Lowenstein Medical prisma SMART User manual

prisma SMART
prisma SOFT
Sleep therapy devices
EN Instructions for Use for devices of type WM 090 TD

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WM 68201a 06/2016
Contents
Contents
1 Introduction 4
1.1 Intended use ............................................................................................. 4
1.2 Description of function ............................................................................. 4
1.3 User qualifications ..................................................................................... 4
1.4 Indications ................................................................................................ 4
1.5 Contraindications ...................................................................................... 5
1.6 Side effects ............................................................................................... 5
2 Safety 6
2.1 Safety information .................................................................................... 6
2.2 General information .................................................................................. 6
2.3 Warnings in this document ....................................................................... 8
3 Product description 9
3.1 Overview .................................................................................................. 9
3.2 Operating states ..................................................................................... 10
3.3 Control panel .......................................................................................... 10
3.4 Symbols in the display ............................................................................. 11
3.5 Accessories ............................................................................................. 12
4 Preparation and operation 13
4.1 Set up and connect the device ................................................................ 13
4.2 Start therapy ........................................................................................... 15
4.3 End therapy/switch off device ................................................................. 15
4.4 Set humidifier ......................................................................................... 15
4.5 Performing the mask test ........................................................................ 16
4.6 Switch softSTART on and off ................................................................... 17
4.7 Use SD card (optional) ............................................................................. 18
5 Menu settings 19
5.1 Function of the keys ................................................................................ 19
5.2 Settings menu ......................................................................................... 19
5.3 Info menu/read out operating hours ....................................................... 21

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Contents
6 Hygiene treatment 22
6.1 General information ................................................................................ 22
6.2 Cleaning intervals ................................................................................... 22
6.3 Hygiene treatment for device .................................................................. 23
6.4 Hygiene treatment for breathing tube ..................................................... 25
7 Function check 25
8 Troubleshooting 26
8.1 Device faults ........................................................................................... 26
8.2 Display messages .................................................................................... 27
9 Servicing 28
10 Storage 28
11 Disposal 28
12 Appendix 29
12.1Technical data ......................................................................................... 29
12.2Marks and symbols ................................................................................. 33
12.3Scope of supply ...................................................................................... 35
12.4Accessories and replacement parts .......................................................... 36
12.5Warranty ................................................................................................ 36
12.6Declaration of conformity ....................................................................... 36

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1 Introduction
1 Introduction
1.1 Intended use
Devices of the WM 090 TD type are pressure-controlled, non-invasive, non-life-
supporting therapy devices for treating sleep-related breathing disorders (SRBDs) using
a mask. The devices are used on persons weighing 30 kg or more. CPAP mode can be
used on persons aged 3 years upwards. The device may only be used on a physician's
instructions. (auto)CPAP mode provides positive airway pressure for treating
obstructive sleep apnea in patients who breathe spontaneously. Devices of the
WM 090 TD type are used in clinical facilities and in the domestic environment. In the
domestic environment, the devices also accompany the owner on trips away.
1.2 Description of function
A blower takes in ambient air through a filter and pumps it to the patient at therapy
pressure through the patient circuit and the patient/ventilator interface. The user
interface is for displaying and setting the available parameters. Therapy data are saved
on the SD card and can be evaluated using PC software.
1.3 User qualifications
The person operating the device is referred to in these Instructions for Use as the user.
A patient, on the other hand, is the person receiving the therapy.
As an owner/operator or user you must be familiar with the operation of this medical
device. The owner/operator is responsible for ensuring the compatibility of the device
and of all the components or accessories connected to the patient before use.
When the device is handed over to the patient, as the attending physician or medical
specialist you must provide instruction in the function of the device.
1.4 Indications
prisma SOFT
CPAP therapy device for treating patients with obstructive sleep apnea with a constant
pressure requirement.
prisma SMART
APAP therapy device for treating patients with obstructive sleep apnea with a variable
pressure requirement. Therapy pressure adapts automatically to the patient's pressure
requirement.

