Maquet Alphamaxx User manual

ALPHAMAXX

1133.02BX/FX

Operating instructions

Universal operating table

Englisch

GA113302GB11

1133.02BX

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4

6

11

8

2	3	5							7	10
		12								9
										12
		14								14

15

20 13

Potential equalization

Socket for mains cable 17

Mains cable 16	15

18

19

Overview

1Head rest (e.g. 1130.64)

2Fastening screws for head rest

3Locking lever for upper back plate

4Back plate, removable

1133.31X0 Back plate for general surgery

5Connection point for removable back plates

6Lower back plate

7Bellows

8Leg plates

9Locking lever for leg plate abduction

10Unlocking of leg plates

11Seat plate

12Infrared receiver and transmitter

13Override system with status indicators for operating table

14Sockets for cable-connected hand control and foot switch

15Socket for mains cable

16Mains cable

17Potential equalization

18Cable-connected hand control (optional)

19IR remote control (optional)

20Interface for servicing

2	GA113302GB11

1133.02BX

Contents

I.	Important safety instructions .......................................................................................................			4
II.	Important information ..................................................................................................................			6
	1.	Important notes on these operating instructions .......................................................................		6
	2.	Using the operating table in accordance with the intended purpose ..........................................		6
	3.	Intended purpose .....................................................................................................................		6
	4.	Fundamental safety aspects ....................................................................................................		6
III.	General description ......................................................................................................................			7
	1.	General features.......................................................................................................................		7
	2.	Control of functions ..................................................................................................................		8
		2.1. Cable-connected hand control – functions .........................................................................		9
		2.2. Override system = emergency operation .........................................................................		10
		2.3	IR remote control (optional) .............................................................................................	12
			2.3.1 IR system code ......................................................................................................	13
			2.3.2 IR charging station .................................................................................................	14
		2.4	IR wall control panel ........................................................................................................	14
		2.5	Control via foot switch .....................................................................................................	14
		2.6	Special functions.............................................................................................................	14
	3.	Table top ................................................................................................................................		15
		3.1	General features .............................................................................................................	15
		3.2	Table top components .....................................................................................................	16
		3.3	Attaching the back plate modules ...................................................................................	17
		3.4	Removing the back plate modules ...................................................................................	18
		3.5	Leg plates .......................................................................................................................	18
		3.6	Table top padding ............................................................................................................	19
		3.7	Accessories ....................................................................................................................	19
	4.	Motor drive for the base ..........................................................................................................		20
IV. Use of the operating table ...........................................................................................................				21
	1.	General ..................................................................................................................................		21
	2.	Operation on battery power ....................................................................................................		21
	3.	Operation on mains power......................................................................................................		22
	4.	HF surgery / Use of defibrillators ............................................................................................		22
V.	Patient positioning .....................................................................................................................			23
	1.	General ..................................................................................................................................		23
	2.	Positioning a patient weighing up to 135 kg (300 lb.) ..............................................................		25
	3.	Positioning a patient weighing from 135 kg up to 225 kg (300 lb. up to 500 lb.) ......................		28
	4.	Positioning a patient weighing from 225 kg up to 450 kg (500 lb. up to 1000 lb.) ....................		31
VI. Care and maintenance ..............................................................................................................				32
	1.	Cleaning .................................................................................................................................		32
	2.	Disinfection ............................................................................................................................		32
	3.	Maintenance ..........................................................................................................................		33
	4.	Malfunctions ..........................................................................................................................		33
	5.	Environmental protection ........................................................................................................		34
VII. Technical data ............................................................................................................................				35
	1.	Operating table adjustments ..................................................................................................		35
	2.	Electrical data ........................................................................................................................		35
VIII. List of accessories ......................................................................................................................				36
	1.	Accessories for the head rest interface ..................................................................................		38
	2.	Accessories for the back plate interface .................................................................................		40
	3.	Accessories for the legplate interface .....................................................................................		40
	4.	Accessories for attachment to the side rails...........................................................................		41
	5.	Special accessories ...............................................................................................................		41
	6.	Control modules .....................................................................................................................		42
IX.	Spare parts list ............................................................................................................................			42

GA113302GB11

3

			I. Important safety instructions	1133.02BX

I. Important safety instructions

Mount only the accessories listed in Chapter VIII.

