Orthofix Ltd
A-V Impulse System MODEL 6000 Operators Instruction Manual Jan 2003
Operators Instruction Manual
20 Pages
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Model 6000 Operators Instruction Manual The A-V Impulse System Controller and Accessories
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Contents 1.
A-V Impulse System™...3
2.
Features of The A-V Impulse System Model 6000...4
3.
Installation...4
4.
Product Overview...5
5.
Operating Precautions...6
6.
Contraindications...6
7.
Patient and Skin Care...7
8.
Indications For Use...7
9. 9.1. 9.2. 9.3.
Fitting the Single Patient Use ImPads...9 ImPad Rigid Sole Foot Cover(s)...9 Hand ImPad Cover...10 ImPad Under Cast Inflation Pad...10
10. 10.1. 10.2. 10.3. 10.4.
Getting Started...11 Sequence of Operation...11 Pausing Treatment...11 Display...12 Night Mode...12
11. Preset Parameters...13 11.1. Presets and their Uses...13 11.2. Customising Parameters...14 12. 12.1 12.2
What to do if the Controller Detects a Fault...15 Fault Codes...15 Hardware Error Codes...15
13. 13.1. 13.2. 13.3. 13.4. 13.5.
Maintenance...16 Routine Maintenance...16 Repair...16 AC Fuse Replacement...16 Cleaning...16 Disposal...16
14.
Warranty and Factory Service...17
15. 15.1 15.2. 15.3.
Specification...18 Description of Symbols...18 Specifications...19 Impulse Pressure Conversion Table mmHg/KPa...19
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A-V Impulse System™
Clinical studies report that the veins in the sole of the foot act as a very powerful natural blood pump. During walking, blood is pumped from these veins in a high velocity surge, up the leg to the heart. A similar mechanism exists in the hand, returning venous blood up the arm on fist clenching. The A-V Impulse System was developed to mimic these natural physiological processes, maintaining blood circulation in the arms and legs. The system consists of a controller connected by air supply hoses to specially designed inflation pads - ImPad™. The ImPad inflation pad is rapidly inflated by an impulse of air from the controller. Following each impulse the controller automatically allows the inflation pad to deflate. The inflation pad is available as an ImPad rigid sole foot cover, an undercast inflation pad, and as a hand cover.
Plexus Full
Plexus Empty Venous Plexus - Foot
Plexus Full
Plexus Empty
Venous Plexus - Hand 3 / 20
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Features of The A-V Impulse System Model 6000
3.
Liquid Crystal Display Simple set-up Microprocessor controller technology Alarms and displays to alert user to help with rapid troubleshooting.
Installation
Warning:Ensure adequate clearance is provided around the controller to allow for free air circulation. Check that there is reasonable freedom from dust and lint. Do NOT use on wet surfaces. Do NOT cover the controller. Check the controller is complete, undamaged and that the voltage rating specified on the rating label is compatible with your AC power supply. Items supplied with the A-V Impulse System are: A-V Impulse System Controller Fitted AC Power Cable (as requested) Air Supply Hoses
1. 2.
Note:
Operators Manual Protective Packaging Service Manual
Connect the fitted AC power plug to an earthed electrical supply. The A-V Impulse System is designed to fit to the patient's bed using the hanging handle. The controller can also be used on any stable flat surface. If used on a bed's footboard, ensure that the controller is positioned securely in the centre. If located on the floor take care not to crush the controller when altering the bed height.
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Product Overview Liquid Crystal Display
Membrane Switch Panel AC Power ON/OFF Switch Front View Air Output Socket Patient Right Air Output Socket Patient Left
Communications Port (Authorised Service Use Only - Refer to the Maintenance Section)
Hanging Handle & Instruction Label Rear View
Rating Label Tamper Label
Close Up - Rear View 5 / 20
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Operating Precautions If this controller is dropped, subjected to excessive moisture, fluid spillage, humidity or high temperature, or suspected to have been damaged, remove it from service for inspection by qualified service personnel. When transporting or storing the controller use the original packaging, where possible, and adhere to the transport and storage conditions stated in the specifications section and on the outer packaging. An electrical shock hazard exists if the casing is opened, removed, or if the unit is in contact with water. This system should not be used on wet surfaces, while the patient is bathing or otherwise in contact with water. An explosion hazard exists if the system is used in the presence of flammable anaesthetics. Exercise care to locate the system away from hazardous sources. When connected to AC power supply a three-wire (Live, Neutral and Earth) supply must be used. If the integrity of the external protective conductor is in doubt do not use the controller. A comprehensive service manual containing servicing and testing information is available for the A-V Impulse System. Illustrations used in this manual show typical values that may be used in the function of the controller. These settings and values are for illustrative purposes only. The complete range of settings and values are stated in the specification section. Refer all servicing to authorised service personnel.
