responsibilities
13. Protective gloves and eye protection
recommended, consult cleaning agent SDS
It is the responsibility of the facility that owns the device to perform regular service and maintenance checks of medical equipment to verify basic device safety and function prior to any re-use or after prolonged storage of more than 6 months. The retention of any device service and maintenance records is the responsibility of the party performing the procedure. A sample checklist is provided within this manual to provide guidance on documenting the recommended service and maintenance checks; however, this should be managed at the discretion of each facility.
14. Cotton swabs (e.g., Q-tips®) 15. Disposable paper towels or cloth 16. Stopwatch 17. #1 Pozidriv® screwdriver 18. Vented hood, or local SOP guidelines for handling bio hazardous materials
Cleaning materials: The choice of suitable cleaning material will depend upon facility protocols and local ordinances in addition to availability of particular brands in your location.
Training It is recommended that individuals performing service and maintenance on the RENASYS GO device be trained professionals familiar with regular service and maintenance of medical equipment and use of test equipment required.
The following are recommended options:
1. Alcohol based disinfectant solutions or wipes.
These may be ethanol or isopropyl alcohol (IPA) based, and are most effective if the alcohol concentration is 70%.
Equipment and materials required The following equipment is recommended to support service and maintenance of the RENASYS GO device. Availability and usage is done at the discretion of each facility.
2. Chlorine based disinfectants up to a maximum of
1,000 ppm available chlorine. Always rinse and dry thoroughly after using this type of disinfectant (e.g., Chlor-Clean®, Actichlor® Plus, Klorsept®, BioSpot®, Sani-chlor®).
1. RENASYS power cord (REF country dependent) 2. RENASYS power supply (REF country dependent)
3. Specifically formulated disinfectants for medical devices with broad spectrum activity (e.g., Trionic® D).
3. RENASYS GO canister (REF 66800914, 66800916, 66800165, 66800695)
4. RENASYS quick click adaptor [REF 66801259
included with RENASYS drain kits (REF 66801251,66801252, 66801253, 66801254, 66801255, 66801256, 66801257, 66801258)]
5. RENASYS Y-connector (REF 66800971, 66800504) 4
RENASYS™ GO features Front view
Status/alarm indicator Power button
Display screen
Battery status indicator Start/pause therapy and select
Up and down selectors
O-ring Rear view
Inlet port
Keypad lock
Audio pause
Rubber feet 300ml 200ml 100ml
Odor filter door
50ml
Specification badge
Left side view
Rubber feet
Right side view
Carry strap pins
Air exhaust port
5
AC mains power inlet
6. Remove Pozidriv® screw holding the rear flap and
Service and maintenance performed after each patient use Device cleaning and single-use component removal
open the flap to reveal odor filters.
Note: A suction cup may be used to aid in opening door.
Recommended personnel: Device cleaning and single-use component removal should be performed by a trained technician. Equipment and materials required: Gloves, eye protection, germicidal/antibacterial treated disposable wipes, cotton swab, dry disposable cloth, plastic O-ring removal tool, #1 Pozidriv® screw driver, suction cup (optional), plastic tweezers.
Suction cup
7. Remove the 2 odor filter elements, close odor filter
Precautions:
flap, and replace screw. Tighten only until door is flush with case. Note: Do not replace odor filters at this current step.
Use of gloves, eye protection or other personal and environmental protections is recommended. Party conducting any cleaning should consult the cleaning agent SDS and their facility or local operating procedures for handling biohazards for specific requirements. Device should not be connected to AC mains power while being cleaned with mode of operation in “OFF” setting.
1. Place device and all associated items in appropriate service setting for handling biohazardous material. This includes all items that may be associated with use of the device inclusive of power supply and power cord.
Precaution: TAKE CARE NOT TO OVERTIGHTEN SCREW!
8. Dispose of used O-ring and odor filters in
accordance with facility protocols and/or local ordinances for disposal of potentially infected or bio-hazardous materials.
2. Place all single-use accessories (canister, carrybag, carry strap) in plastic bag and dispose of in accordance with facility protocols and/or local ordinances for disposal of potentially infected or bio-hazardous materials.
9. Apply germicidal/antibacterial product to a cotton swab and clean inlet port and air exhaust port.
3. Ensure inlet port and air exhaust port are free of obstructions, dust or foreign materials.
4. To remove the device inlet port O-ring, the existing
O-ring must be carefully removed using a plastic removal tool, ensuring that the inlet connector is not damaged during removal.
10. Clean all external surfaces of device, power cord
Note: Do not replace O-ring at this current step.
and power supply with one of the recommended antimicrobial disposable wipes. Pay close attention to areas where canister connects to device.
Note: Do not immerse any part of device in fluid, directly spray cleanser onto device or use a wet cloth that is dripping fluid. No fluids should be allowed to enter device. If any liquids penetrate device, contact your local distributor.
5. Place device face down on soft surface.
11. If device surface appears wet, dry all surfaces with disposable towel or cloth.
12. Dispose of cleaning materials in accordance with
facility protocols or local ordinances for disposal of potentially infected or bio-hazardous materials.
