Service manual

Respiratory therapy device point 2

Contents

1 Symbols in this manual....................................................................................................3

2 General.............................................................................................................................3
3 Safety information............................................................................................................3
4 Device description............................................................................................................4
4.1 Housing, display and control elements...............................................................................4
4.2 Exploded view drawing......................................................................................................5
4.3 Controller circuit board......................................................................................................6
5 Technical explanations.....................................................................................................8
6 Tools and measuring equipment....................................................................................10
6.1 Preliminary Steps.............................................................................................................10
6.2 Pressure measurement (Three-point measurement)..........................................................11
6.3 Checking display and contrast.........................................................................................12
6.4 Opening the device..........................................................................................................12
6.5 Cleaning..........................................................................................................................13
6.6 Checking the heating cable..............................................................................................13
6.7 Assembling the device.....................................................................................................13
6.8 Checking the keys...........................................................................................................13
6.9 Sensor test......................................................................................................................14
6.10 Resetting counters, setting date and time........................................................................14
6.11 Restoring device settings.................................................................................................14
6.12 Checking electrical safety................................................................................................14
7 Resetting the therapy hour counter and de-/activating the PIN code function directly
at the device...................................................................................................................15
7.1 Resetting the therapy hour counter..................................................................................15
7.2 De-/activating the PIN code function................................................................................15
8 Final steps......................................................................................................................15
9 Spare parts list...............................................................................................................16
10 Disposal.........................................................................................................................17
10.1 Device and components..................................................................................................17
10.2 Packaging.......................................................................................................................17
10.3 Batteries..........................................................................................................................17
10.4 Accessories and wear parts.............................................................................................17
Other tests (not part of device servicing).....................................................................................18
Pressure stability measurement.....................................................................................................18

-2-
1 Symbols in this manual
Important information is denoted by symbols in this service manual. Be sure to follow these instruc-
tions in order to avoid accidents, personal injury and material damage.
In addition, the local accident prevention regulations and general safety regulations in force in the
area of use must be observed.

This symbol denotes general safety instructions. Follow these instructions to avoid accidents,
personal injury or material damage.

This symbol denotes hazardous situations that may lead to moderately severe injuries.

This symbol denotes situations that may lead to material damage or damage to the device.

This symbol denotes information, tips and instructions for efficient, error-free use of the
device.

2 General

•• Before starting maintenance, read this service manual through carefully. Observe
the user’s manual as well as the warning and safety instructions it contains.
•• Repair and maintenance may only be carried out by qualified, authorized and
competent specialist personnel.
•• This manual refers solely to the point 2 respiratory therapy device. It does not
deal with accessories such as therapy tubes and masks. If an accessory is sus-
pected of being defective, it should be visually inspected by the service techni-
cian and the result recorded in the servicing report.

3 Safety information

•• For hygiene reasons, we recommend wearing disposable gloves whenever work-

ing on the device. Before further work, the device must be subjected to wipe
disinfection with a standard disinfectant solution. When doing so, observe the
manufacturer‘s safety instructions and instructions for use.
•• The documents delivered with the device must be checked when the device
arrives at the Service department. Devices contaminated with MRSA (methicillin-
resistant Staphylococcus aureus) must be subjected to hygienic preparation
according to the validated KR1000 (Keredusy) preparation procedure. All other
devices must be prepared according to the point 2 hygiene concept.
•• Special hygiene measures are advisable when performing maintenance or repairs
on devices contaminated with MRSA. In this case, protective clothing such as
disposable gloves, mask and disposable apron should be worn without fail.
Hygienic preparation according to the validated KR1000 (Keredusy) preparation
procedure must be carried out before performing maintenance or repair.

-3-
4 Device description
4.1 Housing, display and control elements
Control panel and display

Humidifier lock

Therapy tube con-

nection

Contact socket for humidifier1 Controls for humidifier1

Fig. 1: Front view of the device

SD card slot Air inlet for barometric sensor

(as of serial no. JAA1305000)
24 V DC connection

JAA1305028

RS232
Rating plate interface

Filter or connection port for the filtersystempoint 2

Fig. 2: Rear view of the device

Window element for display underneath ON / OFF key

1 Selector keys Enter key

Fig. 3: Control panel

1 optional equipment variant for use with humidifier

-4-
4.2 Exploded view drawing

Membrane keyboard
Top section
of housing

Display

SD card slot
(as of serial no. JAA1305000)
Controller cir-
cuit board

Microphone cover
Meander lid

Acoustic hood

Fixing element
Blower
bellows Retaining Blower
ring

Fixing element
Fixing element

Flow resistance Damper

Blower mount
Damper
Sealing gasket Damper
(internal) - air outlet

Room divider

Acoustic protection
plate

Cover plate
Air outlet for DC and PC
connection

Bottom PC connection
section of cover
housing

Base (front) Filter insert

Control Base (rear)

panel base

Housing foot, glued on

the housing (as of serial
no. JAA1305000)
Cover for humidifier
Adapter for Housing foot Housing foot
electronics guide
humidifier

