Operation Manual

Intermed and Inter names and logos are trademarks

proprietary to Intermed Equipamento Médico Hospitalar Ltda.

São Paulo – Brazil © 2002

 Operation Manual

Blender
Air / O2 Blender

CAUTION:

! Please read this manual fully before using the Blender.

This equipment may be changed without prior notice to the user.

Operation Manual Blender

Code 806.00230 – Revision 001 Intermed
 Presentation

Presentation
Product Identification
This Operation Manual presents the required information for the proper use of the
Intermed-brand air / oxygen blender, Blender model

Trade Name: Blender

Technical Name: Air / Oxygen Blender

Technician in Charge: Engineer Jorge Bonassa – CREA [Regional

Council of Engineering, Architecture and Agronomy] 137.189/D

Legally Liable Person: Milton Rubens Salles

Manufacturer:
Intermed Equipamento Médico Hospitalar Ltda.
CNPJ [National Registry of Legal Entities]: 49.520.521/0001-69 – I.E.
[State Enrollment No.]: 278.082.665-115
Rua Santa Mônica, 980 – Parque Industrial San José
Cotia/SP – Brazil
Phone: +55 (11) 4615-9300 / Fax: +55 (11) 4615-9310
website: www.intermed.com.br
email: contato@intermed.com.br

Milton Rubens Salles Engineer Jorge Bonassa

Commercial Manager Technical Manager
Legally Liable Person Technician in Charge
CREA 137.189/D

Operation Manual Blender

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 Introduction 7

Table of Contents

Chapter 1: Introduction ............................................................... 8

Chapter 2: Precautions and Notes ........................................... 10

Chapter 3: Controls and Alarms ............................................... 13

Chapter 4: Assembly ................................................................. 16

Chapter 5: Operation ................................................................. 18

Chapter 6: Troubleshooting ...................................................... 20

Chapter 7: Cleaning ................................................................... 22

Chapter 8: Accessories and Parts ............................................ 24

Chapter 9: Preventive Maintenance.......................................... 26

Chapter 10: Technical Characteristics ..................................... 34

Chapter 11: Warranty ................................................................. 37

Attachment A: Symbology and Terminology ........................... 38

Attachment B: Schematic Flow Chart ...................................... 40

Operation Manual Blender

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 Introduction 8

Chapter 1: Introduction

In this chapter:

Description
Always use the
Working Principle
Operation Manual as
reference

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 Introduction 9

Description
Blender is an air / oxygen blender which features a sound alarm and
a safety system to prevent low pressure of one of the gases.

Working Principle
The nominal gas input working pressure of the blender is 3.5
kgf/cm2.

When the input pressure of only one of the gases (air or oxygen) is
reduced, the blender automatically reduces the pressure of the other
gas internally, provided the difference between input pressures is not
higher than 1 kgf/cm2.

NOTE:

! The blender meets the reverse gas flow requirements set forth by
clause 6 of ISO 11195:1995.

The manufacturing of the equipment parts as well as its assembly

are based on processes that do not use grease or petroleum
products.

WARNING:

! If the difference in input pressure between the gases is higher than 1

kgf/cm2, an internal valve is opened in order to maintain the supply of
gas to the ventilator, by means of the higher pressure,
interconnecting the air and oxygen input ways and activating the
sound alarm.

At such moment, the blender stops working, and the percentage of

oxygen in the blend will depend on input pressures of each gas.

In order to meet elevated inspiratory flows, the blender must be

appropriately connected to the ventilator.

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 Chapter 2 – Precautions and Notes 10

Chapter 2: Precautions and Notes

In this chapter:

Precautions

Caution

Warning
Always refer to the
Operation Manual
Notes
regarding the risks
and cares
associated to the
equipment. You must read the entire Operation Manual before using the
blender.

The improper use of the equipment without full knowledge of its

characteristics and functions can lead to risks to the operator, the
patient and to the equipment itself.

The paragraphs preceded by the following words must be carefully

read:

! CAUTION: Indicates conditions that may adversely affect the

operator or the patient.