6.
Contraindications The A-V Impulse System is contraindicated for patients with conditions where an increase of fluid to the heart may be detrimental, including some patients with congestive heart failure, and those with pre-existing deep vein thrombosis, thrombophlebitis or pulmonary embolism. The device should be used with caution on the infected or insensitive extremity. Special attention, additional padding and additional checks should be given to patients with poor circulation, fragile skin, insensitive extremities, diabetes and those who may be predisposed to tissue viability problems, including those receiving anti-coagulation therapy. To minimise pressure effects, reduce the impulse pressure and set the impulse duration to 1 second. Check for skin reddening and any early signs that may lead to tissue viability problems. Use additional padding, or discontinue treatment, according to clinical judgement.
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Patient and Skin Care
Caution: The consumables designed for use with the A-V Impulse Systems are single patient use. The transfer of consumables between patients may result in cross infection or unexpected consumable failure due to extended use. For optimum results, good priming of the veins is required. This is assisted by a slight degree (approximately 15 degrees) of leg dependency (foot use) or positioning of the hand below the heart (hand use). Avoid leg elevation unless using an anti-embolism stocking, and do not let the limb get cool. For optimum DVT prophylaxis, it is recommended the A-V Impulse System be used with anti-embolism stockings on moderate and high risk patients. As with any treatment technique it is important to check regularly according to hospital protocol, for patient comfort and compliance and to pay particular attention to skin care and hygiene. Regularly Check Impulse is felt directly under the arch of the foot or the palm of their hand, depending on the type of consumable fitted. ImPad cover fits snugly and comfortably. Skin integrity (remove stocking/stockinette). Skin (colour) redness.
8.
Indications For Use
The A-V Impulse System is safe and effective for the indications shown below. The proper duration of use for each indication is subject to clinical judgement. Note: The indications and recommendations guidelines will vary depending on the type of ImPad used.
Key -
= Foot Use
Indication Circulation Enhancement
Relieves circulatory disorders secondary to diminished blood flow, such as ischaemia secondary to peripheral vascular disease.
= Hand Use Recommended Guidelines
ImPad Type
For temporary impairments such as temporary trauma or disease conditions, continuous use until the condition is resolved. For chronic impairments, daily use depending on the severity of the patient's condition and activity level.
Deep Vein Thrombosis Prophylaxis and Pulmonary Embolism Prophylaxis Use for effective prophylaxis for patients at Continuous use until the patient risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), including providing is fully ambulatory and weight bearing (not just mobilised). pre-intra and post-operative prophylaxis for DVT and PE. 7 / 20
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Indication
Page 8
Recommended Guidelines
ImPad Type
Acute Oedema Reduces acute oedema, such as elevated compartment pressures, oedema secondary to trauma and/or surgical procedures, postbypass graft oedema, post operative oedema secondary to venus ligation or venous stripping and oedema secondary to sprains, strains and sports related injuries of the extremity.
Continuous use until oedema is reduced.
Chronic Oedema
Reduces chronic oedema.
As required, but at least 4 hours per day.
Extremity Pain Associated with Incident, Trauma or Surgery Relieves pain, increase range of motion and limb mobility, and expedites return of function following trauma or surgery.
Continuous use until severity of pain is reduced or physician recommends alternative therapy.
