Portable Therapeutix SQUID Model One User manual

ACTIVE COLD COMPRESSION DEVICE & COLD PACK
(OVER-THE-COUNTER USE)
REUSABLE
INSTRUCTIONS FOR USE

GO DEEP

TABLE OF CONTENTS
PACKAGE COMPONENTS & ACCESSORIES 1
TECHNICAL DESCRIPTION 2
INDICATIONS FOR USE 3
WARNING 4
CONTRAINDICATIONS 4
KNOWN AND FORSEEABLE RISKS 5
CAUTIONS 5
SAFETY INFORMATION 6
BATTERY INFORMATION AND CHARGING 6
OPERATING INSTRUCTIONS 7
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
SYMBOL DESCRIPTION 29
INFORMATION ON LI-ION BATTERIES 30
INFORMATION ON ELECTROMAGNETIC COMPATIBILITY 31
GUIDANCE AND MANUFACTURER’S DECLARATION EMISSIONS 32
GUIDANCE AND MANUFACTURER’S DECLARATION-IMMUNITY 33
RECOMMENDED SEPARATION DISTANCES FROM SQUID 35
WARRANTY 36
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 Adaptor
(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
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TABLE 1 - MODE DESCRIPTION
The Squid Model One combines cold therapy with intermittent
compression. The Squid Model One pump provides intermittent air
pressure to an air bladder in the wrap. Wraps come in a variety of
sizes to best t the treatment area. Pump pressure, inate cycle
time and deate 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 dierent peak pressures and time on and
time o cycles. The total duration of treatment time is 15 minutes.
TECHNICAL DESCRIPTION
DEFAULT
MODE
PEAK
PRESSURE
(ON)
12
34
30 50 70 85
mmHG mmHG mmHG mmHG
0000
mmHG mmHG mmHG mmHG
40 35 30 25
secondsseconds seconds seconds
20 25 30 35
secondsseconds seconds seconds
1515
minutes
15
minutes
15
minutes minutes
LOW
PRESSURE
TIME
ON
TIME
OFF
DURATION
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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 congurations for
specic 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 inatable 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.
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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 ow.
• 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, inamed, or damaged skin or if you have a broken or
open wound
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).
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KNOWN AND FORSEEABLE RISKS
• 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
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ow 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.
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CAUTIONS
• 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 o or
aer treatment is over.
• Do not use gel packs if air temperature is below 50°F.
• To avoid the risk of electrical shock, do not remove any panels
from the Squid Model One pump.
• To avoid the risk of electrical shock, always turn o 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
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.
• Attempting to self-service any part of the Squid Model One will
void 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.
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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 power cords or connector
hoses 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.
CAUTIONS
• 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 modications 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 battery life.
• Removing the connector tube from the pump without using the
metal tab will cause damage to the pump.
BATTERY INFORMATION AND CHARGING
Squid Model One can be used for up to 50 treatments on a single
charge.
Actual number may vary based on treatment conditions and the wrap
model being used.
Battery charging cycle life: 70% of initial minimum capacity aer 500
cycles at 68˚F (20˚C).
The Squid Model One may be used with the AC adaptor plugged into a
wall outlet, or it may be used with battery power. The Squid Model One
may be operated while charging.
Please note that the rechargeable battery inside the Portable
Therapeutix Squid Model One is not removeable. Attempting to
self-service will void the warranty and may cause injury.
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