WARNING: Indicates conditions that may affect and/or damage the

equipment or its accessories.

NOTE: Indicates an additional information for better understanding

of the operation of the equipment.

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 Chapter 2 – Precautions and Notes 11

CAUTION:

!
In case of replacement, always use ORIGINAL ACCESSORIES,

PIECES AND PARTS, at the risk of compromising equipment
performance, patient and/or user safety, and the validity of the
warranty.

DO NOT DISASSEMBLE the equipment. In case of problems or

®
difficulties, always contact Intermed .

Conduct the VERIFICATION TESTS set forth under Chapter 9 –

Preventive Maintenance, BEFORE THE PRODUCT IS USED FOR
THE FIRST TIME and at least ONCE A MONTH, or whenever there
are any DOUBTS about the operation of the equipment. In case any
problem is found during the TEST, discontinue the use of the
equipment and request the performance of corrective maintenance
by the Intermed® Technical Service.

Do not obstruct the alarm pores, located on the rear portion, nor the
purge located on the bottom portion of the blender. Use regulating
valves which are periodically calibrated and reviewed.

The blender must be cleaned before it is used for the first time, using
isopropyl alcohol 70% (cleaning must also occur before and after
use).

The equipment must be DISCONNECTED FROM THE PATIENT

when the Verification Tests are conducted.

Any equipment that is not operating ACCORDING TO THE

SPECIFICATIONS MENTIONED IN THE MANUAL MUST NOT BE
USED. Please contact Intermed®.

WARNING:

!
NEVER sterilize the blender. Its internal components are not

compatible with sterilization techniques.

FOLLOW the equipment cleaning and component sterilization

instructions CORRECTLY.

Blender maintenance must be performed by INTERMED®

Technical Service.

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 Chapter 2 – Precautions and Notes 12

The operation of this equipment must be started according to the

instructions in this Manual.

Whenever the operator notices a problem he/she is not able to

®
solve, discontinue the use of the equipment and contact Intermed .

NEVER sterilize or put the blender into liquid solutions. Its internal
components are not compatible with sterilization techniques.

The hoses (for input gases) supplied as accessory comply with

NBR 11906.

The hoses supplied as accessories for European Community

comply with ISO 5359.

Use a gas analyzer in compliance with ISO 7767 whenever the

equipment is in use;

Every 12 months, the equipment must be subjected to verification

by the Intermed Authorized Technical Service.

NOTES:

!
For the appropriate operation of the sound alarm, place the

equipment on the pedestal support and make sure there is no
obstruction to the alarm system vent on the rear portion of the
equipment.

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 Chapter 3 – Controls and Alarms 13

Chapter 3: Controls and Alarms

In this chapter:

Front portion
It is important to
be familiar with

Control
equipment control.
Alarm

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 Chapter 3 – Controls and Alarms 14

Front portion

Figure 3-1. The control knob of the Blender is located on its front
portion.

Control

% OXYGEN
This control enables to adjust the % of oxygen to be used for patient
ventilation.

The scale is graduated from 21 to 100%, corresponding to the

minimum and maximum % of oxygen used for ventilation.

Figure 3-2. Blender knob

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 Chapter 3 – Controls and Alarms 15

Alarm

The blender features a sound alarm and a safety system in order to

prevent low pressure of one of the gases.

The blender nominal gas input working pressure is 3.5 kgf/cm2.

NOTE:

! For the appropriate operation of the sound alarm, place the

equipment on the pedestal support and make sure there is no
obstruction to the alarm system vent on the rear portion of the
equipment.

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 Chapter 4 - Assembly 16

Chapter 4: Assembly

In this chapter:

The assembly of the

blender must comply
Assembly
with the instructions
in this manual.

WARNING:

! The assembly / installation of this equipment must be completed

according to the instructions in Operation Manual of the equipment

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 Chapter 4 - Assembly 17

Assembly

Fit the blender on the pedestal of the ventilator, according to

equipment instructions.

