OP Blender All EN REV06 A5
OP Blender All EN REV06 A5
OP Blender All EN REV06 A5
maintenance instructions
Model 1085_15:
© Copyright notice
This document is the exclusive property of medin Medical Innovations GmbH. No part of
this document may be copied or otherwise reproduced or stored in any form on electronic
media without prior written consent of the company, except in the case of express
authorisation from the company. Contact the manufacturer for further information.
This document is valid until it is changed or revoked by the manufacturer and it must be
available until the end of the lifespan of the product.
Classification
Warranty
With this warranty, the manufacturer guarantees, for a period of 24 months, that this product has no material and
processing defects at the time of initial purchase. If the product should have any defects during the period of the
warranty (at the time of the initial purchase) based on material or workmanship, the manufacturer or his authori sed
sales and service partner will repair the product at no charge for labour or material costs under the following conditions,
or (at the manufacturer's discretion) will replace the product itself or its defective parts. The manufacturer and his
authorised sales and service partner may replace defective products or parts with new or reconditioned products or
parts. All replaced products and parts become the property of the manufacturer.
Conditions:
1. Warranty claims can only be made if the model name or the serial number on the product has not been
changed, effaced, removed, or made illegible.
2. This warranty does not cover the costs for transporting the product to the manufacturer or its authorised
sales and service partner, or any risks associated with the transport.
3. This warranty does not cover:
- regular maintenance and repair or replacement of parts due to normal wear and tear
- consumables (components which could be expected to need regular replacement over the course of the
life of the product)
- damage or defects caused by use, operation or handling of the product not in accordance with the
intended use specified in the instructions for use
- damage or changes to the product caused by:
a) improper use
b) improper installation
c) improper cleaning
d) failure to follow the manufacturer's instructions for use and installation
e) failure to follow the manufacturer's care and maintenance instructions
f) connecting or using the product in a manner that is contrary to the applicable technical
or safety regulations or to the standards of the country in which the product is used
g) use of the product in systems or under conditions which are not intended for use with
the product
h) use of the product with accessories, accessory devices and other products which
differ in nature, condition or standard from those authorised by the manufacturer
i) repairs or attempts at repair made by persons not authorised by the manufacturer
j) adaptations or changes without prior written agreement of the manufacturer
k) product upgrades beyond the specifications or features described in the instructions
for use
l) modifications to the product to adapt it to national or local technical or safety
standards in countries other than those for which the product was specially
manufactured
m) neglect
n) accidents, fire, liquids, chemicals, other substances, flooding, vibrations, excessive
heat, insufficient ventilation, sudden power spikes, overly high or inverse voltage or
input voltage, radiation, electrostatic discharges (including lightening strikes, other
external forces and impacts).
Table of Contents
1. Product Description ........................................................................................................6
1.1. Description...........................................................................................................6
1.2. Intended Use .......................................................................................................6
2. Product Specifications ....................................................................................................7
2.1. Operating Ranges ................................................................................................7
2.2. Controls ...............................................................................................................7
2.3. Monitoring ............................................................................................................7
2.4. Alarms .................................................................................................................7
2.5. Pneumatic Supply ................................................................................................7
2.5.1. Gas discharge to the patient: ..........................................................................7
2.5.2. Gas supply inlet ..............................................................................................7
2.6. Operating Conditions ...........................................................................................7
2.7. Dimensions and Weight .......................................................................................7
2.7.1. Model 1090 .....................................................................................................7
2.7.2. Model 1085_15 ...............................................................................................7
2.7.3. Model 1085_easy (can only be used as a replacement part) ...........................8
2.8. Connection Options .............................................................................................8
2.9. Number List .........................................................................................................8
2.10. Accessories .........................................................................................................9
3. Unpacking and Set-Up ................................................................................................. 10
3.1. Mounting on a 10 mm x 25 mm rail .................................................................... 10
3.2. Mounting 1085_15 with Bubble Water Column (2040) ........................................ 10
3.3. Gas Supply Connection ..................................................................................... 10
