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INSTRUCTION MANUAL

IN STR UCTI O N M A N UAL

CONTENTS
Important safety precautions 3

1. Introduction 4

2. Product description 5

3. Assembly/ Installation 6

4. Operation 7

5. Modes of operation 8

6. Maintenance 8

7. Troubleshooting 9

8. Technical description 9

9. Storage 10

10. Accessories 10

11. Warranty 10

12. Other information 11

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I M P O RTA N T S A F E TY P R E CA U T I O N

Read all instructions prior to use..

1. The product must only be used for its intended used for individuals needing special supervision, such as
purpose as described in this manual. The product may children.
not be combined, assembled, or repaired with other 8. Prevent damage to the Cuffs from sharp objects.
parts (e.g. Control unit and Cuffs), accessories or spare
9. Do not open the control unit housing – risk for electric
parts other than those described in this manual or other
shock. Servicing and maintenance must be performed by
documentation from BCOS Healthcare Pvt. Ltd.
BCOS Healthcare Pvt. Ltd. or one of its authorized service
2. Do not use the product in wet rooms or where there is technicians.
a risk of the control unit coming into contact with water
10. Route the power cable to the control unit carefully
or another liquid. Never handle the control unit that has
to avoid tripping. Also make sure that the user is lying
come into contact with water/liquid. Pull the plug out of
correctly on the bed according to the instructions.
the electrical socket immediately and send the product to
an authorized service technician for servicing. 11. To avoid the risk of strangulation, make sure that the
cable and tubes are routed to prevent someone getting
3. DO NOT USE in the vicinity of or in contact with fire
caught up in them.
sources/hot surfaces, such as fire, burning cigarettes or hot
lamps. it could become damaged if it comes into contact 12. Do not store or use the product in direct sunlight. The
with fire sources. product may be damaged by the elevated temperature and
UV light
4. Position and use the product in a manner that prevents it
from becoming trapped or damaged. NOTE: Be particularly 13. To prevent the Power supply Adapter from being pulled
aware of trapping damage when using bed rails. out, exercise caution when there are children and pets in
the environment around the equipment.
5. Never use the product if the control unit power cord
or power supply adapter is defective, the control unit 14. Use of this product adjacent to or stacked with other
casing is damaged, or it is not functioning properly. Pay equipment should be avoided because it could result in
extra attention when using bed rails that no wires become improper operation. If such use is necessary, this product
trapped between the bed and the rail. Contact a service and the other equipment should be observed to verify that
technician for examination and repair. they are operating normally.
6. Regularly check product functionality.
7. Continual monitoring is required when the product is

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1 . IN T RO D U CT IO N
ELIRA deep vein thrombosis prevention system is a pneumatic compression
device that noninvasively helps reduce the incidence of deep vein thrombosis, a
potentially life-threatening condition in which a blood clot forms in a vein deep
inside the body. The system consists of a pump that inflates the soft compression
garments wrapped around the calf or calf-thigh, during an automatically timed
cycle. The application of external pneumatic compression has two effects:

• Augments venous blood flow velocity, thereby reducing stasis.

• Enhances fibrinolytic activity to reduce the risk of early clot formation.

Always read the user manual prior to use.

1.1 General information


This ELIRA deep vein thrombosis prevention system is a medical device.
According to statutory regulations made by the authorities regarding medical
devices, the manufacturer is required to report all accidents or incidents
involving the products. We would be very grateful for all information involving
accidents or incidents relating to our products, by reporting them immediately
to us, here at BCOS Healthcare Pvt. Ltd.

1.2 Intended use


The system consists of a pneumatic compression device and a pair of cuffs either
thigh or calf muscles which can be used for deep vein thrombosis prevention.

1.3 Indications
For users without deep vein thrombosis and to those who are prone to deep
vein thrombosis.

1.4 Contraindications
The ELIRA should NOT be used in the following conditions:

• Severe atherosclerosis or other ischemic vascular diseases

• Suspected or known acute deep vein thrombosis

• Severe congestive cardiac failure

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• Existing pulmonary edema

• Existing pulmonary embolisms

• Extreme deformity of the limbs

• Any local skin or tissue condition in which the garments would interfere, such
as: Gangrene, Untreated or infected wounds, Recent skin grafts, Dermatitis, etc.

• Known presence of malignancy in the legs Limb infections, including cellulitis,


that have not received antibiotic coverage

• Presence of lymphangiosarcoma

1.5 User application


The system can be used in all kinds of health care environments.

2 . P RO D U CT D E S CRIPTION
2.1 Control Unit functions

Digital Display Mute switch

ON/OFF Switch

LED Indicator

Cycle counter Switch

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3 . A S S E M B LY/ I N STALLATIO N
Unpacking the unit, check that none of the parts are damaged. In the event of
damage, contact the manufacturer or your local dealer before using the product.

1. Hang the control unit at the foot end of the


bed or place it on a flat, sturdy surface. Route the
power cord so that there is no risk of it causing
someone to trip, being damaged.

Velcro
Straps 2. Connect the cuffs around the calf or thigh as
instructed by the physician, with the tubes directed
to ground. Make sure the pump is still turned off
before wrapping the cuffs around the leg.

3. Connect the ends of the cuffs to the control


unit. The control unit and cuff ends are equipped
with quick connectors. An audible “click” sound will
be heard when these have been connected correctly.

4. Check that the switch of the control unit is in


the “OFF” position. Connect the plug to an approved
electrical socket.