Screw the air and O2 hoses (supply hoses) on the AIR INLET and
OXYGEN INLET connections, respectively.

Connect the blending hose to the AIR/O2 OUTLET connection on

the blender and on the ventilator.

Figure 4-1. Blender to be assembled on the pedestal of a ventilation

system.

CAUTION:

! Do not obstruct the alarm pores located on the rear portion, or the
purge located on the bottom portion of the blender.

Use regulating valves which are periodically calibrated and reviewed.

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 Chapter 5 – Operation 18

Chapter 5: Operation

Follow the
instructions
contained in this
In this chapter:
manual correctly
and obtain
maximum
Operation
equipment
performance.

WARNING:

! The operation of this equipment must be started according to the

instructions in this Manual.

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 Chapter 5 – Operation 19

Operation

Rotate blender’s knob from right to left to adjust the FiO2 used for
the ventilation (SCALE: 21-100% O2).

Figure 4-1. FiO2 adjustment.

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 Chapter 6 – Troubleshooting 20

Chapter 6: Troubleshooting

Some problems may

In this chapter:
be solved by the
operator himself.

Troubleshooting matrix

WARNING:

! Whenever the operator notices a problem he/she is not able to solve,

discontinue the use of the equipment and contact Intermed®.

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 Chapter 6 – Troubleshooting 21

PROBLEM POSSIBLE CAUSE CORRECTIVE ACTION

1. Check if the gas input

Low gas pressure
pressure from the blender is
alarm on the
Low air and/or oxygen lower than 1.6 kgf/cm2.
ventilator is on
supply pressure 2. Increase air and/or oxygen
input pressure.
(LO GAS)

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 Chapter 7 – Cleaning 22

Chapter 7: Cleaning

The durability of
the blender and
In this chapter:
patient safety
depend on its
proper use.

Blender

CAUTION:

! The blender must be cleaned before it is used for the first time using
isopropyl alcohol 70% (cleaning must also occur before and after the
use).

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 Chapter 7 – Cleaning 23

WARNING:

! NEVER sterilize or place the blender into liquid solutions. Its internal
components are not compatible with sterilization techniques.

Sterilizing agents which contain phenol, ammonium chloride,

dimethyl and glutaraldehyde solutions at concentrations higher than
2% may deteriorate the plastic components.

NEVER use abrasive products on the surface of the blender.

NEVER allow liquids to penetrate into the internal portion of the
blender.

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 Chapter 8 – Accessories and Parts 24

Chapter 8: Accessories and Parts

Always use original

accessories and
pieces. In this chapter

Accessories and Parts

CAUTION:

In case of replacement, always use ORIGINAL ACCESSORIES,

! AND PARTS, at the risk of compromising equipment performance,

patient and/or user safety, and the validity of the warranty.

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 Chapter 8 – Accessories and Parts 25

Blender Accessories and Parts

CODE DESCRIPTION

130.01400 MICROBLENDER AIR/O2 - HIGH FLOW

131.00950 MICROBLENDER AIR/O2-HF COMPLETE

CODE ACESSORIES

130.01420 AIR HOSE – 4 METERS

138.01000 AIR REGULATING VALVE

138.02000 O2 REGULATING VALVE

408.00002 BLENDER O2 HOSE – F/F 4 M

408.00003 BLENDER AIR HOSE – F/F 4 M

WARNING:

! The hoses (for input gases) supplied as accessories comply with

NBR 11906.

The hoses supplied as accessories for European Community comply

with ISO 5359.

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 Chapter 9 – Preventive Maintenance 26

Chapter 9: Preventive Maintenance

In this chapter:

Reverse Gas Flow Test

Follow the
preventive
O2 Concentration Verification Test
maintenance plan
Sound Alarm Activation Test
correctly.

Flow and Pressure Verification Test

WARNING:

! In order to avoid early wear of the equipment and to obtain a safe

performance within the required specifications, the following must be
conducted:

Routine Preventive Maintenance

It must be conducted on a DAILY BASIS, or prior to each use,
according to the instructions in this chapter.