6
Single-use component replacement
Device physical appearance check
Recommended personnel: Single-use component replacement should be performed by a trained technician.
Recommended personnel: Device physical appearance check should be performed by a trained technician.
Equipment and materials required: RENASYS™ inlet O-ring, #1 Pozidriv® screw driver, suction cup (optional), plastic tweezers, 2 RENASYS odor filter replacements.
1. Confirm device is unplugged from AC mains power
Inlet O-ring (REF 66800603) Precaution: Do not lubricate O-ring
3. Confirm buttons and indicator lights below display
and placed on a flat surface.
2. Visually assess device for damage, cracks or missing pieces.
screen and display screen itself is undamaged.
4. Confirm inlet port is undamaged.
1. To ensure the canister seal is secure, the device inlet port O-ring should be replaced after each patient use.
2. Clean the device inlet port and carefully slide new
inlet port O-ring onto device inlet port; checking that any rolling of the O-ring is corrected once it is located in the groove of the inlet port.
5. Confirm AC mains power inlet is undamaged.
Odor filter (REF 66800061)
1. To minimize unpleasant odors from RENASYS GO devices, it is recommended that the device odor filters be replaced between each patient use.
2. Turn the device over and lay it on a soft surface to avoid damage.
3. Remove Pozidriv® screw holding the rear flap and
6. Visually confirm carry strap pins on each side of
open to reveal the odor filter space.
device are present and secure.
4. Insert 2 new odor filter elements.
7. Visually inspect entire length of power cord for any fraying, missing insulation, loose or missing plug blades or earth/ground.
5. Close the door flap and insert screw, tightening only until door flap is flush with case.
8. Visually inspect entire length of power supply cord
Precaution: TAKE CARE NOT TO OVERTIGHTEN SCREW!
for any fraying or missing insulation, and plug to confirm it is not bent, loose or missing.
9. Rotate device 360° in vertical and horizontal planes. Confirm device does not have loose components.
10. Inspect rear of device and confirm device specification
badge is present and REF and SN numbers are clearly visible. Reference number (REF) Serial number (SN)
11. Confirm power supply front and rear labels are clearly visible.
7
Functionality check
Modes of operation check
Recommended personnel: Functionality checks should be performed by a trained technician.
1. Attach canister to device and engage orange
Equipment required: RENASYS™ power cord, RENASYS power supply, RENASYS quick click adaptor, RENASYS GO canister.
2. Connect canister quick click connector to quick
canister clips. Ensure canister viewing window is facing forward. click adaptor and engage tethered cap into open connector of quick click adaptor.
Operations check 1. Connect power supply to AC mains power inlet on device. Connect power cord to power supply and to AC mains power.
2. Verify all indicator lights and status/alarm indicator flash briefly as AC mains power is connected.
Continuous mode:
3. Verify battery indicator light flashes green, or
1. Adjust therapy set-point to 80 mmHg using UP
illuminates solid green if battery is fully charged.
and DOWN buttons, press SELECT button to start device. Verify device starts operating, status/alarm indicator illuminates solid green and screen displays “Continuous” and therapy set-point.
4. Press and hold POWER button for 2 seconds to turn
on device. Verify display screen shows “Welcome, Starting”, current software version (e.g., V 1.06), and changes to show “Standby” and therapy set-point. Record software version on record sheet.
2. Press SELECT button to stop device operation. Verify device stops operating, status/alarm indicator is no longer illuminated, and screen displays “Standby” and therapy set-point.
Language check To change language selection:
1. Press and hold POWER button for 2 seconds to turn device off.
2. Simultaneously press and hold UP, SELECT and POWER buttons for 2 seconds.
3. Language can now be selected using UP and DOWN buttons to scroll to desired language followed by SELECT button.
4. Screen will display “Welcome, Starting”, current
software version (e.g. V 1.06), and change to show “Standby” and therapy set-point.
Note: The language should be set back to original language upon device receipt once checks are completed.
8
Intermittent mode
Keypad lock check
1. Press and hold POWER button for 2 seconds to turn
1. Press SELECT button to start device with set-point
at 80 mmHg. Verify device starts operating, status/ alarm indicator illuminates solid green, and screen displays “Continuous” and therapy set-point.
off device.
2. Simultaneously press and hold DOWN, SELECT and POWER buttons for 2 seconds. Screen will display “Continuous” and “Intermittent” on two lines.
2. Press and hold KEYPAD LOCK button for 2 seconds. Verify indicator light above button illuminates solid blue, screen displays “Keypad Locked”, and changes to “Continuous” and therapy set-point.
3. Press SELECT button to attempt to stop device.
Verify device does not stop operating and screen displays “Keypad Locked”.
3. Use DOWN button to scroll to “Intermittent”.
4. Press and hold KEYPAD LOCK button for 2 seconds.
4. Press SELECT button to confirm selection. Screen
Verify indicator light above button is no longer illuminated and the screen displays “Keypad Active”.
will display “Welcome, Starting”, current software version (e.g., V 1.06), and change to display “Standby” and therapy set-point.
