Celleration orporated CP-80033 Ultrasound Healing Therapy User Manual

Celleration Incorporated Ultrasound Healing Therapy

User Manual

GENERATOR
1 Generator
2 Power Switch (Back of Generator)
3 Generator Power Cord
4 Peristaltic Pump
5 Tubing Guides
6 Adjustable Hook
7 Indicator Light
8 Treatment Wand Connector
9 Treatment Wand Cradle
10 USB Port/Cover
TREATMENT WAND
11 Treatment Wand
12 Display Screen
13 Keypad
14 Treatment Wand Cable with Connector
15 Tubing Channel
16 Treatment ON/OFF Button (Trigger)
17 Treatment Wand Tip
APPLICATOR
18 Applicator
19 Tubing-Cable Clip
20 Tubing Clamp
21 Infusion Tubing
22 Tubing Spike
23 Tubing Spike Protective Cover
PLEASE READ INSTRUCTIONS BEFORE USE.
UltraMIST
™
System
ULTRAMIST™ SYSTEM INSTRUCTIONS FOR USE
Other Materials Required
• 0.9% Normal Saline 100cc - 1000cc bag
• Germicidal wipes for cleaning/disinfecting
• Absorbent pads
Caution: Rx Only. This medical device is to be operated by a healthcare professional in accordance with the instructions for use.
Generator Treatment Wand
Applicator
1
2
3
4
567
8
9
10
11
12 13
14
15
16
17
18
19
20
21
22
23
PL-61044_B 1
Clean the UltraMIST System prior to and after each treatment session with the Power Switch in the “off” position.
CLEANING THE ULTRAMIST SYSTEM
Do not sterilize the treatment wand including tip with steam,
ETO, radiation, gas/plasma, or cold sterilants. After completion
of the UltraMIST treatment, repeat the cleaning process.
PREPARING THE PATIENT FOR TREATMENT WITH THE ULTRAMIST SYSTEM
Collect all required materials (generator, treatment wand,
applicator, IV saline, germicidial wipes, absorbent pads
and gloves).
Use facility approved Infection Control Procedures
throughout the treatment session.
Treatment with the UltraMIST System will require a clean
environment.
Depending on the wound location, position the patient in
a comfortable position for treatment.
WARNING: The UltraMIST applicator is designed as a single patient-use disposable unit to avoid contamination. Do not
re-sterilize or reuse applicators. Re-using the applicator and/or saline may result in infection and degraded performance.
DESCRIPTION & INDICATIONS FOR USE
Description: The UltraMISTTM System delivers low frequency ultrasound to the treatment site using a noncontact saline mist.
Indications for Use: The MIST Therapy System produces a low energy ultrasound-generated mist used to promote wound healing
through wound cleansing and maintenance debridement by the removal of fibrin, yellow slough, tissue exudates and bacteria.
Contraindications: Do not use near electronic implants/prosthesis (e.g. Near or over the heart or over the thoracic area if the patient
is using a cardiac pacemaker); on the lower back during pregnancy or over the pregnant uterus; over areas of malignancies.
Potential Complications: Tingling, redness.
CONTRAINDICATIONS & POTENTIAL COMPLICATIONS
Prior to treatment, clean the entire system using facility approved
infection control procedures.
PL-61044_B 2
1
2
3
4
Remove soiled dressings and discard all contaminated
materials (gloves, dressings, pads) prior to UltraMIST
treatment.
Place an absorbent pad under the portion of the patient
being treated to collect the saline runoff.
Measure the area of the wound to be treated.
5
6
7
12
ULTRAMIST™ SYSTEM INSTRUCTIONS FOR USE
Preparing the UltraMIST System continued on next page
PREPARING THE ULTRAMIST™ SYSTEM
Withthepowerswitchinthe‘o’posion,plugthe
supplied generator power cord into the back of the
generator and into an electrical outlet.
1
Ensurethetreatmentwandcableisaachedandfully
seated to the front of the generator by aligning the red
mark on the cable with the red mark on the connector.
2
Turn the power switch located on the back of the
generatortothe‘on’posion.
3
Aertheself-testiscompleted,usethekeypadonthe
treatment wand to select the number of wounds to be
treated. Press toconnue.
