VENAPRESS IPCS User Manual Ver 1.00

Contents Product Description…………………………………………………….…………... 2 Operating Instruction..……………………………………………………….…….. 6 Garment Application Instructions……………………………………………… 10 Cleaning………………….……………………………………………………………….. 11 Waste Disposal…………………………………………………………………………. 11 EMC…………………………………………………………………………………………. 11 Technical Data………………………………………………………………………….. 15 Symbols Used …………………………………………………..……………………… 16 Warranty…………………………………………………………………………………. 17

Warning 1. Connect the Master Control unit to an adequate power source. 2. Do not use the system in the presence of any flammable gases (such as Anaesthetic

Agents). 3. Keep the pump and garment away from sources of liquid and open flames. 4. Keep the pump and garment away from sharp objects.

Caution The VENAPRESS® IPCS should always be used in conjunction with hospital policy 1. The control unit should only be repaired by an authorised distributor. 2. Do not drop the control unit or store it in direct sunlight or extreme cold

conditions.

Safety These usage and safety guidelines are IMPORTANT! Please follow them carefully. General Use 1. Carefully unpack the contents of the pump package. 2. Connect the master control unit to a proper power source. 3. Do not use or store your pump any of the listed environments –  Do not drop the control unit or store it in direct sunlight or extreme cold conditions.  Do not use the system in the presence of any flammable gases (such as Anaesthetic Agents).  Keep the pump and garments away from sources of liquid and open flames.  Keep the garments away from sharp objects.  Keep the pump and garments away from heating devices. 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% Control Unit 1. 2. 3.

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.

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Product Description The VENAPRESS® IPCS 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 VENAPRESS® IPCS is a non-invasive mechanical prophylactic system that massages the 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.

Intended Use The system consists of a pump and a soft pliable compression single patient use garment(s) for the foot. The pump supplies compression on a pre-set inflation pressure of 30mmHg and 130mmHg. The inflation hold (seconds) is 3 and the cycle time is 30 seconds. The pressure in the garments is transferred to the extremity, augmenting venous blood flow when the foot is circumferentially compressed, reducing stasis. This process also stimulates fibrinolysis; thus, reducing the risk of early clots formation. Please note: It is NOT RECOMMENDED to patients with following symptoms to use this product without consulting your clinical physician

Caution Contraindications for use: The use of the VENAPRESS® IPCS is NOT RECOMMENDED in the following conditions – 1. Severe congestive cardiac failure. 2. Severe arteriosclerosis or other ischaemic vascular disease. 3. Extreme deformity of the limbs. 4. Known or suspected deep vein thrombosis. 5. Known or suspected Pulmonary Embolism 6. Any local condition in which the garments would interfere: i.e. i. Gangrene ii. Dermatitis iii. Untreated or infected wounds iv. Recent skin grafts

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VENAPRESS ® IPCS Pump

Power Switch

Control Panel

Control Unit Features Battery Indicator

Blue LED Display Window

Alarm Light

Timer in Hours

Timer Reset Button

Power Button

Power Light

Single Garment Mode

Pressure Settings for Foot at 130mmHg

Pressure Setting for Calf/Thigh at 40 mmHg. 3

Power Cord and Battery Charging System

Lithium Battery Backup System

Lithium Battery

Battery Socket

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Connection Instruction Step 1- Connect the air hoses to control unit.

Step 2 – Connect the air hoses to garments.

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Operating Instructions The VENAPRESS® IPCS 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 garments have been removed from their packaging, plug the pump into an electrical outlet. DO NOT SWITCH ON. 2. Position the pump on any flat surface or suspend the pump at the foot of the bed using the swing-out hooks. 3. The garments may be used on either leg or either foot (depending on the garment) 4. Unfold the garments and lay the unfolded garments on a flat surface with the foam lining facing up. 5. Position the garment at the appropriate ankle or knee landmark. 6. Place the patient’s leg on the garment lining, position the back of the knee over the popliteal opening in the case of thigh high garments. 7. Starting at the side opposite the air hose, wrap the garment snugly around the patient’s leg. 8. Fasten the garment securely with the Velcro fasteners starting at the ankle and then moving to the calf and/or thigh. 9. Check the fit and patient’s comfort by inserting two fingers between the garment and the patient’s leg at the knee opening. 10. Using the same procedure, apply the second garment if needed. If only one garment is to be used, simply leave the unused air outlet on the pump free (no air hose attached). 11. Air hoses are required to connect the garment(s) to the pump and are provided separately. Attach the garments to the air tubing using the white snap lock connectors. Each tube has a male end connector at one end and a female end connector at the other. The female end (large white connector) will fit to the male end (small white connector) that is on the garment. Make certain that a “click” sound is heard to ensure a solid connection. 12. Attach the other end(s) of the air tubing (male end) to the large white female connector(s) on the pump. Make certain that a click is heard with each snap lock connection. If you need to disconnect the tubing, press the silver coloured tab on large white (female) connector and pull apart. 13. Press the on/off switch to turn pump on. 14. Pump will start initialization process approximately for 10 seconds. 15. The pump will automatically detect for Single/Dual garment/s during start-up process with set pressures for Calf/Thigh and Foot. 16. To activate Foot Therapy, press FOOT button on control panel for 5 seconds during start-up initialization process. “Ft” will be indicated in upper display window when Foot Therapy is engaged.

