Portable Therapeutix SQUID Model One User manual

ACTIVE COLD COMPRESSION DEVICE & COLD PACK
(OVER-THE-COUNTER USE)
REUSABLE
INSTRUCTIONS FOR USE
PORTABLE THERAPEUTIX LLC
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GO DEEP
TABLE OF CONTENTS
PACKAGE COMPONENTS & ACCESSORIES.............................................................1
TECHNICAL DESCRIPTION............................................................................................. 2
INDICATIONS FOR USE.................................................................................................... 3
WARNING.............................................................................................................................. 4
CONTRAINDICATIONS..................................................................................................... 4
KNOWN AND FORESEEABLE RISKS............................................................................ 5
CAUTIONS............................................................................................................................. 6
SAFETY INFORMATION ....................................................................................................7
BATTERY INFORMATION AND CHARGING...............................................................7
OPERATING INSTRUCTIONS...................................................................................9-10
AVAILABLE SQUID WRAPS...................................................................................11-12
QUICK START GUIDES (ALL MODELS)............................................................ 13-24
CLEANING...........................................................................................................................25
OPERATING CONDITIONS............................................................................................25
STORAGE AND TRANSPORTATION...........................................................................26
STORAGE AND TRANSPORTATION CONDITIONS...............................................26
TROUBLESHOOTING................................................................................................27-28
SYMBOL DESCRIPTION .................................................................................................29
INFORMATION ON LI-ION BATTERIES....................................................................29
INFORMATION ON ELECTROMAGNETIC COMPATIBILITY............................. 31
GUIDANCE AND MANUFACTURER’S DECLARATION EMISSIONS...............32
GUIDANCE AND MANUFACTURER’S DECLARATION-IMMUNITY....... 33-34
RECOMMENDED SEPARATION DISTANCES FROM SQUID ............................35
WARRANTY................................................................................................................. 36-37
SUPPORT....................................................................................................... BACK COVER
Read instructions prior to use.
Manufactured for Portable Therapeutix - Houston, TX
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Squid Pump
Control Unit
Squid Wrap
Connector
Tube
AC Adapter
(Power Supply)
Barrier Cloth*
* Type BF applied part
* Barrier Cloth not included with ankle and shoulder models
This manual describes the Portable Therapeutix Squid Model One Cold
Compression (“Squid”) device and Cold Pack, and provides instructions
for its use. Please read the entire manual carefully before use. This
manual contains information, contraindications, and warnings that
must be observed to ensure safe operation and maintain the Squid
Model One in a safe condition. The Squid Model One MUST be used
in accordance with the instructions.
PACKAGE COMPONENTS & ACCESSORIES
ABOUT THIS MANUAL
FIGURE 1 – PACKAGE COMPONENTS & ACCESSORIES
PUMP COMPONENTS:
WRAP COMPONENTS:
Reusable Cold
Gel Pack
GEL PACK:
Potential patient contacting materials include the following:
• Wrap – Nylon with TPU backing
• Gel Pack – Ethylene-Vinyl Acetate (EVA)
• Barrier Cloth – Polyester
1
TABLE 1 – MODE DESCRIPTION
The Squid Model One combines cold therapy with intermient
compression. The Squid Model One Pump provides intermient air
pressure to an air bladder in the Wrap. Wraps come in a variety of
sizes to best fit the treatment area. Pump pressure, inflate cycle
time and deflate cycle time are automated to control the amount of
compression and the treatment time. For patient comfort, there are
4 modes (Table 1), which have different peak pressures and time on
and time off cycles. The total duration of treatment is 15 minutes.
