BellaVista 1000 User manual

Service Manual
bellavista 1000/1000e
Software Version V3.0 02.13 (in work)

2

3
Service Manual
bellavista 1000/1000e

4
Table of contents
1. Introduction ................................................................... 5
2. Description of the ventilator........................................... 7
3. Maintenance Schedule................................................ 11
4. Software Upgrade ....................................................... 13
5. Service Menu Overview .............................................. 18
6. Shipment Test............................................................. 25
7. Annual Maintenance ................................................... 34
8. Electrical test............................................................... 57
9. Quick Check................................................................ 62
10. Diagnosing and Repair................................................ 63
11. Spare Parts ................................................................. 91
12. Index ........................................................................... 93

Introduction
5
1. Introduction
Welcome to bellavista. This manual instructs you how to service
your bellavista ventilator. Some parts serve as checklist for
maintenance tasks.
According to the EU Directive, bellavista is classified as a Class
IIb medical device.
Preventive maintenance and calibration has to be performed
according to the corresponding schedule (p. 11)
Danger Only manufacturer-authorized trained pro-
fessionals may perform maintenance and
repair.
Appropriate measuring equipment and test-
ing devices must be available.
Danger Before and after each service task, bel-
lavista must be
- turned off and unplugged
- cleaned and disinfected
Danger Service must be performed in a clean envi-
ronment and with protection against elec-
trostatic discharge ESD.
Danger In the event an error message is obtained
during self-test or during the ventilator
check, do not use bellavista on a patient!
Danger Bellavista must not be used on a patient in
service mode. After service level login re-
start bellavista before connecting it to a pa-
tient.
Caution Do not sterilise in liquids or in the autoclave.
Factory repair
Repair shipment: https://imt-ag.net/easycal/wizard/easysend.aspx
If possible, use original packaging
Warning Never return bellavista uncleaned.
Hotline
Should you, against expectations, encounter problems with
bellavista, please contact your local distributor or us directly:
Hotline [phone] (09:00 –16:00 CET)
www.imtmedical.com
www.imtmedical.com/easysend (for repair)
1st and 2nd Generation bellavista (G1, G2)
This manual is valid for
1st generation (G1) bellavista 1000
SN: MB100001 … 99
with low pressure oxygen connection
2nd generation (G2) bellavista 1000 and 1000e
SN: MB100100 … 100999
with low and high pressure oxygen connection and oxygen
blender
3rd generation (G3) bellavista 1000 and 1000e
SN: MB103000 and above
with new blower for pressure up to 80 mbar
Wherever necessary this manual discriminates between the two
generations.

6
Conditioning, cleaning and sterilising
Clean and sterilize bellavista before and after each service task.
Proceed as follows:
Step
Activity
1
Turn off bellavista to prevent damage by pene-
trating liquid.
2
Clean surfaces incl. screen with a damp, lint-
free cloth. The cloth should not be too wet!
Never use abrasive cloth or cleaning agent.
Disinfect only with approved cleaning agents:
Soapy water or mild cleaning agent
Pantasept Spray (isopropyl alcohol)
(Xeropharm, CH-1163 Etoy)
Isopropyl alcohol
Ethyl alcohol
Disinfecting wipes (alkyl dimethyl benzyl
ammonium)
3
Make sure, bellavista is dry.
For the breathing circuit, follow the instructions of the manufac-
turer.

Description of the Ventilator
7
bellavista view from front right
2. Description of the ventilator
No
Description
1
Alarm lights
Red: Alarm e. g. high pressure
Yellow: Danger e. g. apnea backup acti-
vated
Blue: Info, e. g. battery operation
2
Screen with touch screen feature
3
Cover for external sensors
4
Patient connectors
5
Speaker
6
Cover bellavista bay
bellavista view from rear left
No
Description
7
Handle
8
Cover for ventilator air filter
9
Cover for communication interfaces
10
On/off switch and power connectors
11
Cover for patient air filter
12
Speaker
At the bottom of bellavista, there are two slots for the storage of
covers (3, 9) and access to the battery compartment.
2
6
5
4
3
1
1
8
10
11
9
7
12

8
bellavista side panel right
Connectors
No
Description
1
Data storage (USB stick)
2
Push button Connection Assist
3
Connector for SpO2sensor (optional)
4
Connector for CO2sensor (optional)
5
Cover bellavista bay
6
Patient connector inspiration
7
Cover O2sensor
8 blue
Connector for proximal pressure measurement
9 white
Connector for flow sensor (optional)
10 red
Connector for expiration valve
bellavista side panel left
No
Description
11
bellavista bus
12
Nurse call
13
2x USB 2.0
14
100 MBit Ethernet network
15
Push button Connection Assist
16
Status lights
17
Push button On/Off
18
Strain relief power cord
19
Oxygen supply
20
External DC supply 24 VDC
21
Power indicator (green LED)
22
Power plug
23
Fuse 2 x T 6.3 AH, 250 V
24
Cover for patient air filter
6
8
9
10
5
1
2
3
4
7
1
11
12
13
14
15
16
17
20
22
23
18
19
24
21