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1 Introduction
1.5 Contraindications
The following contraindications are known - in the individual case, responsibility for
deciding whether to use the device rests with the attending physician. Threatening
situations have not ever been observed.
Cardiac decompensation, severe cardiac arrhythmias, severe hypotension, especially in
combination with intravascular volume depletion, severe epistaxis, high risk of
barotrauma, severe lung disease (e.g. COPD), pneumothorax or pneumomediastinum,
pneumoencephalus, head injury, status following brain surgery and following surgical
procedures on the hypophysis or middle or inner ear, acute inflammation of the nasal
sinuses (sinusitis), middle ear infection (otitis media) or perforated eardrum,
dehydration.
1.6 Side effects
When using the device, the following undesired side effects may occur in short-term
or long-term use: pressure points from the mask and the forehead cushion on the face,
reddening of the facial skin, dry throat, mouth, nose, feeling of pressure in the sinuses,
irritated mucous membrane in the eyes, gastrointestinal insufflation of air
("bloating"), nosebleeds, reduced auditory capacity.
These are general side effects not attributable specifically to use of devices of the
WM 090 TD type.

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2 Safety
2 Safety
2.1 Safety information
2.1.1 Handling the device, the components and the accessories
If the device is damaged or its function is restricted, patients, users and people in the vicinity
may be injured.
⇒Only operate the device and its components if they are externally undamaged.
⇒Perform a function check at regular intervals (see "7 Function check", page 25).
⇒Only operate device within the specified ambient conditions (see "12.1 Technical
data", page 29).
⇒Do not reuse disposables. Disposables may be contaminated and/or their function may
be impaired.
⇒Water and dirt in the device may damage the device.
⇒Only transport the device with the cover fitted.
⇒Transport the device in the associated carrying bag.
⇒Do not transport or tilt the device with the humidifier full.
⇒Use the gray air filter.
⇒Use the white pollen filter (optional accessory) if required.
2.1.2 Energy supply
Operating the device outside the specified energy supply may injure the user and damage
the device.
⇒Operate the device only with the power supply unit provided on voltages from 100 V
to 240 V.
⇒Use the DC adapter for operation on voltages of 12 V or 24 V.
⇒Keep access to the power supply connector and the power supply free at all times.
2.1.3 Handling oxygen
Supplying oxygen without a special safety device can lead to fire and injure people.
⇒Follow the Instructions for Use for the oxygen supply system.
⇒Set up oxygen sources at a distance of over 1 m from the device.
⇒At the end of therapy, shut off the oxygen supply and allow the device to run on briefly
to flush residual oxygen out of the device.
2.2 General information
• The use of third-party articles may lead to incompatibility with the device. In such
cases, please be aware that any claim under warranty and liability will be void if neither
the accessories nor the genuine replacement parts recommended in the Instructions
for Use are used.

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2 Safety
• Have measures such as repairs, servicing and maintenance work carried out by the
manufacturer or by specialists expressly so authorized by the manufacturer.
• Connect only the devices and modules permitted in accordance with these Instructions
for Use. The devices must meet the product standard applicable to them. Non-medical
equipment should be positioned away from the patient's vicinity.
• The device is subject to special precautions with regard to EMC (electromagnetic
compatibility). Maintain the recommended safety distances (see "12.1.5 Safety
distances", page 33) between the device and devices which emit high-frequency
radiation (e.g. cellphones) to prevent malfunctions.
• In combination with the device itself, the use of tube heating will generate a slightly
higher temperature at the patient connection opening.
• The operator is responsible for ensuring that the setting of the therapeutic pressure
has been determined for each patient individually with the device configuration to be
used.
• The operator should regularly assess the effectiveness of the therapeutic settings.
• To prevent infection or bacterial contamination, follow the section about hygiene
treatment (see "6 Hygiene treatment", page 22).
• Keep therapy device and accessories away from children and pets. Store therapy
device in transportation case when not in use or being transported.

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2 Safety
2.3 Warnings in this document
Warnings indicate information relevant to safety.
Within procedures, you will find warnings in front of a step which contains a hazard
to persons or objects.
Warning!
Indicates an unusually significant hazardous situation. If you
ignore this instruction, severe irreversible or fatal injuries may
result.
Caution!
Indicates a hazard. If you do not follow this instruction, mild
or moderate injuries may result
Note!
Indicates a harmful situation. If you do not follow this
instruction, material damage may result.
Indicates useful information within procedures.