TECHNICAL DESCRIPTION
DEFAULT
MODE
PEAK
PRESSURE
(ON)
30 50 70 85
mmHG mmHG mmHG mmHG
mmHG mmHG mmHG mmHG
40 35 30 25
seconds seconds seconds seconds
20 25 30 35
seconds seconds seconds seconds
1515
minutes 15 minutes 15
minutes minutes
LOW
PRESSURE
TIME
ON
TIME
OFF
DURATION
2
0000
312 4
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FIGURE 2 – MODE DISPLAY
Mode Selection
Button
Start Button
Power Button
WRAPS
Squid Model One Wraps come in various sizes and configurations
for specific body parts and uses. Never use any wrap or Squid Model One
Cold Gel Pack directly on the skin. Always use the included cloth or
clothing over the skin.
INDICATIONS FOR USE
The Squid Model One Cold Compression device and Cold Pack for OTC
use is indicated for the temporary relief of minor muscle aches and pains.
The compression device is indicated for temporary increase in
circulation of the treated areas in people who are in good health, and
simulates kneading and stroking of tissues using an inflatable garment.
The Cold Pack is indicated for localized therapy in situations where
cold temperature therapy is necessary or desirable.
The modes are visible on the LCD display. Example of mode 1 is seen
in Figure 2.
3
CONTRAINDICATIONS
DO NOT USE IF YOU HAVE ANY OF THE
FOLLOWING CONDITIONS:
• Cold urticaria (hives aer being exposed to cold)
• Cold hypersensitivity or bradycardia; (slowing of the heart rate and/or
skin swelling surrounded by redness; may be itchy aer being exposed
to the cold).
• Vasospastic disease (tissue swelling or embolus which can lead to death
of the skin aer being exposed to the cold).
• Paroxysmal cold hemoglobinuria (anemia or presence of hemoglobin
in the urine aer being exposed to the cold).
• Raynaud’s syndrome (numb or prickly feeling and/or skin turns blue aer
being exposed to the cold).
• Cryoglobulinemia (higher than normal levels of blood cryoglobulins which
are proteins).
• Thrombosis (blood clots in the brain, heart or other blood vessels) or
suspected Deep Vein Thrombosis (DVT).
• Aneurysm (enlargement of a blood vessel artery caused by a weak
artery wall).
• Vascular disease which includes narrowing of blood vessels or thickening
of blood vessel walls causing loss of blood flow.
• Diabetes (blood glucose disease)
• High blood pressure
• Compromised local circulation (blood circulation that is not normal).
• Heart disease
• Cancer (active disease)
• Do not use the device during or 3 months aer pregnancy.
• To prevent skin irritation or rash, do not use the device if you have sensitive,
inflamed, or damaged skin or if you have a broken or open wound.
• Do not use the device over or near the site of a broken bone or a
healing fracture.
• Not for use if you are under 18 years of age.
WARNING
DO NOT USE ON EXPOSED SKIN. ONLY USE THE DEVICE OVER A LAYER
OF CLOTHING OR SUPPLIED CLOTH TO PREVENT FROSTNIP. PATIENTS
WHO ARE TAKING ANTICOAGULANT MEDICATION FOR VALVULAR HEART
DISEASE OR SOME OTHER CONDITION MAY BE AT RISK OF DEVELOPING
A HEMATOMA (CLOTTED BLOOD IN THE TISSUE FROM A BROKEN
BLOOD VESSEL).
4
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KNOWN AND FORESEEABLE RISKS
There is a risk of:
• Excessive cooling and frostnip if the Gel Pack is used directly on the skin,
if the clothing barrier is wet, or if the wrap is exposed to a large amount
of water.
• Irritation if the Gel Pack leaks.
• Irritation, pain, irregular blood flow if the wrap is exposed to excessive
external pressure.
• Strangulation or asphyxiation if the user’s neck is entangled by system
tubes and/or cords.
• Hematoma if the user is on anticoagulant medication.
5
CAUTIONS
6
• Allow at least one hour before repeating the treatment.
• Do not use Cold Gel Pack over wet clothing.
• Use only a dry Wrap. Do not use the Wrap if it is wet.
• Do not leave on the treated part when control unit is off or aer
treatment is over.
• Do not use Gel Packs if air temperature is below 50ºF.
• To avoid the risk of electrical shock, do not remove any panels from the
Squid Model One Pump.