-5-
4.3 Controller circuit board
4.3.1 solder side

SD card module
(as of serial no. JAA1305000)

Battery Battery
contact contact

Alarm
generator

Plug connection for Plug connection for Display

humidifier electronics membrane keyboard

Fig. 4: Controller board (solder side)

-6-
4.3.2 Component side

Serial interface 24 V DC input

Microphone

Motor control
connection

P246

Motor voltage P257

connection

Battery
contact
Battery
contact Pressure
sensor
Backup
battery for
internal
clock

CPU (ATMEGA 2561) PK (display contrast)

Fig. 5: Controller (component side)

The settings on the potentiometers P246 and P257 must not be changed, as this would
necessitate recalibration at the factory.

-7-
5 Technical explanations

Patient, Humdifier
Respiratory (optional)
mask

point 2 Blower
device box

Load
Blower
management

Pressure PI controller Motor

Sensor

D/A
converter Motor
controller

CPU external
Display
EEPROM
Flash
RAM
EEPROM
Control panel ADC RS232

SD card

DC power
AC mains RCI
supply unit

Battery

Fig. 6: Block diagram

Heating (when optional humidifier is connected)

The humidifier heating consists of a heating element in the bottom of the humidifier. The heating
power can be set to 5 different heating levels using the controls.
The maximum temperature of the heating plate is limited to 60 °C. In addition, there is a thermal
fuse in the electronic unit of the humidifier, which trips at a temperature of 90 °C in the event of a
fault.

Power supply
The device is operated via an external switched-mode power supply with a wide input range of
100 - 240 V AC and a frequency of 50 - 60 Hz.
No maintenance or repairs should be performed on the switched-mode power supply.

-8-
Motor control
A piezoelectric sensor (differential pressure measuring procedure, measuring range: 0 ... 3500 Pa)
continuously measures the actual output pressure. The set-point pressure value is output by the
computer. The difference between these two values is corrected by the PI controller and the motor
control. Switching controllers are used to minimize power losses.

Motor
DC motor, operating voltage 4 - 24 V, electronically commutated

point 2 processor (ATmega2561)

The ATmega 2561 processor is a microcontroller which is used in all point 2 devices. The key tech-
nical data includes:
•• 256kByte flash memory
•• 4kByte EEPROM
•• 8kByte RAM
•• programmable interface
•• an integrated A/D converter (10 bit)
•• 54 programmable I/O pins

Clock
The point 2 has a real-time clock. The real-time clock is supplied by an internal battery (CR2032),
which offers an operating time of 8 to 10 years. This battery supplies the IC with power when the
device is disconnected from the mains. With mains operation the clock is supplied with power by
the power supply unit.

Alarm generator
Output of an acoustic alarm for wake-up function as well as in the case of absent or excessive
mask pressure.

-9-
6 Tools and measuring equipment
6.1 Preliminary Steps
6.1.1 Protective Agents and Disinfectants
•• Hand sanitizers: e.g. Sterillium® (Bode)
•• Disinfectant sprays: e.g. Mikrozid® AF Liquid
•• Surface disinfectants: e.g. Mikrozid® AF
•• In the case of medical devices exposed to hazardous contamination (MRSA), additional protective
clothing such as disposable gloves, a mask and a disposable apron and goggles should be worn.

Where possible, wipe disinfection is preferable to spray disinfection.

