Download DVT User Manual - Advanced Medical Solutions

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vider D
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on
Docuument #10122; rev 13; 7/114/10
Copyrigght ©2010 M
Michigan Medical Innovaations
CA5 USER MANUAL
Table of Contents
User Assistance Information
1
User Maintenance
6
Environmental Conditions
7
General Warnings
2-3
Purpose of Device
3
Troubleshooting
7
Intended Uses
3
Contraindications
8
Description of Device
4
Storage
8
Default Settings
4
Cleaning & Disinfecting
8
Set-Up Instructions
5
Technical Data
Donning Leg Cuffs
5
Disposal
11
AC Adapter
6
Index
11
9-11
Operating Instructions
Manufactured by:
Michigan Medical Innovations
481 Pettis Ave. NE Ada, Michigan 49301 USA
www.michmedical.com
Please Fill in for Future Reference
Date Purchased: ____________________ Serial Number: ______________________
General Warnings
WARNING: Electric shock hazard. Do not remove cover.
WARNING: Do not attempt to service the pump control unit for any reason. Contact DVTCare
for replacement instructions (page 56).
WARNING: If pulsations or throbbing occur, the cuff is wrapped too tight. Loosen
immediately.
WARNING: Stop using device if swelling occurs; consult physician.
Page #2
WARNING: Devicce to be used
d only by thee patient preescribed, andd only for its intended usse.
WARNING: Ensurre the pump control unitt is turned offf and unpluggged from thhe power maains
(wall outtlet) prior to and while clleaning or diisinfecting.
WARNING: Equip
pment not su
uitable for usse in the pressence of a FL
LAMMABLE
E ANESTHE
ETIC
MIXTUR
RE WITH AIR
A OR WIT
TH OXYGEN
N OR NITR OUS OXIDE.
WARNING: Leg cuffs
c
are not to be used in
n direct conttact with thee skin.
CAUTIO
ON: Do no
ot immerse in
n any liquid for any reasson.
CAUTIO
ON: Do not operate dev
vice in a wett environmennt.
CAUTIO
ON: Allow
w cuffs to warrm to room temperature
t
if exposed tto temperatuures below 5° C
CAUTIO
ON: Do no
ot subject thee unit to shoccks, such as dropping the pump unitt.
CAUTIO
ON: Contaiins no servicceable parts. Contact prrovider for sservice (pagee 2)
CAUTIO
ON: Do no
ot place any items
i
in an autoclave.
a
CAUTIO
ON: This unit
u needs to be installed
d according tto informatioon provided in EMC sec. 38.
CAUTIO
ON: Portab
ble and mobiile RF comm
munications equipment ccan affect thee
operation
n of this device.
Purpos
se of Dev
vice
The purp
pose of the CA5
C personall circulation assistant is to aid in thee prevention of Deep Veiin
Thrombo
osis (DVT) by
b helping to
o stimulate blood
b
flow inn the legs. Thhis is accom
mplished by tthe
electronically controllled pump un
nit deliverin
ng a set amouunt of air to the leg cuffss that, in turnn,
compresss the calf(s) to aid blood
d flow out off the lower exxtremities.
This pum
mp unit will inflate
i
to a specified pressure, set byy the user or health care pprovider, annd
deflate on
nce that presssures is reacched. Cycles are repeatedd until the unnit is turned ooff. In additiion to
having siingle and dou
uble leg mod
des, the CA5
5 also incorpoorates adjusttable cycle tiimes (adjustted by
healthcarre providor) to accommo
odate a wide range of treaatment profiiles. The hold and cycle ttimes
can only be adjusted by a healthccare providerr. Internal reechargeable batteries alloow the systeem to
be complletely portab
ble, thus prev
venting many
y interruptioons in treatm
ment.
