VENTURI AVANTI and COMPACT User Guidelines Oct 2013

Explanation of Label Symbols and Statements Protect from heat and radioactive sources

Caution

Refer to instructions of use / booklet

Temperature limitation

Medical Devices Directive 93/42/EEC

Humidity limitation

Atmospheric pressure limitation

North America ETL listed

The Type 19 is suitable for connection to type BF applied parts

Class II Equipment (Double Insulated)

Do not dispose of with the normal household waste (please refer to www.talleygroup.com for further details)

WARNING

This is a statement that alerts the user to the possibility of serious injury or other adverse reactions with the use or misuse of the device

CAUTION

This is a statement that alerts the user to the possibility of a problem with the system associated with its use or misuse

Manufacturer

Operating Instructions Date of Manufacture

IP22 Fragile, handle with care

IP: Ingress Protection (Pump only) 2: Protection against fingers or other object not greater than 80mm in length and 12mm in diameter 2: Protection from vertically dripping water when tilted to 15o)

Note: Abbreviation: Negative Pressure Wound Therapy is abbreviated to ‘NPWT’ throughout this document 1

Contents Explanation of Symbols and Statements Introduction / Intended Use Contraindications List of Components Cautions and Warnings Information How to Apply NPWT:Getting Started Operating the Vacuum Power Unit User Information Battery Information Care and Maintenance Warning and Fault Indicators Specification EMI / EMC Statement EMC Manufacturer’s Declaration

Page

1 4 4 5

6 7 9 11 11 13 14 Back Cover

Introduction / Intended Use Thank you for choosing to use the VENTURI® AVANTI / VENTURI® COMPACT Negative Pressure Wound Therapy (NPWT) system from Talley. In doing so you have selected an efficient, competitively priced product for the treatment of many wounds including pressure ulcers, dehisced surgical wounds, diabetic/neuropathic ulcers, venous leg ulcers, post surgical wounds, sinus drainage and management, traumatic wounds and pre- and post-op flaps/grafts. The VENTURI® AVANTI / VENTURI® COMPACT NPWT system offers a choice of continuous or intermittent therapy modes and features a lightweight, versatile vacuum power unit which benefits from dual-power technology, offering a seamless choice of mains or battery operation. The integral battery is charge-optimised, and provides long-lasting power back-up when needed. The battery operation option allows the system to function away from a mains power supply for extended periods of time, allowing the patient full mobility during therapy, if required (optional carry case with shoulder strap available). NPWT is applied utilising a choice of VENTURI® Wound Care Sets (supplied separately) which include a choice of gauze or foam dressing, a silicone drain and transparent adhesive film. Foam Wound Care Sets are supplied with a portal drain and Gauze Wound Care Sets are available with a choice of portal, flat or channel drain. Both foam and gauze Wound Care Sets are available in a range of sizes according to the wound type being treated. 2

The VENTURI® AVANTI / VENTURI® COMPACT NPWT system will benefit from careful installation and use, providing a long and effective service life. Please read and understand this document completely before applying NPWT.

CONTRAINDICATIONS Do not place NPWT dressings directly in contact with exposed blood vessels, anastomotic sites, organs or nerves. NPWT is contraindicated for patients with: 1. Malignancy in the wound 2. Untreated osteomyelitis 3. Non-enteric and unexplored fistulas 4. Wounds with difficult haemostasis 5. Necrotic tissue with eschar present NOTE: After debridement of necrotic tissue and complete removal of eschar, NPWT can be used.

List of Components Your VENTURI® AVANTI / VENTURI® COMPACT NPWT system should comprise the following items - please ensure you have all of these before installation. Note: Wound Care Sets are supplied separately. l VENTURI® AVANTI (TG600/07) / VENTURI® COMPACT (TG600/08) vacuum power unit l 15V Mains adapter FW7362M/15 (VENTURI® AVANTI only) l 12V Mains adapter FW7556M/12 (VENTURI® COMPACT only) l Canister (supplied fitted to power unit): - capacity 600ml (VENTURI® AVANTI); 300ml (VENTURI® COMPACT) l Carry bag* l IV pole attachment bracket (supplied with VENTURI® COMPACT only)*

WOUND CARE SETS (supplied separately: available in singles and packs of 10)

l Gauze Wound Care Set - flat drain (standard/large/abdominal) l Gauze Wound Care Set - portal drain (standard/large) l Gauze Wound Care Set - channel drain l Foam Wound Care Set - portal drain (small/standard/large) Note: Other Wound Care Sets may be available; please contact Talley for latest information.

