Eberle P2 User manual

OPERATING INSTRUCTIONS
Arthroscopy Pump P2
EBERLE Arthroscopy Pump P2 913031

Power switch1
Start/stop key2
Key for pressure increase3
Key for pressure decrease4
Key for filling5
LCD display6
Key for call of storage on memory location 17
Key for call of storage on memory location 28
Key for call of storage on memory location 39
Memory key10
Release button12
Locking tab13
Clamping bracket14
Locking lever15
Tube holder16
Pressure transducer retainer11
6a Graphic pressure display
6b Current pressure
6c Display of selected memory location
6d Display of maximum delivery volume
6e Display of set pressure
K1Brief description
1 4 5
2 3 76
10 9
11 15
12 13 16
146b 6c 8
6a 6e 6d
OPERATING INSTRUCTIONS
Arthroscopy Pump P2

K2Brief description
23
18b18a
19 18
17
222120
Equipotential bonding17
Power connector18
18a Mains fuse box with fuse holder
18b Connector for power plug
Type plate19
Mains power cable23
Certification label22
Service port21
ECB (external communication)20
OPERATING INSTRUCTIONS
Arthroscopy Pump P2

Tube-Set for Arthroscopy (art. no. 900154 and art. no. 900155)
Bleeder pin art. no. 90015424
Luer-lock art. no. 90015525
Tube clamp26
Pressure transducer27
Reservoir28
Filter screen29
Tube clamp30
White Sealing cap31
K3Brief description
24
26
27
28
29
31
30
25
900155
900154
OPERATING INSTRUCTIONS
Arthroscopy Pump P2

K4
Patient-Tube with Luer-Lock (art. no. 900153)
Brief description
Sterile buffer zone33
Tube clamp34
Luer-connector35
Highly flexible end tube
36
End cap37
Blue sealing cap32
Sealing cap38
34
32
33
35
36
37
38
OPERATING INSTRUCTIONS
Arthroscopy Pump P2

Contents
OPERATING INSTRUCTIONS
Arthroscopy Pump P2
Contents
1.
2.
3.
4.
5.
5.1
5.2
6.
7.
7.1
8.
9.
9.1
10.
11.
12.
13.
General Information, description and field of application
Scope of Delivery
Symbol definitions
Connection and Start-Up of Device
Operating
Key assignment
Setting of Maximum Flow Rate
Device-specific Symbols
Preparing of Device and Accessories
Cleaning of Device
Service, Maintenance, Inspection and Disposa
Trouble Shooting
Software version
Technical data
Compatibility
Warranty
Addresses
1
1
2
4
8
9
9
10
11
11
11
12
12
13
14
14
15
Page
5.3 Contrast Setting 9
5.4 Connectors / Ports 10
4.1 Inserting the Tube-Set and the Complete-Set for Arthroscopy
(art. no. 900154,900155, 900209 and art. no. 900210) 4
4.1.1 Leakage Checks of Tube-Set and the Complete-Set for
4.1.2 Filling of Tube-Set and the Complete-Set for Arthroscopy 5
4.2
Connecting of Patient End-Tube with Luer-Lock (art. no. 900153)
5
4.2.1 Filling of Patient End-Tube with Luer-Lock 6
4.3 After Surgery 6
4.4 Preparing of Next Surgery 6
4.5 After Last Surgery of the Day 7
Arthroscopy 5
Safety Instructions and Warnings
3
3.1
9.2 Factory Settings 12

1
OPERATING INSTRUCTIONS
Arthroscopy Pump P2
1. General Information, description and field of application
The EBERLE arthroscopy pump P2 was developed for surgical use in the field of arthroscopy.
The device assures a continouos flow of the flush medium by permanently monitoring and
controlling pressure.
Utilizing or operating the device in non-conformance to these operating
instructions can injure the patient and /or the operating personnel and damage the
pump!
!
We thank you for your confidence and wish you much success with the EBERLE arthroscopy-
pump P2!
2. Scope of Delivery
After delivery of the arthroscopy-pump, at first the packaging should be checked for external
damage.
The delivery of the arthroscopy-pump (art. no. 913031) includes the following items:
Should one or several components be damaged or found to be missing, please immediately
contact an EBERLE representative or an authorized service or distribution center.
Arthroscopy pump P2
Mains power cable 1,8m [23]
article no. 913031 1
1
Operating instructions P2
The arthroscopy pump P2 should only be used by trained personnel in designated
medical institutions.
!
Before operating the pump, please read these instructions carefully. They contain all
necessary information to ensure an appropriate connection and operation of the device.
Additionally, important safety and cleaning information is explained.
Keep these operating instructions in a safe and easily accessible place for future reference.
The EBERLE arthroscopy pump P2 is intended for use in arthroscopic joint surgery of knee,
shoulder, elbow, wrist or ankle. Use in other areas is prohibited!
article no. 913035