Inten
nded Use
es
The DVT
Tcare™ CA5
5 is intended
d to be an easy to use, poortable system that is preescribed by
healthcarre profession
nals, to help prevent
p
the onset
o
of DVT
T in patients, by stimulatting blood floow in
the legs (simulating
(
muscle
m
contrractions). Fu
urthermore, tthe unit can be used as aan aid in the
prophylaaxis for DVT
T by persons traveling, orr those expeecting to be sstationary foor long periodds of
time (greeater than 4 hours).
h
The designed
d
porrtability alloows patients to wear the unit during m
many
hospital stay
s related activities,
a
su
uch as physiccal therapy ssessions, whheel chair trannsportation,
cafeteria sittings, and
d during geneeral mobility
y throughoutt the facility.. This devicee can also bee used
by patien
nts to: aid in the preventiion of DVT, enhance bloood circulatiion, diminishh post-operaative
pain and swelling, reduce wound
d healing tim
me, and aid inn the treatmeent and healiing of: stasiss
a
and diabetic
d
leg uulcers, chronnic venous innsufficiencyy, and
dermatitiis, venous staasis ulcers, arterial
reduction
n of edema in
n the lower limbs.
l
Page #3
Descripttion of De
evice
Defau
ult Settings
Pressure Se
et Point
Pressure Lim
mit
Pressure Ad
djustment
Range
R
Hold
H
Time
Cycle
C
Time
Page #4
50 mmHg
50 mmHg
20-50
mmHg
1 second
1 minute
Set-Up Instructiions
NOTE: The
T DVTCa
are CA5 requ
uires EMC precautions,
p
and needs too be installedd and put intto
service according thee EMC inforrmation prov
vided at www
w.michmedical.com/ca5emcdata
NOTE: Portable
P
and mobile radio frequencyy communicaations can afffect the DVT
TCare
CA5
1. For future refference, enterr the date of purchase annd unit Seriall Number fouund on
th
he rear label of each pum
mp unit) in th
he spaces proovided on paage 2.
2. Remove
R
item
ms from pack
kaging and pllastic bags (iif present).
3. Make
M
sure alll of the piecees listed on page
p
4 are reeadily availaable.
4. In
nspect all components fo
or damage. If any parts aappear damaaged or are
in
noperable, co
ontact Provid
der Customeer Service (ppage 1)
5. Uncoil
U
the tub
bing attached to the cufff(s).
6. Apply
A
garmen
nts to leg callf (see Donning Leg Cufffs on page
6), route tubin
ng under clo
othing or in a manner to pprevent a
trripping hazarrd and to avo
oid kinking.
7. Ensure
E
metal thumb tabs on the pump
p units air ouutlets are
depressed to allow
a
the airr tube connector to engagge.
8. In
nsert pump in
n pouch and align the pu
ump air outletts with the
tw
wo access ho
oles in the po
ouch.
9. Connect
C
air tu
ube(s) to pum
mp air outletts by routingg them throuugh the carryy
pouch air access holes.
10. Secure carry case as desirred using thee strap or bellt loop proviided.
Donn
ning the Leg
L Cuffs
s
M
sure thaat the securin
ng Velcro iss on the insidde of the
1. Make
slleeve relative to your leg
g.
2. Place the cufff so the midd
dle of the blaadder outlinee is against
th
he back of yo
our calf with
h the air tubee fitting facinng out.
3. Wrap
W
the cuff
ff around you
ur calf so thaat it is a snugg fit.
4. Adjust
A
as neccessary.
WARNING:
W
ng occur, thee cuff is
If pulsationss or throbbin
wrapped
w
too tightly.
t
Loossen immediaately.
AC
C Adapterr
Insert thee supplied po
ower supply plug into th
he adapter jacck in the pum
mp and connnect the pow
wer
supply ad
dapter to a 100-240V~ wall
w socket. The
T batter chharge LED w
will illuminaate while chaarging
battery an
nd remain tu
urn off when charge is co
omplete. It w
will not be illluminated if the charger is not
connected. To maxim
mize perform
mance during
g extended ooperation, connect AC addapter while in
use. Full charge is ap
pproximately
y 7.0 volts.
