lung monitor Serial
Model 4000
User Training Manual
Medical Devices Directive
93/42/EEC L169, Vol. 36.
EN ISO 13485
FDA QSR 21 CFR 820/803
Manufacturer: Vitalograph (Ireland) Ltd, Ennis, Ireland
UK Sales
Vitalograph Ltd.
Maids Moreton, Buckingham, MK18 1SW, England
Phone: (01280) 827110
Fax: (01280) 823302
e-mail: sales@vitalograph.co.uk
www.vitalograph.co.uk
Export Sales
Vitalograph Ltd.
Maids Moreton, Buckingham, MK18 1SW, England
Phone: +44 1280 827120
Fax: +44 1280 823302
e-mail: sales@vitalograph.co.uk
www.vitalograph.eu
Vitalograph GmbH
Rellinger Straße 64a, 20257 Hamburg, Germany
Phone: (040) 54 73 91-0
Fax: (040) 547 391 40
e-mail: info@vitalograph.de
www.vitalograph.de
Vitalograph Inc.
13310 West 99th Street, Lenexa, Kansas 66215, U.S.A.
Toll Free: 800 255 6626
Phone: (913) 730-3200
Fax: (913) 730-3232
e-mail: vitcs@vitalograph.com
www.vitalograph.com
Vitalograph (Irl.) Ltd.
Gort Road Business Park, Ennis, Co. Clare, Ireland
Phone: (065) 6864100
Fax: (065) 6829289
e-mail: sales@vitalograph.ie
www.vitalograph.ie
© Copyright Vitalograph 2013
Current Edition (Issue 4)
Cat. No. 07563
is a
registered trademark
Note: Please read all the information in this manual before using the Vitalograph lung monitor serial device. A full set of instructions, including cleaning instructions, is available at www.vitalograph.co.uk.
* If the patient at home thinks that the device is not reading correctly, they must advise the healthcare professional immediately.
A |
Keypad - Up, Down & Enter Button |
B |
LCD |
C |
Flowhead |
D |
Serial Connector |
On/Off Button | |
Down Button | |
Up Button | |
Enter Button |
The Vitalograph lung monitor serial is an easy to use home monitoring device designed to record key lung function parameters for those with respiratory conditions, including cystic fibrosis and transplant patients. The lung monitor can also be used in primary and secondary care, occupational health and clinical studies.
The primary features of the Vitalograph lung monitor are:
Personal Best (reference) values can be set for forced expiratory volume after 1 second (FEV1).
To set the Personal Best (reference) FEV1, follow these steps:
Note: to de-activate zones, set the FEV1 reference value to 0.00.
The Vitalograph lung monitor can be set for use with 3 or 4 zone management plans. The zone percentages are factory set to 2 boundaries, 95% & 90%, i.e. 3 Zones (95-100%, 90-95%, 0-90%). For 4 zones the middle boundary is set last. The colour systems for each zone type are as follows;
To set the boundary percentage values for 3 zones, follow these steps;
To set the boundary percentage values for 4 zones, follow these steps;
Note: if an exclamation mark ! appears, this means it was not a good quality blow and the subject should blow again. ! appears when: The Vext (extrapolated volume) is > 5% or 150mL of FEV6 or a cough is detected in the 1st second.
If the subject experiences dizziness or fatigue during the test session, wait until this passes before blowing again or terminate the session.
The Vitalograph lung monitor can store up to 200 test sessions. In order to view previously performed test sessions, follow these steps:
Caution: Once the history has been deleted it cannot be recovered.
To delete the history entirely, i.e. all previously stored session results, follow these steps:
The test session may be transmitted to the Vitalograph Reports Utility on your PC where it can be stored as a PDF file and viewed or printed.
Before you can transmit you must first have the Vitalograph Reports Utility installed and running on your PC. If the ‘Snake V’ icon is showing in your PC System Tray then the utility is running, if not refer to Vitalograph Reports Utility instructions.