Venous Stasis/Venous Insufficiency For temporary impairments such as temporary trauma or disease conditions, continuous use until Treats venous stasis, venous insufficiency and condition is resolved. varicose veins. For chronic impairments, daily use depending on the severity of the patient's condition and activity level. Lymphoedema Reduces lymphoedema, including lymphoedema secondary to trauma and/or surgery and reduces or controls chronic lymphoedema, including post-paralytic lymphoedema due to stroke or spinal cord injury.
As required, but at least 4 hours per day.
Leg Ulcers Assists healing of cutaneous ulcers.
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Continuous use until ulcer severity is reduced or physician recommends alternative therapy. 8 / 20
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Fitting the Single Patient Use ImPads
Warning:The consumables designed for use with the A-V Impulse System are single patient use. The transfer of consumables between patients may result in cross infection or unexpected consumable failure due to extended use. Caution: Check the skin for irritation and use additional padding according to clinical judgement. The ImPad should be fitted following the instructions supplied with the pad. It is recommended that ImPads are fitted to the patient in pairs.
9.1.
ImPad Rigid Sole Foot Cover(s)
Caution: For full ImPad life do not walk or weight bear on the ImPad when the controller is impulsing and only inflate when fitted to the foot. Ensure that the ImPad is placed directly under the arch of the foot. 1. 2.
3. 4. 5. 6.
Fit anti-embolism stockings / stockinette as required, avoiding wrinkles. Select the appropriately sized Left or Right ImPad. Place the foot centrally on the ImPad (A). Wrap the inside of the ImPad foot cover over the top of the foot (B). Wrap the outside of the ImPad foot cover over the top, secure with the strap (C). Wrap the rear strap around the heel, secure in place (D). Ensure that the patient is comfortable and the ImPad cover is fitted securely.
(A)
(A/B)
(C)
(D)
(D) or (D) Note:
9 / 20
When the ImPad is correctly fitted you should be able to insert two fingers between the ImPad and the stocking / stockinette. 10/JAN/2003 10247(1)
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Hand ImPad Cover
Caution: For full ImPad life only inflate when fitted to the hand. Ensure that the ImPad is placed directly under the palm of the hand.
(A) 1. 2. 3. 4. 5. 6.
Fit stockinette as required, avoiding wrinkles. Select the appropriate Left or Right ImPad. Place the hand on top of the inflation pad, locate the thumb in the cut-out (A). Wrap the cover across the back of the hand and secure (B, C). Wrap the wrist strap around the base of the thumb and secure (D). Ensure that the patient is comfortable and the ImPad cover is fitted securely.
(B)
(C)
(D) Note:
The Hand ImPad Cover can be modified to suit patients fitted with external fixators. Take care not to damage the bladder component.
9.3.
ImPad Under Cast Inflation Pad
Caution: Do not inflate the cast pad until the cast has fully hardened. Use 1 second impulse duration for the cast limb. 1. 2. 3. 4. 5.
6.
7. 8.
Fit anti-embolism stockings/stockinette as required, avoiding wrinkles. Fit under cast padding according to hospital protocol. Select the appropriate Left or Right Under Cast Inflation Pad. Place the foot centrally on the cast pad (A). Wrap the inside of the cast pad cover over the top of the foot (B). Ensure the pad inlet tube is pointing to the rear (C). Secure with adhesive tab. Completely cover and secure the cast pad in place with under cast padding, according to hospital protocol. Ensure that extra padding is placed over anklebones and on top of the foot to eliminate possible irritation (D). Ensure that the patient is comfortable and the ImPad cover is fitted securely. Cast normally, take extra care that the inside of the cast is smoothly finished. Ensure the inlet tubing does not kink or become obstructed.
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(A)
(B)
(C)
(D) 10 / 20
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Getting Started
Caution: Before you start to use The A-V Impulse System controller read the Operating Precautions, Contraindications and Symbol Definition sections. Do not stand or walk when the controller is impulsing as this may cause damage to the consumable. Note:
When the ImPad(s) are fitted correctly and the controller is switched on the patient will feel an impulse under the arch of their foot or the palm of their hand, depending on the type of consumable fitted.
10.1.
Sequence of Operation
Note:
10.2.