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3 Product description
3 Product description
3.1 Overview
1 Humidifier connection with cover
2 Release catch
3 Control panel with display
4 Interface for connecting the communication module
5 Handle
6 Filter compartment
7 Connection for power supply cable
8 Breathing tube with connection for mask
12
3
45
6
7
8
9
12
10
11
13

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3 Product description
9 SD card slot
10 Power supply unit
11 SD card
12 Power cord
13 Device outlet port
3.2 Operating states
•On: therapy is running.
•Standby: blower is off, but immediately operational if the On/off key is pressed briefly.
Settings can be made on the device when it is in standby mode.
•Off: the device is de-energized. No settings can be made and the display remains dark.
3.3 Control panel
1 key*
2 key*
3 On/Off key*
4 Menu key*
5 softSTART key*
p
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i
s
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12345

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3 Product description
3.4 Symbols in the display
*
The keys of the device may have different functions. If there is a symbol above the key in
the display, the key adopts the function of the symbol in question. If there is no symbol
above the key, the key retains its original function.
SYMBOL DESCRIPTION
Orange symbol: expert area active.
White symbol: parameters enabled for patient.
Parameter is disabled for patient.
Info menu
Settings menu
SoftSTART symbol
Green symbol: SD card inserted. When the symbol is flashing, data
are being written to the SD card.
Orange symbol: SD card fault
Leak display. Mask or tube leaking.
White symbol: Humidifier connected.
Green symbol: Humidifier switched on.
Back to start screen
Cancel
Forward one menu item
Back one menu item
Confirms the current selection.
Selection adopted successfully.

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3 Product description
3.5 Accessories
1 Humidifier
2 Pollen filter (white)
3 12-24 V DC adapter
2
3
1

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4 Preparation and operation
4 Preparation and operation
4.1 Set up and connect the device
1. Connect the power supply unit to the device.
Risk of injury due to contaminated or infected patient circuit!
A contaminated or infected patient circuit may transmit contamination or infections
to the next patient.
⇒Do not reprocess disposable patient circuits.
⇒Subject reusable patient circuits to the correct hygiene treatment.
Material damage from overheating!
Excessive temperatures may lead to the device overheating and damage the device.
⇒Do not cover device and power supply unit with textiles (e.g. bedclothes).
⇒Do not operate device in the vicinity of a radiator.
⇒Do not expose device to direct sunlight.
⇒Do not operate device in the carrying bag.

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4 Preparation and operation
2. Connect the power cord to the power supply unit and the socket.
The operating hours of the device are displayed briefly. The device switches to
standby.
3. Push breathing tube onto the device outlet port.
Risk of injury if breathing tube routed incorrectly!
An incorrectly routed breathing tube may injure the patient.
⇒Never wrap the breathing tube around the neck.
⇒Do not crush the breathing tube.

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4 Preparation and operation
4. Connect the mask to the breathing tube (see Instructions for Use for the breathing
mask).
4.2 Start therapy
Requirement
Device is set up and connected (see "4.1 Set up and connect the device", page 13).
1. If the display is dark: press any key briefly.
The device switches to standby.
2. Briefly press the On/off key .
or
If the autoSTART function is activated: breathe into the mask.
Current therapy pressure appears in the display. Therapy starts.
4.3 End therapy/switch off device
1. Briefly press the On/off key .
or
If the autoSTART function is activated: remove mask.
The device displays the therapy hours for the current day and then switches to
standby.
4.4 Set humidifier
Requirement
Humidifier is connected and filled with water (see Instructions for Use for humidifier).
The humidifier symbol can be seen in the display.
Risk of suffocation if full-face masks without an exhalation system are used!
If full-face masks without an exhalation system are used, the CO2concentration may
rise to critical values and put the patient at risk.
⇒Use full-face masks with an external exhalation system if there is no integrated
exhalation system.
⇒Follow the Instructions for Use for the exhalation system.
The proper position and arrangement of the mask on the face of the patient is
critical for uniform use of the device.
For more information on autoSTART (see "5 Menu settings", page 19).
To save energy, you can disconnect the plug from the socket during the day.