4
Use the keypad to enter the size of each wound to be
treated per the screen prompts.
5
The total saline requirement for the combined treatment
area is displayed (approximately 100mL for every 25
cm2). Select the appropriate saline bag size. Press to
connue.
6
The display screen will ask for the applicator to be
loaded. Remove applicator from packaging and press
the applicator onto the treatment wand. Ensure the
applicatorisfullyseatedpriortousewiththemetalp
visible in the center.
7
Note: Aer the set up is complete, DO NOT remove the applicator
unl the treatment has been fully concluded. This is a single use
product that once removed will need to be replaced with a new
applicator.
Up
Down
Back Select
(Forward)
-- Treatment TimeWound Number --
-- Wound Size
PL-61044_B 3
20-29
ULTRAMIST™ SYSTEM INSTRUCTIONS FOR USE
PREPARING THE ULTRAMIST™ SYSTEM
Allowthesalinetorunthroughtheapplicatortubingunl
salineisnotedatthedistalp.Closethetubingclamp.
10
Ifulizingtheadjustablehook,posiongeneratornearthe
edgeofaatworksurface(i.e.tabletoporcart).Extend
thehookbeyondtheedgeandaachthesalinebag.
Adjustposionasnecessarysothesalinebaghangsfreely
and the generator is stable.
11
The display screen will ask for the saline pump to be
loaded. Open the saline pump door.
12
Loop the applicator tubing from the saline bag through
thesalinepumpfromletoright,centerontubing
guides, and close the pump door. Leave enough tubing
toallowthesalinebagtohangfreelywiththemajorityof
the tubing between the pump and treatment wand.
13
Openthetubingclamp.Salinewillnotowunlthe
treatmenton/obuonisiniated.
14
The system is now set up and ready for treatment.
Note: Saline will only ow in conjuncon with ultrasound
delivery.
-- Total Treatment Time
Number of --
Wounds
-- Treatment Time
for Wound 1
PL-61044_B 4
Remove saline bag from outer packaging. Remove the
protecvecoverfromapplicatortubingspikeandfrom
saline bag port. Insert spike fully into saline bag.
9
Insert applicator tubing into the treatment wand tubing
channelandaachthetubingcliptothetreatmentwand
cable. Place treatment wand in cradle once completed.
8
ULTRAMIST™ SYSTEM INSTRUCTIONS FOR USE
Tubing Guides
TREATING THE PATIENT WITH THE ULTRAMIST™ SYSTEM
The treatment wand should be oriented so that it is perpendicular to the
wound with the leading edge of the applicator approximately 0.5 to 1.5 cm
(0.2-0.6 inches) from the wound.
Depressandreleasethetreatmenton/obuon(trigger)onthetreatment
wandhandle.Thiswilliniateboththesalineowandultrasounddelivery.
Thetreatmentmerwillstarttocountdownonthedisplay.
1
The UltraMIST System will begin to deliver the ultrasound through a
connuousmist.Movethetreatmentwandvercallyacrossthewound
usingmulplepasses.Followthisbymovingthetreatmentwand
horizontallyacrossthewoundusingmulplepasses.Thetreatmentwand
should be moved across the wound using slow, even strokes.
Audible (gurgling) and surface visual bubbling may occur. This is normal
when moving back and forth through the recommended treatment range.
For best results, the treatment wand should be perpendicular to the wound
andparalleltotheoorduringtreatment.
Note: It is important to maintain a 0.5 to 1.5 cm (0.2 – 0.6 inch) distance from
the leading edge of the applicator to the treatment area at all mes to maximize
therapeuc eect.
3
Connuetreatmentunl3audibletonessoundindicangtheendof
treatmentme.Theultrasoundandsalinewillautomacallystop,ensuring
accuratetreatmentmeforthewoundsizeselected.
If there is more than one wound to treat, the next wound screen will
appear.Pressthetreatmenton/obuontostarttreangthenextwound.
Note: if at anyme during the treatment it is determined addional me will be
required, use the up/down buons to add me in increments of 1 minute. Press
to connue.
5
Note: You may pause treatment by depressing and
releasing the treatment on/o buon. The treatment
mer will be paused unl restarted.
0.5 - 1.5 cm

