PM 211AA User Manual Ver 1.1

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IMPORTANT SAFEGUARDS READ ALL INSTRUCTIONS BEFORE USING DANGER - To reduce the risk of electrocution: 1. 2. 3. 4. 5.

Always unplug this product immediately after using. Do not use while bathing. Do not place or store this product where it can fall or be pulled into a tub or sink. Do not place in or drop into water or other liquid. Do not reach for a product that has fallen into water. Unplug immediately.

WARNING -To reduce the risk of burns, electrocution, fire, or injury to persons: 1. 2. 3. 4.

5. 6.

7. 8.

This product should never be left unattended when plugged in. Close supervision is necessary when this product is used by, on, or near children or invalids. Use this product only for its intended use as described in this manual. Do not use attachments not recommended by the manufacturer Never operate this product if it has a damaged cord or plug, if it is not working properly, or if it has been dropped, damaged, or dropped into water. Return the product to a service center for examination and repair. Keep the cord away from heated surfaces. Never block the air openings of this product or place it on a soft surface, such as a bed or couch, where their openings may be blocked. Keep the air openings free of lint, hairs, and other similar particles. Never drop or insert any object into any opening or hose. Connect this product to a properly grounded outlet only.

NOTE, CAUTION AND WARNING STATEMENTS: NOTE - Indicate some tips. CAUTION - Indicate correct operating or maintenance procedures in order to prevent damage to or destruction of the equipment or other property WARNING - Calls attention to a potential danger that requires correct procedures or practices in order to prevent personal injury.

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SYMBOLS Manufacturer Authorized representative in the European community Attention, should read the instructions "BF" symbol, indicate this product is according to the degree of protecting against electric shock for type BF equipment. Grounding terminal (for 230V System) Functional earth(for UL only) Consult operating instructions Class II (for UL only) Disposal of Electrical & Electronic Equipment (WEEE): This product should be handed over to an applicable collection point for the recycling of electrical and electronic equipment. For more detailed information about the recycling of this product, please contact your local city office, household waste disposal service or the retail store where you purchased this product.

1. INTRODUCTION This manual should be used for initial set up of the system and for reference purposes. 1.1 General Information The system is a high quality and affordable mattress system suitable for treatment and prevention of pressure ulcers. The system has been tested and successfully approved to the following standards:

APEX MEDICAL S.L. Máximo Aguirre 18 Bis, 8a planta, 48011 Bilbao. Vizcaya. SPAIN

EN 60601-1 EN 60601-1-2 EN 55011 Class B IEC61000-3-2 IEC 61000-3-3

APEX MEDICAL CORP. 9, Min Sheng St., Tu-Cheng, Taipei County, 236, Taiwan 2

526002-1680 V1.1

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1.2 Intended Use This product is intended to help and reduce the incidence of pressure ulcers while optimizing patient comfort. It also provides following purposes: ‧Individual home care setting and long term care of whom suffering from pressure ulcer. ‧Pain management as prescribed by a physician NOTE - Equipment not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide.

2. PRODUCT DESCRIPTION Unpack the box to check for any damage which may have occurred during shipment. If there are damages, please contact your dealer immediately. 2.1 Pump and Mattress System

1. 2. 3. 4.

CPR Pump unit Mattress System Quick Connector

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2.2 Pump Unit

Front

1.Quick Connectors 2.Front Panel

Rear

1.Power Switch 2.Power Cord 3.Air Filter 4. Fuses 5.Mounting Brackets

2.3 Front panel

1.

POWER Enable / Disable the control unit NOTE: Check and ensure the main power switch, found from the side of pump, is ON.

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2.

MAXFIRM The Maxfirm mode will be forced to execute every time the power switch is turned on. It insures the pump is able to reach its maximum operating pressure. This mode will last for 20 minutes and then it will return to previous setting automatically. To disable this function, press Maxfirm button again.

3.

Pressure Adjust The function can automatically adjust the mattress pressure based on the patient’s weight. To remind user the process is on-going, the function LED lights will be periodically flashed from left to right until the Ready LED turn on permanently (the process is completed). There are three conditions will trigger this function to ensure the appropriate pressure setting for the patient. A) Press the Auto-Adjust button for 2 seconds, system will automatically re-adjust the pressure setting. B) The system will automatically start Auto-Adjust immediately after the initial mattress inflation is completed. C) While the system detects a significant change in patient’s weight on the mattress (e.g. patient Ingress) for a period of time, the system will automatically run the function again. While the process is completed, system will return to previous setting automatically. To disable this function, press Auto-Adjust button again. NOTE: During the Auto-Adjust operation, it is normal that system will go through a series of inflation and deflation.