ALSO AVAILABLE

l 300ml/600ml/1200ml canister with solidifier l Spare battery l 12V Fused Vehicle adapter/charger l Y-connector x 5 l Adhesive Gel Patch x 5 l Carry case l Bedside holder (VENTURI® AVANTI only) l IV pole attachment bracket 3

* may not be included in all markets

Cautions and Warnings l There are no special skills required to operate the pump unit however, Negative Pressure Wound Therapy should only be used under the advice, recommendation and supervision of a licensed Physician and / or a registered nurse. l The medical professional is responsible for applying his/her best medical judgment when using this system. Prior to use, the medical professional(s) treating the wound must assess how to best use the system for an individual wound. l Select correct setting for therapy required. Care should be taken not to accidently change pressures once set as the efficiency of the therapy may be reduced. This could also be caused by pets, pests or children. l The electricity supply is of the type indicated on the power adapter. l Check the power adapter lead is free from damage and is positioned so as not to cause an obstruction, or injury, e.g. strangulation. Do not position the vacuum power unit or power adapter such that makes it difficult to disconnect the supply or drain plug. l Ensure the power adapter lead, drain tube or vacuum power unit cannot become trapped or crushed, e.g. via raising or lowering of bed or bed rails or any other moving object. All tubes must be free of kinks, twists, properly connected and positioned so as not to cause an obstruction or injury. l Do not place the vacuum power unit or power adapter on or near a heat source. l Never use the power adapter whilst placed on top of or near to material which is flammable or can be damaged by heat. (The supplied power adapters plug directly into the power source partly mitigating this issue). l The VENTURI® AVANTI TG600/7 vacuum power unit must only be used with the approved power adapter supplied by Talley (see Specification on page 13) l The VENTURI® COMPACT TG600/8 vacuum power unit must only be used with the approved power adapter supplied by Talley (see Specification on page 13) l The VENTURI® NPWT system (Vacuum power unit and power adapter) is not used in the presence of flammable anesthetics or in an oxygen enriched environment. l Suitable for continuous or intermittent use. l Not suitable for sterilisation. l The materials used in the manufacture of all components of the system comply with the required fire safety regulations. l Talley advice against smoking whilst the system is in use, to prevent the accidental secondary ignition of associated items which may be flammable. l Do not modify any of the medical devices or accessories in any way or use unspecified parts. Do not use unspecified parts. l Choking may result from a child swallowing a small part that has become detached from the ME equipment. l A Wound Care Set must be used with the VENTURI® AVANTI / VENTURI® COMPACT system to carry out NPWT. 4

Cautions and Warnings (continued) l Please refer to the Wound Care Set ‘Instructions for Use’ leaflet (supplied with Wound Care Set) for dressing application and setup. Note that the dressings in the set are sterile and for single patient / single use only, not intended for reuse. l Intended for home healthcare and professional healthcare facility environments. l The device is intended to be used with its carry bag or holder. l Do not connect to any other medical device or equipment. l When the canister is not fitted on the vacuum power unit, it is essential that the aperture on the rear face of the unit (Fig. 1) is not blocked or covered (e.g. with a label). l The power unit and power adapter should be cleaned between patient use (refer to Care and Maintenance Section).

DO NOT COVER

Fig. 1

Figure shows VENTURI® AVANTI.

l The VENTURI® power unit battery is installed inside VENTURI® COMPACT is similar the unit and is not accessible by users. Battery replacement should only be carried out by qualified Talley service personnel.

l Wireless equipment such as mobile phones should be kept at least 10 feet or 3.3m away from this equipment. l The above warnings, cautions and any safety considerations should be observed on a routine and regular basis, not only upon installation.