6.1.2 Tools, measuring equipment and aids

The following equipment is required for servicing:
•• Service manual, user‘s manual and maintenance documents
•• Battery pack (powerpackpoint 2) or point 2 power supply unit with mains cable
•• Phillips screwdriver PH0 and PH1
•• Slot screwdriver 06x3,5
•• Soft brush and vacuum cleaner
•• Soft base
•• point auxiliary tool (art. no. 00007939)
•• Therapy tube (1.80 m with 22 mm therapy tube connection as per ISO 5356-1)
•• Flow resistor, 4 mm with measuring tube (art. no. 00007304)
•• Flow resistor, 5 mm (art. no. 00007306)
•• Adapter valve tube system 22/22 (art. no. 00004942)
•• Pressure meter with following minimum requirements:
–– Pressure measuring range: 0...100 hPa
–– Measuring accuracy: ± 0.2 % of the pressure measuring range
–– Display accuracy: 0.01 hPa
–– Units: hPa, mbar, cmH2O
•• Device for testing electrical safety (e.g. SECUTEST SIII/DIN EN 62353:2008)
•• PC cable (art. no. 00005232)
•• PC with following system requirements:
–– MS Windows® 98, 2000, NT4.0, ME, XP, Server 2003, Vista, 7 or 8
–– Microsoft .NET Framework 2.0 Redistribut
–– 1 free COM interface per device
–– 1 free SD interface (only when using DATA box)
•• HOFFRICHTER TRENDset PC software
•• Cleaning agent for cleaning surfaces, e.g. solution of soapy water in a standard concentration

All tools, measuring equipment and aids possibly exposed to contamination must be cleaned
after they have been used and treated with disinfectant.

- 10 -
6.1.3 Unpacking and disinfecting

To protect against germs, the surface of the device and, where present, the humidifier must
be treated with a disinfectant immediately after unpacking.

6.1.4 Checking for external damage

Before starting the service, check the device and, where present, the humidifier for external dam-
age.

6.1.5 Data backup

Before starting the service, perform a data backup.
1. Connect the device to the mains power (using mains cable and power supply unit).
2. Use the PC cable to connect the device to the PC.
3. Start the TRENDset PC software.
4. For security reasons, make sure you save the device settings (File > Save as...).
5. Print out the device settings (File > Print) and keep the printout for data recovery.

6.2 Pressure measurement (Three-point measurement)

1. Connect the adapter valve tube system 22/22 with the flow resistor and the therapy tube. Plug
the therapy tube onto the point 2 air outlet and the silicone measuring tube of the flow resistor
on the connector of the pressure meter.

Measurement setup:

Flow resistor

Adapter

2. Take the following settings at the point 2:

–– Mode: CPAP
–– Pressure: 4 hPa
–– Start-Stop-Automatic: OFF
–– Unit: same as pressure meter
–– I-FLEX / E-FLEX: 0
–– Ramp: 0 min
–– Bacterial filter: No
–– Mask test: 0 s
3. Start the blower of point 2 by pressing the ON/OFF button.
4. Compare the set pressure (4 hPa) with measured value at the pressure meter. The maximum
deviation must not exceed ± 0.25 hPa.
5. Press the ON/OFF button of the point 2, in order to turn off the point 2. Set the pressure of the
point to 12 hPa and perform the pressure measurement again. The maximum deviation must
not exceed ± 0.5 hPa.

- 11 -
6. Perform the pressure measurement, as already described, at 20 hPa. The maximum deviation
must not exceed ± 0.5 hPa.

The pressure deviation is too high - What is to do?

1. Check the measurement setup. Are all connections firmly fixed and tight?
2. Perform the measurement again.
3. If the maximum deviation is already too high, operate the device for min. 2 hours in standby.
During this period, the device continuously measures the ambient temperature and determines
a correction factor that is used as a basis for the pressure sensor‘s zero-point calibration sys-
tem. Perform zero-point calibration at the same location as for performance of the pressure
measurement. This will lead to better results. Then perform the pressure measurement once
again.
4. If the measured pressure deviation still exceeds the maximum deviation limits, contact the
manufacturer.

6.3 Checking display and contrast

1. Press any key. The display lights up with a brightness of 100%.
2. Check the display to see whether all characters are shown correctly and completely.
3. The background of the display is illuminated – the display should be clearly legible in daylight.
4. After 15 seconds the display fades to the basic brightness level selected in the device menu
(0 - 100 %). The display should still be clearly legible.
5. If required, the display contrast can be re-adjusted via PK with the device open (see Fig. 5 on
page 7).

6.4 Opening the device

1. Unplug the mains plug.
2. Remove the filter or the filter system filtersystempoint 2 (optional).
3. Remove the humidifier, where present.
4. Remove the two batteries (powerpackpoint 2), where present.
5. Place the device top down on the soft base.
6. Open the device as follows:
a. Remove the feet of the housing.
b. If the point 2 is set up for the connection of a humidifier, remove the control electronics of
the humidifier and disconnect the plug connection.
c. Release the four screws at the housing.
d. Take off the upper casing of the housing.
7. Disconnect the plug connections and the pressure measuring connection.
8. Carefully remove the heating cable (using aids if necessary).

Avoid any tension on the microphone tubing.

