Intermed blender operation manual

Operation Manual

Intermed and Inter names and logos are trademarks

proprietary to Intermed Equipamento Médico Hospitalar Ltda.

São Paulo – Brazil © 2002

Operation Manual Code 806.00230 – Revision 001

Blender Intermed

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.

!

Presentation


Blender Intermed

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: [email protected]

Milton Rubens Salles

Commercial Manager Legally Liable Person

Engineer Jorge Bonassa

Technical Manager Technician in Charge

CREA 137.189/D

Introduction 7


Blender Intermed

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

Introduction 8


Blender Intermed

Chapter 1: Introduction

In this chapter:

� Description � Working Principle

Always use the Operation Manual as

reference

Introduction 9


Blender Intermed

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/cm

2.

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/cm

2, 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


Blender Intermed

Chapter 2: Precautions and Notes

In this chapter:

� Precautions � Caution � Warning � Notes

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.

Always refer to the Operation Manual regarding the risks

and cares associated to the

equipment.

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Blender Intermed

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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Blender Intermed

� 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.

!

Chapter 3 – Controls and Alarms 13


Blender Intermed

Chapter 3: Controls and Alarms

In this chapter:

� Front portion � Control � Alarm

It is important to be familiar with

equipment control.



Blender Intermed

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



Blender Intermed

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/cm

2.

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.

!

Chapter 4 - Assembly 16


Blender Intermed

Chapter 4: Assembly

In this chapter:

� Assembly

WARNING:

The assembly / installation of this equipment must be completed according to the instructions in Operation Manual of the equipment

The assembly of the blender must comply with the instructions

in this manual.

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Chapter 4 - Assembly 17


Blender Intermed

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.

!

Chapter 5 – Operation 18


Blender Intermed

Chapter 5: Operation

In this chapter:

� Operation

WARNING:

The operation of this equipment must be started according to the instructions in this Manual.

Follow the instructions

contained in this manual correctly

and obtain maximum equipment

performance.

!

Chapter 5 – Operation 19


Blender Intermed

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.

Chapter 6 – Troubleshooting 20


Blender Intermed

Chapter 6: Troubleshooting

In this chapter:

� 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

®.

Some problems may be solved by the operator himself.

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Chapter 6 – Troubleshooting 21


Blender Intermed

PROBLEM POSSIBLE CAUSE CORRECTIVE ACTION

Low gas pressure alarm on the

ventilator is on

(LO GAS)

Low air and/or oxygen supply pressure

1. Check if the gas input pressure from the blender is lower than 1.6 kgf/cm2. 2. Increase air and/or oxygen input pressure.

Chapter 7 – Cleaning 22


Blender Intermed

Chapter 7: Cleaning

In this chapter:

� 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).

!

The durability of the blender and patient safety depend on its proper use.

Chapter 7 – Cleaning 23


Blender Intermed

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


Blender Intermed

Chapter 8: Accessories and Parts

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.

!

Always use original accessories and

pieces.

Chapter 8 – Accessories and Parts 25


Blender Intermed

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


Blender Intermed

Chapter 9: Preventive Maintenance

In this chapter:

� Reverse Gas Flow Test � O2 Concentration Verification Test � Sound Alarm Activation Test � 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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Follow the preventive

maintenance plan correctly.



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WARNING:

ON A DAILY BASIS, or prior to each use, check hose connections. Adjust one of the regulating valves to 1.5 Kgf/cm

2 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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!



Blender Intermed

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;



Blender Intermed

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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Blender Intermed

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.

!



Blender Intermed

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.

!



Blender Intermed

Preventive Routine Maintenance

On a daily basis or prior to use: 1. Check hose connections;

2. Adjust one of the regulating valves to 1.5 Kgf/cm2 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.



Blender Intermed

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.

Chapter 10 – Technical Characteristics 34


Blender Intermed

Chapter 10: Technical Characteristics

In this chapter:

blender � Controls � Alarms � Dimensions � Accessories � Other characteristics

Always use the Operation Manual

as reference.



Blender Intermed

Blender

Air / O2 input pressure 2.0 to 5,0 kgf/cm2 (kPa x 100)

FIO2 21 to 100%

Flow 1 to 100 L/min

Bleed Flow 9 L/min

Precision + 3% (v/v)*

Alarm (sound) / bypass Air/O2 Whenever the difference between the air and O2 input pressures is higher than 1 kgf/cm

2 (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

Input Pressure (Air and O2) %O2

adjusted %O2

obtained Flow Range

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

Pressure) 60% 56.0% 1 to 62 L/min

5.25 Kgf/cm2 (1.5 * Nominal

Pressure) 60% 60.0% 1 to 140 L/min



Blender Intermed

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

Air Compressed Air in compliance with ISO 8573, NBR 12188 and RDC No. 50.

Oxygen Oxygen in compliance with ISO 8573, NBR 12188 and RDC No. 50.

Condensation Points: (Only for EC requirements)

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.

Chapter 11: Warranty 37


Blender Intermed

Chapter 11: Warranty

Intermed Equipamento Médico Hospitalar Ltda products are warranted against material and manufacturing defects and comply with the published characteristics. The warranty and the technical assistance are ensured by Intermed Equipamento Médico Hospitalar Ltda. nationwide, and in those countries where there is an 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.

Read the terms of the warranty

carefully . In case of doubts or

problems, always request help from

Intermed Authorized Service.

Attachment A: Simbology and Terminology 38


Blender Intermed

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) Symbol No. 1

FRAGILE: The content of the package is fragile, therefore it must be handled carefully.

ISO 780:1997(E)

Symbol No. 3

THIS SIDE UP. Indicates the upper side of the package.

ISO 780:1997(E)

Symbol No. 4

PROTECT FROM SUNLIGHT. Package must be kept protected from sunlight.


PROTECT AGAINST RAIN. Package must be kept protected from rain.

ISO 780:1997(E) Symbol No.14

MAXIMUM STACKING HEIGHT. Indicates the maximum number of identical packages that may be overlapped.


TEMPERATURE LIMIT. Indicates the limit temperature for storage and handling of the package as load for transportation.

ISO 7000:1989 (E/F)

Symbol No. 0505

RELATIVE HUMIDITY. Indicates the limit humidity for storage and handling of the package as load for transportation.

BS EN 980:2008 Symbol 4.6

MANUFACTURING DATE: Indicates the manufacturing date of the equipment.

BS EN 980:2008 Symbol 5.2

MANUFACTURER: Indicates the manufacturer of the equipment.

3

Attachment A: Simbology and Terminology 39


Blender Intermed

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.

Attachment B: Schematic Flow Chart 40


Blender Intermed

Attachment B: Schematic Flow Chart

1st STAGE:

BALANCER

2nd

STAGE: BALANCER

BYPASS (ALARM)

PROPORTIONAL VALVE

O2 INLET

SOUND ALARM

AIR INLET

BLEED OUTLET

AIR+O2 BLEND OUTLET

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: [email protected]

Intermed blender operation manual

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