CLINNOVA Gynae Pro NV8xxx Instructions for Use Issue 1

These Instructions for Use (IFU) apply to the following couches in the SEERS Medical CLINNOVA™ Clinical Product Range. CLINNOVA Gynae Pro NV8483-CLS-DSP, NV8483-PRM-DSP, NV8583-CLS-DSP, NV8583-PRM-DSP, NV8683-CLS-DSP, NV8683-PRM-DSP

WARNING! To avoid injury, always read this Instructions for Safe Use and accompanied documents before using the product. It is Mandatory to read these Instructions for Use

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INDEX 1. GENERAL INFORMATION – INTENDED USE, WARNINGS & CAUTIONS 2. HOW TO USE – a. RETRACTABLE WHEEL SYSTEM – NV8583 b. ADJUSTABLE FOOT LEVELLING – NV8583 c. CENTRAL LOCKING WHEEL SYSTEM – NV8683 d. INDEPENDENTLY BRAKING CASTORS – NV8483 e. ADJUSTING THE HEIGHT OF THE COUCH f. ALTERING THE BACKREST ANGLE g. APPLYING TILT TO THE COUCH (POSITIVE & NEGATIVE) h. APPLYING TRENDELENBURG TILT FUNCTION i. CPR FUNCTION j. PADLOCK FUNCTION ON HANDSET k. GYNAE LEG SUPPORTS l. PAPER ROLL HOLDER m. OPTIONAL FOOT SWITCH OPERATION 3. CLEANING INSTRUCTIONS 4. MAINTENANCE 5. WARRANTY 6. TROUBLESHOOTING GUIDE 7. TECHNICAL DATA Electrical Information Upholstery Materials Environmental Transport & Storage Symbols

CLINNOVA CLINICAL RANGE – INSTRUCTIONS FOR USE PAGES

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DATE 15/04/2021

1. GENERAL INFORMATION. 03-204-IFU-UK

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CONGRATULATIONS on the purchase of your new CLINNOVA™ Gynae Pro from SEERS MEDICAL. If these operating instructions are adhered too, this product will provide many years of safe use. IF THESE OPERATING INSTRUCTIONS ARE NOT FOLLOWED - YOUR WARRANTY COULD BE INVALIDATED! Always keep these Operating Instructions available for reference. ALL User Interfaces are identified by the DARK GREY COLOUR. INTENDED USE: The CLINNOVA Gynae Pro is designed for a wide range of applications for rehabilitation, assessment and examination procedures. The couch should only be operated by trained medical personnel or clinicians. The CLINNOVA Gynae Pro has a safe working load of 285KG (628lb)

Contraindications The safe working load (SWL) of the couch ... 285kg 285Kg

The maximum recommended patient weigh ... 265kg Accessories (including attached loads) ... 20kg

WARNINGS! 03-204-IFU-UK

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Warnings identify potential hazards which if not followed correctly, could result in serious injury, or possibly even death! •

• •

Ensure electric couches are not used in the presence of flammable gasses such as an anaesthetic agent. DO NOT EXCEED the Maximum Safe Working Load of 285 Kg (628lbs) – which must be distributed evenly across the working surface Do not concentrate uneven weight on either side of the couch. When the plug is disconnected, this acts as a disconnect device. Use only accessories that have been designed or approved for use with this couch. Children must not play with the couch at any time. Adequately supervise children in the proximity of the couch. THE OPERATOR OF THIS COUCH MUST BE VIGILENT AT ALL TIMES AS MIS-USE RESULT IN DAMAGE/HARM TO THE COUCH OR SURROUNDING PEOPLE OR EQUIPMENT! Make sure the patient is positioned correctly to avoid entrapment or imbalance. Take care not to allow clothing to become snagged on moving parts of the couch

•

These products are not intended for Patient Transportation.

•

The patient should not be left on the couch unattended at any time. Do not use the Couch in areas of high humidity (e.g. shower room).