3.4. Patient Circuit Connections ................................................................................ 10
3.5. Serial Number .................................................................................................... 10
4. Operation ..................................................................................................................... 11
4.1. Model 1090 ........................................................................................................ 11
4.1.1. FiO2 Concentration ....................................................................................... 11
4.1.2. Flow.............................................................................................................. 11
4.1.3. Important Note .............................................................................................. 11
4.2. Model 1085_15 .................................................................................................. 12
4.2.1. FiO2 Concentration ....................................................................................... 12
4.2.2. Flow.............................................................................................................. 12
4.2.3. Important Note .............................................................................................. 12
4.3. Model 1085_15 in combination with Bubble Water Column (2040)...................... 13
4.3.1. FiO2 Concentration ....................................................................................... 13
4.3.2. Flow.............................................................................................................. 13
4.3.3. CPAP ........................................................................................................... 13
4.3.4. Overpressure Valve ...................................................................................... 13
4.3.5. Important Note .............................................................................................. 13
5. Alarm Functions and Displays ...................................................................................... 14
5.1. Acoustic alarm in cases of.................................................................................. 14
5.2. If an alarm sounds, check if ................................................................................ 14
5.3. Alarm Specification: ........................................................................................... 14
6. Explanations................................................................................................................. 15
6.1. Explanation of the Symbols ................................................................................ 15
6.2. List of Abbreviations ........................................................................................... 15
7. Cleaning and Maintenance ........................................................................................... 16
7.1. Cleaning ............................................................................................................ 16
7.2. Maintenance ...................................................................................................... 16
8. Maintenance Record/Device Passport (1090) ............................................................... 17
9. Maintenance Record/Device Passport (1085_15) ......................................................... 18
10. History of changes........................................................................................................ 19
Note
Please read these instructions carefully before using the device.
Please keep the original packaging in the event the device needs to be returned.
Please make a note of the serial number on the identification plate on the backside of the
gas mixer (1090) for your records. Please be aware that the serial number of the easy
medinBLENDER (1085_15) can be found on the bottom, and that the Bubble System
does not have any serial number.
Warning:
Do not use any oil or lubricant on or near the oxygen equipment
Do not place any containers with liquids on the device
Oxygen may only be supplied via the connection provided
The oxygen supply must be monitored
The settings can be changed without being noticed.
Important note:
Only trained hospital staff are authorised to use the gas mixer on patients.
For hospital use only!
1. Product Description
1.1. Description
The medinBLENDER is an air and oxygen mixer with an integrated flow regulator.
It has an acoustic alarm unit and a safety warning system in the case of low gas
pressure.
Normal operating pressure of the mixer is 3.5-6.0 bar (350kPa to 600kPa).
In the case of reduced inlet pressure of one of the gases, the mixer automatically reduces
the pressure of the other gas, as long as the difference between the two gases is not
more than 100 kPa (1 bar).
In addition, the mixer has a 'bleed flow'. This function ensures that the adjusted
concentration is immediately available. The 'bleed flow' is normally 7 l/min.
The flow regulator with a needle valve is available in various designs (adjustable from 0 -
15 l/min).
In case of medinBLENDER 1090 you can find two flowmeters (0 – 15 l/min and 0 – 3,5
l/min). The small flowmeter is combined with a bleed of 3 l/min.
WARNING:
If the difference between the gas pressures of the two gases is more than 1 bar, an
internal valve opens in order to compensate for the lower gas supply. This will trigger an
acoustic alarm. As of this point in time, the mixer loses its function and the oxygen
content of the gas mixture becomes uncontrollable.
Important note:
To ensure a sufficiently high flow of the breathing gas, the mixer must be properly
connected to full gas cylinders (O2 and air) or a central gas supply.
Important note:
- The gas supply must be controlled and monitored.
- When gas bottles are used: set initial pressure regulator to a pressure between
3.5 and 6.0 bar.
- When connected to a central gas supply system, the pressure must be
constant and demonstrate fluctuations of max. 1 bar.
The gas supply must consist of clean, dry, and oil-free medical compressed air and
medical oxygen. The supply pressure must be between 3.5 and 6 bar. The pressure
difference may not be more than 1 bar. In the case of a higher pressure difference, an
acoustic alarm is triggered.
2. Product Specifications
The product specification is based on your specific product.
