Medline HEMO-FORCE MDS600INT2 User manual

HEMO-FORCE®
INTERMITTENT DVT PUMP
USER MANUAL
MDS600INT2

2
TABLE OF CONTENTS
Introduction 3
Intended Use 3
Warnings And Cautions 4
General Safety 5
Control Panel Features 6
Operating Instructions 9
Operating Functions 12
Contraindications & Cautions 13
Cleaning 13
Warning Troubleshooting Guide 14
Technical Data 15
Electromagnetic Compatibility 17
Symbols Used 21
Warranty 22
Français 23
Español 45

3
INTRODUCTION
The Hemo-Force® is an Intermittent Pneumatic Compression System
that counteracts blood stasis and coagulation changes; two of the three
major factors that promote deep vein thrombosis (DVT) a potentially
life threatening condition which can lead to pulmonary embolism.
The Hemo-Force® is a non-invasive mechanical prophylactic system
that massages the feet or legs in a wavelike, milking motion that
promotes blood flow and deters thrombosis, helping to empty pooled
or static blood from the valve cusps of the femoral vein. Fibrinolytic
activity is increased, stimulating the release of a plasminogen
activator. This therapy typically complements other prophylactic
measures, such as antiembolic stockings and anticoagulants.
Some exciting features include:
• User friendly master control unit that is designed so that its functions
are self-explanatory
• Power button (ON/OFF)
• An alarm displays a fault status with an audio alarm and LCD display
• LCD display that can monitor errors, statuses
and pressure values of the device
• Timer indicator that reflects each hour of compression
• A button (RESET) that causes a counter to take the state
corresponding to a specified initial number (zero)
• Battery indicator that can show remaining battery status
• Unique hanging bracket that provides easy attachment
INTENDED USE
The system consists of an air pump and single-patient-use compression
sleeve – one for the foot, one for the calf and one for the thigh. The air
pump and compression sleeve may be used on one lower extremity. The
inflation pressure settings are pre-set by the manufacturer and cannot be
changed. The compression level for the foot sleeve is 120mmHg (16kPa).
The compression level for the calf and thigh sleeve is 40mmHg. The sleeve
inflates and maintains compression for 12 seconds. Then, the sleeve deflates
for a period of 48 seconds. As the sleeve inflates, it compresses the foot,
calf or thigh which augments venous blood flow, thereby reducing stasis.
This process also stimulates fibrinolysis; thus, reducing the risk of early clot
formation. Regularly check the system while in use, assuring pump operation
and sleeve fit. Please note: The intended user of the system includes children,
adolescents and adult but the system can only be used under the instruction
from the physician no matter in hospital, nursing home or other locations.

4
WARNINGS AND CAUTIONS
1. Keep the pump and sleeve away from sources of liquid and open
flames.
2. Keep the pump and sleeve away from sharp objects. If pain, irrita-
tion, numbness, swelling, or redness occurs discontinue use and
contact a healthcare professional.
3. The Pump should always be used in conjunction with hospital
policy.
4. The Pump should only be repaired by an authorized professional.
5. Do not drop the Pump or store it in direct sunlight or extreme cold
conditions.
6. Do not use the system in the presence of any flammable gases (such
as Anaesthetic Agents).
7. Connect the Pump to an adequate power source.
8. No modification of this equipment is allowed.
9. Power cable & pump shall be placed at the foot-side of the patient
to prevent any risk of strangulation due to cable.
NOTE: If you are unsure of any contraindications please refer to the patient’s
physician before using the Hemo-Force® Intermittent Pneumatic Compression
System.

5
GENERAL SAFETY
These usage and safety guidelines are IMPORTANT!
Please follow them carefully.
General Use
Carefully unpack the contents of the pump package.
Connect the Pump to a proper power source.
Storage Environment Specification
It is recommended that the following guidelines be used whenever
the system is being stored or transported to another location:
Temperature limitations: 5°C ~ 60°C
Relative humidity: 30% ~ 75%
Pump
Check the power cord and plug for abrasions and excessive wear.
Plug in the unit and verify airflow from the hose connection ports.
Place in a dry storage area when not in use.