Description of the Ventilator
9
Block schematics pneumatics
A) Device fan (cooling)
B) Air intake with filter
C) O2 connection 0…7 bar: DISS *), NIST*), CPC
D) O2 cell
E) Inspiration connection
F) Bacteria filter and breathing circuit
G) Proximal pressure measurement
H) Proximal flow measurement
J) Expiration valve control line
K) Release for expiration valve control
L) Bypass for blower cooling
1 Blower (Turbine)
2 Check valve
3 Inspiratory flow measurement (internal)
4 Inspiratory proportional valve
5 Airway pressure measurement
6 O2 pressure regulation *)
7 O2 safety valve
8 O2 proportional valve *)
9 O2 flow measurement*)
10 Rinse flow O2 cell
11 Proximal pressure measurement
12 Rinse valve proximal pressure measurement
13 Proximal flow measurement
14 Rinse valve proximal flow measurement
15 Exp. valve control valve
16 Control-pressure measurement exp. valve
17 Exp. valve release valve
18 O2 high pressure sensor *)
19 O2 regulated pressure sensor *)
20 O2 temperature sensor *)
21 O2 differential pressure sensor for flow measurement *)
22 Differential pressure sensor for internal flow measurement
23 Blower pressure
24 Airway pressure (internal)
25 Airway temperature (internal)
26 Internal device temperature
27 Ambient pressure (barometer)
NC Valve normally closed
NO Valve normally open
*) not with 1st generation bellavista 1000 (SN: MB100001 … 99)
3) LFE Insp (R1)
Air Intake
Cooling
22) dpFlowInsp (B6)
xx
D)
O2 concO2 (B8)
E)
Cone
F)
Bacteria
Filter
27) pAmbient (B5)
2) CheckValve
Insp (V1)
11) pPatProx (B4) Connection
proximal Pressure and
proximal Flow Measurement
24) pPatInsp (B3)
L)
Diffusor
10) Rinse
Flow
4) Insp-Valve (Y1)
NO
23) pBlower (B2)
T
26) tempDevice (B15)
Cooling
A)
Filter
6) Pressure Regulator
O2 (T1) 19) pO2_Regulated
(B10)
NC
8) O2-Valve (Y4) 9) LFE O2 (R3)
21) dpFlowO2 (B13)
Connection
proximal Flow Measurement
Connection
Mushroom-Valve
(Patient)
15) Mushroom-Valve (Y6)
NC 17) Bypass
16) pMushroom (B17)
12) Rinse-Valve (Y7)
NC
13) dpFlowProx (B18)
14) Rinse-Valve (Y8)
NC
Life Module (1000)
Bypass for
blower cooling
H)
Connector
J)
Connector
G)
Connector
Diffusor
18) pO2_Supply
(B1)
C) DISS
O2 or
NIST O2 Stainless Steel
Filter 100μm
(R2)
T
20) tempO2
(B20)
25) tempInsp
(B21)
T
Filter
Water Trap
Colder
(P)MC
Proportional-
Valve
Noise reduction
T
28) tempBlower (B16)
1) Blower (G1)
Pressure side
Suction side
B) Grid
with
Filter
NC
7) O2-Safety
Valve (Y9)
Proportional-
Valve