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17. TIMER – To activate the TIMER, switch on the pump and timing will commence. The TIMER reflects each HOUR of compression, when compression is interrupted i.e. the patient is removed from therapy, the timer will suspend timing until the patient is reconnected to therapy and therapy is continued. 18. RESETTING TIMER – to reset the timer press “RESET” for 5 seconds and it will reset itself. 19. Disconnect Device：Disconnect by plug. 20. Install the battery from the box in the back side of the device to prevent any circumstance of power failure. 21. Respond to alarms instruction appropriately and follow the manufacturer’s recommendations. 22. To remove the garments, switch off the pump and depress the latches on each side of the connectors and pull the connectors apart. Suggestions Ensure that there are no kinks in the hoses and the connectors are properly locked. Never apply or remove the garments while inflated as this may cause damage to the garment. The parts and/or accessories supplied are specifically designed for use with VENAPRESS IPCS control unit. Use other products in conjunction with the system is not recommended. Operating Functions 1. Low Pressure Alarm i. This device has both a visual and audible low pressure alarm built in. The device constantly monitors the internal pressures of the garments to avoid a pressure malfunction occurring in any case. ii. If a low pressure is detected, the pump will send a visual and audio alarm warning after two cycles. 2. Battery Backup System i. This device has a Lithium battery backup system. The device constantly monitors the outer AC electric power supply. In case of power failure situation, the pump will switch to battery operation automatically. ii. The “Battery Indicator” indicates the battery capacity status as illustrated.

iii. iv.

Under normal condition of use, the battery will last approximately 5 hours of operation time when it is fully charged. It may take up to 16 hours to fully charge to an empty battery. The pump will show a red flashing light from “Battery Indicator” and trigger the audio alarm to give a low battery warning before the pump is shutting down by itself within 15 minutes. 7

Caution Indicator Light: Green Amber BlueBlue LED Display -

TIMER -

illuminated to indicate power on. illuminated to indicate a fault has been detected follow by an audio alarm after 5 minutes. illuminated to indicate initialization is in process and (Int) code will be displayed in upper window. Upper display indicates therapy selected for Calf/Thigh (LEG) or FOOT (Ft). Lower display indicate pressure delivered to each chamber of compression and alarm status for low pressure (LO), high pressure (HI), error garment (GE) and fault (F) – redirect for service. Indication of therapy time in hours from commencement of therapy per patient.

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Alarm Codes

Indicates the error information for VENAPRESS® IPCS, these include: - Lo, Hi, GE and F. Alarm Codes LO

Fault Type Low Pressure

Description 



HI

GE

High Pressure

Garment Error



System Failure

Air hose disconnected at garment.

Air hose is kinked.



Check garment application is not too loose or tight.



Check for leaks in the garments or air hose set and replace if faulty.



Turn the pump off and restart.



Call 1300 283 122 for technical assistance.



Check air hose set for any kinks.



Call 1300 283 122 for technical assistance.



No garments attached during start up.



Attach garments to pump and restart.



Garments are not fully deflated during each restart.



Ensure garments are fully deflated before restart.



Check garment configuration and restart.



Check connectors for any blockage and restart.



Call 1300 283 122 for technical assistance.



Check air hoses connection.



Turn the pump off and restart.



Call 1300 283 122 for technical assistance.



F

Leg is less than set pressure; Foot Pressure is less than 130mmHg after 2 consecutive cycles.

Troubleshooting

The initialization process has detected an inconsistent garment configuration.



The initialization failed due to a possible blockage in air hose/garment connectors.



Loose air hose connection on both ports at pump.



Pressure is lower than set pressure after 2 consecutive cycles.



Pressure is greater than set pressure after two inflations.



Electrical malfunction.