• • • • • • •

CAUTIONS! Cautions identify circumstances which if not followed correctly, could result in failure or damage of the equipment!

Attention refer to these Operating Instructions for further information

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2. HOW TO USE. a.

RETRACTABLE WHEEL SYSTEM (NV8583-CLS-DSP, NV8583-PRM-DSP)

Lever UP Wheels RETRACTED and OFF

Lever DOWN Wheels ENGAGED and ON

Lever LOCKED DOWN Wheels LOCKED and ON

CAUTIONS! This Couch is not designed for patient transportation Ensure Wheels are Locked prior to patient transfer or treatment. Disconnect the electric lead prior to re-locating the couch, ensuring the lead is not trapped in the mechanism, or placed in a position to cause a trip hazard!

b.

ADJUSTABLE FOOT (NV8583-CLS-DSP, NV8583-PRM-DSP) CAUTION! Ensure Wheels are retracted before adjusting the adjustable foot.

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1.

Ensure the wheels are retracted and off.

2.

Adjust the foot by turning clockwise or anti clockwise until the couch is stable on all legs.

3.

Secure the foot by tightening the nut until it locks against the threaded cap.

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c.

CENTRAL LOCKING WHEEL SYSTEM (NV8683-CLS-DSP, NV8683-PRM-DSP)

Wheel Lever Down All castors locked

Wheel Lever Horizontal Castors un-locked

Lever Up – Directional steering castor engaged at rear of couch

CAUTIONS! Ensure Castors are LOCKED prior to Patient use.

d.

INDEPENDENTLY BRAKING WHEELS (NV8483-CLS-DSP, NV8483-PRM-DSP)

Castor in free roam mode

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Castor braked/locked

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e.

ADJUSTING THE HEIGHT OF THE COUCH WARNING! ENSURE the switch operating cable does not become entangled in the frame mechanism when Raising or Lowering the table

STEP 1 To adjust the height of the couch, simply press the backrest function button indicated by the symbol, on the left hsnd side of the handset (key1) Once selected, the graphic in the display window changes to show the backrest function has been chosen.

STEP 2 To adjust the height of the couch up or down, press and hold the desired up or down direction arrow (key2 or key4). In releasing the arrow, the height of the couch automatically locks at that position. If the up or down arrow is pressed and held again within ten seconds the height function will continue to be selected. If a button is not pressed within 10 seconds the function will need to be selected once again (step 1)

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WARNING! The Couch is fitted with an intelligent control system, that knows it’s position of the motors. Rules to the system have been set that will not allow certain functions. For example, if there is not enough height for the table to tilt safely, it will automatically raise the height of the table before tilt can continue.

f.

ALTERING THE BACKREST ANGLE

STEP 1 To adjust the backrest angle of the couch, simply press the backrest function button indicated by the symbol, on the left hsnd side of the handset (key3) Once selected, the graphic in the display window changes to show the backrest function has been chosen.

STEP 2 To adjust the backrest angle of the couch up or down, press and hold the desired up or down direction arrow (key2 or key4). In releasing the arrow, the backrest angle automatically locks at that position. If the up or down arrow is pressed and held again within ten seconds the backrest function will continue to be selected. If a button is not pressed within 10 seconds the function will need to be selected once again (step 1) 03-204-IFU-UK

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g.

APPLYING TILT TO THE COUCH (POSITIVE OR NEGATIVE) WARNING! ENSURE the switch operating cable does not become entangled in the frame mechanism when Tilting the table

STEP 1 To apply tilt to the couch, simply press the tilt function button indicated by the symbol, at the bottom of the handset on the left hand side (key9) Once selected, the graphic in the display window changes to show the Tilt function has been chosen.

