Stephan MedAir User manual

MedAir
Mobile Compressed Air Unit
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Operating and service Instructions
F. STEPHAN GmbH Medizintechnik D-56412 Gackenbach Kirchstr. 19 Tel. (06439) 9125-0 Fax (06439) 9125-111 info@stephan-gmbh.com www.stephan-gmbh.com
Preface
The present Operating and service Instructions are written to give the operator a clear and concise guide as to the operation and care of
the MedAirs mobile compressed-air unit, and
to answer any questions that might arise.
This manual does not contain any information as to repair and assembly of the system.
Should there arise any problems with the functioning of the system, please get in touch with the Technical Support team at F. Stephan GmbH, or the authorized dealer from whom you have received the equipment and received training in its use.
The manufacturer guarantees the safety and
reliability of the MedAirs, only when the
equipment is operated in compliance with the Operating Instructions.
F. Stephan GmbH
- Medizintechnik ­Kirchstraße 19
56412 Gackenbach, Germany
Technical data subject to change.
Status: February 2007
Version: V1.1

Table of Contents

Table of Contents
Table of Contents ..................................................................................................................................... 3
1. General Information....................................................................................................................... 4
1.1. Product combinations ................................................................................................................ 4
1.2. Equipment designation and manufacturer ................................................................................. 4
1.3. Designated application............................................................................................................... 4
1.4. Packaging and waste disposal................................................................................................... 4
1.5. Introduction ................................................................................................................................ 4
1.6. Abbreviations and technical terminology ................................................................................... 4
1.7. Technical Data ........................................................................................................................... 5
2. Safety Instructions ......................................................................................................................... 6
2.1. Danger warnings........................................................................................................................ 6
2.2. Caution warnings ....................................................................................................................... 6
3. Description of the Design and Functioning.................................................................................... 7
3.1. Front view................................................................................................................................... 7
3.2. Side view, left ............................................................................................................................. 8
3.3. Rear view ................................................................................................................................... 8
4. Preparing the Equipment for Operation......................................................................................... 9
4.1. Setting up the MedAir ................................................................................................................ 9
4.2. Connection to the mains power supply...................................................................................... 9
5. Operation ..................................................................................................................................... 10
6. Problems, Causes and Remedies ............................................................................................... 11
7. Care and Servicing ...................................................................................................................... 12
7.1. Cleaning ................................................................................................................................... 12
7.2. Safety technical inspections..................................................................................................... 12
7.3. Servicing .................................................................................................................................. 12
8. Accessories / Replacement Parts................................................................................................ 13
9. Warranty ...................................................................................................................................... 14
Operating Instructions MedAir, February 2007
1 General Information

1. General Information

1.1. Product combinations

F. Stephan GmbH will not consider any warranty claims in the event of use of unauthorized equipment combinations with products not licensed by the manufacturer or approved for compatibility.
Use only those accessories and replacement parts as found in Section
8 on page 13.

1.2. Equipment designation and manufacturer

Equipment designation: MedAir Article number: 1 610 61 000
Manufacturer:
F. Stephan GmbH
- Medizintechnik ­Kirchstraße 19 D – 56412 Gackenbach, Germany
+49 (0)6439 / 9125 – 0
Fax +49 (0)6439 / 9125 – 11
info@stephan-gmbh.com www.stephan-gmbh.com

1.3. Designated application

The MedAir generates compressed-air for use
in ventilating and anesthesia equipment that operate with an inlet pressure of 3 to 6 bar and producing compressed-air at 45 l/min. The quality of the medical compressed-air meets the requirements of DIN EN 12021
The MedAir is designed for use in dry areas
free from spray and dripping water. Moist or wet ambient conditions can greatly impair the functioning of the equipment.

1.4. Packaging and waste disposal

The packaging used to pack this system consists primarily of recyclable or reuseable materials.
The cardboard cartoning can be reused or disposed of as waste paper.
The immediate wrapping around the system is of CFC-free material. It can be disposed of along with the foil using the recyclable waste bin.