2
3. Symbol definitions
This symbol on the packaging, instruction manuals, and / or the device indicates
that this product shall not be treated as consumer waste. The correct disposal
will help to prevent health or environmental impacts.
!
This symbol indicates a device with one or more applied parts of Type B
This symbol on the packaging indicates the upper and lower storage
temperature for the device.
This symbol alerts the user to an information that must be observed. Failure to
observe this information can result in patient or user injury and / or damage the
unit.
This circular symbol indicates that products with damaged packaging must not
be used.
This circular symbol identifies products that are approved for single use only and
may not be reused.
This symbol identifies products that contain phthalates in the form of di-2-
ethylhexyl phthalate.
This symbol in conjunction with a date e.g. 2007-06, shows the usability of the
product until the specified date.
This symbol alerts the user to follow the operating instructions.
PHT
DEHP
This symbol indicates a device with one or more applied parts of Type BF
XX
XX
XXXX-YY
This symbol identifies products that have been sterilized in the final packaging
and additional the sterilization process, in the illustrated case, the sterilization
with ethylene oxide.
Triangular icons advise the user to important information that must be
observed.
Circular icons with a diagonal bar indicate actions that are prohibited.
!
OPERATING INSTRUCTIONS
Arthroscopy Pump P2

3
3.1 Safety Instructions and Warnings
The electrical installation of the operation room must adhere to the requirements of
the applying IEC standards and national regulations! The device is only reliably
grounded, if the device is connected to a ground-type receptacle. Routinely check
the plug and the cable and do not use if damaged.
!
The pump may only be switched on, once all connecting cables are completely
connected. Prior to every application check the device with regard to possible
damages and operational capability!
Do not open the device! Risk of electric shock! Arbitrary opening, repairing or
modifying of the device absolves us from any liability regarding the operational
safety of the device and results in expiry of any claims whatsoever during the
period of warranty
Mobile HF communication devices such as mobile phones can influence electrical
medical equipment! Do not operate such communication devices close to electrical
medical devices!
Using non-compatible foreign auxiliaries can result in the patient and/or the
operator being endangered or injured!
Ensure sufficient aeration at the vents on the rear of the device. Insufficient
aeration results in damage or malfunction!
Pay attention to the permissible environmental conditions!
Utilizing or operating the device in non-conformance to these operating
instructions can injure the patient and /or the operating personnel and damage the
pump!
Position the pump out of the reach of the patient on a secure support.
Do not operatet the device in harzardous areas. Using ignitable anesthetic gas in
the near vicinity of the pump increases the risk of explosion.
The device must be disconnected from the mains prior to any kind of maintenance,
cleaning and disinfection procedures. The external surfaces of the pump can be
cleaned with a disinfectant and cleaning agent that preserves the paint. Attention
must be paid that no liquid enters the device!
Where possible, the pump should be placed at the level of the surgical area for a
precise pressure measurement!
In case of failure (e.g. overvoltage) a replacement device or an alternative
supply is to keep ready.
Avoid contact with moving parts.
All Tube sets are singel use products and must not be reused
Damaged or defective hose systems are no longer to be used and replaced
immediately!
!
!
!
!
OPERATING INSTRUCTIONS
Arthroscopy Pump P2

4
4. Connection and Start-Up of Device
All components should again be checked visually for any signs of damage before connecting
the device and starting it up.
The sequence shown below must always be observed for connection and start-up.
!
A damaged packaging can lead to unsterile or damaged parts. Damaged parts and
parts from damaged sterile packaging must not be used and replaced immediately!
OPERATING INSTRUCTIONS
Arthroscopy Pump P2
Please follow the steps described below:
Switch off power switch [1] at the front panel of the pump (position 0)
Insert the mains power cable [23] into the connector [18] at the back of the device,
now connect to mains.
Establish equipotential bonding [17] (where required, by skilled personnel)
Switch on power switch [1] at the front of the pump (position I) and check the
operational controls for correct functioning.
4.1. Inserting the Tube-Set and the Complete-Set for Arthroscopy
(art. no. 900154, 900155, 900209 and )art. no. 900210
If applicable, open locking lever [15] by turning it clockwise
If applicable, fold in the clamping bracket [14] anticlockwise
Remove tube-set (art. no. 900154 or art. no. 900155) from the sterile packaging
Insert the Luer connection of the pressure transducer [27] into the cone of the pressure
transducer retainer [11]. If necessary solve the locking tab [13] by pressing the release
button [12], then close the locking tab [13] completely.
Insert the black tapper of the tube from below into the therefore provided opening
(marked with a black dot) of the tube holder [16]
Place the tube in the middle round the pump roller and then pull it downwards through
the opening marked white
Let the tube relax and slide the white tapper from below into the therefore provided
opening
Check the position of the tube (the tube must be in the middle of the clamp roller)
and, if required, correct the position of the tube in the area of the pump rollers.
Fold in the clamping bracket [14] clockwise
Turn the locking lever [15] anticlockwise until it clicks into place in the clamping bracket
[14]
Press the patient end of the day's tube-set or the complete-set into the notch on the
side of the pressure transducer retainer [11]
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