- 12 -
6.5 Cleaning
1. Clean the inside of the device carefully using the brush and the vacuum cleaner.
2. Use compressed air to clean areas which are not readily accessible. Then remove loose parti-
cles with the vacuum cleaner.
3. Remove stubborn dirt inside and outside the upper casing of the housing and in the opened
device (not circuit boards) using a damp cloth and a solution of soapy water in a standard con-
centration.
4. Optional: If a humidifier is present, wash out the water container with water and apply a 5%
solution of vinegar to stubborn limescale.

6.6 Checking the heating cable

Check that the heating cable is still intact and that the contact springs are not bent. On assembly,
the heating cable must be protected from tension, compression and clamping.

6.7 Assembling the device

Only start assembly once all cleaning agents and disinfectants have dried completely.
1. Position the motor cable in the space between the motor and the wall of the housing and run
the heating cable between the box and the wall of the housing.
2. Position the pressure measuring tube above the controller circuit board and connect it to the
pressure sensor.
3. Check whether the controller circuit board is properly seated in its correct position.
4. Check all plug connections on the controller circuit board for secure positioning and, where
necessary, correct deficiencies.
5. Carefully fit the upper case of the housing, making sure that no cables or tubes are com-
pressed or crushed.
6. Turn the device over and screw the upper and lower casing together. Then reattach the hous-
ing feet.
7. If the point 2 was set up for the connection of a humidifier, install the controls and the control
electronics of the humidifier.
8. Insert the filter or fit the filtersystempoint 2 (optional).

6.8 Checking the keys

1. Check that the turbine switches on and off properly when the ON/OFF key is pressed.
2. Check whether the menu can be operated properly using the arrow keys.

- 13 -
6.9 Sensor test
The sensor test needs to be performed whenever changes to the controller circuit board were
made.
1. Use the PC cable to connect the device to the PC.
2. Connect the therapy tube to the device and plug the 5 mm flow resistor into the tube’s patient
side endpiece.
3. Start the TRENDset PC software and click on the device at “Found devices”.
4. Go to “Settings > Service > Log in” in the menu bar.
5. Enter „service“ as the User Name.
6. Enter „user140372“ as the Password.
7. Select view „Times and Counters“.
8. Click on the „Sensor test“ button.
9. Follow the instructions on the PC screen.
If the microphone- and/or barometer test fails despite the sensor test being executed correctly,
check whether all tubes are properly connected and not squeezed or kinked. If the test fails perma-
nently, please contact the HOFFRICHTER service department.

6.10 Resetting counters, setting date and time

1. Use the PC cable to connect the device to the PC.
2. Start the TRENDset PC software and open the connected device at „Found devices“.
3. Select the view „Times and Counters“.
4. Reset the filter counter if the filter was changed.
5. Reset the blower runtime if the blower box was changed.
6. Reset the date and time if necessary.
7. Click on „Send“.

6.11 Restoring device settings

1. Select the view „Patient Data“.
2. If necessary, enter the patient data using the data backup (printout).
3. Click on „Send“ to store the settings in the device.
4. Select the view „Device Settings“.
5. If necessary, enter the patient data using the data backup (printout).
6. Click on „Send“ to store the settings in the device.

6.12 Checking electrical safety

The point 2 basic device is equipped with protective insulation and does not have any exposed
electrically conductive parts at the housing. As such, electrical safety testing of the device is unpro-
vided for.
Electrical safety testing is only possible on the power supply unit and is performed by a device
safety tester (e.g. SECUTEST SIII), which complies with the DIN EN 62353:2008 standard. The ref-
erence point is the ground conductor on the secondary side of the power supply unit (external con-
tact).

- 14 -
7 Resetting the therapy hour counter and de-/activating the PIN
code function directly at the device

7.1 Resetting the therapy hour counter

1. Keep the selector keys and both pressed down while connecting the power supply to
the device’s DC power connection.
2. Therapy Counter Reset Press  appears on the display.
3. Press the enter key .
4. Therapy Counter deleted appears on the display.

7.2 De-/activating the PIN code function

Deactivating the PIN code function
1. Keep selector key and enter key both pressed down while connecting the power supply
to the device’s DC power connection.
2. PIN Code OFF? Press  appears on the display.
3. Press the enter key .
4. PIN Code OFF appears on the display.

Make sure to reactivate the PIN code function before the device is passed on (e.g. to patients).

Activating the PIN code function

1. Keep selector key and enter key both pressed down while connecting the power supply
to the device’s DC power connection.
2. PIN Code ON? Press  appears on the display.
3. Press the enter key .
4. PIN Code ON. appears on the display.