How to Apply NPWT NB. A Wound Care Set must be used with the VENTURI® AVANTI / VENTURI® COMPACT system to carry out NPWT (see page 3 for available options). Please refer to the ‘Wound Care Set Instructions for Use’ leaflet (supplied with Wound Care Set) for dressing application and setup. CAUTION! The medical professional is responsible for using his/her best medical judgment when using this system. Prior to use, the medical professional(s) treating the wound must assess how to best use the system for an individual wound. 1. Remove all packaging from the power unit and mains adapter. Note: The power unit internal battery may be mostly discharged or in an inert state (VENTURI® COMPACT only) on first use. This will require the power unit to be used with the power adapter, which will automatically wake an inert battery (VENTURI® COMPACT only), operate the system and charge the internal battery. 2. If not already in place, attach canister to flat face of power unit by matching up the rear location pegs and rotating locking knob 1/4 turn clockwise to secure. Ensure canister is correctly located and secured otherwise NO CANISTER message will appear and power unit will not operate. 3. Prepare and seal wound as described in Wound Care Set ‘Instructions for Use’. 5

How to Apply NPWT (continued) 4. Attach Wound Care Set to the VENTURI® AVANTI / VENTURI® COMPACT power unit canister by lining up locator stud on the tubing connector with the notch on the canister tubing port located on top corner of canister, pushing down gently and twisting clockwise to lock. A tube guide is fitted to assist with the routing of the tubing. 5.

OPERATING THE VACUUM POWER UNIT:

a) If using the mains or vehicle power adapter, insert the smaller end (DC outlet) of the supplied power adapter cable into the side of the VENTURI® AVANTI / VENTURI® COMPACT power unit, and the other end into the appropriate power outlet. The power adapter indicator should be illuminated. NB. The battery will charge when the unit is connected to the power source (indicated by battery charge status icon on display screen scrolling from left to right) and provides automatic power back-up if the external power supply or adapter fails. It is recommended to use the power adapter when convenient to do so as this will ensure the battery is fully charged when needed. A fully discharged battery will take a number of hours to fully charge. b) Press RUN/STOP button to invoke and display STAND-BY mode (the power unit will beep and therapy mode, operating pressure and battery charge status will be displayed). c) The power unit will default to continuous therapy mode at 80mmHg. To switch between continuous and intermittent therapy modes, press and hold the THERAPY MODE button until power unit beeps to confirm change of mode. Adjust vacuum level if required using the UP and DOWN arrow buttons. d) Press RUN/STOP button again to initialise and run the power unit. NB. Vacuum level and therapy mode can be adjusted when in stand-by mode and for up to 1 minute after power unit is running. Power unit will automatically lock 1 minute after last button operation when running to prevent inadvertent operation of button functions (except MUTE), as indicated by 'L' on the display screen. Press and hold the UNLOCK button until power unit beeps if further button operation is needed. Display screen is only illuminated for a short period after button operation in battery mode. 6. Once the power unit is running, observe the wound site. The dressing should contract noticeably, becoming firm to the touch. If the dressing fails to contract, the dressing has not been completely sealed. Reinforce the dressing seal and/or adjust the drain and initiate suction again.

WARNING: Particularly when used outside of a medical institution, get immediate medical assistance from those responsible for the prescription and setting of the NPWT system should any of the following occur:- obvious bleeding or pain; the wound site or exudate presents unexpected changes in its condition, colour or odour; the wound dressing becomes detached or ineffective; the tubing becomes blocked.

7. To change or remove dressing, unlock power unit (press and hold UNLOCK until power unit beeps), then press and hold the RUN/STOP button until power unit beeps three times to return to stand-by mode. Clamp Wound Care Set tubing and remove by turning anticlockwise and lifting out of tubing port on canister. Dispose of used Wound Care Set according to local clinical waste policy. If required, apply new Wound Care Set and continue NPWT. 6

How to Apply NPWT (continued) 8. Canisters should be replaced as required or weekly. To change canister, make sure power unit is in stand-by mode (if still running, press and hold the UNLOCK button, followed by the RUN/STOP button). Clamp Wound Care Set tubing and remove by turning anticlockwise and lifting out of tubing port (this can be reconnected to new canister and unclamped if wound dressing is not being changed). Remove sealing plug from its location on top corner of canister and use to cap tubing port to seal in contents. Rotate locking knob 1/4 turn anticlockwise and remove canister. Dispose of used canister according to local clinical waste policy. If continuing NPWT, attach new canister and connect Wound Care Set tubing as previously described. 9. To stop the power unit, press and hold the UNLOCK button until power unit beeps and ‘L’ clears from display screen. Then press and hold the RUN/STOP button until power unit beeps three times to return to stand-by mode (if using the power adapter, disconnect it from the power unit and unplug from the power source). The power unit will then power off automatically after one minute of inactivity or may be forced off by pressing the MUTE key. 10. Place the user manual in a safe place for future use.