6
CONTROL PANEL FEATURES
Icon Indication
A
Status:
Int: Initialization
LEG: Calf/Thigh
Ft: Foot
GE: Garment Error Alarm
F: System Failure Alarm
HI: High Pressure Alarm
LO: Low Pressure Alarm
BInitialization Timer Pressure
C Timer
DTimer Reset
EPower Button
FMaintenance
GMute
HCaution
IBattery
JGarment Configuration
KAlarm Mute
Timer Reset
Timer Reset Fr
)
EKJIHGF
DCBA

7
COMPONENTS
SLEEVE
AIR HOSE

8
CONNECTION INSTRUCTION
PACKING LIST
Package 1 of 1 contains:
1 – Hemo-Force® Pump
1 – Air Tube Pair
1 – User Manual
SLEEVE
HOSE
Step 2 - Connect the air hoses to Sleeves.
Step 1 - Connect the air hoses to Control Unit.

9
OPERATING INSTRUCTIONS
The Hemo-Force® System is easy to set up. The following steps should
be followed. Please read this instruction manual in its entirety before
setting up.
1. Once the pump and sleeves have been removed
from their packaging plug the pump into an
electrical outlet. DO NOT TURN ON.
2. Position the pump on any flat surface or suspend the
pump at the foot of the bed using the swing-out hooks.
Do not hook on a slanted or curved surface.
3. Measure patient’s calf/foot/thigh circumference
at the widest point to ensure proper fit.
4. Application of the Calf / Thigh sleeve(s).
a) Sleeves come in identical pairs and may be used on either leg.
b) Unfold the sleeve and lay the unfolded sleeve on
a flat surface with the inside of the sleeve facing up.
c) Position the sleeve at the appropriate ankle or knee landmark.
d) Place the patient’s leg on the sleeve lining,
position the back of the knee over the popliteal
opening in the case of thigh high sleeve.
e) Starting at the side opposite the air hose, wrap the main
flap of the sleeve snugly around the patient’s leg.
f) Fasten the sleeve securely with the hook and loop fasteners
starting at the ankle and then moving to the calf and/or
thigh. Secure with tabs starting at the bottom tab. Check
that none of the hook and loop flaps hang off the end of
the sleeve (entirety of hook and loop area is secured to
the sleeve). The sleeve should fit securely but not tightly
around all parts of the patient’s leg. Confirm sleeve is
properly sized by checking that the index line falls between
the range markers. Follow the instructions and select the
next size up or down if the index line falls out of range.
g) Use the “two-finger” rule to check that the correct fit
is used. Insert 2 fingers horizontally (with palm up and
both fingers touching the patient’s leg) in between
the sleeve and the patient. This practice should be
done at both the top and bottom of the sleeve.
h) Using the same procedures apply the second model sleeve
if needed. If only one sleeve is to be used, simply leave the
unused air outlet on the pump free (no sleeve attached).

10
5. Application of the Foot sleeve(s).
a) Foot sleeves come in identical pairs and may be used on either foot.
b) Place the sleeve on the patient’s foot ensuring the
hook and loop attachments are visible.
c) Ensure a snug fit by placing two fingers around the back of
the sleeve to ensure the sleeve is not too tight. Routinely
inspect the patient’s feet once compression commences.
d) Using the same procedures, apply the second model sleeve if needed.
e) If only one sleeve is to be used simply leave the unused
air outlet on the pump free (no sleeve attached).
6. Air hose(s) are required to connect the sleeve(s) to the pump
and are provided separately. Attach the sleeve(s) to the
air hose(s) using the connectors. Each tube has a male end
connector at one end and a female connector at the other.
The female end will fit to the male end on the sleeve.
7. Attach the other end(s) of the air hose(s) (male end) to the
female connector(s)on the pump. If you need to disconnect the
tubing, press the tab on female connector and pull apart.
8. Press and hold the power button to turn pump on when
air hose(s) and sleeve(s)are properly connected.
9. The pump will automatically detect single/dual and leg (calf/
thigh)/foot model of sleeve(s) during the initialization process
lasting approximately 10 seconds. Highlighted graphics will
display how many foot versus leg sleeves are attached.
10. After initialization, check to confirm the screen
graphic(s) displays the desired settings.
11. To activate the timer, turn the pump on and timing will commence.
The timer will reflect minutes of compression. When compression is
interrupted and the pump is turned off, the timer will suspend timing
until the patient is reconnected to therapy and therapy is continued.
12. To reset the timer press “TIMER RESET” for
5 seconds and it will reset itself.
13. To turn pump off, hold POWER button for 1 second.
14. To disconnect device remove plug from electrical outlet.
15. To remove the sleeves, pull the connectors apart.
OPERATING INSTRUCTIONS (CONT)