4.

TUNING The Tuning function is to fine-tune the system auto-adjusted preset pressure. Three Tuning levels are available. “0” is system auto-adjusted preset pressure. “+” is one level higher than preset pressure, and “-” is one level lower than preset pressure. NOTE: The Tuning function is only available in alternate and static mode.

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4.2 CPR

4.2 CPR Im Notfall, und falls ein Atemstillstand eintritt, öffnen Sie unverzüglich das CPR-Ventil der Matratze. Die CPR-Ventile befinden sich an der linken unteren Seite der Matratze. (Nur verfügbar bei Matratzen mit Luftzellen über 6,35 cm). Für eine schnellere Entleerung können auch am Kompressor angeschlossenen Luftschläuche abgetrennt werden, doch nur bei Modellen, die mit “quick connectors” (Steckverbindungen) ausgestattet sind.

When there is an emergency to perform CPR on the patient, quickly pull the CPR valves to release air from mattress. The CPR valves are located at the head-end, right-hand-side of the mattress. (Only available for air cell types mattress) The quick connector on the pump unit can be disconnected for even faster deflation. 4.3 PRESSURE FINE-TUNE

4.3 FEINABSTIMMUNG DES DRUCKS

Depending on the desired preference, user can adjust mattress pressure slightly by pressing Tuning button. NOTE - Check to see if the suitable pressure is selected by sliding one hand between the deflated air cells and the patient to feel's patient's buttock. Users should be able to feel the minimum contact.

If the pump unit is equipped without alarm buzzer, the Low Pressure indicator will light up until the low-pressure fault condition is resolved. 4.4 Low Pressure Function When an abnormal low pressure is occurred, the Low Pressure indicator (yellow LED) will light up. Check that connections are correctly made and that they are correctly installed as per installation instructions. NOTE - If the pressure level is consistently low, check for any leakage (tubes or connecting hoses). If necessary, replace any damaged tubes or hoses. Or contact local qualified dealer for repair. If the pump unit is equipped with alarm buzzer, the alarm will buzz and the Low Pressure indicator light up when air pressure is below normal. To mute the alarm, simply press the Alarm Reset button on the side. However, the low pressure indicator remains until the low-pressure fault condition is solved. 4.5 Static Mode

Je nach der gewünschten Einstellung kann der Benutzer den Matratzendruck leicht durch Drücken des Abstimmungs-Knopfes anpassen. WICHTIG: Prüfen Sie den Druck der Matratze, indem Sie mit der Hand unter dem Patienten, zwischen dem Körper und den luftleeren Zellen, entlangfahren. Der Patient sollte möglichst wenig Kontakt spüren. 4.4 NIEDRIGDRUCK-FUNKTION Falls der Druck der Matratze niedriger als normal sein sollte, schaltet sich der Niedrigdruckanzeiger ein (gelbe Lampe), zusammen mit dem Alarm. Versichern Sie sich, dass die Anschlüsse korrekt und gemäß den Installationshinweisen installiert sind. WICHTIG: Falls das Druckniveau sich nicht erhöht, versichern Sie sich, dass kein Luftaustritt (an den Schläuchen oder Anschlüssen) erfolgt. Falls erforderlich, ersetzen Sie die Luftschläuche oder wenden Sie sich an einen Fachmann, um sie reparieren zu lassen. Falls der Kompressor nicht mit Warnanzeige ausgestattet ist, leuchtet der Niedrigdruckanzeiger auf (gelbe Lampe), bis der Störfall beseitigt ist. 4.5 STATISCHER MODUS Falls das System mit der THERAPIE Funktion ausgestattet ist, stellen Sie den Regler auf staischen Modus ein, um den Modus mit alternierendem Druck der Matratze auszuschalten. Durch die Deaktivierung dieser Funktion kehrt die Matratze zum Modus mit alternierendem Druck zurück.

Press the THERAPY button to suspend the alternating mode of mattress. By pressing this button again, the mattress will be back to alternating therapy mode.

