PETERMANN PM-1699 Bed Wedges User Manual

PETERMANN PM-1699 Bed Wedges

Product Information

The Positionierungskeile Bed Wedges are a set of positioning wedges used for specific purposes and conditions. The set includes 2 x Positionierungskeil (250 x 220 x 130/0 mm) and 1 x Positionierungskeil (500 x 220 x 130/0 mm). The product is made of PU material to provide slip resistance and comes in a dark blue color. It is designed for specific indications and should be used according to the manufacturer’s instructions.

Product Usage Instructions

1. Ensure that the product is used only for its intended purpose and conditions.
2. Check the product variants and accessories included in the set:
   • Positionierungskeil (250 x 220 x 130/0 mm) – 2 units
   • Positionierungskeil (500 x 220 x 130/0 mm) – 1 unit
3. Follow the safety guidelines and symbols provided:
   • Warning symbols and medical device labeling
   • Refer to the user manual provided by the manufacturer
   • Identify the batch/lot number for product identification
4. Understand the product application:
   • Indications and further use
   • Contraindications, such as individual pain sensitivity
   • Risks associated with application
   • Approved areas of application
   • Illustration of the application process
5. Follow the recommended cleaning, care, and disinfection procedures:
   • Clean the product with warm water and mild cleaning agents
   • Avoid abrasive or bleaching substances
   • Refer to the manufacturer’s instructions for disinfection, if necessary
6. Take note of the technical specifications:
   • Material : PU-rutschhemmend
   • Color : Dark blue
   • Weight : 500 g (Positionierungskeil), 125 g (Positionierungskeil), 250 g (Positionierungskeil)
   • UDI : Universal Device Identifier
7. Refer to the warranty information provided.
8. Dispose of the product according to the given instructions.

General Information

Thank you for choosing a Petermann product. Please read the user manual carefully before using the product for the first time! Bed Wedges are part of a product line which is used specifically to assist with positioning of patients in hospitals and other health care facilities in the field of emergency care, diagnostics, nursing and therapy, as well as in home care. The product may only be used for the specified purpose and under the specified conditions. The information in this user manual is for the patient who is being transferred and moved, as well as the user performing the transfer / position change. Contact us if you require additional information or assistance using the Petermann product.

Product versions
Item no.: PM-8010 Bed Wedges set includes:

• 2 x PM-8012
• 1 x PM-8015

Accessories
No accessories are available for this device.

Scope of delivery

Bed Wedges set includes:

• 2 x Bed Wedges 250 x 220 x 130/0 mm
• 1 x Bed Wedge 500 x 220 x 130/0 mm
• User manual

Storage, transport

• Store/transport at -5 C – 40°C
• Other : protect from sunlight

Service life / lifecycle
If the product is used in accordance with the safety instructions, then the expected product service life is three years. However, the effective service life may vary depending on the frequency and intensity of use and the number of cleaning and disinfection cycles.
Perform regular function checks on the product and be sure to observe the safety information (see item 2).

Safety information

WARNING indicates a potential danger which could lead to personal injury or material damage.

• It is the responsibility of the organisation / the user to determine, on the basis of the circumstances (weight / health condition of the patient) and the capabilities of the user, whether several users may be required for the transfer and/or whether additional safety measures are required.
• Defective products may no longer be used.
• Any use of the Bed Wedges other than the intended use is prohibited!
• Ensure that the positionings are performed by the users in a back-friendly manner.
• In case of direct skin contact, observation of changes in skin appearance is indicated.
• Don’t use any pointy objects in combination with the non-slip cushion, since this could result in damage to the product.
• The use of disinfectants containing alcohol should be avoided. Coloured disinfectants (containing iodine) may cause slight discolouration.

Symbols used

Function check
Transfer products are also subject to a natural ageing process. Inspect the equipment regularly and carefully, in particular before each use.

Visual inspection
Ensure that material, seams, handle loops and buckles are undamaged and in functional order. Defective products may no longer be used!

Using the product

Indication and further use

Due to the wide range of possible applications, the indications cannot be tied to a specific clinical picture, since positioning aids are suitable for all applications involving people who require assistance. The product can be used in support of the following diagnoses:

• Support for positioning
• Stabilisation for positioning
• Pressure relief for positioning
• Further applications in combination with turn sheets / sliding mats.

This product may be reused.
Before reusing the product, be sure to perform a thorough function check (see item 2.2) as well as cleaning or disinfection of the product. (see item 5)

Contraindications
Contraindications cannot be tied to a specific clinical picture. Under consideration of the safety information (see item 2), the product may not be used if the patient has any of the following conditions: Individually perceived pain

Application risks

• Increasing the support pressure on wounds or bedsores. → worsening of the skin condition
• Insufficient stabilisation → positioning is not retained
• Improper placement → positioning is not retained

Please contact us in these cases, so that we can offer you an alternate solution.

