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
i
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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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ATTENTION: CONSULT ACCOMPANYING DOCUMENTS BEFORE USE
17
12
HOURS
KNEE WRAP: QUICK START GUIDE
1
2
3
4
Place Gel Pack in
freezer for 12 hours
prior to use.
Remove
Gel Pack
from freezer
and fasten its
Velcro strap.
Aach Cold Gel Pack inside of Wrap
using Velcro.
Place Barrier Cloth over knee.
Squid Model One also works
over clothing.
ATTENTION: CONSULT ACCOMPANYING DOCUMENTS BEFORE USE
18
7
Place Squid Model
One on knee and
fasten the lower
strap first.
Fasten the top
strap snugly.
Aach Connector
Tube to Pump
and Wrap.
Begin 15 Minute
Tr e a t m e n t .
5
6
8
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ATTENTION: CONSULT ACCOMPANYING DOCUMENTS BEFORE USE
ATTENTION: CONSULT ACCOMPANYING DOCUMENTS BEFORE USE
19
12
HOURS
LEG WRAP: QUICK START GUIDE
1
2
3
4
Place Gel Pack in
freezer for 12 hours
prior to use.
Wrap Squid
Model One
around the leg.*
Place Barrier Cloth over leg.
Squid Model One also works
over clothing.
Aach Cold Gel Pack inside of Wrap
using Velcro.
20
Fasten the Wrap
around the leg
snugly using the
Velcro panels.
Aach Connector
Tube to Pump
and Wrap.
Begin 15 Minute
Treatment.
5
6
7
*
TREATMENT TIP:
The Squid Model One Leg Wrap
can be positioned in a variety
of ways to beer treat affected
areas:
• QUADRICEP
• HAMSTRING
• KNEE
• CALF
• SHIN
ATTENTION: CONSULT ACCOMPANYING DOCUMENTS BEFORE USE
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ATTENTION: CONSULT ACCOMPANYING DOCUMENTS BEFORE USE
1
2
3
4
21
12
HOURS
SHOULDER WRAP: QUICK START GUIDE
Place Gel Pack in
freezer for 12 hours
prior to use.
Before puing on
Wrap, fasten the
straps on either side
of the Connector
Tube together to
create an armhole.
Aach Cold Gel Pack inside of Wrap
using Velcro.
SHOULDER STRAP
(FRONT)
Insert arm with
the Connector
pointing towards
wrist. Wear Wrap
over clothing.
ATTENTION: CONSULT ACCOMPANYING DOCUMENTS BEFORE USE
22
5
6
7
8
Aach Connector
Tube to Pump
and Wrap.
Two straps are
behind you. Fasten
the shorter strap
under the arm
receiving treatment.
Wrap the longer
strap around the
torso, under the
opposite arm.
SECOND
FIRST
Begin 15 Minute
Treatment.
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ATTENTION: CONSULT ACCOMPANYING DOCUMENTS BEFORE USE
23
12
HOURS
WRIST WRAP: QUICK START GUIDE
1
2
3
4
Place Gel Pack in
freezer for 12 hours
prior to use.
Place thumb
through the hole
in the Wrap.*
Place Barrier Cloth over
wrist. Squid Model One
also works over clothing.
Aach Cold Gel Pack inside of Wrap
using Velcro.
ATTENTION: CONSULT ACCOMPANYING DOCUMENTS BEFORE USE
24
Fasten Squid Model
One around the
wrist snugly using
the Velcro panels.
Aach Connector
Tube to Pump
and Wrap.
Begin 15 Minute
Tr e a t m e n t .
5
6
7
*
THUMB
HOLE
TREATMENT TIP:
The Squid Model One Wrist Wrap works
on either wrist. Right hand pictured.
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25
The Cold Gel Pack Connectors, Tubes and Wrap can be cleaned with
a so cloth, soap, and water.
Wrap: Wipe dry and air dry following each use. Do not machine wash.
Do not dry clean. Do not iron. Do not submerge in water.
Gel Pack: Wipe dry following each use.
Cloth: Machine wash warm. Tumble dry low. Do not bleach. Do not dry
clean. Avoid the use of fabric soeners.
CLEANING
Conditions of Visibility:
OPERATING CONDITIONS
Te m p e r a t u r e ................................ 50ºF – 104ºF (10ºC – 40ºC)
The Squid control unit is not intended
to be worn or hand held.
Maximum Atmospheric Pressure..... 700 – 1060 hPa
Humidity..................................... 30%RH – 90%RH
Ambient Luminescent Range.......... 100 lx – 1500 lx
Viewing Distance......................... 20 cm – 50 cm
Viewing Angle.............................. Normal to the display ± 30ºC
CAUTION!