11
Recommendations during operation
• Avoid placing the tubing and/or any connections
or components under the patient as this may
negatively impact the effectiveness of the pump and/
or cause a skin integrity issue for the patient
• Make sure that there are no kinks in the tubing
and that the connectors are properly locked.
• Never apply or remove the sleeves while inflated
as this may cause damage to the sleeve.
• The parts and/or accessories supplied are specifically designed
for use with Hemo-Force® Control Unit. Use of other products
in conjunction with the system is not recommended.
• Respond to the instrument alarms appropriately and
follow the manufacturer’s recommendations.
• After initialization, ensure highlighted graphics
displayed match the desired settings.

12
OPERATING FUNCTIONS
1. BATTERY OPTION (Battery sold separately)
i. This device has a Lithium battery option that can serve
as a backup. The device constantly monitors the outer AC
electric power supply. In the case of a power failure the
pump will switch to battery operation automatically.
ii. The “Battery Indicator” indicates the battery
capacity status as illustrated.
iii. Under normal conditions a fully charged battery will last
approximately 4 hours of continuous operation. It may
take up to 16 hours to fully charge a depleted battery.
iv. The pump will show a flashing light from “Battery Indicator”
and trigger the audio alarm to give a low battery warning
5 minutes before the pump automatically shuts down.
2. INDICATOR LIGHT (behind power button)
i. Green: Illuminated to indicate power on with AC power.
ii. Amber: Illuminated to indicate power on with battery.
iii. Amber: Flashing to indicate a fault has been
detected followed by an audio alarm.
3. AUDIBLE ALARM
Press the alarm mute button and the audible alarm can be turned off.
The audible alarm will alarm after 10 minutes if the error still happens.

13
WARNING TROUBLESHOOTING GUIDE
Indicates the error information for Hemo-Force®,
these include: Lo, Hi, GE and F.
Alarm
Codes Fault Type Description Troubleshooting
LO Low Pressure • Leg is less than
40mmHg pressure; foot
pressure is less than
120mmHg after
2 consecutive cycles.
• Air hose disconnected
mid-operation.
• Check sleeve application
to ensure proper fit.
• Check for leaks in the
sleeves or air hose set and
replace if faulty.
• Turn the pump off and
restart.
• Refer to a service profes-
sional if problem persists.
HI High Pressure • Air hose is kinked.
• Leg is more than
40mmHg pressure; foot
is more than 120mmHg
after 2 consecutive cycles.
• Check air hose set for
any kinks.
• Refer to a service profes-
sional if problem persists.
GE Sleeve Error • No sleeves attached dur-
ing start up.
• Sleeves are not fully de-
flated during each restart.
• The initialization failed
due to a possible blockage
in air hose/sleeve con-
nectors.
• Attach sleeves to pump
and restart.
• Ensure sleeves are fully
deflated before restart.
• Check connectors for any
blockage and restart.
• Refer to a professional for
service if problem persists.
FSystem Failure • Pressure is greater
than set pressure after
two inflations.
• Electrical malfunction.
• Check air hose connection.
• Turn the pump off and
restart.
• Refer to a service profes-
sional if problem persists.