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4. FUNKTIONSWEISE

4.6 Alarm Mute

WICHTIG - Lesen Sie die Hinweise zur Funktionsweise vor dem Gebrauch durch. 4.1 ALLGEMEINE FUNKTIONSWEISE 1. Schalten Sie den Netzschalter seitlich an der Pumpe an. 2. Die Pumpeneinheit pumpt Luft in die Matratze; warten Sie mindestens 20 Minuten, bis die Matratze aufgeblasen ist. 3. Solange die Matratze nicht vollständig aufgeblasen ist, leuchtet die gelbe LED (Druck niedrig). 4. Wenn der entsprechende Druck erreicht ist, schaltet die gelbe LED aus und die Pumpe wechselt in den Bedarfsmodus. 5. Alternativ können Sie das Gerät voreinstellen, indem Sie beim erstmaligen Aufblasen auf die Tasten THERAPY, COMFORT und CYCLE TIME drücken (Autofirm-Vorgang). Ihre Einstellungen werden automatisch durchgeführt, sobald der Autofirm-Vorgang abgeschlossen ist (siehe Abschnitt 2.3.3). 6. Stellen Sie den Druck entsprechend dem Gewicht und der Größe des Patienten für bestmöglichen Komfort ein, bei dem der Patient nicht durchliegt. Der Druck in der Matratze baut sich dann langsam auf den gewünschten Druck auf und die Matratze ist einsatzbereit.

When low-pressure situation occurred, both the LED light and buzzer will sound off to warn the patient. By pressing the button, it will temporary mute the buzzer so the care giver may check for possible air leaks. Should the situation not resolved within 5 minutes; the alarm will resume beeping.

5. CLEANING It is important to follow the cleaning procedures before using the equipment on human bodies; otherwise, patients and/or doctors may have the possibility of getting infection. Wipe the pump unit with a damp cloth and a mild detergent, and keep it away from dust. If other detergent is used, choose one that will have no chemical effects on the surface of the plastic case of the pump unit. CAUTION- Do not immerse or soak pump unit. Wipe down the mattress with warm water containing a mild detergent. The cover may also be cleaned by using sodium hypochlorite diluted in water. All parts should be air dried thoroughly before use. CAUTION- Do not use phenolic-based product for cleaning. CAUTION- Dry the mattress on SUNLESS capitalized area after cleaning. The carrying bag (if available) should be turned inside out and completely wiped down using the disinfectant solutions. Allow it to air-dry thoroughly. Once the inside is dry, turn it back and wipe down the outside of the bag with disinfectant solutions.

6. STORAGE 1. To store the mattress, lay the mattress out flat and upsides down. 2. Roll from the head end towards the foot end with CPR valve open. 3. Foot-end strap can then be stretched around the rolled mattress to prevent unrolling. NOTE- Do not fold, crease or stack the mattresses.

WICHTIG: Immer wenn Sie die Matratze aufpumpen möchten, ist es empfehlenswert, den Druckregler auf den Höchststand einzustellen, um ein schnelleres Aufpumpen zu erreichen. Sobald die Matratze aufgepumpt ist, kann der Benutzer die Festigkeit oder den Druck derselben regeln.

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7. MAINTENANCE 7.1 General 1. Check main power cord and plug if there is abrasions or excessive wear. 2. Check mattress cover for signs of wear or damage. Ensure mattress cover and tubes are stubbed together correctly. 3. Check airflow from the quick connector. The airflow should alternate between each connector every half-cycle time if it's in alternating mode. 4. Check the air hoses if there is kink or breaks. For replacement, please contact our local dealers. 7.2 Fuse Replacement

Im Falle eines Stromausfalls kann der Pfleger die Transporttasche verwenden (nur für Matratzen-Modelle ohne Luftverlust (“no air loss”), um die Zellen aufgepumpt zu halten, wobei die “quick connectors” abgedeckt werden (siehe Abbildung) Erdanschluss: Bevor es irgendwo angeschlossen wird, muss das Gerät an einen Schutzleiter, wie ein Kabel mit drei Adern, angeschlossen werden; der Stecker darf nur in eine geerdete Steckdose eingeführt werden. Diese Erdung darf nicht durch die Verwendung eines Verlängerungskabels ohne Schutzleiter außer Kraft gesetzt werden. Verschiedene Tipps zur Installation:

1. Disconnect the plug form mains power when a blown fuse is suspected.

Nach der Installation müssen die restlichen Teile des Kabels, die noch offen liegen könnten, ordentlich aufgewickelt werden, um zu vermeiden, dass man darüber stolpert. Das Gerät muss stabil und an einem für den Nutzer oder den Arzt leicht zugänglichen Ort aufgestellt werden.

2. Remove the cover of the fuse holder by means of a small screwdriver. 3. Insert a new fuse of the correct rating in, and replace the cover of the fuse holder back. The fuse should be rated as T1A/250V type and VDE approved. 7.3 Air Filter Replacement 1. Loosen the screws from the air filter plate located at the back of pump. 2. The filter is reusable and can be washed gently with a mild detergent and water. Dry the filter before use. 3. Check and replace environment is dirty.

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filter

regularly

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