2.2. Controls
Knob to operate mixer (oxygen concentration)
Knob to operate flow regulator
Push-rotate for opening and closing the bleed (flowmeter 0 – 3,5 l/min)
2.3. Monitoring
Oxygen supply pressure
Air supply pressure
2.4. Alarms
Alarm in the event of low air supply pressure
Alarm in the event of low oxygen supply pressure
Alarm in the event of a difference in pressure between oxygen and air that is
greater than 1 bar
The volume of the alarm is 45dbA - 85dbA, depending on the flow
Description REF
medinBLENDER 1090
medinEASY BLENDER (without flowmeter - 1085_easy
replacement part)
medinBLENDER with 15 L flowmeter 1085_15
Outlet converter (F15 mm, M22) optional 51091
Tapped connector (4-7 mm internal diameter tube) 1244-3DW
Bracket for mounting to a rail (10 x 25 mm) - 5005
1085_15
Bracket for mounting to a rail (10 x 25 mm) - 1090 2013B
Bracket for mounting to a pole – 1090 2013BFEU
dual pole clamp 20CL02
Fastening screw for fastening the bracket to a rail 5007-2
various versions
Gas supply tubes
available
Table 1: Order numbers
2.10. Accessories
Description REF
Medijet® – Active CPAP Generator 1000 (single-use)
1010/ 1020 re-use
Miniflow® – CPAP Generator 4000
Prongs (7 sizes available) various
Masks (4 sizes available) various
Patient tube kit (with and without humidifier 1207/ 1207MKI
chamber) – heated, single-use for Medijet®
Patient tube kit (with and without humidifier 206746, 206748
chamber) – heated, single-use for Miniflow® in
combination with 2040
Patient tube kit – re-use Various
Surge tank 1050
Bubble water column 2040
Table 2: Accessory order numbers
Warning:
It must be ensured that the alarm opening (on the back of the device) is never closed and
that the device is placed such that the alarm opening remains unobstructed!
This is ensured when the original bracket for rail or pole mounting is used.
4. Operation
% O2
adjustment knob °
FiO2
Warning:
The medinBLENDER 1085 may be used for CPAP therapy only in combination with the
surge tank (REF 1050) and the Medijet®. Feedback regarding the CPAP pressure
generated can only be obtained with this combination.
Flowmeter
(V) Mixer
Adjustment °
knob for
amount of outgoing flow
(0-15 l/min)
% O2 display
% O2
° adjustment knob
(V) flow outlet FiO2
Warning:
The system may only be used with an overpressure valve. This is provided in the
shipment.
6. Explanations
Source/ Source/
Symbol Meaning Symbol Meaning
Compliance Compliance
MDD
EN 980:2008 Manufacturer Regulation CE mark
93/42/EEC
Year of
EN 980:2008 EN 980:2008 Serial number
manufacture
Maintenance Follow
In-house interval ISO 60601-1 instructions
sticker for use
EN 980:2008
Reference
number
Table 3: Symbols
7.1. Cleaning
Disinfect the surface of the mixer before using it for the first time, after every use on a
patient, and after any maintenance/repair.
A 70% isopropyl alcohol solution can be used.
Warning:
The mixer must never be sterilised or immersed in cleaning fluid.
7.2. Maintenance
Every 12 months:
The manufacturer recommends a complete operational test of the mixer every 12 months
in order to check the accuracy of the mixing process. In doing so, the function of the lip
valve which prevents reverse gas flow must be checked. For the testing, the gas supply is
connected at the outlet and it is checked whether there is any gas leaking at the two
bases (actual gas supply connection).
At this point in time the mixer should also be checked corresponding to the requirements
of the device passport.
If the mixer demonstrates any damage, repairs are necessary.
Important Instructions:
During the operational test or maintenance procedure, the mixer must not be connected
to the patient.
Check the accuracy of the mixing procedure as well as the function of the alarms at least
once per year.
Fill out the device passport after each maintenance procedure.
If the device should have any cracks or leaks in the plastic parts, the mixer should not be
used any further, since the measurement values could be distorted and inexact.
Contact the manufacturer and/or the sales and service partner responsible for your
country.
Every 3 years:
It is additionally recommended that all filters, the lip valves and O-rings that move
frequently be replaced every three years. These parts can be ordered as replacement
parts under REF 9060.
A full operational test must be performed thereafter corresponding to the requirements of
the device passport.
Device Passport
Test equipment:
Test settings:
Alarm test:
Flowmeter check:
Operating range 0 – 3,5/15 LPM Ball can move up/ down ok / nok
Blender Check:
Sign:
Production:
Device Passport
Test settings:
Alarm test:
Flowmeter check:
Operating range 0 – max. LPM Ball can move up/ down ok / nok
Blender Check:
Sign:
Production:
Final check:
Notes: