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SMITH & NEPHEW RENASYS EZ (01) PDF MANUAL
SMITH & NEPHEW RENASYS EZ (01) User guide For use with Soft Port
RENASYSTM EZ RENASYS EZ PLUS
Negative Pressure Wound
Therapy
User guide
Table of contents
Introduction Device description Indications for use Contraindications Warnings Precautions Glossary of symbols Physician orders Canister selection Canister installation Dressing changes Removing or changing the canister Operating the device Safety alarms Troubleshooting guide Maintenance Cleaning Battery operation Fuse replacement Returning the device Storage Electromagnetic compatibility Specifications Customer assistance/warranty
page
4 4 6 6 6 6 8 9 9 9 10 10 11 12 14 17 17 17 17 18 18 19 21 22
RENASYSTM EZ RENASYS EZ PLUS
Negative Pressure Wound
Therapy
Introduction
This user manual contains important information regarding the safe and effective operation of RENASYSTM EZ (p/n 66800059) and RENASYS EZ Plus (p/n 66800697) Negative Pressure Wound Therapy [NPWT] devices. This manual is intended to aid in training of personnel and to provide a reference for experienced users. Also included are instructions for commissioning the device, maintenance, cleaning and disposal.
Device description
Canister holder bracket Handle Mode of operation switch Vacuum port Pressure selector Pressure selector lock Vacuum gauge Status lights Audio pause button and status light Air exhaust outlet AC power inlet and fuse IV pole lock knob IV pole pad Bed hooks Specification badge Rubber feet
Front view of device (RENASYS EZ shown)
Vacuum port Canister
holder bracket Status lights Audio pause button and status light
Rear view of device
Handle
Vacuum gauge
Pressure selector Pressure selector lock Mode of operation switch
Handle
The following Smith & Nephew components are required for the proper and effective use of the device: RENASYS-G Gauze Dressing Kit with Soft Port RENASYS-F Foam Dressing Kit with Soft Port RENASYS AB Abdominal Dressing Kit with Soft Port 250ml S-Canister Kit (p/n 66800913) 800ml S-Canister Kit (p/n 66800912) Bacterial Overflow Guard (p/n 66800194)
IV pole lock knob
Bed hooks Specification badge
IV pole pad
4
Rear view of device showing bed hooks and IV pole mount in use
Left view of device
AC power inlet Fuse cover
Underside of device
Rubber feet
Air exhaust outlet Rubber feet
5
Indications for use
RENASYSTM EZ and RENASYS EZ Plus devices are indicated for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via removal of fluids, including irrigation and body fluids, wound exudates and infectious materials.
Examples of appropriate wound types include: · Chronic · Acute · Traumatic · Sub-acute and dehisced wounds · Ulcers (such as pressure or diabetic) · Partial-thickness burns · Flaps and grafts
Contraindications
The use of the device is contraindicated in the presence of: · Necrotic tissue with eschar · Untreated osteomyelitis · Malignancy in wound (with exception of palliative
care to enhance quality of life) · Exposed arteries, veins, organs or nerves · Non-enteric and unexplored fistulas · Anastomotic sites
Warnings
1. Carefully monitor patients for signs of sudden or increased bleeding. If such symptoms are observed, immediately discontinue therapy, take appropriate measures to control the bleeding, and contact the treating clinician.
2. Patients suffering from difficult hemostasis or who are receiving anticoagulant therapy have an increased risk of bleeding. During negative pressure therapy, avoid using hemostatic products that may increase the risk of bleeding.
3. Do not use on exposed blood vessels or organs. Sharp edges such as bone fragments must be covered or removed prior to initiating therapy, due to risk of puncturing organs or blood vessels drawn closer under the action of negative pressure.
4. Foam or gauze must not be tightly packed or forced into any wound area.
5. In the event defibrillation is required, disconnect the device from the wound dressing prior to defibrillation. Remove the wound dressing only if its location will interfere with defibrillation.