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.
26
This unit contains a Lithium-ion Baery. Please observe the
following Baery Storage Cautions:
Do not store Squid Model One Pump where it is exposed to high
temperatures, direct sunlight, rain, water, or high humidity.
STORAGE AND TRANSPORTATION
Te m p e r a t u r e ................................ Storeatroomtemperature
14ºF – 104ºF (-10ºC – 40ºC);
less than 95ºF (35ºC)
for improved battery life.
Avoid direct sunlight
STORAGE CONDITIONS AND
TRANSPORTATION CONDITIONS
• Make sure the Pump control unit is turned off and not plugged
to a power source.
• Place the Squid Model One Pump control unit and AC Adapter in
a safe, cool, and dry place when not in use.
• Wrap and Connector Tube must be dry before storing in a cool
and dry place. The Wrap and Connector Tube may be rolled prior
to storage.
• The Cold Gel Pack should be wiped dry and stored in a cool dark
place. When storing for longer than two weeks, place the Cold Gel
Pack inside a sealed plastic container or bag prior to storing to
minimize evaporation.
Maximum Atmospheric Pressure.....
700 – 1060 hPa
Humidity..................................... 30%RH – 90%RH
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27
TROUBLESHOOTING
The Pump pressure did not reach the minimum
pressure. Can occur if the cuff is not connected to
to the Pump or the Wrap/Tube has an air leak
preventing the Pump from reaching minimum
pressure within 3 minutes.
Verify that Connector Tube to the Squid Model One
Pump and Wrap are securely connected and that
there is no leak from the system. If no visible reason
for a leak is apparent and error signal persists,
contact Customer Service.
ALARM SYMBOL E1
WHAT DOES
IT MEAN?
WHAT CAN
I DO?
The Pump pressure exceeded the maximum
pressure of the mode. This can occur if the user
applies external pressure to the Wrap. Any other
over-pressure would also indicate a malfunction.
Remove external pressure from the Wrap or
remove Wrap. Do not use for one hour. If problem
persists, contact Customer Service.
The Pump motor is not working
and no compression.
Contact Customer Service.
ALARM SYMBOL E2
ALARM SYMBOL E3
WHAT DOES
IT MEAN?
WHAT CAN
I DO?
ERROR
ERROR
ERROR
WHAT DOES
IT MEAN?
WHAT CAN
I DO?
28
The Pump is working but the Wrap
is not compressing.
Charge the Squid Model One Pump by connecting
the provided charger to the Squid Model One unit
and a wall power source.
SQUID PUMP DOES NOT TURN ON
NO COMPRESSION
• Make sure that the Wrap is positioned against the
body and secured using the Velcro closure.
• Make sure Wrap is fully deflated prior to wearing.
• Make sure the Connector Tube is connected to the
Pump control unit and the Wrap.
• Inspect the Wrap and Connector Tube for an air leak.
Baery is drained and the AC Adapter
is not connected.
Gel Pack is not cold or is missing.
NO COLD
• Make sure that the Gel Pack is placed in a freezer
for 12 hours prior to use.
• Verify that the Gel Pack is placed inside the Wrap.
ERROR
ERROR
ERROR
WHAT DOES
IT MEAN?
WHAT CAN
I DO?
WHAT DOES
IT MEAN?
WHAT CAN
I DO?
WHAT DOES
IT MEAN?
WHAT CAN
I DO?
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29
PRODUCT CONTAINS LI-ION BATTERIES
Li-ion baeries contain large amount of energy and are manufactured
with safety features incorporated. Mishandling may cause the baery to
leak, catch fire, or explode and result in personal injury and/or property
damage. Please strictly observe the following prohibitive measures.
Medical Equipment with respect to electrical shock,
fire, and mechanical hazards only in accordance with
UL 60601-1
Powered by Direct Current
Type BF Applied Parts
Do not use this device if you have any of the conditions
listed in the User Manual. Consult accompanying
documents before use.
Manufacturer: Portable Therapeutix LLC
9000 Southwest Freeway, Suite 424
Houston, TX 77074 USA
SYMBOLS DESCRIPTION MODEL: ONE
9sV/2Av/1A
IP 21 IP 21 Classified
Class II Equipment
Operating Instructions
DANGER!
Failure to observe the following procedures may result in
baery leakage, heat, bursting, and serious personal injury.
1. Do not remove baery from Squid Model One Pump.
2. Never dispose of baeries in fire.
3. Keep Squid Model One Pump away from combustible materials.
4. Do not incinerate or heat Squid Model One Pump.
5. Do not disassemble, alter, or reconstruct Squid Model One Pump.
6. Baeries contain strong colorless electrolyte, which may cause
permanent loss of eyesight and injury when in direct contact with
eyes or skin. Immediately flush with clean water when in contact
with leaked electrolyte and consult a physician.


