DebritomTM - Medaxis AG

Transcription

DebritomTM
High-Pressure Micro Jet Device for Wound Care
Class IIb, MDD 93/42/EEC
Instructions for Use and Maintenance
Revison Date 05.01.2015 / 150105 IFU Debritom EN.ppt
1
Contents
Page
03
Description of product (device front view)
04
Description of product (device back view)
05
Product application
06
Instructions of operation
07
Accessories required
08
Set-up and Preparation Instructions
09
Inserting of the single use nozzle 'SUN Derma' 10
Treatment procedure
11
Medical Warnings with Use of the Device
12
Disinfection Procedure - Debritom and Handpiece 13
Trouble shooting
14
Maintenance and Service / Symbols for Labeling
15
Conditions of Use
16
Warranty conditions
17
Contact address
2
Description of product (device front view)
(1) 
(2) 
(3) 
(4) 
(5) 
(6) 
(7) 
(8) 
(9) 
Device housing
Footpedal
Connecting lead to foot pedal
Manometer for compressed air input lead
Regulator for high – pressure liquid outlet
Manometer for high – pressure liquid outlet
Luer-lock connection for operating liquids
Connecting hand-piece/High pressure liquid outlet
6
5
1
4
9
3
Hand-piece with high pressure tubing
2
8
7
3
Description of product (device back view)
(10) Connection for compressed air input
(11)
Connector for footpedal lead
17
(12) Outlet 1 Luer-lock connection for release bag
(13) Outlet 2 Luer-lock connection for release high pressure relief bag
(14) Voltage equipotential connection,yellow-green cable (earth)
(15) Serial and model numbers identification plate
(16) Counter
11
10
16
15
(17)  Suspension hooks for liquid container
12
14
13
4
Product application
The Debritom a portable high-pressure micro jet device is indicated for the cleaning, irrigating and debriding of wounds and other tissue
conditions. By placing liquid under high pressure, kinetic impact energy is put utilsed Indications, for the use of the Debritom:
Cleaning and debriding necrotic, dry or wet wounds that are not healing well for other reasons, for example with the following conditions:
•  Varicose ulcer (ischemic)
•  Gangrene,especially micro-angiopathy in diabetes
•  Pressure sores
•  Anal abscesses and fistulas
•  Varicose ulcer of the leg (arterial,vennous)
•  Cleaning and debriding 3rd degree skin burns.
•  Removal of foreign bodies from wounds,e.g.after e.g.after traffic accidents
Contraindications, for the use of the Debritom:
•  Malignant tumor types
•  Open injury to vessels, unprotected exposed vessels
•  Eyes, ears, nose
Warnings, with regard to the use device for the following conditions since they are associated with more risk:
•  Patients with increase tendency to hemorrhage •  Patients with arterial ulcers
•  Invasilely contaminated wounds
If treatment is indicated for the above listed conditions (listed under warnings), this treatment should be done under medical guidance and
supervision.
The contra-indications and the indications listed above were determined during clinical use. If additional contraindications or warnings with
regards to the use of the Debritom come to light to the provider, patients, medical staff and others affected will be duly informed. The use of the Debritom™ has been shown through clinical use to be safe and effective with the following recommended fluids: NaCl 0.9 %,
aqua ad injectabilia and Ringer’s solution.
5
Instructions of Operation
When the foot pedal (2) is actuated, compressed air flows from an external source of compressed air (compressed air supply or air compressor)
through the connecting tube (3) into the pump. The input pressure has to be between 5 and 7 bar in order to initiate operation.
SAFETY NOTE: In case the connection pressure (compressed air supply or air compressor) is exceeding 7 bar an inside high pressure safety
valve is automatically initiated, limiting the applied pressure to a maximum of 7 bar in order to protect the device and to ensure proper and safe
function of the Debritom. In the worst case of a though ineligable exceeded pressure (see pressure gauge of the external connection air '4')
please IMMEDIATELY release the foot pedal ('2') and direct the handpiece ('9') away from the treating area towards a safe position and
simultaneously reduce the working pressure by turning the regulator ('5') counterclockwise to zero. The foot pedal acts only as an on/off switch and does not affect the working pressure, which is set at the regulator for high-pressure liquid
outlet (5).
The liquid pump draws the operating liquid (e.g. NaCl 0.9 %) from the suspended container, takes it through the Luer-lock inlet (7), puts it under
pressure and through the high pressure tubing delivers it to the hand-piece with nozzle. The liquid leaves the nozzle at the head of the handpiece, under high-pressure, as a fine stream of liquid.
The handpiece with high pressure tubing is reusable.The nozzle is a single use sterile accessorie
The pressure of the liquid can be modified by the regulator for high-pressure liquid outlet (5) and is indicated by the manometer for highpressure liquid outlet (6). The Debritom™ has a positive safety protection: when the foot pedal (2) is released, the pressure on the whole hydraulic system is immediately
reduced to 0bar.The liquid left of 1-2 ml in the liquid circulation-system will be outcast through the outlet (12). The high –pressure liquid pump built into the Debritom is equipped with an intermediate atmospheric chamber between the high-pressure