Verification Tests
They must be conducted at least ONCE A MONTH or whenever
there are doubts regarding the operation of the equipment.

Annual Preventive Maintenance – APM

Request, on an YEARLY BASIS, the verification, adjustment and
calibration of the equipment, performed by Intermed®.

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 Chapter 9 – Preventive Maintenance 27

WARNING:

! ON A DAILY BASIS, or prior to each use, check hose connections.

2
Adjust one of the regulating valves to 1.5 Kgf/cm and check if the
sound alarm of the Blender is activated.

CAUTION

!
The equipment must be DISCONNECTED FROM THE PATIENT for

the performance of the VERIFICATION TESTS.

Any equipment that is not operating ACCORDING TO THE

SPECIFICATIONS MENTIONED IN THE MANUAL MUST NOT BE
®
USED. Please contact Intermed .

NEVER RELY on equipment maintenances conducted by

UNAUTORIZED PERSONNEL. In case of problems or difficulties,
contact Intermed®.

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 Chapter 9 – Preventive Maintenance 28

Reverse Gas Flow Test

The reverse gas flow test is conducted in order to check the
occurrence of leaks in the compressed air branch.

1. Disconnect the oxygen hose from the gas supply source;

2. Connect a flow meter to the equipment oxygen inlet;
3. Gradually increase the compressed air input pressure in the
interval from 2.0 to 5.0 Kgf/cm2 (kPax100), making sure that the
flow that is read in the flow meter is not above 100 ml/min;
4. In case of leakages higher than 100 ml/min, contact the
Authorized Technical Service for the replacement of the one-way
valve of the oxygen branch;
5. Repeat the steps above to check the occurrence of leaks in the
compressed air branch;

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 Chapter 9 – Preventive Maintenance 29

O2 Concentration Verification Test

The O2 concentration verification test is conducted to check the

concentration that is supplied to the patient.

1. Make sure that the equipment inlets are connected to the

respective input gas hoses and that they are correctly adjusted to
3.5 Kgf/cm2 (kPa x 100);
2. Connect a serial flow meter with an oximeter (both with a 1-100
l/min range) between the blender output and the hose
interconnecting it to the ventilator;
3. Adjust a 10 l/min output flow and read the O2 concentration in the
oximeter.

WARNING:

! Use a gas analyzer in compliance with ISO 7767 whenever the

equipment is in use;

The gas blend concentration must be checked regarding the

adjusted values while the equipment is DISCONNECTED from the
patient.

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 Chapter 9 – Preventive Maintenance 30

Sound Alarm Activation Test

The sound alarm activation test is conducted in order to check

whether it is working properly.

1. Make sure that the equipment inlets are duly connected to the
respective input gas hoses;
2. Gradually reduce the pressure in the compressed air supply inlet
until the difference between the air and oxygen input branches is
1.0 + 0.2 kgf/cm2;
3. Check if the sound alarm is activated, which indicates it is
working properly;
4. Then gradually increase the pressure in the compressed air
supply inlet, observing that the sound alarm turns off, until the
difference between them reaches 1.0 + 0.2 kgf/cm2 again;
5. In this situation the sound alarm must be activated again;
6. Repeat the same procedure, now changing the pressure in the
oxygen supply inlet;
7. In case the alarm does not work properly, contact Authorized
Technical Service;

WARNING:

! For the appropriate operation of the sound alarm, place the

equipment on the pedestal support and make sure there is no
obstruction to the alarm system vent on the rear portion of the
equipment.

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 Chapter 9 – Preventive Maintenance 31

Flow and Pressure Verification Test

The flow and pressure verification test is conducted to confirm the
measured values.

1. Make sure the equipment inlets are duly connected to the respective
input gas hoses;
2. Connect the outlet of the Blender to a Flow Meter (1-100 l/min range)
and a T-ramification on this same point to a Pressure Meter;
3. Operate the equipment normally and check the flow and pressure
values in the respective meters;

WARNING:

! Every 12 months, the equipment must be subjected to verification by

the Intermed Authorized Technical Service.