STEP 2 To adjust the tilt angle of the couch up or down, press and hold the desired up or down direction arrow (key2 or key4) In releasing the arrow, the couch automatically locks at that tilted angle. If the up or down arrow is pressed and held again within ten seconds the height function will continue to be selected. If a button is not pressed within 10 seconds the function will need to be selected once again (step 1)

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H. TRENDELENBURG TILT (head down) WARNING! ENSURE the switch operating cable does not become entangled in the frame mechanism when Tilting the table

To apply tilt to the couch, simply press the tilt function button indicated by the symbol, at the bottom of the handset on the right hand side (key6) and hold until desired head down angle is achieved Once selected, the graphic in the display window changes to show the Tilt function has been chosen. In releasing the key6 , the couch automatically locks at that tilted angle. If a button is not pressed within 10 seconds the function will need to be selected once again (step 1)

I. CPR FUNCTION The table is fitted with a CPR function. In activating the CPR function, the table puts it itself in to a low horizontal position as quickly as it can, to allow CPR to be carried out if necessary. To use this function, follow the steps below…. 1. Press the and hold the CPR key button until the table stops moving (key8) 2. THE CPR function will display on the handset display identifying the CPR function has been activated. 3. Once the table stops moving release the button to lock the tables position.

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J. PADLOCK FUNCTION The handset has a lockout function, so functions of the table can be safeguarded against if necessary. To use this function, follow the steps below…. LOCKING A FUNCTION To lockout any function, press the corresponding function to lock out (ie height would be key1) and key10, the padlock, simultaneously and hold for 2 seconds. When lockout of the function is achieved a short beep will be heard signifying locked. UN-LOCKING A FUNCTION To unlock the locked function, press the corresponding function to unlock (ie height would be key1) and key10, the padlock, simultaneously and hold for 2 seconds. When un-lock of the function is achieved a short beep will be heard signifying locked.

K. LEG SUPPORTS & STIRRUPS 1

1. 2.

A

3. 4.

B 5.

To adjust the angle of the leg support, loosen locking knob on underside (A) and adjust support to desired position. Re-tighten locking knob to secure. To adjust height of the leg support, loosen locking knob on underside (B) and adjust support to desired height Re-tighten locking knob to secure. To adjust the leg support length position, loosen the locking knob on underside of main frame (not shown) and slide the chrome slider in or out of box section to desired position. Re-tighten locking knob to secure.

CAUTION! Ensure ALL Locking Knobs are secure and tightened fully, prior to commencing treatment 03-204-IFU-UK

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L. PAPER ROLL HOLDER To fit and change the paper towel, simply spring the bracket outwards, and remove the tube. Place the paper roll onto the tube and refit into paper towel holder, by springing frame out gently. Releasing the frame once the tube is in place.

M. OPTIONAL FOOT SWITCH OPERATION

RAISE HEIGHT

LOWER HEIGHT

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RAISE BACKREST

POSITIVE TILT

LOWER BACKREST

NEGATIVE TILT

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CPR

CPR

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3.

CLEANING INSTRUCTIONS WARNING! Disconnect the couch from the mains power supply prior to carrying out any cleaning or decontaminating. DO NOT SATURATE PRODUCT IF PRODUCT GETS SATURATED DURING CLEANING, THIS COULD ACCELERATE CORROSION, REDUCING PRODUCTS LENGTH OF SERVICE.

