Stryker SurgiCount+ User manual

SSuurrggiiCCoouunntt®®++ SSyysstteemm
IInnssttrruuccttiioonnss FFoorr UUssee
CCrraaddllee
0694-002-002
RReeaaddeerr
0694-002-005
SSttaanndd
0694-002-001
AAlltteerrnnaattiivvee CCrraaddllee MMoouunnttss
0694-002-003
0694-002-004
DDiissppoossaabblleess
0694-002-010
0694-002-006
EN
700001138880 Rev-AC2021-02

TTaabbllee ooff CCoonntteennttss
Important Information ....................................................................................2
Using this Manual.......................................................................................2
Contact Information.....................................................................................2
Intended Users..........................................................................................2
Indications For Use .....................................................................................2
Contraindications .......................................................................................2
For Use With ............................................................................................3
Documentation..........................................................................................3
Safety Directives........................................................................................4
Acronyms................................................................................................5
Definitions ...............................................................................................6
Product Overview.........................................................................................7
Cradle....................................................................................................7
Reader ...................................................................................................8
Stand (Recommended Cradle Mounting Option). .. .... .... .... .... ....................... .... .... .. 9
Alternative Cradle Mounting Options ................... .... .... .... .... .. .. .. .. .. .. .. .. .. .. .. .. .... .10
Getting Started ...........................................................................................11
Before Use..............................................................................................11
Using Your Product......................................................................................12
Charging the System ..................................................................................12
Interacting with the Cradle ............................................................................12
Reader Instructions....................................................................................13
Docking and Undocking the Reader ............... .... .... .... .... .. .. .. .. .. .. .. .. .. .. .. .. .... .13
Replacing the Reader Battery.. .... .... .... .. .. .. .. .. .. .. .. .. .. .. .. .... .... .... .... ..............14
Preparing the Reader for Sterile Use.......................... .... .... .... .. .. .. .. .. .. .. .. .. .. ..16
Interacting with the Stand.............................................................................17
After Use ...................................................................................................18
Cleaning and Disinfection.............................................................................18
References ................................................................................................19
Inspection and Maintenance.... .... .... .... .... .. .. .. .. .. .. .. .. .. .. .. .. .... .... .... .... ..............19
Service..................................................................................................19
Troubleshooting........................................................................................20
Disposal/Recycle ......................................................................................21
Specifications ..........................................................................................22
Environmental Conditions.... .... .... .... .. .. .. .... .... .. .. .... .. .... .... .... ....................... ..24
Electromagnetic Compatibility............. .... .... .... .. .. .. .. .. .. .. .. .. .. .. .. .... .... .... .... .......25
700001138880 Rev-AC 1 EN

IImmppoorrttaanntt IInnffoorrmmaattiioonn
UUssiinngg tthhiiss MMaannuuaall
This manual is the most comprehensive source of information for the safe, effective, and
compliant use and/or maintenance of your product. This product is intended for use by trained and
experienced healthcare professionals only. Read and understand this manual before using the
product or any component compatible with the product. Contact Stryker for training as needed.
This manual is a permanent part of the product. Keep this manual for future reference.
The following signal words may be used throughout this manual:
WWAARRNNIINNGG -- Highlights a safety-related issue. Always comply with this information to prevent
patient and/or healthcare staff injury.
CCAAUUTTIIOONN -- Highlights a product reliability issue. Always comply with this information to prevent
product damage.
NNoottee -- Supplements and/or clarifies procedural information.
CCoonnttaacctt IInnffoorrmmaattiioonn
Stryker Representative
1-269-323-7700, 1-800-253-3210
[email protected]
www.stryker.com
IInntteennddeedd UUsseerrss
This equipment is intended for use by physicians, nurses, surgical assistants, and biomedical
equipment technicians.
IInnddiiccaattiioonnss FFoorr UUssee
Refer to the instructions for use for the applicable Surgical Tablet software application.
CCoonnttrraaiinnddiiccaattiioonnss
Refer to the instructions for use for the applicable Surgical Tablet software application.
EN 2 700001138880 Rev-AC