Make sure that the operating table is set up horizontally and is stable!

Lock the operating table in position prior to use! Press the LOCK key!

Lock the operating table in position prior to transferring the patient! Press the LOCK key!

The patient may only be transferred from the side of the operating table.

It is not allowed to transfer the patient from the head or foot end onto the table.

Danger of tipping over!

Danger of injury! If the patient is not secured during transport, adjustments of the operating table or positioning (especially in Trendelenburg positions), he/she may slip off the operating table. Always secure and observe the patient.

Danger of burns to the patient!

When using HF surgical equipment, defibrillators and defibrillation monitors, make sure to avoid that the patient comes into contact with the metal parts of the operating table, the table tops or the accessories. Also make sure to avoid that the patient is lying on moist underlays or sheets on the conductive pads.

Be absolutely sure to comply with the manufacturer’s operating instructions.

Danger of damage! Take care to avoid collisions between accessories and the operating table during adjustment procedures.

Consult MAQUET prior to using accessories produced by other manufacturers if they affect the longitudinal geometry of the table top.

There is no explosion protection while recharging the batteries or the operating table is on mains power.

When connecting and removing the mains cable, observe the correct order of the procedure! (see page 22)

The patient has to be positioned and observed so as to avoid hazards to respiration, the nervous system and the circulatory system.

The operating table’s electrical conductivity has to be checked once a year by trained service personnel!

Unplug the operating table before opening!

Electrical devices (such as cellphones, radios, magnetic resonance tomographs) can interfere with the functioning of the operating table when used near the operating table.

Please observe the Technical Description for the operating table.

It contains information on electromagnetic compatibility (EMC) for the operating table (both radiation and resistance to interference).

Adhere to those specifications when using electrical equipment and respond properly in the event of effects on the operating table.

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1133.02BX		I. Important safety instructions

Danger of pinching!

Î

Danger of collision!

Î

Danger of injury!

Before aligning the leg plates horizontally, check the patient’s position carefully, particularly when using knee crutches.

Danger of crushing!

Do not touch the side rails in the area of the joints when adjusting the operating table top!

Danger of pinching!

Do not reach under the table top or between the table top components during adjustment procedures.

Danger of crushing!

When locking the operating table (LOCK), the operator’s feet may be crushed or shorn. When setting the operating table, keep enough distance from the table base.

Danger of damage!

Do not place any objects on the base of the operating table!

Danger of damage!

Do not press or pull on the covers of the joints.

Danger of damage!

Make sure the cable of the hand control does not get jammed when adjusting the operating table.

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			II. Important information	1133.02BX

II. Important information

Your hospital has opted for the 1133.02 operating table. Thank you for the confidence you have demonstrated in doing so.

1. Important notes on these operating instructions:

•Please read these operating instructions thoroughly and carefully. They were written to make you familiar with the features of the operating table.

•Please observe these instructions at all times.

•Please keep these instructions close to the equipment for ease of reference.

•In these operating instructions we have used the following symbols:

This symbol indicates safety instructions in accordance with the prevailing international standard for medical equipment.

ÎNote

This symbol is placed before all instructions that ensure the trouble-free operation of the unit.

(X) An „X“ in the order number (e.g. 1133.53XX) stands in place of the different versions.

2. Using the operating table in accordance with the intended purpose

The operating tables distributed by MAQUET are to be used exclusively in the field of human medicine. The user must have been instructed in the proper operation of the table before using it. This familiarization session is confirmed in an acceptance log. The location selected for the table must satisfy the requirements set down in applicable standards and guidelines. Mandatory for utilization is the proper assembly and maintenance of the unit.

3. Intended purpose

The 1133.02 operating table serves to support and position patients for surgical treatment

•immediately before, during and after the operative phase

•in rooms designated for medical use and which provide the following required features:

–equipment to protect against electric shocks

–additional potential equalization

–electrically conductive floor (corresponding to Group 1 or 2 as per VDE 0100 part 710);

•under medical supervision.

•Considering patient positioning a max. 450 kg (1000 lb.) patient weight is permissible.

Avoid excentric patient positions, i.e. the patient’s centre of gravity (near the navel) must be as close as possible to the centre of the column.