• Do not aach Wrap too tightly prior to active compression.
• To avoid the risk of electrical shock, always turn off the Squid Model One
and disconnect the power line cord from its electrical outlet when
not in use.
• To avoid damage to your product, do not operate the Squid Model One
without a Wrap connected to the Squid Model One Pump.
• Do not tamper with the plug to allow easy disconnection of the
AC Adapter plug from the mains.
• Only use the Cold Gel Pack provided with the Squid Model One.
• Keep Gel Pack content away from mouth and eyes. In case of ingestion,
seek medical care. In case of contact with eyes, wash with water and
seek medical care.
• The Squid Model One Pump is not waterproof. Do not apply a direct
stream of any liquid onto the Squid Model One Pump; do not submerge it;
and do not allow any liquid to pool on the surface of the front panel.
• Aempting to self-service any part of the Squid Model One will avoid the
warranty and may cause injury.
• Avoid contact of Wrap and Gel Pack with sharp objects.
• Use this device only at its intended body part and according to instructions.
• To avoid risk of strangulation from the output AC Power Cord and
the Connector Tube, always keep the device away from children.
• Do not make modifications to the device.
• Exposure to lint, dust, direct sunlight, and moisture will accelerate
the aging of the device.
• Disconnect the AC Power Line Cord once the Pump is fully charged
to reduce the chance of decreasing baery life.
• Removing the Connector Tube from the Pump without using the
metal tab will cause damage to the Pump.
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7
SAFETY INFORMATION
This device has been manufactured and tested in accordance to
UL/IEC 60601-1 and 60601-1-2.
There are no serviceable parts in the Squid Model One.
To avoid electrical shock, product malfunction or damage, never operate
the Squid Model One with damaged AC Power Cord or Connector Tube or
other mechanical damage, or if the unit is otherwise not fully operational.
Never operate the Squid Model One with any AC Adapter other than
that provided by Portable Therapeutix. Use of other adapters may result
in electrical shock and will void the Squid Model One warranty.
BATTERY INFORMATION AND CHARGING
Squid Model One can be used for up to 50 treatments on a single charge.
Baery charging cycle life: 70% of initial minimum capacity aer 500 cycles
at 68ºF (20ºC).
Actual number may vary based on treatment conditions and the Wrap
model being used.
The Squid Model One may be used with the AC Adapter plugged into a
wall outlet, or it may be used with baery power. The Squid Model One
may be operated while charging.
Please note that the rechargeable baery inside the Portable Therapeutix
Squid Model One is not removable. Aempting to self-service will void the
warranty and may cause injury.
8
CHARGING THE SQUID PUMP UNIT:
1. Charge the Squid Model One Pump by plugging the charger to
the wall and the Squid Model One Pump. Full charge will require
8 hours.
2. When the baery charge indicator shows empty baery aer the unit
is turned on, the unit will have sufficient power for up to 3 treatments.
Flashing empty baery symbol indicates drained baery and the unit
will not start. The unit can then be used while plugged into a wall outlet.
If baery is completely drained (baery icon flashing), the unit may
require 5-10 minutes of charging before it may be used while plugged
into a wall outlet.
Bottom of Squid Pump
Charging
Port
Charging Indicator
Low Battery Indicator
FIGURE 3 – LOW BATTERY & CHARGING INDICATORS
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9
OPERATING INSTRUCTIONS
THE COLD GEL PACK:
1. Place the Squid Model One Cold Gel Pack in a home freezer, 0-8ºF
(-18ºC – 14ºC) for 12 hours use.
2. Under normal use conditions, the Squid Model One Cold Gel Pack
recommended life cycle is one year for maximum efficacy.
3. To obtain a replacement Gel Pack, contact Portable Therapeutix
Customer Service.
NOTE: The Squid Model One is reusable.
WEARING THE WRAP:
1. Remove the Cold Gel Pack from the freezer and place within the
Compression Wrap, aligning the Velcro on the Wrap with the Velcro
on the Gel Pack and secure the Velcro hooks fro firm aachment.
