Ferno Pegasus User manual

IMPORTANT NOTE
To comply with BS EN 1789: 2007, the four-point harness MUST be used as a
patient restraint and the Pegasus MUST be secured with the two-part locking
device.
Pegasus / Pegasus MK2 Trolley
User Manual

FERNO/MAN/01/18/159/UK 1 Pegasus Trolley
1. Intended Use of the Pegasus/Pegasus MK 2
The Pegasus trolley is intended for use by fully qualified, trained and competent
carers, attendants, paramedics or other such medical staff as an aid to provide safe
and secure transportation of patients.
The Pegasus trolley’s primary intended use is for the transportation of patients, either
physically impaired, ill, or with other types of injures from ground or hospital bed level
to and from an ambulance providing effortless powered lifting and lowering making
use of its self contained hydraulic system.
The Pegasus trolley’s secondary intended use (PTS version only) is as a seat base
for a maximum of three passengers, when positioned at the bulk head of a Patient
Transfer Vehicle, with the foot end of the trolley folded down and the trolley secured
by the correct locking device. When used as a seat base the trolley DOES NOT meet
CEN requirements.
Pegasus MK 2 Trolley can be fitted with a mattress that is constructed of moulded
cellular foam that is impermeable to bodily fluids and has an antibacterial additive
impregnated through the material during manufacturing to assist infection control.

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2. Checking the trolley
The following checks are recommended before the start of each shift's use of the
Pegasus Trolley.
1. Does the trolley have a properly installed mattress and patient restraining
system? Check the mattress for damage; if any damage is found, it must be
replaced. (Please refer to page 12 for fitting instructions)
2. Do the trolley cot sides raise, lower and lock in position properly?
3. Check that the wheels and brakes operate satisfactorily.
4. Does the trolley lower and raise satisfactorily?
5. Does the ambulance have a properly installed approved locking device?
6. Check the operation of the push/pull handles and ensure the head end handle
clips in the stowed position.
7. Does the headrest extension operate correctly and lock in position.
8. Study this manual before use. Practice without a patient until totally competent in
using the trolley.
Once these checks have been completed, then the trolley is ready to be used in
regular service.
SAFE WORKING LOAD
300 kg in lowest position
200kg in highest position
(Tested in accordance with the requirements of BS EN 1789: 2007)
WARNING
DO NOT OPERATE THE HEIGHT ADJUSTMENT PEDAL WHEN
THE TROLLEY IS FIXED INTO THE VEHICLE LOCK.
THIS WILL CAUSE THE TROLLEY TO JAM IN THE LOCKS AND
MAY CAUSE DAMAGE

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Important Notes
Always ensure that two operators are with the trolley at all times.
A non-laden trolley may be controlled by one operator provided it is considered
safe to do so.
When rolling the trolley in the elevated position along hospital corridors or
similar smooth surfaces, DO NOT use the pull handles, instead roll the trolley
by firmly grasping the main frame, for added control.
Trapping hazards cannot be eliminated due to the operation of this product.
EXTRA CARE to be taken whilst raising and lowering the trolley, operating leg
rest features and any features with hinge assemblies.
Before driving the ambulance, make sure that the trolley is secured with the
recommended locking device to prevent its movement in the patient
compartment.
REFER TO PAGES 9 & 10 IF USING PRODUCT WITH 2-PART TRACK-MOUNTED
FLOOR LOCK
This product must be regularly serviced and maintained in line with the
manufacturer’s recommendation to ensure satisfactory operation. A
preventative maintenance scheme should be contracted at time of purchase.
Regular cleaning helps reduce the risk of transmitting disease and enables the
equipment to function at its optimum.
PLEASE NOTE
Always ensure the drop down foot end and head end are in the raised
position before operating the lifting mechanism on the trolley.
PLEASE NOTE
Cot Sides are not intended to be used to either manoeuvre or lift the trolley,
damage may result from this practice.