14
CONTRAINDICATIONS & CAUTIONS
Do not use the Hemo-Force® where increased venous or
lymphatic return is not desired. The Hemo-Force® Intermittent
Compression System could be contraindicated and should
not be used by persons with known or suspected deep vein
thrombosis, pulmonary edema, congestive heart failure, severe
arteriosclerosis, thrombophlebitis, or active infection. Do not
use on persons with painful and sensitive extremities, where the
sleeve will interfere with gangrenous limbs, on persons with vein
ligation or recent skin grafts, or extreme deformity of the leg.
NOTE: If you are unsure of any contraindications please refer to the patient’s
physician before using the Hemo-Force® Intermittent Pneumatic Compression
System.
CLEANING
Caution
•Do not use phenol based cleaning solutions.
•Switch off the electrical supply to the pump and disconnect the
power cord from the main supply before cleaning and inspection.
The pump: The casing of the pump is manufactured from ABS
plastic which is a combination of different resins that is hard and
durable through a broad range of temperatures. If soiled, it can
be wiped down with a sodium hypochlorite solution to dilution of
1000ppm or with any EPA approved, hospital grade cleaner.
The control unit (face) should also be cleaned weekly
using a damp soft cloth and mild detergent.
The Sleeve: It is a single patient use sleeve. Do
not wash or clean. Discard after use.

15
TECHNICAL DATA
Product Name Control Unit Hemo-Force®
Model Name Intermittent DVT Pump
Model No. MDS600INT2
Size 7.54”x 5.12”x7.95”
Weight 5 lbs (2.8 Kg) - without battery
Pressure Range Calf/Thigh Sleeve: 40 mmHg +/- 5mmHg (5.3kPa +/-
0.7kPa)
Foot Sleeve: 120 mmHg + 10/- 5mmHg (16kPa + 13/-
0.7kPa)
Input Rating AC 100-240V 50/60Hz
Fuse Rating 1A 250V
Classification Class II, Type BF
Not AP or APG type
Ingress Protection IP22
Operation Humidity 30-75%
Operation Temperature 15 - 35°C
Operation Atmospheric
Pressure Range
700 hPa to 1060 hPa
Mode of Operation Continuous
Applied Part Sleeve and Air Tube
Battery Pack Model. (op-
tional)
MDS600BAT
(14.4 Vdc, 2200 mAh / 31.68 Wh Lithium-ion recharge-
able battery pack)

16
SLEEVES FOR HEMO-FORCE®PUMP
Model name Size
MDS601P2 Intermittent Sleeve Knee-High Small, 1pr/Ea
MDS601M2 Intermittent Sleeve Knee-High Medium, 1pr/Ea
MDS601L2 Intermittent Sleeve Knee-High Large, 1pr/Ea
MDS601B2 Intermittent Sleeve Knee-High X-Large, 1pr/Ea
MDS630S2 Intermittent Sleeve Thigh-High Small, 1pr/Ea
MDS630M2 Intermittent Sleeve Thigh-High Medium, 1pr/Ea
MDS630L2 Intermittent Sleeve Thigh-High Large, 1pr/Ea
MDS630B2 Intermittent Sleeve Thigh-High X-Large, 1pr/Ea
MDS6202 Intermittent Foot Medium, 1pr/Ea
MDS620L2 Intermittent Foot Large, 1pr/Ea
HEMO-FORCE®PUMPS
Model name Size
MDS600INT2 Second Generation DVT Pump
TUBING FOR HEMO-FORCE®PUMP
Model name Size
MDS610S2 Intermittent Tubing 5 Foot (1.5 Meters)
MDS610L2 Intermittent Tubing 10 Foot (3 Meters)
BATTERY FOR HEMO-FORCE®PUMP
Model name Size
MDS600BAT Battery For DVT Pump