FFoorr UUssee WWiitthh
WWAARRNNIINNGG
• Use only Stryker-approved electronic components and accessories. Failure to comply may
result in degraded performance, increased electromagnetic emissions or decreased
electromagnetic immunity of the system, see
Electromagnetic Compatibility (page 25).
• Use only Stryker-approved components and accessories, unless otherwise specified.
This product is intended for use with:
CCoommppoonneennttss RREEFF
Surgical Tablet 0794-001-010
SurgiCount®+ Reader 0694-002-005
SurgiCount®+ Stand 0694-002-001
AAcccceessssoorriieess
AAlltteerrnnaattiivvee CCrraaddllee MMoouunnttss RREEFF
SurgiCount®+ Cradle Wall Mount 0694-002-003
SurgiCount®+ Cradle Pole Mount 0694-002-004
DDiissppoossaabblleess RREEFF
SurgiCount®+ Sponge Counting Bag (QTY 250) 0694-002-010
SurgiCount®+ Reader Cover (QTY 90) 0694-002-006
NNoottee -- For ordering information, contact a Stryker sales representative.
DDooccuummeennttaattiioonn
This table identifies documentation associated with the SurgiCount®+ System.
IInnssttrruuccttiioonnss ffoorr UUssee RREEFF
Surgical Tablet 700000794727
SurgiCount®+ System (Cradle, Reader, Stand, Alternative
Cradle Mounts, Disposables)
700001138880
IInnssttaallllaattiioonn GGuuiiddeess ((MMoouunnttiinngg OOppttiioonnss)) RREEFF
SurgiCount®+ Stand 700001353738
SurgiCount®+ Cradle Wall Mount 700001130845
SurgiCount®+ Cradle Pole Mount 700001130854
700001138880 Rev-AC 3 EN

SSaaffeettyy DDiirreeccttiivveess
GGeenneerraall SSaaffeettyy
WWAARRNNIINNGG
• Only healthcare professionals that are trained and experienced in the use of this medical
device should operate this equipment, see
Intended Users (page 2).
• Equipment is limited to professional use within a professional healthcare environment.
• Healthcare professionals should be thoroughly familiar with the instructions for use, handling
characteristics, and the indicated, contraindicated, and intended uses of this equipment.
Contact your Stryker sales representative or customer service for in-service training.
• Always inspect the product and all system components for damage upon initial receipt and
before each use. Do not use the product if damage is apparent.
• Do not disassemble, modify, or repair this product without the authorization of the
manufacturer. Contact Stryker for service.
• Always operate, store, and transport the equipment within the specified environment, see
Environmental Conditions (page 24).
• Do not stare directly into the SurgiCount®+ Reader barcode scanner.
EElleeccttrriiccaall SSaaffeettyy
WWAARRNNIINNGG
• Take special precautions regarding electromagnetic compatibility (EMC) when using the
SurgiCount®+ System. Install and place this medical electrical equipment into service
according to the EMC information contained in this manual. Portable and mobile
radiofrequency equipment and high frequency (HF) surgical equipment can affect the function
of this medical electrical equipment, see
Electromagnetic Compatibility (page 25).
• Always maintain a minimum separation distance of 6 inches [15 cm] from an in-use pacemaker
and the UHF RFID antenna of the SurgiCount®+ Reader while in use. Failure to comply may
cause interference with the pacemaker.
BBaatttteerryy SSaaffeettyy
WWAARRNNIINNGG
• Do not allow battery contacts to touch metal objects.
• The SurgiCount+ Cradle and SurgiCount+ Reader use lithium-ion batteries. To reduce the risk
of fire or burns, do not disassemble, crush, burn, or puncture the batteries. For disposal/
recycle information, see
Disposal/Recycle (page 21).
IInnffeeccttiioonn CCoonnttrrooll aanndd SSaaffeettyy
WWAARRNNIINNGG
• Do not allow any equipment other than a properly prepared reader to enter the sterile field.
Always prepare the reader for sterile use before using the device within the sterile field, see
Preparing the Reader for Sterile Use (page 16). Failure to comply may cause infection and
result in patient or healthcare staff injury.
• Do not contact the patient with the SurgiCount®+ Reader or SurgiCount®+ Reader Cover.
Failure to comply may cause infection and result in patient or healthcare staff injury.
• Always clean and disinfect the equipment as indicated upon initial receipt and after before use.
Failure to comply may cause infection and result in patient or healthcare staff injury. For
cleaning and disinfection information, see
Cleaning and Disinfection (page 18).
EN 4 700001138880 Rev-AC