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3. Operating Procedure
WARNING
Always ensure that two operators are with a laden trolley at all times.
Ensure that the following procedures are complied with:
1. Advise the patient before making adjustments, lifting or loading the trolley.
2. Stay with the patient and control the trolley at all times.
3. Keep the patient restrained and the cot side rails up when using the trolley.
4. Use help when needed to ensure patient and operator safety.
Transferring a Patient onto a Trolley
1. Lower the cot side rails.
2. Place the trolley beside the patient and open the restraints.
3. Ensure that at least one wheel brake at each end of the trolley is applied.
4. Transfer the patient onto the trolley using recognised manual handling
procedures.
5. Close the restraints around the patient (see page 11).
6. Raise the cot side rails and lock in position.
7. Make adjustments as necessary.
When transferring a patient from a bed or other apparatus,
1. Raise/lower the trolley to a suitable height.
2. Proceed with the transfer as aforementioned.
Height Adjustment –Do not raise the trolley when located in the vehicle lock.
1. The height adjustment of the Pegasus is achieved by a simple hydraulic pumping
action.
2. The raising and lowering action is achieved by means of foot pedals, which are
located on each side of the trolley. NOTE ensure pedals on both sides are clear
before operating.

FERNO/MAN/01/18/159/UK 5 Pegasus Trolley
3. The foot pedal is a rocker action about an off centre pivot, the longer pedal is for
raising the trolley top and the shorter for lowering.
4. To raise the trolley, operate the long side of the foot pedal through full strokes to
achieve the desired height, this operation may be better achieved with two wheel
brakes engaged.
5. To lower the trolley, depress the short pedal. Slight repositioning of the foot
pedal will control the rate of lowering.
6. Using two operators, making use of both pump pedals, can ease the raising a
heavily laden trolley. Practice is advised to achieve unison of action.
Wheeling the Trolley
1. Transporting a patient should be done with the side rails raised and restraints
fastened.
2. The trolley is best rolled by two attendants, one pulling and the other assisting with
guidance and steering as necessary.
3. If low obstacles (such as door sills) are encountered, roll up to them squarely and
lift the leading wheels over the obstacle using the corner frame grips. Repeat for
the trailing wheels.
4. High obstacles such as kerbs or steps, rough terrain, etc. should be recognised as
potentially hazardous to smooth rolling and trolley balance and may require
physical assistance or an alternative route.
5. Ensure that the restraints are fastened around the patient (see page 11).
Place the trolley in the lowest position possible. However, the trolley may be
wheeled in an elevated position along hospital corridors or similar smooth
surfaces, provided that the patient is securely strapped to the trolley and that the
two attendants are in control of the patient and trolley at all times.
6. To lift the trolley top and base together the operator sited at the foot end needs to
lift slightly before the head end operator. This is necessary to ensure that the
lifting notches engage. Apart from the fully raised position there are two other
positions at which the lifting notches engage these are at mid lift and just above
fully lowered. When lifting from the fully lowered position the top and base will
separate slightly prior to the notch engaging, this is a normal action. It is
recommended that this process is practiced on an un-laden trolley.
PLEASE NOTE: Cot sides are not intended to be used to either manoeuvre
or lift the trolley; damage may result from this practice.
IMPORTANT
Ensure the push/pull handles are clear of any obstructions when raising or
lowering.

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Locking system –dependent on type fitted.
Manual Foot End Lock
1. To load the trolley, ensure that the pedal on the foot end lock is depressed, and
guide the trolley into the head end floor lock. The foot end will automatically lock
when the trolley is in the correct position. To remove trolley, depress pedal whilst
pulling back on the trolley.
DO NOT OPERATE PUMP WHILST THE TROLLEY IS LOCATED IN THE LOCKING SYSTEM, AS
THIS WILL DAMAGE THE TROLLEY FRAME.
Loading/Unloading from a vehicle with ramp or lift
When using a powered winch, reference must be made to the winch
manufacturer’s instructions and Ferno UK Ltd for trolley winch connection
positions.
Unloading the trolley from a vehicle fitted with ramps
1. Make sure that the patient is disconnected from any vehicle mounted apparatus
or instrumentation.
2. Operation by a minimum of two operators at all times.
3. Disengage the trolley from the two part locking.
4. Unfold the push/pull handles and ensure they are locked in the extended position.
5. Using two operators guide the trolley down the ramp and out of the vehicle.
Loading the trolley into a vehicle fitted with ramps
1. Make sure that the patient is secure at all times whilst on the trolley.
2. The trolley is loaded with the patient's head towards the front of the ambulance.
3. Ensure that the trolley is in its lowest position.
4. Ensure that the push/pull handles are locked in the extended position.
5. Position the trolley at the base of the ramp, head end first.
6. With the operator at the head end pulling and the operator at the foot end
pushing simultaneously, the trolley can now be advanced into the vehicle.
7. IMPORTANT: ONCE IN THE VEHICLE, BEFORE ENTERING THE LOCK, FOLD THE
HEAD END PUSH/PULL HANDLE AND ROTATE UNDER THE TROLLEY TOP UNTIL
IT IS SECURED IN THE RETAINING CLIPS AS DAMAGE TO THE HANDLE WILL
OCCUR IF IT IS INCORRECTLY STOWED. NEVER ROTATE THE PUSH/PULL
HANDLE OVER THE TOP OF THE TROLLEY AS DAMAGE COULD OCCUR WHEN
THE BACKREST IS LOWERED.