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 Chapter 9 – Preventive Maintenance 32

Preventive Routine Maintenance

On a daily basis or prior to use:

1. Check hose connections;

2
2. Adjust one of the regulating valves to 1.5 Kgf/cm and check if
the Blender sound alarm is activated.

Monthly:

Conduct the Verification Tests or request technical assistance from

Intermed®.

Yearly:

Submit the equipment or request Annual Preventive Maintenance –

APM, including the verification and adjustment of the equipment
through Intermed®.

Component disposal:

This equipment includes metallic parts that must not be disposed in

the environment.
Maintenance should only be conducted by Intermed®, which will adopt
all the required procedures for proper disposal.

Annual Preventive Maintenance – APM

Annual Preventive Maintenance – APM is an exclusive service
®
provided by Intermed in order to extend the life span of the
equipment and ensure its safe operation, in compliance with the
original specifications and the requirements of standard NBR IEC
601-1/1994.

The APM basically consists in the adjustment and verification of all

equipment functions and the replacement of defective parts which
may present normal wear and tear.
®
The verification and adjustment are performed by Intermed with
measurement equipment traceable to internationally acknowledged
metrological standards, which comply with the requirements of ISO
9001:2008 Quality System standard.

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 Chapter 9 – Preventive Maintenance 33

The APM must meet the following conditions:

®
1. The client must send the equipment to Intermed for the
performance of APM when it has been used for 12 months. In
®
case of doubts, contact Intermed .
®
2. APM must be performed within Intermed facilities, and the
client shall be responsible for the shipping;

3. When it is performed while the WARRANTY is effective, the

conditions set forth in Chapter 11 will be applicable.

4. APM is limited to the equipment, and does not include the

accessories.

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 Chapter 10 – Technical Characteristics 34

Chapter 10: Technical Characteristics

In this chapter:

blender
Always use the
Operation Manual
Controls
as reference.
Alarms

Dimensions

Accessories

Other characteristics

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 Chapter 10 – Technical Characteristics 35

Blender

2
Air / O2 input pressure 2.0 to 5,0 kgf/cm (kPa x 100)

FIO2 21 to 100%

Flow 1 to 100 L/min

Bleed Flow 9 L/min

Precision + 3% (v/v)*
Whenever the difference between the
Alarm (sound) / bypass Air/O2 air and O2 input pressures is higher
than 1 kgf/cm2 (kPa x 100)
Dimensions 7.6 x 3.8 x 7.4 cm

Weight 0.65 kg

*(v/v): Percentage in Volume. It expresses the oxygen volume per 100 units of air. Or,
in practical terms, it is equal to the percentage on the scale background (100).

Effects on the gas supplied in ranges between 0 to 1.5 times the input
pressure

%O2 %O2
Input Pressure (Air and O2) Flow Range
adjusted obtained

2.0 Kgf/cm2 (lower limit) 60% 56.8% 1 to 62 L/min

5.0 Kgf/cm2 (upper limit) 60% 60.2% 1 to 130 L/min

1.75 Kgf/cm2 (0.5 * Nominal 60% 56.0% 1 to 62 L/min

Pressure)
5.25 Kgf/cm2 (1.5 * Nominal 60% 60.0% 1 to 140 L/min
Pressure)

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 Chapter 10 – Technical Characteristics 36

Accessories

130.01420 AIR HOSE – 4 METERS

138.01000 AIR REGULATING VALVE

138.02000 O2 REGULATING VALVE

408.00002 BLENDER O2 HOSE – F/F 4 M

408.00003 BLENDER AIR HOSE – F/F 4 M

Composition and Characteristics of the Input Gases

Compressed Air in compliance with ISO 8573,

Air
NBR 12188 and RDC No. 50.