6. RENASYS devices are not MRI compatible. Do not bring the RENASYS device into the MRI suite.
7. When operating, transporting, repairing or disposing of RENASYS devices and accessories, the risk of infectious liquids being aspirated, or contamination of the device assembly through incorrect use, cannot be eliminated. Universal precautions should be observed whenever working with potentially contaminated parts or equipment.
8. NPWT has not been studied on pediatric patients. Patient size and weight should be considered when prescribing RENASYS devices.
9. RENASYS devices are unsuitable for use in areas where there is danger of explosion (e.g., hyperbric oxygen unit, or in the presence of a flammable anesthetic mixture with air or nitrous oxide). Disconnect the device from the dressing prior to entering an area where this equipment will be used.
10. Canister kits are provided non-sterile and should not be placed within a sterile field.
Precautions
1. Precautions should be taken for patients who are or may be:
- Receiving anticoagulant therapy or platelet aggregation inhibitors, actively bleeding or have friable blood vessels or organs
- Suffering from abnormal wound hemostasis
- Untreated for malnutrition
- Noncompliant or combative
- Suffering from wounds in close proximity to blood vessels or delicate fascia.
2. CT scans and x-ray have the potential to interfere with some electronic medical devices. Where possible, move the device out of the x-ray or scanner range. If the device has been taken into the CT scan or x-ray range, check that it is functioning correctly following the procedure.
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3. As a condition of use, the RENASYSTM device should only be used by qualified and authorized personnel. The user must have the necessary knowledge of the specific medical application for which NPWT is being used.
4. If the RENASYS device has been at temperatures below freezing the device must be brought to room temperature prior to use or the pump unit may be damaged.
5. Inspect the Bacterial Overflow Guard on the canister and replace the canister as necessary. At minimum, the canister should be changed weekly. Always use the smallest canister volume possible do not use a large canister on patients with a high risk of bleeding.
6. If any liquids penetrate the RENASYS device, discontinue use and return to your authorized provider for service.
7. Do not use a dressing kit with breached or damaged packaging.
8. The use of NPWT presents a risk of tissue ingrowth. Tissue in-growth may be reduced by reducing therapy pressure, using a wound contact layer or by increasing the frequency of dressing changes.
9. Underlying structures, such as tendons, ligaments and nerves should be covered with natural tissue or a non-adherent dressing layer prior to applying the NPWT dressing kit.
10. If multiple pieces of foam or gauze are needed to fill the wound profile, count and record how many foam pieces are present to ensure all the foam pieces are removed at a dressing change.
11. Infected wounds may require more frequent dressing changes. Regular monitoring of the wound should be maintained to check for signs of infection.
12. NPWT should remain on for the duration of the treatment. If the patient must be disconnected, the ends of the tubing should be protected using the tethered cap. The length of time a patient may be disconnected from the RENASYS device is a clinical decision based on individual characteristics of the patient and the wound.
Factors to consider include the location of the wound, the volume of drainage, the integrity of the dressing seal, the assessment of bacterial burden and the patient's risk of infection.
13. Ensure that tubing and Soft Port are installed completely and without any kinks to avoid leaks or blockages in the vacuum circuit. Position the RENASYS device and tubing appropriately to avoid the risks of causing a trip hazard. Whenever possible, the device and system tubing should be positioned level with or below the wound.
14. When bathing or showering, the patient must disconnect from the RENASYS device and should protect both ends of the tubing using the tethered caps. Ensure that the aeration disc, located near the Quick Click Connector, is free of excess moisture before reactivation of therapy.
15. NPWT should not be painful. If the patient reports discomfort, consider reducing the pressure.
16. Maintain regular monitoring of the RENASYS device and wound site during therapy to ensure therapeutic treatment and patient comfort.
17. As with all adhesive products apply and remove the dressing carefully from sensitive or fragile skin to avoid skin stripping, especially after frequent dressing changes.
Precaution specific to foam:
1. Foam should be cut to fit loosely into the wound bed. Never force or tightly pack foam into any areas of the wound, to avoid damaging underlying tissue.