5. Set stopwatch to zero. 6. Adjust therapy set-point to 80 mmHg using UP and
DOWN buttons. Press SELECT button to start device and simultaneously start stopwatch.
7. Verify device operates, status/alarm indicator illuminates solid green, screen displays “Intermittent” and therapy set-point.
5. Press SELECT button to stop device.
8. Verify device operates for 5 minutes ± 30 seconds and then stops operating.
9. Once device stops, reset stopwatch to zero and
start stopwatch. Verify device does not operate for 2 minutes ± 30 seconds, status/alarm indicator remains illuminated solid green, and screen displays “Intermittent” and “--- mmHg”.
10. Press SELECT to stop device. Verify device stops operating, status/alarm indicator is no longer illuminated, and screen displays “Standby” and therapy set-point.
11. Pause stopwatch and return device to “Continuous” mode.
9
Alarm indicator check
Homecare lock check (REF 66801496 only)
1. Press SELECT button to start device. 2. Simultaneously press and hold KEYPAD LOCK and
Recommended personnel: Alarm indicator checks should be performed by a trained technician.
AUDIO PAUSE button for 5 seconds.
Equipment required: Stopwatch, RENASYS™ GO canister.
3. Verify indicator light above KEYPAD LOCK button
Complete blockage/canister over-capacity alarm and audio pause button check
illuminates solid blue, screen displays “Keypad Locked”, “Continuous” on the upper line and the set-point followed by “***” on lower line.
Note: Alarms can be tested on either battery or AC mains power. If testing on internal battery power, ensure internal battery charge is sufficient. See the RENASYS GO user manual for details.
4. Press SELECT button to stop device. Verify device
does not stop and screen displays “Keypad Locked”.
5. Press UP and DOWN buttons in attempt to change
1. Disconnect quick click adaptor from canister quick
therapy. Verify device does not change and screen displays “Keypad Locked”.
click connector and insert tethered cap into canister tubing.
6. Press and hold POWER for 2 seconds to turn device
2. Reset stopwatch to zero. 3. Adjust therapy set-point to 100 mmHg using UP and
off.
7. Press and hold POWER for 2 seconds to turn device
DOWN buttons and press SELECT button to start device. Start stopwatch.
on. Verify device turns on, starts operating, and displays therapy set-point followed by “***” on lower line.
Attention: If device runs continuously at any time during test (as determined by a quiet “putt-putt” sound), seal of test equipment is inadequate and test will provide an inaccurate result (alarm will not activate).
8. Simultaneously press and hold the KEYPAD
LOCK and AUDIO PAUSE for 5 seconds to remove homecare lock. Verify indicator light above KEYPAD LOCK is no longer illuminated and screen displays “Keypad Active”.
Solution: Check canister for signs of cracks, check O-ring for damage and ensure tethered cap is fully inserted into canister tubing quick click connector.
9. Press SELECT to stop device. Press and hold POWER for 2 seconds to turn device off.
4. Verify within 5 minutes the screen displays
Battery function check
“!! WARNING !! BLOCKAGE/FULL”, status/alarm indicator illuminates solid yellow, and audible alarm beeps 2 times every 20 seconds.
1. Disconnect power supply from device and power cord from AC mains power.
2. Press and hold POWER button for 2 seconds to
turn device on. Verify during POWER button press, status/alarm indicator illuminates solid yellow, and all indicator lights illuminate.
3. Verify display shows “Welcome, Starting”, current
software version (e.g. V 1.06), and changes to show “Standby” and therapy set-point.
4. With device still set to 80 mmHg, press SELECT
Note: Due to device normal internal leakage, device may run at a very slow rate but still activate “!! WARNING !! BLOCKAGE/FULL” alarm after approximately 5 minutes. If alarm is activated, device passed test successfully.
button. Verify device starts operating, status/ alarm indicator illuminates solid green, and screen displays “Continuous” and therapy set-point.
5. Press SELECT button to stop device.
5. If device fails on first attempt check for possible
air leaks in system. Address leaks, and re-test. If device fails a second time, remove from service and return for repair.
6. If alarm activates, press AUDIO PAUSE button. Verify audible alarm is temporarily paused, the audio pause indicator illuminates solid yellow, and screen displays “!! AUDIO PAUSED !! BLOCKAGE/FULL”.
7. Press SELECT button to stop device, and pause stopwatch.
10
Low vacuum, leak and audio pause button check
Over vacuum check
1. Disconnect canister, leaving device inlet port
1. Reset stopwatch to zero.
exposed.
2. Adjust therapy set-point to 200 mmHg using UP
2. Reset stopwatch to zero.
and DOWN buttons and press SELECT button to start device.
3. Adjust therapy set-point to 180 mmHg using UP and DOWN buttons and press SELECT button to start device. Start stopwatch.
3. Wait 5-10 seconds, allowing device to accelerate. 4. Quickly cover inlet port with a gloved thumb or
4. Verify within 30 ± 5 seconds the screen displays
finger. Verify device stops and screen displays “!! THERAPY STOP !! OVER VACUUM” alternating with “!! THERAPY STOP !! Restart Device”, status/ alarm indicator illuminates solid yellow, audible alarm beeps 2 times every 20 seconds, and keypad lock indicator illuminates solid blue.
