QA4 Powered Surgery Trolley Operating Instructions Ver 1.0 Issue 7 June 2010

QA4 Powered Function Operating Instructions

Contents

Page

1. Introduction 1.1. Scope of Use 1.2. Warnings, Cautions & Notes 1.3. Explanation of Symbols 1.4. Equipment Classification 1.5. Serial Label 2. Product Specifications 3. Product Functions 3.1. Powered Trolley Functions 3.1.1. Using the Handset 3.1.2. Height Adjustment 3.1.3. Backrest Articulation 3.1.4. Patient Platform Traverse 3.1.5. Trendelenberg Tilt 3.2. Manual Trolley Functions 3.2.1. Braking 3.2.2. Steering 3.2.3. Lateral Tilt 3.2.4. Head Section 3.2.5. Leg Section 3.2.5.1. Removing the Leg Section 3.2.5.2. Replacing the Leg Section 3.2.5.3. Articulating Leg Section (optional) 3.2.6. Cotsides 3.2.6.1. Rotating the Cotsides 3.2.6.2. Removing the Cotsides 3.2.6.3. Replacing the Cotsides 3.2.7. Emergency Backrest Release 3.2.7.1. Releasing the Emergency Backrest Handle 3.2.7.2. Reengaging the Emergency Backrest Handle 4. Battery Charging / Maintenance 4.1. Power Lead 4.2. Charging 4.3. Low Battery Alarm 4.4. Manufacturers Recommendation 4.5. Battery Deep Discharge 5. Weight Limits 6. K8 Pressure Care Mattress 7. Cleaning and Disinfecting 8. Product Maintenance

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Portsmouth Surgical Equipment Ltd Document No. 992006 Issue 7, 22/06/10 Page 1

QA4 Powered Function Operating Instructions

1. Introduction

These instructions are intended to assist you with the operation of the QA4 day surgery trolley. It is important that these instructions are read thoroughly before using the equipment.

1.1. Scope of Use

This product is intended for use within a day surgery environment for the induction, transport, treatment and recovery of patients. Due to its extra functionality and higher weight capacity this trolley is heavier than a conventional patient transfer trolley and therefore less suitable for this function. In addition the trolley has very low ground clearance that may cause problems when traversing uneven ground. CAUTION: Damage may be caused to the trolley by traversing uneven ground as the trolley has very low ground clearance.

1.2. Warnings, Cautions & Notes

Various warnings, cautions and notes are made throughout these operating instructions; each of these carries a special meaning and should be read carefully.

following text for an explanation as to their specific meanings. The label shown below is an instruction to the reader, its literal meaning is ‘Consult Operating Instructions’, wherein the operating instructions provided with the trolley will provide further information and clarification.

The following label is an instruction to the reader but carries more force than the previous symbol, its literal meaning is ‘Attention, Consult Accompanying Documents’, wherein the operating instructions provided with the trolley will provide further information and clarification.

1.4. Equipment Classification

The trolley has been classified as a ‘Class II Type B’ device.

1.5. Serial Label

The serial label is located on the patient’s right hand side of the trolley just below the patient platform, see fig. 1 overleaf.

A WARNING is given when the personnel safety of the patient or user may be involved. Disregarding this information could result in injury to the patient or user. A CAUTION is given when special instructions must be followed. Disregarding this information could result in permanent damage being caused to the trolley. A NOTE provides specific information that makes important instructions clear. NOTE: It is important that these operating instructions are read thoroughly before using the equipment.

1.3. Explanation of Symbols

The following two symbols are used on labels affixed to the trolley; read the Portsmouth Surgical Equipment Ltd Document No. 992006 Issue 7, 22/06/10 Page 1

QA4 Powered Function Operating Instructions

2. Product Specifications

Fig. 1

Key to Fig. 1 A. B. C. D. E. F. G. H.