User Information l The VENTURI® AVANTI / VENTURI® COMPACT power unit will automatically lock 1 minute after last button operation when running to prevent inadvertent operation of button functions (except MUTE), as indicated by 'L' on the display screen. Press and hold the UNLOCK button until power unit beeps if further button operation is needed (i.e. change of therapy mode or vacuum level, or returning power unit to stand-by mode). The power unit will lock again 1 minute after last button operation. Please note that when running, the VENTURI® AVANTI / VENTURI® COMPACT power unit must be unlocked before it can be returned to stand-by mode, i.e. the power unit cannot be put into stand-by mode when the ‘L’ is displayed on the screen. l During operation, the power unit should be placed upright on a horizontal surface with the display uppermost. The VENTURI® AVANTI power unit can be placed in the optional metal holder for use at the bedside or attached to an IV pole using the optional bracket. The VENTURI® COMPACT is supplied with a bracket for IV pole attachment. To allow patient full mobility during therapy, both power units can also be placed in the carry cases provided. In all instances the power unit/canister assembly should be kept upright during use to ensure correct operation. The VENTURI® COMPACT will display a warning if the unit is over tilted.

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User Information (continued) BUTTON FUNCTIONS RUN/STOP

Press to invoke stand-by mode prior to running power unit. Press again to run power unit. Press and hold whilst power unit is running (and unlocked) to cease operation and return to stand-by mode. In battery operation the power unit will then power off after 1 minute of inactivity. If using mains power, switch off by disconnecting power cable from power unit or turning off mains power.

VACUUM LEVEL

Vacuum level can be adjusted when in stand-by mode and for up to 1 minute after last button operation when power unit is running using the UP and DOWN arrow buttons. Pressure can be adjusted in 5mmHg increments between 10mmHg and 180mmHg according to treatment requirements, the most widely used being between 60-80mmHg. The power unit will begin operation at the default pressure of 80mmHg. The selected vacuum level is shown on the display screen.

THERAPY MODE

The VENTURI® AVANTI / VENTURI® COMPACT power unit offers a choice of continuous or intermittent therapy modes. On power-on, the power unit will default to continuous therapy mode. To switch between therapy modes, press and hold the THERAPY MODE button until power unit beeps to confirm change of mode. When in intermittent therapy mode, the power unit will provide vacuum therapy for periods of 5 minutes followed by a 2 minute rest period. The selected therapy mode is displayed on the power unit screen and can be altered in either stand-by or (unlocked) run modes.

MUTE

Press to silence the sounder and to clear the message from the display screen. The MUTE button can also be used to force power-off in stand-by mode.

UNLOCK / LIGHT

The VENTURI® AVANTI / VENTURI® COMPACT power unit will automatically lock 1 minute after last button operation when running to prevent inadvertent operation of button functions (except MUTE), as indicated by 'L' on the display screen. Press and hold the UNLOCK button until power unit beeps if further button operation is needed (i.e. change of therapy mode or vacuum level, or returning power unit to stand-by mode). The power unit will lock again 1 minute after last button operation. Pressing this button will also illuminate the display screen for 10 seconds if power unit is in battery operation (screen will always be illuminated in mains operation).

USER SELECTABLE FUNCTIONS (VENTURI™ COMPACT only) The following functions are selectable in a user menu:l Language selection l Tilt indicator, switch on or off l Internal contamination sensor, switch on or off l Tube constriction indicator, switch on or off l Battery inert. Note that it is essential that the battery is put to this condition before international transportation.

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User Information (continued) The menu is accessed by a three second press of the unlock key. The arrow key scrolls to the functions shown above, and the mode select key allows the function to be toggled on or off, or selected. For language selection, press and hold the mode key until the required language is displayed. Releasing the mode key will then set the display for the language. Pressing the unlock key returns the device to stand-by mode.