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Garment Application Instructions VENAPRESS® IPCS Garments are 100% PVC FREE VENAPRESS® IPCS Garments are 100% Latex FREE Instructions for use: 1. Plug the VENAPRESS® IPCS into a suitable electrical outlet 2. Connect Air hoses to the pump 3. Connect Garments or Garment to the air hose hearing a clear Click that confirms connection. 4. Place the garments on the patient’s feet ensuring the Velcro attachments are visible. 5. Ensure a snug fit, place two fingers around the back of the garment to ensure the garment is not too tight. Routinely inspect the patients feet once compression commences. 6. TURN THE PUMP ON, the power indicator light will illuminate confirming operation. 7. Starting at the side opposite the air hose, wrap the garment snugly around the patient's leg. 8. Should you require further instructions please refer to your Prius Healthcare Solutions Sales Specialist.

Contraindications & Cautions Do not use the VENAPRESS® IPCS where increased venous or lymphatic return is not desired. The VENAPRESS® IPCS Sequential Compression System could be contraindicated and should not be used by persons with known or suspected deep vein thrombosis, pulmonary oedema, congestive heart failure, severe arteriosclerosis, thrombophlebitis, or active infection. Do not use on persons with painful and sensitive extremities, where the garment will interfere with gangrenous limbs, on persons with vein ligation or recent skin grafts, or extreme deformity of the leg. NB. If you are unsure of any contraindications please refer to the patient’s physician before using the VENAPRESS IPCS Intermittent Pneumatic Compression System.

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Cleaning The pump: The casing of the pump is manufactured from ABS plastic. If soiled it can be wiped down with a sodium hypochlorite solution to dilution of 1000ppm or any EPA approved, hospital grade. The control unit (face) should also be cleaned weekly using a damp soft cloth and mild detergent. (Switch off the electrical supply to the pump and disconnect the power cord from the main supply before cleaning and inspection) The Garment: It is a single patient use garment. Do not wash or clean discard after use.

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.

Waste Disposal This Product has been supplied from an environmentally aware manufacturer that complies with the WEEE. This product may contain substances that could be harmful to the environment if disposed of in places (landfills) that are not appropriate according the legislation. Please be environmentally responsible and recycle this product through your recycling facility at its end of life.

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EMC Electric devices may interact due to electro-magnetic radiation. We recommend a safety distance of at least 1-metre distance 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 VENAPRESS® IPCS The VENAPRESS® IPCS is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the VENAPRESS® IPCS can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the VENAPRESS® IPCS as recommended below, according to the maximum output power of the communications equipment. Rated maximum output Separation distance according to frequency of transmitter power of transmitter m W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz d = 1,2 d = 1,2 d = 2,3 0,12 0,12 0,23 0,01 0,38 0,38 0,73 0,1 1,2 1,2 2,3 1 3,8 3,8 7,3 10 12 12 23 100 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter 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.

Article I. Guidance and manufacturer’s declaration – electromagnetic emissions The VENAPRESS® IPCS is intended for use in the electromagnetic environment specified below. The customer or the user of the VENAPRESS® IPCS should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment – guidance RF emissions Group 1 The VENAPRESS® IPCS uses RF CISPR 11 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. RF emissions Class B The VENAPRESS® IPCS is suitable for CISPR 11 use in all establishments, including domestic establishments and those Harmonic emissions Class A directly connected to the public IEC 61000-3-2 low-voltage power supply network Voltage fluctuations/ Complies that supplies buildings used for flicker emissions domestic purposes. IEC 61000-3-3

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Article II. Guidance and manufacturer’s declaration – electromagnetic immunity The VENAPRESS® IPCS is intended for use in the electromagnetic environment specified below. The customer or the user of the VENAPRESS® IPCS should assure that it is used in such an environment. Immunity test IEC 60601 Compliance level Electromagnetic test level environment – guidance Electrostatic Floors should be wood, discharge (ESD) concrete, or ceramic tile. If floors are covered with IEC 61000-4-2 synthetic material, the relative humidity should be at least 30 %. Electrical fast er Mains power quality should be that of a typical transient/burst supply lines supply lines commercial or hospital environment. IEC 61000-4-4

Surge IEC 61000-4-5

interruptions and voltage variations on power supply input lines IEC 61000-4-11

input/output lines

input/output lines

line(s)

line(s)

earth <5 % UT (>95 % dip in UT) for 0,5 cycle

earth <5 % UT (>95 % dip in UT) for 0,5 cycle

40 % UT (60 % dip in UT) for 5 cycles

40 % UT (60 % dip in UT) for 5 cycles

70 % UT (30 % dip in UT) for 25 cycles

70 % UT (30 % dip in UT) for 25 cycles

<5 % UT (>95 % dip in UT) for 5 sec

<5 % UT (>95 % dip in UT) for 5 sec

Power frequency (50/60 Hz) magnetic field

Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the VENAPRESS® IPCS requires continued operation during power mains interruptions, it is recommended that the VENAPRESS® IPCS be powered from an uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels 3 A/m 3 A/m characteristic of a typical location in a typical commercial or hospital IEC 61000-4-8 environment. NOTE UT is the a.c. mains voltage prior to application of the test level.