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Unloading the trolley from a vehicle fitted with a tail lift
1. Make sure that the patient is disconnected from any vehicle mounted apparatus
or instrumentation.
2. Operation by a minimum of two operators at all times.
3. Disengage the trolley from the two part locking device by depressing the foot
pedal (manual lock), or pressing the green button (electric lock) and roll the trolley
to the rear of the ambulance compartment.
4. Guide the trolley onto the tail lift and out of the vehicle.
Loading the trolley into a vehicle fitted with a tail lift
1. Make sure that the patient is secure at all times whilst on the trolley.
2. The trolley is loaded with the patient's head towards the front of the ambulance.
3. Ensure that the trolley is in its lowest position and there are no trailing straps,
blankets etc.
4. IMPORTANT: BEFORE LOADING ONTO THE TAIL LIFT, FOLD THE HEAD
END PUSH/PULL HANDLE AND ROTATE UNDER THE TROLLEY TOP UNTIL
IT IS SECURED IN THE RETAINING CLIPS AS DAMAGE TO THE HANDLE
WILL OCCUR IF IT IS INCORRECTLY STOWED. NEVER ROTATE THE
PUSH/PULL HANDLE OVER THE TOP OF THE TROLLEY AS DAMAGE
COULD OCCUR WHEN THE BACKREST IS LOWERED.
5. Guide the trolley on to the tail lift, head end first.
6. Operate the tail lift as per manufacturer’s instructions.
IMPORTANT NOTE
Ensure the trolley is secure at all times when on board the tail lift

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User Guide for 2-part Track-Mounted Floor Lock (255-mm Gauge NMI System)
TROLLEY
255
GAUGE
TRACKING
FOOT
END
HEAD
END
FRONT OF
VEHICLE
VEHICLE OFFSIDE WALL
HEAD END
FLOOR LOCK
SLOTS FOR ADJUSTMENT
OF LOCKING DEVICES
PERMANENT
POSITIONAL
GUIDE PLATE
FOOT END
FLOOR LOCK
PERMANENT POSITIONAL
GUIDE PLATE
1. Removal of Head End and Foot End Lock Assemblies
On each locking assembly, retract the plunger and pull up release handle and
blade of both locking devices.
Remove lock assemblies.
The small positional guide plates at the head end and foot end must remain fitted
to the floor of the vehicle.
2. Installation of Head End Lock Assembly
As shown in diagram A(left), ensure handle and
blade of locking devices are in the fully open (up)
position.
Adjacent to the positional guide plate fitted to the
vehicle floor between the tracking at the head
end, locate the pegs on the underside of the lock
assembly in the tracking.
As shown in diagrams B& C, push blade of each
locking mechanism down by hand until it stops.
Push handle of each locking mechanism fully
down (diagram D) until the integral plunger locks
into place (diagram E).
Test for security & safety.
3. Installation of Foot End Lock Assembly
Install foot end lock assembly in exactly the same
way as above adjacent to the positional guide plate
at the foot end.