“!!WARNING !!LOW VACUUM”, status/alarm indicator illuminates solid yellow, and audible alarm beeps 2 times every 20 seconds.
5. Press AUDIO PAUSE button. Verify audible alarm
is temporarily silenced, audio pause indicator illuminates solid yellow, and the screen displays, “!! AUDIO PAUSED !! LOW VACUUM”.
5. Press AUDIO PAUSE button to attempt to silence
audible alarm. Verify audible alarm does not silence and screen displays “!! Press !! POWER Key” while AUDIO PAUSE button is pressed.
6. Allow device to continue operating. 7. Verify within 1 minute ± 5 seconds the audible
6. Press SELECT button to attempt to restart device.
alarm resets and beeps 2 times every 20 seconds and screen displays “!! WARNING !! LEAK” alternating with “!! WARNING !! LOW VACUUM”.
Verify device does not restart, audible alarm does not silence and screen displays “!! Press !! POWER Key” while SELECT button is pressed.
8. Press SELECT button to stop device and pause stopwatch.
7. Press and hold POWER button for 2 seconds to turn device off and reset stopwatch to zero.
11
Service and maintenance performed annually
Equipment leakage current check
1. Equipment leakage current check shall only be
performed after the protective earth resistance check has been passed.
Electrical safety check Recommended personnel: Electrical safety checks should be performed by a trained bio-technician or biomedical engineer.
2. Connect female end of power cord to power supply,
and power supply to AC mains power. Connect male end of power cord to electrical safety analyzer. Use probe of electrical safety analyzer to make firm contact with metal screw located in odor filter door on base of device. Device does not have to be turned on.
Equipment and materials required: RENASYS™ power cord, RENASYS power supply, electrical safety analyzer. Note: When electrical safety check is performed, it should be performed before functional checks.
Note: Probe must touch metal.
Perform the following electrical safety checks IN THE ORDER LISTED BELOW using the electrical safety analyzer, in accordance with IEC 62353 for internally powered medical electrical equipment with class I or class II power supply. Consult local/country requirements. If they are more rigorous than the requirements of IEC 62353, follow local/country requirements. (e.g. in Australia AS/NZS 3551 is applicable).
3. Test 1: Normal polarity (closed neutral, open ground).
Power cord protective earth resistance check (perform test only for class I power supply REF 66800161)
Acceptance criteria (device with class I power supply REF 66800161 paired with appropriate power cord): Max: 500 μA. Acceptance criteria (device with class II power supply REF 66801558 paired with appropriate power cord): Max: 100 μA
Note: For measurement of protective earth resistance, test equipment must be able to deliver at least 200 mA into 500 mΩ. Open circuit voltage must not exceed 24 volts.
4. Test 2: Reversed polarity (closed neutral, open
Power cord acceptance criteria: electrical resistance <100 mΩ.
ground).
Acceptance criteria (device with class I power supply REF 66800161 paired with appropriate power cord): Max: 500 μA. Acceptance criteria (device with class II power supply REF 66801558 paired with appropriate power cord): Max: 100 μA
1. Connect male end of power cord to electrical safety analyzer outlet.
Electrical safety analyzer outlet
Power cord
Note: Perform equipment leakage current check in reverse polarity for per country requirements. If electrical safety analyzer gives a printout, attach it to RENASYS GO acceptance test record.
2. Use probe of electrical safety analyzer to make firm
If required by your market, ensure a copy of electrical safety test record remains with device so they are shipped to the customer together.
contact with middle ground wire of power cord. Confirm electrical resistance is <100 mΩ.
Caution: Disconnect electrical safety analyzer before proceeding to next check.
12
Device pressure check
Preparation for return to clinical use
Recommended personnel: Device pressure checks should be performed by a trained bio-technician or biomedical engineer.
Recommended personnel: Preparation for return to clinical use should be performed by a trained technician. Equipment required: RENASYS power cord, RENASYS power supply.
Equipment required: RENASYS™ power cord, RENASYS power supply, RENASYS Y-connector, RENASYS quick click adaptor, RENASYS GO canister, calibrated pressure gauge.
Battery charge - short term storage If device is to be returned to field within a short period (up to 3 months), battery should be re-charged to between 50–60%, to provide maximum battery life.
1. Connect power cord and power supply to device and to AC mains power.
1. Run device until extremely low battery indicator
2. Connect canister to device. 3. Connect canister tubing quick click connector to
activates.
Y-connector.
2. Recharge battery for approximately 1 hour. Battery charge - long term storage If device is to be stored for an extended period, battery should be recharged to an almost fully charged state. While this may reduce long-term life of the battery, it will enable device to be stored for about 9 months and provide up to 4 hours of use at 80 mmHg before recharge is required.
4. Connect one of the Y-connectors quick click
connectors to the quick click adaptor and insert tethered cap into quick click connector of quick click adaptor.