1.5. Introduction

The German Equipment Regulations (MPG), the Medical Products Operations Act (MPBetreibV) and the law governing technical materials stipulate that the attention of the user/operator must be drawn to the following points:
Operation of the equipment should be carried out only by trained and authorized personnel. A thorough knowledge of the Operating Instructions is a prerequisite for operating this equipment.
Carefully read and comply with the Operating Instructions. Flawless
functioning of the MedAir and the
safety of the patient and operator can only be guaranteed when these instructions are carefully observed.
Use the MedAir only for the purpose
as stipulated in these Operating Instructions.
Insufficient care and operating error can lead to operational failure and accidents.
The Operating Instructions must always be at hand where the equipment is being used.
Warranty claims arising from improper operation, insufficient servicing and maintenance shall not be acknowledged by the manufacturer.
The manufacturer guarantees the safety and
dependability of the MedAirs, only when it is
operated in accordance with the Operating Instructions.

1.6. Abbreviations and technical terminology

AIR medical quality compressed air

1.7. Technical Data

Ambient conditions
Operation: Temperature: 15 –40 °C
Operating pressure: max. 3.5 bar
Storage: Temperature: 15 – 40 °C
rel. humidity: 10 – 65 %
protect against moisture and humidity
store dust-free and free from frost
Electrical supply
Mains power: 230V / 50Hz
Power consumption: 250 W
Current consumtion: approx. 5A
Power output: 600 VA
1 General Information
Fuse protection: 3.15 AT
Noise level: 45 dB (A)
Operating pressure: 3.5 bar
Output flow: 0 – 45 l/min
General
Protection rating: I
Inspection / maintenance: annually or every 3500 operating hours
Dimensions (L x W x H): 500x510x1150
Weight: 50 kg
Operating position: up-right
Operating Instructions MedAir, February 2007
2 Safety Instructions

2. Safety Instructions

The folowing safety instructions will be repeated at all relevant sections of the Operating Instructions and must be complied with at all times.
Indicates a danger that, in the event of non-compliance, could lead to life-threatening injuries for the patient and/or the operator.
Indicates a caution that, in the event of non-compliance, could lead to malfunctioning of, damage to, or defects on the equipment, and possibly endanger the patient.

2.1. Danger warnings

The MedAir may be operated only
by trained and authorized personnel.
The MedAir must be operated in
accordance with these Operating Instructions.
The MedAir may not be operated in
areas exposed to a danger of explosion.
The equipment may not be operated without a micro-filter.
The air intake filter on the rear side may not be covered by any objects.
In order to ensure an optimal supply of fresh air and air circulation the equipment is only to be operated in an adequate sized room which is well-ventilated and preferably dust­free. Otherwise this can be seriously damaging to the equipment.

2.2. Caution warnings

For medical/technical equipment with electrical connection, DIN EN 60601-1 and VDE 0751-1 are to be complied with. Accordingly, such equipment may only be put into initial operation by the manufacturer or authorized technical support personnel.
3 Description of the Design and Functioning

3. Description of the Design and Functioning

The MedAir – compressor has dew point
reduction, grit filter, preliminary filter, bacterial filter and an additional condensation water extractor.
The MedAir is mobile, vibration and sound
insulated. A side rail, 25x10 mm, allows the mounting of additional equipment.
Monitoring and operation are via a control panel with mains power switch, operating hours counter, fuses and pressure gauge.

3.1. Front view

1. Power switch »ON/OFF«
2. Fuses 3.15 AT
3. Operating hours counter
4. Pressure gauge
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Operating Instructions MedAir, February 2007
3 Description of the Design and Functioning

3.2. Side view, left

1. AIR – outlet coupling

3.3. Rear view

MADE IN GERMANY
1. Air intake filter matting
2. Bacterial micro-filter with the intake
sound damper positioned behind
3. Moisture micro-filter with moisture micro-
filter insert
4. Mains power connection cable
5. Drainage valve
Depending on fill level, the condensation water is to be drained from catch tank. For doing this, the drainage valve lever ( 5 ) must be pushed upwards.

4. Preparing the Equipment for Operation

4.1. Setting up the MedAir

The MedAir is designed for use in dry areas
free from spray and dripping water. Moist or wet ambient conditions can greatly impair the functioning of the equipment.
The ambient temperature may not exceed +40 °C.
Should the relative humidity exceed 70 %, it is recommended that the equipment only be operated in air-conditioned areas.
The air intake filter positioned at the rear of the unit may not be covered by any objects.
The rear side of the unit must be at least 10 cm from the wall.