13:00
Wound 2
Acve
3:00
Treating the Patient continued on next page PL-61044_B 5
2
4
0.5 - 1.5 cm
ULTRAMIST™ SYSTEM INSTRUCTIONS FOR USE
ULTRAMISTTM SYSTEM SHUTDOWN PROCEDURE
Turnpowerswitchtoo.Clampthetubingwiththepinch
clamp. There may be saline remaining in the bag which
is normal depending upon the size of the wound being
treated.
1Remove the tubing from the treatment wand channel and
pump, remove the applicator from the treatment wand
andsalinebagfromadjustablehookanddiscard.Follow
facility approved biohazard disposal procedures.
Usethefacility’sapprovedinfeconcontrolproceduresto
clean the system.
2
USB PORT
The generator USB port is designed for the following:
• DownloadencryptedperformancedatatoaCelleraonapprovedUSBdrivefortroubleshoongpurposes
• UploadsowareupgradesfromaCelleraonprovidedUSBdrive
Specicinstruconsforuseoftheportwillbeprovidedwhenrequired.
Note: System does not collect and/or store paent specic data. All data is encrypted to prevent usage by unauthorized personnel.
WARNING: DO NOT ATTACH ANY UNAPPROVED USB DRIVES, CABLES, OR EQUIPMENT TO THE DRIVE AS IT
MAY INTERFERE WITH OPERATION OF THE DEVICE.
Accessing USB Port
• Remove Treatment Wand from Generator cradle and set aside
• Turn Generator over
• Usingacoinoratheadscrewdriver,rotatethelockcounterclockwiseaquarterturntounlockandremove
the cover
• Toreplacethecover,posionitovertheport,thenusingacoinoratheadscrewdriver,rotatethelock
clockwise a quarter to lock the door in place
TREATING THE PATIENT WITH THE ULTRAMIST™ SYSTEM
Once all the wounds are completed, the summary screen will
be displayed.
2 Wounds
110-139 cm2
17:00
2
Completed -- Result
-- Total Size
Total Time --
Wound Count --
NOTE: To cancel a treatment at any me press the back
buon. The “cancel treatment” screen will appear. Use
the up down buons to select “yes” or “no” then press
select. If you cancel treatment, the treatment summary
screen will appear.
23:00
Cancel
Treatment?
1
2
PL-61044_B 6
6
ULTRAMIST™ SYSTEM INSTRUCTIONS FOR USE
COMMON ERRORS (noted on display screen)
#ERROR CAUSE SOLUTIONS
008 OVERHEAT Treatment wand temperature has
exceeded the allowed limit



the system
20 minutes is the expected maximum treatment


to count down the minutes required to cool
the system. Once this completes, the “paused
treatment” screen will appear and the treatment
can now be completed.
DO NOT TURN OFF SYSTEM during cool down (this
will require a replacement of the applicator)
200 INVALID
REPLACE APPLICATOR
Applicator has been previously used
and should be replaced
Replace applicator
201 REPOSITION
APPLICATOR

treatment wand
Adjust current applicator properly on treatment
wand
202 MAX USE
REPLACE APPLICATOR
Applicator has been used for the


203 NOT READING
APPLICATOR
Applicator is not being sensed by
treatment wand
Properly align the applicator on the treatment
wand


INDICATOR LIGHT (located on front of generator)
RED A
GREEN 
PL-61044_B 7
ULTRAMIST™ SYSTEM INSTRUCTIONS FOR USE
PROBLEM CAUSES SOLUTIONS
SYSTEM WILL NOT TURN ON System not plugged in and/or power
cord not properly seated in the
generator outlet on back of
instrument
Ensure power cord is plugged in and properly

and the other end to the power outlet
Power is not being delivered to outlet 
on
Fuse is missing or blown on system 
NO POWER TO TREATMENT WAND