RRaaddiioo FFrreeqquueennccyy EExxppoossuurree aanndd MMaaggnneettiicc RReessoonnaannccee ((MMRR)) SSaaffeettyy
WWAARRNNIINNGG
• Always maintain a minimum separation distance of 9 inches [23 cm] from the head and torso of
a person and the UHF RFID antenna of the SurgiCount®+ Reader while in use. Failure to
comply may cause FCC RF exposure limits to be exceeded.
• The SurgiCount®+ System is MR unsafe. Do not use the system in an MR environment.
AAccrroonnyymmss
AAccrroonnyymm DDeeffiinniittiioonn
CEC California Energy Commission
EMC ElectroMagnetic Compatibility
EPA Environmental Protection Agency
FCC Federal Communications Commission
HF High Frequency
LAN Local Area Network
LED Light-Emitting Diode
MR Magnetic Resonance
PPE Personal Protection Equipment
RF Radio Frequency
RFID Radio Frequency IDentification
UHF Ultra High Frequency
US EPA United States Environmental Protection Agency
USB Universal Serial Bus
WEEE Waste Electrical and Electronic Equipment
700001138880 Rev-AC 5 EN

DDeeffiinniittiioonnss
NNoottee -- Additional product and/or labeling symbols are defined in the Symbol Definition Chart
supplied with the product.
LLaabbeelliinngg
Fragile
Magnetic Resonance (MR)
Crossed-Out Wheeled Bin Lithium-Ion
Universal Recycling Lithium-Ion
SSuurrggiiCCoouunntt++ EEqquuiippmmeenntt SSyymmbboollss aanndd DDeeffiinniittiioonnss
UHF RFID Antenna
USB Type-A
Power Cord Hook Release Indicator
EN 6 700001138880 Rev-AC

PPrroodduucctt OOvveerrvviieeww
CCrraaddllee
The cradle facilitates communication between the tablet and the reader. Additionally, the cradle
provides battery backup power to the system when disconnected from electrical power.
CCrraaddllee MMoouunnttiinngg OOppttiioonnss::
• SurgiCount+ Stand (recommended)
• SurgiCount+ Wall Mount (alternative)
• SurgiCount+ Pole Mount (alternative)
B
A
C
FFiigguurree 11 –– CCrraaddllee ((FFrroonntt VViieeww))
D
F
E
FFiigguurree 22 –– CCrraaddllee ((RReeaarr VViieeww))
AA Tablet Dock DD Tilt Adjustment
BB Insertion/Removal Tab EE Power Cord Receptacle
CC Reader Dock FF Vent Holes
700001138880 Rev-AC 7 EN

RReeaaddeerr
The reader is a handheld battery powered device that provides UHF RFID and barcode
functionality.
B
C
D
A
F
E
FFiigguurree 33 –– RReeaaddeerr ((FFrroonntt VViieeww))
J
I
G
H
FFiigguurree 44 –– RReeaaddeerr ((RReeaarr VViieeww))
AA Battery Cover FF USB Port (manufacturer use only)
BB Battery Cover Release Buttons GG Charging Connection
CC Barcode Scanner HH Operation Indicator
DD UHF RFID Antenna II Handle
EE Trigger JJ Speaker
EN 8 700001138880 Rev-AC

SSttaanndd ((RReeccoommmmeennddeedd CCrraaddllee MMoouunnttiinngg OOppttiioonn))
NNoottee -- The stand is the recommended cradle mounting option for the SurgiCount®+ System.
C
D
B
A
E
F
H
I
G
J
FFiigguurree 55 –– SSttaanndd ((FFrroonntt VViieeww))
AA Handle FF Arm (hinged)
BB Cradle Mounting Location GG Power Cord Hook (quick release)
CC Storage Tray (sponge bags) HH Power Cord
DD Arm Hooks II Stabilizing Base
EE Storage Tray (reader covers) JJ
Swivel Casters (x3)
Locking Casters (x2)
700001138880 Rev-AC 9 EN

AAlltteerrnnaattiivvee CCrraaddllee MMoouunnttiinngg OOppttiioonnss
FFiigguurree 66 –– WWaallll MMoouunntt FFiigguurree 77 –– PPoollee MMoouunntt
EN 10 700001138880 Rev-AC