4.2. Connection to the mains power supply

4 Preparing the Equipment for Operation
Check to determine whether the mains power voltage matches the power voltage as indicated on the rating plate on the unit.
Make sure that the mains power switch "ON/OFF is in the OFF position.
Plug the mains power connection cable found at the rear of the unit into the wall socket-outlet in the room.
Operating Instructions MedAir, February 2007
5 Operation

5. Operation

To turn on the unit, press the "ON/OFF switch
found at the front side of MedAirs to on
position.
After switching on the unit, the ventilator of the
MedAirs is activated which ensures adequate
cooling of the unit's interior. Generation of compressed air begins approximately 10 seconds after that. The compressor of the
MedAirs builds up an operating pressure of
3.8 bar in approximately 4 seconds.
The pressure gauge on the front side of the unit shows the pressure at the AIR outlet.
The outlet connection coupling is positioned on
the left side of the MedAirs unit.
6 Problems, Causes and Remedies

6. Problems, Causes and Remedies

Problem Cause Remedy
No pressure No mains power Check mains power connection
Micro-filter is dirty or clogged.
Outlet pressure falls below 1.5 bar
Leakage in line. Defective compressor Gas usage is too high
Pressure continuously below 3.5 bar
Intake sound damper is dirty
Defective pressure safety valve
Not functioning Mains power failure
Replace micro-filter Contact Technical Support Reduce gas usage
Replace intake sound damper
Replace defective presurre safety valve The equipment automatically restarts after a response delay of 10 seconds.
Operating Instructions MedAir, February 2007
7 Care and Servicing

7. Care and Servicing

7.1. Cleaning

For reasons of hygiene, the unit should regularly be cleaned with a wipe disinfectant using a commercially available household detergent or disinfectant (e.g. Sagrotan).
The intake filter matting and the bacterial micro-filter must be replaced every 6 months or after every 500 operating hours.
The intake sound damper should be replaced when found dirty or at least every 6 months.

7.2. Safety technical inspections

Safety technical inspections as well as checking the quality of air generated are to be carried out annually or after 3500 operating hours by the manufacturer or by the authorized Technical Support team of F. STEPHAN.

7.3. Servicing

For reasons of safety, it is recommended that
the servicing of the MedAirs be carried out
annually in conjunction with the safety technical inspections.
Servicing is to be carried out only by the authorized Technical Support team of F. STEPHAN.
Only original replacement parts supplied by F. STEPHAN are to be used.

8. Accessories / Replacement Parts

Replacement parts:
Item. Article number Article desription Servicing intevals
1 1 804 60 007 Fuses 3.15 AT when defect
2 1 600 61 123 Intake filter matting semiannually / 500 op. hours
3 1 600 60 115 Bacterial micro-filter semiannually / 500 op. hours
4 1 600 40 046 Intake sound damper semiannually / dirt degree
5 1 925 60 362 Moisture micro-filter
insert yearly
6 1 950 60 031 O-Ring 4.47 x 1.78 for nippel coupling, AIR when leakage detected
Items 1 to 6 can be ordered in a set (Art.No. : 1 610 61 500), which is sufficient for three years.
The set additionally includes a replacement parts case and diverse small parts
8 Accessories / Replacement Parts
.
1 1 602 61 112 Connection hose for compressed air, length 3 m 1
2 1 600 40 010 Shock-proof socket rail, 4-fold mounted on
rear of unit 1
3 1 600 61 050 Stand with upper monitor console 700 x 400mm
mobile with 4 double castors, 100mm, antistatic 1
4 1 600 60 214 Compressed air membrane drier ( with grating 1μm and
micro-filter 0.01 μm) 1
5 1600 60 215 Micro-filter with float divertor 1
Optional accessories:
Item Article number Article description Quantity
Operating Instructions MedAir, February 2007
9 Warranty

9. Warranty

The manufacturer grants a warranty of 24 months, beginning at purchase date.
Modifications or repair work may only be carried out by the manufacturer, F. Stephan GmbH, or authorized technicians. Otherwise the warranty becomes void.
Warranty shall also become void as a result of improper use and treatment of the equipment.
Personal Notes
Notes
Operating Instructions MedAir, February 2007
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