Due to the design of the table top, the operating table is suitable for all surgical disciplines. The patient positioning options are listed in these Operating instructions.

The operating table adjustments are made electrohydraulically using a cable-connected hand control, an IR remote control, an IR wall control panel or a foot switch.

Side rails serve to attach accessory components in accordance with the manufacturer’s specifications. The radiotranslucent operating table top allows for intraoperative use of X-ray equipment.

ÎNote

Make sure to comply with the generally applicable provisions relating to hygienics, and to cover the table top of the operating table with sheets before positioning the patient.

4. Basic safety aspects

„CLASSIFIED BY UNDERWRITERS LABORATORIES INC: WITH RESPECT TO ELECTRIC SHOCK; FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 2601-1“

This operating table meets the requirements set forth in the IEC 601-1 international standard, which is equivalent to EN 60601-1.

The operating table is classified as Class I equipment of the Medical Device Directive.

Whenever maintenance work is required, remember that the MAQUET service is the right address in terms of quality and maintaining guarantee protection. You will certainly understand that MAQUET can be held responsible for the safety technology features of the product only if assembly, enhancements, readjustment, modifications and repairs are made exclusively by our service department or by an authorized agent and if the unit is used in full compliance with the Operating Instructions.

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1133.02BX		III. General description

III. General description

Fig. 1: Permissible patient orientation

NO

YES

1. General features

In principle, the ALPHAMAXX 1133.02 operating table is suitable for the following surgical procedures:

in the thorax and abdominal areas

in the head area

in gynaecology

in urology

in orthopaedics

If required, separate accessories can be attached to the operating table.

The table top is subdivided into 6 sections:

Head rest (removable)

Upper back plate (removable)

Lower back plate

Seat plate

Split leg plates

The lower back, seat and leg plates are adjusted under motor power.

The head rest and the upper back plate are adjusted manually.

X-ray cassettes can be inserted underneath the back plate.

The side rails are used to fix the accessories.

For patients weighing up to 135 kg (300 lb), place the operating table only on its castors (UNLOCK) up to the maximum table top height of 940 mm (37 in)! The warning sign is not seen!

For patients weighing from 135 kg up to 225 kg (300 - 500 lb), place the operating table only on its castors (UNLOCK) when the table top is in its lowest position!

Using the UNLOCK function for patient weights exceeding 225 kg (500 lb) is not permissible!

2. Versions

Various versions of the 1133.02 operating table are available:

1133.02B1 Operating table incl. SFC pads and standard side rails

1133.02B3 Operating table incl. SFC pads, standard side rails and motor drive for the base

1133.02F1 Operating table incl. SFC pads and US side rails

1133.02F3 Operating table incl. SFC pads and US side rails and motor drive for the base

The cable-connected hand control, the IR transmitter and charging station for the IR transmitter as well as the head rests, upper back plates and leg plates are to be ordered separately. The order numbers are listed in Chapters VIII and IX.

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			III. General description	1133.02BX

2. Control of functions

The electrohydraulic functions of the operating table can be operated using the following control elements:

• Cable-connected hand control (see 2.1)

• Override system = emergency operation (see 2.2)

or optionally:
•	IR remote control	(see 2.3)
•	Wall control panel	(see 2.4)
•	Foot switch 1009.79F0	(see 2.5)

The cable-connected hand control and the IR remote control have almost the same function keys.

The override system is only used for emergency operation of the operating table.

The foot switch functions are: table height, Trendelenburg/reverse Trendelenburg position and another function (lateral tilt, longitudinal shift for the back plate or leg plate adjustment).

Î Note:

For safety reasons only the TRENDELENBURG/ REVERSE TRENDELENBURG functions can be used when the UNLOCK function is activated.

The sockets 14 for the cable-connected hand control and the foot switch are located on the override control panel.

Î Note:

If the functions are controlled simultaneously by more than one operating element, each movement of the operating table is stopped immediately.

Danger of operating table tipping over!

Make sure to remove any potential hindrances before adjusting the operating table!

Danger of damage during adjustments!

Do not place any objects on the base of the operating table!

Danger of pinching!

Do not reach under the table top or between the table top components during adjustment procedures.

Danger of injury!

If the patient is not secured during transport, adjustments of the operating table or positioning (especially in Trendelenburg positions), he/she may slip off the operating table. Always secure and observe the patient.

