Phlebo PRESS Model 601 DVT 601 User Manual Rev. 1.1 Oct 2010

Phlebo Press DVT 601

Mego Afek AC Ltd.

User Manual

Table of contents 1

GENERAL ... 1

2

MAIN COMPONENTS ... 4

3

OPERATING THE PHLEBO PRESS DVT ... 6

4

MAINTENANCE ... 9

5

MANUFACTURER DETAILS AND WARRANTY ... 13

6

EMC MANUFACTURER DECLARATIONS ... 14

Table of Contents

Phlebo Press DVT 601

Mego Afek AC Ltd.

User Manual

1 General The information listed in this user manual will assist you in using the Phlebo Press DVT device & accessories to obtain maximum benefits from the treatment. Should you have any questions or require further information, please do not hesitate to contact your local dealer. The Phlebo Press DVT is used to help prevent deep vein thrombosis in patients who may be susceptible. Patients who are unable to maintain movement of the lower limbs before, during and after operative procedures are also susceptible. The non-invasive sequential compression massage of the Phlebo Press DVT moves from the distal to the proximal part of the treated limb, enhancing blood flow in the deep veins of the legs, particularly the femoral veins.

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Caution: Treatment with the Phlebo Press DVT is by physician prescription only. Use only in accordance with physician's orders. A physician should determine treatment time, pressure, and frequency.

1.1 Indications The Phlebo Press DVT is prescribed to help prevent deep vein thrombosis in patients who may be susceptible.

1.2 Contraindications Note: Do not use the Phlebo Press DVT, in the presence of the following conditions:  Known or suspected Deep Vein Thrombosis, congestive heart failure, pulmonary edema, thrombophlebitis, severe arteriosclerosis, or active infections.  In the presence of any pain or numbness.  On extremities that are not sensitive to pain.  Vein ligation or other ischemic vascular diseases.  When increased venous or lymphatic return is undesirable.  Extreme deformity of the limbs.  Gangrene.  Recent skin grafts.  Dermatitis.

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Phlebo Press DVT 601

Mego Afek AC Ltd.

User Manual

1.3 The Phlebo Press DVT Cycle The intermittent sequential massage applied by the Phlebo Press DVT is smooth, painless and comfortable. During inflation, the cells inside the compression garment are inflated one after the other from distal to proximal, originating at the lower part of the limb and progressing towards the body. The time required for inflation will depend on the pressure level selected and on the size of the treatment garment. When all four cells have reached the required pressure, all of the cells will deflate, followed by a pause time of 50 seconds, after which the inflation cycle repeats. The cycle of inflation, deflation, and pause time allows application of pressure to the limbs, stimulating venous return, while alternating with the pause time for vascular refill.

1.4 Safety Features  Safety Over-pressure Valve (Relief Valve) An over-pressure valve is assembled in the pneumatic control unit, to ensure that the pressure in the garments cannot exceed normal human blood pressure.  Power Failure In the event of power failure, the pneumatic control unit is designed to deflate all of the air from the garments automatically.  Electronic Safety System If, due to air leakage anywhere in the system, or for any other reason, the device continues to inflate the garments beyond the maximum cycle time allowed (preset by the manufacturer to about 1 minute), the compressor will shut down by an electronic safety mechanism, causing an automatic deflation of the garments. A warning indicator will flash and a buzzer will also be heard. The device will only begin operating again after the user turns the power switch OFF and then ON again.  Overload Protection Fuses The device is equipped with two overload fuses, on each of the power lines (“~” and “0”)  One-way Hose Connection In order to prevent incorrect connection of the air hose bundle to the device, which will cause improper inflation order (sequence) of the garments, the connector is designed for one-way connection. Proper connection can only be done when the connector plug is

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Phlebo Press DVT 601

Mego Afek AC Ltd.

User Manual

inserted in the proper direction, with the connector’s Phlebo Press DVT logo facing up. The hose end fittings (on the garment side of the hose bundle) are color- and number- coded, indicating the correct order in which they are to be connected to the garment, from distal to proximal, to correspond to the colored and numbered air inlets on the garment.

1.5 Symbols on Devices !

Caution! Read instructions carefully before use. (Located on back of device) Consult instructions before use. (Located on sleeve's tag) Level of protection - type BF equipment. (Located on back of device) Separate collection for waste electrical and electronic equipment. (Located on bottom of air pump) Date of manufacture. (Located on bottom of device) CE label showing compliance with European Directive 2007/47/EC amending Directive 93/42/EEC, concerning medical devices. Accompanied by the name and the address of the manufacturer. (Located on sleeve tag)

1.6 Dimensions Height Length Width Net Wt.

100 mm 260 mm 130 mm 2.3 kg.