2. Never place foam into blind or unexplored tunnels. If a tunnel of known depth presents, cut the foam longer than the tunnel, to ensure direct contact is made with the foam in the primary wound cavity.
3. Do not cut the foam directly over the wound cavity to avoid foam fragments from falling into the wound. Rub the edges of the foam, away from the open wound, to remove loose fragments after cutting.
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Glossary of symbols
Operation switch
Continuous therapy Device will maintain the preset vacuum level without stopping until switched off
OFF position Device stops delivering NPWT
Intermittent therapy · RENASYSTM EZ device produces vacuum for
approximately 32 seconds and turns off for approximately 16 seconds · RENASYS EZ Plus device produces vacuum for approximately 5 minutes and turns off for approximately 2 minutes
Status lights
Mains power (Feature available only on RENASYS EZ) When the system is connected to an AC outlet, the status light will illuminate green; does not indicate device is turned on
On/off (Feature available only on RENASYS EZ Plus) When the operation switch is in the Continuous or Intermittent mode, the status light will illuminate green
Equipment classification Isolation type BF applied part
CSA international classification
Single use do not reuse
Keep dry
Battery indicator
· Battery full: solid green status light · Battery charging: blinking green status light · Battery low: blinking yellow status light and
audible alarm · Battery fault (feature available only on
RENASYS EZ Plus): solid yellow status light
Over vacuum When the system encounters excessively high vacuum (of >235mmHg) the device will stop delivering NPWT. The audible alarm will sound and the status light will flash yellow
Leak When the system detects a significant leak the audible alarm will sound and the status light will flash yellow
Low vacuum If the vacuum level is lower than set point of therapy by >15mmHg, the audible alarm will sound and the status light will flash yellow
Blockage/Canister full When the system detects that the canister is full or that there is a blockage in the system the audible alarm will sound and the status light will flash yellow
Alarm suppress Pressing the alarm suppress button will silence the alarm for approximately 2-4 minutes
European representative
Lot number
Serial number
EU: not for general waste
Caution: see instructions for use
Storage temperature Date of manufacture
Product catalog number
CE mark
Do not use if package is damaged
Fuse
Place of manufacture
Earthing location of protective earthing terminals
8
Caution: U.S. Federal law restricts this device to sale by or on the order of a physician
Keep upright
Physician orders
Prior to placement of the device, the medical professional treating the wound must assess how to best use the system for an individual wound. It is important to carefully assess the wound and patient to ensure clinical indications for NPWT are met.
All orders should include: · Wound location, size and type · Smith & Nephew wound dressing kit type · Vacuum settings · Frequency of dressing changes
Canister installation
Installing the canister holder
Slide the canister holder onto the canister holder bracket on the front of the device casing until it stops.
Installing the canister
1. Ensure vacuum is turned off. 2. Connect the in-line Bacterial Overflow Guard to
the vacuum opening on the device:
Adjunctive dressings
Canister selection
The device is to be used only with the following Smith & Nephew Canister kits:
· 250ml S-Canister kit (p/n 66800913)
· 800ml S-Canister kit (p/n 66800912)
Always use the smallest canister volume possbile. Do not use non-sterile canister kits in a sterile field. Canister kits are single-use devices. Do not reuse.
3. Connect the blue end of the canister tubing to the canister lid port labelled with the patient symbol:
Canister kits may have to be changed regularly within single-patient treatment episodes if exudate levels are high. Canister kits should be changed at least once a week .
4. Securly connect the opposite end of the canister tubing to the wound dressing tubing:
The device uses an in-line Bacterial Overflow Guard for protection of the device against overflow and the spread of aspirated micro-organisms. The guard is designed for single-patient use and should be replaced whenever there is a change of patient or in the event of overflow. Check the guard for any changes in color, liquid in the guard, or poor vacuum performance. Replace the guard if any one of these occurs.
9
CAUTION: Ensure the 250ml S-Canister viewing window is checked regularily for signs of bleeding, as the canister holder obscures the viewing window.