The Vitalograph lung monitor should continue to give reliable measurements for up to three years in home use. Then replace it with a new device.
Keep it clean and dust free. If you suspect the device is damaged or is measuring incorrectly, contact the doctor immediately.
The mouthpiece is the only part of the device, which needs to be routinely cleaned in home use.
The outer surfaces should be thoroughly cleaned every week, more often if necessary. We recommend the use of an ordinary alcohol wipe, paying special attention to the mouthpiece area.
Part | Material | Cleaning Recommendation | Disinfection Recommendation |
---|---|---|---|
Plastic Mouthpieces | ABS | Wash in warm soapy water. Rinse in clean water | Cold liquid, e.g. Effervescent Chlorine solution |
Body | ABS | Wipe with a damp cloth | Alcohol wipe (IPA 70-90%) |
Fascia | PMMA/ PET | Wipe with a damp cloth | Alcohol wipe (IPA 70-90%) |
Buttons | Synthetic Rubber | Wipe with a damp cloth | Alcohol wipe (IPA 70-90%) |
A new mouthpiece (either SafeTway or BVF) should be used for each subject. A delay of at least 5 minutes should be allowed between subjects to allow settling of previously aerosolized particles in the measuring device.
It is recommended that the device be regularly cleaned according to the guidelines of the user’s facility. The disinfection materials and procedures applied in the users’ facility may be more appropriate than the methods outlined below.
In the event of visible contamination of the flowhead element, it should be cleaned or disinfected as described in the accompanying table. The device should be replaced in the event of damage, or if visibly contaminated.
The frequency of cleaning and disinfecting is dependent on the facility’s risk assessment, usage, and test environment, but it should be at least monthly or every 100 subjects (300 blows).
It is recommended that the device be replaced annually or test and calibration serviced at least annually. There is no planned preventive maintenance for this medical device.
5.2.1. Table of Materials Used & Cleaning/Disinfection Methods
This listing of materials used is given to provide clinical users with information to allow the assessment of other cleaning and disinfecting procedures available in the facility on this device.
Part
Material
Clean/ Disinfect
Autoclave Possible?
Recommended Disinfectants
Plastic Mouthpiece
ABS
Do not use in clinic
No
Disinfect by immersion in sodium dichloroisocyanurate solution at 1000ppm concentration of free chlorine for 15 minutes
SafeTway mouthpiece or BVF
Cardboard/ ABS
Dispose – single use
No
Dispose – single use
Case Exterior
ABS
Clean
No
Wiping with a 70% isopropyl alcohol impregnated cloth provides a suitable form of cleaning and low-level disinfection. This may be preceded by cleaning with an anti-static foam cleaner if necessary.
Fascia
PMMA/
PETClean
No
Removable flowhead
ABS, Stainless Steel
Clean
No
Disinfect by immersion in sodium dichloroisocyanurate solution at 1000 ppm concentration of free chlorine for 15 minutes (see following section for recommended cleaning/disinfection method for the flowhead) Maximum of 50 cleaning cycles allowed.
All external parts of the Vitalograph lung monitor require cleaning, i.e. the removal of visible particulate contamination. The parts of the device that make up the flowhead, which comes into contact with the breath of the subjects being tested, also require disinfecting. This device is not designated as a ‘sterile’ device.
Definitions of cleaning and disinfection are as defined in “Sterilization, Disinfection and Cleaning of Medical Equipment:
Guidance on Decontamination from the Microbiology Committee to Department of Health Medical Devices Directorate, 1996”.
Recommendations for chemical disinfectants are derived from the PHLS publication “Chemical Disinfection in Hospitals” 1993.
5.2.2. Removing the Flowhead for Cleaning and Disinfecting
Flowhead Disassembled Flowhead Assembled
- Remove the flowhead from the body with a sharp pulling motion.