1.7 Specifications Model Pressure Power Panel Cat No. Class Voltage Frequency Fuses # Range Consumption Language 601E L10000D3 English 220/230V 601E L10000D8 50-60 I 50/60Hz 11W 2A 601E L10000D9 German mmHg 601A L10000D2 110/115V English 601A L10000D7

Note: The device is equipped with functional grounding (three-pin plug), for technician safety.

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Phlebo Press DVT 601

Mego Afek AC Ltd.

User Manual

2 Main Components 2.1 Device Unit This device is powered by electricity provided by a wall outlet with a grounded connection. The device supplies compressed air in fixed cycles at regulated pressure. The device unit is able to simultaneously operate two garments with 4 air compartments each.

2.2 Hose Bundle The hose assembly that transfers compressed air from the device unit to the compression garments. The hose bundle consists of 4 hoses, a connector that attaches to the corresponding receptacle of the device unit, and 4 numbered and color-coded end fittings that attach to the garment.

2.3 Garments for Lower Extremities There are two types of garments available: reusable and disposable. Each treatment garment has four air compartments. The garment applies cyclic air pressure supplied by the device unit to the treated limb.

2.4 Pronged Plug Plug used to seal off the unused outlet of the device unit, when only one limb is treated.

2.5 Laundering Plugs Plugs used for laundering the reusable garments. The laundering plugs are to be inserted into the air inlets prior to laundering. The laundering plugs seal the air inlets, preventing laundry liquids from entering the garment air compartments (see Section 4.2 below for detailed laundering instructions). Note: The laundry plugs are intended only for the reusable garments. Disposable garments may not be laundered.

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Phlebo Press DVT 601

Mego Afek AC Ltd.

User Manual

Figure 1 - Components

a. Device Unit

b. Hose Bundle

c. Pronged Plug

d. Laundering Plugs

e. Reusable Garment

f. Reusable Footless g. Disposable Garment Garment

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H. Disposable Footless Garment

Phlebo Press DVT 601

Mego Afek AC Ltd.

User Manual

3 Operating the Phlebo Press DVT Before starting treatment, have the patient get into a comfortable, relaxed position, either sitting or lying down.

3.1 Setting up the Phlebo Press DVT Device Place the Phlebo Press DVT on a flat stable surface or suspend it on the end of a bed using the attached hooks located on the bottom of the device. The device should be easily accessible by both the patient and the caregiver during treatment. Be sure the device is securely positioned to ensure that the device will not slip or fall. If the device is hung from the bed rail, it is recommended to center the device in the middle of the rail.

3.2 Putting on the Garment If applying a reusable garment, we be sure to first cover the leg with an inner cotton sleeve (available from your local dealer), and then affixing the Phlebo Press DVT garment as follows: a. Open the garment by separating the two upper flaps. b. Gently slide the garment underneath the leg to be treated. c. Position the patient’s foot into the foot portion of the garment, making sure that the heel is properly situated into the garment's heel area, then pull the garment upwards, towards the back of the patient’s knee. The garment should be taut. d. Close the garment around the patient’s leg and secure using the Velcro strips. The garment should fit snugly but not tightly. e. Separate the foot straps and wrap them around the foot (from the bottom of the foot, around the sides) and secure them on the top of the foot using the Velcro straps. Again, the straps should be snug but comfortable. Note: Do not use any garments other then Phlebo Press DVT garments, made especially for use with the Phlebo Press DVT device. Note: Disposable garments are for SINGLE PATIENT USE ONLY.

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Phlebo Press DVT 601

Mego Afek AC Ltd.

User Manual

3.3 Connecting the Air Hoses Attach the air hoses to the garment by inserting each hose into its appropriate air inlet, matching the numbers and colors on both the end fittings of the hoses and the garment’s inlets. Air inlet number 1 is always the farthest one from the body (at the foot). Note: Proper connection order of the hoses is essential for proper inflation sequence. Securely insert the hose bundle connectors - with the Phlebo Press DVT logo facing up - into one of the air sockets on the Device unit (it does not matter which one). If only one garment is used, remove the Pronged Plug from its storage socket and place it into the unused air outlet. This will prevent air from escaping through the unused socket. Make sure the air hoses are not bent, kinked or pinched.

3.4 Operating Instructions Note: When using the device, do not use any pressure other than the pressure prescribed by your physician (50 mmHg / 60 mmHg). If you have any questions, contact your physician. In the case of a power failure, turn the device OFF and remove the electrical cord from the wall outlet. a. Connect the power cord to the wall outlet. b. Set the pressure knob to the required pressure according to physician instructions, and turn the device ON.