30
CAUTION!
1. Do not remove the baery from the Squid Model One Pump and
do not use the baery outside of the specified temperature range
on the specification; otherwise, the baery might cause heat
generation, damage, or deterioration of its performance.
2. Do not charge Li-ion baery outside the range of 32ºF – 104ºF
(0ºC – 40ºC).
3. Handle damaged or leaking baeries with care, personal injuries
may result from mishandling. If baery is leaking, do not use or
charge the device. Contact customer service.
4. Recycling may be required for your region; consult local recycling
facility for more information.
WARNING!
1. Do not immerse Squid Model One Pump in water.
2. Do not store Squid Model One Pump in temperatures exceeding
104ºF (40ºC) and in direct sunlight.
3. Li-ion baeries have a predetermined operating life even if they
have never been used. Baeries remaining unused and uncharged
for more than 12 months, or having very short usage time should
be replaced. Do not aempt to continue charging or discharging
such baeries.
4. Do not leave the Squid Model One Pump connected to the charger
if it generates an odor and/or heat, leaks electrolyte, or causes any
other abnormality.
5. Use only supplied charger to charge the baery and follow all of the
safety guidelines in this manual.
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31
INFORMATION ON ELECTROMAGNETIC
COMPATIBILITY
1. Medical Electrical Equipment needs special precautions regarding
EMC and needs to be installed and put into service according to the
EMC information provided in the Accompanying Documents.
2. Portable and Mobile RF Communications Equipment can affect
Medical Electrical Equipment.
The use of accessories, transducers and/or cables other than those
specified, with the exception of those sold by the manufacturer as
replacement parts for internal components, may result in increased
emissions or decreased immunity of the equipment or system.
WARNING!
32
GUIDANCE AND MANUFACTURER’S
DECLARATION – EMISSIONS
The Squid Model One is intended for use in the electromagnetic
environment specified below. The customer or user of the Squid Model One
should ensure that it is used in such an environment.
RF EMISSIONS
CISPR 11
The Squid Model One uses RF energy only for
its internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment
COMPLIANCE: GROUP 1
COMPLIANCE: CLASS B
COMPLIANCE: CLASS A
COMPLIES
The Squid Model One is suitable for use in all establishments, including
domestic, and those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic purposes.
RF EMISSIONS
CISPR 11
HARMONICS
IEC 61000-3-2
FLICKER
IEC 61000-3-3
EMISSIONS TEST
ELECTROMAGNETIC ENVIRONMENT – GUIDANCE
The equipment or system should not be used adjacent to or stacked
with other equipment and that if adjacent or stacked use is necessary,
the equipment or system should be observed to verify normal operation
in the configuration in which it will be used.
WARNING!
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33
GUIDANCE AND MANUFACTURER’S
DECLARATION – IMMUNITY
The Squid Model One is intended for use in the electromagnetic
environment specified below. The customer or user of the Squid Model One
should ensure that it is used in such an environment.
ESD
IEC 61000-4-2
±6kV Contact
±8kV Air
±6kV Contact
±8kV Air
Floors should be wood,
concrete or ceramic tile.
If floors are synthetic,
the r/h should be at
least 30%.
EFT
IEC 61000-4-4
±2kV Mains
±1kV I/Os
±2kV Mains
±1kV I/Os
Mains power quality
should be that of typical
commercial or hospital
environment.
SURGE
IEC 61000-4-5
±1kVDierential
±2kVCommon
±1kV Dierential
±2kV Common
Mains power quality
should be that of a typical
commercial or hospital
environment.
VOLTAGE
DIPS/DROPOUTS
IEC 61000-4-11
>95% Dip for
0.5 Cycle
60% Dip for
5 Cycles
30% Dip for
25 Cycles
>95% Dip for
5 Seconds
>95% Dip for
0.5 Cycle
60% Dip for
5 Cycles
30% Dip for
25 Cycles
>95% Dip for
5 Seconds
Mains power quality
should be that of a typical
commercial or hospital
environment. If the user
of the Squid Model One
requires continued
operation during power
mains interruptions,
it is recommended that
the Squid Model One
be powered from an
uninterruptible power
supply or baery.
POWER
FREQUENCY
50/60Hz
MAGNETIC FIELD
IEC 61000-4-8
3A/m 3A/m
Power frequency
magnetic fields should
be that of a typical
commercial or hospital
environment.