- Clean the flowhead by washing in a mild detergent to remove particulate contamination, taking care not to touch the moving vanes. Swill vigorously in water with mild detergent. Do not attempt to “rub” or “scrub” in the area of the vanes. Rinse with clean water.
- Disinfect by immersion in sodium dichloroisocyanurate solution at 1000 ppm concentration of free chlorine for 15 minutes. Prepare disinfectant solution as directed in the manufacturer’s guidelines. Rinse with warm water for faster drying.
- Leave it to dry completely before reassembling. Drying the flowhead may require placing it in a warm place overnight. A drying cabinet is ideal.
Wiping with a 70% Isopropyl Alcohol impregnated cloth provides a suitable form of cleaning and low-level disinfection for the case exterior, display, screen surround and keys. Repeat this at least weekly to prevent a build-up of grime from normal handling and use.
Always follow the safety guidelines given by the manufacturer of cleaning and disinfectant chemicals or equipment.
Reassemble the flowhead by pushing back on until it ‘clicks’ into position. Ensure that the flowhead is pushed fully home.
Cat. No | Description |
---|---|
40168 | Mouthpiece (20) |
20242 | SafeTway Mouthpieces (200) |
20303 | Disposable Noseclips (200) |
20980 | Mini SafeTway mouthpieces (50) |
20991 | Long SafeTway mouthpieces (130) |
28350 | BVF Bacterial/Viral Filters (50) |
40167 | Pouch Spare (x10) |
Type BF equipment | |
Class II | |
Serial Connector | |
Attention (reference relevant section in manual) | |
|
Manufacturer |
|
Year of Manufacture |
The device must be taken to separate collection at the product end-of-life. Do not dispose of these products as unsorted municipal waste. |
Other Labels
Battery status |
|
Blow Now Symbol |
|
! | Bad Test Symbol (Slow start or Cough) |
Transmit Report Symbol | |
Memory 90% - 100% Full
Icon |
Material: |
PC/ABS |
Accuracy: |
Better than ± 3% |
Flow Impedance: |
Better than 0.15kPa/L/s at 14L/s |
Measurement Range: |
0 – 9.99 L BTPS |
Performance And Safety Standards: |
ISO EN 23747:2007 |
Electromagnetic emissions: |
CISPR 11 Group 1 (battery operated) |
Electromagnetic immunity: |
IEC 61000-4-2, IEC 61000-4-3 (battery operated) |
Sensor: |
Stator/rotor |
Power Supply: |
2 x AAA batteries |
Operating Temperature: |
17 – 37°C |
! Bad Test Criteria: |
Slow start of test (Vext>5%) or a cough detected in the first second |
Auto power down time |
Set to 2 minutes as standard |
Communications |
Serial |
Marking by the symbol indicates compliance of the Vitalograph 4000 Respiratory Monitor lung monitor device to the Medical Devices Directive of the European Community. Such marking is indicative that the Vitalograph 4000 Respiratory Monitor lung monitor device meets or exceeds the following technical standards:
Guidance and manufacturer’s declaration – electromagnetic emissions |
||
The 4000 Respiratory Monitor lung monitor is intended for use in the electromagnetic environment specified below. The customer or the user of 4000 Respiratory Monitor lung monitor should assure that it is used in such an environment. |
||
Emissions test |
Compliance |
Electromagnetic environment – guidance |
RF emissions |
Group 1 |
The 4000 Respiratory Monitor lung monitor uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
|
RF emissions |
Class B |
The 4000 Respiratory Monitor lung monitor is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. |
Harmonic emissions |
Class A |
|
Voltage fluctuations/ |
Class A |
Guidance and manufacturer’s declaration – electromagnetic immunity |
|||||
The 4000 Respiratory Monitor lung monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the 4000 Respiratory Monitor lung monitor should assure that it is used in such an environment. |
|||||
Immunity test |
IEC 60601 |
Compliance level |
Electromagnetic environment- guidance |
||
Electrostatic discharge (ESD) |
±6 kV contact ±8 kV air |
±6 kV contact ±8 kV air |
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30% |
||
Electrical fast transient/burst IEC 61000-4-4 |
±2 kV for power supply lines |
Battery operated device |
|
||
Surge |
±1kV differential mode |
Battery operated device |
|
||