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Article III. Guidance and manufacturer’s declaration – electromagnetic immunity The VENAPRESS® IPCS is intended for use in the electromagnetic environment specified below. The customer or the user of the VENAPRESS® IPCS should assure that it is used in such an environment. Immunity test IEC 60601 test Compliance Electromagnetic environment – level guidance level Portable and mobile RF communications equipment should be used no closer to any part of the VENAPRESS® IPCS, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. 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

Recommended separation distance 3 Vrms

3 V/m

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 rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range.b 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 by absorption and reflection from structures, objects and people. a 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 electromagnetic site survey should be considered. If the measured field strength in the location in which the VENAPRESS® IPCS is used exceeds the applicable RF compliance level above, the VENAPRESS® IPCS should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the VENAPRESS® IPCS. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Technical Data The Control Unit Model No. Size Weight Pressure Range Input Rating Fuse Rating Classification Operation Humidity Operation Temperature Applied Part

VENAPRESS IPCS 32 x 11 x 19.5 cm 2.4 Kg Calf/Thigh Garment: 40 mmHg +/- 5mmHg. Foot Garment: 130 mmHg +/- 5mmHg. AC 100-240V 50/60Hz 1A 250V Class II Type BF Not AP or APG type 30-75% 15∘- 35∘C Garment and Air Tube.

PVC Free Garments are designed for use with the VENAPRESS® IPCS Controller. Model name

Size

VPI – 1 (XS)

PVC Free Calf Garment (pair), Extra Small. For calf, size up to 35 cm circumference.

VPI – 001 (S)

PVC Free Calf Garment (pair), Small. For calf, size up to 43 cm circumference.

VPI – 002 (M)

PVC Free Calf Garment (pair), Medium. For calf, size up to 48 cm circumference.

VPI – 003 (M)

PVC Free Thigh Garment (pair), Medium. For thigh, size up to 71 cm circumference.

VPI – 004 (L)

PVC Free Thigh Garment (pair), Large. For thigh,

size up to 89 cm circumference

VPI – 005(B)

PVC Free Calf Garment (pair), Bariatric. For calf, size up to 81 cm circumference.

VPI-UNIF (U)

PVC Free VPI Foot garment (pair). 9

VPI-FOOTL (L)

PVC Free VPI Foot garment (pair) large. Size

VPIAH 1.5m

Air hose extension of 1.5 metres (pair). standard with each pump.

VPIAH 3m

Air hose extension of 3 metres (pair).

VPIAH 4.5m

Air hose extension of 4.5 metres (pair). 15

Regular Size 7 – 9 - 11

Comes

Symbols Used The CE mark and Notified Body Registration Numbers 0197

Type BF Applied Part

Operating Instructions

Authorized Representative

Manufacture

Date of Manufacture

Batch Code Ex. YYMMDD01XX Serial Number

Caution

Class II Equipment

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Warranty  Prius Healthcare Solutions guarantees that this equipment is free from defects in materials and workmanship. Our obligation under this warranty is limited to the repair of equipment returned to the place of purchase within 12 months of delivery date.  We agree to service/adjust any equipment returned, and to replace or repair any part that is proven to be a warranty defect, at no charge. 

This warranty excludes equipment damage through shipping, tampering, improper maintenance, carelessness, accident, negligence or misuse, or products that have been altered, repaired or dismantled other than with the manufacture’s written authorization and by its approved procedures and by properly qualified technicians. In no event shall Prius Healthcare Solutions be liable for any direct, indirect or consequential damages or losses resulting from the use of equipment.

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Unit E, 5 Jubilee Ave Warriewood NSW 2102 Australia Tel: +61 2 9998 7700 Fax: + 61 2 9999 1441

Caremed Supply, Inc. Xin Tien City, Taipei 231, Taiwan, R.O.C. Tel: 886-2-29179808 Fax: 886-2-29186505

0197 AL300130 V1.00

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