General Cleaning: To get rid of any dust or marks on the surface the Faux Leather MUST be wiped DAILY with a moist soft cotton cloth. Visible and loose dirt can be picked up with a vacuum cleaner (Do not use a brush type vacuum) Use a soapy cotton cloth and gently rub stains with circular movements. For more stubborn marks a dilute bleach solution can be used 5% Bleach to 95% Water. Stain Removal: Blot excess liquid as quickly as possible with a clean 100% cotton white absorbent cloth or sponge. If necessary use clean warm water. Clean the entire area where the spot occurred on the cushion, arm etc. Water may dissolve dirt particles and make cleaning easier. Spills that are still moist are the easiest to remove. Leave to air dry naturally, do not use a hair dryer etc to speed up the drying. Coffee, tea etc spills: Use an absorbent white cloth or piece of paper. DO NOT RUB. Allow the stain to be absorbed and removed from the material surface. Then rub gently with white tissue paper in circular movements to remove any remaining dampness and residue. Ink, Ball point pen, Denim, hard stains: Rub the stain by means of gentle circular movements with tissue dampened with 96°alcohol and water (1:1) After this rub the surface with gentle circular movement with tissue paper to dry it. Butter, oil, grease stains: Wipe excess butter, oil or grease off the surface with a clean 100% Cotton white dry cloth. Use a soapy cotton cloth and gently rub the stain with circular movements. Use a clean damp cloth to wipe the area and dry the surface. Chewing gum: Place ice cubes in a plastic bag and apply on the chewing gum. Wait several minutes, lift the ice bag and remove the chewing gum. DO NOT USE CHEMICALS, SADDLE SOAP, CLEANING SOLVENTS, FURNITURE POLISH, OILS, VARNISH, ABRASIVE CLEANERS OR AMMONIA IN WATER. Frequency of routine couch cleaning will depend on exact application. 1. Ensure the couch is in a suitable area for cleaning. 2. The couch must be OFF of the wheels or locked.

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3. Disconnect from mains power supply. 4. Control handsets can be wiped over using an anti-bacterial wipe. 5. Prepare a solution from the guidelines detailed above. 6. DO NOT SATURATE PRODUCT – This should be a wipe down – not a soaking! 7. Start by cleaning the top surface of the couch, working down onto the frames below, ensuring to not accidentally activate any of the release levers, or user interface parts. 8. Ensure the couch is dry before re-use. 9. Safely discard of cleaning materials. 10. Wash hands thoroughly. If DECONTAMINATING the couch then repeat steps above using a dilute Hypochlorite & warm water mixture (mixed at 10,000ppm) instead of warm water and soap. It is crucial that any staining is treated as soon as possible but never later than 24 hours. Delays in cleaning will give stains time to react with the plasticiser in the faux leather making it more and more difficult to remove. Note: These are recommended or suggested methods of cleaning. The manufacturer is not responsible for damage incurred while cleaning. Always try the cleaning method in a hidden area first to see the results. Remember if you are not sure contact you customer representative before proceeding.

LIFTABLE MID SECTION The Seat Section is secured by a hinge and can be lifted to enable cleaning under the mid section and around the debris tray.

This improves infection prevention and ensures a thorough clean of the top frame of the couch.

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4. MAINTENANCE

WARNING! Disconnect the couch from the mains power supply prior to carrying out any maintenance. All electrical maintenance should be performed by a suitably qualified person. BLUE or BROWN wires must not be connected to any earth terminal.

Actions to be done by clinician

Daily

Weekly

Check the power cable and connecting leads on hand and foot switch controls, looking for any cuts, abrasions or any other deterioration that may have occurred and replace if necessary

✓

Visually check castors

✓ ✓ ✓

Visually check power supply cord and mains plug Examine the accessories (if applicable) Visually check the upholstery Check hinge pins are secured correctly by the e clips.

✓ ✓

IF THESE ARE MISSING - DO NOT USE COUCH! Check hydraulic pump (hydraulic variant only) for smooth operation and any signs of leakage.

✓

Check gas strut controls and moveable sections for their full range of movement for locking. The upholstered section should lock once the release lever is no longer operated.

✓

If the result of any of these tests are unsatisfactory, contact your distributor. Actions to be done by qualified personnel

Once a year

Carry out a full test of all electrical couch positioning functions (backrest, height, etc.) Examine the power supply cord and mains plug; if damaged, replace the complete assembly; do not use a rewireable plug

✓

Examine all accessible flexible cables for damage and deterioration

✓

Check all accessible nuts, bolts and other fasteners are present and correctly tightened

✓

Look for any visual signs of damage. Ensure all nuts, bolts and other fasteners are present and fitted where expected. If loose (can be undone by hand), re- tighten using suitable tools – but taking care to not over tighten as this could cause binding, juddering, identifiable by a likely creaking noise Check any accessories fitted to the couch, paying particular attention to fasteners and moving parts

✓

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Ensure that the mains power supply plug is attached securely to the control box.

