Stryker
RemB Electric Handswitch Instructions for Use Rev C Oct 2015
Instructions for Use
13 Pages
Preview
Page 1
NOTE: This portion of the document should not appear
Dimensions:
Color/Material/Finish:
Label Stock:
3.75 inch (width) x 8 inch Booklet
Color Graphics on White Background 20# Bond or Equivalent
N/A
Print Location:
Suppliers/Services:
Print Center
N/A
on produced Labels or IFUs.
Description/Type: Instructions For Use
Stryker Instruments (269) 323-7700 (800) 253-3210
DSGN-fm-50366 rev. None Effective: July 1, 2008
Part Number:
Rev.
6400-009-700
C
Page 1 of 1
RemB Electric Hand Switch ®
6400-009-000
Instructions For Use
ENGLISH (EN) 2015-10
6400-009-700 Rev-C
www.stryker.com
EN
6400-009-700 Rev-C
Introduction This Instructions For Use manual is the most comprehensive source of information for the safe and effective use of your product. This manual may be used by in-service trainers, physicians, nurses, surgical technologists, and biomedical equipment technicians. Keep and consult this reference manual during the life of the product. The following conventions are used in this manual: • A WARNING highlights a safety-related issue. ALWAYS comply with this information to prevent patient and/or healthcare staff injury. • A CAUTION highlights a product reliability issue. ALWAYS comply with this information to prevent product damage. • A NOTE supplements and/or clarifies procedural information. For additional information, especially safety information, or inservice training, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary. NOTE: The RemB Electric Hand Switch (handswitch) is also known as the RemB Hand Switch.
Indications For Use The RemB Electric Hand Switch is intended for use with the Consolidated Operating Room Equipment (CORETM) System and specific RemB Electric handpieces. The RemB Electric Hand Switch is attached to the handpiece and allows direct operation of the handpiece. This device can also be used with specific CORE handpieces, the Total Performance System (TPSTM) and specific TPS handpieces. See For Use With.
Contraindications None known.
2
www.stryker.com
EN
6400-009-700 Rev-C
User/Patient Safety WARNINGS: • Only trained and experienced healthcare professionals should use this equipment. • Before using any system component, or any component compatible with this system, read and understand the instructions. Pay particular attention to WARNING information. Become familiar with system components prior to use. • The healthcare professional performing any procedure is responsible for determining the appropriateness of this equipment and the specific technique for each patient. Stryker, as a manufacturer, does not recommend surgical technique. • Use only Stryker-approved system components and accessories, unless otherwise specified. • DO NOT modify any system component or accessory, unless otherwise specified. • Upon initial receipt and before each use, operate the equipment and inspect each component for damage. DO NOT use any equipment if damage is apparent. • Upon initial receipt and before each use, clean and sterilize the equipment as indicated. See the care instructions manual supplied with the handpiece.
4
www.stryker.com
6400-009-700 Rev-C
EN
Features
B
A
D
C A
Lever
B
Finger Rest
C
Handswitch Band
D
Safety Switch
Definitions The symbols located on the equipment and/or labeling are defined in this section or in the Symbol Definition Chart. See the Symbol Definition Chart supplied with the equipment. SYMBOL
DEFINITION
RUN
Operate Handpiece Position
SAFE
Deactivate Handpiece Position Installation Alignment Mark General warning sign
www.stryker.com
5
EN
6400-009-700 Rev-C
Instructions WARNINGS: • ALWAYS set the safety switch to the SAFE position while the handpiece is idle, when passing the handpiece to another person, or before inserting or removing a cutting accessory or attachment. • DO NOT press the pedal of a connected footswitch while the safety switch is set to the SAFE position. An accidental pedal press will override the SAFE position and activate the handpiece.
To Install the Handswitch 1. Make sure the cord is not connected to the handpiece. 2. Completely retract the finger rest. 3. Set the safety switch to the SAFE position. 4. Align the alignment mark on the handswitch with the alignment mark on the connector end of the handpiece. 5. Slide the handswitch band over the end of the handpiece until the handswitch band is flush with the handpiece connector. NOTE: The cord will not seat properly if the handswitch band is not flush with the handpiece connector.
6
www.stryker.com
6400-009-700 Rev-C
EN
6. Insert the cord into the handpiece connector.
To Operate the Handswitch WARNING: ALWAYS operate the equipment within the specified environmental condition values. See the Specifications section. NOTE: See the instructions for use supplied with the handpiece for information about handpiece operation. 1. Adjust the length of the finger rest so that the handpiece can be held like a pencil. NOTE: When using the handswitch with a TPS Oscillating Saw, fully extend or fully retract the finger rest to clear the handpiece protrusion.
2. Install the cutting accessory into the handpiece. 3. Set the safety switch to the RUN position. 4. Depress the lever to control the variable speed of the handpiece. NOTE: The maximum handpiece speed is selected from the console.
www.stryker.com
7
EN
6400-009-700 Rev-C
Instructions (continued) To Remove the Handswitch 1. Completely retract the finger rest. 2. Set the safety switch to the SAFE position. 3. Remove the cutting accessory from the handpiece. 4. Remove the cord from the handpiece connector. CAUTION: DO NOT pull back on the lever when removing the handswitch from the handpiece. 5. Hold the distal end of the handpiece. Grasp the handswitch band and slide the handswitch off of the handpiece.
Care Instructions For processing instructions and disposal/recycle information, see the care instructions manual supplied with the handpiece.
8
www.stryker.com
6400-009-700 Rev-C
EN
Troubleshooting WARNING: DO NOT disassemble or service this equipment unless otherwise specified. NOTE: For service, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary. PROBLEM
CAUSE
ACTION
The handswitch does not operate.
The handswitch is not properly seated on the handpiece.
Reseat the handswitch on the handpiece.
The safety switch is in the SAFE position.
Set the safety switch to the RUN position.
The handswitch is sideloaded.
Align the lever with the body of the handpiece.
The handpiece does not operate at full speed.
Specifications WARNING: ALWAYS check any documentation that accompanies attachments and/or cutting accessories for special duty cycle and usage instructions. Model:
RemB Electric Hand Switch REF 6400-009-000
Dimensions:
6.0 inch [152.4 mm] length 0.91 inch [23.1 mm] diameter
Mass:
0.036 lb [0.016 kg]
Environmental Conditions:
Operation
Storage and Transportation
Temperature Limitation: Humidity Limitation:
Atmospheric Pressure Limitation:
www.stryker.com
9
ES/DE/FR/IT/NL JA/ZH/KO SV/DA/FI/PT/NO PL/EL
6400-009-713 6400-009-720 6400-009-730 6400-009-750
Stryker Instruments 4100 E. Milham Kalamazoo, Michigan (USA) 49001 1-269-323-7700 1-800-253-3210 2015-10
6400-009-700 Rev-C
www.stryker.com