FERNO/MAN/01/18/159/UK 9 Pegasus Trolley
User Guide 2-Part Track-Mounted Floor Lock (255-mm Gauge Unwin System)
255
GAUGE
TRACKING
FOOT
END
HEAD
END
FRONT OF
VEHICLE
HEAD END
FLOOR LOCK
POSITION OF RH LOCKING
DEVICES ADJUSTABLE
PERMANENT
POSITIONAL
GUIDE PLATE
PERMANENT POSITIONAL
GUIDE PLATE
FOOT END
FLOOR LOCK
VEHICLE OFFSIDE WALL
TROLLEY
1. Removal of Head End and Foot End Lock Assemblies
On each Unwin locking device, rotate the plunger
crossbar and turret anticlockwise a quarter of a turn.
Lift the plunger crossbar from its U-slot in the turret,
and rotate it slightly to rest it on top of the turret.
Remove the assembly from the tracking by sliding the
assembly along the track half a hole pitch (12-13 mm)
and lifting clear.
2. Installation of Head End Lock Assembly
On each Unwin locking device, rotate the plunger crossbar until it snaps into
the U-slot on the turret (diagram Abelow). Do not rotate the turret clockwise
at this stage.
Close to the positional guide plate fitted to the vehicle floor between the
tracking at the head end, engage the pegs on the underside of the lock
assembly in the tracking (diagram B).
Slide the assembly towards its required position until both plungers locate in
the track.
For each of the two Unwin devices, use the plunger crossbar to rotate the
turret clockwise a quarter of a turn (diagram C). The assembly will be locked
rigidly to the tracking.
Test for security and safety.
TRACKING

DEVICE LOCKED
C
PEGS
A
B
3 Installation of Foot End Lock Assembly
Install foot end lock assembly in exactly the same way as above adjacent to the
positional guide plate at the foot end.
DEVICE UNLOCKED

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Using the Restraints (Pegasus Trolley)
1. The patient should be secured using the harness and both single strap restraints.
2. Dispose of and replace any restraints that are worn, damaged or have been
involved in any accident –they may have hidden damage.
3. Unbuckle all restraints and lay the straps out of the way before transferring the
patient.
4. Transfer the patient onto the trolley using recognised techniques.
5. Buckle the harness by inserting all three tangs into the buckle until they lock in
place. Adjust the shoulder straps so they are snug against the patient’s shoulders.
6. Fasten the one-piece restraint across the patient’s chest and under the arms.
7. Fasten the two leg restraints and adjust to ensure patient comfort.
8. To release the harness, twist the buckle lever.
NOTE
To remove the four-point harness, unclip all four brackets from mounting pegs
positioned on the trolley frame.

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Using the Restraints (Pegasus MK2)
9. The patient should be secured using the harness and both single strap restraints.
10.Dispose of and replace any restraints that are worn, damaged or have been
involved in any accident –they may have hidden damage.
11.Unbuckle all restraints and lay the straps out of the way before transferring the
patient.
12.Transfer the patient onto the trolley using recognised techniques.
13.To secure the 4 point harness, slide the two buckles on the shoulder straps onto
the buckle on the right hand side strap and then clip left hand side to the right
hand side buckle. Adjust the shoulder straps so they are snug against the patient’s
shoulders and adjust left and right hand side straps so they are snug against the
patients sides.
14.Fasten the two leg restraints and adjust to ensure patient comfort.
15.To release the harness, press release button.
NOTE:
To remove the four-point harness, unclip two side brackets and un-loop the
shoulder straps from the cross bar at the top of the X Frame.

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Fitting the Mattress to the Pegasus Trolley
To remove the mattress the trolley should be flat. Disengage the four pegs from
the keyhole slots, starting with the two at the head end.
Ensure the trolley is flat before fitting the mattress.
Fit mattress to the Foot End of the trolley first, as follows:
1. Insert the two pegs through the keyhole slots in the Leg
Rest Panel, and slide mattress towards the foot end (see
Fig 1 and Fig 2). Note: Should a peg not fit a slot the
peg will need checking for any damage.
2. Raise the mid-section of the mattress slightly (see Fig 3).
3. Insert the two pegs through the keyhole slots in the
Head Rest Panel and slide the mattress towards the
head end until flat (see enlarged detail in Fig 3).
4. Insert plastic plugs into the round end of keyhole slots to
secure mattress (see enlarged detail in Fig 3).
Note: The pegs in the Head Rest Panel should not reach
the end of the slot when the Head Rest is down. The gap
left allows movement when the Head Rest is raised.
Fig 2
Fig 1
Fig 3