Areas of application
The product can be used in home care and other health care facilities as well as hospitals in the field of emergency care, diagnostics, nursing and therapy.

Application illustration

Application
The Bed Wedges were developed for an activating and supporting positioning of patients. Their versatility allows for goal-oriented and purposeful positioning in accordance with the planned care, therapeutic or diagnostic measures. The use of Bed Wedges has proven particularly effective at night, in order to ensure that the patient’s sleep is as uninterrupted as possible. Even with the best possible positioning, the patient should be repositioned and/or the positioning should be checked regularly in accordance with the risk level.

Application examples

• Safe and stable positioning up to 135° → Dressing changes on the rump, basic care and change of incontinence material.
• Securing a sitting position in bed → Food intake
• Lateral positioning
• Micro position changes

Visit our website at www.pm-med.de or watch our comprehensive product videos on our YouTube channel.

Approved accessories, combination with other products, sets
Bed Wedges are used in combination with the following products:

• Sliding Mats
• Turn Sheets
• PEM-Disposable Sliding Foil

Petermann transfer aids are part of a comprehensive aid product range, which are effective and back-friendly for the user and comfortable and supportive for the patients. Additional Petermann products may be used according to the situation and clinical picture. Ask our experts. We are happy to help you!

Sets

PM-1695

| PM-2098.2 Turn Sheet
PM-2091 Fixing Stripes
PM-1584 Fitted Sheet
PM-7010 Non Slip Mat
PM-8010 Bed Wedges

PM-1699

| PM-2099.1 Turn Sheet Air Sheet
PM-2091 Fixing Stripes
PM-1234 Air Pump
PM-1233 Cover for Air Cushion
PM-1232 Air Cushion
PM-1584 Fitted Sheet
PM-7010 Non Slip Mat
PM-8010 Bed Wedges

Please observe the user manuals of the other items as well

Product marking / CE

The Petermann Bed Wedges are a Class I Medical Device and meets the EU- Regulation 2017/745 of the European Parliament and Council dated 05.04.2017 for medical devices, also called MDR.
Petermann GmbH is certified in accordance with DIN EN ISO 13485 by TÜV Süd, Medical Devices – Quality management systems applicable to the design and development, production and distribution of aids for people of limited mobility.

Cleaning, care and disinfection

–          Trionic® (DGHM/VAH approval, further information on request)

–          Mikrobac® Tissues*

–          Mikrobac® forte*

–          Bacillol® 30 Foam

–          Bacillol® 30 Tissues

–          Bacillol® 30 Sensitive Tissues

–          Mikrobac® Virucidal Tissues*

__Warm water / mild detergent
Do not use abrasive or bleaching agents!
Do not use sharp-edged objects!| * wipe with a cloth soaked in water after disinfection to avoid residues or layer build-up. Please always follow the manufacturer’s manuals for use when wiping disinfection.
---|---
Be sure to follow the care instructions on the label of each product as well as the manuals for use.

Be sure to follow the care instructions on the label of each product as well as the manuals for use.

Technical Data

UDI
---|---|---|---|---
PM-8010| Bed Wedges set includes:|  | 500 g| (01)04250355380104(10)x
PM-8012| 2 x Bed Wedges| 250 x 220 x

130/0

| 125 g| (01)04250355380128(10)x
PM-8015| 1 x Bed Wedge| 500 x 220 x

130/0

| 250 g| (01)04250355380159(10)x

The manufacturing of our products is subject to highest quality standards. Due to usual manufacturing variations published dimensions and further information concerning the condition of the product are defined as target production specifications. Deviations which might occur are monitored by professional quality management procedures and do not represent a reduction in performance of the respective product.

Warranty

• The company Petermann warrants that the product is free from defects in material and workmanship.
• The warranty period is 1 years. It does not cover defects attributable to abrasion, normal wear, improper use or improper cleaning.
• The company Petermann is not liable for accidental or consequential injury or material damage

Disposal information

There are no specific disposal regulations for Bed Wedges, they can be disposed of in accordance with applicable national and local regulations.

Petermann GmbH Waldweg 3 D-91601 Dombühl

• Phone : +49 (0) 9868-9339-0
• Email : petermann@pm-med.de

References

• med.de - Ihr Medizinportal | Chirurgie | Krankheiten | Gesundheit | Arztsuche
• Innovative Hilfsmittel - Manuellen Transferhilfen - Petermann DE

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