Height, MIN Height, MAX Mattress Length Trolley Length, MAX Mattress Width Trolley Width; Side Rail Width Cotside Width Brake Width (Brakes Off) Base Length Mattress Depth Trendelenberg Tilt; Trendelenberg Reverse Trendelenberg Lateral Tilt Backrest Articulation Head Section Articulation C Arm Traverse; Head End Traverse Foot End Traverse Weight Limits; Trolley Head Section Leg Section Trolley Weight Leg Section Weight Castor Diameter

680 mm 1080 mm 2040 mm 2100 mm 600 mm 655 mm 770 mm 835 mm 1190 mm 75 mm 20° 12° ±12° 0 - 80° +25/-30° 230mm 230mm 250 kg 25 kg 50 kg 160 kg 4 kg 150mm

Portsmouth Surgical Equipment Ltd Document No. 992006 Issue 7, 22/06/10 Page 2

QA4 Powered Function Operating Instructions

3. Product Functions

Fig. 2

Key to Fig. 2 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11.

Handset Brake Pedals Steering Pedal Lateral Tilt Handle Head Section Tilt Actuation Lever Removable Leg Section Cotsides Pushing Handles Oxygen Cylinder Mounting Trough ‘V’ Mounting for Suction Canister Mains Input Socket

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QA4 Powered Function Operating Instructions

3.1. Powered Trolley Functions

3.1.1. Using the Handset

CAUTION: The battery must be properly maintained in accordance with these instructions. Failure to do so will result in significant loss of charge capacity or failure of the battery. Refer to section X. ‘Battery Maintenance’ for a full explanation on how to care for the battery.

WARNING: In the event of handset damage the handset should be replaced immediately or the trolley removed from service.

The following four trolley functions are electromechanical in operation and are powered from an on-board battery supply. These functions are operated and controlled through the handset; the layout of the handset is shown below.

CAUTION: Because the handset is in constant use it is particularly vulnerable to wear and tear or damage. Before use it is important to inspect the handset to ensure there is no damage to the cable or the buttons.

WARNING: Handset damage may lead to malfunction during equipment use. If a handset button becomes damaged it is possible for one of the powered functions to operate spontaneously. In this unlikely event the following actions should be taken; 1. Depress and hold the opposing function button, i.e. if the backrest is raising press backrest down. 2. Remove the battery, if accessible, and disconnect the mains power supply, if connected. 3. Transfer the patient to another trolley.

3.1.2. Height Adjustment

The height of the patient platform can be adjusted by using the up and down buttons on the handset. When either button is depressed the green indicator light on the handset will illuminate to indicate that the trolley is powered. CAUTION: Ensure that there are no obstructions in the way before raising or lowering the patient platform. CAUTION: Ensure that there is no equipment stored in the base of the trolley before lowering the patient platform.

Fig 3. Key to Fig. 3 1. 2. 3. 4. 5. 6.

Power Indicator, Green LED Variable Height Functions Backrest Articulation Functions Patient Platform Traverse Functions Trendelenberg & Reverse Trendelenberg Tilt Functions Anetic Aid Logo

3.1.3. Backrest Articulation

The backrest can be raised and lowered by using the up and down buttons on the handset. CAUTION: Ensure that there are no obstructions in the way before raising or lowering the backrest.

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QA4 Powered Function Operating Instructions

3.1.4. Patient Platform Traverse

The patient platform is designed to traverse longitudinally, either towards the head end or the leg end, to provide; full ‘C’ arm access, a gynae position, and improved access at the head end. The patient platform is traversed by using the left and right buttons on the handset. The mattress and patient platform are made from x-ray translucent materials. The areas of ‘C’ arm access are illustrated in fig. 4, with the trolley traversed in both directions. The trolley should be returned to the ‘neutral’ position once the procedure has been completed. Observe that when the patient platform is traversed in either direction the mid section static frame arm is revealed.

NOTE: The patient platform should be returned to the neutral position once the procedure has been completed, see above. CAUTION: Ensure that there are no obstructions in the way before traversing the patient platform. CAUTION: With the leg section folded down caution must be exercised traversing the patient platform towards the head end. CAUTION: When the head section is in the folded away position caution must be exercised when traversing the patient platform. There is a possibility that the head section could clash with other parts of the trolley which may result in permanent damage being caused to the trolley.

In the neutral position the traversing section of the patient platform aligns with the static arm.

Fig 4. Portsmouth Surgical Equipment Ltd Document No. 992006 Issue 7, 22/06/10 Page 5

QA4 Powered Function Operating Instructions

3.1.5. Trendelenberg Tilt

The patient platform can be longitudinally tilted to provide a trendelenberg (head down) or reverse trendelenberg (leg down) position by using one of the two down buttons on the handset. The head down trendelenberg button is in-filled in red to indicated that this button is used for emergency positioning. CAUTION: Ensure that there are no obstructions in the way before tilting the patient platform. CAUTION: Ensure that there is no equipment stored in the base moulding of the trolley before tilting the patient platform (NOTE: This ONLY applies when the trolley is at its lowest height).

CAUTION: The steering wheel must be disengaged manually when the trolley is pushed head first over an obstruction, i.e. a lift threshold, or damage may occur.

3.2.3. Lateral Tilt Lateral tilt is achieved by rotating the lateral tilt handle either clockwise or anticlockwise. To use the lateral tilt handle; extend the handle by pulling it away from the trolley, and unfold the crank handle until it locks into position. Return the handle to its stored position when not in use. CAUTION: The lateral tilt handle must be stored away to ensure that the handle does not get damaged.

3.2. Manual Trolley Functions

The following functions are manually operated and are not powered from the on-board battery supply or mains.

3.2.1. Braking

All four castors are braked simultaneously by depressing either of the brake pedals at any point along the length of the pedal. The brakes are disengaged by lifting either pedal.

3.2.2. Steering

Manoeuvring the trolley can be assisted by engaging the steering mechanism. The mechanism is engaged by depressing the steering pedal, and disengaged by lifting the pedal. CAUTION: Applying the steering pedal with excessive force, i.e. by standing on the pedal, will cause permanent damage to the mechanism. CAUTION: The steering pedal is designed to disengage automatically when the trolley is pushed leg first over an obstruction. Attempting to prevent this will cause damage to the mechanism. The 5th wheel should be allowed to disengage and then can be reengaged after the obstruction.

Rotate

3.2.4. Head Section

The head section is articulated by pulling up on the head section tilt lever. The head section is also designed to fold away for specific theatre procedures; i.e. gynae and urology, to give greater anaesthetist access to the patient. Folding away the head section prior to administering anaesthetic reduces the length of the backrest and the need to reposition the patient in theatre. Folding away the head section also gives greater access to the patient from the head end for theatre staff.

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QA4 Powered Function Operating Instructions

3.2.5.1. Removing the Leg Section Lower Push

Lift

Push Pull The head section is folded away by lifting the release handle and lowering the head section.

Depress both buttons as shown (one button is located on each side of the trolley) and remove the leg section. WARNING: Ensure that any persons responsible for removing the leg section adopt good posture and stance, in accordance with the relevant ‘Moving and Handling’ policies, to prevent injury to the user.

3.2.5.2. Replacing the Leg Section Pull Lift

The head section is returned to the upright position by pulling on the plunger and lifting the head section to the upright position. CAUTION: When the head section is in the folded away position caution must be exercised when tilting the trolley into a trendelenberg position. There is a possibility that the head section could clash with other parts of the trolley which may result in permanent damage being caused to the trolley.

3.2.5. Leg Section

The trolley is fitted as standard with a non-articulating lightweight leg section (if the trolley is fitted with an articulating leg section refer to section 3.7.3).

Push

Engage the locating spigots of the leg section as shown and push home firmly until the leg section is fully engaged. WARNING: Ensure that the leg section is fully engaged and securely locked in position.

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QA4 Powered Function Operating Instructions

3.2.5.3. Articulating Leg Section

Note; the articulating leg section is an optional accessory for this trolley. To articulate the leg section pull up on the leg frame lever and push down on the board. To remove the leg section refer to section 3.7.1.

3.2.6.1. Rotating the Cotsides

Rotate

CAUTION: With the leg section articulated down caution must be exercised when tilting the trolley leg down, i.e. a reverse trendelenberg position. NOTE: With the articulating leg section the leg section should be articulated down to the maximum angle before being removed. This shortens the distance between the end of the leg section and the mounting sockets. This does two things; one, it provides better access to the release buttons, and two, it reduces the distance that the user has to reach to support the weight of the articulating leg section. NOTE: When replacing the articulating leg section pull the actuation handle to operate the gas struts and allow the location spigots to achieve a horizontal position.

Push

Depress the button as indicted and rotate the cotside, the cotside will automatically relock in the next position.

3.2.6.2. Removing the Cotsides Lift

3.2.6. Cotsides

The trolley is fitted with four cotsides that can be individually removed from the trolley or rotated through 180 degrees. Each cotside is mounted into a fixed socket that is labelled with a position number, (1) – (4), this corresponds with the numbered label on the cotside and ensures that each cotside is correctly positioned. See the following sections for more information on rotating, removing and replacing the cotsides.

Push Ensure the cotside is in the ‘up’ position, depress the button as indicted and remove the cotside. Portsmouth Surgical Equipment Ltd Document No. 992006 Issue 7, 22/06/10 Page 8

QA4 Powered Function Operating Instructions

3.2.6.3. Replacing the Cotsides

Align the stem of the cotside to the socket and let the cotside drop into position, the cotside will automatically lock in position when replaced. CAUTION: Ensure that the cotsides are located into their respective numbered sockets to prevent the cotsides clashing.

3.2.7. Emergency Backrest Release

The emergency backrest release handle allows the backrest to be dropped immediately from any articulated angle to the horizontal position. When the emergency backrest release handle is disengaged the backrest will not function; the backrest handle must be engaged for correct backrest operation. NOTE: It is important that staff are clearly informed as to the location of the emergency release handle, its function, and its mode of operation.

the handle is released the backrest will be unsupported and will drop to the horizontal position. WARNING: Caution is required when releasing the emergency backrest handle. Once the handle is released the backrest will fall without resistance, ensure no persons are stood behind or under the backrest when the handle is released.

3.2.7.2. Reengaging the Emergency Backrest Handle Manually lift the backrest until it stops. Grasp the emergency release handle and rotate the handle 90 degrees clockwise until the handle ‘clicks’ into position and physically stops. The release handle is now reengaged enabling the backrest to be operated from the handset.

Lift

3.2.7.1. Releasing the Emergency Backrest Handle

Lower

WARNING: Ensure that the handle is properly reengaged. Failure to do so will result in the backrest not functioning correctly and possibly disengaging unexpectedly.

Grasp the emergency release handle and rotate the handle anticlockwise. As Portsmouth Surgical Equipment Ltd Document No. 992006 Issue 7, 22/06/10 Page 9

QA4 Powered Function Operating Instructions

4. Battery Charging/Maintenance

As with all products that use a rechargeable battery the battery will require recharging at regular intervals. The frequency with which the battery requires recharging is dependant on the battery usage and the state of charge. CAUTION: Only batteries supplied and approved by Anetic Aid Ltd or Portsmouth Surgical Equipment Ltd should be used. CAUTION: The battery unit should not be opened.

From flat the battery will take approximately 8 hours to fully charge. Plugging the trolley in for a short period of time will only partially recharge the battery. The trolley can be left on charge permanently as there is no danger that the battery can be over charged. The control unit manages the status of the battery charge, switching the charging circuit off when the battery is full and back on when the charge dissipates below a preset level.

CAUTION: Use the battery only for its intended purpose.

NOTE: To initiate battery charging the power lead must be connected and any one of the function buttons on the handset must be depressed.

CAUTION: Never use a battery that is damaged.

4.3. Low Battery Alarm

CAUTION: The battery must be recycled, properly disposed of or returned to Anetic Aid Ltd or Portsmouth Surgical Equipment Ltd. The battery must not be discarded with Household waste.

4.1. Power Lead

When the battery charge is low the control unit will emit a continuous ‘beep’ tone when any one of the function buttons is being depressed. This indicates that the battery must be recharged; failure to do so will result in the deep discharge protection being enabled.

The trolley is supplied with an IEC mains power lead which is used to charge the on-board battery.

CAUTION: Failure to charge the battery once the low battery alarm has sounded could result in a permanent loss of maximum charge capacity.

WARNING: Only use the lead supplied with the trolley for charging purposes. Do not use the lead for any other purposes.

4.4. Manufacturers Recommendation

WARNING: Visually inspect the lead for damage on a daily basis. Do not use the lead if damaged in any way.

4.2. Charging

The power lead should be plugged into a mains socket and the appliance connector end plugged into the charging socket on the trolley. The socket should now be switched on. The control unit will ‘beep’ to indicate that mains power has been detected, however, battery charging has not started. To initiate the charging cycle any one of the function buttons on the handset must now be depressed. Charging has now started.

We recommend that the battery is put on charge whenever the trolley is not in use, including overnight. Establishing this routine will ensure that the trolley does not run out of charge in the course of a day.

4.5. Battery Deep Discharge

If the battery has not been charged and the trolley is continuously used, the battery will run flat and eventually reach a ‘deep discharge’ condition. A normal 8 hour charging period will not be sufficient to recover the battery. The battery will need to be on charge for approximately 72 hours to fully recover.

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QA4 Powered Function Operating Instructions

5. Weight Limits Main Body; The trolley is designed to accommodate a maximum patient weight of 250kg (approximately 39 stone). Patients should mount the trolley at the centre of the patient platform and their weight kept as evenly distributed as possible whilst on the trolley. Head Section; The head section is designed to take a maximum weight of 25kg (approximately 4 stone). Leg Section; The leg section is designed to take a maximum weight of 50kg (approximately 8 stone). WARNING: Exceeding any of the maximum specified weight limits could result in failure of the trolley and injury to the patient and staff.

6. K8 Pressure Care Mattress Understanding the needs for greater patient pressure area care the mattress is manufactured using the most up to date materials and manufacturing methods available. Each mattress part is fixed to the patient platform with Velcro, this enables the mattress sections to be removed from the trolley for cleaning and replacement. NOTE: An independent pressure care report from Salford University is available upon request.

6.1. Body Mould Visco Foam

Through it’s sensitivity to temperature this gel feel foam actually moulds to the patient’s body, relieving pressure by distributing the load as evenly as possible.

6.2. Flexi-Fabric

A polyurethane water resistant vapour permeable outer cover with the properties of Lycra ensures maximum effect of the body mould foams.

6.3. Infection Control

NOTE: The mattress parts should be visibly inspected for damage on a daily basis. If the outer mattress fabric is torn then fluids will ingress and the mattress should be replaced.

7. Cleaning and Disinfecting 7.1. Manual Cleaning The trolley should be wiped over thoroughly after each use with warm water and neutral detergent and then wiped dry using a soft cloth; adequate drying is crucial in the care and maintenance of this product. NOTE: If contaminated, follow steps for disinfecting.

7.2. Manual Disinfecting

The trolley should be wiped over thoroughly with warm water and disinfectant; suitable products are diluted chlorine or alcohol based solutions (ensure that manufacturer’s guidelines are followed). NOTE: A 1% solution of sodium hyperchloride is an acceptable option for this product. Wipe over the trolley thoroughly with warm water removing any surface residue (note: this is important). Wipe dry with a soft cloth; adequate drying is crucial in the maintenance of this product. CAUTION: The use of strong bleaching disinfectant solutions must be avoided. CAUTION: Do not clean with organic solvents (i.e. spirits), abrasive powders, or expose materials to excessive heat. NOTE: The mattress parts should be inspected for damage on a daily basis. If the outer fabric is torn then fluids will ingress and the mattress should be replaced. NOTE: Do not attempt to repair tears or splits with self adhesive tapes.

Ultra sonic welding of materials creates an impervious seal ensuring an ideal product for infection control. Portsmouth Surgical Equipment Ltd Document No. 992006 Issue 7, 22/06/10 Page 11

QA4 Powered Function Operating Instructions

8. Product Maintenance

It is recommended that the trolley is serviced on an annual basis in accordance with the manufacturer’s service schedule. Before use, ensure all trolley functions operate to their full range of movement and that all detachable components disengage re-engage and lock correctly. Also visually inspect the trolley for any loose or damaged parts and foreign bodies caught in the castors. Because the handset is in constant use it is particularly vulnerable to wear and tear or damage. Before use it is important to inspect the handset to ensure there is no damage to the cable or the buttons; see section 3.1.1., ‘Using the Handset’, for more information.

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