IV POLE ATTACHMENT (VENTURI® COMPACT only) The VENTURI® COMPACT is supplied with an IV pole attachment bracket, to provide safe deployment and additional mobility. l To fit the IV pole attachment bracket, engage the three screws on the bracket into the corresponding three holes on the underside of the VENTURI® COMPACT. The screws can be hand tightened, and do not require high torque or a tool. l The fit the bracket with VENTURI® COMPACT attached, use the black hand knob to secure it to the vertical IV pole. The bracket will fit to IV poles between 19mm and 26mm diameter. l When dismounting the IV pole bracket from VENTURI® COMPACT, note that the three screws are captive, and will remain on the bracket when unfastened to prevent their loss. An IV pole attachment bracket is available as an optional accessory for the VENTURI® AVANTI. Instructions for its use are included with the part.

Battery Information l A fully charged battery should operate the power unit continuously for at least 24 hours. l Charge status is shown on the display of the power unit when it is in stand-by and run mode. l As the batteries are automatically charged as required when the system is operating on mains power, the battery module should not require removing or changing in normal use. l Use only the mains adapter or optional vehicle adaptor supplied with the system. l When power unit operation times when running from the internal battery are noticeably shorter than normal, it is time to replace the battery pack. Contact Talley or authorised dealer for battery replacement service. l Never use any battery pack that is damaged or worn out. Use the battery pack only for its intended purpose. l The battery pack is not serviceable and should be replaced if faulty (indicated by applicable battery faults displayed in place of battery charge status icon). Contact Talley or authorised dealer for battery replacement service. l For VENTURI® COMPACT only: The internal Lithium Ion Battery may be received or become inert if left for extended periods in storage or a fully discharged condition. Connection a power adapter will wake / charge the battery and immediately allow the full use of the 9

Battery Information (continued) vacuum power unit. It is possible to force the vacuum power unit into making the battery inert should this be required by some airline and other carriers. See ‘User Selectable Functions’ Menu for details (Page 8).

CHARGING THE BATTERY If not fully charged, the battery will automatically charge when the power unit is plugged into a power source via the power adapter. The battery will charge whilst the vacuum power unit is in standby or a run mode.

REPLACING THE BATTERY The battery is installed inside the unit and is not accessible by users. Battery replacement should only be carried out by qualified service personnel. Contact Talley or authorised dealer for battery replacement service.

Care and Maintenance POWER UNIT Always disconnect the VENTURI® AVANTI / VENTURI® COMPACT power unit from the power adapter and the power adapter from the power source before carrying out maintenance, repairs, servicing or cleaning. Check all electrical connections and power lead for signs of excessive wear. The power unit / power adapter can be wiped down with detergent or disinfectant solution or wipe*. Do not use solvents. Unsuitable for sterilisation. Dispose of the power unit / power adapter in accordance with the local regulations including WEEE requirements. The power unit / power adapter should be cleaned between patient use as a minimum.

* In line with the MHRA Medical Device Alert (MDA/2013/019), Talley advises customers

to use pH neutral, high level disinfectant cleaning products to sanitise reusable medical devices to prevent damage to materials and the degradation of plastic surfaces after prolonged use. The use of inappropriate cleaning and detergent materials on medical equipment could damage surfaces and may compromise the ability to decontaminate medical devices adequately or may interfere with device function. Talley recommends the use of TECcare® CONTROL antimicrobial wipes and fluid to clean and decontaminate all products it supplies to health and social care facilities. TECcare® CONTROL products provide class leading broad spectrum, high level disinfection with an exceptional safety profile. Being pH neutral TECcare® CONTROL can be universally used on all hard and soft surfaces without any detrimental effect. TECcare® CONTROL is CE marked for cleaning medical equipment.

WOUND CARE SETS AND CANISTERS Wound Care Sets and canisters are disposable and intended for single use only. After use please dispose of in an appropriate manner in accordance with local regulations and hospital best practice.

SERVICING

Talley recommend that all power units should be serviced every two years or as indicated by the ‘hours to service’ display. The unit contains no user serviceable parts and should only be serviced by either Talley or an authorised dealer. Talley will make available on request 10

Care and Maintenance (continued) service manuals, component parts lists and other information necessary for Talley, an authorised dealer or a competent electrical engineer to repair or service the system. Talley’s standard terms and conditions apply to all sales. A copy is available on request. For service, maintenance and any questions regarding this, or any other product, please contact Talley. It is the customer’s responsibility to ensure the following prior to collection: l the system is cleaned of any obvious contaminants. l contamination status is documented. l assistance is given to Talley personnel to bag the equipment if the device has been in a known or suspected infectious environment.