Oxygen in compliance with ISO 8573, NBR

Oxygen
Condensation Points:
(Only for EC requirements)
12188 and RDC No. 50.
The input points must remain at least at a
temperature 5.5 °C below the minimum
temperature to which the equipment may be
subjected.
The -3.9 °C temperature and the 6 kgf/cm2
pressure are equivalent to 2000 mg/m3.

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 Chapter 11: Warranty 37

Chapter 11: Warranty

Intermed Equipamento Médico Hospitalar Ltda products are

Read the terms of
the warranty warranted against material and manufacturing defects and comply
carefully . In case with the published characteristics. The warranty and the technical
of doubts or
problems, always assistance are ensured by Intermed Equipamento Médico Hospitalar
request help from
Intermed
Ltda. nationwide, and in those countries where there is an
Authorized Service. Authorized Service.

The responsibility for the warranty is limited to replacement, repair

and labor, at the manufacturer’s discretion, for those parts that are
defective or that do not meet the published characteristics while the
warranty is effective.

The warranty does not cover defects caused by accident, improper

use, improper conditions of use, installation or sterilization, service,
installation, operation or changes performed by unauthorized or
unskilled personnel.

Parts subjected to normal wear and tear, adverse use conditions,

improper use or accident are not covered by the WARRANTY.

The warranty is effective for 12 months for the equipment and for 60
days regarding the accessories, provided their original characteristics
are preserved; the effective term will start on the date the equipment
is delivered, or according to specific contractual conditions that may
have been agreed upon.

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 Attachment A: Simbology and Terminology 38

Attachment A: Symbology and Terminology

Simbology
1. The meaning of the standard symbols printed on equipment package is
presented below:
Symbol Standard Description
ISO 780:1997(E) FRAGILE: The content of the
Symbol package is fragile, therefore it must
No. 1 be handled carefully.

ISO 780:1997(E)
THIS SIDE UP. Indicates the upper
Symbol
side of the package.
No. 3

ISO 780:1997(E) PROTECT FROM SUNLIGHT.

Symbol Package must be kept protected
No. 4 from sunlight.

ISO 780:1997(E) PROTECT AGAINST RAIN.

Symbol Package must be kept protected
No. 6 from rain.

MAXIMUM STACKING HEIGHT.

ISO 780:1997(E)
Indicates the maximum number of
3 Symbol
identical packages that may be
No.14
overlapped.
TEMPERATURE LIMIT. Indicates
ISO 780:1997(E)
the limit temperature for storage and
Symbol
handling of the package as load for
No. 17
transportation.
RELATIVE HUMIDITY. Indicates the
ISO 7000:1989
limit humidity for storage and
(E/F)
handling of the package as load for
Symbol No. 0505
transportation.

MANUFACTURING DATE: Indicates

BS EN 980:2008
the manufacturing date of the
Symbol 4.6
equipment.

BS EN 980:2008 MANUFACTURER: Indicates the

Symbol 5.2 manufacturer of the equipment.

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 Attachment A: Simbology and Terminology 39

Terminology
The main terms used in this manual, defined by NBR-IEC 60601-
1/1994, are presented below:

1. ACCOMPANYING DOCUMENTS:
Documents accompanying the equipment or an accessory, which
contain all the important information for the user, operator, installer
or assembler of the equipment, mainly those related to safety.

Operation Manual Blender

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 Attachment B: Schematic Flow Chart 40

Attachment B: Schematic Flow Chart

1st STAGE: 2nd STAGE:

BALANCER BALANCER

PROPORTIONAL
VALVE

BYPASS
(ALARM)

BLEED OUTLET

AIR+O2 BLEND
OUTLET

O2 INLET AIR INLET

SOUND
ALARM

Operation Manual Blender

Code 806.00230 – Revision 001 Intermed
Intermed Equipamento Médico Hospitalar Ltda.
CNPJ: 49.520.521/0001-69 – I.E.: 278.082.665-115
Rua Santa Mônica, 980 – Parque Industrial San José
Cotia / SP – Brazil
Phone: +55 (11) 4615-9300 / Fax: +55 (11) 4615-9310
website: www.intermed.com.br
email: contato@intermed.com.br