hydraulic section and the compressed air drive section.This chamber also serve to prevent contamination between the drive pressure medium
and the working medium.
6
Required Accessories
Device accessories
• 
Source of compressed air, e.g. compressor, high-pressure gas cylinder, internal compressed air wall outlet.
• 
Stand for protection tent
Accessories material single use
• 
Sterile I.V.(intravenous)-liquid tubing with internal Luer-Lock connection
• 
Sterile release bag with two Luer-lock connections
• 
Single use nozzle sterile • 
Protection tent with stand
SAFETY NOTE: In case the sealing of the sterile packaged single use items is broken or damaged do not use its contents for sterile
applications anymore. Sterile packaged items may not be used anymore after expiring. In case of usage of pre-mentioned affected
items may cause unwanted risks and side effects such as – among others – microbiological hazards and complications linked
therewith.
Hospital single use materials
• 
For rinsing procedure, use e.g. NaCl 0,9% Ringer‘s Solution, disinfectant liquid, according to facility guidelines • 
Sterile compresses
• 
Disposable towels or drapes to absorb liquid flowing from wound during treatment
• 
Protective suit • 
Protective gloves • 
Mouth protection
• 
Disinfection liquid (product using for surcical divice) • 
Recommended: eye protection glasses and hair cap, if the procedure is performed without the tent.
7
Set-up and Preparation Instructions
Please Note: Device and handpiece might be filled up with 70% ethanol solution due to the rinsing procedure after last use of the
device (see also page 12)
• 
Set up the device in operation position • 
Connect the appropriate compressed air tubing trough the compressed air connection (10).Ensure the correct input lead
(4). • 
Connect the voltage equipotential connection (14).
• 
Connect connection duct to the foot pedal (3) and to the connector (11) (black to black, blue to blue).
• 
Connect the waste bag to the Luer-lock connections ((12) and (13)+T-part). Ensure that its positioning is
not higher than the device.
• 
Connect the operating solution through the sterile tubing to the Luer –lock connection (7).
• 
Open both the clamp of the connecting tube of the treatment solution (saline) and the flap of the air escape valve at the
opening spike.
• 
Sterilise the handpiece (9) internally prior to first use (see also Disinfection procedure)
• 
Connect the high pressure tubing with handpiece (9) to the connection (8)
• 
Set the working pressure at the manometer for high-pressure liquid outlet by turning the regulator for high-pressure
liquid (5).
• 
Start the pump by operating the foot pedal (2) and let operating solution flow continuously for 20 seconds out of the
hand-piece.
• 
Install the sterile single use nozzle while ensuring the sterility in the hand-piece (9) and screw after connecting correctly
the cap by using the instructions from Medaxis.
• 
Set up the the footpedal and control Waterjet of quality and intensity.
green = sterile condition Revison Date 05.01.2015 / 150105 IFU Debritom EN.ppt
8
Inserting of the single use nozzle 'SUN Derma'
(as of LOT 08/02) 1. Unscrew the nozzle cap
from the handpiece
The 'new' SUN Derma nozzle can be identified by the
additional red O-ring
2. Insert the nozzle with the red
centralizing ring first into the
cap until it stops
3. Please note that the black O-ring
is still visible after the insertion
of the nozzle 4. Screw the cap with the inserted
nozzle into the handpiece
9
Treatment Procedure
• 
• 
• 
• 
• 
• 
• 
• 
• 
Check status and condition of the patient and their pain tolerance to determine if a local anaesthetic (e.g. EMLA cream) needs
to be applied prior to procedure initiation. Lay the patient down in a comfortable position for a treatment time of approximately 20 minutes.
Install the protection tent.
Lay an absorbent disposable towel or drape under the part of body to be treated.
Get the patient accustomed to the waterjet by flowing with minimal pressure (50-100 bar) at a maximum distance on a intact
patient skin location.
Begin the treatment with minimal pressure (100bar) at a tangential angle and with minimal 25 cm distance to the area to be
treated.
Follow the wound rinsing procedure, followed by debridement according to the instructions you have received.
Move the waterjet in wiper movements
Make use of sterile compresses and drapes to absorb liquid and debris flowing from the wound during treatment. Training will be given to cover the important points with regards to waterjet pressure and the usability of the device in terms of
distance of the handpiece to the wound and efficiently using the waterjet. The training will be given by staff certified by
MEDAXIS.
10
Medical Warnings with Use of the Device
• 
Assessment of the indication of Debritom system treatment (warnings, contra-indications) are under the responsibility of the physician • 
Ensure the Debritom and non-sterile delivered accessories are properly cleaned, rinsed, disinfected and sterilised
according to facility guidelines prior and following use. Check that there are no deposits in tubing. • 
Ensure that single-use accessories are in sealed, sterile labelled packaging (not damage), otherwise replace • 
Never point the pressurised jet at any electrical sources (device, plug or any other electricial products)
• 
Never point the pressurised jet towards the eyes, ears and nose
• 
