Ekamed Ekamove Operating Instructions Manual

Adjustable 30° lateral positioning system

Installation and

operating instructions

GmbH & Co.KG

Medical Aids for Geriatric

and Nursing Care

Im Stadtfelde 43 31515 Wunstorf

phone:[phone] Fax [phone]

[e-mail]

Internet: www.ekamed.de

1 List of contents

1 LIST OF CONTENTS 2

ITEMS SUPPLIED 4

2 GENERAL 5

2.1 EXPLANATION OF SYMBOLS 5

2.2 NOTES ON USING THE INSTALLATION AND OPERATING
INSTRUCTIONS 6

2.3 GUARANTEE, WARRANTY AND 7

LIABILITY PROVISIONS 7

2.4 SAFETY 8

3 COMBINATION WITH OTHER APPARATUS 10
4 INDICATIONS AND CONTRA-INDICATIONS 11

4.1 INDICATIONS 11

4.2 CONTRA-INDICATIONS 12

5 NOTIFICATION OF ACCIDENT AND DAMAGE 13
6 OPERATION 14

6.1 ADVANTAGES AT A GLANCE 15

7 OPERATING SUMMARY 17
8 INSTALLATION 18

8.1 INSTALLING THE AIR CHAMBER SYSTEM 18

8.2 INSTALLING THE CONTROL UNIT 20

8.3 CONNECTING AIR CHAMBER, SENSORS AND CONTROL UNIT 21

8.4 CONNECTION WITH THE MAINS SUPPLY 21

9 PUTTING THE APPARATUS INTO OPERATION 22

9.1 SWITCHING ON 22

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9.2 SETTING THE DATE/TIME 22

9.2.1 CALLING UP THE DATE AND TIME 23

9.3 CALIBRATING THE SENSORS (OPTIONAL) 24

9.4 FACTORY SETTINGS 25

10 NORMAL OPERATION 26

10.1 STARTING THE SYSTEM 26

10.2 CARE KEY 27

10.3 CALLING UP THE VALUES SET 27

10.4 STOPPING THE SYSTEM 28

11 SELECTING THE POSITIONING PROGRAMME 29
12 SELECTING THE POSITIONING ANGLE 30
13 SELECTING THE POSITIONING TIME 31
14 FREELY PROGRAMMABLE PROGRAMME 32
15 DOCUMENTATION 34
16 CPR FUNCTION 34
17 CLEANING 35
18 MAINTENANCE 36
19 DISPOSAL 36
20 MALFUNCTIONS/ERROR MESSAGES 37
21 WARNING MESSAGES 39
22 TECHNICAL DATA 40
23 EMC COMPATIBILITY 42
24 STANDARDS 43
25 CONTACT 43

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Items supplied

1x base unit consisting of:

Control unit with clamping device
Power line (fixed to the base unit)
1 SD card 2 GB for data storage
1x air chamber system
Air chamber with connection hoses
Protective cover
Sensors with supply cable (optional)

2x stabilising plates for sensors
1x operating instructions
1x packaging material
1x carry-pouch for transport and storage

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CPR

R

L

Emergency deflation

Indicates the emergency deflation coupling

Symbol for hose connection, right

Symbol for hose connection, left

Plus key for selection

with programme key depressed => next programme
with angle key depressed => angle value is increased
with time key depressed => time value is increased

Minus key for selection

with programme key depressed => previous programme
with angle key depressed => angle value is decreased
with time key depressed => time value is decreased

Programme key for selecting the positioning programme

(Only in combination with Plus or Minus key)

Start key for starting the system

(In programming mode for confirming values)

Stop key for stopping the system

(In programming mode for exiting the programming mode)

Angle key for selecting the positioning angle

(Only in combination with Plus or Minus key)

Time key for selecting the positioning time

(Only in combination with Plus or Minus key)

2 General

2.1 Explanation of symbols

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2.2 Notes on using the Installation and Operating

Instructions

These operating instructions provide some important information
on working with the ekamove system. All the safety advice and
handling instructions given should be followed in order to
guarantee safety when working with the apparatus.

In addition, on-site accident prevention directions and general
safety provisions applicable in the area where the apparatus is
used should be observed.

Note!

Read the instructions very carefully
before starting any work!
These operating instructions belong

to the product and should be kept
close to the apparatus so that they

can be consulted by personnel and

operators at all times.

If the apparatus is passed on to third parties, the operating
instructions must accompany it.

The illustrations in these instructions are intended to give a clear
demonstration of the actual situation and are therefore not
necessarily true to scale; they may vary slightly from the actual
design of the apparatus.

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2.3 Guarantee, warranty and

liability provisions

All information and advice in these operating instructions has been
compiled taking account of the applicable standards and codes
and the best available technology.
With appropriate operation, the ekamed GmbH & Co. KG company
accepts a guarantee of 24 months as from the invoice date. During
this time, in the event of defective parts or malfunction due to a
production defect, the apparatus and its accessories can be
repaired or replaced free of charge.