3.5 End of Treatment a. At the end of the treatment, shut the device OFF and disconnect the power cord from the wall outlet. b. Disconnect the Hose Bundle from the device by pressing the two release clips on the connector’s sides and gently work it free. Remove the garments from the patient's legs. It is not necessary to disconnect the hoses from the garments after each use. (However, if you travel with the device, the hoses should be disconnected from the garments to avoid damage). To disconnect the hoses from the garment, grasp each hose by its end fitting only and using a simultaneous twisting / pulling motion, work it free.

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Phlebo Press DVT 601

Mego Afek AC Ltd.

User Manual

Note: 1. The treatment should be pleasant and relaxing. The pressure should not cause any pain or discomfort. 2. If the device stops working, the warning indicator flashes and a signal sounds, it means that the time needed to fill garment is too long. This may be due to air leakage in the garments or in the connectors. In this case, turn the device OFF, check and solve any problems of this nature, and resume operation. 3. In case of a power failure, turn the device OFF and remove the electrical cord from the wall outlet.

Figure 2 - General View of Front Panel

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Phlebo Press DVT 601

Mego Afek AC Ltd.

User Manual

4 Maintenance !

Warnings: 1. Only an authorized technician should open the device. 2. Before performing any maintenance to the device, always disconnect the power cord from the electrical wall outlet.

4.1 Cleaning the Device Gently wipe the outside of the device using a damp, nonabrasive cloth. Do not spill any liquids on the device.

4.2 Cleaning Reusable Compression Garments !

General Cautions:  Do not machine wash.  Do not wash garments in hot water (exceeding 40°C / 100°F).  Always plug all air valves before soaking garments in cold/lukewarm water to prevent water from entering the air cells.  Do not use solvents based on thinner, kerosene, gasoline, or medical benzene).  Do not use chemical solvents that are not approved for laundry.  Do not machine dry.  Do not use heat blowers to dry the garment  Do not iron.

4.3 Cleaning Methods Warnings:  Always use protective gloves during garment cleaning.  Make sure to wash your hands thoroughly after cleaning the garment. Cautions:  Do not clean the air valves with alcohol.  Do not spill alcohol directly on the garment.

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Phlebo Press DVT 601

Mego Afek AC Ltd.

User Manual

4.3.1. Cleaning Method No. 1 1. Open all zippers or fasteners and spread the garment on a flat surface. 2. Plug the air inlets on the garments using the four special Laundering Plugs provided (see Figure 1 - d). These plugs prevent water from entering the garment air cells. 3. Prepare a bucket with lukewarm water (not more than 40°C / 100°F). 4. Add two spoons of laundry detergent for every one liter (1 quart) of water. 5. Soak a stiff-bristle brush (carpet brush or similar) in the soapy water and gently brush the entire external fabric and internal lining. 6. Make sure to avoid brushing the air valves and preventing water from entering the air valves. 7. Rinse the brush in clear water (without laundry detergent) and brush until the garment is clean of detergent. 8. Wipe dry with a soft cotton cloth. 4.3.2. Cleaning Method No. 2 1. Open all zippers or fasteners and spread the garment on a flat surface. 2. Plug the air inlets on the garments using the four special Laundering Plugs provided (see Figure 1 - d). These plugs prevent water from entering the garment air cells. 3. Use one of the following bactericidal disinfectants:  SEPTAL SCRUB made by Teva Medical  Similar Chlorhexidine Gluconate 4% W/V solution  Appropriate hospital grade disinfectant Or use 70% Alcohol solution 4. Soak a cotton cloth in the disinfectant solution. 5. Use the soaked cotton cloth to wipe the garment, and then immediately wipe dry with a soft cotton cloth. Note: The disposable, single-patient garments are NOT TO BE CLEANED. Be sure to dispose of the garments properly after each use.

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Phlebo Press DVT 601

Mego Afek AC Ltd.

User Manual

4.4 Storage a. Store in a dry, shaded place at temperatures between -20 to 70 degrees, Celsius. b. The device should be stored after rolling up the power cord. Do not bend the cord. c. Since the garment is inflated by compressed air, it must remain airtight. Therefore, avoid contact with pins, needles and any other sharp objects or instruments. If one of the cells is damaged, the garment must be replaced. d. Store the garments flat, without folding. e. The hoses should be kept untwisted and unfolded.

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Phlebo Press DVT 601

Mego Afek AC Ltd.

User Manual

4.5 Troubleshooting !

Note: Before continuing, check all accessories visually for any defects.

Table 1 - Troubleshooting Guide Symptom The device is not working.

Possible cause No electricity.

Corrective action Check the electrical wall outlet.