Fit the ImPad(s) to the patient. Connect the air hose(s) to the appropriate Air Output Socket(s) on the rear of the controller. To switch on the controller press the I/O switch to the on (I) position. The display will illuminate and the controller will go through a self-test routine. The controller will display service and model data. Following the self-test a 5 second countdown is displayed in the top left of the display. The controller will display the current patient hours and total use hours. Press the / button(s) to start the treatment once the countdown is complete. It is recommended that the “Patient Hours” function is reset to zero when the controller is used on a new patient.
Pausing Treatment
To pause the treatment, press the
To continue the treatment, press the
Note:
11 / 20
/
button(s) once. /
button(s).
If the controller remains paused for 2 minutes it will automatically go into Standby mode. To commence the treatment from Standby mode press the / button(s) twice.
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Display
Impulse Pressure (Patient Right)
Impulse Pressure (Patient Left)
Impulse Duration (Patient Right)
Impulse Duration (Patient Left)
Channel Indicator (Patient Right)
Channel Indicator (Patient Left)
Channel Pressure Achieved Icon
The controller displays a tick or checkmark (9) once the selected channel pressure has been achieved. If this icon is not displayed check the positioning and fit of the ImPad.
Controller Status
The bottom section of the display shows the controller’s status. When functioning correctly, an ImPad and air hose will represent each selected channel and the smiling controller icon will be displayed. Shortly before an impulse is due an arrow head flashes at the controller end of the air hose. The arrow head moves down the air hose flashing one second before it is delivered. The impulse is shown on the ImPad icon as it is delivered. In the event of an alarm condition the frowning controller icon is displayed together with a fault code.
Note:
For more information on fault codes refer to the label on the hanging handle or Fault Code section of this manual. The controller status icon will shown a Foot ImPad during foot or hand ImPad use.
10.4.
Night Mode
In Night Mode the audible alarm sounds less frequently and the display flashes to draw attention to the controller in dimly lit conditions, minimising patient disturbance.
To select Night Mode promptly double press
.
To cancel Night Mode promptly double press
.
Night Mode Icon
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Preset Parameters
The controller is pre-programmed with three commonly used impulse pressure/duration settings. These settings are available through use of the buttons.
11.1.
Presets and their Uses
Preset 1 130 mmHg Impulse Pressure, 1 second Impulse Duration, 20 second Impulse Interval Uses
Deep Vein Thrombosis Prophylaxis Oedema Reduction Casted Limbs
Action
Display
Default setting when controller switched On (l).
Preset 2 130 mmHg Impulse Pressure, 3 second Impulse Duration, 20 second Impulse Interval Uses
Deep Vein Thrombosis Prophylaxis Oedema Reduction Patients with Sensitive Limb to Maximise Comfort Arterial Disease
Action
Press
Display
once
Preset 3 80 mmHg Impulse Pressure, 1 second Impulse Duration, 20 second Impulse Interval Uses
Patients with Very Sensitive Extremities Allows Patient to Become Accustomed to Treatment
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Action
Press
Display
twice
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Customising Parameters
Note:
The impulse pressure, duration and interval should be specified by the prescribing physician, according to clinical judgement. As venous repriming is more rapid in the hand than foot, the interval can be customised when using the ImPad hand cover, according to clinical judgement. The following parameters can be adjusted: impulse pressure, impulse duration and interval time. Customising can be carried out while the controller is operating. Parameters
Action
Impulse Pressure Press to increase in 10 mmHg steps. Press 10 mmHg steps. Impulse Duration Press Interval Time *
to decrease in
to choose 3 seconds or 1 second pulse duration.
Press . Press to increase in increments. Press decrease in increments.
to
*The interval icon is left displayed if the default is not used.
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12.
What to do if the Controller Detects a Fault
12.1
Fault Codes
The A-V Impulse System controller is capable of automatic adjustment to correct many situations that may lead to an alarm indication. If the controller is unable to make the necessary adjustment, then an audible alarm will bleep and the controller graphic will show where an adjustment is needed. The fault codes and corrective actions are shown below. Fault Code
Description
1
Air Hose Not Connected
Check the air hose connections.
2
Air Hose Kinked
Check air hose for kinks or occlusion.