Removing or changing the canister
Hold the Quick Click above the wound to allow gravity to help ensure exudate does not leak from the tubing.
1. Turn vacuum off. 2. Disconnect the canister tubing from dressing
tubing at the connection point and cap off.
CAUTION:
The 800ml S-Canister should be orientated so its content can easly be viewed through the transparent window.
Dressing changes
RENASYSTM foam dressings should be changed every 48-72 hours after the inital application of therapy. If no leak is present and the patient is comfortable, dressing changes should occur no less than 3 times per week.
RENASYS gauze dressings should be changed 48 hours after the inital applicaiton of therapy. If no leak is present and the patient is comfortable, dressing changes should occur 2-3 times per week.
Check the dressing regularly and monitor the wound to check for signs of infection. Infected wounds may require more frequent dressing changes. In the event of heavy drainage or drainage with sediment, more frequent dressing changes may be needed.
If there are any signs of systemic infection or advancing infection at the wound site, contact the treating clinician immediately.
3. Disconnect the in-line Bacterial Overflow Guard from the device.
4. Lift the canister out of the holder.
5. Discard the canister, in-line Bacterial Overflow Guard and tubing as one piece.
Disposal of used canisters should follow facility protocols or local ordinances relating to the handling of potentially infected or bio-hazardous materials.
10
Operating the device
Modes of operation There are two modes of operation, Continuous and Intermittent:
Continuous mode: the device will maintain the preset vacuum level without stopping until switched off.
Intermittent mode:
· RENASYSTM EZ device produces vacuum for approximately 32 seconds and turns off for approximately 16 seconds
· RENASYS EZ Plus device produces vacuum for approximately 5 minutes and turns off for approximately 2 minutes
Note: For NPWT with RENASYS EZ, Continuous mode is recommended.
· The vacuum level should never be painful. If the patient reports discomfort with the vacuum level, it should be reduced
Adjust NPWT
The device features a 12-position adjustable pressure selector. Vacuum is increased by turning the knob clockwise. When not in use the pressure selector should be turned to the minimum setting.
The vacuum level is displayed on an analog vacuum gauge above the pressure selector. When the device is set and NPWT is running correctly, the pressure selector can be locked to ensure that no accidental adjustment in vacuum can be made. Turn the pressure selector lock to the lock position as shown below:
When switched off, the device will not maintain vacuum.
Before NPWT · RENASYS EZ device: If battery operation is required
for first use of the device, the battery must be charged from AC power until the green battery indicator light is constantly illuminated. During the charging process the light will flash green:
· RENASYS EZ Plus device: If battery operation is required for first use of the device, the battery must be charged from AC power until the status light is solid green. During the charging process the light will flash green:
Set therapy
Setting the vacuum level is a decision that the healthcare provider must make based on an individual assessment of the particular wound. These general guidelines should be adhered to: · 40-120mmHg is the recommended therapeutic
pressure range
Start NPWT To begin NPWT, select the desired vacuum level on the dial and press the mode of operation switch to either Continuous or Intermittent. NPWT will commence as soon as the switch is selected:
Continuous
Intermittent
Caution: Before starting NPWT ensure that the device system tubing is positioned horizontal with or below the wound and is away from any direct sources of heat.
Stopping NPWT To stop NPWT, return the mode of operation switch to the center position. Turning off the device will stop vacuum and end the NPWT.
Off
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Device orientation during use
The device is designed to operate only in the upright position while delivering NPWT. Any orientation other than described could result in device malfunction, compromising patient safety and resulting in damaging the device.
Stand upright The device can stand in the upright position on a flat hard surface.
Attach to IV pole The device can be attached to an IV pole by releasing the knob enough to allow the IV pole to be located between the upper rubber pad and grip face and also aligned with the lower rubber pad. Once the IV pole is correctly located the knob must be carefully tightened to ensure the pads grip and hold the IV pole securely.