2. The pictures on pages 10 and 11 show the available Wraps.
Pictures demonstrating the Squid Model One being used in
different treatment areas are found on pages 10-11. The Squid
Model One must be used over clothing or over the barrier cloth.
Place the Wrap over the clothing or Barrier Cloth with the Cold Gel
Pack facing the skin and the Connector Tube towards the ground.
3. Secure the Wrap in place using the Velcro.
4. Connect both ends of the tubing to the Connectors on the Wrap
and Pump control unit by pressing the metal clip on the tube side
of the Connector.
Connector Tube Metal Clip
10
INITIATING TREATMENT:
1. Turn the control unit ON by pressing and holding the “POWER”
buon for half a second.
2. Select an operation mode by pressing the “MODE” selection
buon . The selected mode will appear on the display as a
number from 1 to 4 (1 for low pressure and 4 for high pressure).
Always start using in mode 1. Use modes 2, 3, 4 to increase
pressure until a comfortable pressure is achieved. The mode may
be changed during use by pressing the “START” buon for
half a second. When the screen begins to blink, press the “MODE”
selection buon to the level desired. Once the level desired
is flashing on the screen, press the “START” buon again to
continue the treatment.
3. Press the “START” buon for half a second to initiate
treatment. The device will intermiently compress the Cold Gel
Pack to the skin for 15 min.
4. When 15 minutes are over and the timer on the Pump control unit
is showing (0), remove the Wrap from the anatomical location.
The Squid Model One Pump control unit will turn off automatically
aer less that 5 seconds.
5. Use the metal clip to disconnect the Connector Tube from the
Pump. Pulling the tube without disengaging the metal clip will
damage the Connector Tube and Pump.
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11
ELBOW WRAP
*ANKLE WRAP
BACK WRAP
AVAILABLE SQUID MODEL ONE WRAPS
AND GEL PACKS
*Denotes the Wrap comes in multiple sizes.
12
*SHOULDER WRAP
*LEG WRAP
WRIST WRAP
KNEE WRAP
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ATTENTION: CONSULT ACCOMPANYING DOCUMENTS BEFORE USE
13
ANKLE WRAP: QUICK START GUIDE
Place Gel Pack in
freezer for 12 hours
prior to use.
12
HOURS
Place foot (wearing sock) in center
of Wrap, with writing on right side of the
foot and heel at back edge of the Wrap.
1
2
3
4
If possible, keep
knee and ankle
aligned at right
angles.
Velcro the Cold Gel Pack to the inside
of the Ankle Wrap.
KNEE & ANKLE
AT 90º
WRITING
ON WRAP’S
INTERIOR
ATTENTION: CONSULT ACCOMPANYING DOCUMENTS BEFORE USE
14
Fasten the back
strap around calf.
Connect the foot
straps. Adjust Wrap
tightness to your
comfort level.
Pull the straps on
each side of your
foot up and towards
knee. Wrap the strap
with the Squid Model
One logo around your
shin and fasten.
Aach Connector
Tube to Pump
and Wrap.
Begin
15 Minute
Treatment.
5
6
7
8
FASTEN
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15
12
HOURS
ELBOW WRAP: QUICK START GUIDE
Place Gel Pack in
freezer for 12 hours
prior to use.
Place Barrier Cloth over elbow.
Squid Model One also works over clothing.
Position elbow in the
center of the Wrap’s
interior with the
Connector pointing
towards wrist.
1
2
3
4
Aach Cold Gel Pack inside of Wrap
using Velcro.
ATTENTION: CONSULT ACCOMPANYING DOCUMENTS BEFORE USE
16
7
8
Aach Connector
Tube to Pump
and Wrap.
Begin 15 Minute
Treatment.
Fasten the larger
strap around bicep.
Then fasten the
smaller strap
around forearm.
Adjust tightness
as needed.
5
6
ATTENTION: CONSULT ACCOMPANYING DOCUMENTS BEFORE USE
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