8 Final steps
After finishing servicing, draw up a final report and affix a test seal showing the date and tester‘s ini-
tials to a suitable position on the device.

- 15 -
9 Spare parts list
Device
Designation Article no.
Power supply unit, 2-pin 0000 2133
Power supply cable 3110 0029
Carrier bag 0000 2080
Standard coarse filter 45 x 25 x 7 mm 0000 2110
Therapy tube without measuring tube 0000 7875
Blower 0001 2438
Blower mount point 2 4210 0774
Controller circuit board point 2 CPAP 0001 2412
Controller circuit board point 2 CPAP with SD card module
0001 2416
(as of serial no. JAA1305000)
Controller circuit board point 2 AutoCPAP 0001 2413
Controller circuit board point 2 AutoCPAP with SD card module 0001 2417
(as of serial no. JAA1305000)
Controller circuit board point 2 BILEVEL ST20 with SD card module 0001 2418
(as of serial no. JAA1305000)
Display 1520 0017
Heating cable assembled 0001 2238
Battery CR2032 1600 0011
Upper casing 0001 2666
Upper casing with SD card slot (as of serial no. JAA1305000) 0001 2667
Plastic foil keyboard 2200 0109
Air outlet 0001 2435
Sealing ring air outlet 4210 0737
Bellow air outlet 4210 0760
Cover (instead of control electronic aquapoint 2) 4210 0750
Clamp (meander) 4210 0715
Noise absorber 4210 0711
Blind DC input, PC interface 4210 0766
Cover PC interface 4210 0767
Foot for housing 4210 0773

Tab. 1: Spare parts list for device

Humidifier
Designation Article no.
aquapoint 2 humidifier 0001 2949
Control electronic for aquapoint 2 humidifier 0001 2286
Closing cap 4210 0756
Air guide 4210 0758

Tab. 2: Spare parts list for humidifier

Battery pack
Designation Article no.
powerpackpoint 2 battery pack (2 pcs.) 0001 2846

Tab. 3: Spare parts list for battery pack

- 16 -
Filter system
Designation Article no.
Filter system filtersystempoint 2 with coarse and fine filter, ready for use 0001 2847
Filter cassette for filter system filtersystempoint 2 without filter 4210 0751
Fine filter for filter system filtersystempoint 2 0000 2109
Coarse filter for filter system filtersystempoint 2 0000 2108

Tab. 4: Spare parts list for filter system

User’s manuals
Designation Article no.
Brief instructions point 2 5000 0519
User’s manual point 2 5000 0510
User’s manual aquapoint 2 5000 0537
User’s manual filtersystempoint 2 5000 0546
User’s manual powerpackpoint 2 5000 0528

Tab. 5: Spare parts list for user’s manuals

10 Disposal
Proper disposal saves natural resources and prevents the release of harmful substances into the
environment.

10.1 Device and components

The device and its electronic components must not be disposed of with household waste. They
must be disposed of at a communal collection point or public waste disposal authority.

10.2 Packaging
The packaging can be recycled or be disposed of with household waste.

10.3 Batteries
Batteries must not be disposed of with household waste. They must be returned to the distributor
or disposed of at a communal collection point.

10.4 Accessories and wear parts

Disposal of accessories such as tubing, masks, filter cassettes and wear parts (e.g. sealing gaskets)
and other replaced components must be carried out according to the statutory provisions in force
at the area of use. This also applies to contaminated accessories.

- 17 -
Other tests (not part of device servicing)
Pressure stability measurement
To check the device’s pressure stability according to EN ISO 17510-1:2009 clause 6.8.2 aa) appen-
dix BB.2 (14-4 3/2007 MDS Hi), the device has to be put in basic CPAP mode by deactivating
oscillation.

Deactivating oscillation
1. Keep selector key and enter key both pressed down while connecting the power supply
to the device’s DC power connection.
2. Oscillation OFF? Press  appears on the display.
3. Press the enter key .
4. Oscillation OFF appears on the display.

Make sure to reactivate the oscillation after pressure stability measurement. Otherwise
obstructive apneas won’t be detected during therapy.

Activating oscillation
1. Keep selector key and enter key both pressed down while connecting the power supply
to the device’s DC power connection.
2. Oscillation ON? Press  appears on the display.
3. Press the enter key .
4. Oscillation ON appears on the display.

HOFFRICHTER GmbH
Mettenheimer Straße 12 / 14
19061 Schwerin
Germany
phone: +49 385 39925 - 0
fax: +49 385 39925 - 25
e-mail: info@hoffrichter.de
web: www.hoffrichter.de point 2 Service ENG_2013-09-17_05

- 18 -