TRANSPORT AND STORAGE

Handle with care. Please report instances of damage or impact to Talley Service Department. Transport –25 °C without relative humidity control; and +70 °C at a relative humidity up to 93 %, non-condensing. An atmospheric pressure range of 700 hPa to 1 060 hPa. Suitable for all standard modes of transport when in the correct packaging.

OPERATIONAL CONDITIONS

A temperature range of +5 °C to +40 °C; A relative humidity range of 15% to 93%, non-condensing Operational Atmospheric Pressure: 700 hPa to 1060 hPa Suitable for pollution degree 2 Operational altitude ≤ 2 000 m IP Rating: IP22 pump only

MANUFACTURER’S GUARANTEE

All power units are covered by a 24 month manufacturer’s guarantee. The intended design life is 5 years if fully serviced.

Warning and Fault Indicators All sounders can be silenced and messages cleared by pressing the MUTE button once. Should any fault occur, press the MUTE button to reset the power unit. If fault remains/ re-occurs, contact Talley.

WARNING INDICATORS NO CANISTER – indicates canister is missing or is not correctly fitted. The power unit will

fail to operate whilst this message is displayed. Check that canister is correctly located and secured, as detailed on page 6.

NO BATTERY (VENTURI® AVANTI only)– indicates battery is not correctly fitted. The power

unit will only operate using the power adapter whilst this message is displayed. Contact Talley or authorised dealer to check battery and installation.

LOW BATTERY (only appears during battery operation) – the power unit will continue to 11

run whilst this warning is displayed. Press the MUTE button to silence the sounder and clear the message. Note that the system will automatically shut down when the battery is fully discharged. Plug into a power source to charge.

Warning and Fault Indicators (continued) CANISTER FULL – indicates that the canister has reached its capacity and should be

changed. The power unit will cease to run and the message/sounder will continue until the RUN/STOP button is pressed or the canister is removed, both of which cancels the message and sounder and returns the power unit to stand-by mode. Change canister as detailed on page 7. NB. The ‘Canister Full’ sounder can be silenced by pressing the MUTE button, however if the canister is not removed/changed the sounder will reoccur after 10 minutes.

LOW VACUUM / CHECK DRESSING (alternating messages)– indicates vaccum

pressure has fallen below minimum allowable levels. Power unit will continue to run whilst these messages is displayed. Check that wound dressing is completely sealed and that all tubing connections are secure. Press the MUTE button to silence the sounder and clear the messages. If fault re-occurs, contact Talley.

TUBE CONSTRICTION – indicates that pump demand has abruptly ceased. Note that a

certain level of flow in the drain is required for the indicator to be active. The message will occur for example in the case of a blocked tube, kinked tube or if the dressing is obstructed. Note that the tube constriction indicator can be selected on or off as required (see ‘User Selectable Functions’ on page 8). Default is on.

TILT (VENTURI® COMPACT only)– activates when the device is in active mode and is placed

at an angle that could affect the canister full indication. The sounder delays for 5 seconds, and is self-muting when the unit is returned to an upright position. Note that the tilt indicator can be selected to be on or off as required (see ‘User Selectable Functions’ on page 8). Default is on.

FAULT INDICATORS EMI Fault – indicates that the unit detects the pressure sensor amplifier is adversely affected by external RF fields. The power unit will continue to run whilst this message is displayed. Press the MUTE button to silence the sounder. This indicator will clear when interference ceases.

CHECK MOISTURE (VENTURI® COMPACT only) – indicates that moisture or exudate has

been detected in the power unit. The power unit will cease to operate on this indication. Refer to Talley for service assistance.

O/C Batt or CCT Fail (VENTURI® AVANTI only – will appear instead of battery charge status icon) – indicates that the battery is not functioning correctly and cannot be used. The power unit will only operate using mains power whilst this message is displayed. Contact Talley to order a replacement battery.