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4 . O PE RAT I O N
NOTE! Always read the user manual prior to use

4.1 Choice of programs


There are two different programs IC (Intermittent Compression) and SC
(Sequential Compression). We recommend SC mode by default.

4.2 Start-up
i. Start the control unit by pressing “O” (On)

ii. The control unit starts with initial beep sound

iii. Once the device start it will be in SC (Sequential Compression) mode by


default

iv. The mode of the device can be selected based on the doctor’s prescription

4.3 Pressure setting


The pressure for the deep vein thrombosis prevention can be adjusted according
to each patient. Always consult the prescriber or other authorized personnel for
appropriate setting.

1. Once the device is on press and hold the mute and N switch together,
then a pale green LED is lit.

2. Use the mute switch for increasing the pressure

3. Use the N switch for decreasing the pressure

4. Once the desired pressure limit is attained, power OFF the device

5. Now turn ON the device for new settings

NOTE! The device will be in 40 mmHg pressure by default. Range of


pressure that is applicable to this device is 38 mmHg to 55mmHg

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5. MODES OF OPERATION

5.1 SC
Sequential Compression mode is the default mode in this device. In this mode
the cuff will be inflated one after the other. During inflation the set pressure will
be displayed in the panel. This mode is indicated by green LED.

5.2 IC
Intermittent Compression mode can be set by press and holding the mute
switch and then turn on the device. A Blue LED will be lit to indicate the IC
mode. It will automatically move to SC after 30 cycles.

5.3 SLC
Single Limb Compression mode is mainly intended for the amputee. This mode
can be set by press and holding the N switch and then turning the device ON.
A pale purple LED will be lit to indicate the SLC mode. In order to move to the
default mode, press and hold the N switch and turn ON the device.

MODE LED INDICATION


SC The cuff will be inflated one after the other
IC It will automatically move to SC after 30 cycles
SLC Mainly intended for the amputee.

6. MAINTENANCE
7.1 General
1. Check the power cord and plug for damage and scratches.

2. Check that the air flow alternates between each outlet on the side of the
control unit.

3. Check for damaged or pinched tubes and connectors on the cuffs. Contact the
manufacturer or your local dealer for spare parts

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7. TROUBLE SHOOTING

If your questions are not answered by the above information, please contact
BCOS Healthcare Pvt. Ltd. or your local dealer for further assistance.

PROBLEM SOLUTION
Control unit does not start Check that the power cord is connected to the power
socket, or the adapter is not damaged

Notification for faulty cuffs Check that the air tubes of cuffs are connected to the
Control unit.

Control unit is noisy Check how the Control unit is hung on the bed. Resonance
can occur in vibrations are felt arts of the bed. Remove
the Control unit and listen to see whether this makes
a difference. Can be remedied by putting the Control unit
on a flat, steady surface or by placing a towel between the
Control unit and bed.

8. TECHNICAL DESCRIPTION
8.1 Technical specification
Modes of Operation ICD, SCD
Pressure ranges 30-50mmHg
Suggested therapeutic pressure 40mmHg
Cycle time ICD 80s (approx)
Cycle time SCD 120s (approx.)
Inflation time 12 - 16s
Relaxation time 44 - 48s
Display 7 segment 4 digit display
Display content Pressure/cycles

WARNING! Follow operating and maintenance instructions carefully


to prevent injury, as well as damage to the product or other equipment

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9. STORAGE
The mattress and control unit are best stored in the product bag (optional extra).
Handle the packed product with care. Do not put anything heavy on top of it.

10. ACCESSORIES
ART. NO. DESCRIPTION
VTD0010M Sleeve Calf Medium
VTD0010L Sleeve Calf Large
VTD0011M sleeve Thigh Medium
VTD0011L sleeve Thigh Large

11. WARRANTY
11.1 Scope
This ELIRA deep vein thrombosis prevention system is covered by a 1-year
warranty for manufacturing defects. The warranty does not apply to normal
wear and tear or damage due to negligence or improper handling/care. since
the cuffs are disposable, it will not be covered under warranty.

11.2 Service and repairs


This ELIRA deep vein thrombosis prevention system is a medical device, that
is used as an aid in preventing deep vein thrombosis. For this reason, we
recommend that the control unit be regularly serviced and inspected to maintain
functionality and performance. Like other technical devices, a control unit that
is properly cared for works better and lasts longer. Service and maintenance
must always be performed by BCOS Healthcare Pvt. Ltd. or one of its authorized
technicians. Only use spare parts that have been approved by BCOS Healthcare
Pvt. Ltd. Use of non-approved spare parts invalidates the warranty. A warranty
claim must be submitted to BCOS Healthcare Pvt. Ltd. before the product is
returned.
Please contact BCOS Healthcare Pvt. Ltd. or your local dealer if you have
questions regarding warranty and service.

NOTE! Disposable cuffs are not included in the warranty.


WARRANTY VOID IF THE SEAL IS BROKEN OR OPENED BY AN
UNAUTHORIZED PERSONNEL.

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12. OTHER INFORMATION

12.1 Disassembly and recycling


Except for certain parts of the control unit, energy recovery is possible for
almost all material in Elira products through incineration in waste incineration
facilities.

CONTROL UNIT
A used ELIRA deep vein thrombosis prevention unit must not be disassembled.
It must instead be taken to a recycling center and sorted as electronic waste.

12.2 Returns and complaints


Complaints are to be reported to the supplier. Return of a product shall follow
the supplier’s instructions and can only be done after the complaint has
been reported. Damages due to the transportation should be reported to the
transportation agent.

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