IMMUNITY
TEST
IEC 60601
TEST LEVEL
COMPLIANCE
LEVEL
ELECTROMAGNETIC
ENVIRONMENT – GUIDANCE
34
IMMUNITY
TEST
IEC 60601
TEST LEVEL
COMPLIANCE
LEVEL
ELECTROMAGNETIC
ENVIRONMENT – GUIDANCE
CONDUCTED RF
IEC 61000-4-6
RADIATED RF
IEC 61000-4-3
3 Vrms
150 kHz to
80 MHz
3 V/ms
80 MHz to
2.5 GHz
(V1)= 3Vrms
(E1)= 3V/m
Portable and mobile
communications
equipment should
be separated from the
Squid Model One by
no less than the distances
calculated/listed below:
D = (3.5/V1)(Sqrt P)
150kHz to 80MHz
D = (3.5/E1)(Sqrt P)
80 to 800MHz
D = (7/E1)(Sqrt P)
800MHz to 2.5 GHz
Where P is the max power
in was and D is the
recommended separation
distance in meters.
Field strengths from
fixed transmiers,
as determined by an
electromagnetic site
survey, should be less
than the compliance
levels (V1 and E1).
Interference may occur in
the vicinity of equipment
containing a transmier.
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35
RECOMMENDED SEPARATIONS DISTANCES
FROM THE SQUID MODEL ONE
The Squid Model One is intended for use in the electromagnetic
environment in which radiated disturbances are controlled. The customer
or user of the Squid Model One can help prevent electromagnetic
interference by maintaining a minimum distance between portable and
mobile RF Communications Equipment and the Squid Model One as
recommended below, according to the maximum output power of the
communications equipment.
0.11667 0.11667 0.23333
0.36894 .36894 0.73785
1.1667 1.1667 2.3333
3.6894 3.6894 7.3785
11.667 11.667 23.333
0.01
0.1
1
10
100
MAX
OUTPUT
POWER
(WATS)
Separation (m)
150kHz to
80MHz
D=(3.5/V1)(Sqrt P)
Separation (m)
80 to
800MHz
D=(3.5/E1)(Sqrt P)
Separation (m)
800MHz to
2.5GHz
D=(7/E1)(Sqrt P)
36
MANUFACTURER’S LIMITED WARRANTY
Opening the Squid Model One Pump case or aempting to
self-service any part of the Squid Model One will void the warranty
and may cause injury.
PUMP LIMITED WARRANTY
Portable Therapeutix, warrants that the Squid Model One Pump
Control Unit (“Pump”) (if properly used) will be free from defects in
materials and workmanship for a period of one year from the date of
purchase. If the Pump, malfunctions during the warranty period, then
Portable Therapeutix will at its option either repair or replace the
Pump. If Portable Therapeutix elects to replace the Pump it may do
so with a new or reconditioned Pump. Your original one year warranty
period shall be extended by the number of days that the Pump is in
the possession of Portable Therapeutix until it ships the repaired or
replacement Pump back to you. This warranty and other warranties
that may exist under state or federal laws is non-transferable and only
available to the original purchaser.
WRAP AND TUBE LIMITED WARRANTY
Portable Therapeutix warrants that the Squid Model One Wrap and
Connector Tube (if properly used, including following the care and use
instructions) will be free from defects in material and workmanship for a
period of one year from the date of purchase. If the Wrap or Connector
Tube, malfunctions during the warranty period, then Portable Therapeutix
will at its option either repair or replace the Wrap or Connector Tube.
If Portable Therapeutix elects to replace the Wrap or Connector Tube
it may do so with a new or reconditioned Wrap or Connector Tube. Your
original one year warranty period shall be extended by the number of
days that the Wrap or Connector Tube is in the possession of Portable
Therapeutix until it ships the repaired or replacement Wrap or Connector
Tube back to you. This warranty and other warranties that may exist under
state or federal laws is non-transferable and only available to the
original purchaser.
GEL PACK LIMITED WARRANTY
Portable Therapeutix warrants that the Gel Pack (if properly used,
including following the care and use instructions) will be free from
defects in material and workmanship for a period of one year from the
date of purchase. If the Gel Pack, malfunctions during the warranty
period, then Portable Therapeutix will at its option either repair or
replace the Gel Pack. If Portable Therapeutix elects to replace the Gel
Pack it may do so with a new or reconditioned Gel Pack. Your original
one year warranty period shall be extended by the number of days
that the Gel Pack is in the possession of Portable Therapeutix until it
ships the repaired or replacement Gel Pack back to you. This warranty
and other warranties that may exist under state or federal laws is
non-transferable and only available to the original purchaser.
THE GEL PACK WILL HAVE A NATURAL EVAPORATION OVER TIME.
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