Danger of damage!

When not in use, hang up the cable-connected hand control at the side rail of the operating table. Make sure the cable of the hand control does not get jammed when adjusting the operating table.

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1133.02BX		III. General description

			2.1 Cable-connected hand control
			The cable-connected hand control is connected to the
			operating table at one of the two sockets 14 at the over-
			ride control panel (for simultaneous connection of ca-
			ble-connected hand control and foot switch). The elec-
			tric motor-powered adjustments of the operating table
			can be made immediately by pressing completely the
			corresponding function keys.
			a)	Lower table top
			b)	Raise table top
			c)	Tilt to the left (view from head end)
			d)	Tilt to the right (view from head end)
	v	w	e)	Trendelenburg position
			f)	Reverse Trendelenburg position
	t	u	g)	Flex position
				operates the reverse Trendelenburg and lower
				back plate functions until a flex position is
	r	s		achieved to force the surgical field upward
			h)	Beach chair
	p	q		raises the back plate, moves the entire table top
				into Trendelenburg position and lowers the leg
				plates. The patient is moved into a seated posi-
	l	m		tion.
			j)	Slope (both) leg plates downward
	j	k	k)	Slope (both) leg plates upward
			l)	Slope (lower) back plate downward
	g	h	m)	Slope (lower) back plate upward
			p)	Shift the table top toward the foot end
	e	f	q)	Shift the table top toward the head end
			r)	Adjust the left leg plate individually
	c	d		The left leg plate can be controlled individually
				only together with the appropriate function key
	a			for the desired movement – downward (r+j) or
		b		upward (r+k), under two-button control
			s)	Adjust the right leg plate individually
		z		Similar to the individual plate, by pressing the
				two keys for downward movement (s+j) or for
				upward movement (s+k) (two-button control)
			t)	Lock
				Press the LOCK key for at least 1 second; the
				table will be locked automatically.
			u)	Unlock
				To unlock the operating table, press the UNLOCK
				key for at least 1 second, then the castors will
				be extended automatically and the table can
				be displaced.
			v)	Motor drive for the base for 1133.02B2 (optional)
				Displace the operating table backward (toward
				the head end).
			w)	Displace the operating table forward (toward the
				foot end).
				When displacing the operating table under motor
				power, it must be guided with a hand.
	GA113302GB11			9

			III. General description	1133.02BX

z) 0-position

Resets the lateral tilt, Trendelenburg/reverse Trendelenburg, back plate and leg plate adjustments to the horizontal position. If the function key z is pressed, the operating table top will first reset the adjustments in the following order – lateral tilt, Trendelenburg/reverse Trendelenburg, back plate. An acoustic signal will indicate that these adjustments have been reset. Release the function key z and press once again to reset the back plates to the horizontal position; if the leg plates have been adjusted individually, they will be positioned parallel to one another.

Î Notes:

Manual adjustment functions such as those for the upper back plate, head rest and leg plate abduction will not be affected by the IR remote control (and as a consequence neither by the automatic 0-position function).

Î The transmission power of the IR hand control is sufficient to be able to adjust the operating table even from a greater distance. If the operating table does not respond to the command even though the function key is completely depressed, either reaim the hand control or move to a slightly different transmission position. In such cases the receiver at the column is probably being blocked by a person’s body.

2.2. Override system = emergency operation

2.2.1 Override control panel

In case of a malfunction or a defective hand control, you can control the operating table functions via the control panel 13 on the upper column casing = emergency operation.

Î Note:

Always press the ON key together with the desired

13function key.

ÎNote:

If the operating table batteries are discharged, the override system only works if the operating table is connected to the mains.

ÎNote:

When using the override control panel, the anticollision feature is not activated. Avoid extreme adjustments – the combination of maximum Trendelenburg/reverse Trendelenburg position and maximum lateral tilt.

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1133.02BX		III. General description

A	C E G I L N

B D F H K M O

The functions of the override control panel are shown in the following:

A) LED status indicators of operating table

ÎNote:

The status indicators are only active when the ca- ble-connected hand control or IR remote control is switched on.