Attach to bed board The device can be attached to the head or foot of the patient's bed. This is achieved by pulling the 2 metal hooks from the recess on the back of the device to a 90° angle. This allows the device to be placed over the bed board.
Caution: When not in use ensure knob is completely closed.
Safety alarms
The device is equipped with alarms for the following errors. Errors are indicated with an audible signal and a status light.
Over vacuum:
If the system encounters an excessively high vacuum (of >235mmHg) the device will stop delivering NPWT. The audible alarm will sound and the status light will flash yellow. Pressing the audio pause button will silence the alarm for approximately 2-4 minutes. To reset this alarm function the device must be completely switched off by returning the mode selector switch back to `O' position. If this alarm occurs again there is potentially a fault with the device. Contact your authorized provider for service.
High flow/leak:
When the system detects a significant leak the audible alarm will sound and the status light will flash yellow. Pressing the audio pause button will silence the alarm for approximately 2-4 minutes. Once the system is sealed, the alarm will automatically reset.
Low vacuum alarm:
If the vacuum level is lower than set point of NPWT by >15mmHg, the audible alarm will sound and the status light will flash yellow. Pressing the audio pause button will silence the alarm for approximately 2-4 minutes. Once the system is sealed, the alarm will automatically reset.
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Blockage/canister full:
When the system detects that the canister is full or that there is a blockage in the system, the audible alarm will sound and the status light will blink yellow. NOTE: The blockage/canister full alarm will detect blockage from the wound to the canister when vacuum is set within the recommended therapeutic range (40-120mmHg).
Low battery alarm:
The low battery is signalled by audible alarm and a blinking yellow status light. Plug the device into an AC power outlet immediately when the alarm occurs. Once the alarm sounds, approximately 1 hour of therapy time remains. Pressing the audio pause button will silence the alarm for approximately 2-4 minutes.
Battery fault alarm: (RENASYSTM EZ Plus)
The battery fault alarm is signalled by a solid yellow status light indicating that the device has encountered a fault with the battery/charging system. If the device has encountered temperatures outside its recommended temperature range, let the device come to ambient temperature. If alarm persists, contact your authorized provider for service.
Suppress alarm:
Pressing the alarm suppress button will silence the alarm for approximately 2-4 minutes. If the cause of the alarm is not resolved during this time, the alarm will recommence sounding.
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Troubleshooting guide
Symptom
No mains power indication
Cause
Electrical power interrupted from wall outlet
Remedy Check wall outlet
Electrical power cord may be loose
Check electrical power cord at device and at wall socket
Blown fuses
Disconnect system power and replace both fuses. If problem persists contact authorized Smith & Nephew representative
Over vacuum alarm Device has reached high vacuum levels
1. Check for blocked or kinked tubing between the canister and the device
2. Check for a blocked or wetted in-line Bacterial Overflow Guard
3. Confirm that the canister is not full
4. If the problem persists, the device may have malfunctioned. Contact authorized Smith & Nephew representative
High flow/leak alarm the system detects a significant leak
There is a leak or defect in the canister tubing between the wound site and the device
1. Check that all connections are tight and secure
2. If connections are secure, disconnect drain from canister tubing and close clamp
3. If pump returns to set pressure, this indicates that the leak is at the dressing site
4. If pump does not return to set pressure, this indicates that the leak is related to the canister, in-line Bacterial Overflow Guard and/or canister tubing
There is a poor seal at one of the canister connection sites
1. Check that all connections are tight and secure
2. Check the in-line Bacterial Overflow Guard is pushed firmly into pump
There is a poor seal at the filter connection site
Ensure filter is securely inserted into the vacuum port on pump
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Symptom
Cause
Remedy
There is a leak in or around the dressing site
1. Check for inconsistencies in or around the dressing such as creases, crevices, or skin folds:
- Look for `loose' dressing appearance - Listen for the movement of air at the wound site - Feel the dressing for `hardness to the touch'.
All indicating a leak in/around the wound site. If a leak is found, patch with transparent film or waterproof tape or use ostomy paste to seal the leak.
