SchureMed 800-0074-P Pediatric Stirrup Dolly Instructions
- June 11, 2024
- SchureMed
Table of Contents
SchureMed 800-0074-P Pediatric Stirrup Dolly Instructions
Pediatric Stirrup Dolly 800-0074-P
INTENDED USE
Intended use is to store components of our Great White Pediatric Stirrups. The intended users of this device are medical professionals within hospitals and surgery centers.
INSTRUCTIONS
- Position stirrup mounting blade as shown. If mounting blade doesn’t face down as shown, squeeze trigger on handle and it will automatically position itself.
- Insert blade completely into blocks mounted on dolly
- Locate left and right stirrup by label on bottom of boot
- Use hook and loop fastener straps provided on dolly to wrap around stirrups and fasten down
COMPONENT OVERVIEW
Pediatric Stirrup Dolly is a storage cart used to store the components of our Great White Pediatric Stirrups.
GENERAL SPECIFICATIONS
Device Dimensions (maximum)
- Length: 27” +/- 0.5” (69 cm +/- 1 cm)
- Width: 12” +/- 0.5” (31 cm +/- 1 cm)
- Height: 38” +/- 0.5” (97 cm +/- 1 cm)
- Device Weight: 28 +/- 0.5 lbs. (12.7 +/- .22 kg)
- Fully Assembled
GENERAL INFORMATION
- Product not made with Natural Rubber Latex
- Product warranty covers product from manufacturing defects for period of 2 years
- CE marked medical device according to MDR (EU) 2017/745
- Product is maintenance-free, check product condition before next use
- Life of device is 5 years under normal use
- Store device between -4°F to +86°F (-20°C to 30°C)
DISPOSAL
- General – Prevent infection by cleaning and disinfecting product before disposal
- Packaging – Dispose packaging material via household waste according to national requirements
- SchureMed accepts back used or retired products – or dispose of product in accordance with national requirements
PRODUCT USE WARNINGS
WARNING!
Hazard resulting from incorrect use. Be absolutely sure to follow Instructions
for Use when operating dolly.
WARNING! Do not reuse device if there are obvious signs of damage or functional issues. Consult manufacturer before reusing.
CLEANING & DISINFECTING
Spray and wipe clean with hospital approved disinfectant. No sterilization.
USER NOTICE
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.
Basic UDI-DI: 081001460F0006DU
Symbol Glossary
| Symbol | Title | Symbol Description |
|---|---|---|
| Manufacturer | Indicates the medical device manufacturer. | |
| Authorized Representative in the European Community | Indicates the |
authorized representative in the european community.
| Use-by Date| Indicates the date after which the medical device is not to be
used.
| Batch Code| Indicates the manufacturer’s batch code so that the batch or lot
can be identified.
| Catalogue or Item Number| Indicates the manufacturer’s catalogue or item
number so that the medical device can be identified.
| Serial Number| Indicates the manufacturer’s serial number so that a specific
medical device can be identified.
| Caution| To indicate that caution is necessary when operating the device or
control close to where the symbol is placed, or to indicate that the current
situation needs operator awareness or operator action in order to avoid
undesirable consequences.
| Medical Device| Indicates the item is a medical device.
| Unique Device Identifier| Indicates a barcode as containing unique device
identifier information.
| CE Marking| European Conformity.
| Single Patient Use| Indicates the item is a single patient use medical
device.
Manufacturer
SchureMed (081001460)
Authorized Representative
Emergo Europe, Prinsessegracht 20, 2514 AP The Hague, The Netherland