Description of the symbols from left to right:

zMains connection: the green LED lights up when the operating table is connected to the mains.

zBattery charge level: the red LED flashes when the operating table batteries have to be recharged as soon as possible.

zLock operating table: the green LED lights up when the operating table is locked, i.e. LOCK activated.

zExtend operating table castors: the red LED lights up when the operating table is on its castors and can be displaced, e.g. UNLOCK activated.

B)ON

switches the motor ON and must be pressed in addition to each function key

C)TREND

Moves table top into Trendelenburg position

D)REV.

Moves table top into reverse

Trendelenburg position

E)UP

Move table top up

F)DOWN

Move table top down

G)TILT

Lateral tilt to the left

H)TILT

Lateral tilt to the right

I)UP

Slope back plate upward

K)DOWN

Slope back plate downward

L)UP

Slope leg plate upward

GA113302GB11

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			III. General description		1133.02BX
			M)	DOWN
				Slope leg plate downward
			N)	LOCK
				Operating table locked

			O)	UNLOCK
				Operating table on castors, movable
	v	w
			2.3. IR remote control (optional)
	t	u	The operating table can be equipped with an IR remote
			control, as desired.
	r	s	The required charging station for the IR remote control
			is not included with the order no. 1133.91A0.
	p	q	The layout of the function keys for the operating table
			adjustments is the same on the cable-connected hand
			control and IR remote control apart from the following
	l	m	exceptions:
			There are no function keys for the motor drive for the
		k	base. For safety reasons, you can only activate this
	j		function via the cable-connected hand control.
	g	h
			Î Note:
		f		When switching on the IR remote control, the LED
	e			status indicators on the control panel on the oper-
				ating table column are active (see chapter on “Over-
	c	d		ride system”).
	a	b	Î Note:
				When using the IR remote control or the cable-con-
		z		nected hand control, the electronics generally avoid
				collisions with the floor or parts of the operating
				table.
	12			GA113302GB11

1133.02BX		III. General description

0 3

2.3.1 IR system code

An IR remote control is clearly assigned to each operating table through a code. The operating table has the same system code as the associated IR remote control. You can see from the label at the operating table column whether the IR reception has been activated for this operating table. If the system code is crossed out, then the IR reception has been locked for this operating table. The operating table and the IR remote control are activated / locked for IR reception by authorized personnel.

The operating table and the associated IR remote control are marked by adhesive labels bearing the set system code:

•The adhesive labels are affixed to the operating table column next to the IR receiver.

•The adhesive labels are affixed to the back of the IR remote control.

The two dot-shaped adhesive labels bear a number from 0 to 9 or a letter from A to F:

•left: 0, 1, 2 ...A, B, ... F

•right: 0, 1, 2 ...A, B, ... F

Examples of preset IR system code markings:

1	5
3	A

C2

DA

ÎNote:

The order of the identification letters/numbers is significant, i.e. the IR system code 4 B does not equal

B 4.

ÎNote:

Always leave the IR remote control in the immediate vicinity of the operating table to which it is assigned, since the operating table can only be moved via this IR remote control.

Of course, the operating table can be adjusted via a cable-connected hand control or the override system at any time, regardless of the IR remote control.

ÎNote:

The transmission power of the IR hand control is sufficient to be able to adjust the operating table even from a greater distance. If the operating table does not respond to the command even though the function key is completely depressed, either reaim the hand control or move to a slightly different transmission position. In such cases the IR sensor at the column is being blocked by a person’s body.

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			III. General description	1133.02BX

2.3.2 Charging station

Recharging the IR remote control:

• Connect the charging station to the mains.

The green LED in the charging station indicates whether the required supply voltage is available or not.

• Place the IR remote control in the charging station as follows:

– Keypad visible, in the position for normal use, i.e. the 0-position key x is located at the bottom right

– The base of the hand control is in contact with the lower limit stop of the holder.

Î Note:

The rechargeable battery of the IR remote control has enough capacity to ensure several day’s use of the operating table. Nevertheless, we recommend that you insert the hand control into the holder of the charging station so that the battery is recharged overnight.

2.4 Control via IR wall panel

The desired adjustment functions for the operating table can be controlled by means of the function keys (1) at the wall control panel or the separate IR hand control (2).

Î Note:

The IR wall control panel can be mounted to the wall at a later date. For further information, please refer to the operating instructions GA115095GBxx.

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