1. Run device until extremely low battery indicator activates.
2. Recharge battery for approximately 2 hours. Battery charge - charge level check
1. Ensure device is disconnected from AC mains
power and press and hold POWER button for 2 seconds to turn device on. If top light on battery indicator is illuminating solid solid green the charge level is above 50%.
5. Connect second Y-connector quick click connector
2. Battery level may be checked in more detail by
to a calibrated pressure gauge.
entering clinician mode as follows:
• Press and hold POWER button for 2 seconds to turn off device. • Simultaneously press and hold DOWN, SELECT and POWER buttons for 2 seconds. Screen will display “Continuous” and “Intermittent” on two lines.
6. Adjust therapy set-point to 40 mmHg using UP and DOWN buttons and press SELECT button to start device. Allow pressure level to stabilize (may take up to 60 seconds) and verify pressure measured on calibrated pressure gauge controls to 40 mmHg ± 10 mmHg.
• Use DOWN button to scroll to “Battery Charge”. • Press SELECT button to confirm selection. Screen will display “Battery Charge” followed by battery charge level in %. Note: It is not recommended to store device connected to AC mains power, over time this will reduce available battery capacity.
7. Adjust set-point to 180 mmHg using UP button.
Allow pressure level to stabilize (may take up to 60 seconds) and verify pressure measured on calibrated pressure gauge controls to 180 mmHg ± 10 mmHg.
8. Press SELECT button to stop device operation. 9. Press and hold POWER button for 2 seconds to turn device off. 13
Clearing therapy time Therapy time must be cleared between each patient use by entering clinician mode as follows:
1. Press and hold POWER button for 2 seconds to turn device off.
2. Simultaneously press and hold DOWN, SELECT and POWER buttons for 2 seconds. Screen will display “Continuous” and “Intermittent” on two lines.
3. Use DOWN button to scroll to “Clear Time”, press SELECT button.
4. The screen will display “Clear Active Time?”, press SELECT button.
5. Use DOWN button to scroll to “Yes”, press SELECT button.
6. The screen will display “Active Time Cleared” for 5 seconds and return to main menu displaying “Continuous” and “Intermittent” on two lines.
7. Press and hold POWER button for 2 seconds to turn device off.
Total time of operation RENASYS™ GO devices display total number of accumulated hour’s device has been used for therapy. Total time can be viewed by entering clinician mode as follows:
1. Press and hold POWER button for 2 seconds to turn off device.
2. Simultaneously press and hold DOWN, SELECT and POWER buttons for 2 seconds. Screen will display “Continuous” and “Intermittent” on two lines.
3. Use DOWN button to scroll to “Total Time”, press SELECT button.
4. Screen will display “Total Time” followed by a value
indicating the number of accumulated hours device has delivered therapy.
5. After 5 seconds, screen will clear and return to main menu displaying “Continuous” and “Intermittent” on two lines.
6. Press and hold POWER button for 2 seconds to turn device off.
14
Service and maintenance sample checklist Note: In the event a device fails any test, has sustained obvious damage, has a missing or illegible specification badge, or has any indication it may not be fit for intended use, return unit to Smith & Nephew global repair center.
UNIT SERIAL # Steps
Yes
No
Comments
Device cleaning and single-use component removal (performed after each patient use) 1
Device cleaning record is present and/or cleaned according to this procedure.
2
Inlet port and air exhaust port are free from obstructions, dust or foreign materials.
3
Existing O-ring and odor filters are removed.
4
Inlet port and air exhaust port cleaned.
5
All external surfaces of the device, power cord and power supply are cleaned with recommended antimicrobial disposable wipes.
Single-use component replacement (performed after each patient use) 6
New O-ring correctly fitted on inlet port.
Date (mm/dd/yyyy):
7
Two (2) odor filters placed within odor filter door.
Date (mm/dd/yyyy):
Device physical appearance check (performed after each patient use) 8
Device is unplugged and placed on flat surface.
9
Device is free of damage, cracks or missing pieces.
10
Buttons and indicator lights below display screen and display itself are undamaged.
11
Inlet port is undamaged.
12
AC mains power inlet is undamaged.
13
Carry strap pins are present and secure.
14
Power cord is not fraying, missing insulation, and has no bent, loose or missing plug blades or earth/ground.
15
Power supply cord is not fraying, missing insulation, and DC plug is not bent, loose or missing.
16
Device is free from rattles indicating loose components.
17
The device specification badge is present and REF and SN numbers are clearly visible.
REF:
SN:
18
The power supply labels are present and clearly visible.
REF:
SN:
Functionality check - Operations check (performed after each patient use) 19
All indicator lights and status/alarm indicator flash briefly as AC mains power is connected.
20
When AC mains power is connected the battery indicator light flashes green or illuminates solid green if battery is fully charged.
21
Screen display shows “Welcome, Starting”, current software version, and changes to “Standby” and therapy set-point after powering on. Record the software version under comments. 15
Version:
Steps
Yes
No
Comments
Functionality check - Language check (performed after each patient use) 22
Record set language. (If language is changed during functionality check, set to original language once checks are complete).