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 |
<5 % 100V (>95% dip in 100V) for 0,5 cycle |
Battery operated device |
|
||
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 |
3 A/m |
Performance A |
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. |
Guidance and manufacturer’s declaration – electromagnetic immunity |
||||||
The 4000 Respiratory Monitor lung monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the 4000 Respiratory Monitor lung monitor should assure that it is used in such an environment. |
||||||
Immunity test |
IEC 60601 |
Compliance level |
Electromagnetic environment - guidance |
|||
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3 |
10 Vrms
3 V/m |
Battery operated device
3V/m from 80MHz to 2.5 GHz |
Portable and mobile RF communications equipment should be used no closer to any part of the 4000 Respiratory Monitor lung monitor including cables, than the recommended separation distance calculated form the equation applicable to the frequency of the transmitter. Recommended separation distance
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol: |
Recommended separation distances between portable and mobile RF communication equipment and the 4000 Respiratory Monitor lung monitor |
|||
The 4000 Respiratory Monitor lung monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the 4000 Respiratory Monitor lung monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the 4000 Respiratory Monitor lung monitor as recommended below, according to the maximum output power of the communications equipment. |
|||
Rated maximum W |
Separation distance according to frequency of transmitter (m) |
||
150 kHz to 80 MHz |
80 MHz to 800 MHz |
800 MHz to 2.5GHz |
|
0.01 |
0.1m |
0.1m |
0.2m |
0.1 |
0.4m |
0.4m |
0.7m |
1 |
1.2m |
1.2m |
2.3m |
10 |
3.7m |
3.7m |
7.4m |
100 |
11.7m |
11.7m |
23.3m |
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (w) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. |
Medical Devices may be affected by cellular telephones and other personal or household devices not intended for medical facilities. It is recommended that all equipment used near the Vitalograph product comply with the medical electromagnetic compatibility standard and to check before use that no interference is evident or possible. If interference is suspected or possible, switching off the offending device is the normal solution, as is required in aircraft and medical facilities.
Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided.
Portable and mobile RF communications equipment can affect medical electrical equipment.
Caution: Federal Law restricts this device to sale by, or on the order of a physician.
Product: Vitalograph 4000 Respiratory Monitor lung monitor
Vitalograph hereby ensures and declares that the above product associated with this user manual, is designed and manufactured in accordance with the following QMS regulations and standards:
European Medical Devices Directive {MDD} 93/42/EEC.
This device, classified as 2a as per Annex IX of MDD 93/42/EEC, meets the following provisions of Annex II of the Medical Devices Directive as per Article 11, section 3a, excluding point 4 of Annex II.
This device complies with the EMC Directive 89/336/EC, conformance demonstrated by following standard EN60601-1-2:2001.
Equipment classification: Residential.
Canadian Medical Device Regulation {CMDR}
FDA Quality System Regulation {QSR} 21 CFR 820.
EN ISO 13485: 2003. Medical devices. Quality management systems. Requirements for regulatory purposes.
Certifying Body {for 93/42/EEC and CMDR}: British Standards Institute {BSI}
Certificate Nos. CE 00772, MD 82182, FM 83550
Signed on behalf of Vitalograph (Ireland) Ltd.
B. R. Garbe.
Group Managing Director
Subject to the conditions listed below, Vitalograph Ltd. and its associated companies, (hereinafter called the Company) guarantee to repair or at its opinion replace any component thereof, which, in the opinion of the Company is faulty or below standard as a result of inferior workmanship or materials.
The conditions of this Guarantee are:
This Guarantee is offered as an additional benefit to the Consumer’s statutory rights and does not affect these rights in any way.