System is not turned on Toggle power switch located on back of system

Treatment wand is not connected to
the generator
Insert or re-insert treatment wand cable into
connector or generator
SINGLE KEY ON KEYPAD NOT
FUNCTIONING
Mechanical failure 
ALL KEYS ON KEYPAD NOT
FUNCTIONING
 

Customer Service
OVERHEAT Treatment wand temperature has
exceeded the allowed limit




20 minutes is the expected maximum treatment


to count down the minutes required to cool
the system. Once this completes, the “paused
treatment” screen will appear and the
treatment can now be completed.
DO NOT TURN OFF SYSTEM during cool
down(this will require a replacement of the
applicator)
ERROR MESSAGE ON DISPLAY
SCREEN
An error has occurred Refer to the common errors table to determine

the contents of the error message and call

TROUBLESHOOTING
Troubleshooting continued on next page
PL-61044_B 8
ULTRAMIST™ SYSTEM INSTRUCTIONS FOR USE
PROBLEM CAUSES SOLUTIONS
NO SALINE OR INSUFFICIENT
SALINE IS COMING OUT OF
APPLICATOR
Wound ready screen is not visible on
display screen

screen is seen on display

for treatment to begin
Ensure system power is on and press treatment

Saline pump door is open Close pump door
Tubing is not properly loaded in the
saline pump
Load tubing into saline pump using tubing
guides and close pump door
Tubing is clamped 
 Unkink or remove knot from tubing

aligned in center of applicator


applicator opening and fully seated on the
applicator housing
Tubing spike not fully mated with
saline bag
Ensure spike and saline bag are fully mated
SALINE LEAKING AROUND
APPLICATOR

aligned in center of applicator


applicator opening

treatment caused saline to
accumulate inside applicator


DAMAGED APPLICATOR Damaged in shipment Replace with new applicator
OPEN OR DAMAGED STERILE
APPLICATOR PACKAGE
Damaged in shipment Replace with new applicator
TROUBLESHOOTING
PL-61044_B 9
ULTRAMIST™ SYSTEM INSTRUCTIONS FOR USE
Caution: Federal law restricts this device to sale by or on the order
of a licensed practitioner.
Risk of electric shock - Do not remove cover or loosen cable
connections. Refer servicing to qualified service personnel.
Do not use if treatment wand or cables show evidence of
deterioration or damage. Discard disposable applicator
components appropriately.
Risk of burns - Do not touch the metal tip of the treatment wand
during operation - Never depress treatment on/off button without
applicator in place.
Always have the applicator properly seated and tubing clamp open
when activating the treatment on/off button.
Treatment effectiveness may be diminished if any of the
following occur:
The applicator is not fully engaged, aligned and securely
attached to the treatment wand.
The distance between the leading edge of the applicator and
the wound is greater than 1.5 cm (0.6 inches).
The treatment wand is not held perpendicular to the wound.
WARNINGS PRECAUTIONS
For technical questions about the operation of the UltraMIST System contact Celleration Customer Service:
PHONE: 1-866-307-MIST (6478)
ADDRESS: 6321 Bury Drive, Suite 15, Eden Prairie, MN 55346
WEBSITE: www.Celleration.com
EMAIL: customerservice@celleration.com
TECHNICAL SERVICE
ULTRAMIST™ PRODUCT SPECIFICATIONS
SAFETY REQUIREMENTS 
ETL listed as ‘Conforms to UL 60601-1’

ELECTRONIC COMPATIBILITY
SYSTEM CLASSIFICATION
Meets the requirements of IEC 60601-1-2 and FCC Part 18
Class II equipment
Type BF applied parts
STERILIZATION METHOD
IPX RATING

Generator: IP21
Treatment Wand: IP22
INPUT
DETACHABLE POWER CORD
CURRENT
FUSE
100-240 VAC; 50-60Hz
125V, 10A UL or equivalent listed for hospital grade. Note: this Class II equipment