If any of the following faults are displayed the power unit will cease to operate:- PUMP OPEN; NO CANISTER; PUMP OFF FAULT (PUMP SHORT); RELEASE KEY; BATTERY FAULT (VENTURI® COMPACT only). Should any of these faults occur, press the MUTE button to reset the power unit. If fault remains/re-occurs, contact Talley. The VENTURI® AVANTI / VENTURI® COMPACT power unit may also display the following information (the power unit will continue to run whilst these messages are displayed):l SERVICE DUE - Contact Talley to arrange service l UNCALIBRATED - Contact Talley for recalibration 12

Specification POWER UNIT

Model Ref: Construction: Dimensions: Weight: DC Input Voltage: Operating Voltage: Peak Current: Max. Load Wattage: Vacuum Application: Pressure Range: Fixed Internal Battery:

CANISTER Construction: Capacity: Dimensions:

300ml 600ml 1200ml

POWER ADAPTER Mains Adapter Type: Input: Output: Cable Length: Part Number:

VENTURI® AVANTI

Venturi v.II TG600/07 Flame retardant ABS 210mm x 205mm x 105mm 2.2 kg 15V Nominal 6V 850mA RMS 7W Continuous (default therapy) or intermittent 10 to 180mmHg 6V 2.5Ah NiMH

VENTURI® COMPACT

Venturi v.II TG600/08 Flame retardant ABS 161mm x 155mm x 90mm 1.0 kg 12V Nominal 3.7V 450mA RMS 12W Continuous (default therapy) or intermittent 10 to 180mmHg 3.7V 10Wh Lithium Ion Rechargeable Cell

ABS Trans smoked grey, textured (includes 1 x 8g dissolvable sachet of desiccant) 600ml or 1200ml 300ml n/a 156mm x 163mm x 32mm 200mm x 190mm x 35mm n/a 200mm x 190mm x 70mm n/a FW7362M/15 (supplied) 100-240V / 50-60Hz / 700mA 15V dc / 2A 4 metres 34-26-05-103

FW7556M/12 (supplied) 100-240V / 50-60Hz / 400mA 12V dc / 1.5A 4 metres 34-26-05-104

The above mains adapters are considered part of the ME equipment 12V vehicle power adapter is available as an optional accessory The VENTURI® AVANTI / VENTURI® COMPACT power units must only be used with the specific external power adapters as supplied by Talley. Talley products are manufactured to comply with International and National safety standards. Talley design and manufacture products to conform to the requirements of ISO9001, ISO13485 and Directive (93/42/EEC). Talley reserves the right to modify the specification of any product without prior notice in line with a policy of continual product development. Our standard terms and conditions apply.

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EMI/EMC Statement and Manufacturer’s Declaration This equipment has been tested and found to comply with the limits of EN 60601-1-2. These limits are designed to provide reasonable protection against harmful interference in both a medical and residential environment. This equipment generates, uses and can radiate radio frequency energy and, if not used in accordance with manufacturer’s instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception or other equipment, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one of the following measures: l Reorient or relocate the receiving antenna. l Increase the separation between the equipment. l Connect the equipment to an outlet on a circuit different from that to which the receiver or equipment was connected. The equipment having been tested to operate within the limits of electromagnetic compatibility. (Immunity to interference from nearby sources radiating radio frequency energy). Sources exceeding these limits may give rise to operation faults. Where possible the system will sense the interference and if it is of short duration transparently take countermeasures whilst operating near normally, or failing this will issue a warning and take measures for the continued safely of the user. Further increased levels of energy may cause the system to stop operating, continuously generate random faults or continuous resets. Try to ascertain the source of the interference by turning nearby or suspect equipment off, and see if the interference effects stop. In any such event the user is encouraged to try to correct the interference by one of the following measures: l Have the interfering equipment repaired or replaced. l Reorient or relocate the interfering equipment. l Increase the separation between the equipment and the possible source of the interference. l Connect the equipment to an outlet on a circuit different from that to which the interfering equipment was connected. Information regarding Electro Magnetic Compatibility (EMC) according to IEC60601-1-2, clause 6.8 With the increased number of electronic devices such as PC’s and mobile telephones, medical devices in use may be susceptible to electromagnetic interference from other devices. The EMC (Electro Magnetic Compatibility) standard IEC60601-1-2 defines the levels of immunity to these electromagnetic interferences. From the other hand, medical devices must not interfere with other devices. IEC60601-12 also defines the maximum levels of emissions for these medical devices. The VENTURI® conforms to this IEC60601-1-2 standard for immunity and emission. Nevertheless, special precautions need to be observed: l l l l

The VENTURI® needs to be installed and put into service according to the EMC information below. The VENTURI® is intended for use in the electromagnetic environment specified in the tables below. The user of the VENTURI® should assure that it is used in such environment. In general, although the VENTURI® complies to the EMC standards, it can be affected by portable and mobile RF communications equipment (such as mobile telephones). The VENTURI® should not be used adjacent to or stacked with other equipment. In case adjacent or stacked use is necessary, the VENTURI® should be observed to verify normal operation.