U power su
upply provid
ded ITE FJ-S
SW1280c0299
NOTE: Use
Input: 110-240V~, 50
0/60Hz, 0.5A
A
Output: +12V
+
- - - 1.2 A
NOTE:
N
To iso
olate unit, un
nplug from AC
A adapter/ppower supplly.
Page #5
Operating Instructions
1. After following the set-up instructions on page 5, ensure leg cuffs are
firmly around legs as indicated on page 5.
2. To turn the system on, press and hold the power button for 2
seconds.
3. The system will self diagnose and the display will show the
remaining battery voltage followed by the current set pressure. If
battery voltage is below 5.8, connect the power supply prior to use. Any error
codes will be displayed as well (see page 7). If the unit will not
power on, connect the wall supply to charge battery. Unit may be
used while plugged into wall outlet.
4. Set pressure by using the  and  buttons, to either increase or
decrease the set pressure.
wrapped
5. Press the “Mode” button to change between single and double leg
modes.
6. While in “Double Leg” mode, only one leg cuff fills at a time. The
leg bladders vent immediately after filling and continue to vent
until the next cycle.
7. Healthcare providers please reference supplemental instructions for entering the “Health
care provider access code” to adjust the upper pressure limit and access the reset function.
8. Pressure adjustments can be made at any time during the cycle, by pressing the  or 
arrow keys. Each press will change the pressure in 1mmHg increments. Press and hold
either key for 1 second to scroll in 5mmHg increments.
9. To turn off the pump unit, depress and hold the power button for approximately 2 seconds.
10. To maximize performance during extended operation, connect AC adapter while in use.
11. To remove cuff, pull securing straps and unwrap from leg.
12. To disconnect the air tube from pump unit, depress thumb tab on pump unit while pulling
the tube away.
User Maintenance
WARNING: Do not attempt to service the pump control unit for any reason.








Inspect the unit and components for any damage that may have occurred during shipping or
general handling prior to each use (ie: cut cord, split air tubes, cracked plastic housing, torn
cuff, etc). Refer to Description of Device (pg 5) for description of all components.
Do not attempt to connect the wall supply if any damage is noticed.
Avoid subjecting the unit to shocks, such as dropping the pump unit.
Notify provider for immediate replacement of any kinked or damaged tubes.
Do not handle the leg cuffs with any sharp objects. If bladder is punctured, do not repair.
Roll cuff for storage transportation; avoid folding or creasing the bladder.
Battery is not replaceable – return unit to provider.
This device is not protected by a protective earth ground.
Page #6









Environme
ental Con
nditions
Do no
ot expose deevice to direcct sunlight.
Do no
ot operate pu
ump below 0o C (32o F).
Do no
ot expose to heat exceed
ding 65o C (1
149o F).
Do no
ot operate th
he pump if itt has been sto
ored in freezzing conditioons. Allow ccuffs to warm
m to
room
m temperaturee if exposed to temperatu
ures below 5 o C (41o F)..
Do no
ot unroll or don
d the leg cuff
c in below
w freezing tem
mperatures ((0o C / 32o F)) as damage tto the
air blladder can occcur, making
g it unable to
o hold pressuure.
Do no
ot expose deevice to a dirrect heat sou
urce with tem
mperatures exxceeding 500o C (122 o F)) for
exten
nded periods of time.
Storee in a dry loccation betweeen +10 o C (5
50 o F) and +
+40 o C (1044 o F), 30% -775% relativee
humidity.
Transsport temperrature and reelative humid
dity: Temperrature Rangee -20o C (-4o F) to +60o C
o
(140 F); Relativee Humidity 30%
3
tp 75%
%; Keep Dry
Norm
mal Operating Conditionss: Temperatu
ure Range + 10o C (50o F
F) to +40o C ((104o F); Rellative
Humidity 30% o 75%
Troub
ble Shooting
Prroblem
Solution
Air tube outlet conneector will not fit in port
Unit willl not turn on
Cannot feel
fe pressure on leg(s)
Pressure is too high on
o leg
HI
LO
Lb
Er
Controll unit detecteed high
pressuree
u
ed
Pressure cuff(s) is under-inflate
w not operaate
Pump will
Battery pack has ex
xpired.
w not operaate.