Low vacuum alarm the vacuum level is lower than set point of NPWT by >15mmHg
The device is unable to achieve the selected vacuum level as there is a significant leak between the device and the wound site
1. Cover the adapter opening with gloved thumb
2. While covered, feel to see if vacuum is applied
3. If no vacuum, reconnect all of the tubing junctions, ensuring connections are airtight
4. If no resolution, remove guard and cover vacuum port with gloved thumb. If the alarm condition clears, the leak condition is in the tubing and/or canister. Examine the tubing/canister for a leak
5. If the alarm situation still is not resolved, there is likely a malfunction of the device. Contact your authorized Smith & Nephew representative
Blockage/canister full alarm no negative pressure at the wound site
There is blockage in the vacuum line
1. Check for canister tube blockage (e.g. tube kinking or sediment blockage)
2. Ensure canister is not full
Low battery alarm Battery depleted Battery fault alarm Battery/charger fault
Plug unit into AC power outlet to charge the battery
If the device has encountered temperatures outside its recommended temperature range, let the device come to ambient temperature. If alarm persists, contact your authorized provider for service.
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Blockage alarm
Description
Cause
Remedy
A blockage has been detected.
Blockage located is within canister, Quick Click or dressing.
Refer to diagram and begin the diagnosis algorithm below.
Keep in mind, blockage alarm from device may take up to 30 seconds to clear.
1. Detatch the Quick Click Connector Pump suction increases.
Blockage is located in Quick Click or dressing.
Examine the dressing.
2. Examine the canister 3. Examine the dressing
Nothing happens
Blockage is within Examine the
canister.
canister.
Canister tubing is obstructed.
Flush with sterile saline, massage the tubing to break apart, or simply replace the canister.
Canister tubing is clear. If canister is full or almost full, replace it.
Canister filter is wet.
Turn off device. Release vacuum. Remove canister from device. Gently tap conister to remove excess fluid. Reattach canister. If alarm sounds, replace canister
The Quick Click lumen is blocked.
Flush with sterile saline, or attempt to mechanically clear the blockage.
Blockage is deeper within Soft Port. Flush with sterile saline.
Aeration disc is
Remove tape or
blocked by tape or wet. dab the aeration
disc dry.
Replace Soft Port. See attached removal instructions to preserve dressing.
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Maintenance
Battery operation
The device should be visually inspected before each use, including the in-line Bacterial Overflow Guard and the canister and tubing.
The device contains a lithium-ion rechargeable battery good for approximately 300-500 recharges. A fully charged battery lasts up to 40 hours.
If the device has been dropped or is showing signs of damage the device should be returned to your authorized provider in the original packaging supplied.
The battery charges when plugged into AC power outlet both during operation and when turned off and not in use.
As there are no serviceable parts in the device, do not attempt to open. Contact your Smith & Nephew representative, distributor or an authorized provider if service is required.
Cleaning
Adherence to facility directives concerning hygiene is of prime importance. The instructions supplied with all cleaning agents as well as sterilization and/or disinfection units must be followed.
Cleaning of the device outer casing should be done in accordance with the guidelines below:
· Wipe down the device surface, including vent on underside of unit, with a damp soft cloth, using a low-level cleaning agent or disinfectant and ensure that it is compatible with plastics.
· Dampen another soft cloth with clean water and use this to wipe down all surfaces to remove any excess solution.
· Dry with a separate soft cloth.
If the device is fully charged and is not going to be used further, unplug the AC supply.
The device will indicate when the battery is low. The yellow status light will flash and the audible alarm will activate. Plug into AC power outlet immediately when the low battery alarm occurs.
Battery maintenance
If the device is stored for longer than 6 months, the battery may need to be charged before it will operate on battery power.
Fuse replacement
WARNING: To prevent electric shock, unplug the unit from the electrical outlet before attempting to replace the fuses.
WARNING: To avoid fire hazard, use only fuses of the correct type, voltage rating, and current rating.
To inspect and/or replace fuses:
· Do not use plastic solvents or abrasives.