Keep the pressurised jet at 45°angle to the wound area. Never use jet at 90° angle.
• 
During treatment: check treatment liquid level and release bag to ensure no overflowing.
• 
Completion of treatment: close air supply and remove air supply connection; operate the foot pedal till manometer shows 0 bar. • 
All Debritom users are required to be trained by MEDAXIS. Revison Date 05.01.2015 / 150105 IFU Debritom EN.ppt
11
Disinfection Procedure - Debritom and Handpiece First use of Handpiece with high pressure Tubing •  The complete handpiece will be delivered as a non-sterile item. After first use you must autoclave the complete set (steam / 134°
for 18 minutes)
First use of Debritom (Device will be delivered filled with 70% ethanol solution)
•  Rinse device and handpiece with connected sterile solution for 20 seconds
•  Insert single use nozzle and start treatement
Use a clean handpiece after each patient
•  Remove single use nozzle and dispose of it
•  Remove handpiece with high-pressure tubing and put it into a disinfection solution (at the end of the day disinfect according to
step 4 on this page before using on next patient)
•  Disinfect the device and equipment on the outside with disinfecting solution
•  Use a completely disinfected (in- and outside according to step 4) or sterilised handpiece for you next patient
Disinfection at the end of the day
•  Remove single use nozzle and dispose of it
•  Remove sterile fluid and connect a syringe filled with 50ml 70% ethanol or disinfection liquid (concentration for
longterm disinfection, e.g. Microzid) and rinse device and handpiece at 100bar for 20 seconds. (Repeat this procedure or
each handpiece you used)
•  Leave the ethanol 70% or the disinfection solution in the unit until next day
•  Disinfect handpiece and tubing on the outside by putting it into a disinfection solution
•  As an alternative, you can autocalve the complete handpiece incl. Tubing (steam / 134° for 18 minutes)
•  Important: If you autoclave the handpiece, you must blow out all the disinfection solution inside the handpiece with
compressed air before doing so
12
Trouble shooting
If the nozzle does not work properly when the device is used, release the foot pedal (2), disengage the defect nozzle
out of the handpiece and put in a new single use nozzle sterile (aseptic). After screwing correctly the cap, continue
with the treatment.
If no liquid flows out of the handpiece (8)(9) by operating the footpedal (2), controll the liquid supply. Check the
following: no air in the liquid tubing; tubing is open and not bent; manometer for compressed air input lead (4) is in
red zone.
If air gets aspirated into the system by mistake (operating the system without having rinsing fluid connected), please
follow these steps:
Connect rinsing fluid as described before, remove the nozzle from the handpiece (see also page 9), and then operate
the foot pedal until fluid flow is steady (maximum operating pressure 100 bar) If liquid flows more or less continuously from outlets 12 ,13, this may indicate that the high-pressure seal on the
pump needs to be replaced. Return the device to the manufacturer or to the authorised service centre, stating the
serial number of the device. This number is to be found on the serial model number identification plate (16) on the
rear of the device.
If you hear a noise from the device that indicates a leakage of compressed air, cease operation and contact your
MEDAXIS service centre.
13
Maintenance and service
An annual check of the Debritom equipment is mandatory. Please contact Medaxis AG for further details of this service.
Symbols
for Labeling
14
Conditions of Use
MEDAXIS recommends compliance with the following conditions:
Transport and Storage
• 
Ambient temperature between – 20°C bis + 70°C.
• 
Relative humidity between 10% bis 100% including condensation.
• 
Atmospheric pressure between 500 hPa and 1060 hPa.
• 
Secure the packaging to prevent falling
Use
• 
Ambient temperature in the range +10°C to +40°C .
• 
Relative humidity in the range 30% to 75%.
• 
Atmospheric pressure in the range 700 hPa to 1060 hPa.
15
Warranty conditions
• 
• 
• 
• 
The Medaxis Device undergoes functional testing and system checks prior to delivery.
Guarantee period for the device is 12 months.
Not included for guarantee are the single use articles.
Guarantee is void
if the Debritom will be operated not according to IFU instructions (for example: insufficient rinsing) and if the
devise is used and manipulated by unauthorised persons.
Any damage caused by the voltage equipotential cable not being connected during operation is not covered
by this guarantee.
Important:
•  Never use device without any liquid •  Never leave any sterile fluids in the device after treatment
•  Always leave the ethanol 70% or the disinfection solution in the unit until next day or next treatment
•  Use disinfection fluids for surgical instruments and endoscopes
•  Always follow the instructions from disinfection solution company regarding concentration of solutions and
residence time
16
Contact address
Medaxis AG
Bahnhofstrasse 9
6340 Baar
Switzerland
Phone +41 62 823 88 00
Fax
+41 62 823 88 01
Email
[email protected]
Homepage
www.medaxis.ch In case of any malfunctions or defects, please communicate the serial number and model number shown on the
identification plate.
17

DebritomTM - Medaxis AG

Transcription

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