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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WM 68201a 06/2016
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
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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*
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