✓

Check mains plug connections are tight and the correct fuse is fitted to the mains plug if applicable.

✓

5. WARRANTY and PRODUCT LIFETIME SEERS MEDICAL Limited standard terms and conditions apply to this device. A copy of this is available upon request. This contains full details of warranty terms and does not affect your statutory rights. For any further information on this product, regarding spares, warranty, service or maintenance information, please contact:

SEERS MEDICAL Limited Kenton Road Debenham Suffolk IP14 6LA T: +44 (0)1728 861590 F: +44 (0)1728 861868 E: [email protected] W: www.seersmedical.com © SEERS MEDICAL Limited 2020 Manufactured in the UK by SEERSMEDICAL Limited.

As part of our ongoing development programme SEERS MEDICAL Limited reserves the right to modify specifications and materials of this couch without prior notice. Product lifetime: The lifetime of this equipment is typically 10 years from the manufacturing date. “ lifetime “ is defined as the period during which the product will maintain the specified performance and safety provided it has been maintained and operated under normal condition in accordance with the requirements stated in this manual.

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6.

TROUBLESHOOTING

Fault

Possible Cause

Solution

Electrical functions not working correctly

Mains cable has become disconnected, either from the wall socket or the control box

Locate control box and see whether the power light is illuminated and that the lead is connected at both ends.

Fuse blown in mains plug

Locate control box and see whether the power light is illuminated, if not replace fuse.

Actuator/handset leads not plugged in

Check plugs for loose connections on the control box and the actuators

Damage to mains cable, actuator cable or handset cables

Turn off at mains power and contact SEERS or local distributor for spare parts.

Safe working load exceeded

If the couch has been overloaded, it is possible to damage the actuators and control box. Contact SEERS or local distributor for spare parts or repair if this has occurred.

Duty Cycle exceeded

The couch is designed to work for short periods and then rest, check technical data for duty cycle info at the back of this booklet.

Switch stuck. If an EPFS model, ensure all segments of the foot bar system are not jammed and operate freely. Ensure no surrounding furniture is also engaging on the switch system

The electrical control system is not designed to have the switches depressed for long periods of time. If the switch is left pressed on, then this can result in the control box being damaged. This could result in the control box needing to be replaced

Squeaking or grinding noise

An over tight pivot point either a bolt or pin is not rotating freely.

Locate the noisy pivot point, then slacken the securing nut by ¼ turn and lubricate until noise reduces.

Wheels will not raise or lower

Couch is not on level floor

Level couch by adjusting the adjustable foot if fitted.

Couch raises or lowers on its own

Mechanical faults

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SYSTEM RESET The Gynae Pro is fitted with an advanced intelligent actuator system. If maintenance has been carried out, or an actuator has been disconnected for any reason, it may be necessary to reset the control system. If you are in any doubt Contact your reseller for after sales support and advice. To reset the actuator control system…..

1. Press and hold key6 and key8 simultaneously for 3 seconds. 2. Continue to hold these keys until the reset is complete 3. The two motors of the couch should fully retract to their lowest positions. 4. Continue to hold these keys until the LED beneath the display blinks 3 times. 5. Once the LED goes back to a constant LIT state, the RESET is complete.

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7.

TECHNICAL DATA – CLINNOVA™ Gynae Pro

Index / Model No.

NV8483

NV8583

NV8683

Independent Braked Castors

Retractable Wheel Design

Large Mobile Wheel Design

Configuration

Wheel System Minimum Height

53cm

Maximum Height

99cm

Overall Length

160cm (without optional leg extension)

Head Length

95cm

Mid Length

64

Foot Length

38cm – 49cm (extended)

Width

70cm (as standard)

Safe Working Load & Lifting Capacity

285 Kg (628lbs)

Upholstery covering

Mundial vinyl :88% PVC -12% cotton

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