· Do not immerse any part of the device in fluid or use an unnecessarily wet cloth. No fluids should be allowed to enter the device. If any liquids penetrate the device contact your Smith & Nephew distributor or authorized provider.
1. Unplug the power cord from the power outlet and from the device's side panel.
2. To open the fuse compartment door on the AC power inlet, push down the release clip and slide out the two-fuse carrier.
FUSE
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3. Replace fuses. See `Specifications' for replacement fuse types.
4. Reinsert fuse carrier using the arrows on the inside of the fuse compartment door as a guide.
5. Snap the fuse compartment door closed.
Returning the device
Prior to returning the device to your authorized provider, at the end of your rental period or if a fault has occurred, the device must be cleaned in line with the steps laid out under the cleaning section of this manual. The device should be returned in the original packaging supplied.
Storage
Prior to storage ensure that the battery is approximately 40-60% charged. Some battery discharge may occur in storage. The device should be stored between 41-104°F/5-40°C for optimal battery performance but can be stored between 14-131°F/-10-55°C for short periods of time. Caution: If the device has been stored at temperatures below freezing, it must be brought to room temperature prior to use or the pumping unit may be damaged.
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Electromagnetic compatibility
This equipment has been tested and found to comply with the limits for medical devices to IEC 60601-1-2-2001. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation.
Guidance and manufacturer's declaration electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
Immunity test IEC 60601 test level
Compliance level
Electromagnetic environment guidelines
Electrostatic ±6kV contact discharge (ESD) ±8kV air IEC 61000-4-2
±6kV contact ±8kV air
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%
Electrical fast ±2kV for power supply lines transient/burst IEC 61000-4-4
±2kV for power supply lines Mains power quality should be that of a typical commercial or hospital environment
Surge
±1kV differential mode
IEC 61000-4-5 ±2kV common mode
±1kV line to line ±2kV line to earth
Mains power quality should be that of a typical commercial or hospital environment
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
<5% UT (>95% dip in UT) for 0.5 cycles 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec
>95% for 10ms 60% for 100ms 30% for 500ms >95% for 5000ms
Mains power quality should be that of a typical commercial or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptable power supply or battery
NOTE UT is the a.c. mains voltage prior to application of the test level
Conducted RF 3Vrms 150 kHz to 80 MHz IEC 61000-4-6
3Vrms
Radiated RF IEC 3V/m 80 MHz to 2.5 GHz 61000-4-3
3V/m
NOTE 1: At 80MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. -----------------------------------------------------------------------------------------------------------------------a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds 3V/m, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device.
b. Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.
Portable and mobile RF communications equipment should be used no closer to any part of device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance:
d = 1.2P d = 1.2P (80MHz-800MHz) d = 2.3P (800MHz-2.5GHz) where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in yards/metres (yd./m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:
19
Guidance and manufacturer's declaration - electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment guidelines
RF emissions CISPR 11
Group 1
The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause interference in nearby electronic equipment.
RF emissions CISPR 11
Class B
Harmonic emissions IEC 61000-3-2 Not applicable
Voltage fluctuations/flicker emissions Comply IEC 61000-3-2
The device is suitable for use in all establishments including domestic and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes.
WARNING: The device should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the device should be observed to verify normal operation in the configuration in which it will be used.
Recommended separation distances between portable and mobile RF communications equipment and the device
The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of transmitter (W)
Separation distance according to frequency of transmitter (m):
150kHz-80MHz d = 1.2P
80MHz-800MHz d = 1.2P
800MHz-2.5GHz d = 2.3P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1.0
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
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Caution
This User Guide is not intended as a guarantee or warranty. It is intended only as a guide. For medical questions please consult a physician. For additional product information, or a specific product question, please call the toll-free number in the Customer Assistance section of this guide.
In order for Smith & Nephew products to provide safe and proper performance, the following conditions must be met:
· All assembly, operation, adjustment, modification, maintenance and/or repair should be carried out by qualified personnel authorized by Smith & Nephew.