Language:
Functionality check - Modes of operation check (performed after each patient use) 23
Device starts operating, status/alarm indicator illuminates solid green, and the screen displays “Continuous” and therapy set-point.
24
Device stops operating, status/alarm indicator is no longer illuminated and the screen displays “Standby” and therapy set-point.
25
Intermittent operation selected.
26
Device starts operating, status/alarm indicator illuminates solid green, and the screen displays “Intermittent” and therapy set-point.
27
Device operates for 5 minutes ± 30 seconds and then stops operating.
28
Device does not operate for 2 minutes ± 30 seconds, status/alarm indicator remains illuminated and the screen displays “Intermittent” and therapy set-point.
Functionality check - Keypad lock check (performed after each patient use) 29
Device starts operating, status/alarm indicator illuminates solid green, and the screen displays “Continuous” and the therapy set-point.
30
The blue indicator light above the KEYPAD LOCK button illuminates solid blue and the screen displays “Keypad Locked”, then changes to “Continuous” and the therapy set-point.
31
Verify device does not stop operating when the SELECT button is pressed and the screen displays “Keypad Locked”.
32
The indicator light above the KEYPAD LOCK button is no longer illuminated and the screen displays “Keypad Active”.
Functionality check - Homecare lock check 33
Verify indicator above KEYPAD LOCK button illuminates solid blue, screen displays “Keypad Locked”, “Continuous” and the therapy set-point on upperline, followed by ”***” on lower line.
34
Verify device does not stop operating when the SELECT, UP and DOWN buttons are pressed and the screen displays “Keypad Locked”.
35
Verify indicator light above KEYPAD LOCK button is no longer illuminated and screen displays “Keypad Active”. 16
Steps
Yes
No
Comments
Functionality check - Battery function check (performed after each patient use) 36
During the 2 seconds the POWER button is pressed, status/alarm indicator illuminates solid yellow and all indicator lights illuminate.
37
Display shows “Welcome, Starting”, current software version (e.g. V 1.06), and changes to show “Standby” and therapy set-point.
38
Device starts operating, status/alarm indicator illuminates solid green, and screen displays “Continuous” and therapy set-point.
Alarm indicator check – Complete blockage / canister over capacity alarm and audio pause button check (performed after each patient use) 39
Within 5 minutes the screen displays “!! WARNING !! BLOCKAGE/FULL”, status/alarm indicator illuminates solid yellow, audible alarm beeps 2 times every 20 seconds.
40
The audible alarm is temporarily paused, audio pause indicator illuminates solid yellow, and screen displays “!! AUDIO PAUSED !! BLOCKAGE/FULL”.
Alarm indicator check – Low vacuum, leak and audio pause button check (performed after each patient use) 41
Within 30 ± 5 seconds the screen displays “ !! WARNING !! LOW VACUUM”, status/alarm indicator illuminates solid yellow, and audible alarm beeps 2 times every 20 seconds.
42
The audible alarm is temporarily paused, audio pause indicator illuminates solid yellow, and the screen displays “!! AUDIO PAUSED !! LOW VACUUM”.
43
Devices with software V 1.06 or later Within 1 minute ± 5 seconds the audible alarm resets and beeps 2 times every 20 seconds and the screen displays “!! WARNING !! LEAK” alternating with “!! WARNING !! LOW VACUUM”.
Alarm indicator check – Over vacuum check (performed after each patient use) 44
Device stops, screen displays “!! THERAPY STOP !! OVER VACUUM” alternating with “!! THERAPY STOP !! Restart Device”, status/alarm indicator illuminates solid yellow, audible alarm beeps 2 times every 20 seconds and the keypad lock indicator illuminates solid blue.
45
The audible alarm does not pause, and the screen displays “!! Press !! POWER Key” while the AUDIO PAUSE button is pressed.
46
Device does not restart, audible alarm does not pause, and the screen displays “!! Press !! POWER Key” while the SELECT button is pressed.
17
Steps
Yes
No
Comments
Electrical safety check (performed annually) 47
Power cord protective check resistance check (perform test only for class I power supply REF 66800161): Power cord acceptance criteria: electrical resistance <100 mΩ IN ACCORDANCE WITH IEC 62353
Class:
mΩ
48
Equipment leakage current check (normal polarity): Acceptance criteria (class I power supply REF 66800161 paired with appropriate power cord): Max: 500 μA Acceptance criteria (class II power supply REF 66801558 paired with appropriate power cord): Max: 100 μA IN ACCORDANCE WITH IEC 62353
Class:
μA
49
Equipment leakage current check (reversed polarity) Acceptance criteria (class I power supply REF 66800161 paired with appropriate power cord): Max: 500 μA Acceptance criteria (class II power supply REF 66801558 paired with appropriate power cord): Max: 100 μA IN ACCORDANCE WITH IEC 62353
Class:
μA
Device pressure check (performed annually) 50
Pressure measured on the calibrated pressure gauge controls to 40 mmHg ± 10 mmHg.
mmHg
51
Pressure measured on the calibrated pressure gauge controls to 180 mmHg ± 10 mmHg.
mmHg
Battery charge: Charge level check (preparation for return to clinical use) 52
Battery charge level is above 50%.