Pump will
Make ssure the metaal thumb latcch is pressedd until
it clickks, such that the tube connnector will enter
the air outlet fittingg.
Batter charge is tooo low. Connnect unit to a wall
supplyy for a fresh ccharge and tturn on.
Cuff iss not wrappeed tightly enoough
Air tubbes are not connected
Bladdeer is damageed and will nnot hold air
Tube iss damaged
Ensuree “Double Leeg” mode is selected whhen
using bboth cuffs
Verify settings are correct as pprescribed byy
physiciian
Decreaase pressure setting. Conntact physician.
Removve any kinkss from line. B
Be sure all tuubes
are nott tangled or cconstricted. S
Start pump aagain.
Make ssure tubing iis properly cconnected. L
Listen
and loook for air leaaks.
Batteryy charge is loow. Connectt charger.
Contacct DVTCaree
Contacct DVTCaree for return innformation.
If problems persist, contact
c
yo
our equipm
ment provid
der as per page 1.
Page #7
Contraindications
The DVTCare CA5 should not be used to treat the following conditions.
 Persons with suspected, active or untreated: deep vein thrombosis, ischemic vascular disease,
severe arteriosclerosis, pulmonary edema, congestive heart failure, thrombophlebitis or an
active infection.
 It is not recommended for use on a leg where cuffs would interfere with the following
conditions: vein ligation, gangrene, dermatitis, open wounds, a recent skin graft, massive
edema or extreme deformity of the leg.
 Not for use with patients with neuropathy.
 Do not use on extremities that are insensitive to pain.
 Do not use where increased venous or lymphatic return is undesirable.
 Leg cuffs are not to be used in direct contact with skin.






Storage
o
Store in a dry location between +10 C (50 o F) and +40 o C (104 o F), 30% -75% relative
humidity.
Do not expose to heat exceeding 65o C (149o F).
Do not store items in direct sunlight.
Ensure zipper/covers of the carry pouch/storage bags are firmly closed to prevent dust and
damage.
Roll cuff and do not fold, as folding will decrease the life of your product.
Connect unit to charger for recharge no less than 6 hours every 30 days to preserve integrity of
internal batteries.
Cleaning and Disinfecting
Note: Inspect the DVTCare unit and follow the cleaning and disinfecting procedures prior to each
use.
WARNING: Device must be turned off and disconnected from the wall outlet prior to and while
cleaning or disinfecting.
CAUTION: Contains no serviceable parts. Contact equipment provider for service.
CAUTION: Do not place any items in an autoclave.
CAUTION: Do not immerse pump unit in any liquid for any reason.

Clean the outer surface of the pump unit using a soft cloth, moistened with soapy water or 70%
isopropyl alcohol.
 Do not use bleach on any item.
 Do not use abrasive or volatile cleaners – display could become scratched and hard to read.
 Do not place cuff or carry pouch in dryer, as the bladder could melt.
 Hand wash exterior of cuff and carry pouch using a soft cloth moistened with soapy water or
70% isopropyl alcohol and let air dry.
 To ensure product is completely dry prior to use, leave unit in the off condition and
disconnected from power (wall outlet) for 30 minutes after cleaning or disinfecting.
Note: Inspect unit and follow the cleaning and disinfecting procedures prior to each use.
Page #8
Technic
cal Data – DVTCarre Model CA5
Electro Magnetic
M
Compatibility Data
D availab
ble at www.m
michmedicall.com/ca5em
mcdata
Refer to useer manual fo
or further insstructions.
This symbo
ol designatess the degree of protectionn against eleectrical shocck as being a type
BF applied
d part.
This unit iss an electrom
mechanical device that inncludes printted circuit booards and
rechargeablle batteries. Do
D not discaard in landfil l. Consult loocal, state, federal and coountry
requiremen
nts for properr disposal in
nstructions.