10
Block schematics electronics
Patientboard (A5)
Blower (G1)
Sensorboard (A3)
tempBlower
T
xy Connector to the outside
Legend
Electrical connection
DC_in
Interfaceboard (A4)
USB
Host
CAN
DC_out
AC IN
Mainboard (A1)
uP System
(CFB) Embedded PC
Ethernet
Digital Out
Connector
Cable
Cable
Cable
Cable
Cable
Connector
Cable
Cable
Powerboard (A2)
Cable
Cable
Cable
Left Side
DC_out
LEDBoard
(red, yellow, blue)
TFT Display
Touchscreen
Loudspeaker (left)
Loudspeaker (right)
USB Stick
(Trending)
Ethernet incl.
Vrb LEDs
Monitoring
USB-Host
to ext. PC
USB-Host
Keyboard,
Mouse
Nurse Call
bellavista bus
O2
konzO2 (B8)
4 Status LED
AC OUT
DC IN (X1)
AC IN (X2)
Device On/OFF
Button (S1)
Supply LED
Galvanic Isolation
Cable
PWR
Supply
Cable
Cable
Cable
Cooling fan
Cable
bellavisa bus
CAN
Buzzer
Backlight Inverter
Cable
Cable
Connector
Connector
Bellavista bay
Cable
CO2
Sensor
SpO2
Sensor
Cable
Right Side
(Patient side)
Left Side
Battery A
Lifeboard (A8)
dPFlowProx (B18)
pMushroom (B17)
Mushroom-Valve (Y6)
Cable
Rinse-Valve (Y7)
Cable
Cable
LEDBoard
(red, yellow, blue)
Rinse-Valve (Y8)
Cable
Cable
Lifeboard
T
tempLifeboard
pPatProx (B4a)
Fuse
(single
phase)
O2 Safety Valve (Y9)
Cable
O2 Proportional Valve
Cable
USB USB
Microphone
USB
RS232
CFB 5V
RS232
Phasein CO2
RS-232
Nonin SpO2
RS232
CFB
CAN 5V
Battery B
Cable
dpFlowInsp
(B6) pAmbient (B5)
pO2_Supply
(B1)
pPatInsp
(B3)
dpFlowO2
(B13) pO2_Regulated (B10)
pBlower
(B2)
T
tempDevice
(B15)
Cable
Insp Proportional Valve (Y1)

Maintenance Schedule
11
3. Maintenance Schedule
Time interval
Activity, Material
Maintenance date, who
Next maintenance
Weekly or
before every
new patient
Quick Check (p. 62)
Requirement: Mandatory
Performed by: User
Material:
New breathing circuit
New patient air filter
New airway adapter for CO2capnography (if used)
n.a.
n.a.
Monthly
Patient Air Filter Replacement (p 64)
Requirement: Mandatoy
Performed by: user or hospital technician
Material: Patient air filter
......................... .........................
......................... .........................
Every 6
months
Cooling Air Filter Replacement (p 64)
Requirement: Mandatoy
Performed by: user or hospital technician
Material: Cooling air filter
......................... .........................
......................... .........................
Every 12
months
Annual Maintenance (p. 34)
Maintenance and safety check in accordance with EN 60601-1.
Requirement: Mandatoy
Performed by: trained technician
Material: see p. 34
......................... .........................
......................... .........................
......................... .........................
......................... .........................
......................... .........................
......................... .........................
Every 5 years
Full service at the manufacturer

12
Time interval
Activity, Material
Maintenance date, who
Next maintenance
When new
bellavista soft-
ware becomes
available
Software Upgrade (p. 13)
After a software upgrade the users have to be trained regarding
the new functions and/or changes.
Requirement: depends on separate communication
Performed by: Product- or application specialist
Material: Internet connection, USB stick
.......................... .........................
.......................... .........................
.......................... .........................
....................................................
....................................................
....................................................
Before sending
a previously
used bellavista
to a customer
Shipment test (p. 18)
Requirement: Recommended
Performed by: trained technician
Material: see p. 18
.......................... .........................
.......................... .........................
....................................................
....................................................

Software Upgrade
13
4. Software Upgrade
Software upgrades are downloaded from the internet with iVista
and transferred to bellavista via USB stick.
1. Make USB stick “bellavista ready” (p. 14)
2. Get bellavista device information (SN and configuration)
(p. 14)
3. Download the upgrade onto the USB stick and install it on
bellavista (p. 15)
4. After completing the upgrade please upload the device
information to the bellavista traceability data base (p. 16)
The following chapters describe the above steps in detail.
Install iVista
1. Download iVista from https://www.ivista.ch on any Windows
computer and install it.
2. You require administration rights on your computer.
3. iVista automatically checks for new versions every time it is
started
1.
2.
3.
4.

14
iVista detects the plugged-in USB stick
Make USB stick bellavista-ready
1. Start iVista (internet connection required).
2. Insert USB stick into the computer
3. Select the USB stick
4. If the USB stick is used for upgrading the first time press
Prepare USB key. This makes the USB stick bellavista-
ready (and thus prevents a reaction of bellavista to any
other USB stick).
Existing Data on your USB stick will not be affected.
This directory and its content makes the USB stick “bellavista-
ready”. It can be e-mailed or copied to other USB sticks.
Get bellavista device information and LOG
Files
Insert bellavista-ready USB key into the bellavista unit.
5. bellavista automatically stores LOG files and device ID.
A small window pops up in the upper left corner of the
screen showing the download process.
This file contains device ID of bellavista with serial number
“MB100009”. It is required for iVista to download the upgrade. It
can be e-mailed or copied to other USB sticks.
This is a bellavista LOG file. Please e-mail for trouble shooting.