· The electrical installation of the room must comply with the appropriate electrical wiring standards.
· The product must be used in accordance with this User Guide and all applicable labeling.
Failure to comply with these conditions will void any pertinent warranties.
Specifications
Maximum vacuum Power requirements
Fuse Dimensions Weight Operating time battery Battery type Earth protection Patient protection Ingress protection Storage and transport Operational temperature Relative humidity Atmospheric pressure Compliance
200mmHg 100-240VAC
50/60Hz
90VA Dual quick blow fuses 3.15A/250VAC 14.5 x 9.5 x 7in./ 361 x 240 x 170mm 8.14lbs/3.7kg ~ 40 hours (therapy) Lithium ion Class I Type BF IP2X 14-131°F/-10-55°C 41-104°F/5-40°C 30%-70% RH 700mbar-1,060mbar UL 60601-1 IEC 60601-1 IEC 60601-1-2 CAN/CSA C22.2
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Limited warranty
WARRANTY; LIMITATION OF REMEDIES/LIABILITY: Smith & Nephew RENASYSTM Negative Pressure Wound Therapy pumps, disposables and accessories (collectively "Products") are warranted to conform in all material respects to Smith & Nephew's standard specification for a particular Product in effect at the time of Product delivery to the buyer (including any tolerance parameters) for the warranty period for the Products specified below ("Warranty Period"). Smith & Nephew reserves the right to discontinue Products or to change specifications or designs from time to time. For any Products found to be defective during the Warranty Period, this warranty provides and is restricted to, as elected by Smith & Nephew, either (i) repair or replacement of such Products without charge and within a reasonable period of time or (ii) a refund or credit in the amount of the purchase price of such Products. This warranty does not cover and is voided by any of the following: (i) Products packaged or labeled by someone other than Smith & Nephew or its authorized agents; (ii) Products not used in compliance with the specifications, instructions or claims for use of the Products; (iii) RENASYS NPWT pumps used in conjunction with disposables or accessories not specified for use with such equipment; (iv) RENASYS NPWT pumps used in conjunction with reprocessed disposables or accessories; (v) 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 Products including but not limited to storage, handling or cleaning; and (vi) any other damage inflicted to Products 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.
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.
Except as set forth above in this warranty, Smith & Nephew will not be liable for any losses, whether arising from breach of contract, tort (including negligence) or otherwise, and whether or not flowing directly, indirectly or as a consequence of such breach, tort or other cause. This includes, but is not limited to, loss of profit or anticipated savings, loss of anticipated profit, economic loss, loss of data, wasted expenditure and loss of reputation or goodwill. The following Warranty Periods are in effect at this time, which Warranty Periods Smith & Nephew reserves the right to modify:
Products*
Warranty period
RENASYS NPWT pumps
2 years from date of delivery to original buyer
All RENASYS NPWT disposables and accessories
As of date of delivery to original buyer
*See Smith & Nephew's product catalogue for complete listing of specific Product names.
Customer assistance
For more information regarding the device, NPWT System, or for additional customer assistance, please see the Customer Contact Information section in this guide.
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Questions?
For 24/7 NPWT clinical support, call 1-800-876-1261.
With over 150 years of experience in advanced wound care, Smith & Nephew is an industry leader providing innovative solutions to meet the needs of chronic, acute and traumatic wounds across all care settings.
Smith & Nephew, Inc.
USA 970 Lake Carillon Drive Suite 110 St. Petersburg, FL 33716
Customer Care Center 1-800-876-1261 T 727-392-1261 F 727-392-6914
Canada 2250 Alfred-Nobel Blvd. Suite 300 St-Laurent, Quebec H4S 2C9
Customer Action Center T 1-800-463-7439 F 1-800-671-9140
www.smith-nephew.com www.myrenasys.com
©2012 Smith & Nephew, Inc., All rights reserved. TMTrademark of Smith & Nephew. Certain trademarks registered in the US Patent & Trademark Office RA 3000
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