Clearing therapy time (preparation for return to clinical use) 53
Therapy time cleared.
Total time of operation (preparation for return to clinical use) 54
Total time of operation recorded.
Cleaning and packing 55
Device cleaned and re-packaged with all necessary items for customer use.
Performed by: Print Name:
Date:
Signature:
Day
Location (Address):
18
Month
Year
Repair and returning device
but not limited to storage, handling or cleaning; and (viii) any other damage inflicted to a Device by the owner, user or handler. This warranty applies only to the original buyer from Smith & Nephew or its authorized distributor and is not transferable.
There are non-user-serviceable components inside the RENASYS™ GO NPWT device. Repairs and adjustments are to be performed only by Smith & Nephew authorized service centers. To arrange repair, please contact the Smith & Nephew Customer Care Center or your Smith & Nephew Representative.
THIS WARRANTY IS THE SOLE WARRANTY OF SMITH & NEPHEW. ALL OTHER WARRANTIES OF ANY KIND OR DESCRIPTION WHATSOEVER, INCLUDING WARRANTIES OF MERCHANTABILITY, SATISFACTORY QUALITY AND FITNESS FOR A PARTICULAR PURPOSE, EXPRESSED OR IMPLIED, ARE EXCLUDED TO THE FULLEST EXTENT PERMITTED BY LAW.
WARNING: Device should not be opened at a facility level. Opening or attempting to open case will void all warranties and render user responsible for all subsequent liabilities associated with device. Prior to returning device to your Smith & Nephew global repair center, device must be cleaned according to steps outlined under device cleaning and single use component removal section of this manual. Device should be returned within the original packaging.
Device
Warranty Period
RENASYS NPWT electromechanical devices (inclusive of the power cord and power supply)
Two (2) years from date of delivery to original buyer
CUSTOMER’S SOLE REMEDY, AND SMITH & NEPHEW’S SOLE LIABILITY, FOR ANY CLAIM WILL BE THE REPAIR OR REPLACEMENT BY SMITH & NEPHEW AS PROVIDED FOR IN THIS WARRANTY. EXCEPT FOR THIS LIMITED LIABILITY OF SMITH & NEPHEW, SMITH & NEPHEW UNDER NO CIRCUMSTANCES WILL BE LIABLE FOR ANY (A) CLAIM, FOR DAMAGES OR OTHERWISE, WHETHER ARISING FROM BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, AND WHETHER OR NOT BASED ON OR FLOWING DIRECTLY, INDIRECTLY OR AS A CONSEQUENCE OF A WARRANTY CLAIM, BREACH OF CONTRACT, A TORT, BREACH OF LAW, OR ANY OTHER CAUSE OR LEGAL THEORY, OR (B) DIRECT, INCIDENTAL, CONSEQUENTIAL OR SPECIAL DAMAGES, LOSSES OR EXPENSES ARISING FROM THIS AGREEMENT OR ITS PERFORMANCE OR LACK THEREOF, OR IN CONNECTION WITH THE SALE OR USE OF, OR INABILITY TO USE, THE DEVICE, INCLUDING BUT NOT LIMITED TO, LOSS OF PROFIT OR ANTICIPATED SAVINGS, LOSS OF ANTICIPATED PROFIT, COST OF COVER FOR REPLACEMENT OR ALTERNATIVE PRODUCT, ECONOMIC LOSS, LOSS OF DATA, WASTED EXPENDITURE OR LOSS OF REPUTATION OR GOODWILL.