Power cord.

Check the power cord visually for any defects. Check the fuses and replace if necessary. If they burn out again, contact an authorized service center. Check hose bundles for kinks, twists and folds.

Fuses.

The device starts The air cannot working and stops move through the immediately. hose bundle. One garment inflates The second Check hose bundle for kinks, twists but the second one garment does not and folds. does not. receive air. 1. The device stops Hose bundle is not Check and fasten all air working, a connected connections. warning light properly. flashes and a buzzer sounds. 2. The device works Defective garment Replace garment and check again. at very low An internal Contact an authorized service pressure, ignoring problem. center. the pressure setting. An irregular noise. Transferring of Make sure the device is standing on vibrations to the all four of its bumpers, or is hung table or the properly on its hooks while patient’s bed. supported by the two rear bumpers. An internal Contact an authorized service problem. center.

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Phlebo Press DVT 601

Mego Afek AC Ltd.

User Manual

5 Manufacturer Details and Warranty 5.1 Manufacturer Address Mego Afek AC Ltd. Kibbutz Afek 30042 Israel

5.2 Warranty a. Mego Afek AC Ltd. warrants the Phlebo Press DVT and its garments to be free of defects in materials and workmanship. b. This warranty applies as follows:  For devices: for a period of twenty-four (24) months from the date of purchase.  For reusable garments: for a period of twelve (12) months from the date of purchase.  For disposable garments: for thirty-thousand (30,000) inflation cycles - single patient use. c. This warranty does not include or cover malfunctions caused by unreasonable use, noncompliance with operation and maintenance instructions, or damage caused by unauthorized or unqualified repairs.

5.3 MDD - Authorized Representative in Europe Rolf Davidsen Helseagenturer A/s Postboks 238, Vestiieimvegen 35, Bygnes, 4250 Kopervik Norway Tel: +47-52-844500 Fax: +47-52-844509

5.4 Representative in USA LYMPHA PRESS USA, Ltd. 232 Park Avenue Manalapan NJ 07726 Tel.: 1-888-596-7421 Fax: 1-732-792-9745

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Phlebo Press DVT 601

Mego Afek AC Ltd.

User Manual

6 EMC Manufacturer Declarations Model 601E&A - electromagnetic emissions - manufacturer declaration The Model 601E&A is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 601E&A should assure that it is used in such an environment. Emissions Test

Compliance

Electromagnetic environment - guidance

RF emissions

Group 1

The Model 601E&A 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.

CISPR 11 RF emissions

Class B

CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/flicker emissions IEC 61000-3-3

Not applicable for Model 601 E&A Complies for Model 601E,

The Model 601E&A is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.

Not applicable for Model 601A

Model 601E&A - electromagnetic immunity - manufacturer declaration The Model 601E&A is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 601E&A should assure that it is used in such an environment. Immunity Test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance

Electrostatic discharge (ESD)

±6 kV contact

Complies

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

±2 kV for power supply lines

Complies

Mains power quality should be that of a typical commercial or hospital environment.

±1 kV line to line

Complies

Mains power quality should be that of a typical commercial or hospital environment.

Complies

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Model 601E&A requires continued operation during power mains interruptions, it is recommended that the Model 601E&A be powered from an uninterruptible power supply or a UPS.

Complies

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

±8 kV air

IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5

±2 kV line to erth Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

>95% dip in U T for 10ms 60% dip in U T for 100ms 30% dip in U T for 500ms >95% dip in U T for 5000ms

Power frequency (50/60 Hz) magnetic field

3 A/m

IEC 61000-4-8

NOTE: U T is the a.c. mains voltage prior to application of the test level.

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Phlebo Press DVT 601

Mego Afek AC Ltd.

User Manual

Model 601E&A - electromagnetic immunity - manufacturer's declaration The Model 601E&A is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 601E&A should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the Model 601E&A, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms

d = 1,2 P

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2,5 GHz

3 V/m

d = 1,2 P 80 MHz to 800 MHz d = 2,3 P 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 meters (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 Model 601E&A is used exceeds the applicable RF compliance level above, the Model 601E&A should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Model 601E&A.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and the Model 601E&A The Model 601E&A is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the M o d e l 6 0 1 E & A can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the M o d e l 6 0 1 E & A as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W

0,01 0,1 1 10 100

Separation distance according to frequency of transmitter m

150 kHz to 80 MHz d = 1,2 P 0,12 0,38 1,2 3,8 12

80 MHz to 800 MHz d = 1,2 P 0,12 0,38 1,2 3,8 12

800 MHz to 2,5 GHz d = 2,3 P 0,23 0,73 2,3 7,3 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 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.

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