User's Manual

134 - K4 b
2
User Manual
System maintenance
All service operations which are not specified in this user manual should be performed
by qualified personnel in accordance with the service handbook (to be required to the
manufacturer).
Rubber mouthpieces, face masks, breathing valve and the other parts are not shipped
sterile. They should be disinfected before using according to the following instructions.
All materials used in the construction of the K4 b
2
are non toxic and pose no safety risk
to the patient or operator.
Prior to the device cleaning, disinfection and inspection it is necessary to switch off the
device and to disconnect adapters from the supply mains.
In order to guarantee the highest accuracy of measurements we recommend you to
disinfect the turbine periodically.
Use disposable anti-bacterial filters or disinfect each part in contact with the patient
before each test.
Cleaning and disinfection
Cleaning and disinfecting instructions are of fundamental importance to control
infections and assure patient safety. In fact aspiration of residue, particles and
contaminated agents are life threatening.
In this handbook we strongly recommend you to follow the rules worked out by ATS
and ERS (see: ”Lung Volume Equipment and Infection Control” ERS/ATS
WORKSHOP REPORT SERIES, European Respiratory Journal 1997; 10: 1928
1932), which are summarised as follows:
Accessible internal as well as external surfaces of equipment exposed to expired
gas should be washed and disinfected prior to testing of subsequent patients.
Liquid disinfection can be used if the equipment is well cleaned first (no droplets of
saliva/sputum remain).
Disposable gloves should be worn when handling mouthpieces, when cleaning
equipment exposed to saliva or sputum and especially when drawing blood.
Laboratory staff should wash hands prior to testing of each patient.
Adopt particular precautions when testing patients with recognised high risk
communicable diseases (e.g. tuberculosis, multidrug resistant staphylococcus). In
these cases, the clinical need for such testing should justify the risks.
During the disinfection:
do not use alcohol or other liquids containing gluteraldehyde on the exterior
surfaces of the equipment. Actually they can damage polycarbonates plastics and
may produce unhealthy substances.
do not use abrasive powders or glass cleaners containing alcohol or ammonia on the
plexiglas components of the equipment
do not steam autoclave any parts of the equipment unless it is clearly specified.
do not immerse the optoelectronic reader.
Preparing the disinfecting solution
The following recommendations are retrieved from:
APIC (Association for Professionals in Infection Control and Epidemiology, Inc.):
APIC Guidelines for Selection and Use of Disinfectants; William A. Rutala, PhD, MPH,
CIC. American Journal of Infection Control, vol.24, N.4, pp. 313-342, August 1996 -
http://www.apic.org/pdf/gddisinf.pdf
As disinfecting solution it is suggested:
Sodium hypochlorite 0.5% (5000 ppm) prepared fresh for use within 24 hours.
Sodium hypochlorite 1% (10000 ppm) prepared fresh for use within 30 days.
The first solution can be easily prepared by adding 1 part household bleach (sodium
hypochlorite 5.25%) to 9 parts water, the second one by adding 1 part household bleach
to 4 parts water.