3
Low Pressure
Check ImPad is not loose, has been disconnected from patient, or the ImPad has been removed by the patient during use. Refit ImPad.
4
High Pressure
Check ImPad is not too tight and the air hose is not kinked or occluded.
Display
Actions
Note:
Explanation of the fault codes can also be found on the hanging handle label.
12.2
Hardware Error Codes
When the A-V Impulse System controller detects a hardware error an audible alarm will bleep and the controller graphic will show where an adjustment is needed. The hardware error codes and corrective actions are shown below. Fault Code
Description
Technical E1-11 Error Code
E12 15 / 20
Over Temperature Protection
Display
Actions Switch off the controller. Contact your local representative for the repairs and returns procedure. Check that the controller's air vents are free from obstruction and that there is free air circulation around the controller. Ensure that the environment is not excessively hot. Allowing the controller to cool will reset the alarm. If the problem re-occurs see the Maintenance section. 10/JAN/2003 10247(1)
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Maintenance
Warning:Before performing any servicing, maintenance or cleaning procedures, the equipment MUST be switched OFF (O) and disconnected from the AC supply. Servicing should only be performed by authorised service personnel with reference to the Service Manual (AV 6927-01). The 6-pin communication port on the rear of the controller is for use by authorised service personnel ONLY and there must be no patient connection. To ensure that the A-V Impulse System remains in good operating condition, it is important to keep it clean and carry out the routine maintenance procedures described below.
13.1.
Routine Maintenance Interval As Required
Routine Maintenance Procedure Thoroughly clean external surfaces of the controller before transfer between patients and after prolonged periods of storage. Attention should be paid to the fan grills, ensure these are clean at all times. Annually / 3000 hours 1. Inspect the AC power supply plug and cable for damage. 2. Perform the functional tests outlined in the Service Manual.
13.2.
Repair
In the event of any problems occurring with this equipment, contact your local representative for repair and the returns procedure.
13.3.
AC Fuse Replacement
If the controller does not operate when AC power is applied check the fuses on the rear panel and replace if necessary with fuses of the correct value and type, refer to the specification section of this manual. If the fuses blow again or the controller fails to power up remove it from use and have it examined by authorised service personnel.
13.4.
Cleaning
Warning:Disinfectants that are known to be corrosive to metals must not be used. Use of Iodine can cause surface discolouration. Concentrated Isopropyl Alcohol based cleaners may degrade plastic parts. Do not spray liquids into the fan grills. Do not immerse or steam autoclave or ETO sterile. Before the transfer of the system between patients and periodically during use, clean the controller by wiping with a lint free cloth lightly dampened with warm water and a standard disinfectant / detergent solution.
13.5.
Disposal
The controller should be disposed of as outlined by local country regulations taking environmental factors into consideration. Do not send the controller back to the manufacturer.
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Warranty and Factory Service
Novamedix warrants that your A-V Impulse System controller does not contain defective material or workmanship. This warranty is for one year from the delivery of the controller to the original purchaser. If within the first year there is a fault on the unit, the controller should be returned to the Novamedix Service Department at the address shown below, and Novamedix will free of charge, inspect the unit and replace any part which upon their examination, appears to be defective provided that there is no evidence that the unit has been tampered with, or mistreated. This warranty does not apply to the air supply hoses or the disposable ImPad inflation pads or equipment damaged through shipping, tampering, negligence, or misuse, including liquid immersion, autoclaving, or ETO sterilisation. If, within the first year of purchase the controller is serviced by personnel other than those expressly authorised by Novamedix, the warranty becomes void, and the company cannot be held liable for any consequential damage caused as a