2.0A
T2AL250V
OPERATING AND STORAGE
CONDITIONS
º to 25º C
Atmospheric Pressure: 700 to 1060 mmHg
Applicator/System Transport and Storage: Temperature: -25º to 75º C
Relative Humidity: 30% to 75% (non-condensing)
ACOUSTIC OUTPUT POWER Operating Frequency: 40 Khz ± 1 Khz
Maximum Unintentional Ultrasound Energy: < 100mW/cm2
Tip Displacement Range: 65µm ± 10µm
PL-61044_B 10
ULTRAMIST™ SYSTEM INSTRUCTIONS FOR USE
PL-61044_B 11
CONTROL LOCATION FUNCTION
 Back panel of generator Controls power to the system
Keypad Treatment control panel Allows full set up of treatment parameters
Treatment ON/OFF  Front treatment wand handle 
Note: No parts of the UltraMIST System are serviceable during use or by user.
EXPLANATION OF SYMBOLS
FREQUENTLY USED FUNCTIONS OF THIS SYSTEM
Fragile, Handle with Care
This End Up
Keep Dry
Recycle

in the European Community
CE Mark
Temperature Limit

for Use
Manufacturer
Date of Manufacture
Lot Number

Device
Do Not Reuse
Use-By Date

ETL Symbol
Class II Equipment

Type BF Applied Part
Serial Number
Catalog Number
Up
Down
Back
Select

Do Not Dispose in
Municipal Waste
Open Closed

Accompanying Documents
Do Not Allow Fingers to
Contact Moving Parts Do Not Resterilize
ULTRAMIST™ SYSTEM INSTRUCTIONS FOR USE
Operation of the UltraMIST System is limited to the following:
PL-61044_B 12

of the UltraMIST Therapy System should assure that it is used in such an environment.
Emissions Test Compliance 
RF emissions
CISPR 11
Group 1 TheUltraMISTSystemusesRFenergyonlyforitsinternalfuncon.
Therefore, its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions
CISPR 11
Class A The UltraMIST System is suitable for use in all establishments other
thandomesc,andmaybeusedindomescestablishmentsandthose
directly connected to the public low-voltage power supply network that
suppliesbuildingsusedfordomescpurposes,providedthefollowing
warning is heeded:
Warning: This equipment/system is intended for use by healthcare
professionals only. This equipment/system may cause radio
interferenceormaydisrupttheoperaonofnearbyequipment.It
maybenecessarytotakemigaonmeasures,suchasre-orienngor
relocangtheUltraMISTSystemorshieldingthelocaon.
Harmonic emissions
IEC 61000-3-2
Class A
Voltageuctuaons/icker
emissions
IEC 61000-3-3
Complies
Ref. IEC 60601-1-2:2007 §5.2.1.1
Emissions Test Compliance 
MaximumAcouscOutput
Power
Complies TheUltraMISTSystemrequirementfortheMaximumAcouscOutput
Power is that the measured value be less than 3W/cm2, which is a
requirementestablishedbytheWorldHealthOrganizaonforacousc
safety.Theactualoutputissignicantlylessthantheabovelimit,which
is considered to be safe.
SidewallRadiaon Complies TheUltraMISTSystemrequirementforSidewallRadiaonisthatthe
measured value be less than 100mW/cm2, which is a requirement
establishedbytheWorldHealthOrganizaonforacouscsafety.
Theactualoutputissignicantlylessthantheabovelimit,whichis
considered to be safe.
Ref. TR-75143 on le at Celleraon


ULTRAMIST™ SYSTEM INSTRUCTIONS FOR USE

ULTRAMIST™ SYSTEM INSTRUCTIONS FOR USE
PL-61044_B 13
Reference PC-50186 for printing requirements.
6321 Bury Drive Suite 15
Eden Prairie, MN 55346
phone: 952.224.8700
fax: 952.224.8750
customer service: 866.307.MIST (6478)
email:info@celleraon.com
web:www.celleraon.com
patentinformaon:www.Celleration.com/company/IP
The UltraMIST System has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the
FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential 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 inference to radio communications. However, there is no guarantee that interference will not
occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be
determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the
following measures:
• Reorientorrelocatethereceivingantenna.
• Increasetheseparationbetweentheequipmentandreceivers.
• Connecttheequipmentintoandoutletonadifferentcircuitdifferentfromthattowhichthereceiverisconnected.
• Consultthedealeroranexperiencedradio.TVtechnicianforhelp.

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