The ekamed GmbH & Co. KG company does not accept any
liability for damage due to:

1. Failure to follow the operating instructions

2. Use which is not in accordance with the instructions

3. Unauthorised alterations

4. Technical modifications

5. Use of unauthorised spare parts
The warranty is based on legal provisions and directives.
If any work or interventions are carried out on the apparatus or its

accessories by the client or by third parties without the prior
approval of ekamed GmbH & Co. KG, the warranty lapses.

For medical products within the meaning of EU Directive
93/42/EEC which have to be regularly serviced or conditioned, the
warranty only applies if the prescribed maintenance intervals are
observed.

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If claims are made on the warranty and if, after checking where
applicable, it should turn out that these are based on signs of wear
or other forms of damage not covered by the warranty, the ekamed
GmbH & Co. KG company is entitled to pass any expenses
incurred (testing, transport costs and similar) on to the client.

2.4 Safety

This section provides a summary of all the important safety
aspects for optimum protection of the user and third parties and for
safe and problem-free operation.

The apparatus is used in the home and in care establishments
(commercial area). In commercial areas the user of the apparatus
must comply with legal obligations regarding safety at work.

In addition to the instructions on safe working given in these
instructions, the safety, accident prevention and environmental
regulations applicable to the area of use of the apparatus must be
observed. The following in particular applies here:

- The operator must clearly define and manage the areas of
responsibility for operation, servicing and cleaning.

- The operator must make sure that all members of personnel
who handle the apparatus have read and understood the
operating instructions.

Furthermore, the operator is responsible for ensuring that the
apparatus is always in a technically faultless condition; therefore
the following applies:

- The operator must make sure that the intervals for
maintenance work described in these operating instructions
are observed.

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- The operator must make sure that authorised accessories
exclusively are used in connection with the apparatus.

Warning: Changes to the ME apparatus are not permitted
Note: In order to prevent the risk of an electric shock, this

apparatus should only be connected to the mains power
supply via a protective earth conductor.

Do not use the ekamove system without side rails.
The apparatus should not be set up in the immediate vicinity

of sources of interference such as microwaves or apparatus
emitting powerful radiation. To ensure electromagnetic
compatibility, the apparatus should only be connected to the
mains power supply via a protective earth conductor.

The location of the apparatus and the routing of the power line
should be selected so that accidental disconnection from the
supply network is excluded. The power line is to be routed in
such a way that it cannot be pinched or crushed. Also it
should be laid in such a way that it does not present a tripping
hazard.

The supply cable should only be provided by the ekamed
GmbH & Co. KG company or by a company authorised by it.

The fire hazard in case of use in oxygen enriched enviroments
has been vastly reduced. The housing is self-extinguishing.

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3 Combination with other apparatus

If done properly, ekamove® can be used with a PC or laptop as an
option for storing positioning data. For this, a software programme
can be acquired from ekamed GmbH & Co. KG as an option.
Standard commercial 2 GB SD cards can be used as the storage
medium.

Installation together with an alternating pressure system is not
permissible as this may result in an unstable position.

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4 Indications and contra-indications

4.1 Indications

Ekamove® is suitable for the prevention of decubitus ulcers
(prophylaxis) for patients / residents who are at risk of developing
decubitus ulcers or as an auxiliary decubitus therapy for patients /
residents who are already suffering from existing decubitus ulcers
up to and including stage 3 (EPUAP). The system is designed for
patients with a bodyweight of up to 300 kg. In exceptional cases
the system can also be used for higher stage decubitus ulcers.
However, it is essential that a doctor should be consulted for this
and his approval is necessary.

The ekamove ® is suitable and recommended

o for pre-existing decubitus ulcers (up to and including stage

III EPUAP)

o for people with a moderate to high risk of decubitus ulcers

(as per Braden)

o for people whose disability or illness means that they must

spend long periods lying down

o for people who cannot change their position when lying

down themselves

o for people who have suffered a stroke with partial paralysis
o for people with paraplegia who want to change the position

in which they are lying with the use of their arms

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4.2 Contra-indications

The product cannot be used

o with unstable fractures
o with severe burn injuries
o with equilibrium disturbances
o with underlying neurological diseases which lead to anxiety

behaviour in patients

Claims of any kind for damages resulting from incorrect or
inappropriate use are excluded. Ekamove ® is an aid for the
avoidance of decubitus ulcers and an auxiliary therapy for
decubitus ulcers. Even when using ekamove® the skin should also
be regularly examined by the person himself – where possible – or
by carers and/or qualified medical personnel for pressure points. If
no improvement occurs in the condition, specialist medical
personnel should be consulted.

Note! Claims of any kind for damages resulting from
incorrect or inappropriate use are excluded. The
operator alone is liable for all damages in case of
incorrect or inappropriate use.

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5 Notification of accident and damage

Malfunctions or breakdowns in the apparatus which have caused
personal injury must be notified without delay to the competent
authority and the company ekamed GmbH & Co. KG.

Comment!

The competent authority may demand that the operator
has the event to be notified assessed by an expert at his
own cost and that he submits the assessment in writing.
The expert is selected in agreement with the competent
authority.

The technical safety assessment includes the determination of the
following elements

- to what the event can be ascribed,

- whether the product was in good condition,

- whether any further hazard exists after elimination of the

defect,

- whether new knowledge has been gained which requires

other or additional precautions.

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