result. Some countries do not allow the exclusion or limitation of accidental or consequential damages, so the foregoing limitation or exclusion regarding damages may not apply. Also, this Limited Warranty gives you specific legal rights, and you may also have other rights, which vary, from country to country. The Service Manual is intended as a guide to technically qualified personnel when evaluating instrument malfunctions, it is not to be construed as authorisation to perform warranty repairs. Unauthorised service will void the warranty. If you have any service maintenance problems, contact Customer Services at Novamedix. If possible, the original packaging should be used to ensure safe arrival. Before shipping your unit please call the number below to obtain a return material authorisation number. Novamedix maintains a service facility with the capability to promptly repair an A-V Impulse System controller. Controllers requiring repair must be shipped fully assembled, prepaid and insured to: The Service Department Novamedix Services Limited, Viscount Court, South Way, Andover, Hampshire, SP10 5NW, England. Telephone: +44 (0) 1264 334212 Facsimile +44 (0) 1264 334007
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Specification
15.1
Description of Symbols
secs
Impulse Duration in seconds
mmHg Impulse Pressure in mmHg I
ON - Power connection to the electrical supply
O
OFF - Power disconnection from electrical supply Run / Stop - Patient Channel Left and Right Increase Impulse Pressure Setting (secondary function - select configuration code. Patient Right Only) Decrease Impulse Pressure Setting (secondary function - select compressor pressure. Patient Right Only) Interval Adjustment - Display and select interval. (secondary function - select / deselect night mode ) Preset Setting - Display and select preset parameter settings (secondary function - resets patient hours to zero) Type B Equipment Dangerous Voltage Consult accompanying documents CE Approved. Complies with Directive 93/42 EEC 14 June 1993 as a Class IIa Product (0086 - signifies British Standards Institute as the notified body)
Note:
Patient Right is the left channel when viewing the controller from the front.
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Specifications
All values stated are nominal. Height: 16.2cm overall Depth: 12.7cm (less handle) Width: 23.4cm Weight: 3.4kg Electrical Supply: 100V±10V 0.3A 50-60Hz 120V 0.3A 50-60Hz 230V 0.2A 50-60Hz Fuses: T1A x 20mm (Antisurge) 250V Manufactured by: Novamedix Services Limited, Viscount Court, South Way, Andover, Hampshire, SP10 5NW, England. Standards: The Controller is built and tested to: EN60601-1, IEC606-1, IEC601-1-2, CFR47 as a Class 1 Type B device. Variants also comply to CSA C22.2 601-1, AS3200.1, JIS T1001 and FDA Reviewer Guidance for Pre-Market 510K Notification Submissions. CE Approved. Complies with Directive 93/42 EEC 14 June 1993 as a Class IIa Product Output Impulse Pressure: 60 - 200 mmHg Impulse Duration: 1 second / 3 second (1 second factory set default) Impulse Interval: 12 - 50 seconds (20 seconds factory set default), 12 - 20 seconds - 2 second steps (hand pad) 20 - 50 seconds - 5 second steps (foot pad) Transport/Storage Conditions: Temperature: -40°C - +70°C Relative Humidity: 10% - 1*00% condensing Atmospheric Pressure: 500mbar - 1060mbar
15.3.
19 / 20
Impulse Pressure Conversion Table mmHg/KPa mmHg
KPa
mmHg
KPa
mmHg
KPa
60
8.0
110
14.7
160
21.3
70
9.3
120
16.0
170
22.7
80
10.7
130
17.3
180
24.0
90
12.0
140
18.7
190
25.3
100
13.3
150
20.0
200
26.7
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GB Distributed by:-
Novamedix, A-V Impulse System and ImPad are Trademarks of Novamedix Distribution Limited. Orthofix is a trademark of Orthofix International NV. Made in England. Manufactured under one or more of the following patent or patent applications. CANADA: Patent No. 1291386/Appl. No. 515,462. DENMARK: Patent No. 161426/Appl. No. 5913/86. EPO: Patent Nos 0150553 0221636/Appl. Nos. 84304060.1 86306163.6 86307731.9 89305062.5. GREECE: Patent Nos 86.2079 86.2883. IRELAND: Appl. Nos 2107/86 2654/86. JAPAN: Appl. Nos 59-126542 186684/86 135683/89. KOREA: Appl. No. 6529/1986. PORTUGAL: Appl. Nos 83 176 83 814. SPAIN: Patent Nos 8600924 8602577. TAIWAN: Patent Nos 036041. In line with its policy of continuing product improvement, the Company maintains the right to change specifications without notice. © Novamedix Distribution Limited 2003 - All rights reserved.
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