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4. Trolley Features
Restraints
Each trolley is equipped with a 4-point harness and two restraint straps, all of which
should be used at all times. The harness is secured to the trolley using locating
posts with hooks, and each strap has loops so that they can be easily attached to the
trolley frame.
Cot Sides
Cot sides should always be used when the patient has been placed on the trolley.
These can be lowered by pulling out the lock pin, the cot sides lock automatically
when raised to the vertical position.
Backrest
The backrest may be locked in any inclined position. Support the backrest with one
hand (to avoid sudden movement). Squeeze the control lever with the other hand.
Raise the backrest to the desired angle and release the lever to lock it in position.
Support the backrest while making adjustments. The backrest also incorporates
superior support for CPR. DO NOT use the backrest to manoeuvre the trolley under
any circumstances. When using the trolley as a seat in a PTS vehicle ensure the
headrest is in its lowest position.
Headrest
The Pegasus is provided with a detachable headrest that affords support particularly
in the patient seated position. The black push button, located at the top of the
backrest, allows the fitting and removal of the headrest, which can be rotated through
half a turn to provide either a cup shape head support or flat support to incorporate a
pillow. A vehicle CEN tested stowage bracket, for the headrest, is also available.
NOTE:- Cot sides are not intended to be used to manoeuvre; lift the
trolley; or as seat, damage may result from this practice.

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Push/Pull Handles
The pull handles have a unique feature, which enables them to be locked securely
into the extended position. This enables them to be used as push/pull handles.
To operate this feature, unclip the push/pull handle extension from the securing clip
and fully extend the handle. Slide the knurled sleeves over the hinges to prevent the
handle folding up, enabling the push handle feature.
When folding the handles, pull and HOLD the knurled sleeves against the stops to
ensure the knurled sleeves are clear of the hinges, then fold the handle and push
into the securing clip.
The head end push/pull handle should be locked in place when not in use.
NOTE:- If knurled sleeves are not held clear of the hinge section during the
folding procedure damage may result to same.
Length Reduction Facility
A feature of the trolley is the capability of the head end of the trolley to fold down,
thus allowing the trolley to be adapted for different circumstances.
Additionally, the foot end of the top frame and tray on the PTS version of the
Pegasus will fold down, thus enabling the trolley to be used within a Patient
Transport Vehicle as either a normal trolley or as a seat base.
Head End Fold Down
The benefit of a shorter trolley using the head end fold section can only be achieved
with the trolley in the elevated position, the backrest in a partially raised.
Using the foot pedal raise the trolley to its maximum height.
Stand at the head end of the trolley and grasp the two knurled sleeves,
located one each side of the trolley frame.
Pull each knurled sleeve against the springs until the head end section can be
folded down.
Adjust the backrest angle to achieve the shortest length possible whilst
considering the comfort of the patient. Only leave the trolley in this
condition until sufficient space allows its return to normal length.
Always ensure that two operators are with a laden trolley at all times
IMPORTANT
When the push/pull handles are not in use then they should be locked in
their folded position.

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To return the trolley to normal length, lift the folded head end and the spring
loaded knurled sleeves will return to their locked position. Adjust the backrest
as necessary.
Hold the foot pedal down and lower the trolley.
Foot End Fold Down (PTS version only)
Stand at the foot end of the trolley and grasp the two knurled sleeves, located
one each side of the trolley frame.
Depress the spring loaded pins, which are positioned underneath each sleeve.
This will allow each sleeve to be pushed along the frame, thus releasing the
foot end of the frame to drop down.
The foot end tray can now be shortened by simply pulling out the spring
loaded knob and folding the tray down.
Stow the push/pull handle below the lock-bracket. Do not raise the trolley
top when in this condition.
The trolley is now ready for use as a seat base within the Patient Transport
Vehicle.
To return the trolley to its normal length, the reverse procedure should be
applied: raise the lowered foot end to its horizontal position and slide both
sleeves back over the hinged positions until they lock in position. The trolley is
now ready for use normally.
Wheels
All wheels have a braking system ensuring that the castor wheel will neither roll nor
rotate when the brake lever is applied. A minimum of two brakes should be engaged
whenever a patient is being transferred onto or off the trolley.
IMPORTANT:
When using as a seat base the length reduction feature at the foot end
MUST BE FOLDED DOWN.
Thus enabling seating for a maximum of three persons (total weight 200 kg)
IMPORTANT
When changing from PTS vehicle position, with the fold down frame
locked into its normal position, ensure the push/pull handle does not
interfere with the foot end floor lock bracket