The use of accessories,
a
transducers and cables oother than thhose specifieed, may resuult in
increased em
missions or decreased im
mmunity of tthe DVTCarre CA5.
Designatess Class II meedical electriical equipmeent.
The cuffs are
a single-use devices. One
O patient m
may use a cufff multiple tiimes, but a ssingle
cuff may no
ot be shared
d between paatients.
~
Alternating
A
Current
C
D
Direct Curreent
Fragile
T
This end up
Temperature Limiits
Keep away from rain
General (Technical Data Contiinued)
i
(15 x 10 x 4 centemeters)
Size: 5.9 x 3.9 x 1.6 inches
0 kg)
Weight: 1.1 lbs (0.50
otected again
nst the ingreess of water ((ordinary prootection, IPX
X0).
This deviice is not pro
mable anesthhetic mixturre with air orr with
Equipmeent is not suittable for usee in the preseence of flamm
oxygen or
o nitrous oxide.
Page #9
Power
This device is internally powered and operates under continuous loading. This device is not
protected by a protective earth ground.
Power Supply: ITE FJ-SW1280c029
Input: 110-240V~, 50/60Hz, 0.5A
Output: +12VDC 1.2 A
NOTE: This power supply is not approved for hospital, oxygen rich use.
Battery*:
Single-leg mode run time:
Double-leg mode run time:
Recharge time:
Approximate number of charges:
* Based on default settings
17 hours
8 hours
3-4 hours
500 Cycles
NOTE: Recharge batteries using only the power supply supplied with this system. Batteries are
best cycled a minimum of once every 60 days to sustain 500 cycle life.
NOTE: This unit is provided with rechargeable batteries and are not replaceable. Return to
provider for service (see page 1).
Default Settings
Pressure
Hold Time
Cycle Time
50mmHg
1 second
60 seconds
Feature Adjustment Range
Pressure
20-65 mmHg
Hold Time
Not adjustable
Cycle Time
60-75 seconds
Tolerances
Pressure
Cycle Time
Displayed battery charge
Recharge Time
Single-leg run time
Double-let run time
±4 mmHg
±1 second
±0.1 V
3-4 hours
17 hours
8 hours
Explanation of button functions
1. Power
Depress and hold to turn unit on. Depress and hold to turn unit off.
2. Up Arrow
Depress briefly to increase pressure by 1mmHg. Depress and hold to increase pressure by
5mmHg increments.
3. Down Arrow
Depress briefly to decrease pressure by 1mmHg. Depress and hold to decrease pressure by
5mmHg increments.
4. Mode
Depress briefly to change from single-leg mode to double-leg mode and vice versa. Confirm
garment connections to “single-leg” fitting when in single-leg mode and garment connections
to both fittings when in double-leg mode.
Page #10
Explanation of LED indicators
1. Single-leg mode Indicates unit is operating in single-leg mode.
2. Double-leg mode Indicates unit is operating in double-leg mode.
3. Charge status If charge light is on, unit is charging. If charge light is off, charging, while
connected to power supply and plugged into wall power supply, charge is complete.
Disposal
This unit is an electromechanical device that includes printed circuit boards and rechargeable
batteries. Do not discard in landfill. Consult local, state, federal and country requirements for
proper disposal instructions.
Cuffs may be discarded in US landfills.
Index
A
E
S
Assistance, 1
Environment, 7
Set-Up, 6
AC Adapter, 5
Error Codes, 7
Single Leg, 6
B
Starting, 6
H
Battery, 10
H1, 7
C
Storage, 8
L
T
Cautions, 5
Lb, 7
Troubleshooting, 7
Cleaning, 8
L0, 7
Turning Off, 6
Contraindications, 8
Cuffs Using,
5
Customer Service, 2
D
Default Settings, 10
Description, 4
M
W
Maintenance, 8
Warnings, 2,3
Mode, 6
Wrapping, 5
O
Operating, 6
P
Disposal, 11
Phone Numbers, 1
Double Leg, 6
Pressure Adjust, 6
Page #11
See Service Provider Documentation for
Service and Technical Support Information.
Page #12