17
ELECTROMAGNETIC COMPATIBILITY
Electric devices may interact due to electromagnetic radiation. We recommend
a safety distance of at least 3.3 feet (1 meter) especially for sensitive equipment.
Upon request, we will provide you with a table for more detailed information.
Recommended separation distances between
portable and mobile RF communications equipment and the Hemo-Force®
The Hemo-Force® is intended for use in an electromagnetic environment in which radi-
ated RF disturbances are controlled. The customer or the user of the Hemo-Force® can
help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the Hemo-Force®
as recommended below, according to the maximum output power of the communications
equipment.
Rated maximum
output power of
transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d = 1,2
80 MHz to 800 MHz
d = 1,2
800 MHz to 2,5 GHz
d = 2,3
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
1 1,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmit-
ter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.

18
ELECTROMAGNETIC COMPATIBILITY
(CONT)
Guidance and manufacturer’s declaration – electromagnetic emissions
The Hemo-Force® is intended for use in the electromagnetic environment specified below.
The customer or the user of the Hemo-Force® should ensure that it is used in such an
environment.
Emissions test Compliance Electromagnetic
environment – guidance
RF emissions
CISPR 11
Group 1 The Hemo-Force® uses RF
energy only for its internal func-
tion. Therefore, its RF emissions
are very low and are not likely
to cause any interference in
nearby electronic equipment
RF emissions
CISPR 11
Class B The Hemo-Force® is suitable for
use in all establishments, includ-
ing domestic establishments
and those directly connected to
the public low-voltage power
supply network that supplies
buildings used for domestic
purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies

19
Guidance and manufacturer’s declaration – electromagnetic immunity
The Hemo-Force® is intended for use in the electromagnetic environment specified below.
The customer or the user of the Hemo-Force® should ensure that it is used in such an envi-
ronment.
Immunity test IEC 60601 test level Compliance level Electromagnetic envi-
ronment – guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood,
concrete, or ceramic
tile. If floors are cov-
ered with synthetic
material, the relative
humidity should be at
least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/
output
lines
±2 kV for power
supply lines
±1 kV for
input/output lines
Mains power qual-
ity should be that of a
typical commercial or
hospital environment.
Surge
IEC 61000-4-5
±1 kV line(s) to
line(s)
±2 kV line(s) to
earth
±1 kV line(s) to line(s)
±2 kV line(s) to earth
Mains power qual-
ity should be that of a
typical commercial or
hospital environment.
Interruptions and
voltage varia-
tions
on power supply
input lines
IEC 61000-4-11
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
<5 % UT
(>95 % dip in UT)
for 5 sec
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
Mains power qual-
ity should be that of
a typical commercial
or hospital environ-
ment. If the user of the
Hemo-Force® requires
continued operation
during power main
interruptions, it is
recommended that the
Hemo-Force® be pow-
ered from an uninter-
ruptible power supply
or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m Power frequency mag-
netic fields should be
at levels characteristic
of a typical location in
a typical commercial or
hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.

20
ELECTROMAGNETIC COMPATIBILITY (CONT)
Guidance and manufacturer’s declaration – electromagnetic immunity (cont)
The Hemo-Force® is intended for use in the electromagnetic environment specified below.
The customer or the user of the Hemo-Force® should ensure that it is used in such an
environment.
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/m
80 MHz to
2,5 GHz
3 Vrms
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the Hemo-Force® , including cables,
than the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
d = 1,2
d = 1,2 80 MHz to 800 MHz
d = 1,2 800 MHz to 2,5 GHz
Where P is the maximum output power rat-
ing of the transmitter in watts (W) according
to the transmitter manufacturer and d is the
recommended separation distance in meters
(m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey, should be less than the compliance
level in each frequency range.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation
is affected
• Field strengths from fixed transmitters, such as base stations for radio (cellular/
cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an electro-
magnetic site survey should be considered. If the measured field strength in the
location in which the Hemo-Force® is used exceeds the applicable RF compliance
level above, the Hemo-Force® should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such
as reorienting or relocating the Hemo-Force® .
• Over the frequency range 150 kHz to 80 MHz, field strengths should be less than
3 V/m.