FERNO/MAN/01/18/159/UK 16 Pegasus Trolley
Leg Rest Features
The following features must be executed with the operator positioned at the
foot end of the trolley.
Trendelenberg Position
To raise the leg rest to the Trendelenberg position, grip and support the leg rest
frame at the foot end. Lift the leg rest until the support bar locks into position.
Maintain a grip on the frame and gradually reduce support of the leg rest until you
are confident that the support bar has locked.
To lower the leg rest from the Trendelenberg position, hold the leg rest frame at both
sides at the foot end. Slide hands forward until fingers contact the support bar on
the underside of the leg rest frame. At this point, simultaneously lift and move the
support bar forward, thus releasing it from its locked position and slowly lower the leg
rest frame to its resting position.
Knee Contour (Fowler) Position (when fitted)
To raise the knee contour position, hold both lifting straps (yellow) and lift up.
Gradually release the lifting straps, ensuring that the support bar has locked in
position.
To lower the knee contour position, hold both release straps (red), lift up and pull
straps in the direction of the foot end and slowly lower the frame to its resting
position.
NOTE:
Potential pinch point - care should be taken during operation
NOTE:
Potential pinch point - care should be taken during operation

FERNO/MAN/01/18/159/UK 17 Pegasus Trolley
5. Cleaning and Lubrication
Cleaning
Regular cleaning helps reduce the risk of transmitting disease and enables
equipment to function at its optimum.
Steam cleaning with a suitable cleaning additive is the most effective method. The
same results may be achieved by using a sponge and mild detergent soap mixed in
warm water. For particularly grimy cases, especially if the trolley has been in storage
for a long period, it may be necessary to first wash the trolley with a water soluble
solvent soaked cloth prior to using soap and water.
Once cleaned, dry the trolley with a soft towel, paying particular attention to swivel
and sliding joints. If a compressed air hose is available, you may find that
compressed air jets are more effective in drying the hard-to-reach places. Once the
trolley is dry, you may wish to apply a liquid car wax to polished surfaces.
Lubrication
Your Ferno Pegasus trolley will work efficiently and safely only when it is well
lubricated. You MUST lubricate all moving and sliding parts after every inspection or
preventative maintenance programme, or if there is inadequate lubrication for the
moving parts to operate easily and quietly.
In general terms, almost all sliding and moving parts may be lubricated with a light
duty grease. A penetrating fluid lubrication is used on some sliding parts of the
trolley. However, when a penetrating fluid lubricant is used, all excess MUST be
wiped away, to prevent any build-up of dust or grime, which can clog up working
parts and impede movement.
Specific recommendations are available in the Pegasus Service Book which is
provided at the point of sale. Service and Repair is to be carried out by a Ferno
Trained Engineer. Contact Ferno Service on 01274 854511 for further details.

FERNO/MAN/01/18/159/UK 18 Pegasus Trolley
6. Warranty and Service
Ferno (UK) Ltd. standard terms and conditions apply to all sales. A copy is available
on request. These contain full details of warranty terms and do not limit the statutory
rights of the customer.
For service, maintenance and any questions regarding this, or any other Ferno
product, please contact:
Ferno (UK) Limited
Ferno House
Stubs Beck Lane
Cleckheaton
West Yorkshire
England
BD19 4TZ
Telephone: [phone]
Fax: [phone]
or your local distributor.
PREVENTATIVE MAINTENANCE MUST BE IN ACCORDANCE WITH THE
RECOMMENDATIONS IN THE SERVICE BOOK PROVIDED WITH EACH
TROLLEY

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7. Technical Data
Product Name
Pegasus Trolley
Overall Length
1950 mm
Folded Length (Foot End Only)
Folded Length (Head End Only)
Minimum Folded Length (Both Ends)
1730 mm
1650 mm
1450 mm
Overall Width
570 mm
Maximum Height (excluding
mattress)
880 mm
Minimum Height
460 mm
Weight
(Including Mattress, head pad &
restraints)
76.17 kg
Max SWL lowest Position
Max SWL Elevated
300 kg
200kg
Construction Materials
Aluminium Tubing
Aluminium Castings
Plastic Injection Mouldings
IMPORTANT NOTE
The ambulance vehicle must be fitted with a ramp or tail lift to assist trolley
loading. Contact our Technical Sales Department on 01274 851999 for
further details.
The CE mark on this product demonstrates conformity with the
requirements of the EC Directive 93/42/EEC for Medical Devices.