LIMITED WARRANTY LIMITATION OF REMEDIES/LIABILITY: The Smith & Nephew negative pressure wound care electro-mechanical device (“Device”) is warranted against defects in workmanship and materials for the warranty period specified below (“Warranty Period”). Smith & Nephew reserves the right to discontinue any Device or change any Device’s specifications or designs from time to time. For any Device that fails to meet the foregoing warranty, this warranty provides and is restricted to replacement or repair (on-site service not included) as elected by Smith & Nephew in its sole discretion. If Smith & Nephew replaces a Device under this warranty and requests Customer to return the Device that was replaced, Customer will be invoiced, at Smith & Nephew’s then current list price, for the replacement Device if Customer does not return the replaced Device within thirty (30) days after Smith & Nephew’s shipment of the replacement Device. This warranty does not cover and is voided by any of the following: (i) a warranty claim not made within the first to occur of expiration of the Warranty Period or thirty (30) days following the failure of the Device to perform as warranted; (ii) a Device packaged or labeled by someone other than Smith & Nephew or its authorized agents; (iii) a Device not used in compliance with the specifications, instructions or claims for use of the Device; (iv) a Device used in conjunction with disposables, accessories or any other products not specified for use with the Device; (v) a Device used in conjunction with expired or reprocessed disposables, accessories or other products specified for use with the Device; (vi) modification of the Device; (vii) damage due to misuse, reprocessing, alteration, unauthorized repair or negligent handling or damage due to lack of care by the owner, user, or handler of the Device including 19
Global customer assistance For more information regarding RENASYS™ GO or for additional customer assistance, please refer to Smith & Nephew Customer Care Center details below:
Australia
Smith & Nephew Pty Ltd. 315 Ferntree Gully Road PO Box 242 Mount Waverley, Victoria 3149
Tel: +61 3 8540 6777 Fax:+61 3 9544 5086
Austria
Smith & Nephew GmbH Concorde Business Park C3 Österreich A-2320 Schwechat
Tel: +43 1 70 79102 Fax:+43 1 70 79101 [email protected]
Belgium
Smith & Nephew SA-NV Hector Henneaulaan 366 1930 Zaventem
Tel: +32 2 702 2911 Fax:+32 2 702 2904 [email protected]
Canada
Smith & Nephew Inc. 2250 Alfred Nobel Boulevard St. Laurent, Quebec H4S 2C9
Tel: 1 800 463 7439 Fax: 1 800 671 9140
Denmark
Smith & Nephew A/S Slotsmarken 14 2970 Hoersholm
Tel: +45 4580 6100 Fax:+45 4580 6151 [email protected]
Finland
Smith & Nephew Oy Äyritie 12 C 01510 Vantaa
Tel: +358 (0)207 866 300 Fax:+358 (0)207 866 320
France
Smith & Nephew SAS Espace Novaxis 25 Blvd. Marie et Alexandre Oyon 72019 Le Mans Cedex 2
Tel: (33) 02 43 83 23 23 Fax:(33) 02 43 83 24 18 [email protected]
Germany
Smith & Nephew GmbH Wound Management Osterbrooksweg 71 D-22869 Schenefeld
Tel: +49 (040) 87 97 44 0 Fax:+49 (040) 87 97 44 375 [email protected]
Smith & Nephew Wound Management Via de Capitani, 2A 23864 Agrate Brianza (MB)
Tel: 800 393 060 (numero verde attivo 8.30-18.00) 039 6094224 Fax:039 6094274 Centro Assistenza Clienti: [email protected]
Ireland
Smith & Nephew Healthcare Ltd. Healthcare House 101 Hessle Road Hull HU3 2BN
Customer Care: 01276 9700 Fax: 01276 4970 [email protected] 24hr Clinical Support: 1800 303622 Tel: 81-03-5667-2166
Japan
Smith & Nephew Wound Management Tokyo Warehouse Center C-3F 3-5-1, Rinkai-cho, Edogawa-ku, Tokyo 134-0086 Japan
Italy
20
Netherlands
Smith & Nephew B.V. Postbus 525 2130 AM Hoofddorp Bezoekadres: Kruisweg 637 2132 NB Hoofddorp
Tel.: 020-654 39 99 Fax: 020-654 20 99 [email protected]
New Zealand
Smith & Nephew Limited PO Box 442 Shortland Street Auckland 1140
Tel: +64 9 828 4059 Fax:+64 9 820 2866
Norway
Smith & Nephew A/S Postboks 224 1379 Nesbru Besøksadresse: Nye Vakåsvei 64 1395 Hvalstad
Tel: +47 66 84 20 20 Fax:+47 66 84 20 90 [email protected]
Portugal
Smith & Nephew, Lda. Parque Tejo EN 10, Km 131 2625-445 Forte da Casa
Tel: +351 21 446 0650 Fax:+351 21 446 0679
South Africa
Smith & Nephew (Pty) Ltd. PO Box 92 Pinetown 3600
Tel: +27 (0)31 242 8111 Fax:+27 (0)31 242 8120
Spain
Smith & Nephew SAU Fructuós Gelabert 2 y 4 08970 Sant Joan Despí Barcelona
Tel: +34 93 373 73 01 Fax:+34 93 373 7453
Sweden
Smith & Nephew AB Kråketorpsgatan 20 PO Box 143 431 22 Mönldal
Tel: +46 31 746 58 00 Fax:+46 31 87 05 32
Switzerland
Smith & Nephew AG Glutz Blotzheim-Strasse 1 4502 Solothurn
Tel: +41 32 624 56 60 Fax:+41 32 624 56 81
Turkey
Smith & Nephew Ltd. Şti. Orkide Sokak NO:8/E Bahçeköy 34473 Istanbul Turkey
Tel: +90 212 226 22 55 Fax:+90 212 226 44 47 [email protected] Tel: +971 4 429 9111 Fax:+971 4 429 9100
United Arab Emirates
Smith & Nephew FZE Level 4 National Bank of Abu Dhabi Building Dubai Health Care City PO Box 9715 Dubai
United Kingdom
Smith & Nephew Healthcare Limited Healthcare House 101 Hessle Road Hull, HU3 2BN
Tel: 0 800 590 173 Fax: 0 1482 222 211 [email protected] [email protected]
United States
Smith & Nephew, Inc. 970 Lake Carillon Drive St. Petersburg, FL 33716
Tel: 1 800 876 1261 Fax: 727 392 6914 [email protected] 21