GGeettttiinngg SSttaarrtteedd
BBeeffoorree UUssee
1. Remove all the components from packaging material.
2. Inspect equipment for damage, see
Inspection and Maintenance (page 19).
WWAARRNNIINNGG -- When installing the cradle to a mounting option, always follow the installation
guide provided with the equipment. Failure to comply may result in healthcare staff injury.
3. [Facility Maintenance Staff] – Refer to the applicable installation guide and complete the cradle
installation, see
Documentation (page 3).
4. Clean and disinfect the equipment before first use, see
Cleaning and Disinfection (page 18).
5. Verify the power cord is connected to an electrical power receptacle.
6. Verify the tablet is ready for use. Refer to the tablet instructions for use as needed, see
Documentation (page 3).
7. Dock the tablet, see
Interacting with the Cradle (page 12).
8.
Remove the Reader Battery Cover (page 14).
9.
Install the Reader Battery (page 15).
10.
Install the Reader Battery Cover (page 15).
11.
Dock the Reader (page 13).
12.[Stand Configuration] – Load a carton of sponge bags and reader covers (disposables) into the
stand storage trays, see
Interacting with the Stand (page 17).
700001138880 Rev-AC 11 EN

UUssiinngg YYoouurr PPrroodduucctt
CChhaarrggiinngg tthhee SSyysstteemm
CCAAUUTTIIOONN -- Do not use the USB port to charge the reader. Failure to comply may result in
damage to the device.
NNoottee
• When connected to electrical power, the system will take approximately five (5) hours to fully
charge. It is recommended to fully charge the system before each use.
• When disconnected from electrical power, a fully charged system will provide approximately
ten (10) hours of use.
• System component charging status and battery life can be viewed within the Surgical Tablet
software application user interface. For additional information, refer to the instructions for use
for the applicable Surgical Tablet software application.
1. Verify the power cord is connected to an electrical power receptacle.
2. Dock the tablet, see
Interacting with the Cradle (page 12).
3.
Dock the Reader (page 13).
4. Verify the charging status and battery life of the system components.
IInntteerraaccttiinngg wwiitthh tthhee CCrraaddllee
FFiigguurree 88 –– DDoocckkiinngg//UUnnddoocckkiinngg tthhee TTaabblleett FFiigguurree 99 –– AAddjjuussttiinngg tthhee TTiilltt PPoossiittiioonn
EN 12 700001138880 Rev-AC

RReeaaddeerr IInnssttrruuccttiioonnss
• Docking and Undocking the Reader (page 13).
•
Replacing the Reader Battery (page 14).
•
Preparing the Reader for Sterile Use (page 16).
DDoocckkiinngg aanndd UUnnddoocckkiinngg tthhee RReeaaddeerr
DDoocckk tthhee RReeaaddeerr
1. Rotate the reader and grasp the front of the device.
2. Insert the reader into the cradle (Figure 10).
UUnnddoocckk tthhee RReeaaddeerr
1. Grasp the front of the reader.
2. Pull the reader out of the cradle (Figure 10).
3. Rotate the reader and grasp the handle of the device.
FFiigguurree 1100 –– DDoocckkiinngg//UUnnddoocckkiinngg tthhee RReeaaddeerr
700001138880 Rev-AC 13 EN

RReeppllaacciinngg tthhee RReeaaddeerr BBaatttteerryy
1. Remove the Reader Battery Cover (page 14).
2.
Remove the Reader Battery (page 15).
3.
Install the Reader Battery (page 15).
4.
Install the Reader Battery Cover (page 15).
RReemmoovvee tthhee RReeaaddeerr BBaatttteerryy CCoovveerr
1. Press and hold the battery cover release buttons (Figure 11).
2. Slide the cover back and remove (Figure 12).
FFiigguurree 1111 –– PPrreessss aanndd HHoolldd RReelleeaassee
BBuuttttoonnss FFiigguurree 1122 –– RReemmoovvee tthhee BBaatttteerryy CCoovveerr
EN 14 700001138880 Rev-AC

RReemmoovvee tthhee RReeaaddeerr BBaatttteerryy
1. Press in on the battery (Figure 13).
2. Remove the battery (Figure 14).
FFiigguurree 1133 –– PPrreessss iinn oonn tthhee BBaatttteerryy FFiigguurree 1144 –– RReemmoovvee tthhee BBaatttteerryy
IInnssttaallll tthhee RReeaaddeerr BBaatttteerryy
1. Align and insert the battery tabs into the slots in the battery compartment (Figure 15).
2. Press down on the battery (Figure 16).
FFiigguurree 1155 –– AAlliiggnn aanndd IInnsseerrtt tthhee BBaatttteerryy FFiigguurree 1166 –– PPrreessss DDoowwnn oonn tthhee BBaatttteerryy
IInnssttaallll tthhee RReeaaddeerr BBaatttteerryy CCoovveerr
1. Align the battery cover over the battery.
2. Slide the battery cover forward until it locks into place.
700001138880 Rev-AC 15 EN