Software Upgrade
15
Use iVista do download the upgrade
Download the upgrade
1. Insert the USB stick into the computer running iVista.
2. Select the bellavista serial number you want to upgrade in
the Devices panel
3. Select the (latest) version you want to upgrade to on the
right side.
4. Press Get Updates
5. When finished, safely remove the USB stick using the Win-
dows functionality
This file contains the upgrade for one particular bellavista. It is
typically marked with the serial number and can be very large
(1GB) if the upgrade includes also the operating system.
A valid upgrade is indicated with a new icon on the bellavista main screen
Upgrade bellavista
1. Insert USB stick in bellavista
2. Select Software Update to start the installation and follow
the on-screen instructions
3. Finally switch on bellavista again. During the prolonged
startup period the new version is initialized and then ready
for use.
4. Check the software version in the bellavista About Screen
5. Perform a quick check (p. 62) to ensure full functionality.
Optional steps / diagnosing:
If the upgrade includes the operating system, it will ask for
system time and touchscreen calibration.
If bellavista seems to lock or does not restart then press the
on/off button for 5s to forcibly shut down bellavista.
Switch bellavista on again while you press both Connection
Assist buttons (on left and right connection panels) for the
first 10s. This enforces the upgrade installation.
Danger After an upgrade always perform a quick
check (p. 62) to ensure full functionality.

16
Update the bellavista data base
1. Insert the USB key into the bellavista unit you just upgrad-
ed.
2. bellavista automatically stores the device information.
3. Insert the USB stick into the computer running iVista.
4. iVista will automatically update the bellavista data base with
the up-to-date device information.
Information on a bellavista-ready USB stick
File / Directory
Purpose
Makes this USB
stick bellavista-
ready
(can be multiple files)
Identification infor-
mation of bellavista
with serial
No MB100009
(“Desc” can be multiple files)
Upgrade to Version
V2.0.26.4
“Data” contains
actual upgrade
“Desc” contains
serial numbers
and options re-
leased
(can be multiple files)
LOG file of bellavista
with serial
No MB100296 dated
…
Background on Updates
Content
Updates consist of one or multiple of the following elements. It
is not always required to update all of them. Major updates
contain all of them.
Windows XP embedded for EPC running the user interface
(700MB). Touch screen may require re-calibration after
Windows update.
UI software (DeviceSoftware.Application.exe and related
resources) and core software. These two are always bun-
dled to ensure compatibility. (20 MB)
Manuals, videos, images (usually bundled) (200 MB)
Process
Upgdating is a 2-stage process:
a) While the normal bellavista infrastructure is running, the
update is copied from USB memory to a temporary loca-
tion. Then bellavista is switched off.
b) Upon re-starting, the core processor runs a special program
which moves the update from the temporary location to the
final location for both, the embedded PC and the core pro-
cessor.

Software Upgrade
17
Update Trouble Shooting
A) If there is an upgrade on the USB stick, but no “Software
Update” icon is displayed or the UI software is not running:
When you plug in the USB key, on the upper left corner a
small window shows the progress.
As soon as it says “Update Detected…” long-click on it until
a popup window lets you install the upgrade.
If the small windows says something like “waiting for …”
then again long-click on the little window to force progres-
sion.
B) If the update fails step b) try the following:
Force the core process to install the update by keeping
pressed both “Connection Assist” buttons while starting up
bellavista.

18
5. Service Menu Overview
Picture
What to do / Protocol
Login into Service level
Password “service!”
Danger Bellavista must not be used on a patient
in service mode. After service level login
restart bellavista before connecting it to a
patient.
1 Versions
Provides detailed information on software and printed circuit
board versions.
2 ADCs
Provides current values of all ADCs (analog to digital con-
verters). This screen can be used for diagnosing.
No action required.

Service Menu Overview
19
Picture
What to do / Protocol
3 Sensors
Current values of all sensors (pressure, temperature, voltage,
flow) for diagnosis purpose.
4 Calibrations
Steps of calibration each consisting of:
Prepare: enables the measurement, puts all valves in the
correct position.
Wait for steady conditions!
Calibrate: Performs the actual measurement and calibra-
tion process (averaging, filtering, calculation)
Reset: Sets back all valves and special
Some calibrations are grouped: executing the first means,
you have to do them all, otherwise the calibration data is
marked as invalid and bellavista becomes stops being opera-
tional.

20
Picture
What to do / Protocol
5 Output CFB Pneumatics
Allows the controlling of all valves for diagnosing purpose.
Caution Do not damage bellavista with unintended
operation.
6 Output CFB Misc
Allows the controlling of additional outputs for diagnosing
purpose:
Nurse Call
Buzzer
Caution Do not damage bellavista with unintended
operation.
7 Display / User Input
Allows display and button diagnosing as well as touch screen
calibration.