Guidance and Manufacturer’s Declaration: Electromagnetic Emissions (IEC 60601-1-2)

Emissions Test

Compliance

Electromagnetic environment - guidance

RF emissions CISPR 11

Class B

Harmonics emissions 61000-3-2

Class A

Voltage fluctuations / flicker emissions 61000-3-3

Complies

The VENTURI® systems are suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage pump supply network that supplies buildings used for domestic purposes.

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Guidance and Manufacturer’s Declaration: Electromagnetic Immunity (IEC 60601-1-2)

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment - Guidance

Electrostatic discharge (ESD) IEC 61000-4-2

± 6kV contact ± 8kV air

± 6kV contact ± 8kV air

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

Electrical fast transient/burst IEC 61000-4-4

± 2 kV For mains supply lines ± 1kV For input/output lines

± 2 kV For mains supply lines ± 1kV For input/output lines

Mains supply quality for the mains adapter should be that of a typical commercial and/or hospital environment.

Surge IEC61000-4-5

± 1kV line(s) to line

± 1kV line(s) to line

Mains supply quality for the mains adapter should be that of a typical commercial and/or hospital environment.

Voltage dips, short interruptions and voltage variations on mains supply IEC 61000-4-11

<5%Ur (>95%Ur) for 0.5 cycle

<5%Ur (>95%Ur) for 0.5 cycle

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

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

Mains supply quality for the mains adapter should be that of a typical commercial and/or hospital environment. In the event of a mains interruption the VENTURI® 70%Ur (30% dip in Ur) for 25 cycles 70%Ur (30% dip in Ur) for 25 cycles system will automatically use internal battery power, unless the battery is exhausted. >5%Ur (>95% dip in Ur) for 5 secs >5%Ur (>95% dip in Ur) for 5 secs

Mains frequency (50/60Hz) magnetic field IEC61000-4-8

Mains frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial and/or hospital environment. Note: Ur is the A.C. mains voltage prior to application of the test level.

3 A/m

3 A/m

Guidance and Manufacturer’s Declaration: Electromagnetic Immunity (IEC 60601-1-2) Immunity Test

IEC 60601 Test Level

Compliance Level

3 V rms Conducted RF 150 kHz ~ 80 MHz IEC 61000-4-6 3 V rms 3 V/m Radiated RF 80 MHz ~ IEC 61000-4-3 2.5 GHz

3 V/m

Electromagnetic Environment - Guidance Portable and mobile RF communications equipment should be used no closer to any part of the VENTURI® including cables, than the recommended separation distance calculated from the equation appropriate to the frequency of the transmitter. Recommend separation distance d = 1.2 √P 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:

Note1: At 80 MHz and 800 MHz, the higher frequency range applies. Note2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile 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 VENTURI® is used exceeds the applicable RF compliance level above, the VENTURI® should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the VENTURI®. b Over the frequency range 150 kHz to 80MHz, field strengths should be less than 3 V/m. a

Recommended Separation Distance Between Portable and Mobile RF Communications Equipment and the VENTURI® The VENTURI® is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the VENTURI® can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the VENTURI®® as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter in Meters (m) 150 kHz to 80 MHz d = 1.2 √P 80 MHz to 800 MHz d = 1.2 √P 800 MHz to 2.5GHz d = 2.3 √P 0.01 0.01 0.01 0.01 0.12 0.12 0.12 0.12 0.12 0.12 0.12 0.12 0.23 0.23 0.23 0.23 0.1 0.1 0.1 0.1 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: At 80MHz and 800MHz, the separation distance for the higher frequency range applies. Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. Output Power of Transmitter in Watts (W)

This medical device is compliant with: IEC 60601.1 3rd edition Medical electrical equipment safety and essential performance IEC 60601.1.11 2010 Home healthcare environment

USER MANUAL PART NUMBER 50-02-15-108/6 Talley Group Limited

Premier Way, Abbey Park Industrial Estate Romsey, Hampshire, SO51 9DQ England TEL: +44(0)1794 503500 FAX: +44(0)1794 503555 EMAIL: [email protected]

10/2013

www.talleygroup.com