PPrreeppaarriinngg tthhee RReeaaddeerr ffoorr SStteerriillee UUssee
1. [Circulating Nurse] – Open the reader cover sterile packaging.
2. [Circulating Nurse] – Aseptically transfer the reader cover to the sterile field.
3. [Scrub Technician] – Unfold the closed end of reader cover.
4. [Scrub Technician] – Place hands inside the reader cover cuff to create an opening.
5. [Circulating Nurse] – Aseptically transfer the reader into the opening of reader cover.
6. [Scrub Technician] – After the reader is placed inside of the reader cover, move hands to each
end of the closure slide and allow the reader cover to fully extend.
7. [Scrub Technician] – Move the slider across to seal the reader cover.
FFiigguurree 1177 –– AAsseeppttiicc TTrraannssffeerr
EN 16 700001138880 Rev-AC

IInntteerraaccttiinngg wwiitthh tthhee SSttaanndd
WWAARRNNIINNGG -- Always remove used sponge bags and fold the arms inward prior to transporting or
positioning the stand on inclined surfaces.
FFiigguurree 1188 –– UUnnffoollddiinngg tthhee
AArrmmss
FFiigguurree 1199 –– HHaannggiinngg
SSppoonnggee BBaaggss
FFiigguurree 2200 –– LLooaaddiinngg
DDiissppoossaabblleess
CCAAUUTTIIOONN
• Always ensure the power cord is properly wrapped prior to transporting.
• Always lock the casters when the stand is stationary, and unlock prior to transporting.
FFiigguurree 2211 –– LLoocckkiinngg tthhee
CCaasstteerrss
FFiigguurree 2222 –– UUnnlloocckkiinngg tthhee
CCaasstteerrss
FFiigguurree 2233 –– WWrraappppiinngg tthhee
PPoowweerr CCoorrdd
700001138880 Rev-AC 17 EN

AAfftteerr UUssee
CClleeaanniinngg aanndd DDiissiinnffeeccttiioonn
WWAARRNNIINNGG
• Always clean and disinfect the equipment as indicated upon initial receipt and before each use.
Failure to comply may cause infection and result in patient or healthcare staff injury.
• Always consult the instructions for use that accompanies accessories for product specific
cleaning requirements.
CCAAUUTTIIOONN
• Do not immerse the equipment in liquid.
• Do not allow liquids or moisture to enter any electrical connection.
• Do not sterilize the equipment.
• Do not use solvents, lubricants, or other chemicals, including glutaraldehyde or similar
chemical cleaners, unless otherwise specified.
• Use of unapproved disinfectants may cause damage to equipment.
• Do not clean the reader when the battery cover is removed.
Failure to comply may cause damage to the equipment or degrade performance.
RReeccoommmmeennddeedd MMaatteerriiaallss
PPE as recommended by the disinfectant manufacturer
Soft, lint-free cloth
United States Environmental Protection Agency (US EPA) registered disinfectant with a claim
for activity against Hepatitis B. The following disinfectants have been validated for use on the
exterior surfaces of the equipment:
• Quaternary Ammonium Based – CaviCide (EPA #: 46781-6)
• Clorox Healthcare® Bleach Germicidal Wipes (EPA Reg. # 67619-12)
1. Wipe all external surfaces of the equipment with a soft, lint-free cloth moistened with a non-
abrasive, hospital disinfectant prepared according to the manufacturer’s instructions. Clean
surfaces until all visible soil is removed.
2. After removing all visible gross soil, use a clean cloth moistened with disinfectant and wipe all
surfaces. Make sure all surfaces remain visibly wet at room temperature for at least the
minimum time specified in the instructions supplied by the disinfectant manufacturer.
3. Remove any excess disinfectant solution using a soft, lint-free cloth moistened with water if
required by the instructions supplied by the disinfectant manufacturer.
CCAAUUTTIIOONN
• Do not use an aerosol spray directly on the reader barcode scanner window. Failure to
comply may result in damage to the device.
• Do not let liquid pool around the reader barcode scanner window. Failure to comply may
result in degraded performance.
4. Apply glass cleaner to a soft, lint-free cloth and clean the reader barcode scanner window.
EN 18 700001138880 Rev-AC