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4 Preparation and operation
1. Start therapy (see "4.2 Start therapy", page 15).
The humidifier switches on automatically. The humidifier symbol goes green .
2. To increase the humidifier stage: press the key.
3. To decrease the humidifier stage: press the key.
4. To switch off the humidifier: press the key until
0 appears in the display.
4.5 Performing the mask test
Requirement: Therapy is running.
1. Press menu button .
2. To start the mask test: Press .
The remaining time and the mask test pressure are displayed.
3. If necessary: Press or button to change the mask test pressure.
4. Check mask for leaks.
Proper mask location: Green checkmark.
Mediocre mask location: Leakage display turns orange.
Poor mask location: Leakage display flashes.
5. If necessary: Adjust mask.
6. Wait until the device has completed the mask test.
or
Press .
• The humidifier stage suitable for you depends on room temperature and
humidity. If you have dry airways in the morning, heating output is set too low.
If condensation has formed in the breathing tube in the morning, heating
output is set too high.
• When the water level in the humidifier is too low, the device switches off the
humidifier automatically.
• If the humidifier symbol is flashing, you need to fill the humidifier with water
(see Instructions for Use for humidifier).

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4 Preparation and operation
4.6 Switch softSTART on and off
Requirement
Therapy is running. softSTART is activated by the physician.
If the soft start is activated, the device automatically turns on every time therapy is
started.
1. Press the softSTART key briefly to switch on softSTART manually.
Remaining time and the current softSTART pressure are displayed.
2. Press the softSTART key briefly to switch off softSTART.
4.7 Use SD card (optional)
If an SD card is present, the device automatically saves the therapy data to the SD card.
An SD card is not required to operate the device.
Requirement
The device is on standby.
• If you press the softSTART key when the device is on standby, the device
switches to the patient menu and you can adjust the softSTART time (see "5.2
Settings menu", page 19).
• To deactivate softSTART, set the softSTART time to
OFF
Loss of data if power is interrupted!
If the device is disconnected from the power supply during the save process, data may
be lost.
⇒Leave the device connected to the power supply during the save process (SD card
symbol flashing).

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4 Preparation and operation
1. Push the SD card into the SD card slot until you hear it engage.
The SD card symbol appears in the display.
2. To remove it, press the SD card briefly and remove the SD card. In doing so, please
note: do not remove the SD card while the SD card symbol is flashing.

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5 Menu settings
5 Menu settings
5.1 Function of the keys
The keys of the device may have different functions. If there is a symbol above the key
in the display (e.g. above the softSTART key), the key adopts the function of the
symbol in question. If there is no symbol above the key (e.g. in the case of the
key), the key retains its original function.
5.2 Settings menu
5.2.1 Navigate in the menu
Requirement
The device is on standby.
1. Press the menu key .
2. To call up the settings menu: press .
3. Make settings in the menu.

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5 Menu settings
5.2.2 Menu structure
You can set the following parameters if your physician has enabled them for you.
FUNCTION KEY DESCRIPTION
Scroll forward through menu
Scroll back through menu
Increase value
Reduce value
Confirm value
Discard value
Exit menu. Switch back to start screen.
PARAMETER DESCRIPTION
softSTART (
t )
Here you can set the time for which ventilation pressure rises to
therapy pressure during the softSTART. If this function cannot be
selected, it needs to be enabled by the physician or specialist
dealer.
autoSTART
If autoSTART is activated (
ON ), the device can be switched on by a
breath (> 0.5 hPa) being taken into the mask and switches off
automatically after 5 seconds without a breath being taken.
Switch autoSTART to
OFF to switch off this function.
softPAP
The device temporarily reduces therapy pressure in stages
1 and 2
before the transition to exhalation.
softPAP breathing relief is suitable for patients who find it
unpleasant to exhale against a high pressure. Switch softPAP to
OFF to deactivate this function.
Time You can set the current time here.
Format time
display
Here you can set whether the time is to be displayed in the form
0-24 (
24-h clock) or 0-12 ( 12-h clock).